Cadence Pharmaceuticals, Inc.
As filed with the Securities and Exchange Commission on
July 17, 2006
Registration
No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
Under
The Securities Act of 1933
CADENCE PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware |
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2834 |
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41-2142317 |
(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification Number) |
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
(858) 436-1400
(Address, including zip code, and telephone number, including
area code, of Registrants principal executive offices)
Theodore R. Schroeder
President and Chief Executive Officer
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
(858) 436-1400
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
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Faye H. Russell, Esq.
Cheston J. Larson, Esq.
Ali D. Fawaz, Esq.
Latham & Watkins LLP
12636 High Bluff Drive, Suite 400
San Diego, CA 92130
(858) 523-5400 |
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Mark B. Weeks, Esq.
Ross L. Burningham, Esq.
Ryan A. Murr, Esq.
Heller Ehrman LLP
4350 La Jolla Village Drive, 7th Floor
San Diego, CA 92122
(858) 450-8400 |
Approximate date of commencement of proposed sale to the
public: As soon as practicable after the effective date of
this Registration Statement.
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933, check the
following
box. o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
please check the following box and list the Securities Act
registration statement number of the earlier effective
registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Title of Each Class |
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Aggregate Offering |
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Amount of |
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of Securities to be Registered |
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Price(1)(2) |
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Registration Fee |
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Common Stock, $0.0001 par value
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$86,250,000 |
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$9,229 |
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(1) |
Estimated solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457(o) under the
Securities Act of 1933, as amended. |
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(2) |
Includes offering price of shares that the underwriters have the
option to purchase to cover over-allotments, if any. |
The Registrant hereby amends this Registration Statement on
such date or dates as may be necessary to delay its effective
date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the Registration
Statement shall become effective on such date as the Commission,
acting pursuant to said Section 8(a), may determine.
The information
contained in this prospectus is not complete and may be changed.
We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these
securities and we are not soliciting offers to buy these
securities in any jurisdiction where the offer or sale is not
permitted.
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Subject to Completion
Preliminary Prospectus dated
July 17, 2006
P R O S P E C T U S
Shares
Common Stock
This is our initial public offering. We are
offering shares
of common stock.
We expect the initial public offering price to be between
$ and
$ per
share. Currently, no public market exists for our common stock.
After pricing of the offering, we expect that our common stock
will be quoted on the Nasdaq Global Market under the symbol
CADX.
Investing in our common stock involves risks that are
described in the Risk Factors section beginning on
page 8 of this prospectus.
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Per Share | |
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Total | |
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Public offering price
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$ |
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$ |
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Underwriting discount
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$ |
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$ |
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Proceeds, before expenses, to us
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$ |
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$ |
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The underwriters may also purchase up to an
additional shares
of common stock from us at the public offering price, less the
underwriting discount, within 30 days from the date of this
prospectus to cover overallotments.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The shares of common stock will be ready for delivery on or
about ,
2006.
Merrill Lynch & Co.
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Pacific Growth Equities, LLC |
The date of this prospectus
is ,
2006.
TABLE OF CONTENTS
You should rely only on the information contained in this
prospectus. We have not, and the underwriters have not,
authorized anyone to provide you with information different from
or in addition to that contained in this prospectus. If anyone
provides you with different or inconsistent information, you
should not rely on it. We are offering to sell, and seeking
offers to buy, shares of our common stock only in jurisdictions
where offers and sales are permitted. The information contained
in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this
prospectus or of any sale of our common stock. Our business,
financial condition, results of operations and prospects may
have changed since that date.
For investors outside the United States: Neither we nor any of
the underwriters have done anything that would permit this
offering or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other
than in the United States. You are required to inform yourselves
about and to observe any restrictions relating to this offering
and the distribution of this prospectus.
PROSPECTUS SUMMARY
This summary does not contain all of the information you
should consider before buying shares of our common stock. You
should read the entire prospectus carefully, especially the
Risk Factors section and our financial statements
and the related notes appearing at the end of this prospectus,
before deciding to invest in shares of our common stock. Unless
the context requires otherwise, references in this prospectus to
Cadence, we, us and
our refer to Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals, Inc.
Our Company
We are a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates
principally for use in the hospital setting. Since our inception
in 2004, we have in-licensed rights to two Phase III
product candidates, both of which have been studied in prior
Phase III clinical trials conducted by our licensors. We
have in-licensed the exclusive U.S. and Canadian rights
to IV APAP, an intravenous formulation of acetaminophen
that is currently marketed in Europe for the treatment of acute
pain and fever by Bristol-Myers Squibb Company, or BMS. We
believe that IV APAP is the only stable,
pharmaceutically-acceptable intravenous formulation of
acetaminophen. We have also in-licensed the exclusive North
American and European rights to omiganan pentahydrochloride 1%
aqueous gel, or omiganan, for the prevention and treatment of
device-related, surgical wound-related and burn-related
infections. We believe that the hospital setting is a
concentrated, underserved market for pharmaceuticals and
anticipate building our own, hospital-focused sales force as our
product candidates approach potential U.S. Food and Drug
Administration, or FDA, approval. We intend to build a leading
franchise in the hospital setting, continuing to focus on
products that are in late-stages of development, currently
commercialized outside the United States, or approved in the
United States but with significant commercial potential for
proprietary new uses or formulations.
The Hospital Market
Large, multinational pharmaceutical companies have generally
decreased marketing efforts focused on hospital-use drugs,
instead focusing on drugs that can be marketed in the larger
outpatient setting. We believe this reduced emphasis on the
hospital marketplace presents us with an excellent opportunity
to in-license, acquire, develop and commercialize products that
address unmet medical needs in the hospital setting. We believe
the concentrated nature of the hospital marketplace will allow
for our expansion into other therapeutic areas without
substantial investment in additional commercial infrastructure.
According to data from IMS Health Inc., or IMS, an independent
marketing research firm, approximately $28 billion was
spent on promotional activities by the pharmaceutical industry
in 2004. Of this amount, IMS estimates that only $1 billion
was directed towards hospital-based physicians and directors of
pharmacies. In contrast, U.S. hospitals and clinics
accounted for approximately $54 billion or 21% of
U.S. pharmaceutical sales in 2005, according to IMS.
Furthermore, we believe pharmaceutical sales to acute care
hospitals are highly concentrated among a relatively small
number of large institutions. For example, according to Wolters
Kluwer Health, an independent marketing research firm, only
2,000 of the approximately 5,000 acute care hospitals in the
United States represent more than 80% of injectable analgesic
sales. We believe the relative lack of promotional efforts
directed toward the highly concentrated hospital marketplace
makes it an underserved and compelling opportunity, especially
for a biopharmaceutical company commercializing its products
directly through its own dedicated sales force.
Our Product Candidates
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IV APAP for the Treatment of Acute Pain |
We are developing IV APAP in the U.S. market for the
treatment of acute pain. According to IMS, over 500 million
units of injectable analgesics, typically used to treat acute
pain, were sold in the United States in 2005. Opioids represent
the majority of unit volume in the market but are associated with
1
a variety of unwanted side effects including sedation, nausea,
vomiting, constipation, cognitive impairment and respiratory
depression. Ketorolac, a non-steroidal anti-inflammatory drug,
or NSAID, is the only
non-opioid injectable
analgesic available in the United States for the treatment of
acute pain. However, ketorolac carries strong warnings from the
FDA for various side effects, including an increased risk of
bleeding a particularly troubling side-effect in the
surgical setting.
Acetaminophen was first available for sale in the United States
in 1955 when it was introduced under the brand name Tylenol.
Acetaminophen is the most widely used drug for pain relief and
the reduction of fever in the United States and is currently
available in over 600 pharmaceutical products. Historically,
poor stability in aqueous solutions and inadequate solubility of
acetaminophen prevented the development of an intravenous dosage
form. The patent protection for IV APAP extends through
various dates in 2017 to 2021.
IV APAP has previously been studied in six completed
Phase III trials and is currently marketed in Europe by
BMS. Since its introduction in Europe in mid-2002, over
100 million doses of IV APAP have been administered to
patients, and it has become the market share leader among
injectable analgesics, with 2005 sales of more than
$140 million according to IMS. In the fourth quarter of
2006, we expect to initiate the remaining Phase III
clinical trial requirements. We expect these Phase III
clinical trial results to be available in the first half of 2008
and, if positive, to subsequently submit a new drug application,
or NDA, for IV APAP in the second half of 2008.
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Omiganan for the Prevention of Intravascular
Catheter-Related Infections |
We are currently developing omiganan for the prevention of
intravascular catheter-related infections. According to the
February 2004 Catheter: Global Markets &
Technologies report from Theta Reports, eight million
central venous catheters, or CVCs, were sold in the United
States in 2003, and unit sales are projected to grow to
11 million by 2007. Although CVCs have become an important
part of medical care, they can give rise to dangerous and costly
complications, including: local catheter site infections, or
LCSIs, which are infections at the catheter insertion site;
catheter colonization, which is the growth of microorganisms on
the portion of the catheter below the skin surface; and
catheter-related bloodstream infections, or CRBSIs, which are
infections in the bloodstream caused by microorganisms
associated with the catheter. The Centers for Disease Control
and Prevention estimates that there are 250,000 CRBSIs each year
in the United States. The attributable mortality rate of CRBSIs
is approximately 12% to 25% with an average marginal cost to the
healthcare system of $25,000 per infection. Currently,
topical antiseptics are the primary agent used to cleanse the
skin surface around the catheter insertion site prior to
insertion. However, the utility of these antiseptics is limited,
principally due to their short duration of antimicrobial
activity.
Omiganan is a topical antimicrobial that has been demonstrated
to be rapidly bactericidal and fungicidal with prolonged
duration of activity against microorganisms commonly found on
the skin surface, including multi-drug resistant microorganisms
such as methicillin-resistant staphylococcus aureus, or
MRSA. Importantly, resistance to omiganan has not been induced
in the laboratory after extensive study, nor has omiganan
demonstrated potential to induce cross-resistance to other
antimicrobial therapeutics. We have in-licensed the patents and
the exclusive development and commercialization rights to
omiganan in North America and Europe for the prevention of
device-related, surgical wound-related and burn-related
infections from Migenix Inc. The patent protection for omiganan
extends through various dates in 2017 to 2022.
Omiganan has previously been studied in a large, completed
Phase III trial that demonstrated statistically significant
outcomes for the reduction of LCSI and catheter colonization.
The presence of an LCSI may result in replacement of the
catheter and/or administration of antibiotics, both of which
create additional costs to hospitals and have the potential for
adverse safety outcomes. In addition, catheter colonization is
well correlated with CRBSIs, according to a published review of
clinical trials. We reached agreement with the FDA through the
special protocol assessment, or SPA, process on the trial
design, endpoints and statistical analysis plan for a single
confirmatory Phase III clinical trial with a primary
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endpoint of prevention of LCSIs. We initiated this
Phase III clinical trial in August 2005 and expect the
results to be available in the second half of 2007 and, if
positive, to subsequently submit an NDA for omiganan in the
first half of 2008.
Our Strategy
Our goal is to be a leading biopharmaceutical company focused on
the development and commercialization of proprietary
pharmaceuticals principally for use in the hospital setting.
Specifically, we intend to:
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Obtain regulatory approval for our Phase III hospital
product candidates. We have designed our Phase III
clinical programs in an effort to reduce clinical development
risk, facilitate regulatory approval and optimize marketing
claims. To that end, we plan to resume a
U.S. Phase III program later this year for IV
APAP previously initiated by BMS, and we expect to submit an NDA
in the second half of 2008 based on the previously completed
trials and any further trials that may be required by the FDA.
In addition, we have reached a written agreement with the FDA
through the SPA process for a single confirmatory Phase III
study of omiganan for the prevention of LCSIs. |
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Build a highly leverageable sales organization targeting
hospitals. We intend to build a commercial organization
focused on promoting our products principally to hospitals in
the United States. We believe that both IV APAP and
omiganan can be effectively promoted by our own sales force
targeting key hospitals in the United States. Importantly, we
believe the number of institutions in the hospital marketplace
is relatively limited and a small number of these institutions
account for a substantial portion of the prescribing activity.
The concentrated nature of this market creates the opportunity
for significant marketing synergies as we intend to leverage our
sales force across multiple therapeutic categories in the
hospital. Outside the United States, we intend to establish
strategic partnerships for the commercialization of our products
where we have commercialization rights. |
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Expand our product portfolio through acquiring or
in-licensing additional late-stage, hospital-focused products
with well-understood risk profiles. We will seek additional
opportunities to acquire or in-license products to more fully
exploit our clinical, regulatory, manufacturing, sales and
marketing capabilities. We believe that our focus on the
hospital market enables us to evaluate a broader range of
products across multiple therapeutic areas for possible
acquisition. We focus on products that are in late-stages of
development, currently commercialized outside the United States,
or approved in the United States but with significant commercial
potential for proprietary new uses, including new indications,
dosage forms or delivery systems. |
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Pursue additional indications and commercial opportunities
for our product candidates. We will seek to maximize the
value of IV APAP, omiganan and any other product candidates
we may in-license, acquire or develop by pursuing other
indications and commercial opportunities for such candidates.
For example, we have rights to develop and commercialize
omiganan for additional indications related to the prevention
and treatment of device-related, surgical wound-related and
burn-related infections. |
Risk Factors
We are a development stage company with no revenues, and our
operations to date have generated substantial and increasing
needs for cash. Our business and our ability to execute on our
business strategy are subject to a number of risks that you
should be aware of before you decide to buy our common stock.
3
In particular, you should consider the following risks, which
are discussed more fully in Risk Factors beginning
on page 8:
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we are largely dependent on the success of our only two product
candidates, IV APAP and omiganan, and we cannot be certain that
either product candidate will receive regulatory approval or be
successfully commercialized; |
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delays in the commencement, enrollment or completion of clinical
testing for either of our product candidates could result in
increased costs to us and delay or limit our ability to obtain
regulatory approval; |
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even if our product candidates are approved by regulatory
authorities, we expect intense competition in the hospital
marketplace for our targeted indications; |
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competitors may seek to develop and market products targeted for
the same indications as our product candidates but having
formulations that are outside the scope of our patent rights; and |
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we will require substantial additional funding and may be unable
to raise capital when needed, which would force us to delay,
reduce or eliminate our development programs and
commercialization efforts. |
Corporate Information
We were incorporated in Delaware on May 26, 2004. Our
principal executive offices are located at 12730 High Bluff
Drive, Suite 410, San Diego, California 92130, and our
telephone number is
(858) 436-1400.
Prior to November 2004, we were named Strata Pharmaceuticals,
Inc. Our website address is http://www.cadencepharm.com. The
information on, or accessible through, our website is not part
of this prospectus.
The U.S. Patent and Trademark Office has issued a Notice of
Allowance in connection with our
intent-to-use trademark
application for the mark
CADENCEtm,
covering pharmaceutical preparations for the treatment or
prevention of diseases or infections of the bodys major
organs, including the heart, lungs, liver and kidneys;
pharmaceutical preparations for the treatment or prevention of
diseases of the bodys systems, including the immune system
and the cardiovascular system; and pharmaceutical preparations
to treat or manage pain, anesthesia, surgical and medical
procedures. This prospectus also contains trademarks of others,
including
Bactroban®,
Betadine®,
BioPatch®,
DepoDur®,
Dermagraft®,
Habitrol®,
Lotensin®,
Neosporin®,
Perfalgan®,
Pro-Dafalgan®,
Toradol®
and
Tylenol®.
4
THE OFFERING
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Common stock offered |
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shares |
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Common stock to be outstanding after this offering |
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shares |
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Use of proceeds |
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We expect to use the net proceeds from this offering to fund
clinical trials and other research and development activities,
and to fund working capital, capital expenditures and other
general corporate purposes. We may also use a portion of the net
proceeds to in-license, acquire or invest in complementary
businesses or products. |
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Risk factors |
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See Risk Factors and other information included in
this prospectus for a discussion of factors you should carefully
consider before deciding to invest in shares of our common stock. |
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Proposed Nasdaq Global Market symbol |
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CADX |
The number of shares of common stock to be outstanding after
this offering is based on 87,400,455 shares outstanding as
of March 31, 2006, and excludes:
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1,017,000 shares of common stock issuable upon the exercise
of options outstanding as of March 31, 2006 at a weighted
average exercise price of $0.10 per share; |
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385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of March 31, 2006 at a weighted
average exercise price of $1.00 per share; |
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shares
of common stock reserved for future issuance under our 2006
equity incentive award plan, which will become effective on the
day prior to the day on which we become subject to the reporting
requirements of the Securities Exchange Act of 1934, as amended,
or the Exchange Act (including 5,713,000 shares of common
stock reserved for future grant or issuance under our 2004
equity incentive award plan, which shares will be added to the
shares to be reserved under our 2006 equity incentive award plan
upon the effectiveness of the 2006 equity incentive award plan);
and |
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shares
of common stock reserved for issuance under our 2006 employee
stock purchase plan. |
Except as otherwise indicated, all information in this
prospectus assumes:
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no exercise by the underwriters of their option to purchase up
to an
additional shares
of common stock to cover over-allotments; |
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the filing of our amended and restated certificate of
incorporation and amended and restated bylaws upon completion of
this offering; |
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the conversion of all outstanding shares of our preferred stock
into 79,630,455 shares of common stock upon completion of
this offering; and |
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a
one-for- reverse
stock split of our common stock to be effected before the
completion of this offering. |
5
SUMMARY FINANCIAL DATA
The following table summarizes certain of our financial data.
The summary financial data are derived from our audited
financial statements for the period from May 26, 2004
(inception) through December 31, 2004, and the year
ended December 31, 2005. Data are also derived from our
unaudited financial statements for the three-month periods ended
March 31, 2005 and 2006, and for the period from
May 26, 2004 (inception) through March 31, 2006.
The data should be read together with our financial statements
and related notes, Selected Financial Data, and
Managements Discussion and Analysis of Financial
Condition and Results of Operations included elsewhere in
this prospectus. The pro forma as adjusted balance sheet data
gives effect to the conversion of all outstanding shares of our
preferred stock into 79,630,455 shares of our common stock
and our sale
of shares
of our common stock in this offering at the initial offering
price of
$ per
share, after deducting the estimated underwriting discounts and
commissions and estimated offering costs payable by us.
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Period from | |
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Period from | |
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May 26, 2004 | |
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May 26, 2004 | |
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(Inception) | |
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Three Months Ended | |
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(Inception) | |
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Through | |
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Year Ended | |
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March 31, | |
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Through | |
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December 31, | |
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December 31, | |
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March 31, | |
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2004 | |
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2005 | |
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2005 | |
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2006 | |
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2006 | |
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(In thousands, except per share amounts) | |
Statement of Operations Data:
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Operating expenses:
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Research and development
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$ |
2,233 |
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$ |
6,126 |
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$ |
577 |
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$ |
27,835 |
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$ |
36,195 |
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Marketing
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41 |
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240 |
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130 |
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96 |
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377 |
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General and administrative
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877 |
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1,412 |
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263 |
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537 |
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2,826 |
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Total operating expenses
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3,151 |
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7,778 |
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970 |
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28,468 |
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39,398 |
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Loss from operations
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(3,151 |
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(7,778 |
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(970 |
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(28,468 |
) |
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(39,398 |
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Other income (expense):
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Interest income
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9 |
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255 |
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7 |
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144 |
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409 |
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Interest expense
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(17 |
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(17 |
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Total other income
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9 |
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255 |
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7 |
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127 |
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392 |
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Net loss
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$ |
(3,142 |
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$ |
(7,523 |
) |
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$ |
(963 |
) |
|
$ |
(28,341 |
) |
|
$ |
(39,006 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share(1)
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.21 |
) |
|
$ |
(5.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share(1)
|
|
|
3,658 |
|
|
|
4,624 |
|
|
|
4,519 |
|
|
|
4,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share(1)
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share(1)
|
|
|
|
|
|
|
20,649 |
|
|
|
|
|
|
|
32,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
See Note 1 of Notes to Financial Statements for an
explanation of the method used to compute the historical and pro
forma net loss per share and the number of shares used in the
computation of the per share amounts. |
6
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2006 | |
|
|
| |
|
|
|
|
Pro Forma | |
|
|
Actual | |
|
As Adjusted(1) | |
|
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data(2):
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
40,617 |
|
|
$ |
|
|
Working capital
|
|
|
39,994 |
|
|
|
|
|
Total assets
|
|
|
41,822 |
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(39,006 |
) |
|
|
|
|
Total stockholders equity
|
|
|
40,574 |
|
|
|
|
|
|
|
(1) |
Each $1.00 increase or decrease in the assumed initial public
offering price of
$ would
increase or decrease, respectively, the amount of cash and cash
equivalents, working capital, total assets and total
stockholders equity by
$ ,
assuming the number of shares offered by us, as set forth on the
cover page of this prospectus, remains the same and after
deducting the estimated underwriting discounts and commissions
and estimated offering costs payable by us. |
|
(2) |
Does not reflect $7.0 million of indebtedness incurred in
June 2006 under our loan and security agreement with Silicon
Valley Bank and Oxford Finance Corporation. |
7
RISK FACTORS
Investing in our common stock involves a high degree of risk.
You should carefully consider the following risk factors, as
well as the other information in this prospectus, before
deciding whether to invest in shares of our common stock. The
occurrence of any of the following risks could harm our
business, financial condition, results of operations or growth
prospects. In that case, the trading price of our common stock
could decline, and you may lose all or part of your
investment.
Risks Related to Our Business and Industry
We are largely dependent on the success of our two product
candidates, IV APAP and omiganan, and we cannot be certain that
either of these product candidates will receive regulatory
approval or be successfully commercialized.
We currently have no drug products for sale and we cannot
guarantee that we will ever have marketable drug products. The
research, testing, manufacturing, labeling, approval, selling,
marketing and distribution of drug products are subject to
extensive regulation by the U.S. Food and Drug
Administration, or FDA, and other regulatory authorities in the
United States and other countries, which regulations differ from
country to country. We are not permitted to market our product
candidates in the United States until we receive approval of a
new drug application, or NDA, from the FDA. We have not
submitted an NDA or received marketing approval for either of
our product candidates. Obtaining approval of an NDA is a
lengthy, expensive and uncertain process. We currently have only
two product candidates, and our business success currently
depends entirely on their successful development and
commercialization.
We have not developed either of our product candidates
independently. We recently in-licensed exclusive rights
to IV APAP, an intravenous formulation of acetaminophen
that is currently marketed in Europe for the treatment of acute
pain and fever by Bristol-Myers Squibb Company, or BMS. We
intend to initiate a Phase III clinical program for this
product candidate for the treatment of acute pain in the fourth
quarter of 2006 following a planned meeting with the FDA in the
third quarter of 2006. In July 2004, we in-licensed the rights
to our only other product candidate, omiganan pentahydrochloride
1% aqueous gel, or omiganan, which is currently being evaluated
in a single Phase III clinical trial for the prevention of
local catheter site infections, or LCSIs, and will require the
successful completion of this Phase III clinical trial
before we are able to submit an NDA to the FDA for approval. Our
clinical development programs for IV APAP and omiganan may
not lead to commercial products if we fail to demonstrate that
the product candidates are safe and effective in clinical trials
and we may therefore fail to obtain necessary approvals from the
FDA and similar foreign regulatory agencies, or because we may
have inadequate financial or other resources to advance these
product candidates through the clinical trial process. Any
failure to obtain approval of IV APAP or omiganan would
have a material and adverse impact on our business.
If clinical trials of our current or future product
candidates do not produce results necessary to support
regulatory approval in the United States or elsewhere, we will
be unable to commercialize these products.
To receive regulatory approval for the commercial sale
of IV APAP, omiganan or any other product candidates that
we may in-license or acquire, we must conduct, at our own
expense, adequate and well controlled clinical trials to
demonstrate efficacy and safety in humans. Clinical testing is
expensive, takes many years and has an uncertain outcome.
Clinical failure can occur at any stage of the testing. Our
clinical trials may produce negative or inconclusive results,
and we may decide, or regulators may require us, to conduct
additional clinical and/or non-clinical testing. For example,
Migenix Inc., or Migenix, the licensor for our omiganan product
candidate, together with its former collaborator, Fujisawa
Healthcare, Inc., or Fujisawa, completed enrollment in a
Phase III trial in February 2003 that demonstrated
statistically significant results for the prevention of
secondary endpoints of the trial: LCSIs and catheter
colonization, which is the growth of microorganisms on the
portion of the catheter below the skin surface.
8
However, the trial did not show statistical significance for the
prevention of the primary endpoint: catheter-related bloodstream
infections, or CRBSIs.
After the termination of the collaboration between Migenix and
Fujisawa in January 2004, we in-licensed the rights to omiganan
from Migenix in July 2004 and subsequently reached an agreement
under the special protocol assessment, or SPA, process with the
FDA concerning the protocol for our own Phase III clinical
trial for omiganan. In connection with the SPA for omiganan, the
FDA agreed that a single confirmatory Phase III trial will
be required for approval of omiganan and that the prevention of
LCSIs will be the sole primary efficacy endpoint. However, we
cannot be certain that our ongoing Phase III trial for
omiganan will demonstrate statistical significance or otherwise
demonstrate sufficient efficacy and safety to support the filing
of an NDA or ultimately lead to regulatory approval.
Furthermore, despite having completed the SPA process, the
FDAs agreement with us on the trial protocol remains
subject to future public health concerns unrecognized at the
time of the FDAs protocol assessment.
Our failure to adequately demonstrate the efficacy and safety
of IV APAP, omiganan or any other product candidates that
we may in-license or acquire would prevent receipt of regulatory
approval and, ultimately, the commercialization of that product
candidate.
Because the results of earlier clinical trials are not
necessarily predictive of future results, IV APAP, omiganan or
any other product candidate we advance into clinical trials may
not have favorable results in later clinical trials or receive
regulatory approval.
Success in clinical testing and early clinical trials does not
ensure that later clinical trials will generate adequate data to
demonstrate the efficacy and safety of the investigational drug.
A number of companies in the pharmaceutical industry, including
those with greater resources and experience, have suffered
significant setbacks in Phase III clinical trials, even
after promising results in earlier clinical trials.
In March 2006, we in-licensed the rights to IV APAP from
BMS, which is currently marketing IV APAP in Europe and
other parts of the world under the brand name Perfalgan. BMS has
completed nine clinical trials, mostly in Europe, primarily in
support of European regulatory approvals for this product
candidate. However, we do not know at this time what regulatory
weight, if any, the U.S. and Canadian regulatory agencies will
give to these clinical data in supplementing clinical data
generated by us for potential regulatory approval of IV
APAP in the United States and Canada. The FDA and foreign
regulatory agencies may reject these clinical trial results if
they determine that the clinical trials were not conducted in
accordance with requisite regulatory standards and procedures.
Furthermore, we have not audited or verified the accuracy of the
primary clinical data provided by BMS and cannot determine their
applicability to our regulatory filings. Even though BMS has
obtained marketing approval in Europe and other territories
for IV APAP, we must conduct additional adequate and well
controlled clinical trials in the United States to
demonstrate IV APAPs safety and efficacy in specific
indications to gain regulatory approval in the United States. We
may not be able to demonstrate the same safety and efficacy
for IV APAP in our planned Phase III clinical trial as
was demonstrated previously by BMS.
Our other product candidate, omiganan, is a novel antimicrobial
peptide and is not yet approved in any jurisdiction. No
antimicrobial peptide has been approved by the FDA, including
two antimicrobial peptides with mechanisms of action similar to
omiganan that were studied in Phase III clinical trials.
Although omiganan has been studied in more than
750 patients, all of the patients studied were enrolled in
trials conducted or sponsored by Migenix or Fujisawa. Since
in-licensing rights to omiganan from Migenix in July 2004, we
have initiated a Phase III clinical trial in which we are
still seeking to enroll the target patient population. We do not
expect to complete enrollment in this Phase III clinical
trial until the second half of 2007. Similar to IV APAP, we
have obtained electronic databases from the completed
Phase III trials sponsored by Migenix and Fujisawa, and are
currently analyzing these data. We have not audited or verified
the accuracy of the primary clinical data provided by our
licensor and its former collaborator and cannot determine their
applicability to our regulatory filings. Although the
Phase III clinical trial for omiganan conducted by Migenix
and Fujisawa demonstrated favorable, statistically significant
results for the prevention of LCSIs and catheter colonization,
secondary endpoints in their trial,
9
we may not observe similar results in our ongoing Phase III
clinical trial. Furthermore, the earlier Phase III clinical
trial failed to show statistical significance for the prevention
of the primary endpoint of that trial, the prevention of CRBSIs.
While we will measure the prevention of CRBSIs as a secondary
endpoint in our ongoing Phase III clinical trial for
omiganan, our trial is not designed to demonstrate statistical
significance for this secondary endpoint. Although we are
targeting a different primary endpoint in our trial, the
prevention of LCSIs, it is possible that we will experience
similar, unexpected results. Failure to satisfy a primary
endpoint in a Phase III clinical trial would generally mean
that a product candidate would not receive regulatory approval
without a further successful Phase III clinical trial.
The data collected from our clinical trials may not be adequate
to support regulatory approval of IV APAP, omiganan or any
other product candidates that we may in-license or acquire.
Moreover, all clinical data reported is taken from databases
that may not have been fully reconciled against medical records
kept at the clinical sites. Despite the results reported by
others in earlier clinical trials for our product candidates, we
do not know whether any Phase III or other clinical trials
we may conduct will demonstrate adequate efficacy and safety to
result in regulatory approval to market our product candidates.
Delays in the commencement or completion of clinical testing
could result in increased costs to us and delay or limit our
ability to obtain regulatory approval for our product
candidates.
Delays in the commencement or completion of clinical testing
could significantly affect our product development costs. We do
not know whether planned clinical trials for IV APAP will
begin on time or be completed on schedule, if at all. Similarly,
we may not complete enrollment for our ongoing Phase III
clinical trial for omiganan on schedule, or at all. The
commencement and completion of clinical trials requires us to
identify and maintain a sufficient number of trial sites, many
of which may already be engaged in other clinical trial programs
for the same indication as our product candidates or may not be
eligible to participate in or may be required to withdraw from a
clinical trial as a result of changing standards of care. For
example, the number of potential clinical trial sites for our
Phase III clinical trial for omiganan is limited as a
result of the increasing use of the topical antiseptic
chlorhexidine to sterilize the catheter insertion site, rather
than 10% povidone-iodine, the comparator product agreed to with
the FDA under the SPA process for use in our trial. The
commencement and completion of clinical trials can be delayed
for a variety of other reasons, including delays related to:
|
|
|
|
|
reaching agreements on acceptable terms with prospective
clinical research organizations, or CROs, and trial sites, the
terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and trial sites; |
|
|
|
obtaining regulatory approval to commence a clinical trial; |
|
|
|
obtaining institutional review board approval to conduct a
clinical trial at a prospective site; |
|
|
|
recruiting and enrolling patients to participate in clinical
trials for a variety of reasons, including competition from
other clinical trial programs for the same indication as our
product candidates; and |
|
|
|
retaining patients who have initiated a clinical trial but may
be prone to withdraw due to the treatment protocol, lack of
efficacy, personal issues, side effects from the therapy or who
are lost to further follow-up. |
In addition, a clinical trial may be suspended or terminated by
us, the FDA or other regulatory authorities due to a number of
factors, including:
|
|
|
|
|
failure to conduct the clinical trial in accordance with
regulatory requirements or our clinical protocols; |
|
|
|
inspection of the clinical trial operations or trial sites by
the FDA or other regulatory authorities resulting in the
imposition of a clinical hold; |
10
|
|
|
|
|
unforeseen safety issues or any determination that a trial
presents unacceptable health risks; or |
|
|
|
lack of adequate funding to continue the clinical trial,
including the incurrence of unforeseen costs due to enrollment
delays, requirements to conduct additional trials and studies
and increased expenses associated with the services of our CROs
and other third parties. |
Additionally, changes in regulatory requirements and guidance
may occur and we may need to amend clinical trial protocols to
reflect these changes. Amendments may require us to resubmit our
clinical trial protocols to institutional review boards for
reexamination, which may impact the costs, timing or successful
completion of a clinical trial. If we experience delays in the
completion of, or if we terminate, our clinical trials, the
commercial prospects for our product candidates will be harmed,
and our ability to generate product revenues will be delayed. In
addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also
ultimately lead to the denial of regulatory approval of a
product candidate. Even if we are able to ultimately
commercialize our product candidates, other therapies for the
same indications may have been introduced to the market and
established a competitive advantage.
We expect intense competition in the territories in which we
have rights to our product candidates, and new products may
emerge that provide different or better therapeutic alternatives
for our targeted indications.
The biotechnology and pharmaceutical industries are subject to
rapid and intense technological change. We face, and will
continue to face, competition in the development and marketing
of our product candidates from academic institutions, government
agencies, research institutions and biotechnology and
pharmaceutical companies. There can be no assurance that
developments by others will not render our product candidates
obsolete or noncompetitive. Furthermore, new developments,
including the development of other drug technologies and methods
of preventing the incidence of disease, occur in the
pharmaceutical industry at a rapid pace. These developments may
render our product candidates obsolete or noncompetitive.
We intend to develop IV APAP for the treatment of acute
pain in the hospital setting, which will compete with well
established injectable drugs for this and similar indications,
including opioids such as morphine, fentanyl, meperidine and
hydromorphone, each of which is available generically from
several manufacturers, as well as an extended release injectable
formulation of morphine, DepoDur, currently marketed by an
affiliate of Endo Pharmaceuticals Holdings Inc. Ketorolac, an
injectable non-steroidal anti-inflammatory drug, or NSAID, is
also available generically from several manufacturers and used
to treat acute pain. During the time that it will take us to
obtain regulatory approval for IV APAP, if at all, we
anticipate that several additional products may be developed for
the treatment of acute pain, including other injectable NSAIDs,
novel opioids, new formulations of currently available opioids,
long-acting local anesthetics and new chemical entities as well
as alternative delivery forms of various opioids and NSAIDs.
We are also developing our omiganan product candidate for the
prevention of intravascular catheter-related infections in the
hospital setting. If approved, omiganan will compete with well
established topical products that are currently used in practice
to prevent these infections as well as BioPatch, a device
marketed by Johnson & Johnson, which has been approved
for wound dressing and prevention of catheter-related
infections. Other competitive products may be under development.
In addition, competitors may seek to develop alternative
formulations of our product candidates that address our targeted
indications that do not directly infringe on our in-licensed
patent rights. For example, we are aware of several U.S. and
Canadian patents and patent applications covering various
potential injectable formulations of acetaminophen, including
intravenous formulations, as well as methods of making and using
these potential formulations. Furthermore, analogs of omiganan
have been developed by others that are not covered by patents
licensed to or owned by us. The commercial opportunity for our
product candidates could be significantly harmed if competitors
are able to develop alternative
11
formulations outside the scope of our in-licensed patents.
Compared to us, many of our potential competitors have
substantially greater:
|
|
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|
|
capital resources; |
|
|
|
development resources, including personnel and technology; |
|
|
|
clinical trial experience; |
|
|
|
regulatory experience; |
|
|
|
expertise in prosecution of intellectual property rights; and |
|
|
|
manufacturing, distribution and sales and marketing experience. |
As a result of these factors, our competitors may obtain
regulatory approval of their products more rapidly than we are
able to or may obtain patent protection or other intellectual
property rights that limit our ability to develop or
commercialize our product candidates. Our competitors may also
develop drugs that are more effective, useful and less costly
than ours and may also be more successful than us in
manufacturing and marketing their products. We also expect to
face similar competition in our efforts to identify appropriate
collaborators or partners to help develop or commercialize our
product candidates in markets outside the United States.
If any of our product candidates for which we receive
regulatory approval do not achieve broad market acceptance, the
revenues that we generate from their sales will be limited.
The commercial success of our product candidates for which we
obtain marketing approval from the FDA or other regulatory
authorities will depend upon the acceptance of these products by
the medical community and coverage and reimbursement of them by
third-party payors, including government payors. The degree of
market acceptance of any of our approved products will depend on
a number of factors, including:
|
|
|
|
|
limitations or warnings contained in a products
FDA-approved labeling, including potential limitations or
warnings for IV APAP that may be more restrictive than oral
formulations of acetaminophen; |
|
|
|
changes in the standard of care for the targeted indications for
either of our product candidates, including, in the case of
omiganan, the decreasing use of 10% povidone-iodine, the
comparator product in our ongoing Phase III clinical trial,
in favor of another topical antiseptic, chlorhexidine, which
change could reduce the marketing impact of any superiority
claims that we could make following FDA approval; |
|
|
|
limitations inherent in the approved indication for either of
our product candidates compared to more commonly-understood or
addressed conditions, including, in the case of omiganan, the
ability to promote omiganan to hospitals and physicians who may
be more focused on an indication specifically for the prevention
of CRBSIs compared to the prevention of LCSIs, the primary
endpoint in our ongoing Phase III clinical trial; and |
|
|
|
potential advantages over, and availability of, alternative
treatments, including, in the case of IV APAP, a number of
products already used to treat acute pain in the hospital
setting, and in the case of omiganan, a number of competitive
topical products as well as a device that has been approved for
wound dressing and prevention of catheter-related infections. |
Our ability to effectively promote and sell our product
candidates in the hospital marketplace will also depend on
pricing and cost effectiveness, including our ability to produce
a product at a competitive price and our ability to obtain
sufficient third-party coverage or reimbursement. Since many
hospitals are members of group purchasing organizations, which
leverage the purchasing power of a group of entities to obtain
discounts based on the collective buying power of the group, our
ability to attract customers in the hospital marketplace will
also depend on our ability to effectively promote our product
candidates to group
12
purchasing organizations. We will also need to demonstrate
acceptable evidence of safety and efficacy as well as relative
convenience and ease of administration. Market acceptance could
be further limited depending on the prevalence and severity of
any expected or unexpected adverse side effects associated with
our product candidates. If our product candidates are approved
but do not achieve an adequate level of acceptance by
physicians, health care payors and patients, we may not generate
sufficient revenue from these products, and we may not become or
remain profitable. In addition, our efforts to educate the
medical community and third-party payors on the benefits of our
product candidates may require significant resources and may
never be successful.
Even if our product candidates receive regulatory approval,
they may still face future development and regulatory
difficulties.
Even if U.S. regulatory approval is obtained, the FDA may
still impose significant restrictions on a products
indicated uses or marketing or impose ongoing requirements for
potentially costly post-approval studies. Any of these
restrictions or requirements could adversely affect our
potential product revenues. For example, the label ultimately
approved for IV APAP, omiganan or any other product
candidates that we may in-license or acquire, if any, may
include a restriction on the term of its use, or it may not
include one or more of our intended indications.
Our product candidates will also be subject to ongoing FDA
requirements for the labeling, packaging, storage, advertising,
promotion, record-keeping and submission of safety and other
post-market information on the drug. In addition, approved
products, manufacturers and manufacturers facilities are
subject to continual review and periodic inspections. If a
regulatory agency discovers previously unknown problems with a
product, such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is
manufactured, a regulatory agency may impose restrictions on
that product or us, including requiring withdrawal of the
product from the market. If our product candidates fail to
comply with applicable regulatory requirements, such as current
Good Manufacturing Practices, or cGMPs, a regulatory agency may:
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|
issue warning letters or untitled letters; |
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|
|
require us to enter into a consent decree, which can include
imposition of various fines, reimbursements for inspection
costs, required due dates for specific actions and penalties for
noncompliance; |
|
|
|
impose other civil or criminal penalties; |
|
|
|
suspend regulatory approval; |
|
|
|
suspend any ongoing clinical trials; |
|
|
|
refuse to approve pending applications or supplements to
approved applications filed by us; |
|
|
|
impose restrictions on operations, including costly new
manufacturing requirements; or |
|
|
|
seize or detain products or require a product recall. |
Even if our product candidates receive regulatory approval in
the United States, we may never receive approval or
commercialize our products outside of the United States.
Our rights to IV APAP are limited to the United States and
Canada, and our rights to omiganan are limited to North America
and Europe. In order to market any products outside of the
United States, we must establish and comply with numerous and
varying regulatory requirements of other countries regarding
safety and efficacy. Approval procedures vary among countries
and can involve additional product testing and additional
administrative review periods. The time required to obtain
approval in other countries might differ from that required to
obtain FDA approval. The regulatory approval process in other
countries may include all of the risks detailed above regarding
FDA approval in the United States as well as other risks.
Regulatory approval in one country does not ensure regulatory
approval in another, but a
13
failure or delay in obtaining regulatory approval in one country
may have a negative effect on the regulatory process in others.
Failure to obtain regulatory approval in other countries or any
delay or setback in obtaining such approval could have the same
adverse effects detailed above regarding FDA approval in the
United States. As described above, such effects include the
risks that our product candidates may not be approved for all
indications requested, which could limit the uses of our product
candidates and have an adverse effect on product sales and
potential royalties, and that such approval may be subject to
limitations on the indicated uses for which the product may be
marketed or require costly, post-marketing
follow-up studies.
We have never marketed a drug before, and if we are unable to
establish an effective sales and marketing infrastructure, we
will not be able to successfully commercialize our product
candidates.
In the United States, we plan to build our own sales force to
market our products directly to physicians, nurses, hospitals,
group purchasing organizations and third-party payors. We
currently do not have significant internal sales, distribution
and marketing capabilities. In order to commercialize any of our
product candidates, we must either acquire or internally develop
sales and marketing capabilities, or enter into collaborations
with partners to perform these services for us. The acquisition
or development of a hospital-focused sales and marketing
infrastructure for our domestic operations will require
substantial resources, will be expensive and time consuming and
could negatively impact our commercialization efforts, including
delay any product launch. Moreover, we may not be able to hire a
sales force that is sufficient in size or has adequate
expertise. If we are unable to establish our sales and marketing
capability or any other capabilities necessary to commercialize
any products we may develop, we will need to contract with third
parties to market and sell our products. If we are unable to
establish adequate sales and marketing capabilities, whether
independently or with third parties, we may not be able to
generate any product revenue, may generate increased expenses
and may never become profitable.
Our product candidates may have undesirable side effects that
could delay or prevent their regulatory approval or
commercialization.
Undesirable side effects caused by our product candidates could
interrupt, delay or halt clinical trials and could result in the
denial of regulatory approval by the FDA or other regulatory
authorities for any or all targeted indications, and in turn
prevent us from commercializing our product candidates and
generating revenues from their sale. When used outside the
current guidelines for administration, acetaminophen has the
potential to cause liver toxicity. While administration of
acetaminophen in intravenous form is not expected to result in
an increased risk of toxicity to the liver compared with an
equivalent dose of acetaminophen administered orally, we cannot
be certain that increased liver toxicity or other drug-related
side effects will not be observed in future clinical trials or
that the FDA will not require additional trials or impose more
severe labeling restrictions due to liver toxicity or other
concerns. In addition, while the drug-related adverse events
observed in clinical trials completed to date for omiganan have
all been related to the skin, including the catheter insertion
site, we cannot be certain that other drug-related side effects
will not be reported in clinical trials or thereafter.
If either of our product candidates receives marketing approval
and we or others later identify undesirable side effects caused
by the product:
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|
regulatory authorities may require the addition of labeling
statements, specific warnings or a contraindication; |
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|
|
regulatory authorities may withdraw their approval of the
product; |
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|
|
we may be required to change the way the product is
administered, conduct additional clinical trials or change the
labeling of the product; and |
|
|
|
our reputation may suffer. |
14
Any of these events could prevent us from achieving or
maintaining market acceptance of the affected product or could
substantially increase our commercialization costs and expenses,
which in turn could delay or prevent us from generating
significant revenues from its sale.
If the government or third-party payors fail to provide
coverage and adequate coverage and payment rates for our future
products, if any, or if hospitals choose to use therapies that
are less expensive, our revenue and prospects for profitability
will be limited.
In both domestic and foreign markets, our sales of any future
products will depend in part upon the availability of coverage
and reimbursement from third-party payors. Such third-party
payors include government health programs such as Medicare,
managed care providers, private health insurers and other
organizations. In particular, many U.S. hospitals receive a
fixed reimbursement amount per procedure for certain surgeries
and other treatment therapies they perform. Because this amount
may not be based on the actual expenses the hospital incurs,
hospitals may choose to use therapies which are less expensive
when compared to our product candidates. Accordingly, IV APAP,
omiganan or any other product candidates that we may in-license
or acquire, if approved, will face competition from other
therapies and drugs for these limited hospital financial
resources. We may need to conduct post-marketing studies in
order to demonstrate the cost-effectiveness of any future
products to the satisfaction of hospitals, other target
customers and their third-party payors. Such studies might
require us to commit a significant amount of management time and
financial and other resources. Our future products might not
ultimately be considered cost-effective. Adequate third-party
coverage and reimbursement might not be available to enable us
to maintain price levels sufficient to realize an appropriate
return on investment in product development.
Governments continue to propose and pass legislation designed to
reduce the cost of healthcare. In the United States, we expect
that there will continue to be federal and state proposals to
implement similar governmental controls. For example, in
December 2003, Congress enacted a limited prescription drug
benefit for Medicare beneficiaries in the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003. Under this
program, drug prices for certain prescription drugs are
negotiated by drug plans, with the goal to lower costs for
Medicare beneficiaries. In some foreign markets, the government
controls the pricing of prescription pharmaceuticals. In these
countries, pricing negotiated with governmental authorities can
take six to 12 months or longer after the receipt of
regulatory marketing approval for a product. Cost control
initiatives could decrease the price that we would receive for
any products in the future, which would limit our revenue and
profitability. Accordingly, legislation and regulations
affecting the pricing of pharmaceuticals might change before our
product candidates are approved for marketing. Adoption of such
legislation could further limit reimbursement for
pharmaceuticals.
If we breach any of the agreements under which we license
rights to our product candidates from others, we could lose the
ability to continue the development and commercialization of our
product candidates.
In March 2006, we entered into an exclusive license agreement
with BMS relating to our IV APAP product candidate for the
United States and Canada, and in July 2004, we entered into an
exclusive license agreement with Migenix relating to our
omiganan product candidate for North America and Europe. Because
we have in-licensed the rights to our two product candidates
from third parties, if there is any dispute between us and our
licensors regarding our rights under these license agreements,
our ability to develop and commercialize these product
candidates may be adversely affected. In addition, our license
for IV APAP is subject to the terms and conditions of a
license from SCR Pharmatop to BMS, under which BMS originally
licensed the intellectual property rights covering IV APAP.
If BMS materially breaches the terms or conditions of this
underlying license from SCR Pharmatop, and neither BMS nor we
adequately cure that breach, or BMS and SCR Pharmatop otherwise
become involved in a dispute, the breach by BMS or disputes with
SCR Pharmatop could result in a loss of, or other material
adverse impact on, our rights under our license agreement with
BMS. While we would expect to exercise all rights and remedies
available to us, including seeking to cure any such breach by
BMS, and otherwise
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seek to preserve our rights under the patents licensed by SCR
Pharmatop, we may not be able to do so in a timely manner, at an
acceptable cost or at all. Any uncured, material breach under
these license agreements could result in our loss of exclusive
rights to the related product candidate and may lead to a
complete termination of our product development efforts for the
related product candidate.
We rely on third parties to conduct our clinical trials,
including our planned Phase III clinical program
for IV APAP and our ongoing Phase III clinical trial
for omiganan. If these third parties do not successfully carry
out their contractual duties or meet expected deadlines, we may
not be able to obtain regulatory approval for or commercialize
our product candidates on our anticipated timeline or at all.
We intend to rely primarily on third-party CROs to oversee our
clinical trials for our IV APAP and omiganan product
candidates, and we depend on independent clinical investigators,
medical institutions and contract laboratories to conduct our
clinical trials. Although we rely on CROs to conduct our
clinical trials, we are responsible for ensuring that each of
our clinical trials is conducted in accordance with its
investigational plan and protocol. Moreover, the FDA requires us
to comply with regulations and standards, commonly referred to
as good clinical practices, or GCPs, for conducting, monitoring,
recording and reporting the results of clinical trials to ensure
that the data and results are scientifically credible and
accurate and that the trial subjects are adequately informed of
the potential risks of participating in clinical trials. Our
reliance on CROs does not relieve us of these responsibilities
and requirements. CROs and investigators are not our employees,
and we cannot control the amount or timing of resources that
they devote to our programs. If our CROs or independent
investigators fail to devote sufficient time and resources to
our drug development programs, or if their performance is
substandard, it will delay the approval of our FDA applications
and our introductions of new products. The CROs with which we
contract for execution of our clinical trials play a significant
role in the conduct of the trials and the subsequent collection
and analysis of data. Failure of the CROs to meet their
obligations could adversely affect clinical development of our
product candidates. Moreover, these independent investigators
and CROs may also have relationships with other commercial
entities, some of which may have competitive products under
development or currently marketed. If independent investigators
and CROs assist our competitors, it could harm our competitive
position. If any of these third parties do not successfully
carry out their contractual duties or obligations or meet
expected deadlines, or if the quality or accuracy of the
clinical data is compromised for any reason, our clinical trials
may be extended, delayed or terminated, and we may not be able
to obtain regulatory approval for IV APAP, omiganan or
future product candidates.
If the manufacturers upon whom we rely fail to produce our
product candidates in the volumes that we require on a timely
basis, or to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the
development and commercialization of, or be unable to meet
demand for, our products and may lose potential revenues.
We do not manufacture any of our product candidates, and we do
not currently plan to develop any capacity to do so. We do not
yet have agreements established regarding commercial supply of
either of our product candidates and may not be able to
establish or maintain commercial manufacturing arrangements on
commercially reasonable terms for IV APAP, omiganan or any
other product candidates that we may in-license or acquire. Any
problems or delays we experience in preparing for
commercial-scale manufacturing of a product candidate may result
in a delay in FDA approval of the product candidate or may
impair our ability to manufacture commercial quantities, which
would adversely affect our business. For example, our
manufacturers will need to produce specific batches of our
product candidates to demonstrate acceptable stability under
various conditions and for commercially viable lengths of time.
We and our contract manufacturers will need to demonstrate to
the FDA and other regulatory authorities this acceptable
stability data for our product candidates, as well as validate
methods and manufacturing processes, in order to receive
regulatory approval to commercialize IV APAP, omiganan or
any other product candidate. Furthermore, if our commercial
manufacturers fail to deliver the required commercial quantities
of bulk drug substance or finished product on a timely basis and
at commercially reasonable prices, we would likely be unable to
meet demand for our products and we would lose potential
revenues.
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We currently have what we believe are adequate clinical supplies
of our omiganan product candidate. We have contracted with BMS
to manufacture clinical supplies of IV APAP and are
currently negotiating with suppliers for the potential
commercial supply of the finished drug product for IV APAP.
We do not have any long-term commitments from our suppliers of
clinical trial material or guaranteed prices for our product
candidates or placebos. The manufacture of pharmaceutical
products requires significant expertise and capital investment,
including the development of advanced manufacturing techniques
and process controls. Manufacturers of pharmaceutical products
often encounter difficulties in production, particularly in
scaling up initial production. These problems include
difficulties with production costs and yields, quality control,
including stability of the product candidate and quality
assurance testing, shortages of qualified personnel, as well as
compliance with strictly enforced federal, state and foreign
regulations. Our manufacturers may not perform as agreed. If our
manufacturers were to encounter any of these difficulties, our
ability to provide product candidates to patients in our
clinical trials would be jeopardized.
In addition, all manufacturers of our product candidates must
comply with cGMP requirements enforced by the FDA through its
facilities inspection program. These requirements include
quality control, quality assurance and the maintenance of
records and documentation. Manufacturers of our product
candidates may be unable to comply with these cGMP requirements
and with other FDA, state and foreign regulatory requirements.
We have little control over our manufacturers compliance
with these regulations and standards. A failure to comply with
these requirements may result in fines and civil penalties,
suspension of production, suspension or delay in product
approval, product seizure or recall, or withdrawal of product
approval. If the safety of any quantities supplied is
compromised due to our manufacturers failure to adhere to
applicable laws or for other reasons, we may not be able to
obtain regulatory approval for or successfully commercialize our
product candidates.
Our future growth depends on our ability to identify and
acquire or in-license products and if we do not successfully
identify and acquire or in-license related product candidates or
integrate them into our operations, we may have limited growth
opportunities.
We in-licensed the rights to each of our two current product
candidates, IV APAP and omiganan, from third parties who
conducted the initial development of each product candidate. An
important part of our business strategy is to continue to
develop a pipeline of product candidates by acquiring or
in-licensing products, businesses or technologies that we
believe are a strategic fit with our focus on the hospital
marketplace. Future in-licenses or acquisitions, however, may
entail numerous operational and financial risks, including:
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exposure to unknown liabilities; |
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disruption of our business and diversion of our
managements time and attention to develop acquired
products or technologies; |
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incurrence of substantial debt or dilutive issuances of
securities to pay for acquisitions; |
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higher than expected acquisition and integration costs; |
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increased amortization expenses; |
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difficulty and cost in combining the operations and personnel of
any acquired businesses with our operations and personnel; |
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impairment of relationships with key suppliers or customers of
any acquired businesses due to changes in management and
ownership; and |
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inability to retain key employees of any acquired businesses. |
We have limited resources to identify and execute the
acquisition or in-licensing of third-party products, businesses
and technologies and integrate them into our current
infrastructure. In particular, we may compete with larger
pharmaceutical companies and other competitors in our efforts to
establish new
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collaborations and in-licensing opportunities. These competitors
likely will have access to greater financial resources than us
and may have greater expertise in identifying and evaluating new
opportunities. Moreover, we may devote resources to potential
acquisitions or in-licensing opportunities that are never
completed, or we may fail to realize the anticipated benefits of
such efforts.
We will need to increase the size of our organization, and we
may experience difficulties in managing growth.
As of June 30, 2006, we had 24 full-time employees. We
will need to continue to expand our managerial, operational,
financial and other resources in order to manage and fund our
operations and clinical trials, continue our development
activities and commercialize our product candidates. Our
management, personnel, systems and facilities currently in place
may not be adequate to support this future growth. Our need to
effectively manage our operations, growth and various projects
requires that we:
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manage our clinical trials effectively, including our planned
Phase III clinical program for IV APAP, which will be
conducted at numerous clinical trial sites, and our ongoing
Phase III clinical trial for omiganan, which is being
conducted at numerous clinical sites; |
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manage our internal development efforts effectively while
carrying out our contractual obligations to licensors and other
third parties; and |
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continue to improve our operational, financial and management
controls, reporting systems and procedures. |
We may be unable to successfully implement these tasks on a
larger scale and, accordingly, may not achieve our development
and commercialization goals.
We may not be able to manage our business effectively if we
are unable to attract and retain key personnel.
We may not be able to attract or retain qualified management and
scientific and clinical personnel in the future due to the
intense competition for qualified personnel among biotechnology,
pharmaceutical and other businesses, particularly in the
San Diego, California area. If we are not able to attract
and retain necessary personnel to accomplish our business
objectives, we may experience constraints that will
significantly impede the achievement of our development
objectives, our ability to raise additional capital and our
ability to implement our business strategy. In particular, if we
lose any members of our senior management team, we may not be
able to find suitable replacements, and our business may be
harmed as a result.
Our industry has experienced a high rate of turnover of
management personnel in recent years. We are highly dependent on
the product acquisition, development, regulatory and
commercialization expertise of our senior management. If we lose
one or more of the members of our senior management team or
other key employees, our ability to implement our business
strategy successfully could be seriously harmed. Replacing key
employees may be difficult and may take an extended period of
time because of the limited number of individuals in our
industry with the breadth of skills and experience required to
develop, gain regulatory approval of and commercialize products
successfully. Competition to hire from this limited pool is
intense, and we may be unable to hire, train, retain or motivate
these additional key personnel.
In addition, we have scientific and clinical advisors who assist
us in our product development and clinical strategies. These
advisors are not our employees and may have commitments to, or
consulting or advisory contracts with, other entities that may
limit their availability to us, or may have arrangements with
other companies to assist in the development of products that
may compete with ours.
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We face potential product liability exposure, and if
successful claims are brought against us, we may incur
substantial liability for a product candidate and may have to
limit its commercialization.
The use of our product candidates in clinical trials and the
sale of any products for which we obtain marketing approval
expose us to the risk of product liability claims. Product
liability claims might be brought against us by consumers,
health care providers or others using, administering or selling
our products. If we cannot successfully defend ourselves against
these claims, we will incur substantial liabilities. Regardless
of merit or eventual outcome, liability claims may result in:
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withdrawal of clinical trial participants; |
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termination of clinical trial sites or entire trial programs; |
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decreased demand for our product candidates; |
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impairment of our business reputation; |
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costs of related litigation; |
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substantial monetary awards to patients or other claimants; |
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loss of revenues; and |
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the inability to commercialize our product candidates. |
We have obtained limited product liability insurance coverage
for our clinical trials with a $10 million annual aggregate
coverage limit and additional amounts in selected foreign
countries where we are conducting clinical trials. However, our
insurance coverage may not reimburse us or may not be sufficient
to reimburse us for any expenses or losses we may suffer.
Moreover, insurance coverage is becoming increasingly expensive,
and, in the future, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts to
protect us against losses due to liability. We intend to expand
our insurance coverage to include the sale of commercial
products if we obtain marketing approval for our product
candidates in development, but we may be unable to obtain
commercially reasonable product liability insurance for any
products approved for marketing. On occasion, large judgments
have been awarded in class action lawsuits based on drugs that
had unanticipated side effects. A successful product liability
claim or series of claims brought against us could cause our
stock price to fall and, if judgments exceed our insurance
coverage, could decrease our cash and adversely affect our
business.
Recent proposed legislation may permit re-importation of
drugs from foreign countries into the United States, including
foreign countries where the drugs are sold at lower prices than
in the United States, which could materially adversely affect
our operating results and our overall financial condition.
Legislation has been introduced in Congress that, if enacted,
would permit more widespread re-importation of drugs from
foreign countries into the United States, which may include
re-importation from foreign countries where the drugs are sold
at lower prices than in the United States. Such legislation, or
similar regulatory changes, could decrease the price we receive
for any approved products which, in turn, could materially
adversely affect our operating results and our overall financial
condition.
Our business involves the use of hazardous materials and we
and our third-party manufacturers must comply with environmental
laws and regulations, which can be expensive and restrict how we
do business.
Our third-party manufacturers activities and, to a lesser
extent, our own activities involve the controlled storage, use
and disposal of hazardous materials, including the components of
our product candidates and other hazardous compounds. We and our
manufacturers are subject to federal, state and local laws and
regulations governing the use, manufacture, storage, handling
and disposal of these hazardous materials. Although we believe
that the safety procedures for handling and disposing of these
materials comply with the standards prescribed by these laws and
regulations, we cannot eliminate the risk of accidental
contamination or injury from these materials. In the event of an
accident, state or federal authorities may curtail our use of
these materials and interrupt our business operations.
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Our business and operations would suffer in the event of
system failures.
Despite the implementation of security measures, our internal
computer systems are vulnerable to damage from computer viruses,
unauthorized access, natural disasters, terrorism, war and
telecommunication and electrical failures. Any system failure,
accident or security breach that causes interruptions in our
operations could result in a material disruption of our drug
development programs. For example, the loss of clinical trial
data from completed or ongoing clinical trials for IV APAP
or omiganan could result in delays in our regulatory approval
efforts and significantly increase our costs to recover or
reproduce the data. To the extent that any disruption or
security breach results in a loss or damage to our data or
applications, or inappropriate disclosure of confidential or
proprietary information, we may incur liability and the further
development of our product candidates may be delayed.
Risks Related to Intellectual Property
The patent rights that we have in-licensed covering IV
APAP are limited to a specific intravenous formulation of
acetaminophen, and our market opportunity for this product
candidate may be limited by the lack of patent protection for
the active ingredient itself and other formulations that may be
developed by competitors.
The active ingredient in IV APAP is acetaminophen. There
are no patents claiming acetaminophen as an active ingredient in
the territories licensed to us: the United States and Canada. As
a result, competitors who obtain the requisite regulatory
approval can offer products with the same active ingredient
as IV APAP so long as the competitors do not infringe any
process or formulation patents that we have in-licensed from BMS
and its licensor, SCR Pharmatop. We are aware of a number of
third-party patents in the United States that claim methods of
making acetaminophen. If a supplier of the active pharmaceutical
ingredient, or API, for our IV APAP product candidate is
found to infringe any of these method patents covering
acetaminophen, our supply of the API could be delayed and we may
be required to locate an alternative supplier. We are also aware
of several U.S. and Canadian patents and patent applications
covering various potential injectable formulations of
acetaminophen as well as methods of making and using these
potential formulations. In addition, Injectapap, a formulation
of acetaminophen for intramuscular injection was approved by the
FDA for the reduction of fever in adults in March 1986 but was
withdrawn from the market by McNeil Pharmaceutical in July 1986.
Although we are not aware of any announcement regarding the
reasons for Injectapaps withdrawal, we believe it was
likely withdrawn from the market due to product-related concerns
either related to the intramuscular injection mode of
administration or the sodium bisulfite in the formulation.
The number of patents and patent applications covering products
in the same field as IV APAP indicates that competitors
have sought to develop and may seek to market competing
formulations that may not be covered by our licensed patents and
patent applications. In addition, the Canadian patent
applications that we have in-licensed have yet to be examined by
the Canadian Patent Office. Thus, they may issue with claims
that cover less than the corresponding in-licensed
U.S. patents, or simply not issue at all. The commercial
opportunity for our IV APAP product candidate could be
significantly harmed if competitors are able to develop an
alternative formulation of acetaminophen outside the scope of
our in-licensed patents.
The patent rights that we have in-licensed covering omiganan
are limited in scope and limited to specific territories.
We have an exclusive license from Migenix for omiganan in North
America and Europe for the licensed field, although currently
there are issued patents only in the United States and certain
European countries. Canadian applications are pending; however,
the claims that ultimately issue in Canada may be narrower than
the protection obtained in the United States and Europe or may
simply not issue at all. In addition, no patent protection has
been sought in Mexico. Accordingly, the manufacture, sale and
use of omiganan in Mexico by a competitor cannot be prevented.
Furthermore, analogs of omiganan have been
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developed by others that are not covered by patents licensed to
us. At least some of these analogs are covered by third-party
patents. It is possible that competitors having rights to these
third-party patents may develop competing products having the
same, similar or better efficacy compared to omiganan.
Furthermore, our license agreement with Migenix may be construed
to cover only the use of omiganan for the licensed field, which
is the treatment of burn-related, surgical wound-related, or
device-related infections. Thus, Migenix or third-party
licensees of Migenix may be able to market omiganan for other
uses, including treatment of non-surgery related wound
infections. We may be unable to prevent physicians from using
any such competitive omiganan product off-label for the field
licensed to us. Furthermore, the license covers only omiganan
pentahydrochloride and its pharmaceutical formulations. Although
the license agreement may prevent Migenix from developing a
competing product for use in the licensed field, the agreement
may not prevent Migenix from licensing a competing product, such
as another salt of omiganan, to a third-party for use in the
licensed field. Accordingly, we may face competition from a
third-party licensee of Migenix using a different formulation of
omiganan.
We depend on our licensors for the maintenance and
enforcement of our intellectual property and have limited
control, if any, over the amount or timing of resources that our
licensors devote on our behalf.
We depend on our licensors, BMS and Migenix, to protect the
proprietary rights covering IV APAP and omiganan.
Regarding IV APAP, either BMS or its licensor, SCR
Pharmatop, depending on the patent or application, is
responsible for maintaining issued patents and prosecuting
patent applications. Regarding omiganan, Migenix is responsible
for maintaining issued patents and prosecuting patent
applications. We have limited, if any, control over the amount
or timing of resources that our licensors devote on our behalf
or the priority they place on maintaining these patent rights
and prosecuting these patent applications to our advantage. SCR
Pharmatop is under a contractual obligation to BMS to diligently
prosecute their patent applications and allow BMS the
opportunity to consult, review and comment on patent office
communications. However, we cannot be sure that SCR Pharmatop
will perform as required. Should BMS decide it no longer wants
to maintain any of the patents licensed to us, BMS is required
to afford us the opportunity to do so at our expense. However,
we cannot be sure that BMS will perform as required. If BMS does
not perform, and if we do not assume the maintenance of the
licensed patents in sufficient time to make required payments or
filings with the appropriate governmental agencies, we risk
losing the benefit of all or some of those patent rights. For
patents and applications licensed from Migenix, Migenix is
obligated to use commercially reasonable efforts to obtain and
maintain patent rights covering omiganan in North America and
Europe. If Migenix intends to abandon prosecution or maintenance
of any patents or applications, they are obligated to notify us,
and at that time, we will be granted an opportunity to maintain
and prosecute the patents and applications. In such a case,
Migenix is required to transfer all necessary rights and
responsibilities to facilitate our maintenance and prosecution
of the patents and applications. Similar to BMS, however, we
cannot be certain that Migenix will perform its contractual
obligations as required or that we will be able to adequately
assume the prosecution or maintenance of the omiganan-related
patents and applications.
As part of a debt financing transaction, Migenix has pledged as
collateral to its lenders the patents and patent applications
covering omiganan. While we believe our license agreement with
Migenix would survive any foreclosure on these patents and
patent applications, we cannot be sure that the lenders will
have adequate expertise or resources to properly perform
Migenixs obligations to us under the license agreement,
including maintaining and prosecuting the patents and patent
applications.
While we intend to take actions reasonably necessary to enforce
our patent rights, we depend, in part, on our licensors to
protect a substantial portion of our proprietary rights. In the
case of the IV APAP patents, BMS has the first right to
prosecute a third-party infringement of the SCR Pharmatop
patents, and has the sole right to prosecute third-party
infringement of the BMS patents. We will have the ability to
cooperate with BMS in third-party infringement suits involving
the SCR Pharmatop patents. In certain instances, we may be
allowed to pursue the infringement claim ourselves. With respect
to omiganan, we have the first right to prosecute a third-party
for infringement of the in-licensed Migenix patents provided
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the infringing activities are in North America or Europe and
relate primarily to the licensed field of use. Migenix is
obligated to reasonably cooperate with any such suit.
Our licensors may also be notified of alleged infringement and
be sued for infringement of third-party patents or other
proprietary rights. We may have limited, if any, control or
involvement over the defense of these claims, and our licensors
could be subject to injunctions and temporary or permanent
exclusionary orders in the United States or other countries. Our
licensors are not obligated to defend or assist in our defense
against third-party claims of infringement. We have limited, if
any, control over the amount or timing of resources, if any,
that our licensors devote on our behalf or the priority they
place on defense of such third-party claims of infringement.
Finally, Migenix is not obligated to defend or assist in our
defense of a third-party infringement suit relating to our
omiganan product candidate; however, Migenix has the right to
control the defense and settlement that relates to the validity
and enforceability of claims in the in-licensed Migenix patents.
For a third-party challenge to the SCR Pharmatop in-licensed
patents relating to IV APAP, we will have some ability to
participate in either SCR Pharmatops or BMSs defense
thereof. In the case that neither party elects to defend the
third-party challenge, then we may have the opportunity to
defend it. For a third-party challenge to the in-licensed BMS
patents relating to IV APAP, BMS has the sole right to
defend such challenge. If it chooses not to, we may have the
right to renegotiate or terminate the license regarding the
in-licensed BMS patents.
Because of the uncertainty inherent in any patent or other
litigation involving proprietary rights, we or our licensors may
not be successful in defending claims of intellectual property
infringement by third parties, which could have a material
adverse affect on our results of operations. Regardless of the
outcome of any litigation, defending the litigation may be
expensive, time-consuming and distracting to management.
Because it is difficult and costly to protect our proprietary
rights, we may not be able to ensure their protection.
Our commercial success will depend in part on obtaining and
maintaining patent protection and trade secret protection
for IV APAP, omiganan or any other product candidates that
we may in-license or acquire and the methods we use to
manufacture them, as well as successfully defending these
patents against third-party challenges. We will only be able to
protect our technologies from unauthorized use by third parties
to the extent that valid and enforceable patents or trade
secrets cover them.
The patent positions of pharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and
factual questions for which important legal principles remain
unresolved. No consistent policy regarding the breadth of claims
allowed in pharmaceutical or biotechnology patents has emerged
to date in the United States. The patent situation outside the
United States is even more uncertain. Changes in either the
patent laws or in interpretations of patent laws in the United
States and other countries may diminish the value of our
intellectual property. Accordingly, we cannot predict the
breadth of claims that may be allowed or enforced in our patents
or in third-party patents.
The degree of future protection for our proprietary rights is
uncertain, because legal means afford only limited protection
and may not adequately protect our rights or permit us to gain
or keep our competitive advantage. For example:
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our licensors might not have been the first to make the
inventions covered by each of our pending patent applications
and issued patents; |
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our licensors might not have been the first to file patent
applications for these inventions; |
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others may independently develop similar or alternative
technologies or duplicate any of our product candidates or
technologies; |
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it is possible that none of the pending patent applications
licensed to us will result in issued patents; |
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the issued patents covering our product candidates may not
provide a basis for commercially viable active products, may not
provide us with any competitive advantages, or may be challenged
by third parties; |
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we may not develop additional proprietary technologies that are
patentable; or |
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patents of others may have an adverse effect on our business. |
Patent applications in the United States are maintained in
confidence for at least 18 months after their earliest
effective filing date. Consequently, we cannot be certain that
our licensors were the first to invent or the first to file
patent applications on some of our product candidates. In the
event that a third party has also filed a U.S. patent
application relating to our product candidates or a similar
invention, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark
Office to determine priority of invention in the United States.
The costs of these proceedings could be substantial and it is
possible that our efforts would be unsuccessful, resulting in a
material adverse effect on our U.S. patent position.
Furthermore, we may not have identified all U.S. and foreign
patents or published applications that affect our business
either by blocking our ability to commercialize our drugs or by
covering similar technologies that affect our drug market.
In addition, some countries, including many in Europe, do not
grant patent claims directed to methods of treating humans, and
in these countries patent protection may not be available at all
to protect our drug candidates. Even if patents issue, we cannot
guarantee that the claims of those patents will be valid and
enforceable or provide us with any significant protection
against competitive products, or otherwise be commercially
valuable to us.
We also rely on trade secrets to protect our technology,
particularly where we do not believe patent protection is
appropriate or obtainable. However, trade secrets are difficult
to protect. While we use reasonable efforts to protect our trade
secrets, our licensors, employees, consultants, contractors,
outside scientific collaborators and other advisors may
unintentionally or willfully disclose our information to
competitors. Enforcing a claim that a third party illegally
obtained and is using our trade secrets is expensive and time
consuming, and the outcome is unpredictable. In addition, courts
outside the United States are sometimes less willing to protect
trade secrets. Moreover, our competitors may independently
develop equivalent knowledge, methods and know-how.
If our licensors or we fail to obtain or maintain patent
protection or trade secret protection for IV APAP, omiganan
or any other product candidate we may in-license or acquire,
third parties could use our proprietary information, which could
impair our ability to compete in the market and adversely affect
our ability to generate revenues and achieve profitability.
If we are sued for infringing intellectual property rights of
third parties, it will be costly and time consuming, and an
unfavorable outcome in any litigation would harm our
business.
Our ability to develop, manufacture, market and sell IV
APAP, omiganan or any other product candidates that we may
in-license or acquire depends upon our ability to avoid
infringing the proprietary rights of third parties. Numerous
U.S. and foreign issued patents and pending patent
applications, which are owned by third parties, exist in the
general fields of pain treatment and prevention of infections
and cover the use of numerous compounds and formulations in our
targeted markets. In addition, because patent applications can
take many years to issue, there may be currently pending
applications, unknown to us, which may later result in issued
patents that IV APAP or omiganan may infringe. There could
also be existing patents of which we are not aware that IV
APAP or omiganan may inadvertently infringe.
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There is a substantial amount of litigation involving patent and
other intellectual property rights in the biotechnology and
biopharmaceutical industries generally. If a third party claims
that we infringe on their products or technology, we could face
a number of issues, including:
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infringement and other intellectual property claims which, with
or without merit, can be expensive and time consuming to
litigate and can divert managements attention from our
core business; |
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substantial damages for past infringement which we may have to
pay if a court decides that our product infringes on a
competitors patent; |
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a court prohibiting us from selling or licensing our product
unless the patent holder licenses the patent to us, which it is
not required to do; |
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if a license is available from a patent holder, we may have to
pay substantial royalties or grant cross licenses to our
patents; and |
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redesigning our processes so they do not infringe, which may not
be possible or could require substantial funds and time. |
We may be subject to claims that our employees have
wrongfully used or disclosed alleged trade secrets of their
former employers.
As is common in the biotechnology and pharmaceutical industry,
we employ individuals who were previously employed at other
biotechnology or pharmaceutical companies, including our
competitors or potential competitors. Although no claims against
us are currently pending, we may be subject to claims that these
employees or we have inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. Even if we are successful in defending
against these claims, litigation could result in substantial
costs and be a distraction to management.
Risks Related to Our Finances and Capital Requirements
We have incurred significant operating losses since our
inception and anticipate that we will incur continued losses for
the foreseeable future.
We are a development stage company with a limited operating
history. We have focused primarily on in-licensing and
developing our two product candidates, IV APAP and omiganan,
with the goal of supporting regulatory approval for these
product candidates. We have financed our operations almost
exclusively through private placements of preferred stock and
have incurred losses in each year since our inception in May
2004. Net losses were $3.1 million in 2004,
$7.5 million in 2005 and $28.3 million for the first
three months of 2006. The net loss for the first three months of
2006 was principally attributed to our expense related to the
$25.0 million licensing fee for IV APAP paid to BMS
and clinical trial and regulatory expenses. As of March 31,
2006, we had an accumulated deficit of $39.0 million. These
losses, among other things, have had and will continue to have
an adverse effect on our stockholders equity and working
capital. We expect our development expenses as well as clinical
product manufacturing expenses to increase in connection with
our ongoing and planned Phase III clinical trials for our
product candidates. In addition, if we obtain regulatory
approval for IV APAP or omiganan, we expect to incur
significant sales, marketing and outsourced manufacturing
expenses as well as continued development expenses. As a result,
we expect to continue to incur significant and increasing
operating losses for the foreseeable future. Because of the
numerous risks and uncertainties associated with developing
pharmaceutical products, we are unable to predict the extent of
any future losses or when we will become profitable, if at all.
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We currently have no source of revenue and may never be
profitable.
Our ability to become profitable depends upon our ability to
generate revenue. To date, we have not generated any revenue
from our development-stage product candidates, and we do not
know when, or if, we will generate any revenue. Our ability to
generate revenue depends on a number of factors, including, but
not limited to, our ability to:
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successfully complete our ongoing and planned clinical trials
for IV APAP and omiganan; |
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obtain regulatory approval for either of our two product
candidates; |
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assuming these regulatory approvals are received, manufacture
commercial quantities of our product candidates at acceptable
cost levels; and |
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successfully market and sell any approved products. |
Even if one or more of our product candidates is approved for
commercial sale, we anticipate incurring significant costs
associated with commercializing any approved product. We also do
not anticipate that we will achieve profitability for at least
several years after generating material revenues, if ever. If we
are unable to generate revenues, we will not become profitable
and may be unable to continue operations without continued
funding.
Our short operating history makes it difficult to evaluate
our business and prospects.
We were incorporated in May 2004 and have only been conducting
operations with respect to our IV APAP product candidate
since March 2006 and our omiganan product candidate since July
2004. Our operations to date have been limited to organizing and
staffing our company, in-licensing our two product candidates
and initiating product development activities for our two
product candidates. We have not yet demonstrated an ability to
obtain regulatory approval for or successfully commercialize a
product candidate. Consequently, any predictions about our
future performance may not be as accurate as they could be if we
had a history of successfully developing and commercializing
pharmaceutical products.
We will need additional funding and may be unable to raise
capital when needed, which would force us to delay, reduce or
eliminate our product development programs or commercialization
efforts.
Developing products for use in the hospital setting, conducting
clinical trials, establishing outsourced manufacturing
relationships and successfully manufacturing and marketing drugs
that we may develop is expensive. We will need to raise
additional capital to:
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fund our operations and continue to conduct adequate and
well-controlled clinical trials to provide clinical data to
support regulatory approval of marketing applications; |
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continue our development activities; |
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qualify and outsource the commercial-scale manufacturing of our
products under cGMP; and |
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commercialize IV APAP, omiganan or any other product
candidates that we may in-license or acquire, if any of these
product candidates receive regulatory approval. |
We believe that our existing cash, cash equivalents and
short-term investments will be sufficient to meet our projected
operating requirements through at least June 30, 2007. We
have based this estimate on assumptions that may prove to be
wrong, and we could spend our available financial resources much
faster than we currently expect. Our future funding requirements
will depend on many factors, including, but not limited to:
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the rate of progress and cost of our clinical trials and other
product development programs for IV APAP, omiganan and any
other product candidates that we may in-license or acquire; |
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights associated
with our product candidates; |
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the cost and timing of completion of an outsourced commercial
manufacturing supply for each product candidate; |
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the costs and timing of regulatory approval; |
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the costs of establishing sales, marketing and distribution
capabilities; |
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the effect of competing technological and market developments;
and |
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the terms and timing of any collaborative, licensing,
co-promotion or other arrangements that we may establish. |
Future capital requirements will also depend on the extent to
which we acquire or invest in additional complementary
businesses, products and technologies, but we currently have no
commitments or agreements relating to any of these types of
transactions.
Until we can generate a sufficient amount of product revenue, if
ever, we expect to finance future cash needs through public or
private equity offerings, debt financings or corporate
collaboration and licensing arrangements, as well as through
interest income earned on cash balances. We cannot be certain
that additional funding will be available on acceptable terms,
or at all. If adequate funds are not available, we may be
required to delay, reduce the scope of or eliminate one or more
of our development programs or our commercialization efforts.
Our quarterly operating results may fluctuate
significantly.
We expect our operating results to be subject to quarterly
fluctuations. Our net loss and other operating results will be
affected by numerous factors, including:
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the timing of milestone payments required under our license
agreements for IV APAP and omiganan; |
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our execution of other collaborative, licensing or similar
arrangements, and the timing of payments we may make or receive
under these arrangements; |
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our addition or termination of clinical trials or funding
support; |
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variations in the level of expenses related to our two existing
product candidates or future development programs; |
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any intellectual property infringement lawsuit in which we may
become involved; |
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regulatory developments affecting our product candidates or
those of our competitors; and |
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if either of our product candidates receives regulatory
approval, the level of underlying hospital demand for our
product candidates and wholesalers buying patterns. |
If our quarterly operating results fall below the expectations
of investors or securities analysts, the price of our common
stock could decline substantially. Furthermore, any quarterly
fluctuations in our operating results may, in turn, cause the
price of our stock to fluctuate substantially. We believe that
quarterly comparisons of our financial results are not
necessarily meaningful and should not be relied upon as an
indication of our future performance.
Raising additional funds by issuing securities may cause
dilution to existing stockholders and raising funds through
lending and licensing arrangements may restrict our operations
or require us to relinquish proprietary rights.
To the extent that we raise additional capital by issuing equity
securities, our existing stockholders ownership will be
diluted. If we raise additional funds through licensing
arrangements, it may be necessary
26
to relinquish potentially valuable rights to our potential
products or proprietary technologies, or grant licenses on terms
that are not favorable to us. Any debt financing we enter into
may involve covenants that restrict our operations. These
restrictive covenants may include limitations on additional
borrowing and specific restrictions on the use of our assets as
well as prohibitions on our ability to create liens, pay
dividends, redeem our stock or make investments. For example, in
February 2006, we entered into a $7.0 million loan and
security agreement with Silicon Valley Bank and Oxford Finance
Corporation which contains a variety of affirmative and negative
covenants, including required financial reporting, limitations
on the disposition of assets other than in the ordinary course
of business, limitations on the incurrence of additional debt
and other requirements. To secure our performance of our
obligations under the loan and security agreement, we pledged
substantially all of our assets other than intellectual property
assets, to the lenders. Our failure to comply with the covenants
in the loan and security agreement could result in an event of
default that, if not cured or waived, could result in the
acceleration of all or a substantial portion of our debt.
We will incur increased costs as a result of changes in laws
and regulations relating to corporate governance matters.
As a public reporting company, we will need to comply with the
Sarbanes-Oxley Act of 2002 and the related rules and regulations
adopted by the SEC and by the Nasdaq Stock Market, including
expanded disclosures, accelerated reporting requirements and
more complex accounting rules. Compliance with Section 404
of the Sarbanes-Oxley Act of 2002 and other requirements will
increase our costs and require additional management resources.
Additionally, these laws and regulations could make it more
difficult or more costly for us to obtain certain types of
insurance, including director and officer liability insurance,
and we may be forced to accept reduced policy limits and
coverage or incur substantially higher costs to obtain the same
or similar coverage. The impact of these events could also make
it more difficult for us to attract and retain qualified persons
to serve on our board of directors, our board committees or as
executive officers. We are presently evaluating and monitoring
developments with respect to these laws and regulations and
cannot predict or estimate the amount or timing of additional
costs we may incur to respond to their requirements.
Risks Relating to Securities Markets and Investment in Our
Stock
There may not be a viable public market for our common
stock.
Prior to this offering, there has been no public market for our
common stock, and there can be no assurance that a regular
trading market will develop and continue after this offering or
that the market price of our common stock will not decline below
the initial public offering price. The initial public offering
price will be determined through negotiations between us and the
representatives of the underwriters and may not be indicative of
the market price of our common stock following this offering.
Among the factors considered in such negotiations are prevailing
market conditions, certain of our financial information, market
valuations of other companies that we and the representatives of
the underwriters believe to be comparable to us, estimates of
our business potential, the present state of our development and
other factors deemed relevant. See Underwriting for
additional information.
As a new investor, you will experience immediate and
substantial dilution in the net tangible book value of your
shares.
The initial public offering price of our common stock in this
offering is considerably more than the net tangible book value
per share of our outstanding common stock. Investors purchasing
shares of common stock in this offering will pay a price that
substantially exceeds the value of our assets after subtracting
liabilities. As a result, investors will:
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incur immediate dilution of
$ per
share, based on an assumed initial public offering price of
$ per
share, the midpoint of our expected public offering price range;
and |
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contribute % of the total amount
invested to date to fund our company based on an assumed initial
offering price to the public of
$ per
share, the mid point of our expected public offering price
range, but will own only % of the
shares of common stock outstanding after the offering. |
To the extent outstanding stock options or warrants are
exercised, there will be further dilution to new investors.
We believe that our existing cash, cash equivalents and
short-term investments will be sufficient to meet our projected
operating requirements through at least June 30, 2007.
However, because we will need to raise additional capital to
fund our clinical development programs, among other things, we
may conduct substantial additional equity offerings. These
future equity issuances, together with the exercise of
outstanding options or warrants and any additional shares issued
in connection with acquisitions, will result in further dilution
to investors.
We expect that the price of our common stock will fluctuate
substantially.
The initial public offering price for the shares of our common
stock sold in this offering has been determined by negotiation
between the representatives of the underwriters and us. This
price may not reflect the market price of our common stock
following this offering. The price of our common stock may
decline. In addition, the market price of our common stock is
likely to be highly volatile and may fluctuate substantially due
to many factors, including:
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the results from our clinical trial programs, including our
planned Phase III clinical program for IV APAP and our
ongoing Phase III clinical trial for omiganan; |
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the results of clinical trial programs for IV APAP and
omiganan being performed by others; |
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FDA or international regulatory actions, including failure to
receive regulatory approval for any of our product candidates; |
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failure of any of our product candidates, if approved, to
achieve commercial success; |
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announcements of the introduction of new products by us or our
competitors; |
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market conditions in the pharmaceutical and biotechnology
sectors; |
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developments concerning product development results or
intellectual property rights of others; |
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litigation or public concern about the safety of our potential
products; |
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actual and anticipated fluctuations in our quarterly operating
results; |
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deviations in our operating results from the estimates of
securities analysts or other analyst comments; |
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additions or departures of key personnel; |
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third-party coverage and reimbursement policies; |
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developments concerning current or future strategic
collaborations; and |
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discussion of us or our stock price by the financial and
scientific press and in online investor communities. |
The realization of any of the risks described in these
Risk Factors could have a dramatic and material
adverse impact on the market price of our common stock. In
addition, class action litigation has often been instituted
against companies whose securities have experienced periods of
volatility in market price. Any such litigation brought against
us could result in substantial costs and a diversion of
managements attention and resources, which could hurt our
business, operating results and financial condition.
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Our management team may invest or spend the proceeds of this
offering in ways in which you may not agree or in ways which may
not yield a return.
Our management will have broad discretion over the use of
proceeds from this offering. The net proceeds from this offering
will be used to fund clinical trials and other research and
development activities, and to fund working capital, capital
expenditures and other general corporate purposes. We may also
use a portion of the net proceeds to in-license, acquire or
invest in complementary businesses or products. We have no
present understandings, commitments or agreements with respect
to any such in-licenses, acquisitions or investments and no
portion of the net proceeds has been allocated for any specific
transaction. Our management will have considerable discretion in
the application of the net proceeds, and you will not have the
opportunity, as part of your investment decision, to assess
whether the proceeds are being used appropriately. The net
proceeds may be used for corporate purposes that do not increase
our operating results or market value. Until the net proceeds
are used, they may be placed in investments that do not produce
significant income or that lose value.
Future sales of our common stock may depress our stock
price.
Sales of a substantial number of shares of our common stock in
the public market could occur at any time. These sales, or the
perception in the market that the holders of a large number of
shares intend to sell shares, could reduce the market price of
our common stock. After this offering, we will have
outstanding shares of common stock based on the number of
shares outstanding as of March 31, 2006. This includes the
shares that we are selling in this offering, which may be resold
in the public market immediately. Of the remaining shares,
shares are currently restricted as a result of securities laws
or lock-up agreements
but will be able to be sold after the offering as described in
the Shares Eligible for Future Sale section of this
prospectus. Moreover, after this offering, holders of an
aggregate of shares of our common stock will have rights,
subject to some conditions, to require us to file registration
statements covering their shares or to include their shares in
registration statements that we may file for ourselves or other
stockholders. We also intend to register all shares of common
stock that we may issue under our equity compensation plans.
Once we register these shares, they can be freely sold in the
public market upon issuance, subject to the
lock-up agreements
described in the Underwriting section of this
prospectus.
Our executive officers and directors and their affiliates
will exercise control over stockholder voting matters in a
manner that may not be in the best interests of all of our
stockholders.
Immediately following this offering, our executive officers and
directors and their affiliates will together control
approximately % of our outstanding
common stock. As a result, these stockholders will collectively
be able to significantly influence all matters requiring
approval of our stockholders, including the election of
directors and approval of significant corporate transactions.
The concentration of ownership may delay, prevent or deter a
change in control of our company even when such a change may be
in the best interests of all stockholders, could deprive our
stockholders of an opportunity to receive a premium for their
common stock as part of a sale of our company or our assets and
might affect the prevailing market price of our common stock.
Anti-takeover provisions under our charter documents and
Delaware law could delay or prevent a change of control which
could limit the market price of our common stock and may prevent
or frustrate attempts by our stockholders to replace or remove
our current management.
Our amended and restated certificate of incorporation and
amended and restated bylaws, which are to become effective at
the closing of this offering, contain provisions that could
delay or prevent a change of control of our company or changes
in our board of directors that our stockholders might consider
favorable. Some of these provisions include:
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a board of directors divided into three classes serving
staggered three-year terms, such that not all members of the
board will be elected at one time; |
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a prohibition on stockholder action through written consent; |
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a requirement that special meetings of stockholders be called
only by the chairman of the board of directors, the chief
executive officer, the president or by a majority of the total
number of authorized directors; |
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advance notice requirements for stockholder proposals and
nominations; |
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a requirement of approval of not less than
662/3%
of all outstanding shares of our capital stock entitled to vote
to amend any bylaws by stockholder action, or to amend specific
provisions of our certificate of incorporation; and |
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the authority of the board of directors to issue preferred stock
on terms determined by the board of directors without
stockholder approval. |
In addition, we are governed by the provisions of
Section 203 of the Delaware General Corporate Law, which
may prohibit certain business combinations with stockholders
owning 15% or more of our outstanding voting stock. These and
other provisions in our amended and restated certificate of
incorporation, amended and restated bylaws and Delaware law
could make it more difficult for stockholders or potential
acquirers to obtain control of our board of directors or
initiate actions that are opposed by the then-current board of
directors, including to delay or impede a merger, tender offer
or proxy contest involving our company. Any delay or prevention
of a change of control transaction or changes in our board of
directors could cause the market price of our common stock to
decline.
We have never paid dividends on our capital stock, and we do
not anticipate paying any cash dividends in the foreseeable
future.
We have paid no cash dividends on any of our classes of capital
stock to date and we currently intend to retain our future
earnings, if any, to fund the development and growth of our
business. We do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Furthermore, our loan
and security agreement with Silicon Valley Bank and Oxford
Finance Corporation restricts our ability to pay dividends. As a
result, capital appreciation, if any, of our common stock will
be your sole source of gain for the foreseeable future.
We may become involved in securities class action litigation
that could divert managements attention and harm our
business.
The stock markets have from time to time experienced significant
price and volume fluctuations that have affected the market
prices for the common stock of pharmaceutical companies. These
broad market fluctuations may cause the market price of our
common stock to decline. In the past, following periods of
volatility in the market price of a particular companys
securities, securities class action litigation has often been
brought against that company. We may become involved in this
type of litigation in the future. Litigation often is expensive
and diverts managements attention and resources, which
could adversely affect our business.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements, including
statements regarding the progress and timing of clinical trials,
the safety and efficacy of our product candidates, the goals of
our development activities, estimates of the potential markets
for our product candidates, estimates of the capacity of
manufacturing and other facilities to support our products,
projected cash needs and our expected future revenues,
operations and expenditures. The forward-looking statements are
contained principally in the sections entitled Prospectus
Summary, Risk Factors, Managements
Discussion and Analysis of Financial Condition and Results of
Operations and Business. These statements
relate to future events or our future financial performance and
involve known and unknown risks, uncertainties and other factors
that could cause our actual results, levels of activity,
performance or achievement to differ materially from those
expressed or implied by these forward-looking statements. These
risks and uncertainties include, among others:
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our ability to successfully complete clinical development of our
only two product candidates, IV APAP and omiganan, on expected
timetables, or at all, which includes enrolling sufficient
patients in our clinical trials and demonstrating the safety and
efficacy of these product candidates in such trials; |
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the content and timing of submissions to and decisions made by
the FDA and other regulatory agencies, including foreign
regulatory agencies, demonstrating to the satisfaction of the
FDA and such other agencies the safety and efficacy of our
product candidates; |
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intense competition in our markets and the ability of our
competitors, many of whom have greater resources than we do, to
offer different or better therapeutic alternatives than our
product candidates; |
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market acceptance of and future development and regulatory
difficulties relating to any product candidates for which we do
receive regulatory approval; |
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our ability to develop sales, distribution and marketing
capabilities or enter into agreements with third parties to
sell, distribute and market any of our product candidates that
may be approved for sale; |
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our ability to obtain coverage and reimbursement for any of our
product candidates that may be approved for sale from the
government or third-party payors, and the extent of such
coverage and reimbursement, and the willingness of hospitals to
pay for our product candidates versus less expensive therapies; |
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our compliance with the agreements under which we license the
rights to our product candidates; |
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our reliance on third parties to conduct our clinical trials and
manufacture our product candidates; |
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our ability to grow our business by identifying and acquiring or
in-licensing new product candidates, increasing the size of our
organization and attracting and retaining key personnel; |
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our and our licensors ability to obtain, maintain and
successfully enforce adequate patent and other intellectual
property protection of our product candidates and the rights
relating thereto; and |
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our short operating history, our lack of revenue and
profitabililty, our significant historical operating losses and
our ability to obtain additional funding to continue to operate
our business, which funding may not be available on commercially
reasonable terms, or at all. |
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Forward-looking statements include all statements that are not
historical facts. In some cases, you can identify
forward-looking statements by terms such as may,
will, should, could,
would, expect, plan,
anticipate, believe,
estimate, project, predict,
potential, or the negative of those terms, and
similar expressions and comparable terminology intended to
identify forward-looking statements. These statements reflect
our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. These forward-looking statements
represent our estimates and assumptions only as of the date of
this prospectus and, except as required by law, we undertake no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future
events or otherwise after the date of this prospectus. The
forward-looking statements contained in this prospectus are
excluded from the safe harbor protection provided by the Private
Securities Litigation Reform Act of 1995 and Section 27A of
the Securities Act of 1933, as amended.
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USE OF PROCEEDS
We estimate that we will receive net proceeds of approximately
$ million
from the sale of the shares of common stock offered in this
offering, based on an assumed initial public offering price of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus) and after deducting the estimated
underwriting discounts and commissions and estimated offering
costs payable by us. Each $1.00 increase or decrease in the
assumed public offering price of
$ per
share would increase or decrease, the net proceeds to us from
this offering by approximately
$ million,
assuming the number of shares offered by us, as set forth on the
cover page of this prospectus, remains the same and after
deducting the estimated underwriting discounts and commissions
and estimated offering costs payable by us.
The principal purposes for this offering are to fund clinical
trials and other research and development activities, including
with respect to our two product candidates, to fund our working
capital, to make capital expenditures, for other general
corporate purposes, to create a public market for our common
stock, to increase our ability to access the capital markets in
the future and to provide liquidity for our existing
stockholders.
We currently expect to use our net proceeds from this offering
as follows:
|
|
|
|
|
approximately
$ million
to fund clinical trials and other research and development
activities; and |
|
|
|
the remainder to fund working capital, capital expenditures and
other general corporate purposes. |
We anticipate that the net proceeds from this offering, together
with our existing cash and cash equivalents, will allow us to
complete the clinical trials necessary to support an NDA filing
for omiganan. However, due to the risks inherent in the clinical
trial process and given the stage of development of IV
APAP, we are unable to estimate with any certainty the total
costs or when we will incur these costs in the continued
development of IV APAP for potential commercialization.
We may also use a portion of the net proceeds to in-license,
acquire or invest in complementary businesses or products.
However, we have no current understandings, commitments or
agreements to do so.
The amounts and timing of our actual expenditures will depend on
numerous factors, including the progress in, and costs of, our
clinical trials and other product development programs. We
therefore cannot estimate the amount of net proceeds to be used
for all of the purposes described above. We may find it
necessary or advisable to use the net proceeds for other
purposes, and we will have broad discretion in the application
of the net proceeds. Pending the uses described above, we intend
to invest the net proceeds in short-term, interest-bearing,
investment-grade securities.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our capital
stock and we do not currently intend to pay any cash dividends
on our common stock. We expect to retain future earnings, if
any, to fund the development and growth of our business. The
payment of dividends by us on our common stock is limited by our
loan and security agreement with Silicon Valley Bank and Oxford
Finance Corporation. Any future determination to pay dividends
on our common stock will be at the discretion of our board of
directors and will depend upon, among other factors, our results
of operations, financial condition, capital requirements and
contractual restrictions.
33
CAPITALIZATION
The following table sets forth our capitalization as of
March 31, 2006:
|
|
|
|
|
on an actual basis; and |
|
|
|
on a pro forma as adjusted basis to reflect the conversion of
all outstanding shares of our preferred stock into
79,630,455 shares of common stock and our receipt of the
estimated net proceeds from this offering, based on an assumed
initial public offering price of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus) and after deducting the estimated
underwriting discounts and commissions and estimated offering
costs payable by us. |
The pro forma information below is illustrative only and our
capitalization following the completion of this offering will be
adjusted based on the actual initial public offering price and
other terms of this offering determined at pricing. You should
read this table together with Managements Discussion
and Analysis of Financial Condition and Results of
Operations and our financial statements and the related
notes appearing elsewhere in this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2006 | |
|
|
| |
|
|
|
|
Pro Forma | |
|
|
Actual | |
|
as Adjusted(1) | |
|
|
| |
|
| |
|
|
(In thousands, except share | |
|
|
and par value amounts) | |
Cash and cash equivalents
|
|
$ |
40,617 |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value actual and pro forma as
adjusted; actual 80,015,455 shares authorized;
79,630,455 issued and outstanding; pro forma as
adjusted 10,000,000 shares authorized; no
shares issued and outstanding
|
|
$ |
|
|
|
|
|
|
|
Series A-1 convertible preferred stock, actual
8,085,108 shares authorized, issued and outstanding; pro
forma as adjusted no shares authorized; no shares
issued and outstanding
|
|
|
1 |
|
|
|
|
|
|
Series A-2 convertible preferred stock, actual
18,060,347 shares authorized; 17,675,347 issued and
outstanding; pro forma as adjusted no shares
authorized; no shares issued and outstanding
|
|
|
2 |
|
|
|
|
|
|
Series A-3 convertible preferred stock, actual
53,870,000 shares authorized, issued and outstanding; pro
forma as adjusted no shares authorized; no shares
issued and outstanding
|
|
|
5 |
|
|
|
|
|
Common stock, $0.0001 par value; actual
100,000,000 shares authorized; 7,770,000 shares issued
and outstanding; pro forma as adjusted
100,000,000 shares
authorized; shares
issued and outstanding
|
|
|
1 |
|
|
|
|
|
Additional paid-in capital
|
|
|
79,571 |
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(39,006 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$ |
40,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Each $1.00 increase or decrease in the assumed public offering
price of
$ per
share would increase or decrease, respectively, the amount of
cash and cash equivalents, additional paid-in capital and total
capitalization by approximately
$ million,
assuming the number of shares offered by us, as set forth on the
cover page of this prospectus, remains the same and after
deducting the estimated underwriting discounts and commissions
and estimated offering costs payable by us. |
The cash and cash equivalents and securities available-for-sale
as of March 31, 2006 does not reflect $7.0 million of
indebtedness incurred in June 2006 under our loan and security
agreement with Silicon Valley Bank and Oxford Finance
Corporation. The number of pro forma as adjusted common
34
shares shown as issued and outstanding in the table is based on
the number of shares of our common stock outstanding as of
March 31, 2006, and excludes:
|
|
|
|
|
1,017,000 shares of common stock issuable upon the exercise
of options outstanding as of March 31, 2006 at a weighted
average exercise price of $0.10 per share; |
|
|
|
385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of March 31, 2006 at a weighted
average exercise price of $1.00 per share; |
|
|
|
shares
of our common stock reserved for future issuance under our 2006
equity incentive award plan, which will become effective on the
day prior to the day on which we become subject to the reporting
requirements of the Exchange Act (including
5,713,000 shares of common stock reserved for future grant
or issuance under our 2004 equity incentive award plan, which
shares will be added to the shares to be reserved under our 2006
equity incentive award plan upon the effectiveness of the 2006
equity incentive award plan); and |
|
|
|
shares
of common stock reserved for issuance under our 2006 employee
stock purchase plan. |
35
DILUTION
If you invest in our common stock in this offering, your
interest will be diluted to the extent of the difference between
the public offering price per share of our common stock and the
pro forma as adjusted net tangible book value per share of our
common stock after this offering. As of March 31, 2006, our
historical net tangible book value was $40.6 million, or
$5.22 per share of common stock. Our historical net
tangible book value per share represents the amount of our total
tangible assets reduced by the amount of our total liabilities,
divided by the total number of shares of our common stock
outstanding as of March 31, 2006. After giving effect to
the conversion of all outstanding shares of our preferred stock
into 79,630,455 shares of our common stock, our pro forma
net tangible book value as of March 31, 2006 would have
been $40.6 million, or $0.46 per share. After giving
effect to our sale in this offering
of shares
of our common stock at an assumed initial public offering price
of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus) and after deducting estimated
underwriting discounts and commissions and estimated offering
costs payable by us, our pro forma as adjusted net tangible book
value as of March 31, 2006 would have been
$ million,
or
$ per
share of our common stock. This represents an immediate increase
of net tangible book value of
$ per
share to our existing stockholders and an immediate dilution of
$ per
share to investors purchasing shares in this offering. The
following table illustrates this per share dilution:
|
|
|
|
|
|
|
|
|
|
Assumed initial public offering price per share
|
|
|
|
|
|
$ |
|
|
|
Historical net tangible book value per share as of
March 31, 2006
|
|
$ |
5.22 |
|
|
|
|
|
|
Decrease per share attributable to conversion of preferred stock
|
|
|
(4.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net tangible book value per share before giving effect
to this offering
|
|
|
0.46 |
|
|
|
|
|
|
Increase per share attributable to investors purchasing shares
in this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net tangible book value per share, as adjusted to give
effect to this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilution to investors purchasing shares in this offering
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Each $1.00 increase or decrease in the assumed public offering
price of
$ per
share would increase or decrease, our pro forma as adjusted net
tangible book value by approximately
$ million,
the pro forma as adjusted net tangible book value per share
after this offering by approximately
$ per
share and the dilution as adjusted to investors purchasing
shares in this offering by approximately
$ per
share, assuming the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same and after
deducting the estimated underwriting discounts and commissions
and estimated offering costs payable by us.
If the underwriters exercise their over-allotment option in
full, the pro forma net tangible book value per share after
giving effect to this offering would be
$ per
share, and the dilution in pro forma net tangible book value per
share to investors in this offering would be
$ per
share.
36
The following table summarizes, as of March 31, 2006, the
differences between the number of shares of common stock
purchased from us, after giving effect to the conversion of our
preferred stock into common stock, the total effective cash
consideration paid, and the average price per share paid by our
existing stockholders and by our new investors purchasing stock
in this offering at an assumed initial public offering price of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus) before deducting the estimated
underwriting discounts and commissions and estimated offering
costs payable by us:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased | |
|
Total Consideration | |
|
|
|
|
| |
|
| |
|
Average Price | |
|
|
Number | |
|
Percent | |
|
Amount | |
|
Percent | |
|
Per Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing stockholders before this offering
|
|
|
87,400,455 |
|
|
|
|
% |
|
$ |
79,476,849 |
|
|
|
|
% |
|
$ |
0.91 |
|
Investors purchasing shares in this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
100.0 |
% |
|
$ |
|
|
|
|
100.0 |
% |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Each $1.00 increase or decrease in the assumed public offering
price of
$ per
share would increase or decrease total consideration paid by new
investors, total consideration paid by all stockholders and the
average price per share paid by all stockholders by
$ million,
$ million
and
$ ,
respectively, assuming the number of shares offered by us, as
set forth on the cover page of this prospectus, remains the same
and after deducting the estimated underwriting discounts and
commissions and estimated offering costs payable by us.
If the underwriters exercise their over-allotment option in
full, our existing stockholders would
own % and our new investors would
own % of the total number of
shares of our common stock outstanding after this offering.
The above information assumes no exercise of stock options or
warrants outstanding as of March 31, 2006, and does not
reflect $7.0 million of indebtedness incurred in June 2006
under our loan and security agreement with Silicon Valley Bank
and Oxford Finance Corporation. As of March 31, 2006, there
were:
|
|
|
|
|
1,017,000 shares of common stock issuable upon the exercise
of options outstanding as of March 31, 2006 at a weighted
average exercise price of $0.10 per share; |
|
|
|
385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of March 31, 2006 at a weighted
average exercise price of $1.00 per share; |
|
|
|
shares
of our common stock reserved for future issuance under our 2006
equity incentive award plan, which will become effective on the
day prior to the day on which we become subject to the reporting
requirements of the Exchange Act (including
5,713,000 shares of common stock reserved for future grant
or issuance under our 2004 equity incentive award plan, which
shares will be added to the shares to be reserved under our 2006
equity incentive award plan upon the effectiveness of the 2006
equity incentive award plan); and |
|
|
|
shares
of common stock reserved for issuance under our 2006 employee
stock purchase plan. |
37
SELECTED FINANCIAL DATA
The following selected statement of operations data for the
period from May 26, 2004 (inception) through
December 31, 2004, the year ended December 31, 2005
and the balance sheet data as of December 31, 2004 and 2005
have been derived from our audited financial statements included
elsewhere in this prospectus. The statement of operations data
for the three-month periods ended March 31, 2005 and 2006,
the period from May 26, 2004 (inception) through
March 31, 2006 and the balance sheet data as of
March 31, 2006 have been derived from our unaudited
financial statements included elsewhere in this prospectus. The
unaudited financial statements have been prepared on a basis
consistent with our audited financial statements and, in the
opinion of management, contain all adjustments, consisting only
of normal recurring adjustments, we consider necessary for the
fair presentation of the financial data. The selected financial
data should be read in conjunction with Managements
Discussion and Analysis of Financial Condition and Results of
Operations and our financial statements and related notes
included elsewhere in this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
Period from | |
|
|
May 26, 2004 | |
|
|
|
|
|
May 26, 2004 | |
|
|
(Inception) | |
|
|
|
Three Months Ended | |
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
March 31, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
March 31, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
2,233 |
|
|
$ |
6,126 |
|
|
$ |
577 |
|
|
$ |
27,835 |
|
|
$ |
36,195 |
|
|
Marketing
|
|
|
41 |
|
|
|
240 |
|
|
|
130 |
|
|
|
96 |
|
|
|
377 |
|
|
General and administrative
|
|
|
877 |
|
|
|
1,412 |
|
|
|
263 |
|
|
|
537 |
|
|
|
2,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,151 |
|
|
|
7,778 |
|
|
|
970 |
|
|
|
28,468 |
|
|
|
39,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,151 |
) |
|
|
(7,778 |
) |
|
|
(970 |
) |
|
|
(28,468 |
) |
|
|
(39,398 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
9 |
|
|
|
255 |
|
|
|
7 |
|
|
|
144 |
|
|
|
409 |
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17 |
) |
|
|
(17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
9 |
|
|
|
255 |
|
|
|
7 |
|
|
|
127 |
|
|
|
392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142 |
) |
|
$ |
(7,523 |
) |
|
$ |
(963 |
) |
|
$ |
(28,341 |
) |
|
$ |
(39,006 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share(1)
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.21 |
) |
|
$ |
(5.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share(1)
|
|
|
3,658 |
|
|
|
4,624 |
|
|
|
4,519 |
|
|
|
4,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share(1)
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share(1)
|
|
|
|
|
|
|
20,649 |
|
|
|
|
|
|
|
32,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
See Note 1 of Notes to Financial Statements for an
explanation of the method used to compute the historical and pro
forma net loss per share and the number of shares used in the
computation of the per share amounts. |
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
As of | |
|
|
| |
|
March 31, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents and securities available-for-sale
|
|
$ |
4,271 |
|
|
$ |
15,025 |
|
|
$ |
40,617 |
|
Working capital
|
|
|
4,161 |
|
|
|
14,405 |
|
|
|
39,994 |
|
Total assets
|
|
|
4,536 |
|
|
|
15,769 |
|
|
|
41,822 |
|
Deficit accumulated during the development stage
|
|
|
(3,142 |
) |
|
|
(10,665 |
) |
|
|
(39,006 |
) |
Total stockholders equity
|
|
|
4,422 |
|
|
|
14,623 |
|
|
|
40,574 |
|
39
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial
condition and results of operations should be read in
conjunction with Selected Financial Data and our
financial statements and related notes appearing elsewhere in
this prospectus. In addition to historical information, this
discussion and analysis contains forward-looking statements that
involve risks, uncertainties and assumptions. Our actual results
may differ materially from those anticipated in these
forward-looking statements as a result of certain factors,
including but not limited to those set forth under Risk
Factors and elsewhere in this prospectus.
Overview
We are a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates
principally for use in the hospital setting. Since our inception
in 2004, we have in-licensed rights to two Phase III
product candidates, both of which have been studied in prior
Phase III clinical trials conducted by our licensors. We
have in-licensed the exclusive U.S. and Canadian rights
to IV APAP, an intravenous formulation of acetaminophen
that is currently marketed in Europe for the treatment of acute
pain and fever by Bristol-Myers Squibb Company, or BMS. We
believe that IV APAP is the only stable,
pharmaceutically-acceptable intravenous formulation of
acetaminophen. We have also in-licensed the exclusive North
American and European rights to omiganan pentahydrochloride 1%
aqueous gel, or omiganan, for the prevention and treatment of
device-related, surgical wound-related and burn-related
infections.
We believe that the hospital setting is a concentrated,
underserved market for pharmaceuticals and anticipate building
our own, hospital-focused sales force as our product candidates
approach potential U.S. Food and Drug Administration, or
FDA, approval. We intend to build a leading franchise in the
hospital setting, continuing to focus on products that are in
late-stages of development, currently commercialized outside the
United States, or approved in the United States but with
significant commercial potential for proprietary new uses or
formulations.
We were incorporated in May 2004. During 2004, we focused on
hiring our management team and initial operating employees and
on in-licensing our first product candidate, omiganan.
Substantial operations did not commence until September 2004.
During 2005, we completed the special protocol assessment, or
SPA, for omiganan, and initiated Phase III clinical trials
for this product candidate. In March 2006, we
in-licensed rights
to IV APAP from BMS. Pending further discussions with the
FDA concerning our Phase III development program
for IV APAP, we plan to initiate the remaining
Phase III clinical trial requirements for this product
candidate in the fourth quarter of 2006.
We are a development stage company. We have incurred significant
net losses since our inception. As of March 31, 2006, we
had an accumulated deficit of $39.0 million. These losses
have resulted principally from costs incurred in connection with
research and development activities, including license fees,
costs of clinical trial activities associated with our current
product candidates and general and administrative expenses. We
expect to continue to incur operating losses for the next
several years as we pursue the clinical development and market
launch of our product candidates and acquire or in-license
additional products, technologies or businesses that are
complementary to our own.
We have not generated any revenues to date, and we do not expect
to generate any revenues from licensing, achievement of
milestones or product sales until we are able to commercialize
our product candidates ourselves or execute a collaboration
arrangement.
40
|
|
|
Research and Development Expenses |
Our research and development expenses consist primarily of
license fees, salaries and related employee benefits, costs
associated with clinical trials managed by our contract research
organizations, or CROs, and costs associated with non-clinical
activities, such as regulatory expenses. Our most significant
costs are for license fees and clinical trials. The clinical
trial expenses include payments to vendors such as CROs,
investigators, clinical suppliers and related consultants. Our
historical research and development expenses relate
predominantly to the in-licensing of IV APAP and omiganan
and clinical trials for omiganan. We charge all research and
development expenses to operations as incurred because the
underlying technology associated with these expenditures relates
to our research and development efforts and has no alternative
future uses.
We use external service providers and vendors to conduct our
clinical trials, to manufacture our product candidates to be
used in clinical trials and to provide various other research
and development related products and services. A substantial
portion of these external costs are tracked on a project basis.
We use our internal research and development resources across
several projects and many resources are not attributable to
specific projects. A substantial portion of our internal costs,
including personnel and facility related costs, are not tracked
on a project basis and are included in the
unallocated category in the table below.
The following summarizes our research and development expenses
for the periods indicated:
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
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|
Period from | |
|
|
|
|
|
|
|
Period from | |
|
|
May 26, 2004 | |
|
|
|
|
|
May 26, 2004 | |
|
|
(Inception) | |
|
|
|
Three Months | |
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
Ended March 31, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
March 31, | |
Product Candidate |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
IV APAP
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
25,464 |
|
|
$ |
25,464 |
|
Omiganan
|
|
|
2,001 |
|
|
|
4,802 |
|
|
|
333 |
|
|
|
1,885 |
|
|
|
8,687 |
|
Unallocated
|
|
|
232 |
|
|
|
1,324 |
|
|
|
244 |
|
|
|
486 |
|
|
|
2,044 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,233 |
|
|
$ |
6,126 |
|
|
$ |
577 |
|
|
$ |
27,835 |
|
|
$ |
36,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At this time, due to the risks inherent in the clinical trial
process and given the early stage of our product development
programs, we are unable to estimate with any certainty the costs
we will incur in the continued development of our product
candidates for potential commercialization. Clinical development
timelines, the probability of success and development costs vary
widely. While we are currently focused on advancing each of our
product development programs, our future research and
development expenses will depend on the determinations we make
as to the scientific and clinical success of each product
candidate, as well as ongoing assessments as to each product
candidates commercial potential. In addition, we cannot
forecast with any degree of certainty which product candidates
will be subject to future collaborations, when such arrangements
will be secured, if at all, and to what degree such arrangements
would affect our development plans and capital requirements.
We expect our development expenses to be substantial over the
next few years as we continue the advancement of our product
development programs. We initiated our Phase III clinical
trial program for omiganan in August 2005, and we have not yet
commenced our own Phase III clinical trials for IV
APAP. We expect to receive results from the ongoing omiganan
clinical trial in the second half of 2007. In the fourth quarter
of 2006, we expect to initiate the remaining Phase III
clinical trial requirements for IV APAP for submission to
the FDA and expect these Phase III clinical trial results
to be available in the first half of 2008. The lengthy process
of completing clinical trials and seeking regulatory approval
for our product candidates requires the expenditure of
substantial resources. Any failure by us or delay in completing
clinical trials, or in obtaining regulatory approvals, could
cause our research and development expense to increase and, in
turn, have a material adverse effect on our results of
operations.
41
Our marketing expenses consist primarily of market research
studies, salaries, benefits and professional fees related to
building our marketing capabilities. We anticipate increases in
marketing expenses as we add personnel and continue to develop
and prepare for the potential commercialization of our product
candidates.
|
|
|
General and Administrative |
Our general and administrative expenses consist primarily of
salaries, benefits and professional fees related to our
administrative, finance, human resources, legal, business
development and internal systems support functions, as well as
insurance and facility costs. We anticipate increases in general
and administrative expenses as we add personnel, comply with the
reporting obligations applicable to publicly-held companies, and
continue to build our corporate infrastructure in support of our
continued development and preparation for the potential
commercialization of our product candidates.
|
|
|
Interest and Other Income |
Interest and other income consist primarily of interest earned
on our cash, cash equivalents and short-term investments.
As of December 31, 2005, we had both federal and state net
operating loss carryforwards of approximately $8.7 million.
If not utilized, the net operating loss carryforwards will begin
expiring in 2024 for federal purposes and 2014 for state
purposes. As of December 31, 2005, we had both federal and
state research and development tax credit carryforwards of
approximately $0.3 million and $0.1 million,
respectively. The federal tax credits will begin expiring in
2024 unless previously utilized and the state tax credits
carryforward indefinitely. Under Section 382 of the
Internal Revenue Code of 1986, as amended, or the Internal
Revenue Code, substantial changes in our ownership may limit the
amount of net operating loss carryforwards that could be
utilized annually in the future to offset taxable income. Any
such annual limitation may significantly reduce the utilization
of the net operating losses before they expire. In each period
since our inception, we have recorded a valuation allowance for
the full amount of our deferred tax asset, as the realization of
the deferred tax asset is uncertain. As a result, we have not
recorded any federal or state income tax benefit in our
statement of operations.
Critical Accounting Policies and Estimates
Our managements discussion and analysis of our financial
condition and results of operations is based on our financial
statements, which have been prepared in conformity with
generally accepted accounting principles in the United States.
The preparation of these financial statements requires us to
make estimates and assumptions that affect the reported amounts
of assets, liabilities, expenses and related disclosures. Actual
results could differ from those estimates.
We believe the following accounting policies to be critical to
the judgments and estimates used in the preparation of our
financial statements.
|
|
|
Research and Development Expenses |
A substantial portion of our on-going research and development
activities are performed under agreements we enter into with
external service providers, including CROs, who conduct many of
our research and development activities. We accrue for costs
incurred under these contracts based on factors such as
estimates of work performed, milestones achieved, patient
enrollment and experience with similar contracts. As actual
costs become known, we adjust our accruals. To date, our
accruals have been within managements estimates, and no
material adjustments to research and development expenses have
been recognized. We expect to expand the level of research and
development activity performed by external
42
service providers in the future. As a result, we anticipate that
our estimated accruals will be more material to our operations
in future periods. Subsequent changes in estimates may result in
a material change in our accruals, which could also materially
affect our results of operations.
Effective January 1, 2006, we adopted Statement of
Financial Accounting Standards, or SFAS, No. 123(R),
Share-Based Payment, which revises
SFAS No. 123, Accounting for Stock-Based
Compensation and supersedes Accounting Principles Board, or
APB, Opinion No. 25, Accounting for Stock Issued to
Employees. SFAS No. 123(R) requires that
share-based payment transactions with employees be recognized in
the financial statements based on their fair value and
recognized as compensation expense over the vesting period.
Prior to SFAS No. 123(R), we disclosed the pro forma
effects of applying SFAS No. 123 under the minimum
value method. We adopted SFAS No. 123(R) effective
January 1, 2006, prospectively for new equity awards issued
subsequent to December 31, 2005. The adoption of
SFAS No. 123(R) in the first quarter of 2006 did not
result in the recognition of additional stock-based compensation
expense.
Under SFAS No. 123(R), we calculate the fair value of
stock option grants using the Black-Scholes option-pricing
model. The weighted average assumptions used in the
Black-Scholes model were 6.08 years for the expected term,
70% for the expected volatility, 4.36% for the risk free rate
and 0% for dividend yield for the three months ended
March 31, 2006. Future expense amounts for any particular
quarterly or annual period could be affected by changes in our
assumptions.
The weighted average expected option term for 2006 reflects the
application of the simplified method set out in Securities and
Exchange Commission Staff Accounting Bulletin, or SAB,
No. 107 which was issued in March 2005. The simplified
method defines the life as the average of the contractual term
of the options and the weighted average vesting period for all
option tranches.
Estimated volatility for fiscal 2006 also reflects the
application of SAB No. 107 interpretive guidance and,
accordingly, incorporates historical volatility of similar
public entities.
As of March 31, 2006, we had no material unrecognized
share-based compensation costs related to nonvested equity
awards. As of March 31, 2006, we had outstanding vested
options to purchase 196,873 shares of our common stock and
unvested options to purchase 820,127 shares of our common
stock with an intrinsic value
of and ,
respectively, based on an estimated initial public offering
price
of per
share.
Prior to January 1, 2006, we applied the
intrinsic-value-based method of accounting prescribed by APB
Opinion No. 25 and related interpretations. Under this
method, if the exercise price of the award equaled or exceeded
the fair value of the underlying stock on the measurement date,
no compensation expense was recognized. The measurement date was
the date on which the final number of shares and exercise price
were known and was generally the grant date for awards to
employees and directors. If the exercise price of the award was
below the fair value of the underlying stock on the measurement
date, then compensation cost was recorded, using the
intrinsic-value method, and was generally recognized in the
statements of operations over the vesting period of the award.
The fair value of our common stock has been established by our
board of directors and took into consideration contemporaneous
independent valuations of the Companys common stock
beginning in March 2006. We have considered the guidance in the
American Institute of Certified Public Accountants, or AICPA,
Audit and Accounting Practice Aid Series, Valuation of
Privately-Held-Company Equity Securities Issued as
Compensation, to determine the fair value of our common
stock for purposes of setting the exercise prices of stock
options granted to employees and others. This guidance
emphasizes the importance of the operational development in
determining the value of the enterprise. As a development stage
enterprise, we are at an early stage of existence, primarily
focused on development with an unproven business model. To date,
we have been funded primarily by venture capitalists with a
history of funding
start-up, high-risk
entities with the potential for high returns in the event the
investments are successful.
43
Prior to the licensing of IV APAP in March 2006, we valued
our common stock at a nominal amount when we were considered to
be in a very early stage of development as defined in the AICPA
guidance where the preferences of the preferred stockholders, in
particular the liquidation preferences, are very meaningful.
Subsequent to our licensing of IV APAP but prior to the
initiation of our initial public offering process on
June 14, 2006, taking into consideration a contemporaneous
independent valuation, we allocated additional enterprise value
to our common stock with an increase in the common stock
valuation to $0.34 per share. Subsequent to the initiation
of our initial public offering process, taking into
consideration a contemporaneous independent valuation, we
increased our common stock valuation to $0.80 per share.
Equity instruments issued to non-employees are recorded at their
fair value as determined in accordance with
SFAS No. 123 and Emerging Issues Task Force 96-18,
Accounting for Equity Instruments That are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling
Goods and Services, and are periodically revalued as the
equity instruments vest and are recognized as expense over the
related service period.
Results of Operations
|
|
|
Comparison of three months ended March 31, 2006 and
2005 |
Research and Development Expenses. Research and
development expenses increased to $27.8 million for the
three months ended March 31, 2006 from $0.6 million
for the comparable period during 2005. This increase of
$27.2 million primarily was due to:
|
|
|
|
|
an increase of $25.5 million in our IV APAP program
primarily as a result of a license fee which was immediately
expensed as in-process research and development; |
|
|
|
an increase of $1.6 million in our omiganan program as a
result of clinical trial and related costs for a Phase III
clinical trial initiated in August 2005; and |
|
|
|
an increase of $0.1 million in unallocated expenses as a
result of increased salaries and related personnel costs from
increased research and development staff to support our clinical
and regulatory efforts related to omiganan and our licensing
efforts related to IV APAP. |
Marketing Expenses. Marketing expenses decreased to
$96,000 for the three months ended March 31, 2006 from
$130,000 for the comparable period during 2005. This decrease of
$34,000 primarily was due to non-recurring market research and
branding costs in 2005 partially offset by increased personnel
costs.
General and Administrative Expenses. General and
administrative expenses increased to $0.5 million for the
three months ended March 31, 2006 from $0.3 million
for the comparable period during 2005. This increase of
$0.2 million primarily was due to legal fees, other
professional fees and consulting fees.
Interest Income. Interest income increased to $144,000
for the three months ended March 31, 2006 from $8,000 for
the comparable period during 2005. This increase of $136,000
primarily was due to the increase in average cash and investment
balances as a result of preferred stock sales and higher
interest rates in 2006.
Interest Expense. Interest expense increased to $17,000
for the three months ended March 31, 2006 from zero for the
comparable period during 2005. This increase of $17,000 was
primarily due to non-cash interest expense related to the
warrants issued to Silicon Valley Bank and Oxford Finance
Corporation in connection with their February 2006 commitment to
lend us $7.0 million.
44
|
|
|
Comparison of year ended December 31, 2005 to the
period from May 26, 2004 (inception) through
December 31, 2004 |
Research and Development Expenses. Research and
development expenses increased to $6.1 million for the year
ended December 31, 2005 from $2.2 million for the
period from May 26, 2004 (inception) through
December 31, 2004. This increase of $3.9 million
primarily was due to:
|
|
|
|
|
an increase of $2.8 million in our omiganan program as a
result of clinical trial and related costs offset by a decrease
in license fees; and |
|
|
|
an increase of $1.1 million in unallocated expenses as a
result of increased salaries and related personnel costs from
increased research and development staff to support our initial
clinical and regulatory efforts. |
Marketing Expenses. Marketing expenses increased to
$240,000 for the year ended December 31, 2005 from $41,000
for the period from May 26, 2004 (inception) through
December 31, 2004. This increase of $199,000 primarily was
due to market research, branding and personnel costs in 2005.
General and Administrative Expenses. General and
administrative expenses increased to $1.4 million for the
year ended December 31, 2005 from $0.9 million for the
period from May 26, 2004 (inception) through
December 31, 2004. This increase of $0.5 million
primarily was due to salaries and related costs as we expanded
our general and administrative functions to support our
operations, as well as legal fees, other professional fees and
consulting fees.
Interest Income. Interest income increased to $256,000
for the year ended December 31, 2005 from $9,000 for the
period from May 26, 2004 (inception) through
December 31, 2004. This increase of $247,000 primarily was
due to the increase in average cash and investment balances and
interest rates in 2005.
Liquidity and Capital Resources
Since inception, our operations have been financed primarily
through the private placement of equity securities. Through
March 31, 2006, we received net proceeds of approximately
$79.2 million from the sale of shares of our preferred and
common stock as follows:
|
|
|
|
|
from July 2004 to March 2006, we issued and sold a total of
7,770,000 shares of common stock for aggregate net proceeds
of $0.3 million; |
|
|
|
from July 2004 to August 2004, we issued and sold a total of
8,085,108 shares of Series A-1 preferred stock for
aggregate net proceeds of $7.5 million; |
|
|
|
from June 2005 to September 2005, we issued and sold
17,675,347 shares of Series A-2 preferred stock for
aggregate net proceeds of $17.6 million; and |
|
|
|
in March 2006, we issued and sold a total of
53,870,000 shares of Series A-3 preferred stock for
aggregate net proceeds of $53.8 million. |
In February 2006, we entered into a $7.0 million loan and
security agreement with Silicon Valley Bank and Oxford Finance
Corporation to provide us with growth capital. We drew down
$7.0 million in June 2006 and have no further credit
available under this agreement. We are required to make interest
only payments on the loan balance for the first six months of
the loan, and beginning February 2007, we are required to make
the first of 30 equal monthly principal and interest payments.
Interest accrues on all outstanding amounts at the fixed rate of
11.47%. The loan is collateralized by substantially all of our
assets other than intellectual property. We are subject to
prepayment penalties. Under the terms of the agreement, we are
precluded from entering into certain financing and other
transactions, including disposing of certain assets and paying
dividends, and are subject to various non-financial covenants.
In conjunction with the loan and security agreement, we issued
warrants to the lenders to purchase 385,000 shares of
Series A-2 preferred stock at an exercise price of
$1.00 per share.
45
As of March 31, 2006, we had $40.6 million in cash and
cash equivalents. We have invested a substantial portion of our
available cash funds in commercial paper and money market funds
placed with reputable financial institutions for which credit
loss is not anticipated. We have established guidelines relating
to diversification and maturities of our investments to preserve
principal and maintain liquidity.
Our operating activities used net cash in the amount of
$28.3 million in the three months ended March 31,
2006, $6.9 million for the year ended December 31,
2005 and $3.1 million for the period from May 26, 2004
(inception) through December 31, 2004. The increase in
net cash used in operating activities from 2004 to 2005
primarily was due to an increase in our net loss as a result of
increased expenses related to the clinical development of
omiganan and increased salaries and overhead of company
personnel. The increase in net cash used in operating activities
from 2005 to 2006 primarily was due to an increase in our net
loss as a result of increased expenses related to the license
fee paid for IV APAP. We cannot be certain if, when or to
what extent we will receive cash inflows from the
commercialization of our product candidates. We expect our
development expenses to be substantial and to increase over the
next few years as we continue the advancement of our product
development programs.
As a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary pharmaceutical
product candidates, we have entered into license agreements to
acquire the rights to develop and commercialize our two product
candidates, IV APAP and omiganan. Pursuant to these agreements,
we obtained exclusive licenses to the patent rights and know-how
for selected indications and territories. Under the IV APAP
agreement, we paid to BMS a $25.0 million up-front fee and
may be required to make future milestone payments totaling up to
$50.0 million upon the achievement of various milestones
related to regulatory or commercial events. Under the omiganan
agreement, we paid to Migenix Inc. an aggregate of
$2.0 million in the form of an up-front fee, including the
purchase of 617,284 shares of Migenix common stock, and may
be required to make future milestone payments totaling up to
$27.0 million upon the achievement of various milestones
related to regulatory or commercial events. Under both
agreements, we are also obligated to pay royalties on any net
sales of the licensed products.
Our future capital uses and requirements depend on numerous
forward-looking factors. These factors include but are not
limited to the following:
|
|
|
|
|
the progress of our clinical trials, including expenses to
support the trials and milestone payments that may become
payable to BMS or Migenix; |
|
|
|
our ability to establish and maintain strategic collaborations,
including licensing and other arrangements; |
|
|
|
the costs involved in enforcing or defending patent claims or
other intellectual property rights; |
|
|
|
the costs and timing of regulatory approvals; |
|
|
|
the costs of establishing sales or distribution capabilities; |
|
|
|
the success of the commercialization of our products; and |
|
|
|
the extent to which we in-license, acquire or invest in other
indications, products, technologies and businesses. |
We believe that our existing cash, cash equivalents and
short-term investments will be sufficient to meet our projected
operating requirements through at least June 30, 2007.
Until we can generate significant cash from our operations, we
expect to continue to fund our operations with existing cash
resources generated from the proceeds of offerings of our equity
securities and our existing borrowings under our loan and
security agreement. In addition, we may finance future cash
needs through the sale of additional equity securities,
strategic collaboration agreements and debt financing. However,
we have drawn down all available amounts under our existing loan
and security agreement, and we may not be successful in
obtaining strategic collaboration agreements or in receiving
milestone or royalty payments under those strategic
collaboration agreements. In addition, we cannot be
46
sure that our existing cash and investment resources will be
adequate, that additional financing will be available when
needed or that, if available, financing will be obtained on
terms favorable to us or our stockholders. Having insufficient
funds may require us to delay, scale-back or eliminate some or
all of our development programs, relinquish some or even all
rights to product candidates at an earlier stage of development
or renegotiate less favorable terms than we would otherwise
choose. Failure to obtain adequate financing also may adversely
affect our ability to operate as a going concern. If we raise
additional funds by issuing equity securities, substantial
dilution to existing stockholders would likely result. If we
raise additional funds by incurring additional debt financing,
the terms of the debt may involve significant cash payment
obligations as well as covenants and specific financial ratios
that may restrict our ability to operate our business.
Contractual Obligations and Commitments
The following table describes our long-term contractual
obligations and commitments as of December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less Than | |
|
|
|
|
Total | |
|
1 Year | |
|
1 - 3 Years |
|
4-5 Years |
|
After 5 Years |
|
|
| |
|
| |
|
|
|
|
|
|
|
|
(In thousands) |
Long-term debt obligations(1)
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating lease obligations(2)
|
|
|
147 |
|
|
|
147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
License obligations(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
147 |
|
|
$ |
147 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Long-term debt obligations do not include $7.0 million of
indebtedness incurred in June 2006 under our loan and security
agreement with Silicon Valley Bank and Oxford Finance
Corporation. |
|
(2) |
In May 2006, we entered into a six-year operating lease for
23,494 square feet of office space. Operating lease
obligations do not include $6.7 million of non-cancelable
operating lease payments related to this lease. Future minimum
payments under the operating lease total $0.2 million,
$1.0 million, $1.1 million, $1.1 million,
$1.2 million, $1.2 million and $0.9 million for
the years ending December 31, 2006, 2007, 2008, 2009, 2010,
2011 and 2012, respectively. |
|
(3) |
License obligations do not include additional payments of up to
$77.0 million due upon the occurrence of certain milestones
related to regulatory or commercial events. We may also be
required to pay royalties on any net sales of the licensed
products. License payments may be increased based on the timing
of various milestones and the extent to which the licensed
technologies are pursued for other indications. These milestone
payments and royalty payments under our license agreements are
not included in the table above because we cannot, at this time,
determine when or if the related milestones will be achieved or
the events triggering the commencement of payment obligations
will occur. |
We also enter into agreements with third parties to manufacture
our product candidates, conduct our clinical trials and perform
data collection and analysis. Our payment obligations under
these agreements depend upon the progress of our development
programs. Therefore, we are unable at this time to estimate with
certainty the future costs we will incur under these agreements.
Related Party Transactions
For a description of our related party transactions, see the
Certain Relationships and Related Party Transactions
section of this prospectus.
47
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
Quantitative and Qualitative Disclosures About Market Risk
Our cash and investments as of March 31, 2006 consisted
primarily of money market funds, commercial paper and
U.S. government agency notes. Our primary exposure to
market risk is interest income sensitivity, which is affected by
changes in the general level of U.S. interest rates,
particularly because the majority of our investments are in
short-term marketable securities. The primary objective of our
investment activities is to preserve principal while at the same
time maximizing the income we receive from our investments
without significantly increasing risk. Some of the securities
that we invest in may be subject to market risk. This means that
a change in prevailing interest rates may cause the value of the
investment to fluctuate. For example, if we purchase a security
that was issued with a fixed interest rate and the prevailing
interest rate later rises, the value of our investment will
probably decline. To minimize this risk, we intend to continue
to maintain our portfolio of cash equivalents and short-term
investments in a variety of securities including commercial
paper, money market funds and government and non-government debt
securities, all with various maturities. In general, money
market funds are not subject to market risk because the interest
paid on such funds fluctuates with the prevailing interest rate.
48
BUSINESS
Overview
We are a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates
principally for use in the hospital setting. Since our inception
in 2004, we have in-licensed rights to two Phase III
product candidates. We have in-licensed the exclusive U.S. and
Canadian rights to IV APAP, an intravenous formulation of
acetaminophen that has previously been studied in six completed
Phase III trials and is currently marketed in Europe for
the treatment of acute pain and fever by Bristol-Myers Squibb
Company, or BMS. We believe that IV APAP is the only
stable, pharmaceutically-acceptable intravenous formulation of
acetaminophen. We intend to initiate Phase III development
for the treatment of acute pain in the fourth quarter of 2006.
We also in-licensed the exclusive North American and European
rights to omiganan pentahydrochloride 1% aqueous gel, or
omiganan, for the prevention and treatment of device-related,
surgical wound-related and burn-related infections. We are
currently conducting a Phase III trial of omiganan for the
prevention of local catheter site infections, or LCSI, to
confirm the results observed for the prevention of LCSI, a
secondary endpoint, in a large, completed Phase III trial.
We believe that the hospital setting is a concentrated,
underserved market for pharmaceuticals and anticipate building
our own, hospital-focused sales force as our products approach
potential U.S. Food and Drug Administration, or FDA,
approval. We intend to build a leading franchise in the hospital
setting, continuing to focus on products that are in late-stages
of development, currently commercialized outside the United
States or approved in the United States but with significant
commercial potential for proprietary new uses or formulations.
Our current portfolio consists of the following product
candidates:
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IV APAP for the treatment of acute pain. We are
developing IV APAP in the U.S. market for the
treatment of acute pain. According to IMS Health, Inc., or IMS,
an independent marketing research firm, over 500 million
units of injectable analgesics, typically used to treat pain,
were sold in the United States in 2005. Opioids such as
morphine, meperdine, hydromorphone and fentanyl represent the
majority of unit volume in the market but are associated with a
variety of unwanted side effects including sedation, nausea,
vomiting, constipation, cognitive impairment and respiratory
depression. Ketorolac, a non-steroidal anti-inflammatory drug,
or NSAID, is the only
non-opioid injectable
analgesic available for the treatment of acute pain in the
United States. However, ketorolac carries strong warnings from
the FDA for various side effects, including an increased risk of
bleeding a particularly troubling side-effect in the
surgical setting. |
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In March 2006, we in-licensed the patents and the exclusive
development and commercialization rights to IV APAP in the
United States and Canada from BMS. IV APAP has been marketed
outside the United States for approximately four years. Since
its introduction in Europe in mid-2002, over 100 million
doses of IV APAP have been administered to patients, and it
has become the market share leader among injectable analgesics
with 2005 sales of more than $140 million according to IMS.
With approval in over 40 countries, the addition of IV APAP
to our product pipeline is consistent with our strategy to
in-license and develop pharmaceutical candidates with
well-understood risk profiles. In the fourth quarter of 2006, we
expect to initiate the remaining Phase III clinical trial
requirements. We expect these Phase III clinical trial
results to be available in the first half of 2008 and, if
positive, to subsequently submit a new drug application, or NDA,
in the second half of 2008. |
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Omiganan for the prevention of intravascular catheter-related
infections. We are developing omiganan for the prevention of
intravascular catheter-related infections in the United States
and Europe. According to the February 2004 Catheter: Global
Markets & Technologies report from Theta Reports,
eight million central venous catheters, or CVCs, were sold in
the United States in 2003, and unit sales are projected to grow
to 11 million by 2007. Although CVCs have become an
important part of medical care, they can give rise to dangerous
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costly complications, including: LCSIs, which are infections at
the catheter insertion site; catheter colonization, which is the
growth of microorganisms on the portion of the catheter below
the skin surface; and catheter-related bloodstream infections,
or CRBSIs, which are infections in the bloodstream caused by
microorganisms associated with the catheter. The Centers for
Disease Control and Prevention, or the CDC, estimates that there
are 250,000 CRBSIs each year in the United States. The
attributable mortality rate of CRBSIs is approximately 12% to
25% with an average marginal cost to the healthcare system of
$25,000 per infection. Currently, topical antiseptics are
the primary agent used to cleanse the skin surface around the
catheter insertion site prior to insertion. However, the utility
of these antiseptics is limited, principally due to the
relatively short duration of antimicrobial activity. |
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Omiganan is a topical antimicrobial that has been demonstrated
to be rapidly bactericidal and fungicidal with prolonged
duration of activity against all microorganisms commonly found
on the skin surface including multi-drug resistant
microorganisms such as methicillin-resistant staphylococcus
aureus, or MRSA. Importantly, resistance to omiganan has not
been induced in the laboratory after extensive study nor has
omiganan demonstrated potential to induce cross-resistance to
other antimicrobial therapeutics. In July 2004, we in-licensed
the patents and the exclusive development and commercialization
rights to omiganan in North America and Europe for the
prevention of device-related, surgical wound-related and
burn-related infections. |
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Omiganan has previously been studied in a large, completed
Phase III trial that demonstrated statistically significant
outcomes for the reduction of LCSI and catheter colonization.
The presence of an LCSI may result in replacement of the
catheter and/or administration of antibiotics, both of which
create additional costs to hospitals and have the potential for
adverse safety outcomes. In addition, catheter colonization is
well correlated with CRBSIs, according to a published review of
clinical trials. In August 2005, we initiated a confirmatory
Phase III clinical trial with a primary endpoint of LCSI.
We reached agreement with the FDA on the trial design, endpoints
and statistical analysis plan received through the special
protocol assessment, or SPA, process. We expect these
Phase III results to be available in the second half of
2007 and to subsequently submit an NDA for omiganan in the first
half of 2008. |
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Other product candidates. We are also exploring the
opportunity to develop new formulations of omiganan for the
prevention and treatment of other device-related, surgical
wound-related and burn-related infections. We are currently
preparing preclinical experiments in animal models prior to
initiating human clinical trials. |
Our Strategy
Our goal is to be a leading biopharmaceutical company focused on
the development and commercialization of proprietary
pharmaceuticals principally for use in the hospital setting. Our
near-term strategy is to focus on completing the development of
and commercializing our existing product candidates. Our
long-term strategy is to in-license, acquire, develop and
commercialize additional product candidates that are in
late-stages of development, currently commercialized outside the
United States or approved in the United States but with
significant commercial potential for proprietary new uses or
formulations. Specifically, we intend to:
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Obtain regulatory approval for our Phase III hospital
product candidates, IV APAP and omiganan. We are applying
the expertise of our development teams to conduct and
successfully complete the Phase III clinical trials
associated with each product candidate. We have designed our
Phase III clinical programs in an effort to reduce clinical
development risk, facilitate regulatory approval and optimize
marketing claims. To that end, we plan to resume a
U.S. Phase III program later this year for IV
APAP previously |
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initiated by BMS, and we expect to submit an NDA in the second
half of 2008 based on the previously completed trials and any
further trials that may be required by the FDA. In addition, we
have reached a written agreement with the FDA through the SPA
process for a single confirmatory Phase III study of
omiganan for the prevention of LCSIs. |
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Build a highly leverageable sales organization targeting
hospitals. We intend to build a commercial organization
focused on promoting our products principally to hospitals in
the United States. We believe that both IV APAP and
omiganan can be effectively promoted by our own sales force
targeting key hospitals in the United States. Importantly, the
number of institutions comprising the hospital marketplace is
relatively limited and we believe a small number of these
institutions account for a substantial portion of the
prescribing activity. The concentrated nature of this market
creates the opportunity for significant marketing synergies as
we intend to leverage our sales force across multiple
therapeutic categories in the hospital. Outside the United
States, we intend to establish strategic partnerships for the
commercialization of our products where we have
commercialization rights. |
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Expand our product portfolio through acquiring or
in-licensing additional late-stage, hospital-focused products
with well-understood risk profiles. We will seek additional
opportunities to acquire or in-license products to more fully
exploit our clinical, regulatory, manufacturing, sales and
marketing capabilities. We believe that our focus on the
hospital market enables us to evaluate a broader range of
products across multiple therapeutic areas for possible
acquisition. In addition, competition from large pharmaceutical
companies has generally diminished in the hospital marketplace
as greater emphasis has shifted toward larger opportunities in
the primary care setting. To reduce the
time-to- market and the
risks and costs of clinical development, we focus on products
that are in late-stages of development, currently commercialized
outside the United States or approved in the United States but
with significant commercial potential for proprietary new uses
or formulations. |
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Pursue additional indications and commercial opportunities
for our product candidates. We will seek to maximize the
value of IV APAP, omiganan and any other product candidates
we may in-license, acquire or develop by pursuing other
indications and commercial opportunities for such candidates.
For example, we have rights to develop and commercialize
omiganan for additional indications related to the prevention
and treatment of device-related, surgical wound-related and
burn-related infections. |
The Hospital Market
Large, multinational pharmaceutical companies have generally
decreased marketing efforts focused on hospital-use drugs,
instead focusing on drugs that can be marketed in the larger
outpatient setting. We believe this reduced emphasis on the
hospital marketplace presents us with an excellent opportunity
to in-license, acquire, develop and commercialize products that
address unmet medical needs in the hospital setting. We believe
the concentrated nature of the hospital marketplace will allow
for our expansion into other therapeutic areas without
substantial investment in additional commercial infrastructure.
According to IMS, approximately $28 billion was spent on
promotional activities by the pharmaceutical industry in 2004.
Of this amount, IMS estimates that only $1 billion was
directed towards hospital-based physicians and directors of
pharmacies. This hospital-focused spending represents
approximately 3% of total promotional expenditures and has
declined from approximately 6% of total spending in 1996. The
significant imbalance towards the outpatient market is
highlighted by spending on
direct-to-consumer
campaigns and drug sampling which now make up close to 80% of
promotional spending for pharmaceuticals.
Despite these declining promotional expenditures,
U.S. hospitals and clinics accounted for approximately
$54 billion or 21% of U.S. pharmaceutical sales in
2005, according to IMS. Furthermore, we believe pharmaceutical
sales to acute care hospitals are highly concentrated among a
relatively small
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number of large institutions. For example, according to Wolters
Kluwer Health, an independent marketing research firm, only
2,000 of the approximately 5,000 acute care hospitals in the
United States represent more than 80% of injectable analgesic
sales. The concentration of high-prescribing institutions
enables effective promotion of pharmaceuticals utilizing a
relatively small, dedicated sales and marketing organization. We
believe the relative lack of promotional efforts directed toward
the highly concentrated hospital marketplace makes it an
underserved and compelling opportunity, especially for a
biopharmaceutical company commercializing its products directly
through its own dedicated sales force.
We believe a typical sales representative focused on
office-based physicians can generally promote only two to three
products effectively; whereas, a typical hospital-focused sales
representative can effectively promote five to six products.
Furthermore, we believe a typical sales representative focused
on office-based physicians can effectively reach five to seven
physicians per day; whereas, a typical hospital-focused sales
representative can reach many more physicians, nurses and
pharmacy directors within a given institution. Notably, a
hospital-focused sales representative also faces significantly
less travel time between sales calls and less wait time in
physician offices as a large number of prescribers can be found
in a single location. Furthermore, drug sampling generally does
not occur in hospitals, which represents a significant cost
advantage versus marketing to office-based physicians. A single
sales representative can promote products from multiple
therapeutic categories to multiple prescribers within the
institution.
In addition to hospitals, we intend to promote our products to
certain ambulatory care centers, including ambulatory surgery
centers and dialysis clinics, which tend to be located in close
proximity to a hospital and can be targeted with our hospital
sales force. According to Verispan, there are approximately
5,000 outpatient surgery centers in the United States. We
estimate that fewer than 500 of these surgery centers represent
the high opportunity segment for our products. According to the
U.S. General Accounting Office, there are approximately
4,000 dialysis clinics in the United States, of which we believe
most are either co-located with a hospital or located in close
proximity to a hospital.
In recent years there has also been significant activity by both
government agencies and accrediting organizations to hold
hospitals accountable for improving patient outcomes across a
wide variety of areas, including infection control, pain
management, cardiovascular care and others. For example,
according to the Association for Professionals in Infection
Control and Epidemiology, there are now 13 U.S. states that
require hospitals to publicly report their infections rates and
there are more than 20 other states that have had legislative
activity related to public reporting of infection rates in 2006.
These types of initiatives support our view that significant
unmet medical needs remain in hospitals today.
Our Product Development Programs
Our current product development programs are focused on
late-stage development products principally for use in the
hospital setting. Our portfolio consists of the following
product candidates:
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IV APAP(1)
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Treatment of acute pain adults |
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Phase III |
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Marketed (by BMS) |
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United States, Canada |
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Treatment of acute pain pediatrics |
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Phase III |
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Marketed (by BMS) |
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United States, Canada |
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Treatment of fever pediatrics |
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Phase III |
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Marketed (by BMS) |
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United States, Canada |
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Omiganan
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Prevention of local catheter site infections |
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Phase III |
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Phase III |
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North America, Europe |
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(1) |
In March 2006, we in-licensed the patents and the exclusive
development and commercialization rights to IV APAP in the
United States and Canada from BMS. BMS has completed
Phase III trials with respect to the above indications
for IV APAP in Europe and the United States, which we
intend to use in our NDA filing following agreement with the FDA
on additional clinical trials needed in the United States for
approval. In the fourth quarter of 2006, we expect to initiate
the remaining Phase III clinical trial requirements for
submission in the United States. We expect these Phase III
clinical trial results to be available in the first half of 2008
and, if positive, to submit an NDA in the second half of 2008. |
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IV APAP for the Treatment of Acute Pain |
Acute pain is generally defined as pain with relatively short
duration and recent onset with an easily identifiable cause. It
serves to warn the patient of tissue damage and is often sharp
initially and followed by aching pain. In the hospital setting,
acute pain is generally classified as post-operative or
non-operative.
Post-operative pain is a response to tissue damage during
surgery that stimulates peripheral nerves, which signal the
brain to produce a sensory and emotional response.
Post-operative pain may occur not only at the surgical site but
also in areas not directly affected by the surgical procedure.
The pain may be experienced by an inpatient or outpatient and
can be felt after surgical procedures.
Numerous studies reveal that the incidence and severity of
post-operative pain is primarily determined by the type of
surgery, duration of surgery and the treatment choice following
surgery. Post-operative pain is usually greatest with abdominal,
head-neck, orthopedic and thoracic surgery and may last up to
eight days after the surgical procedure. In comparison, surgical
procedures such as arthroscopy, breast biopsy, hernia repair and
plastic surgery tend to be less invasive and generally produce
minor surgical trauma.
Despite major improvements in surgical techniques and the
introduction of novel drugs, the overall treatment of
post-operative pain has not substantially improved over the last
20 years. According to the industry research group
Datamonitor, up to 75% of patients report inadequate pain
relief. Such inadequate pain relief often leads to nausea,
vomiting, decreased mobilization and reduced nutritional
intake all of which impede patient
recovery and can lead to infections and blood clots
in the legs and lungs all of which jeopardize
patient safety. All of these factors have a major impact on
patient care and hospital economic outcomes, including prolonged
hospital stays.
Non-operative pain in the hospital is typically associated with
diseases, disorders, trauma and other conditions. The most
common non-operative pain types among hospitalized patients
include pain associated with cancer, trauma, burns, gallstones
and cardiovascular events. Other incidences of non-operative
pain among hospitalized patients are often related to HIV,
pancreatitis, sickle cell disease and other diseases. Inadequate
pain management in these patients also leads to poor health and
economic outcomes.
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Market for Injectable Analgesics |
Drugs used to treat pain are collectively known as analgesics.
Injectable formulations of analgesics are typically used when
patients are unable to take medications by mouth, faster onset
of analgesia is required, or it is otherwise more convenient to
administer drugs in injectable form. Hospitalized patients may
be unable to take medications by mouth for a variety of reasons
including post-anesthesia sedation, other forms of sedation,
nausea, vomiting, gastrointestinal limitations or other
conditions.
According to IMS, the U.S. market for injectable analgesics
exceeded 500 million units in 2005. Morphine is the current
market leader and accounted for more than 300 million units
in 2005. Other
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injectable opioids such as meperidine, hydromorphone and
fentanyl, which are all available in generic forms, accounted
for more than 135 million units in 2005. Ketorolac
(Toradol), a genericized NSAID, is the only
non-opioid injectable
analgesic for acute pain available in the United States.
According to IMS, injectable ketorolac sold more than
40 million units in 2005.
According to Datamonitor, up to 53 million patients undergo
surgical procedures each year in the United States. Datamonitor
projects the number of surgical procedures to increase as the
elderly population increases and as technological advances allow
new surgical procedures to be performed. As such, we expect that
the need for safe and effective drugs to treat pain in the
post-operative setting will continue to increase.
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Limitations of Current Therapies |
Only two classes of injectable analgesics, opioids and NSAIDs,
are currently available in the United States for the treatment
of acute pain.
Opioids have been used as analgesics for over 2,000 years
and continue to be the mainstay of post-operative pain
management. Opioids activate certain receptors in the central
nervous system, which produce analgesia, euphoria and other
positive effects. A range of opioids are available in injectable
form including morphine, fentanyl, meperidine and hydromorphone.
Opioids, however, are associated with a variety of unwanted side
effects including sedation, nausea, vomiting, constipation,
headache, cognitive impairment and respiratory depression.
Respiratory depression can lead to death if not monitored
closely. Side effects from opioids have been demonstrated to
reduce quality of life and side-effect-related dosing
limitations can result in suboptimal pain relief due to
under-dosing. All of these side effects may require additional
medications or treatments and can prolong patient stay in the
post-anesthesia care unit as well as a patients overall
stay in the hospital or in an ambulatory surgical center.
Opioid-related side effects also impose significant economic
burdens on hospitals and ambulatory surgical centers. For
example, nausea and vomiting, common opioid-related side
effects, can cause the need for administration of anti-nausea
medication, increased monitoring by nurses, increased length of
stay in the post-anesthesia care unit and overall length of stay
in the hospital, diverting resources that could otherwise be
utilized in revenue-generating activities. Studies have
demonstrated increased costs related to post-operative opioid
administration from not only increased personnel time and length
of stay but also increased supply and drug costs, including
drugs to manage the nausea and vomiting.
The only non-opioid
injectable analgesic for acute pain available in the United
States is the NSAID ketorolac. NSAIDs act as non-selective
inhibitors of the enzyme cyclooxygenase, inhibiting both the
cyclooxygenase-1, or
COX-1, and cyclooxygenase-2, or COX-2, enzymes. The inhibition
of COX-2 produces an anti-inflammatory effect resulting in
analgesia. Since NSAIDs do not produce respiratory depression or
impair gastrointestinal motility, they are considered to be
useful alternatives to opioids for the relief of acute pain.
Studies have also demonstrated the opioid-sparing potential of
ketorolac when used in combination with opioids, as well as
resulting decreases in hospital costs. Published studies have
shown lower overall per-patient costs ranging from $326 to
$2,031 for the patients treated with ketorolac and opioids
compared to those treated with opioids alone.
Despite these economic advantages, the use of ketorolac is
severely limited in the post-operative period. Non-specific
NSAIDs such as ketorolac block COX-1, which plays a major role
in the release of prostaglandins to regulate platelet
aggregation and protect the lining of the stomach. As a result,
bleeding, gastrointestinal and renal complications are
significant impediments to the post-operative use of ketorolac.
The product carries a black box warning for these side effects.
A black box warning is the strongest type of warning that the
FDA can require for a drug and is generally reserved for warning
prescribers about adverse drug reactions that can cause serious
injury or death. The FDA specifically warns that ketorolac
should not be used in various patient populations that are
at-risk for bleeding, as a prophylactic analgesic prior to major
surgery or for intraoperative administration when stoppage of
bleeding is critical.
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The World Health Organization, or WHO, has established a
three-step analgesic ladder for the treatment of pain, which
recommends initial treatment with a non-opioid such as
acetaminophen, aspirin, or NSAIDs followed by the addition of
opioids as pain increases. The WHO analgesic ladder is
consistent with the practice of multimodal analgesia, which
involves the use of more than one class of drug for pain control
to obtain additional analgesia, reduce side effects or both. In
the United States, this recommended practice of multimodal
analgesia is not fully available to physicians given the current
lack of an intravenous formulation of acetaminophen. With the
availability of IV APAP in Europe, physicians are able to
treat post-operative pain with IV APAP as baseline therapy
and use opioids in combination as needed for increasing levels
of pain.
IV APAP has been marketed by BMS in Europe since its launch in
France in mid-2002 and subsequent approvals in other countries
throughout Europe and other parts of the world. After obtaining
these approvals, BMS elected to seek a partner to develop and
commercialize IV APAP in the United States and Canada based
on a new corporate strategy to focus the companys research
and development on 10 specific disease areas, which do not
include the treatment of pain. In March 2006, we completed our
agreement with BMS to
in-license these rights.
Acetaminophen is the most widely used drug for pain relief and
the reduction of fever in the United States. The mechanism of
action of acetaminophen remains not well understood; however, it
is believed that acetaminophen acts in part on central COX
enzymes without the peripheral anti-inflammatory effects,
platelet inhibition or other side effects associated with
NSAIDs. Acetaminophen was discovered in the late
19th century but was not available for sale until 1955 when
it was introduced under the brand name Tylenol in the United
States. Acetaminophen is currently available in over 600
combination and single ingredient prescription and
over-the-counter
medicines, including tablet, caplet, orally-dosed liquid
suspension, powder and suppository forms for both adults and
children.
Historically, poor stability in aqueous solutions and inadequate
solubility of acetaminophen prevented the development of an
intravenous dosage form. Acetaminophen will decompose in the
presence of moisture or water. The rate of decomposition is
accelerated as the temperature is increased and upon exposure to
light. The stability is also a function of the solutions
pH, which creates a further challenge to formulate acetaminophen
in an aqueous solution suitable for intravenous administration.
We believe that IV APAP is the only stable,
pharmaceutically-acceptable intravenous formulation of
acetaminophen.
Prior to the introduction of IV APAP in Europe, BMS had
developed an intravenous formulation of propacetamol, a prodrug
that is rapidly converted in the bloodstream to acetaminophen.
This formulation was developed as an alternative approach given
the challenges associated with formulating acetaminophen itself
in solution. Available in Europe for more than 20 years,
intravenous propacetamol was marketed under the brand name
Pro-Dafalgan and was generally indicated for the treatment of
acute moderate pain and the reduction of fever. Pro-Dafalgan was
provided for use as a dried powder to be reconstituted in
solution prior to intravenous administration. In healthcare
workers reconstituting the drug, there were reported incidences
of allergic reactions, including mild allergic reactions on the
skin and severe allergic shock from inhalation. Intravenous
propacetamol was also associated with pain at the injection site
and other local reactions in approximately 50% of patients
receiving the drug.
IV APAP was approved in Europe based on clinical data
demonstrating that the formulation provides superior analgesic
efficacy over placebo and similar analgesic efficacy and
bioequivalence to intravenous propacetamol. Well-controlled
clinical trials have demonstrated that IV APAP has a safety
profile similar to placebo with significantly better
tolerability than intravenous propacetamol upon infusion. Pain
at the injection site has been demonstrated to be no different
than placebo.
IV APAP is the only intravenous formulation of acetaminophen
available anywhere in the world and has now been approved in
over 40 countries. BMS markets IV APAP in Europe and other
countries under the brand name Perfalgan. When BMS
launched IV APAP, it withdrew intravenous propacetamol from
the market. Two strengths of IV APAP are commercially
available in these countries in a
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use solution: a 50mL bottle containing 0.5g acetaminophen and a
100mL bottle containing 1g acetaminophen. Both are labeled
for administration via a 15-minute intravenous infusion.
In Europe, IV APAP was initially launched in France in mid-2002,
followed by Germany and Spain in 2003, the United Kingdom in
2004 and Italy in 2005. Despite this country-by-country launch,
according to IMS, IV APAP achieved a 43% dollar share (20%
of unit volume) among all injectable analgesics sold in Europe
in less than four years. In 2005, IV APAP sold more than
55 million units for total sales exceeding
$140 million (U.S. dollars) according to IMS.
We believe the United States represents a substantially larger
market opportunity for IV APAP than Europe. According to
IMS, over 500 million units of injectable analgesics were
sold in the United States in 2005 compared to approximately
320 million in Europe. More significantly, pharmaceutical
pricing continues to be higher in the United States on average.
Each country in the European Union currently employs direct and
other forms of price controls, including reference systems where
prices for new drugs are based upon the prices of existing drugs
that provide similar therapeutic benefit or prices of drugs in
other European countries. According to IMS, the average selling
price in Europe was approximately $2.50 (U.S. dollars) per
unit.
We believe that the key product attributes that will drive
adoption include the proven efficacy and established safety
profile of acetaminophen, the potential ability to reduce
concomitant use of morphine and other opioids and a more rapid
onset of action.
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Clinical Development History |
Clinical Overview. There have been 2,241 subjects,
including 1,780 subjects that received IV APAP, studied in
nine clinical trials completed by BMS, largely submitted to
support the Marketing Authorization Application, or MAA, that
resulted in European approval. These trials included two
Phase I trials, six Phase III trials and one large
Phase IV trial. Overall, we believe that the results of
these nine studies demonstrate that IV APAP is safe and
effective in the treatment of post-operative pain in adults and
children. These trials have also demonstrated that IV APAP
reduces the consumption of opioids when used in combination.
Clinical Studies for Post-Operative Pain in Adults. One
Phase III study evaluated 150 adult subjects with
moderate-to-severe pain
following total hip and total knee replacements. Subjects were
randomized to receive IV APAP, intravenous propacetamol or
placebo. We believe this study best demonstrates the efficacy
of IV APAP since the patients in the trial were undergoing
surgical procedures with more severe levels of pain. On the
primary efficacy endpoint, pain relief scores in the patients
treated with IV APAP were statistically higher
(p-value<0.05) than those treated with placebo and
not statistically different than those treated with intravenous
propacetamol from 15 minutes to six hours, at which point
patients received a second dose. P-values indicate the
likelihood that clinical trial results were due to random
statistical fluctuations rather than a true cause and effect.
The lower the p-value, the more likely there is a true
cause-and-effect
relationship. Therefore, p-values provide a sense of the
reliability of the results of the study in question. Typically,
the FDA requires a p-value of less than 0.05 to establish the
statistical significance of a clinical trial.
56
The following graph presents the results for pain relief
reported by patients in this Phase III study for
post-operative pain in
adults following major orthopedic surgery, based on a five point
verbal scale, with four representing complete pain relief and
zero representing no pain relief:
In addition, this Phase III study demonstrated the
following results:
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Outcome Measure |
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Result |
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p-value | |
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| |
Median time to morphine rescue
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3.0 hours for IV APAP vs. 0.8 hours for placebo |
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<0.001 |
|
Reduction in morphine consumption over the 24-hour period
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33% reduction (19.1mg) for IV APAP compared to placebo |
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<0.01 |
|
This Phase III study also demonstrated a statistically
significant reduction in pain intensity and a statistically
significant improvement in patient satisfaction with pain
treatment for IV APAP compared to placebo. Drug-related adverse
events in this trial were similar to placebo.
Two Phase III studies evaluated a total of 349 adult
subjects with
moderate-to-severe pain
following third molar surgery. Subjects were randomized to
receive IV APAP, intravenous propacetamol or placebo.
Statistically significant effects versus placebo
(p-value<0.01) were obtained with IV APAP for
all efficacy criteria, including pain relief, pain intensity
difference, duration of analgesia and patients global
evaluation. There were no statistically significant differences
in treatment-related adverse events between IV APAP and
placebo. IV APAP demonstrated similar results on all efficacy
parameters compared to intravenous propacetamol with
significantly lower incidence of pain at the injection site.
One Phase III study evaluated 163 adult subjects with
moderate-to-severe pain
following minor gynecologic surgery. Subjects were randomized to
receive IV APAP or intravenous propacetamol. IV APAP
demonstrated similar results on all efficacy parameters compared
to intravenous propacetamol with statistically significantly
lower incidence of pain at the injection site.
One Phase IV study evaluated 1,061 subjects with
mild-to-moderate pain
following surgery. All subjects received up to four doses
of IV APAP over a
24-hour period. This
trial provided additional data regarding the administration of
multiple-doses of IV APAP.
Clinical Studies for Post-Operative Pain in Children. One
Phase III study evaluated 183 pediatric subjects with
moderate-to-severe pain
following surgery for hernia repair. Subjects were randomized to
receive IV APAP or intravenous propacetamol. IV APAP
demonstrated similar results on all efficacy parameters compared
to intravenous propacetamol with significantly lower incidence
of pain at the injection site.
57
Clinical Studies for Fever in Children. One
Phase III study evaluated 67 pediatric subjects (age one
month to 12 years) with fever of infectious origin.
Subjects were randomized to receive IV APAP or intravenous
propacetamol. IV APAP demonstrated similar results on all
efficacy parameters compared to intravenous propacetamol with
statistically significantly lower incidence of pain at the
injection site.
Safety Summary. The safety of acetaminophen has been
well-established through decades of use in oral, suppository and
intravenous formulations. The primary safety concern with
acetaminophen is hepatotoxicity, which is well-understood and
occurs rarely when acetaminophen is dosed in accordance with the
recommended guidelines. In addition, an effective antidote,
N-acetylcysteine, is available to treat acetaminophen overdose.
We believe there is no evidence that IV APAP poses an
increased risk for hepatoxicity or any other adverse event. In
fact, in the 1,780 subjects receiving IV APAP in nine
clinical trials previously completed by BMS, the product has
exhibited a safety profile consistent with published data for
oral acetaminophen. This is also consistent with observations
from the European post-marketing safety database of IV APAP
which covers a time period in which over 100 million doses
were administered to patients.
In pharmacokinetic trials, the peak plasma concentration of
acetaminophen ranged from 50% to 74% higher for IV APAP
compared to oral acetaminophen; however, total plasma
concentrations over time were not meaningfully different.
Further, these results demonstrated that urinary elimination of
acetaminophen metabolites, including metabolites with potential
to interact with the liver, was not meaningfully different
for IV APAP compared to oral acetaminophen at 12 and
24 hour measurements. Therefore, the study concluded
that IV APAP would not be expected to be associated with an
increased risk of toxicity to the liver compared with an
equivalent dose of acetaminophen administered orally.
Opioid Sparing Summary. The use of IV APAP in
clinical trials has consistently been associated with at least a
33% reduction in opioid consumption compared to placebo. In
these cases, opioids were available at the discretion of
patients utilizing patient controlled analgesia, or PCA, devices.
|
|
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Clinical Development Plan |
We are developing IV APAP based on a targeted indication
for the treatment of acute pain, usually in the post-operative
setting. Our proposed development plan to support this
indication integrates the existing body of IV APAP data,
intravenous propacetamol data and the data generated by clinical
studies to be conducted by us. Under our agreement with BMS, we
have rights to reference these BMS data. We intend to submit a
505(b)(2) NDA for IV APAP based on these data sets as well
as references to the extensive literature which supports the
safety and efficacy of acetaminophen in oral formulations.
Section 505(b)(2) of the Federal Food, Drug and Cosmetic
Act permits the submission of an NDA where at least some of the
information required for approval comes from studies not
conducted by or for the applicant and for which the applicant
has not obtained a right of reference.
We intend to initiate a multiple-dose study in healthy
volunteers to compare the pharmacokinetics of IV APAP with oral
acetaminophen in the fourth quarter of 2006. Four doses
of IV APAP 1g will be administered over a 24 hour
period dosed either four or six hours apart.
Additional clinical trial requirements will be determined based
on additional input from the FDA. We are currently scheduled to
meet with the FDA in the third quarter of 2006 to discuss these
requirements.
We also intend to pursue indications for IV APAP for the
management of acute pain and fever in pediatric populations.
According to the National Center for Health Statistics, an
estimated 1.5 million children undergo surgery each year in
the United States. Appropriate pain management in children
remains a significant unmet need as children often underreport
their pain and inadequate doses of analgesics are often
administered due to fears of side effects. Fever is the most
common reason parents
58
bring their children to the emergency department. In addition,
children frequently become feverish in the hospital setting due
the acquisition of infections.
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Omiganan for the Prevention of Intravascular
Catheter-Related Infections |
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Intravascular Catheter-Related Infections
Background |
The use of catheters for vascular access has become essential to
medical practice. Intravascular catheters are inserted through
the skin and advanced so that the tip rests in a vein or artery.
Intravascular catheters are typically classified as either
peripheral lines which access smaller veins or central lines
(such as CVCs, peripherally inserted central catheters and
arterial lines) to access larger veins (such as the jugular,
femoral and subclavian veins) and arteries. Although such
catheters provide necessary access to veins and arteries, their
use puts patients at risk for dangerous and costly
complications, including LCSIs, catheter colonization and
CRBSIs, and, to a lesser degree, infections in other organs
including the heart, lungs, brain and bones.
Based on published clinical studies, we estimate that, of
patients with a CVC, approximately 10% will develop an LCSI and
20% will develop catheter colonization. This translates into
approximately one million LCSIs and two million incidences of
catheter colonization in the United States each year. The
presence of an LSCI may result in replacement of the catheter
and/or administration of antibiotics, both of which create
additional costs to hospitals and have the potential for adverse
safety outcomes. In addition, catheter colonization is well
correlated with CRBSIs, according to a published review of
clinical trials.
The CDC estimates that there are more than 250,000 CRBSIs among
hospitalized patients and more than 75,000 CRBSIs among
hemodialysis patients in the United States each year.
Attributable mortality is estimated by the CDC to be 12% to 25%
for each CRBSI, which translates into 39,000 to 81,250 deaths
annually due to CRBSIs. Further, the CDC estimates that the
average cost per infection is estimated to be $25,000 and, for
patients in the intensive care unit, is estimated to be up to
$56,000.
The additional costs related to infectious complications from
CVCs result in an estimated annual burden to the healthcare
system exceeding $6 billion. The majority of these costs
are shouldered by hospitals due to the reimbursement system.
Adopted by Medicare in 1983, the Prospective Payment System for
acute hospital inpatient services generally establishes
pre-determined reimbursement amounts, or diagnosis-related
groups, which are classifications based on the patients
discharge diagnoses, procedures performed and other patient
factors. Similar prospective payment systems were later adopted
for certain other Medicare inpatient hospital services, such as
rehabilitation and psychiatric hospitals. When the costs of
treating a patient fall below or are above these prospective
payment amounts, the hospital reaps the respective benefit or
bears the respective cost. Therefore, there is a compelling
economic incentive for these hospitals to use all available
means to reduce infections.
The CDC estimates that hospital-acquired bloodstream infections
are the eighth leading cause of death in the United States and
that intravascular catheters are the leading cause of
hospital-acquired bloodstream infections. Furthermore, a recent
study in the New England Journal of Medicine reported that 70%
of these infections are antibiotic-resistant, making them more
difficult and costly to treat. Consumer groups, the CDC and the
Joint Commission on Accreditation of Healthcare Organizations,
or JCAHO, are calling for greater scrutiny and wider reporting
of data on hospital-acquired infections. JCAHO or other
recognized accreditation is necessary for reimbursement
eligibility with Medicare and most insurers. Laws have been
passed mandating public reporting of hospital-acquired infection
data in Colorado, Connecticut, Florida, Illinois, Maryland,
Missouri, New Hampshire, New York, Pennsylvania, South Carolina,
Tennessee, Vermont and Virginia. In 2006, more than 20 other
states have had some legislative activity related to public
reporting of hospital-acquired infections. We believe that the
increased scrutiny on catheter-related infections in addition to
compelling economic incentives will drive adoption of new
products which show an ability to reduce infection rates.
59
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Market for Antimicrobials to Prevent Intravascular
Catheter Infections |
Theta Reports estimates that nearly 500 million
intravascular catheters will be used in the United States in
2006, including approximately 10 million CVCs. Unit sales
of CVCs are projected to grow at 9% per year. Outside the
United States, Theta Reports estimates that approximately
11 million CVCs will be used in 2006. The number of CVC
placements is increasing as the population continues to age and
hospitalized patients become increasingly compromised. We
estimate that patients with a CVC receive, on average, three to
four topical antimicrobial applications during a hospital stay.
This translates into more than an estimated 30 million
applications in the United States in 2006 for CVCs alone.
The Centers for Medicare and Medicaid Services indicate that
there were more than 321,500 patients with end-stage renal
disease receiving dialysis at the end of 2004, of which
approximately 25% had a CVC. This patient population has been
growing at an annual rate of approximately 8% due to the aging
population, rise in diabetes, shortage of organ donors and
improved technologies enabling longer survival of patients with
end-stage renal disease. Patients on hemodialysis receive, on
average, three topical antimicrobial applications per week. This
translates into more than an estimated 12 million
applications in the United States in 2006.
The use of topical antimicrobials to prevent infections
associated with other central lines, including arterial lines
and peripherally inserted central catheters, also represents a
significant market opportunity. According to Theta Reports,
there are more than 2 million peripherally inserted central
catheters inserted in the United States each year. We estimate
there are also approximately 7 million arterials lines
inserted in the United States each year.
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Limitations of Current Therapies |
Microorganisms on the skin surface have been demonstrated to be
the leading cause of intravascular device-related infections,
including LCSIs and CRBSIs. The same microorganisms on the skin
that cause LCSIs can lead to CRBSIs. Given the evidence for the
importance of killing microorganisms on the skin surface to
prevent the development of intravascular device-related
infections, the use of topical antimicrobials is critical.
However, currently available products have significant
limitations.
The standard of care for skin antisepsis prior to catheter
insertion and at dressing changes has been dominated by either
povidone-iodine, also known as Betadine, or chlorhexidine,
although usage patterns are increasingly favoring chlorhexidine.
In 2002, the CDC published guidelines that stated that although
chlorhexidine is preferred, povidone-iodine can be used. In
2002, a meta-analysis of eight heterogeneous studies comparing
various formulations of chlorhexidine to povidone-iodine for the
prevention of catheter-related infections was published. While
the meta-analysis indicated a benefit to chlorhexidine, only one
of the eight studies on its own demonstrated a statistically
significant reduction of CRBSIs. We believe that this change in
medical practice despite the lack of robust clinical evidence
underscores the desire and willingness of healthcare providers
to address this significant unmet need.
Although topical antiseptics tend to have a broad spectrum of
antimicrobial activity, duration of activity ranges from minutes
to hours after application. These products do not provide
sustained antimicrobial coverage throughout the periods between
dressing changes (typically every 72-96 hours), and this
lack of sustained antimicrobial activity can put patients at
increased risk for acquiring an infection at the catheter
insertion site.
In order to address the limited duration of activity associated
with topical antiseptics, topical antibiotics have been used,
either alone or in combination with topical antiseptics, to
confer protection against microbial invasion. Clinical trials
have shown benefits attributable to topical antibiotics, but
these products have either been associated with increased
frequency of fungal infections or emergence of bacterial
resistance, including MRSA. These drawbacks have significantly
diminished the use of topical antibiotics for the prevention of
catheter-related infections. As a result, the market has almost
exclusively switched back to the use of topical antiseptics.
60
There is some limited use of BioPatch, a
chlorhexidine-impregnated foam dressing that is placed around
the catheter at the insertion site. While this product delivers
chlorhexidine to the catheter insertion site over a period of
days, it has not been widely adopted reportedly due to
difficulty in applying the dressing and the inability to visibly
inspect the insertion site through the dressing. Physicians and
nurses must lift up the BioPatch to monitor the insertion site
for redness, swelling and other leading signs of infection. Such
disruption of the dressing has the potential to interfere with
the sterility of the site and promote the spread of pathogens.
Other products either in use or in development to reduce
catheter-related infections are focused on downstream aspects of
the infectious process. Some catheters coated with antiseptics
and antibiotics have demonstrated reductions in catheter-related
infections. Other new technologies being developed include
contamination-resistant hubs, attachable cuffs, new
catheter-coatings and antiseptic catheter lock solutions. We
believe any use of these products would be in addition to the
use of antimicrobial agents on the skin surface to prevent
catheter-related infections.
Omiganan was discovered by researchers at Migenix. Migenix
subsequently entered into a collaboration and license agreement
with Fujisawa Healthcare, Inc., or Fujisawa. In that agreement,
Fujisawa was granted the rights to commercialize omiganan in
North America in return for licensing payments, funding of all
remaining development costs and establishment of a joint
development committee. In January 2004, Migenix reacquired all
rights to omiganan from Fujisawa after completion of the first
Phase III trial and then, in July 2004, licensed both the
North American and European rights to us with the objective of
completing the development program and commercializing the
product.
Unlike other topical antimicrobials, omiganan exhibits a
combination of features that we believe make it an ideal product
for the prevention of catheter-related infections. Such features
include:
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broad spectrum bactericidal and fungicidal activity; |
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activity against resistant strains, including MRSA; |
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rapid and prolonged duration of effect; |
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resistance to omiganan has not been induced in the laboratory; |
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no demonstrated ability to generate cross-resistance to other
antimicrobials; |
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excellent safety profile; and |
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convenient application. |
Omiganan is effective against a wide variety of bacteria and
fungi. The compound has been tested against more than 285
strains of Gram-positive and Gram-negative bacteria as well as
more than 75 fungal strains. These studies demonstrate that
omiganan has broad bactericidal and fungicidal activity against
bacteria and fungi commonly found on the surface of human skin.
Further, omiganan has also demonstrated the ability to kill
multi-drug resistant microorganisms, including MRSA, and
vancomycin-resistant enterococcus, or VRE. The incidence
of resistant infections is increasing, and these microorganisms
represent a potentially significant threat to the public health.
Omiganan has demonstrated not only the ability to kill rapidly
but also, unlike the topical antiseptics, a prolonged duration
of effect. In preclinical studies with omiganan, most
microorganisms were killed after only six minutes of exposure.
In skin surface studies, omiganan demonstrated the ability to
kill more than 99.9% of microorganisms for at least three days.
In laboratory testing conducted by Migenix, resistance to
omiganan, unlike the topical antiseptics, has not been
demonstrated, nor has
cross-resistance to
other antimicrobials been demonstrated. A primary mechanism of
action of omiganan is believed to be depolarization of the outer
cell membrane of infectious microorganisms, resulting in cell
death. Specific receptors within the cell have not been shown to
be
61
involved in the disruption of the cell membrane and, therefore,
this non-specific mechanism of action decreases the likelihood
of the development of resistance.
Omiganan presents a benign toxicological profile when
administered topically at doses as much as 30 times the planned
human dose. The product has been demonstrated to be
non-irritating to the skin, non-sensitizing to the skin, and not
absorbed through the skin into the bloodstream (based on the
inability to detect omiganan in the bloodstream at very low
levels) and, therefore, has no meaningful systemic exposure.
Omiganan is packaged in a convenient, single
unit-of-use plastic
squeeze vial. Omiganan, which is formulated as a 1% clear
viscous, aqueous gel, is applied around the catheter insertion
site by squeezing the plastic vial. Unlike the topical
antiseptics, omiganan does not have to be scrubbed onto the skin
surface. Unlike povidone-iodine, omiganan does not have the
potential to stain the skin and clothes of patients and
healthcare providers.
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Clinical Development History |
Migenix completed one Phase I and two Phase II studies
of omiganan in a total of 273 subjects. These trials
demonstrated no evidence of sensitization, clinically
significant irritation or systemic absorption. In addition, the
Phase I trial exhibited killing of greater than 99.9% of
bacteria and fungi on skin and maintained this level of
antimicrobial activity for at least three days.
Migenix and Fujisawa subsequently completed a multi-center,
randomized, evaluation committee-blinded Phase III trial
that compared omiganan to 10% povidone-iodine in patients
receiving CVCs, peripherally inserted central catheters, and/or
arterial lines. The study was conducted in 1,407 patients
in 27 centers in the United States. The primary efficacy
endpoint was to demonstrate the superiority of omiganan over 10%
povidone-iodine for the prevention of CRBSIs, as determined by a
treatment-blinded evaluation committee. Secondary efficacy
endpoints included demonstrating the superiority of omiganan for
the prevention of LCSI and catheter colonization.
Treatment with omiganan resulted in a statistically significant
reduction in catheter colonization compared to 10%
povidone-iodine (p-value=0.002). The omiganan group had
21.9% fewer incidences of catheter colonization than the 10%
povidone-iodine group.
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Treatment Arm | |
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Variable |
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10% povidone-iodine | |
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omiganan | |
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p-value | |
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| |
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| |
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Catheter colonization present
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232/583 (39.8)% |
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180/578 (31.1)% |
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0.002 |
|
Treatment with omiganan also resulted in a statistically
significant reduction in LCSI
(p-value=0.004).
The table below summarizes data for LCSI in the modified
intent-to-treat
analysis set, which includes only those patients who did not
have a bloodstream infection present at baseline. As shown in
the table, the omiganan group had 49.2% fewer LCSIs than the 10%
povidone-iodine group. Moreover, there was a greater than 50%
reduction in the number of patients that had an LCSI and a
catheter removed (p-value=0.002).
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Treatment Arm | |
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Variable |
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10% povidone-iodine | |
|
omiganan | |
|
p-value | |
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| |
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| |
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LCSI present
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48/699 (6.9)% |
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24/693 (3.5)% |
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0.004 |
|
Despite these favorable, statistically significant results for
LCSI and catheter colonization, the study did not show
statistical significance for the primary endpoint of CRBSI. The
table below compares the incidence of CRBSI in the modified
intent-to-treat
analysis set after treatment with omiganan or 10%
povidone-iodine. The
rates of failure (development of CRBSI) and indeterminate
response were similar for the two treatments arms. There was a
15.4% reduction in the incidence of microbiologically-proven
CRBSI in the omiganan group compared to 10% povidone iodine;
however, this outcome was not statistically significant.
62
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Treatment Arm | |
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Outcome |
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10% povidone-iodine | |
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omiganan | |
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p-value | |
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Failure
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18/699 (2.6)% |
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15/693 (2.2)% |
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0.622 |
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Success
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635/699 (90.8)% |
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630/693 (90.9)% |
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Indeterminate
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46/699 (6.6)% |
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48/693 (6.9)% |
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|
The definition of CRBSI required an organism isolated from a
peripheral blood draw to be genotypically matched to an organism
isolated from the catheter tip. In this study, many catheters
were lost and the organisms could be not isolated from the
catheter tip. Similarly, many patients were administered
systemic antibiotics for suspected bloodstream infections but
were given such antibiotics prior to taking a blood draw. As a
result, the high rate of indeterminate events was observed,
which we believe was a significant factor contributing to the
lower than expected rate of CRBSI. In addition, the study
enrolled a large number of patients that were at relatively low
risk for developing a CRBSI, which we believe further decreased
the event rate to a point where, as observed, a statistically
significant difference for CRBSI between the two treatment arms
could not be detected. We believe that the CRBSI endpoint, as
defined in the previous study, is not achievable without a very
significant increase the number of patients enrolled.
Only 14 patients (2.0%) in each treatment group had adverse
events that were considered drug-related. All of these omiganan
adverse events were related to the catheter insertion site, and
none were serious. Overall, there were no statistically
significant differences between the treatment groups for any
safety variable.
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Clinical Development Plan |
In June 2005, we reached agreement on the clinical development
plan for omiganan with the FDA under the FDAs SPA process.
The SPA process provides for a formal review and written
agreement of clinical protocols that are binding on both the FDA
and the company sponsor. Through the SPA process, the FDA agreed
that a single confirmatory Phase III trial would be
required for approval and that LCSI would be the sole primary
efficacy endpoint. Secondary endpoints include catheter
colonization and other measures of infection.
The presence of an LCSI will typically result in one of several
actions being taken by a physician, including administration of
systemic or topical antimicrobials and/or removal and
replacement of the catheter. The most serious risks from
catheter replacement include bleeding from a damaged artery or
puncturing of a lung. Further, the same microorganisms on the
skin surface that cause LCSIs can cause CRBSIs. A published
review of clinical trials found that catheter colonization is
well correlated to CRBSIs.
We have completed a market research study that indicates
physicians only modestly favor (73% vs. 65%) a profile of
omiganan that demonstrates a statistically significant reduction
in LCSIs, catheter colonization and CRBSIs compared to a profile
of omiganan that demonstrates a statistically significant
reduction in LCSIs and catheter colonization alone. The FDA has
communicated to us that LCSI is a clinically relevant indication
and, based on these market research findings, we believe that a
product indicated for the prevention of LCSIs is also a highly
relevant indication to physicians.
The confirmatory Phase III trial that we are conducting
according to the SPA, known as the Central Line Infection
Reduction Study, or CLIRS trial, is a multi-center, randomized,
evaluation committee-blinded study in patients receiving a CVC.
The primary efficacy endpoint of the study is to evaluate
whether omiganan is superior to 10% povidone-iodine in the
reduction of LCSI in patients requiring central venous
catheterization. Secondary objectives of the study are to
evaluate whether omiganan is superior to 10% povidone-iodine
treatment in preventing significant catheter colonization, CRBSI
and all-cause bloodstream infections in patients requiring
central venous catheterization.
The CLIRS trial is designed to recruit 1,250 patients
randomized to receive either omiganan or 10% povidone-iodine.
The study began enrollment in August 2005 and is currently being
conducted at
63
centers in the United States and Europe. We expect to complete
enrollment and have results available in the second half of
2007. Omiganan for the prevention of LCSIs was awarded fast
track status by the FDA, and we intend to submit an NDA to the
FDA in the first half of 2008.
We also intend to submit an MAA to European regulatory
authorities in the first half of 2008. We have met with
regulatory authorities in several European countries and believe
that no additional clinical trials will be required for
submission if the ongoing CLIRS trial is successful.
We intend to pursue a pediatric indication for omiganan for the
prevention of catheter-related infections. As in the adult
population, CVCs are frequently used in neonates, infants and
children with wide variety of conditions. Pediatric CVCs are a
significant source of infectious complications in hospitalized
children.
We have rights to develop and commercialize omiganan
pentahydrochloride for additional indications related to the
prevention and treatment of device-related, surgical
wound-related and burn-related infections. We believe that
omiganan pentahydrochloride may have significant opportunity in
these areas. For example, the CDC estimates there are
approximately 500,000 post-operative surgical site infections in
the United States annually. The CDC also estimates that there
are 50,000 hospitalizations from burn injuries and that 10,000
people will die from burn-related infections in the United
States every year.
Commercialization Strategy
We intend to build a commercial organization in the United
States focused on promoting our products to physicians, nurses
and pharmacy directors principally in the hospital setting. We
believe that we can achieve our strategic goals by deploying an
experienced sales organization supported by an internal
marketing infrastructure that targets institutions with the
greatest use of pharmaceutical products. We will consider
opportunities to partner our products to reach markets outside
the United States or to expand our reach to other physician
groups outside the hospital where applicable. In particular, we
believe that omiganan is an excellent candidate for partnering
in countries outside the United States, and we anticipate
launching the product in those countries with a partner who has
the resources to be competitive in the hospital market.
For the launch of omiganan in the United States, we intend to
build our own commercial organization and estimate that a sales
force of approximately 75-100 people will reach the top 1,200
institutions, which we believe represents more than 60% of the
market opportunity for the product. Sales calls will primarily
target intensive care physicians, infectious disease physicians
and infection control physicians and nurses. Other targets will
include anesthesiologists, surgeons, intensive care and other
nurses in the hospital, and physicians and nurses in outpatient
dialysis centers. Key elements in the adoption of omiganan will
include formulary acceptance followed by trial and usage and,
ultimately, adoption to standing orders and protocols within the
hospitals and specific units therein. We expect that omiganan
will initially be used in combination with topical antiseptics
but ultimately may be used as a stand-alone treatment after more
widespread use.
For the launch of IV APAP, we intend to expand the sales
force to 150-200 people to reach the top 1,800 to 2,000
institutions, which we believe represents more than 80% of the
opportunity for both products. The primary target audience will
include anesthesiologists and surgeons. Other targets will
include certified registered nurse anesthetists, emergency
medicine physicians, obstetricians and other physicians
throughout the hospital.
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Licensing Agreements
In March 2006, we in-licensed the patents and the exclusive
development and commercialization rights to IV APAP in the
United States and Canada from BMS. BMS has sublicensed these
rights to us under a license agreement with SCR Pharmatop S.A.,
or Pharmatop.
As consideration for the license, we paid a $25.0 million
up-front fee and may be required to make future milestone
payments totaling up to $50.0 million upon the achievement
of various milestones related to regulatory or commercial
events. We are also obligated to pay a royalty on net sales of
the licensed products. We have the right to grant sublicenses to
our affiliates.
The term of the IV APAP agreement generally extends on a
country-by-country basis until the last licensed patent expires,
which is expected to occur in 2022. Either party may terminate
the IV APAP agreement upon delivery of written notice if
the other party commits a material breach of its obligations and
fails to remedy the breach within a specified period or upon the
occurrence of specified bankruptcy, reorganization, liquidation
or receivership proceedings. In addition, BMS may terminate
the IV APAP agreement if we breach, in our capacity as a
sublicensee, any provision of the agreement between BMS and
Pharmatop. The IV APAP agreement will automatically
terminate in the event of a termination of the license agreement
between BMS and Pharmatop. We may terminate the IV APAP
agreement at any time upon specified written notice to BMS after
the occurrence of an event that relates to our territory and
would entitle BMS to terminate the Pharmatop license agreement
pursuant to specified sections thereof. We may also terminate
the IV APAP agreement upon specified written notice after
an uncured failure by Pharmatop to perform any of its material
obligations under the Pharmatop license agreement with respect
to our territory that would permit BMS to terminate the
Pharmatop license agreement.
In July 2004, we in-licensed from Migenix the patents and the
exclusive development and commercialization rights to omiganan
pentahydrochloride for the prevention and treatment of
device-related, surgical wound-related and burn-related
infections in North America and Europe.
As consideration for the license, we paid a $2.0 million
up-front fee, of which $1.9 million was allocated to the
value of the acquired technology and $100,000 was attributed to
the acquisition of 617,284 shares of Migenix common stock.
We may be required to make future milestone payments totaling up
to $27.0 million upon the achievement of various milestones
related to regulatory or commercial events. We are also
obligated to pay a royalty on net sales of the licensed
products. We have the right to grant sublicenses to third
parties.
The term of the omiganan agreement generally extends until the
last licensed patent expires, which is expected to occur in
November 2022. Either party may terminate the omiganan agreement
upon specified written notice after the other party commits a
material breach of its obligations and fails to remedy the
breach or upon the cessation of operations of the other party or
occurrence of specified bankruptcy, reorganization, liquidation
or receivership proceedings involving the other party. We may
terminate the omiganan agreement upon written notice if we
determine, prior to regulatory approval in the United States,
that the product is not reasonably expected to demonstrate
safety or efficacy. We may also terminate the omiganan agreement
upon specified written notice after receipt of any interim
results or the executive summary following database lock of the
on-going Phase III trial for omiganan.
Intellectual Property
We are the exclusive licensee of two U.S. patents and two
pending Canadian patent applications from Pharmatop, under
BMSs license to these patents from Pharmatop.
U.S. Patent No. 6,028,222 (Canadian patent application
2,233,924) covers the formulation of IV APAP and expires in
August 2017.
65
U.S. Patent No. 6,992,218 (Canadian patent application
2,415,403) covers the process used to manufacture IV APAP
and expires in June 2021.
We have also in-licensed the non-exclusive rights to two
U.S. patents from BMS. U.S. Patent No. 6,593,331
covers a method of treating pain with acetaminophen and
concurrent administration of a hydroxyazapirone and expires in
April 2022. US Patent No. 6,511,982 covers a method of
treating pain with acetaminophen and concurrent administration
of buspirone and expires in June 2020.
We are the exclusive licensee of four U.S. patents, two
pending U.S. applications, and their international
equivalents in North America and Europe for the prevention and
treatment of device-related, surgical wound-related, and
burn-related infections. U.S. Patent No. 6,180,604 and
U.S. Patent No. 6,538,106 cover composition of matter
for certain analogues of indolicidin, including omiganan, and
expire in August 2017. U.S. Patent No. 6,503,881
covers composition of matter for additional analogues of
indolicidin (not including omiganan), pharmaceutical
preparations of certain analogues of indolicidin, including
omiganan, and methods of using the pharmaceutical preparations
for treating microbial infections (including covering routes of
administration). U.S. Patent No. 6,503,881 also
expires in August 2017. U.S. Patent No. 6,835,536
covers specific pharmaceutical preparations of certain analogues
of indolicidin, including omiganan, and methods of treatment by
applying pharmaceutical preparations to a target site, including
a target site were a medical device is inserted.
U.S. Patent No. 6,835,536 expires in November 2022.
Manufacturing
We have contracted with BMS to manufacture clinical supplies
of IV APAP. For commercial supply, the active
pharmaceutical ingredient, or API, acetaminophen is readily
available from multiple suppliers. We are currently negotiating
with suppliers for commercial supply of the finished drug
product for IV APAP.
We have purchased clinical supplies of the API omiganan
pentahydrochloride from UCB Bioproducts, which was recently
acquired by Lonza Group, Ltd. We have purchased clinical
supplies of the omiganan finished drug product from Cardinal
Health, Inc. Lonza and Cardinal have produced the clinical
supplies which we are using in our Phase III omiganan
program. We are currently negotiating with suppliers for
commercial supply of the API and finished drug product for
omiganan.
Competition
The pharmaceutical industry is subject to intense competition
and characterized by extensive research efforts and rapid
technological progress. Competition in our industry occurs on a
variety of fronts, including developing and bringing new
products to market before others, developing new technologies to
improve existing products, developing new products to provide
the same benefits as existing products at lower cost and
developing new products to provide benefits superior to those of
existing products. There are many companies, including generic
manufacturers as well as large pharmaceutical companies, that
have significantly greater financial and other resources than we
do, as well as academic and other research institutions that are
engaged in research and development efforts for the indications
targeted by our product candidates.
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Our IV APAP product candidate is being developed for the
treatment of acute pain, usually in the hospital setting. A wide
variety of competitive products already address this target
market, including:
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Morphine is the leading product for the treatment of acute
post-operative pain, and is available generically from several
manufacturers; |
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DepoDur, currently marketed by Endo Pharmaceuticals, is an
extended release injectable formulation of morphine; and |
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other injectable opioids, including fentanyl, meperidine and
hydromorphone, each of which is available generically from
several manufacturers. |
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Ketorolac, an injectable NSAID, is available generically from
several manufacturers. |
We are also aware of a number of product candidates in
development to treat acute pain, including injectable NSAIDs,
novel opioids, new formulations of currently available opioids,
long-acting local anesthetics and new chemical entities as well
as alternative delivery forms of various opioids and NSAIDs. A
variety of pharmaceutical and biotechnology companies are
developing these new product candidates, including but not
limited to Anesiva, Inc (formerly Corgentech Inc.), CeNeS
Pharmaceuticals plc, Cumberland Pharmaceuticals Inc., Durect
Corporation, Javelin Pharmaceuticals, Inc., Pfizer Inc.,
SkyePharma Inc., St. Charles Pharmaceuticals, TheraQuest
Biosciences, LLC and Xsira Pharmaceuticals, Inc.
We are developing our omiganan product candidate for the
prevention of intravascular catheter-related infections.
Although there are no approved drugs for this specific
indication, a number of topical products are currently used in
practice and one device has been approved for wound dressing and
prevention of catheter-related infections. These competitive
products include:
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topical antiseptics such as povidone-iodine and chlorhexidine,
each of which is available generically from several
manufacturers; |
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Neosporin, a topical antibacterial ointment containing
polymyxin, neomycin and bacitracin, available generically from
several manufacturers; |
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Bactroban, a topical antibacterial containing mupirocin,
available generically from several manufacturers; and |
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BioPatch, a chlorhexidine-impregnated foam dressing, from
Johnson & Johnson that is approved both for wound
dressing and the prevention of catheter-related infections. |
Other products may be in development; however, we are not aware
of any other topical drugs being developed for the prevention of
intravascular catheter-related infections.
Government Regulation
Governmental authorities in the United States and other
countries extensively regulate the testing, manufacturing,
labeling, storage, record-keeping, advertising, promotion,
export, marketing and distribution, among other things, of
pharmaceutical products. In the United States, the FDA, under
the Federal Food, Drug and Cosmetic Act and other federal
statutes and regulations, subjects pharmaceutical products to
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rigorous review. If we do not comply with applicable
requirements, we may be fined, the government may refuse to
approve our marketing applications or allow us to manufacture or
market our products, and we may be criminally prosecuted.
We and our manufacturers and clinical research organizations may
also be subject to regulations under other federal, state and
local laws, including the Occupational Safety and Health Act,
the Environmental Protection Act, the Clean Air Act and import,
export and customs regulations as well as the laws and
regulations of other countries.
To obtain approval of a new product from the FDA, we must, among
other requirements, submit data supporting safety and efficacy
as well as detailed information on the manufacture and
composition of the product and proposed labeling. The testing
and collection of data and the preparation of necessary
applications are expensive and time-consuming. The FDA may not
act quickly or favorably in reviewing these applications, and we
may encounter significant difficulties or costs in our efforts
to obtain FDA approvals that could delay or preclude us from
marketing our products.
The process required by the FDA before a new drug may be
marketed in the United States generally involves the following:
completion of preclinical laboratory and animal testing in
compliance with FDA regulations, submission of an
investigational new drug application, or IND, which must become
effective before human clinical trials may begin, performance of
adequate and well-controlled human clinical trials to establish
the safety and efficacy of the proposed drug for its intended
use, and submission and approval of an NDA by the FDA. The
sponsor typically conducts human clinical trials in three
sequential phases, but the phases may overlap. In Phase I
clinical trials, the product is tested in a small number of
patients or healthy volunteers, primarily for safety at one or
more dosages. In Phase II clinical trials, in addition to
safety, the sponsor evaluates the efficacy of the product on
targeted indications, and identifies possible adverse effects
and safety risks in a patient population. Phase III
clinical trials typically involve testing for safety and
clinical efficacy in an expanded population at
geographically-dispersed test sites.
Clinical trials must be conducted in accordance with the
FDAs good clinical practices requirements. The FDA may
order the partial, temporary or permanent discontinuation of a
clinical trial at any time or impose other sanctions if it
believes that the clinical trial is not being conducted in
accordance with FDA requirements or presents an unacceptable
risk to the clinical trial patients. The institutional review
board, or IRB, generally must approve the clinical trial design
and patient informed consent at each clinical site and may also
require the clinical trial at that site to be halted, either
temporarily or permanently, for failure to comply with the
IRBs requirements, or may impose other conditions.
The applicant must submit to the FDA the results of the
preclinical and clinical trials, together with, among other
things, detailed information on the manufacture and composition
of the product and proposed labeling, in the form of an NDA,
including payment of a user fee. The FDA reviews all NDAs
submitted before it accepts them for filing and may request
additional information rather than accepting an NDA for filing.
Once the submission is accepted for filing, the FDA begins an
in-depth review of the NDA. Under the policies agreed to by the
FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA
has 10 months in which to complete its initial review of a
standard NDA and respond to the applicant. The review process
and the PDUFA goal date may be extended by three months if the
FDA requests or the NDA sponsor otherwise provides additional
information or clarification regarding information already
provided in the submission within the last three months of the
PDUFA goal date. If the FDAs evaluations of the NDA and
the clinical and manufacturing procedures and facilities are
favorable, the FDA may issue either an approval letter or an
approvable letter, which contains the conditions that must be
met in order to secure final approval of the NDA. If and when
those conditions have been met to the FDAs satisfaction,
the FDA will issue an approval letter, authorizing commercial
marketing of the drug for certain indications. According to the
FDA, the median total approval time for NDAs approved during
calendar year 2004 was approximately 13 months for standard
applications. If the
68
FDAs evaluation of the NDA submission and the clinical and
manufacturing procedures and facilities is not favorable, the
FDA may refuse to approve the NDA and issue a not approvable
letter.
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Special Protocol Assessment Process |
The special protocol assessment, or SPA, process provides for
official FDA evaluation of a proposed Phase III clinical
trial protocol and generally provides a product sponsor with a
binding agreement from the FDA that the design and analysis of
the trial are adequate to support a license application
submission if the trial is performed according to the SPA. The
FDAs guidance on the SPA process indicates that SPAs are
designed to evaluate individual clinical trial protocols
primarily in response to specific questions posed by the
sponsors. In practice, the sponsor of a product candidate may
request an SPA for proposed Phase III trial objectives,
designs, clinical endpoints and analyses. A request for an SPA
is submitted in the form of a separate amendment to an IND, and
the FDAs evaluation generally will be completed within a
45-day review period
under applicable PDUFA goals, provided that the trials have been
the subject of discussion at an
end-of-Phase II
and pre-Phase III meeting with the FDA, or in other limited
cases. All agreements and disagreements between the FDA and the
sponsor regarding an SPA, including the FDAs responses to
questions about protocol design, primary efficacy endpoints,
study conduct, data analysis and prospective labeling statements
must be documented in writing. In limited circumstances, the FDA
may agree that a specific finding, such as a particular p-value
on the primary efficacy endpoint of a study, will satisfy a
specific objective, such as demonstration of efficacy, or
support an approval decision. However, final determinations by
the FDA are made after a complete review of the applicable NDA
and are based on the entire data in the application, and any SPA
is subject to future public health concerns unrecognized at the
time of protocol assessment.
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Section 505(b)(2) New Drug Applications |
As an alternate path to FDA approval for new indications or
improved formulations of previously-approved products, a company
may file a Section 505(b)(2) NDA, instead of a
stand-alone or full NDA.
Section 505(b)(2) of the Federal Food, Drug and Cosmetic
Act was enacted as part of the Drug Price Competition and Patent
Term Restoration Act of 1984, otherwise known as the
Hatch-Waxman Amendments. Section 505(b)(2) permits the
submission of an NDA where at least some of the information
required for approval comes from studies not conducted by or for
the applicant and for which the applicant has not obtained a
right of reference. For example, the Hatch-Waxman Amendments
permit the applicant to rely upon the FDAs findings of
safety and effectiveness for an approved product. The FDA may
also require companies to perform additional studies or
measurements to support the change from the approved product.
The FDA may then approve the new formulation for all or some of
the label indications for which the referenced product has been
approved, or the new indication sought by the
Section 505(b)(2) applicant.
To the extent that the Section 505(b)(2) applicant is
relying on the FDAs findings for an already-approved
product, the applicant is required to certify to the FDA
concerning any patents listed for the approved product in the
FDAs Orange Book publication. Specifically, the applicant
must certify that: (1) the required patent information has
not been filed; (2) the listed patent has expired;
(3) the listed patent has not expired, but will expire on a
particular date and approval is sought after patent expiration;
or (4) the listed patent is invalid or will not be
infringed by the manufacture, use or sale of the new product. A
certification that the new product will not infringe the already
approved products Orange Book-listed patents or that such
patents are invalid is called a paragraph IV certification.
If the applicant does not challenge the listed patents, the
Section 505(b)(2) application will not be approved until
all the listed patents claiming the referenced product have
expired. The Section 505(b)(2) application may also not be
approved until any non-patent exclusivity, such as exclusivity
for obtaining approval of a new chemical entity, listed in the
Orange Book for the referenced product has expired.
If the applicant has provided a paragraph IV certification
to the FDA, the applicant must also send notice of the
paragraph IV certification to the NDA and patent holders
once the NDA has been accepted for filing by the FDA. The NDA
and patent holders may then initiate a legal challenge to the
69
paragraph IV certification. The filing of a patent
infringement lawsuit within 45 days of their receipt of a
paragraph IV certification automatically prevents the FDA
from approving the Section 505(b)(2) NDA until the earliest
of 30 months, expiration of the patent, settlement of the
lawsuit or a decision in the infringement case that is favorable
to the Section 505(b)(2) applicant. For drugs with
five-year exclusivity, if an action for patent infringement is
initiated after year four of that exclusivity period, then the
30-month stay period is
extended by such amount of time so that 7.5 years has
elapsed since the approval of the NDA with five-year
exclusivity. This period could be extended by six months if the
NDA sponsor obtains pediatric exclusivity. Thus, the
Section 505(b)(2) applicant may invest a significant amount
of time and expense in the development of its products only to
be subject to significant delay and patent litigation before its
products may be commercialized. Alternatively, if the listed
patent holder does not file a patent infringement lawsuit within
the required 45-day
period, the applicants NDA will not be subject to the
30-month stay.
Notwithstanding the approval of many products by the FDA
pursuant to Section 505(b)(2), over the last few years,
certain brand-name pharmaceutical companies and others have
objected to the FDAs interpretation of
Section 505(b)(2) and one pharmaceutical company has sued
the FDA on the matter. Although the issues in that litigation
are specific to the products involved, if the FDA does not
prevail, it may be required to change its interpretation of
Section 505(b)(2), which could delay or even prevent the
FDA from approving any Section 505(b)(2) NDA that we submit.
A drug designated as a fast track product by the FDA must be
intended for the treatment of a serious or life-threatening
condition and demonstrate the potential to address unmet medical
needs for the condition. Fast track designation does not apply
to a product alone, but applies to a combination of the product
and specific indication for which it is being studied. A sponsor
may submit a request for fast track designation at the time of
original submission of its IND, or at any time thereafter prior
to receiving marketing approval of its NDA. Fast track status
enables the sponsor to have more frequent and timely
communication and meetings with the FDA regarding the product
development plans. Fast track status may also result in
eligibility for NDA priority review, under which the PDUFA
review goal for the NDA is six months rather than ten months.
Under the Hatch-Waxman Act, newly-approved drugs and indications
benefit from a statutory period of non-patent marketing
exclusivity. The Hatch-Waxman Act provides five-year marketing
exclusivity to the first applicant to gain approval of an NDA
for a new chemical entity, meaning that the FDA has not
previously approved any other new drug containing the same
active moiety. Hatch-Waxman prohibits the submission of an
abbreviated new drug application, or ANDA, or a
Section 505(b)(2) NDA for another version of such drug
during the five-year exclusive period; however, as explained
above, submission of an ANDA or Section 505(b)(2) NDA
containing a paragraph IV certification is permitted after
four years, which may trigger a
30-month stay of
approval of the ANDA or Section 505(b)(2) NDA. Protection
under Hatch-Waxman will not prevent the submission or approval
of another full NDA; however, the applicant would be required to
conduct its own preclinical and adequate and well-controlled
clinical trials to demonstrate safety and effectiveness. The
Hatch-Waxman Act also provides three years of marketing
exclusivity for the approval of new and supplemental NDAs,
including Section 505(b)(2) NDAs, for, among other things,
new indications, dosages or strengths of an existing drug, if
new clinical investigations that were conducted or sponsored by
the applicant are essential to the approval of the application.
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Other Regulatory Requirements |
We may also be subject to a number of post-approval regulatory
requirements. If we seek to make certain changes to an approved
product, such as promoting or labeling a product for a new
indication, making certain manufacturing changes or product
enhancements or adding labeling claims, we will need
70
FDA review and approval before the change can be implemented.
While physicians may use products for indications that have not
been approved by the FDA, we may not label or promote the
product for an indication that has not been approved. Securing
FDA approval for new indications or product enhancements and, in
some cases, for manufacturing and labeling claims, is generally
a time-consuming and expensive process that may require us to
conduct clinical trials under the FDAs IND regulations.
Even if such studies are conducted, the FDA may not approve any
change in a timely fashion, or at all. In addition, adverse
experiences associated with use of the products must be reported
to the FDA, and FDA rules govern how we can label, advertise or
otherwise commercialize our products.
There are current post-marketing safety surveillance
requirements that we will need to meet to continue to market an
approved product. The FDA also may, in its discretion, require
post-marketing testing and surveillance to monitor the effects
of approved products or place conditions on any approvals that
could restrict the commercial applications of these products.
In addition to FDA restrictions on marketing of pharmaceutical
products, several other types of state and federal laws have
been applied to restrict certain marketing practices in the
pharmaceutical industry in recent years. These laws include
anti-kickback statutes and false claims statutes. The federal
health care program anti-kickback statute prohibits, among other
things, knowingly and willfully offering, paying, soliciting or
receiving remuneration to induce or in return for purchasing,
leasing, ordering or arranging for the purchase, lease or order
of any health care item or service reimbursable under Medicare,
Medicaid or other federally financed health care programs. This
statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers,
purchasers and formulary managers on the other. Violations of
the anti-kickback statute are punishable by imprisonment,
criminal fines, civil monetary penalties and exclusion from
participation in federal health care programs. Although there
are a number of statutory exemptions and regulatory safe harbors
protecting certain common activities from prosecution or other
regulatory sanctions, the exemptions and safe harbors are drawn
narrowly, and practices that involve remuneration intended to
induce prescribing, purchases or recommendations may be subject
to scrutiny if they do not qualify for an exemption or safe
harbor.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to have a false claim
paid. Recently, several pharmaceutical and other health care
companies have been prosecuted under these laws for allegedly
inflating drug prices they report to pricing services, which in
turn were used by the government to set Medicare and Medicaid
reimbursement rates, and for allegedly providing free product to
customers with the expectation that the customers would bill
federal programs for the product. In addition, certain marketing
practices, including off-label promotion, may also violate false
claims laws. The majority of states also have statutes or
regulations similar to the federal anti-kickback law and false
claims laws, which apply to items and services reimbursed under
Medicaid and other state programs, or, in several states, apply
regardless of the payor.
In addition, we and the manufacturers on which we rely for the
manufacture of our products are subject to requirements that
drugs be manufactured, packaged and labeled in conformity with
current good manufacturing practice, or cGMP. To comply with
cGMP requirements, manufacturers must continue to spend time,
money and effort to meet requirements relating to personnel,
facilities, equipment, production and process, labeling and
packaging, quality control, record-keeping and other
requirements. The FDA periodically inspects drug manufacturing
facilities to evaluate compliance with cGMP requirements.
Also, as part of the sales and marketing process, pharmaceutical
companies frequently provide samples of approved drugs to
physicians. This practice is regulated by the FDA and other
governmental authorities, including, in particular, requirements
concerning record-keeping and control procedures.
Outside of the United States, our ability to market our products
will also depend on receiving marketing authorizations from the
appropriate regulatory authorities. The foreign regulatory
approval process includes all of the risks associated with the
FDA approval process described above. The requirements governing
the conduct of clinical trials and marketing authorization vary
widely from country to country.
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Third-Party Reimbursement and Pricing Controls |
In the United States and elsewhere, sales of pharmaceutical
products depend in significant part on the availability of
coverage and reimbursement to providers and the consumer from
third-party payors, such as government and private insurance
plans. Third-party payors are increasingly challenging the
prices charged for medical products and services. Our products
may not be considered cost effective, and coverage and
reimbursement may not be available or sufficient to allow us to
sell our products on a competitive and profitable basis.
In many foreign markets, including the countries in the European
Union, pricing of pharmaceutical products is subject to
governmental control. In the United States, there have been, and
we expect that there will continue to be, a number of federal
and state proposals to implement similar governmental pricing
control. While we cannot predict whether such legislative or
regulatory proposals will be adopted, the adoption of such
proposals could have a material adverse effect on our business,
financial condition and profitability.
Employees
As of June 30, 2006, we had 24 employees, consisting of
clinical development, regulatory affairs, manufacturing and
program management, administration, business development and
marketing. We consider our relations with our employees to be
good.
Facilities
We lease approximately 5,928 square feet of space in our
headquarters in San Diego, California under a sublease that
expires in September 2006. We have entered into a lease that
expires in 2012 for approximately 23,494 square feet of
space for our new headquarters in San Diego, California
which we intend to occupy in September 2006. We intend to
sublease approximately 5,800 square feet of our new
headquarters for a period of two years. We have no laboratory,
research or manufacturing facilities. We believe that our
current facilities are adequate for our needs for the immediate
future and that, should it be needed, suitable additional space
will be available to accommodate expansion of our operations on
commercially reasonable terms.
Legal Proceedings
We are not engaged in any legal proceedings.
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MANAGEMENT
Executive Officers and Directors
The following table sets forth certain information about our
executive officers and directors as of July 15, 2006:
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Name |
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Age | |
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Position |
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Theodore R. Schroeder
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51 |
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President, Chief Executive Officer and Director |
William S. Craig, Ph.D.
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56 |
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Senior Vice President, Pharmaceutical Development and
Manufacturing |
Kenneth R. Heilbrunn, M.D.
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48 |
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Senior Vice President, Clinical Development |
William R. LaRue
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55 |
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Senior Vice President, Chief Financial Officer, Treasurer and
Secretary |
Richard E. Lowenthal
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40 |
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Vice President, Regulatory Affairs and Quality Assurance |
Mike A. Royal, M.D., J.D.
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52 |
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Vice President, Clinical Development, Analgesics |
David A. Socks
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31 |
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Vice President, Business Development |
Cam L. Garner(1)
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58 |
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Chairman of the Board of Directors |
Brian G. Atwood(2)
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53 |
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Director |
Michael A. Berman, M.D.(2)(3)
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63 |
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Director |
James C. Blair, Ph.D.(1)
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67 |
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Director |
Alan D. Frazier(1)(3)
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54 |
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Director |
Alain B. Schreiber, M.D.(2)
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51 |
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Director |
Christopher J. Twomey(3)
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46 |
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Director |
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(1) |
Member of the Compensation Committee. |
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(2) |
Member of the Nominating/ Corporate Governance Committee. |
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(3) |
Member of the Audit Committee. |
Executive Officers
Theodore R. Schroeder is one of our co-founders and has
served as our President and Chief Executive Officer and as a
member of our board of directors since our inception in May
2004. From August 2002 to February 2004, he served as Senior
Vice President of North America Sales and Marketing of Elan
Pharmaceuticals, Inc., a neuroscience-based pharmaceutical
company. From February 2001 to August 2002, Mr. Schroeder
served as General Manager of the Hospital Products Business Unit
at Elan, a position he also held at Dura Pharmaceuticals, Inc.,
a specialty respiratory pharmaceutical and pulmonary drug
delivery company, from May 1999 to November 2000 until its
acquisition by Elan. Prior to joining Dura, Mr. Schroeder
held a number of hospital-related sales and marketing positions
with Bristol-Myers Squibb Company, a global pharmaceutical
company. Mr. Schroeder holds a B.S. in management from
Rutgers University.
William S. Craig, Ph.D. has served as our Senior
Vice President, Pharmaceutical Development and Manufacturing
since November 2004. From January 2000 to November 2004,
Dr. Craig served as Vice President, Research and Product
Development of ISTA Pharmaceuticals, Inc., an
ophthalmology-focused specialty pharmaceutical company. From
1996 to December 1999, Dr. Craig served as Vice President,
Research and Development for Alpha Therapeutics Corporation, a
biotechnology company. From 1988 to 1996, he served as Senior
Director, Research and Development for Telios Pharmaceuticals,
Inc., a biotechnology company. Dr. Craig holds a B.S. in
biochemistry from the University of Michigan and a Ph.D. in
chemistry from the University of California, San Diego.
73
Kenneth R. Heilbrunn, M.D. has served as our Senior
Vice President, Clinical Development since April 2005. From May
2002 to April 2005, Dr. Heilbrunn served as Vice President
of Clinical Development of La Jolla Pharmaceutical Company,
an autoimmune disease-focused biopharmaceutical company. From
1998 to April 2002, he held several positions, the most recent
of which was Vice President of Clinical Research, at Advanced
Tissue Sciences, Inc., a tissue engineering company, where he
was responsible for a multicenter Phase III clinical trial
which ultimately led to the FDA approval of Dermagraft, a
bioengineered human tissue. From 1997 to 1998,
Dr. Heilbrunn served as Vice President of Medical Affairs
at Hepatix, Inc., a company engaged in the development of a
bioengineered liver. From 1994 to 1996, he served as Staff Vice
President of Medical Affairs at C.R. Bard, Inc., a manufacturer
of healthcare products. From 1989 to 1994, he held several
positions in the Medical Affairs department of Ciba-Geigy
Pharmaceuticals Division, a pharmaceutical company, the most
recent of which was Director for Cardiovascular and Pulmonary
Drugs, where he participated in the launch of the nicotine
patch, Habitrol, and the antihypertensive drug, Lotensin. From
1986 to 1989, Dr. Heilbrunn served as Staff Internist and,
ultimately, Director of the Critical Care unit at the
31st Tactical Air Force Hospital in Homestead, Florida.
Dr. Heilbrunn received a B.A. from Brown University and an
M.D. from New York Medical College.
William R. LaRue has served as our Senior Vice President,
Chief Financial Officer, Treasurer and Secretary since June
2006. From April 2001 to May 2006, Mr. LaRue served as
Senior Vice President and Chief Financial Officer of Micromet,
Inc., formerly CancerVax Corporation, a biotechnology company
focused on the treatment and control of cancer. From March 2000
to February 2001, Mr. LaRue served as Executive Vice
President and Chief Financial Officer of eHelp Corporation, a
provider of user assistance software. From January 1997 to
February 2000, Mr. LaRue served as Vice President and
Treasurer of Safeskin Corporation, a medical device company, and
from January 1993 to January 1997 he served as Treasurer of GDE
Systems, Inc., a high technology electronic systems company.
Mr. LaRue received a B.S. in business administration and an
M.B.A. from the University of Southern California.
Richard E. Lowenthal has served as our Vice President,
Regulatory Affairs and Quality Assurance since November 2004.
From November 2002 to November 2004, Mr. Lowenthal served
as Senior Director, Worldwide Regulatory Affairs and Drug Safety
of Maxim Pharmaceuticals, Inc., a biopharmaceutical company.
From December 2001 to November 2002, he served as Vice President
of Regulatory Affairs and Quality Assurance of AnGes, MG, Inc.,
a biopharmaceutical company. From June 1996 to December 2001,
Mr. Lowenthal served in various roles in regulatory affairs
at Janssen Research Foundation, a division of Johnson &
Johnson, most recently as the Global Director of Chemistry,
Manufacturing and Control Regulatory Affairs. Prior to joining
Janssen, he served as the Director of Regulatory Affairs and
Quality Assurance of Somerset Pharmaceuticals, Inc., a
proprietary research and development pharmaceutical company.
Mr. Lowenthal holds a B.S. in biochemistry and a M.S. in
organic chemistry from Florida State University.
Mike A. Royal, M.D., J.D. has served as our
Vice President, Clinical Development, Analgesics since April
2006. From December 2004 to March 2006, Dr. Royal served as
Chief Medical Officer of Solstice Neurosciences, Inc., a
specialty biopharmaceutical company. From May 2003 to December
2004, Dr. Royal served as Vice President, Strategic Brand
Development and Global Medical Affairs of Alpharma Inc., a
global specialty pharmaceutical company. From January 2002 to
May 2003, he served as Senior Medical Director of Elan
Pharmaceuticals, Inc., a neuroscience-based biotechnology
company. From 1994 to January 2002, he owned and managed the
largest private practice pain management clinic and research
center in Oklahoma. Dr. Royal has also served as Director
of the Acute Pain Service, Staff Anesthesiologist, and Assistant
Professor of Anesthesiology and Critical Care Medicine at the
University of Pittsburgh Medical Center. Dr. Royal is board
certified in internal medicine, anesthesiology, pain management,
and addiction medicine and has published extensively in the area
of pain management. He holds a B.S. in chemistry from the
Massachusetts Institute of Technology, an M.D. from the
University of Massachusetts, a J.D. from the University of
Maryland and an M.B.A. from New York University (TRIUM).
74
David A. Socks is one of our co-founders and has served
as our Vice President, Business Development since our inception
in May 2004. From May 2004 to June 2006, Mr. Socks also
served as our Chief Financial Officer, Treasurer, and Secretary.
From July 2000 to May 2004, Mr. Socks was a Venture Partner
at Windamere Venture Partners, a venture capital firm investing
in early stage life science companies. In this capacity,
Mr. Socks held management positions at two portfolio
companies of Windamere Venture Partners. These positions
included Vice President of Business Development of Kanisa
Pharmaceuticals, Inc., an oncology-focused specialty
pharmaceutical company and Vice President of Finance of CelTor
Biosystems, Inc., a drug discovery company. Mr. Socks
co-founded several pharmaceutical companies including Avera
Pharmaceuticals, Inc., Kanisa Pharmaceuticals, Inc., Somaxon
Pharmaceuticals, Inc. and Verus Pharmaceuticals, Inc. and two
medical technology companies including MiraMedica, Inc. and
SpineWave, Inc. In 1999, Mr. Socks worked in business
development at Neurocrine Biosciences, a biopharmaceutical
company. In 1998, he worked in the venture capital arm of EFO
Holdings, L.P., an investment firm. From 1995 to 1998, he worked
at Kaiser Associates, Inc., a strategic management consulting
firm, where he was most recently a Senior Manager.
Mr. Socks holds a B.S. in business administration from
Georgetown University and an M.B.A. from Stanford University.
Board of Directors
Cam L. Garner is one of our co-founders and has served as
a member of our board of directors since our inception in May
2004, and as the chairman of our board of directors since July
2004. Mr. Garner co-founded Verus Pharmaceuticals, Inc.,
Somaxon Pharmaceuticals, Inc. and Xcel Pharmaceuticals, Inc.,
which are specialty pharmaceutical companies. Since July 2004,
he has served as Chairman and Chief Executive Officer of Verus.
He served as Chairman of Xcel Pharmaceuticals, Inc. from January
2001 until it was acquired in March 2005 by Valeant
Pharmaceuticals International. From August 2001 to February
2002, he served as acting Chief Executive Officer of Favrille,
Inc., a biotechnology company, and is currently the Chairman of
its board of directors. From 1989 to 1995, he served as Chief
Executive Officer of Dura Pharmaceuticals, Inc., a specialty
respiratory pharmaceutical and pulmonary drug delivery company,
and Chairman and Chief Executive Officer from 1995 to 2000 until
it was sold to Elan in November 2000. Previously, he served as
Chairman of DJ Pharma, a specialty pharmaceutical sales and
marketing company, which was sold to Biovail Corporation in
2000. Mr. Garner also serves on the board of directors of
two publicly-held companies Somaxon Pharmaceuticals,
Inc. and Pharmion Corporation and other
privately-held pharmaceutical companies. In addition,
Mr. Garner participates on the boards of several charitable
organizations. Mr. Garner holds a B.A. in biology and an
M.B.A. from Baldwin-Wallace College and an honorary Doctor of
Science from Virginia Wesleyan College.
Brian G. Atwood has served as a member of our board of
directors since March 2006. Since 1999, Mr. Atwood has
served as a Managing Director of Versant Ventures, a venture
capital firm focusing on healthcare that he co-founded. Prior to
co-founding Versant Ventures, Mr. Atwood served as a
general partner of Brentwood Associates, a venture capital firm.
Mr. Atwood also serves on the board of directors of
Pharmion Corporation. Mr. Atwood holds a B.S. in biological
sciences from the University of California, Irvine, an M.S. in
ecology from the University of California, Davis and an M.B.A.
from Harvard University.
Michael A. Berman, M.D. has served as a member of
our board of directors since April 2006. Since January 2005,
Dr. Berman has served as President and Chief Executive
Officer of the Michael A. Berman Group, Inc., a consulting firm
specializing in the healthcare industry. Since January 2005,
Dr. Berman has also served as a consultant for Stockamp and
Associates, Inc., a business process consulting firm
specializing in the healthcare industry. From October 1999 to
January 2005, Dr. Berman served as Executive Vice President
and Director of New York Presbyterian Hospital, and from
September 1997 to October 1999 as its Senior Vice President and
Chief Medical Officer. From April 1984 to September 1997, he
served as Professor and Chairman of the Department of Pediatrics
at the University of Maryland School of Medicine.
Dr. Berman holds a M.D. from the State University of New
York, Syracuse.
75
James C. Blair, Ph.D. has served as a member of our
board of directors since September 2005. Since 1985,
Mr. Blair has been a partner of Domain Associates, L.L.C.,
a venture capital management company focused on life sciences.
Mr. Blair also serves on the board of directors of Cell
Biosciences, Inc., Five Prime Therapeutics, Inc., GenVault
Corporation, NeuroPace, Inc., Novacea, Inc., NuVasive, Inc.,
Pharmion Corporation, Verus Pharmaceuticals, Inc. and Volcano
Corporation. Mr. Blair has over 35 years experience
with venture and emerging growth companies. In the course of
this experience, he has been involved in the creation and
successful development at the board level of over forty life
science ventures, including Amgen Inc., Aurora Biosciences
Corporation, Amylin Pharmaceuticals, Inc., Applied Biosystems
Inc., Dura Pharmaceuticals, GeneOhm Sciences, Inc. and Molecular
Dynamics Inc. A former managing director of Rothschild Inc.,
Mr. Blair was directly involved at a senior level with
Rothschild/ New Court venture capital activities from 1978 to
1985. From 1969 to 1978, he was associated with F.S. Smithers
and Co. and White, Weld and Co., two investment banking firms
actively involved with new ventures and emerging growth
companies. From 1961 to 1969, Mr. Blair was an engineering
manager with RCA Corporation, during which time he received a
David Sarnoff Fellowship. He currently serves on the board of
directors of the Prostate Cancer Foundation, a philanthropic
organization, and he is on the advisory boards of the Department
of Molecular Biology at Princeton University and the Department
of Biomedical Engineering at the University of Pennsylvania.
Mr. Blair holds a B.S.E. from Princeton University and an
M.S.E. and Ph.D. from the University of Pennsylvania.
Alan D. Frazier has served as a member of our board of
directors since March 2006. In 1991, Mr. Frazier founded
Frazier Healthcare Ventures, a venture capital firm, and has
served as the managing partner since its inception. From 1983 to
1991, Mr. Frazier served as Executive Vice President, Chief
Financial Officer and Treasurer of Immunex Corporation, a
biopharmaceutical company. From 1980 to 1983, Mr. Frazier
was a principal in the Audit Department of Arthur
Young & Company, which is now Ernst & Young
LLP. Mr. Frazier is a member of the board of directors of
Alexza Pharmaceuticals, Inc. and Rigel Pharmaceuticals, Inc.,
both of which are pharmaceutical companies. Mr. Frazier
received a B.A. in economics from the University of Washington.
Alain B. Schreiber, M.D. has served as a member of
our board of directors since July 2004. Since 2000,
Dr. Schreiber has been a General Partner of ProQuest
Investments, a venture capital firm. From May 1992 to June 2000,
Dr. Schreiber served as President, Chief Executive Officer
and a director of Vical Incorporated, a biopharmaceutical
company. From July 1985 to April 1992, he held various positions
with Rhone-Poulenc Rorer Inc., which is now Sanofi-Aventis, most
recently as Senior Vice President of Discovery Research. From
October 1982 to June 1985, Dr. Schreiber served as
Biochemistry Department Head at Syntex Research, which is now
Roche Bioscience. Dr. Schreiber currently serves on the
board of several privately held companies including BioRexis
Pharmaceutical Corporation, Concentric Medical, Inc. and Optimer
Pharmaceuticals, Inc. Dr. Schreiber holds a B.S. in
chemistry and an M.D. from the Free University in Brussels,
Belgium.
Christopher J. Twomey has served as a member of our board
of directors since July 2006. Mr. Twomey joined Biosite
Incorporated, a medical diagnostic company, in March 1990 and is
currently its Senior Vice President, Finance and Chief Financial
Officer. From 1981 to 1990, Mr. Twomey worked for
Ernst & Young LLP, where he served as an Audit Manager.
Mr. Twomey also serves on the board of directors of
Senomyx, Inc., a biotechnology company, where he serves as Chair
of the Audit Committee. Mr. Twomey holds a B.A. in business
economics from the University of California at
Santa Barbara.
Board Composition
Our board of directors is currently authorized to have eight
members, and is currently composed of seven non-employee members
and our current President and Chief Executive Officer, Theodore
R. Schroeder. Upon completion of this offering, our amended and
restated certificate of incorporation will provide for a
classified board of directors consisting of three classes of
directors, each serving staggered three-year terms. As a result,
a portion of our board of directors will be elected each year.
To implement the classified structure, prior to the consummation
of this offering, two of the nominees to the board will be
appointed to one-year terms, three will be appointed to two-year
terms and three will be appointed to
76
three-year terms. Thereafter, directors will be elected for
three-year terms. Our Class I directors, whose terms will
expire at the 2007 annual meeting of stockholders, will
be , and .
Our Class II directors, whose terms will expire at the 2008
annual meeting of stockholders, will
be , and .
Our Class III directors, whose terms will expire at the
2009 annual meeting of stockholders, will
be , and .
Pursuant to a voting agreement originally entered into in July
2004 and most recently amended in March 2006 by and among us and
certain of our stockholders, Drs. Berman and Schreiber and
Messrs. Atwood, Blair, Frazier, Garner and Schroeder were
each elected to serve as members on our board of directors and,
as of the date of this prospectus, continue to so serve. The
voting agreement will terminate upon completion of this
offering, and members previously elected to our board of
directors pursuant to this agreement will continue to serve as
directors until their successors are duly elected by holders of
our common stock. For a more complete description of the voting
agreement, see Certain Relationships and Related Party
Transactions Voting Agreement.
Board Committees
Our board of directors has established three committees: the
audit committee, the compensation committee and the
nominating/corporate governance committee. Our board of
directors may establish other committees to facilitate the
management of our business.
Audit Committee. Our audit committee consists of
Messrs. Twomey (chair and audit committee financial expert)
and Frazier and Dr. Berman, each of whom our board of
directors has determined is independent within the meaning of
the independent director standards of the Securities and
Exchange Commission and the Nasdaq Stock Market, Inc.
This committees main function is to oversee our accounting
and financial reporting processes, internal systems of control,
independent registered public accounting firm relationships and
the audits of our financial statements. This committees
responsibilities include:
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selecting and hiring our independent registered public
accounting firm; |
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evaluating the qualifications, independence and performance of
our independent registered public accounting firm; |
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approving the audit and non-audit services to be performed by
our independent registered public accounting firm; |
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reviewing the design, implementation, adequacy and effectiveness
of our internal controls and our critical accounting policies; |
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overseeing and monitoring the integrity of our financial
statements and our compliance with legal and regulatory
requirements as they relate to financial statements or
accounting matters; |
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reviewing with management and our auditors any earnings
announcements and other public announcements regarding our
results of operations; |
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preparing the report that the SEC requires in our annual proxy
statement; and |
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reviewing and approving any related party transactions and
reviewing and monitoring compliance with our code of conduct and
ethics. |
Compensation Committee. Our compensation committee
consists of Messrs. Garner (chair) and Frazier and
Dr. Blair, each of whom our board of directors has
determined is independent within the meaning of the independent
director standards of the Nasdaq Stock Market, Inc. This
committees purpose is to assist our board of directors in
determining the development plans and compensation for our
77
senior management and directors and recommend these plans to our
board. This committees responsibilities include:
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reviewing and recommending compensation and benefit plans for
our executive officers and compensation policies for members of
our board of directors and board committees; |
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reviewing the terms of offer letters and employment agreements
and arrangements with our officers; |
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setting performance goals for our officers and reviewing their
performance against these goals; |
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evaluating the competitiveness of our executive compensation
plans and periodically reviewing executive succession plans; and |
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preparing the report that the SEC requires in our annual proxy
statement. |
Nominating/ Corporate Governance Committee. Our
nominating/corporate governance committee consists of
Mr. Atwood (chair) and Drs. Berman and Schreiber,
each of whom our board of directors has determined is
independent within the meaning of the independent director
standards of the Nasdaq Stock Market, Inc. This committees
purpose is to assist our board by identifying individuals
qualified to become members of our board of directors,
consistent with criteria set by our board, and to develop our
corporate governance principles. This committees
responsibilities include:
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evaluating the composition, size and governance of our board of
directors and its committees and making recommendations
regarding future planning and the appointment of directors to
our committees; |
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administering a policy for considering stockholder nominees for
election to our board of directors; |
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evaluating and recommending candidates for election to our board
of directors; |
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overseeing our board of directors performance and
self-evaluation process; and |
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reviewing our corporate governance principles and providing
recommendations to the board regarding possible changes. |
Compensation Committee Interlocks and Insider
Participation
Prior to establishing the compensation committee, our board of
directors as a whole performed the functions delegated to the
compensation committee. None of the members of our compensation
committee has ever been one of our officers or employees. None
of our executive officers currently serves, or has served, as a
member of the board of directors or compensation committee of
any entity that has one or more executive officers serving as a
member of our board of directors or compensation committee.
Director Compensation
From September 2004 through August 2005, we paid Mr. Garner
$5,000 per month plus qualified business expenses for his
services as chairman of our board of directors under the terms
of a consulting agreement between us and a limited liability
company affiliated with Mr. Garner. The agreement expired
on August 31, 2005. From September 2005 to February 2006,
we continued to pay Mr. Garner $5,000 per month for
his services as chairman of our board of directors. In February
2006, Mr. Garners monthly compensation for his
services as chairman of our board of directors was increased to
$8,333 per month.
Other than to Mr. Garner, we have historically not provided
cash compensation to directors for their services as directors
or members of committees of the board of directors. Following
the completion of this offering, we intend to provide cash
compensation in the form of a quarterly retainer of
$ for
each non-employee director. We will also pay an additional
quarterly retainer of
$ to
the chairman of our Audit Committee,
$ to
the Chairmen of our Compensation Committee and our Nominating/
78
Corporate Governance Committee and
$ to
other non-employee directors for their service on each such
committee. We will pay additional cash compensation to the
chairman of our board of directors of
$ per
year. We have reimbursed and will continue to reimburse our
non-employee directors for their reasonable expenses incurred in
attending meetings of our board of directors and committees of
the board of directors.
Following the completion of this offering, any non-employee
director who is first elected to the board of directors will be
granted an option to
purchase shares
of our common stock on the date of his or her initial election
to the board of directors. Such options will have an exercise
price per share equal to the fair market value of our common
stock on the date of grant. In addition, on the date of each
annual meeting of our stockholders following this offering, each
non-employee director will be eligible to receive an option to
purchase shares
of common stock.
The initial options granted to non-employee directors described
above will vest over three years in twelve equal quarterly
installments on the first day of each calendar quarter
subsequent to the date of grant, subject to the directors
continuing service on our board of directors on those dates. The
annual options granted to non-employee directors described above
will vest in four equal quarterly installments on each quarterly
anniversary of the date of grant, subject to the directors
continuing service on our board of directors (and, with respect
to grants to a chairman of the board or board committee, service
as chairman of the board or a committee) on those dates. The
term of each option granted to a non-employee director shall be
ten years. The terms of these options are described in more
detail under Employee Benefit and Stock
Plans.
Executive Compensation
The following table summarizes the compensation that we paid to
our Chief Executive Officer and each of our four other most
highly compensated executive officers during the year ended
December 31, 2005. We refer to these officers in this
prospectus as our named executive officers.
Summary Compensation Table
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Long-Term | |
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Compensation | |
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Annual Compensation | |
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Other Annual | |
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Securities | |
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All Other | |
Name and Principal Position |
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Salary | |
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Bonus | |
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Compensation | |
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Underlying Options | |
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Compensation | |
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Named Executive Officers
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Theodore R. Schroeder
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$ |
250,000 |
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$ |
30,000 |
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250,000 |
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President and Chief
Executive Officer |
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Richard E. Lowenthal
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220,000 |
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25,430 |
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564,000 |
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Vice President, Regulatory Affairs and Quality Assurance |
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William S. Craig, Ph.D.
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220,000 |
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23,161 |
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350,000 |
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Senior Vice President, Pharmaceutical Development
and Manufacturing |
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Kenneth R. Heilbrunn, M.D.(1)
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206,250 |
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6,000 |
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350,000 |
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Senior Vice President,
Clinical Development |
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David A. Socks
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175,000 |
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10,000 |
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Vice President,
Business Development |
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(1) |
Dr. Heilbrunn joined us as our Senior Vice President,
Clinical Development in April 2005 and, therefore, the amounts
set forth above reflect less than a full year. |
79
In May 2006, Dr. Mike A. Royal, M.D., J.D. joined
us as our Vice President, Clinical Development, Analgesics at an
annual salary of $275,000. In June 2006, Mr. William R.
LaRue joined us as our Senior Vice President, Chief Financial
Officer, Treasurer and Secretary at an annual salary of $265,000.
Option Grants in Last Fiscal Year
The following table sets forth certain information with respect
to stock options granted to the individuals named in the Summary
Compensation Table during the fiscal year ended
December 31, 2005, including the potential realizable value
over the ten-year term of the options, based on assumed rates of
stock appreciation of 5% and 10%, compounded annually, minus the
applicable per share exercise price.
These assumed rates of appreciation are mandated by the rules of
the Securities and Exchange Commission and do not represent our
estimate or projection of our future common stock price. We
cannot assure you that any of the values in the table will be
achieved. Actual gains, if any, on stock option exercises will
be dependent on the future performance of our common stock and
overall stock market conditions. The assumed 5% and 10% rates of
stock appreciation are based on the assumed initial public
offering price of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus). The percentage of total options
granted is based upon our granting of options to employees,
directors and consultants in 2005 to purchase an aggregate of
3,077,000 shares of our common stock.
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Potential Realizable |
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Value at Assumed |
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Annual Rates of |
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Stock Price |
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Appreciation for |
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Individual Grants | |
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Option Term |
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% of | |
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Number of | |
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Total Options | |
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Shares | |
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Granted to | |
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Underlying | |
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Employees | |
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Exercise | |
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Options | |
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In Last | |
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Price Per | |
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Expiration | |
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Name |
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Granted | |
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Fiscal Year | |
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Share | |
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Date | |
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5% |
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10% |
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| |
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Theodore R. Schroeder
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250,000 |
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8.12% |
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$ |
0.10 |
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12-29-2015 |
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$ |
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$ |
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Richard E. Lowenthal
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300,000 |
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9.75% |
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0.10 |
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2-15-2015 |
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264,000 |
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8.58% |
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0.10 |
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12-29-2015 |
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William S. Craig, Ph.D.
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350,000 |
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11.37% |
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0.10 |
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2-15-2015 |
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Kenneth R. Heilbrunn, M.D.
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350,000 |
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11.37% |
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0.10 |
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5-19-2015 |
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David A. Socks
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Aggregate Option Exercises in Last Fiscal Year and Fiscal
Year-End Option Values
The following table describes for the named executive officers
the number and value of securities underlying exercisable and
unexercisable options held by them as of December 31, 2005.
The value realized and the value of unexercised
in-the-money options at
December 31, 2005 are based on the assumed initial public
offering price of
$ per
share (the mid-point of the price range set forth on the cover
page of this prospectus) less the per share exercise price,
multiplied by the number of shares issued
80
or issuable, as the case may be, upon exercise of the option.
All options were granted under our 2004 equity incentive award
plan.
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Number of Securities | |
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Underlying | |
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Value of Unexercised | |
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Unexercised Options at | |
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In-the-Money Options at | |
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Number of | |
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December 31, 2005 | |
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December 31, 2005 | |
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Shares Acquired | |
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Value | |
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Name |
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on Exercise | |
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Realized | |
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Exercisable | |
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Unexercisable | |
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Exercisable | |
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Unexercisable | |
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Theodore R. Schroeder
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1,000,000 |
(1) |
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$ |
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$ |
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$ |
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Richard E. Lowenthal
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564,000 |
(2) |
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William S. Craig, Ph.D.
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350,000 |
(3) |
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Kenneth R. Heilbrunn, M.D.
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350,000 |
(4) |
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David A. Socks
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100,000 |
(5) |
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(1) |
Of these 1,000,000 shares, 765,625 were unvested as of
December 31, 2005. |
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(2) |
Of these 564,000 shares, 489,000 were unvested as of
December 31, 2005. |
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(3) |
Of these 350,000 shares, 255,208 were unvested as of
December 31, 2005. |
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(4) |
Of these 350,000 shares, 350,000 were unvested as of
December 31, 2005. |
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(5) |
Of these 100,000 shares, 68,750 were unvested as of
December 31, 2005. |
Employment Agreements
We have entered into employment agreements with Theodore R.
Schroeder, our President and Chief Executive Officer, William S.
Craig, Ph.D., our Senior Vice President, Pharmaceutical
Development and Manufacturing, Kenneth R. Heilbrunn, M.D.,
our Senior Vice President, Clinical Development, William R.
LaRue, our Senior Vice President, Chief Financial Officer,
Treasurer and Secretary, Richard E. Lowenthal, our Vice
President, Regulatory Affairs and Quality Assurance, Mike A.
Royal, M.D., J.D., our Vice President, Clinical
Development, Analgesics, and David A. Socks, our Vice President,
Business Development.
Pursuant to the employment agreements, each executive is
required to faithfully, industriously and to the best of his or
her ability, experience and talent perform all of the duties
that may be assigned to such executive pursuant to his or her
employment agreement, and shall devote substantially all of his
or her productive time and efforts to the performance of such
duties.
The base salaries of the executives are set forth in the
employment agreements. The employment agreements do not provide
for automatic annual increases in salary, but each employment
agreement provides for annual salary reviews. The employment
agreements provide that each executive shall participate in any
bonus plan that our board of directors or its designee may
approve for our senior executives (see
Employee Benefit and Stock Plans
Annual Bonus Plan below). Each executives employment
is at-will and may be terminated by us at any time, with or
without notice. Similarly, each executive may terminate his or
her employment with us at any time, with or without notice.
The employment agreements provide each executive with certain
severance benefits in the event his or her employment is
terminated as a result of his or her death or permanent
disability. Specifically, in the event of such a termination,
each executive will receive any accrued but unpaid base salary
as of the date of termination, a lump sum cash payment equal to
the executives annual base salary, and a lump sum cash
payment equal to the executives prorated annual bonus.
Additionally, in the event of an executives death, his or
her eligible dependents would receive 12 months healthcare
benefits continuation coverage at our expense. In the event of
an executives permanent disability, he or she will receive
12 months healthcare and life insurance benefits
continuation at our expense.
The employment agreements also provide each executive with
certain severance benefits in the event his or her employment is
terminated by us other than for cause, as defined in
the agreements and described below, or if the executive resigns
with good reason, as defined in the agreements and
81
described below. Specifically, if such termination occurs within
three months prior to or within 12 months following a
change of control, each executive will receive any accrued but
unpaid base salary as of the date of termination, a lump sum
cash payment equal to the executives annual base salary, a
lump sum cash payment equal to the executives prorated
annual bonus, and 12 months healthcare and life insurance
benefits continuation coverage at our expense, plus a maximum of
$15,000 towards outplacement services. If such termination
occurs more than three months prior to a change of control or
more than 12 months following a change of control, each
executive will receive the benefits described in the previous
sentence, less the prorated annual bonus.
The employment agreements provide that, in the event an
executives employment is terminated by us other than for
cause or as a result of the executives death or permanent
disability, or if the executive resigns for good reason, that
portion of the executives stock awards, and any unvested
shares issued upon the exercise of such stock awards, which
would have vested if the executive had remained employed for an
additional 12 months following the date of termination will
immediately vest on the date of termination. In addition, if an
executives employment is terminated by us other than for
cause or if an executive resigns for good reason within three
months prior to or twelve months following a change of control,
all of the executives remaining unvested stock awards, and
any unvested shares issued upon the exercise of such stock
awards, will immediately vest on the later of (1) the date
of termination or (2) the date of the change of control.
This accelerated vesting is in addition to any accelerated
vesting provided under our stock option plans.
Provided that the relevant stock award agreements do not specify
a longer exercise period, an executive may generally exercise
his or her stock awards until three months after the date of the
executives termination of employment, except that the
executive may also exercise his or her stock awards three months
after the date of a change of control, if the executives
employment is terminated by us other than for cause or if the
executive resigns for good reason within three months prior to a
change of control, and if such stock awards were granted on or
after the effective date of the executives employment
agreement. In no event, however, may an executive exercise any
stock award later than its original outside expiration date.
In addition, the employment agreements provide that, in
connection with a change of control, 50% of the executives
unvested stock awards, and any unvested shares issued upon the
exercise of stock awards, will immediately become vested. This
accelerated vesting is in addition to any accelerated vesting
provided under our stock option plans.
The employment agreements also include standard noncompetition,
nonsolicitation and nondisclosure covenants on the part of the
executives. During the term of each executives employment
with us, the employment agreements provide that he or she may
not compete with our business in any manner, except that an
executive may own insignificant equity positions in publicly
traded companies so long as the executive does not control such
company. During the term of each executives employment
with us and for any period during which he or she is receiving
severance, the employment agreements provide that he or she may
not solicit our employees or consultants. The employment
agreements also reaffirm the executives obligations under
our standard employee proprietary information and inventions
agreement to which each executive is a party.
For purposes of the employment agreements, cause
means, generally, the executives commission of an act of
fraud, embezzlement or dishonesty that has a material adverse
impact on us, the executives conviction of, or plea of
guilty or no contest to a felony, the executives
unauthorized use or disclosure of our confidential information
or trade secrets that has a material adverse impact on us, the
executives gross negligence, insubordination, material
violation of any duty of loyalty to us or any other material
misconduct on the part of the executive, the executives
ongoing and repeated failure or refusal to perform or neglect of
his or her duties (where such failure, refusal or neglect
continues for 15 days following the executives
receipt of written notice from our board), or a breach by the
executive of any material provision of his or her employment
agreement. Prior to any determination by us that
cause has occurred, we will provide the executive
with written notice of the reasons for such determination, afford
82
the executive a reasonable opportunity to remedy any such
breach, and provide the executive an opportunity to be heard
prior to the final decision to terminate the executives
employment.
For purposes of the employment agreements, good
reason means, generally, a change by us in the
executives position or responsibilities, other than a
change in the executives reporting relationship, that, in
the executives reasonable judgment, represents a
substantial and material reduction in the position or
responsibilities as in effect immediately prior thereto, our
assignment to the executive of any duties or responsibilities
that, in the executives reasonable judgment, are
materially inconsistent with such position or responsibilities,
any removal of the executive from or failure to reappoint or
reelect the executive to any of such positions, except in
connection with the termination of the executives
employment for cause, as a result of his or her permanent
disability or death, or by the executive other than for good
reason, a material reduction in the executives annual base
salary (other than in connection with a general reduction in
wages for personnel with similar status and responsibilities),
our requiring the executive (without the executives
consent) to be based at any place outside a
50-mile radius of his
or her initial place of employment with us, except for
reasonably required travel on behalf of our business, our
failure to provide the executive with compensation and benefits
substantially equivalent (in terms of benefit levels and/or
reward opportunities) to those provided for under each of our
material employee benefit plans, programs and practices as in
effect immediately prior to the date of the employment
agreement, or any material breach by us of our obligations to
the executive under the employment agreement.
Proprietary Information and Inventions Agreement
Each of our named executive officers has also entered into a
standard form agreement with respect to proprietary information
and inventions. Among other things, this agreement obligates
each named executive officer to refrain from disclosing any of
our proprietary information received during the course of
employment and, with some exceptions, to assign to us any
inventions conceived or developed during the course of
employment.
Employee Benefit and Stock Plans
In 2006,
our board of directors approved our 2006 incentive plan.
Pursuant to the 2006 incentive plan, our board of directors
designated for each executive officer a target bonus amount,
expressed as a percentage of his or her base salary
( %
for our president and chief executive officer
and %
for our other executive officers). Our executive officers are
eligible to receive bonuses if certain individual and corporate
performance criteria are achieved during the 2006 fiscal year,
and such bonuses are payable as cash, stock or options. Bonus
payments will be based on the compensation committees
evaluation of our achievement of corporate performance goals for
2006, which were determined by the compensation committee prior
to the inception of the 2006 incentive plan. Such corporate
performance goals include the achievement of performance targets
with respect to business development activities, product and
clinical development activities, financing activities and
financial results. The use of corporate goals is intended to
establish a link between the executives pay and our
business performance. The individual performance of each of the
executive officers during 2006 will also be evaluated by the
compensation committee based on the achievement of individual
performance goals, which were approved by the president and
chief executive officer and the relevant vice presidents prior
to the inception of the 2006 incentive plan. Our president and
chief executive officer will receive a bonus determined solely
by reference to the achievement of corporate goals. The
compensation committee is responsible for approving any bonuses
to our executive officers pursuant to the 2006 incentive plan,
and the compensation committees determination of bonus
amounts will be subject to approval by our board of directors.
83
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2006 Equity Incentive Award Plan |
In 2006,
our board of directors approved our 2006 Equity Incentive Award
Plan, or the 2006 plan, which was approved by our stockholders
in 2006.
The 2006 plan will become effective on the day prior to the day
of this offering.
We have initially
reserved shares
of our common stock for issuance under the 2006 plan. The 2006
plan contains an evergreen provision that allows for
an annual increase in the number of shares available for
issuance under the 2006 plan on January 1 of each year during
the ten-year term of the 2006 plan, beginning on January 1,
2008. The annual increase in the number of shares shall be equal
to the least of:
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%
of our outstanding common stock on the applicable January 1; |
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shares;
and |
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a lesser amount determined by our board of directors. |
The material terms of the 2006 plan are summarized below. The
2006 plan is filed as an exhibit to the registration statement
of which this prospectus is a part.
Administration. The compensation committee of our board
of directors will administer the 2006 plan (except with respect
to any award granted to independent directors (as
defined in the 2006 plan), which must be administered by our
full board of directors). To administer the 2006 plan, our
compensation committee must consist of at least two members of
our board of directors, each of whom is a non-employee
director for purposes of
Rule 16b-3 under
the Securities Exchange Act of 1934, as amended, and, with
respect to awards that are intended to constitute
performance-based compensation under Section 162(m) of the
Internal Revenue Code of 1986, as amended, an outside
director for purposes of Section 162(m). Subject to
the terms and conditions of the 2006 plan, our compensation
committee has the authority to select the persons to whom awards
are to be made, to determine the type or types of awards to be
granted to each person, the number of awards to grant, the
number of shares to be subject to such awards, and the terms and
conditions of such awards, and to make all other determinations
and decisions and to take all other actions necessary or
advisable for the administration of the 2006 plan. Our
compensation committee is also authorized to adopt, amend or
rescind rules relating to administration of the 2006 plan. Our
board of directors may at any time abolish the compensation
committee and revest in itself the authority to administer the
2006 plan. The full board of directors will administer the 2006
plan with respect to awards to non-employee directors.
Eligibility. Options, stock appreciation rights, or SARs,
restricted stock and other awards under the 2006 plan may be
granted to individuals who are then our officers or employees or
are the officers or employees of any of our subsidiaries. Such
awards may also be granted to our non-employee directors and
consultants but only employees may be granted incentive stock
options, or ISOs. The maximum number of shares that may be
subject to awards granted under the 2006 plan to any individual
in any calendar year cannot exceed .
Awards. The 2006 plan provides that our compensation
committee (or the board of directors, in the case of awards to
non-employee directors) may grant or issue stock options, SARs,
restricted stock, restricted stock units, dividend equivalents,
performance share awards, performance stock units, stock
payments, deferred stock, performance bonus awards,
performance-based awards, and other stock-based awards, or any
combination thereof. The compensation committee (or the board of
directors, in the case of awards to non-employee directors) will
consider each award grant subjectively, considering factors such
as the individual performance of the recipient and the
anticipated contribution of the recipient to the attainment of
the companys long-term goals. Each award will be set forth
in a separate agreement with the person receiving the award and
will indicate the type, terms and conditions of the award.
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Nonqualified stock options, or NQSOs, will provide for the right
to purchase shares of our common stock at a specified price
which may not be less than par value of a share of common stock
on the date of grant, and usually will become exercisable (at
the discretion |
84
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of our compensation committee or the board of directors, in the
case of awards to non-employee directors) in one or more
installments after the grant date, subject to the
participants continued employment or service with us
and/or subject to the satisfaction of performance targets
established by our compensation committee (or the board of
directors, in the case of awards to non-employee directors).
NQSOs may be granted for any term specified by our compensation
committee (or the board of directors, in the case of awards to
non-employee directors), but the term may not exceed ten years. |
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ISOs will be designed to comply with the provisions of the
Internal Revenue Code and will be subject to specified
restrictions contained in the Internal Revenue Code. Among such
restrictions, ISOs must have an exercise price of not less than
the fair market value of a share of common stock on the date of
grant, may only be granted to employees, must expire within a
specified period of time following the optionees
termination of employment, and must be exercised within the ten
years after the date of grant. In the case of an ISO granted to
an individual who owns (or is deemed to own) more than 10% of
the total combined voting power of all classes of our capital
stock, the 2006 plan provides that the exercise price must be
more than 110% of the fair market value of a share of common
stock on the date of grant and the ISO must expire upon the
fifth anniversary of the date of its grant. |
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Restricted stock may be granted to participants and made subject
to such restrictions as may be determined by our compensation
committee (or the board of directors, in the case of awards to
non-employee directors). Typically, restricted stock may be
forfeited for no consideration if the conditions or restrictions
are not met, and they may not be sold or otherwise transferred
to third parties until restrictions are removed or expire.
Recipients of restricted stock, unlike recipients of options,
may have voting rights and may receive dividends, if any, prior
to the time when the restrictions lapse. |
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Restricted stock units may be awarded to participants, typically
without payment of consideration or for a nominal purchase
price, but subject to vesting conditions including continued
employment or on performance criteria established by our
compensation committee (or the board of directors, in the case
of awards to non-employee directors). Like restricted stock,
restricted stock units may not be sold or otherwise transferred
or hypothecated until vesting conditions are removed or expire.
Unlike restricted stock, stock underlying restricted stock units
will not be issued until the restricted stock units have vested,
and recipients of restricted stock units generally will have no
voting or dividend rights prior to the time when vesting
conditions are satisfied. |
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SARs may be granted in connection with stock options or other
awards, or separately. SARs granted under the 2006 plan in
connection with stock options or other awards typically will
provide for payments to the holder based upon increases in the
price of our common stock over the exercise price of the related
option or other awards. Except as required by
Section 162(m) of the Internal Revenue Code with respect to
an SAR intended to qualify as performance-based compensation as
described in Section 162(m) of the Internal Revenue Code,
there are no restrictions specified in the 2006 plan on the
exercise of SARs or the amount of gain realizable therefrom. Our
compensation committee (or the board of directors, in the case
of awards to non-employee directors) may elect to pay SARs in
cash or in common stock or in a combination of both. |
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Dividend equivalents represent the value of the dividends, if
any, per share paid by us, calculated with reference to the
number of shares covered by the stock options, SARs or other
awards held by the participant. |
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Performance awards (i.e., performance share awards,
performance stock units, performance bonus awards,
performance-based awards and deferred stock) may be granted by
our compensation committee (or the board of directors, in the
case of awards to non-employee directors) on an individual or
group basis. Generally, these awards will be based upon |
85
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specific performance targets and may be paid in cash or in
common stock or in a combination of both. Performance awards may
include phantom stock awards that provide for
payments based upon increases in the price of our common stock
over a predetermined period. Performance awards may also include
bonuses that may be granted by our compensation committee (or
the board of directors, in the case of awards to non-employee
directors) on an individual or group basis, which may be paid on
a current or deferred basis and may be payable in cash or in
common stock or in a combination of both. |
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Stock payments may be authorized by our compensation committee
(or the board of directors, in the case of awards to
non-employee directors) in the form of common stock or an option
or other right to purchase common stock as part of a deferred
compensation arrangement, made in lieu of all or any part of
compensation, including bonuses, that would otherwise be payable
to employees or consultants or members of our board of directors. |
Corporate Transactions. In the event of a change of
control where the acquiror does not assume awards granted under
the plan, awards issued under the 2006 plan will be subject to
accelerated vesting such that 100% of the awards will become
vested and exercisable or payable, as applicable. Under the 2006
plan, a change of control is generally defined as:
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the direct or indirect sale or exchange in a single or series of
related transactions (other than an offering of our stock to the
general public through a registration statement filed with the
SEC) whereby any person or entity or related group of persons or
entities (other than us, our subsidiaries, an employee benefit
plan maintained by us or any of our subsidiaries or a person or
entity that, prior to such transaction, directly or indirectly
controls, is controlled by, or is under common control with, us)
directly or indirectly acquires beneficial ownership (within the
meaning of
Rule 13d-3 under
the Exchange Act) of more than 50% of the total combined voting
power of our securities outstanding immediately after such
acquisition; |
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during any two-year period, individuals who, at the beginning of
such period, constitute our board of directors together with any
new director(s) whose election by our board of directors or
nomination for election by our stockholders was approved by a
vote of at least two-thirds of the directors then still in
office who either were directors at the beginning of the
two-year period or whose election or nomination for election was
previously so approved, cease for any reason to constitute a
majority of our board of directors; |
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the merger, consolidation, reorganization, or business
combination in which the company is a party (whether directly
involving the company or indirectly involving the company
through one or more intermediaries, other than a merger,
consolidation, reorganization, or business combination that
results in our outstanding voting securities immediately before
the transaction continuing to represent a majority of the voting
power of the acquiring companys outstanding voting
securities or a merger, consolidation, reorganization, or
business combination after which no person or entity owns 50% of
the successor companys voting power); and |
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the sale, exchange or transfer of all or substantially all of
our assets. |
Amendment and Termination of the 2006 Plan. Our board of
directors may terminate, amend or modify the 2006 plan. However,
stockholder approval of any amendment to the 2006 plan will be
obtained to the extent necessary and desirable to comply with
any applicable law, regulation or stock exchange rule, or for
any amendment to the 2006 plan that increases the number of
shares available under the 2006 plan. If not terminated earlier
by the compensation committee or the board of directors, the
2006 plan will terminate on the tenth anniversary of the date of
its initial approval by our board of directors.
86
Securities Laws and Federal Income Taxes. The 2006 plan
is designed to comply with various securities and federal tax
laws as follows:
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Securities Laws. The 2006 plan is intended to conform to
all provisions of the Securities Act and the Exchange Act and
any and all regulations and rules promulgated by the SEC
thereunder, including without limitation,
Rule 16b-3. The
2006 plan will be administered, and awards will be granted and
may be exercised, only in such a manner as to conform to such
laws, rules and regulations. |
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General Federal Tax Consequences. Under current federal
laws, in general, recipients of awards and grants of NQSOs,
SARs, restricted stock, restricted stock units, dividend
equivalents, performance awards and stock payments under the
plan are taxable under Section 83 of the Internal Revenue
Code upon their receipt of common stock or cash with respect to
such awards or grants and, subject to Section 162(m) of the
Internal Revenue Code, we will be entitled to an income tax
deduction with respect to the amounts taxable to such
recipients. However, Section 409A of the Internal Revenue
Code provides certain new requirements on non-qualified deferred
compensation arrangements. Certain awards under the 2006 plan
are subject to the requirements of Section 409A, in form
and in operation, such as restricted stock unit awards. We
intend that all plan awards that are subject to
Section 409A will satisfy the requirements of
Section 409A. However, if a plan award is subject to and
fails to satisfy the requirements of Section 409A, the
recipient of that award may recognize ordinary income on the
amounts deferred under the award, to the extent vested, which
may be prior to when the compensation is actually or
constructively received. Also, if an award that is subject to
Section 409A fails to comply, Section 409A imposes an
additional 20% federal income tax on compensation recognized as
ordinary income, as well as interest on such deferred
compensation. |
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Under Sections 421 and 422 of the Internal Revenue Code,
recipients of ISOs are generally not taxed on their receipt of
common stock upon their exercises of ISOs if the ISOs and option
stock are held for specified minimum holding periods and, in
such event, we are not entitled to income tax deductions with
respect to such exercises. Participants in the 2006 plan will be
provided with detailed information regarding the tax
consequences relating to the various types of awards and grants
under the 2006 plan. |
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Section 162(m) Limitation. In general, under
Section 162(m) of the Internal Revenue Code, income tax
deductions of publicly-held corporations may be limited to the
extent total compensation (including base salary, annual bonus,
stock option exercises and non-qualified benefits paid) for
certain executive officers exceeds $1 million (less the
amount of any excess parachute payments as defined
in Section 280G of the Internal Revenue Code) in any one
year. However, under Section 162(m), the deduction limit
does not apply to certain performance-based
compensation if an independent compensation committee
determines performance goals, and if the material terms of the
performance-based compensation are disclosed to and approved by
our stockholders. In particular, stock options and SARs will
satisfy the performance-based compensation exception
if the awards are made by a qualifying compensation committee,
the 2006 plan sets the maximum number of shares that can be
granted to any person within a specified period and the
compensation is based solely on an increase in the stock price
after the grant date. Specifically, the option exercise price
must be equal to or greater than the fair market value of the
stock subject to the award on the grant date. Under a
Section 162(m) transition rule for compensation plans of
corporations which are privately held and which become publicly
held in an initial public offering, the 2006 plan will not be
subject to Section 162(m) until a specified transition
date, which is the earlier of (i) the material modification
of the 2006 plan, (ii) the issuance of all employer stock
and other compensation that has been allocated under the 2006
plan, or (iii) the first annual meeting of stockholders at
which directors are to be elected that occurs after the close of
the third calendar year following the calendar year in which the |
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initial public offering occurs. After the transition date,
rights or awards granted under the 2006 plan, other than options
and SARs, will not qualify as performance-based
compensation for purposes of Section 162(m) unless
such rights or awards are granted or vest upon pre-established
objective performance goals, the material terms of which are
disclosed to and approved by our stockholders. |
We have attempted to structure the 2006 plan in such a manner
that, after the transition date, the compensation attributable
to stock options and SARs which meet the other requirements of
Section 162(m) will not be subject to the $1 million
limitation. We have not, however, requested a ruling from the
Internal Revenue Service, or IRS, or an opinion of counsel
regarding this issue.
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2004 Equity Incentive Award Plan |
Our 2004 equity incentive award plan, or 2004 plan, was
initially adopted by our board of directors and approved by our
stockholders in November 2004. As amended to date, we have
reserved a total of 11,500,000 shares of common stock for
issuance under the 2004 plan. As of March 31, 2006, options
to purchase 3,300,000 shares of common stock had been
exercised (30,000 shares of which were repurchased by us),
options to purchase 1,017,000 shares of common stock
were outstanding and 5,713,000 shares of common stock
remained available for grant. As of March 31, 2006, the
outstanding options were exercisable at a weighted average
exercise price of approximately $0.10 per share. The
material terms of the 2004 plan are summarized below. The 2004
plan is filed as an exhibit to the registration statement of
which this prospectus is a part.
No Further Grants. After the effective date of the 2006
Plan, no additional awards will be granted under the 2004 plan.
Administration. The compensation committee of our board
of directors administers the 2004 plan. Following the completion
of this offering, to administer the 2004 plan, our compensation
committee must be constituted as described above in our
description of the 2006 Plan. Subject to the terms and
conditions of the 2004 plan, our compensation committee has the
authority to select the persons to whom awards are to be made,
to determine the number of shares to be subject thereto and the
terms and conditions thereof, and to make all other
determinations and to take all other actions necessary or
advisable for the administration of the 2004 plan. Our
compensation committee is also authorized to establish, adopt,
amend or rescind rules relating to administration of the 2004
plan. Our board of directors may at any time abolish the
compensation committee and revest in itself the authority to
administer the 2004 plan. The full board of directors
administers the 2004 plan with respect to awards to non-employee
directors.
Eligibility. Options and restricted stock under the 2004
plan may be granted to individuals who are then our officers or
employees or are the officers or employees of any of our
subsidiaries. Such awards may also be granted to our
non-employee directors or consultants, but only employees may be
granted ISOs.
Awards. The 2004 plan provides that our compensation
committee may grant or issue stock options and restricted stock,
stock appreciation rights, performance share awards, restricted
stock units, dividend equivalents, stock payments or
performance-based awards or any combination thereof. Each award
will be set forth in a separate agreement with the person
receiving the award and will indicate the type, terms and
conditions of the award.
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NQSOs provide for the right to purchase shares of our common
stock at a specified price, which for purposes of the 2004 plan
prior to the date of this offering, may be no less than 85% of
the fair market value on the date of grant, and usually will
become exercisable (at the discretion of our compensation
committee (or the board of directors, in the case of awards to
non-employee directors), in one or more installments after the
grant date, subject to the participants continued
employment or service with us and/or subject to the satisfaction
of performance targets established by our compensation committee
(or the board |
88
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of directors, in the case of awards to non-employee directors).
NQSOs may be granted for a maximum
10-year term. |
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ISOs are designed to comply with the provisions of the Internal
Revenue Code and will be subject to specified restrictions
contained in the Internal Revenue Code and as further described
above in connection with the 2006 Equity Incentive Award Plan. |
To date, we have only granted stock options under the 2004 plan.
Corporate Transactions. In the event of a change of
control where the acquiror does not assume awards granted under
the plan and does not substitute substantially similar awards
for those outstanding under the plan, awards issued under the
plan will be subject to accelerated vesting such that 100% of
the awards will become vested and exercisable or payable, as
applicable. Under the 2004 plan, a change of control is
generally defined as:
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a merger or consolidation of us with or into any other
corporation or other entity or person; or |
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a sale, lease, exchange or other transfer in one transaction or
a series of related transactions of all or substantially all of
our outstanding securities or all or substantially all of our
assets. |
Amendment and Termination of the 2004 plan. The
compensation committee, with the approval of the board of
directors, may terminate, amend or modify the 2004 plan.
However, stockholder approval of any amendment to the 2004 plan
will be obtained to the extent necessary and desirable to comply
with any applicable law, regulation, or stock exchange rule. If
not terminated earlier by the compensation committee, with the
approval of the board of directors, the 2004 plan will terminate
on the tenth anniversary of the date of its initial adoption by
our board of directors.
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2006 Employee Stock Purchase Plan |
In 2006,
our board of directors approved our 2006 Employee Stock Purchase
Plan, or the ESPP, which was approved by our stockholders
in 2006.
The ESPP is designed to allow our eligible employees to purchase
shares of common stock during designated offering periods with
their accumulated payroll deductions.
We have reserved a total
of shares
of our common stock for issuance under the ESPP. The ESPP
provides for an annual increase to the shares of common stock
reserved under the ESPP on each January 1 during the ten-year
term of the ESPP, beginning on January 1, 2008, equal to
the least of:
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% of
our outstanding shares on the applicable January 1; |
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shares;
and |
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a lesser amount determined by our board of directors. |
Offering periods under the ESPP will be months long. The
first offering period under the ESPP will commence on the
effective date of our registration statement on
Form S-8 to be
filed with the SEC to register shares of common stock issuable
under the ESPP. A new offering period will commence on
each 1st and 1st thereafter
during the term of the ESPP. Our compensation committee may
change the frequency and duration of offering periods under the
ESPP.
Individuals scheduled to work more than 20 hours per week
for more than five calendar months per year may join an offering
period on the first day of the offering period.
Participants may contribute up
to %
of their cash earnings through payroll deductions, and the
accumulated deductions will be applied to the purchase of shares
on each purchase date. Currently, the purchase price per share
will be equal to 95% of the fair market value per share on the
purchase date.
In the event of a proposed sale of all or substantially all of
our assets, or our merger with or into another company, the
outstanding rights under the ESPP will be assumed or an
equivalent right substituted by the successor company or its
parent. If the successor company or its parent refuses to
89
assume the outstanding rights or substitute an equivalent right,
then the compensation committee may provide for the automatic
exercise of all outstanding purchase rights prior to the
effective date of the transaction. Currently, the purchase price
will be equal to 95% of the fair market value on the date the
purchase rights are exercised.
The ESPP will terminate no later than the tenth anniversary of
the ESPPs initial adoption by our board of directors.
We provide a basic savings plan, or 401(k) plan, which is
intended to qualify under Section 401(k) of the Internal
Revenue Code so that contributions to our 401(k) plan by
employees or by us, and the investment earnings thereon, are not
taxable to employees until withdrawn from our 401(k) plan. If
our 401(k) plan qualifies under Section 401(k) of the
Internal Revenue Code, contributions by us, if any, will be
deductible by us when made.
All of our employees are eligible to participate in our 401(k)
plan. Pursuant to our 401(k) plan, employees may elect to reduce
their current compensation by up to the statutorily-prescribed
annual limit of $15,000 in 2006 and to have the amount of this
reduction contributed to our 401(k) plan. Our 401(k) plan
permits, but does not require, additional matching or
non-elective contributions to our 401(k) plan by us on behalf of
all participants in our 401(k) plan. To date, we have not made
any matching or non-elective contributions to our 401(k) plan.
Limitations of Liability and Indemnification Matters
We will adopt provisions in our amended and restated certificate
of incorporation that limit the liability of our directors for
monetary damages for breach of their fiduciary duties, except
for liability that cannot be eliminated under the Delaware
General Corporation Law. Delaware law provides that directors of
a corporation will not be personally liable for monetary damages
for breach of their fiduciary duties as directors, except
liability for any of the following:
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any breach of their duty of loyalty to the corporation or its
stockholders; |
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acts or omissions not in good faith or that involve intentional
misconduct or a knowing violation of law; |
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unlawful payments of dividends or unlawful stock repurchases or
redemptions as provided in Section 174 of the Delaware
General Corporation Law; or |
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any transaction from which the director derived an improper
personal benefit. |
This limitation of liability does not apply to liabilities
arising under the federal securities laws and does not affect
the availability of equitable remedies such as injunctive relief
or rescission.
Our amended and restated certificate of incorporation and our
amended and restated bylaws also will provide that we shall
indemnify our directors and executive officers and may indemnify
our other officers and employees and other agents to the fullest
extent permitted by law. We believe that indemnification under
our amended and restated bylaws covers at least negligence and
gross negligence on the part of indemnified parties. Our amended
and restated bylaws also permit us to secure insurance on behalf
of any officer, director, employee or other agent for any
liability arising out of his or her actions in this capacity,
regardless of whether our amended and restated bylaws would
permit indemnification.
We have entered into separate indemnification agreements with
our directors and executive officers, in addition to
indemnification provided for in our charter documents. These
agreements, among other things, provide for indemnification of
our directors and executive officers for expenses, judgments,
fines and settlement amounts incurred by this person in any
action or proceeding arising out of this persons services
as a director or executive officer or at our request. We believe
that these provisions and agreements are necessary to attract
and retain qualified persons as directors and executive officers.
90
PRINCIPAL STOCKHOLDERS
The following table sets forth information about the beneficial
ownership of our common stock at July 15, 2006, and as
adjusted to reflect the sale of the shares of common stock in
this offering, for:
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each person known to us to be the beneficial owner of more than
5% of our common stock; |
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each named executive officer and two additional executive
officers; |
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each of our directors; and |
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all of our executive officers and directors as a group. |
Unless otherwise noted below, the address of each beneficial
owner listed on the table is c/o Cadence Pharmaceuticals,
Inc., 12730 High Bluff Drive, Suite 410, San Diego, CA
92130. We have determined beneficial ownership in accordance
with the rules of the Securities and Exchange Commission. Except
as indicated by the footnotes below, we believe, based on the
information furnished to us by the stockholders, that the
persons and entities named in the tables below have sole voting
and investment power with respect to all shares of common stock
that they beneficially own, subject to applicable community
property laws. We have based our calculation of the percentage
of beneficial ownership on 88,182,195 shares of common
stock outstanding on July 15, 2006, which assumes the
conversion of all outstanding shares of preferred stock into
common stock
and shares
of common stock outstanding upon completion of this offering.
In computing the number of shares of common stock beneficially
owned by a person and the percentage ownership of that person,
we deemed outstanding shares of common stock subject to options
or warrants held by that person that are currently exercisable
or exercisable within 60 days of July 15, 2006. We did
not deem these shares outstanding, however, for the purpose of
computing the percentage ownership of any other person.
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Percentage of | |
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Common Stock | |
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Number of | |
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Beneficially Owned | |
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Shares | |
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Beneficially | |
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Prior to | |
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After | |
Beneficial Owner |
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Owned | |
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Offering | |
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Offering | |
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5% or Greater Stockholders:
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Funds affiliated with Domain Associates, L.L.C.(1)
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22,964,492 |
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26.0 |
% |
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One Palmer Square, Suite 515
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Princeton, NJ 08542
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ProQuest Investments III, L.P.(2)
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12,322,698 |
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14.0 |
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90 Nassau Street, 5th Floor
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Princeton, NJ 08542
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Frazier Healthcare V, LP(3)
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10,100,000 |
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11.4 |
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601 Union Street, Suite 3200
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Seattle, WA 98101
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Funds affiliated with Versant Ventures II, L.L.C.(4)
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8,100,000 |
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9.2 |
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3000 Sand Hill Road
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Building 4, Suite 210
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Menlo Park, CA 94025
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Funds affiliated with Technology Partners(5)
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8,000,000 |
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9.1 |
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100 Shoreline Highway
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Suite 282, Building B
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Mill Valley, CA 94941
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BB Biotech Ventures II, L.P.
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7,000,000 |
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7.9 |
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Trafalgar Court, Les Banques
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St Peter Port, Guernsey, Channel Islands
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GY1 3QL
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91
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Percentage of | |
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Common Stock | |
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Number of | |
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Beneficially Owned | |
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Shares | |
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Beneficially | |
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Prior to | |
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After | |
Beneficial Owner |
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Owned | |
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Offering | |
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Offering | |
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Directors and Executive Officers:
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Theodore R. Schroeder(6)
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4,043,740 |
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4.5 |
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William S. Craig, Ph.D.(7)
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705,303 |
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* |
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Kenneth R. Heilbrunn, M.D.(8)
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650,000 |
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* |
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William R. LaRue(9)
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749,000 |
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* |
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Richard E. Lowenthal(10)
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564,000 |
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* |
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Mike A. Royal, M.D., J.D.(11)
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300,000 |
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* |
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David A. Socks(12)
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1,692,728 |
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1.9 |
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Cam L. Garner(13)
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4,250,123 |
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4.8 |
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Brian G. Atwood(4)
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8,100,000 |
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9.2 |
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Michael A. Berman, M.D.(14)
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100,000 |
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* |
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James C. Blair, Ph.D.(1)
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22,964,492 |
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26.0 |
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Alan D. Frazier(3)
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10,100,000 |
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11.4 |
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Alain B. Schreiber, M.D.(2)
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12,322,698 |
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14.0 |
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Christopher J. Twomey(15)
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100,000 |
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* |
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Executive officers and directors as a group (14 persons)(16)
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66,742,084 |
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70.9 |
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* |
Represents beneficial ownership of less than one percent of our
outstanding common stock. |
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(1) |
Includes 22,612,155 shares of common stock owned by Domain
Partners VI, L.P., 242,337 shares of common stock owned by
DP VI Associates, L.P. and 50,000 shares of common stock
owned by Domain Associates, L.L.C. Of the 50,000 shares
owned by Domain Associates, 30,000 will be subject to our right
of repurchase within 60 days of July 15, 2006. Also
includes 60,000 shares Dr. Blair has the right to
acquire pursuant to outstanding options which are immediately
exercisable, all of which would be subject to our right of
repurchase within 60 days of July 15, 2006.
Dr. Blair is a member of our board of directors and a
managing member of Domain Associates, L.L.C. and a managing
member of One Palmer Square Associates VI, L.L.C., which is the
general partner of Domain Partners VI, L.P. and DP VI
Associates, L.P. Dr. Blair disclaims beneficial ownership
of these shares except to the extent of his pecuniary interest
therein. |
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(2) |
Includes 12,212,698 shares of common stock owned by
ProQuest Investments III, L.P. and 50,000 shares of common
stock owned by ProQuest Management LLC. Of the
50,000 shares owned by ProQuest Management, 20,000 will be
subject to our right of repurchase within 60 days of
July 15, 2006. Also includes 60,000 shares
Dr. Schreiber has the right to acquire pursuant to
outstanding options which are immediately exercisable, all of
which would be subject to our right of repurchase within
60 days of July 15, 2006. Dr. Schreiber is a
member of our board of directors and a managing member of
ProQuest Management LLC and a managing member of ProQuest
Associates III LLC, the ultimate general partner of
ProQuest Investments III, L.P. |
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(3) |
Includes 100,000 shares Mr. Frazier has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 95,000 of which would be subject to our right of
repurchase within 60 days of July 15, 2006. The voting
and disposition of the shares held by Frazier Healthcare V,
LP is determined by FHM V, LLC, which is the general
partner of FHM V, LP, which is the general partner of
Frazier Healthcare V, LP. Mr. Frazier is a member of
our board of directors and a managing member of FHM V, LLC.
Mr. Frazier disclaims beneficial ownership of these shares
except to the extent of his pecuniary interest therein. |
footnotes continued on the following page
92
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(4) |
Includes 7,782,747 shares of common stock owned by Versant
Venture Capital II, L.P., 147,695 shares of common
stock owned by Versant Affiliates Fund II-A, L.P. and
69,558 shares of common stock owned by Versant Side
Fund II, L.P. Also includes 100,000 shares
Mr. Atwood has the right to acquire pursuant to outstanding
options which are immediately exercisable, 95,000 of which would
be subject to our right of repurchase within 60 days of
July 15, 2006. Mr. Atwood is a member of our board of
directors and a managing member of Versant Ventures II,
L.L.C., which is the general partner of each of these Versant
funds. Mr. Atwood disclaims beneficial ownership of shares
owned by these Versant funds except to the extent of his
pecuniary interest therein. |
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(5) |
Includes 7,520,000 shares of common stock owned by
Technology Partners Fund VII, L.P. and 480,000 shares
of common stock owned by Technology Partners Affiliates VII, L.P. |
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(6) |
Includes 2,043,740 shares Mr. Schroeder has the right
to acquire pursuant to outstanding options which are immediately
exercisable, all of which would be subject to our right of
repurchase within 60 days of July 15, 2006. Also
includes 1,000,000 unvested shares acquired by
Mr. Schroeder upon the early exercise of stock options,
625,000 of which will be subject to our right of repurchase
within 60 days of July 15, 2006. |
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(7) |
Includes 705,303 shares Dr. Craig has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 544,887 of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
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(8) |
Includes 650,000 shares Dr. Heilbrunn has the right to
acquire pursuant to outstanding options that are immediately
exercisable, 533,334 of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
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(9) |
Includes 44,000 shares acquired by Mr. LaRue upon
exercise of stock options, 33,000 of which will be subject to
our right of repurchase within 60 days of July 15,
2006. These 44,000 shares are held by a trust for the
benefit of Mr. LaRues family. Also includes
705,000 shares of common stock Mr. LaRue has the right
to acquire pursuant to outstanding options that are immediately
exercisable, all of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
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(10) |
Includes 564,000 shares acquired by Mr. Lowenthal upon
the exercise of stock options, 432,750 of which will be subject
to our right of repurchase within 60 days of July 15,
2006. These 564,000 shares are held of record by a trust
for the benefit of Mr. Lowenthals family. |
|
(11) |
Includes 300,000 shares Dr. Royal has the right to
acquire pursuant to outstanding options which are immediately
exercisable, all of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
|
(12) |
Includes 842,728 shares Mr. Socks has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 792,728 of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
|
(13) |
Includes 2,293,740 shares acquired by Mr. Garner upon
the exercise of stock options, 2,116,023 of which will be
subject to our right of repurchase within 60 days of
July 15, 2006. Of these 2,293,740 shares,
2,153,740 shares are held of record by a trust for which
Mr. Garner serves as trustee and 140,000 shares are
held by a limited liability company for which Mr. Garner is
the sole member. Also includes 1,750,000 shares acquired by
Mr. Garner as one of our co-founders. Of these
1,750,000 shares, 1,600,000 shares are held by a
limited liability company for which Mr. Garner is the sole
member and 150,000 shares are held by siblings of
Mr. Garner. Also includes 206,383 shares acquired by a
limited liability company for which Mr. Garner is the sole
member. |
footnotes continued on the following page
93
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(14) |
Includes 100,000 shares Dr. Berman has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 97,500 of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
|
(15) |
Includes 100,000 shares Mr. Twomey has the right to
acquire pursuant to outstanding options which are immediately
exercisable, all of which would be subject to our right of
repurchase within 60 days of July 15, 2006. |
|
(16) |
Includes 5,766,771 shares of common stock subject to
outstanding options which are immediately exercisable, 5,427,189
of which would be subject to our right of repurchase within
60 days of July 15, 2006. Includes
4,001,740 shares of common stock acquired upon the exercise
of options, 3,256,773 of which will be subject to our right of
repurchase within 60 days of July 15, 2006. |
footnotes continued on the following page
94
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
We describe below transactions and series of similar
transactions, since our inception, to which we were a party or
will be a party, in which:
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the amounts involved exceeded or will exceed $60,000; and |
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a director, executive officer, holder of more than 5% of our
common stock or any member of their immediate family had or will
have a direct or indirect material interest. |
We also describe below certain other transactions with our
directors, executive officers and stockholders.
Preferred Stock Issuances
In July and August 2004, we issued in a private placement an
aggregate of 8,085,108 shares of Series A-1 preferred
stock at a per share price of $0.94, for aggregate consideration
of $7,600,002. In June and September 2005, we issued in a
private placement an aggregate of 17,675,347 shares of
Series A-2 preferred stock at a per share price of $1.00,
for aggregate consideration of $17,675,347. In March 2006, we
issued in a private placement 53,870,000 shares of
Series A-3 preferred stock at a per share price of $1.00,
for aggregate consideration of $53,870,000.
The following table sets forth the aggregate number of these
securities acquired by the listed directors, executive officers
or holders of more than 5% of our common stock, or their
affiliates:
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Shares of Preferred Stock | |
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Investor |
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Series A-1 | |
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Series A-2 | |
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Series A-3 | |
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| |
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| |
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Funds affiliated with Domain Associates, L.L.C.(1)
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3,989,362 |
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6,365,130 |
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12,500,000 |
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ProQuest Investments III, L.P.(2)
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2,393,618 |
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3,819,080 |
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6,000,000 |
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Frazier Healthcare V, LP(3)
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10,000,000 |
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Funds affiliated with Versant Ventures II, L.L.C.(4)
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8,000,000 |
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Funds affiliated with Technology Partners(5)
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8,000,000 |
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BB Biotech Ventures II, L.P.
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3,000,000 |
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4,000,000 |
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Cam L. Garner(6)
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106,383 |
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100,000 |
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(1) |
Includes 3,947,061 shares of Series A-1 preferred
stock, 6,297,638 shares of Series A-2 preferred stock
and 12,367,456 shares of Series A-3 preferred stock
owned by Domain Partners VI, L.P., and 42,301 shares of
Series A-1 preferred stock, 67,492 shares of
Series A-2 preferred stock, and 132,544 shares of
Series A-3 preferred stock owned by DP VI Associates, L.P.
Dr. Blair, a member of our board of directors, is a
managing member of Domain Associates, L.L.C. and a managing
member of One Palmer Square Associates VI, L.L.C., which is the
general partner of Domain Partners VI, L.P. and DP VI
Associates, L.P. |
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(2) |
The voting and disposition of the shares held by ProQuest
Investments III, L.P. is determined by ProQuest
Associates III LLC, the ultimate general partner of
ProQuest Investments III, L.P. Dr. Schreiber, a member
of our board of directors, is a managing member of ProQuest
Associates III LLC. |
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(3) |
The voting and disposition of the shares held by Frazier
Healthcare V, LP is determined by FHM V, LLC, which is
the general partner of FHM V, LP, which is the general
partner of Frazier Healthcare V, LP. Mr. Frazier, a
member of our board of directors, is a managing member of
FHM V, LLC. |
footnotes continued on the following page
95
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(4) |
Includes 7,782,747 shares of Series A-3 preferred
stock owned by Versant Venture Capital II, L.P.,
147,695 shares of Series A-3 preferred stock owned by
Versant Affiliates Fund II-A, L.P., and 69,558 shares
of Series A-3 preferred stock owned by Versant Side
Fund II, L.P. Mr. Atwood, a member of our board of
directors, is a managing member of Versant Ventures II, L.L.C.,
which is the general partner of each of these Versant funds. |
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(5) |
Includes 7,520,000 shares of Series A-3 preferred
stock owned by Technology Partners Fund VII, L.P. and
480,000 shares of Series A-3 preferred stock owned by
Technology Partners Affiliates VII, L.P. |
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(6) |
Shares held by a limited liability company for which
Mr. Garner is the sole member. |
Common Stock Issuances
In July 2004, in connection with the inception of our company,
we issued and sold a total of 4,500,000 shares of common
stock for an aggregate consideration of $4,500. The price for
the common stock was determined through negotiations between our
board of directors and the purchasers based primarily on the
early stage of our development at the time of the transaction.
The following table sets forth the aggregate number of these
securities acquired by the listed directors and executive
officers or their affiliates:
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Investor |
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Common Stock | |
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Cam L. Garner(1)
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1,750,000 |
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Theodore R. Schroeder(2)
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1,000,000 |
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David A. Socks
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850,000 |
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(1) |
Of these 1,750,000 shares, 1,600,000 shares are held
by a limited liability company for which Mr. Garner is the
sole member and 150,000 shares are held by siblings of
Mr. Garner. |
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(2) |
Shares held by a trust for the benefit of
Mr. Schroeders family. |
Investor Rights Agreement
We have entered into an agreement with purchasers of our
preferred stock that provides for certain rights relating to the
registration of their shares of common stock issuable upon
conversion of their preferred stock. The agreement also provides
these rights to shares of common stock held by
Messrs. Schroeder and Socks. These rights will continue
following this offering and will terminate seven years following
the completion of this offering, or for any particular holder
with registration rights, at such time following this offering
when all securities held by that stockholder subject to
registration rights may be sold pursuant to Rule 144 under
the Securities Act. All holders of our preferred stock are
parties to this agreement. See Description of Capital
Stock Registration Rights for additional
information.
Voting Agreement
Pursuant to a voting agreement originally entered into in July
2004 and most recently amended in March 2006 by and among us and
certain of our stockholders, the following directors were each
elected to serve as members on our board of directors and, as of
the date of this prospectus, continue to so serve:
Drs. Berman, Blair and Schreiber and Messrs. Atwood,
Frazier, Garner and Schroeder. Pursuant to the voting agreement,
Mr. Schroeder, as our president and chief executive
officer, and Mr. Garner were initially selected to serve on
our board of directors as representatives of our common stock,
as designated by a majority of our common stockholders.
Dr. Schreiber and Messrs. Atwood, Blair and Frazier
were initially selected to serve on our board of directors as
representatives of our preferred stock, as designated by
ProQuest Investments III, L.P., Versant Venture
Capital II, L.P., Domain Partners VI, L.P. and Frazier
Healthcare V, LP, respectively. Dr. Berman was
selected to serve on our board of directors as a representative
of our common stock and preferred stock, as designated by a
majority of our common and preferred stockholders.
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The voting agreement will terminate upon completion of this
offering, and members previously elected to our board of
directors pursuant to this agreement will continue to serve as
directors until their successors are duly elected by holders of
our common stock.
Stock Option Grants
Certain stock option grants to our directors and executive
officers and related option grant policies are described in this
prospectus under the captions Management
Director Compensation and Management
Option Grants in Last Fiscal Year. Prior to this offering,
we granted the following options to certain non-employee
directors:
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In November 2004, we granted to Dr. Schreiber an option to
purchase 40,000 shares of our common stock at an
exercise price of $0.10 per share, vesting over 16 calendar
quarters from September 2004. |
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In November 2005, we granted to Dr. Blair an option to
purchase 40,000 shares of our common stock at an
exercise price of $0.10 per share, vesting over 16 calendar
quarters from September 2005. |
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In November 2005, we granted to each of Dr. Schreiber and
Mr. Garner an option to purchase 10,000 shares of
our common stock at an exercise price of $0.10 per share,
vesting over four calendar quarters from September 2005. |
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In December 2005, we granted to Mr. Garner an option to
purchase 1,362,000 shares of our common stock at an
exercise price of $0.10 per share, vesting over four years
from December 2005. |
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In May 2006, we granted to Mr. Garner an option to
purchase 781,740 shares of our common stock at an
exercise price of $0.34 per share, vesting over four years
from February 2006. |
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In May 2006, we granted to Dr. Berman an option to
purchase 40,000 shares of our common stock at an
exercise price of $0.34 per share, vesting over 16 calendar
quarters from April 2006. |
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In May 2006, we granted to each of Messrs. Atwood and
Frazier an option to purchase 40,000 shares of our
common stock at an exercise price of $0.34 per share,
vesting over 16 calendar quarters from March 2006. |
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In July 2006, we granted to Mr. Twomey an option to
purchase 100,000 shares of our common stock at an
exercise price of $0.80 per share, vesting over 9 calendar
quarters from July 2006. |
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In July 2006, we granted to each of Mr. Atwood,
Drs. Berman and Blair, Mr. Frazier and
Dr. Schreiber an option to purchase 60,000 shares
of our common stock at an exercise price of $0.80 per
share, vesting over 12 calendar quarters from July 2006. |
In addition, we granted to each of Messrs. Craig, Heilbrunn
and Socks an option in May 2006 to purchase 355,303,
300,000 and 742,728, respectively, shares of our common stock at
an exercise price of $0.34 per share. In June 2006, we
granted to each of Dr. Royal and Mr. LaRue an option
to purchase 300,000 and 705,000, respectively, shares of
our common stock at an exercise price of $0.80 per share.
Each of these options vests with respect to 25% of the shares
subject to the option one year after the applicable vesting
commencement date and monthly thereafter over the following
three years.
Employment Agreements
We have entered into employment agreements with Theodore R.
Schroeder, our President and Chief Executive Officer, William S.
Craig, Ph.D., our Senior Vice President, Pharmaceutical
Development and Manufacturing, Kenneth R. Heilbrunn, M.D.,
our Senior Vice President, Clinical Development,
97
William R. LaRue, our Senior Vice President, Chief Financial
Officer, Treasurer and Secretary, Richard E. Lowenthal, our Vice
President, Regulatory Affairs and Quality Assurance, Mike A.
Royal, M.D., J.D. our Vice President, Clinical
Development, Analgesics, and David A. Socks, our Vice President,
Business Development. For further information, see
Management Employment Agreements.
Indemnification of Officers and Directors
Our restated certificate of incorporation and our amended and
restated bylaws provide that we will indemnify each of our
directors and officers to the fullest extent permitted by the
Delaware General Corporation Law. Further, we have entered into
indemnification agreements with each of our directors and
officers, and we have purchased a policy of directors and
officers liability insurance that insures our directors
and officers against the cost of defense, settlement or payment
of a judgment under certain circumstances. For further
information, see Management Limitations of
Liability and Indemnification Matters.
Consulting Agreement with Mr. Cam L. Garner
From September 2004 through August 2005, we paid Mr. Garner
$5,000 per month plus qualified business expenses for his
services as chairman of our board of directors under the terms
of a consulting agreement between us and a limited liability
company affiliated with Mr. Garner. The agreement expired
on August 31, 2005.
Other Transactions
During 2004, certain investors advanced $500,000 for
pre-operating expenses and an exclusivity fee due in connection
with the Collaboration and License Agreement between us and
Migenix. The advance was repaid with shares of our
Series A-1 preferred stock.
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DESCRIPTION OF CAPITAL STOCK
Upon completion of this offering and filing of our amended and
restated certificate of incorporation, our authorized capital
stock will consist of 100,000,000 shares of common stock,
$0.0001 par value per share, and 10,000,000 shares of
preferred stock, $0.0001 par value per share. The following
description summarizes some of the terms of our capital stock.
Because it is only a summary, it does not contain all the
information that may be important to you. For a complete
description you should refer to our amended and restated
certificate of incorporation and amended and restated bylaws,
copies of which have been filed as exhibits to the registration
statement of which the prospectus is a part.
Common Stock
On March 31, 2006, there were 7,770,000 shares of
common stock outstanding, held of record by 15 stockholders.
This amount excludes our outstanding shares of preferred stock
as of March 31, 2006 which will convert into
79,630,455 shares of common stock upon completion of the
offering. After this offering, there will
be shares
of our common stock outstanding,
or shares
if the underwriters exercise their over-allotment option in full.
The holders of our common stock are entitled to one vote for
each share held of record on all matters submitted to a vote of
the stockholders, including the election of directors, and do
not have cumulative voting rights. Accordingly, the holders of a
majority of the shares of common stock entitled to vote in any
election of directors can elect all of the directors standing
for election, if they so choose. Subject to preferences that may
be applicable to any then outstanding preferred stock, holders
of common stock are entitled to receive ratably those dividends,
if any, as may be declared by the board of directors out of
legally available funds. Upon our liquidation, dissolution or
winding up, the holders of common stock will be entitled to
share ratably in the net assets legally available for
distribution to stockholders after the payment of all of our
debts and other liabilities of our company, subject to the prior
rights of any preferred stock then outstanding. Holders of
common stock have no preemptive or conversion rights or other
subscription rights and there are no redemption or sinking funds
provisions applicable to the common stock. All outstanding
shares of common stock are, and the common stock to be
outstanding upon completion of this offering will be, fully paid
and nonassessable.
Preferred Stock
On March 31, 2006, there were 79,630,455 shares of
preferred stock outstanding, held of record by 32 stockholders.
Our stockholders have agreed to convert their shares of
preferred stock to common stock in connection with the
completion of this offering. Accordingly, upon the completion of
this offering, all outstanding shares of preferred stock as of
March 31, 2006 will automatically convert into
79,630,455 shares of our common stock.
Following the offering, our board of directors will have the
authority, without any action by the stockholders, to issue from
time to time preferred stock in one or more series and to fix
the number of shares, designations, preferences, powers, and
relative, participating, optional or other special rights and
the qualifications or restrictions thereof. The preferences,
powers, rights and restrictions of different series of preferred
stock may differ with respect to dividend rates, amounts payable
on liquidation, voting rights, conversion rights, redemption
provisions, sinking fund provisions, and purchase funds and
other matters. The issuance of preferred stock could decrease
the amount of earnings and assets available for distribution to
holders of common stock or adversely affect the rights and
powers, including voting rights, of the holders of common stock,
and may have the effect of delaying, deferring or preventing a
change in control of our company. The existence of authorized
but unissued preferred stock may enable the board of directors
to render more difficult or to discourage an attempt to obtain
control of us by means of a merger, tender offer, proxy contest
or otherwise. For example, if in the due exercise of its
fiduciary obligations, the board of directors were to determine
that a takeover proposal is not in our best interests, the board
of directors could cause shares of preferred stock to be issued
without stockholder approval in one or more
99
private offerings or other transactions that might dilute the
voting or other rights of the proposed acquirer or insurgent
stockholder or stockholder group.
Warrants
In February 2006, in connection with our loan and security
agreement, we issued a warrant to purchase up to an aggregate of
192,500 shares of our Series A-2 preferred stock to
each of Silicon Valley Bank and Oxford Finance Corporation.
These warrants are immediately exercisable at an exercise price
of $1.00 per share and, excluding certain mergers or
acquisitions, expire upon the later of ten years from the date
of grant, which is February 17, 2016, or five years after
the closing of this offering. These warrants will become
exercisable for an aggregate of 385,000 shares of our
common stock, at an exercise price of $1.00 per share, upon
completion of this offering.
Each of these warrants has a net exercise provision under which
its holder may, in lieu of payment of the exercise price in
cash, surrender the warrant and receive, after this offering, a
net amount of shares of our common stock based on the fair
market value of our common stock at the time of exercise of the
warrant after deduction of the aggregate exercise price. Each of
these warrants for common stock also contains provisions for the
adjustment of the exercise price and the aggregate number of
shares issuable upon the exercise of the warrant in the event of
stock dividends, stock splits, reorganizations and
reclassifications and consolidations.
Registration Rights
After this offering, the holders of approximately
83,555,455 shares of common stock and the holders of
warrants to purchase 385,000 shares of common stock
will be entitled to rights with respect to the registration of
these shares under the Securities Act. These shares are referred
to as registrable securities. Under the terms of the agreement
between us and the holders of the registrable securities, if we
propose to register any of our securities under the Securities
Act, these holders are entitled to notice of such registration
and are entitled to include their shares of registrable
securities in our registration. Certain of these holders are
also entitled to demand registration, pursuant to which they may
require us to use our best efforts to register their registrable
securities under the Securities Act at our expense, up to a
maximum of two such registrations. Holders of registrable
securities may also require us to file an unlimited number of
additional registration statements on
Form S-3 at our
expense so long as the holders propose to sell registrable
securities of at least $1.0 million and we have not already
filed two such registration statements on
Form S-3 in the
previous twelve months.
All of these registration rights are subject to certain
conditions and limitations, among them the right of the
underwriters of an offering to limit the number of shares
included in such registration and our right not to effect a
requested registration 60 days prior to or 180 days
after an offering of our securities, including this offering.
These registration rights have been waived by all of the holders
thereof with respect to this offering.
Anti-Takeover Effects of Provisions of Our Amended and
Restated Certificate of Incorporation, Our Amended and Restated
Bylaws and Delaware Law
Some provisions of Delaware law, our amended and restated
certificate of incorporation and our amended and restated bylaws
contain provisions that could make the following transactions
more difficult: acquisition of us by means of a tender offer;
acquisition of us by means of a proxy contest or otherwise; or
removal of our incumbent officers and directors. It is possible
that these provisions could make it more difficult to accomplish
or could deter transactions that stockholders may otherwise
consider to be in their best interest or in our best interests,
including transactions that might result in a premium over the
market price for our shares.
These provisions, summarized below, are expected to discourage
coercive takeover practices and inadequate takeover bids. These
provisions are also designed to encourage persons seeking to
acquire control of us to first negotiate with our board of
directors. We believe that the benefits of increased
100
protection of our potential ability to negotiate with the
proponent of an unfriendly or unsolicited proposal to acquire or
restructure us outweigh the disadvantages of discouraging these
proposals because negotiation of these proposals could result in
an improvement of their terms.
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Undesignated Preferred Stock |
The ability to authorize undesignated preferred stock makes it
possible for our board of directors to issue preferred stock
with voting or other rights or preferences that could impede the
success of any attempt to change control of us. These and other
provisions may have the effect of deferring hostile takeovers or
delaying changes in control or management of our company.
Our charter documents provide that a special meeting of
stockholders may be called only by our chairman of the board,
chief executive officer or president, or by a resolution adopted
by a majority of our board of directors.
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Requirements for Advance Notification of Stockholder
Nominations and Proposals |
Our amended and restated bylaws establish advance notice
procedures with respect to stockholder proposals and the
nomination of candidates for election as directors, other than
nominations made by or at the direction of the board of
directors or a committee of the board of directors.
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Elimination of Stockholder Action by Written
Consent |
Our amended and restated certificate of incorporation eliminates
the right of stockholders to act by written consent without a
meeting.
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Election and Removal of Directors |
Our board of directors is divided into three classes. The
directors in each class will serve for a three-year term, one
class being elected each year by our stockholders. For more
information on the classified board, see
Management Board of Directors. This
system of electing and removing directors may tend to discourage
a third party from making a tender offer or otherwise attempting
to obtain control of us, because it generally makes it more
difficult for stockholders to replace a majority of the
directors.
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Delaware Anti-Takeover Statute |
We are subject to Section 203 of the Delaware General
Corporation Law, which prohibits persons deemed interested
stockholders from engaging in a business
combination with a publicly held Delaware corporation for
three years following the date these persons become interested
stockholders unless the business combination is, or the
transaction in which the person became an interested stockholder
was, approved in a prescribed manner or another prescribed
exception applies. Generally, an interested
stockholder is a person who, together with affiliates and
associates, owns, or within three years prior to the
determination of interested stockholder status did own, 15% or
more of a corporations voting stock. Generally, a
business combination includes a merger, asset or
stock sale, or other transaction resulting in a financial
benefit to the interested stockholder. The existence of this
provision may have an anti-takeover effect with respect to
transactions not approved in advance by the board of directors.
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Amendment of Charter Provisions |
The amendment of any of the above provisions, except for the
provision making it possible for our board of directors to issue
preferred stock, would require approval by holders of at least
662/3%
of our then outstanding common stock.
The provisions of Delaware law, our amended and restated
certificate of incorporation and our amended and restated bylaws
could have the effect of discouraging others from attempting
hostile
101
takeovers and, as a consequence, they may also inhibit temporary
fluctuations in the market price of our common stock that often
result from actual or rumored hostile takeover attempts. These
provisions may also have the effect of preventing changes in our
management. It is possible that these provisions could make it
more difficult to accomplish transactions that stockholders may
otherwise deem to be in their best interests.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock
is ,
located
at .
Nasdaq Global Market Listing
We have applied to have our common stock approved for quotation
on the Nasdaq Global Market under the symbol CADX.
102
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our
common stock. Future sales of our common stock in the public
market, or the availability of such shares for sale in the
public market, could adversely affect market prices prevailing
from time to time. As described below, only a limited number of
shares will be available for sale shortly after this offering
due to contractual and legal restrictions on resale.
Nevertheless, sales of our common stock in the public market
after such restrictions lapse, or the perception that those
sales may occur, could adversely affect the prevailing market
price at such time and our ability to raise equity capital in
the future.
Sales of Restricted Shares
Upon the closing of this offering, we will have outstanding an
aggregate of
approximately shares
of common stock. Of these shares,
the shares
of common stock to be sold in this offering will be freely
tradable without restriction or further registration under the
Securities Act, unless the shares are held by any of our
affiliates as such term is defined in Rule 144
of the Securities Act. All remaining shares of common stock held
by existing stockholders were issued and sold by us in private
transactions and are eligible for public sale only if registered
under the Securities Act or if they qualify for an exemption
from registration under Rule 144, Rule 144(k) or
Rule 701 under the Securities Act, which rules are
summarized below.
As a result of the
lock-up agreements
described below and the provisions of Rule 144,
Rule 144(k) and Rule 701 under the Securities Act, the
shares of our common stock (excluding the shares sold in this
offering) that will be available for sale in the public market
are as follows:
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shares
will be eligible for sale on the date of this prospectus; |
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shares
will be eligible for sale upon the expiration of the
lock-up agreements, as
more particularly and except as described below, beginning
180 days after the date of this prospectus; |
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shares
will be eligible for sale, upon exercise of vested options, upon
the expiration of the
lock-up agreements, as
more particularly and except as described below, beginning
180 days after the date of this prospectus; and |
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the
remaining restricted
shares will be eligible for sale from time to time thereafter
upon expiration of their respective one-year holding periods. |
Lock-up
Agreements
We, each of our directors and executive officers, and all of the
holders of our common stock and holders of securities
exercisable for or convertible into shares of our common stock
have each agreed not to sell or otherwise dispose of, directly
or indirectly any shares of our common stock or any securities
convertible into or exercisable or exchangeable for shares of
our common stock for a period of not less than 180 days
from the date of this prospectus without the prior written
consent of Merrill Lynch & Co.
Merrill Lynch, in its sole discretion, at any time or from time
to time and without notice, may release for sale in the public
market all or any portion of the shares restricted by the terms
of the lock-up
agreements. The lock-up
restrictions will not apply to transactions relating to common
shares acquired in open market transactions after the closing of
this offering provided that no filing by the transferor under
Rule 144 of the Securities Act or Section 16 of the
Exchange Act is required or will be voluntarily made in
connection with such transactions. The
lock-up restrictions
also will not apply to certain transfers not involving a
disposition for value, provided that the recipient agrees to be
bound by these lock-up
restrictions and provided that no filing by the transferor under
Rule 144 of the Securities Act or Section 16 of the
Exchange Act is required or will be voluntarily made in
connection with such transfers.
103
Rule 144
In general, under Rule 144 as currently in effect,
beginning 90 days after the effective date of this
offering, a person (or persons whose shares are required to be
aggregated) who has beneficially owned restricted securities for
at least one year, including the holding period of any prior
owner other than one of our affiliates, is entitled to sell a
number of restricted shares within any three-month period that
does not exceed the greater of:
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one percent of the number of common shares then outstanding,
which will
equal shares
immediately after this offering (assuming no exercise of the
underwriters over-allotment option and no exercise of
outstanding options or warrants); or |
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the average weekly trading volume of our common shares on the
Nasdaq Global Market during the four calendar weeks preceding
the filing of a notice on Form 144 with respect to such
sale. |
Sales of restricted shares under Rule 144 are also subject
to requirements regarding the manner of sale, notice and the
availability of current public information about us.
Rule 144 also provides that affiliates that sell our common
shares that are not restricted shares must nonetheless comply
with the same restrictions applicable to restricted shares,
other than the holding period requirement.
Rule 144(k)
Under Rule 144(k), a person who is not deemed to have been
our affiliate at any time during the 90 days preceding a
sale and who has beneficially owned the shares proposed to be
sold for at least two years, including the holding period of any
prior owner other than an affiliate, may sell those shares
without complying with the manner of sale, public information,
volume limitation or notice provisions of Rule 144.
Rule 701
In general, under Rule 701 as currently in effect, any of
our employees, directors, officers, consultants or advisors who
acquires common stock from us in connection with a compensatory
stock or option plan or other written agreement before the
effective date of this offering (to the extent such common stock
is not subject to a
lock-up agreement) is
entitled to resell such shares 90 days after the effective
date of this offering in reliance on Rule 144. The SEC has
indicated that Rule 701 will apply to typical stock options
granted by an issuer before it becomes subject to the reporting
requirements of the Exchange Act, along with the shares acquired
upon exercise of such options, including exercises after the
date of this prospectus. Securities issued in reliance on
Rule 701 are restricted securities and, subject to the
lock-up agreements
described above, beginning 90 days after the date of this
prospectus, may be sold by persons other than affiliates, as
defined in Rule 144, subject only to the manner of sale
provisions of Rule 144 and by affiliates under
Rule 144 without compliance with its one-year minimum
holding period requirement.
Stock Plans
We intend to file one or more registration statements on
Form S-8 under the
Securities Act to register shares of our common stock issued or
reserved for issuance under our option and employee stock
purchase plans. The first such registration statement is
expected to be filed soon after the date of this prospectus and
will automatically become effective upon filing with the
Securities and Exchange Commission. Accordingly, shares
registered under such registration statement will be available
for sale in the open market, unless such shares are subject to
vesting restrictions with us or the
lock-up restrictions
described above.
Warrants
As of March 31, 2006, warrants to purchase a total of
385,000 shares of our Series A-2 preferred stock at a
price of $1.00 per share were outstanding. Upon completion
of this offering, these warrants will
104
become exercisable for a total of 385,000 shares of our
common stock at a price of $1.00 per share. See
Description of Capital Stock Warrants.
All of these common shares are subject to the terms of the
lock-up agreements with
the underwriters.
Stock Options
As of March 31, 2006, options to purchase a total of
1,017,000 shares of our common stock were outstanding, of
which 842,707 were exercisable. All of the shares subject to
options are subject to the terms of the
lock-up agreements with
the underwriters. An additional 5,713,000 shares of common
stock were available for future option grants under our stock
plan.
105
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS TO
NON-U.S. HOLDERS
This section summarizes certain material U.S. federal
income tax considerations relating to the ownership and
disposition of common stock to
non-U.S. holders.
This summary does not provide a complete analysis of all
potential tax considerations. The information provided below is
based on existing authorities. These authorities may change, or
the IRS might interpret the existing authorities differently. In
either case, the tax considerations of owning or disposing of
common stock could differ from those described below. For
purposes of this summary, a
non-U.S. holder
is any beneficial owner of our common stock other than a citizen
or resident of the United States, a corporation or a partnership
organized under the laws of the United States or any state, a
trust that is (i) subject to the primary supervision of a
U.S. court and the control of one of more U.S. persons
or (ii) has a valid election in effect under applicable
U.S. Treasury regulations to be treated as a
U.S. person, or an estate whose income is subject to
U.S. income tax regardless of source. If a partnership or
other flow-through entity is a beneficial owner of common stock,
the tax treatment of a partner in the partnership or an owner of
the entity will depend upon the status of the partner or other
owner and the activities of the partnership or other entity.
Accordingly, partnerships and flow-through entities that hold
our common stock and partners or owners of such partnerships or
entities, as applicable, should consult their own tax advisors.
The summary generally does not address tax considerations that
may be relevant to particular investors because of their
specific circumstances, or because they are subject to special
rules, including, without limitation, banks, insurance
companies, or other financial institutions; persons subject to
the alternative minimum tax; tax exempt organizations; dealers
in securities or currencies; traders in securities that elect to
use a mark to market method of accounting for their securities
holdings; persons that own, or are deemed to own, more than five
percent of our company (except to the extent specifically set
forth below); certain former citizens or long term residents of
the United States; persons who hold our common stock as a
position in a hedging transaction, straddle,
conversion transaction or other risk reduction
transaction; or persons deemed to sell our common stock under
the constructive sale provisions of the Internal Revenue Code.
Finally, the summary does not describe the effects of any
applicable foreign, state or local laws.
INVESTORS CONSIDERING THE PURCHASE OF COMMON STOCK SHOULD
CONSULT THEIR OWN TAX ADVISORS REGARDING THE APPLICATION OF THE
U.S. FEDERAL INCOME AND ESTATE TAX LAWS TO THEIR PARTICULAR
SITUATIONS AND THE CONSEQUENCES OF FOREIGN, STATE, OR LOCAL
LAWS, AND TAX TREATIES.
Dividends
We have not made any distributions on our common stock, and we
do not plan to make any distributions for the foreseeable
future. However, if we do make distributions on our common
stock, those payments will constitute dividends for
U.S. tax purposes to the extent paid from our current and
accumulated earnings and profits, as determined under
U.S. federal income tax principles. To the extent those
distributions exceed our current and accumulated earnings and
profits, they will constitute a return of capital and will first
reduce a
non-U.S. holders
basis in our common stock, but not below zero, and then will be
treated as gain from the sale of stock. Any dividend paid to a
non-U.S. holder on
our common stock will generally be subject to
U.S. withholding tax at a 30 percent rate. The
withholding tax might not apply, however, or might apply at a
reduced rate, under the terms of an applicable income tax treaty
between the United States and the
non-U.S. holders
country of residence. A
non-U.S. holder
must demonstrate its entitlement to treaty benefits by
certifying its nonresident status. A
non-U.S. holder
can meet this certification requirement by providing a
Form W-8BEN or appropriate substitute form to us or our
paying agent. If the holder holds the stock through a financial
institution or other agent acting on the holders behalf,
the holder will be required to provide appropriate documentation
to such financial institution or the agent. The financial
institution or the agent will then be required to provide
certification to us or our paying agent, either directly or
through other intermediaries. For payments made to a foreign
partnership or other flow-through entity, the certification
requirements generally apply to the partners or other owners
rather than to the partnership or other entity, and the
partnership or other entity must provide the partners or
other owners documentation to us or our paying agent.
Special rules, described
106
below, apply if a dividend is effectively connected with a
U.S. trade or business conducted by the
non-U.S. holder.
Sale of Common Stock
Non-U.S. holders
will generally not be subject to U.S. federal income tax on
any gains realized on the sale, exchange, or other disposition
of common stock. This general rule, however, is subject to
several exceptions. For example, the gain would be subject to
U.S. federal income tax if:
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the gain is effectively connected with the conduct by the
non-U.S. holder of
a U.S. trade or business (in which case the special rules
described below apply); |
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the
non-U.S. holder is
an individual who holds our common stock as a capital asset
(generally, an asset held for investment purposes) and who is
present in the U.S. for a period or periods aggregating
183 days or more during the calendar year in which the sale
or disposition occurs and certain other conditions are met; |
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the
non-U.S. holder
was a citizen or resident of the United States and thus is
subject to special rules that apply to expatriates; or |
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the rules of the Foreign Investment in Real Property Tax Act, or
FIRPTA (described below) treat the gain as effectively connected
with a U.S. trade or business. |
An individual
non-U.S. holder
described in the second bullet point immediately above will be
subject to a flat 30% tax on the gain derived from the sale,
which may be offset by U.S. source capital losses, even
though the individual is not considered a resident of the
U.S. If a
non-U.S. holder is
described in the third bullet point above, the
non-U.S. holder
should consult its own tax advisor to determine the
U.S. federal, state, local and other tax consequences that
may be relevant to such holder.
The FIRPTA rules may apply to a sale, exchange or other
disposition of common stock if we are, or were within five years
before the transaction, a U.S. real property holding
corporation, or a USRPHC. In general, we would be a USRPHC
if interests in U.S. real estate comprised most of our
assets. We do not believe that we are a USRPHC or that we will
become one in the future. If we are or become a USRPHC, so long
as our common stock is regularly traded on an established
securities market, only a
non-U.S. holder
who, actually or constructively, holds or held (at any time
during the shorter of the five year period preceding the date of
disposition or the holders holding period) more than 5% of
our common stock will be subject to U.S. federal income tax
on the disposition of our common stock.
Dividends or Gain Effectively Connected With a
U.S. Trade or Business
If any dividend on common stock, or gain from the sale, exchange
or other disposition of common stock, is effectively connected
with a U.S. trade or business conducted by the
non-U.S. holder,
then the dividend or gain will be subject to U.S. federal
income tax at the regular graduated rates. If the
non-U.S. holder is
eligible for the benefits of a tax treaty between the United
States and the holders country of residence, any
effectively connected dividend or gain would
generally be subject to U.S. federal income tax only if it
is also attributable to a permanent establishment or fixed base
maintained by the holder in the United States. Payments of
dividends that are effectively connected with a U.S. trade
or business, and therefore included in the gross income of a
non-U.S. holder,
will not be subject to the 30 percent withholding tax. To
claim exemption from withholding, the holder must certify its
qualification, which can be done by filing a Form W-8ECI.
If the
non-U.S. holder is
a corporation, that portion of its earnings and profits that is
effectively connected with its U.S. trade or business would
generally be subject to a branch profits tax. The
branch profits tax rate is generally 30 percent, although
an applicable income tax treaty might provide for a lower rate.
107
Backup Withholding and Information Reporting
The Internal Revenue Code and the Treasury regulations require
those who make specified payments to report the payments to the
IRS. Among the specified payments are dividends and proceeds
paid by brokers to their customers. The required information
returns enable the IRS to determine whether the recipient
properly included the payments in income. This reporting regime
is reinforced by backup withholding rules. These
rules require the payors to withhold tax from payments subject
to information reporting if the recipient fails to cooperate
with the reporting regime by failing to provide his taxpayer
identification number to the payor, furnishing an incorrect
identification number, or repeatedly failing to report interest
or dividends on his returns. The withholding tax rate is
currently 28 percent. The backup withholding rules do not
apply to payments to certain exempt holders, including
corporations, whether domestic or foreign, who establish their
exempt status.
Payments to
non-U.S. holders
of dividends on common stock will generally not be subject to
backup withholding, and payments of proceeds made to
non-U.S. holders
by a broker upon a sale of common stock will not be subject to
information reporting or backup withholding, in each case so
long as the
non-U.S. holder
certifies its nonresident status. Some of the common means of
certifying nonresident status are described under
Dividends. We must report annually to
the IRS any dividends paid to each
non-U.S. holder
and the tax withheld, if any, with respect to such dividends.
Copies of these reports may be made available to tax authorities
in the country where the
non-U.S. holder
resides.
Any amounts withheld from a payment to a holder of common stock
under the backup withholding rules can be credited against any
U.S. federal income tax liability of the holder.
THE PRECEDING DISCUSSION OF U.S. FEDERAL INCOME TAX
CONSIDERATIONS IS FOR GENERAL INFORMATION ONLY. IT IS NOT TAX
ADVICE. EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS OWN TAX
ADVISOR REGARDING THE PARTICULAR U.S. FEDERAL, STATE,
LOCAL, AND FOREIGN TAX CONSEQUENCES OF PURCHASING, HOLDING, AND
DISPOSING OF OUR COMMON STOCK, INCLUDING THE CONSEQUENCES OF ANY
PROPOSED CHANGE IN APPLICABLE LAWS.
108
UNDERWRITING
Merrill Lynch, Pierce, Fenner & Smith Incorporated,
Deutsche Bank Securities Inc., Pacific Growth Equities, LLC and
JMP Securities LLC are acting as representatives of each of the
underwriters named below. Subject to the terms and conditions
set forth in a purchase agreement among us and the underwriters,
we have agreed to sell to the underwriters, and each of the
underwriters has agreed, severally and not jointly, to purchase
from us, the number of shares of common stock set forth opposite
its name below.
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Underwriter |
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Merrill Lynch, Pierce, Fenner & Smith
Incorporated
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Deutsche Bank Securities Inc.
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Pacific Growth Equities, LLC
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JMP Securities LLC
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Total
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Subject to the terms and conditions set forth in the purchase
agreement, the underwriters have agreed, severally and not
jointly, to purchase all of the shares sold under the purchase
agreement if any of these shares are purchased. If an
underwriter defaults, the purchase agreement provides that the
purchase commitments of the nondefaulting underwriters may be
increased or the purchase agreement may be terminated.
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act, or
to contribute to payments the underwriters may be required to
make in respect of those liabilities.
The underwriters are offering the shares, subject to prior sale,
when, as and if issued to and accepted by them, subject to
approval of legal matters by their counsel, including the
validity of the shares, and other conditions contained in the
purchase agreement, such as the receipt by the underwriters of
officers certificates and legal opinions. The underwriters
reserve the right to withdraw, cancel or modify offers to the
public and to reject orders in whole or in part.
Commissions and Discounts
The representatives have advised us that the underwriters
propose initially to offer the shares to the public at the
initial public offering price set forth on the cover page of
this prospectus and to dealers at that price less a concession
not in excess of
$ per
share. The underwriters may allow, and the dealers may reallow,
a discount not in excess of
$ per
share to other dealers. After the initial public offering, the
public offering price, concession and discount may be changed.
The following table shows the public offering price,
underwriting discount and proceeds before expenses to us. The
information assumes either no exercise or full exercise by the
underwriters of their overallotment option.
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Per Share | |
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Without Option | |
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Public offering price
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$ |
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Proceeds, before expenses, to us
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$ |
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The expenses of the offering, not including the underwriting
discount, are estimated at $ and are payable by us.
109
Overallotment Option
We have granted an option to the underwriters to purchase up
to additional
shares at the public offering price, less the underwriting
discount. The underwriters may exercise this option for
30 days from the date of this prospectus solely to cover
any overallotments. If the underwriters exercise this option,
each will be obligated, subject to conditions contained in the
purchase agreement, to purchase a number of additional shares
proportionate to that underwriters initial amount
reflected in the above table.
No Sales of Similar Securities
We and our officers, directors, stockholders, warrant holders
and option holders, who hold all of our shares of common stock,
on a fully diluted basis, have agreed, subject to certain
exceptions, not to sell or transfer any common stock or
securities convertible into, exchangeable for, exercisable for,
or repayable with common stock, for 180 days after the date
of this prospectus without first obtaining the written consent
of Merrill Lynch. Specifically, we and these other individuals
have agreed not to directly or indirectly
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sell any option or contract to purchase any common stock, |
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purchase any option or contract to sell any common stock, |
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grant any option, right or warrant for the sale of any common
stock, |
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lend or otherwise dispose of or transfer any common stock, |
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request or demand that we file a registration statement related
to the common stock, or |
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enter into any swap or other agreement that transfers, in whole
or in part, the economic consequence of ownership of any common
stock, whether any such swap or transaction is to be settled by
delivery of shares or other securities, in cash or otherwise. |
This lockup provision applies to common stock and to securities
convertible into or exchangeable or exercisable for or repayable
with common stock. It also applies to common stock owned now or
acquired later by the person executing the agreement or for
which the person executing the agreement later acquires the
power of disposition.
Quotation on the Nasdaq Global Market
We expect the shares to be approved for quotation on the Nasdaq
Global Market, subject to notice of issuance, under the symbol
CADX.
Before this offering, there has been no public market for our
common stock. The initial public offering price will be
determined through negotiations among us and the
representatives. In addition to prevailing market conditions,
the factors to be considered in determining the initial public
offering price are
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the valuation multiples of publicly traded companies that the
representatives believe to be comparable to us, |
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our financial information, |
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the history of, and the prospects for, our company and the
industry in which we compete, |
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an assessment of our management, its past and present
operations, and the prospects for, and timing of, our future
revenues, |
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the present state of our development, and |
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the above factors in relation to market values and various
valuation measures of other companies engaged in activities
similar to ours. |
An active trading market for the shares may not develop. It is
also possible that after the offering the shares will not trade
in the public market at or above the initial public offering
price.
The underwriters do not expect to sell more than 5% of the
shares in the aggregate to accounts over which they exercise
discretionary authority.
Price Stabilization, Short Positions and Penalty Bids
Until the distribution of the shares is completed, SEC rules may
limit underwriters and selling group members from bidding for
and purchasing our common stock. However, the representatives
may engage in transactions that stabilize the price of the
common stock, such as bids or purchases to peg, fix or maintain
that price.
In connection with the offering, the underwriters may purchase
and sell our common stock in the open market. These transactions
may include short sales, purchases on the open market to cover
positions created by short sales and stabilizing transactions.
Short sales involve the sale by the underwriters of a greater
number of shares than they are required to purchase in the
offering. Covered short sales are sales made in an
amount not greater than the underwriters option to
purchase additional shares in the offering. The underwriters may
close out any covered short position by either exercising their
overallotment option or purchasing shares in the open market. In
determining the source of shares to close out the covered short
position, the underwriters will consider, among other things,
the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through
the overallotment option. Naked short sales are
sales in excess of the overallotment option. The underwriters
must close out any naked short position by purchasing shares in
the open market. A naked short position is more likely to be
created if the underwriters are concerned that there may be
downward pressure on the price of our common stock in the open
market after pricing that could adversely affect investors who
purchase in the offering. Stabilizing transactions consist of
various bids for or purchases of shares of common stock made by
the underwriters in the open market prior to the completion of
the offering.
The underwriters may also impose a penalty bid. This occurs when
a particular underwriter repays to the underwriters a portion of
the underwriting discount received by it because the
representatives have repurchased shares sold by or for the
account of such underwriter in stabilizing or short covering
transactions.
Similar to other purchase transactions, the underwriters
purchases to cover the syndicate short sales may have the effect
of raising or maintaining the market price of our common stock
or preventing or retarding a decline in the market price of our
common stock. As a result, the price of our common stock may be
higher than the price that might otherwise exist in the open
market.
Neither we nor any of the underwriters make any representation
or prediction as to the direction or magnitude of any effect
that the transactions described above may have on the price of
our common stock. In addition, neither we nor any of the
underwriters make any representation that the representatives
will engage in these transactions or that these transactions,
once commenced, will not be discontinued without notice.
Electronic Offer, Sale and Distribution of Shares
A prospectus in electronic format will be made available on the
websites maintained by one or more of the underwriters of this
offering. Other than the electronic prospectus, the information
on the websites of the underwriters is not part of this
prospectus. The underwriters may agree to allocate a number of
shares to underwriters for sale to their online brokerage
account holders. Internet distributions will be allocated to
underwriters that may make Internet distributions on the same
basis as other allocations.
111
Other Relationships
Some of the underwriters and their affiliates have provided from
time to time, and may provide in the future, investment and
commercial banking and financial advisory services to us in the
ordinary course of business, for which they have received and
may continue to receive customary fees and commissions.
LEGAL MATTERS
The validity of our common stock offered by this prospectus will
be passed upon for us by Latham & Watkins LLP,
San Diego, California. Latham & Watkins LLP and
certain attorneys and investment funds affiliated with the firm
collectively own an aggregate of 90,000 shares of our
preferred stock, which will convert into an aggregate of
90,000 shares of our common stock upon the completion of
this offering. Certain legal matters in connection with this
offering will be passed upon for the underwriters by Heller
Ehrman LLP, San Diego, California.
EXPERTS
Ernst & Young LLP, independent registered public accounting
firm, has audited our financial statements as of
December 31, 2004 and 2005 and for the period from
May 26, 2004 (inception) through December 31,
2004 and for the year ended December 31, 2005 as set forth
in their report. We have included our financial statements in
this prospectus and elsewhere in the registration statement in
reliance on Ernst & Young LLPs report, given on
their authority as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the Securities and Exchange Commission a
registration statement on
Form S-1 under the
Securities Act of 1933, as amended, with respect to the shares
of our common stock offered hereby. This prospectus does not
contain all of the information set forth in the registration
statement and the exhibits and schedules thereto. Some items are
omitted in accordance with the rules and regulations of the SEC.
For further information with respect to us and the common stock
offered hereby, we refer you to the registration statement and
the exhibits and schedules filed therewith. Statements contained
in this prospectus as to the contents of any contract, agreement
or any other document are summaries of the material terms of
this contract, agreement or other document. With respect to each
of these contracts, agreements or other documents filed as an
exhibit to the registration statement, reference is made to the
exhibits for a more complete description of the matter involved.
A copy of the registration statement, and the exhibits and
schedules thereto, may be inspected without charge at the public
reference facilities maintained by the SEC at 100 F Street NE,
Washington, D.C. 20549. Copies of these materials may be
obtained from the Public Reference Section of the SEC at
100 F Street NE, Washington, D.C. 20549.
Please call the SEC at
1-800-SEC-0330 for
further information on the operation of the public reference
facility. The SEC maintains a web site that contains reports,
proxy and information statements and other information regarding
registrants that file electronically with the SEC. The address
of the SECs website is http://www.sec.gov.
112
INDEX TO FINANCIAL STATEMENTS
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of
Cadence Pharmaceuticals, Inc.
We have audited the accompanying balance sheets of Cadence
Pharmaceuticals, Inc. (a development stage company) as of
December 31, 2004 and 2005 and the related statements of
operations, stockholders equity and cash flows for the
period from May 26, 2004 (inception) through
December 31, 2004 and for the year ended December 31,
2005. These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. We were not engaged to perform an
audit of the Companys internal control over financial
reporting. Our audits included consideration of internal control
over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of
the Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Cadence Pharmaceuticals, Inc. (a development stage company)
at December 31, 2004 and 2005 and the results of its
operations and its cash flows for the period from May 26,
2004 (inception) through December 31, 2004 and for the
year ended December 31, 2005 in conformity with generally
accepted accounting principles in the United States.
San Diego, California
April 21, 2006
F-2
Cadence Pharmaceuticals, Inc.
(a development stage company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma | |
|
|
|
|
|
|
Stockholders | |
|
|
December 31, | |
|
|
|
Equity at | |
|
|
| |
|
March 31, | |
|
March 31, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
4,271,229 |
|
|
$ |
8,025,285 |
|
|
$ |
40,617,049 |
|
|
|
|
|
|
Securities available-for-sale
|
|
|
|
|
|
|
7,000,000 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
3,854 |
|
|
|
526,173 |
|
|
|
625,348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
4,275,083 |
|
|
|
15,551,458 |
|
|
|
41,242,397 |
|
|
|
|
|
Property and equipment, net
|
|
|
108,735 |
|
|
|
117,740 |
|
|
|
154,811 |
|
|
|
|
|
Other assets
|
|
|
152,159 |
|
|
|
100,000 |
|
|
|
425,006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
4,535,977 |
|
|
$ |
15,769,198 |
|
|
$ |
41,822,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
68,509 |
|
|
$ |
715,781 |
|
|
$ |
828,607 |
|
|
|
|
|
|
Accrued liabilities
|
|
|
45,965 |
|
|
|
430,220 |
|
|
|
419,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
114,474 |
|
|
|
1,146,001 |
|
|
|
1,248,512 |
|
|
|
|
|
Commitments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A-1 convertible preferred stock,
8,085,108 shares authorized, issued and outstanding at
December 31, 2004 and 2005 and March 31, 2006
(unaudited); aggregate liquidation preference of $7,600,002; no
shares issued and outstanding pro forma (unaudited)
|
|
|
809 |
|
|
|
809 |
|
|
|
809 |
|
|
$ |
|
|
|
|
Series A-2 convertible preferred stock,
12,900,001 shares, 17,675,347 shares and
18,060,347 shares authorized at December 31, 2004 and
2005 and March 31, 2006 (unaudited), respectively; no
shares, 17,675,347 shares and 17,675,347 shares issued
and outstanding at December 31, 2004 and 2005 and
March 31, 2006 (unaudited), respectively; aggregate
liquidation preference of $17,675,347; no shares issued and
outstanding pro forma (unaudited)
|
|
|
|
|
|
|
1,767 |
|
|
|
1,767 |
|
|
|
|
|
|
|
Series A-3 convertible preferred stock,
53,870,000 shares authorized at March 31, 2006
(unaudited); 53,870,000 shares issued and outstanding at
March 31, 2006 (unaudited); aggregate liquidation
preference of $53,870,000; no shares issued and outstanding pro
forma (unaudited)
|
|
|
|
|
|
|
|
|
|
|
5,387 |
|
|
|
|
|
|
Common stock, $0.0001 par value; 33,000,000 shares,
40,000,000 shares and 100,000,000 shares authorized at
December 31, 2004 and 2005 and March 31, 2006
(unaudited), respectively; 4,680,000 shares,
7,616,000 shares and 7,770,000 shares issued and
outstanding at December 31, 2004 and 2005 and
March 31, 2006 (unaudited), respectively;
87,400,455 shares issued and outstanding pro forma
(unaudited)
|
|
|
468 |
|
|
|
762 |
|
|
|
777 |
|
|
|
8,740 |
|
|
Additional paid-in capital
|
|
|
7,562,463 |
|
|
|
25,472,308 |
|
|
|
79,570,891 |
|
|
|
79,570,891 |
|
|
Stock subscription receivable
|
|
|
|
|
|
|
(187,600 |
) |
|
|
|
|
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(3,142,237 |
) |
|
|
(10,664,849 |
) |
|
|
(39,005,929 |
) |
|
|
(39,005,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
4,421,503 |
|
|
|
14,623,197 |
|
|
|
40,573,702 |
|
|
$ |
40,573,702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
4,535,977 |
|
|
$ |
15,769,198 |
|
|
$ |
41,822,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
Cadence Pharmaceuticals, Inc.
(a development stage company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
Period from | |
|
|
May 26, 2004 | |
|
|
|
|
|
|
|
May 26, 2004 | |
|
|
(Inception) | |
|
|
|
|
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
Three Months Ended March 31, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
March 31, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
|
(Unaudited) | |
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
2,233,357 |
|
|
$ |
6,126,226 |
|
|
$ |
577,013 |
|
|
$ |
27,835,246 |
|
|
$ |
36,194,829 |
|
|
Marketing
|
|
|
41,114 |
|
|
|
240,361 |
|
|
|
130,450 |
|
|
|
95,758 |
|
|
|
377,233 |
|
|
General and administrative
|
|
|
877,146 |
|
|
|
1,411,810 |
|
|
|
262,829 |
|
|
|
537,349 |
|
|
|
2,826,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,151,617 |
|
|
|
7,778,397 |
|
|
|
970,292 |
|
|
|
28,468,353 |
|
|
|
39,398,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,151,617 |
) |
|
|
(7,778,397 |
) |
|
|
(970,292 |
) |
|
|
(28,468,353 |
) |
|
|
(39,398,367 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
9,380 |
|
|
|
255,785 |
|
|
|
7,634 |
|
|
|
143,939 |
|
|
|
409,104 |
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,666 |
) |
|
|
(16,666 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
9,380 |
|
|
|
255,785 |
|
|
|
7,634 |
|
|
|
127,273 |
|
|
|
392,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(962,658 |
) |
|
$ |
(28,341,080 |
) |
|
$ |
(39,005,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.21 |
) |
|
$ |
(5.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
|
|
|
3,658,356 |
|
|
|
4,623,517 |
|
|
|
4,519,194 |
|
|
|
4,895,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share
|
|
|
|
|
|
|
20,648,526 |
|
|
|
|
|
|
|
32,451,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
Cadence Pharmaceuticals, Inc.
(a development stage company)
STATEMENTS OF STOCKHOLDERS EQUITY
For the Period from May 26, 2004
(inception) through March 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A-1 | |
|
Series A-2 | |
|
Series A-3 | |
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
Convertible | |
|
Convertible | |
|
Convertible | |
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
Preferred Stock | |
|
Preferred Stock | |
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
Stock | |
|
During the | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
Paid-In | |
|
Subscription | |
|
Development | |
|
Stockholders | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Receivable | |
|
Stage | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Issuance of common stock to founders for cash at $0.001 per
share in July
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
4,500,000 |
|
|
$ |
450 |
|
|
$ |
4,050 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,500 |
|
Exercise of common stock options for cash at $0.10 per
share in December
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
180,000 |
|
|
|
18 |
|
|
|
17,982 |
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
Issuance of Series A-1 preferred stock for cash at
$0.94 per share, net of $59,573 of offering costs, in July
and August
|
|
|
8,085,108 |
|
|
|
809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,539,620 |
|
|
|
|
|
|
|
|
|
|
|
7,540,429 |
|
Issuance of common stock options for consulting services in
November
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
811 |
|
|
|
|
|
|
|
|
|
|
|
811 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,142,237 |
) |
|
|
(3,142,237 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
8,085,108 |
|
|
|
809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,680,000 |
|
|
|
468 |
|
|
|
7,562,463 |
|
|
|
|
|
|
|
(3,142,237 |
) |
|
|
4,421,503 |
|
Exercise of common stock options at $0.10 per share in
February, June and December, net of the repurchase of
30,000 shares at $0.10 per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,936,000 |
|
|
|
294 |
|
|
|
293,306 |
|
|
|
(187,600 |
) |
|
|
|
|
|
|
106,000 |
|
Issuance of Series A-2 preferred stock for cash at
$1.00 per share, net of $57,041 of offering costs, in June
and September
|
|
|
|
|
|
|
|
|
|
|
17,675,347 |
|
|
|
1,767 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,616,539 |
|
|
|
|
|
|
|
|
|
|
|
17,618,306 |
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,522,612 |
) |
|
|
(7,522,612 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
8,085,108 |
|
|
|
809 |
|
|
|
17,675,347 |
|
|
|
1,767 |
|
|
|
|
|
|
|
|
|
|
|
7,616,000 |
|
|
|
762 |
|
|
|
25,472,308 |
|
|
|
(187,600 |
) |
|
|
(10,664,849 |
) |
|
|
14,623,197 |
|
Exercise of common stock options at $0.10 per share in
January (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
154,000 |
|
|
|
15 |
|
|
|
15,385 |
|
|
|
|
|
|
|
|
|
|
|
15,400 |
|
Collection of stock subscription receivable (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187,600 |
|
|
|
|
|
|
|
187,600 |
|
Issuance of Series A-3 preferred stock for cash at
$1.00 per share, net of $94,987 of offering costs, in March
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,870,000 |
|
|
|
5,387 |
|
|
|
|
|
|
|
|
|
|
|
53,769,626 |
|
|
|
|
|
|
|
|
|
|
|
53,775,013 |
|
Issuance of warrants in connection with loan and security
agreement in February (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
313,572 |
|
|
|
|
|
|
|
|
|
|
|
313,572 |
|
Net loss and comprehensive loss (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(28,341,080 |
) |
|
|
(28,341,080 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 (unaudited)
|
|
|
8,085,108 |
|
|
$ |
809 |
|
|
|
17,675,347 |
|
|
$ |
1,767 |
|
|
|
53,870,000 |
|
|
$ |
5,387 |
|
|
|
7,770,000 |
|
|
$ |
777 |
|
|
$ |
79,570,891 |
|
|
$ |
|
|
|
$ |
(39,005,929 |
) |
|
$ |
40,573,702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
Cadence Pharmaceuticals, Inc.
(a development stage company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
Period from | |
|
|
May 26, 2004 | |
|
|
|
|
|
May 26, 2004 | |
|
|
(Inception) | |
|
|
|
Three Months Ended | |
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
March 31, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
March 31, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
|
(Unaudited) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(962,658 |
) |
|
$ |
(28,341,080 |
) |
|
$ |
(39,005,929 |
) |
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
8,389 |
|
|
|
36,876 |
|
|
|
7,784 |
|
|
|
10,732 |
|
|
|
55,997 |
|
|
|
Stock-based compensation
|
|
|
811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
811 |
|
|
|
Non-cash interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,666 |
|
|
|
16,666 |
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
(56,013 |
) |
|
|
(470,160 |
) |
|
|
(114,811 |
) |
|
|
(127,275 |
) |
|
|
(653,448 |
) |
|
|
|
Accounts payable and accrued liabilities
|
|
|
114,474 |
|
|
|
1,031,527 |
|
|
|
282,520 |
|
|
|
102,511 |
|
|
|
1,248,512 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,074,576 |
) |
|
|
(6,924,369 |
) |
|
|
(787,165 |
) |
|
|
(28,338,446 |
) |
|
|
(38,337,391 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(100,000 |
) |
|
|
(7,000,000 |
) |
|
|
|
|
|
|
|
|
|
|
(7,100,000 |
) |
Maturities of marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000,000 |
|
|
|
7,000,000 |
|
Purchases of property and equipment
|
|
|
(117,124 |
) |
|
|
(45,881 |
) |
|
|
|
|
|
|
(47,803 |
) |
|
|
(210,808 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(217,124 |
) |
|
|
(7,045,881 |
) |
|
|
|
|
|
|
6,952,197 |
|
|
|
(310,808 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
22,500 |
|
|
|
106,000 |
|
|
|
4,000 |
|
|
|
203,000 |
|
|
|
331,500 |
|
Proceeds from sale of preferred stock, net of issuance costs
|
|
|
7,540,429 |
|
|
|
17,618,306 |
|
|
|
|
|
|
|
53,775,013 |
|
|
|
78,933,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
7,562,929 |
|
|
|
17,724,306 |
|
|
|
4,000 |
|
|
|
53,978,013 |
|
|
|
79,265,248 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
4,271,229 |
|
|
|
3,754,056 |
|
|
|
(783,165 |
) |
|
|
32,591,764 |
|
|
|
40,617,049 |
|
Cash and cash equivalents at beginning of period
|
|
|
|
|
|
|
4,271,229 |
|
|
|
4,271,229 |
|
|
|
8,025,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
4,271,229 |
|
|
$ |
8,025,285 |
|
|
$ |
3,488,064 |
|
|
$ |
40,617,049 |
|
|
$ |
40,617,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
|
|
1. |
The Company and Summary of Significant Accounting Policies |
|
|
|
The Company and Basis of Presentation |
Cadence Pharmaceuticals, Inc. (the Company) was
incorporated in the state of Delaware in May 2004. The Company
is a biopharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates
principally for use in the hospital setting.
The Companys primary activities since incorporation have
been organizational activities, including recruiting personnel,
establishing office facilities, conducting research and
development, including clinical trials, and raising capital. To
date, the Company has in-licensed rights to two Phase III
product candidates. Since the Company has not begun principal
operations of commercializing a product candidate, the Company
is considered to be in the development stage.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates.
|
|
|
Unaudited Interim Financial Statements |
The accompanying unaudited interim balance sheet as of
March 31, 2006, the statements of operations and cash flows
for the three months ended March 31, 2005 and 2006 and the
period from May 26, 2004 (inception) through
March 31, 2006 and the statement of stockholders
equity for the three months ended March 31, 2006 are
unaudited. The unaudited interim financial statements have been
prepared on the same basis as the annual financial statements
and, in the opinion of management, reflect all adjustments,
which include only normal recurring adjustments necessary to
present fairly the Companys financial position as of
March 31, 2006 and results of operations and cash flows for
the three months ended March 31, 2005 and 2006. The results
of operations for the three months ended March 31, 2006 are
not necessarily indicative of the results to be expected for the
year ending December 31, 2006 or for any other interim
period or for any other future year.
|
|
|
Unaudited Pro Forma Stockholders Equity |
The unaudited pro forma stockholders equity information in
the accompanying balance sheet assumes the conversion of the
outstanding shares of convertible preferred stock at
March 31, 2006 into 79,630,455 shares of common stock
as though the completion of the initial public offering
contemplated by the filing of this prospectus had occurred on
March 31, 2006. Common shares issued in such initial public
offering and any related estimated net proceeds are excluded
from such pro forma information.
|
|
|
Cash and Cash Equivalents |
Cash and cash equivalents consists of cash and other highly
liquid investments with original maturities of three months or
less from the date of purchase.
F-7
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
|
|
|
Investment Securities Available-for-Sale |
The Company classifies all securities as available-for-sale, as
the sale of such securities may be required prior to maturity to
implement management strategies. These securities are carried at
fair value, with the unrealized gains and losses reported as a
component of accumulated other comprehensive loss until
realized. Realized gains and losses from the sale of
available-for-sale securities, if any, are determined on a
specific identification basis. As of December 31, 2004 and
2005 and March 31, 2006, the carrying value of the
investments approximated their fair market value.
|
|
|
Fair Value of Financial Instruments |
The carrying amount of cash and cash equivalents, accounts
payable and accrued liabilities are considered to be
representative of their respective fair values because of the
short-term nature of those instruments.
|
|
|
Concentration of Credit Risk |
Financial instruments that potentially subject the Company to a
significant concentration of credit risk consist primarily of
cash and cash equivalents and securities available-for-sale. The
Company maintains deposits in federally insured financial
institutions in excess of federally insured limits. However,
management believes the Company is not exposed to significant
credit risk due to the financial position of the depository
institutions in which those deposits are held. Additionally, the
Company has established guidelines regarding diversification of
its investments and their maturities, which are designed to
maintain safety and liquidity.
Property and equipment, including leasehold improvements, are
stated at cost. Depreciation is calculated using the
straight-line method over the estimated useful lives of the
assets, generally two to five years.
|
|
|
Impairment of Long-Lived Assets |
In accordance with Statement of Financial Accounting Standards
(SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, long-lived
assets, such as property and equipment are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the
asset. If the carrying amount of an asset exceeds its estimated
future cash flows, an impairment charge is recognized by the
amount by which the carrying amount of the asset exceeds the
fair value of the asset. Assets to be disposed of would be
separately presented in the balance sheet and reported at the
lower of the carrying amount or the fair value less costs to
sell, and are no longer depreciated. The assets and liabilities
of a disposed group classified as held for sale would be
presented separately in the appropriate asset and liability
sections of the balance sheet. Although the Company has
accumulated losses since inception, the Company believes the
future cash flows to be received from the long-lived assets will
exceed the assets carrying value and, accordingly, the
Company has not recognized any impairment losses through
March 31, 2006.
F-8
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
The Company accounts for research and development costs in
accordance with SFAS No. 2, Accounting for Research
and Development Costs. SFAS No. 2 specifies that
research and development costs should be charged to expense
until technological feasibility has been established for the
product. Once technological feasibility is established, all
product costs should be capitalized until the product is
available for general release to customers. The Company has
determined that technological feasibility for its product
candidates is reached when the requisite regulatory approvals
are obtained to make the product available for sale. The
Companys research and development expenses consist
primarily of license fees, salaries and related employee
benefits, costs associated with clinical trials managed by our
contract research organizations, or CROs, and costs associated
with non-clinical activities, such as regulatory expenses. The
Company uses external service providers and vendors to conduct
clinical trials, to manufacture product candidates to be used in
clinical trials and to provide various other research and
development related products and services. Through
March 31, 2006, research and development expenses relate
predominantly to the in-licensing of IV APAP and omiganan
and clinical trials for omiganan.
Income taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for
the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and
liabilities and their respective tax bases and operating loss
and tax credit carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to
apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect
on deferred tax assets and liabilities of a change in tax rates
is recognized in income in the period that includes the
enactment date. The Company provides a valuation allowance
against net deferred tax assets unless, based upon the available
evidence, it is more likely than not that the deferred tax
assets will be realized.
Effective January 1, 2006, the Company adopted the
provisions of SFAS No. 123(R), Share-Based
Payment, using the prospective transition method and
therefore, prior period results will not be restated.
SFAS No. 123(R) supersedes Accounting Principles Board
(APB) Opinion No. 25, Accounting for Stock
issued to Employees, and related interpretations, and
revises guidance in SFAS No. 123, Accounting for
Stock-Based Compensation. Under this transition method, the
compensation cost related to all equity instruments granted
prior to, but not yet vested as of, the adoption date is
recognized based on the grant-date fair value which is estimated
in accordance with the original provisions of
SFAS No. 123; however, those options issued prior to
but unvested on January 1, 2006 and valued using the
minimum value method are excluded from the options subject to
SFAS No. 123(R). Compensation costs related to all equity
instruments granted after January 1, 2006 is recognized at
grant-date fair value of the awards in accordance with the
provisions of SFAS No. 123(R). Additionally, under the
provisions of SFAS No. 123(R), the Company is required
to include an estimate of the number of the awards that will be
forfeited in calculating compensation costs, which is recognized
over the requisite service period of the awards on a
straight-line basis.
During the three months ended March 31, 2006, the Company
granted an option to purchase 15,000 shares of common
stock but recorded no stock-based compensation costs due to the
F-9
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
insignificance of the amount. Had this amount been significant,
the Company would have allocated the expense between research
and development, sales and marketing and general and
administrative expenses based on the department to which the
associated employee reports. No related tax benefits of the
stock-based compensation costs have been recognized since the
inception of the Company.
The following table shows the assumptions used to compute the
stock-based compensation costs for the stock options granted
during the three months ended March 31, 2006 using the
Black-Scholes option pricing model:
|
|
|
|
|
Employee Stock Options
|
|
|
|
|
Risk-free interest rate
|
|
|
4.36 |
% |
Dividend yield
|
|
|
0.00 |
% |
Weighted average expected life of options (years)
|
|
|
6.08 |
|
Volatility
|
|
|
70.00 |
% |
The risk-free interest rate assumption was based on the United
States Treasurys rates for U.S. Treasury zero-coupon
bonds with maturities similar to those of the expected term of
the award being valued. The assumed dividend yield was based on
the Companys expectation of not paying dividends in the
foreseeable future. The weighted average expected life of
options was calculated using the simplified method as prescribed
by the Securities and Exchange Commissions Staff
Accounting Bulletin (SAB) No. 107. This
decision was based on the lack of relevant historical data due
to the Companys limited historical experience. In
addition, due to the Companys limited historical data, the
estimated volatility also reflects the application of
SAB No. 107, incorporating the historical volatility
of comparable companies whose share prices are publicly
available.
The weighted average grant-date fair values of stock options
granted during the three months ended March 31, 2006 was
$0.07 per share.
As of March 31, 2006, the Company has no significant
unrecognized stock-based compensation costs related to the
non-vested balance of the 15,000 stock options granted during
the three months ended March 31, 2006 or any prior periods.
Prior to January 1, 2006, the Company applied the
intrinsic-value-based method of accounting prescribed by APB
Opinion No. 25, and related interpretations including
Financial Accounting Standards Board (FASB)
Interpretation No. 44, Accounting for Certain
Transactions involving Stock Compensation an
interpretation of APB Opinion No. 25, to account for
its equity-based awards to employees and directors. Under this
method, if the exercise price of the award equaled or exceeded
the fair value of the underlying stock on the measurement date,
no compensation expense was recognized. The measurement date was
the date on which the final number of shares and exercise price
were known and was generally the grant date for awards to
employees and directors. If the exercise price of the award was
below the fair value of the underlying stock on the measurement
date, then compensation cost was recorded, using the
intrinsic-value method, and was generally recognized in the
statements of operations over the vesting period of the award.
The effect on net loss as if the fair-value-based method had
been applied to all outstanding and unvested awards in each
period would have been less than a $10,000 increase in the net
loss for each period in the period from May 26, 2004
(inception) through December 31, 2005. For purposes of
disclosures required by SFAS No. 123, the estimated
fair value of the options is amortized on a straight-
F-10
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
line basis over the vesting period. The fair value of these
awards was estimated using the Minimum Value pricing model, with
the following weighted-average assumptions for 2004 and 2005:
risk-free interest rate of 3.53% and 4.17%, respectively;
dividend yield of 0%; expected volatility of 0%; and a life of
four years.
Equity instruments issued to non-employees are recorded at their
fair value as determined in accordance with
SFAS No. 123 and Emerging Issues Task Force
(EITF) 96-18, Accounting for Equity Instruments
That are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling Goods and Services, and are
periodically revalued as the equity instruments vest and are
recognized as expense over the related service period.
Compensation expense related to the 10,000 stock options issued
to a non-employee was $811 for both the period from May 26,
2004 (inception) through December 31, 2004 and the
period from May 26, 2004 (inception) through
March 31, 2006. The fair value of these stock options was
estimated using the Black-Scholes pricing model, with the
following weighted-average assumptions: risk-free interest rate
of 4.19%; dividend yield of 0%; expected volatility of 70%; and
a life of 10 years.
The Company has applied SFAS No. 130, Reporting
Comprehensive Income, which requires that all components of
comprehensive income, including net income, be reported in the
financial statements in the period in which they are recognized.
Comprehensive income is defined as the change in equity during a
period from transactions and other events and circumstances from
non-owner sources. Net income and other comprehensive income,
including foreign currency translation adjustments and
unrealized gains and losses on investments, shall be reported,
net of their related tax effect, to arrive at comprehensive
income. The net loss and comprehensive loss were the same for
all periods presented.
Basic net loss per share is calculated by dividing the net loss
by the weighted average number of common shares outstanding for
the period, without consideration for common stock equivalents.
Diluted net loss per share is computed by dividing the net loss
by the weighted average number of common share equivalents
outstanding for the period determined using the treasury-stock
method. For purposes of this calculation, convertible preferred
stock, stock options and warrants are considered to be common
stock equivalents and are only included in the calculation of
diluted net loss per share when their effect is dilutive.
The unaudited pro forma basic and diluted net loss per share is
calculated by dividing the net loss by the weighted average
number of common shares outstanding for the period plus the
weighted average number of common shares resulting from the
assumed conversion of the outstanding shares of convertible
preferred stock. The assumed conversion is calculated using the
as-if-converted method, as if such conversion had occurred as of
the beginning of each period presented or as of the original
issuance date, if later.
F-11
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
May 26, 2004 | |
|
|
|
|
|
|
|
|
(Inception) | |
|
|
|
|
|
|
Through | |
|
Year Ended | |
|
Three Months Ended March 31, | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
Historical
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(962,658 |
) |
|
$ |
(28,341,080 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
3,680,548 |
|
|
|
5,277,468 |
|
|
|
4,697,333 |
|
|
|
7,727,933 |
|
|
Weighted average unvested common shares subject to repurchase
|
|
|
(22,192 |
) |
|
|
(653,951 |
) |
|
|
(178,139 |
) |
|
|
(2,832,922 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
3,658,356 |
|
|
|
4,623,517 |
|
|
|
4,519,194 |
|
|
|
4,895,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.21 |
) |
|
$ |
(5.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss used above
|
|
|
|
|
|
$ |
(7,522,612 |
) |
|
|
|
|
|
$ |
(28,341,080 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used above
|
|
|
|
|
|
|
4,623,517 |
|
|
|
|
|
|
|
4,895,011 |
|
Pro forma adjustments to reflect assumed weighted average effect
of conversion of preferred stock
|
|
|
|
|
|
|
16,025,009 |
|
|
|
|
|
|
|
27,556,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma shares used to compute basic and diluted net loss per
share
|
|
|
|
|
|
|
20,648,526 |
|
|
|
|
|
|
|
32,451,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical weighted average anti-dilutive securities not
included in diluted net loss per share calculation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
5,661,130 |
|
|
|
16,025,009 |
|
|
|
8,085,108 |
|
|
|
27,556,122 |
|
Preferred stock warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161,700 |
|
Common stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
751,969 |
|
Common stock subject to repurchase
|
|
|
22,192 |
|
|
|
653,951 |
|
|
|
178,139 |
|
|
|
2,832,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,683,322 |
|
|
|
16,678,960 |
|
|
|
8,263,247 |
|
|
|
31,302,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2. |
Securities Available-for-Sale |
As of December 31, 2005, the Company held $7,000,000 of
commercial paper issued by U.S. corporations and rated by
debt rating agencies.
F-12
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
|
|
3. |
Property and Equipment |
Property and equipment are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
|
|
| |
|
March 31, | |
|
|
Useful Lives | |
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
Leasehold improvements
|
|
|
2 years |
|
|
$ |
1,146 |
|
|
$ |
1,146 |
|
|
$ |
1,146 |
|
Computer equipment and software
|
|
|
3 years |
|
|
|
55,245 |
|
|
|
63,972 |
|
|
|
77,274 |
|
Furniture and equipment
|
|
|
5 years |
|
|
|
60,733 |
|
|
|
94,982 |
|
|
|
129,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,124 |
|
|
|
160,100 |
|
|
|
207,903 |
|
Less accumulated depreciation
|
|
|
|
|
|
|
(8,389 |
) |
|
|
(42,360 |
) |
|
|
(53,092 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
108,735 |
|
|
$ |
117,740 |
|
|
$ |
154,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4. |
Related Party Transactions |
From September 2004 through August 2005, we paid Mr. Cam L.
Garner $5,000 per month plus qualified business expenses
for his services as chairman of our board of directors under the
terms of a consulting agreement between us and a limited
liability company affiliated with Mr. Garner. The agreement
expired on August 31, 2005. From September 2005 to February
2006, we continued to pay Mr. Garner $5,000 per month
for his services as chairman of our board of directors. In
February 2006, Mr. Garners monthly compensation for
his services as chairman of our board of directors was increased
to $8,333 per month. For the period from May 26, 2004
(inception) through December 31, 2004, the year ended
December 31, 2005, the three months ended March 31,
2005 and 2006 and the period from May 26, 2004
(inception) through March 31, 2006, the Company
expensed $20,000, $60,000, $15,000, $18,333, and $98,333,
respectively for payments to Mr. Garner for services as
chairman of our board of directors. The unpaid balance as of
December 31, 2004 and 2005 and March 31, 2006 was
$20,000, $10,000 and $8,333, respectively.
During 2004, certain investors advanced $500,000 for
pre-operating expenses and an exclusivity fee due for the
collaboration and license agreement with Migenix (see
Note 6). The advance was repaid with shares of
Series A-1 preferred stock.
|
|
|
Loan and Security Agreement |
In February 2006, the Company entered into a $7,000,000 loan and
security agreement with Silicon Valley Bank and Oxford Finance
Corporation to provide growth capital to the Company (see
Note 10). The commitment to lend expires on June 30,
2006. The Company will make interest only payments on growth
capital advances until the first day of the month following the
six month anniversary of each growth capital advance, at which
date the Company will make the first of 30 equal principal and
interest payments. Interest accrues on all outstanding amounts
at the fixed rate equal to the greater of (a) 10.83% or
(b) the Treasury Rate plus 6.25% as of the date the first
principal and interest payment is due. The loans will be
collateralized by substantially all the assets of the Company
(excluding intellectual property) and are subject to prepayment
penalties. Under the terms of the agreement, the Company may be
precluded from entering into certain financing and other
transactions, including disposing of certain
F-13
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
assets and paying dividends, and is subject to certain
non-financial covenants. Upon the occurrence of an event of
default, including a Material Adverse Change (as defined in the
agreement), the lenders may declare all outstanding amounts due
and payable.
In conjunction with the loan and security agreement, the Company
issued fully exercisable warrants to the lenders to purchase an
aggregate of 385,000 shares of the Companys
Series A-2 preferred stock at an exercise price of
$1.00 per share. Excluding certain mergers or acquisitions,
the warrants expire upon the later of: (a) 10 years
from issuance or (b) five years after the closing of an
initial public offering of the Companys common stock. The
$313,572 fair value of the warrants was determined using the
Black-Scholes valuation model, recorded as debt issuance costs
which are included as other long-term assets in the accompanying
balance sheets, and amortized to interest expense over the
expected term of the loan agreement. The warrants were valued
using the following assumptions: risk-free interest rate of
4.57%; dividend yield of 0%; expected volatility of 70%; and
contractual term of 10 years.
In 2004, the Company subleased its corporate headquarters under
a non-cancelable operating lease that expires in September 2006.
Rent expense was $67,579, $190,911, $50,684, $50,684 and
$309,174 for the period from May 26, 2004
(inception) through December 31, 2004, the year ended
December 31, 2005, the three months ended March 31,
2005 and 2006 and the period from May 26, 2004
(inception) through March 31, 2006, respectively. As
of December 31, 2005 and March 31, 2006, the sublessor
held a security deposit of $50,685. Future minimum payments
under the operating lease will be $146,985 for the year ending
December 31, 2006.
|
|
6. |
License Agreements and Acquired Development and
Commercialization Rights |
In July 2004, the Company in-licensed from Migenix the
technology and the exclusive development and commercialization
rights to its omiganan product candidate for the prevention and
treatment of device-related, wound-related, and burn-related
infections in North America and Europe. As consideration for the
license, the Company paid a $2,000,000 up-front fee, of which
$1,900,000 was allocated to the value of the acquired technology
and $100,000 was recorded as other long-term assets in the
accompanying balance sheet for the 617,284 shares of
Migenix common stock acquired. The Company may also be required
to make future milestone payments totaling up to $27,000,000
upon the achievement of various milestones related to regulatory
or commercial events. The Company is also obligated to pay a
royalty on future net sales (as defined) of the licensed
products and has the right to grant sublicenses to affiliates.
The Company expects results from Phase III clinical trials
for the licensed product in the second half of 2007 but does not
expect FDA approval prior to 2008. Accordingly, all payments
related to the Migenix agreement (other than for the acquisition
of common stock) have been recorded as research and development
expense.
In March 2006, the Company in-licensed the technology and the
exclusive development and commercialization rights to
its IV APAP product candidate in the United States and
Canada from Bristol-Myers Squibb Company (BMS). BMS
sublicensed these rights to the Company under a license
agreement with SCR Pharmatop S.A. As consideration for the
license, the Company paid a $25,000,000 up-front fee, and may be
required to make future milestone payments totaling up to
$50,000,000 upon the achievement of various milestones related
to regulatory or commercial events. The Company is also
obligated to pay a royalty on net sales of the licensed products
and has the right to grant sublicenses to
F-14
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
third parties. The Company expects to initiate Phase III
clinical trials for the licensed product in 2006 but does not
expect FDA approval prior to 2008. Accordingly, all payments
related to the BMS agreement have been recorded as research and
development expense.
|
|
|
Convertible Preferred Stock |
In July and August 2004, the Company issued
8,085,108 shares of
Series A-1
preferred stock at $0.94 per share for cash of $7,600,002.
The Company incurred offering costs of $59,573 resulting in net
cash proceeds of $7,540,429.
In June and September 2005, the Company issued an aggregate of
17,675,347 shares of
Series A-2
preferred stock at $1.00 per share for cash of $17,675,347.
The Company incurred offering costs of $57,041 resulting in net
cash proceeds of $17,618,306.
In March 2006, the Company issued 53,870,000 shares of
Series A-3
preferred stock at $1.00 per share for cash of $53,870,000.
The Company incurred offering costs of $94,987 resulting in net
cash proceeds of $53,775,013.
Each holder of
Series A-1,
A-2 and
A-3 preferred stock has
the right, at the option of the holder at any time, to convert
shares of preferred stock into shares of common stock at an
initial conversion ratio of
one-to-one, subject to
adjustment. Each share of preferred stock will automatically
convert into shares of common stock, at the then effective
applicable conversion rate upon the earlier of: (i) the day
preceding the closing of the sale of the Companys common
stock in connection with a firmly underwritten public offering
in which the Company receives gross proceeds of at least
$30,000,000 at a price of at least $3.00 per share (as
adjusted from time to time) or (ii) the consent of at least
60% of the then outstanding shares of preferred stock, as a
single class.
Unless 60% of the
Series A-3
preferred stockholders vote otherwise, certain
Series A-3
preferred stockholders that fail to participate in future equity
financings up to specified amounts will lose their right of
first offer related to any subsequent equity financings and any
Series A-1
preferred stock held by them will automatically convert into
newly created Series A-4 preferred stock and any
Series A-2 and
A-3 preferred stock
held by them will automatically convert into newly created
Series A-5 preferred stock. Series A-4 and A-5
preferred stock shall have identical rights and preferences as
Series A-1,
A-2 and
A-3 preferred stock
with the exception of certain anti-dilution protections.
The holders of
Series A-1,
A-2 and
A-3 preferred stock are
entitled to receive, when, as and if declared by the
Companys Board of Directors out of legally available
funds, non-cumulative dividends payable to holders of the
preferred stock in an amount equal to $0.0752, $0.08 and
$0.08 per share, respectively, in preference and priority
to the payment of any dividends on common stock. As of
December 31, 2005 and March 31, 2006, no dividends
have been declared by the Board of Directors.
In the event of any liquidation, dissolution or winding up of
the Company, the holders of
Series A-1,
A-2 and
A-3 preferred stock
will be entitled to receive in preference to the holders of
common stock, the amount of their original purchase price per
share, plus declared and unpaid dividends, if any. If the assets
and funds available to be distributed among the holders of the
preferred stock shall be insufficient to permit the payment to
such holders of the full preferences, then the entire assets and
funds legally available for distribution to such holders shall
be distributed ratably based on the total due each
F-15
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
such holder. Any remaining assets of the Company will be
distributed ratably among the holders of the common stock and
preferred stock, with the preferred stock limited to the
aggregate of three times the original purchase price per share,
based upon the number of shares of common stock held by each
stockholder, treating each share of preferred stock as if it
were converted into shares of common stock at the
then-applicable conversion rate.
Preferred stockholders are entitled to the number of votes they
would have upon conversion of their preferred shares into common
stock at the then-applicable conversion rate. The preferred
stockholders have been granted certain rights with regard to the
election of board members and various other corporate actions.
In 2004, the Company adopted the Cadence Pharmaceuticals, Inc.
2004 Equity Incentive Plan (the 2004 Plan). The 2004
Plan allows for the grant of options, restricted stock awards,
performance share awards, dividend equivalents, restricted stock
units, stock payments and stock appreciation rights to
employees, directors and consultants of the Company. As of
December 31, 2005 and March 31, 2006, respectively,
the 2004 Plan had 4,500,000 and 10,000,000 shares of common
stock reserved for issuance. Options granted under the 2004 Plan
expire no later than 10 years from the date of grant.
Options generally vest over a four-year period and may be
immediately exercisable. After one year, the options generally
vest 25%. Thereafter, options generally vest monthly in 36 equal
installments. The exercise price of incentive stock options
shall not be less than 100% of the fair value of the
Companys common stock on the date of grant. The exercise
price of any option granted to a 10% stockholder may be no less
than 110% of the fair value of the Companys common stock
on the date of grant. The fair value of the Companys
common stock is established by the Companys board of
directors and in 2006 took into consideration contemporaneous
independent valuations of the Companys common stock.
The Company has considered the guidance in the American
Institute of Certified Public Accountants (AICPA)
Audit and Accounting Practice Aid Series, Valuation of
Privately-Held-Company Equity Securities Issued as
Compensation, to determine the fair value of its common
stock for purposes of setting the exercise prices of stock
options granted to employees and others. This guidance
emphasizes the importance of the operational development in
determining the value of the enterprise. As a development stage
enterprise, the Company is at an early stage of existence,
primarily focused on product development with an unproven
business model. To date, the Company has been funded primarily
by venture capitalists with a history of funding
start-up, high-risk
entities with the potential for high returns in the event the
investments are successful. Prior to the licensing of IV
APAP in March 2006, the Company was considered to be in a very
early stage of development as defined in the AICPA guidance
where the preferences of the preferred stockholders, in
particular the liquidation preferences, are very meaningful.
Subsequent to our licensing of IV APAP but prior to the
initiation of our initial public offering process on
June 14, 2006, taking into consideration a contemporaneous
independent valuation, we allocated additional enterprise value
to our common stock with an increase in the common stock
valuation to $0.34 per share. Subsequent to the initiation
of our initial public offering process, taking into
consideration a contemporaneous independent valuation, we
increased our common stock valuation to $0.80 per share.
F-16
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
At December 31, 2005 and March 31, 2006, respectively,
a total of 228,000 and 5,713,000 shares of common stock
remained available for issuance under the 2004 Plan. A summary
of the Companys stock option activity under the 2004 Plan
and related information are as follows:
|
|
|
|
|
|
|
|
|
|
|
Options | |
|
Weighted Average | |
|
|
Outstanding | |
|
Exercise Price | |
|
|
| |
|
| |
Granted
|
|
|
1,225,000 |
|
|
$ |
0.10 |
|
Exercised
|
|
|
(180,000 |
) |
|
$ |
0.10 |
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
1,045,000 |
|
|
$ |
0.10 |
|
Granted
|
|
|
3,077,000 |
|
|
$ |
0.10 |
|
Exercised
|
|
|
(2,966,000 |
) |
|
$ |
0.10 |
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
1,156,000 |
|
|
$ |
0.10 |
|
Granted
|
|
|
15,000 |
|
|
$ |
0.10 |
|
Exercised
|
|
|
(154,000 |
) |
|
$ |
0.10 |
|
|
|
|
|
|
|
|
Balance at March 31, 2006
|
|
|
1,017,000 |
|
|
$ |
0.10 |
|
|
|
|
|
|
|
|
During the period from May 26, 2004 (inception) through
December 31, 2004 and the quarterly periods ended
March 31, 2005, June 30, 2005, September 30,
2005, December 31, 2005 and March 31, 2006, the
Company granted options to purchase shares of the Companys
common stock in the amount of 1,225,000, 650,000, 360,000,
191,000, 1,876,000 and 15,000, respectively. All such grants had
both a fair value and exercise price of $0.10.
As of December 31, 2005 and March 31, 2006,
respectively, 989,521 and 842,707 of the outstanding options
under the 2004 Plan were exercisable, 186,813 and 196,873 were
vested and 2,767,875 and 2,802,000 of the options exercised were
subject to repurchase by the Company since they were unvested.
The weighted average remaining contractual life of the options
outstanding at December 31, 2005 and March 31, 2006,
respectively, was 9.2 and 9.0 years. The weighted average
remaining contractual life of the options exercisable at
December 31, 2005 and March 31, 2006, respectively,
was 9.2 and 8.9 years.
|
|
|
Shares Reserved For Future Issuance |
The following shares of common stock are reserved for future
issuance:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
March 31, | |
|
|
2005 | |
|
2006 | |
|
|
| |
|
| |
Conversion of preferred stock
|
|
|
25,760,455 |
|
|
|
79,630,455 |
|
Common stock options granted and outstanding
|
|
|
1,156,000 |
|
|
|
1,017,000 |
|
Preferred stock warrants outstanding
|
|
|
|
|
|
|
385,000 |
|
Common stock options reserved for future issuance
|
|
|
228,000 |
|
|
|
5,713,000 |
|
|
|
|
|
|
|
|
|
|
|
27,144,455 |
|
|
|
86,745,455 |
|
|
|
|
|
|
|
|
F-17
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
Significant components of the Companys deferred tax assets
for federal and state income taxes at December 31, 2004 and
2005 are shown below. A valuation allowance has been established
as realization of such deferred tax assets has not met the more
likely than not threshold requirement under
SFAS No. 109.
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
December 31, | |
|
|
2004 | |
|
2005 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$ |
361,000 |
|
|
$ |
3,528,000 |
|
Tax credit carryforwards
|
|
|
29,000 |
|
|
|
359,000 |
|
Capitalized research and development
|
|
|
591,000 |
|
|
|
520,000 |
|
Other, net
|
|
|
157,000 |
|
|
|
111,000 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
1,138,000 |
|
|
|
4,518,000 |
|
Valuation allowance for deferred tax assets
|
|
|
(1,138,000 |
) |
|
|
(4,518,000 |
) |
|
|
|
|
|
|
|
Net deferred taxes
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
At December 31, 2005, the Company had federal and state net
operating loss carryforwards of approximately $8,659,000 and
$8,663,000, respectively. The federal and state tax loss
carryforwards will begin to expire in 2024 and 2014,
respectively, unless previously utilized. The Company also had
federal research and development tax credit carryforwards of
approximately $283,000 which will begin expiring in 2024 unless
previously utilized. The Company had state research and
development tax credit carryforwards of approximately $116,000,
which carryforward indefinitely.
Utilization of the net operating loss carry forwards and credits
may be subject to a substantial annual limitation due to the
ownership change limitations provided by the Internal Revenue
Code of 1986, as amended, and similar state provisions. The
annual limitation may result in the expiration of net operating
losses and credits before utilization.
Effective January 1, 2005, the Company established a 401(k)
plan covering substantially all employees. Employees may
contribute up to 100% of their compensation per year (subject to
a maximum limit prescribed by federal tax law). The Company may
elect to make a discretionary contribution or match a
discretionary percentage of employee contributions. As of
December 31, 2005 and March 31, 2006, the Company had
not elected to make any contributions to the plan.
|
|
10. |
Subsequent Events (unaudited) |
In June 2006, the Companys stockholders approved the
increase of the number of shares of common stock reserved for
issuance under the 2004 Plan by 1,500,000 shares.
In May 2006, the Company entered into a six-year operating
lease for 23,494 square feet of office space. The Company
will receive certain tenant improvement allowances and rent
abatement and has an option to extend the lease for five years.
Monthly rental payments are adjusted on an annual basis and the
lease expires in September 2012. As security for the lease,
the landlord required a letter of credit in the
F-18
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of March 31, 2006 and thereafter and for
the three months ended
March 31, 2005 and 2006 and the period from May 26,
2004 (inception)
through March 31, 2006 is unaudited)
amount of $1,581,130. The letter of credit is collateralized by
a certificate of deposit in the same amount which will be
classified as restricted cash in the balance sheet. The required
amount subject to the letter of credit and corresponding
certificate of deposit will be reduced by 22% on each of the
first four anniversaries of the commencement of the lease.
Future minimum payments under the operating lease total
$197,936, $1,009,000, $1,074,851, $1,112,206, $1,151,676,
$1,191,851 and $917,676 for the years ending December 31,
2006, 2007, 2008, 2009, 2010, 2011 and 2012, respectively.
In June 2006, the Company drew down $7,000,000 under its
loan and security agreement with Silicon Valley Bank and Oxford
Finance Corporation and has no further credit available under
this agreement. The Company is required to make interest only
payments on the loan balance for the first six months of the
loan, and beginning February 2007 is required to make the
first of 30 equal monthly principal and interest payments.
Interest accrues on all outstanding amounts at the fixed rate of
11.47%.
From April 1, 2006 through July 15, 2006, the Company
granted options to employees, directors and consultants of the
Company to purchase an aggregate of 5,953,261 shares of
common stock at an exercise price ranging from $0.34 to
$0.80 per share. The exercise price was established by the
Companys board of directors and took into consideration
contemporaneous independent valuations of the Companys
common stock.
F-19
Through and
including ,
2006 (the 25th day after the date of this prospectus), all
dealers effecting transactions in these securities, whether or
not participating in this offering, may be required to deliver a
prospectus. This is in addition to the dealers obligation
to deliver a prospectus when acting as underwriters and with
respect to their unsold allotments or subscriptions.
Shares
Common Stock
PROSPECTUS
Merrill Lynch & Co.
Deutsche Bank Securities
Pacific Growth Equities, LLC
JMP Securities
,
2006
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
|
|
Item 13. |
Other Expenses of Issuance and Distribution |
The following table sets forth the fees and expenses, other than
underwriting discounts and commissions, payable by us in
connection with the registration of the common stock hereunder.
All amounts shown are estimates except for the SEC registration
fee, the NASD filing fee and the Nasdaq Global Market listing
fee.
|
|
|
|
|
|
|
|
Amount | |
Item |
|
to be Paid | |
|
|
| |
SEC Registration Fee
|
|
$ |
9,229 |
|
NASD Filing Fee
|
|
|
9,125 |
|
Nasdaq Global Market Listing Fee
|
|
|
100,000 |
|
Legal Fees and Expenses
|
|
|
* |
|
Accounting Fees and Expenses
|
|
|
* |
|
Printing and Engraving Expenses
|
|
|
* |
|
Blue Sky, Qualification Fees and Expenses
|
|
|
* |
|
Transfer Agent and Registrar Fees
|
|
|
* |
|
Miscellaneous Expenses
|
|
|
* |
|
|
|
|
|
|
Total
|
|
$ |
* |
|
|
|
|
|
|
|
* |
To be completed by amendment. |
|
|
Item 14. |
Indemnification of Directors and Officers |
Section 145 of the Delaware General Corporation Law permits
a corporation to include in its charter documents, and in
agreements between the corporation and its directors and
officers, provisions expanding the scope of indemnification
beyond that specifically provided by the current law.
Our amended and restated certificate of incorporation provides
for the indemnification of directors to the fullest extent
permissible under Delaware law.
Our amended and restated bylaws provide for the indemnification
of officers, directors and third parties acting on our behalf if
such persons act in good faith and in a manner reasonably
believed to be in and not opposed to our best interest, and,
with respect to any criminal action or proceeding, such
indemnified party had no reason to believe his or her conduct
was unlawful.
We are entering into indemnification agreements with each of our
directors and executive officers, in addition to the
indemnification provisions provided for in our charter
documents, and we intend to enter into indemnification
agreements with any new directors and executive officers in the
future.
The underwriting agreement (to be filed as Exhibit 1.1
hereto) will provide for indemnification by the underwriters of
us, our executive officers and directors, and indemnification of
the underwriters by us for certain liabilities, including
liabilities arising under the Securities Act of 1933, as
amended, in connection with matters specifically provided in
writing by the underwriters for inclusion in the registration
statement.
We intend to purchase and maintain insurance on behalf of any
person who is or was a director or officer against any loss
arising from any claim asserted against him or her and incurred
by him or her in that capacity, subject to certain exclusions
and limits of the amount of coverage.
II-1
|
|
Item 15. |
Recent Sales of Unregistered Securities |
Since inception, we have issued and sold the following
unregistered securities:
|
|
|
1. In July 2004, we issued 4,500,000 shares of common
stock to a limited liability company and individual investors
for aggregate consideration of $4,500. |
|
|
2. In July and August 2004, we issued and sold an aggregate
of 8,085,108 shares of
Series A-1
preferred stock to certain venture capital funds and individual
investors at a per share price of $0.94, for aggregate
consideration of $7,600,001.52. Upon completion of this
offering, these shares of
Series A-1
preferred stock will convert into 8,085,108 shares of our
common stock. |
|
|
3. In June and September 2005, we issued and sold an
aggregate of 17,675,347 shares of
Series A-2
preferred stock to certain existing and new investors at a per
share price of $1.00, for aggregate consideration of
$17,675,347. Upon completion of this offering, these shares of
Series A-2
preferred stock will convert into 17,675,347 shares of our
common stock. |
|
|
4. In February 2006, in connection with a loan and security
agreement, we issued two warrants to two lenders to purchase an
aggregate of 385,000 shares of
Series A-2
preferred stock, at an initial exercise price of $1.00 per
share, subject to adjustment. The warrants are exercisable
through the later of February 2016 or five years from the
closing of this offering. These warrants will be exercisable for
an aggregate of 385,000 shares of common stock at an
exercise price of $1.00 per share upon the completion of
this offering. |
|
|
5. In March 2006, we issued and sold an aggregate of
53,870,000 shares of
Series A-3
preferred stock to certain existing and new investors at a per
share price of $1.00, for aggregate consideration of
$53,870,000. Upon completion of this offering, these shares of
Series A-3
preferred stock will convert into 53,870,000 shares of our
common stock. |
|
|
6. Since our inception through March 31, 2006, we
granted stock options to purchase 4,317,000 shares of
our common stock at an exercise price of $0.10 per share to
our employees, consultants and directors under our 2004 equity
incentive award plan. Since our inception through March 31,
2006, we issued and sold an aggregate of 3,300,000 shares
of our common stock to our employees, consultants and directors
at a price of $0.10 per share pursuant to exercises of
options granted under our 2004 equity incentive award plan.
During this period, 30,000 unvested shares were repurchased by
us resulting in a net of 3,270,000 shares issued and sold
under our 2004 equity incentive award plan. |
The issuance of securities described above in
paragraphs (1) through (5) were exempt from
registration under the Securities Act of 1933, as amended, in
reliance on Section 4(2) of the Securities Act of 1933, as
amended, and Regulation D promulgated thereunder, as
transactions by an issuer not involving any public offering. The
purchasers of the securities in these transactions represented
that they were accredited investors or qualified institutional
buyers and they were acquiring the securities for investment
only and not with a view toward the public sale or distribution
thereof. Such purchasers received written disclosures that the
securities had not been registered under the Securities Act of
1933, as amended, and that any resale must be made pursuant to a
registration statement or an available exemption from
registration. All purchasers either received adequate financial
statement or non-financial statement information about the
registrant or had adequate access, through their relationship
with the registrant, to financial statement or non-financial
statement information about the registrant. The sale of these
securities was made without general solicitation or advertising.
The issuance of securities described above in
paragraph (6) was exempt from registration under the
Securities Act of 1933, as amended, in reliance on Rule 701
of the Securities Act of 1933, as amended, pursuant to
compensatory benefit plans approved by the registrants
board of directors.
All certificates representing the securities issued in these
transactions described in this Item 15 included appropriate
legends setting forth that the securities had not been offered
or sold pursuant to a
II-2
registration statement and describing the applicable
restrictions on transfer of the securities. There were no
underwriters employed in connection with any of the transactions
set forth in this Item 15.
|
|
Item 16. |
Exhibits and Financial Statement Schedules |
(a) Exhibits
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
1.1* |
|
|
Form of Underwriting Agreement |
|
3.1 |
|
|
Restated Certificate of Incorporation of the Registrant, as
currently in effect |
|
3.2* |
|
|
Form of Amended and Restated Certificate of Incorporation of the
Registrant, to be in effect upon completion of the offering |
|
3.3 |
|
|
Amended and Restated Bylaws of the Registrant, as currently in
effect |
|
3.4* |
|
|
Form of Amended and Restated Bylaws of the Registrant, to be in
effect upon completion of the offering |
|
4.1* |
|
|
Form of the Registrants Common Stock Certificate |
|
4.2 |
|
|
Amended and Restated Investor Rights Agreement dated
February 21, 2006 |
|
4.3 |
|
|
Warrant issued by Registrant in February 2006 to Silicon Valley
Bank |
|
4.4 |
|
|
Warrant issued by Registrant in February 2006 to Oxford Finance
Corporation |
|
5.1* |
|
|
Opinion of Latham & Watkins LLP |
|
10.1* |
|
|
Form of Director and Executive Officer Indemnification Agreement |
|
10.2* |
|
|
Form of Executive Officer Employment Agreement |
|
10.3# |
|
|
2004 Equity Incentive Award Plan and forms of option agreements
thereunder |
|
10.4#* |
|
|
Director Equity Compensation Policy |
|
10.5#* |
|
|
2006 Equity Incentive Award Plan and forms of option and
restricted stock agreements thereunder |
|
10.6#* |
|
|
2006 Employee Stock Purchase Plan and form of offering document
thereunder |
|
10.7#* |
|
|
2006 Incentive Plan |
|
10.8 |
|
|
Sublease dated August 31, 2004 by and between the
Registrant and Townsend and Townsend and Crew, LLP |
|
10.9 |
|
|
Lease dated May 12, 2006 by and between the Registrant and
Prentiss/ Collins Del Mar Heights LLC |
|
10.10 |
|
|
Collaboration and License Agreement dated July 30, 2004 by
and between the Registrant and Migenix Inc. (formerly Micrologix
Biotech Inc.) |
|
10.11 |
|
|
IV APAP Agreement (US and Canada) dated February 21, 2006
by and between the Registrant and Bristol-Myers Squibb Company |
|
10.12 |
|
|
License Agreement dated December 23, 2002 by and among SCR
Pharmatop and Bristol-Myers Squibb Company |
|
10.13 |
|
|
Loan and Security Agreement dated February 17, 2006 by and
among the Registrant, Silicon Valley Bank and Oxford Finance
Corporation |
|
23.1 |
|
|
Consent of Ernst & Young LLP, independent registered
public accounting firm |
|
23.2* |
|
|
Consent of Latham & Watkins LLP (included in
Exhibit 5.1) |
|
24.1 |
|
|
Power of Attorney (See page II-5) |
|
|
* |
To be filed by amendment. |
|
|
Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission. |
|
# |
Indicates management contract or compensatory plan. |
II-3
(b) Financial Statement Schedules
Schedules not listed above have been omitted because the
information required to be set forth therein is not applicable
or is shown in the financial statements or notes thereto.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933, as amended, may be permitted to
directors, officers and controlling persons of the Registrant
pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act of
1933, as amended, and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other
than the payment by the Registrant of expenses incurred or paid
by a director, officer or controlling person of the Registrant
in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Securities Act of 1933, as amended, and will be governed by
the final adjudication of such issue.
We hereby undertake that:
|
|
|
(a) We will provide to the underwriters at the closing as
specified in the underwriting agreement certificates in such
denominations and registered in such names as required by the
underwriters to permit prompt delivery to each purchaser. |
|
|
(b) For purposes of determining any liability under the
Securities Act of 1933, as amended, the information omitted from
a form of prospectus filed as part of this registration
statement in reliance upon Rule 430A and contained in the
form of prospectus filed by the Registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act of 1933, as amended, shall be deemed to be part of this
registration statement as of the time it was declared effective. |
|
|
(c) For the purpose of determining any liability under the
Securities Act of 1933, as amended, each post-effective
amendment that contains a form of prospectus shall be deemed to
be a new registration statement relating to the securities
offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering
thereof. |
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, Cadence Pharmaceuticals, Inc. has duly caused this
Registration Statement on
Form S-1 to be
signed on its behalf by the undersigned, thereunto duly
authorized, in San Diego, California on the
17th
day of July, 2006.
|
|
|
CADENCE PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Theodore R. Schroeder
|
|
|
|
|
|
Theodore R. Schroeder |
|
President and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints Theodore R.
Schroeder and William R. LaRue, and each of them, his true and
lawful
attorneys-in-fact and
agents, each with full power of substitution and resubstitution,
for him and in his name, place and stead, in any and all
capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and
to sign any registration statement for the same offering covered
by this Registration Statement that is to be effective upon
filing pursuant to Rule 462(b) promulgated under the
Securities Act of 1933, as amended, and all post-effective
amendments thereto, and to file the same, with all exhibits
thereto and all documents in connection therewith, with the
Securities and Exchange Commission, granting unto said
attorneys-in-fact and
agents, and each of them, full power and authority to do and
perform each and every act and thing requisite and necessary to
be done in and about the premises, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and
confirming all that such
attorneys-in-fact and
agents or any of them, or his or their substitute or
substitutes, may lawfully do or cause to be done by virtue
hereof.
Pursuant to the requirements of the Securities Act of 1933, as
amended, this Registration Statement on
Form S-1 has been
signed by the following persons in the capacities and on the
dates indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Theodore R.
Schroeder
Theodore
R. Schroeder |
|
President, Chief Executive Officer and Director (Principal
Executive Officer) |
|
July 17, 2006 |
|
/s/ William R. LaRue
William
R. LaRue |
|
Senior Vice President, Chief Financial Officer,
Treasurer and Secretary (Principal Financial and Accounting
Officer) |
|
July 17, 2006 |
|
/s/ Cam L. Garner
Cam
L. Garner |
|
Chairman of the Board of Directors |
|
July 17, 2006 |
|
/s/ Brian G. Atwood
Brian
G. Atwood |
|
Director |
|
July 17, 2006 |
|
/s/ Michael A. Berman
Michael
A. Berman, M.D. |
|
Director |
|
July 17, 2006 |
II-5
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ James C. Blair,
Ph.D.
James
C. Blair, Ph.D. |
|
Director |
|
July 17, 2006 |
|
/s/ Alan D. Frazier
Alan
D. Frazier |
|
Director |
|
July 17, 2006 |
|
/s/ Alain B. Schreiber,
M.D.
Alain
B. Schreiber, M.D. |
|
Director |
|
July 17, 2006 |
|
/s/ Christopher J.
Twomey
Christopher
J. Twomey |
|
Director |
|
July 17, 2006 |
II-6
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
1.1* |
|
|
Form of Underwriting Agreement |
|
3.1 |
|
|
Restated Certificate of Incorporation of the Registrant, as
currently in effect |
|
3.2* |
|
|
Form of Amended and Restated Certificate of Incorporation of the
Registrant, to be in effect upon completion of the offering |
|
3.3 |
|
|
Amended and Restated Bylaws of the Registrant, as currently in
effect |
|
3.4* |
|
|
Form of Amended and Restated Bylaws of the Registrant, to be in
effect upon completion of the offering |
|
4.1* |
|
|
Form of the Registrants Common Stock Certificate |
|
4.2 |
|
|
Amended and Restated Investor Rights Agreement dated
February 21, 2006 |
|
4.3 |
|
|
Warrant issued by Registrant in February 2006 to Silicon Valley
Bank |
|
4.4 |
|
|
Warrant issued by Registrant in February 2006 to Oxford Finance
Corporation |
|
5.1* |
|
|
Opinion of Latham & Watkins LLP |
|
10.1* |
|
|
Form of Director and Executive Officer Indemnification Agreement |
|
10.2* |
|
|
Form of Executive Officer Employment Agreement |
|
10.3# |
|
|
2004 Equity Incentive Award Plan and forms of option agreements
thereunder |
|
10.4#* |
|
|
Director Equity Compensation Policy |
|
10.5#* |
|
|
2006 Equity Incentive Award Plan and forms of option and
restricted stock agreements thereunder |
|
10.6#* |
|
|
2006 Employee Stock Purchase Plan and form of offering document
thereunder |
|
10.7#* |
|
|
2006 Incentive Plan |
|
10.8 |
|
|
Sublease dated August 31, 2004 by and between the
Registrant and Townsend and Townsend and Crew, LLP |
|
10.9 |
|
|
Lease dated May 12, 2006 by and between the Registrant and
Prentiss/ Collins Del Mar Heights LLC |
|
10.10 |
|
|
Collaboration and License Agreement dated July 30, 2004 by
and between the Registrant and Migenix Inc. (formerly Micrologix
Biotech Inc.) |
|
10.11 |
|
|
IV APAP Agreement (US and Canada) dated February 21, 2006
by and between the Registrant and Bristol-Myers Squibb Company |
|
10.12 |
|
|
License Agreement dated December 23, 2002 by and among SCR
Pharmatop and Bristol-Myers Squibb Company |
|
10.13 |
|
|
Loan and Security Agreement dated February 17, 2006 by and
among the Registrant, Silicon Valley Bank and Oxford Finance
Corporation |
|
23.1 |
|
|
Consent of Ernst & Young LLP, independent registered
public accounting firm |
|
23.2* |
|
|
Consent of Latham & Watkins LLP (included in
Exhibit 5.1) |
|
24.1 |
|
|
Power of Attorney (See page II-5) |
|
|
* |
To be filed by amendment. |
|
|
Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission. |
|
# |
Indicates management contract or compensatory plan. |
exv3w1
EXHIBIT 3.1
RESTATED CERTIFICATE OF INCORPORATION
OF
CADENCE PHARMACEUTICALS, INC.
Cadence Pharmaceuticals, Inc., a corporation organized and existing under and by
virtue of the General Corporation Law of the State of Delaware (the Corporation),
DOES HEREBY CERTIFY:
First: That the name of the Corporation is Cadence Pharmaceuticals, Inc. The
Corporation, which was originally known as Strata Pharmaceuticals, Inc., originally filed its
Certificate of Incorporation with the Secretary of the State of Delaware on May 26, 2004.
Second: Pursuant to Sections 242 and 245 of the General Corporation Law of the State
of Delaware, this Restated Certificate of Incorporation was adopted by the Corporations Board of
Directors (the Board of Directors) and stockholders.
Third: The text of the Corporations Certificate of Incorporation as heretofore
amended, restated and or supplemented is hereby restated and further amended to read in its
entirety as follows:
I
The name of the Corporation is Cadence Pharmaceuticals, Inc.
II
The address of the Corporations registered office in the State of Delaware is 1209 Orange
Street, City of Wilmington, County of New Castle 19801. The name of its registered agent at such
address is The Corporation Trust Company.
III
The purpose of the Corporation is to engage in any lawful act or activity for which a
corporation may be organized under the General Corporation Law of the State of Delaware.
IV
The Corporation is authorized to issue two classes of stock designated Common Stock and
Preferred Stock. The Preferred Stock shall consist of three series designated Series A-1
Preferred Stock, Series A-2 Preferred Stock and Series A-3 Preferred Stock.
The number of shares of Common Stock that the Corporation is authorized to issue is One
Hundred Million (100,000,000). The number of shares of Preferred Stock that the Corporation is
authorized to issue is Eighty Million Fifteen Thousand Four Hundred Fifty-Five (80,015,455), of
which Eight Million Eighty-Five Thousand One Hundred Eight (8,085,108) shares shall be designated
Series A-1 Preferred Stock, Eighteen Million Sixty Thousand Three Hundred Forty Seven, (18,060,347)
shares shall be designated Series A-2 Preferred Stock, and Fifty-Three Million Eight Hundred
Seventy Thousand (53,870,000) shares shall be designated Series A-3 Preferred Stock.
All shares of Common Stock, Series A-1 Preferred Stock, Series A-2 Preferred Stock and Series
A-3 Preferred Stock shall have a par value of $0.0001 per share. Except as specifically set forth
herein,
references hereinafter to Preferred Stock shall mean the Series A-1 Preferred Stock, the
Series A-2 Preferred Stock and Series A-3 Preferred Stock.
The rights, preferences, privileges and restrictions granted to or imposed upon the respective
classes and series of shares of capital or the holders thereof are set forth below in this Article
IV.
1. Dividends.
(a) Rights to Receive Dividends. The holder of each then outstanding share of Series
A-1 Preferred Stock, Series A-2 Preferred Stock and Series A-3 Preferred Stock shall be entitled to
receive dividends at the per annum rate of eight percent (8%) of the Series A-1 Original Purchase
Price (as defined herein), Series A-2 Original Purchase Price (as defined herein) or Series A-3
Original Purchase Price (as defined herein), as applicable (as adjusted for all stock splits, stock
dividends, consolidations, recapitalizations and reorganizations with respect to such shares),
payable out of funds legally available therefor. Such dividends shall be payable in preference and
priority to any payment of any dividend on any shares of Common Stock of the Corporation, when, as
and if declared by the board of directors of the Board of Directors. The Series A-1 Original
Purchase Price shall be $0.94 per share (as adjusted for all stock splits, stock dividends,
consolidations, recapitalizations and reorganizations with respect to such shares); the Series A-2
Original Purchase Price shall be $1.00 per share (as adjusted for all stock splits, stock
dividends, consolidations, recapitalizations and reorganizations with respect to such shares); and
the Series A-3 Original Purchase Price shall be $1.00 per share (as adjusted for all stock
splits, stock dividends, consolidations, recapitalizations and reorganizations with respect to such
shares). The right to such dividends on the Preferred Stock shall not be cumulative, and no right
shall accrue to holders of Preferred Stock by reason of the fact that dividends on such shares are
not declared or paid in any prior year, whether or not the earnings of the Corporation were
sufficient to pay such dividends in whole or in part. The Board of Directors may fix a record date
for the determination of holders of Preferred Stock entitled to receive payment of a dividend
declared thereon, which record date shall be not more than thirty (30) days prior to the date fixed
for the payment thereof (the Preferred Stock Date of Accrual). Notwithstanding the foregoing,
dividends, if paid, or if declared and set apart for payment, must be paid, or declared and set
apart for payment, on all outstanding shares of the Preferred Stock contemporaneously.
(b) Payment of Dividends. The Corporation shall pay to each holder of Preferred Stock
on the Preferred Stock Date of Accrual with respect to shares held by each of such holders any and
all dividends which have been declared through such date.
(c) Other Dividends. Subject to the provisions of Sections 1(a) and (b) hereof, no
dividend or other distribution shall be paid, or declared and set apart for payment, other than
dividends of Common Stock on the Common Stock of the Corporation, on the shares of any class or
series of capital stock of the Corporation, unless and until there shall first be declared and paid
on each share of the Preferred Stock a cash dividend in an amount equal to such dividend or other
distribution with each share of Preferred Stock entitled to receive the amount specified in Section
1(a) plus the product of (i) the amount of the dividend, if any, declared on each share of Common
Stock and (ii) the number of shares of Common Stock into which the share of Preferred Stock is then
convertible under Section 5 of this Article IV determined by reference to the Conversion Price in
effect at the record date for such dividend.
Neither the Corporation nor any of its Subsidiaries shall purchase, redeem or otherwise
acquire for value any shares of any class or series of the Corporations capital stock (other than
the shares of Common Stock issued by the Corporation to its employees, directors, advisors, outside
consultants, contractors, or stockholders pursuant to plans, agreements or arrangements duly
approved by the Board of
Directors) and no money shall be paid into or set aside or made available for a sinking fund
for the purchase, redemption or acquisition thereof.
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2. Liquidation.
(a) Preference. In the event of any voluntary or involuntary dissolution, liquidation
or winding up of the affairs of the Corporation (a Liquidation Event), after payment or provision
for payment of the debts and other liabilities of the Corporation, the holders of each share of
Series A-1 Preferred Stock, Series A-2 Preferred Stock and Series A-3 Preferred Stock shall be
entitled to receive on a pari passu basis out of the assets of the Corporation,
whether such assets are capital, surplus or earnings, an amount equal to the Series A-1 Original
Purchase Price, the Series A-2 Original Purchase Price and the Series A-3 Original Purchase Price
for each share of Series A-1 Preferred Stock, Series A-2 Preferred Stock and/or Series A-3
Preferred Stock, as applicable, then held by each such holder, plus any declared but unpaid
dividend on each such share, before any payment shall be made or assets distributed on the Common
Stock or any other class or series of capital stock of the Corporation.
(b) Partial Payment. If upon any Liquidation Event the assets of the Corporation
distributable as aforesaid among the holders of the Series A-1 Preferred Stock, the Series A-2
Preferred Stock and the Series A-3 Preferred Stock shall be insufficient to permit the payment to
them of the full preferential amounts to which they are entitled, then the entire assets of the
Corporation so to be distributed shall be distributed ratably among the holders of the Series A-1
Preferred Stock, the Series A-2 Preferred Stock and the Series A-3 Preferred Stock, in proportion
to the sum of their respective per share liquidation values, until payment in full of such amount
per share.
(c) Remaining Assets. After payment to the holders of the Preferred Stock of the
amounts set forth in Section 2(a) above, the entire remaining assets and funds of the corporation
legally available for distribution, if any, shall be distributed ratably among the holders of the
Common Stock and the holders of the Preferred Stock, with the Preferred Stock holders participating
on the basis of the number of shares they would be entitled to receive if they were to convert
their shares of Preferred Stock into shares of Common Stock only until such holders of Preferred
Stock have received, including amounts paid pursuant to Section 2(a) of this Article IV, an amount
equal to three (3) times the Series A-1 Original Purchase Price, three (3) times the Series A-2
Original Purchase Price and three (3) times the Series A-3 Original Purchase Price for each share
of Series A-1 Preferred Stock, Series A-2 Preferred Stock and Series A-3 Preferred Stock, as
applicable, then held by them.
(d) Reorganization. For purposes of this Section 2, a Liquidation Event shall be
deemed to be occasioned by, and to include, the Corporations (i) sale of all or substantially all
of its assets or (ii) consolidation or merger with or into another Person (as defined in Section 8
below) if, as a result of such consolidation or merger, the holders of the Common Stock and the
Preferred Stock prior to such consolidation or merger do not hold at least fifty-one percent (51%)
of the combined voting power of the surviving Person.
3. Redemption. The Corporation shall not be obligated to, and shall not have the
right to call or redeem any shares of the Preferred Stock.
4. Voting Rights; Directors.
(a) Generally. On all matters to come before the stockholders, the Preferred Stock
shall have that number of votes per share (rounded up to the nearest whole share) equivalent to the
number of shares of Common Stock into which such share of Preferred Stock is then convertible
determined by reference to the applicable Conversion Price in effect at the record date of the
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determination of the holders of the shares entitled to vote or, if no such record date is
established, at the date such vote is taken or any written consent of stockholders is first
solicited. Each holder of shares of Common Stock shall be entitled to one (1) vote for each share
thereof held. Except as otherwise provided by law or this Restated Certificate of Incorporation,
the holders of Preferred Stock shall vote together with the holders of the outstanding shares of
Common Stock, and not as a separate class or series.
(b) Directors.
(i) The holders of the outstanding shares of Preferred Stock, voting together as a class and
to the exclusion of all other classes of capital stock of the Corporation, shall be entitled to
elect four (4) members of the Board of Directors (the Preferred Directors). The holders of the
outstanding shares of Common Stock, voting together or as a class and to the exclusion of all other
classes of capital stock of the Corporation shall be entitled to select two (2) members of the
Board of Directors (the Common Directors). The holders of the outstanding shares of Common Stock
and Preferred Stock, voting together as a single class and to the exclusion of all other classes of
capital stock of the Corporation, shall be entitled to elect two (2) members of the Board of
Directors in accordance with Section 4(a) above (the General Directors); provided, however, that
any such General Director must be approved by (x) the holders of a majority of the Common Stock,
voting together as a single class and to the exclusion of all other classes of capital stock of the
Corporation, and (y) the holders of a majority of the Preferred Stock, voting together as a single
class and to the exclusion of all other classes of capital stock of the Corporation.
(ii) In the case of any vacancy in the office of a director occurring among the Preferred
Directors, the Common Directors or the General Directors, the remaining Preferred Director(s), the
Common Director(s) or the General Director(s), as the case may be, may, by affirmative vote of a
majority thereof (or the remaining director so elected if there is but one, or if there is no such
director remaining, by the affirmative vote of the holders of a majority of the shares of the class
or classes entitled to vote on the election of the Preferred Director, the Common Director or the
General Director, as the case may be), elect a successor or successors to hold the office for the
unexpired term of the director or directors whose place or places shall be vacant. Any director
may be removed during the aforesaid term of office, whether with or without cause, only by the
affirmative vote of the holders of a majority of the shares eligible to vote in an election for the
seat occupied by that director (e.g., in order to remove a Preferred Director, the holders of a
majority of the Preferred Stock, voting together as a single class and to the exclusion of all
other classes of capital stock of the Corporation, must so vote).
(c) Protective Provisions. The Corporation shall not (by amendment, merger,
consolidation or otherwise), without the consent of the holders of at least sixty percent (60%) of
the outstanding shares of Series A-3 Preferred Stock voting or consenting as a separate class and
to the exclusion of all other classes of capital stock of the Corporation, given in person or by
proxy, either in writing or by vote at a meeting called for that purpose at which the holders of
the Preferred Stock shall vote together as a single class:
(i) amend or repeal any provision of, or add any provision to, this Restated Certificate of
Incorporation or the Corporations By-laws if such action would materially and adversely alter or
change the preferences, rights, privileges or powers of, or the restrictions provided for the
benefit of, the Preferred Stock;
(ii) increase or decrease the authorized number of shares of the Corporations Preferred
Stock;
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(iii) authorize, issue or otherwise create shares of any class or series of stock having any
preference over, or on parity with, the Preferred Stock with respect to any rights, preferences or
privileges associated with the Preferred Stock;
(iv) (A) sell or otherwise dispose of all or substantially all of its assets or (B)
consolidate or merge with or into another Person if, as a result of such consolidation or merger,
the holders of the Common Stock and the Preferred Stock prior to such consolidation or merger do
not hold at least fifty-one percent (51%) of the combined voting power of the surviving
corporation;
(v) declare or pay any dividends on any capital stock of the Corporation; provided, however,
that the restriction shall not apply to dividends payable solely in Common Stock;
(vi) take any action which would result in taxation of the holders of shares of the Preferred
Stock under Section 305 of the Internal Revenue Code of 1986, as amended (or any comparable
provision of the Internal Revenue Code as hereafter from time to time amended); or
(vii) increase or decrease the size of the Board of Directors.
5. Conversion. Except with respect to the Special Mandatory Conversion described in
Section 7, the rights of the holders of shares of Preferred Stock to convert such shares into
shares of Common Stock (as defined in Section 5(i) below) of the Corporation (the Conversion
Rights), and the terms and conditions of such conversion, shall be as follows:
(a) Right to Convert; Automatic Conversion.
(i) Each share of the Preferred Stock shall be convertible, at the option of the holder
thereof, at any time after the date of the issuance of such share, at the office of the Corporation
or any transfer agent for the Preferred Stock or the Common Stock, into that number of the fully
paid and nonassessable shares of Common Stock determined in accordance with the provisions of
Section 5(b) below. In order to convert shares of the Preferred Stock into shares of Common Stock,
the holder thereof shall surrender the certificate or certificates therefor, duly endorsed, at the
office of the Corporation or to the transfer agent for the Preferred Stock or the Common Stock,
together with written notice to the Corporation stating that it elects to convert the same and
setting forth the name or names in which it wishes the certificate or certificates for Common Stock
to be issued, and the number of shares of Preferred Stock being converted.
(ii) The Corporation shall, as soon as practicable after the surrender of the certificate or
certificates evidencing shares of Preferred Stock for conversion at the office of the Corporation
or the transfer agent for the Preferred Stock or the Common Stock, issue to each holder of such
shares, or its nominee or nominees, a certificate or certificates evidencing the number of shares
of Common Stock (and any other securities and property) to which it shall be entitled and, in the
event that only a part of the shares evidenced by such certificate or certificates are converted, a
certificate evidencing the number of shares of Preferred Stock which are not converted. Such
conversion shall be deemed to have been made immediately prior to the close of business on the date
of such surrender of the shares of Preferred Stock to be converted, and the Person or Persons
entitled to receive the shares of Common Stock issuable upon such conversion shall be treated for
all purposes as the record holder or holders of such shares of Common Stock at such date and shall,
with respect to such shares, have only those rights of a holder of Common Stock of the Corporation.
(iii) Each share of Preferred Stock then outstanding shall be automatically converted into
that number of fully paid and nonassessable shares of Common Stock determined in
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accordance with the provisions of Section 5(b) below upon the earlier of (A) the close of
business of the day immediately preceding the closing of the sale of its Common Stock in connection
with a Qualified Public Offering (as defined in Section 8 below) or (B) the consent of the holders
of at least sixty percent (60%) of the outstanding shares of Preferred Stock voting or consenting
together as a single class and to the exclusion of all other classes of capital stock of the
Corporation, given in person or by proxy, either in writing or by vote at a meeting called for that
purpose at which the holders of Preferred Stock shall vote together as a single class.
(b) Conversion of Preferred Stock.
(i) Each share of Series A-1 Preferred Stock shall be convertible into the number of shares of
Common Stock which results from dividing the Series A-1 Conversion Price (as defined herein) per
share in effect at the time into the Series A-1 Original Purchase Price;
(ii) Each share of Series A-2 Preferred Stock shall be convertible into the number of shares
of Common Stock which results from dividing the Series A-2 Conversion Price (as defined herein) per
share in effect at the time into the Series A-2 Original Purchase Price; and
(iii) Each share of Series A-3 Preferred Stock shall be convertible into the number of shares
of Common Stock which results from dividing the Series A-3 Conversion Price (as defined herein) per
share in effect at the time into the Series A-3 Original Purchase Price.
(c) Conversion Price.
(i) The conversion price per share for the Series A-1 Preferred Stock shall initially be $0.94
(the Series A-1 Conversion Price) and shall be subject to adjustment from time to time as
provided herein;
(ii) The conversion price per share for the Series A-2 Preferred Stock shall initially be
$1.00 (the Series A-2 Conversion Price) and shall be subject to adjustment from time to time as
provided herein.
(iii) The conversion price per share for the Series A-3 Preferred Stock shall initially be
$1.00 (the Series A-3 Conversion Price) and shall be subject to adjustment from time to time as
provided herein.
The conversion price as it applies to each series of Preferred Stock is sometimes referred to
herein as the Conversion Price.
(d) Adjustment for Stock Splits and Combinations. If outstanding shares of the Common
Stock of the Corporation shall be subdivided into a greater number of shares, or a dividend in
Common Stock or other securities of the Corporation convertible into or exchangeable for Common
Stock (in which latter event the number of shares of Common Stock issuable upon the conversion or
exchange of such securities shall be deemed to have been distributed), shall be paid in respect to
the Common Stock of the Corporation, the Series A-1 Conversion Price, the Series A-2 Preferred
Conversion Price and the Series A-3 Conversion Price in effect immediately prior to such
subdivision or at the record date of such dividend shall be proportionately reduced, and
conversely, if outstanding shares of the Common Stock of the Corporation shall be combined into a
smaller number of shares, the Series A-1 Conversion Price, the Series A-2 Conversion Price and the
Series A-3 Conversion Price in effect immediately prior to such combination shall be
proportionately increased.
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Any adjustment to the Series A-1 Conversion Price, the Series A-2 Conversion Price or the
Series A-3 Conversion Price under this Section 5(d) shall become effective at the close of business
on the date the subdivision or combination referred to herein becomes effective.
(e) Reorganizations, Mergers, Consolidations or Reclassifications. In the event of
any capital reorganization, any reclassification of the Common Stock (other than a change in par
value or as a result of a stock dividend, subdivision, split-up or combination of shares), the
consolidation or merger of the Corporation with or into another Person (excluding a consolidation
or merger described in Section 2(d) of this Article IV) (collectively referred to hereinafter as
Reorganizations), the holders of the Series A-1 Preferred Stock, the Series A-2 Preferred Stock
and the Series A-3 Preferred Stock shall thereafter be entitled to receive, and provision shall be
made therefor in any agreement relating to a Reorganization, upon conversion of the Series A-1
Preferred Stock, the Series A-2 Preferred Stock and the Series A-3 Preferred Stock the kind and
number of shares of Common Stock or other securities or property (including cash) of the
Corporation, or other corporation resulting from such consolidation or surviving such merger to
which a holder of the number of shares of the Common Stock of the Corporation which the Series A-1
Preferred Stock, the Series A-2 Preferred Stock and the Series A-3 Preferred Stock entitled the
holder thereof to convert to immediately prior to such Reorganization would have been entitled to
receive with respect to such Reorganization; and in any such case appropriate adjustment shall be
made in the application of the provisions herein set forth with respect to the rights and interests
thereafter of the holders of the Series A-1 Preferred Stock, the Series A-2 Preferred Stock and the
Series A-3 Preferred Stock, to the end that the provisions set forth herein (including the
specified changes and other adjustments to the Conversion Price) shall thereafter be applicable, as
nearly as reasonably may be, in relation to any shares, other securities or property thereafter
receivable upon conversion of the Series A-1 Preferred Stock, the Series A-2 Preferred Stock and
the Series A-3 Preferred Stock. The provisions of this Section 5(e) shall similarly apply to
successive Reorganizations.
(f) Sale of Additional Shares.
(i) If at any time or from time to time following the date of the initial issuance of shares
of Series A-3 Preferred Stock, the Corporation shall issue or sell Additional Shares of Common
Stock (as hereinafter defined) other than as a dividend or other distribution on any class of stock
and other than as a subdivision or combination of shares of Common Stock as provided in Section
5(d) above, for a consideration per share less than the then existing Series A-1 Conversion Price,
the then existing Series A-2 Conversion Price and/or the then existing Series A-3 Conversion Price,
then, and in each such case, the then existing Series A-1 Conversion Price, the then existing
Series A-2 Conversion Price and/or the then existing Series A-3 Conversion Price, as the case may
be, shall be reduced, as of the opening of business on the date of such issuance or sale, to a
price determined by multiplying the applicable Conversion Price by a fraction, the numerator of
which shall be the number of shares of Common Stock outstanding immediately prior to such issuance
(including shares of Common Stock issuable upon conversion of the Preferred Stock and the number of
shares of Common Stock which could be obtained through the exercise or conversion of all other
rights, options and convertible securities outstanding on the date immediately prior to such
issuance) plus the number of shares of Common Stock that the aggregate consideration received by
the Corporation for such issuance would purchase at the applicable Conversion Price; and the
denominator of which shall be the number of shares of Common Stock outstanding immediately prior to
such issuance (including shares of Common Stock issuable upon conversion of the Preferred Stock and
the number of shares of Common Stock which could be obtained through the exercise or conversion of
all other rights, options and convertible securities outstanding on the date immediately prior to
such issuance) plus the number of shares of Additional Shares of Common Stock actually issued in
such issuance.
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(ii) For the purpose of making any adjustment in either (a) the Series A-1 Conversion Price,
the Series A-2 Conversion Price or the Series A-3 Conversion Price, or (b) number of shares of
Common Stock issuable upon conversion of either the Series A-1 Preferred Stock, the Series A-2
Preferred Stock or the Series A-3 Preferred Stock, as provided above, the consideration received by
the Corporation for any issue or sale of securities shall:
(a) To the extent it consists of cash, be computed at the net amount of cash received by the
Corporation after deduction of any expenses payable directly or indirectly by the Corporation and
any underwriting or similar commissions, compensations, discounts or concessions paid or allowed by
the Corporation in connection with such issue or sale;
(b) To the extent it consists of property other than cash, the consideration other than cash
shall be computed at the fair market value thereof as determined in good faith by the Board of
Directors, at or about, but as of, the date of the adoption of the resolution specifically
authorizing such issuance or sale, irrespective of any accounting treatment thereof; provided,
however, that such fair market value as determined by the Board of Directors, when added to any
cash consideration received in connection with such issuance or sale, shall not exceed the
aggregate market price of the Additional Shares of Common Stock being issued, as of the date of the
adoption of such resolution; and
(c) If Additional Shares of Common Stock, Convertible Securities (as defined below) or Rights
(as defined below) are issued or sold together with other stock or securities or other assets of
the Corporation for consideration which covers both, the consideration received for the Additional
Shares of Common Stock, Convertible Securities or Rights shall be computed as that portion of the
consideration so received which is reasonably determined in good faith by the Board of Directors to
be allocable to such Additional Shares of Common Stock, Convertible Securities or Rights.
(iii) For the purpose of making any adjustment in the Series A-1 Conversion Price , the Series
A-2 Conversion Price or the Series A-3 Conversion Price provided in Section 5(f) hereof, if at any
time, or from time to time, the Corporation issues any stock or other securities convertible into
Additional Shares of Common Stock (such stock or other securities being hereinafter referred to as
Convertible Securities) or issues any rights or options to purchase Additional Shares of Common
Stock or Convertible Securities (such rights or options being hereinafter referred to as Rights),
then, and in each such case, if the Effective Conversion Price (as hereinafter defined) of such
Rights or Convertible Securities shall be less than the Series A-1 Conversion Price, the Series A-2
Conversion Price and/or the Series A-3 Conversion Price in effect immediately prior to the issuance
of such Rights or Convertible Securities, the Corporation shall be deemed to have issued at the
time of the issuance of such Rights or Convertible Securities the maximum number of Additional
Shares of Common Stock issuable upon exercise or conversion thereof and to have received in
consideration for the issuance of such shares an amount equal to the aggregate Effective Conversion
Price of such Rights or Convertible Securities. For the purposes of this Section 5(f)(iii),
Effective Conversion Price shall mean an amount equal to the sum of the lowest amount of
consideration, if any, received or receivable by the Corporation with respect to any one (1)
Additional Share of Common Stock upon issuance of the Rights or Convertible Securities and upon
their exercise or conversion, respectively. No further adjustment of the Series A-1 Conversion
Price, the Series A-2 Conversion Price or the Series A-3 Conversion Price adjusted upon the
issuance of such Rights or Convertible Securities shall be made as a result of the actual issuance
of Additional Shares of Common Stock on the exercise of any such Rights or the conversion of any
such Convertible Securities. If any such Rights or the conversion privilege represented by any
such Convertible Securities shall expire without having been exercised, such Series A-1 Conversion
Price, the Series A-2 Conversion Price or the Series A-3 Conversion Price, as applicable, as
adjusted upon the issuance of such Rights or Convertible Securities shall be readjusted to the
Series A-1 Conversion Price,
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the Series A-2 Conversion Price or the Series A-3 Conversion Price, as applicable, which would
have been in effect had such adjustment been made on the basis that the only Additional Shares of
Common Stock so issued were the Additional Shares of Common Stock, if any, actually issued or sold
on the exercise of such Rights or on the conversion of such Convertible Securities, and such
Additional Shares of Common Stock, if any, were issued or sold for the consideration actually
received by the Corporation upon such exercise, plus the consideration, if any, actually received
by the Corporation for the granting of all such Rights, whether or not exercised, plus the
consideration received for issuing or selling the Convertible Securities actually converted plus
the consideration, if any, actually received by the Corporation (other than by cancellation of
liabilities or obligations evidenced by such Convertible Securities) on the conversion of such
Convertible Securities.
(g) Additional Shares of Common Stock. Additional Shares of Common Stock as used in
this Section 5 shall mean all shares of Common Stock issued or deemed to be issued by the
Corporation, whether or not subsequently reacquired or retired by the Corporation, other than:
(i) shares of Common Stock issued upon the conversion of any shares of the Companys Preferred
Stock;
(ii) shares of Common Stock issued or issuable to employees, officers, directors, advisors,
outside consultants or contractors of the Corporation or any Subsidiary pursuant to a plan,
agreement or arrangement duly approved by the Board of Directors;
(iii) shares of Common Stock issued or issuable pursuant to the exercise of options, warrants
or convertible securities outstanding as of the date hereof;
(iv) shares of Common Stock and/or options, warrants or other Common Stock purchase rights
issued in connection with the Corporation obtaining equipment lease financing, whether issued to a
lessor, guarantor or other Person, provided that such issuance is pursuant to an agreement or
arrangement duly approved by the Board of Directors, and provided, further, that such issuance
shall not be primarily for general capital raising purposes;
(v) shares of Common Stock issued to effect any stock split, stock dividend, recapitalization
or like transaction of the Corporation;
(vi) shares of Common Stock and/or options, warrants or other Common Stock purchase rights
issued in connection with any borrowings, direct or indirect from financial institutions or other
Persons by the Corporation, provided that such issuance is pursuant to an agreement or arrangement
duly approved by the Board of Directors;
(vii) shares of Common Stock and/or options, warrants or other Common Stock purchase rights
issued in connection with the acquisition of all or a substantial portion of the assets or the
business of another entity by the Corporation, provided that such issuance is pursuant to an
agreement or arrangement duly approved by the Board of Directors; and
(viii) shares of Common Stock and/or options, warrants or other Common Stock purchase rights
issued in connection with any corporate partnering transaction, strategic alliance, technology
transfer or similar transaction between the Corporation and any other Person, provided that such
issuance is pursuant to an agreement or arrangement duly approved by the Board of Directors.
(h) Common Stock. Common Stock as used in this Section 5 shall mean any shares of
any class of the Corporations capital stock other than the Preferred Stock. The Common Stock
issuable upon conversion of the Preferred Stock, however, shall be the Common Stock of the
Corporation as constituted on the date hereof, except as otherwise provided in this Section 5.
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(i) Certificate of Adjustment. In each case of an adjustment or readjustment of the
Series A-1 Conversion Price, the Series A-2 Conversion Price or the Series A-3 Conversion Price or
the number of shares of Common Stock or other securities issuable upon conversion of the Series A-1
Preferred Stock, the Series A-2 Preferred Stock or the Series A-3 Preferred Stock, the Corporation,
at its expense, shall cause the Chief Financial Officer of the Corporation to compute such
adjustment or readjustment in accordance with this Restated Certificate of Incorporation and
prepare a certificate showing such adjustment or readjustment, and shall mail such certificate, by
first-class mail, postage prepaid, to each registered holder of the Series A-1 Preferred Stock, the
Series A-2 Preferred Stock or the Series A-3 Preferred Stock at the holders address as shown on
the Corporations stock transfer books. The certificate shall set forth such adjustment or
readjustment, showing in reasonable detail the facts upon which such adjustment or readjustment is
based, including a statement of (i) the consideration received or to be received by the Corporation
for any Additional Shares of Common Stock issued or sold or deemed to have been issued or sold;
(ii) Conversion Price at the time in effect for the Series A-1 Preferred Stock, the Series A-2
Preferred Stock or the Series A-3 Preferred Stock, respectively; and (iii) the number of Additional
Shares of Common Stock and the type and amount, if any, of other property which at the time would
be received upon conversion of the Series A-1 Preferred Stock, the Series A-2 Preferred Stock or
the Series A-3 Preferred Stock. Such notice may be given in advance of such adjustment or
readjustment and may be included as part of a notice required to be given pursuant to Section 5(j)
below.
(j) Notices of Record Date. In the event the Corporation shall propose to take any
action of the type or types requiring an adjustment to the Conversion Price of the Series A-1
Preferred Stock, the Series A-2 Preferred Stock or the Series A-3 Preferred Stock, or the number or
character of the Series A-1 Preferred Stock, the Series A-2 Preferred Stock or the Series A-3
Preferred Stock as set forth herein, the Corporation shall give notice to the holders of the Series
A-1 Preferred Stock, the Series A-2 Preferred Stock or the Series A-3 Preferred Stock as applicable
in the manner set forth in Section 5(i) above, which notice shall specify the record date, if any,
with respect to any such action and the date on which such action is to take place. Such notice
shall also set forth such facts with respect thereto as shall be reasonably necessary to indicate
the effect of such action (to the extent such effect may be known at the date of such notice) on
the Series A-1 Conversion Price, the Series A-2 Conversion Price or the Series A-3 Conversion Price
and the number, kind or class of shares or other securities or property which shall be deliverable
upon the occurrence of such action or deliverable upon the conversion of the Series A-1 Preferred
Stock, the Series A-2 Preferred Stock or the Series A-3 Preferred Stock. In the case of any action
which would require the fixing of a record date, such notice shall be given at least ten (10) days
prior to the date so fixed, and in case of all other action, such notice shall be given at least
fifteen (15) days prior to the taking of such proposed action. Notwithstanding the requirements of
this Section 5(j), this Section 5(j) shall not be applicable and no such notice shall be required
with respect to any action that is, or has been, approved by the holders of at least sixty percent
(60%) of the outstanding shares of Preferred Stock voting or consenting together as a single class
and to the exclusion of all other classes of capital stock of the Corporation.
(k)
Reservation of Stock Issuable Upon Conversion. The Corporation shall at all times
reserve and keep available out of its authorized but unissued shares of Common Stock, solely for
the purpose of effecting the conversion of the shares of Series A-1 Preferred Stock, Series A-2
Preferred Stock and Series A-3 Preferred Stock, such number of its shares of Common Stock as shall
from time to time be sufficient to effect a conversion of all outstanding shares of Series A-1
Preferred Stock, Series A-2 Preferred Stock and Series A-3 Preferred Stock, and if at any time the
number of authorized but unissued shares of Common Stock shall not be sufficient to effect the
conversion of all then outstanding shares of Series A-1 Preferred Stock, Series A-2 Preferred Stock
and Series A-3 Preferred Stock, the
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Corporation shall promptly seek such corporate action as may, in the opinion of its counsel,
be necessary to increase its authorized but unissued shares of Common Stock to such number of
shares as shall be sufficient for such purpose. In the event of the consolidation or merger of the
Corporation with another corporation where the Corporation is not the surviving corporation,
effective provisions shall be made in the certificate or articles of incorporation, merger or
consolidation, or otherwise of the surviving corporation so that such corporation will at all times
reserve and keep available a sufficient number of shares of Common Stock or other securities or
property to provide for the conversion of Series A-1 Preferred Stock, Series A-2 Preferred Stock
and Series A-3 Preferred Stock in accordance with the provisions of this Section 5.
(l) Payment of Taxes. The Corporation shall pay all taxes and other governmental
charges (other than any income or other taxes imposed upon the profits realized by the recipient)
that may be imposed in respect of the issue or delivery of shares of Common Stock or other
securities or property upon conversion of shares of Series A-1 Preferred Stock, Series A-2
Preferred Stock and Series A-3 Preferred Stock, excluding any tax or other charge imposed in
connection with any transfer involved in the issue and delivery of shares of Common Stock or other
securities in a name other than that in which the shares of Series A-1 Preferred Stock, Series A-2
Preferred Stock and Series A-3 Preferred Stock so converted were registered.
(m) Status of Converted Stock. In the event any shares of Series A-1 Preferred Stock,
Series A-2 Preferred Stock and Series A-3 Preferred Stock shall be converted pursuant to Section 5
hereof, the shares so converted shall be cancelled and shall not be issuable by the Corporation,
and this Restated Certificate of Incorporation shall be appropriately amended to effect the
corresponding reduction in the Corporations authorized capital stock.
(n) No Impairment. Subject to the right of the Corporation to amend its Certificate
of Incorporation or take any other corporate action upon obtaining the necessary approvals required
by its Certificate of Incorporation and applicable law, the Corporation shall not amend this
Restated Certificate of Incorporation or participate in any reorganization, transfer of assets,
consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, for
the purpose of avoiding or seeking to avoid the observance or performance of any of the terms to be
observed or performed hereunder by the Corporation, but shall at all times in good faith use its
best efforts, and assist in carrying out all such action as may be reasonably necessary or
appropriate in order to protect the conversion rights of the holders of the Series A-1 Preferred
Stock, the Series A-2 Preferred Stock and the Series A-3 Preferred Stock against dilution or other
impairment.
6. Common Stock.
(a) Dividend Rights. Subject to the prior rights of holders of all classes of stock
at the time outstanding having prior rights as to dividends, the holders of the Common Stock shall
be entitled to receive, when and as declared by the Board of Directors, out of any assets of the
Corporation legally available therefor, such dividends as may be declared from time to time by the
Board of Directors.
(b) Liquidation Rights. Upon the liquidation, dissolution or winding up of the
Corporation, the assets of the Corporation shall be distributed as provided in Section 2 of this
Article IV.
(c) Redemption. The Common Stock is not redeemable.
(d) Voting Rights. The holder of each share of Common Stock shall have the right to
one (1) vote, and shall be entitled to notice of any stockholders meeting in accordance with the
By-laws of the Corporation, and shall be entitled to vote upon such matters and in such manner as
may be
- 11 -
provided by this Restated Certificate of Incorporation and law. The number of authorized
shares of Common Stock may be increased or decreased (but not below the number of shares thereof
then outstanding) by the affirmative vote of the holders of shares of stock of the Corporation
representing a majority of the votes represented by all outstanding shares of stock of the
Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the Delaware
General Corporation Law.
7. Special Mandatory Conversion for Failure to Exercise Right of First Offer. Unless
(i) the holders of sixty percent (60%) of the Series A-3 Preferred Stock then outstanding deem
otherwise (by vote or by action by written consent) or (ii) the Corporation requests in writing a
lesser investment commitment of the holders of Series A-3 Preferred Stock, at any time or from time
to time following the date of the initial issuance of shares of Series A-3 Preferred Stock, if (A)
any holder of at least 1,700,000 shares of Series A-3 Preferred Stock (as adjusted for all stock
splits, stock dividends, consolidations, recapitalizations and reorganizations with respect to such
shares) is entitled to exercise the right of first offer (the Right of First Offer) as set forth
in Section 4 of that certain Amended and Restated Investors Rights Agreement among the Corporation
and the holders of the Preferred Stock, as such agreement may from time to time be amended (the
Rights Agreement) with respect to an issuance of securities of the Corporation (a Securities
Issuance), (B) the Corporation has complied with its obligations under the Rights Agreement with
respect to the Right of First Offer, and (C) such holder does not acquire at least the holders
Minimum Share (as such term is defined in the Rights Agreement) in such Securities Issuance that
such holder is entitled to purchase pursuant to Section 4.4 of the Rights Agreement (a
Non-Participating Holder), then, effective immediately prior to the consummation of such
Securities Issuance:
(a) each Non-Participating Holder shall lose his, her or its Right of First Offer pursuant to
Section 4 of the Rights Agreement for all subsequent securities issuances by the Corporation which
would otherwise trigger anew the Right of First Offer;
(b) all shares of Series A-1 Preferred Stock held by each and every Non-Participating Holder
shall be converted, subject to and concurrently with, the effectuation of the Securities Issuance,
into an equivalent number of shares of Series A-4 Preferred Stock. All shares of Series A-2
Preferred Stock and Series A-3 Preferred Stock held by each and every Non-Participating Holder
shall be converted, subject to and concurrently with, the effectuation of the Securities Issuance,
into an equivalent number of shares of Series A-5 Preferred Stock. The Series A-4 Preferred Stock
and Series A-5 Preferred Stock shall be created concurrently with the Securities Issuance. The
designations, powers, preferences and rights and the qualifications, limitations and restrictions
of the Series A-4 Preferred Stock and Series A-5 Preferred Stock shall be identical to those of the
Series A-1 Preferred Stock and the Series A-3 Preferred Stock, respectively, except that the
conversion price for the Series A-4 Preferred Stock and Series A-5 Preferred Stock shall not be
subject to any adjustment pursuant to Section 5(f) of this Article IV, but shall be subject to
further adjustment pursuant to Sections 5(d) and 5(e) of this Article IV. Upon such exchange, the
conversion price for the Series A-4 Preferred Stock and Series A-5 Preferred Stock shall be equal
to the conversion price immediately prior to the Securities Issuance for the converted shares of
Series A-1 Preferred Stock and Series A-3 Preferred Stock, as applicable; and
(c) Promptly following the closing of the Securities Issuance, each such Non-Participating
Holder shall surrender to the Corporation during regular business hours at the office of any
transfer agent for the Corporation, or at such other place as may be designated by the Corporation,
the certificate or certificates representing the Preferred Stock so exchanged, duly endorsed or
assigned in blank or to the Corporation. As promptly as practicable thereafter, the Corporation
shall issue and deliver to such holder, at the place designated by such holder, a certificate or
certificates for the number of full shares of the Series A-4 Preferred Stock or Series A-5
Preferred Stock, as applicable, to be issued and such holder shall be deemed to have become the
holder of record of such shares of Series A-4 Preferred
- 12 -
Stock or Series A-5 Preferred Stock, as applicable, on the date of the Securities Issuance.
The right to receive any dividend declared but unpaid at the time of conversion on any shares of
Preferred Stock exchanged pursuant to the provisions of this Section 7 shall accrue to the benefit
of the new shares of Series A-4 Preferred Stock or Series A-5 Preferred Stock, as applicable,
issued upon exchange thereof.
8. Miscellaneous.
(a) Definitions.
(i) Additional Shares of Common Stock shall have that meaning set forth in Section 5(g)
hereof.
(ii) Common Stock shall have that meaning set forth in Section 5(h) hereof.
(iii) Conversion Price shall have that meaning set forth in Section 5(c) hereof.
(iv) Conversion Rights shall have that meaning set forth in Section 5 hereof.
(v) Convertible Securities shall have that meaning set forth in Section 5(f)(iii) hereof.
(vi) Effective Conversion Price shall have that meaning set forth in Section 5(f)(iii)
hereof.
(vii) Liquidation Event shall have that meaning set forth in Section 2(a) hereof.
(viii) Person shall mean an individual, a corporation, a partnership, a trust or
unincorporated organization or any other entity or organization.
(ix) Preferred Stock Date of Accrual shall have that meaning set forth in Section 1(a)
hereof.
(x) Qualified Public Offering means a firmly underwritten public offering of the
Corporations Common Stock on a Form S-1 Registration Statement, or any similar form of
registration statement, adopted by the Securities and Exchange Commission (the Commission) from
and after the date hereof, filed with the Commission under the Securities Act of 1933, as amended,
with respect to which the Corporation receives gross proceeds of at least $30,000,000 (prior to
deduction for underwriters discounts and expenses relating to such public offering, including
without limitation, fees of the Corporations counsel) and the price to the public is at least
$3.00 per share (equitably adjusted for all stock splits, sub-divisions, stock dividends,
combinations and the like with respect to such shares).
(xi) Series A-1 Original Purchase Price shall have that meaning set forth in Section 1(a)
hereof.
(xii) Series A-1 Preferred Stock shall have that meaning set forth in the first paragraph of
this Article IV.
- 13 -
(xiii) Series A-2 Original Purchase Price shall have that meaning set forth in Section 1(a)
hereof.
(xiv) Series A-2 Preferred Stock shall have that meaning set forth in the first paragraph of
this Article IV.
(xv) Series A-3 Original Purchase Price shall have that meaning set forth in Section 1(a)
hereof.
(xvi) Series A-3 Preferred Stock shall have that meaning set forth in the first paragraph of
this Article IV.
(xvii) Subsidiary means any corporation of which equity securities possessing a majority of
the ordinary voting power in electing the board of directors are, at the time as of which such
determination is being made, owned by the Corporation either directly or indirectly through one or
more Subsidiaries.
(b) Notices. All notices referred to herein, except as otherwise expressly provided,
shall be made by registered or certified mail, return receipt requested, postage prepaid and shall
be deemed to have been given when so mailed.
(c) Conflicts. So long as any of the Preferred Stock is outstanding, in the event of
any conflict between the provisions of this Article IV and the remainder of this Restated
Certificate of Incorporation or the By-laws of the Corporation (both as presently existing or
hereafter amended and supplemented), the provisions of this Article IV shall be and remain
controlling.
V
EXCULPATION AND INDEMNIFICATION
1. Exculpation. A director of the Corporation shall not be personally liable to the
Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director,
except for liability (i) for any breach of the directors duty of loyalty to the Corporation or its
stockholders; (ii) for acts or omissions not in good faith or which involve intentional misconduct
or a knowing violation of law; (iii) under Section 174 of the Delaware General Corporation Law; or
(iv) for any transaction from which the director derived any improper personal benefit. If the
Delaware General Corporation Law is hereafter amended to further reduce or to authorize, with the
approval of the Corporations stockholders, further reductions in the liability of the
Corporations directors for breach of fiduciary duty, then a director of the Corporation shall not
be liable for any such breach to the fullest extent permitted by the Delaware General Corporation
Law as so amended.
2. Indemnification. To the extent permitted by applicable law, the Corporation is
also authorized to provide indemnification of (and advancement of expenses to) such agents (and any
other Persons to which Delaware law permits the Corporation to provide indemnification) through
bylaw provisions, agreements with such agents or other Persons, vote of stockholders or
disinterested directors or otherwise, in excess of the indemnification and advancement otherwise
permitted by Section 145 of the Delaware General Corporation Law, subject only to limits created by
applicable Delaware law (statutory or non-statutory), with respect to actions for breach of duty to
the Corporation, its stockholders and others.
- 14 -
3. Effect of Repeal or Modification. Any repeal or modification of any of the
foregoing provisions of this Article V shall not adversely affect any right or protection of a
director, officer, agent or other Person existing at the time of, or increase the liability of any
director of the Corporation with respect to any acts or omissions of such director occurring prior
to, such repeal or modification.
VI
BOARD POWER REGARDING BY-LAWS
In furtherance and not in limitation of the powers conferred by statute, the Board of
Directors is expressly authorized to make, repeal, alter, amend and rescind the By-laws of the
Corporation without the vote or assent of the stockholders.
VII
ELECTION OF DIRECTORS
Elections of directors need not be by written ballot unless the By-laws of the Corporation
shall so provide.
VIII
CORPORATE POWER
The Corporation reserves the right to amend, alter, change or repeal any provision contained
in this Restated Certificate of Incorporation, in the manner now or hereafter prescribed by
statute, and all rights conferred on stockholders herein are granted subject to this reservation.
- 15 -
IN WITNESS WHEREOF, this Restated Certificate of Incorporation which restates and amends the
provisions of the Restated Certificate of Incorporation of the Corporation, and which has been duly
adopted in accordance with Sections 228, 242 and 245 of the General Corporation Law of the State of
Delaware and has been executed by its President this 27th day of March, 2006.
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CADENCE PHARMACEUTICALS, INC. |
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By:
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/s/ Theodore R. Schroeder |
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Theodore R. Schroeder, |
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President and Chief Executive Officer |
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exv3w3
EXHIBIT
3.3
AMENDED AND RESTATED BYLAWS
OF
CADENCE PHARMACEUTICALS, INC.
AMENDED AND RESTATED BYLAWS
OF
CADENCE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
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Page |
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ARTICLE I OFFICES |
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1 |
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Section 1. REGISTERED OFFICES |
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1 |
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Section 2. OTHER OFFICES |
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1 |
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ARTICLE II MEETINGS OF STOCKHOLDERS |
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1 |
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Section 1. PLACE OF MEETINGS |
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1 |
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Section 2. ANNUAL MEETING OF STOCKHOLDERS |
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1 |
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Section 3. QUORUM; ADJOURNED MEETINGS AND NOTICE THEREOF |
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1 |
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Section 4. VOTING |
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2 |
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Section 5. PROXIES |
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2 |
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Section 6. SPECIAL MEETINGS |
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2 |
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Section 7. NOTICE OF STOCKHOLDERS MEETINGS |
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2 |
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Section 8. MAINTENANCE AND INSPECTION OF STOCKHOLDER LIST |
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2 |
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Section 9. STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING |
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2 |
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ARTICLE III DIRECTORS |
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3 |
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Section 1. THE NUMBER OF DIRECTORS |
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3 |
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Section 2. VACANCIES |
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3 |
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Section 3. POWERS |
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3 |
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Section 4. PLACE OF DIRECTORS MEETINGS |
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4 |
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Section 5. REGULAR MEETINGS |
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4 |
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Section 6. SPECIAL MEETINGS |
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4 |
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Section 7. QUORUM |
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4 |
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Section 8. ACTION WITHOUT MEETING |
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4 |
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Section 9. TELEPHONIC MEETINGS |
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4 |
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Section 10. COMMITTEES OF DIRECTORS |
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4 |
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Section 11. MINUTES OF COMMITTEE MEETINGS |
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5 |
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Section 6. CHAIRMAN OF THE BOARD |
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5 |
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Section 12. COMPENSATION OF DIRECTORS |
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5 |
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ARTICLE IV OFFICERS |
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5 |
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Section 1. OFFICERS |
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5 |
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Section 2. ELECTION OF OFFICERS |
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5 |
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Section 3. SUBORDINATE OFFICERS |
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5 |
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Section 4. COMPENSATION OF OFFICERS |
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6 |
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Section 5. TERM OF OFFICE; REMOVAL AND VACANCIES |
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6 |
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Section 7. PRESIDENT |
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6 |
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Section 8. VICE PRESIDENTS |
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Section 9. SECRETARY |
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Section 10. ASSISTANT SECRETARY |
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Section 11. TREASURER |
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Section 12. ASSISTANT TREASURER |
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ARTICLE V INDEMNIFICATION OF DIRECTORS AND OFFICERS |
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ARTICLE VI INDEMNIFICATION OF EMPLOYEES AND AGENTS |
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ARTICLE VII CERTIFICATES OF STOCK |
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Section 1. CERTIFICATES |
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Section 2. SIGNATURES ON CERTIFICATES |
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Section 3. STATEMENT OF STOCK RIGHTS, PREFERENCES, PRIVILEGES |
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Section 4. LOST CERTIFICATES |
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Section 5. TRANSFERS OF STOCK |
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Section 6. FIXED RECORD DATE |
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Section 7. REGISTERED STOCKHOLDERS |
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ARTICLE VIII GENERAL PROVISIONS |
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Section 1. DIVIDENDS |
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Section 2. PAYMENT OF DIVIDENDS; DIRECTORS DUTIES |
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Section 3. CHECKS |
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Section 4. FISCAL YEAR |
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Section 5. CORPORATE SEAL |
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Section 6. MANNER OF GIVING NOTICE |
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Section 7. WAIVER OF NOTICE |
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Section 8. ANNUAL STATEMENT |
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ARTICLE IX AMENDMENTS |
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Section 1. AMENDMENT BY DIRECTORS OR STOCKHOLDERS |
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ARTICLE X RIGHT OF FIRST REFUSAL |
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12 |
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Section 1. RESTRICTION ON TRANSFER |
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Section 2. NOTICE REQUIREMENT |
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Section 3. OPTION OF THE CORPORATION |
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Section 4. SPECIAL PROVISIONS REGARDING EXCHANGES |
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Section 4. EFFECT OF PURCHASE |
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Section 6. CERTAIN TRANSFERS EXEMPT |
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Section 7. LIMITATIONS ON RIGHT OF FIRST REFUSAL |
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Section 8. WAIVER |
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Section 9. ASSIGNMENT; ALTERNATIVE RIGHTS |
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Section 10. LEGEND |
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iii
AMENDED AND RESTATED BYLAWS
OF
CADENCE PHARMACEUTICALS, INC.
ARTICLE I
OFFICES
Section 1. REGISTERED OFFICE. The registered office shall be in the City of Dover, County of
Kent, State of Delaware.
Section 2. OTHER OFFICES. The corporation may also have offices at such other places both
within and without the State of Delaware as the Board of Directors may from time to time determine
or the business of the corporation may require.
ARTICLE II
MEETINGS OF STOCKHOLDERS
Section 1. PLACE OF MEETINGS. Meetings of stockholders shall be held at any place within or
outside the State of Delaware designated by the Board of Directors. In the absence of any such
designation, stockholders meetings shall be held at the principal executive office of the
corporation.
Section 2. ANNUAL MEETING OF STOCKHOLDERS. The annual meeting of stockholders shall be held
each year on a date and a time designated by the Board of Directors. At each annual meeting
directors shall be elected in the manner provided in the certificate of incorporation of the
corporation (the Certificate of Incorporation) and in the Bylaws, and any other proper business
may be transacted.
Section 3. QUORUM; ADJOURNED MEETINGS AND NOTICE THEREOF. A majority of the stock issued and
outstanding and entitled to vote at any meeting of stockholders, the holders of which are present
in person or represented by proxy, shall constitute a quorum for the transaction of business except
as otherwise provided by law, by the Certificate of Incorporation, or by these Bylaws. A quorum,
once established, shall not be broken by the withdrawal of enough votes to leave less than a quorum
and the votes present may continue to transact business until adjournment. If, however, such
quorum shall not be present or represented at any meeting of the stockholders, a majority of the
voting stock represented in person or by proxy may adjourn the meeting from time to time, without
notice other than announcement at the meeting, until a quorum shall be present or represented. At
such adjourned meeting at which a quorum shall be present or represented, any business may be
transacted which might have been transacted at the meeting as originally notified. If the
adjournment is for more than thirty days, or if after the adjournment a new record date is fixed
for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of
record entitled to vote thereat.
1
Section 4. VOTING. When a quorum is present at any meeting, in all matters other than the
election of directors, the vote of the holders of a majority of the stock having voting power
present in person or represented by proxy shall decide any question brought before such meeting,
unless the question is one upon which by express provision of the statutes, or the Certificate of
Incorporation, or these Bylaws, a different vote is required in which case such express provision
shall govern and control the decision of such question. Directors shall be elected by a plurality
of the votes of the shares present in person or represented by proxy at the meeting and entitled to
vote on the election of directors.
Section 5. PROXIES. At each meeting of the stockholders, each stockholder having the right
to vote may vote in person or may authorize another person or persons to act for him or her by
proxy appointed by an instrument in writing subscribed by such stockholder and bearing a date not
more than three years prior to said meeting, unless said instrument provides for a longer period.
All proxies must be filed with the Secretary of the corporation at the beginning of each meeting in
order to be counted in any vote at the meeting. Except as may be otherwise provided in the
Certificate of Incorporation, each stockholder shall have one vote for each share of stock having
voting power, registered in his or her name on the books of the corporation on the record date set
by the Board of Directors as provided in Article VII, Section 6 hereof.
Section 6. SPECIAL MEETINGS. Special meetings of the stockholders, for any purpose, or
purposes, unless otherwise prescribed by statute or by the Certificate of Incorporation, may be
called by the President and shall be called by the Chairman of the Board, President or the
Secretary at the request in writing of a majority of the Board of Directors, or at the request in
writing of stockholders owning a majority in amount of the entire capital stock of the corporation
issued and outstanding, and entitled to vote. Such request shall state the purpose or purposes of
the proposed meeting. Business transacted at any special meeting of stockholders shall be limited
to the purposes stated in the notice.
Section 7. NOTICE OF STOCKHOLDERS MEETINGS. Whenever stockholders are required or permitted
to take any action at a meeting, a written notice of the meeting shall be given which notice shall
state the place, date and hour of the meeting, and, in the case of a special meeting, the purpose
or purposes for which the meeting is called. The written notice of any meeting shall be given to
each stockholder entitled to vote at such meeting not less than ten nor more than sixty days before
the date of the meeting. If mailed, notice is given when deposited in the United States mail,
postage prepaid, directed to the stockholder at his or her address as it appears on the records of
the corporation.
Section 8. MAINTENANCE AND INSPECTION OF STOCKHOLDER LIST. The officer who has charge of the
stock ledger of the corporation shall prepare and make, at least ten days before every meeting of
stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in
alphabetical order, and showing the address of each stockholder and the number of shares registered
in the name of each stockholder. Such list shall be open to the examination of any stockholder,
for any purpose germane to the meeting, during ordinary business hours, for a period of at least
ten days prior to the meeting, either at a place within the city where the meeting is to be held,
which place shall be specified in the notice of the meeting, or, if not so specified, at the place
where the meeting is to be held. The list shall also be produced and kept at the time and place of
the meeting during the whole time thereof, and may be inspected by any stockholder who is present.
Section 9. STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING. Unless otherwise
provided in the Certificate of Incorporation, any action required to be taken at any annual or
special meeting of stockholders of the corporation, or any action which may be taken at any annual
or special meeting of such stockholders, may be taken without a meeting, without prior notice
2
and
without a vote, if a consent in writing, setting forth the action so taken, shall be signed by the
holders of outstanding stock having not less than the minimum number of votes that would be
necessary to authorize or take such action at a meeting at which all shares entitled to vote
thereon were present and voted and shall be delivered to the corporation by delivery to its
registered office in Delaware, its principal place of business, or to an officer or agent of the
corporation having custody of the book in which proceedings of meetings of stockholders are
recorded. Every written consent shall bear the date of signature of each stockholder who signs the
consent and no written consent shall be effective to take the corporate action referred to therein
unless, within sixty days of the earliest dated consent delivered in the manner required by this
Section 9 to the corporation, written consents signed by a sufficient number of holders to take
action are delivered to the corporation by delivery to its registered office in Delaware, its
principal place of business or to an officer or agent of the corporation having custody of the book
in which proceedings of meetings of stockholders are recorded. Delivery made to a corporations
registered office shall be by hand or by certified or registered mail, return receipt requested.
Prompt notice of the taking of the corporate action without a meeting by less than unanimous
written consent shall be given to those stockholders who have not consented in writing.
ARTICLE III
DIRECTORS
Section 1. THE NUMBER OF DIRECTORS. Unless otherwise provided by law, the number of
directors which shall constitute the whole Board of Directors shall be determined from time to time
solely by resolution adopted by the affirmative vote of a majority of the directors. The directors
need not be stockholders. The directors shall be elected at the annual meeting of the
stockholders, except as provided in Section 2 of this Article, and each director elected shall hold
office until his or her successor is elected and qualified; provided, however, that
unless otherwise restricted by the Certificate of Incorporation or by law, any director or the
entire Board of Directors may be removed, either with or without cause, from the Board of Directors
at any meeting of stockholders by a majority of the stock represented and entitled to vote thereat.
Section 2. VACANCIES. Vacancies on the Board of Directors by reason of death, resignation,
retirement, disqualification, removal from office, or otherwise, and newly created directorships
resulting from any increase in the authorized number of directors may be filled by a majority of
the directors then in office, although less than a quorum, or by a sole remaining director. The
directors so chosen shall hold office until the next annual election of directors and until their
successors are duly elected and shall qualify, unless sooner displaced. If there are no directors
in office, then an election of directors may be held in the manner provided by statute. If, at the
time of filling any vacancy or any newly created directorship, the directors then in office shall
constitute less than a majority of the whole Board of Directors (as constituted immediately prior
to any such increase), the Court of Chancery may, upon application of any stockholder or
stockholders holding at least ten percent of the total number of the shares at the time outstanding
having the right to vote for
such directors, summarily order an election to be held to fill any such vacancies or newly created
directorships, or to replace the directors chosen by the directors then in office.
Section 3. POWERS. The property and business of the corporation shall be managed by or under
the direction of its Board of Directors. In addition to the powers and authorities by these Bylaws
expressly conferred upon them, the Board of Directors may exercise all such powers of the
corporation and do all such lawful acts and things as are not by statute or by the Certificate of
Incorporation or by these Bylaws directed or required to be exercised or done by the stockholders.
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Section 4. PLACE OF DIRECTORS MEETINGS. The directors may hold their meetings and have one
or more offices, and keep the books of the corporation outside of the State of Delaware.
Section 5. REGULAR MEETINGS. Regular meetings of the Board of Directors may be held without
notice at such time and place as shall from time to time be determined by the Board of Directors.
Section 6. SPECIAL MEETINGS. Special meetings of the Board of Directors may be called by the
President on forty-eight (48) hours notice to each director, either personally or by mail, e-mail
or by telegram; special meetings shall be called by the Chairman of the Board, President or the
Secretary in like manner and on like notice on the written request of two directors unless the
Board of Directors consists of only one director; in which case special meetings shall be called by
the Chairman of the Board, President or Secretary in like manner or on like notice on the written
request of the sole director.
Section 7. QUORUM. At all meetings of the Board of Directors a majority of the authorized
number of directors shall be necessary and sufficient to constitute a quorum for the transaction of
business, and the vote of a majority of the directors present at any meeting at which there is a
quorum, shall be the act of the Board of Directors, except as may be otherwise specifically
provided by statute, by the Certificate of Incorporation or by these Bylaws. If a quorum shall not
be present at any meeting of the Board of Directors, the directors present at such meeting may
adjourn the meeting from time to time, without notice other than announcement at the meeting, until
a quorum shall be present. If only one director is authorized, such sole director shall constitute
a quorum.
Section 8. ACTION WITHOUT MEETING. Unless otherwise restricted by the Certificate of
Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the
Board of Directors or of any committee thereof may be taken without a meeting, if all members of
the Board of Directors or committee, as the case may be, consent thereto in writing, and the
writing or writings are filed with the minutes of proceedings of the Board of Directors or
committee.
Section 9. TELEPHONIC MEETINGS. Unless otherwise restricted by the Certificate of
Incorporation or these Bylaws, members of the Board of Directors, or any committee designated by
the Board of Directors, may participate in a meeting of the Board of Directors, or any committee,
by means of conference telephone or similar communications equipment by means of which all persons
participating in the meeting can hear each other, and such participation in a meeting shall
constitute presence in person at such meeting.
Section 10. COMMITTEES OF DIRECTORS. The Board of Directors may, by resolution passed by a
majority of the whole Board of Directors, designate one or more committees, each such committee to
consist of one or more of the directors of the corporation. The Board of Directors may designate
one or more directors as alternate members of any committee, who may replace any absent or
disqualified member at any meeting of the committee. In the absence or disqualification of a
member of a committee, the member or members thereof present at any meeting and not disqualified
from voting, whether or not he or she or they constitute a quorum, may unanimously appoint another
member of the Board of Directors to act at the meeting in the place of any such absent or
disqualified member. Any such committee, to the extent provided in the resolution of the Board of
Directors, shall have and may exercise all the powers and authority of the Board of Directors in
the management of the business and affairs of
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the corporation, and may authorize the seal of the
corporation to be affixed to all papers which may require it; but no such committee shall have the
power or authority in reference to amending the Certificate of Incorporation, adopting an agreement
of merger or consolidation, recommending to the stockholders the sale, lease or exchange of all or
substantially all of the corporations property and assets, recommending to the stockholders a
dissolution of the corporation or a revocation of a dissolution, or amending the Bylaws of the
corporation; and, unless the resolution or the Certificate of Incorporation expressly so provide,
no such committee shall have the power or authority to declare a dividend or to authorize the
issuance of stock.
Section 11. MINUTES OF COMMITTEE MEETINGS. Each committee shall keep regular minutes of its
meetings and report the same to the Board of Directors when required.
Section 12. CHAIRMAN OF THE BOARD. The Board of Directors may designate one of its members
to serve as Chairman of the Board, and if so, the Chairman of the Board shall, if present, preside
at all meetings of the Board of Directors and stockholders, and exercise and perform such other
powers and duties as may be from time to time assigned to him or her by the Board of Directors or
prescribed by these Bylaws.
Section 13. COMPENSATION OF DIRECTORS. Unless otherwise restricted by the Certificate of
Incorporation or these Bylaws, the Board of Directors shall have the authority to fix the
compensation of directors. The directors may be paid their expenses, if any, of attendance at each
meeting of the Board of Directors and may be paid a fixed sum for attendance at each meeting of the
Board of Directors or a stated salary as director. No such payment shall preclude any director from
serving the corporation in any other capacity and receiving compensation therefor. Members of
special or standing committees may be allowed like compensation for attending committee meetings.
ARTICLE IV
OFFICERS
Section 1. OFFICERS. The officers of this corporation shall be chosen by the Board of
Directors and shall include a President and a Secretary. The corporation may also have at the
discretion of the Board of Directors such other officers as are desired, including a Vice-Chairman
of the Board of Directors, a Chief Executive Officer, a Chief Financial Officer or Treasurer, one
or more Vice Presidents, one or more Assistant Secretaries and Assistant Treasurers, and such other
officers as may be appointed in accordance with the provisions of
Section 3 hereof. In the event there are two or more Vice Presidents, then one or more may be
designated as Executive Vice President, Senior Vice President, or other similar or dissimilar
title. At the time of the election of officers, the directors may by resolution determine the
order of their rank. Any number of offices may be held by the same person, unless the Certificate
of Incorporation or these Bylaws otherwise provide.
Section 2. ELECTION OF OFFICERS. The Board of Directors, at its first meeting after each
annual meeting of stockholders, shall choose the officers of the corporation.
Section 3. SUBORDINATE OFFICERS. The Board of Directors may appoint such other officers and
agents as it shall deem necessary who shall hold their offices for such terms and shall exercise
such powers and perform such duties as shall be determined from time to time by the Board of
Directors.
5
Section 4. COMPENSATION OF OFFICERS. The salaries of all officers and agents of the
corporation shall be fixed by the Board of Directors.
Section 5. TERM OF OFFICE; REMOVAL AND VACANCIES. The officers of the corporation shall hold
office until their successors are chosen and qualify in their stead. Any officer elected or
appointed by the Board of Directors may be removed at any time by the affirmative vote of a
majority of the Board of Directors. If the office of any officer or officers becomes vacant for
any reason, the vacancy shall be filled by the Board of Directors.
Section 6. PRESIDENT. Subject to such supervisory powers, if any, as may be given by the
Board of Directors to the Chairman of the Board, the President shall be the Chief Executive Officer
of the corporation and shall, subject to the control of the Board of Directors, have general
supervision, direction and control of the business and officers of the corporation. In the absence
of the Chairman of the Board, the President shall preside at all meetings of the stockholders and
at all meetings of the Board of Directors. He or she shall be an ex-officio member of all
committees and shall have the general powers and duties of management usually vested in the office
of President and Chief Executive Officer of corporations, and shall have such other powers and
duties as may be prescribed by the Board of Directors or these Bylaws.
Section 7. VICE PRESIDENTS. In the absence or disability of the President, the Vice
Presidents in order of their rank as fixed by the Board of Directors, or if not ranked, the Vice
President designated by the Board of Directors, shall perform all the duties of the President, and
when so acting shall have all the powers of and be subject to all the restrictions upon the
President. The Vice Presidents shall have such other duties as from time to time may be prescribed
for them, respectively, by the Board of Directors.
Section 8. SECRETARY. The Secretary shall attend all sessions of the Board of Directors and
all meetings of the stockholders and record all votes and the minutes of all proceedings in a book
to be kept for that purpose; and shall perform like duties for the standing committees when
required by the Board of Directors. He or she shall give, or cause to be given, notice of all
meetings of the stockholders and of the Board of Directors, and shall perform such other duties as
may be prescribed by the Board of Directors or these Bylaws. He or she shall keep in safe custody
the seal of the corporation, and when authorized by the Board of Directors,
affix the same to any instrument requiring it, and when so affixed it shall be attested by his or
her signature or by the signature of an Assistant Secretary. The Board of Directors may give
general authority to any other officer to affix the seal of the corporation and to attest the
affixing by his or her signature.
Section 9. ASSISTANT SECRETARY. The Assistant Secretary, or if there be more than one, the
Assistant Secretaries in the order determined by the Board of Directors, or if there be no such
determination, the Assistant Secretary designated by the Board of Directors, shall, in the absence
or disability of the Secretary, perform the duties and exercise the powers of the Secretary and
shall perform such other duties and have such other powers as the Board of Directors may from time
to time prescribe.
Section 10. CHIEF FINANCIAL OFFICER OR TREASURER. The Chief Financial Officer or Treasurer
shall have the custody of the corporate funds and securities and shall keep full and accurate
accounts of receipts and disbursements in books belonging to the corporation and shall deposit all
moneys, and other valuable effects in the name and to the credit of the corporation, in such
depositories as may be designated by the Board of Directors. He or she shall disburse the funds of
the corporation as may be ordered by the Board of Directors, taking proper vouchers for such
disbursements,
6
and shall render to the Board of Directors, at its regular meetings, or when the
Board of Directors so requires, an account of all his or her transactions as Chief Financial
Officer or Treasurer and of the financial condition of the corporation. If required by the Board
of Directors, he or she shall give the corporation a bond, in such sum and with such surety or
sureties as shall be satisfactory to the Board of Directors, for the faithful performance of the
duties of his or her office and for the restoration to the corporation, in case of his or her
death, resignation, retirement or removal from office, of all books, papers, vouchers, money and
other property of whatever kind in his or her possession or under his or her control belonging to
the corporation.
Section 11. ASSISTANT TREASURER. The Assistant Treasurer, or if there shall be more than
one, the Assistant Treasurers in the order determined by the Board of Directors, or if there be no
such determination, the Assistant Treasurer designated by the Board of Directors, shall, in the
absence or disability of the Chief Financial Officer or Treasurer, perform the duties and exercise
the powers of the Chief Financial Officer or Treasurer and shall perform such other duties and have
such other powers as the Board of Directors may from time to time prescribe.
ARTICLE V
INDEMNIFICATION OF DIRECTORS AND OFFICERS
(a) The corporation shall indemnify to the maximum extent permitted by law any person who was
or is a party or is threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative (other than an action
by or in the right of the corporation) by reason of the fact that he or she is or was a director or
officer of the corporation, or is or was serving at the request of the corporation as a director or
officer of another corporation, partnership, joint venture, trust or other enterprise, against
expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by him or her in connection with such action, suit or proceeding if he or she
acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or
upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that
the person did not act in good faith and in a manner which he or she reasonably believed to be in
or not opposed to the best interests of the corporation, and, with respect to any criminal action
or proceeding, had reasonable cause to believe that his or her conduct was unlawful.
(b) The corporation shall indemnify to the maximum extent permitted by law any person who was
or is a party or is threatened to be made a party to any threatened, pending or completed action or
suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact
that he or she is or was a director or officer of the corporation, or is or was serving at the
request of the corporation as a director or officer of another corporation, partnership, joint
venture, trust or other enterprise against expenses (including attorneys fees) actually and
reasonably incurred by him or her in connection with the defense or settlement of such action or
suit if he or she acted in good faith and in a manner he or she reasonably believed to be in or not
opposed to the best interests of the corporation and except that no such indemnification shall be
made in respect of any claim, issue or matter as to which such person shall have been adjudged to
be liable to the corporation unless and only to the extent that the Court of Chancery of Delaware
or the court in which such action or suit was brought shall determine upon application that,
despite the adjudication of liability but in view of all the circumstances of the case, such
7
person
is fairly and reasonably entitled to indemnity for such expenses which such Court of Chancery or
such other court shall deem proper.
(c) To the extent that a director or officer of the corporation shall be successful on the
merits or otherwise in defense of any action, suit or proceeding referred to in paragraphs (a) and
(b), or in defense of any claim, issue or matter therein, he or she shall be indemnified against
expenses (including attorneys fees) actually and reasonably incurred by him or her in connection
therewith.
(d) Any indemnification under paragraphs (a) and (b) (unless ordered by a court) shall be made
by the corporation only as authorized in the specific case upon a determination that
indemnification of the director or officer is proper in the circumstances because he or she has met
the applicable standard of conduct set forth in paragraphs (a) and (b). Such determination shall
be made (1) by a majority vote of the directors who are not parties to such action, suit or
proceeding, even though less than a quorum, or (2) if there are no such directors, or if such
directors so direct, by independent legal counsel in a written opinion, or (3) by the stockholders.
The corporation, acting through its Board of Directors or otherwise, shall cause such
determination to be made if so requested by any person who is indemnifiable under this Article V.
(e) Expenses (including attorneys fees) incurred by an officer or director in defending any
civil, criminal, administrative or investigative action, suit or proceeding shall be paid by the
corporation in advance of the final disposition of such action, suit or proceeding upon receipt of
an undertaking by or on behalf of such director or officer to repay such amount if it shall
ultimately be determined that he or she is not entitled to be indemnified by the corporation as
authorized in this Article V.
(f) The indemnification and advancement of expenses provided by, or granted pursuant to, the
other paragraphs of this Article V shall not be deemed exclusive of any other rights to which those
seeking indemnification or advancement of expenses may be entitled under any bylaw, agreement, vote
of stockholders or disinterested directors or otherwise, both as to action in his or her official
capacity and as to action in another capacity while holding such office.
(g) The Board of Directors may authorize, by a vote of a majority of a quorum of the Board of
Directors, the corporation to purchase and maintain insurance on behalf of any person who is or was
a director or officer of the corporation, or is or was serving at the request of the corporation as
a director or officer of another corporation, partnership, joint venture, trust or other enterprise
against any liability asserted against him or her and incurred by him or her in any such capacity,
or arising out of his or her status as such, whether or not the corporation would have the power to
indemnify him or her against such liability under the provisions of this Article V.
(h) For the purposes of this Article V, references to the corporation shall include, in
addition to the resulting corporation, any constituent corporation (including any constituent of a
constituent) absorbed in a consolidation or merger which, if its separate existence had continued,
would have had power and authority to indemnify its directors or officers so that any person who is
or was a director or officer of such constituent corporation, or is or was serving at the request
of such constituent corporation as a director or officer of another corporation, partnership, joint
venture, trust or other enterprise, shall stand in the same position under the provisions of this
Article V with respect to the resulting or surviving corporation as he or she would have with
respect to such constituent corporation if its separate existence had continued.
8
(i) For purposes of this section, references to other enterprises shall include employee
benefit plans; references to fines shall include any excise taxes assessed on a person with
respect to an employee benefit plan; and references to serving at the request of the corporation
shall include service as a director or officer of the corporation which imposes duties on, or
involves services by, such director or officer with respect to an employee benefit plan, its
participants or beneficiaries; and a person who acted in good faith and in a manner he or she
reasonably believed to be in the interest of the participants and beneficiaries of an employee
benefit plan shall be deemed to have acted in a manner not opposed to the best interests of the
corporation as referred to in this section.
(j) The indemnification and advancement of expenses provided by, or granted pursuant to, this
Article V shall, unless otherwise provided when authorized or ratified, continue as to a person who
has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and
administrators of such a person.
(k) The corporation shall be required to indemnify a person in connection with an action, suit
or proceeding (or part thereof) initiated by such person only if the action, suit or proceeding (or
part thereof) was authorized by the Board of Directors of the corporation.
ARTICLE VI
INDEMNIFICATION OF EMPLOYEES AND AGENTS
The corporation may indemnify every person who was or is a party or is or was threatened to be
made a party to any action, suit, or proceeding, whether civil, criminal, administrative or
investigative, by reason of the fact that he or she is or was an employee or agent of the
corporation or, while an employee or agent of the corporation, is or was serving at the request of
the corporation as an employee or agent or trustee of another corporation, partnership, joint
venture, trust, employee benefit plan or other enterprise, against expenses (including attorneys
fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him or
her in connection with such action, suit or proceeding, to the extent permitted by applicable law.
ARTICLE VII
CERTIFICATES OF STOCK
Section 1. CERTIFICATES. Every holder of stock of the corporation shall be entitled to have
a certificate signed by, or in the name of the corporation by, the Chairman or Vice-Chairman of the
Board of Directors, or the President or a Vice President, and by the Secretary or an Assistant
Secretary, or the Chief Financial Officer or Treasurer or an Assistant Treasurer of the
corporation, certifying the number of shares represented by the certificate owned by such
stockholder in the corporation.
Section 2. SIGNATURES ON CERTIFICATES. Any or all of the signatures on the certificate may
be a facsimile. In case any officer, transfer agent, or registrar who has signed or whose
facsimile signature has been placed upon a certificate shall have ceased to be such officer,
transfer agent, or registrar before such certificate is issued, it may be issued by the corporation
with the same effect as if he or she were such officer, transfer agent, or registrar at the date of
issue.
Section 3. STATEMENT OF STOCK RIGHTS, PREFERENCES, PRIVILEGES. If the corporation shall be
authorized to issue more than one class of stock or more than one series of any
9
class, the powers,
designations, preferences and relative, participating, optional or other special rights of each
class of stock or series thereof and the qualifications, limitations or restrictions of such
preferences and/or rights shall be set forth in full or summarized on the face or back of the
certificate which the corporation shall issue to represent such class or series of stock,
provided that, except as otherwise provided in section 202 of the General Corporation Law
of Delaware, in lieu of the foregoing requirements, there may be set forth on the face or back of
the certificate which the corporation shall issue to represent such class or series of stock, a
statement that the corporation will furnish without charge to each stockholder who so requests the
powers, designations, preferences and relative, participating, optional or other special rights of
each class of stock or series thereof and the qualifications, limitations or restrictions of such
preferences and/or rights.
Section 4. LOST CERTIFICATES. The Board of Directors may direct a new certificate or
certificates to be issued in place of any certificate or certificates theretofore issued by the
corporation alleged to have been lost, stolen or destroyed, upon the making of an affidavit of that
fact by the person claiming the certificate of stock to be lost, stolen or destroyed. When
authorizing such issue of a new certificate or certificates, the Board of Directors may, in its
discretion and as a condition precedent to the issuance thereof, require the owner of such lost,
stolen or destroyed certificate or certificates, or his or her legal representative, to advertise
the same in such manner as it shall require and/or to give the corporation a bond in such sum as it
may direct as indemnity against any claim that may be made against the corporation with respect to
the certificate alleged to have been lost, stolen or destroyed.
Section 5. TRANSFERS OF STOCK. Upon surrender to the corporation, or the transfer agent of
the corporation, of a certificate for shares duly endorsed or accompanied by proper evidence of
succession, assignation or authority to transfer, it shall be the duty of the corporation to issue
a new certificate to the person entitled thereto, cancel the old certificate and record the
transaction upon its books.
Section 6. FIXED RECORD DATE. In order that the corporation may determine the stockholders
entitled to notice of or to vote at any meeting of the stockholders, or any adjournment thereof, or
entitled to receive payment of any dividend or other distribution or allotment of any rights, or
entitled to exercise any rights in respect of any change, conversion or exchange of stock or for
the purpose of any other lawful action, the Board of Directors may fix a record date which shall
not precede the date upon which the resolution fixing the record date is adopted by the Board of
Directors, and which record date shall not be more than sixty nor less than ten days before the
date of such meeting. A determination of stockholders of record entitled to notice of or to vote
at a meeting of stockholders shall apply to any adjournment of the meeting; provided,
however, that the Board of Directors may fix a new record date for the adjourned meeting.
In order that the corporation may determine the stockholders entitled to consent to corporate
action in writing without a meeting, the Board of Directors may fix a record date which shall not
be more than ten days after the date upon which the resolution fixing the record date is adopted by
the Board of Directors.
Section 7. REGISTERED STOCKHOLDERS. The corporation shall be entitled to treat the holder of
record of any share or shares of stock as the holder in fact thereof and accordingly shall not be
bound to recognize any equitable or other claim or interest in such share on the part of any other
person, whether or not it shall have express or other notice thereof, save as expressly provided by
the laws of the State of Delaware.
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ARTICLE VIII
GENERAL PROVISIONS
Section 1. DIVIDENDS. Dividends upon the capital stock of the corporation, subject to the
provisions of the Certificate of Incorporation, if any, may be declared by the Board of Directors
at any regular or special meeting, pursuant to and subject to law. Dividends may be paid in cash,
in property, or in shares of the capital stock, subject to the provisions of the Certificate of
Incorporation.
Section 2. PAYMENT OF DIVIDENDS; DIRECTORS DUTIES. Before payment of any dividend there may
be set aside out of any funds of the corporation available for dividends such sum or sums as the
directors from time to time, in their absolute discretion, think proper as a reserve fund to meet
contingencies, or for equalizing dividends, or for repairing or maintaining any property of the
corporation, or for such other purpose as the directors shall think conducive to the interests of
the corporation, and the directors may abolish any such reserve.
Section 3. CHECKS. All checks or demands for money and notes of the corporation shall be
signed by such officer or officers as the Board of Directors may from time to time designate.
Section 4. FISCAL YEAR. The fiscal year of the corporation shall be fixed by resolution of
the Board of Directors.
Section 5. CORPORATE SEAL. The corporate seal shall contain two concentric circles with the
name of the corporation between the two circles and the date and state of incorporation appearing
in the inner circle.
Section 6. MANNER OF GIVING NOTICE. Whenever, under the provisions of the statutes or of the
Certificate of Incorporation or of these Bylaws, notice is required to be given to any director or
stockholder, it shall not be construed to mean personal notice, but such notice may be given in
writing, by mail, addressed to such director or stockholder, at his or her address as it appears on
the records of the corporation, with postage thereon prepaid, and such notice shall be deemed to be
given at the time when the same shall be deposited in the United States mail. Notice to directors
may also be given by telegram.
Section 7. WAIVER OF NOTICE. Whenever any notice is required to be given under the
provisions of the statutes or of the Certificate of Incorporation or of these Bylaws, a waiver
thereof in writing, signed by the person or persons entitled to said notice, whether before or
after the time stated therein, shall be deemed equivalent thereto.
Section 8. ANNUAL STATEMENT. The Board of Directors shall present at each annual meeting,
and at any special meeting of the stockholders when called for by vote of the stockholders, a full
and clear statement of the business and condition of the corporation.
ARTICLE IX
AMENDMENTS
Section 1. AMENDMENT BY DIRECTORS OR STOCKHOLDERS. These Bylaws may be altered, amended or
repealed or new Bylaws may be adopted by the stockholders or by the Board
11
of Directors, when such
power is conferred upon the Board of Directors by the Certificate of Incorporation, at any regular
meeting of the stockholders or of the Board of Directors or at any special meeting of the
stockholders or of the Board of Directors if notice of such alteration, amendment, repeal or
adoption of new Bylaws be contained in the notice of such special meeting. If the power to adopt,
amend or repeal Bylaws is conferred upon the Board of Directors by the Certificate of Incorporation
it shall not divest or limit the power of the stockholders to adopt, amend or repeal Bylaws.
ARTICLE X
RIGHT OF FIRST REFUSAL
Section 1. RESTRICTION ON TRANSFER. No stockholder of the corporation shall transfer,
assign, hypothecate, encumber, pledge or otherwise alienate (hereinafter Transfer) any shares of
Common Stock of the corporation (the Common Stock) owned by such stockholder unless such
stockholder previously complied with all provisions of this Article X. Any Transfer not made in
accordance with this Article X shall be void, and the corporation shall not treat the transferee in
such transaction as a stockholder for any purpose.
Section 2. NOTICE REQUIREMENT. If a stockholder seeks to Transfer any Common Stock, whether
voluntarily or involuntarily, such stockholder (the Offering Stockholder) shall first give
simultaneous written notice of such intention (Notice of Transfer) to the Secretary of the
corporation. The Notice of Transfer shall specify the number of shares of Common Stock to be
transferred (the Offered Shares), and state the price and all other terms of the proposed
transaction. The Notice of Transfer shall constitute an irrevocable offer to sell the Offered
Shares during the periods described below.
Section 3. OPTION OF THE CORPORATION. For twenty-five (25) days following the delivery of a
Notice of Transfer (the Option Period), the corporation shall have an irrevocable right to
purchase all or a portion of the Offered Shares in accordance with the terms stated in the Notice
of Transfer. The right may be exercised by a written notice, signed by the President of the
corporation (the Corporation Notice), stating that the corporation desires to purchase the
Offered Shares and tendering the purchase price therefor. Such notice and the purchase price for
the Offered Shares shall be delivered to the Offering Stockholder before expiration of the Option
Period. Failure to so respond within the Option Period to the Notice of Transfer shall be deemed
an irrevocable waiver by the corporation of its right to acquire the Offered Shares. The
corporation shall effect the purchase of the Offered Shares, including payment of the purchase
price, not more than five (5) business days after delivery of the Corporation Notice, and at such
time the Offering Stockholder shall deliver to the corporation the certificate(s) representing the
Offered Shares to be purchased by the corporation, each certificate to be properly endorsed for
transfer. Any Common Stock so purchased by the corporation shall thereupon be cancelled and cease
to be issued and outstanding shares of the corporations Common Stock.
Section 4. SPECIAL PROVISIONS REGARDING EXCHANGES. If the Notice of Transfer specifies
consideration other than cash, then the Offered Shares may be purchased in cash for the fair market
value of such property, as determined in good faith by the Board of Directors. In the event that
the Board of Directors decides to hire an independent appraiser in connection with such
determination, all expenses for such independent appraiser shall be borne by the Offering
Stockholder.
Section 5. EFFECT OF PURCHASE. For purposes of Section 3 of this Article X, the purchase
price for Offered Shares shall be deemed tendered, and said Offered Shares shall be deemed
12
purchased, at such time as the Offering Stockholder receives written notice enclosing a cashiers
check for the purchase price or stating that the purchase price has been delivered to a third party
(such as counsel to the corporation) with instructions to deliver such amount to the Offering
Stockholder upon surrender of certificates representing the Offered Shares, duly endorsed with
signatures guaranteed. All rights accorded the Offering Stockholder with respect to the Offered
Shares, other than the right to payment therefor, shall cease at that time. If payment is tendered
directly to the Offering Stockholder, the Offering Stockholder shall promptly, but in no event
later than five (5) business days, cause to be delivered certificate(s) representing the Offered
Shares, duly endorsed with signatures guaranteed, to the corporations transfer agent for
cancellation or transfer.
Section 6. CERTAIN TRANSFERS EXEMPT. Notwithstanding anything else contained in this Article
X to the contrary, an Offering Stockholder shall be permitted to make Transfers of certain shares
of Common Stock held by such Offering Stockholder without complying with the provisions of Sections
1 through 5 of this Article X above if such Transfer is:
(a) to the Offering Stockholders spouse, parents, children, or siblings or other members of
the Offering Stockholders family (including relatives by marriage), or to a trust for the benefit
of the Offering Stockholder or any of the foregoing members of his or her family, or to a
custodian, trustee or other fiduciary for the account of the Offering Stockholder or any of the
foregoing members of his or her family in connection with a bona fide estate planning transaction;
provided, however, that this Section shall not permit any Transfer to be made by
the Offering Stockholder in connection with the dissolution of the Offering Stockholders marriage
or the legal separation of the Offering Stockholder and Offering Stockholders spouse to such
spouse on the account of any settlement of any community property or other marital property rights
such spouse may have in such shares;
(b) by way of bequest or inheritance upon death;
(c) to any person, association or entity that, directly or indirectly, through one or more
intermediaries, has voting control or has its voting controlled by, or is under common voting
control with, such Offering Stockholder;
(d) by way of a bona fide gift;
(e) in connection with a Change of Control (as defined in Section 7 of this Article X below);
or
(f) subject to an alternative right of first refusal or similar right granted by the
corporation to a third party or parties which is more restrictive than the corporations rights
under this Article X.
Any Transfer set forth in clauses (a) through (f) of this Section 6 may be referred to herein
as a Permitted Transfer.
Section 7. LIMITATIONS ON RIGHT OF FIRST REFUSAL. The restrictions imposed by this Article X
shall not apply to and shall terminate upon (i) the closing of a firmly underwritten public
offering of Common Stock or (ii) the closing of any transaction or series of related transactions
constituting (a) a reorganization, merger, consolidation or sale of all or substantially all of the
corporations stock, as a result of which transaction or series of related transactions the
corporations stockholders of record as constituted immediately prior to such transaction or series
of related transactions
13
hold less than a majority of the outstanding voting power of the surviving
or acquiring entity after the consummation of such transaction or series of related transactions;
or (b) a sale of all or substantially all of the assets of the corporation (each of clauses (a) and
(b) a Change of Control).
Section 8. WAIVER. The provisions of this Article X may be waived with respect to any
Transfer only in writing signed by the corporation.
Section 9. ASSIGNMENT; ALTERNATIVE RIGHTS. The corporation may assign its rights under this
Article X or grant alternative rights of first refusal or similar rights to a third party or
parties.
Section 10. LEGEND. Any and all certificates representing any shares of Common Stock shall
bear a legend referring to the restrictions imposed by this Article X in substantially the form
below:
THE SHARES EVIDENCED HEREBY ARE SUBJECT TO A RIGHT OF FIRST REFUSAL OPTION
IN FAVOR OF THE CORPORATION AND/OR ITS ASSIGNEE(S), AS PROVIDED IN THE
AMENDED AND RESTATED BYLAWS OF THE CORPORATION, A COPY OF WHICH ARE ON FILE
WITH THE SECRETARY OF THE CORPORATION.
[Remainder of page intentionally left blank]
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CERTIFICATE OF SECRETARY
I, the undersigned, do hereby certify:
(1) That I am the duly elected and acting Secretary of Cadence Pharmaceuticals, Inc., a
Delaware corporation (the Corporation); and
(2) That the foregoing amended and restated bylaws constitute the bylaws of the
Corporation as duly adopted by the written consent of the stockholders of the Corporation dated
as of November 2, 2004.
IN WITNESS WHEREOF, I have hereunto subscribed my name this 2nd day of November, 2004.
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/s/ David A. Socks |
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David A. Socks, Secretary
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exv4w2
EXHIBIT 4.2
CADENCE PHARMACEUTICALS, INC.
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
February 21, 2006
CADENCE PHARMACEUTICALS, INC.
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
This Amended and Restated Investor Rights Agreement (this Agreement) is made as of
February 21, 2006, by and among Cadence Pharmaceuticals, Inc., a Delaware corporation (the
Company), and each of the entities and persons listed on Schedule A hereto (collectively,
the Investors).
This Agreement supersedes and replaces that certain Amended and Restated Investor Rights
Agreement, dated September 30, 2005 (the Prior Agreement), entered into by and among the Company
and the other parties thereto, contingent upon and effective as of the Closing (as defined in the
Purchase Agreement).
Recitals
A. Certain of the Investors purchased shares of the Companys Series A-1 Preferred Stock, par
value $0.0001 per share (the Series A-1 Preferred Stock), and Series A-2 Preferred Stock, par
value $0.0001 per share (the Series A-2 Preferred Stock), and are purchasing shares of the
Companys Series A-3 Preferred Stock, par value $0.0001 per share (the Series A-3 Preferred
Stock) pursuant to that certain Series A-3 Preferred Stock Purchase Agreement of even date
herewith (the Purchase Agreement).
B. Certain of the obligations in the Purchase Agreement are conditioned upon the execution and
delivery of this Agreement.
C. The Prior Agreement provides that any amendment or waiver thereof shall be effective with
the written consent of the Company and by Persons holding at a majority of the Convertible
Securities (as such terms are defined in the Prior Agreement).
D. The undersigned parties constitute Persons holding at least a majority of the Convertible
Securities, and, therefore, are entitled to bind all holders of Convertible Securities (as such
terms are defined in the Prior Agreement).
The Parties Agree as Follows:
SECTION 1. CERTAIN DEFINITIONS.
As used in this Agreement, the following terms shall have the following respective meanings:
(a) Affiliate shall mean with respect to any Person, any Person which directly or indirectly
through one or more intermediaries, controls, is controlled by or is under common control with such
Person.
(b) Board shall mean the Board of Directors of the Company.
(c) Commission shall mean the Securities and Exchange Commission or any other federal agency
at the time administering the Securities Act.
(d) Common Stock shall mean the Companys common stock, par value $0.0001
per share.
(e) Convertible Securities shall mean the Series A-1 Preferred Stock, Series A-2 Preferred
Stock, Series A-3 Preferred Stock and, only to the extent circumstances arise which require their
creation, Series A-4 Preferred Stock and Series A-5 Preferred Stock.
(f) Exchange Act shall mean the Securities Exchange Act of 1934, as amended, or any similar
federal statute, and the rules and regulations of the Commission thereunder, all as the same shall
be in effect at the time.
(g) Form S-3 shall mean Form S-3 issued by the Commission or any substantially similar form
then in effect.
(h) Holder shall mean any Person entering into this Agreement and any holder of outstanding
Registrable Securities or an assignee or transferee of Registration rights as permitted by Section
3.8.
(i) Initiating Holders shall mean Holders who in the aggregate hold at least twenty percent
(20%) of the Registrable Securities.
(j) Material Adverse Event shall mean an occurrence having a consequence that either (i) is
materially adverse as to the business, properties, prospects or financial condition of the Company
and its subsidiary, taken as a whole, or (ii) is reasonably foreseeable, has a reasonable
likelihood of occurring, and if it were to occur would reasonably be expected to materially
adversely affect the business, properties, prospects or financial condition of the Company and its
subsidiary, taken as a whole.
(k) Person shall mean an individual, a corporation, a partnership, a trust or unincorporated
organization or any other entity or organization.
(l) Preferred Directors shall mean the members of the Board elected by the holders of the
Convertible Securities voting together as a class and to the exclusion of all other classes of
capital stock of the Company.
(m) Qualified Public Offering shall mean a firmly underwritten public offering of the
Companys Common Stock Registered under the Securities Act and involving gross proceeds to the
Company of at least Thirty Million Dollars ($30,000,000) (prior to deduction for underwriters
discounts and other expenses relating to such public offering, including, without limitation, fees
of the Companys counsel) and the price to the public is at least Three Dollars ($3.00) per share
(equitably adjusted for all stock splits, sub-divisions, stock dividends, combinations and the like
with respect to such shares).
(n) The terms Register, Registered and Registration refer to a registration effected by
preparing and filing a registration statement in compliance with the Securities Act (Registration
Statement), and the declaration or ordering of the effectiveness of such Registration Statement.
(o)
Registrable Securities shall mean (i) all Common Stock not previously sold to the public
issued or issuable upon conversion of any of the Convertible Securities purchased by or issued to
the Investors, (ii) all shares of Common Stock owned by the Investors, (iii) for the purposes of
Section 3.2, the shares of Common Stock owned by Theodore R. Schroeder and David A. Socks, (iv) the
192,500 shares of Common Stock issuable upon conversion of the Convertible Securities issuable upon
exercise of
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that certain Warrant to Purchase Stock dated February 17, 2006 by and between the Corporation
and Silicon Valley Bank, (v) the 192,500 shares of Common Stock issuable upon conversion of the
Convertible Securities issuable upon exercise of that certain Warrant to Purchase Stock dated
February 17, 2006 by and between the Corporation and Oxford Finance Corporation, and (vi) any
Common Stock of the Company issued as (or issuable upon the conversion or exercise of any warrant,
right or other security that is issued as) a dividend or other distribution with respect to, or in
exchange for, or in replacement of, the Common Stock described in clauses (i) through (v) of this
definition.
(p) Registration Expenses shall mean all expenses incurred by the Company in complying with
Sections 3.1 or 3.2 of this Agreement, including, without limitation, all federal and state
registration, qualification and filing fees, printing expenses, fees and disbursements of counsel
for the Company and fees and disbursements of not more than one (1) special counsel for the Holders
(if different from the Company) not to exceed twenty-five thousand dollars ($25,000), blue sky fees
and expenses, and the expense of any special audits incident to or required by any such
Registration.
(q) Securities Act shall mean the Securities Act of 1933, as amended, or any similar federal
statute, and the rules and regulations of the Commission thereunder, all as the same shall be in
effect at the time.
(r) Selling Expenses shall mean all underwriting discounts and selling commissions
applicable to the sale of Registrable Securities pursuant to this Agreement.
(s) Series A-1 Preferred Stock shall mean the Companys Series A-1 Preferred Stock, par
value $0.0001 per share.
(t) Series A-2 Preferred Stock shall mean the Companys Series A-2 Preferred Stock, par
value $0.0001 per share.
(u) Series A-3 Preferred Stock shall mean the Companys Series A-3 Preferred Stock, par
value $0.0001 per share.
(v) Series A-4 Preferred Stock shall mean the Companys Series A-4 Preferred Stock, par
value $0.0001 per share, if the circumstances arise which require the creation of such series.
(w) Series A-5 Preferred Stock shall mean the Companys Series A-5 Preferred Stock, par
value $0.0001 per share, if the circumstances arise which require the creation of such series.
(x) Special Registration Statement shall mean (i) a registration statement relating to any
employee benefit plan, (ii) with respect to any corporate reorganization or transaction under Rule
145 of the Securities Act, including any registration statements related to the resale of
securities issued in such a transaction, or (iii) a registration related to stock issued upon
conversion of debt securities.
SECTION 2. COVENANTS OF THE COMPANY
2.1 Financial Statements and Reports to Stockholders; Budget. (a) As soon as
practicable after the end of each fiscal year of the Company, and in any event within one hundred
twenty (120) days thereafter, the Company shall deliver to each Investor an audited consolidated
balance sheet of the Company as of the end of such year and audited consolidated statements of
income, stockholders equity and cash flows for such year, which year-end financial reports
shall be in reasonable detail and shall be
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accompanied by the opinion of independent public
accountants of recognized standing selected by the Company.
(b) So long as an Investor or subsequent holder of Convertible Securities holds or is deemed
to hold at least One Hundred Fifty Thousand (150,000) shares of Registrable Securities (subject to
adjustment for stock splits, reverse stock splits, stock dividends and other similar transactions
with respect to such shares), the Company shall deliver to such Investor:
(i) as soon as practicable after the end of each month, and in any event within thirty (30)
days thereafter, unaudited consolidated balance sheets of the Company and its subsidiaries, if any,
as of the end of each such month and unaudited consolidated statements of income and cash flow for
such month; and
(ii) within sixty (60) days prior to the end of each fiscal year, an operating budget and plan
respecting the Companys next fiscal year in substantially the same form as that which will be
subject to the approval of the Board.
2.2 Qualified Small Business. The Company covenants that so long as any Convertible
Securities, or the Common Stock into which such shares are converted, are held by a Holder in whose
hands such shares of Common Stock are eligible to qualify as qualified small business stock as
defined in Section 1202(c) of the Internal Revenue Code of 1986, as amended (the Code)
(Qualified Small Business Stock), it will (i) comply with any applicable filing or reporting
requirements imposed by the Code on issuers of Qualified Small Business Stock and (ii) execute and
deliver to each Holder, from time to time, such forms, documents, schedules and other instruments
as may be reasonably requested thereby to cause the Convertible Securities, or the Common Stock
into which such shares are converted, to qualify as Qualified Small Business Stock. The Company
shall submit to the Investors and to the Internal Revenue Service any reports that may be required
under Section 1202(d)(1)(C) of the Code and any related Treasury Regulations. In addition, within
ten (10) days after any Investor has delivered to the Company a written request therefor, the
Company shall deliver to such Investor a written statement informing the Investor whether, in the
Companys good-faith judgment after a reasonable investigation, such Investors interest in the
Company constitutes qualified small business stock as defined in Section 1202(c) of the Code, or
would constitute qualified small business stock, if determination of whether stock constitutes
qualified small business stock were made by taking into account the modifications set forth in
Section 1045(b)(4) of the Code. The Companys obligation to furnish a written statement pursuant
to this Section 2.2 shall continue notwithstanding the fact that a class of the Companys stock may
be traded on an established securities market.
2.3 Board Meeting; Compensation of Directors. The Company hereby covenants that so
long as the holders of the Convertible Securities are entitled to appoint any members of the Board
pursuant to the Companys Restated Certificate of Incorporation, as amended, the Board shall not
meet less frequently than quarterly. All non-employee directors will be compensated by the Company
identically; provided however, that additional compensation may be provided to the Chairman of the
Board or the Chairman of any Committee of the Board; provided, that such compensation is approved
by the Board, including the approval of at least one (1) of the Preferred Directors. All
out-of-pocket and travel expenses of the directors incurred in attending Board meetings (or
meetings of committees thereof) or in connection with the performance of their duties as directors
shall be paid or reimbursed promptly by the Company. The Company shall also agree to indemnify
each of its officers and directors to the fullest extent permitted by the Delaware General
Corporation Law and enter into customary indemnification agreements with each of its officers
and directors evidencing such indemnification obligation.
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2.4 Employee Stock. With respect to any shares issued or options or rights granted to
employees, consultants and directors after the date hereof, unless otherwise approved by the Board,
the Company shall cause each employee, consultant, and director of the Company to enter into an
agreement providing for vesting of such shares or options or rights over forty-eight (48) months,
with no shares or options or rights being vested for twelve (12) months from the date of
commencement of services in the case of stock or option grants for new hires, or the date of
issuance or grant in the case of subsequent stock or option grants, at which time 1/4th of the
shares or options or rights shall be vested and 1/48th of such shares, options or rights shall be
vested monthly thereafter. Any options providing for early exercise and any grant of restricted
stock shall provide for a repurchase option so that upon termination of the employment or
consulting relationship of the stockholder, the Company or its assignee (to the extent permissible
under applicable securities law qualification) retains the option to repurchase at cost any
unvested shares held by such stockholder.
2.5 Board Observer Rights. For so long as an Investor or subsequent holder of
Convertible Securities holds or is deemed to hold at least One Million Five Hundred Thousand
(1,500,000) shares of Registrable Securities (subject to adjustment for stock splits, reverse stock
splits, stock dividends and other similar transactions with respect to such shares), the Company
shall allow one representative designated by such Investor (the Observer) to attend meetings of
the Board in a non-voting capacity; provided, however, that no Investor or subsequent holder of
Convertible Securities shall be entitled to designate an Observer if such holder or an Affiliate of
such holder is entitled to nominate a director to the Board pursuant to the Companys Amended and
Restated Voting Agreement, dated as of the date hereof. The Company shall provide the Observer
with copies of all materials that are provided by the Company to its directors; provided, however,
that a majority of the members of the Board shall be entitled to recuse the Observer from portions
of any Board meeting and to redact portions of any Board or Board committee materials delivered to
the Observer where and to the extent that such majority determines, in good faith that (i) such
recusal is reasonably necessary, in the opinion of counsel to the Company, to preserve
attorney-client privilege with respect to a material matter, (ii) there exists, with respect to any
deliberation or Board materials, an actual or potential conflict of interest between the Investor
who has appointed such Observer and the Company or (iii) the presence of the Observer would
otherwise be materially injurious to the Company in such circumstances; provided, further, that
such Investors right to appoint an Observer to the Board shall automatically expire upon the
effectiveness of the registration statement for the Companys Qualified Public Offering. Any
Observer will be subject to the confidentiality provisions set forth in Section 2.6. The Observer
shall receive no compensation from the Company for service as an Observer and shall not be
reimbursed for any expenses incurred by the Observer in connection with attendance of any meeting
of the Board.
2.6 Confidentiality. Each Investor agrees and will cause any representative of the
Investor, including any Observer, to hold in confidence and trust and not use or disclose any
information provided to or learned by it in connection with its rights under this Section 2, except
that such Investor may disclose such information to any general partner, limited partner, member,
subsidiary or parent (and their respective representatives) of such Investor for the purpose of
evaluating its investment in the Company as long as (a) such general partner, limited partner,
member, subsidiary or parent is advised of the confidentiality
provisions of this Section 2.6 and (b) such Investor uses its commercially reasonable best
efforts to ensure that such general partner, limited partner, member, subsidiary or parent holds
such information in confidence and trust and will not use or disclose any information provided to
or learned by it except as required by law. Notwithstanding the foregoing, however, the obligation
of each Investor to hold information confidential as provided herein or any other document or
agreement relating thereto shall not prohibit such Investor from disclosing such information: (i)
to its board of directors, investment advisers, attorneys, accountants, consultants and other
professionals to the extent necessary to obtain their services in connection with its investment in
the Company, provided that such persons agree to hold such information confidential as provided
herein; (ii) to any prospective purchaser of any shares of the
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Company owned by such Investor as
long as such prospective purchaser agrees in writing to be bound by the confidentiality provisions
as provided herein; (iii) to such Investors investment advisor or any investment companies managed
by such Investors investment advisor, provided that such persons agree to hold such information
confidential as provided herein; or (iv) as required by applicable law or regulation, regulatory
body, stock exchange, court or administrative order, or any listing or trading agreement concerning
such Investor or the Company. Furthermore, nothing in this Section 2.6 shall restrict any
Investors ability to disclose the existence or nature of its relationship with the Company, the
nature or amount of its investment in securities of the Company or to provide its affiliates with
quarterly, annual or other reports and such other information about the Company prepared by such
Investor in the ordinary course of its business, provided that said Investor takes commercially
reasonable measures to ensure that any such affiliates protect the confidential nature of such
confidential information.
2.7 Termination of Covenants. The covenants of the Company set forth in this Section
2 shall be terminated and be of no further force or effect upon the earlier of (a) the effective
date of the Companys Registration Statement filed in connection with the Companys first Qualified
Public Offering and (b) the date of the closing of a sale, lease, or other disposition of all or
substantially all of the Companys assets or the Companys merger into or consolidation with any
other corporation or other entity, or any other corporate reorganization, in which the holders of
the Companys outstanding voting stock immediately prior to such transaction own, immediately after
such transaction, securities representing less than fifty percent (50%) of the voting power of the
corporation or other entity surviving such transaction, provided that this Section 2.7 shall not
apply to a merger effected exclusively for the purpose of changing the domicile of the Company or a
sale of shares by the Company for primarily equity financing purposes.
SECTION 3. REGISTRATION RIGHTS
3.1 Demand Registration.
3.1.1. Request for Registration on Form other than Form S-3. Subject to the terms of
this Agreement, in the event that the Company shall receive from the Initiating Holders, at any
time after, six (6) months from the effective date of the first registration statement for a public
offering of securities of the Company (other than a Special Registration Statement), a written
request that the Company effect any Registration with respect to all or a part of the Registrable
Securities on a form other than Form S-3 for an offering of all or a part of the then outstanding
Registrable Securities, the reasonably anticipated aggregate offering price to the public of which
would exceed Five Million Dollars ($5,000,000), net of Selling Expenses, the Company shall (i)
promptly give written notice of the proposed Registration to all other Holders and shall (ii) as
soon as practicable, use its reasonable best efforts to effect Registration of the Registrable
Securities specified in such request, together with any Registrable Securities of any Holder
joining in such request as are specified in a written request given within twenty (20) days after
written notice from the Company. The
Company shall not be obligated to take any action to effect any such Registration pursuant to
this Section 3.1.1:
(i) in any particular jurisdiction in which the Company would be required to execute a general
consent to service of process in effecting such registration, unless the Company is already subject
to service in such jurisdiction and except as may be required under the Securities Act;
(ii) after the Company has effected two (2) such Registrations pursuant to this Section 3.1.1
and such Registrations have been declared effective;
(iii) during the period starting with the date sixty (60) days prior to the Companys good
faith estimate of the date of filing of, and ending on the date one hundred eighty (180)
- 6 -
days
following the effective date of the registration statement pertaining to any public offering, other
than pursuant to a Special Registration Statement; provided that the Company makes reasonable good
faith efforts to cause such registration statement to become effective;
(iv) if within thirty (30) days of receipt of a written request from the Initiating Holders
pursuant to Section 3.1.1, the Company gives notice to the Holders of the Companys intention to
file a registration statement for a public offering, other than pursuant to a Special Registration
Statement, within one hundred twenty (120) days; or
(v) if the Initiating Holders propose to dispose of shares of Registrable Securities that may
be immediately registered on Form S-3 pursuant to a request made pursuant to Section 3.1.3 below.
3.1.2. Right of Deferral of Registration on Form other Than Form S-3. If the Company
shall furnish to all such Holders who joined in the request a certificate signed by the President
of the Company stating that, in the good faith judgment of the Board, it would be seriously
detrimental to the Company for any Registration to be effected as requested under Section 3.1.1,
the Company shall have the right to defer the filing of a Registration Statement with respect to
such offering for a period of not more than one hundred twenty (120) days from delivery of the
request of the Initiating Holders; provided, however, that the Company may not utilize this right
more than once in any twelve (12)-month period.
3.1.3. Request for Registration on Form S-3. Subject to the terms of this Agreement,
in the event that the Company receives from Holders of twenty percent (20%) or more of the then
outstanding Registrable Securities, a written request that the Company effect any Registration on
Form S-3 (or any successor form to Form S-3 regardless of its designation) at a time when the
Company is eligible to Register securities on Form S-3 (or any successor form to Form S-3
regardless of its designation) for an offering of Registrable Securities which such Holders in
their good faith discretion determine would have an anticipated offering price of at least One
Million Dollars ($1,000,000), the Company will promptly give written notice of the proposed
Registration to all the Holders and will as soon as practicable use its best efforts to effect
Registration of the Registrable Securities specified in such request, together with all or such
portion of the Registrable Securities of any Holder joining in such request as are specified in a
written request delivered to the Company within twenty (20) days after written notice from the
Company of the proposed Registration. There shall be no limit to the number of occasions on which
the Company shall be obligated to effect Registration under this Section 3.1.3, but the Company
shall not be required to effect more than two (2)
such Registrations in any twelve (12)-month period. Notwithstanding the foregoing, the
Company shall not be obligated to effect any Registration pursuant to this Section 3.1.3:
(i) if Form S-3 is not available for such offering by the Holders;
(ii) if the Holders, together with the holders of any other securities of the Company entitled
to inclusion in such registration, propose to sell Registrable Securities and such other securities
(if any) at an aggregate price to the public of less than One Million Dollars ($1,000,000) before
deduction of Selling Expenses;
(iii) if within thirty (30) days of receipt of a written request from any Holder or Holders
pursuant to this Section 3.1.3, the Company gives notice to such Holder or Holders of the Companys
intention to make a public offering within ninety (90) days, other than pursuant to a Special
Registration Statement;
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(iv) if the Company shall furnish to the Holders a certificate signed by the President of the
Company stating that, in the good faith judgment of the Board, it would be seriously detrimental to
the Company for any Registration to be effected as requested under Section 3.1.3, the Company shall
have the right to defer the filing of a Registration Statement with respect to such offering for a
period of not more than ninety (90) days from delivery of the request of the Holders requesting
such Registration; provided, however, that the Company may not utilize this right more than once in
any twelve (12)-month period; or
(v) in any particular jurisdiction in which the Company would be required to qualify to do
business or to execute a general consent to service of process in effecting such registration,
qualification or compliance.
3.1.4. Registration of Other Securities in Demand Registration. Any Registration
Statement filed pursuant to the request of the Initiating Holders under this Section 3 may, subject
to the provisions of Section 3.1.5, include securities of the Company other than Registrable
Securities.
3.1.5. Underwriting in Demand Registration.
a. Notice of Underwriting.
If the Initiating Holders intend to distribute the Registrable Securities covered by their
request by means of an underwriting, they shall so advise the Company, as a part of their request
made pursuant to Section 3.1.1, and the Company shall include such information in the written
notice referred to in Section 3.1.1 or 3.1.3. The right of any Holder to Registration pursuant to
Section 3 shall be conditioned upon such Holders agreement to participate in such underwriting and
the inclusion of such Holders Registrable Securities in the underwriting.
b. Inclusion of other Holders in
Demand Registration.
If the Company, officers or directors of the Company holding Common Stock other than
Registrable Securities or holders of securities issued by the Company other than Registrable
Securities, request inclusion in such Registration, the Initiating Holders, to the extent they deem
advisable and consistent with the goals of such Registration, shall, on behalf of all Holders,
offer to any or all of the Company, such officers or directors and such holders of securities other
than Registrable
Securities that such securities other than Registrable Securities be included in the
underwriting and may condition such offer on the acceptance by such persons of the terms of this
Section 3.1.
c. Selection of Underwriter in
Demand Registration.
The Company shall (together with all Holders proposing to distribute their securities through
such underwriting) enter into an underwriting agreement with the representative (Underwriters
Representative) of the underwriter or underwriters selected for such underwriting by the Holders
of a majority of the Registrable Securities being Registered by the Initiating Holders and agreed
to by the Company.
d. Marketing Limitation in
Demand Registration.
In the event the Underwriters Representative advises the Initiating Holders in writing that
market factors (including, without limitation, the aggregate number of shares of Common Stock
requested to be Registered, the general condition of the market, and the status of the persons
proposing to sell securities pursuant to the Registration) require a limitation of the number of
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shares to be underwritten, then (i) first the securities other than Registrable Securities and (ii)
next the securities requested to be registered by the Company, shall be excluded from such
Registration to the extent required by such limitation. If a limitation of the number of shares is
still required, the Initiating Holders shall so advise all Holders and the number of shares of
Registrable Securities that may be included in the Registration and underwriting shall be allocated
among all Holders in proportion, as nearly as practicable, to the respective amounts of Registrable
Securities entitled to inclusion in such Registration held by such Holders at the time of filing
the Registration Statement. No Registrable Securities or other securities excluded from the
underwriting by reason of this Section 3.1.5(d) shall be included in such Registration Statement.
To facilitate the allocation of shares in accordance with the above provisions, the Company or the
Underwriters Representative may round the number of shares allocated to any Holder to the nearest
one hundred (100) shares.
e. Right of Withdrawal in Demand
Registration.
If any Holder of Registrable Securities, or a holder of other securities entitled (upon
request) to be included in such Registration, disapproves of the terms of the underwriting, such
person may elect to withdraw therefrom by written notice to the Company, the underwriter and the
Initiating Holders delivered at least seven (7) business days prior to the effective date of the
Registration Statement. The securities so withdrawn shall also be withdrawn from the Registration
Statement.
3.1.6. Blue Sky in Demand Registration. In the event of any Registration pursuant to
Section 3.1, the Company will exercise its reasonable best efforts to Register and qualify the
securities covered by the Registration Statement under such other securities or Blue Sky laws of
such jurisdictions (not exceeding twenty (20) at the expense of the Company) as shall be reasonably
appropriate for the distribution of such securities; provided, however, that (i) the Company shall
not be required to qualify to do business or to file a general consent to service of process in any
such states or jurisdictions, and (ii) notwithstanding anything in this Agreement to the contrary,
in the event any jurisdiction in which the securities shall be qualified imposes a non-waivable
requirement that expenses incurred in connection with the qualification of the securities be borne
by selling stockholders, such expenses shall be payable pro rata by selling stockholders.
3.2 Piggyback Registration.
3.2.1. Notice of Piggyback Registration and Inclusion of Registrable Securities.
Subject to the terms of this Agreement, in the event the Company decides to Register any of its
Common Stock (either for its own account or the account of a security holder or holders or other
securities under the Securities Act in connection with the public offering of such securities
(other than a Special Registration Statement), the Company will: (i) promptly give each Holder
written notice thereof (which shall include a list of the jurisdictions in which the Company
intends to attempt to qualify such securities under the applicable Blue Sky or other state
securities laws) and (ii) include in such Registration (and any related qualification under Blue
Sky laws or other compliance), and in any underwriting involved therein, all the Registrable
Securities specified in a written request delivered to the Company by any Holder within fifteen
(15) days after delivery of such written notice from the Company.
3.2.2. Underwriting in Piggyback Registration.
a. Notice of Underwriting in
Piggyback Registration.
If the Registration of which the Company gives notice pursuant to Section 3.2.1 is for a
Registered public offering involving an underwriting, the Company shall so advise the Holders as a
part of the written notice given pursuant to Section 3.2.1. In such event the right of any
- 9 -
Holder
to Registration shall be conditioned upon such underwriting and the inclusion of such Holders
Registrable Securities in such underwriting to the extent provided in this Section 3. All Holders proposing to distribute their securities through such underwriting shall (together with the Company
and the other holders distributing their securities through such underwriting) enter into an
underwriting agreement with the Underwriters Representative for such offering. The Holders shall
have no right to participate in the selection of the underwriters for an offering pursuant to this
Section 3.2.
b. Marketing Limitation in
Piggyback Registration.
In the event the Underwriters Representative advises the Holders seeking Registration of
Registrable Securities pursuant to Section 3.2 in writing that market factors (including, without
limitation, the aggregate number of shares of Common Stock requested to be Registered, the general
condition of the market, and the status of the persons proposing to sell securities pursuant to the
Registration) require a limitation of the number of shares to be underwritten, the Underwriters
Representative (subject to the allocation priority set forth in Section 3.2.2(c)) may:
i. in the case of the first registered offering of the Companys securities, exclude some or
all Registrable Securities from such Registration and underwriting; and
ii. in the case of any subsequent registered public offering of the Companys securities,
limit the number of shares of Registrable Securities to be included in such Registration and
underwriting to not less than thirty percent (30%) of the securities included in such Registration
(based on aggregate market values).
c. Allocation of Shares in
Piggyback Registration.
In the event that the Underwriters Representative limits the number of shares to be included
in a Registration pursuant to Section 3.2.2(b), the number of shares to be included in such
Registration shall be allocated (subject to Section 3.2.2(b)) in the following manner: The number
of shares, if any, that may be included in the Registration and underwriting by selling
stockholders shall first
be allocated among all the requesting Holders pro rata according to the respective amounts of
Registrable Securities entitled to be included in such offering by such requesting Holders and then
among all other holders of securities other than Registrable Securities requesting and legally
entitled to include shares in such Registration, in proportion, as nearly as practicable, to the
respective amounts of securities (including Registrable Securities) which such Holders and such
other holders would otherwise be entitled to include in such Registration. No Registrable
Securities or other securities excluded from the underwriting by reason of this Section 3.2.2(c)
shall be included in the Registration Statement. To facilitate the allocation of shares in
accordance with the above provisions, the Company or the Underwriters Representative may round the
number of shares allocated to any Holder to the nearest one hundred (100) shares.
d. Withdrawal in Piggyback
Registration.
If any Holder disapproves of the terms of any such underwriting, he may elect to withdraw
therefrom by written notice to the Company and the underwriter delivered at least seven (7)
business days prior to the effective date of the Registration Statement. Any Registrable
Securities or other securities excluded or withdrawn from such underwriting shall be withdrawn from
such Registration.
3.2.3. Blue Sky in Piggyback Registration. In the event of any Registration of
Registrable Securities pursuant to Section 3.2, the Company will exercise its best efforts to
Register and
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qualify the securities covered by the Registration Statement under such other
securities or Blue Sky laws of such jurisdictions (not exceeding twenty (20) unless otherwise
agreed to by the Company) as shall be reasonably appropriate for the distribution of such
securities; provided, however, that (i) the Company shall not be required to qualify to do business
or to file a general consent to service of process in any such states or jurisdictions, and (ii)
notwithstanding anything in this Agreement to the contrary, in the event any jurisdiction in which
the securities shall be qualified imposes a non-waivable requirement that expenses incurred in
connection with the qualification of the securities be borne by selling stockholders, such expenses
shall be payable pro rata by selling stockholders.
3.3 Expenses of Registration. All Registration Expenses incurred in connection with
two (2) Registrations pursuant to Section 3.1.1, all Registrations pursuant to Section 3.1.3 (Form
S-3) and all Registrations pursuant to Section 3.2 shall be borne by the Company. All Registration
Expenses incurred in connection with any other registration, qualification or compliance shall be
apportioned among the Holders and other holders of the securities so registered on the basis of the
number of shares so registered. Notwithstanding the above, the Company shall not be required to
pay for any expenses of any Registration proceeding begun pursuant to Section 3.1 if the
Registration request is subsequently withdrawn at the request of the Holders of a majority of the
Registrable Securities to be Registered (which Holders shall bear such expenses), unless the
Holders of a majority of the Registrable Securities agree to forfeit their right to demand
Registration pursuant to Section 3.1; provided further, however, that if at the time of such
withdrawal, (a) the Holders have learned of a Material Adverse Event either (i) not known to the
Holders at the time of their request or (ii) not made known to the Holders within fifteen (15) days
after their request and (b) the Holders have withdrawn the request with reasonable promptness
following the discovery of such Material Adverse Event, then the Holders shall not be required to
pay any of such expenses and shall retain their rights pursuant to Section 3.1. All Selling
Expenses shall be borne by the respective holders of the securities Registered pro rata on the
basis of the number of shares registered.
3.4 Registration Procedures. In the case of each registration, qualification or
compliance effected by the Company pursuant to this Section 3, the Company will:
(a) Keep each Holder whose Registrable Securities are included in any Registration pursuant to
this Agreement advised as to the initiation and completion of such Registration. At its expense
the Company will: (i) use its best efforts to keep such Registration effective for a period of one
hundred twenty (120) days or until the Holder or Holders have completed the distribution described
in the Registration Statement relating thereto, whichever first occurs; and (ii) furnish such
number of prospectuses (including preliminary prospectuses) and other documents as a Holder from
time to time may reasonably request. With respect to clause (i) of the preceding sentence, the
Company may at any time upon written notice to the participating Holders and for a period not to
exceed sixty (60) days thereafter (the Suspension Period) delay the filing or effectiveness of
any registration statement or suspend the use or effectiveness of any registration statement (and
the Holders hereby agree not to offer or sell any Registrable Securities pursuant to such
registration statement (or any prospectus relating thereto) during the Suspension Period) if the
Company reasonably believes that the Company may, in the absence of such delay or suspension
hereunder, be required under state or federal securities laws to disclose any corporate development
the disclosure of which could reasonably be expected to have an adverse effect upon the Company,
its stockholders, a potentially significant transaction or event involving the Company, or any
negotiations, discussions, or proposals directly relating thereto. In the event that the Company
shall exercise its rights hereunder, the applicable time period during which the registration
statement is to remain effective shall be extended by a period of time equal to the duration of the
Suspension Period. The Company may extend the Suspension Period for an additional consecutive
sixty (60) days with the consent of the holders of a majority of the Registrable Securities
proposed to be sold by the Holders in the applicable Registration, which consent shall not be
unreasonably withheld. If so
- 11 -
directed by the Company, the Holders shall use their best efforts to
deliver to the Company (at the Companys expense) all copies, other than permanent file copies then
in such Holders possession, of the prospectus relating to such Registrable Securities current at
the time of receipt of such notice. Notwithstanding anything to the contrary contained herein, the
Company shall not be required to file, cause to become effective or maintain the effectiveness of
any registration statement that contemplates a distribution of securities on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act.
(b) Prepare and file with the Commission such amendments and supplements to such registration
statement and the prospectus used in connection with such registration statements as may be
necessary to comply with the provisions of the Securities Act with respect to the disposition of
all securities covered by such registration statement for a period of up to one hundred twenty
(120) days;
(c) Promptly notify each Holder of Registrable Securities covered by the registration
statement at any time when the Company becomes aware of the happening of any event as a result of
which the registration statement or the prospectus included in such registration statement or any
supplement to the prospectus (as then in effect) contains any untrue statement of a material fact
or omits to state a material fact necessary to make the statements therein (in the case of the
prospectus, in light of the circumstances under which they were made) not misleading or, if for any
other reason it shall be necessary during such time period to amend or supplement the registration
statement or the prospectus in order to comply with the Securities Act, whereupon, in either case,
each Holder shall immediately cease to use such registration statement or prospectus for any
purpose and, as promptly as practicable thereafter, the Company shall prepare and file with the
Commission, and furnish without charge to the appropriate Holders and managing underwriters, if
any, a supplement or amendment to such registration statement or prospectus which will correct such
statement or omission or effect such compliance and such copies thereof as the Holders and any
underwriters may reasonably request;
(d) Use its reasonable best efforts to register and qualify the securities covered by such
registration statement under such other securities or Blue Sky laws of such jurisdictions as shall
be reasonably requested by the Holders, provided that the Company shall not be required in
connection therewith or as a condition thereto to qualify to do business or to file a general
consent to service of process in any such states or jurisdictions except as may be required by law;
(e) Cause all such Registrable Securities to be listed on each securities exchange on which
similar securities issued by the Company are then listed;
(f) Provide a transfer agent and registrar for all Registrable Securities and a CUSIP number
for all such Registrable Securities, in each case not later than the effective date of such
registration;
(g) In the event of any underwritten public offering, enter into and perform its obligations
under an underwriting agreement, in usual and customary form, with the managing underwriter of such
offering. Each Holder participating in such underwriting shall also enter into and perform its
obligations under such an agreement; and
(h) Use its reasonable best efforts to furnish, at the request of any Holder requesting
registration of Registrable Securities pursuant to this Section 3, on the date that such
Registrable Securities are delivered to the underwriters for sale in connection with a registration
pursuant to this Section 3, if such securities are being sold through underwriters, or, if such
securities are not being sold through underwriters, on the date that the registration statement
with respect to such securities becomes effective, (i) an opinion, dated such date, of the counsel
representing the Company for the purposes of such registration, in form and substance as is
customarily given to underwriters in an underwritten public
- 12 -
offering, addressed to the
underwriters, if any, and to the Holders requesting registration of Registrable Securities and (ii)
a letter dated such date, from the independent certified public accountants of the Company, in form
and substance as is customarily given by independent certified public accountants to underwriters
in an underwritten public offering, addressed to the underwriters, if any, and to the Holders
requesting registration of Registrable Securities (to the extent the then applicable standards of
professional conduct permit said letter to be addressed to the Holders).
3.5 Information Furnished by Holder. It shall be a condition precedent of the
Companys obligations under this Agreement that each Holder of Registrable Securities included in
any Registration furnish to the Company such information regarding such Holder and the distribution
proposed by such Holder or Holders as the Company may reasonably request.
3.6 Indemnification.
3.6.1. Companys Indemnification of Holders. To the extent permitted by law, the
Company will indemnify each Holder, each of its officers, directors and constituent partners, legal
counsel for the Holders, and each person controlling such Holder, with respect to which
Registration, qualification or compliance of Registrable Securities has been effected pursuant to
this Agreement, and each underwriter, if any, and each person who controls any underwriter, against
all claims, losses, damages or liabilities (or actions in respect thereof) to the extent such
claims, losses, damages or liabilities arise out of or are based upon any untrue statement (or
alleged untrue statement) of a material fact contained in any prospectus or other document
(including any related Registration Statement) incident to any such Registration, qualification or
compliance, or are based on
any omission (or alleged omission) to state therein a material fact required to be stated
therein or necessary to make the statements therein not misleading, or any violation by the Company
of any rule or regulation promulgated under the Securities Act or Exchange Act or state or federal
law applicable to the Company and relating to action or inaction required of the Company in
connection with any such Registration, qualification or compliance; and the Company will reimburse
each such Holder, each such underwriter and each person who controls any such Holder or underwriter
for any legal and any other expenses reasonably incurred in connection with investigating or
defending any such claim, loss, damage, liability or action; provided, however, that the indemnity
contained in this Section 3.6.1 shall not apply to amounts paid in settlement of any such claim,
loss, damage, liability or action if settlement is effected without the consent of the Company
(which consent shall not unreasonably be withheld); and provided, further, that the Company will
not be liable in any such case to the extent that any such claim, loss, damage, liability or
expense arises out of or is based upon any untrue statement or omission based upon written
information furnished to the Company by such Holder, underwriter, or controlling person and stated
to be for use in connection with the offering of securities of the Company.
3.6.2. Holders Indemnification of Company. To the extent permitted by law, each
Holder will, if Registrable Securities held by such Holder are included in the securities as to
which such Registration, qualification or compliance is being effected pursuant to this Agreement,
indemnify the Company, each of its directors and officers that has signed the registration
statement, each underwriter, if any, of the Companys securities covered by such a Registration
Statement, each person who controls the Company or such underwriter within the meaning of the
Securities Act, and each other such Holder, each of its officers, directors and constituent
partners and each person controlling such other Holder, against all claims, losses, damages and
liabilities (or actions in respect thereof) arising out of or based upon any untrue statement (or
alleged untrue statement) of a material fact contained in any such Registration Statement,
prospectus, offering circular or other document, or any omission (or alleged omission) to state
therein a material fact required to be stated therein or necessary to make the statements therein
not misleading, or any violation by such Holder of any rule or regulation promulgated under the
Securities Act or Exchange Act or state or federal law applicable to such Holder and relating to
action or inaction
- 13 -
required of such Holder in connection with any such Registration, qualification
or compliance; and will reimburse the Company, such Holders, such directors, officers, partners,
persons, underwriters or control persons for any legal and any other expenses reasonably incurred
in connection with investigating or defending any such claim, loss, damage, liability or action, in
each case to the extent, but only to the extent, that such untrue statement (or alleged untrue
statement) or omission (or alleged omission) is made in such Registration Statement, prospectus,
offering circular or other document in reliance upon and in conformity with written information
furnished to the Company by such Holder and stated to be specifically for use in connection with
the offering of securities of the Company; provided, however, that each Holders liability under
this Section 3.6.2 shall be several, and not joint with other Holders, and shall not exceed such
Holders net proceeds from the offering of securities made in connection with such Registration,
except in the case of willful fraud by such holder.
3.6.3. Indemnification Procedure. Promptly after receipt by an indemnified party
under this Section 3.6 of notice of the commencement of any action, such indemnified party will, if
a claim in respect thereof is to be made against an indemnifying party under this Section 3.6,
notify the indemnifying party in writing of the commencement thereof and generally summarize such
action. The indemnifying party shall have the right to participate in and to assume the defense of
such claim; provided, however, that the indemnifying party shall be entitled to select counsel for
the defense of such claim with the approval of any parties entitled to indemnification, which
approval shall not be unreasonably withheld; provided further, however, that if either party
reasonably determines that there may be a conflict between the position of the
indemnifying party and the indemnified party in conducting the defense of such action, suit or
proceeding by reason of recognized claims for indemnity under this Section 3.6, then counsel for
such party shall be entitled to conduct the defense to the extent reasonably determined by such
counsel to be necessary to protect the interest of such party. The failure to notify an
indemnifying party promptly of the commencement of any such action, if prejudicial to the ability
of the indemnifying party to defend such action, shall relieve such indemnifying party, to the
extent so prejudiced, of any liability to the indemnified party under this Section 3.6, but the
omission so to notify the indemnifying party will not relieve such party of any liability that such
party may have to any indemnified party otherwise other than under this Section 3.6.
3.6.4. Contribution. If the indemnification provided for in this Section 3.6 is held
by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any
loss, liability, claim, damage or expense referred to therein, then the indemnifying party, in lieu
of indemnifying such indemnified party hereunder, shall contribute to the amount paid or payable by
such indemnified party as a result of such loss, liability, claim, damage or expense in such
proportion as is appropriate to reflect the relative fault of the indemnifying party on the one
hand and of the indemnified party on the other in connection with the statements or omissions that
resulted in such loss, liability, claim, damage or expense as well as any other relevant equitable
considerations. The relative fault of the indemnifying party and of the indemnified party shall be
determined by reference to, among other things, whether the untrue or alleged untrue statement of a
material fact or the omission to state a material fact relates to information supplied by the
indemnifying party or by the indemnified party and the parties relative intent, knowledge, access
to information and opportunity to correct or prevent such statement or omission.
3.6.5. Underwriting Agreement. Notwithstanding the foregoing, to the extent that the
provisions on indemnification and contribution contained in the underwriting agreement entered into
in connection with the underwritten public offering are in conflict with the foregoing provisions,
the provisions in the underwriting agreement shall control.
3.6.6. Survival. The obligations of the Company and Holders under this Section 3.6
shall survive the completion of any offering of Registrable Securities in a registration statement
under this Section 3, and otherwise. No indemnifying party, in defense of any claim of litigation
set forth under this
- 14 -
Section 3.6, shall, except with the consent of each indemnified party, consent
to entry of any judgment or enter into any settlement that does not include as an unconditional
term thereof the giving by the claimant or plaintiff to such indemnified party of a release from
all liability in respect to such claim or litigation.
3.7 Limitations on Registration Rights Granted to Other Securities. From and after
the date of this Agreement, the Company shall not enter into any other agreement with any holder or
prospective holder of any securities of the Company providing for the granting to such holder of
any Registration rights, except that, with the consent of the Holders of sixty-seven percent (67%)
of the Convertible Securities then outstanding, additional holders may be added as parties to this
Agreement with regard to any or all securities of the Company held by them. Any such additional
parties shall execute a counterpart of this Agreement, and upon execution by such additional
parties and by the Company, shall be considered an Investor for all purposes of this Agreement.
The additional parties and the additional Registrable Securities shall be identified in an
amendment to Schedule A hereto.
3.8 Transfer of Rights. The right to cause the Company to Register securities granted
by the Company to the Investors under Sections 3.1 and 3.2 may be assigned by any Holder to a
transferee or assignee of any Convertible Securities not sold to the public acquiring at least One
Hundred Fifty Thousand (150,000) shares of such Holders Convertible Securities (equitably adjusted
for all stock splits, subdivisions, stock dividends, combinations and the like with respect to such
shares); provided, however, that the Company must receive written notice prior to the time of said
transfer, stating the name and address of said transferee or assignee and identifying the
securities with respect to which such rights are being assigned. Notwithstanding the limitation
set forth in the foregoing sentence respecting the minimum number of shares which must be
transferred, (a) any Holder which is a partnership may transfer such Holders rights to such
Holders constituent partners, limited partners, retired partners (including spouses, ancestors,
lineal descendants and siblings of such partners or spouses who acquire Convertible Securities or
Registrable Securities by gift, will or intestate succession), (b) any Holder which is a limited
liability company may transfer such Holders rights to such Holders constituent members or retired
members (including spouses, ancestors, lineal descendants and siblings of such members or spouses
who acquire Convertible Securities or Registrable Securities by gift, will or intestate
succession), (c) any Holder which is a natural person may transfer such Holders rights to any
immediate family member, niece or nephew or to any trust created for the benefit of such Holder or
his or her immediate family members, nieces or nephews, (d) any Holder may transfer such Holders
rights to an Affiliate, subject in each case to such transferees agreeing to be bound by the
rights and restrictions of this Agreement, and (e) any Holder may transfer such Holders rights to
any other Holder who has the right to cause the Company to Register securities granted by the
Company to the Investors under Sections 3.1 and 3.2. The rights under Sections 4 and 5 may be
assigned by an Investor only as provided in such Sections.
3.9 Market Stand-off. If requested in writing by the underwriters for the initial
public offering of the Companys Common Stock, each holder of Registrable Securities who is a party
to this Agreement shall agree not to sell publicly any shares of Registrable Securities or any
other securities of the Company (other than shares of Registrable Securities or other securities of
the Company being registered in such offering), without the consent of such underwriters, for a
period of not more than one hundred eighty (180 days) following the effective date of the
registration statement relating to such offering; provided, however that all executive officers and
directors of the Company and holders of at least one percent (1%) of the Companys voting
securities shall also have agreed not to sell publicly their Common Stock under the circumstances
and pursuant to the terms set forth in this section. Each Holder agrees to execute and deliver
such other agreements as may be reasonably requested by the Company, or the Companys underwriters,
which are consistent with the foregoing, or which are reasonably necessary to give further effect
thereto. In order to enforce the covenants of this Section 3.9, the Company shall have the right
to place restrictive legends on the certificates representing the securities of each Holder and may
impose stop-transfer instructions with respect to such securities.
- 15 -
3.10 No-Action Letter or Opinion of Counsel in Lieu of Registration; Conversion of
Convertible Securities. Notwithstanding anything else in this Agreement, if the Company shall
have obtained from the Commission a no-action letter in which the Commission has indicated that
it will take no action if, without Registration under the Securities Act, any Holder disposes of
Registrable Securities
covered by any request for Registration made under this Agreement in the specific manner in
which such Holder proposes to dispose of the Registrable Securities included in such request (such
as including, without limitation, the inclusion of such Registrable Securities in an underwriting
initiated by either the Company or the Holders), or if in the opinion of counsel for the Company
concurred in by counsel for such Holder, which concurrence shall not be unreasonably withheld, no
Registration under the Securities Act is required in connection with such disposition, the shares
included in such request shall not be eligible for Registration under this Agreement; provided,
however, that any Registrable Securities not so disposed of shall be eligible for Registration in
accordance with the terms of this Agreement with respect to other proposed dispositions to which
this Section 3.10 does not apply. The Registration rights of the Holders of Convertible Securities
set forth in this Agreement are conditioned upon the conversion of the Convertible Securities with
respect to which Registration is sought into Common Stock prior to the effective date of the
Registration Statement.
3.11 Rule 144 Requirements. Immediately after the date on which a Registration
Statement filed by the Company under the Securities Act becomes effective, the Company shall
undertake to make publicly available, and available to the Holders of Registrable Securities, such
information as is necessary to enable the holders of Registrable Securities to make sales of
Registrable Securities pursuant to Rule 144 of the Commission under the Securities Act. The
Company shall furnish to any holder of Registrable Securities, upon request, a written statement
executed by the Company as to the steps it has taken to comply with the current public information
requirements of Rule 144.
3.12 Reports Under Securities Exchange Act of 1934. With a view to making available
to the Investors the benefits of Rule 144 and any other rule or regulation of the Commission that
may at any time permit an Investor to sell securities of the Company to the public without
registration or pursuant to a registration on Form S-3, the Company agrees to use its commercially
reasonable efforts to:
(a) make and keep public information available, as those terms are defined in Rule 144, at all
times after ninety (90) days after the effective date of the first registration statement filed by
the Company for the offering of its securities to the general public; file with the Commission in a
timely manner all reports and other documents required of the Company under the Securities Act and
the Exchange Act; and
(b) furnish to any Investor, so long as such Investor owns any Registrable Securities or
Convertible Securities, forthwith upon request (i) a written statement by the Company that it has
complied with the reporting requirements of Rule 144 (at any time after ninety (90) days after the
effective date of the first registration statement filed by the Company), the Securities Act and
the Exchange Act (at any time after it has become subject to such reporting requirements), or that
it qualifies as a registrant whose securities may be resold pursuant to Form S-3 (at any time after
it so qualifies), (ii) a copy of the most recent annual or quarterly report of the Company and such
other reports and documents so filed by the Company, and (iii) such other information as may be
reasonably requested in availing any Investor of any rule or regulation of the Commission which
permits the selling of any such securities without registration or pursuant to such plan.
3.13 Termination of Company Agreements. The Registration rights set forth in Sections
3.1 and 3.2 shall terminate seven (7) years after the effective date of the Companys Registration
Statement filed in connection with the Companys first Qualified Public Offering or, as to any
Holder, at any time following the effective date of the Companys first Qualified Public Offering,
when such Holder is
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entitled to sell all of such Investors
Registrable Securities pursuant to Rule 144 (including Rule 144(k)) of the Commission under
the Securities Act.
SECTION 4. RIGHT OF FIRST OFFER
4.1 Right of First Offer. Subject to Section 4.4 hereof, the Company hereby grants to
each Investor the right of first refusal (the Right of First Offer) to purchase such Investors
pro rata share of New Securities (as defined in Section 4.2) which the Company may from time to
time propose to sell and issue. For purposes of the Right of First Offer an Investors pro rata
share (the Pro Rata Share) shall be determined as follows: an Investors Pro Rata Share shall be
equal to that number or amount of New Securities to be sold multiplied by a fraction, the numerator
of which shall be the number of shares of Common Stock owned by such Investor (including shares of
Common Stock issuable upon the full exercise and conversion of all convertible or exercisable
securities owned by such Investor) and the denominator of which shall be the total number of shares
of the Companys Common Stock deemed to be outstanding assuming the conversion of all outstanding
convertible securities and the exercise of all outstanding options and warrants. Notwithstanding
the foregoing, any Investor that elects to purchase all of its respective Pro Rata Share (a
Fully-Exercising Investor) may, at the time it accepts the Companys offer, subscribe to purchase
any or all of the securities offered (Oversubscription Securities) which may be available as a
result of the rejection, or partial rejection, of the offer by other Investors. All such
Oversubscription Securities shall be allocated among each Fully-Exercising Investor subscribing to
purchase them in a proportion equal to that number of shares of Common Stock owned by such
Fully-Participating Investor (including shares of Common Stock issuable upon the full exercise and
conversion of all convertible or exercisable securities owned by such Fully-Participating Investor)
bears to the total number of shares of Common Stock (including shares of Common Stock issuable upon
the full exercise and conversion of all convertible or exercisable securities) held by all
Fully-Exercising Investors who elected to purchase some of the Oversubscribed Securities.
Notwithstanding the foregoing, the Company shall not be required to offer or sell such New
Securities to any Investor who would cause the Company to be in violation of applicable federal
securities laws by virtue of such offer or sale. The Right of First Offer shall be subject to the
provisions of this Section 4.
4.2 Definition of New Securities. New Securities shall mean any shares of Common
Stock or Preferred Stock of the Company, whether now authorized or not, and rights, options, or
warrants to purchase such shares of Common Stock or Preferred Stock, and all other securities
having equity features, such as convertible notes or notes issued in conjunction with options or
warrants; provided that New Securities shall not include:
(a) Securities issued pursuant to the Purchase Agreement;
(b) securities issued upon the conversion of any shares of the Convertible Securities;
(c) securities issued to the Companys employees, officers, directors, advisors, outside
consultants or contractors pursuant to a plan, agreement or arrangement duly approved by the Board;
(d) securities issued or issuable pursuant to the exercise of options, warrants or convertible
securities outstanding as of the date hereof;
(e) securities issued in connection with obtaining equipment lease financing, credit
agreements, debt financing and other similar transactions, whether issued to a lessor, guarantor or
other Person, provided that such issuance is pursuant to an agreement or arrangement duly approved
by the Board, and provided, further, that such issuance shall not be primarily for general capital
raising purposes;
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(f) securities issued to effect any stock split, stock dividend or recapitalization or like
transactions of the Company;
(g) securities issued in connection with the acquisition of all or a substantial portion of
the assets or the business of another entity by the Company, provided that such issuance is
pursuant to an agreement or arrangement duly approved by the Board;
(h) securities issued in connection with a research and development partnership, corporate
partnering transaction, licensing or collaborative arrangements, strategic alliance, technology
acquisition or transfer, or similar transaction, provided that such issuance is pursuant to an
agreement or arrangement duly approved by the Board; and
(i) securities issued pursuant to a Qualified Public Offering.
4.3 Notices. In the event the Company proposes to undertake an issuance of New
Securities, it shall give each Investor written notice (the Notice) of its intention, describing
the type of New Securities, the price, and the principal terms upon which the Company proposes to
issue the same. Each Investor shall have twenty (20) days from the delivery of the Notice to agree
to purchase up to such Investors Pro Rata Share plus, in the event of a Fully-Participating
Investor, any Oversubscription Securities, for the price and upon the terms specified in the Notice
by giving written notice to the Company and stating therein the quantity of New Securities and
Oversubscription Securities to be purchased.
4.4 Failure to Exercise Right. Unless (i) Investors holding at least 60% of the then
outstanding shares of Series A-3 Preferred Stock deem otherwise (by vote or by action by written
consent) or (ii) the Company requests in writing a lesser investment commitment of such holders, at
any time or from time to time following the date of the issuance of shares of Series A-3 Preferred
Stock in the Closing (as defined in the Purchase Agreement), if (A) any Investor holding an
aggregate of at least One Million Seven Hundred Thousand (1,700,000) shares of Series A-3 Preferred
Stock (as adjusted for all stock splits, stock dividends, consolidations, recapitalizations and
reorganizations with respect to such shares) (a Significant Holder) is entitled to exercise the
Right of First Offer provided in this Section 4, (B) the Company has complied with its obligations
under this Section 4 with respect to the Right of First Offer, and (C) such Significant Holder does
not by exercise of such Significant Holders Right of First Offer to acquire at least its Minimum
Share (as defined below) of New Securities (a Non-Participating Holder), then, effective
immediately prior to the issuance of such New Securities each Non-Participating Holder shall lose
its Right of First Offer for all subsequent issuances of New Securities which would otherwise
trigger the Right of First Offer pursuant to this Section 4. Each Significant Holders Minimum
Share of the New Securities shall be a number of shares equal to (X) the product of (i) 0.5
multiplied by (ii) (A) sixty percent (60%) of the aggregate original purchase price paid by such
Significant Holder for the shares of Series A-3 Preferred Stock held by such Significant Holder,
divided by (Y) the per share price of the New Securities, rounded down to a whole number.
Notwithstanding anything contained in this Agreement to the contrary, this Section 4.4 may not be
amended or modified in a manner that adversely affects the
rights or otherwise increases the obligations of a Significant Holder to purchase New
Securities without the written consent of such Significant Holder.
4.5 Company Right to Offer New Securities. In the event an Investor does not elect to
purchase all of such Investors Pro Rata Share of the New Securities pursuant to Section 4.1 and
such New Securities are not purchased by other Fully-Participating Investors, the Company shall
have ninety (90) days after the last date on which any Investors right to purchase lapsed to sell
or enter into an agreement (pursuant to which the sale of New Securities covered thereby shall be
closed, if at all, within ninety (90) days from the date of said agreement) to sell the New
Securities respecting which such
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Investors option was not exercised, at or above the price and
upon terms not materially more favorable to the purchasers of such securities than the terms
specified in the initial Notice given in connection with such sale. In the event the Company has
not sold the New Securities within said 90-day period (or sold and issued New Securities in
accordance with the foregoing within ninety (90) days from the date of said agreement), the Company
shall not thereafter issue or sell any New Securities without first offering such New Securities to
the Investors in the manner provided in this Section 4.
4.6 Rights of Affiliated Investors. For the purposes of this Section 4, Investors who
are Affiliates of one or more other Investors shall, at the election of an Investor and one or more
such Affiliates, be treated as a group (an Investor Group). Members of an Investor Group shall
have the right to reallocate the rights granted by this Section 4 among themselves as they
determine.
4.7 Assignment. The Right of First Offer set forth in this Section 4 may not be
assigned or transferred, except that each Investor shall have the right to assign its right to
purchase securities under this Section 4 to any Affiliate of such Investor; provided such Affiliate
agrees in writing with the Company and the Investor, prior to and as a condition precedent to such
transfer, to be bound by all the provisions of Sections 3.9, 4, 5 and 6 of this Agreement.
4.8 Termination. The Right of First Offer granted under this Section 4 shall not
apply to, and shall terminate on and be of no further force or effect upon the earlier of (a) the
effective date of the Companys Registration Statement filed in connection with the Companys first
Qualified Public Offering and (b) the date of the closing of a sale, lease, or other disposition of
all or substantially all of the Companys assets or the Companys merger into or consolidation with
any other corporation or other entity, or any other corporate reorganization, in which the holders
of the Companys outstanding voting stock immediately prior to such transaction own, immediately
after such transaction, securities representing less than fifty percent (50%) of the voting power
of the corporation or other entity surviving such transaction, provided that this Section 4.8 shall
not apply to a merger effected exclusively for the purpose of changing the domicile of the Company
or a sale of shares by the Company for primarily equity financing purposes.
SECTION 5. TRANSFERS OF SECURITIES BY INVESTORS.
5.1 Notices. If any Investor (the Transferor) proposes to sell, assign, hypothecate
or otherwise transfer (a Transfer) any securities of the Company owned by such Investor from and
after the date of
this Agreement, other than pursuant to the provisions of Section 5.6 of this Agreement, the
Transferor shall first give each of the other Investors the right to purchase such securities by
delivering to them a written offer which shall state the price and other terms and conditions of
the proposed Transfer. If the Transferor proposes to Transfer the securities for consideration
other than solely cash and/or promissory notes, the offer to the Investors shall, to the extent of
such consideration, permit each Investor to pay in lieu thereof, cash equal to the fair market
value of such consideration, and the offer shall state the estimate of such fair market value as
determined by the Board. The Transferor shall fix the period of the offer which shall be a minimum
of thirty (30) days or such longer period as is necessary to determine the fair market value of the
consideration referred to in the preceding sentence.
5.2 Acceptance of Offer. An Investor may accept an offer (Purchasing Investor) only
by giving written notice to the Transferor before the offer expires that such Purchasing Investor
has accepted the offer to purchase some or all of the securities offered (the Accepted
Securities); provided, however, that the maximum number or amount of securities a Purchasing
Investor shall be entitled to purchase shall be equal to that number or amount of securities to be
transferred multiplied by a fraction, the numerator of which shall be the number of shares of
Common Stock owned by such Purchasing Investor (including shares of Common Stock issuable upon the
full exercise and conversion of all convertible or exercisable
- 19 -
securities owned by such Investor)
and the denominator of which shall be the aggregate number of shares of Common Stock held by all
Investors (including shares of Common Stock issuable upon the full exercise and conversion of all
convertible or exercisable securities owned by all Investors), excluding the Transferors shares of
Common Stock. Notwithstanding the foregoing, any Purchasing Investor may, at the time it accepts
the offer, subscribe to purchase any or all securities offered which may be available as a result
of the rejection, or partial rejection, of the offer by other Investors, which securities shall be
allocated on a pro rata basis among those Purchasing Investors subscribing to purchase them.
5.3 Allocation of Securities and Payment. Promptly following the expiration of an
offer, the Transferor shall allocate the securities subscribed for among the Purchasing Investors
accepting or partially accepting the offer, pro rata, based upon their respective holdings as
aforesaid, and shall by written notice (the Acceptance Notice) advise all Purchasing Investors of
the number or amount of securities allocated to each of the Purchasing Investors. Within ten (10)
days following receipt of the Acceptance Notice, each of the Purchasing Investors shall deliver to
the Transferor payment in full for the Accepted Shares purchased by it against delivery by the
Transferor to each Purchasing Investor of a certificate or certificates evidencing the Accepted
Securities purchased by it.
5.4 Failure to Exercise. To the extent an offer pursuant to Section 5.1 is not
accepted by the other Investors, the Transferor may, for a period of ninety (90) days thereafter,
transfer the unaccepted securities, or any of them, at or above the price, and upon the other terms
and conditions specified in such offer, to any Person or Persons; provided that such Person or
Persons agrees in writing with the Company and the Investors, prior to and as a condition precedent
to such Transfer, to be bound by all of the provisions of Sections 3.9, 5 and 6 of this Agreement.
5.5 Assignment. The right of first refusal set forth in this Section 5 may not be
assigned or transferred, except that each Investor shall have the right to assign its rights to
purchase such securities under this
Section 5 to any Affiliate of such Investor; provided such Affiliate agrees in writing with
the Company and the Investors, prior to and as a condition precedent to such assignment, to be
bound by all of the provisions of Sections 3.9, 5 and 6 of this Agreement.
5.6 Permitted Transfers.
(a) Notwithstanding anything to the contrary contained herein, any Investor which is a
partnership or limited liability company may transfer, without first offering any securities of the
Company to any other Investor, all or any of its securities to any of its Affiliates or successor
funds or to a partner, limited partner, member or retired partner of such partnership or retired
member of such limited liability company or to the estate of any such partner or transfer by will
or intestate succession to his spouse or to the siblings, lineal descendants or ancestors of such
partner or his spouse; provided such transferee agrees in writing with the Company and the
Investors, prior to and as a condition precedent to such Transfer, to be bound by all of the
provisions of Sections 3.9, 5 and 6 of this Agreement.
(b) Notwithstanding anything to the contrary contained herein, any Investor which is a
corporation may Transfer, without first offering any securities of the Company to any other
Investor, all or any of its securities to any of its Affiliates, provided such Affiliate agrees in
writing with the Company and the Investors, prior to and as a condition precedent to such Transfer,
to be bound by all of the provisions of Sections 3.9, 5 and 6 of this Agreement.
(c) Notwithstanding anything to the contrary contained herein, any Investor who is an
individual may Transfer, without first offering any securities of the Company to any other
Investor, all or any of his or her securities to his or her spouse or their spouses siblings,
lineal descendants or ancestors, nieces or nephews, or any entity that is an Affiliate of such
Investor; provided such transferee
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agrees in writing with the Company and the Investors, prior to
and as a condition precedent to such Transfer, to be bound by all of the provisions of Sections
3.9, 5 and 6 of this Agreement.
5.7 Termination. The right of first refusal granted under this Section 5 shall expire
upon the effective date of the Companys registration statement filed in connection with the
Companys first Qualified Public Offering and shall not be applicable to any shares sold pursuant
thereto.
SECTION 6. MISCELLANEOUS.
6.1 Entire Agreement; Successors and Assigns. This Agreement constitutes the entire
contract between the Company and the Investors relative to the subject matter hereof. Any previous
agreement between the Company, the Investors and the Holders concerning Registration rights and the
other matters set forth herein is superseded by this Agreement. Subject to the exceptions
specifically set forth in this Agreement, the terms and conditions of this Agreement shall inure to
the benefit of and be binding upon the respective executors, administrators, heirs, successors and
assigns of the parties.
6.2 Aggregation of Stock. All Convertible Securities and Registrable Securities held
or acquired by affiliated entities or persons shall be aggregate together for the purpose of
determining the availability of any rights under this Agreement.
6.3 Governing Law. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE
WITH THE LAWS OF THE STATE OF CALIFORNIA APPLICABLE TO CONTRACTS ENTERED INTO AND WHOLLY TO BE
PERFORMED WITHIN THE STATE OF CALIFORNIA BY CALIFORNIA RESIDENTS.
6.4 Counterparts. This Agreement may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the
same instrument.
6.5 Headings. The headings of the Sections of this Agreement are for convenience and
shall not by themselves determine the interpretation of this Agreement.
6.6 Notices. Any notice required or permitted hereunder shall be given in writing and
shall be conclusively deemed effectively given upon personal delivery, or five (5) days after
deposit in the United States mail, by registered or certified mail (or airmail, if notice shall be
sent outside the United States), postage prepaid, or two (2) days after delivery to a nationally
known air courier company, addressed (a) if to the Company, to the Companys address as set forth
below the Companys name on the signature page of this Agreement and (b) if to an Investor, to such
Investors address as set forth on the signature page of this Agreement, or at such other address
as the Company or such Investor may designate by ten (10) days, advance written notice to the other
parties hereto. Any notice sent outside the United States shall also be telexed or telecopied.
6.7 Amendment of Agreement; Waivers. Subject to Section 3.7 and Section 4.4, any
provision of this Agreement may be amended or waived by a written instrument signed by the Company
and by Persons holding at least 60% of the Convertible Securities issued or issuable upon
conversion of the Series A-3 Preferred Stock provided, however, if such amendment would adversely
affect the rights of a specific Investor in a manner different from the other Investors, then such
amendment shall require the consent of such Investor. Any amendment or waiver effected in
accordance with Section 3.7 or this Section 6.7 shall be binding upon the Company and all Holders
and each of their respective successors and assigns. In addition, the Company may waive performance
of any obligation owing to it, as to some or all of the Investors, or agree to accept alternatives
to such performance, without obtaining the consent of any Investor.
- 21 -
6.8 Effect of Amendment or Waiver. The Investors and their successors and
assigns acknowledge that by the operation of Section 6.7 hereof Investors holding at least sixty
percent (60%) of the Convertible Securities issued or issuable upon conversion of the Series A-3
Preferred Stock, acting in conjunction with the Company, will have the right and power to diminish
or eliminate any or all rights pursuant to this Agreement.
6.9 Waiver of Right of First Offer. Upon execution of this Agreement by the Company and Persons holding at least a
majority of the Convertible Securities under the Prior Agreement, all provisions of, rights granted
and covenants made in the Prior Agreement (including, without limitation, the rights of first offer
set forth in Section 4 of the Prior Agreement) are hereby waived, released and terminated in their
entirety and shall have no further force and effect (including, without limitation, with respect to
the Series A-3 Preferred Stock issued pursuant to the Purchase Agreement and the shares issued upon
conversion thereof).
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date
first above written.
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COMPANY: |
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CADENCE PHARMACEUTICALS, INC. |
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By: |
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/s/ Theodore R. Schroeder |
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Name:
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Theodore R. Schroeder |
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Title:
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President and Chief Executive Officer |
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Address:
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12730 High Bluff Drive, Suite 410 |
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San Diego, California 92130 |
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Fax No.: (858) 436-1401 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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FRAZIER HEALTHCARE V, LP |
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By FHM V, LP, its general partner |
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By FHM V, LLC, its general partner |
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By |
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/s/ Patrick Heron |
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Patrick Heron, Authorized Representative |
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Address:
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601 Union Steet, Suite 3200
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Seattle, WA 98101 |
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Phone No.: (206) 621-7200 |
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Fax No.: (206) 621-1848 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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Versant Side Fund II, L.P. |
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By:
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Versant Ventures II, L.L.C. |
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Its:
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General Partner |
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By: |
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/s/ Brian G. Atwood |
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Name:
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Brian G. Atwood |
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Title:
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Managing Director |
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Versant Venture Capital II, L.P. |
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By:
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Versant Ventures II, L.L.C. |
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Its:
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General Partner |
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By: |
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/s/ Brian G. Atwood |
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Name:
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Brian G. Atwood |
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Title:
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Managing Director |
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Versant Affiliates Fund II-A, L.P. |
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By:
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Versant Ventures II, L.L.C. |
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Its:
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General Partner |
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By: |
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/s/ Brian G. Atwood |
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Name:
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Brian G. Atwood |
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Title:
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Managing Director |
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Address:
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3000 Sand Hill Road, Bldg 4, Suite 210
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Menlo Park, CA 94025 |
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Phone No.: (650) 233-7877 |
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Fax No.: (650) 854-9513 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and
year first above written.
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INVESTOR: |
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TECHNOLOGY PARTNERS FUND VII, L.P. |
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By:
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TP MANAGEMENT VII, L.L.C. |
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By: |
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/s/ Sheila Mutter |
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Managing Member |
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TECHNOLOGY PARTNERS AFFILIATES VII, L.P. |
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By:
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TP MANAGEMENT VII, L.L.C. |
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By: |
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/s/ Sheila Mutter |
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Managing Member |
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Address:
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100 Shoreline Hwy, Suite 282, Building B
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Mill Valley, CA 94941 |
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Phone No.: (415) 332-9999 |
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Fax No.: (415) 332-9998 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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ABBOTT INVESTMENT COMPANY, LLC |
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By: |
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/s/ James C. Gilstrap |
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Name: |
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James C. Gilstrap |
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President |
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Address:
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5067 Shore Drive
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Carlsbad, CA 92008 |
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Fax No.: (858) 756-9518 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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DOMAIN PARTNERS VI, L.P. |
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By: |
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One Palmer Square Associates VI, L.L.C., its
General Partner |
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By: |
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/s/ Kathleen K. Schoemaker |
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Name: Kathleen K. Schoemaker |
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Title: Managing Member |
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Address:
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Domain Associates, L.L.C.
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One Palmer Square |
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Princeton, New Jersey 08542 |
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Attn: Kathleen K. Schoemaker |
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Fax No.: (609) 683-9789 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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DP VI ASSOCIATES, L.P. |
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By: |
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One Palmer Square Associates VI, L.L.C., its
General Partner |
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By: |
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/s/ Kathleen K. Schoemaker |
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Name:
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Kathleen K. Schoemaker |
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Title:
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Managing Member |
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Address:
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Domain Associates, L.L.C.
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One Palmer Square |
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Princeton, New Jersey 08542 |
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Attn: Kathleen K. Schoemaker |
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Fax No.: (609) 683-9789 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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PROQUEST INVESTMENTS III, L.P. |
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By: |
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ProQuest Associates III LLC, its General Partner |
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By: |
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/s/ Pasquale DeAngelis |
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Name:
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Pasquale DeAngelis |
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Title:
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Managing Member |
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Address:
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90 Nassau Street, 5th Floor
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Princeton, New Jersey 08540 |
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Fax No.: (609) 375-1047 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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WINDAMERE III, LLC |
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By: |
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/s/ Scott L. Glenn |
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Name:
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Scott L. Glenn |
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Title:
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Managing Member |
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Address:
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c/o Windamere Venture Partners L.L.C.
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6402 Cardeno Drive |
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La Jolla, California 92037 |
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Fax No.: (858) 456-2295 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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GARNER INVESTMENTS, L.L.C. |
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By: |
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/s/ Cam L. Garner |
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Name:
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Cam L. Garner |
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Title:
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President |
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Address:
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P.O. Box 675866 |
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5949 Greensview Court |
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Rancho Santa Fe, California 92067 |
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Fax No.: (858) 756-9518 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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HALE FAMILY TRUST UDT 2/10/86, David F. and Linda C.
Hale, Trustees |
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By: |
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/s/ David F. Hale |
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Name:
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David F. Hale |
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Title:
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Trustee |
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Address:
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2110 Rutherford Road
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Carlsbad, California 92008 |
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Fax No.: (760) 431-7917 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
day and year first above written.
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INVESTOR: |
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By: |
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/s/ Cam S. Gallagher |
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Name:
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Cam Stephen Gallagher |
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Address:
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3888 Quarter Mile Drive
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San Diego, California 92130 |
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Fax No.: (858) 436-1601 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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JAMES C. GILSTRAP IRA |
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By: |
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/s/ James C. Gilstrap |
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Name:
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James C. Gilstrap |
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Address:
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5067 Shore Drive
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Carlsbad, California 92008 |
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Fax No.: (760) 431-2424 |
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Copy to:
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Daniel J. Gatto, CPA |
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Gatto & Pope |
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550 West C Street, #1700 |
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San Diego, California 92101 |
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Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and
year first above written.
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INVESTOR: |
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JAMES C. GILSTRAP TRUST DATED 1/16/95 |
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By: |
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/s/ James C. Gilstrap |
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Name: James C. Gilstrap, Trustee |
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Address: |
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5067 Shore Drive |
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Carlsbad, California 92008 |
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Fax No.: (760) 431-2424 |
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Copy to: |
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Daniel J. Gatto, CPA |
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Gatto & Pope |
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550 West C Street, #1700 |
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San Diego, California 92101 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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WALTERS GROUP GENERAL PARTNERSHIP |
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By: |
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/s/ Michael E. Luce |
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Name: Michael E. Luce |
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Title: President |
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Address: |
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5500 East Flamingo Road |
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Las Vegas, Nevada 89122 |
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Fax No.: (702) 450-8055 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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GRAHAM CAPITAL GROUP, LLC |
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By: |
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/s/ John Graham |
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Name: John Graham |
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Title: Manager |
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Address: |
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1505 Westlake Avenue N., Suite 320 |
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Seattle, Washington 98109 |
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Fax No.: (206) 284-4061 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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GRAHAM PACIFIC, INC. |
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By: |
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/s/ Ron Graham |
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Name: Ron Graham |
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Title: President |
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Address: |
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1505 Westlake Avenue N., Suite 320 |
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Seattle, Washington 98109 |
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Fax No.: (206) 284-4061 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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STEVEN A. LYMAN TRUST II, dated 8/27/90 |
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By: |
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/s/ Steven A. Lyman |
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Name: Steven A. Lyman |
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Title: Trustee |
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Address: |
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P.O. Box 676046 |
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Ranch Santa Fe, California 92067 |
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Fax No.: (858) 756-7465 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and
year first above written.
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INVESTOR: |
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BB BIOTECH VENTURES II, L.P. |
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By: |
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Its General Partner, BB
BIOTECH VENTURES GP (Guernsey) Limited |
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By: |
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/s/ Christopher Cochrane |
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Name: Christopher Cochrane |
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Title: Director |
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Address: |
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Trafalgar Court |
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Les Banques |
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St Peter Port |
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Guernsey |
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Channel Islands |
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GY1 3QL |
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Contact :C W Cochrane/P Mahieux |
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Fax 00 44 1481 745074 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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CDIB BIOSCIENCE VENTURES I, INC. |
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By: |
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/s/ Benny Hu |
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Name: Benny Hu |
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Title: Chairman |
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Address: |
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c/o CDIB BioScience Venture Management |
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9F-1, No. 205, Sec 3, Beisin Road |
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Sindian City, Taipei County 231, Taiwan |
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Attn: Karen Huang |
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Phone No.: 886-02-8913-1956 |
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Fax Nos.: 886-02-8913-1955 / 886-02-8913- 1726 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and
year first above written.
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INVESTOR: |
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EPSTEIN FAMILY TRUST DATED 4/14/93 |
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By: |
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/s/ Dan Epstein |
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Name: Dan Epstein |
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Title: Trustee |
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Address: |
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c/o Con Am |
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3990 Ruffin Road, Suite 100 |
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San Diego, California 92123 |
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Fax No.: (858) 614-1874 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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By: |
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/s/ J. Bradley Forrester |
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Name: J. Bradley Forrester |
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Address: |
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c/o Con Am |
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3990 Ruffin Road, Suite 100 |
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San Diego, California 92123 |
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Fax No.: (858) 614-1874 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day
and year first above written.
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INVESTOR: |
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STEPHEN F. GALLAGHER, TRUSTEE WITH |
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FIRST NATIONAL BANK, N.A., AS SUCCESSOR |
|
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TRUSTEE U/A DATED MARCH 21, 2005 AS MAY |
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BE AMENDED |
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By: |
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/s/ Stephen F. Gallagher |
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Name: Stephen F. Gallagher |
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Title: Trustee |
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Address:
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3015 Fleming Road |
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Middletown, Ohio 45042 |
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|
Phone No.: (513) 423-1064 |
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Fax No.: (513) 422-2609 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day
and year first above written.
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INVESTOR: |
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LYNDA GALLAGHER |
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By: |
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/s/ Lynda Gallagher |
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Lynda Gallagher |
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Address:
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3015 Fleming Road |
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Middletown, Ohio 45042 |
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Phone No.: (513) 423-1064 |
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Fax No.: (513) 422-2609 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and
year first above written.
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INVESTOR: |
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VP COMPANY INVESTMENTS 2004, LLC |
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By: |
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/s/ David Raab |
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Name: David Raab |
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Title: Member of Management Committee |
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Address:
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555 W. Fifth Street, Suite 800 |
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Los Angeles, California 90013-1010 |
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|
|
Attention: Grant Johnson |
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|
|
Fax No.: (213) 891-7123 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
|
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INVESTOR: |
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FAYE HUNTER RUSSELL TRUST UTD 7/11/88 |
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By: |
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/s/ Faye H. Russell |
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Name: Faye H. Russell |
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Title: Trustee |
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Address:
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|
c/o Latham & Watkins LLP |
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|
12636 High Bluff Drive, Suite 400 |
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|
San Diego, California 92130 |
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|
|
Fax No.: (858) 523-5450 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
|
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|
|
INVESTOR: |
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|
|
/s/ Scott N. Wolfe |
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Scott N. Wolfe |
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Address:
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c/o Latham & Watkins LLP |
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12636 High Bluff Drive, Suite 400 |
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San Diego, California 92130 |
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Fax No.: (858) 523-5450 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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/s/ Cheston J. Larson |
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Cheston J. Larson |
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Address:
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c/o Latham & Watkins LLP |
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12636 High Bluff Drive, Suite 400 |
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San Diego, California 92130 |
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Fax No.: (858) 523-5450 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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/s/ Adam K. Simpson |
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Adam K. Simpson |
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Address:
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c/o Verus Pharmaceuticals, Inc. |
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12671 High Bluff Drive, Ste 200 |
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San Diego, California 92130 |
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Fax No.: (858) 436-1601 |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first above written.
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INVESTOR: |
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Print Name: |
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Signature: |
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Title: |
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(if signing on behalf of a partnership, corporation, trust
Or other entity) |
Cadence Pharmaceuticals, Inc.
Amended and Restated Investor Rights Agreement
Counterpart Signature Page
Schedule A
INVESTORS
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Series A-1 |
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Series A-2 |
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Series A-3 |
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Preferred |
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Preferred |
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Preferred |
Investor |
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Stock |
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Stock |
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Stock |
FRAZIER HEALTHCARE V, LP |
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10,000,000 |
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VERSANT VENTURE CAPITAL II, L.P. |
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|
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7,782,747 |
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VERSANT AFFILIATES FUND II-A, L.P. |
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147,695 |
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VERSANT SIDE FUND II, L.P. |
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69,558 |
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TECHNOLOGY PARTNERS FUND VII, L.P. |
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7,520,000 |
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TECHNOLOGY PARTNERS AFFILIATES VII, L.P. |
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480,000 |
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ABBOTT INVESTMENT COMPANY, LLC |
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400,000 |
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DOMAIN PARTNERS VI, L.P. |
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3,947,061 |
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6,297,638 |
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12,367,456 |
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DP VI ASSOCIATES, L.P. |
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42,301 |
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67,492 |
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132,544 |
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PROQUEST INVESTMENTS III, L.P. |
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2,393,618 |
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3,819,080 |
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6,000,000 |
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WINDAMERE III, LLC |
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531,915 |
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848,684 |
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GARNER INVESTMENTS LLC |
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106,383 |
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100,000 |
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HALE FAMILY TRUST UDT 2/10/86 |
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106,383 |
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50,000 |
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100,000 |
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CAM STEPHEN GALLAGHER |
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106,383 |
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20,000 |
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10,000 |
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JAMES C. GILSTRAP IRA |
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319,149 |
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500,000 |
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JAMES C. GILSTRAP TRUST DATED 1/16/95 |
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1,000,000 |
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WALTERS GROUP GENERAL PARTNERSHIP |
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319,149 |
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500,000 |
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1,400,000 |
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GRAHAM PACIFIC, INC. |
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106,383 |
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87,453 |
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GRAHAM CAPITAL GROUP, LLC |
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100,000 |
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STEVEN A. LYMAN TRUST II, DATED 8/27/90 |
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106,383 |
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150,000 |
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BB BIOTECH VENTURES II, L.P. |
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3,000,000 |
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4,000,000 |
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CDIB BIOSCIENCE VENTURES I, INC. |
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2,000,000 |
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1,800,000 |
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EPSTEIN FAMILY TRUST DATED 4/14/93 |
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250,000 |
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150,000 |
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J. BRADLEY FORRESTER |
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100,000 |
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50,000 |
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STEPHEN F. GALLAGHER, TRUSTEE WITH
FIRST NATIONAL BANK, N.A., AS SUCCESSOR
TRUSTEE U/A DATED MARCH 21, 2005 AS MAY
BE AMENDED |
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85,000 |
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50,000 |
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LYNDA GALLAGHER |
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10,000 |
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VP COMPANY INVESTMENTS 2004, LLC |
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25,000 |
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25,000 |
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Series A-1 |
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Series A-2 |
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Series A-3 |
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Preferred |
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Preferred |
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Preferred |
Investor |
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Stock |
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Stock |
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Stock |
FAYE HUNTER RUSSELL TRUST UTD 7/11/88 |
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10,000 |
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10,000 |
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SCOTT N. WOLFE |
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5,000 |
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5,000 |
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CHESTON J. LARSON |
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5,000 |
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5,000 |
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ADAM K. SIMPSON |
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5,000 |
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5,000 |
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TOTAL |
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8,085,108 |
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17,675,347 |
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53,870,000 |
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exv4w3
Exhibit 4.3
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES
ACT OF 1933, AS AMENDED (THE ACT), OR THE SECURITIES LAWS OF ANY STATE AND, EXCEPT AND PURSUANT
TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR
HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR, IN
THE OPINION OF LEGAL COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER OF THESE SECURITIES,
SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM REGISTRATION.
WARRANT TO PURCHASE STOCK
Company: CADENCE PHARMACEUTICALS, INC., a Delaware corporation
Number of Shares: 192,500
Class of Stock: Series A-2 Preferred
Warrant Price: $1.00 per shares
Issue Date: February 17, 2006
Expiration Date: Subject to Section 1.6 hereof, the longer of (i) the 10th anniversary after the
Issue Date, and (ii) five years after the closing of the Companys initial public offering of its
Common Stock
THIS WARRANT CERTIFIES THAT, for the agreed upon value of $1.00 and for other good and
valuable consideration, including without limitation the mutual promises contained in that certain
Loan and Security Agreement of even date herewith (the Loan Agreement) entered into by and among
SILICON VALLEY BANK (Holder), Oxford Finance Corporation and the company named above (the
Company), Holder is entitled to purchase the number of fully paid and nonassessable shares of the
class of securities (the Shares) of the Company at the Warrant Price, all as set forth above and
as adjusted pursuant to Article 2 of this Warrant, subject to the provisions and upon the terms and
conditions set forth in this Warrant. This Warrant is issued in connection with the Loan
Agreement.
ARTICLE 1. EXERCISE.
1.1 Method of Exercise. Holder may exercise this Warrant by delivering a duly
executed Notice of Exercise in substantially the form attached as Appendix 1 to the principal
office of the Company. Unless Holder is exercising the conversion right set forth in Article 1.2,
Holder shall also deliver to the Company a check, wire transfer (to an account designated by the
Company), or other form of payment acceptable to the Company for the aggregate Warrant Price for
the Shares being purchased.
1.2 Conversion Right. In lieu of exercising this Warrant as specified in Article 1.1,
Holder may from time to time convert this Warrant, in whole or in part, into a number of Shares
determined by dividing (a) the aggregate fair market value of the Shares or other securities
otherwise issuable upon exercise of this Warrant minus the aggregate Warrant Price of such Shares
by (b) the fair market value of one Share. The fair market value of the Shares shall be determined
pursuant to Article 1.3.
1
1.3 Fair Market Value. If the Companys common stock is traded in a public market and
the Shares are common stock, the fair market value of each Share shall be the closing price of a
Share reported for the business day immediately before Holder delivers its Notice of Exercise to
the Company (or in the instance where the Warrant is exercised immediately prior to the
effectiveness of the Companys initial public offering, the price to public per share price
specified in the final prospectus relating to such offering). If the Companys common stock is
traded in a public market and the Shares are preferred stock, the fair market value of a Share
shall be the closing price of a share of the Companys common stock reported for the business day
immediately before Holder delivers its Notice of Exercise to the Company (or, in the instance where
the Warrant is exercised immediately prior to the effectiveness of the Companys initial public
offering, the initial price to public per share price specified in the final prospectus relating
to such offering), in both cases, multiplied by the number of shares of the Companys common stock
into which a Share is convertible. If the Companys common stock is not traded in a public market,
the Board of Directors of the Company shall determine fair market value in its reasonable good
faith judgment.
1.4 Delivery of Certificate and New Warrant. Promptly after Holder exercises or
converts this Warrant and, if applicable, the Company receives payment of the aggregate Warrant
Price, the Company shall deliver to Holder certificates for the Shares acquired and, if this
Warrant has not been fully exercised or converted and has not expired, a new Warrant representing
the Shares not so acquired.
1.5 Replacement of Warrants. On receipt of evidence reasonably satisfactory to the
Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss,
theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and
amount to the Company or, in the case of mutilation on surrender and cancellation of this Warrant,
the Company shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor.
1.6 Treatment of Warrant Upon Acquisition of Company.
1.6.1 Acquisition. For the purpose of this Warrant, Acquisition means any sale,
license, or other disposition of all or substantially all of the assets of the Company, or any
reorganization, consolidation, or merger of the Company where the holders of the Companys
securities before the transaction beneficially own less than 50% of the outstanding voting
securities of the surviving entity after the transaction.
1.6.2 Treatment of Warrant at Acquisition.
A) Upon the written request of the Company, Holder agrees that, in the event of an Acquisition that
is not an asset sale and in which the sole consideration is cash, either (a) Holder shall exercise
its conversion or purchase right under this Warrant and such exercise will be deemed effective
immediately prior to the consummation of such Acquisition or (b) if Holder elects not to exercise
the Warrant, this Warrant will expire upon the consummation of such Acquisition. The Company shall
provide the Holder with written notice of its request relating to the foregoing (together with such
reasonable information as the Holder may request in connection with such contemplated Acquisition
giving rise to such notice), which is to be delivered to Holder not less than ten (10) days prior
to the closing of the proposed Acquisition.
2
B) Upon the written request of the Company, Holder agrees that, in the event of an Acquisition that
is an arms length sale of all or substantially all of the Companys assets (and only its assets)
to a third party that is not an Affiliate (as defined below) of the Company (a True Asset Sale),
either (a) Holder shall exercise its conversion or purchase right under this Warrant and such
exercise will be deemed effective immediately prior to the consummation of such Acquisition or (b)
if Holder elects not to exercise the Warrant, this Warrant will continue until the Expiration Date
if the Company continues as a going concern following the closing of any such True Asset Sale. The
Company shall provide the Holder with written notice of its request relating to the foregoing
(together with such reasonable information as the Holder may request in connection with such
contemplated Acquisition giving rise to such notice), which is to be delivered to Holder not less
than ten (10) days prior to the closing of the proposed Acquisition.
C) Notwithstanding the foregoing provisions of this Section 1.6, in the event that the acquirer in
an Acquisition does not agree to assume this Warrant at and as of the closing thereof, this
Warrant, to the extent not exercised or converted on or prior to such closing, shall terminate and
be of no further force or effect as of immediately following such closing if all of the following
conditions are met: (i) the acquirer is subject to the reporting requirements of Section 13 or
Section 15(d) of the Securities Exchange Act of 1934, as amended, (ii) the class of stock or other
security of the acquirer that would be received by Holder in connection with such Acquisition were
Holder to exercise or convert this Warrant on or prior to the closing thereof is listed for trading
on a national securities exchange or approved for quotation on an automated inter-dealer quotation
system, (iii) the value (determined as of the closing of such Acquisition in accordance with the
definitive agreements therefor) of the acquirer stock and/or other securities that would be
received by Holder in respect of each Share were Holder to exercise or convert this Warrant on or
prior to the closing of such Acquisition is equal to or greater than three (3) times the
then-effective Warrant Price, and (iv) upon the exercise or conversion of this Warrant on or prior
to the closing of such Acquisition, Holder would be able to publicly resell all of the acquirer
stock and/or other securities that would be received by Holder in such Acquisition within 120 days
following the closing thereof pursuant to an effective registration statement covering such
acquirer stock and/or other securities or pursuant to the provisions of Rule 144 under the Act.
D) Upon the closing of any Acquisition other than those particularly described in subsections (A),
(B) and (C) above, the successor entity shall assume the obligations of this Warrant, and this
Warrant shall be exercisable for the same securities, cash, and property as would be payable for
the Shares issuable upon exercise of the unexercised portion of this Warrant as if such Shares were
outstanding on the record date for the Acquisition and subsequent closing. The Warrant Price
and/or number of Shares shall be adjusted accordingly.
As used herein Affiliate shall mean any person or entity that owns or controls directly
or indirectly ten (10) percent or more of the stock of Company, any person or entity that controls
or is controlled by or is under common control with such persons or entities, and each of such
persons or entitys officers, directors, joint venturers or partners, as applicable.
3
ARTICLE 2. ADJUSTMENTS TO THE SHARES.
2.1 Stock Dividends, Splits, Etc. If the Company declares or pays a dividend on the
Shares payable in common stock, or other securities, then upon exercise of this Warrant, for each
Share acquired, Holder shall receive, without cost to Holder, the total number and kind of
securities to which Holder would have been entitled had Holder owned the Shares of record as of the
date the dividend occurred. If the Company subdivides the Shares by reclassification or otherwise
into a greater number of shares or takes any other action which increases the amount of stock into
which the Shares are convertible, the number of shares purchasable hereunder shall be
proportionately increased and the Warrant Price shall be proportionately decreased. If the
outstanding shares are combined or consolidated, by reclassification or otherwise, into a lesser
number of shares, the Warrant Price shall be proportionately increased and the number of Shares
shall be proportionately decreased.
2.2 Reclassification, Exchange, Combinations or Substitution. Upon any
reclassification, exchange, substitution, or other event that results in a change of the number
and/or class of the securities issuable upon exercise or conversion of this Warrant, Holder shall
be entitled to receive, upon exercise or conversion of this Warrant, the number and kind of
securities and property that Holder would have received for the Shares if this Warrant had been
exercised immediately before such reclassification, exchange, substitution, or other event. Such
an event shall include any automatic conversion of the outstanding or issuable securities of the
Company of the same class or series as the Shares to common stock pursuant to the terms of the
Companys Restated Certificate of Incorporation, as may be amended from time to time (the
Certificate of Incorporation) upon the closing of a registered public offering of the Companys
common stock, but shall not include any conversions as a result of a failure to participate in any
subsequent equity financings of the Company or any Right of First Offer or other pay to play
provisions set forth in the Companys Certificate of Incorporation. The Company or its successor
shall promptly issue to Holder an amendment to this Warrant setting forth the number and kind of
such new securities or other property issuable upon exercise or conversion of this Warrant as a
result of such reclassification, exchange, substitution or other event that results in a change of
the number and/or class of securities issuable upon exercise or conversion of this Warrant. The
amendment to this Warrant shall provide for adjustments which shall be as nearly equivalent as may
be practicable to the adjustments provided for in this Article 2 including, without limitation,
adjustments to the Warrant Price and to the number of securities or property issuable upon exercise
of the new Warrant. The provisions of this Article 2.2 shall similarly apply to successive
reclassifications, exchanges, substitutions, or other events.
2.3 Adjustments for Diluting Issuances. The Warrant Price and the number of Shares
issuable upon exercise of this Warrant or, if the Shares are preferred stock, the number of shares
of common stock issuable upon conversion of the Shares, shall be subject to adjustment, from time
to time in the manner set forth in the Companys Certificate of Incorporation as if the Shares
were issued and outstanding on and as of the date of any such required adjustment. The provisions
set forth for the Shares in the Companys Certificate of Incorporation relating to the above in
effect as of the Issue Date may not be amended, modified or waived, without the prior written
consent of Holder unless such amendment, modification or waiver affects the rights associated with
the Shares in the same manner as such amendment, modification or waiver affects the rights
associated with all other shares of the same series and class as the Shares granted to the Holder.
4
2.4 No Impairment. The Company shall not, by amendment of its Certificate of
Incorporation or through a reorganization, transfer of assets, consolidation, merger, dissolution,
issue, or sale of securities or any other voluntary action, avoid or seek to avoid the observance
or performance of any of the terms to be observed or performed under this Warrant by the Company,
but shall at all times in good faith assist in carrying out of all the provisions of this Article 2
and in taking all such action as may be necessary or appropriate to protect Holders rights under
this Article against impairment; provided, however, that notwithstanding the foregoing, nothing in
this Section 2.4 shall restrict or impair the Companys right to effect changes to the rights,
preferences and privileges associated with the Shares with the requisite consent of the
stockholders as may be required to amend the Certificate of Incorporation from time to time so long
as such amendment affects the rights, preferences and privileges granted to Holder associated with
the Shares in the same manner as the other holders of Series A-2 Preferred Stock.
2.5 Fractional Shares. No fractional Shares shall be issuable upon exercise or
conversion of this Warrant and the number of Shares to be issued shall be rounded down to the
nearest whole Share. If a fractional share interest arises upon any exercise or conversion of the
Warrant, the Company shall eliminate such fractional share interest by paying Holder the amount
computed by multiplying the fractional interest by the fair market value, as determined in
accordance with Section 1.3, of a full Share.
2.6 Certificate as to Adjustments. Upon each adjustment of the Warrant Price, the
Company shall promptly notify Holder in writing, and, at the Companys expense, promptly compute
such adjustment, and furnish Holder with a certificate of its Chief Financial Officer setting forth
such adjustment and the facts upon which such adjustment is based. The Company shall, upon written
request, furnish Holder a certificate setting forth the Warrant Price in effect upon the date
thereof and the series of adjustments leading to such Warrant Price.
ARTICLE 3. REPRESENTATIONS AND COVENANTS OF THE COMPANY.
3.1 Representations and Warranties. The Company represents and warrants and covenants
to the Holder as follows:
(a) The initial Warrant Price referenced on the first page of this Warrant is not greater than
the price per share at which the Shares were last issued in an arms-length transaction in which at
least $500,000 of the Shares were sold.
(b) All Shares which may be issued upon the exercise of the purchase right represented by this
Warrant, and all securities, if any, issuable upon conversion of the Shares, shall, upon issuance,
be duly authorized, validly issued, fully paid and nonassessable, and free of any liens and
encumbrances except for restrictions on transfer provided for herein or under applicable federal
and state securities laws. Notwithstanding the foregoing, such Shares of Series A-2 Preferred
Stock have not been authorized or reserved for issuance as of the Issue Date, but the Company shall
use its best efforts to cause an amendment no later than February 28, 2006 of its Restated
Certificate of Incorporation to authorize sufficient shares of Series A-2 Preferred Stock to permit
reservation of all Shares which may be issued upon the exercise of the purchase right represented
by this Warrant, upon exercise of this Warrant; provided, however, in any event, the Company
covenants and agrees that all such Shares of Series A-2
5
Preferred Stock which may be issued upon the exercise of the purchase right represented by this
Warrant shall be authorized and reserved for issuance prior to the earliest to occur of the
following: (1) any Liquidation Event (as defined in the Companys Restated Certificate of
Incorporation), (2) any amendment to the Companys Restated Certificate of Incorporation, (3) the
closing of the Companys next equity financing or (4) the closing of the Companys initial public
offering of its Common Stock.
(c) The Capitalization Table previously provided to Holder remains true and complete as of the
Issue Date.
3.2 Notice of Certain Events. If the Company proposes at any time (a) to declare any
dividend or distribution upon any of its stock, whether in cash, property, stock, or other
securities and whether or not a regular cash dividend; or (b) to merge or consolidate with or into
any other corporation, or sell, lease, license, or convey all or substantially all of its assets,
or to liquidate, dissolve or wind up; then, in connection with each such event, the Company shall
give Holder: (1) at least 10 calendar days prior written notice of the date on which a record will
be taken for such dividend or distribution (and specifying the date on which the holders of common
stock will be entitled thereto) or for determining rights to vote, if any, in respect of the
matters referred to in (a) above; and (2) in the case of the matters referred to in (b) above at
least 10 calendar days prior written notice of the date when the same will take place (and
specifying the date on which the holders of common stock will be entitled to exchange their common
stock for securities or other property deliverable upon the occurrence of such event). While the
Company is a private company, the Company shall send a concurrent written notice to Holder if the
Company sends any written notice to its preferred stockholders regarding: (a) the Company offering
for sale any shares of the Companys capital stock (or other securities convertible into such
capital stock), other than (i) pursuant to the Companys stock option or other compensatory plans,
(ii) in connection with commercial credit arrangements or equipment financings, or (iii) in
connection with strategic transactions for purposes other than capital raising; or (b) the Company
proposing to effect any reclassification or recapitalization of any of its stock. The Company
shall send concurrently to Holder the same notice as the Company gives to the holders of
registration rights if the Company proposes to offer holders of registration rights the opportunity
to participate in an underwritten public offering of the Companys securities for cash.
3.3 Registration Under Securities Act of 1933, as amended. The Company agrees that
the Shares or, if the Shares are convertible into common stock of the Company, such common stock,
shall have certain incidental, or Piggyback, registration rights pursuant to and as set forth in
the Companys Amended and Restated Investor Rights Agreement dated September 30, 2005 (as amended
from time to time, the Investor Rights Agreement) or similar agreement. The provisions set forth
in the Companys Investors Right Agreement or similar agreement relating to the above in effect as
of the Issue Date may not be amended, modified or waived without the prior written consent of
Holder unless such amendment, modification or waiver affects the rights associated with the Shares
in the same manner as such amendment, modification, or waiver affects the rights associated with
all other shares of the same series and class as the Shares granted to the Holder.
6
3.4 No Shareholder Rights. Except as provided in this Warrant, the Holder
will not have any rights as a shareholder of the Company until the exercise of this Warrant.
3.5 Information. So long as the Company is not a public company and after
the Companys obligations to provide financial information under the Loan Agreement have
terminated, upon the request by Holder, the Company shall provide to the Holder: (i) the monthly
reports furnished to certain of Companys investors under Section 2.1(b)(i) of the Investor Rights
Agreement (as defined in Section 3.3 of this Warrant), (ii) the annual reports furnished to certain
of Companys investors under Section 2.1(a) of the Investor Rights Agreement; and (iii) the annual
budget furnished to certain of Companys investors under Section 2.1(b)(ii) of the Investor Rights
Agreement.
ARTICLE 4. REPRESENTATIONS, WARRANTIES OF THE HOLDER. The Holder represents and warrants
to the Company as follows:
4.1 Purchase for Own Account. This Warrant and the securities to be acquired upon
exercise of this Warrant by the Holder will be acquired for investment for the Holders account,
not as a nominee or agent, and not with a view to the public resale or distribution within the
meaning of the Act. Holder also represents that the Holder has not been formed for the specific
purpose of acquiring this Warrant or the Shares.
4.2 Disclosure of Information. The Holder has received or has had full access to all
the information it considers necessary or appropriate to make an informed investment decision with
respect to the acquisition of this Warrant and its underlying securities. The Holder further has
had an opportunity to ask questions and receive answers from the Company regarding the terms and
conditions of the offering of this Warrant and its underlying securities and to obtain additional
information (to the extent the Company possessed such information or could acquire it without
unreasonable effort or expense) necessary to verify any information furnished to the Holder or to
which the Holder has access.
4.3 Investment Experience. The Holder understands that the purchase of this Warrant
and its underlying securities involves substantial risk. The Holder has experience as an investor
in securities of companies in the development stage and acknowledges that the Holder can bear the
economic risk of such Holders investment in this Warrant and its underlying securities and has
such knowledge and experience in financial or business matters that the Holder is capable of
evaluating the merits and risks of its investment in this Warrant and its underlying securities
and/or has a preexisting personal or business relationship with the Company and certain of its
officers, directors or controlling persons of a nature and duration that enables the Holder to be
aware of the character, business acumen and financial circumstances of such persons.
4.4 Accredited Investor Status. The Holder is an accredited investor within the
meaning of Regulation D promulgated under the Act.
4.5 The Act. The Holder understands that this Warrant and the Shares issuable upon
exercise or conversion hereof have not been registered under the
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Act in reliance upon a specific exemption therefrom, which exemption depends upon, among other
things, the bona fide nature of the Holders investment intent as expressed herein. The Holder
understands that this Warrant and the Shares issued upon any exercise or conversion hereof must be
held indefinitely unless subsequently registered under the Act and qualified under applicable state
securities laws, or unless exemption from such registration and qualification are otherwise
available.
ARTICLE 5. MISCELLANEOUS.
5.1 Term: This Warrant is exercisable in whole or in part at any time and from time
to time on or before the Expiration Date.
5.2 Legends. This Warrant and the Shares (and the securities issuable, directly or
indirectly, upon conversion of the Shares, if any) shall be imprinted with a legend in
substantially the following form:
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE ACT), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR, IN THE OPINION
OF LEGAL COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER OF THESE
SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
5.3 Compliance with Securities Laws on Transfer. This Warrant and the Shares issuable
upon exercise of this Warrant (and the securities issuable, directly or indirectly, upon conversion
of the Shares, if any) may not be transferred or assigned in whole or in part without compliance
with applicable federal and state securities laws by the transferor and the transferee (including,
without limitation, the delivery of investment representation letters and legal opinions reasonably
satisfactory to the Company, as reasonably requested by the Company). The Company shall not
require Holder to provide an opinion of counsel if the transfer is to Holders parent company, SVB
Financial Group (formerly Silicon Valley Bancshares), or any other affiliate of Holder.
Additionally, the Company shall also not require an opinion of counsel if there is no material
question as to the availability of Rule 144, including, without limitation, the availability of
current information as referenced in Rule 144(c), Holder represents that it has complied with Rule
144(d) and (e) in reasonable detail, the selling broker represents that it has complied with Rule
144(f), and the Company is provided with a copy of Holders notice of proposed sale.
5.4 Transfer Procedure. Upon receipt by Holder of the executed Warrant, Holder will
transfer all of this Warrant to Holders parent company, SVB Financial Group, by execution of an
Assignment substantially in the form of Appendix 2. Subject to the provisions of Article 5.3 and
upon providing Company with written notice, SVB Financial Group and any subsequent Holder may
transfer all or part of this Warrant or the Shares issuable upon exercise of this Warrant (or the
Shares issuable directly or indirectly, upon conversion of the Shares, if any) to any transferee,
provided, however, in
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connection with any such transfer, SVB Financial Group or any subsequent Holder will give the
Company notice of the portion of the Warrant being transferred with the name, address and taxpayer
identification number of the transferee and Holder will surrender this Warrant to the Company for
reissuance to the transferee(s) (and Holder if applicable). The Company may refuse to transfer
this Warrant or the Shares to any person who directly competes with the Company, unless, in either
case, the stock of the Company is publicly traded.
5.5 Notices. All notices and other communications from the Company to the Holder, or
vice versa, shall be deemed delivered and effective when given personally or mailed by first-class
registered or certified mail, postage prepaid, at such address as may have been furnished to the
Company or the Holder, as the case may (or on the first business day after transmission by
facsimile) be, in writing by the Company or such Holder from time to time. Effective upon receipt
of the fully executed Warrant and the initial transfer described in Article 5.4 above, all notices
to the Holder shall be addressed as follows until the Company receives notice of a change of
address in connection with a transfer or otherwise:
SVB Financial Group
Attn: Treasury Department
3003 Tasman Drive, HA 200
Santa Clara, CA 95054
Telephone: 408-654-7400
Facsimile: 408-496-2405
Notice to the Company shall be addressed as follows until the Holder receives notice of a change in
address:
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
Attn: Chief Executive Officer
Telephone: (858) 436-1400
Facsimile: (858) 436-1401
5.6 Waiver. This Warrant and any term hereof may be changed, waived, discharged or
terminated only by an instrument in writing signed by the party against which enforcement of such
change, waiver, discharge or termination is sought.
5.7 Attorneys Fees. In the event of any dispute between the parties concerning the
terms and provisions of this Warrant, the party prevailing in such dispute shall be entitled to
collect from the other party all costs incurred in such dispute, including reasonable attorneys
fees.
5.8 Automatic Conversion upon Expiration. In the event that, upon the Expiration
Date, the fair market value of one Share (or other security issuable upon the exercise hereof) as
determined in accordance with Section 1.3 above is greater than the Warrant Price in effect on such
date, then this Warrant shall automatically be deemed on and as of such date to be converted
pursuant to Section 1.2 above as to all Shares (or such other securities) for which it shall not
previously have been exercised or
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converted, and the Company shall promptly deliver a certificate representing the Shares (or such
other securities) issued upon such conversion to the Holder.
5.9 Counterparts. This Warrant may be executed in counterparts, all of which together
shall constitute one and the same agreement.
5.10 Governing Law. This Warrant shall be governed by and construed in accordance
with the laws of the State of California, without giving effect to its principles regarding
conflicts of law.
[Remainder of page intentionally left blank; signature page follows]
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CADENCE PHARMACEUTICALS, INC. |
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By:
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/s/ Theodore R. Schroeder |
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/s/ David A. Socks |
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Theodore R. Schroeder |
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David A. Socks |
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President
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Secretary |
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HOLDER |
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SILICON VALLEY BANK |
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/s/ Edgar Arvizu |
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Edgar Arvizu |
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APPENDIX 1
NOTICE OF EXERCISE
1. Holder elects to purchase shares of the Common/Series ___ Preferred [strike
one] Stock of pursuant to the terms of the attached Warrant, and tenders payment
of the purchase price of the shares in full.
[or]
1. Holder elects to convert the attached Warrant into Shares/cash [strike one] in the manner
specified in the Warrant. This conversion is exercised for of the Shares
covered by the Warrant.
[Strike paragraph that does not apply.]
2. Please issue a certificate or certificates representing the shares in the name specified
below:
3. By its execution below and for the benefit of the Company, Holder hereby restates each of
the representations and warranties in Article 4 of the Warrant as the date hereof.
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APPENDIX 2
ASSIGNMENT
For value received, Silicon Valley Bank hereby sells, assigns and transfers unto
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Tax ID:
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that certain Warrant to Purchase Stock issued by Cadence Pharmaceuticals, Inc. (the
Company), on ___, 200___ (the Warrant) together with all rights, title and
interest therein.
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Date:
By its execution below, and for the benefit of the Company, SVB Financial Group makes each of the
representations and warranties set forth in Article 4 of the Warrant and agrees to all other
provisions of the Warrant as of the date hereof.
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exv4w4
Exhibit 4.4
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES
ACT OF 1933, AS AMENDED (THE ACT), OR THE SECURITIES LAWS OF ANY STATE AND, EXCEPT AND PURSUANT
TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR
HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR, IN
THE OPINION OF LEGAL COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER OF THESE SECURITIES,
SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM REGISTRATION.
WARRANT TO PURCHASE STOCK
Company: CADENCE PHARMACEUTICALS, INC., a Delaware corporation
Number of Shares: 192,500
Class of Stock: Series A-2 Preferred
Warrant Price: $1.00 per shares
Issue Date: February 17, 2006
Expiration Date: Subject to Section 1.6 hereof, the longer of (i) the 10th anniversary after the
Issue Date, and (ii) five years after the closing of the Companys initial public offering of its
Common Stock
THIS WARRANT CERTIFIES THAT, for the agreed upon value of $1.00 and for other good and
valuable consideration, including without limitation the mutual promises contained in that certain
Loan and Security Agreement of even date herewith (the Loan Agreement) entered into by and among
OXFORD FINANCE CORPORATION (Holder), Silicon Valley Bank and the company named above (the
Company), Holder is entitled to purchase the number of fully paid and nonassessable shares of the
class of securities (the Shares) of the Company at the Warrant Price, all as set forth above and
as adjusted pursuant to Article 2 of this Warrant, subject to the provisions and upon the terms and
conditions set forth in this Warrant. This Warrant is issued in connection with the Loan
Agreement.
ARTICLE 1. EXERCISE.
1.1 Method of Exercise. Holder may exercise this Warrant by delivering a duly
executed Notice of Exercise in substantially the form attached as Appendix 1 to the principal
office of the Company. Unless Holder is exercising the conversion right set forth in Article 1.2,
Holder shall also deliver to the Company a check, wire transfer (to an account designated by the
Company), or other form of payment acceptable to the Company for the aggregate Warrant Price for
the Shares being purchased.
1.2 Conversion Right. In lieu of exercising this Warrant as specified in Article 1.1,
Holder may from time to time convert this Warrant, in whole or in part, into a number of Shares
determined by dividing (a) the aggregate fair market value of the Shares or other securities
otherwise issuable upon exercise of this Warrant minus the aggregate Warrant Price of such Shares
by (b) the fair market value of one Share. The fair market value of the Shares shall be determined
pursuant to Article 1.3.
1
1.3 Fair Market Value. If the Companys common stock is traded in a public market and
the Shares are common stock, the fair market value of each Share shall be the closing price of a
Share reported for the business day immediately before Holder delivers its Notice of Exercise to
the Company (or in the instance where the Warrant is exercised immediately prior to the
effectiveness of the Companys initial public offering, the price to public per share price
specified in the final prospectus relating to such offering). If the Companys common stock is
traded in a public market and the Shares are preferred stock, the fair market value of a Share
shall be the closing price of a share of the Companys common stock reported for the business day
immediately before Holder delivers its Notice of Exercise to the Company (or, in the instance where
the Warrant is exercised immediately prior to the effectiveness of the Companys initial public
offering, the initial price to public per share price specified in the final prospectus relating
to such offering), in both cases, multiplied by the number of shares of the Companys common stock
into which a Share is convertible. If the Companys common stock is not traded in a public market,
the Board of Directors of the Company shall determine fair market value in its reasonable good
faith judgment.
1.4 Delivery of Certificate and New Warrant. Promptly after Holder exercises or
converts this Warrant and, if applicable, the Company receives payment of the aggregate Warrant
Price, the Company shall deliver to Holder certificates for the Shares acquired and, if this
Warrant has not been fully exercised or converted and has not expired, a new Warrant representing
the Shares not so acquired.
1.5 Replacement of Warrants. On receipt of evidence reasonably satisfactory to the
Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss,
theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and
amount to the Company or, in the case of mutilation on surrender and cancellation of this Warrant,
the Company shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor.
1.6 Treatment of Warrant Upon Acquisition of Company.
1.6.1 Acquisition. For the purpose of this Warrant, Acquisition means any sale,
license, or other disposition of all or substantially all of the assets of the Company, or any
reorganization, consolidation, or merger of the Company where the holders of the Companys
securities before the transaction beneficially own less than 50% of the outstanding voting
securities of the surviving entity after the transaction.
1.6.2 Treatment of Warrant at Acquisition.
A) Upon the written request of the Company, Holder agrees that, in the event of an Acquisition that
is not an asset sale and in which the sole consideration is cash, either (a) Holder shall exercise
its conversion or purchase right under this Warrant and such exercise will be deemed effective
immediately prior to the consummation of such Acquisition or (b) if Holder elects not to exercise
the Warrant, this Warrant will expire upon the consummation of such Acquisition. The Company shall
provide the Holder with written notice of its request relating to the foregoing (together with such
reasonable information as the Holder may request in connection with such contemplated Acquisition
giving rise to such notice), which is to be delivered to Holder not less than ten (10) days prior
to the closing of the proposed Acquisition.
2
B) Upon the written request of the Company, Holder agrees that, in the event of an Acquisition that
is an arms length sale of all or substantially all of the Companys assets (and only its assets)
to a third party that is not an Affiliate (as defined below) of the Company (a True Asset Sale),
either (a) Holder shall exercise its conversion or purchase right under this Warrant and such
exercise will be deemed effective immediately prior to the consummation of such Acquisition or (b)
if Holder elects not to exercise the Warrant, this Warrant will continue until the Expiration Date
if the Company continues as a going concern following the closing of any such True Asset Sale. The
Company shall provide the Holder with written notice of its request relating to the foregoing
(together with such reasonable information as the Holder may request in connection with such
contemplated Acquisition giving rise to such notice), which is to be delivered to Holder not less
than ten (10) days prior to the closing of the proposed Acquisition.
C) Notwithstanding the foregoing provisions of this Section 1.6, in the event that the acquirer in
an Acquisition does not agree to assume this Warrant at and as of the closing thereof, this
Warrant, to the extent not exercised or converted on or prior to such closing, shall terminate and
be of no further force or effect as of immediately following such closing if all of the following
conditions are met: (i) the acquirer is subject to the reporting requirements of Section 13 or
Section 15(d) of the Securities Exchange Act of 1934, as amended, (ii) the class of stock or other
security of the acquirer that would be received by Holder in connection with such Acquisition were
Holder to exercise or convert this Warrant on or prior to the closing thereof is listed for trading
on a national securities exchange or approved for quotation on an automated inter-dealer quotation
system, (iii) the value (determined as of the closing of such Acquisition in accordance with the
definitive agreements therefor) of the acquirer stock and/or other securities that would be
received by Holder in respect of each Share were Holder to exercise or convert this Warrant on or
prior to the closing of such Acquisition is equal to or greater than three (3) times the
then-effective Warrant Price, and (iv) upon the exercise or conversion of this Warrant on or prior
to the closing of such Acquisition, Holder would be able to publicly resell all of the acquirer
stock and/or other securities that would be received by Holder in such Acquisition within 120 days
following the closing thereof pursuant to an effective registration statement covering such
acquirer stock and/or other securities or pursuant to the provisions of Rule 144 under the Act.
D) Upon the closing of any Acquisition other than those particularly described in subsections (A),
(B) and (C) above, the successor entity shall assume the obligations of this Warrant, and this
Warrant shall be exercisable for the same securities, cash, and property as would be payable for
the Shares issuable upon exercise of the unexercised portion of this Warrant as if such Shares were
outstanding on the record date for the Acquisition and subsequent closing. The Warrant Price
and/or number of Shares shall be adjusted accordingly.
As used herein Affiliate shall mean any person or entity that owns or controls directly
or indirectly ten (10) percent or more of the stock of Company, any person or entity that controls
or is controlled by or is under common control with such persons or entities, and each of such
persons or entitys officers, directors, joint venturers or partners, as applicable.
3
ARTICLE 2. ADJUSTMENTS TO THE SHARES.
2.1 Stock Dividends, Splits, Etc. If the Company declares or pays a dividend on the
Shares payable in common stock, or other securities, then upon exercise of this Warrant, for each
Share acquired, Holder shall receive, without cost to Holder, the total number and kind of
securities to which Holder would have been entitled had Holder owned the Shares of record as of the
date the dividend occurred. If the Company subdivides the Shares by reclassification or otherwise
into a greater number of shares or takes any other action which increases the amount of stock into
which the Shares are convertible, the number of shares purchasable hereunder shall be
proportionately increased and the Warrant Price shall be proportionately decreased. If the
outstanding shares are combined or consolidated, by reclassification or otherwise, into a lesser
number of shares, the Warrant Price shall be proportionately increased and the number of Shares
shall be proportionately decreased.
2.2 Reclassification, Exchange, Combinations or Substitution. Upon any
reclassification, exchange, substitution, or other event that results in a change of the number
and/or class of the securities issuable upon exercise or conversion of this Warrant, Holder shall
be entitled to receive, upon exercise or conversion of this Warrant, the number and kind of
securities and property that Holder would have received for the Shares if this Warrant had been
exercised immediately before such reclassification, exchange, substitution, or other event. Such
an event shall include any automatic conversion of the outstanding or issuable securities of the
Company of the same class or series as the Shares to common stock pursuant to the terms of the
Companys Restated Certificate of Incorporation, as may be amended from time to time (the
Certificate of Incorporation) upon the closing of a registered public offering of the Companys
common stock, but shall not include any conversions as a result of a failure to participate in any
subsequent equity financings of the Company or any Right of First Offer or other pay to play
provisions set forth in the Companys Certificate of Incorporation. The Company or its successor
shall promptly issue to Holder an amendment to this Warrant setting forth the number and kind of
such new securities or other property issuable upon exercise or conversion of this Warrant as a
result of such reclassification, exchange, substitution or other event that results in a change of
the number and/or class of securities issuable upon exercise or conversion of this Warrant. The
amendment to this Warrant shall provide for adjustments which shall be as nearly equivalent as may
be practicable to the adjustments provided for in this Article 2 including, without limitation,
adjustments to the Warrant Price and to the number of securities or property issuable upon exercise
of the new Warrant. The provisions of this Article 2.2 shall similarly apply to successive
reclassifications, exchanges, substitutions, or other events.
2.3 Adjustments for Diluting Issuances. The Warrant Price and the number of Shares
issuable upon exercise of this Warrant or, if the Shares are preferred stock, the number of shares
of common stock issuable upon conversion of the Shares, shall be subject to adjustment, from time
to time in the manner set forth in the Companys Certificate of Incorporation as if the Shares
were issued and outstanding on and as of the date of any such required adjustment. The provisions
set forth for the Shares in the Companys Certificate of Incorporation relating to the above in
effect as of the Issue Date may not be amended, modified or waived, without the prior written
consent of Holder unless such amendment, modification or waiver affects the rights associated with
the Shares in the same manner as such amendment, modification or waiver affects the rights
associated with all other shares of the same series and class as the Shares granted to the Holder.
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2.4 No Impairment. The Company shall not, by amendment of its Certificate of
Incorporation or through a reorganization, transfer of assets, consolidation, merger, dissolution,
issue, or sale of securities or any other voluntary action, avoid or seek to avoid the observance
or performance of any of the terms to be observed or performed under this Warrant by the Company,
but shall at all times in good faith assist in carrying out of all the provisions of this Article 2
and in taking all such action as may be necessary or appropriate to protect Holders rights under
this Article against impairment; provided, however, that notwithstanding the foregoing, nothing in
this Section 2.4 shall restrict or impair the Companys right to effect changes to the rights,
preferences and privileges associated with the Shares with the requisite consent of the
stockholders as may be required to amend the Certificate of Incorporation from time to time so long
as such amendment affects the rights, preferences and privileges granted to Holder associated with
the Shares in the same manner as the other holders of Series A-2 Preferred Stock.
2.5 Fractional Shares. No fractional Shares shall be issuable upon exercise or
conversion of this Warrant and the number of Shares to be issued shall be rounded down to the
nearest whole Share. If a fractional share interest arises upon any exercise or conversion of the
Warrant, the Company shall eliminate such fractional share interest by paying Holder the amount
computed by multiplying the fractional interest by the fair market value, as determined in
accordance with Section 1.3, of a full Share.
2.6 Certificate as to Adjustments. Upon each adjustment of the Warrant Price, the
Company shall promptly notify Holder in writing, and, at the Companys expense, promptly compute
such adjustment, and furnish Holder with a certificate of its Chief Financial Officer setting forth
such adjustment and the facts upon which such adjustment is based. The Company shall, upon written
request, furnish Holder a certificate setting forth the Warrant Price in effect upon the date
thereof and the series of adjustments leading to such Warrant Price.
ARTICLE 3. REPRESENTATIONS AND COVENANTS OF THE COMPANY.
3.1 Representations and Warranties. The Company represents and warrants and covenants
to the Holder as follows:
(a) The initial Warrant Price referenced on the first page of this Warrant is not greater than
the price per share at which the Shares were last issued in an arms-length transaction in which at
least $500,000 of the Shares were sold.
(b) All Shares which may be issued upon the exercise of the purchase right represented by this
Warrant, and all securities, if any, issuable upon conversion of the Shares, shall, upon issuance,
be duly authorized, validly issued, fully paid and nonassessable, and free of any liens and
encumbrances except for restrictions on transfer provided for herein or under applicable federal
and state securities laws. Notwithstanding the foregoing, such Shares of Series A-2 Preferred Stock
have not been authorized or reserved for issuance as of the Issue Date, but the Company shall use
its best efforts to cause an amendment no later than February 28, 2006 of its Restated Certificate
of Incorporation to authorize sufficient shares of Series A-2 Preferred Stock to permit reservation
of all Shares which may be issued upon the exercise of the purchase right represented by this
Warrant, upon exercise of this Warrant; provided, however, in any event, the Company covenants and
agrees that all such Shares of Series A-2
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Preferred Stock which may be issued upon the exercise of the purchase right represented by this
Warrant shall be authorized and reserved for issuance prior to the earliest to occur of the
following: (1) any Liquidation Event (as defined in the Companys Restated Certificate of
Incorporation), (2) any amendment to the Companys Restated Certificate of Incorporation, (3) the
closing of the Companys next equity financing or (4) the closing of the Companys initial public
offering of its Common Stock.
(c) The Capitalization Table previously provided to Holder remains true and complete as of the
Issue Date.
3.2 Notice of Certain Events. If the Company proposes at any time (a) to declare any
dividend or distribution upon any of its stock, whether in cash, property, stock, or other
securities and whether or not a regular cash dividend; or (b) to merge or consolidate with or into
any other corporation, or sell, lease, license, or convey all or substantially all of its assets,
or to liquidate, dissolve or wind up; then, in connection with each such event, the Company shall
give Holder: (1) at least 10 calendar days prior written notice of the date on which a record will
be taken for such dividend or distribution (and specifying the date on which the holders of common
stock will be entitled thereto) or for determining rights to vote, if any, in respect of the
matters referred to in (a) above; and (2) in the case of the matters referred to in (b) above at
least 10 calendar days prior written notice of the date when the same will take place (and
specifying the date on which the holders of common stock will be entitled to exchange their common
stock for securities or other property deliverable upon the occurrence of such event). While the
Company is a private company, the Company shall send a concurrent written notice to Holder if the
Company sends any written notice to its preferred stockholders regarding: (a) the Company offering
for sale any shares of the Companys capital stock (or other securities convertible into such
capital stock), other than (i) pursuant to the Companys stock option or other compensatory plans,
(ii) in connection with commercial credit arrangements or equipment financings, or (iii) in
connection with strategic transactions for purposes other than capital raising; or (b) the Company
proposing to effect any reclassification or recapitalization of any of its stock. The Company
shall send concurrently to Holder the same notice as the Company gives to the holders of
registration rights if the Company proposes to offer holders of registration rights the opportunity
to participate in an underwritten public offering of the Companys securities for cash.
3.3 Registration Under Securities Act of 1933, as amended. The Company agrees that
the Shares or, if the Shares are convertible into common stock of the Company, such common stock,
shall have certain incidental, or Piggyback, registration rights pursuant to and as set forth in
the Companys Amended and Restated Investor Rights Agreement dated September 30, 2005 (as amended
from time to time, the Investor Rights Agreement) or similar agreement. The provisions set forth
in the Companys Investors Right Agreement or similar agreement relating to the above in effect as
of the Issue Date may not be amended, modified or waived without the prior written consent of
Holder unless such amendment, modification or waiver affects the rights associated with the Shares
in the same manner as such amendment, modification, or waiver affects the rights associated with
all other shares of the same series and class as the Shares granted to the Holder.
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3.4 No Shareholder Rights. Except as provided in this Warrant, the Holder
will not have any rights as a shareholder of the Company until the exercise of this Warrant.
3.5 Information. So long as the Company is not a public company and after
the Companys obligations to provide financial information under the Loan Agreement have
terminated, upon the request by Holder, the Company shall provide to the Holder: (i) the monthly
reports furnished to certain of Companys investors under Section 2.1(b)(i) of the Investor Rights
Agreement (as defined in Section 3.3 of this Warrant), (ii) the annual reports furnished to certain
of Companys investors under Section 2.1(a) of the Investor Rights Agreement; and (iii) the annual
budget furnished to certain of Companys investors under Section 2.1(b)(ii) of the Investor Rights
Agreement.
ARTICLE 4. REPRESENTATIONS, WARRANTIES OF THE HOLDER. The Holder represents and warrants
to the Company as follows:
4.1 Purchase for Own Account. This Warrant and the securities to be acquired upon
exercise of this Warrant by the Holder will be acquired for investment for the Holders account,
not as a nominee or agent, and not with a view to the public resale or distribution within the
meaning of the Act. Holder also represents that the Holder has not been formed for the specific
purpose of acquiring this Warrant or the Shares.
4.2 Disclosure of Information. The Holder has received or has had full access to all
the information it considers necessary or appropriate to make an informed investment decision with
respect to the acquisition of this Warrant and its underlying securities. The Holder further has
had an opportunity to ask questions and receive answers from the Company regarding the terms and
conditions of the offering of this Warrant and its underlying securities and to obtain additional
information (to the extent the Company possessed such information or could acquire it without
unreasonable effort or expense) necessary to verify any information furnished to the Holder or to
which the Holder has access.
4.3 Investment Experience. The Holder understands that the purchase of this Warrant
and its underlying securities involves substantial risk. The Holder has experience as an investor
in securities of companies in the development stage and acknowledges that the Holder can bear the
economic risk of such Holders investment in this Warrant and its underlying securities and has
such knowledge and experience in financial or business matters that the Holder is capable of
evaluating the merits and risks of its investment in this Warrant and its underlying securities
and/or has a preexisting personal or business relationship with the Company and certain of its
officers, directors or controlling persons of a nature and duration that enables the Holder to be
aware of the character, business acumen and financial circumstances of such persons.
4.4 Accredited Investor Status. The Holder is an accredited investor within the
meaning of Regulation D promulgated under the Act.
4.5 The Act. The Holder understands that this Warrant and the Shares issuable upon
exercise or conversion hereof have not been registered under the
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Act in reliance upon a specific exemption therefrom, which exemption depends upon, among other
things, the bona fide nature of the Holders investment intent as expressed herein. The Holder
understands that this Warrant and the Shares issued upon any exercise or conversion hereof must be
held indefinitely unless subsequently registered under the Act and qualified under applicable state
securities laws, or unless exemption from such registration and qualification are otherwise
available.
ARTICLE 5. MISCELLANEOUS.
5.1 Term: This Warrant is exercisable in whole or in part at any time and from time
to time on or before the Expiration Date.
5.2 Legends. This Warrant and the Shares (and the securities issuable, directly or
indirectly, upon conversion of the Shares, if any) shall be imprinted with a legend in
substantially the following form:
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE ACT), OR THE SECURITIES LAWS OF ANY
STATE AND, EXCEPT AND PURSUANT TO THE PROVISIONS OF ARTICLE 5 BELOW, MAY NOT BE
OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL
REGISTERED UNDER SAID ACT AND APPLICABLE STATE SECURITIES LAW OR, IN THE OPINION
OF LEGAL COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER OF THESE
SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS EXEMPT FROM
REGISTRATION.
5.3 Compliance with Securities Laws on Transfer. This Warrant and the Shares issuable
upon exercise of this Warrant (and the securities issuable, directly or indirectly, upon conversion
of the Shares, if any) may not be transferred or assigned in whole or in part without compliance
with applicable federal and state securities laws by the transferor and the transferee (including,
without limitation, the delivery of investment representation letters and legal opinions reasonably
satisfactory to the Company, as reasonably requested by the Company). The Company shall not
require Holder to provide an opinion of counsel if the transfer is to any other affiliate of
Holder. Additionally, the Company shall also not require an opinion of counsel if there is no
material question as to the availability of Rule 144, including, without limitation, the
availability of current information as referenced in Rule 144(c), Holder represents that it has
complied with Rule 144(d) and (e) in reasonable detail, the selling broker represents that it has
complied with Rule 144(f), and the Company is provided with a copy of Holders notice of proposed
sale.
5.4 Transfer Procedure. Upon receipt by Holder of the executed Warrant, Holder may
transfer this Warrant to any affiliate of Holder, by execution of an Assignment substantially in
the form of Appendix 2. Subject to the provisions of Article 5.3 and upon providing Company with
written notice, any subsequent Holder may transfer all or part of this Warrant or the Shares
issuable upon exercise of this Warrant (or the Shares issuable directly or indirectly, upon
conversion of the Shares, if any) to any transferee, provided, however, in connection with any such
transfer, any subsequent Holder will give the Company notice of the portion of the Warrant being
transferred with
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the name, address and taxpayer identification number of the transferee and Holder will
surrender this Warrant to the Company for reissuance to the transferee(s) (and Holder if
applicable). The Company may refuse to transfer this Warrant or the Shares to any person who
directly competes with the Company, unless, in either case, the stock of the Company is publicly
traded.
5.5 Notices. All notices and other communications from the Company to the Holder, or
vice versa, shall be deemed delivered and effective when given personally or mailed by first-class
registered or certified mail, postage prepaid, at such address as may have been furnished to the
Company or the Holder, as the case may (or on the first business day after transmission by
facsimile) be, in writing by the Company or such Holder from time to time. Effective upon receipt
of the fully executed Warrant and the initial transfer described in Article 5.4 above, all notices
to the Holder shall be addressed as follows until the Company receives notice of a change of
address in connection with a transfer or otherwise:
Oxford Finance Corporation
133 N. Fairfax Street
Alexandria, VA 22314
Attn: Michael J. Altenburger, Chief Financial Officer
Telephone: (703) 519-4900
Facsimile: (703) 519-5225
Notice to the Company shall be addressed as follows until the Holder receives notice of a change in
address:
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
Attn: Chief Executive Officer
Telephone: (858) 436-1400
Facsimile: (858) 436-1401
5.6 Waiver. This Warrant and any term hereof may be changed, waived, discharged or
terminated only by an instrument in writing signed by the party against which enforcement of such
change, waiver, discharge or termination is sought.
5.7 Attorneys Fees. In the event of any dispute between the parties concerning the
terms and provisions of this Warrant, the party prevailing in such dispute shall be entitled to
collect from the other party all costs incurred in such dispute, including reasonable attorneys
fees.
5.8 Automatic Conversion upon Expiration. In the event that, upon the Expiration
Date, the fair market value of one Share (or other security issuable upon the exercise hereof) as
determined in accordance with Section 1.3 above is greater than the Warrant Price in effect on such
date, then this Warrant shall automatically be deemed on and as of such date to be converted
pursuant to Section 1.2 above as to all Shares (or such other securities) for which it shall not
previously have been exercised or converted, and the Company shall promptly deliver a certificate
representing the Shares (or such other securities) issued upon such conversion to the Holder.
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5.9 Counterparts. This Warrant may be executed in counterparts, all of which together
shall constitute one and the same agreement.
5.10 Governing Law. This Warrant shall be governed by and construed in accordance
with the laws of the State of California, without giving effect to its principles regarding
conflicts of law.
[Remainder of page intentionally left blank; signature page follows]
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COMPANY
CADENCE PHARMACEUTICALS, INC.
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By:
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/s/ Theodore R. Schroeder |
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By: |
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/s/ David A. Socks |
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Name:
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Theodore R. Schroeder |
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David A. Socks |
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(Print)
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Title:
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President
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Title:
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Secretary |
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HOLDER
OXFORD FINANCE CORPORATION
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By: |
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/s/ Michael J. Altenburger |
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Michael J. Altenburger |
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Chief Financial Officer |
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APPENDIX 1
NOTICE OF EXERCISE
1. Holder elects to purchase shares of the Common/Series Preferred [strike
one] Stock of pursuant to the terms of the attached Warrant, and tenders payment
of the purchase price of the shares in full.
[or]
1. Holder elects to convert the attached Warrant into Shares/cash [strike one] in the manner
specified in the Warrant. This conversion is exercised for of the Shares
covered by the Warrant.
[Strike paragraph that does not apply.]
2. Please issue a certificate or certificates representing the shares in the name specified
below:
Holders Name
(Address)
3. By its execution below and for the benefit of the Company, Holder hereby restates each of
the representations and warranties in Article 4 of the Warrant as the date hereof.
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HOLDER: |
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APPENDIX 2
ASSIGNMENT
For value received, Oxford Finance Corporation hereby sells, assigns and
transfers unto
Name:
Address:
Tax ID:
that certain Warrant to Purchase Stock issued by Cadence Pharmaceuticals, Inc. (the
Company), on ___, 200___(the Warrant) together with all rights, title and
interest therein.
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By its
execution below, and for the benefit of the Company, ___ makes each of the
representations and warranties set forth in Article 4 of the Warrant and agrees to all other
provisions of the Warrant as of the date hereof.
exv10w3
EXHIBIT 10.3
CADENCE PHARMACEUTICALS, INC.
2004 EQUITY INCENTIVE AWARD PLAN
ARTICLE 1
PURPOSE
1.1 General. The purpose of the Cadence Pharmaceuticals, Inc. 2004 Equity Incentive
Award Plan (the Plan) is to promote the success and enhance the value of Cadence Pharmaceuticals,
Inc. (the Company) by linking the personal interests of the members of the Board, employees,
consultants and other independent advisors, and officers of the Company and any Parent or
Subsidiary, to those of Company stockholders and by providing such individuals with an incentive
for outstanding performance to generate superior returns to Company stockholders. The Plan is
further intended to provide flexibility to the Company in its ability to motivate, attract, and
retain the services of members of the Board, employees, consultants and other independent advisors,
and officers of the Company upon whose judgment, interest, and special effort the successful
conduct of the Companys operation is largely dependent.
ARTICLE 2
DEFINITIONS AND CONSTRUCTION
2.1 Definitions. The following words and phrases shall have the following meanings:
(a) Award means an Option, a Restricted Stock award, a Stock Appreciation Right award, a
Performance Share award, a Dividend Equivalents award, a Stock Payment award, a Restricted Stock
Unit award, or a Performance-Based Award granted to a Participant pursuant to the Plan.
(b) Award Agreement means any written or electronic agreement, contract, or other instrument
or document evidencing an Award.
(c) Board means the Board of Directors of the Company.
(d) Change of Control means (i) a merger or consolidation of the Company with or into any
other corporation or other entity or person or (ii) a sale, lease, exchange or other transfer in
one transaction or a series of related transactions of all or substantially all of the Companys
outstanding securities or all or substantially all of the Companys assets; provided, however, that
the following events shall not constitute a Change of Control: (A) a merger or consolidation of
the Company in which the holders of the voting securities of the Company immediately prior to the
merger or consolidation hold at least a majority of the voting securities in the successor
corporation immediately after the merger or consolidation; (B) a sale, lease, exchange or other
transaction in one transaction or a series of related transactions of all or substantially all of
the Companys assets to a wholly-owned subsidiary corporation; (C) a mere reincorporation of the
Company; or (D) a transaction undertaken for the sole purpose of creating a holding company that
will be owned in substantially the same proportion by the persons who held the Companys securities
immediately before such transaction.
(e) Code means the Internal Revenue Code of 1986, as amended, and the regulations issued
thereunder.
(f) Committee means the Board or a committee of the Board described in Article 12.
(g) Covered Employee means an Employee who is, or could be, a covered
employee within the meaning of Section 162(m) of the Code.
(h) Disability means a permanent and total disability within the meaning of Section 22(e)(3)
of the Code, as it may be amended from time to time.
(i) Dividend Equivalents means a right granted to a Participant pursuant to Article 8 to
receive the equivalent value (in cash or Stock) of dividends that otherwise would have been paid on
Stock which is subject to an Award.
(j) Employee means any officer or other employee (as defined in accordance with Section
3401(c) of the Code) of the Company or any Parent or Subsidiary. A person shall not cease to be an
Employee in the case of (i) any leave of absence approved by the Company or (ii) transfers between
locations of the Company or between the Company, any Parent or Subsidiary, or any successor. For
purposes of Incentive Stock Options, no such leave may exceed ninety days, unless reemployment upon
expiration of such leave is guaranteed by statute or contract. Neither service as a director nor
payment of a directors fee by the Company shall be sufficient, by itself, to constitute
employment by the Company.
(k) Exchange Act means the Securities Exchange Act of 1934, as amended.
(l) Fair Market Value shall mean, as of any date, the value of Stock determined as follows:
(i) If the Stock is listed on any established stock exchange or a national market system,
including without limitation the Nasdaq National Market or The Nasdaq SmallCap Market of The Nasdaq
Stock Market, its Fair Market Value shall be the closing sales price for such stock (or the closing
bid, if no sales were reported) as quoted on such exchange or system for the last market trading
day prior to the date of determination, as reported in The Wall Street Journal or such other source
as the Committee deems reliable;
(ii) If the Stock is regularly quoted by a recognized securities dealer but selling prices are
not reported, its Fair Market Value shall be the mean of the closing bid and asked prices for the
Stock on the date prior to the date of determination as reported in The Wall Street Journal or such
other source as the Committee deems reliable; or
(iii) In the absence of an established market for the Stock, the Fair Market Value
thereof shall be determined in good faith by the Committee.
(m) Incentive Stock Option means an Option that is intended to meet the requirements of
Section 422 of the Code or any successor provision thereto.
(n) Misconduct means the commission of any act of fraud, embezzlement or dishonesty by the
Participant, any unauthorized use or disclosure by such person of confidential information or trade
secrets of the Company (or any Parent or Subsidiary), or any other intentional misconduct by such
person adversely affecting the business or affairs of the Company (or any Parent or Subsidiary) in
a material manner. The foregoing definition shall not in any way preclude or restrict the right of
the Company (or any Parent or Subsidiary) to discharge or dismiss any Participant or other person
in the service of the Company (or any Parent or Subsidiary) for any other acts or omissions, but
such other acts or omissions shall not be deemed, for purposes of the Plan, to constitute grounds
for termination for Misconduct.
2
(o) Non-Employee Director means a member of the Board who qualifies as a Non-Employee
Director as defined in Rule 16b-3(b)(3) of the Exchange Act, or any successor definition adopted
by the Board under applicable law.
(p) Non-Qualified Stock Option means an Option that is not intended to be or otherwise does
not qualify as an Incentive Stock Option.
(q) Option means a right granted to a Participant pursuant to Article 5 of the Plan to
purchase a specified number of shares of Stock at a specified price during specified time periods.
An Option may be either an Incentive Stock Option or a Non-Qualified Stock Option.
(r) Parent means any corporation in an unbroken chain of corporations ending with the
Company if each of the corporations other than the Company then owns stock possessing 50% or more
of the total combined voting power of all classes of stock in one of the other corporations in such
chain at the relevant time, including after the Effective Date (as defined in Section 13.1).
(s) Participant means a person who, as a member of the Board, consultant to the Company or
any Parent or Subsidiary or Employee, has been granted an Award pursuant to the Plan.
(t) Performance-Based Award means an Award granted to selected Covered Employees, but which
is subject to the terms and conditions set forth in Article 9.
(u) Performance Criteria means the criteria that the Committee selects for purposes of
establishing the Performance Goal or Performance Goals for a Participant for a Performance Period.
The Performance Criteria that will be used to establish Performance Goals are limited to the
following: net earnings (either before or after interest, taxes, depreciation and amortization),
net losses, sales or revenue, operating earnings, operating cash flow, return on net assets, return
on stockholders equity, return on assets, return on capital, stockholder returns, gross or net
profit margin, earnings per share, price per share of Stock, and market share, any of which may be
measured either in absolute terms or as compared to any incremental increase or as compared to
results of a peer group.
(v) Performance Goals means, for a Performance Period, the goals established in writing by
the Committee for the Performance Period based upon the Performance Criteria. Depending on the
Performance Criteria used to establish such Performance Goals, the Performance Goals may be
expressed in terms of overall Company performance or the performance of a division, business unit,
or an individual. The Committee, in its discretion, may adjust or modify the calculation of
Performance Goals for such Performance Period in order to prevent the dilution or enlargement of
the rights of Participants (i) in the event of, or in anticipation of, any unusual or extraordinary
corporate item, transaction, event, or development, or (ii) in recognition of, or in anticipation
of, any other unusual or nonrecurring events affecting the Company, or the financial statements of
the Company, or in response to, or in anticipation of, changes in applicable laws, regulations,
accounting principles, or business conditions.
(w) Performance Period means the one or more periods of time, which may be of varying and
overlapping durations, as the Committee may select, over which the attainment of one or more
Performance Goals will be measured for the purpose of determining a Participants right to, and the
payment of, a Performance-Based Award.
(x) Performance Share means a right granted to a Participant pursuant to Article 8, to
receive cash, Stock, or other Awards, the payment of which is contingent upon achieving certain
performance goals established by the Committee.
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(y) Plan means this Cadence Pharmaceuticals, Inc. 2004 Equity Incentive Award Plan, as it
may be amended from time to time.
(z) Public Trading Date means the first date upon which Stock is listed upon notice of
issuance on any securities exchange or designated upon notice of issuance as a national market
security on an interdealer quotation system.
(aa) Qualified Performance-Based Compensation means any compensation that is intended to
qualify as qualified performance-based compensation as described in Section 162(m)(4)(C) of the
Code.
(bb) Restricted Stock means Stock awarded to a Participant pursuant to Article 6 that is
subject to certain restrictions and to risk of forfeiture.
(cc) Restricted Stock Unit means a right to receive a share of Stock during specified time
periods pursuant to Article 8.
(dd) Securities Act means the Securities Act of 1933, as amended.
(ee) Stock means the common stock of the Company and such other securities of the Company
that may be substituted for Stock pursuant to Article 11.
(ff) Stock Appreciation Right or SAR means a right granted pursuant to Article 7 to
receive a payment equal to the excess of the Fair Market Value of a specified number of shares of
Stock on the date the SAR is exercised over the Fair Market Value on the date the SAR was granted
as set forth in the applicable Award Agreement.
(gg) Stock Payment means (a) a payment in the form of shares of Stock, or (b) an option or
other right to purchase shares of Stock, as part of any bonus, deferred compensation or other
arrangement, made in lieu of all or any portion of the compensation, granted pursuant to Article 8.
(hh) Subsidiary means any corporation or other entity of which a majority of the outstanding
voting stock or voting power is beneficially owned directly or indirectly by the Company at the
relevant time, including after the Effective Date (as defined in Section 13.1).
ARTICLE 3
SHARES SUBJECT TO THE PLAN
3.1 Number of Shares.
(a) Subject to Article 11, the aggregate number of shares of Stock which may be issued or
transferred pursuant to Awards under the Plan shall be 4,500,000 shares.
(b) To the extent that an Award terminates, expires, or lapses for any reason, any shares of
Stock subject to the Award shall again be available for the grant of an Award pursuant to the Plan.
Additionally, any shares of Stock tendered or withheld to satisfy the grant or exercise price or
tax withholding obligation pursuant to any Award shall again be available for the grant of an Award
pursuant to the Plan. To the extent permitted by applicable law or any exchange rule, shares of
Stock issued in assumption of, or in substitution for, any outstanding awards of any entity
acquired in any form of combination by the Company or any Parent or Subsidiary shall not be counted
against shares of Stock available for grant pursuant to this Plan. If shares of Stock issued
pursuant to Awards are repurchased by
4
the Company at no less than their original purchase price, such shares of Stock shall become
available for future grant under the Plan (unless the Plan has terminated).
(c) Notwithstanding the provisions of this Section 3.1, no shares of Stock may again be
optioned, granted or awarded if such action would cause an Incentive Stock Option to fail to
qualify as an Incentive Stock Option under Code Section 422.
3.2 Stock Distributed. Any Stock distributed pursuant to an Award may consist, in
whole or in part, of authorized and unissued Stock, treasury Stock or, on and after the Public
Trading Date, Stock purchased on the open market.
3.3 Limitation on Number of Shares Subject to Awards. Notwithstanding any provision
in the Plan to the contrary, and subject to Article 11, on and after the Public Trading Date and
upon expiration of any transition period provided for under Section 162(m) of the Code, the maximum
number of shares of Stock with respect to one or more Awards that may be granted to any one
Participant during a calendar year shall be 2,250,000.
ARTICLE 4
ELIGIBILITY AND PARTICIPATION
4.1 Eligibility.
(a) General. Persons eligible to participate in this Plan include all Employees, consultants
to the Company or any Parent or Subsidiary and all members of the Board, as determined by the
Committee.
(b) Foreign Participants. In order to assure the viability of Awards granted to Participants
employed in foreign countries, the Committee may provide for such special terms, as it may consider
necessary or appropriate to accommodate differences in local law, tax policy, or custom. Moreover,
the Committee may approve such supplements to, or amendments, restatements, or alternative versions
of, the Plan as it may consider necessary or appropriate for such purposes without thereby
affecting the terms of the Plan as in effect for any other purpose; provided, however, that no such
supplements, amendments, restatements, or alternative versions shall increase the share limitations
contained in Sections 3.1 and 3.3 of the Plan.
4.2 Actual Participation. Subject to the provisions of the Plan, the Committee may,
from time to time, select from among all eligible individuals, those to whom Awards shall be
granted and shall determine the nature and amount of each Award. No individual shall have any
right to be granted an Award pursuant to this Plan.
ARTICLE 5
STOCK OPTIONS
5.1 General. The Committee is authorized to grant Options to Participants on the
following terms and conditions:
(a) Exercise Price. The exercise price per share of Stock subject to an Option shall be
determined by the Committee and set forth in the Award Agreement; provided that the exercise price
for any Option shall not be less than par value of a share of Stock on the date of grant.
(b) Time And Conditions Of Exercise. The Committee shall determine the time or
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times at which an Option may be exercised in whole or in part, provided that the term of any
Option granted under the Plan shall not exceed ten years. The Committee shall also determine the
performance or other conditions, if any, that must be satisfied before all or part of an Option may
be exercised.
(c) Payment. The Committee shall determine the methods by which the exercise price of an
Option may be paid, the form of payment, including, without limitation:
(1) cash,
(2) on and after the Public Trading Date, shares of Stock held for longer than six months
having a Fair Market Value on the date of delivery equal to the aggregate exercise price of the
Option or exercised portion thereof,
(3) other property acceptable to the Committee, or
(4) on and after the Public Trading Date, delivery of a notice that the Participant has placed
a market sell order with a broker with respect to shares of Stock then issuable upon exercise of
the Option, and that the broker has been directed to pay a sufficient portion of the net proceeds
of the sale to the Company in satisfaction of the Option exercise price, provided that payment of
such proceeds is then made to the Company upon settlement of such sale).
The Committee shall also determine the methods by which shares of Stock shall be delivered or
deemed to be delivered to Participants. The Committee may permit any Participant to pay the option
exercise price or the purchase price for shares of Stock under an Award by delivering a
full-recourse, interest bearing promissory note payable in one or more installments and secured by
the purchased shares, as long as the portion of the option exercise price or purchase price, as
applicable, which is equal to the par value of the shares purchased thereby is paid in cash or
other legal consideration permitted by applicable law. In no event, however, may the maximum
credit available to the Participant exceed the sum of (i) the aggregate option exercise price or
purchase price payable for the purchased shares (less the par value of those shares) plus (ii) any
Federal, state and local income and employment tax liability incurred by the Participant in
connection with the option exercise or share purchase; provided, however, that prior to the first
date on which the Company has filed a registration statement under the Securities Act to register
the public offering of securities of the Company under the Securities Act, then, to the extent that
any director or executive officer of the Company, as defined under Rule 3b-7 promulgated under the
Exchange Act, has outstanding a promissory note or other pending mode of payment for shares under
the Plan, and the Company has reasonably determined that to permit such promissory note or other
pending mode of payment to remain outstanding would be unlawful under the Exchange Act or any other
law, then such note or other pending mode of payment must be immediately paid to the Company in
full or replaced by a mode of payment provided for under the Plan that is acceptable to the Company
and reasonably determined by it to be lawful under the Exchange Act or any other applicable law.
(d) Evidence Of Grant. All Options shall be evidenced by a written Award Agreement between
the Company and the Participant. The Award Agreement shall include such additional provisions as
may be specified by the Committee.
5.2 Incentive Stock Options. Incentive Stock Options shall be granted only to
employees (as defined in accordance with Section 3401(c) of the Code) of the Company or a
Subsidiary which constitutes a subsidiary corporation of the Company within Section 424(f) of the
Code or a Parent which constitutes a parent corporation of the Company within the meaning of
Section 424(e) of the Code and the terms of any Incentive Stock Options granted pursuant to the
Plan must comply with the following additional provisions of this Section 5.2:
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(a) Exercise Price. The exercise price per share of Stock shall be set by the Committee,
provided that the exercise price for any Incentive Stock Option shall not be less than 100% of the
Fair Market Value on the date of grant.
(b) Expiration Of Option. An Incentive Stock Option may not be exercised to any extent by
anyone after the first to occur of the following events:
(1) Ten years from the date it is granted, unless an earlier time is set in the Award
Agreement.
(2) One year after the date of the Participants termination of employment or service on
account of Disability or death, unless in the case of death a shorter or longer period is
designated in the Award Agreement. Upon the Participants Disability or death, any Incentive Stock
Options exercisable at the Participants Disability or death may be exercised by the Participants
legal representative or representatives, by the person or persons entitled to do so pursuant to the
Participants last will and testament, or, if the Participant fails to make testamentary
disposition of such Incentive Stock Option or dies intestate, by the person or persons entitled to
receive the Incentive Stock Option pursuant to the applicable laws of descent and distribution.
(c) Individual Dollar Limitation. The aggregate Fair Market Value (determined as of the time
the Option is granted) of all shares of Stock with respect to which Incentive Stock Options are
first exercisable by a Participant in any calendar year may not exceed $100,000 or such other
limitation as imposed by Section 422(d) of the Code, or any successor provision. To the extent
that Incentive Stock Options are first exercisable by a Participant in excess of such limitation,
the excess shall be considered Non-Qualified Stock Options.
(d) Ten Percent Owners. An Incentive Stock Option shall be granted to any individual who, at
the date of grant, owns stock possessing more than ten percent of the total combined voting power
of all classes of stock of the Company or any subsidiary corporation of the Company or parent
corporation of the Company (each within the meaning of Section 424 of the Code) only if such
Option is granted at a price that is not less than 110% of Fair Market Value on the date of grant
and the Option is exercisable for no more than five years from the date of grant.
(e) Transfer Restriction. The Participant shall give the Company prompt notice of any
disposition of shares of Stock acquired by exercise of an Incentive Stock Option within (1) two
years from the date of grant of such Incentive Stock Option or (2) one year after the transfer of
such shares of Stock to the Participant.
(f) Expiration Of Incentive Stock Options. No Award of an Incentive Stock Option may be made
pursuant to this Plan after the tenth anniversary of the Effective Date.
(g) Right To Exercise. During a Participants lifetime, an Incentive Stock Option may be
exercised only by the Participant.
5.3 Early Exercisability. The Committee may provide in the terms of a Participants
Award Agreement that the Participant may, at any time before the Participants status as an
Employee, member of the Board or consultant or other independent advisor to the Company terminates,
exercise the Option(s) granted to such Participant in whole or in part prior to the full vesting of
the Option(s); provided, however, shares of Stock acquired upon exercise of an Option which has not
fully vested may be subject to any forfeiture, transfer or other restrictions as the Committee may
determine in its sole discretion.
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ARTICLE 6
RESTRICTED STOCK AWARDS
6.1 Grant of Restricted Stock. The Committee is authorized to make Awards of
Restricted Stock to any Participant selected by the Committee in such amounts and subject to such
terms and conditions as determined by the Committee. All Awards of Restricted Stock shall be
evidenced by a Restricted Stock Award Agreement.
6.2 Issuance and Restrictions. Restricted Stock shall be subject to such restrictions
on transferability and other restrictions as the Committee may impose (including, without
limitation, limitations on the right to vote Restricted Stock or the right to receive dividends on
the Restricted Stock). These restrictions may lapse separately or in combination at such times,
pursuant to such circumstances, in such installments, or otherwise, as the Committee determines at
the time of the grant of the Award or thereafter.
6.3 Forfeiture. Except as otherwise determined by the Committee at the time of the
grant of the Award or thereafter, upon termination of employment or service during the applicable
restriction period, Restricted Stock that is at that time subject to restrictions shall be
forfeited; provided, however, that the Committee may provide in any Restricted Stock Award
Agreement that restrictions or forfeiture conditions relating to Restricted Stock will be waived in
whole or in part in the event of terminations resulting from specified causes, and the Committee
may in other cases waive in whole or in part restrictions or forfeiture conditions relating to
Restricted Stock.
6.4 Certificates For Restricted Stock. Restricted Stock granted pursuant to the Plan
may be evidenced in such manner as the Committee shall determine. If certificates representing
shares of Restricted Stock are registered in the name of the Participant, certificates must bear an
appropriate legend referring to the terms, conditions, and restrictions applicable to such
Restricted Stock, and the Company may, at its discretion, retain physical possession of the
certificate until such time as all applicable restrictions lapse.
ARTICLE 7
STOCK APPRECIATION RIGHTS
7.1 Grant of Stock Appreciation Rights. A Stock Appreciation Right may be granted to
any Participant selected by the Committee. A Stock Appreciation Right may be granted (a) in
connection and simultaneously with the grant of an Option, (b) with respect to a previously granted
Option, or (c) independent of an Option. A Stock Appreciation Right shall be subject to such terms
and conditions not inconsistent with the Plan as the Committee shall impose and shall be evidenced
by an Award Agreement.
7.2 Coupled Stock Appreciation Rights.
(a) A Coupled Stock Appreciation Right (CSAR) shall be related to a particular Option and
shall be exercisable only when and to the extent the related Option is exercisable.
(b) A CSAR may be granted to a Participant for no more than the number of shares subject to
the simultaneously or previously granted Option to which it is coupled.
(c) A CSAR shall entitle the Participant (or other person entitled to exercise the Option
pursuant to the Plan) to surrender to the Company unexercised a portion of the Option to which the
CSAR relates (to the extent then exercisable pursuant to its terms) and to receive from the Company
8
in exchange therefor an amount determined by multiplying the difference obtained by
subtracting the Option exercise price from the Fair Market Value of a share of Stock on the date of
exercise of the CSAR by the number of shares of Stock with respect to which the CSAR shall have
been exercised, subject to any limitations the Committee may impose.
7.3 Independent Stock Appreciation Rights.
(a) An Independent Stock Appreciation Right (ISAR) shall be unrelated to any Option and
shall have a term set by the Committee. An ISAR shall be exercisable in such installments as the
Committee may determine. An ISAR shall cover such number of shares of Stock as the Committee may
determine. The exercise price per share of Stock subject to each ISAR shall be set by the
Committee; provided, however, that, the Committee in its sole and absolute discretion may provide
that the ISAR may be exercised subsequent to a termination of employment or service, as applicable,
or following a Change of Control of the Company, or because of the Participants retirement, death
or Disability, or otherwise.
(b) An ISAR shall entitle the Participant (or other person entitled to exercise the ISAR
pursuant to the Plan) to exercise all or a specified portion of the ISAR (to the extent then
exercisable pursuant to its terms) and to receive from the Company an amount determined by
multiplying the difference obtained by subtracting the exercise price per share of the ISAR from
the Fair Market Value of a share of Stock on the date of exercise of the ISAR by the number of
shares of Stock with respect to which the ISAR shall have been exercised, subject to any
limitations the Committee may impose.
7.4 Payment and Limitations on Exercise.
Payment of the amounts determined under Section 7.2(c) and 7.3(b) above shall be in cash, in
Stock (based on its Fair Market Value as of the date the Stock Appreciation Right is exercised) or
a combination of both, as determined by the Committee.
ARTICLE 8
OTHER TYPES OF AWARDS
8.1 Performance Share Awards. Any Participant selected by the Committee may be
granted one or more Performance Share awards which may be denominated in a number of shares of
Stock or in a dollar value of shares of Stock and which may be linked to any one or more of the
Performance Criteria or other specific performance criteria determined appropriate by the
Committee, in each case on a specified date or dates or over any period or periods determined by
the Committee. In making such determinations, the Committee shall consider (among such other
factors as it deems relevant in light of the specific type of award) the contributions,
responsibilities and other compensation of the particular Participant.
8.2 Dividend Equivalents.
Any Participant selected by the Committee may be granted Dividend Equivalents based on the
dividends declared on the shares of Stock that are subject to any Award, to be credited as of
dividend payment dates, during the period between the date the Award is granted and the date the
Award is exercised, vests or expires, as determined by the Committee. Such Dividend Equivalents
shall be converted to cash or additional shares of Stock by such formula and at such time and
subject to such limitations as may be determined by the Committee.
9
8.3 Stock Payments. Any Participant selected by the Committee may receive Stock
Payments in the manner determined from time to time by the Committee. The number of shares shall
be determined by the Committee and may be based upon the Performance Criteria or other specific
performance criteria determined appropriate by the Committee, determined on the date such Stock
Payment is made or on any date thereafter.
8.4 Restricted Stock Units. Any Participant selected by the Committee may be granted
an award of Restricted Stock Units in the manner determined from time to time by the Committee.
The number of Restricted Stock Units shall be determined by the Committee and may be linked to the
Performance Criteria or other specific performance criteria determined to be appropriate by the
Committee, in each case on a specified date or dates or over any period or periods determined by
the Committee. Stock underlying a Restricted Stock Unit will not be issued until the Restricted
Stock Unit has vested, pursuant to a vesting schedule or performance criteria set by the Committee.
Unless otherwise provided by the Committee, a Participant awarded Restricted Stock Units shall
have no rights as a Company stockholder with respect to such Restricted Stock Units until such time
as the Restricted Stock Units have vested and the Stock underlying the Restricted Stock Units has
been issued.
8.5 Term. The term of any Award of Performance Shares, Dividend Equivalents, Stock
Payments or Restricted Stock Units shall be set by the Committee in its discretion.
8.6 Exercise or Purchase Price. The Committee may establish the exercise or purchase
price of any Award of Performance Shares, Restricted Stock Units or Stock Payments; provided,
however, that such price shall not be less than the par value of a share of Stock, unless otherwise
permitted by applicable state law.
8.7 Exercise Upon Termination of Employment or Service. An Award of Performance
Shares, Dividend Equivalents, Restricted Stock Units and Stock Payments shall only be exercisable
or payable while the Participant is an Employee, consultant to the Company or a member of the
Board, as applicable; provided, however, that the Committee in its sole and absolute discretion may
provide in the Award Agreement or otherwise that an Award of Performance Shares, Dividend
Equivalents, Stock Payments or Restricted Stock Units may be exercised or paid subsequent to a
termination of employment or service, as applicable, upon or following a Change of Control of the
Company, or because of the Participants retirement, death, Disability, or otherwise.
8.8 Form of Payment. Payments with respect to any Awards granted under this Article 8
shall be made in cash, in Stock or a combination of both, as determined by the Committee.
8.9 Award Agreement. All Awards under this Article 8 shall be subject to such
additional terms and conditions as determined by the Committee and shall be evidenced by a written
Award Agreement.
ARTICLE 9
PERFORMANCE-BASED AWARDS
9.1 Purpose. The purpose of this Article 9 is to provide the Committee the ability to
qualify Awards as Qualified Performance-Based Compensation. If the Committee, in its discretion,
decides to grant a Performance-Based Award to a Covered Employee, the provisions of this Article 9 shall
control over any contrary provision of the Plan; provided, however, that the Committee may in its
discretion grant Awards to Covered Employees that are based on Performance Criteria or Performance
Goals but that do not satisfy the requirements of this Article 9.
10
9.2 Applicability. This Article 9 shall apply only to those Covered Employees
selected by the Committee to receive Performance-Based Awards which are intended to be Qualified
Performance Based Compensation. The designation of a Covered Employee as a Participant for a
Performance Period shall not in any manner entitle the Participant to receive an Award for the
period. Moreover, designation of a Covered Employee as a Participant for a particular Performance
Period shall not require designation of such Covered Employee as a Participant in any subsequent
Performance Period and designation of one Covered Employee as a Participant shall not require
designation of any other Covered Employees as a Participant in such period or in any other period.
9.3 Procedures With Respect to Performance-Based Awards. To the extent necessary to
comply with the Qualified Performance-Based Compensation requirements of Section 162(m)(4)(C) of
the Code, with respect to any Award granted under Articles 6 and 8 which may be granted to one or
more Covered Employees, no later than ninety days following the commencement of any fiscal year in
question or any other designated fiscal period or period of service (or such other time as may be
required or permitted by Section 162(m) of the Code), the Committee shall, in writing, (i)
designate one or more Covered Employees, (ii) select the Performance Criteria applicable to the
Performance Period, (iii) establish the Performance Goals, and amounts of such Awards, as
applicable, which may be earned for such Performance Period, and (iv) specify the relationship
between Performance Criteria and the Performance Goals and the amounts of such Awards, as
applicable, to be earned by each Covered Employee for such Performance Period. Following the
completion of each Performance Period, the Committee shall certify in writing whether the
applicable Performance Goals have been achieved for such Performance Period. In determining the
amount earned by a Covered Employee, the Committee shall have the right to reduce or eliminate (but
not to increase) the amount payable at a given level of performance to take into account additional
factors that the Committee may deem relevant to the assessment of individual or corporate
performance for the Performance Period.
9.4 Payment of Performance-Based Awards. A Participant shall be eligible to receive
payment pursuant to a Performance-Based Award for a Performance Period only if the Performance
Goals for such period are achieved. In determining the amount earned under a Performance-Based
Award, the Committee may reduce or eliminate the amount of the Performance-Based Award earned for
the Performance Period, if in its sole and absolute discretion, such reduction or elimination is
appropriate.
9.5 Additional Limitations. Notwithstanding any other provision of the Plan, any
Award which is granted to a Covered Employee and is intended to constitute Qualified
Performance-Based Compensation shall be subject to any additional limitations set forth in Section
162(m) of the Code (including any amendment to Section 162(m) of the Code) or any regulations or
rulings issued thereunder that are requirements for qualification as qualified performance-based
compensation as described in Section 162(m)(4)(C) of the Code, and the Plan shall be deemed amended
to the extent necessary to conform to such requirements.
ARTICLE 10
PROVISIONS APPLICABLE TO AWARDS
10.1 Stand-Alone and Tandem Awards. Awards granted pursuant to the Plan may, in the
discretion of the Committee, be granted either alone, in addition to, or in tandem with, any other
Award granted pursuant to the Plan. Awards granted in addition to or in tandem with other Awards
may be granted either at the same time as or at a different time from the grant of such other Awards.
10.2 Award Agreement. Awards under the Plan shall be evidenced by Award Agreements
that set forth the terms, conditions and limitations for each Award which may include the term of
an Award, the provisions applicable in the event the Participants employment or service
terminates, and the
11
Companys authority to unilaterally or bilaterally amend, modify, suspend,
cancel or rescind an Award.
10.3 Limits on Transfer. No right or interest of a Participant in any Award may be
pledged, encumbered, or hypothecated to or in favor of any party other than the Company or a Parent
or Subsidiary, or shall be subject to any lien, obligation, or liability of such Participant to any
other party other than the Company or a Parent or Subsidiary. Except as otherwise provided by the
Committee, no Award shall be assigned, transferred, or otherwise disposed of by a Participant other
than by will or the laws of descent and distribution. The Committee by express provision in the
Award or an amendment thereto may permit an Award (other than an Incentive Stock Option) to be
transferred to, exercised by and paid to certain persons or entities related to the Participant,
including but not limited to members of the Participants family, charitable institutions, or
trusts or other entities whose beneficiaries or beneficial owners are members of the Participants
family and/or charitable institutions, or to such other persons or entities as may be expressly
approved by the Committee, pursuant to such conditions and procedures as the Committee may
establish. Any permitted transfer may be subject to the condition that the Committee receive
evidence satisfactory to it that the transfer is being made for estate and/or tax planning purposes
(or to a blind trust in connection with the Participants termination of employment or service
with the Company or a Parent or Subsidiary to assume a position with a governmental, charitable,
educational or similar non-profit institution) and on a basis consistent with the Companys lawful
issue of securities.
10.4 Beneficiaries. Notwithstanding Section 10.3, a Participant may, in the manner
determined by the Committee, designate a beneficiary to exercise the rights of the Participant and
to receive any distribution with respect to any Award upon the Participants death. A beneficiary,
legal guardian, legal representative, or other person claiming any rights pursuant to the Plan is
subject to all terms and conditions of the Plan and any Award Agreement applicable to the
Participant, except to the extent the Plan and Award Agreement otherwise provide, and to any
additional restrictions deemed necessary or appropriate by the Committee. If the Participant is
married and resides in a community property state, a designation of a person other than the
Participants spouse as his beneficiary with respect to more than 50% of the Participants interest
in the Award shall not be effective without the prior written consent of the Participants spouse.
If no beneficiary has been designated or survives the Participant, payment shall be made to the
person entitled thereto pursuant to the Participants will or the laws of descent and distribution.
Subject to the foregoing, a beneficiary designation may be changed or revoked by a Participant at
any time provided the change or revocation is filed with the Committee.
10.5 Stock Certificates; Book Entry Procedures.
(a) The Company shall not be required to issue or deliver any certificates evidencing shares
of Stock pursuant to the exercise of any Award, unless and until the Board has determined, with
advice of counsel, that the issuance and delivery of such certificates is in compliance with all
applicable laws, regulations of governmental authorities and, if applicable, the requirements of
any exchange on which the shares of Stock are listed or traded. All Stock certificates delivered
pursuant to the Plan are subject to any stop-transfer orders and other restrictions as the
Committee deems necessary or advisable to comply with federal, state, or foreign jurisdiction,
securities or other laws, rules and regulations and the rules of any national securities exchange
or automated quotation system on which the Stock is listed, quoted, or traded. The Committee may
place legends on any Stock certificate to reference restrictions applicable to the Stock. In
addition to the terms and conditions provided herein, the Board may require that a Participant make
such reasonable covenants, agreements, and representations as the Board, in its
discretion, deems advisable in order to comply with any such laws, regulations, or
requirements. The Committee shall have the right to require any Participant to comply with any
timing or other restrictions with respect to the settlement or exercise of any Award, including a
window-period limitation, as may be imposed in the discretion of the Committee.
12
(b) Notwithstanding any other provision of the Plan, unless otherwise determined by
the Committee or required by applicable law, rule or regulation, the Company shall not deliver to
any Participant certificates evidencing shares of Stock issued in connection with any Award or
exercise of any Award and instead such shares of Stock will be recorded in the books of the Company
(or as applicable, its transfer agent or stock plan administrator).
ARTICLE 11
CHANGES IN CAPITAL STRUCTURE
11.1 Adjustments.
(a) In the event of any stock dividend, stock split, combination or exchange of shares,
merger, consolidation, spin-off, recapitalization or other distribution (other than normal cash
dividends) of Company assets to stockholders, or any other change affecting the shares of Stock or
the share price of the Stock, the Committee shall make such proportionate adjustments, if any, as
the Committee in its discretion may deem appropriate to reflect such change with respect to (i) the
aggregate number and type of shares that may be issued under the Plan (including, but not limited
to, adjustments of the limitations in Sections 3.1 and 3.3); (ii) the terms and conditions of any
outstanding Awards (including, without limitation, any applicable performance targets or criteria
with respect thereto); and (iii) the grant or exercise price per share for any outstanding Awards
under the Plan. Any adjustment affecting an Award intended as Qualified Performance-Based
Compensation shall be made consistent with the requirements of Section 162(m) of the Code.
(b) In the event of any transaction or event described in Section 11.1(a) or any unusual or
nonrecurring transactions or events affecting the Company, any affiliate of the Company, or the
financial statements of the Company or any affiliate (including without limitation any Change of
Control), or of changes in applicable laws, regulations or accounting principles, and whenever the
Committee determines that action is appropriate in order to prevent the dilution or enlargement of
the benefits or potential benefits intended to be made available under the Plan or with respect to
any Award under the Plan, to facilitate such transactions or events or to give effect to such
changes in laws, regulations or principles, the Committee, in its sole discretion and on such terms
and conditions as it deems appropriate, either by amendment of the terms of any outstanding Awards
or by action taken prior to the occurrence of such transaction or event and either automatically or
upon the Participants request, is hereby authorized to take any one or more of the following
actions:
(i) To provide for either (A) termination of any such Award in exchange for an amount of cash
and/or other property, if any, equal to the amount that would have been attained upon the exercise
of such Award or realization of the Participants rights (and, for the avoidance of doubt, if as of
the date of the occurrence of the transaction or event described in this Section 11.1(b) the
Committee determines in good faith that no amount would have been attained upon the exercise of
such Award or realization of the Participants rights, then such Award may be terminated by the
Company without payment) or (B) the replacement of such Award with other rights or property
selected by the Committee in its sole discretion;
(ii) To provide that such Award be assumed by the successor or survivor corporation, or a
Parent or Subsidiary thereof, or shall be substituted for by similar options, rights or
awards covering the stock of the successor or survivor corporation, or a Parent or Subsidiary
thereof, with appropriate adjustments as to the number and kind of shares and prices;
(iii) To make adjustments in the number and type of shares of Stock (or other securities or
property) subject to outstanding Awards, and in the number and kind of outstanding
13
Restricted Stock
or Restricted Stock Units and/or in the terms and conditions of (including the grant or exercise
price), and the criteria included in, outstanding options, rights and awards and options, rights
and awards which may be granted in the future;
(iv) To provide that such Award shall be exercisable or payable or fully vested with respect
to all shares covered thereby, notwithstanding anything to the contrary in the Plan or the
applicable Award Agreement; and
(v) To provide that the Award cannot vest, be exercised or become payable after such event.
11.2 Acceleration Upon a Change of Control. Notwithstanding anything to the contrary
contained in Section 11.1, if a Change of Control occurs and a Participants Awards are not assumed
by the surviving or successor entity or its Parent or Subsidiary and such successor does not
substitute substantially similar awards for those outstanding under the Plan, such Awards shall
become fully exercisable and/or payable as applicable, and all forfeiture restrictions on such
Awards shall lapse. Upon, or in anticipation of, a Change of Control, the Committee may cause any
and all Awards outstanding hereunder to terminate at a specific time in the future and shall give
each Participant the right to exercise such Awards during a period of time as the Committee, in its
sole and absolute discretion, shall determine. The Committee shall have sole discretion to
determine whether an Award has been assumed by the surviving or successor entity or its Parent or
Subsidiary or whether such successor has substituted substantially similar awards for those
outstanding under the Plan in connection with a Change of Control.
11.3 Outstanding Awards Certain Mergers. Subject to any required action by the
stockholders of the Company, in the event that the Company shall be the surviving corporation in
any merger or consolidation (except a merger or consolidation as a result of which the holders of
shares of Stock receive securities of another corporation), each Award outstanding on the date of
such merger or consolidation shall pertain to and apply to the securities that a holder of the
number of shares of Stock subject to such Award would have received in such merger or consolidation
and the exercise price shall be appropriately adjusted.
11.4 Outstanding Awards Other Changes. In the event of any other change in the
capitalization of the Company or corporate change other than those specifically referred to in this
Article 11, the Committee may, in its absolute discretion, make such adjustments in the number and
class of shares subject to Awards outstanding on the date on which such change occurs and in the
per share grant or exercise price of each Award as the Committee may consider appropriate to
prevent dilution or enlargement of rights.
11.5 No Other Rights. Except as expressly provided in the Plan, no Participant shall
have any rights by reason of any subdivision or consolidation of shares of stock of any class, the
payment of any dividend, any increase or decrease in the number of shares of stock of any class or
any dissolution, liquidation, merger, or consolidation of the Company or any other corporation.
Except as expressly provided in the Plan or pursuant to action of the Committee under the Plan, no
issuance by the Company of shares of stock of any class, or securities convertible into shares of
stock of any class, shall affect, and no adjustment by reason thereof shall be made with respect
to, the number of shares of Stock subject to an Award or the grant or exercise price of any Award.
14
ARTICLE 12
ADMINISTRATION
12.1 Committee. Unless and until the Board delegates administration to a committee as
set forth below, the Plan shall be administered by the Board. The Board may delegate
administration of the Plan to a Committee or Committees of one or more members of the Board, and
the term Committee shall apply to any person or persons whom at the time has the authority to
administer the Plan. If administration is delegated to a Committee, the Committee shall have, in
connection with the administration of the Plan, the powers theretofore possessed by the Board,
including the power to delegate to a subcommittee any of the administrative powers the Committee is
authorized to exercise (and references in this Plan to the Board shall thereafter be to the
Committee or subcommittee), subject, however, to such resolutions, not inconsistent with the
provisions of the Plan, as may be adopted from time to time by the Board. Notwithstanding the
foregoing, however, from and after the Public Trading Date, a Committee of the Board shall
administer the Plan and the Committee shall consist solely of two or more members of the Board each
of whom is both an outside director, within the meaning of Section 162(m) of the Code, and a
Non-Employee Director. Within the scope of such authority, the Board or the Committee may (i)
delegate to a committee of one or more members of the Board who are not outside directors, within
the meaning of Section 162(m) of the Code the authority to grant awards under the Plan to eligible
persons who are either (1) not then covered employees, within the meaning of Section 162(m) of
the Code and are not expected to be covered employees at the time of recognition of income
resulting from such award or (2) not persons with respect to whom the Company wishes to comply with
Section 162(m) of the Code and/or (ii) delegate to a committee of one or more members of the Board
who are not Non-Employee Directors, the authority to grant awards under the Plan to eligible
persons who are not then subject to Section 16 of the Exchange Act. The Board may abolish the
Committee at any time and/or revest in the Board the administration of the Plan. Appointment of
Committee members shall be effective upon acceptance of appointment. Committee members may resign
at any time by delivering written notice to the Board. Vacancies in the Committee may only be
filled by the Board. Notwithstanding anything to the contrary, the full Board shall conduct the
administration of the Plan with respect to Awards granted to directors and with respect to any
individual subject to Section 16 of the Exchange Act; provided, however, that the Board will have
only the right to ratify any grants with respect to Awards which are intended to be Qualified
Performance Based Compensation issued to individuals who are subject to Section 16 of the Exchange
Act in order to exempt such grants under the provisions of Rule 16b-3 of the Exchange Act.
12.2 Action by the Committee. A majority of the Committee shall constitute a quorum.
The acts of a majority of the members present at any meeting at which a quorum is present, and acts
approved in writing by a majority of the Committee in lieu of a meeting shall be deemed the acts of
the Committee. Each member of the Committee is entitled to, in good faith, rely or act upon any
report or other information furnished to that member by any officer or other employee of the
Company or any Parent or Subsidiary, the Companys independent certified public accountants, or any
executive compensation consultant or other professional retained by the Company to assist in the
administration of the Plan.
12.3 Authority of Committee. Subject to any specific designation in the Plan, the
Committee has the exclusive power, authority and discretion to:
(a) Designate Participants to receive Awards;
(b) Determine the type or types of Awards to be granted to each Participant;
(c) Determine the number of Awards to be granted and the number of shares of Stock to which an
Award will relate;
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(d) Determine the terms and conditions of any Award granted pursuant to the Plan, including,
but not limited to, the exercise price, grant price, or purchase price, any reload provision, any
restrictions or limitations on the Award, any schedule for lapse of forfeiture restrictions or
restrictions on the exercisability of an Award, and accelerations or waivers thereof, any
provisions related to non-competition and recapture of gain on an Award, based in each case on such
considerations as the Committee in its sole discretion determines; provided, however, that the
Committee shall not have the authority to accelerate the vesting or waive the forfeiture of any
Performance-Based Awards;
(e) Determine whether, to what extent, and pursuant to what circumstances an Award may be
settled in, or the exercise price of an Award may be paid in, cash, Stock, other Awards, or other
property, or an Award may be canceled, forfeited, or surrendered;
(f) Prescribe the form of each Award Agreement, which need not be identical for each
Participant;
(g) Decide all other matters that must be determined in connection with an Award;
(h) Establish, adopt, or revise any rules and regulations as it may deem necessary or
advisable to administer the Plan;
(i) Interpret the terms of, and any matter arising pursuant to, the Plan or any Award
Agreement; and
(j) Make all other decisions and determinations that may be required pursuant to the Plan or
as the Committee deems necessary or advisable to administer the Plan.
12.4 Decisions Binding. The Committees interpretation of the Plan, any Awards
granted pursuant to the Plan, any Award Agreement and all decisions and determinations by the
Committee with respect to the Plan are final, binding, and conclusive on all parties.
ARTICLE 13
EFFECTIVE AND EXPIRATION DATE
13.1 Effective Date. The Plan will be submitted for the approval of the Companys
stockholders within twelve months after the date of the Boards initial adoption of the Plan (the
Effective Date). Awards may be granted or awarded prior to such stockholder approval, provided
that such Awards shall not be exercisable, shall not vest and the restrictions thereon shall not
lapse prior to the time when the Plan is approved by the stockholders, and provided further that if
such approval has not been obtained at the end of said twelve-month period, all Awards previously
granted or awarded under the Plan shall thereupon be canceled and become null and void.
13.2 Expiration Date. The Plan will expire on, and no Award may be granted pursuant
to the Plan after, the earlier of (A) the tenth anniversary of (i) the Effective Date or (ii) the
date this Plan is approved by the Companys stockholders; (B) the date on which all
shares available for issuance under the Plan shall have been issued as vested shares; or (C) the
termination of all outstanding options in connection with a Change of Control. Any Awards that are
outstanding on the tenth anniversary of the Effective Date shall remain in force according to the
terms of the Plan and the applicable Award Agreement.
16
ARTICLE 14
AMENDMENT, MODIFICATION, AND TERMINATION
14.1 Amendment, Modification, and Termination. With the approval of the Board, at any
time and from time to time, the Committee may terminate, amend or modify the Plan; provided,
however, that to the extent necessary and desirable to comply with any applicable law, regulation,
or stock exchange rule, the Company shall obtain stockholder approval of any Plan amendment in such
a manner and to such a degree as required. The Committee shall have the authority to effect, at
any time and from time to time, with the consent of the affected Option holders, the cancellation
of any or all outstanding Options under the Plan and to grant in substitution therefor new options
covering the same or different number of shares of Stock but with an exercise price per share based
on the Fair Market Value per share of Stock on the new option grant date.
14.2 Awards Previously Granted. No termination, amendment, or modification of the
Plan shall adversely affect in any material way any Award previously granted pursuant to the Plan
without the prior written consent of the Participant.
ARTICLE 15
GENERAL PROVISIONS
15.1 No Rights to Awards. No Participant, employee, or other person shall have any
claim to be granted any Award pursuant to the Plan, and neither the Company nor the Committee is
obligated to treat Participants, employees, and other persons uniformly.
15.2 No Stockholders Rights. No Award gives the Participant any of the rights of a
stockholder of the Company unless and until shares of Stock are in fact issued to such person in
connection with such Award.
15.3 Withholding. The Company or any Parent or Subsidiary shall have the authority
and the right to deduct or withhold, or require a Participant to remit to the Company, an amount
sufficient to satisfy federal, state, local and foreign taxes (including the Participants payroll,
social security or other tax obligations) required by law to be withheld with respect to any
taxable event concerning a Participant arising as a result of this Plan. The Committee may in its
discretion and in satisfaction of the foregoing requirement allow a Participant to elect to have
the Company withhold shares of Stock otherwise issuable under an Award (or allow the return of
shares of Stock) having a Fair Market Value equal to the sums required to be withheld.
Notwithstanding any other provision of the Plan, the number of shares of Stock which may be
withheld with respect to the issuance, vesting, exercise or payment of any Award (or which may be
repurchased from the Participant of such Award within six months after such shares of Stock were
acquired by the Participant from the Company) in order to satisfy the Participants federal, state,
local and foreign tax liabilities with respect to the issuance, vesting, exercise or payment of the
Award shall be limited to the number of shares which have a Fair Market Value on the date of
withholding or repurchase equal to the aggregate amount of such liabilities based on the minimum
statutory withholding rates for federal, state, local and foreign tax purposes that are applicable
to such taxable income.
15.4 No Right to Employment or Services. Nothing in the Plan or any Award Agreement
shall interfere with or limit in any way the right of the Company or any Parent or Subsidiary to
terminate any Participants employment or services at any time, nor confer upon any Participant any
right to continue in the employ or service of the Company or any Parent or Subsidiary.
15.5 Unfunded Status of Awards. The Plan is intended to be an unfunded plan
for incentive compensation. With respect to any payments not yet made to a Participant pursuant to
an Award, nothing
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contained in the Plan or any Award Agreement shall give the Participant any rights that are
greater than those of a general creditor of the Company or any Parent or Subsidiary.
15.6 Indemnification. To the extent allowable pursuant to applicable law, each member
of the Committee or of the Board shall be indemnified and held harmless by the Company from any
loss, cost, liability, or expense that may be imposed upon or reasonably incurred by such member in
connection with or resulting from any claim, action, suit, or proceeding to which he or she may be
a party or in which he or she may be involved by reason of any action or failure to act pursuant to
the Plan and against and from any and all amounts paid by him or her in satisfaction of judgment in
such action, suit, or proceeding against him or her, provided he or she gives the Company an
opportunity, at its own expense, to handle and defend the same before he or she undertakes to
handle and defend it on his or her own behalf. The foregoing right of indemnification shall not be
exclusive of any other rights of indemnification to which such persons may be entitled pursuant to
the Companys Certificate of Incorporation or Bylaws, as a matter of law, or otherwise, or any
power that the Company may have to indemnify them or hold them harmless.
15.7 Relationship to Other Benefits. No payment pursuant to the Plan shall be taken
into account in determining any benefits pursuant to any pension, retirement, savings, profit
sharing, group insurance, welfare or other benefit plan of the Company or any Parent or Subsidiary
except to the extent otherwise expressly provided in writing in such other plan or an agreement
thereunder.
15.8 Expenses. The expenses of administering the Plan shall be borne by the Company
and its Subsidiaries.
15.9 Titles and Headings. The titles and headings of the Sections in the Plan are for
convenience of reference only and, in the event of any conflict, the text of the Plan, rather than
such titles or headings, shall control.
15.10 Fractional Shares. No fractional shares of Stock shall be issued and the
Committee shall determine, in its discretion, whether cash shall be given in lieu of fractional
shares or whether such fractional shares shall be eliminated by rounding up or down as appropriate.
15.11 Limitations Applicable to Section 16 Persons. Notwithstanding any other
provision of the Plan, the Plan, and any Award granted or awarded to any Participant who is then
subject to Section 16 of the Exchange Act, shall be subject to any additional limitations set forth
in any applicable exemptive rule under Section 16 of the Exchange Act (including any amendment to
Rule 16b-3 of the Exchange Act) that are requirements for the application of such exemptive rule.
To the extent permitted by applicable law, the Plan and Awards granted or awarded hereunder shall
be deemed amended to the extent necessary to conform to such applicable exemptive rule.
15.12 Government And Other Regulations. The obligation of the Company to make payment
of awards in Stock or otherwise shall be subject to all applicable laws, rules, and regulations,
and to such approvals by government agencies as may be required. The Company shall be under no
obligation to register pursuant to the Securities Act any of the shares of Stock paid pursuant to
the Plan. If the shares paid pursuant to the Plan may in certain circumstances be exempt from
registration pursuant to the Securities Act, the Company may restrict the transfer of such shares
in such manner as it deems advisable to ensure the availability of any such exemption.
15.13 Governing Law. The Plan and all Award Agreements shall be construed in
accordance with and governed by the laws of the State of California.
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15.14 Compliance with California Securities Laws. Prior to the Public Trading Date,
this Plan is intended to comply with Section 25102(o) of the California Corporations Code and the
regulations issued thereunder. If any of the provisions contained in this Plan are inconsistent
with such requirements, such provisions shall be deemed null and void. The invalidity of any
provision of this Plan shall not affect the validity or enforceability of any other provision of
this Plan, which shall remain in full force and effect.
15.15 Appendices. The Committee may approve such supplements to, or amendments, or
appendices to, the Plan as it may consider necessary or appropriate for purposes of compliance with
applicable laws or otherwise and such supplements, amendments or appendices shall be considered a
part of the Plan; provided, however, that no such supplements, amendments or appendices shall
increase the share limitations contained in Sections 3.1 and 3.3 of the Plan.
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APPENDIX I
TO
CADENCE PHARMACEUTICALS, INC.
2004 EQUITY INCENTIVE AWARD PLAN
California State Securities Law Compliance
Notwithstanding anything to the contrary contained in the Plan, the provisions set forth in
this Appendix shall apply to all Awards granted under the Cadence Pharmaceuticals, Inc. 2004 Equity
Incentive Award Plan (the Plan) prior to the Public Trading Date. This Appendix shall be of no
further force and effect on or after the Public Trading Date. Definitions as set out in Section 2
of the Plan are applicable to this Appendix.
The purpose of this Appendix is to set forth those provisions of the Plan necessary to comply
with Section 25102(o) of the California Corporations Code and the regulations issued thereunder.
If any of the provisions contained in this Appendix are inconsistent with such requirements, such
provisions shall be deemed null and void. The invalidity of any provision of this Appendix shall
not affect the validity or enforceability of any other provision of this Appendix, which shall
remain in full force and effect.
References to Articles set forth in this Appendix are to those Articles of the Plan.
1.1 Term of Awards. The term of each Award shall be no more than ten years from the
date of grant thereof.
2.1 Award Exercise or Purchase Price. Except as provided in Article 11, the per share
exercise or purchase price for the Stock to be issued upon exercise of an Award shall be such price
as is determined by the Administrator, but shall be subject to the following:
In the case of an Award:
(a) granted to a Participant who, at the time of grant of such Award, owns stock representing
more than 10% of the voting power of all classes of stock of the Company or any parent (as defined
in Section 175 of the California Corporations Code) or Subsidiary, the per share exercise or
purchase price shall be no less than 110% of the Fair Market Value per share on the date of the
grant (100% in the case of an Award other than an Option); and
(b) granted to any other Participant, the per share exercise or purchase price shall be no
less than 85% of the Fair Market Value per share on the date of grant.
Notwithstanding the foregoing, Awards may be granted with a per share exercise or purchase
price other than as required above pursuant to a merger or other corporate transaction.
3.1 Exercisability. Except with regard to Awards granted to officers, members of the
Board, managers or consultants, in no event shall an Award granted hereunder become vested and
exercisable at a rate of less than 20% per year over five years from the date the Award is granted,
subject to reasonable conditions, such as continuing to be a service provider.
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4.1 Exercisability Following Termination of Relationship as a Service Provider.
(a) Termination Other Than Death, Disability or Misconduct. If a Participants employment or
service terminates for any reason other than by reason of the Participants Disability, death or
Misconduct, such Participant may exercise his or her Award within such period of time as is
specified in the Award Agreement to the extent that the Award is vested on the date of termination;
provided, however, that prior to the Public Trading Date, such period of time shall not be less
than thirty days (but in no event later than the expiration of the term of the Award as set forth
in the Award Agreement). In the absence of a specified time in the Award Agreement, the Option
shall remain exercisable for three months following the Participants termination for any reason
other than death, Disability or Misconduct.
(b) Death. If a Participants employment or service terminates as a result of the
Participants death, the Award may be exercised within such period of time as is specified in the
Award Agreement; provided, however, that prior to the Public Trading Date, such period of time
shall not be less than six months (but in no event later than the expiration of the term of such
Award as set forth in the Notice of Grant), by the Participants estate or by a person who acquires
the right to exercise the Award by bequest or inheritance, but only to the extent that the Award is
vested on the date of death. In the absence of a specified time in the Award Agreement, the Award
shall remain exercisable for twelve months following the Participants termination for death.
(c) Disability of Participant. If a Participants employment or service terminates as a
result of the Participants Disability, the Participant may exercise his or her Award within such
period of time as is specified in the Award Agreement to the extent the Award is vested on the date
of termination; provided, however, that prior to the Public Trading Date, such period of time shall
not be less than six months (but in no event later than the expiration of the term of such Award as
set forth in the Award Agreement). In the absence of a specified time in the Award Agreement, the
Award shall remain exercisable for twelve months following the Participants termination for
Disability.
(d) Misconduct of Participant. If a Participants employment or service terminates as a
result of the Participants Misconduct or should Participant otherwise engage in Misconduct while
holding one or more outstanding Awards under the Plan, the Award shall terminate immediately and
cease to remain outstanding.
5.1 Repurchase Provisions. In the event the Committee provides that the Company may
repurchase Stock acquired upon exercise of an Award upon the occurrence of certain specified
events, including, without limitation, termination of a Participants employment or service,
divorce, bankruptcy or insolvency, then any such repurchase right shall be set forth in the
applicable Award Agreement or in another agreement referred to in such agreement and, to the extent
required by Section 260.140.41 and Section 260.140.42 of Title 10 of the California Code of
Regulations (or any successor regulation), any such repurchase right set forth in an Award granted
prior to the Public Trading Date to a person who is not an officer, member of the Board, manager or
consultant shall be upon the following terms: (i) if the repurchase option gives the Company the
right to repurchase the shares upon the Participants termination of employment or service at not
less than the Fair Market Value of the shares to be purchased on the date of termination of
employment or service, then (A) the right to repurchase shall be exercised for cash or cancellation
of purchase money indebtedness for the shares within ninety days of termination of employment or
service (or in the case of shares issued upon exercise of Awards after such date of termination,
within ninety days after the date of the exercise) or such longer period as may be agreed to by the
Administrator and the Participant and (B) the right terminates on the Public Trading Date; and (ii)
if the repurchase option gives the Company the right to repurchase the Stock upon the Participants
termination of employment or service at the original purchase price for such Stock, then (A) the
right to
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repurchase at the original purchase price shall lapse at the rate of at least 20% of the
shares per year over five (5) years from the date the Award is granted (without respect to the date
the Award was exercised or became exercisable) and (B) the right to repurchase shall be exercised
for cash or cancellation of purchase money indebtedness for the shares within ninety days of
termination of employment or service (or, in the case of shares issued upon exercise of Awards,
after such date of termination, within ninety days after the date of the exercise) or such longer
period as may be agreed to by the Company and the Participant.
6.1 Information Rights. Prior to the Public Trading Date and to the extent required
by Section 260.140.46 of Title 10 of the California Code of Regulations, the Company shall provide
to each Participant and to each individual who acquires Stock pursuant to the Plan, not less
frequently than annually during the period such Participant has one or more Awards outstanding,
and, in the case of an individual who acquires Stock pursuant to the Plan, during the period such
individual owns such Stock, copies of annual financial statements. Notwithstanding the preceding
sentence, the Company shall not be required to provide such statements to key employees whose
duties in connection with the Company assure their access to equivalent information.
7.1 Transferability. Prior to the Public Trading Date, no Award shall be assigned,
transferred, or otherwise disposed of by a Participant other than by will or the laws of descent
and distribution or, with respect to Awards other than Incentive Stock Options, as permitted by
Rule 701 of the Securities Act.
8.1 Limitation on Number of Shares. Prior to the Public Trading Date, at no time
shall the total number of shares of Stock issuable upon exercise of all outstanding Options under
the Plan and any shares of Stock provided for under any bonus or similar plan or agreement of the
Company exceed 30% of the then-outstanding shares of Stock of the Company, as calculated pursuant
to Section 260.140.45 of Title 10 of the California Code of Regulations (or any successor
regulation), unless a percentage higher than 30% is approved by at least two-thirds of the
outstanding securities of the Company entitled to vote. The number of shares of Stock which may be
issued or transferred pursuant to Awards under the Plan shall be reduced to the extent necessary to
comply with this provision.
22
CADENCE PHARMACEUTICALS, INC.
STOCK OPTION GRANT NOTICE AND STOCK OPTION AGREEMENT
UNDER THE 2004 EQUITY INCENTIVE AWARD PLAN
Cadence Pharmaceuticals, Inc. (the Company), pursuant to its 2004 Equity Incentive
Award Plan (the Plan), hereby grants to the Optionee listed below (Optionee), an option to
purchase the number of shares of the Companys Stock set forth below. This option is subject to
all of the terms and conditions as set forth herein and in the Stock Option Agreement and the Plan,
each of which are incorporated herein by reference. Unless otherwise defined herein, the terms
defined in the Plan shall have the same meanings in this Stock Option Agreement.
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Exercise Price per Share:
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$ per share |
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Total Exercise Price:
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Type of Option:
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o Incentive Stock Option o Non-Qualified Stock Option |
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Vesting Schedule:
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[25% of the shares of Stock subject to the Option (rounded down to the next whole number of shares) shall
vest one year after the Vesting Commencement Date, and 1/48th of the shares of Stock subject to
the Option (rounded down to the next whole number of shares) shall vest on the first day of each full month
thereafter, so that all of the shares subject to the Option shall be vested on the first day of the
48th month after the Vesting Commencement Date.] |
By his or her signature and the Companys signature below, Optionee agrees to be bound by the
terms and conditions of the Plan and the Stock Option Agreement attached hereto. Optionee has
reviewed the Stock Option Agreement and the Plan in their entirety, has had an opportunity to
obtain the advice of counsel prior to executing this option and fully understands all provisions of
this Grant Notice, the Stock Option Agreement and the Plan. Optionee hereby agrees to accept as
binding, conclusive and final all decisions or interpretations of the administrator of the Plan
upon any questions arising under the Plan or this option. Optionee further agrees to notify the
Company upon any change in the residence address indicated below.
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CADENCE PHARMACEUTICALS, INC.: |
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By:
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Address: 12730 High Bluff Drive, Suite 410 |
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CADENCE PHARMACEUTICALS, INC.
2004 EQUITY INCENTIVE AWARD PLAN
STOCK OPTION AGREEMENT
Pursuant to the Stock Option Grant Notice (Grant Notice) to which this Stock Option
Agreement (this Agreement) is attached, Cadence Pharmaceuticals, Inc. (the Company) has granted
to the Optionee an option under the Companys 2004 Equity Incentive Award Plan (the Plan) to
purchase the number of shares of Stock indicated in the Grant Notice at the exercise price
indicated in the Grant Notice.
ARTICLE I
GENERAL
Capitalized terms not specifically defined herein shall have the meanings specified in the
Plan. The Option is subject to the terms and conditions of the Plan which are incorporated herein
by reference.
ARTICLE II
GRANT OF OPTION
2.1 Grant of Option. In consideration of the Optionees agreement to remain in the
employ of the Company or its Parents or Subsidiaries and for other good and valuable consideration,
effective as of the Grant Date set forth in the Grant Notice (the Grant Date), the Company
irrevocably grants to the Optionee the Option to purchase any part or all of an aggregate of the
number of shares of Stock set forth in the Grant Notice, upon the terms and conditions set forth in
this Agreement. Unless designated as a Non-Qualified Stock Option in the Grant Notice, the Option
shall be an Incentive Stock Option to the maximum extent permitted by law.
2.2 Purchase Price. The purchase price of the shares of Stock subject to the Option
per share shall be as set forth in the Grant Notice, without commission or other charge; provided,
however, that if this Option is designated as an Incentive Stock Option the price per share of the
shares subject to the Option shall not be less than the greater of (i) 100% of the Fair Market
Value of a share of Stock on the Grant Date, or (ii) 110% of the Fair Market Value of a share of
Stock on the Grant Date in the case of an Optionee then owning (within the meaning of Section
424(d) of the Code) more than 10% of the total combined voting power of all classes of stock of the
Company or any subsidiary corporation of the Company or any parent corporation of the Company
(each within the meaning of Section 424 of the Code).
2.3 Consideration to the Company. In consideration of the granting of the Option by
the Company, the Optionee agrees to render faithful and efficient services to the Company or any
Parent or Subsidiary, with such duties and responsibilities as the Company shall from time to time
prescribe. Nothing in the Plan or this Agreement shall confer upon the Optionee any right to (a)
continue in the employ of the Company or any Parent or Subsidiary or shall interfere with or
restrict in any way the rights of the Company and its Parents or Subsidiaries, which are hereby
expressly reserved, to discharge the Optionee, if the Optionee is an Employee, or (b) continue to
provide services to the Company or any Parent or Subsidiary or shall interfere with or restrict in
any way the rights of the Company or its Parents or Subsidiaries, which are hereby expressly
reserved, to terminate the services of Optionee, if the Optionee is a consultant, at any time for
any reason whatsoever, with or without cause, except to the extent expressly provided otherwise in
a written agreement between the Company and the Optionee.
STOCK OPTION AGREEMENT PAGE 1
ARTICLE III
PERIOD OF EXERCISABILITY
3.1 Commencement of Exercisability.
(a) Subject to Sections 3.3 and 5.11, the Option shall become exercisable in such amounts and
at such times as are set forth in the Grant Notice.
(b) No portion of the Option which has not become exercisable at Termination of Service (as
defined below) shall thereafter become exercisable, except as may be otherwise provided by the
Committee or as set forth in a written agreement between the Company and the Optionee.
3.2 Duration of Exercisability. The installments provided for in the vesting schedule
set forth in the Grant Notice are cumulative. Each such installment which becomes exercisable
pursuant to Section 3.1 shall remain exercisable until it becomes unexercisable under Section 3.3.
3.3 Expiration of Option. The Option may not be exercised to any extent by anyone
after the first to occur of the following events:
(a) The expiration of ten years from the Grant Date; or
(b) If this Option is designated as an Incentive Stock Option and the Optionee owned (within
the meaning of Section 424(d) of the Code), at the time the Option was granted, more than 10% of
the total combined voting power of all classes of stock of the Company or any subsidiary
corporation of the Company or any parent corporation of the Company (each within the meaning of
Section 424 of the Code), the expiration of five years from the date the Option was granted; or
(c) The expiration of ninety days following the date of the Optionees Termination of Service,
unless such Termination of Service occurs by reason of the Optionees death, Disability or
Misconduct or as set forth in a written agreement with the Company; or
(d) The expiration of one year following the date of the Optionees Termination of Service by
reason of the Optionees death or Disability; or
(e) The Optionees Termination of Service as a result of the Optionees Misconduct or in the
event the Optionee otherwise engages in Misconduct while the Option is outstanding.
(f) For purposes of this Agreement, Termination of Service means the time when the service
relationship (whether as an Employee or a consultant) between the Optionee and the Company or any
Parent or Subsidiary is terminated for any reason, with or without cause, including, but not by way
of limitation, a termination by resignation, discharge, death, Disability or Misconduct; but
excluding (i) a termination where there is a simultaneous reemployment or continuing employment or
consultancy of the Optionee by the Company or any Subsidiary or Parent of the Company, (ii) at the
discretion of the Committee, a termination which results in a temporary severance of the
employee-employer relationship, and (iii) at the discretion of the Committee, a termination which
is followed by the simultaneous establishment of a consulting relationship by the Company or a
Parent or Subsidiary with the former Employee. The Committee, in its absolute discretion, shall
determine the effect of all matters and questions relating to Termination of Service for the
purposes of this Agreement, including, but not by way of limitation, the question of whether, for
Optionees who are Employees of the Company or any of its Parents or Subsidiaries, a Termination of
Service resulted from a discharge for cause, and all questions of whether particular leaves of
absence for Optionees who are Employees of the Company or any of its
STOCK OPTION AGREEMENT PAGE 2
Parents or Subsidiaries constitute Terminations of Service; provided, however, that, if this
Option is designated as an Incentive Stock Option, unless otherwise determined by the Committee in
its discretion, a leave of absence, change in status from an Employee to an independent contractor
or other change in the employee-employer relationship shall constitute a Termination of Service if,
and to the extent that, such leave of absence, change in status or other change interrupts
employment for the purposes of Section 422(a)(2) of the Code and the then applicable regulations
and revenue rulings under said Section. Notwithstanding any other provision of the Plan or this
Agreement, the Company or any Parent or Subsidiary has an absolute and unrestricted right to
terminate the Optionees employment and/or consultancy at any time for any reason whatsoever, with
or without cause, except to the extent expressly provided otherwise in a written agreement between
the Company and the Optionee.
3.4 Special Tax Consequences. The Optionee acknowledges that, to the extent that the
aggregate Fair Market Value of Stock with respect to which Incentive Stock Options (but without
regard to Section 422(d) of the Code), including the Option, are exercisable for the first time by
the Optionee during any calendar year (under the Plan and all other incentive stock option plans of
the Company, any subsidiary corporation of the Company and any parent corporation of the
Company (each within the meaning of Section 424 of the Code)) exceeds $100,000, the Option and such
other options shall be treated as not qualifying under Section 422 of the Code but rather shall be
taxed as Non-Qualified Stock Options. The Optionee further acknowledges that the rule set forth in
the preceding sentence shall be applied by taking options into account in the order in which they
were granted. For purposes of these rules, the Fair Market Value of Stock shall be determined as of
the time the option with respect to such Stock is granted.
ARTICLE IV
EXERCISE OF OPTION
4.1 Person Eligible to Exercise. Except as provided in Sections 5.2(b) and 5.2(c),
during the lifetime of the Optionee, only the Optionee may exercise the Option or any portion
thereof. After the death of the Optionee, any exercisable portion of the Option may, prior to the
time when the Option becomes unexercisable under Section 3.3, be exercised by the Optionees
beneficiary designated in accordance with Section 10.4 of the Plan. If no beneficiary has been
designated or survives the Optionee, the Option may be exercised by the person entitled to such
exercise pursuant to the Optionees will or the laws of descent and distribution.
4.2 Partial Exercise. Any exercisable portion of the Option or the entire Option, if
then wholly exercisable, may be exercised in whole or in part at any time prior to the time when
the Option or portion thereof becomes unexercisable under Section 3.3.
4.3 Manner of Exercise. The Option, or any exercisable portion thereof, may be
exercised solely by delivery to the Secretary of the Company or the Secretarys office of all of
the following prior to the time when the Option or such portion thereof becomes unexercisable under
Section 3.3:
(a) An exercise notice in writing signed by the Optionee or the other person then entitled to
exercise the Option or portion thereof, stating that the Option or portion thereof is thereby
exercised, such notice complying with all applicable rules established by the Committee. Such
notice shall be substantially in the form attached as Exhibit A (or such other form as is
prescribed by the Committee) (the Exercise Notice);
(b) (i) Full payment (in cash or by check) for the shares with respect to which the
Option or portion thereof is exercised, to the extent permitted under applicable laws; or
STOCK OPTION AGREEMENT PAGE 3
(ii) On and after the Public Trading Date, and with the consent of the Committee, such
payment may be made, in whole or in part, through the delivery of shares of Stock which have
been owned by the Optionee for at least six months, duly endorsed for transfer to the
Company with a Fair Market Value on the date of delivery equal to the aggregate exercise
price of the Option or exercised portion thereof; or
(iii) On and after the Public Trading Date, and to the extent permitted under
applicable laws, through the delivery of a notice that the Optionee has placed a market sell
order with a broker with respect to shares of Stock then issuable upon exercise of the
Option, and that the broker has been directed to pay a sufficient portion of the net
proceeds of the sale to the Company in satisfaction of the Option exercise price, provided,
that payment of such proceeds is made to the Company upon settlement of such sale; or
(iv) With the consent of the Committee, such payment may be made through the delivery
of a promissory note in accordance with the provisions of Section 4.3(f) below; or
(v) With the consent of the Committee, any combination of the consideration provided in
the foregoing subparagraphs (i), (ii), (iii) and (iv); and
(c) A bona fide written representation and agreement, in such form as is prescribed by the
Committee, signed by the Optionee or other person then entitled to exercise such Option or portion
thereof, stating that the shares of Stock are being acquired for the Optionees own account, for
investment and without any present intention of distributing or reselling said shares or any of
them except as may be permitted under the Securities Act and then applicable rules and regulations
thereunder, and that the Optionee or other person then entitled to exercise such Option or portion
thereof will indemnify the Company against and hold it free and harmless from any loss, damage,
expense or liability resulting to the Company if any sale or distribution of the shares by such
person is contrary to the representation and agreement referred to above. The Committee may, in
its absolute discretion, take whatever additional actions it deems appropriate to ensure the
observance and performance of such representation and agreement and to effect compliance with the
Securities Act and any other federal or state securities laws or regulations. Without limiting the
generality of the foregoing, the Committee may require an opinion of counsel acceptable to it to
the effect that any subsequent transfer of shares acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing Stock issued on exercise of the Option shall bear an appropriate legend referring to the
provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (c) shall, however, not be required
if the shares to be issued pursuant to such exercise have been registered under the Securities Act,
and such registration is then effective in respect of such shares; and
(d) Full payment to the Company (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option. With the
consent of the Committee, (i) shares of Stock owned by the Optionee for at least six months duly
endorsed for transfer or (ii) shares of Stock issuable to the Optionee upon exercise of the Option,
having a Fair Market Value at the date of Option exercise equal to the statutory minimum sums
required to be withheld, may be used to make all or part of such payment; and
(e) In the event the Option or portion thereof shall be exercised pursuant to Section 4.1 by
any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
STOCK OPTION AGREEMENT PAGE 4
(f) The Committee may permit the Optionee to pay the option exercise price for the shares
with respect to which the Option or portion thereof is exercised by delivering a
full-recourse, interest bearing promissory note payable in one or more installments and secured by
the purchased shares, as long as the portion of the option exercise price which is equal to the par
value of the shares purchased thereby is paid in cash or other legal consideration permitted by
applicable law. In no event, however, may the maximum credit available to the Optionee exceed the
sum of (i) the aggregate option exercise price or purchase price payable for the purchased shares
(less the par value of those shares) plus (ii) any Federal, state and local income and employment
tax liability incurred by the Optionee in connection with the option exercise or share purchase;
provided, however, that prior to the first date on which the Company has filed a registration
statement under the Securities Act to register the public offering of securities of the Company
under the Securities Act, then, to the extent that the Optionee is a director or executive officer
of the Company, as defined under Rule 3b-7 promulgated under the Exchange Act, and has outstanding
a promissory note or other pending mode of payment for shares under the Plan, and the Company has
reasonably determined that to permit such promissory note or other pending mode of payment to
remain outstanding would be unlawful under the Exchange Act or any other law, then such note or
other pending mode of payment must be immediately paid to the Company in full or replaced by a mode
of payment provided for under the Plan that is acceptable to the Company and reasonably determined
by it to be lawful under the Exchange Act or any other applicable law.
4.4 Conditions to Issuance of Stock Certificates. The shares of Stock deliverable
upon the exercise of the Option, or any portion thereof, may be either previously authorized but
unissued shares or issued shares which have then been reacquired by the Company. Such shares shall
be fully paid and nonassessable. The Company shall not be required to issue any shares of Stock
purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of the
following conditions:
(a) The admission of such shares to listing on all stock exchanges on which such Stock is then
listed; and
(b) The completion of any registration or other qualification of such shares under any state
or federal law or under rulings or regulations of the Securities and Exchange Commission or of any
other governmental regulatory body, which the Committee shall, in its absolute discretion, deem
necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by the Company of full payment for such shares, including payment of all
amounts which, under federal, state or local tax law, the Company (or other employer corporation)
is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
4.5 Rights as Stockholder; Book Entry Procedures. The holder of the Option shall not
be, nor have any of the rights or privileges of, a stockholder of the Company in respect of any
shares purchasable upon the exercise of any part of the Option unless and until such shares shall
have been issued by the Company to such holder. Notwithstanding any other provision of the Plan or
this Agreement, unless otherwise determined by the Committee or required by applicable law, rule or
regulation, the Company shall not deliver to the Optionee certificates evidencing shares of Stock
issued in
STOCK OPTION AGREEMENT PAGE 5
connection with the exercise of this Option and instead such shares of Stock will be
recorded in the books of the Company (or as applicable, its transfer agent or stock plan
administrator).
ARTICLE V
OTHER PROVISIONS
5.1 Administration. The Committee shall have the power to interpret the Plan and this
Agreement and to adopt such rules for the administration, interpretation and application of the
Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions
taken and all interpretations and determinations made by the Committee in good faith shall be final
and binding upon the Optionee, the Company and all other interested persons. No member of the
Committee shall be personally liable for any action, determination or interpretation made in good
faith with respect to the Plan, this Agreement or the Option. In its absolute discretion, the
Board may at any time and from time to time exercise any and all rights and duties of the Committee
under the Plan and this Agreement.
5.2 Option Not Transferable.
(a) Subject to Section 5.2(b), the Option may not be sold, pledged, assigned or transferred in
any manner other than by will or the laws of descent and distribution unless and until the Option
has been exercised, or the shares underlying such Option have been issued, and all restrictions
applicable to such shares have lapsed. Neither the Option nor any interest or right therein shall
be liable for the debts, contracts or engagements of the Optionee or his or her successors in
interest or shall be subject to disposition by transfer, alienation, anticipation, pledge,
encumbrance, assignment or any other means whether such disposition be voluntary or involuntary or
by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable
proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void
and of no effect, except to the extent that such disposition is permitted by the preceding
sentence.
(b) Notwithstanding any other provision in this Agreement, with the consent of the Committee
and to the extent the Option is designated as a Non-Qualified Stock Option, the Option may be
transferred to, exercised by and paid to certain persons or entities related to the Optionee,
including but not limited to members of the Optionees family, charitable institutes or trusts or
other entities whose beneficiaries or beneficial owners are members of the Optionees family or to
such other persons or entities as may be expressly approved by the Committee (each a Permitted
Transferee), pursuant to such conditions and procedures as the Committee may require.
(c) Unless transferred to a Permitted Transferee in accordance with Section 5.2(b), during the
lifetime of the Optionee, only the Optionee may exercise the Option or any portion thereof.
Subject to such conditions and procedures as the Committee may require, a Permitted Transferee may
exercise the Option or any portion thereof during the Optionees lifetime. After the death of the
Optionee, any exercisable portion of the Option may, prior to the time when the Option becomes
unexercisable under Section 3.3, be exercised by the Optionees beneficiary designated in
accordance with Section 10.4 of the Plan. If no beneficiary has been designated or survives the
Optionee, the Option may be exercised by the person entitled to such exercise pursuant to the
Optionees will or the laws of descent and distribution.
5.3 Lock-Up Period. The Optionee hereby agrees that, if so requested by the Company
or any representative of the underwriters (the Managing Underwriter) in connection with any
registration of the offering of any securities of the Company under the Securities Act, the
Optionee shall not sell or otherwise transfer any shares of Stock or other securities of the
Company during such period as may be requested in writing by the Managing Underwriter and agreed to
in writing by the Company (which
STOCK OPTION AGREEMENT PAGE 6
period shall not be longer than one hundred eighty days) (the
Market Standoff Period) following the effective date of a registration statement of the Company
filed under the Securities Act; provided, however, that such restriction shall apply only to the
first registration statement of the Company to become effective under the Securities Act that
includes securities to be sold on behalf of the Company to
the public in an underwritten public offering under the Securities Act.
5.4 Restrictive Legends and Stop-Transfer Orders.
(a) The share certificate or certificates, if issued, evidencing the shares of Stock purchased
hereunder shall be endorsed with any legends that may be required by state or federal securities
laws.
(b) The Optionee agrees that, in order to ensure compliance with the restrictions referred to
herein, the Company may issue appropriate stop transfer instructions to its transfer agent, if
any, and that, if the Company transfers its own securities, it may make appropriate notations to
the same effect in its own records.
(c) The Company shall not be required: (i) to transfer on its books any shares of Stock that
have been sold or otherwise transferred in violation of any of the provisions of this Agreement, or
(ii) to treat as owner of such shares of Stock or to accord the right to vote or pay dividends to
any purchaser or other transferee to whom such shares shall have been so transferred.
5.5 Shares to Be Reserved. The Company shall at all times during the term of the
Option reserve and keep available such number of shares of Stock as will be sufficient to satisfy
the requirements of this Agreement.
5.6 Notices. Any notice to be given under the terms of this Agreement to the Company
shall be addressed to the Company in care of the Secretary of the Company, and any notice to be
given to the Optionee shall be addressed to the Optionee at the address given beneath the
Optionees signature on the Grant Notice. By a notice given pursuant to this Section 5.6, either
party may hereafter designate a different address for notices to be given to that party. Any
notice which is required to be given to the Optionee shall, if the Optionee is then deceased, be
given to the Optionees designated beneficiary if any, or the person otherwise entitled to exercise
his or her Option pursuant to Section 4.1 by written notice under this Section 5.6. Any notice
shall be deemed duly given when sent via email or enclosed in a properly sealed envelope or wrapper
addressed as aforesaid and deposited (with postage prepaid) in a post office or branch post office
regularly maintained by the United States Postal Service.
5.7 Titles. Titles are provided herein for convenience only and are not to serve as a
basis for interpretation or construction of this Agreement.
5.8 Stockholder Approval. The Plan will be submitted for approval by the Companys
stockholders within twelve months after the date the Plan was initially adopted by the Board. The
Option may not be exercised to any extent by anyone prior to the time when the Plan is approved by
the stockholders, and if such approval has not been obtained by the end of said twelve month
period, the Option shall thereupon be canceled and become null and void.
5.9 Notification of Disposition. If this Option is designated as an Incentive Stock
Option, the Optionee shall give prompt notice to the Company of any disposition or other transfer
of any shares of stock acquired under this Agreement if such disposition or transfer is made (a)
within two years from the Grant Date with respect to such shares or (b) within one year after the
transfer of such shares to him. Such notice shall specify the date of such disposition or other
transfer and the amount realized, in cash,
STOCK OPTION AGREEMENT PAGE 7
other property, assumption of indebtedness or other
consideration, by the Optionee in such disposition or other transfer.
5.10 Construction. This Agreement shall be administered, interpreted and enforced
under the laws of the State of California without regard to conflicts of laws thereof.
5.11 Conformity to Securities Laws. The Optionee acknowledges that the Plan is
intended to conform to the extent necessary with all provisions of the Securities Act and the
Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange
Commission thereunder, and state securities laws and regulations. Notwithstanding anything herein
to the contrary, the Plan shall be administered, and the Option is granted and may be exercised,
only in such a manner as to conform to such laws, rules and regulations. To the extent permitted
by applicable law, the Plan and this Agreement shall be deemed amended to the extent necessary to
conform to such laws, rules and regulations.
5.12 Amendments. This Agreement may not be modified, amended or terminated except by
an instrument in writing, signed by the Optionee or such other person as may be permitted to
exercise the Option pursuant to Section 4.1 and by a duly authorized representative of the Company.
5.13 Restrictions on Shares. Optionee hereby agrees that shares of Stock purchased
upon the exercise of the Option shall be subject to such terms and conditions as the Committee
shall determined in its sole discretion, including, without limitation , restrictions on the
transferability of shares of Stock, the right of the Company to repurchase shares of Stock, and a
right of first refusal in favor of the Company with respect to permitted transfers of shares of
Stock. Such terms and conditions may, in the Committees sole discretion, be contained in the
Exercise Notice with respect to the Option or in such other agreement as the Committee shall
determine and which the Optionee hereby agrees to enter into at the request of the Company.
STOCK OPTION AGREEMENT PAGE 8
EXHIBIT A
TO GRANT NOTICE AND STOCK OPTION AGREEMENT
FORM OF EXERCISE NOTICE
Effective as of today, , , the undersigned (Optionee) hereby elects to
exercise Optionees option to purchase
shares of the Common Stock (the Shares) of
Cadence Pharmaceuticals, Inc. (the Company) under and pursuant to the Cadence Pharmaceuticals,
Inc. 2004 Equity Incentive Award Plan (the Plan) and the Grant Notice and Stock Option Agreement
dated , , (the Option Agreement). Capitalized terms used herein without
definition shall have the meanings given in the Option Agreement.
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Number of Shares as to which Option is
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Exercise Price per Share:
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Total Exercise Price:
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Certificate
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Cash Payment delivered
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$
(Representing the full Exercise
Price for the Shares, as well as any
applicable withholding tax) |
Type of Option: ¨ Incentive Stock Option ¨ Non-Qualified Stock Option
1. Representations of Optionee. Optionee acknowledges that Optionee has received,
read and understood the Plan and the Option Agreement. Optionee agrees to abide by and be bound by
their terms and conditions.
2. Rights as Stockholder. Until the Shares are issued (as evidenced by the
appropriate entry on the books of the Company or of a duly authorized transfer agent of the
Company), no right to vote or receive dividends or any other rights as a stockholder shall exist
with respect to Shares subject to the Option, notwithstanding the exercise of the Option. No
adjustment will be made for a dividend or other right for which the record date is prior to the
date the Shares are issued, except as provided in Article 11 of the Plan.
Optionee shall enjoy rights as a stockholder until such time as Optionee disposes of the
Shares or the Company and/or its assignee(s) exercises the Right of First Refusal hereunder. Upon
such exercise, Optionee shall have no further rights as a holder of the Shares so purchased except
the right to receive payment for the Shares so purchased in accordance with the provisions of this
Agreement, and Optionee shall forthwith cause the certificate(s), if any issued, evidencing the
Shares so purchased to be surrendered to the Company for transfer or cancellation.
EXERCISE NOTICE PAGE 1
3. Optionees Rights to Transfer Shares.
(a) Companys Right of First Refusal. Before any Shares held by Optionee or any
permitted transferee (each, a Holder) may be sold, pledged, assigned, hypothecated, transferred,
or otherwise disposed of (each, a Transfer), the Company or its assignee(s) shall have a right of
first refusal to purchase the Shares proposed to be Transferred on the terms and conditions set
forth in this Section (the Right of First Refusal). In the event that the Companys Bylaws
contain a right of first refusal with respect to the Shares, such right of first refusal shall
apply to the Shares to the extent such provisions are more restrictive than the Right of First
Refusal set forth in this Section.
(b) Notice of Proposed Transfer. In the event any Holder desires to Transfer any
Shares, the Holder shall deliver to the Company a written notice (the Notice) stating: (i) the
Holders bona fide intention to sell or otherwise Transfer such Shares; (ii) the name of each
proposed purchaser or other transferee (Proposed Transferee); (iii) the number of Shares to be
Transferred to each Proposed Transferee; and (iv) the price for which the Holder proposes to
Transfer the Shares (the Offered Price), and the Holder shall offer such Shares at the Offered
Price to the Company or its assignee(s).
(c) Exercise of Right of First Refusal. Within twenty-five days after receipt of the
Notice, the Company and/or its assignee(s) may elect in writing to purchase all, but not less than
all, of the Shares proposed to be Transferred to any one or more of the Proposed Transferees by
delivery of a written exercise notice to the Holder (a Company Notice). The purchase price will
be determined in accordance with subsection (d) below.
(d) Purchase Price. The purchase price (Purchase Price) for the Shares repurchased
under this Section shall be the Offered Price.
(e) Payment. Payment of the Purchase Price shall be made, at the option of the
Company or its assignee(s), in cash (by check), by cancellation of all or a portion of any
outstanding indebtedness of the Holder to the Company (or, in the case of repurchase by an
assignee, to the assignee), or by any combination thereof within five days after delivery of the
Company Notice or in the manner and at the times mutually agreed to by the Company and the Holder.
Should the Offered Price specified in the Notice be payable in property other than cash, the
Company shall have the right to pay the purchase price in the form of cash equal in amount to the
value of such property. If the Holder and the Company cannot agree on such cash value within ten
days after the Companys receipt of the Notice, the valuation shall be made by the Board. The
payment of the purchase price shall then be held on the later of (i) five days following delivery
of the Company Notice or (ii) five days after such valuation shall have been made.
(f) Holders Right to Transfer. If all or a portion of the Shares proposed in the
Notice to be Transferred are not purchased by the Company and/or its assignee(s) as provided in
this Section, then the Holder may sell or otherwise Transfer such Shares to that Proposed
Transferee at the Offered Price or at a higher price, provided that such sale or other Transfer is
consummated within sixty days after the date of the Notice and provided further that any such sale
or other Transfer is effected in accordance with any applicable securities laws and the Proposed
Transferee agrees in writing that the provisions of this Section shall continue to apply to the
Shares in the hands of such Proposed Transferee. If the Shares described in the Notice are not
Transferred to the Proposed Transferee within such sixty-day period, a new Notice shall be given to
the Company, and the Company and/or its assignees shall again be offered the Right of First Refusal
as provided herein before any Shares held by the Holder may be sold or otherwise Transferred.
(g) Exception for Certain Family Transfers. Anything to the contrary contained in
this Section notwithstanding, the Transfer of any or all of the Shares during the Optionees
lifetime or
EXERCISE NOTICE PAGE 2
upon the Optionees death by will or intestacy to the Optionees Immediate Family or a trust for
the benefit of the Optionees Immediate Family shall be exempt from the Right of First Refusal. As
used herein, Immediate Family shall mean spouse, lineal descendant or antecedent, father, mother,
brother or sister or stepchild (whether or not adopted). In such case, the transferee or other
recipient shall receive and hold the Shares so Transferred subject to the provisions of this
Section (including the Right of First Refusal) and the Restricted Stock Purchase Agreement, if
applicable, and there shall be no further Transfer of such Shares except in accordance with the
terms of this Section.
(h) Termination of Right of First Refusal. The Right of First Refusal shall terminate
as to all Shares upon the Public Trading Date.
(i) Transfer Restrictions. Any transfer or sale of the Shares is subject to
restrictions on transfer imposed by any applicable state and federal securities laws. Any Transfer
or attempted Transfer of any of the Shares not in accordance with the terms of this Agreement shall
be void and the Company may enforce the terms of this Agreement by stop transfer instructions or
similar actions by the Company and its agents or designees.
4. Tax Consultation. Optionee understands that Optionee may suffer adverse tax
consequences as a result of Optionees purchase or disposition of the Shares. Optionee represents
that Optionee has consulted with any tax consultants Optionee deems advisable in connection with
the purchase or disposition of the Shares and that Optionee is not relying on the Company for any
tax advice.
5. Restrictive Legends and Stop-Transfer Orders.
(a) Legends. Optionee understands and agrees that the Company shall cause any
certificates issued evidencing the Shares shall have the legends set forth below or legends
substantially equivalent thereto, together with any other legends that may be required by state or
federal securities laws:
THE SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (ACT), NOR HAVE THEY BEEN
REGISTERED OR QUALIFIED UNDER THE SECURITIES LAWS OF ANY STATE. NO
TRANSFER OF SUCH SECURITIES WILL BE PERMITTED UNLESS A REGISTRATION
STATEMENT UNDER THE ACT IS IN EFFECT AS TO SUCH TRANSFER, THE TRANSFER
IS MADE IN ACCORDANCE WITH RULE 144 UNDER THE ACT, OR IN THE OPINION OF
COUNSEL (WHICH MAY BE COUNSEL FOR THE COMPANY) REGISTRATION UNDER THE
ACT IS UNNECESSARY IN ORDER FOR SUCH TRANSFER TO COMPLY WITH THE ACT AND
WITH APPLICABLE STATE SECURITIES LAWS.
THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY IN
ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE
STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE
COMPANY. SUCH TRANSFER RESTRICTIONS ARE BINDING ON TRANSFEREES OF THESE
SHARES.
EXERCISE NOTICE PAGE 3
(b) Stop-Transfer Notices. Optionee agrees that, in order to ensure compliance with
the restrictions referred to herein, the Company may issue appropriate stop transfer instructions
to its transfer agent, if any, and that, if the Company transfers its own securities, it may make
appropriate notations to the same effect in its own records.
(c) Refusal to Transfer. The Company shall not be required (i) to transfer on its
books any Shares that have been sold or otherwise transferred in violation of any of the provisions
of this Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay
dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
6. Optionee Representations. Optionee hereby makes the following certifications and
representations with respect to the Shares listed above:
(a) Optionee is aware of the Companys business affairs and financial condition and has
acquired sufficient information about the Company to reach an informed and knowledgeable decision
to acquire the Shares. Optionee is acquiring these Shares for investment for Optionees own
account only and not with a view to, or for resale in connection with, any distribution thereof
within the meaning of the Securities Act.
(b) Optionee acknowledges and understands that the Shares constitute restricted securities
under the Securities Act and have not been registered under the Securities Act in reliance upon a
specific exemption therefrom, which exemption depends upon, among other things, the bona fide
nature of Optionees investment intent as expressed herein. Optionee understands that the Shares
must be held indefinitely unless they are subsequently registered under the Securities Act or an
exemption from such registration is available. Optionee further acknowledges and understands that
the Company is under no obligation to register the Shares. Optionee understands that the
certificate evidencing the Shares will be imprinted with a legend which prohibits the transfer of
the Shares unless they are registered or such registration is not required in the opinion of
counsel satisfactory to the Company and any other legend required under applicable state securities
laws.
(c) Optionee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under
the Securities Act, which, in substance, permit limited public resale of restricted securities
acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the
satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701
at the time of the grant of the Option to the Optionee, the exercise will be exempt from
registration under the Securities Act. In the event the Company becomes subject to the reporting
requirements of Section 13 or 15(d) of the Exchange Act, ninety days thereafter (or such longer
period as any market stand-off agreement may require) the securities exempt under Rule 701 may be
resold, subject to the satisfaction of certain of the conditions specified by Rule 144, including:
(i) the resale being made through a broker in an unsolicited brokers transaction or in
transactions directly with a market maker (as said term is defined under the Exchange Act); and, in
the case of an affiliate, (ii) the availability of certain public information about the Company,
(iii) the amount of securities being sold during any three month period not exceeding the
limitations specified in Rule 144(e), and (iv) the timely filing of a Form 144, if applicable.
(d) In the event that the Company does not qualify under Rule 701 at the time of grant of the
Option, then the securities may be resold in certain limited circumstances subject to the
provisions of Rule 144, which requires the resale to occur not less than one year after the later
of the date the securities were sold by the Company or the date the securities were sold by an
affiliate of the Company, within the meaning of Rule 144; and, in the case of acquisition of the
securities by an affiliate,
EXERCISE NOTICE PAGE 4
or by a non-affiliate who subsequently holds the securities less than two years, the
satisfaction of the conditions set forth in sections (i), (ii), (iii) and (iv) of paragraph (c)
above.
(e) Optionee further understands that in the event all of the applicable requirements of Rule
701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A,
or some other registration exemption will be required; and that, notwithstanding the fact that
Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has
expressed its opinion that persons proposing to sell private placement securities other than in a
registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden
of proof in establishing that an exemption from registration is available for such offers or sales,
and that such persons and their respective brokers who participate in such transactions do so at
their own risk. Optionee understands that no assurances can be given that any such other
registration exemption will be available in such event.
7. Successors and Assigns. The Company may assign any of its rights under this
Agreement to single or multiple assignees, and this Agreement shall inure to the benefit of the
successors and assigns of the Company. Subject to the restrictions on transfer herein set forth,
this Agreement shall be binding upon Optionee and his or her heirs, executors, administrators,
successors and assigns.
8. Interpretation. Any dispute regarding the interpretation of this Agreement shall
be submitted by Optionee or by the Company forthwith to the Committee, which shall review such
dispute at its next regular meeting. The resolution of such a dispute by the Administrator shall
be final and binding on the Company and on Optionee.
9. Governing Law; Severability. This Agreement shall be governed by and construed in
accordance with the laws of the State of California excluding that body of law pertaining to
conflicts of law. Should any provision of this Agreement be determined by a court of law to be
illegal or unenforceable, the other provisions shall nevertheless remain effective and shall remain
enforceable.
10. Notices. Any notice required or permitted hereunder shall be given in accordance
with the provisions set forth in Section 5.6 of the Option Agreement.
11. Further Instruments. The parties agree to execute such further instruments and to
take such further action as may be reasonably necessary to carry out the purposes and intent of
this Agreement.
12. Entire Agreement. The Plan and Option Agreement are incorporated herein by
reference. This Agreement, the Plan and the Option Agreement constitute the entire agreement of
the parties and supersede in their entirety all prior undertakings and agreements of the Company
and Optionee with respect to the subject matter hereof.
(Signature Page Follows)
EXERCISE NOTICE PAGE 5
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ACCEPTED BY: |
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SUBMITTED BY: |
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CADENCE PHARMACEUTICALS, INC. |
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OPTIONEE |
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By: |
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Name:
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Optionee
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Its:
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Address: |
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EXERCISE NOTICE PAGE 6
CADENCE PHARMACEUTICALS, INC.
STOCK OPTION GRANT NOTICE AND STOCK OPTION AGREEMENT
UNDER THE 2004 EQUITY INCENTIVE AWARD PLAN
Cadence Pharmaceuticals, Inc. (the Company), pursuant to its 2004 Equity Incentive
Award Plan (the Plan), hereby grants to the Optionee listed below (Optionee), an option to
purchase the number of shares of the Companys Stock set forth below. This option is subject to
all of the terms and conditions as set forth herein and in the Stock Option Agreement and the Plan,
each of which are incorporated herein by reference. Unless otherwise defined herein, the terms
defined in the Plan shall have the same meanings in this Stock Option Agreement.
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Optionee: |
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Grant Date: |
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Vesting Commencement Date: |
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Exercise Price per Share:
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$ |
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per share |
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Total Number of Shares Granted: |
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Total Exercise Price:
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$ |
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Type of Option:
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¨ Incentive Stock Option ¨ Non-Qualified Stock Option |
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Exercise Schedule:
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þ Early Exercise Permitted |
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Vesting Schedule:
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This Option is exercisable immediately, in whole or in part, at such times as are established by the
Committee, conditioned upon Optionee entering into a Restricted Stock Purchase Agreement with respect to any
unvested shares of Stock. The shares subject to this Option shall vest and/or be released from the
Companys Repurchase Option, as set forth in the Restricted Stock Purchase Agreement attached hereto as
Exhibit B (the Restricted Stock Purchase Agreement), according to the following schedule: |
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[25% of the shares of Stock subject to the Option (rounded down to the next whole number of shares) shall
vest one year after the Vesting Commencement Date, and 1/48th of the shares of Stock subject to
the Option (rounded down to the next whole number of shares) shall vest on the first day of each full month
thereafter, so that all of the shares subject to the Option shall be vested on the first day of the
48th month after the Vesting Commencement Date.] |
By his or her signature and the Companys signature below, Optionee agrees to be bound by the
terms and conditions of the Plan and the Stock Option Agreement attached hereto. Optionee has
reviewed the Stock Option Agreement and the Plan in their entirety, has had an opportunity to
obtain the advice of counsel prior to executing this option and fully understands all provisions of
this Grant Notice, the Stock Option Agreement and the Plan. Optionee hereby agrees to accept as
binding, conclusive and final all decisions or interpretations of the administrator of the Plan
upon any questions arising under the Plan or this option. Optionee further agrees to notify the
Company upon any change in the residence address indicated below.
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CADENCE PHARMACEUTICALS, INC.: |
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OPTIONEE: |
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By:
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Print Name: |
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Print Name: |
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Title: |
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Address:
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12730 High Bluff Drive, Suite 410
San Diego, CA 92130
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Address: |
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CADENCE PHARMACEUTICALS, INC.
2004 EQUITY INCENTIVE AWARD PLAN
STOCK OPTION AGREEMENT
Pursuant to the Stock Option Grant Notice (Grant Notice) to which this Stock Option
Agreement (this Agreement) is attached, Cadence Pharmaceuticals, Inc. (the Company) has granted
to the Optionee an option under the Companys 2004 Equity Incentive Award Plan (the Plan) to
purchase the number of shares of Stock indicated in the Grant Notice at the exercise price
indicated in the Grant Notice.
ARTICLE I
GENERAL
Capitalized terms not specifically defined herein shall have the meanings specified in the
Plan. The Option is subject to the terms and conditions of the Plan which are incorporated herein
by reference.
ARTICLE II
GRANT OF OPTION
2.1 Grant of Option. In consideration of the Optionees agreement to remain in the
employ of the Company or its Parents or Subsidiaries and for other good and valuable consideration,
effective as of the Grant Date set forth in the Grant Notice (the Grant Date), the Company
irrevocably grants to the Optionee the Option to purchase any part or all of an aggregate of the
number of shares of Stock set forth in the Grant Notice, upon the terms and conditions set forth in
this Agreement. Unless designated as a Non-Qualified Stock Option in the Grant Notice, the Option
shall be an Incentive Stock Option to the maximum extent permitted by law.
2.2 Purchase Price. The purchase price of the shares of Stock subject to the Option
per share shall be as set forth in the Grant Notice, without commission or other charge; provided,
however, that if this Option is designated as an Incentive Stock Option the price per share of the
shares subject to the Option shall not be less than the greater of (i) 100% of the Fair Market
Value of a share of Stock on the Grant Date, or (ii) 110% of the Fair Market Value of a share of
Stock on the Grant Date in the case of an Optionee then owning (within the meaning of Section
424(d) of the Code) more than 10% of the total combined voting power of all classes of stock of the
Company or any subsidiary corporation of the Company or any parent corporation of the Company
(each within the meaning of Section 424 of the Code).
2.3 Consideration to the Company. In consideration of the granting of the Option by
the Company, the Optionee agrees to render faithful and efficient services to the Company or any
Parent or Subsidiary, with such duties and responsibilities as the Company shall from time to time
prescribe. Nothing in the Plan or this Agreement shall confer upon the Optionee any right to (a)
continue in the employ of the Company or any Parent or Subsidiary or shall interfere with or
restrict in any way the rights of the Company and its Parents or Subsidiaries, which are hereby
expressly reserved, to discharge the Optionee, if the Optionee is an Employee, or (b) continue to
provide services to the Company or any Parent or Subsidiary or shall interfere with or restrict in
any way the rights of the Company or its Parents or Subsidiaries, which are hereby expressly
reserved, to terminate the services of Optionee, if the Optionee is a consultant, at any time for
any reason whatsoever, with or without cause, except to the extent expressly provided otherwise in
a written agreement between the Company and the Optionee.
STOCK OPTION AGREEMENT PAGE 1
ARTICLE III
PERIOD OF EXERCISABILITY
3.1 Commencement of Exercisability.
(a) Subject to Sections 3.3 and 5.11, the Option shall become exercisable in such amounts and
at such times as are set forth in the Grant Notice. Alternatively, at the election of the
Optionee, this Option may be exercised in whole or in part at such times as are established by the
Committee as to shares of Stock which have not yet vested. Vested shares shall not be subject to
the Companys Repurchase Option (as set forth in the Restricted Stock Purchase Agreement). As a
condition to exercising this Option for unvested shares of Stock, the Optionee shall execute the
Restricted Stock Purchase Agreement.
(b) No portion of the Option which has not become exercisable at Termination of Service (as
defined below) shall thereafter become exercisable, except as may be otherwise provided by the
Committee or as set forth in a written agreement between the Company and the Optionee.
3.2 Duration of Exercisability. The installments provided for in the vesting schedule
set forth in the Grant Notice are cumulative. Each such installment which becomes exercisable
pursuant to Section 3.1 shall remain exercisable until it becomes unexercisable under Section 3.3.
3.3 Expiration of Option. The Option may not be exercised to any extent by anyone
after the first to occur of the following events:
(a) The expiration of ten years from the Grant Date; or
(b) If this Option is designated as an Incentive Stock Option and the Optionee owned (within
the meaning of Section 424(d) of the Code), at the time the Option was granted, more than 10% of
the total combined voting power of all classes of stock of the Company or any subsidiary
corporation of the Company or any parent corporation of the Company (each within the meaning of
Section 424 of the Code), the expiration of five years from the date the Option was granted; or
(c) The expiration of ninety days following the date of the Optionees Termination of Service,
unless such Termination of Service occurs by reason of the Optionees death, Disability, Misconduct
or as set forth in a written agreement with the Company;
(d) The expiration of one year following the date of the Optionees Termination of Service by
reason of the Optionees death or Disability; or
(e) The Optionees Termination of Service as a result of the Optionees Misconduct or in the
event the Optionee otherwise engages in Misconduct while the Option is outstanding.
(f) For purposes of this Agreement, Termination of Service means the time when the service
relationship (whether as an Employee or a consultant) between the Optionee and the Company or any
Parent or Subsidiary is terminated for any reason, with or without cause, including, but not by way
of limitation, a termination by resignation, discharge, death, Disability or Misconduct; but
excluding (i) a termination where there is a simultaneous reemployment or continuing employment or
consultancy of the Optionee by the Company or any Parent or Subsidiary of the Company, (ii) at the
discretion of the Committee, a termination which results in a temporary severance of the
employee-employer relationship, and (iii) at the discretion of the Committee, a termination which
is followed by the simultaneous establishment of a consulting relationship by the Company or a
Parent or Subsidiary with the former
STOCK OPTION AGREEMENT PAGE 2
Employee. The Committee, in its absolute discretion, shall determine the effect of all
matters and questions relating to Termination of Service for the purposes of this Agreement,
including, but not by way of limitation, the question of whether, for Optionees who are Employees
of the Company or any of its Parents or Subsidiaries, a Termination of Service resulted from a
discharge for cause, and all questions of whether particular leaves of absence for Optionees who
are Employees of the Company or any of its Parents or Subsidiaries constitute Terminations of
Service; provided, however, that, if this Option is designated as an Incentive Stock Option, unless
otherwise determined by the Committee in its discretion, a leave of absence, change in status from
an Employee to an independent contractor or other change in the employee-employer relationship
shall constitute a Termination of Service if, and to the extent that, such leave of absence, change
in status or other change interrupts employment for the purposes of Section 422(a)(2) of the Code
and the then applicable regulations and revenue rulings under said Section. Notwithstanding any
other provision of the Plan or this Agreement, the Company or any Parent or Subsidiary has an
absolute and unrestricted right to terminate the Optionees employment and/or consultancy at any
time for any reason whatsoever, with or without cause, except to the extent expressly provided
otherwise in a written agreement between the Company and the Optionee.
3.4 Special Tax Consequences. The Optionee acknowledges that, to the extent that the
aggregate Fair Market Value of Stock with respect to which Incentive Stock Options (but without
regard to Section 422(d) of the Code), including the Option, are exercisable for the first time by
the Optionee during any calendar year (under the Plan and all other incentive stock option plans of
the Company, any subsidiary corporation of the Company and any parent corporation of the
Company (each within the meaning of Section 424 of the Code)) exceeds $100,000, the Option and such
other options shall be treated as not qualifying under Section 422 of the Code but rather shall be
taxed as Non-Qualified Stock Options. The Optionee further acknowledges that the rule set forth in
the preceding sentence shall be applied by taking options into account in the order in which they
were granted. For purposes of these rules, the Fair Market Value of Stock shall be determined as of
the time the option with respect to such Stock is granted.
ARTICLE IV
EXERCISE OF OPTION
4.1 Person Eligible to Exercise. Except as provided in Sections 5.2(b) and 5.2(c),
during the lifetime of the Optionee, only the Optionee may exercise the Option or any portion
thereof. After the death of the Optionee, any exercisable portion of the Option may, prior to the
time when the Option becomes unexercisable under Section 3.3, be exercised by the Optionees
beneficiary designated in accordance with Section 10.4 of the Plan. If no beneficiary has been
designated or survives the Optionee, the Option may be exercised by the person entitled to such
exercise pursuant to the Optionees will or the laws of descent and distribution.
4.2 Partial Exercise. Any exercisable portion of the Option or the entire Option, if
then wholly exercisable, may be exercised in whole or in part at any time prior to the time when
the Option or portion thereof becomes unexercisable under Section 3.3.
4.3 Manner of Exercise. The Option, or any exercisable portion thereof, may be
exercised solely by delivery to the Secretary of the Company or the Secretarys office of all of
the following prior to the time when the Option or such portion thereof becomes unexercisable under
Section 3.3:
(a) An exercise notice in writing signed by the Optionee or the other person then entitled to
exercise the Option or portion thereof, stating that the Option or portion thereof is thereby
exercised, such notice complying with all applicable rules established by the Committee. Such
notice
STOCK OPTION AGREEMENT PAGE 3
shall be substantially in the form attached as Exhibit A (or such other form as is
prescribed by the Committee) (the Exercise Notice);
(b) A Restricted Stock Purchase Agreement, if applicable, substantially in the form attached
as Exhibit B;
(c) (i) Full payment (in cash or by check) for the shares with respect to which the Option or
portion thereof is exercised, to the extent permitted under applicable laws; or
(ii) On and after the Public Trading Date, and with the consent of the Committee, such
payment may be made, in whole or in part, through the delivery of shares of Stock which have
been owned by the Optionee for at least six months, duly endorsed for transfer to the
Company with a Fair Market Value on the date of delivery equal to the aggregate exercise
price of the Option or exercised portion thereof; or
(iii) On and after the Public Trading Date, and to the extent permitted under
applicable laws, through the delivery of a notice that the Optionee has placed a market sell
order with a broker with respect to shares of Stock then issuable upon exercise of the
Option, and that the broker has been directed to pay a sufficient portion of the net
proceeds of the sale to the Company in satisfaction of the Option exercise price, provided,
that payment of such proceeds is made to the Company upon settlement of such sale;
(iv) With the consent of the Committee, such payment may be made through the delivery
of a promissory note in accordance with the provisions of Section 4.3(g) below; or
(v) With the consent of the Committee, any combination of the consideration provided in
the foregoing subparagraphs (i), (ii), (iii) and (iv); and
(d) A bona fide written representation and agreement, in such form as is prescribed by the
Committee, signed by the Optionee or other person then entitled to exercise such Option or portion
thereof, stating that the shares of Stock are being acquired for the Optionees own account, for
investment and without any present intention of distributing or reselling said shares or any of
them except as may be permitted under the Securities Act and then applicable rules and regulations
thereunder, and that the Optionee or other person then entitled to exercise such Option or portion
thereof will indemnify the Company against and hold it free and harmless from any loss, damage,
expense or liability resulting to the Company if any sale or distribution of the shares by such
person is contrary to the representation and agreement referred to above. The Committee may, in
its absolute discretion, take whatever additional actions it deems appropriate to ensure the
observance and performance of such representation and agreement and to effect compliance with the
Securities Act and any other federal or state securities laws or regulations. Without limiting the
generality of the foregoing, the Committee may require an opinion of counsel acceptable to it to
the effect that any subsequent transfer of shares acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing Stock issued on exercise of the Option shall bear an appropriate legend referring to the
provisions of this subsection (d) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (d) shall, however, not be required
if the shares to be issued pursuant to such exercise have been registered under the Securities Act,
and such registration is then effective in respect of such shares; and
(e) Full payment to the Company (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option. With the
consent of the Committee, (i) shares of Stock owned by the Optionee for at least six months duly
STOCK OPTION AGREEMENT PAGE 4
endorsed for transfer or (ii) shares of Stock issuable to the Optionee upon exercise of the
Option, having a Fair Market Value at the date of Option exercise equal to the statutory minimum
sums required to be withheld, may be used to make all or part of such payment; and
(f) In the event the Option or portion thereof shall be exercised pursuant to Section 4.1 by
any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
(g) The Committee may permit the Optionee to pay the option exercise price for the shares with
respect to which the Option or portion thereof is exercised by delivering a full-recourse, interest
bearing promissory note payable in one or more installments and secured by the purchased shares, as
long as the portion of the option exercise price which is equal to the par value of the shares
purchased thereby is paid in cash or other legal consideration permitted by applicable law. In no
event, however, may the maximum credit available to the Optionee exceed the sum of (i) the
aggregate option exercise price or purchase price payable for the purchased shares (less the par
value of those shares) plus (ii) any Federal, state and local income and employment tax liability
incurred by the Optionee in connection with the option exercise or share purchase; provided,
however, that prior to the first date on which the Company has filed a registration statement under
the Securities Act to register the public offering of securities of the Company under the
Securities Act, then, to the extent that the Optionee is a director or executive officer of the
Company, as defined under Rule 3b-7 promulgated under the Exchange Act, and has outstanding a
promissory note or other pending mode of payment for shares under the Plan, and the Company has
reasonably determined that to permit such promissory note or other pending mode of payment to
remain outstanding would be unlawful under the Exchange Act or any other law, then such note or
other pending mode of payment must be immediately paid to the Company in full or replaced by a mode
of payment provided for under the Plan that is acceptable to the Company and reasonably determined
by it to be lawful under the Exchange Act or any other applicable law.
4.4 Conditions to Issuance of Stock Certificates. The shares of Stock deliverable
upon the exercise of the Option, or any portion thereof, may be either previously authorized but
unissued shares or issued shares which have then been reacquired by the Company. Such shares shall
be fully paid and nonassessable. The Company shall not be required to issue any shares of Stock
purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of the
following conditions:
(a) The admission of such shares to listing on all stock exchanges on which such Stock is then
listed; and
(b) The completion of any registration or other qualification of such shares under any state
or federal law or under rulings or regulations of the Securities and Exchange Commission or of any
other governmental regulatory body, which the Committee shall, in its absolute discretion, deem
necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by the Company of full payment for such shares, including payment of all
amounts which, under federal, state or local tax law, the Company (or other employer corporation)
is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
STOCK OPTION AGREEMENT PAGE 5
4.5 Rights as Stockholder; Book Entry Procedures. The holder of the Option shall not
be, nor have any of the rights or privileges of, a stockholder of the Company in respect of any
shares purchasable upon the exercise of any part of the Option unless and until such shares shall
have been issued by the Company to such holder. Notwithstanding any other provision of the Plan or
this Agreement, unless otherwise determined by the Committee or required by applicable law, rule or
regulation, the Company shall not deliver to the Optionee certificates evidencing shares of Stock
issued in connection with the exercise of this Option and instead such shares of Stock will be
recorded in the books of the Company (or as applicable, its transfer agent or stock plan
administrator).
ARTICLE V
OTHER PROVISIONS
5.1 Administration. The Committee shall have the power to interpret the Plan and this
Agreement and to adopt such rules for the administration, interpretation and application of the
Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions
taken and all interpretations and determinations made by the Committee in good faith shall be final
and binding upon the Optionee, the Company and all other interested persons. No member of the
Committee shall be personally liable for any action, determination or interpretation made in good
faith with respect to the Plan, this Agreement or the Option. In its absolute discretion, the
Board may at any time and from time to time exercise any and all rights and duties of the Committee
under the Plan and this Agreement.
5.2 Option Not Transferable.
(a) Subject to Section 5.2(b), the Option may not be sold, pledged, assigned or transferred in
any manner other than by will or the laws of descent and distribution unless and until the Option
has been exercised, or the shares underlying such Option have been issued, and all restrictions
applicable to such shares have lapsed. Neither the Option nor any interest or right therein shall
be liable for the debts, contracts or engagements of the Optionee or his or her successors in
interest or shall be subject to disposition by transfer, alienation, anticipation, pledge,
encumbrance, assignment or any other means whether such disposition be voluntary or involuntary or
by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable
proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void
and of no effect, except to the extent that such disposition is permitted by the preceding
sentence.
(b) Notwithstanding any other provision in this Agreement, with the consent of the Committee
and to the extent the Option is designated as a Non-Qualified Stock Option, the Option may be
transferred to, exercised by and paid to certain persons or entities related to the Optionee,
including but not limited to members of the Optionees family, charitable institutes or trusts or
other entities whose beneficiaries or beneficial owners are members of the Optionees family or to
such other persons or entities as may be expressly approved by the Committee (each a Permitted
Transferee), pursuant to such conditions and procedures as the Committee may require.
(c) Unless transferred to a Permitted Transferee in accordance with Section 5.2(b), during the
lifetime of the Optionee, only the Optionee may exercise the Option or any portion thereof.
Subject to such conditions and procedures as the Committee may require, a Permitted Transferee may
exercise the Option or any portion thereof during the Optionees lifetime. After the death of the
Optionee, any exercisable portion of the Option may, prior to the time when the Option becomes
unexercisable under Section 3.3, be exercised by the Optionees beneficiary designated in
accordance with Section 10.4 of the Plan. If no beneficiary has been designated or survives the
Optionee, the Option
STOCK OPTION AGREEMENT PAGE 6
may be exercised by the person entitled to such exercise pursuant to the Optionees will or
the laws of descent and distribution.
5.3 Lock-Up Period. The Optionee hereby agrees that, if so requested by the Company
or any representative of the underwriters (the Managing Underwriter) in connection with any
registration of the offering of any securities of the Company under the Securities Act, the
Optionee shall not sell or otherwise transfer any shares of Stock or other securities of the
Company during such period as may be requested in writing by the Managing Underwriter and agreed to
in writing by the Company (which period shall not be longer than one hundred eighty days) (the
Market Standoff Period) following the effective date of a registration statement of the Company
filed under the Securities Act; provided, however, that such restriction shall apply only to the
first registration statement of the Company to become effective under the Securities Act that
includes securities to be sold on behalf of the Company to the public in an underwritten public
offering under the Securities Act.
5.4 Restrictive Legends and Stop-Transfer Orders.
(a) The share certificate or certificates, if issued, evidencing the shares of Stock purchased
hereunder shall be endorsed with any legends that may be required by state or federal securities
laws.
(b) The Optionee agrees that, in order to ensure compliance with the restrictions referred to
herein, the Company may issue appropriate stop transfer instructions to its transfer agent, if
any, and that, if the Company transfers its own securities, it may make appropriate notations to
the same effect in its own records.
(c) The Company shall not be required: (i) to transfer on its books any shares of Stock that
have been sold or otherwise transferred in violation of any of the provisions of this Agreement, or
(ii) to treat as owner of such shares of Stock or to accord the right to vote or pay dividends to
any purchaser or other transferee to whom such shares shall have been so transferred.
5.5 Shares to Be Reserved. The Company shall at all times during the term of the
Option reserve and keep available such number of shares of Stock as will be sufficient to satisfy
the requirements of this Agreement.
5.6 Notices. Any notice to be given under the terms of this Agreement to the Company
shall be addressed to the Company in care of the Secretary of the Company, and any notice to be
given to the Optionee shall be addressed to the Optionee at the address given beneath the
Optionees signature on the Grant Notice. By a notice given pursuant to this Section 5.6, either
party may hereafter designate a different address for notices to be given to that party. Any
notice which is required to be given to the Optionee shall, if the Optionee is then deceased, be
given to the Optionees designated beneficiary if any, or the person otherwise entitled to exercise
his or her Option pursuant to Section 4.1 by written notice under this Section 5.6. Any notice
shall be deemed duly given when sent via email or enclosed in a properly sealed envelope or wrapper
addressed as aforesaid and deposited (with postage prepaid) in a post office or branch post office
regularly maintained by the United States Postal Service.
5.7 Titles. Titles are provided herein for convenience only and are not to serve as a
basis for interpretation or construction of this Agreement.
5.8 Stockholder Approval. The Plan will be submitted for approval by the Companys
stockholders within twelve months after the date the Plan was initially adopted by the Board. The
Option may not be exercised to any extent by anyone prior to the time when the Plan is approved by
the
STOCK OPTION AGREEMENT PAGE 7
stockholders, and if such approval has not been obtained by the end of said twelve month
period, the Option shall thereupon be canceled and become null and void.
5.9 Notification of Disposition. If this Option is designated as an Incentive Stock
Option, the Optionee shall give prompt notice to the Company of any disposition or other transfer
of any shares of stock acquired under this Agreement if such disposition or transfer is made (a)
within two years from the Grant Date with respect to such shares or (b) within one year after the
transfer of such shares to him. Such notice shall specify the date of such disposition or other
transfer and the amount realized, in cash, other property, assumption of indebtedness or other
consideration, by the Optionee in such disposition or other transfer.
5.10 Construction. This Agreement shall be administered, interpreted and enforced
under the laws of the State of California without regard to conflicts of laws thereof.
5.11 Conformity to Securities Laws. The Optionee acknowledges that the Plan is
intended to conform to the extent necessary with all provisions of the Securities Act and the
Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange
Commission thereunder, and state securities laws and regulations. Notwithstanding anything herein
to the contrary, the Plan shall be administered, and the Option is granted and may be exercised,
only in such a manner as to conform to such laws, rules and regulations. To the extent permitted
by applicable law, the Plan and this Agreement shall be deemed amended to the extent necessary to
conform to such laws, rules and regulations.
5.12 Amendments. This Agreement may not be modified, amended or terminated except by
an instrument in writing, signed by the Optionee or such other person as may be permitted to
exercise the Option pursuant to Section 4.1 and by a duly authorized representative of the Company.
5.13 Restrictions on Shares. Optionee hereby agrees that shares of Stock purchased
upon the exercise of the Option shall be subject to such terms and conditions as the Committee
shall determine in its sole discretion, including, without limitation, restrictions on the
transferability of shares of Stock, the right of the Company to repurchase shares of Stock, and a
right of first refusal in favor of the Company with respect to permitted transfers of shares of
Stock. Such terms and conditions may, in the Committees sole discretion, be contained in the
Exercise Notice with respect to the Option or in such other agreement as the Committee shall
determine and which the Optionee hereby agrees to enter into at the request of the Company.
STOCK OPTION AGREEMENT PAGE 8
EXHIBIT A
TO GRANT NOTICE AND STOCK OPTION AGREEMENT
FORM OF EXERCISE NOTICE
Effective as of today, , , the undersigned
(Optionee) hereby elects to
exercise Optionees option to purchase shares of the Common Stock (the Shares) of
Cadence Pharmaceuticals, Inc. (the Company) under and pursuant to the Cadence Pharmaceuticals,
Inc. 2004 Equity Incentive Award Plan (the Plan) and the Grant Notice and Stock Option Agreement
dated , , (the Option Agreement). Capitalized terms used herein without
definition shall have the meanings given in the Option Agreement.
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Grant Date:
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Number of Shares as to which Option is
Exercised:
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Exercise Price per Share:
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Total Exercise Price:
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Certificate to be issued in name of:
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Cash Payment delivered herewith:
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$ (Representing the full Exercise Price for the Shares, as well as any applicable withholding tax) |
Type of Option: o Incentive Stock Option o Non-Qualified Stock Option
1. Representations of Optionee. Optionee acknowledges that Optionee has received,
read and understood the Plan and the Option Agreement. Optionee agrees to abide by and be bound by
their terms and conditions.
2. Rights as Stockholder. Until the Shares are issued (as evidenced by the
appropriate entry on the books of the Company or of a duly authorized transfer agent of the
Company), no right to vote or receive dividends or any other rights as a stockholder shall exist
with respect to Shares subject to the Option, notwithstanding the exercise of the Option. No
adjustment will be made for a dividend or other right for which the record date is prior to the
date the Shares are issued, except as provided in Article 11 of the Plan.
Optionee shall enjoy rights as a stockholder until such time as Optionee disposes of the
Shares or the Company and/or its assignee(s) exercises the Right of First Refusal hereunder. Upon
such exercise, Optionee shall have no further rights as a holder of the Shares so purchased except
the right to receive payment for the Shares so purchased in accordance with the provisions of this
Agreement, and Optionee shall forthwith cause the certificate(s), if any issued, evidencing the
Shares so purchased to be surrendered to the Company for transfer or cancellation.
EXERCISE NOTICE PAGE 1
3. Optionees Rights to Transfer Shares.
(a) Companys Right of First Refusal. Before any Shares held by Optionee or any
permitted transferee (each, a Holder) may be sold, pledged, assigned, hypothecated, transferred,
or otherwise disposed of (each, a Transfer), the Company or its assignee(s) shall have a right of
first refusal to purchase the Shares proposed to be Transferred on the terms and conditions set
forth in this Section (the Right of First Refusal). In the event that the Companys Bylaws
contain a right of first refusal with respect to the Shares, such right of first refusal shall
apply to the Shares to the extent such provisions are more restrictive than the Right of First
Refusal set forth in this Section.
(b) Notice of Proposed Transfer. In the event any Holder desires to Transfer any
Shares, the Holder shall deliver to the Company a written notice (the Notice) stating: (i) the
Holders bona fide intention to sell or otherwise Transfer such Shares; (ii) the name of each
proposed purchaser or other transferee (Proposed Transferee); (iii) the number of Shares to be
Transferred to each Proposed Transferee; and (iv) the price for which the Holder proposes to
Transfer the Shares (the Offered Price), and the Holder shall offer such Shares at the Offered
Price to the Company or its assignee(s).
(c) Exercise of Right of First Refusal. Within twenty-five days after receipt of the
Notice, the Company and/or its assignee(s) may elect in writing to purchase all, but not less than
all, of the Shares proposed to be Transferred to any one or more of the Proposed Transferees by
delivery of a written exercise notice to the Holder (a Company Notice). The purchase price will
be determined in accordance with subsection (d) below.
(d) Purchase Price. The purchase price (Purchase Price) for the Shares repurchased
under this Section shall be the Offered Price.
(e) Payment. Payment of the Purchase Price shall be made, at the option of the
Company or its assignee(s), in cash (by check), by cancellation of all or a portion of any
outstanding indebtedness of the Holder to the Company (or, in the case of repurchase by an
assignee, to the assignee), or by any combination thereof within five days after delivery of the
Company Notice or in the manner and at the times mutually agreed to by the Company and the Holder.
Should the Offered Price specified in the Notice be payable in property other than cash, the
Company shall have the right to pay the purchase price in the form of cash equal in amount to the
value of such property. If the Holder and the Company cannot agree on such cash value within ten
days after the Companys receipt of the Notice, the valuation shall be made by the Board. The
payment of the purchase price shall then be held on the later of (i) five days following delivery
of the Company Notice or (ii) five days after such valuation shall have been made.
(f) Holders Right to Transfer. If all or a portion of the Shares proposed in the
Notice to be Transferred are not purchased by the Company and/or its assignee(s) as provided in
this Section, then the Holder may sell or otherwise Transfer such Shares to that Proposed
Transferee at the Offered Price or at a higher price, provided that such sale or other Transfer is
consummated within sixty days after the date of the Notice and provided further that any such sale
or other Transfer is effected in accordance with any applicable securities laws and the Proposed
Transferee agrees in writing that the provisions of this Section and the Restricted Stock Purchase
Agreement, if applicable, shall continue to apply to the Shares in the hands of such Proposed
Transferee. If the Shares described in the Notice are not Transferred to the Proposed Transferee
within such sixty-day period, a new Notice shall be given to the Company, and the Company and/or
its assignees shall again be offered the Right of First Refusal as provided herein before any
Shares held by the Holder may be sold or otherwise Transferred.
(g) Exception for Certain Family Transfers. Anything to the contrary contained in
this Section notwithstanding, the Transfer of any or all of the Shares during the Optionees
lifetime or
EXERCISE NOTICE PAGE 2
upon the Optionees death by will or intestacy to the Optionees Immediate Family or a trust for
the benefit of the Optionees Immediate Family shall be exempt from the Right of First Refusal. As
used herein, Immediate Family shall mean spouse, lineal descendant or antecedent, father, mother,
brother or sister or stepchild (whether or not adopted). In such case, the transferee or other
recipient shall receive and hold the Shares so Transferred subject to the provisions of this
Section (including the Right of First Refusal) and the Restricted Stock Purchase Agreement, if
applicable, and there shall be no further Transfer of such Shares except in accordance with the
terms of this Section.
(h) Termination of Right of First Refusal. The Right of First Refusal shall terminate
as to all Shares upon the Public Trading Date.
(i) Transfer Restrictions. Any transfer or sale of the Shares is subject to
restrictions on transfer imposed by any applicable state and federal securities laws. Any Transfer
or attempted Transfer of any of the Shares not in accordance with the terms of this Agreement shall
be void and the Company may enforce the terms of this Agreement by stop transfer instructions or
similar actions by the Company and its agents or designees.
4. Tax Consultation. Optionee understands that Optionee may suffer adverse tax
consequences as a result of Optionees purchase or disposition of the Shares. Optionee represents
that Optionee has consulted with any tax consultants Optionee deems advisable in connection with
the purchase or disposition of the Shares and that Optionee is not relying on the Company for any
tax advice.
5. Restrictive Legends and Stop-Transfer Orders.
(a) Legends. Optionee understands and agrees that the Company shall cause any
certificates issued evidencing the Shares shall have the legends set forth below or legends
substantially equivalent thereto, together with any other legends that may be required by state or
federal securities laws:
THE SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (ACT), NOR HAVE THEY BEEN
REGISTERED OR QUALIFIED UNDER THE SECURITIES LAWS OF ANY STATE. NO
TRANSFER OF SUCH SECURITIES WILL BE PERMITTED UNLESS A REGISTRATION
STATEMENT UNDER THE ACT IS IN EFFECT AS TO SUCH TRANSFER, THE
TRANSFER IS MADE IN ACCORDANCE WITH RULE 144 UNDER THE ACT, OR IN
THE OPINION OF COUNSEL (WHICH MAY BE COUNSEL FOR THE COMPANY)
REGISTRATION UNDER THE ACT IS UNNECESSARY IN ORDER FOR SUCH TRANSFER
TO COMPLY WITH THE ACT AND WITH APPLICABLE STATE SECURITIES LAWS.
THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY
IN ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND
THE STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF
THE COMPANY. SUCH TRANSFER RESTRICTIONS ARE BINDING ON TRANSFEREES
OF THESE SHARES.
EXERCISE NOTICE PAGE 3
(b) Stop-Transfer Notices. Optionee agrees that, in order to ensure compliance with
the restrictions referred to herein, the Company may issue appropriate stop transfer instructions
to its transfer agent, if any, and that, if the Company transfers its own securities, it may make
appropriate notations to the same effect in its own records.
(c) Refusal to Transfer. The Company shall not be required (i) to transfer on its
books any Shares that have been sold or otherwise transferred in violation of any of the provisions
of this Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay
dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
6. Optionee Representations. Optionee hereby makes the following certifications and
representations with respect to the Shares listed above:
(a) Optionee is aware of the Companys business affairs and financial condition and has
acquired sufficient information about the Company to reach an informed and knowledgeable decision
to acquire the Shares. Optionee is acquiring these Shares for investment for Optionees own
account only and not with a view to, or for resale in connection with, any distribution thereof
within the meaning of the Securities Act.
(b) Optionee acknowledges and understands that the Shares constitute restricted securities
under the Securities Act and have not been registered under the Securities Act in reliance upon a
specific exemption therefrom, which exemption depends upon, among other things, the bona fide
nature of Optionees investment intent as expressed herein. Optionee understands that the Shares
must be held indefinitely unless they are subsequently registered under the Securities Act or an
exemption from such registration is available. Optionee further acknowledges and understands that
the Company is under no obligation to register the Shares. Optionee understands that the
certificate evidencing the Shares will be imprinted with a legend which prohibits the transfer of
the Shares unless they are registered or such registration is not required in the opinion of
counsel satisfactory to the Company and any other legend required under applicable state securities
laws.
(c) Optionee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under
the Securities Act, which, in substance, permit limited public resale of restricted securities
acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the
satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701
at the time of the grant of the Option to the Optionee, the exercise will be exempt from
registration under the Securities Act. In the event the Company becomes subject to the reporting
requirements of Section 13 or 15(d) of the Exchange Act, ninety days thereafter (or such longer
period as any market stand-off agreement may require) the securities exempt under Rule 701 may be
resold, subject to the satisfaction of certain of the conditions specified by Rule 144, including:
(i) the resale being made through a broker in an unsolicited brokers transaction or in
transactions directly with a market maker (as said term is defined under the Exchange Act); and, in
the case of an affiliate, (ii) the availability of certain public information about the Company,
(iii) the amount of securities being sold during any three month period not exceeding the
limitations specified in Rule 144(e), and (iv) the timely filing of a Form 144, if applicable.
(d) In the event that the Company does not qualify under Rule 701 at the time of grant of the
Option, then the securities may be resold in certain limited circumstances subject to the
provisions of Rule 144, which requires the resale to occur not less than one year after the later
of the date the securities were sold by the Company or the date the securities were sold by an
affiliate of the Company, within the meaning of Rule 144; and, in the case of acquisition of the
securities by an affiliate,
EXERCISE NOTICE PAGE 4
or by a non-affiliate who subsequently holds the securities less than two years, the
satisfaction of the conditions set forth in sections (i), (ii), (iii) and (iv) of paragraph (c)
above.
(e) Optionee further understands that in the event all of the applicable requirements of Rule
701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A,
or some other registration exemption will be required; and that, notwithstanding the fact that
Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has
expressed its opinion that persons proposing to sell private placement securities other than in a
registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden
of proof in establishing that an exemption from registration is available for such offers or sales,
and that such persons and their respective brokers who participate in such transactions do so at
their own risk. Optionee understands that no assurances can be given that any such other
registration exemption will be available in such event.
7. Successors and Assigns. The Company may assign any of its rights under this
Agreement to single or multiple assignees, and this Agreement shall inure to the benefit of the
successors and assigns of the Company. Subject to the restrictions on transfer herein set forth,
this Agreement shall be binding upon Optionee and his or her heirs, executors, administrators,
successors and assigns.
8. Interpretation. Any dispute regarding the interpretation of this Agreement shall
be submitted by Optionee or by the Company forthwith to the Committee, which shall review such
dispute at its next regular meeting. The resolution of such a dispute by the Administrator shall
be final and binding on the Company and on Optionee.
9. Governing Law; Severability. This Agreement shall be governed by and construed in
accordance with the laws of the State of California excluding that body of law pertaining to
conflicts of law. Should any provision of this Agreement be determined by a court of law to be
illegal or unenforceable, the other provisions shall nevertheless remain effective and shall remain
enforceable.
10. Notices. Any notice required or permitted hereunder shall be given in accordance
with the provisions set forth in Section 5.6 of the Option Agreement.
11. Further Instruments. The parties agree to execute such further instruments and to
take such further action as may be reasonably necessary to carry out the purposes and intent of
this Agreement.
12. Entire Agreement. The Plan and Option Agreement are incorporated herein by
reference. This Agreement, the Plan, the Option Agreement and the Restricted Stock Purchase
Agreement, if applicable, constitute the entire agreement of the parties and supersede in their
entirety all prior undertakings and agreements of the Company and Optionee with respect to the
subject matter hereof.
(Signature Page Follows)
EXERCISE NOTICE PAGE 5
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CADENCE PHARMACEUTICALS, INC. |
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EXERCISE NOTICE PAGE 6
EXHIBIT B
TO GRANT NOTICE AND STOCK OPTION AGREEMENT
RESTRICTED STOCK PURCHASE AGREEMENT
THIS RESTRICTED STOCK PURCHASE AGREEMENT is made between (the Purchaser) and
Cadence Pharmaceuticals, Inc. (the Company), as of ,
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RECITALS
(1) Pursuant to the exercise of the Option granted to Purchaser under the Companys 2004
Equity Incentive Award Plan (the Plan) and pursuant to the Stock Option Agreement (the Option
Agreement) dated , , by and between the Company and Purchaser with respect to
such grant, which Option Agreement is hereby incorporated by reference, Purchaser has elected to
purchase of those shares which have not become vested under the vesting schedule set
forth in the Option Agreement (Unvested Shares). The Unvested Shares and the shares subject to
the Option Agreement which have become vested are sometimes collectively referred to herein as the
Shares.
(2) As required by the Option Agreement, as a condition to Purchasers election to exercise
the option, Purchaser must execute this Restricted Stock Purchase Agreement, which sets forth the
rights and obligations of the parties with respect to Shares acquired upon exercise of the Option.
1. Repurchase Option.
(a) In the event of Purchasers Termination of Service (as defined in the Option Agreement)
for any reason, including for cause, death, Disability or Misconduct, the Company shall have the
right and option to purchase from Purchaser, or Purchasers personal representative, as the case
may be, all of Purchasers Unvested Shares as of the date of the Purchasers Termination of Service
at the exercise price paid by Purchaser for such Shares in connection with the exercise of the
Option (the Repurchase Option).
(b) The Company may exercise its Repurchase Option by delivering, personally or by registered
mail, to Purchaser (or his or her transferee or legal representative, as the case may be), within
ninety days of the date of the Purchasers Termination of Service, a notice in writing indicating
the Companys intention to exercise the Repurchase Option and setting forth a date for closing not
later than thirty days from the mailing of such notice. The closing shall take place at the
Companys office. At the closing, the holder of the certificates for the Unvested Shares being
transferred shall deliver the stock certificate or certificates evidencing the Unvested Shares, and
the Company shall deliver the purchase price therefor.
(c) At its option, the Company may elect to make payment for the Unvested Shares to a bank
selected by the Company. The Company shall avail itself of this option by a notice in writing to
Purchaser stating the name and address of the bank, date of closing, and waiving the closing at the
Companys office.
RESTRICTED STOCK AGREEMENT PAGE 1
(d) If the Company does not elect to exercise the Repurchase Option conferred above by giving
the requisite notice within ninety days following the date of Purchasers Termination of Service,
the Repurchase Option shall terminate.
(e) 100% of the Unvested Shares shall initially be subject to the Repurchase Option. The
Unvested Shares shall be released from the Repurchase Option in accordance with the Vesting
Schedule set forth in the Option Agreement until all Shares are released from the Repurchase
Option. Fractional Shares shall be rounded down to the nearest whole share.
2. Transferability of the Shares; Escrow.
(a) Purchaser hereby authorizes and directs the secretary of the Company, or such other person
designated by the Company from time to time, to transfer the Unvested Shares as to which the
Repurchase Option has been exercised from Purchaser to the Company.
(b) To insure the availability for delivery of Purchasers Unvested Shares upon repurchase by
the Company pursuant to the Repurchase Option under Section 1, Purchaser hereby appoints the
assistant secretary, or any other person designated by the Company from time to time as escrow
agent, as its attorney-in-fact to sell, assign and transfer unto the Company, such Unvested Shares,
if any, repurchased by the Company pursuant to the Repurchase Option. If certificates for the
Shares are issued, then Purchaser shall, upon execution of this Agreement, deliver and deposit with
the assistant secretary of the Company, or such other person designated by the Company from time to
time, any share certificate(s) issued representing the Unvested Shares, together with the stock
assignment duly endorsed in blank, attached hereto as Exhibit B-1. The Unvested Shares and
stock assignment shall be held by the assistant secretary in escrow, pursuant to the Joint Escrow
Instructions of the Company and Purchaser attached as Exhibit B-2 hereto, until the Company
exercises its Repurchase Option as provided in Section 1, until such Unvested Shares are vested, or
until such time as this Agreement no longer is in effect. As a further condition to the Companys
obligations under this Agreement, the spouse of Purchaser, if any, shall execute and deliver to the
Company the Consent of Spouse set forth on the signature page hereto. Upon vesting of the Unvested
Shares, the escrow agent shall promptly deliver to Purchaser the certificate or certificates
representing such Shares in the escrow agents possession belonging to Purchaser, and the escrow
agent shall be discharged of all further obligations hereunder; provided, however, that the escrow
agent shall nevertheless retain such certificate or certificates as escrow agent if so required
pursuant to other restrictions imposed pursuant to this Agreement. If the Shares are held in book
entry form, then such entry will reflect that the Shares are subject to the restrictions of this
Agreement.
(c) The Company, or its designee, shall not be liable for any act it may do or omit to do with
respect to holding the Shares in escrow and while acting in good faith and in the exercise of its
judgment.
(d) Transfer or sale of the Shares is subject to restrictions on transfer imposed by any
applicable state and federal securities laws. Any transferee shall hold such Shares subject to all
the provisions hereof and the Exercise Notice executed by Purchaser with respect to any Unvested
Shares purchased by Purchaser and shall acknowledge the same by signing a copy of this Agreement.
Any transfer or attempted transfer of any of the Shares not in accordance with the terms of this
Agreement shall be void and the Company may enforce the terms of this Agreement by stop transfer
instructions or similar actions by the Company and its agents or designees.
RESTRICTED STOCK AGREEMENT PAGE 2
3. Ownership, Voting Rights, Duties. This Agreement shall not affect in any way the
ownership, voting rights or other rights or duties of Purchaser, except as specifically provided
herein.
4. Legends. Any share certificate evidencing the Shares issued hereunder shall be
endorsed with the following legend (in addition to any legend required under applicable securities
laws):
THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY IN
ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE
STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE
COMPANY.
5. Adjustment for Stock Split. All references to the number of Shares and the
purchase price of the Shares in this Agreement shall be appropriately adjusted to reflect any stock
split, stock dividend or other change in the Shares which may be made by the Company after the date
of this Agreement.
6. Notices. Notices required hereunder shall be given in person or by registered mail
to the address of Purchaser shown on the records of the Company, and to the Company at its
principal executive office.
7. Survival of Terms. This Agreement shall apply to and bind Purchaser and the
Company and their respective permitted assignees and transferees, heirs, legatees, executors,
administrators and legal successors.
8. Section 83(b) Elections.
(a) Election for Unvested Shares Purchased Pursuant to a Non-Qualified Stock Option.
Purchaser hereby acknowledges that he or she has been informed that, with respect to the exercise
of a Non-Qualified Stock Option for Unvested Shares, that unless an election is filed by Purchaser
with the Internal Revenue Service and, if necessary, the proper state taxing authorities,
within thirty days of the purchase of the Shares, electing pursuant to Section 83(b) of the
Code (and similar state tax provisions if applicable) to be taxed currently on any difference
between the purchase price of the Shares and their Fair Market Value on the date of purchase, there
will be a recognition of taxable income to the Optionee, measured by the excess, if any, of the
fair market value of the Shares, at the time the Companys Repurchase Option lapses over the
purchase price for the Shares. Optionee represents that Optionee has consulted any tax
consultant(s) Optionee deems advisable in connection with the purchase of the Shares or the filing
of the Election under Section 83(b) and similar tax provisions.
(b) Election for Unvested Shares Purchased Pursuant to an Incentive Stock Option.
Purchaser hereby acknowledges that he or she has been informed that, with respect to the exercise
of an Incentive Stock Option for Unvested Shares, that unless an election is filed by Purchaser
with the Internal Revenue Service and, if necessary, the proper state taxing authorities,
within thirty days of the purchase of the Shares, electing pursuant to Section 83(b) of the
Code (and similar state tax provisions if applicable) to be taxed currently on any difference
between the purchase price of the Shares and their Fair Market Value on the date of purchase, there
will be a recognition of income to the Purchaser, for alternative minimum tax purposes, measured by
the excess, if any, of the fair market value of the Shares at the time the Companys
RESTRICTED STOCK AGREEMENT PAGE 3
Repurchase
Option lapses over the purchase price for the Shares. Purchaser represents that Purchaser has
consulted any tax consultant(s) Purchaser deems advisable in connection with the purchase of the
Shares or the filing of the Election under Section 83(b) and similar tax provisions.
PURCHASER ACKNOWLEDGES THAT IT IS PURCHASERS SOLE RESPONSIBILITY AND NOT THE COMPANYS TO
FILE TIMELY THE ELECTION UNDER SECTION 83(b), EVEN IF PURCHASER REQUESTS THE COMPANY OR ITS
REPRESENTATIVE TO MAKE THIS FILING ON PURCHASERS BEHALF.
9. Representations. Purchaser has reviewed with his or her own tax advisors the
federal, state, local and foreign tax consequences of this investment and the transactions
contemplated by this Agreement. Purchaser is relying solely on such advisors and not on any
statements or representations of the Company or any of its agents. Purchaser understands that
Purchaser (and not the Company) shall be responsible for his or her own tax liability that may
arise as a result of this investment or the transactions contemplated by this Agreement.
10. Governing Law; Severability. This Agreement shall be governed by and construed in
accordance with the laws of the State of California excluding that body of law pertaining to
conflicts of law. Should any provision of this Agreement be determined by a court of law to be
illegal or unenforceable, the other provisions shall nevertheless remain effective and shall remain
enforceable.
Purchaser represents that he or she has read this Agreement and is familiar with its terms and
provisions. Purchaser hereby agrees to accept as binding, conclusive and final all decisions or
interpretations of the Committee upon any questions arising under this Agreement.
(Signature Page Follows)
RESTRICTED STOCK AGREEMENT PAGE 4
IN WITNESS WHEREOF, this Agreement is deemed made as of the date first
set forth above.
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CADENCE PHARMACEUTICALS, INC. |
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PURCHASER |
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CONSENT OF SPOUSE
I, , spouse of the Purchaser listed above,
have read and approve this
Agreement. In consideration of granting of the right to my spouse to purchase shares of the
Company as set forth in this Agreement, I hereby appoint my spouse as my attorney-in-fact in
respect to the exercise of any rights under this Agreement and agree to be bound by the provisions
of this Agreement insofar as I may have any rights in said Agreement or any shares issued pursuant
thereto under the community property laws or similar laws relating to marital property in effect in
the state of our residence as of the date of the signing of this Agreement.
RESTRICTED STOCK AGREEMENT PAGE 5
EXHIBIT B-1
TO RESTRICTED STOCK PURCHASE AGREEMENT
ASSIGNMENT SEPARATE FROM CERTIFICATE
FOR VALUE RECEIVED I, , hereby sell, assign and transfer unto
( ) shares of the Common Stock of Cadence Pharmaceuticals, Inc. registered in my name
on the books of said corporation represented by Certificate No. herewith and do hereby
irrevocably constitute and appoint
to transfer the said stock on the books of the within named corporation with full power
of substitution in the premises.
This Assignment Separate from Certificate may be used only in accordance with the Restricted
Stock Purchase Agreement between Cadence Pharmaceuticals, Inc. and the undersigned dated
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Dated: ,
Signature:
INSTRUCTIONS: Please do not fill in any blanks other than the signature line. The purpose of
this assignment is to enable the Company to exercise the Repurchase Option, as set forth in the
Restricted Stock Purchase Agreement, without requiring additional signatures on the part of
Purchaser.
STOCK ASSIGNMENT PAGE 1
EXHIBIT B-2
TO RESTRICTED STOCK PURCHASE AGREEMENT
JOINT ESCROW INSTRUCTIONS
,
Secretary
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
As Escrow Agent for both Cadence Pharmaceuticals, Inc. (the Company) and the undersigned
purchaser of stock of the Company (the Purchaser), you are hereby authorized and directed to hold
the documents delivered to you pursuant to the terms of that certain Restricted Stock Purchase
Agreement (Agreement) between the Company and the undersigned, in accordance with the following
instructions:
1. In the event the Company and/or any assignee of the Company (referred to collectively for
convenience herein as the Company) exercises the Companys Repurchase Option set forth in the
Agreement, the Company shall give to Purchaser and you a written notice specifying the number of
shares of stock to be purchased, the purchase price, and the time for a closing hereunder at the
principal office of the Company. Purchaser and the Company hereby irrevocably authorize and direct
you to close the transaction contemplated by such notice in accordance with the terms of said
notice.
2. At the closing, you are directed (a) to date the stock assignments necessary for the
transfer in question, (b) to fill in the number of shares being transferred, and (c) to deliver the
same, together with the certificate evidencing the shares of stock to be transferred, to the
Company or its assignee, against the simultaneous delivery to you of the purchase price (by cash, a
check, or a combination thereof) for the number of shares of stock being purchased pursuant to the
exercise of the Companys Repurchase Option.
3. Purchaser irrevocably authorizes the Company to deposit with you any certificates
evidencing shares of stock to be held by you hereunder and any additions and substitutions to said
shares as defined in the Agreement. Purchaser does hereby irrevocably constitute and appoint you
as Purchasers attorney-in-fact and agent for the term of this escrow to execute, with respect to
such securities, all documents necessary or appropriate to make such securities negotiable and to
complete any transaction herein contemplated, including but not limited to the filing with any
applicable state blue sky authority of any required applications for consent to, or notice of
transfer of, the securities. Subject to the provisions of this paragraph 3, Purchaser shall
exercise all rights and privileges of a stockholder of the Company while the stock is held by you.
4. Upon written request of Purchaser, but no more than once per calendar year, unless the
Companys Repurchase Option has been exercised, you will deliver to Purchaser a certificate or
certificates representing the number of shares of stock as are not then subject to the Companys
Repurchase Option. Within one hundred twenty days after the date of the Purchasers Termination of
Service (as defined in the Agreement), you will deliver to Purchaser a certificate or certificates
representing the aggregate number of shares held or issued pursuant to the Agreement and not
purchased by the Company or its assignees pursuant to exercise of the Companys Repurchase Option.
JOINT ESCROW INSTRUCTIONS PAGE 1
5. If at the time of termination of this escrow you should have in your possession any
documents, securities, or other property belonging to Purchaser, you shall deliver all of the same
to Purchaser and shall be discharged of all further obligations hereunder.
6. Your duties hereunder may be altered, amended, modified or revoked only by a writing signed
by all of the parties hereto.
7. You shall be obligated only for the performance of such duties as are specifically set
forth herein and may rely and shall be protected in relying or refraining from acting on any
instrument reasonably believed by you to be genuine and to have been signed or presented by the
proper party or parties. You shall not be personally liable for any act you may do or omit to do
hereunder as Escrow Agent or as attorney-in-fact for Purchaser while acting in good faith, and any
act done or omitted by you pursuant to the advice of your own attorneys shall be conclusive
evidence of such good faith.
8. You are hereby expressly authorized to disregard any and all warnings given by any of the
parties hereto or by any other person or corporation, excepting only orders or process of courts of
law and are hereby expressly authorized to comply with and obey orders, judgments or decrees of any
court. In case you obey or comply with any such order, judgment or decree, you shall not be liable
to any of the parties hereto or to any other person, firm or corporation by reason of such
compliance, notwithstanding any such order, judgment or decree being subsequently reversed,
modified, annulled, set aside, vacated or found to have been entered without jurisdiction.
9. You shall not be liable in any respect on account of the identity, authorities or rights of
the parties executing or delivering or purporting to execute or deliver the Agreement or any
documents or papers deposited or called for hereunder.
10. You shall not be liable for the expiration of any rights under any applicable state,
federal or local statute of limitations or similar statute or regulation with respect to these
Joint Escrow Instructions or any documents deposited with you.
11. You shall be entitled to employ such legal counsel and other experts as you may deem
necessary properly to advise you in connection with your obligations hereunder, may rely upon the
advice of such counsel, and may pay such counsel reasonable compensation therefore.
12. Your responsibilities as Escrow Agent hereunder shall terminate if you shall cease to be
an officer or agent of the Company or if you shall resign by written notice to each party. In the
event of any such termination, the Company shall appoint a successor Escrow Agent.
13. If you reasonably require other or further instruments in connection with these Joint
Escrow Instructions or obligations in respect hereto, the necessary parties hereto shall join in
furnishing such instruments.
14. It is understood and agreed that should any dispute arise with respect to the delivery
and/or ownership or right of possession of the securities held by you hereunder, you are authorized
and directed to retain in your possession without liability to anyone all or any part of said
securities until such disputes shall have been settled either by mutual written agreement of the
parties concerned or by a final order, decree or judgment of a court of competent jurisdiction
after the time for appeal has expired and no appeal has been perfected, but you shall be under no
duty whatsoever to institute or defend any such proceedings.
JOINT ESCROW INSTRUCTIONS PAGE 2
15. Any notice required or permitted hereunder shall be given in writing and shall be deemed
effectively given upon personal delivery or upon deposit in the United States Post Office, by
registered or certified mail with postage and fees prepaid, addressed to each of the other parties
thereunto entitled at such addresses as a party may designate by written notice to each of the
other parties hereto.
16. By signing these Joint Escrow Instructions, you become a party hereto only for the purpose
of said Joint Escrow Instructions; you do not become a party to the Agreement.
17. This instrument shall be binding upon and inure to the benefit of the parties hereto, and
their respective successors and permitted assigns.
18. These Joint Escrow Instructions shall be governed by, and construed and enforced in
accordance with, the laws of the State of California, excluding that body of law pertaining to
conflicts of law.
(Signature Page Follows)
JOINT ESCROW INSTRUCTIONS PAGE 3
IN WITNESS WHEREOF, these Joint Escrow Instructions shall be effective as of the date first
set forth above.
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CADENCE PHARMACEUTICALS, INC. |
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ESCROW AGENT: |
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JOINT ESCROW INSTRUCTIONS PAGE 4
exv10w8
EXHIBIT 10.8
SUBLEASE
THIS SUBLEASE (the Sublease) is dated for reference purposes only as of the 31st
day of August, 2004, and is by and between Townsend and Townsend and Crew, LLP, a California
limited liability partnership (Sublessor) and Strata Pharmaceuticals, Inc., a Delaware
corporation (Sublessee).
RECITALS
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Sublessor, as tenant, and Square 24 Associates L.P., a District of Columbia
limited partnership, as landlord (the Landlord), previously entered into that certain
Lease dated as of June 30, 2003, as amended by that certain First Amendment to Lease
dated as of June 9, 2004, (collectively the Lease) for Suites 400 and 410 (the
Premises) in the Building constituting a portion of the Project known as Highlands
Corporate Center located at 12730 High Bluff Drive, San Diego, California. A copy of
the Lease is attached hereto as Exhibit A. |
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All capitalized terms used but not defined in this Sublease shall have the
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Sublessor desires to sublease the Subleased Premises (as hereinbelow defined)
to Sublessee and Sublessee desires to sublease the Subleased Premises from Sublessor. |
NOW, THEREFORE, the parties agree as follows:
1. Subleased Premises. Sublessor hereby leases to Sublessee and Sublessee hereby
leases from Sublessor that portion of the Premises commonly known as Suite 410 of the Building (the
Subleased Premises) consisting of 5,928 rentable square feet, as depicted on Exhibit B
attached hereto.
2. Tender of Subleased Premises; Condition of Subleased Premises. Sublessor shall
deliver the Subleased Premises to Sublessee upon Sublessors Substantial Completion of the tenant
improvements (Tenant Improvements) as more specifically set forth on Exhibit C attached
thereto (the Commencement Date). As used herein, the term Substantial Completion shall mean
that date on which Sublessors or Sublessors agent or architect notifies Sublessee that the Tenant
Improvements are substantially complete, or would have been completed absent a Sublessee Delay,
except for such work as cannot be complete until Sublessee performs portions of Sublessees work,
and Sublessors or Sublessors agent or architect notifies Sublessee thereof. The term Sublessee
Delay as used herein shall mean any delay in construction of the Tenant Improvements caused by any
acts or omissions of Sublessee (i) in failing to grant any approvals or consents required of
Sublessee within the stipulated period of time; (ii) in unreasonably withholding any approval or
consent required by Sublessee; (iii) in materially interfering with construction of the Tenant
Improvements; or (iv) in failing diligently to obtain any consents or approvals required of
Landlord. Sublessor agrees to pay an amount not to exceed Three Thousand Dollars ($3,000.00)
towards the costs of expediting the delivery of Tenant Improvement materials (including, but not
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limited to doors, door frames and door hardware) to enable Sublessee to occupy the perimeter
offices of the Premises on or about September 15, 2004 and it is anticipated that Substantial
Completion of the Tenant Improvements by Sublessor will occur on or about September 22, 2004.
Sublessee shall be solely responsible for the costs of expediting the delivery of Tenant
Improvement materials in excess of Three Thousand Dollars ($3,000.00) and shall promptly reimburse
Sublessor for such excess costs upon demand. Provided Sublessee does not interfere with the
construction of the Tenant Improvements, Sublessee shall have the right with the prior consent of
Landlord, if required, to enter the Subleased Premises for the purpose of installing Sublessees
furniture, trade fixtures, data and telecommunication wiring and equipment, photocopy equipment and
other business equipment and to conduct limited business activities (the Early Access Period);
provided, all of the terms of this Sublease shall apply to such Early Access Period, except that no
Rent shall be due for any period of time prior to the Commencement Date, including the Early Access
Period. Sublessee and Sublessor shall coordinate such early access during the Early Access Period.
Sublessee shall immediately cease any work being undertaken by Sublessee and vacate the Subleased
Premises if Sublessee is notified that Sublessee is interfering with construction of the Tenant
Improvements. Sublessee shall also have access and use of the mailbox corresponding to the
Subleased Premises during the Early Access Period at no additional cost to Sublessee. Sublessee
agrees and acknowledges that, except as set forth on Exhibit C attached hereto, Sublessor
has not agreed to install any improvements to the Subleased Premises or perform any work to ready
the Subleased Premises for occupancy by Sublessee. Except as otherwise set forth in this Sublease
(including Exhibit C), Sublessee accepts the Subleased Premises as is, in its present
condition. Sublessee acknowledges that certain acts or conduct of Sublessee under this Sublease or
otherwise affecting the Subleased Premises may require the prior consent of Landlord. Sublessor
shall bear no responsibility in the event the Landlord withholds its consent under the Lease to
certain proposed conduct of Sublessee as provided for under the terms of this Sublease, but
Sublessor agrees to use its reasonable efforts and due diligence to obtain such consent from
Landlord.
3. Master Lease. Except as otherwise specifically set forth herein, this Sublease is
subject to all of the terms and conditions of the Lease during the Term (as hereinabove defined.).
During the Term, Sublessee assumes and agrees to perform each and every obligation, and to comply
with each and every negative covenant, of Sublessor, as Tenant under the Lease, to the extent such
terms and conditions are applicable to the Subleased Premises, except Sublessees obligation for
payment of Base Rent and Sublessees Proportionate Share of Operating Costs Share Rent, Tax Share
Rent and Electricity Share Rent which shall be as set forth in Section 6 below. Sublessee shall
not commit or permit to be committed on the Subleased Premises any act or omission which would
violate any such term or condition of the Lease and shall indemnify and hold Sublessor harmless
against any and all loss, cost, expense, liability, claim, judgment, demand or cause of action
arising from any such violation committed or permitted to be committed by Sublessee in connection
with the Subleased Premises during the Term. Sublessor shall not by its act or omission to act,
cause a default under the Lease. Accordingly, in order to afford to Sublessee the benefits of this
Sublease and of those provisions of the Lease which by their nature are intended to benefit
Sublessee, and in order to protect Sublessor against a default by Sublessee which might cause a
default or event of default by Sublessor under the Lease:
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(a) provided Sublessee shall timely pay all Rent when and as due under this Sublease,
Sublessor shall pay, when and as due, all Rent and other charges payable by Sublessor to Landlord
under the Lease;
(b) except as otherwise expressly provided herein, Sublessor shall perform its covenants and
obligations under the Lease which do not require for their performance possession of the Subleased
Premises and which are not otherwise to be performed hereunder by Sublessee on behalf of Sublessor;
and
(c) Sublessor hereby grants to Sublessee the right to receive all of the services and benefits
with respect to the Subleased Premises which are to be provided by Landlord under the Lease.
4. Incorporation of Terms. Except for the following provisions of the Lease which
impose obligations on Landlord; Schedule items 6, 7, 8, 9, 10, 11, 12, and 14, Sections 1 (second
sentence through remainder of paragraph), 2.A(1), 2.D.(3) (reference to square footage of Premises
only), 2.D.(4), 3.A. (first sentence), 3.B, 4.H. (second sentence), 20, 23, 25, 30, 31, 32,
Appendix C, and Appendix E of the Lease; First Amendment to Lease Sections 4, 5, 6, 8 (last
sentence), all of the terms and conditions contained in the Lease are incorporated herein as terms
and conditions of this Sublease (with each reference therein to Landlord and Tenant to be
deemed to refer to Sublessor and Sublessee, respectively, and each reference therein to the
Premises to be deemed to refer to the Subleased Premises, to the extent applicable) and, along
with all of the paragraphs contained in this Sublease, shall be the complete terms and conditions
of this Sublease. Sublessee hereby assumes and agrees to perform all of the obligations of the
Tenant under the Lease with respect to the Subleased Premises (to the extent applicable);
provided, however, Sublessee shall have no right to exercise any option to extend, option to
expand, right of first offer, right of first negotiation, right of first refusal, or any other
similar right granted to Sublessor as Tenant under the Lease and Sublessee shall only be
obligated to perform such obligations as they relate to the Subleased Premises during the Term.
All waivers of claims against, and exculpations of, Landlord under the incorporated provisions of
the Lease shall run from Sublessee in favor of Sublessor. All waivers of claims against, and
exculpations of, Tenant, under the incorporated provisions of the Lease shall run from Sublessor in
favor of Sublessee. To the extent there is a conflict between the provisions of the Lease which
are incorporated herein by reference and the express provisions of this Sublease, the express
provisions of this Sublease shall prevail to the extent Landlords rights under the Lease are not
affected. The Lease contains express representations made by Landlord and describes Landlords
duties in connection with the operation of the Premises, Building and Project. Sublessor is not
obligated to perform any of Landlords obligations under the Lease, and Sublessor shall not be
liable for Landlords violation of any provision of the Lease or for any misrepresentation by
Landlord. If Landlord fails to perform any of its obligations under the Lease, then Sublessee
shall notify Sublessor of such failure, and thereafter Sublessor shall promptly notify Landlord and
demand performance. If Landlord continues to fail to perform, then Sublessee may seek recourse
against Landlord. If Sublessor has the right to proceed against Landlord, or otherwise enforce any
rights of Sublessee against Landlord, and Sublessee has no standing to enforce such rights, then
Sublessor, upon request, shall take such action as is reasonably necessary to enforce such rights.
Sublessee shall indemnify Sublessor against all expenses, including reasonable attorneys fees,
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incurred by Sublessor as a result of or in connection with enforcing rights against Landlord on
behalf of Sublessee.
5. Term. The term (the Term) of this Sublease shall commence on the Commencement
Date and shall expire twenty-four (24) months after the Commencement Date (the Expiration Date).
6. Base Rent.
(a) Base Rent. Sublessee shall pay monthly base rent (Base Rent) for the Subleased
Premises for the Term in the amount of Sixteen Thousand Eight Hundred Ninety-Four and 80/100
Dollars ($16,894.80), in advance on the first day of each month, commencing on the Commencement
Date, without deduction, offset, prior notice or demand, in lawful money of the United States of
America. Concurrently with the execution of this Sublease, Sublessee shall pay to Sublessor the
Base Rent due for the first full month of the Term.
(b) Other Payment Obligations. Commencing on the Commencement Date and continuing
during each Fiscal Year or part thereof during the Term, Sublessee shall pay to Sublessor, monthly
in advance, as Additional Rent within twenty (20) days after receipt of an invoice therefor,
Sublessees Proportionate Share, as defined below, of (i) Sublessors Proportionate Share of Excess
Operating Costs (as defined in the Lease), (ii) Sublessors Proportionate Share of Excess Taxes (as
defined in the Lease), and (iii) Sublessors Electricity Share Rent (as defined in the Lease) for
the applicable Fiscal Year. Sublessees Proportionate Share is 45.85% of Sublessors Proportionate
Share of the Building and/or Sublessors Proportionate Share of Project. In addition, Sublessee
shall reimburse to Sublessor, within twenty (20) days after receipt of an invoice, for all amounts
paid by Sublessor pursuant to the Lease to the extent attributable to the Subleased Premises or to
the acts or omission of Sublessee, its agents or employees. To the extent Sublessor is able to
obtain the same from Landlord, Sublessor shall, promptly after execution of this Sublease, provide
Sublessee with an itemized estimate of projected Additional Rent for 2005.
(c) General Conditions. If the Term commences on a day other than the first (1st) day
of a calendar month or ends on a day other than the last day of a calendar month, a prorated
monthly installment of Base Rent and other charges shall be paid at the then current rate for the
fractional month during which the Sublease commences and/or terminates. All Base Rent and other
sums required to be paid by Sublessee shall be paid to Sublessor at the address specified at the
end of this Sublease or at such other place as Sublessor may designate in writing.
(d) Security Deposit. Upon execution of this Sublease, Sublessee shall deposit with
Sublessor the sum of Fifty Thousand Six Hundred Eighty-Five and 00/100 Dollars ($50,685.00), which
shall be held by Sublessor as a security deposit for Sublessees performance of all the terms,
covenants and conditions of this Sublease (the Security Deposit). If Sublessee defaults under
any provision of this Sublease, Sublessor may (but shall not be required to) use, apply or retain
all or any part of this Security Deposit for the payment of any amount Sublessor may spend by
reason of Sublessees default or to compensate Sublessor for any loss or damage Sublessor may
suffer because of Sublessees default. If any portion of the Security Deposit is so used or
applied, Sublessee shall, immediately after written demand, deposit cash with Sublessor in an
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amount sufficient to restore the Security Deposit to its original amount. Sublessor is not
required to keep the Security Deposit separate from its general funds, and all interest earned on
the security deposit shall accrue to the benefit of Sublessor. If Sublessee performs each of its
obligations under this Sublease, the Security Deposit, or any balance thereof, shall be returned to
Sublessee within thirty (30) days after the later of (i) the expiration of the Term or sooner
termination of the Sublease; (ii) the date Sublessee vacates the Subleased Premises; or (iii) the
date Sublessee will have no further unperformed obligations herein. Sublessee hereby waives the
provisions of Section 1950.7 of the California Civil Code (providing that a landlord may claim from
a security deposit only those sums reasonably necessary to remedy defaults in the payment of rent,
to repair damage caused by a tenant, or to clean the premises); provided, in so waiving the
provisions of Section 1950.7, Sublessee shall not be deemed to have agreed to permit Sublessor to
retain any portion of the Security Deposit in excess of that which would be required to make
Sublessor whole (whether prior to or following termination of the Sublease).
(d) Rent. As used in this Sublease, the term Rent includes Base Rent, Additional Rent
and all other sums payable by Sublessee under this Sublease.
8. Late Charge; Interest. If any sums due from Sublessee are not received by
Sublessor within five (5) days when due, Sublessee shall pay to Sublessor a late charge equal to
five percent (5%) of such overdue amount. The parties agree that such late charge represents a fair
and reasonable estimate of the costs Sublessor will incur by reason of late payment by Sublessee.
In addition, every payment due hereunder from Sublessee to Sublessor which is not paid when due
shall bear interest at ten percent (10%) per annum from the date that the same became due and
payable until paid, whether or not demand be made therefor.
9. Use. Sublessee shall use the Subleased Premises in compliance with the Lease.
Sublessee shall not store, use or dispose of any Hazardous Materials in, on or about the Subleased
Premises, the Building or the Project. Sublessee shall immediately provide Sublessor with copies
of any notice, report or other correspondence between Sublessee and any governmental agency
concerning any Hazardous Materials in, on or about the Subleased Premises, the Building or the
Project.
10. Default.
(a) Events of Default. In addition to any other event specified in this Sublease as
an event of default, the occurrence of any one or more of the following events (Events of
Default) shall constitute a breach of this Sublease by Sublessee: (i) failure by Sublessee to pay
rent or any other sum when and as the same becomes due and payable and such failure continues for
more than four (4) days after Sublessor gives written notice thereof to Sublessee; or (ii) failure
by Sublessee to perform or observe any other obligations of Sublessee and such failure continues
for more than fourteen (14) days (or such shorter period as is allowed for the cure of the subject
default pursuant to the Lease) after Sublessor gives written notice thereof to Sublessee; provided,
however, that, except as hereinbelow set forth, if, by the nature of such agreement, covenant or
condition, such failure cannot reasonably be cured within the allotted time, an Event of Default
shall not exist as long as Sublessee commences with due diligence and dispatch the curing of such
failure within the allotted time and, having so commenced, thereafter prosecutes with diligence and
dispatch and
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completes the curing of such failure. Anything herein to the contrary notwithstanding, in no event
shall any grace period provided in this Section 10(a)(ii) be longer than the grace period for such
default provided in the Lease.
(b) Sublessors Remedies. If an Event of Default occurs, Sublessor shall be entitled
to exercise against Sublessee all of the rights and remedies afforded to Landlord under the Lease
with respect to breaches of the Lease by Sublessor, and Sublessee shall indemnify, defend and hold
Sublessor harmless from all damages resulting from such Event of Default and shall reimburse
Sublessor for all sums incurred by Sublessor in fulfilling Sublessees obligations, together with
interest on those sums at ten percent (10%) per annum.
11. Holding Over. Sublessor and Sublessee recognize that Sublessors damages resulting
from Sublessees failure to timely surrender possession of the Subleased Premises may be
substantial, may exceed the amount of the Rent payable hereunder, and will be impossible to
accurately measure. Accordingly, if possession of the Subleased Premises is not surrendered to
Sublessor on the Expiration Date or sooner termination of this Sublease, in addition to any other
rights or remedies Sublessor may have hereunder or at law, Sublessee shall pay to Sublessor during
the period Sublessee holds over in the Subleased Premises after the Expiration Date or sooner
termination of this Sublease, a sum equal to 200% of the Base Rent payable under this for each full
or partial month plus all other sum due under this Sublease. In addition, Sublessee shall
indemnify Sublessor against any and all claims, losses and liabilities for damages resulting from
failure to surrender possession, including, without limitation, any claims made by Landlord or any
succeeding tenant, and any Rent and other charges due under the Lease. In addition, no
holding-over by Sublessee, nor the payment to Sublessor of the amounts specified above, shall
operate to extend the Term hereof. Nothing herein contained shall be deemed to authorize Sublessee
to retain possession of the Subleased Premises after the Expiration Date or sooner termination of
this Sublease.
12. Assignment and Subletting.
(a) General. Sublessee shall not, without the prior written consent of Landlord and
Sublessor, which consent as to Sublessor shall not be unreasonably withheld, assign, sublet,
mortgage, pledge, encumber or otherwise transfer (collectively, Transfer) this Sublease, the term
or estate hereby granted, or any interest hereunder, or permit the Subleased Premises to be used or
occupied by anyone other than Sublessee. The foregoing notwithstanding, Sublessee acknowledges
that it shall be reasonable for Sublessor to withhold its consent to the proposed Transfer if the
Transferee proposes making any alterations to the Subleased Premises or Sublessee is not
transferring the entire Subleased Premises. In addition, Sublessee acknowledges and agrees that
Landlord may withhold its consent to a Transfer pursuant to the terms of the Lease, and that
Sublessor will not consent to any Transfer if Landlord does not consent to such Transfer. The
foregoing notwithstanding, Verus Pharmaceuticals, Inc. will be entitled to cohabitate with
Sublessee during the Term, provided that no alterations are made to the Subleased Premises.
(b) Notice and Procedure. If at any time during the Term, Sublessee desires to
Transfer this Sublease, then Sublessee shall give Sublessor a notice (the Notice) which shall set
forth the name, address and business of the proposed transferee, financial statements and
references
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of the proposed assignee or sublessee and all material terms and conditions of the proposed
assignment or subletting, all in such detail as Sublessor may reasonably require. Within ten (10)
days of receipt of the Notice, Sublessor shall have the option, exercisable by giving notice to
Sublessee, to (a) consent to the Transfer, (b) withhold consent to the Transfer to the extent it is
reasonable to do so, or (c) terminate this Sublease as of the date upon which the Transfer was to
have occurred, in which event Sublessee shall be relieved of all further obligations hereunder. No
failure of Sublessor to exercise its termination right shall be deemed to be Sublessors consent to
the assignment or subletting.
(c) Continuing Liability of Sublessee. No Transfer shall release Sublessee from its
obligation or alter the primary liability of Sublessee to pay the Rent and to perform all other
obligations to be performed by Sublessee hereunder. The acceptance of Rent by Sublessor from any
other person shall not be deemed a waiver by Sublessor of any provision hereof.
13. Waiver of Liability; Indemnity.
(a) Sublessor shall not be liable or responsible for, and Sublessee waives all claims against
Sublessor, its agents, employees, officers, directors and invitees with respect to or arising out
of, any death of or injury to Sublessee, its agents, employees, officers, directors invitees, or
any other person, from any causes whatsoever, or for any loss of or damage to any property outside
or within the Subleased Premises, unless such death, injury, loss or damage is caused by the
negligence or willful misconduct of Sublessor or its agents, employees, officers, directors and
invitees.
(b) Sublessee shall hold Sublessor and Landlord and their respective agents and employees
harmless and defend Sublessor and Landlord, and their agents, employees, officers, directors and
invitees from and against any and all losses, damages, claims or liability for any damage to any
property or injury, illness or death of any person occurring in or about the Subleased Premises
arising at any time during the Term and from any cause whatsoever other than by reason of the
negligence or willful misconduct of Sublessor or Landlord or either of their agents, employees,
officers, directors and invitees including without limitation, claims, costs and liabilities,
including reasonable attorneys fees and costs, arising out of or in connection with the removal,
cleanup or abatement of any hazardous materials which may be in or about the Subleased Premises or
the Premises as a result of any act or omission of Sublessee, its employees, agents or contractors
during the Term. This Section 13(b) shall survive the termination of this Sublease.
14. Insurance.
(a) With respect to the Subleased Premises only, Sublessee shall comply with the obligations
of Tenant under the Lease with respect to insurance and subrogation including those obligations set
forth, without limitation, in Article 8 of the Lease, and shall cause Landlord and Sublessor to be
named as additional insureds and/or loss payees within all required policies of insurance with
waivers of subrogation in favor of Landlord and Sublessor.
(b) Insurance Criteria. All the insurance required under this Sublease shall: (i) be
issued by insurance companies authorized to do business in the State in which the Building is
located and which are reasonably satisfactory to Sublessor; (ii) name Sublessor, Landlord and any
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managing agent and other designee as an additional insured; (iii) be issued as a primary policy and
not excess over or contributory with any other applicable insurance in force for or on behalf of
Sublessor and/or Landlord; (iv) contain an endorsement requiring thirty (30) days written notice
from the insurance company to both parties before cancellation or change in the coverage, scope, or
amount of any policy; and (v) specifically include the liability to be assumed hereunder by
Sublessee (provided, however, that the amount of such insurance shall not be construed to limit the
liability of Sublessee hereunder). A certificate of each policy, together with evidence of payment
of premiums, shall be deposited with Sublessor the earlier of Sublessees entry on the Subleased
Premises or the Commencement Date, and on renewal of the policy not less than twenty (20) days
before expiration of the term of the policy.
15. Notices. All notices or demands shall be given only by personal service,
certified mail with a return-receipt (which shall be deemed delivered two (2) days after mailing,
postage prepaid) or delivery by a reputable overnight air courier service which provides written
evidence of delivery (which shall be deemed to be given on the next business day after delivery to
the courier service, prepaid). Notices shall be addressed to the addresses under the signatures
below. Either party may change its address for notices or demands by written notice delivered as
set forth above. Sublessee shall promptly after receipt thereof send to Sublessor copies of all
notices Sublessee receives from Landlord. For purposes of Sublessors response to any request by
Sublessee, all time periods in the Lease within which Landlord is required to act or respond shall
be extended by ten (10) business days.
16. Parking. Sublessee have the right to use within the Project twenty (23)
unreserved surface parking spaces at no additional cost or expense to Sublessee, so long as Landlord
does not impose a charge for such surface parking, and if Landlord does impose a charge for such
parking, at Landlords prevailing monthly rate, without markup by Sublessor.
17. Termination, Amendment and Modification of Lease. Except as specifically
permitted in the Lease, Sublease shall not terminate, amend or otherwise modify the Lease in any
way that could reasonably be expected to have a materially adverse effect on Sublessees rights
under this Sublease without the prior written consent of Sublessee, which consent shall not be
unreasonably withheld or delayed.
18. Signage. Subject to Landlords consent, Sublessee shall be entitled have its name
listed in the Building standard directory and its name next to the door of the Subleased Premise.
19. Attorneys Fees. The prevailing party in any action or proceeding (whether at the
administrative, trial or appellate levels) brought by either party against the other under this
Sublease shall recover attorneys fees and costs in such amount as the court or administrative body
may adjudge reasonable.
20. Administration of this Sublease. If Sublessee requests that Sublessor execute any
document relating to or in connection with the Sublease or approve any assignment or subletting,
Sublessee shall reimburse Sublessor, within ten (10) days after billing, for the reasonable cost of
review and processing of Sublessees request including, without limitation, reasonable attorneys
fees.
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21. Estoppel Certificate. Sublessee shall, without charge to Sublessor or Landlord,
and Sublessor, without charge to Sublessee, at any time from time to time, within ten (10) business
days after receipt of written request therefor, deliver an executed certificate certifying, if
true: (a) that this Sublease is unmodified and in full force and effect, or if there have been any
modifications, that same is in full force and effect as modified and stating any such
modifications; (b) whether or not there is then existing any claim of default of the other party
hereunder and if so, specifying the nature thereof; and (c) the current amount of Base Rent payable
hereunder by Sublessee and the date to which the same has been paid.
22. Damage and Destruction/Eminent Domain. If the Lease confers upon Sublessor the
right to terminate the Lease in the event of damage, destruction, eminent domain or similar
circumstances, the exercise by Sublessor of such termination right shall not constitute a default
or breach by Sublessor hereunder.
23. Brokers. Sublessee and Sublessor represent to each other that they have not dealt
with any brokers in connection with this Sublease other than Corporate Real Estate Advisors and
Cushman & Wakefield of California, and Sublessee and Sublessor shall indemnify, protect, defend and
hold each other harmless from and against any and all claims, costs or liability arising out of or
relating to its breach of this representation. Sublessor shall pay the brokerage commissions or
fees owed to Corporate Real Estate Advisors pursuant to a separate agreement.
24. Severability. If any provision of this Sublease shall be judicially or
administratively held invalid or unenforceable for any reason, such holding shall not be deemed to
affect, alter, modify or impair in any manner any other provision of this Sublease.
25. Entire Agreement. This Sublease and the exhibits attached hereto constitute the
sole and exclusive agreement between the parties with respect to the Subleased Premises. No
amendment, modification of or supplements to this Sublease shall be effective unless in writing and
executed by Sublessor and Sublessee.
26. Survival. All indemnities contained in this Sublease shall survive the expiration
or termination hereof.
27. Landlord Consent. The effectiveness of this Sublease is contingent upon
Landlords written consent to the terms and conditions of this Sublease.
28. Exhibits. Exhibits A, B and C attached hereto are incorporated herein by
reference.
29. Counterparts. This Sublease may be executed concurrently in counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument.
9
IN WITNESS WHEREOF, this Sublease is made the day and year first above written.
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SUBLESSOR: |
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SUBLESSEE: |
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Townsend and Townsend and Crew, LLP,
a California limited liability
partnership |
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Strata Pharmaceuticals, Inc., a
Delaware corporation |
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By: |
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/s/ Theodore R. Schroeder |
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By:
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/s/ [Unintelligible] |
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Its: |
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President & CEO |
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Its: |
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Executive Director |
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By: |
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By:
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Its: |
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Address: |
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Address: |
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Two Embarcadero Center, Suite 700 |
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10923 Cloverhurst Way |
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San Francisco, CA 94111 |
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San Diego, CA 92130 |
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Attn: Executive Director |
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exv10w9
EXHIBIT 10.9
SUMMARY OF BASIC LEASE INFORMATION AND DEFINITIONS
This SUMMARY OF BASIC LEASE INFORMATION AND DEFINITIONS (Summary) is hereby incorporated
into and made a part of the attached Office Lease which pertains to the Building described in
Section 1.4 below. All references in the Lease to the Lease shall include this Summary.
All references in the Lease to any term defined in this Summary shall have the meaning set forth in
this Summary for such term. Any initially capitalized terms used in this Summary and any initially
capitalized terms in the Lease which are not otherwise defined in this Summary shall have the
meaning given to such terms in the Lease. If there is any inconsistency between the Summary and
the Lease, the provisions of the Lease shall control.
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1.1
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Landlords Address: |
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For Notice:
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Prentiss/Collins Del Mar Heights LLC |
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c/o Prudential Real Estate Investors |
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4 Embarcadero Center, Suite 2700 |
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San Francisco, California 94111 |
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Attn: Asset Management, PRISA II Portfolio |
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Facsimile: (415) 398-1025 |
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With a copy to:
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Prentiss/Collins Del Mar Heights LLC |
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c/o Prudential Real Estate Investors |
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8 Campus Drive, 4th Floor |
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Parsippany, New Jersey 07054 |
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Attention: Gregory D. Shanklin, Law Department |
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With a copy to:
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c/o Brandywine Realty Trust |
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705 Palomar Airport Road, Suite 320 |
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Carlsbad, California 92011 |
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Attention: Vice President |
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For Payment:
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Prentiss/Collins Del Mar Heights LLC |
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P.O. Box 100125 |
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Pasadena, California 91189-0125 |
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1.2
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Tenants Address:
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Cadence Pharmaceuticals, Inc. |
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12730 High Bluff Drive, Suite 410 |
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San Diego, California 92130 |
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Attn: David Socks |
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Telephone: (858) 436-1400 |
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Facsimile: (858) 436-1401 |
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(Prior to Commencement Date) |
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12481 High Bluff Drive, Suite 200 |
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San Diego, California 92130 |
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Attn: Chief Financial Officer |
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Telephone: (858) 436-1400 |
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Facsimile: (858) 436-1401 |
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(After Commencement Date) |
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1.3 |
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Site; Project: The Site consists of the parcel(s) of real property
in that certain Project commonly known as High Bluff Ridge at Del Mar located at
12481-12531 High Bluff Drive, City of San Diego, County of San Diego, State of
California, as shown on the site plan attached hereto as Exhibit A as
such area may be expanded or reduced from time to time. The Project includes the
Site and all buildings, improvements and facilities, now or subsequently located
on the Site from time to time, including, without limitation, the buildings
currently located on the Site, as depicted on the site plan attached hereto as
Exhibit A. The aggregate rentable square feet of the Project contains
(as of the date hereof) approximately 157,567 rentable square feet. |
Summary and Definitions, Page 1
1.4 |
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Building: The term Building shall mean (i) a three (3) story
office building located on the Site and containing approximately 68,038 rentable
square feet, the address of which is 12481 High Bluff Drive, San Diego,
California 92130 (the 12481 Building) and (ii) during the 12531 term only (as
defined below), a four (4) story office building located on the Site and
containing approximately 89,529 rentable square feet, the address of which is
12531 High Bluff Drive, San Diego, California 92130 (the 12531 Building). |
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Premises: The term Premises shall mean (i) those certain
premises known as Suite 200 as generally shown on the plan attached hereto as
Exhibit B-1, located on the second (2nd) floor of the 12481
Building, and containing approximately 23,494 rentable square feet (22,405 usable
square feet) (the 12481 Premises and (ii) during the 12531 Term only, those
certain premises known as Suite 120 as generally shown on the plan attached
hereto as Exhibit B-2, located on the first (1st) floor of
the 12531 Building, and containing approximately 1,832 rentable square feet
(1,655 usable square feet) (the 12531 Premises). |
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Term: As used herein, Term shall mean (i) with respect to the
12481 Premises, a term of six (6) years, with one option to extend for five (5)
years pursuant to Section 37 below (the 12481
Term), and (ii) with respect to the 12531 Premises, month-to-month, terminable
by either party upon 30 days written notice to the other party (the 12531
Term). |
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Commencement Date: The Commencement Date for the 12481 Term shall
be the later to occur of (i) the date upon which Substantial Completion (as such
term is defined in Exhibit C attached hereto) of the Tenant
Improvements for the 12481 Premises occurs, or (ii) September 15, 2006. The
Commencement Date for the 12531 Term shall be June 1, 2006. |
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1.8 |
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Monthly Basic Rent: Upon the commencement of the 12481 Term of
this Lease, and on the first day of each month thereafter during the Term of this
Lease, Tenant shall pay to Landlord, in advance and without offset, as Monthly
Basic Rent for the Premises the following monthly payments: |
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Monthly Basic Rent |
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Monthly Basic Rent |
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per Rentable Square Foot* |
**Commencement Date 01/31/07 |
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***$ 56,553.10 |
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$3.65 |
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$ 85,753.10 |
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$3.65 |
10/01/07 09/30/08 |
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$ 88,807.32 |
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$3.78 |
10/01/08 09/30/09 |
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$ 91,861.54 |
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$3.91 |
10/01/09 09/30/10 |
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$ 95,150.70 |
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$4.05 |
10/01/10 09/30/11 |
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$ 98,439.86 |
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$4.19 |
10/01/11 09/30/12 |
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$101,963.96 |
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$4.34 |
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* |
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Monthly Basic Rent is calculated solely based on the approximately 23,494 rentable square feet
contained in the 12481 Premises. |
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Including any partial month at the beginning of the Term if the Commencement Date does not fall
on the first day of the month. |
Summary and Definitions, Page 2
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*** |
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Monthly Basic Rent for the period from 09/15/06 through 01/31/07 is abated with respect to 8,000
square feet of the approximately 23,494 rentable square feet contained in the 12481 Premises. |
1.9 |
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Tenants Percentage: The term Tenants Percentage shall mean 14.91%, which
is the ratio that the rentable square footage of the 12481 Premises bears to the
rentable square footage of the Project. Tenants Percentage is subject to
adjustment in accordance with Section 1.3 of the Lease. |
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1.10 |
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Landlords Contribution to Operating Expenses: Landlords
Contribution to Operating Expenses shall mean Tenants Percentage of Operating
Expenses incurred by Landlord during calendar year 2007 (the Base Year),
adjusted to reflect an assumption that the Project is fully assessed for real
property tax purposes as a completed Project ready for occupancy and that the
Project is ninety-five percent (95%) occupied during such year. |
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1.11 |
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Security Deposit: In the form of a Letter of Credit in the amount
of $1,581,130, subject to the terms and conditions of, Section 5 below. |
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1.12 |
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Permitted Use: General office purposes only consistent with the
character of the Building as a first class office building and for no other
purpose or purposes whatsoever. |
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1.13 |
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Brokers: Grubb & Ellis/BRE Commercial representing Landlord and
Cushman & Wakefield representing Tenant. |
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Interest Rate: The lesser of: (a) the rate announced from time to
time by Wells Fargo Bank or, if Wells Fargo Bank ceases to exist or ceases to
publish such rate, then the rate announced from time to time by the largest (as
measured by deposits) chartered bank operating in California, as its prime rate
or reference rate, plus five percent (5%); or (b) the maximum rate permitted by
law. |
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1.15 |
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Tenant Improvements: The tenant improvements installed or to be
installed in the Premises as described in the Work Letter Agreement attached
hereto as Exhibit C. |
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Parking: A total of one hundred six (106) parking privileges at
the 12481 Building, which shall be comprised of (i) a minimum of seventy-nine
(79) unreserved, uncovered parking privileges at no additional cost to Tenant,
and (ii) a maximum of twenty-seven (27) reserved, covered parking privileges at
an additional cost to Tenant of $100 per stall per month. All such parking
privileges shall be subject to the provisions set forth in Section 6.2 of
this Lease. |
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1.17 |
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Business Hours for the Building. 7:00 a.m. to 6:00 p.m., Mondays
through Fridays (except Building Holidays) and 8:00 a.m. to 12:00 p.m. on
Saturdays (except Building Holidays). Building Holidays shall mean New Years
Day, Labor Day, Thanksgiving Day, Memorial Day, Independence Day and Christmas
Day. |
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1.18 |
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Guarantor(s): N/A. |
Summary and Definitions, Page 3
OFFICE LEASE
This LEASE (the Lease), which includes the preceding Summary of Basic Lease Information and
Definitions (the Summary) attached hereto and incorporated herein by this reference, is made and
entered into as of the 12th day of May, 2006, by and between PRENTISS/COLLINS DEL MAR HEIGHTS LLC,
a Delaware limited liability company (Landlord), and CADENCE PHARMACEUTICALS, INC, a Delaware
corporation (Tenant).
1. Premises.
1.1 |
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Premises. Landlord hereby leases to Tenant, and Tenant hereby leases from
Landlord, the Premises described in Section 1.5 of the Summary above, improved
or to be improved with the Tenant Improvements. Such lease is upon, and subject to, the
terms, covenants and conditions herein set forth and each party covenants, as a material
part of the consideration for this Lease, to keep and perform their respective
obligations under this Lease. |
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1.2 |
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Landlords Reservation of Rights. Provided Tenants use of and access to the
Premises is not materially interfered with in an unreasonable manner, and subject to the
terms of this Lease, Landlord reserves for itself the right from time to time to
install, use, maintain, repair, replace and relocate pipes, ducts, conduits, wires and
appurtenant meters and equipment above the ceiling surfaces, below the floor surfaces
and within the walls of the Building and the Premises. |
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1.3 |
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Measurement of Premises, Building and/or the Project. Landlord and Tenant each
hereby stipulate and agree that (a) the terms usable area, usable square footage,
rentable area and rentable square footage shall refer to the square footage
measurements set forth in Sections 1.3, 1.4 and 1.5, (b) such
measurements shall be conclusive for purposes of this Lease and (c) any re-measurement
of the Premises, the Building and/or the Project shall not result in the adjustment of
any provisions of this Lease which are based upon the area of the Premises, the Building
and/or the Project such as Tenants Percentage, Buildings Share, Monthly Basic Rent,
and the Allowance, if any. As used in this Lease, the following terms have the meanings
indicated: |
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1.4 |
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Project. The term Project, as used in this Lease, shall include, collectively,
(i) the 12481 Building and the 12531 Building, (ii) the other buildings in the Project
(if and when constructed), (iii) any outside plaza areas, walkways, driveways,
courtyards, public and private streets, transportation facilitation areas and other
improvements and facilities now or hereafter constructed surrounding and/or servicing
the Building and the other buildings in the Project (if and when constructed), including
parking structures and surface parking facilities now or hereafter servicing the
Building and the other buildings in the Project (if and when constructed) (collectively,
the Parking Facilities), which are designated from time to time by Landlord as common
areas (or parking facilities, as the case may be) appurtenant to or servicing the
Building and the other buildings in the Project; (iv) any additional buildings,
improvements, facilities, parking areas and structures and common areas which Landlord
(and/or any common area association formed by Landlord or Landlords assignee for the
Project) may add thereto from time to time within or as part of the Project; and (v) the
land upon which any of the foregoing are situated. The site plan depicting the current
configuration of the proposed Project is set forth in Exhibit A attached
hereto (the Site). Notwithstanding the foregoing or anything contained in this Lease
to the contrary, (1) Landlord has no obligation to expand or otherwise make any
improvements within the Project, including, without limitation, any of the outside plaza
areas, walkways, driveways, courtyards, public and private streets, transportation
facilitation areas and other improvements and facilities depicted on Exhibit A
attached hereto (as the same may be modified by Landlord from time to time without
notice to Tenant), other than Landlords obligations set forth in the Work Letter
Agreement to construct the Base, Shell and Core of the Building, and (2) Landlord shall
have the right from time to time to include or exclude any improvements or facilities
within the Project, at Landlords reasonable discretion. |
2. Term. The Term of this Lease shall be for the periods designated in Section 1.6
of the Summary commencing on the Commencement Date, and ending on the expiration of such period,
unless the Term is sooner terminated as provided in this Lease. Notwithstanding the foregoing, if
the Commencement Date falls on any day other than the first day of a calendar month then the term
of this Lease will be measured from the first day of the month following the month in which the
Commencement Date occurs so that the Term will end on the last day of a month. By written
instrument substantially in the form of Exhibit D attached hereto, Landlord shall notify
Tenant of the Commencement Date, the rentable and usable square feet of the Premises, Tenants
Percentage and all other matters stated therein, and Tenant shall, within ten (10) days following
delivery of such Commencement Notice, either (i) acknowledge and agree to all matters set forth in
the Commencement Notice by executing the same and delivering the fully executed Commencement Notice
to Landlord (in which case the Commencement Notice shall be conclusive and binding on Tenant as to
all matters set forth therein), or (ii) deliver written notice to Landlord of any objections to
matters contained in the Commencement Notice. The foregoing notwithstanding, Landlords failure to
deliver any Commencement Notice to Tenant shall not affect Landlords determination of the
Commencement Date nor Tenants right to object thereto.
3. Rent.
3.1 |
|
Basic Rent. Tenant agrees to pay Landlord, as basic rent for the Premises, the
Monthly Basic Rent in the amounts designated in Section 1.8 of the Summary. The
Monthly Basic Rent shall be paid by Tenant in monthly installments in the amounts
designated in Section 1.8 of the Summary in advance on the first day of each and
every calendar month during the Term, without demand, notice, deduction or offset except
that the first full months Monthly Basic Rent shall be paid upon Tenants execution and
delivery of this
Lease to Landlord. Monthly Basic Rent for any partial month shall be prorated in the
proportion that the number of days this Lease is in effect during such month bears to
the actual number of days in such month. |
3.2 |
|
Additional Rent. All amounts and charges payable by Tenant under this Lease in
addition to the Monthly Basic Rent described in Section 3.1 above (including,
without limitation, payments for insurance, repairs and parking, and Tenants Percentage
of Operating Expenses in excess of Landlords Contribution to Operating Expenses as
provided in Section 1.10 of the Summary) shall be considered additional rent for
the purposes of this Lease, and the word rent in this Lease shall include such
additional rent unless the context specifically or clearly implies that only the Monthly
Basic Rent is referenced. The Monthly Basic Rent and additional rent shall be paid to
Landlord as provided in Section 7, without any prior notice or demand therefor
and without any deduction or offset whatever, in lawful money of the United States of
America. |
4. Common Areas; Operating Expenses.
4.1 |
|
Definitions; Tenants Rights. During the Term of this Lease, Tenant shall have
the non-exclusive right to use, in common with other tenants in the Project, and subject
to the Rules and Regulations referred to in Section 6 below, those portions of
the Project (the Common Areas ) not leased or designated for lease to tenants that are
provided for use in common by Landlord, Tenant and any other tenants of the Project (or
by the sublessees (agents, employees, customers invitees, guests or licensees of any
such party), whether or not those areas are open to the general public. The Common
Areas shall include, without limitation, |
(i) any fixtures, systems, decor, facilities and landscaping contained, maintained or
used in connection with those areas, and shall be deemed to include any city sidewalks
adjacent to the Project, any pedestrian walkway system, park or other facilities located
on the Site and open to the general public;
(ii) the common entrances, lobbies, restrooms on multi-tenant floors, elevators,
stairways and accessways, loading docks, ramps, drives and platforms and any passageways
and serviceways thereto to the extent not exclusively serving another tenant or
contained within another tenants premises, and the common pipes, conduits, wires and
appurtenant equipment serving the Project; and
(iii) the parking structure and parking areas (subject to Section 6.2 below),
exercise facilities, loading and unloading areas, trash areas, roadways, sidewalks,
walkways, parkways, driveways and landscaped areas appurtenant to the Project.
4.2 |
|
Landlords Reserved Rights. Landlord reserves the right from time to time to use
any of the Common Areas and to do any of the following, as long as such acts do not
unreasonably interfere with Tenants use of or access to the Premises: |
|
(a) |
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expand the Building and construct or alter other buildings or improvements on the
Site; |
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(b) |
|
make any changes, additions, improvements, repairs or replacements in or to the
Project, the Site, the Common Areas and/or the Building (including the Premises if
required to do so by any law or regulation) and the fixtures and equipment thereof,
including, without limitation: (i) maintenance, replacement and relocation of pipes,
ducts, conduits, wires and meters; and (ii) changes in the location, size, shape and
number of driveways, entrances, stairways, elevators, loading and unloading areas,
ingress, egress, direction of traffic, landscaped areas and walkways and, subject to
Section 6.2, parking spaces and parking areas; |
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(c) |
|
close temporarily any of the Common Areas while engaged in making repairs,
improvements or alterations to the Project, Site and/or Building; |
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(d) |
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perform such other acts and make such other changes with respect to the Project,
Site, Common Areas and Building, as Landlord may, in the exercise of its good faith
business judgment, reasonably deem to be appropriate; |
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(e) |
|
form a common area association or associations under covenants, conditions and
restrictions to own, manage, operate, maintain, repair and/or replace all or any portion
of the landscaping, driveways, walkways, parking areas, public and private streets,
plazas, courtyards, transportation facilitation areas and/or other common areas located
outside of the Building and, subject to Section 4.4 below, include the common
area assessments, fees and taxes charged by the association(s) and the cost of
maintaining, managing, administering and operating the association(s), in Operating
Expenses; and |
|
(f) |
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perform such other acts and make such other changes with respect to the Project
as Landlord may, in the exercise of good faith business judgment, reasonably deem to be
appropriate. |
Tenant hereby agrees that Landlords actions pursuant to this Section 4.2 shall in no
way constitute a constructive eviction of Tenant nor entitle Tenant to any abatement of rent.
Landlord shall have no responsibility or for any reason be liable to Tenant for any direct or
indirect injury to or interference with Tenants business arising from Landlords actions with
respect to this Section 4.2, nor shall Tenant be entitled to any compensation or damages
from Landlord for loss of the use of the whole or any part of the Premises or of Tenants personal
property or improvements resulting from Landlords
actions with respect to this Section 4.2, or for any inconvenience or annoyance
occasioned by Landlords actions with respect to this Section 4.2.
4.3 |
|
Excess Expenses. In addition to the Monthly Basic Rent required to be paid by
Tenant pursuant to Section 3.1 above, during each month during the Term of this
Lease (after the Base Year noted in Section 1.10 of the Summary), Tenant shall
pay to Landlord (a) the amount by which Tenants Percentage of Operating Expenses for
such calendar year exceeds Landlords Contribution to Operating Expenses (such amount
shall be referred to in this Section 4 as the Excess Expenses), in the manner
and at the times set forth in the following provisions of |
2
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this Section 4, and
(b) during the 12531 Term only, the sum of One Thousand Six Hundred Seventy Five and
No/100 Dollars ($1,675.00) per month. |
4.4 |
|
Definition of Operating Expenses. As used in this Lease, the term Operating
Expenses shall consist of all costs and expenses of operation, maintenance, repair and
replacement of the Project and the Common Areas as determined by Landlord utilizing
standard commercial real estate accounting practices consistently applied and calculated
assuming the Project is ninety-five percent (95%) occupied. Operating Expenses shall
include the following costs by way of illustration but not limitation: (a) Real
Property Taxes and Assessments (as defined in Section 4.5 below) and any taxes
or assessments imposed in lieu thereof; (b) any and all assessments imposed with respect
to the Project, Common Areas, and/or Site pursuant to any covenants, conditions and
restrictions affecting the Site, Common Areas or Project; (c) except to the extent paid
by Tenant as part of Electricity Utility Charges (as defined in Section 16.1
below), water and sewer charges and the costs of electricity, heating, ventilating, air
conditioning and other utilities; (d) except to the extent paid by Tenant as part of
Electricity Utility Charges, utilities surcharges and any other costs, levies or
assessments resulting from statutes or regulations promulgated by any government
authority in connection with the use or occupancy of the Site, Project or the Premises
or the parking facilities serving the Site, Project or the Premises; (e) costs of
insurance obtained by Landlord pursuant to Section 21 of this Lease; (f) except
to the extent paid by Tenant as part of Electricity Utility Charges, waste disposal and
janitorial services; (g) security (if any); (h) costs incurred in the management of the
Site, Project and Common Areas, including, without limitation: (1) supplies, (2) wages,
salaries, benefits, pension payments, fringe benefits, uniforms and dry-cleaning thereof
(and payroll taxes, insurance and similar governmental charges related thereto) of
employees used exclusively in the operation and maintenance of the Site, Project and
Common Areas, (3) the rental of personal property used by Landlords personnel in the
maintenance, repair and operation of the Project, (4) reasonable management office
expenses including rent and operating costs, (5) accounting fees, legal fees and real
estate consultants fees, and (6) a management/administrative fee not to exceed five
percent (5%) of the annual gross revenues of the Project; (i) supplies, materials,
equipment and tools; (j) repair, replacement and maintenance of the elevators and the
structural portions of the Project, including the plumbing, heating, ventilating,
air-conditioning, electrical and other utility systems installed or furnished by
Landlord; (k) maintenance, costs and upkeep of all parking and Common Areas; (l)
amortization on a straight-line basis over the useful life (as reasonably determined by
Landlord utilizing standard commercial real estate accounting practices consistently
applied), together with interest at the Interest Rate (as defined in Section
1.14 of the Summary of this Lease) on the unamortized balance of all costs of a
capital nature (including, without limitation, capital improvements, capital
replacements, capital repairs, capital equipment and capital tools): (1) intended to
produce a reduction in operating charges or energy consumption or effect other economies
in the operation or maintenance of the Project; or (2) required after the date of this
Lease under any governmental law or regulation; (3) for repair or replacement of any
equipment or improvements needed to operate and/or maintain the Project, the Common
Areas and/or the Site at the same quality levels as prior to the repair or replacement;
or (4) which are reasonably determined by Landlord to be in the best interests of the
Project; (m) costs and expenses of gardening and landscaping; (n) maintenance of signs;
(o) personal property taxes levied on or attributable to personal property used in
connection with the Project, the Common Areas and/or the Site; and (p) costs and
expenses of repairs, resurfacing, repairing, maintenance, painting, lighting, cleaning,
refuse removal, security and similar items, including appropriate reserves. For
purposes of determining Landlords Contribution to Operating Expenses, Operating
Expenses shall not include (i) one-time special assessments, charges, costs or fees or
extraordinary charges or costs incurred in the Base Year only, (ii) market-wide
labor-rate increases due to extraordinary circumstances including, but not limited to,
boycotts and strikes, (iii) utility rate increases due to extraordinary circumstances
including, but not limited to, conservation surcharges, boycotts, embargoes or other
shortages, and (iv) amortization of any capital items including, but not limited to,
capital improvements, capital repairs and capital replacements (including such amortized
costs where the actual improvement, repair or replacement was made in prior years). In
no event shall costs for any item of utilities included in Operating Expenses for any
year subsequent to the Base Year be less than the amount included in Operating Expenses
for the Base Year for such utility item. In addition, if in any calendar year
subsequent to the Base Year, the amount of Operating Expenses decreases due to a
reduction in the cost of providing utilities, security and/or other services to the
Project for any reason, including without limitation, because of deregulation of the
utility industry and/or reduction in rates achieved in contracts with utilities and/or
service providers, then for purposes of the calendar year in which such decrease in
Operating Expenses occurred and all subsequent calendar years, the Operating Expenses
for the Base Year shall be decreased by an amount equal to such decrease. |
Landlord shall have the right, from time to time, to equitably and in good faith allocate some
or all of the Operating Expenses between the different tenants of the Project and/or different
buildings of the Project as and when such different buildings are constructed and added to (and/or
excluded from) the Project or otherwise (the Cost Pools); provided that such Cost Pools may not
exceed 100% of the actual cost of such items. Such Cost Pools may include, without limitation, the
office space tenants of the Project or of a building or buildings in the Project. Such Cost
Pools may also include an allocation of certain Operating Expenses within or under covenants,
conditions and restrictions affecting the Project. In addition, Landlord shall have the right from
time to time, in its reasonable discretion, to include or exclude existing or future buildings in
the Project for purposes of determining Operating Expenses and/or the provision of various services
and amenities thereto, including allocation of Operating Expenses in any such Cost Pools.
Notwithstanding anything in the definition of Operating Expenses set forth above, Operating
Expenses shall not include the following:
(a) |
|
costs incurred in correcting construction defects in the original construction of
the Project; |
|
(b) |
|
the following costs incurred with respect to the tenant leases at the Project:
(i) the legal expenses and brokerage fees incurred in connection with negotiating and
documenting such leases, (ii) the cost with respect to tenant |
3
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improvements to the
premises demised by such leases, (iii) free rent and tenant allowance concessions
provided by Landlord to tenants under such leases, and (iv) the expenses of advertising
the Project to prospective tenants; |
(c) |
|
depreciation, interest and principal payments on mortgage debt and other
non-operating debt of Landlord, if any; |
|
(d) |
|
costs for which the Landlord is reimbursed, or would have been reimbursed, if
Landlord had carried the insurance Landlord is required to carry pursuant to this Lease; |
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(e) |
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any bad debt loss, rent loss, or reserves for bad debts or rent loss or any
reserves of any kind (but Operating Expenses may include reasonable reserves imposed
upon the Project as part of the assessments under any covenants, conditions and
restrictions recorded against the Project); |
|
(f) |
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costs associated with the operation of the business of the partnership or entity
which constitutes the Landlord, as the same are distinguished from the costs of
operation of the Project, including partnership accounting and legal matters, costs of
defending any lawsuits with any mortgagee (except as the actions of the Tenant may be in
issue), costs of selling, syndicating, financing, mortgaging or hypothecating any of the
Landlords interest in the Project, and costs incurred in connection with any disputes
between Landlord and its employees, between Landlord and Project management, or between
Landlord and other tenants or occupants (and not such other tenants or occupants
generally); |
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(g) |
|
the wages and benefits of any employee who does not devote substantially all of
his or her employed time to the Project unless such wages and benefits are prorated to
reflect time spent on operating and managing the Project vis-à-vis time spent on matters
unrelated to operating and managing the Project; provided, that in no event shall
Operating Expenses for purposes of this Lease include wages and/or benefits attributable
to personnel above the level of Project general manager unless those personnel are
acting in the capacity of their respective positions and the amount of salary being
charged to the Project is comparable to Comparable Buildings in the area; |
|
(h) |
|
late charges, penalties, liquidated damages, and interest arising out of
Landlords failure to make timely payment of any of Taxes or Operating Expenses; |
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(i) |
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amount paid by Landlord as ground rental for the Project; |
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(j) |
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costs of capital improvements (including rentals which would constitute a capital
improvement if purchased), alterations and repairs except as set forth in clause
(l) of the first paragraph of this Section 4.4 above; |
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(k) |
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any amount paid by Landlord or to the parent organization or a subsidiary or
affiliate of the Landlord for supplies and/or services in the Project to the extent the
same exceeds the costs of such supplies and/or services rendered by qualified,
first-class unaffiliated third parties on a competitive basis; |
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(l) |
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the cost of all items and services for which Tenant or any other tenant in the
Project is obligated to reimburse Landlord such cost, or the cost of such items and
services for which Landlord provides selectively to one or more tenants (other than
Tenant) without reimbursement; |
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(m) |
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electric power costs or costs for other utilities for which any tenant (including
Tenant) directly contracts with a public service company; |
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(n) |
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costs, other than those incurred in ordinary maintenance and repair, for
sculpture, paintings or other objects of art not constituting fixtures; |
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(o) |
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depreciation; |
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(p) |
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Landlords general corporate overhead and general and administrative expenses,
except for the property management fee and except as they relate to the specific
management of the Project such as tax management services and project accounting fees; |
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(q) |
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costs arising from the gross negligence or willful misconduct of Landlord; |
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(r) |
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costs incurred to comply with applicable laws with respect to Hazardous Materials
(as such term is defined in Section 6.4 below) in, on or under the Project and/or the
Building to the extent such Hazardous Materials are: (1) in existence as of the
Commencement Date and in violation of any applicable Environmental Law (as defined in
Section 6.4 below) in effect as of the Commencement Date, and were of such a nature that
a federal, state or municipal governmental or quasi-governmental authority, if it had
then had knowledge of the presence of such Hazardous Materials, in the state and under
the conditions that the same existed in the Building or on the Project, would have then
required removal, remediation or other action with respect to such Hazardous Materials;
or (2) introduced onto the Project and/or the Building after the Commencement Date by
Landlord or other tenants of the Project in violation of applicable laws in effect at
the date of introduction, and were of such a nature that a federal, state or municipal
governmental or quasi-governmental authority, if it had then had knowledge of the
presence of such Hazardous Materials, in the state and under the conditions that the
same existed in the Building or on the Project, would have then required removal,
remediation or other action with respect to such Hazardous Materials; |
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(s) |
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costs arising from Landlords charitable or political contributions; |
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(t) |
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the cost of any employee training or incentive programs, other than for tenant
life safety information services; and |
4
(u) |
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in-house legal and/or accounting (as opposed to office building bookkeeping)
fees. |
Landlord shall (i) not make a profit by charging items to Operating Expenses that are
otherwise also charged separately to others and (ii) Landlord shall not collect Operating Expenses
from Tenant and all other tenants/occupants in the Building in an amount in excess of what Landlord
incurred for the items included in Operating Expenses. All assessments and premiums which are not
specifically charged to Tenant hereunder, which can be paid by Landlord in installments without the
imposition of fees, penalties or interest, shall be paid by Landlord in the maximum number of
installments that are permitted by law without the imposition of fees, penalties or interest and
not included as Operating Expenses except in the calendar year in which the assessment or premium
installment is actually paid; provided, however, that if the prevailing practice in Comparable
Buildings is to pay such assessments or premiums on an earlier basis, and Landlord pays on such
earlier basis, such assessments or premiums shall be included in Operating Expenses, as the case
may be, in the calendar year that such assessments or premiums are paid by Landlord; provided
further, however, that in such event, Landlord shall pro-rate the amount of any such assessment
and/or premiums and Tenant shall only pay the amount allocable to the Term.
4.5 |
|
Definition of Real Property Taxes and Assessments. All Real Property Taxes and
Assessments shall be adjusted to reflect an assumption that the Project is fully
assessed for real property tax purposes as a completed building(s) ready for occupancy.
As used in this Lease, the term Real Property Taxes and Assessments shall mean: any
form of assessment, license fee, license tax, business license fee, commercial rental
tax, levy, charge, improvement bond, tax, water and sewer rents and charges, utilities
and communications taxes and charges or similar or dissimilar imposition imposed by any
authority having the direct power to tax, including any city, county, state or federal
government, or any school, agricultural, lighting, drainage or other improvement or
special assessment district thereof, or any other governmental charge, general and
special, ordinary and extraordinary, foreseen and unforeseen, which may be assessed
against any legal or equitable interest of Landlord in the Premises, Building, Common
Areas, Site or Project, including the following by way of illustration but not
limitation: |
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(a) |
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any tax on Landlords right to rent or right to other income from the
Premises or as against Landlords business of leasing the Premises; |
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(b) |
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any assessment, tax, fee, levy or charge in substitution, partially or totally,
of any assessment, tax, fee, levy or charge previously included within the definition of
real property tax, it being acknowledged by Tenant and Landlord that Proposition 13 was
adopted by the voters of the State of California in the June, 1978 election and that
assessments, taxes, fees, levies and charges may be imposed by governmental agencies for
such services as fire protection, street, sidewalk and road maintenance, refuse removal
and for other governmental services formerly provided without charge to property owners
or occupants. It is the intention of Tenant and Landlord that all such new and
increased assessments, taxes, fees, levies and charges be included within the definition
of Real Property Taxes and Assessments for the purposes of this Lease; |
|
(c) |
|
any assessment, tax, fee, levy or charge allocable to or measured by the area of
the Premises or other premises in the Building or the rent payable by Tenant hereunder
or other tenants of the Project, including, without limitation, any gross receipts tax
or excise tax levied by state, city or federal government, or any political subdivision
thereof, with respect to the receipt of such rent, or upon or with respect to the
possession, leasing, operation, management, maintenance, alteration, repair, use or
occupancy by Tenant of the Premises, or any portion thereof but not on Landlords other
operations; |
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(d) |
|
any assessment, tax, fee, levy or charge upon this transaction or any document to
which Tenant is a party, creating or transferring an interest or an estate in the
Premises; and/or |
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(e) |
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any assessment, tax, fee, levy or charge by any governmental agency related to
any transportation plan, fund or system (including assessment districts) instituted
within the geographic area of which the Project is a part. |
Notwithstanding the foregoing, if after the Commencement Date Real Property Taxes and
Assessments are reduced, then for purposes of all subsequent calendar years including the calendar
year in which the reduction occurs, Landlords Contribution to Operating Expenses shall be
proportionately reduced. Notwithstanding the foregoing provisions of this Section 4.5
above to the contrary, Real Property Taxes and Assessments shall not include Landlords federal
or state income, franchise, inheritance, estate, capital, stock, succession, transfer, franchise,
or gift tax; (ii) any item to the extent otherwise included in Operating Costs; (iii) costs or fees
payable to public authorities in connection with any future construction, renovation and/or
improvements to the Project other than the Improvements to the Premises made by or for Tenant,
including fees for transit, housing, schools, open space, child care, arts programs, traffic
mitigation measures, environmental impact reports, traffic studies, and transportation system
management plans; (iv) reserves for future Taxes; or (v) any personal property taxes attributable
to sculptures, paintings or other objects of art (except for objects of art installed in the Common
Areas pursuant to requirements of public authority). If any Taxes are payable in installments over
a period of time, Tenant shall be liable only for the payment of those installments falling due and
payable during the Term, with appropriate proration for fractional years.
4.6 |
|
Estimate Statement. By the first day of April of each calendar year during the Term
of this Lease (after the Base Year noted in Section 1.10 of the Summary),
Landlord shall deliver to Tenant a statement (Estimate Statement) estimating the
Operating Expenses for the current calendar year and the estimated amount of Excess
Expenses payable by Tenant. Landlord shall have the right no more than three (3) times
in any calendar year to deliver a revised Estimate Statement showing the Excess Expenses
for such calendar year if Landlord determines that the Excess Expenses are greater than
those set forth in the original Estimate Statement (or previously delivered revised
Estimate Statement) for such calendar year. The Excess Expenses shown on the Estimate
Statement (or revised Estimate Statement, as applicable) shall be divided into twelve
(12) equal monthly installments, and |
5
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Tenant shall pay to Landlord, concurrently with the
regular Monthly Basic Rent payment next due following the receipt of the Estimate
Statement (or revised Estimate Statement, as applicable), an amount equal to one (1)
monthly installment of such Excess Expenses multiplied by the number of months from
January in the calendar year in which such statement is submitted to the month of such
payment, both months inclusive (less any amounts previously paid by Tenant with respect
to any previously delivered Estimate Statement or revised Estimate Statement for such
calendar year). Subsequent installments shall be paid concurrently with the regular
monthly rent payments for the balance of the calendar year and shall continue until the
next calendar years Estimate Statement (or current calendar years revised Estimate
Statement) is received. |
4.7 |
|
Actual Statement. By the first day of April of each succeeding calendar year
during the Term of this Lease, Landlord shall deliver to Tenant a statement (Actual
Statement) of the actual Operating Expenses and Excess Expenses for the immediately
preceding calendar year. If the Actual Statement reveals that Excess Expenses were
over-stated or under-stated in any Estimate Statement (or revised Estimate Statement)
previously delivered by Landlord pursuant to Section 4.6 above, then within
thirty (30) days after delivery of the Actual Statement, Tenant shall pay to Landlord
the amount of any such under-payment, or, Landlord shall credit Tenant against the next
monthly rent falling due (or promptly refund such amount if after the expiration or
earlier termination of the Lease), the amount of such over-payment, as the case may be.
Such obligation will be a continuing one which will survive the expiration or earlier
termination of this Lease. |
|
4.8 |
|
No Release. Any delay or failure by Landlord in delivering any Estimate or
Actual Statement pursuant to this Section 4 shall not constitute a waiver of its
right to receive Tenants payment of Excess Expenses, nor shall it relieve Tenant of its
obligations to pay Excess Expenses pursuant to this Section 4, except that
Tenant shall not be obligated to make any payments based on such Estimate or Actual
Statement until ten (10) business days after receipt of such statement. |
|
4.9 |
|
Audit Rights. In the event Tenant disputes the amount of the Operating Expenses
set forth in the Actual Statement for any particular calendar year delivered by Landlord
to Tenant pursuant to Section 4.7 above, Tenant shall have the right, at
Tenants cost, after reasonable notice to Landlord, to have Tenants authorized
employees or agents inspect, at Landlords office during normal business hours,
Landlords books, records and supporting documents concerning the Operating Expenses set
forth in such Actual Statement and any Operating Expenses attributable to the Base Year;
provided, however, Tenant shall have no right to conduct such inspection, have an audit
performed by the Accountant as described below, or object to or otherwise dispute the
amount of the Operating Expenses set forth in any such Actual Statement, unless Tenant
notifies Landlord of such objection and dispute, and has the Accountant commence such
audit within ninety (90) days immediately following Landlords delivery of the
particular Actual Statement in question (the Review Period); provided, further, that
notwithstanding any such timely objection, dispute, inspection, and/or audit, and as a
condition precedent to Tenants exercise of its right of objection, dispute, inspection
and/or audit as set forth in this Section 4.9, Tenant shall not be permitted to
withhold payment of, and Tenant shall timely pay to Landlord, the full amounts as
required by the provisions of this Section 4 in accordance with such Actual
Statement. However, such payment may be made under protest pending the outcome of any
audit which may be performed by the Accountant as described below. In connection with
any such inspection by Tenant, Landlord and Tenant shall reasonably cooperate with each
other so that such inspection can be performed pursuant to a mutually
acceptable schedule, in an expeditious manner and without interference with Landlords
operation and management of the Building. If after such inspection and/or request for
documentation, Tenant still disputes the amount of the Operating Expenses set forth in
the Actual Statement, Tenant shall have the right, within the Review Period, to cause
an independent certified public accountant which is not paid on a contingency basis,
which is not performing and has not performed similar audit work for other tenants of
the Project in connection with the Project, and which is mutually approved by Landlord
and Tenant (the Accountant) to complete an audit of Landlords books and records
pertaining to Operating Expenses for the calendar year which is the subject of such
Actual Statement to determine the proper amount of the Operating Expenses incurred and
amounts payable by Tenant for such calendar year. Such audit by the Accountant shall
be final and binding upon Landlord and Tenant. If Landlord and Tenant cannot mutually
agree as to the identity of the Accountant within thirty (30) days after Tenant
notifies Landlord that Tenant desires an audit to be performed, then the Accountant
shall be one of the Big 4 accounting firms or other national or regional accounting
firms, which is not paid on a contingency basis, which is not performing and has not
performed similar audit work for other tenants of the Project in connection with the
Project, and which is selected by Tenant and reasonably approved by Landlord. If such
audit reveals that Landlord has over-charged Tenant, then within thirty (30) days
after the results of such audit are made available to Landlord, Landlord shall
reimburse to Tenant the amount of such over-charge. If the audit reveals that the
Tenant was under-charged, then within thirty (30) days after the results of such audit
are made available to Tenant, Tenant shall reimburse to Landlord the amount of such
under-charge. Tenant agrees to pay the cost of such audit unless it is subsequently
determined that Landlords original Actual Statement which was the subject of such
audit was in error to Tenants disadvantage by five percent (5%) or more of the total
Operating Expenses which was the subject of such audit. The payment by Tenant of any
amounts pursuant to this Section 4 shall not preclude Tenant from questioning
the correctness of any Actual Statement provided by Landlord at any time during the
Review Period, but the failure of Tenant to object thereto, conduct and complete its
inspection and have the Accountant conduct and complete the audit as described above
prior to the expiration of the Review Period shall be conclusively deemed Tenants
approval of the Actual Statement in question and the amount of Operating Expenses
shown thereon. In connection with any inspection and/or audit conducted by Tenant
pursuant to this Section 4.9, Tenant agrees to keep, and to cause all of
Tenants employees and consultants and the Accountant to keep, all of Landlords books
and records and the audit, and all information pertaining thereto and the results
thereof, confidential, and in connection therewith, Tenant shall cause such employees,
consultants and the Accountant to execute such commercially reasonable confidentiality
agreements as Landlord may require prior to conducting any such inspections and/or
audits. |
6
5. Security Deposit.
5.1 |
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Letter of Credit. The Security Deposit shall be in the form of a Letter of
Credit in the amount set forth in Section 1.11 of the Summary above, subject to
the following additional terms and conditions: |
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(a) |
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(i) Tenant shall cause a Letter of Credit, in the amount of the Security Deposit
to be issued by a financial institution reasonably acceptable to Landlord and Tenant
(the L/C Bank) in favor of Landlord, and its successors, assigns, and transferees;
(ii) Tenant will cause the Letter of Credit to remain in full force and effect during
the entire Term and thereafter until thirty (30) days after expiration or earlier
termination of the Lease; (iii) the initial Letter of Credit will be delivered to
Landlord upon Tenants execution and delivery of this Lease to Landlord. The specific
requirements for the Letter of Credit and the rights of Landlord to make draws thereon
will be as set forth in this Section 5.1. Tenants failure to deliver and/or
thereafter cause the Letter of Credit to remain in full force and effect during the
entire Term shall constitute a default under the Lease. |
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(b) |
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Immediately upon, and at any time or from time to time after, the occurrence of
any one or more Draw Events (as hereinafter defined), Landlord will have the
unconditional right to draw on the Letter of Credit in accordance with this Section
5.1. Upon the payment to Landlord of the Draw Proceeds (as hereinafter defined),
Landlord will hold the Draw Proceeds in its own name and for its own account, without
liability for interest, to use and apply any and all of the Draw Proceeds only (i) to
cure any Event of Default by Tenant; (ii) to pay any other sum to which Landlord becomes
obligated by reason of Tenants failure to carry out its obligations under this Lease;
or (iii) to compensate Landlord for any monetary loss or damage which Landlord suffers
thereby arising from Tenants failure to carry out its obligations under this Lease. In
addition, if the Draw Event is the failure of Tenant to renew the Letter of Credit as
required hereunder, the Landlord shall be entitled to draw the entire Letter of Credit
as a cash security deposit, held as a pledge to secure Tenants obligations under this
Lease. Among other things, it is expressly understood that the Draw Proceeds will not
be considered an advance payment of Basic Rent or Additional Rent or a measure of
Landlords damages resulting from any Event of Default hereunder (past, present or
future). Further, immediately upon the occurrence and during the continuance of any one
or more Draw Events, Landlord may, from time to time and without prejudice to any other
remedy, use the Draw Proceeds (whether from a contemporaneous or prior draw on the
Letter of Credit) to the extent necessary to make good any arrearages of Basic Rent or
Additional Rent, to pay to Landlord any and all amounts to which Landlord is entitled in
connection with the pursuit of any one or more of its remedies hereunder, and to
compensate Landlord for any and all other damage, injury, expense, or liability caused
to Landlord by any and all such Events of Default. Any delays in Landlords draw on the
Letter of Credit or in Landlords use of the Draw Proceeds as provided in this
Section 5.1 will not constitute a waiver by Landlord of any of its rights
hereunder with respect to the Letter of Credit or the Draw Proceeds. Following any such
application of the Draw Proceeds, Tenant will either pay to Landlord on demand the cash
amount so applied in order to restore the Draw Proceeds to the full amount thereof
immediately prior to such application or cause the Letter of Credit to be replenished to
its full amount thereunder. In no
event shall Tenant be required to deposit or post at any time any amount which would
result in Landlords having a Security Deposit larger than the then-required amount of
the Letter of Credit after giving effect to all Scheduled Decreases (as hereinafter
defined) to which Tenant shall then be entitled under the provisions of this
Section 5.1. Landlord will not be liable for any indirect, consequential,
special, or punitive damages incurred by Tenant arising from a claim that Landlord
violated the Bankruptcy Codes automatic stay in connection with any draw by Landlord
of any Draw Proceeds, Landlords liability (if any) under such circumstances being
limited to the reimbursement of direct costs as and to the extent expressly provided
in this Section 5.1. Nothing in this Lease or in the Letter of Credit will
confer upon Tenant any property rights or interests in any Draw Proceeds; provided,
however, that upon the expiration or earlier termination of this lease, and so long as
there then exist no Draw Events or Events of Default hereunder, Landlord agrees to
return any remaining unapplied balance of the Draw Proceeds then held by Landlord, and
the Letter of Credit itself (if and to the extent not previously drawn in full) to the
L/C Bank. |
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(c) |
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Applicable Definitions. |
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Draw Event means each of the following events: |
(i) the occurrence of any one or more of the following which shall have also been
preceded, simultaneously accompanied, or succeeded by a Tenants Default (as hereinafter
defined) under this Lease regardless of the absence of any notice of default which might
otherwise be required with respect to a Tenants Default if the giving of notice to
Tenant about such breach by Tenant is stayed or barred due to one of the following
events: (A) Tenants filing of a petition under any chapter of the Bankruptcy Code, or
under any federal, state or foreign bankruptcy or insolvency statute now existing or
hereafter enacted, or Tenants making a general assignment or general arrangement for
the benefit of creditors, (B) the filing of an involuntary petition under any chapter of
the Bankruptcy Code, or under any federal, state or foreign bankruptcy or insolvency
statute now existing or hereafter enacted, or the filing of a petition for adjudication
of bankruptcy or for reorganization or rearrangement, by or against Tenant and such
filing not being dismissed within sixty (60) days, (C) the entry of an order for relief
under any chapter of the Bankruptcy Code, or under any federal, state or foreign
bankruptcy or insolvency statute now existing or hereafter enacted, (D) the appointment
of a custodian, as such term is defined in the Bankruptcy Code (or of an equivalent
thereto under any federal, state or foreign bankruptcy or insolvency statute now
existing or hereafter enacted), for Tenant, or the appointment of a trustee or receiver
to take possession of substantially all of Tenants assets located at the Premises or of
Tenants interest in this Lease and possession not being restored to Tenant within sixty
(60) days, or (E) the subjection of all or substantially all of Tenants assets located
at the Premises or of Tenants interest in this Lease to attachment, execution or other
judicial seizure and such subjection not being discharged within sixty (60) days;
(ii) the failure of Tenant, not less then thirty (30) days prior to the stated
expiration date of the Letter of Credit then in effect, to cause an extension, renewal
or replacement issuance of the Letter of Credit, at the
7
reduced amount, if any,
applicable under this Section 5.1, to be effected, which extension, renewal or
replacement issuance will be made by the L/C Bank, and, except as expressly provided in
this Section 5.1, will otherwise meet all of the requirements of the initial
Letter of Credit hereunder, which failure will be an Event of Default under this Lease;
(iii) the failure of Tenant to make when due any payment of Base Rent, of any monthly
installment of any Additional Rent, or pay any other monetary obligation within ten (10)
business days after the amount is due; or
(iv) the payment by Landlord of any sum to cure a failure by Tenant to comply with any
non-monetary obligation hereunder which Tenant has not cured within thirty (30) days
after notice thereof by Landlord (or, if Landlord is prevented from giving notice by
application of the Bankruptcy Codes automatic stay, the payment of Landlord of any sum
to cure a failure by Tenant to comply with any non-monetary obligation hereunder that
Tenant has not cured within thirty (30) days from the date of breach).
Draw Proceeds means the proceeds of any draw or draws made by Landlord under the Letter of
Credit, together with any and all interest accruing thereon.
L/C Bank means any United Stated bank which is approved by Landlord, with such approval not
to be unreasonably withheld, conditioned or delayed.
Letter of Credit means that certain one-year irrevocable letter of credit, in the amount set
forth in Section 1.11 of the Summary above, issued by the L/C Bank, as required under this
Section 5.1 and, if applicable, as extended, renewed, replaced or modified from time to
time in accordance with this Lease, which letter of credit will be in substantially the same form
as Exhibit G attached hereto.
(d) |
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If the Security Deposit is in the form of a Letter of Credit, then
notwithstanding the preceding or any other provision of this Lease or the Letter of
Credit to the contrary, the parties understand and agree that: (i) the annual
anniversary dates of this Lease and the annual extension date(s) of the Letter of Credit
could be different due to the Letter of Credit possibly being posted on a date other
than the first (1st) day of the anniversary of the date of this Lease; and
(ii) due to such non-synchronous timing as described in the immediately preceding
clause, there could be certain periods when Tenant is entitled to a Scheduled Decrease
that is not yet reflected in the Letter of Credit because the Scheduled Decrease occurs
only upon the extension date of the Letter of Credit, and not upon the anniversary of
the date of this Lease; and (iii) notwithstanding that the then-face amount of the
Letter of Credit may exceed the amount that
Landlord is entitled to draw upon under the Lease because a Scheduled Decrease has not
yet been given effect under the Letter of Credit for the reasons described in the
immediately preceding clauses (i) and (ii), Landlord shall not be entitled to, nor
shall Landlord, draw upon the Letter of Credit in an amount which would result in
Landlords obtaining proceeds from the Letter of Credit which include all or any
portion of that amount which should otherwise have been a Scheduled Decrease to such
Letter of Credit to which Tenant is otherwise entitled under this Lease. |
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5.2 |
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Scheduled Decreases. Commencing on the first anniversary of the Commencement
Date, the Security Deposit shall be decreased automatically on each of the first four
anniversaries of the Commencement Date by an amount equal to twenty-two percent (22%) of
the face amount of the Security Deposit as of the Commencement Date (a Scheduled
Decrease). |
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5.3 |
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Transfer of Letter of Credit. If Landlord transfers its interest in the
Premises, or any portion thereof, during the Term, Landlord may transfer the Security
Deposit (whether in the form of case or if Tenant has provided a Letter of Credit, then
the Letter of Credit and all Draw Proceeds held by Landlord) to the transferee and
thereafter will have no further liability with respect to the Security Deposit,
including, without limitation, any liability for the return of the Letter of Credit (if
issued). Landlord shall pay any and all fees or costs (whether payable to the L/C Bank
or otherwise) in order to effectuate such transfer of the Letter of Credit. |
6. Use.
6.1 |
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General. Tenant shall use the Premises solely for the Permitted Use specified in
Section 1.12 of the Summary, and shall not use or permit the Premises to be used
for any other use or purpose whatsoever. Tenant shall observe and comply with the
Rules and Regulations attached hereto as Exhibit E, and all reasonable
non-discriminatory modifications thereof and additions thereto from time to time put
into effect and furnished to Tenant by Landlord; provided that such modifications do not
materially increase Tenants obligations or decrease Tenants rights under this Lease.
Landlord shall use commercially reasonable efforts to enforce the Rules and Regulations,
but shall have no liability to Tenant for the violation or non-performance by any other
tenant or occupant of the Project or the Building of any such Rules and Regulations.
Tenant shall, at its sole cost and expense, observe and comply with all requirements of
any board of fire underwriters or similar body relating to the Premises, all recorded
covenants, conditions and restrictions now or hereafter affecting the Premises and all
laws, statutes, codes, rules and regulations now or hereafter in force relating to or
affecting the condition, use, occupancy, alteration or improvement of the Premises,
including, without limitation, the provisions of Title III of the Americans with
Disabilities Act of 1990 as it pertains to Tenants use, occupancy, improvement and
alteration of the Premises (whether, except as otherwise expressly provided herein,
structural or nonstructural, including unforeseen and/or extraordinary alterations
and/or improvements to the Premises, regardless of the period of time remaining in the
Lease Term). Tenant shall not use or allow the Premises to be used (a) in violation of
any recorded covenants, conditions and restrictions affecting the Site or of any law or
governmental rule or regulation, or of any certificate of occupancy issued for the
Premises or Building, or (b) for any improper, immoral, unlawful or reasonably
objectionable purpose. Tenant shall not do or permit to be done anything which will
unreasonably obstruct or interfere with the rights of other tenants or occupants of the
Project or the Building, or injure them.
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Tenant shall not cause, maintain or permit any
nuisance in, on or about the Premises, the Building, the Project or the Site, nor commit
or suffer to be committed any waste in, on or about the Premises. |
6.2 |
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Parking. |
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(a) |
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Tenants Parking Privileges. During the Term of this Lease and any
extensions thereof, Landlord shall lease to Tenant, and Tenant shall lease from
Landlord, the number of parking privileges specified in Section 1.16 of the
Summary hereof for use by Tenants employees in the common parking areas for the
Building within the Project, as designated by Landlord from time to time. Landlord
shall at all times have the right to establish and modify the nature and extent of the
parking areas for the Building and Project (including whether such areas shall be
surface, underground and/or other structures) as long as Tenant is provided the number
of parking privileges designated in Section 1.16 of the Summary. In addition,
Landlord may, in its sole discretion, assign any unreserved and unassigned parking
privileges, and/or make all or a portion of such privileges reserved. |
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(b) |
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Visitor Parking. In addition to such parking privileges for use by
Tenants employees, Landlord shall permit access to the uncovered, unreserved parking
areas for Tenants visitors free of charge, subject to availability of spaces. |
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(c) |
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Parking Rules. The use of the parking areas shall be subject to the
Parking Rules and Regulations contained in Exhibit E attached hereto and any
other reasonable, non-discriminatory rules and regulations adopted by Landlord and/or
Landlords parking operators from time to time, including any system for controlled
ingress and egress. Tenant shall not use more parking privileges than its allotment and
shall not use any parking spaces specifically assigned by Landlord to other tenants of
the Building or Project or for such other uses as visitor parking. Tenants parking
privileges shall be used only for parking by vehicles no larger than normally sized
passenger automobiles or pick-up trucks. Tenant shall not permit or allow any vehicles
that belong to or are controlled by Tenant or Tenants employees, suppliers, shippers,
customers or invitees to be loaded, unloaded, or parked in areas other than those
designated by Landlord for such activities. If Tenant permits or allows any of the
prohibited activities described herein, then Landlord shall have the right, without
notice, in addition to such other rights and
remedies that it may have, to remove or tow away the vehicle involved and charge the
cost thereof to Tenant, which cost shall be immediately payable by Tenant upon demand
by Landlord. |
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6.3 |
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Signs and Auctions. Tenant shall be entitled, at its sole cost and expense, to
one (1) identification sign on or near the entry doors of the Premises. Such sign shall
be installed by a signage contractor designated by Landlord. The location, quality,
design, style, lighting and size of such signs shall be consistent with the Landlords
Building standard signage program and shall be subject to Landlords prior written
approval, in its reasonable discretion. Upon the expiration or earlier termination of
this Lease, Tenant shall be responsible, at its sole cost and expense, for the removal
of such signage and the repair of all damage to the Building caused by such removal.
Except for such identification sign, Tenant may not install any signs on the exterior or
roof of the Building or the common areas of the Building or the Project. Any signs,
window coverings, or blinds (even if the same are located behind the Landlord approved
window coverings for the Building), or other items visible from the exterior of the
Premises or Building are subject to the prior approval of Landlord, in its reasonable
discretion. Tenant shall have no right to conduct any auction in, on or about the
Premises, the Building or Site. Tenant shall be entitled to one (1) line on the
Building directory to display Tenants name and suite number. Tenant shall also be
entitled to a sign on the Buildings monument, located on the south side of the Project.
Tenants logo shall appear on the upper right quadrant of the monument sign. |
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6.4 |
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Hazardous Materials. Tenant will (i) obtain and maintain in full force and
effect all Environmental Permits (as defined below) that may be required from time to
time under any Environmental Laws (as defined below) applicable to Tenants use of the
Premises and (ii) be and remain in compliance in all respects with all terms and
conditions of all such Environmental Permits and with all other limitations,
restrictions, conditions, standards, prohibitions, requirements, obligations, schedules
and timetables contained in all Environmental Laws applicable to Tenants use of the
Premises. As used in this Lease, the term Environmental Law means any past, present
or future federal, state, local or foreign statutory or common law, or any regulation,
ordinance, code, plan, order, permit, grant, franchise, concession, restriction or
agreement issued, entered, promulgated or approved thereunder, relating to (a) the
environment, human health or safety, including, without limitation, emissions,
discharges, releases or threatened releases of Hazardous Materials (as defined below)
into the environment (including, without limitation, air, surface water, groundwater or
land), or (b) the manufacture, generation, refining, processing, distribution, use,
sale, treatment, receipt, storage, disposal, transport, arranging for transport, or
handling of Hazardous Materials. Environmental Permits means, collectively, any and
all permits, consents, licenses, approvals and registrations of any nature at any time
required pursuant to, or in order to comply with, any Environmental Law. Except for
ordinary and general office supplies, such as copier toner, liquid paper, glue, ink and
common household cleaning materials (some or all of which may constitute Hazardous
Materials as defined in this Lease), Tenant agrees not to cause or permit any Hazardous
Materials to be brought upon, stored, used, handled, generated, released or disposed of
on, in, under or about the Premises, the Building, the Common Areas or any other portion
of the Project by Tenant, its agents, employees, subtenants, assignees, licensees,
contractors or invitees (collectively, Tenants Parties), without the prior written
consent of Landlord, which consent Landlord may withhold in its reasonable discretion.
Upon the expiration or earlier termination of this Lease, Tenant agrees to promptly
remove from the Premises, the Building and the Project, at its sole cost and expense,
any and all Hazardous Materials, including any equipment or systems containing Hazardous
Materials which are installed, brought upon, stored, used, generated or released upon,
in, under or about the Premises, the Building and/or the Project or any portion thereof
by Tenant or any of Tenants Parties. To the fullest extent permitted by law, Tenant
agrees to promptly indemnify, protect, defend and hold harmless Landlord and Landlords
partners, officers, directors, employees, agents, successors and assigns (collectively,
Landlord Indemnified Parties) from and against any and all claims, damages, judgments,
suits, causes of action, losses, |
9
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liabilities, penalties, fines, expenses and costs
(including, without limitation, clean-up, removal, remediation and restoration costs,
sums paid in settlement of claims, attorneys fees, consultant fees and expert fees and
court costs) which arise or result from the presence of Hazardous Materials on, in,
under or about the Premises, the Building or any other portion of the Project to the
extent caused or permitted by Tenant or any of Tenants Parties. Tenant agrees to
promptly notify Landlord of any release of Hazardous Materials in the Premises, the
Building or any other portion of the Project which Tenant becomes aware of during the
Term of this Lease, whether caused by Tenant or any other persons or entities. In the
event of any release of Hazardous Materials caused or permitted by Tenant or any of
Tenants Parties, Landlord shall have the right, but not the obligation, to cause
Tenant, at Tenants sole cost and expense, to immediately take all steps required under
Environmental Law to remediate such release and prevent any similar future release. At
all times during the Term of this Lease, but not more frequently than once in any twelve
(12) month period, Landlord, at Landlords expense, will have the right, but not the
obligation, to enter upon the Premises to inspect, investigate, sample and/or monitor
the Premises to determine if Tenant is in compliance with the terms of this Lease
regarding Hazardous Materials. Tenant will, upon the request of Landlord or any
mortgagee at any time during which Tenant is in default under this Lease, cause to be
performed an environmental audit of the Premises at Tenants expense by an established
environmental consulting firm reasonably acceptable to Landlord and Landlords
mortgagee(s). As used in this Lease, the term Hazardous Materials shall mean and
include any hazardous or toxic materials, substances or wastes as now or hereafter
designated under any Environmental Laws, including, without limitation, asbestos,
petroleum, petroleum hydrocarbons and petroleum based products, urea formaldehyde foam
insulation, polychlorinated biphenyls (PCBs), and freon and other chlorofluorocarbons.
The provisions of this Section 6.4 will survive the expiration or earlier
termination of this Lease. |
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Landlord represents to its actual knowledge that, as of the Commencement Date, the
Premises do not contain Hazardous Materials in violation of any applicable Environmental Law.
If the foregoing representation shall prove to be false, Tenants sole remedies shall be to
require Landlord to remediate such violation, at Landlords expense, and, if Tenant is unable
to use the Premises as a result of such violation, to abate Monthly Basic Rent and Operating
Expenses pursuant to Section 16.4, provided, however that the Eligibility Period
shall not apply with respect to such abatement. |
7. Payments and Notices. All rent and other sums payable by Tenant to Landlord
hereunder shall be paid to Landlord at the address designated in Section 1.1 of the
Summary, or to such other persons and/or at such other places as Landlord may hereafter designate
in writing. Any notice required or permitted to be given hereunder must be in writing and may be
given by personal delivery (including delivery by nationally recognized overnight courier or
express mailing service), facsimile transmission sent by a machine capable of confirming
transmission receipt, with a hard copy of such notice delivered no later than one (1) business day
after facsimile transmission by another method specified in this Section 7, or by
registered or certified mail, postage prepaid, return receipt requested, addressed to Tenant at the
address(es) designated in Section 1.2 of the Summary, or to Landlord at the address
designated in Section 1.1 of the Summary. Either party may, by prior written notice to the
other, specify a different address for notice purposes. Notice given in the foregoing manner shall
be deemed given (i) upon confirmed transmission if sent by facsimile transmission, provided such
transmission is prior to 5:00 p.m. on a business day (if such transmission is after 5:00 p.m. on a
business day or is on a non-business day, such notice will be deemed given on the following
business day), (ii) when actually received or refused by the party to whom sent if delivered by a
carrier or personally served or (iii) if mailed, on the day of actual delivery or refusal as shown
by the certified mail return receipt or the expiration of three (3) business days after the day of
mailing, whichever first occurs. For purposes of this Section 7, a business day is
Monday through Friday, excluding holidays observed by the United States Postal Service.
8. Brokers. Landlord has entered into an agreement with the real estate broker specified
in Section 1.13 of the Summary as representing Landlord (Landlords Broker ), and
Landlord shall pay any commissions or fees that are payable to Landlords Broker with respect to
this Lease in accordance with the provisions of a separate commission contract. Landlord shall
have no further or separate obligation for payment of commissions or fees to any other real estate
broker, finder or intermediary. Tenant represents that it has not had any dealings with any real
estate broker, finder or intermediary with respect to this Lease, other than Landlords Broker and
the broker specified in Section 1.13 of the Summary as representing Tenant (Tenants
Broker). Any commissions or fees payable to Tenants Broker with respect to this Lease shall be
paid exclusively by Landlords Broker. Each party represents and warrants to the other, that, to
its knowledge, no other broker, agent or finder (a) negotiated or was instrumental in negotiating
or consummating this Lease on its behalf, and (b) is or might be entitled to a commission or
compensation in connection with this Lease. Tenant shall indemnify, protect, defend (by counsel
reasonably approved in writing by Landlord) and hold Landlord harmless from and against any and all
claims, judgments, suits, causes of action, damages, losses, liabilities and expenses (including
attorneys fees and court costs) resulting from any breach by Tenant of the foregoing
representation, including, without limitation, any claims that may be asserted against Landlord by
any broker, agent or finder undisclosed by Tenant herein. Landlord shall indemnify, protect,
defend (by counsel reasonably approved in writing by Tenant) and hold Tenant harmless from and
against any and all claims, judgments, suits, causes of action, damages, losses, liabilities and
expenses (including attorneys fees and court costs) resulting from any breach by Landlord of the
foregoing representation, including, without limitation, any claims that may be asserted against
Tenant by any broker, agent or finder undisclosed by Landlord herein. The foregoing indemnities
shall survive the expiration or earlier termination of this Lease.
9. Surrender; Holding Over.
9.1 |
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Surrender of Premises. Upon the expiration or sooner termination of this Lease,
Tenant shall surrender all keys for the Premises to Landlord, and exclusive possession
of the Premises to Landlord broom clean and in a condition customary for office space
leased for a similar term and in good repair, reasonable wear and tear and casualty
excepted, with all of Tenants personal property (and those items, if any, of Tenant
Improvements and Tenant Changes identified by Landlord pursuant to Section 12.2
below) removed therefrom and all damage caused by such removal repaired, as required
pursuant to Sections 12.2 and 12.3 below. If, for any reason, |
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Tenant
fails to surrender the Premises on the expiration or earlier termination of this Lease
(including upon the expiration of any subsequent month-to-month tenancy consented to by
Landlord pursuant to Section 9.2 below), with such removal and repair
obligations completed, then, in addition to the provisions of Section 9.3 below
and Landlords rights and remedies under Section 12.4 and the other provisions
of this Lease, Tenant shall indemnify, protect, defend (by counsel approved in writing
by Landlord) and hold Landlord harmless from and against any and all claims, judgments,
suits, causes of action, damages, losses, liabilities and expenses (including attorneys
fees and court costs) resulting from such failure to surrender, including, without
limitation, any claim made by any succeeding tenant based thereon. The foregoing
indemnity shall survive the expiration or earlier termination of this Lease. |
9.2 |
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Hold Over With Landlords Consent. If, with or without Landlords express
written consent, Tenant remains in possession of the Premises after the expiration or
earlier termination of the Lease Term, Tenant shall become a tenant from month-to-month
upon the terms and conditions set forth in this Lease (including Tenants obligation to
pay all Excess Expenses and any other additional rent under this Lease), but at a
Monthly Basic Rent equal to the greater of: (a) one hundred fifty percent (150%) of the
Monthly Basic Rent applicable to the Premises immediately prior to the date of such
expiration or earlier termination; or (b) one hundred fifty percent (150%) of the
prevailing market rate (as reasonably determined by Landlord) for the Premises in effect
on the date of such expiration or earlier termination. Tenant shall pay an entire
months Monthly Basic Rent calculated in accordance with this Section 9.2 for
any portion of a month it holds over and remains in possession of the Premises pursuant
to this Section 9.2. This Section 9.2 shall not be construed to create any
expressed or implied right to holdover beyond the expiration of the Lease Term or any
extension thereof. |
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9.3 |
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No Effect on Landlords Rights. The foregoing provisions of this Section
9 are in addition to, and do not affect, Landlords right of re-entry or any other
rights of Landlord hereunder or otherwise provided by law or equity. |
10. Taxes on Tenants Property. Tenant shall be liable for, and shall pay before
delinquency, all taxes and assessments (real and personal) levied against (a) any personal property
or trade fixtures placed by Tenant in or about the Premises (including any increase in the assessed
value of the Premises based upon the value of any such personal property or trade fixtures); and
(b) any Tenant Improvements or alterations in the Premises (whether installed and/or paid for by
Landlord or Tenant) to the extent such items are assessed at a valuation higher than the valuation
at which tenant improvements conforming to the Buildings standard tenant improvements are
assessed. If any such taxes or assessments are levied against Landlord or Landlords property,
Landlord may, after written notice to Tenant, pay such taxes and assessments, and Tenant shall
reimburse Landlord therefor within thirty (30) days after demand by Landlord.
11. Condition of Premises; Repairs.
11.1 |
|
Condition of Premises. Tenant acknowledges and agrees that it has had an
opportunity to inspect the Premises, the Building, the Site and the Project, and finds
the same in satisfactory condition and repair. Tenant accepts the Premises, the
Building, the Site and the Project in their then as-is condition as of the date
hereof, subject to Landlords obligations hereunder. Tenant also acknowledges that,
except as otherwise expressly set forth in this Lease, neither Landlord nor any agent of
Landlord has made any representation or warranty with respect to the Premises, the
Building, the Site or the Project or their condition, or with respect to the suitability
thereof for the conduct of Tenants business. The taking of possession of the Premises
by Tenant shall conclusively establish that the Project, the Site, the Premises, the
Tenant Improvements therein, the Building and the Common Areas were at such time
complete and in good, sanitary and satisfactory condition and repair with all work
required to be performed by Landlord, if any, pursuant to Exhibit C completed
and without any obligation on Landlords part to make any alterations, upgrades or
improvements thereto, subject to Landlords obligations hereunder (including, but not
limited to, Landlords obligations in Section 6 of Exhibit C); provided,
however, in the event that, as of the date of Substantial Completion, (A) the Base,
Shell and Core of the Building (as defined in Section 1 of Exhibit C), in its
condition existing as of such date without regard to any of the Tenant Improvements,
alterations or other improvements to be constructed or installed by or on behalf of
Tenant in the Premises or Tenants specific use of the Premises, but based on an
intended occupancy for general office, does not comply with all applicable laws in
effect as of the Commencement Date (including, without limitation, any Environmental Law
or the Americans with Disabilities Act of 1990), or (B) the Base, Shell and Core or
Tenant Improvements contain latent defects (not caused by Tenants acts or omissions),
then Landlord shall be responsible, at its sole cost and expense which shall not be
included in Operating Expenses (except as otherwise permitted in (and not excluded in)
Section 4 hereof), for promptly correcting any such non-compliance to the extent and as
and when required by applicable laws, and/or correcting any such latent defects as soon
as reasonably possible after receiving notice thereof from Tenant. |
|
11.2 |
|
Landlords Repair Obligations. Subject to Sections 4.4, 18 and
19 of this Lease, Landlord shall, as part of the Operating Expenses, repair,
maintain and replace, as necessary (a) the Building shell and other structural portions
of the Building (including the roof and foundations), (b) the basic heating,
ventilating, air conditioning (HVAC), sprinkler, mechanical, plumbing and electrical
systems within the Building core and standard conduits, connections and distribution
systems thereof within the Premises (but not any above standard improvements installed
in the Premises such as, for example, but by way of limitation, custom lighting, special
or supplementary HVAC or plumbing systems or distribution extensions, special or
supplemental electrical panels or distribution systems, or kitchen or restroom
facilities and appliances to the extent such facilities and appliances are intended for
the exclusive use of Tenant), and (c) the Common Areas and exterior glass (including
exterior plate glass); provided, however, to the extent such maintenance, repairs or
replacements are required as a result of any act, neglect, fault or omission of Tenant
or any of Tenants agents, employees, contractors, licensees or invitees, Tenant shall
pay to Landlord, as additional rent, the costs of such maintenance, repairs and
replacements. Landlord shall not be liable to Tenant for failure to perform any such
maintenance, repairs or replacements, unless Landlord shall fail to make such
maintenance, repairs or replacements and such failure shall continue for |
11
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|
an unreasonable
time following written notice from Tenant to Landlord of the need therefor.
Notwithstanding the foregoing, Landlord shall be responsible, as part of the Operating
Expenses for repairing, maintaining and replacing, as necessary, the plumbing in the
kitchen and restroom facilities, provided, however, that if such work is necessary due
to the neglect, fault or omission of Tenant or any of Tenants agents, employees,
contractors, licensees or invitees, such work shall be performed at Tenants expense and
shall not be included in Operating Expenses. Without limiting the foregoing, Tenant
waives the right to make repairs at Landlords expense under any law, statute or
ordinance now or hereafter in effect (including the provisions of California Civil Code
Section 1942 and any successive sections or statutes of a similar nature). Except as
otherwise expressly provided in this Lease, Landlord shall not be liable under any
circumstances for a loss of, or injury to, property or for injury to, or interference
with, Tenants business, including, without limitation, loss of profits, however
occurring. |
11.3 |
|
Tenants Repair Obligations. Except for Landlords obligations specifically set
forth in Sections 11.1, 11.2, 16.1, 18.1 and
19.2 hereof, Tenant shall at all times and at Tenants sole cost and expense,
keep, maintain, clean, repair, preserve and replace, as necessary, the Premises and all
parts thereof including,
without limitation, all Tenant Improvements, Tenant Changes, utility meters, all
special or supplemental HVAC systems, electrical systems, pipes and conduits, located
within the Premises, all fixtures, furniture and equipment, Tenants storefront (if
any), Tenants signs, locks, closing devices, security devices, windows, window
sashes, casements and frames, floors and floor coverings, shelving, kitchen and/or
restroom facilities and appliances located within the Premises to the extent such
facilities and appliances are intended for the exclusive use of Tenant, if any, custom
lighting, and any alterations, additions and other property located within the
Premises in good condition and repair, reasonable wear and tear and casualty excepted.
Tenant shall replace, at its expense, any and all interior glass in the Premises
which is damaged or broken from any cause whatsoever except due to the gross
negligence or willful misconduct of Landlord, its agents, contractors or employees and
not covered by insurance maintained, or required to be maintained, by Tenant
hereunder. Such maintenance and repairs shall be performed with due diligence,
lien-free and in a good and workmanlike manner, by licensed contractor(s) which are
selected by Tenant and approved by Landlord, which approval Landlord shall not
unreasonably withhold or delay. Except as otherwise expressly provided in this Lease,
Landlord shall have no obligation to alter, remodel, improve, repair, renovate,
redecorate or paint all or any part of the Premises. |
12. Alterations.
12.1 |
|
Tenant Changes; Conditions. After installation of the initial Tenant
Improvements for the Premises pursuant to Exhibit C, Tenant may, at its sole
cost and expense, make alterations, additions, improvements and decorations to the
Premises (collectively, Tenant Changes) subject to and upon the following terms and
conditions: |
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(a) |
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Notwithstanding any provision in this Section 12 to the contrary, Tenant
is absolutely prohibited from making any alterations, additions, improvements or
decorations which: (i) affect any area outside the Premises; (ii) affect the Buildings
structure, equipment, services or systems, or the proper functioning thereof, or
Landlords access thereto; (iii) affect the outside appearance, character or use of the
Project, the Building or the Common Areas; (iv) weaken or impair the structural strength
of the Building; (v) in the reasonable opinion of Landlord, lessen the value of the
Project or Building; or (vi) will violate or require a change in any occupancy
certificate applicable to the Premises. |
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(b) |
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Before proceeding with any Tenant Change which is not otherwise prohibited in
Section 12.1(a) above, Tenant must first obtain Landlords written approval
thereof (including approval of all plans, specifications and working drawings for such
Tenant Change), which approval shall not be unreasonably withheld. However, Landlords
prior approval shall not be required for any Tenant Change which satisfies the following
conditions (hereinafter a Pre-Approved Change): (i) the costs of such Tenant Change
does not exceed Ten Thousand Dollars ($10,000) individually; (ii) the costs of such
Tenant Change when aggregated with the costs of all other Tenant Changes made by Tenant
during the Term of this Lease do not exceed Thirty Thousand Dollars ($30,000); (iii)
Tenant delivers to Landlord final plans, specifications and working drawings for such
Tenant Change at least ten (10) days prior to commencement of the work thereof; (iv) the
Tenant Change is not prohibited in Section 12.1(a) above; (v) the Tenant Change
does not require a building permit; and (vi) Tenant and such Tenant Change otherwise
satisfy all other conditions set forth in this Section 12.1. |
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(c) |
|
After Landlord has approved the Tenant Changes and the plans, specifications and
working drawings therefor (or is deemed to have approved the Pre-Approved Changes as set
forth in Section 12.1(b) above), Tenant shall: (i) enter into an agreement for
the performance of such Tenant Changes with such contractors and subcontractors selected
by Tenant and approved by Landlord, which approval shall not be unreasonably withheld or
delayed; (ii) before proceeding with any Tenant Change (including any Pre-Approved
Change), provide Landlord with ten (10) days prior written notice thereof; and (iii)
pay to Landlord, within ten (10) days after written demand, the costs of any increased
insurance premiums incurred by Landlord to include such Tenant Changes in the fire and
extended coverage insurance obtained by Landlord pursuant to Section 21 below,
if Landlord elects in writing to insure such Tenant Changes. Landlord shall not be
required to include the Tenant Changes under such insurance. If such Tenant Changes are
not included in Landlords insurance, Tenant shall insure the Tenant Changes under its
casualty insurance pursuant to Section 20.1(a) below. In addition, before
proceeding with any Tenant Change, Tenants contractors shall obtain, on behalf of
Tenant and at Tenants sole cost and expense: (A) all necessary governmental permits and
approvals for the commencement and completion of such Tenant Change; and (B) security
reasonably satisfactory to Landlord for such Tenant Change. Landlords approval of any
contractor(s) and subcontractor(s) of Tenant shall not release Tenant or any such
contractor(s) and/or subcontractor(s) from any liability for any conduct or acts of such
contractor(s) and/or subcontractor(s). |
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(d) |
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Tenant shall pay to Landlord, as additional rent, the reasonable costs of
Landlords engineers and other consultants (but not Landlords on-site management
personnel) for review of all plans, specifications and working drawings for the Tenant
Changes and for the incorporation of such Tenant Changes in the Landlords master
Building drawings, within ten (10) business days after Tenants receipt of invoices
either from Landlord or such consultants together with (in any event) an administrative
charge of five percent (5%) of the actual costs of such work. |
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(e) |
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All Tenant Changes shall be performed: (i) in accordance with the approved plans,
specifications and working drawings; (ii) lien-free and in a first-class workmanlike
manner; (iii) in compliance with all laws, rules, regulations of all governmental
agencies and authorities including, without limitation, the provisions of Title III of
the Americans with Disabilities Act of 1990; (iv) in such a manner so as not to
interfere with the occupancy of any other tenant in the Project or Building, nor impose any
additional expense upon nor delay Landlord in the maintenance and operation of the
Project or Building; and (v) at such times, in such manner and subject to such rules
and regulations as Landlord may from time to time reasonably designate. |
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(f) |
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Throughout the performance of the Tenant Changes, Tenant shall obtain, or cause
its contractors to obtain, workers compensation insurance and general liability
insurance in compliance with the provisions of Section 20 of this Lease. |
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12.2 |
|
Removal of Tenant Changes and Tenant Improvements. All Tenant Changes and the
initial Tenant Improvements in the Premises (whether installed or paid for by Landlord
or Tenant), shall become the property of Landlord and shall remain upon and be
surrendered with the Premises at the end of the Term of this Lease; provided, however,
Landlord may, by written notice delivered to Tenant (i) at the same time as Landlords
consent to such Tenant Change is given (if consent is required), (ii) within thirty (30)
days following notice of any Tenant Change for which Landlords consent is not required
or (iii) with respect to any Tenant Improvements, at the same time as Landlord approves
the Final Space Plan described in Section 3.2 of Exhibit C attached hereto,
require Tenant to remove such Tenant Change or Tenant Improvement, as applicable, at the
end of the Term of this Lease. If Landlord requires Tenant to remove any such items as
described above, Tenant shall, at its sole cost, remove the identified items on or
before the expiration or sooner termination of this Lease and repair any damage to the
Premises caused by such removal (or, at Landlords option, shall pay to Landlord all of
Landlords costs of such removal and repair). |
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12.3 |
|
Removal of Personal Property. All articles of personal property owned by Tenant
or installed by Tenant at its expense in the Premises (including business and trade
fixtures, furniture and moveable partitions) shall be, and remain, the property of
Tenant, and shall be removed by Tenant from the Premises, at Tenants sole cost and
expense, on or before the expiration or sooner termination of this Lease. Tenant shall
promptly repair any damage caused by such removal. |
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12.4 |
|
Tenants Failure to Remove. If Tenant fails to remove by the expiration or
sooner termination of this Lease all of its personal property, or any items of Tenant
Improvements or Tenant Changes identified by Landlord for removal pursuant to
Section 12.2 above, or if Tenant fails to comply with its obligations under
Section 12.3, Landlord may, at its option, treat such failure as a hold over
pursuant to Section 9.3 above, and/or may (without liability to Tenant for loss
thereof, at Tenants sole cost and in addition to Landlords other rights and remedies
under this Lease, at law or in equity: (a) remove and store such items in accordance
with applicable law; and/or (b) upon ten (10) days prior notice to Tenant, sell all or
any such items at private or public sale for such price as Landlord may obtain as
permitted under applicable law. Landlord shall apply the proceeds of any such sale to
any amounts due to Landlord under this Lease from Tenant (including Landlords
attorneys fees and other costs incurred in the removal, storage and/or sale of such
items), with any remainder to be paid to Tenant. |
13. Liens. Tenant shall not permit any mechanics, materialmens or other liens to be
filed against all or any part of the Project, the Site, the Building or the Premises, nor against
Tenants leasehold interest in the Premises, by reason of or in connection with any repairs,
alterations, improvements or other work contracted for or undertaken by Tenant or any other act or
omission of Tenant or any Tenant Parties. Tenant shall, at Landlords request, provide Landlord
with enforceable, unconditional and final lien releases (and other evidence reasonably requested by
Landlord to demonstrate protection from liens) from all persons furnishing labor and/or materials
with respect to the Premises. Landlord shall have the right at all reasonable times to post on the
Premises and record any notices of non-responsibility which it deems necessary for protection from
such liens. If any such liens are filed, Tenant shall, at its sole cost, cause such lien to be
released of record or bonded to Landlords reasonable satisfaction within ten (10) business days of
Tenants obtaining knowledge of such a lien, so that the lien no longer affects title to the
Project, the Site, the Building or the Premises. If Tenant fails to cause such lien to be so
released or bonded, Landlord may, without waiving its rights and remedies based on such breach, and
without releasing Tenant from any of its obligations, cause such lien to be released by any means
it shall deem proper, including payment in satisfaction of the claim giving rise to such lien.
Tenant shall pay to Landlord within five (5) days after receipt of invoice from Landlord, any sum
paid by Landlord to remove such liens, together with interest at the Interest Rate from the date of
such payment by Landlord. NOTICE IS HEREBY GIVEN THAT LANDLORD SHALL NOT BE LIABLE FOR ANY LABOR,
SERVICES OR MATERIALS FURNISHED OR TO BE FURNISHED TO TENANT, OR TO ANYONE HOLDING THE PREMISES
THROUGH OR UNDER TENANT, AND THAT NO MECHANICS OR OTHER LIENS FOR ANY SUCH LABOR, SERVICES OR
MATERIALS SHALL ATTACH TO OR AFFECT THE INTEREST OF LANDLORD IN THE PREMISES.
14. Assignment and Subletting.
14.1 |
|
Restriction on Transfer. Except as otherwise expressly provided in this
Section 14, Tenant shall not, without the prior written consent of Landlord,
which consent Landlord will not unreasonably withhold, condition or delay, assign this
Lease or any interest herein or sublet the Premises or any part thereof, or permit the
use or occupancy |
13
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of the Premises by any party other than Tenant (any such assignment,
encumbrance, sublease, license or the like shall sometimes be referred to as a
Transfer). In no event may Tenant encumber or hypothecate this Lease. Any Transfer
without Landlords consent (except for a Permitted Transfer pursuant to Section
14.2 below) shall constitute a default by Tenant under this Lease, without the
benefit of any additional notice or cure period specified in Section 23.1 below,
and in addition to all of Landlords other remedies at law, in equity or under this
Lease, such Transfer shall be voidable at Landlords election. In addition, this Lease
shall not, nor shall any interest of Tenant herein, be assignable by operation of law
without the written consent of Landlord, which consent shall not be unreasonably
withheld, conditioned or delayed. For purposes of this Section 14, other than
with respect
to a Permitted Transfer under Section 14.2 and transfers of stock of Tenant if
Tenant is a publicly-held corporation and such stock is transferred publicly over a
recognized security exchange or over-the-counter market, if Tenant is a corporation,
partnership or other entity, any direct or indirect transfer, assignment, encumbrance
or hypothecation of fifty percent (50%) or more (individually or in the aggregate) of
any stock or other ownership interest in such entity, and/or any transfer, assignment,
hypothecation or encumbrance of any controlling ownership or voting interest in such
entity, shall be deemed a Transfer and shall be subject to all of the restrictions and
provisions contained in this Section 14. |
14.2 |
|
Permitted Controlled Transfers. Notwithstanding the provisions of Section
14.1 above to the contrary, Tenant may assign this Lease or sublet the Premises or
any portion thereof (herein, a Permitted Transfer), without Landlords consent and
without extending any sublease or termination option to Landlord, to any entity which
controls, is controlled by or is under common control with Tenant, or to any entity
resulting from a merger or consolidation with Tenant, or to any person or entity which
acquires substantially all the assets of Tenants business as a going concern, provided
that: (a) at least twenty (20) days prior to such assignment or sublease, Tenant
delivers to Landlord the financial statements and other financial and background
information of the assignee or sublessee described in Section 14.3 below; (b) if
an assignment, the assignee assumes, in full, the obligations of Tenant under this Lease
(or if a sublease, the sublessee of a portion of the Premises or Term assumes, in full,
the obligations of Tenant with respect to such portion); (c) if an assignment, the
financial net worth of the assignee or sublessee equals or exceeds that of Tenant as of
the date of execution of this Lease; (d) Tenant remains fully liable under this Lease;
(e) the use of the Premises under Section 6 remains unchanged; and (f) such
transaction is not entered into as a subterfuge to avoid the restrictions and provisions
of this Lease. |
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14.3 |
|
Landlords Options. If at any time or from time to time during the Term Tenant
desires to effect a Transfer (other than a Permitted Transfer), Tenant shall deliver to
Landlord, at least thirty (30) days prior to the date Tenant desires the Transfer to be
effective (Transfer Date), written notice (Transfer Notice) setting forth the
Transfer Date, the terms and provisions of the proposed Transfer, the identity of the
proposed assignee, sublessee or other transferee (sometimes referred to hereinafter as a
Transferee), and any ownership or commercial relationship between Tenant and the
proposed Transferee. Tenant shall also deliver to Landlord with the Transfer Notice, a
current financial statement and financial statements for the preceding two (2) years of
the Transferee which (i) with respect to any assignee or sublessee proposing to sublease
more than one half (1/2) of the rentable square footage in the Premises, have been
certified or audited by a reputable independent accounting firm acceptable to Landlord,
or (ii) with respect to any sublessee proposing to sublease less than one half (1/2) of
the rentable square footage of the Premises, have been certified or audited by a
reputable independent accounting firm acceptable to Landlord if such financial
statements are available, otherwise which have been certified by such sublessees chief
financial officer or equivalent officer, and in any event such other information
concerning the business background and financial condition of the proposed Transferee as
Landlord may reasonably request. Except with respect to a Permitted Transfer, Landlord
shall have the option, exercisable by written notice delivered to Tenant within thirty
(30) days after Landlords receipt of the Transfer Notice, such financial statements and
other information requested by Landlord, either to: |
|
(a) |
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approve or disapprove such Transfer, which approval shall not be unreasonably
withheld, conditioned or delayed; or |
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(b) |
|
sublet from Tenant that portion of the Premises which Tenant has requested to
sublease at the rental and on the other terms set forth in this Lease prorated for the
portion of the Premises to be sublet and for the term set forth in Tenants Notice, or,
in the case of an assignment or encumbrance, terminate this Lease with respect to the
entire Premises and recapture the Premises, which termination shall be effective as set
forth in Landlords notice. |
If Landlord exercises its option to sublease any such space from Tenant following Tenants
request for Landlords approval of the proposed sublease of such space, (i) Landlord shall be
responsible for the construction of any partitions which Landlord reasonably deems necessary to
separate such space from the remainder of the Premises, and (ii) Landlord and any sub-subtenant or
assignee of Landlord with respect to such subleased space shall have the right to use in common
with Tenant all lavatories, corridors and lobbies which are within the Premises and which are
reasonably required for the use of such space. Landlord may sub-sublease such space or lease the
Premises to any person, including, without limitation, Tenants proposed sublessee or assignee.
14.4 |
|
Additional Conditions; Excess Rent. If for a Transfer other than a Permitted
Transfer Landlord does not exercise its sublease or termination option and instead
approves of the proposed Transfer pursuant to Section 14.3(a) above, Tenant may
enter into the proposed Transfer with such proposed Transferee subject to the following
further conditions: |
|
(a) |
|
the Transfer shall be on the same terms set forth in the Transfer Notice
delivered to Landlord (if the terms have changed, Tenant must submit a revised Transfer
Notice to Landlord and Landlord shall have another twenty (20) days after receipt
thereof to make the election in Sections 14.3(a) or 14.3(b) above); |
14
(b) |
|
no Transfer shall be valid and no Transferee shall take possession of the
Premises until an executed counterpart of the assignment, sublease or other instrument
affecting the Transfer has been delivered to Landlord pursuant to which the Transferee
shall expressly assume all of Tenants obligations under this Lease (or with respect to
a sublease of a portion of the Premises or for a portion of the Term, all of
Tenants obligations applicable to such portion) and the Transferee shall have
executed Landlords standard form of consent; |
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(c) |
|
no Transferee shall have a further right to assign, encumber or sublet, except on
the terms herein contained; and |
|
(d) |
|
fifty percent (50%) of any rent or other economic consideration received by
Tenant as a result of such Transfer which exceeds, in the aggregate, (i) the total rent
which Tenant is obligated to pay Landlord under this Lease (prorated to reflect
obligations allocable to any portion of the Premises subleased, but excluding any
amortized tenant improvement costs, if any), (ii) any reasonable brokerage commissions,
attorneys fees, and moving costs actually paid by Tenant in connection with such
Transfer, and (iii) the actual, reasonable, out-of-pocket costs of any improvements to
the Premises (subject to Section 12 of this Lease) and/or any space planning,
architectural or design fees or marketing costs incurred by Tenant in connection with
such Transfer, provided that such costs shall be amortized over the remaining Lease Term
if such Transfer is an assignment or, if such Transfer is a sublease, over the term of
such sublease, shall be paid to Landlord within ten (10) days after receipt thereof as
additional rental under this Lease, without affecting or reducing any other obligations
of Tenant hereunder. Notwithstanding the foregoing, if and to the extent Tenant
subleases any portion of the Premises in accordance with this Section 14 during
the period that Monthly Basic Rent hereunder is abated with respect to 8,000 rentable
square feet of the 12481 Premises as set forth in Section 1.8 of the Summary
(i.e., the period between the Commencement Date and January 31, 2007), the excess rent
payable during such period to Landlord pursuant to this paragraph shall be calculated
based on the Monthly Basic Rent payable immediately following such period for the full
rentable square footage of the 12481 Premises. |
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14.5 |
|
Reasonable Disapproval. Landlord and Tenant hereby acknowledge that Landlords
approval of any proposed Transfer (other than a Permitted Transfer) pursuant to
Section 14.3(a) shall be deemed reasonably withheld if based upon any reasonable
factor, including, without limitation, any or all of the following factors: (a) the
proposed Transfer would result in more than two subleases of portions of the Premises
being in effect at any one time during the Term; (b) the net effective rent payable by
the Transferee (adjusted on a rentable square foot basis) is less than 82% of the net
effective rent then being paid by Tenant (unless competing space of comparable size, as
reasonably determined by Landlord, is then available for lease in the Building, in which
case Landlords approval shall be deemed reasonably withheld if the net effective rent
payable by the Transferee (adjusted on a rentable square foot basis) is less than the
net effective rent being quoted by Landlord for new leases in the Building for
comparable size space for a comparable period of time; (c) the proposed Transferee is an
existing tenant of the Project or is negotiating with Landlord (or has negotiated with
Landlord in the last six (6) months) for space in the Project; (d) the proposed
Transferee is a governmental entity; (e) the portion of the Premises to be sublet or
assigned is irregular in shape with inadequate means of ingress and egress; (f) the use
of the Premises by the Transferee (i) is not permitted by the use provisions in
Section 6 hereof, or (ii) violates any exclusive use granted by Landlord to
another tenant in the Building; (g) the Transfer would likely result in significant
increase in the use of the parking areas or Common Areas by the Transferees employees
or visitors, and/or significantly increase the demand upon utilities and services to be
provided by Landlord to the Premises; (h) the Transferee does not have the financial
capability to fulfill the obligations imposed by the Transfer; or (i) the Transferee is
not in Landlords reasonable opinion of reputable or good character or consistent with
Landlords desired tenant mix. Notwithstanding any contrary provision of this Lease, if
Tenant or any proposed Transferee claims that Landlord has unreasonably withheld or
delayed its consent to a proposed Transfer or otherwise has breached its obligations
under this Section 14, Tenants and such Transferees only remedy shall be to
seek a declaratory judgment and/or injunctive relief, and Tenant, on behalf of itself
and, to the extent permitted by law, such proposed Transferee waives all other remedies
against Landlord, including, without limitation, the right to seek monetary damages or
to terminate this Lease. Landlord and Tenant hereby acknowledge that Tenant intends to
sublease a portion of the 12481 Premises consisting of no more than 8,000 rentable
square feet commencing on or near the Commencement Date, which sublease (the Initial
Sublease) shall be subject to the terms and conditions of this Section 14 and
any other provision of this Lease relating to subleases and transfers. Notwithstanding
clause (b) of this Section 14.5, however, but subject to the other
provisions of this Section 14.5, Landlords consent to such Initial Sublease
shall be deemed reasonably withheld if the net effective rent payable by the sublessee
under such Initial Sublease is less than 82% of the net effective rent being paid by
Tenant at the time such Initial Sublease is executed, whether or not competing space (as
described in clause (b)) is then available for lease in the Building. |
|
14.6 |
|
No Release. No Transfer shall release Tenant of Tenants obligations under this
Lease or alter the primary liability of Tenant to pay the rent and to perform all other
obligations to be performed by Tenant hereunder. Landlord may require that, during any
period of default (beyond applicable notice and cure periods) by Tenant, any Transferee
remit directly to Landlord on a monthly basis, all monies due Tenant by said Transferee,
and each sublease shall provide that if Landlord gives said sublessee written notice
that Tenant is in default under this Lease, said sublessee will thereafter make all
payments due under the sublease directly to or as directed by Landlord, which payments
will be credited against any payments due under this Lease. Tenant hereby irrevocably
and unconditionally assigns to Landlord all rents and other sums payable under any
sublease of the Premises; provided, however, that Landlord hereby grants Tenant a
license to collect all such rents and other sums so long as Tenant is not in default
under this Lease. Tenant shall, within ten (10) days after the execution and delivery
of any assignment or sublease, deliver a duplicate original copy there of to Landlord.
However, the acceptance of rent by Landlord from any other person shall not be deemed to
be a waiver by Landlord of any provision hereof. Consent by
Landlord to one Transfer shall not be deemed consent to any subsequent Transfer. In
the event of default by any Transferee of Tenant or any successor of Tenant in the
performance of any of the terms hereof, Landlord may proceed directly against Tenant
without the necessity of exhausting remedies against |
15
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such Transferee or successor.
Landlord may consent to subsequent assignments of the Lease or sublettings or
amendments or modifications to the Lease with assignees of Tenant, without notifying
Tenant, or any successor of Tenant, and without obtaining its or their consent thereto
and any such actions shall not relieve Tenant of liability under this Lease. |
14.7 |
|
Administrative and Attorneys Fees. If Tenant effects a Transfer or requests the
consent of Landlord to any Transfer, then Tenant shall, upon demand, pay any reasonable
attorneys and paralegal fees and costs (not to exceed $2,000) incurred by Landlord in
connection with such Transfer or request for consent (whether attributable to Landlords
in-house attorneys or paralegals or otherwise). Acceptance of the reimbursement of
Landlords attorneys and paralegal fees shall in no event obligate Landlord to consent
to any proposed Transfer. |
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14.8 |
|
Material Inducement. Tenant understands, acknowledges and agrees that (a)
Landlords option to sublease from Tenant any space which Tenant proposes to sublease or
terminate this Lease upon any proposed assignment or encumbrance of this Lease by Tenant
as provided in Section 14.3(b) above rather than approve the proposed sublease,
assignment or encumbrance, and (b) Landlords right to receive any excess consideration
paid by a Transferee in connection with an approved Transfer as provided in Section
14.4(d) above, are a material inducement for Landlords agreement to lease the
Premises to Tenant upon the terms and conditions herein set forth. |
15. Entry by Landlord. Landlord and its employees and agents shall at all reasonable times
have the right to enter the Premises to inspect the same, to supply janitorial service and any
other service required to be provided by Landlord to Tenant under this Lease, to exhibit the
Premises to prospective lenders or purchasers (or during the last six (6) months of the Term, to
prospective tenants), to post notices of non-responsibility, and/or to alter, improve or repair the
Premises or any other portion of the Building or Project, all without being deemed guilty of or
liable for any breach of Landlords covenant of quiet enjoyment or any eviction of Tenant, and
without abatement of rent. In exercising such entry rights, Landlord shall use good faith,
commercially reasonable efforts to comply with Tenants reasonable security and confidentiality
requirements (which may include having such person escorted by an employee of Tenant and/or having
such person execute Tenants non-disclosure/confidentiality agreement) and to minimize, as
reasonably practicable, the interference with Tenants business, and shall provide Tenant with at
least 24 hours advance written notice of such entry (except in emergency situations and for
scheduled services). For each of the foregoing purposes, Landlord shall at all times have and
retain a key with which to unlock all of the doors in, upon and about the Premises, excluding
Tenants vaults, secure storage rooms, office furnishings (including file cabinets and document
storage systems) and safes, and Landlord shall have the means which Landlord may deem proper to
open said doors in an emergency in order to obtain entry to the Premises. Any entry to the
Premises obtained by Landlord by any of said means or otherwise shall not under any circumstances
be construed or deemed to be a forcible or unlawful entry into, or a detainer of, the Premises, or
an eviction of Tenant from the Premises or any portion thereof, or grounds for any abatement or
reduction of rent and Landlord shall not have any liability to Tenant for any damages or losses on
account of any such entry by Landlord except, subject to the provisions of Section 22.1, to
the extent of Landlords gross negligence or willful misconduct.
16. Utilities and Services.
16.1 |
|
Standard Utilities and Services. Subject to the terms and conditions of this
Lease and the obligations of Tenant as set forth hereinbelow, and so long as the Lease
has not been terminated due to an uncured default by Tenant under the Lease, Landlord
shall furnish or cause to be furnished to the Premises the following utilities and
services, the costs of which shall be included in Operating Expenses, unless otherwise
specified below: |
|
(a) |
|
Landlord shall make the elevator of the Building available for Tenants
non-exclusive use, twenty-four (24) hours per day, seven (7) days per week. |
|
(b) |
|
Landlord shall furnish during the Business Hours for the Building specified in
Section 1.17 of the Summary, heating, ventilation and air conditioning (HVAC)
for the Premises as required in Landlords judgment for the comfortable and normal
occupancy of the Premises. The cost of maintenance and service calls to adjust and
regulate the HVAC system shall be charged to Tenant if the need for maintenance work
results from either Tenants adjustment of room thermostats or Tenants failure to
comply with its obligations under this Section 16, including keeping window
coverings closed as needed. Such work shall be charged at hourly rates equal to
then-current journeymans wages for HVAC mechanics. If Tenant desires HVAC at any time
other than during the Business Hours for the Building, Landlord shall provide such
after-hours usage after advance reasonable request by Tenant, and Tenant shall pay to
Landlord, as additional rent (and not as part of the Operating Expenses) the actual
cost, as fairly determined by Landlord, of such after-hours usage (as well as the cost
of any HVAC used by Tenant in excess of standard usage for the Building), including any
minimum hour charges for after-hours requests and any special start-up costs for
after-hours services which requires a special start-up (such as late evenings, weekends
and holidays) together with an administrative fee of ten percent (10%) of the cost of
such after-hours usage, which administrative fee shall also be payable by Tenant to
Landlord for the cost of any other services provided by Landlord to Tenant that are not
otherwise required to be provided by Landlord to Tenant hereunder. Landlords cost
for such after-hours usage shall be based on Landlords actual direct utility costs,
plus Landlords other direct costs. Landlord agrees that such hourly rate shall be
established at an amount which will reimburse Landlord for the actual cost to Landlord
to supply the service, but without a profit to Landlord. |
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(c) |
|
Landlord shall furnish janitorial services to the Premises five (5) days per week
pursuant to janitorial and cleaning specifications as may be adopted by Landlord from
time to time. No person(s) other than those persons approved by Landlord shall be
permitted to enter the Premises for such purposes. Janitorial service shall include
ordinary dusting and cleaning by the janitor assigned to do such work and shall not
include cleaning of carpets or rugs, except normal vacuuming, or moving of furniture,
interior window cleaning, coffee or eating area cleaning and other special services.
Such additional services may be rendered by Landlord pursuant to written agreement |
16
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with
Tenant as to the extent of such services and the payment of the cost thereof.
Janitorial service will not be furnished to rooms that are occupied after 7:30 p.m. or
to rooms which are locked unless a key is furnished to the Landlord for use by the
janitorial contractor. Window cleaning shall be done only by Landlord, at such time and
frequency as determined by Landlord in Landlords reasonable discretion, but otherwise
consistent with other first-class office buildings in the Carmel Valley area of San
Diego. Tenant shall pay to Landlord the cost of removal of any of Tenants refuse and
rubbish to the extent that the same exceeds the refuse and rubbish usually attendant
upon the use of the Premises as offices. |
(d) |
|
Landlord may, in Landlords sole discretion, provide security service or
protection in the Building and/or the Project, in any manner deemed reasonable by
Landlord at Landlords sole discretion, from the Commencement Date throughout the Term. |
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(e) |
|
At Landlords option and at Landlords sole expense, Landlord may install water,
electricity and/or HVAC meters in the Premises to measure Tenants consumption of such
utilities, including any after-hours and extraordinary usage described above. |
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16.2 |
|
Tenants Obligations. Tenant shall control and be separately metered for the
electricity, gas, water, and telephone service for the Premises or other services which
are metered (collectively, the Electricity Utility Charges) to the Premises, at
Tenants sole cost and expense. Tenant shall make all such payments directly to the
utility provider as and when bills are rendered. Should Tenant fail to pay such
amounts, Landlord shall have the right to pay the same on Tenants behalf and Tenant
shall reimburse Landlord for all costs and expenses incurred by Landlord in conjunction
with such payment within ten (10) days after demand therefor. All such costs and
expenses incurred by Landlord on Tenants behalf shall be deemed additional rent payable
by Tenant and collectible by Landlord as such. At no time shall use of electricity in
the Premises exceed the capacity of existing feeders and risers to or wiring in the
Premises. Any risers or wiring to meet Tenants excess electrical requirements shall,
upon Tenants written request, be installed by Landlord, at Tenants sole cost, if, in
Landlords reasonable judgment, the same are necessary and shall not (i) cause permanent
damage or injury to the Project, the Building or the Premises, (ii) cause or create a
dangerous or hazardous condition, (iii) entail excessive or unreasonable alterations,
repairs or expenses, or (iv) interfere with or disturb other tenants or occupants of the
Building. Tenant shall cooperate fully at all times with Landlord, and abide by all
reasonable regulations and requirements which Landlord may prescribe for the proper
functioning and protection of the Buildings services and systems. Tenant shall not use
any apparatus or device in, upon or about the Premises which may in any way increase the
amount of services or utilities usually furnished or supplied to the Premises or other
premises in the Building. In addition, except for Tenant Changes permitted under
Section 12, Tenant shall not connect any conduit, pipe, apparatus or other
device to the Buildings water, waste or other supply lines or systems for any purpose.
Except for Tenant Changes permitted under Section 12, neither Tenant nor its
employees, agents, contractors, licensees or invitees shall at any time enter, adjust,
tamper with, touch or otherwise in any manner affect the mechanical installations or
facilities of the Building. |
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16.3 |
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Failure to Provide Services. Landlords failure to furnish or delay in
furnishing any of the services described in Section 16.1 above when such failure
is caused by all or any of the following shall not result in any liability of Landlord:
(a) casualty, accident, breakage or repairs; (b) acts of terrorism, strikes, lockouts or
other labor disturbances or labor disputes of any such character; (c) governmental
regulation, moratorium or other governmental action; (d) inability, despite the exercise
of reasonable diligence, to obtain electricity, water or fuel, including due to
shortages, blackouts or any other cause; or (e) any other cause beyond Landlords
reasonable control. In addition, in the event of the failure of any said utilities or
services, Tenant shall not be entitled to any abatement or reduction of rent (except as
expressly provided in Sections 18.3 and 19.2 if such failure is a result
of a damage or taking described therein), no eviction of Tenant shall result, and Tenant
shall not be relieved from the performance of any covenant or agreement in this Lease.
Furthermore, Landlord shall not be liable under any circumstances for a loss of, or
injury to, property or for injury to, or interference with, Tenants business,
including, without limitation, loss of profits, however occurring, through or in
connection with or incidental to a failure to furnish any of the services as set forth
in this Section 16. In the event of any stoppage or interruption of services or
utilities, Landlord shall diligently attempt to resume such services or utilities as
promptly as practicable. Tenant hereby waives the provisions of California Civil Code
Section 1932(1) or any other applicable existing or future law, ordinance or
governmental regulation permitting the termination of this Lease due to an interruption,
failure or inability to provide any services. |
|
16.4 |
|
Abatement of Rent When Tenant Is Prevented From Using Premises. In the event
that Tenant is prevented from using, and does not use, the Premises or any portion
thereof, for five (5) consecutive business days (the Eligibility Period) as a result
of (i) any repair, maintenance or alteration performed by Landlord after the
Commencement Date, or (ii) any failure to provide to the Premises any of the essential
utilities and services required to be provided in Sections 16.1(a),
16.1(b) or 16.1(c) above, (iii) any failure to provide access to the
Premises, or (iv) Landlords exercise of its rights in Section 4.1 of this
Lease, then Tenants obligation to pay Monthly Basic Rent and Operating Expenses shall
be abated or reduced,
as the case may be, from and after the first (1st) day following the Eligibility
Period and continuing until such time that Tenant continues to be so prevented from
using, and does not use, the Premises or a portion thereof, in the proportion that the
rentable square feet of the portion of the Premises that Tenant is prevented from
using, and does not use, bears to the total rentable square feet of the Premises;
provided, however, that Tenant shall only be entitled to such abatement of rent if the
matter described in clauses (i), (ii), (iii) or (iv) of this sentence is caused by
Landlords gross negligence or willful misconduct. To the extent Tenant shall be
entitled to abatement of rent because of a damage or destruction pursuant to
Section 18 or a taking pursuant to Section 19, then the Eligibility
Period shall not be applicable |
17
17. Indemnification and Exculpation.
17.1 |
|
Tenants Assumption of Risk and Waiver. Except to the extent such matter is not
covered by the insurance required to be maintained by Tenant under this Lease and such
matter is attributable to the gross negligence or willful misconduct of Landlord,
Landlord shall not be liable to Tenant, Tenants employees, agents or invitees for: (i)
any damage to property of Tenant, or of others, located in, on or about the Premises,
nor for (ii) the loss of or damage to any property of Tenant or of others by theft or
otherwise, (iii) any injury or damage to persons or property resulting from fire,
explosion, falling plaster, steam, gas, electricity, water, rain or leaks from any part
of the Premises or from the pipes, plumbing works or from the roof, street or subsurface
or from any other places or by dampness or by any other cause of whatsoever nature, or
(iv) any such damage caused by other tenants or persons in the Project, occupants of
adjacent property of the Project, or the public, or caused by operations in construction
of any private, public or quasi-public work. Landlord shall in no event be liable to
Tenant for any consequential damages or for loss of revenue or income and Tenant waives
any and all claims for any such damages. Notwithstanding anything to the contrary
contained in this Section 17.1, all property of Tenant, its agents, employees
and invitees kept or stored on the Premises, whether leased or owned by any such
parties, shall be so kept or stored at the sole risk of Tenant and Tenant shall hold
Landlord harmless from any claims arising out of damage to the same, including
subrogation claims by Tenants insurance carriers. |
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17.2 |
|
Tenants Indemnification of Landlord. Tenant shall be liable for, and shall
indemnify, defend, protect and hold Landlord and Landlords partners, officers,
directors, employees, agents, property manager, successors and assigns (collectively,
Landlord Indemnified Parties) harmless from and against, any and all claims, damages,
judgments, suits, causes of action, losses, liabilities and expenses, including
attorneys fees and court costs (collectively, Indemnified Claims), to the extent
arising or resulting from (a) any occurrence at the Premises, unless caused by the gross
negligence or willful misconduct of Landlord or its agents, employees or contractors and
not covered by the insurance required to be maintained by Tenant under this Lease, (b)
any act or omission of Tenant or any of Tenants agents, employees, contractors,
subtenants, assignees, licensees or invitees (collectively, Tenant Parties); (c) the
use of the Premises and Common Areas and conduct of Tenants business by Tenant or any
Tenant Parties, or any other activity, work or thing done, permitted or suffered by
Tenant or any Tenant Parties, in or about the Premises, the Building or elsewhere on the
Project; and/or (d) any default by Tenant of any obligations on Tenants part to be
performed under the terms of this Lease or the terms of any contract or agreement to
which Tenant is a party or by which it is bound, affecting this Lease or the Premises.
The foregoing indemnification shall include, but not be limited to, any injury to, or
death of, any person, or any loss of, or damage to, any property on the Premises, or on
adjoining sidewalks, streets or ways, or connected with the use, condition or occupancy
thereof, whether or not Landlord or its mortgagee has or should have knowledge or notice
of the defect or conditions causing or contributing to such injury, death, loss or
damage. In case any action or proceeding is brought against Landlord or any Landlord
Indemnified Parties by reason of any such Indemnified Claims, Tenant, upon notice from
Landlord, shall defend the same at Tenants expense by counsel approved in writing by
Landlord, which approval shall not be unreasonably withheld. Notwithstanding anything
in this Lease to the contrary, Tenant shall in no event be liable to any Landlord
Indemnified Party for any consequential or incidental damages or for loss of revenue,
and Landlord, for itself waives and shall cause the other Landlord Indemnified Parties
to waive, any and all claims for any such damages. |
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17.3 |
|
Reciprocal Indemnity. Notwithstanding any provisions of Lease Sections
17.1 and 17.2 to the contrary, Tenant shall not be required to indemnify and
hold Landlord harmless from any Indemnified Claims to any person, property or entity
resulting from the gross negligence or willful misconduct of Landlord or its agents,
contractors, servants, employees or licensees in connection with Landlords activities
in the Building (except for damage to the Tenant Improvements and Tenants personal
property, fixtures, furniture and equipment in the Premises, to the extent Tenant is
required to obtain the requisite insurance coverage pursuant to the Lease) or the Site.
Landlord shall indemnify and hold Tenant harmless from any such Indemnified Claims (but
not including any loss of business, loss of profits or other consequential damages);
provided, however, to the extent any damage or repair obligation is covered by insurance
obtained by Landlord as part of Operating Expenses, but is not covered by insurance
obtained by Tenant, then Tenant shall be relieved of its indemnity obligation up to the
amount of the insurance proceeds which Landlord is entitled to receive. |
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17.4 |
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Survival; No Release of Insurers. The indemnification obligations under
Section 17.2 and Section 17.3 shall survive the expiration or earlier
termination of this Lease. The covenants, agreements and indemnification in
Sections 17.1, 17.2 and 17.3 above are not intended to and shall
not relieve any insurance carrier of its obligations under policies required to be
carried by Tenant or Landlord, as applicable, pursuant to the provisions of this Lease
to the extent that such policies cover the results of such acts, omissions or willful
misconduct. |
18. Damage or Destruction.
18.1 |
|
Landlords Rights and Obligations. In the event the Premises or any part of the
Building is damaged by fire or other casualty to an extent not exceeding twenty-five
percent (25%) of the full replacement cost thereof, and Landlords contractor estimates
in a writing delivered to the parties that the damage thereto is such that the Building
and/or Premises may be repaired, reconstructed or restored to substantially its
condition immediately prior to such damage within two hundred seventy (270) days from
the date of such casualty, and Landlord will receive insurance proceeds sufficient to
cover the costs of such repairs, reconstruction and restoration (including proceeds from
Tenant and/or Tenants insurance which Tenant is required to deliver to Landlord
pursuant to Section 18.2 below), then Landlord shall commence and proceed
diligently with the work of repair, reconstruction and restoration and this Lease shall
continue in full force and effect. If, however, the Premises or any other part of the
Building is damaged to an extent exceeding twenty-five percent (25%) of the full
replacement cost thereof, or Landlords contractor estimates that such work of repair,
reconstruction and restoration will require longer than two hundred seventy (270) days
to complete, or Landlord will not receive insurance proceeds (and/or proceeds |
18
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|
from
Tenant, as applicable) sufficient to cover the costs of such repairs, reconstruction and
restoration, then Landlord may elect to either: |
(a) |
|
repair, reconstruct and restore the portion of the Building and Premises damaged
by such casualty (including the, to the extent of insurance proceeds received from
Tenant, the Tenant Improvements and the Tenant Changes), in which case this Lease shall
continue in full force and effect; or |
|
(b) |
|
terminate this Lease effective as of the date which is thirty (30) days after
Tenants receipt of Landlords election to so terminate. |
Under any of the conditions of this Section 18.1, Landlord shall give written notice
to Tenant of its intention to repair or terminate within the later of sixty (60) days after the
occurrence of such casualty, or fifteen (15) days after Landlords receipt of said estimate from
Landlords contractor.
18.2 |
|
Abatement of Rent. In the event that as a result of any such damage, repair,
reconstruction and/or restoration of the Premises or the Building, Tenant is prevented
from using, and does not use, the Premises or any portion thereof, then the Monthly
Basic Rent and Excess Expenses shall be abated or reduced, as the case may be, during
the period that Tenant continues to be so prevented from using and does not use the
Premises or portion thereof, in the proportion that the rentable square feet of the
portion of the Premises that Tenant is prevented from using, and does not use, bears to
the total rentable square feet of the Premises. Notwithstanding the foregoing to the
contrary, if the damage is due to the gross negligence or willful misconduct of Tenant
or any Tenant Parties, there shall be no abatement of Monthly Basic Rent or Excess
Expenses. Except for abatement of Monthly Basic Rent and Excess Expenses as provided
hereinabove, Tenant shall not be entitled to any compensation or damages for loss of, or
interference with, Tenants business or use or access of all or any part of the Premises
resulting from any such damage, repair, reconstruction or restoration. |
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18.3 |
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Inability to Complete. Notwithstanding anything to the contrary contained in
this Section 18, in the event Landlord is obligated or elects to repair,
reconstruct and/or restore the damaged portion of the Building or Premises pursuant to
Section 18.1 above, but is delayed from completing such repair, reconstruction
and/or restoration beyond the date which is three (3) months after the date estimated by
Landlords contractor for completion thereof pursuant to Section 18.1, by reason
of any causes beyond the reasonable control of Landlord (including, without limitation,
delays due to Force Majeure events as defined in Section 32.15, and delays
caused by Tenant or any Tenant Parties), then Landlord or Tenant may elect to terminate
this Lease upon thirty (30) days prior written notice to Tenant. |
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18.4 |
|
Damage Near End of Term. In addition to its termination rights in Sections
18.1 and 18.4 above, Landlord and Tenant shall have the right to terminate
this Lease if any damage to the Building or Premises occurs during the last twelve (12)
months of the Term of this Lease and Landlords contractor estimates in a writing
delivered to the parties that the repair, reconstruction or restoration of such damage
cannot be completed within the earlier of (a) the scheduled expiration date of the Lease
Term, or (b) one hundred twenty (120) days after the date of such casualty. |
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18.5 |
|
Tenants Termination Right. In addition to any other right of termination which
Tenant may have under this Section 18, if the Premises or the Building is
damaged to an extent that Landlords contractor estimates that such work of repair,
reconstruction and restoration will require longer than two hundred seventy (270) days
to complete such that Tenant can make full use of the Premises as contemplated under
this Lease, then, regardless of whether Landlord elects to repair the Premises, Tenant
shall have the right to terminate this Lease by notice delivered to Landlord within
thirty (30) days of Tenants receipt of the notice from Landlord described in the last
sentence of Section 18.1, which termination shall be effective as of the date
which is thirty (30) days after Landlords receipt of Tenants election to so terminate. |
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18.6 |
|
Waiver of Termination Rights. This Lease sets forth the terms and conditions
upon which this Lease may terminate in the event of any damage or destruction.
Accordingly, the parties hereby waive the provisions of California Civil Code Section
1932, Subsection 2, and Section 1933, Subsection 4 (and any successor statutes thereof
permitting the parties to terminate this Lease as a result of any damage or
destruction). |
19. Eminent Domain.
19.1 |
|
Substantial Taking. Subject to the provisions of Section 19.4 below in
case the whole of the Premises, or such part thereof as shall substantially interfere
with Tenants use and occupancy of the Premises as reasonably determined by Landlord,
shall be taken for any public or quasi-public purpose by any lawful power or authority
by exercise of the right of appropriation, condemnation or eminent domain, or sold to
prevent such taking, either party shall have the right to terminate this Lease effective
as of the date possession is required to be surrendered to said authority. |
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19.2 |
|
Partial Taking; Abatement of Rent. In the event of a taking of a portion of the
Premises which does not substantially interfere with the conduct of Tenants business,
then, except as otherwise provided in the immediately following sentence, neither party
shall have the right to terminate this Lease and Landlord shall thereafter proceed to
make a functional unit of the remaining portion of the Premises (but only to the extent
Landlord receives proceeds therefor from the condemning authority), and rent shall be
abated with respect to the part of the Premises which Tenant shall be so deprived on
account of such taking. Notwithstanding the immediately preceding sentence to the
contrary, if any part of the Building or the Site shall be taken (whether or not such
taking substantially interferes with Tenants use of the Premises), Landlord may
terminate this Lease upon thirty (30) days prior written notice to Tenant. |
19
19.3 |
|
Condemnation Award. Subject to the provisions of Section 19.4 below, in
connection with any taking of the Premises or Building, Landlord shall be entitled to
receive the entire amount of any award which may be made or given in such taking or
condemnation, without deduction or apportionment for any estate or interest of Tenant,
it being expressly understood and agreed by Tenant that no portion of any such award
shall be allowed or paid to Tenant for any so-called bonus or excess value of this
Lease, and such bonus or excess value shall be the sole property of Landlord. Tenant
shall not assert any claim against Landlord or the taking authority for any compensation
because of such taking (including any claim for bonus or excess value of this Lease);
provided, however, if any portion of the Premises is taken, Tenant shall be granted the
right to recover from the condemning authority (but not from Landlord) any compensation
as may be separately awarded or recoverable by Tenant for the taking of Tenants
furniture, fixtures, equipment and other personal property within the Premises and for
Tenants relocation expenses. |
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19.4 |
|
Temporary Taking. In the event of a taking of the Premises or any part thereof
for temporary use, (a) this Lease shall be and remain unaffected thereby and rent shall
not abate, and (b) Tenant shall be entitled to receive for itself such portion or
portions of any award made for such use with respect to the period of the taking which
is within the Term, provided that if such taking shall remain in force at the expiration
or earlier termination of this Lease, Tenant shall perform its obligations under
Section 9 with respect to surrender of the Premises and shall pay to Landlord
the portion of any award which is attributable to any period of time beyond the Term
expiration date. For purpose of this Section 19.4, a temporary taking shall be
defined as a taking for a period of two hundred seventy (270) days or less. |
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19.5 |
|
Waiver of Termination Right. This Lease sets forth the terms and conditions upon
which this Lease may terminate in the event of a taking. Accordingly, the parties waive
the provisions of the California Code of Civil Procedure Section 1265.130 and any
successor or similar statutes permitting the parties to terminate this Lease as a result
of a taking. |
20. Tenants Insurance.
20.1 |
|
Types of Insurance. On or before the earlier of the Commencement Date or the
date Tenant occupies all or any portion of the Premises or commences or causes to be
commenced any work of any type in or on the Premises pursuant to this Lease, and
continuing during the entire Term, Tenant shall obtain and keep in full force and
effect, the following insurance: |
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(a) |
|
Special Form (fka All Risk) insurance, including fire and extended coverage,
sprinkler leakage (including earthquake sprinkler leakage), vandalism, malicious
mischief and earthquake and flood coverage upon property of every description and kind
owned by Tenant and located in the Premises or Building, or for which Tenant is legally
liable including, without limitation, furniture, equipment and any other personal
property, in an amount not less then the full replacement cost thereof. |
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(b) |
|
Commercial general liability insurance coverage, on an occurrence basis,
including personal injury, bodily injury (including wrongful death), broad form property
damage, operations hazard, owners protective coverage, contractual liability (including
Tenants indemnification obligations under this Lease, including Section 17
hereof), products and completed operations liability, and owned/non-owned auto
liability, with an initial combined single limit of liability of not less than Three
Million Dollars ($3,000,000.00). The limits of liability of such commercial general
liability insurance shall be increased every five (5) years during the Term of this
Lease to an amount reasonably required by Landlord in an amount consistent with other
first class office projects in the Carmel Valley area of San Diego. |
|
(c) |
|
Workers compensation and employers liability insurance, with limits no less
than One Million Dollars ($1,000,000.00) per occurrence, covering all persons employed
in connection with any work done on or about the Premises for which claims for death or
bodily injury could be asserted against Landlord, Tenant or the Premises. |
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(d) |
|
Loss of income, extra expense and business interruption insurance in such amounts
as will reimburse Tenant for direct or indirect loss of earnings attributable to all
perils commonly insured against by prudent tenants or attributable to prevention of
access to the Premises, Tenants parking areas or to the Building as a result of such
perils. |
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(e) |
|
Any other form or forms of insurance as Tenant or Landlords of comparable
buildings or the mortgagees of Landlord may reasonably require from time to time, in
form, amounts and for insurance risks against which a prudent tenant would protect
itself, but only to the extent such risks and amounts are available in the insurance
market at commercially reasonable costs. |
|
20.2 |
|
Requirements. Each policy required to be obtained by Tenant hereunder shall: (a)
be issued by insurers which are approved by Landlord and/or Landlords mortgagees and
are authorized to do business in the state in which the Building is located and are
rated not less than financial class X, and not less than policyholder rating A in the
most recent version of Bests Key Rating Guide (provided that, in any event, the same
insurance company shall provide the coverages described in Sections 20.1(a) and
20.1(d) above); (b) be in form reasonably satisfactory from time to time to
Landlord; (c) name Tenant as named insured thereunder and shall name Landlord and, at
Landlords request, Landlords mortgagees, ground lessors (if any) and managers of which
Tenant has been informed in writing, as additional insureds thereunder, all as their
respective interests may appear; (d) not have a deductible amount exceeding Ten Thousand
Dollars ($10,000.00), which amount shall be deemed self-insured with full waiver of
subrogation); (e) specifically provide that the insurance afforded by such policy for
the benefit of Landlord and Landlords mortgagees and ground lessors shall be primary,
and any insurance carried by Landlord or Landlords mortgagees and ground lessors shall
be excess and non-contributing; (f) contain an endorsement |
20
|
|
that the insurer waives its right to subrogation as described in Section 22 below;
(g) contain an undertaking by the insurer to notify Landlord (and the mortgagees and ground
lessors of Landlord who are named as additional insureds) in writing not less than thirty
(30) days prior to any material change, reduction in coverage, cancellation or other
termination thereof; (h) contain a cross liability or severability of interest endorsement;
and (i) be in amounts sufficient at all times to satisfy any coinsurance requirements
thereof. Each such policy shall also provide that any loss otherwise payable thereunder
shall be payable notwithstanding (i) any act or omission of Landlord or Landlord Indemnified
Parties or Tenant which might, absent such provision, result in a forfeiture of all or a part
of such insurance payment, (ii) the occupation or use of the Premises for purposes more
hazardous than permitted by the provisions of such policy, (iii) any foreclosure or other
action or proceeding taken by any mortgagee pursuant to any provision of the mortgage upon
the happening of a default thereunder, or (iv) any change in title or ownership of the
Premises. Tenant agrees to deliver to Landlord, in no event later than the earlier of (i)
the Commencement Date or (ii) the date Tenant takes possession of all or any part of the
Premises, certified copies of each such insurance policy (or certificates from the insurance
company evidencing the existence of such insurance and Tenants compliance with the foregoing
provisions of this Section 20). Tenant shall cause replacement policies or
certificates to be delivered to Landlord not less than thirty (30) days prior to the
expiration of any such policy or policies. If any such initial or replacement policies or
certificates are not furnished within the time(s) specified herein, Tenant shall be deemed to
be in material default under this Lease without the benefit of any additional notice or cure
period provided in Section 23.1 below, and Landlord shall have the right, but not the
obligation, to procure such policies and certificates at Tenants expense. |
20.3 |
|
Effect on Insurance. Tenant shall not do or permit to be done anything which will (a)
violate or invalidate any insurance policy maintained by Landlord or Tenant hereunder, or (b)
increase the costs of any insurance policy maintained by Landlord pursuant to Section
21 or otherwise with respect to the Building or the Project. If Tenants occupancy or
conduct of its business in, on or about the Premises results in any increase in premiums for
any insurance carried by Landlord with respect to the Building or the Project, Tenant shall
pay such increase as additional rent within ten (10) days after being billed therefor by
Landlord. If any insurance coverage carried by Landlord pursuant to Section 21 or
otherwise with respect to the Building or the Project shall be cancelled or reduced (or
cancellation or reduction thereof shall be threatened) by reason of the use or occupancy of
the Premises by Tenant or by anyone permitted by Tenant to be upon the Premises, and if Tenant
fails to remedy such condition within five (5) days after notice thereof, Tenant shall be
deemed to be in default under this Lease, without the benefit of any additional notice or cure
period specified in Section 23.1 below, and Landlord shall have all remedies provided
in this Lease, at law or in equity, including, without limitation, the right (but not the
obligation) to enter upon the Premises and attempt to remedy such condition at Tenants cost. |
21. Landlords Insurance. During the Term, Landlord shall insure the Building and the
Premises (excluding, however, Tenants furniture, equipment and other personal property) against
damage by fire and standard extended coverage perils and with vandalism and malicious mischief
endorsements, rental loss coverage, at Landlords option, earthquake damage coverage, and such
additional coverage as Landlord deems appropriate. Landlord shall also carry commercial general
liability insurance, in such reasonable amounts and with such reasonable deductibles as would be
carried by a prudent owner of a similar building in the State of California. At Landlords option,
all such insurance may be carried under any blanket or umbrella policies which Landlord has in
force for other buildings and projects. In addition, at Landlords option, Landlord may elect to
self-insure all or any part of such required insurance coverage. Landlord may, but shall not be
obligated to, carry any other form or forms of insurance as Landlord or the mortgagees or ground
lessors of Landlord may reasonably determine is advisable. The cost of insurance obtained by
Landlord pursuant to this Section 21 (including self-insured amounts and deductibles) shall
be included in Operating Expenses except to the extent excluded by the terms of this Lease.
22. Waiver of Claims; Waiver of Subrogation.
22.1 |
|
Mutual Waiver of Parties. Landlord and Tenant hereby waive their rights against each other
with respect to any claims or damages or losses which are caused by or result from (a)
occurrences insured against under any insurance policy carried by Landlord or Tenant (as the
case may be) pursuant to the provisions of this Lease and enforceable at the time of such
damage or loss, or (b) occurrences which would have been covered under any insurance required
to be obtained and maintained by Landlord or Tenant (as the case may be) under Sections
20 and 21 of this Lease (as applicable) had such insurance been obtained and
maintained as required therein. The foregoing waivers shall be in addition to, and not a
limitation of, any other waivers or releases contained in this Lease. |
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22.2 |
|
Waiver of Insurers. Each party shall cause each property and loss of income insurance policy
required to be obtained by it pursuant to Sections 20 and 21 to provide that
the insurer waives all rights of recovery by way of subrogation against either Landlord or
Tenant, as the case may be, in connection with any claims, losses and damages covered by such
policy. If either party fails to maintain property or loss of income insurance required
hereunder, such insurance shall be deemed to be self-insured with a deemed full waiver of
subrogation as set forth in the immediately preceding sentence. |
23. Tenants Default and Landlords Remedies.
23.1 |
|
Tenants Default. The occurrence of any one or more of the following events shall constitute
a default under this Lease by Tenant: |
|
(a) |
|
the vacation or Abandonment of the Premises by Tenant. Abandonment is defined in Section
1951.3 of the California Civil Code; |
21
(b) |
|
the failure by Tenant to make any payment of rent or additional rent or any other payment
required to be made by Tenant hereunder, where such failure continues for three (3) business
days after written notice thereof from Landlord that such payment was not received; |
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(c) |
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the failure by Tenant to observe or perform any of the express covenants or provisions of
this Lease to be observed or performed by Tenant, other than as specified in Sections
23.1(a) or (b) above, where such failure shall continue for a period of thirty
(30) days after written notice thereof from Landlord to Tenant; provided, however, that if the
nature of Tenants default is such that more than thirty (30) days are reasonably required for
its cure, then Tenant shall not be deemed to be in default if Tenant shall commence such cure
within said thirty (30) day period and thereafter diligently prosecute such cure to
completion; |
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(d) |
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(i) the making by Tenant of any general assignment for the benefit of creditors, (ii) the
filing by or against Tenant of a petition to have Tenant adjudged a bankrupt or a petition for
reorganization or arrangement under any law relating to bankruptcy (unless, in the case of a
petition filed against Tenant, the same is dismissed within sixty (60) days), (iii) the
appointment of a trustee or receiver to take possession of substantially all of Tenants
assets located at the Premises or of Tenants interest in this Lease, where possession is not
restored to Tenant within sixty (60) days, or (iv) the attachment, execution or other judicial
seizure of substantially all of Tenants assets located at the Premises or of Tenants
interest in this Lease where such seizure is not discharged within sixty (60) days; |
|
(e) |
|
any material representation or warranty made by Tenant in this Lease or any other document
delivered in connection with the execution and delivery of this Lease or pursuant to this
Lease proves to be incorrect in any material respect; |
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(f) |
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Tenant shall be liquidated or dissolved or shall begin proceedings towards its liquidation or
dissolution; and |
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(g) |
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The failure by Tenant to deliver and/or maintain in full force and effect the Letter of
Credit described in Section 5. |
Any notice sent by Landlord to Tenant pursuant to this Section 23.1 shall be in lieu of,
and not in addition to, any notice required under California Code of Civil Procedure Section 1161.
23.2 |
|
Landlords Remedies; Termination. In the event of any default by Tenant, in addition to any
other remedies available to Landlord under this Lease, at law or in equity, Landlord shall
have the immediate option to terminate this Lease and all rights of Tenant hereunder. In the
event that Landlord shall elect to so terminate this Lease, then Landlord may recover from
Tenant: |
|
(a) |
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the worth at the time of award of any unpaid rent which had been earned at the time of such
termination; plus |
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(b) |
|
the worth at the time of the award of the amount by which the unpaid rent which would have
been earned after termination until the time of award exceeds the amount of such rental loss
that Tenant proves could have been reasonably avoided; plus |
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(c) |
|
the worth at the time of award of the amount by which the unpaid rent for the balance of the
term after the time of award exceeds the amount of such rental loss that Tenant proves could
be reasonably avoided; plus |
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(d) |
|
any other amount necessary to compensate Landlord for all the detriment proximately caused by
Tenants failure to perform its obligations under this Lease or which, in the ordinary course
of things, would be likely to result therefrom including, but not limited to: unamortized
Tenant Improvement costs; attorneys fees; brokers commissions; the costs of refurbishment,
alterations, renovation and repair of the Premises; and removal (including the repair of any
damage caused by such removal) and storage (or disposal) of Tenants personal property,
equipment, fixtures, Tenant Changes, Tenant Improvements and any other items which Tenant is
required under this Lease to remove but does not remove. |
As used in Sections 23.2(a) and 23.2(b) above, the worth at the time of award is
computed by allowing interest at the Interest Rate set forth in Section 1.14 of the
Summary. As used in Section 23.2(c) above, the worth at the time of award is computed by
discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the
time of award plus one percent (1%).
23.3 |
|
Landlords Remedies; Re-Entry Rights. In the event of any such default by Tenant, in
addition to any other remedies available to Landlord under this Lease, at law or in equity,
Landlord shall also have the right, subject to applicable law, with or without terminating
this Lease, to re-enter the Premises and remove all persons and property from the Premises;
such property may be removed, stored and/or disposed of pursuant to Section 12.4 of
this Lease or any other procedures permitted by applicable law. No re-entry or taking
possession of the Premises by Landlord pursuant to this Section 23.3, and no
acceptance of surrender of the Premises or other action on Landlords part, shall be construed
as an election to terminate this Lease unless a written notice of such intention be given to
Tenant or unless the termination thereof be decreed by a court of competent jurisdiction. |
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23.4 |
|
Continuation of Lease. Landlord shall have the remedy described in California Civil Code
Section 1951.4 (lessor may continue lease in effect after lessees breach and abandonment and
recover rent as it becomes due, if lessee has the right to sublet or assign, subject only to
reasonable limitations). Accordingly, if Landlord does not elect to terminate this Lease on
account of any default by Tenant, Landlord may, from time to time, without terminating this
Lease, enforce all of its rights and remedies under this Lease, including the right to recover
all rent as it becomes due. |
22
23.5 |
|
Landlords Right to Perform. Except as specifically provided otherwise in this Lease, all
covenants and agreements by Tenant under this Lease shall be performed by Tenant at Tenants
sole cost and expense and without any abatement or offset of rent. If Tenant shall fail to
pay any sum of money (other than Monthly Basic Rent) or perform any other act on its part to
be paid or performed hereunder and such failure shall continue for five (5) business days with
respect to monetary obligations (or thirty (30) days with respect to non-monetary obligations,
except in case of emergencies, in which such case, such shorter period of time as is
reasonable under the circumstances) after Tenants receipt of written notice thereof from
Landlord, Landlord may, without waiving or releasing Tenant from any of Tenants obligations,
make such payment or perform such other act on behalf of Tenant. All sums so paid by Landlord
and all necessary incidental costs incurred by Landlord in performing such other acts shall be
payable by Tenant to Landlord within five (5) days after demand therefor as additional rent. |
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23.6 |
|
Interest. If any monthly installment of Rent or Operating Expenses, or any other amount
payable by Tenant hereunder is not received by Landlord within five (5) days following the
date when due, it shall bear interest at the Interest Rate set forth in Section 1.14
of the Summary from the date due until paid. All interest, and any late charges imposed
pursuant to Section 23.7 below, shall be considered additional rent due from Tenant to
Landlord under the terms of this Lease. |
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23.7 |
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Late Charges. Tenant acknowledges that, in addition to interest costs, the late payments by
Tenant to Landlord of any Monthly Basic Rent or other sums due under this Lease will cause
Landlord to incur costs not contemplated by this Lease, the exact amount of such costs being
extremely difficult and impractical to fix. Such other costs include, without limitation,
processing, administrative and accounting charges and late charges that may be imposed on
Landlord by the terms of any mortgage, deed of trust or related loan documents encumbering the
Premises, the Building or the Project. Accordingly, if any monthly installment of Monthly
Basic Rent or Operating Expenses or any other amount payable by Tenant hereunder is not
received by Landlord within five (5) days following the date when due, Tenant shall pay to
Landlord an additional sum of five percent (5%) of the overdue amount as a late charge, but in
no event more than the maximum late charge allowed by law. The parties agree that such late
charge represents a fair and reasonable estimate of the costs that Landlord will incur by
reason of any late payment as hereinabove referred to by Tenant, and the payment of late
charges and interest are distinct and separate in that the payment of interest is to
compensate Landlord for the use of Landlords money by Tenant, while the payment of late
charges is to compensate Landlord for Landlords processing, administrative and other costs
incurred by Landlord as a result of Tenants delinquent payments. Acceptance of a late charge
or interest shall not constitute a waiver of Tenants default with respect to the overdue
amount or prevent Landlord from exercising any of the other rights and remedies available to
Landlord under this Lease or at law or in equity now or hereafter in effect. |
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23.8 |
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Rights and Remedies Cumulative. All rights, options and remedies of Landlord contained in
this Section 23 and elsewhere in this Lease (including Section 28 below) shall
be construed and held to be cumulative, and no one of them shall be exclusive of the other,
and Landlord shall have the right to pursue any one or all of such remedies or any other
remedy or relief which may be provided by law or in equity, whether or not stated in this
Lease. Nothing in this Section 23 shall be deemed to limit or otherwise affect
Tenants indemnification of Landlord pursuant to any provision of this Lease. |
|
23.9 |
|
Tenants Waiver of Redemption. Tenant hereby waives and surrenders for itself and all those
claiming under it, including creditors of all kinds, (i) any right and privilege which it or
any of them may have under any present or future law to redeem any of the Premises or to have
a continuance of this Lease after termination of this Lease or of Tenants right of occupancy
or possession pursuant to any court order or any provision hereof, and (ii) the benefits of
any present or future law which exempts property from liability for debt or for distress for
rent. |
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23.10 |
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Costs Upon Default and Litigation. Tenant shall pay to Landlord and its mortgagees as
additional rent all the expenses incurred by Landlord or its mortgagees in connection with any
default by Tenant hereunder or the exercise of any remedy by reason of any default by Tenant
hereunder, including reasonable attorneys fees and expenses. If Landlord or its mortgagees
shall be made a party to any litigation commenced against Tenant or any litigation pertaining
to this Lease or the Premises, at the option of Landlord and/or its mortgagees, Tenant, at its
expense, shall provide Landlord and/or its mortgagees with counsel approved by Landlord and/or
its mortgagees and shall pay all costs incurred or paid by Landlord and/or its mortgagees in
connection with such litigation. |
24. Landlords Default. Landlord shall not be in default in the performance of any
obligation required to be performed by Landlord under this Lease unless Landlord has failed to
perform such obligation within thirty (30) days after the receipt of written notice from Tenant
specifying in detail Landlords failure to perform; provided however, that if the nature of
Landlords obligation is such that more than thirty (30) days are required for its performance,
then Landlord shall not be deemed in default if it commences such performance within such thirty
(30) day period and thereafter diligently pursues the same to completion. Upon any such uncured
default by Landlord, Tenant may exercise any of its rights provided in law or at equity; provided,
however: (a) Tenant shall have no right to offset or abate rent in the event of any default by
Landlord under this Lease, except to the extent offset rights are specifically provided to Tenant
in this Lease; (b) Tenant shall have no right to terminate this Lease; (c) Tenants rights and
remedies hereunder shall be limited to the extent (i) Tenant has expressly waived in this Lease any
of such rights or remedies and/or (ii) this Lease otherwise expressly limits Tenants rights or
remedies, including the limitation on Landlords liability contained in Section 31 hereof,
and (d) in no event will Landlord be liable for consequential damages or loss of business profits.
Notwithstanding anything in this Lease to the contrary, if Landlord fails beyond the foregoing cure
periods to perform its maintenance and repair obligations under this Lease, and, as a consequence,
Tenants use of the Premises is substantially impaired, then Tenant shall have the right to cause
such repair or maintenance to be performed at Landlords expense and Landlord agrees to reimburse
Tenant for the actual, reasonable, out-of-pocket costs thereof within fifteen (15) business days
following written request for the same.
23
25. Subordination. Without the necessity of any additional document being executed by
Tenant for the purpose of effecting a subordination, except as otherwise provided in Section
26 below, and at the election of Landlord or any mortgagee of a mortgage or a beneficiary of a
deed of trust now or hereafter encumbering all or any portion of the Building or Site, or any
lessor of any ground or master lease now or hereafter affecting all or any portion of the Building
or Site, this Lease shall be subject and subordinate at all times to such ground or master leases
(and such extensions and modifications thereof), and to the lien of such mortgages and deeds of
trust (as well as to any advances made thereunder and to all renewals, replacements, modifications
and extensions thereof). Notwithstanding the foregoing, Landlord and any mortgagee and/or ground
lessor of Landlord (Holder), as applicable, shall have the right to subordinate or cause to be
subordinated any or all ground or master leases or the lien of any or all mortgages or deeds of
trust to this Lease. In the event that any ground or master lease terminates for any reason or any
mortgage or deed of trust is foreclosed or a conveyance in lieu of foreclosure is made for any
reason, at the election of Landlords successor in interest, Tenant shall attorn to and become the
tenant of such successor. Tenant hereby waives its rights under any current or future law which
gives or purports to give Tenant any right to terminate or otherwise adversely affect this Lease
and the obligations of Tenant hereunder in the event of any such foreclosure proceeding or sale.
Tenant covenants and agrees to execute and deliver to Landlord within ten (10) business days after
receipt of written demand by Landlord and in the form reasonably required by Landlord and
reasonably acceptable to Tenant, any additional documents evidencing the priority or subordination
of this Lease with respect to any such Holder or the lien of any such mortgage or deed of trust or
Tenants agreement to attorn. Such documents may include commercially reasonable provisions in
favor of such Holder, including, without limitation, additional time on behalf of such Holder to
cure defaults of the Landlord and provide that (a) neither Holder nor any successor-in-interest
shall be bound by (i) any payment of the rent, additional rent, or other sum due under this Lease
for more than 1 month in advance or (ii) any amendment or modification of the Lease made without
the express written consent of Holder or any successor-in-interest; (b) neither Holder nor any
successor-in-interest will be liable for (i) any act or omission or warranties of any prior
landlord (including Landlord), (ii) the breach of any warranties or obligations relating to
construction of improvements on the Project or any tenant finish work performed or to have been
performed by any prior landlord (including Landlord), or (iii) the return of any security deposit,
except to the extent such deposits have been received by Holder; and (c) neither Holder nor any
successor-in-interest shall be subject to any offsets or defenses which Tenant might have against
any prior landlord (including Landlord). Should Tenant fail to sign and return any such documents
within said ten (10) business day period, Tenant shall be in default hereunder without the benefit
of any additional notice or cure periods specified in Section 23.1 above. Tenant shall
indemnify, defend (with counsel reasonably approved by Landlord in writing) and hold Landlord
harmless from and against any and all claims, judgments, suits, causes of action, damages, losses,
liabilities and expenses (including attorneys fees and court costs) attributable to any failure by
Tenant to timely deliver any such documents to Landlord. Notwithstanding the foregoing, it shall
be a condition precedent to the subordination of this Lease to any future ground or underlying
lease or to the lien of any future mortgage or deed of trust that Landlord shall obtain for the
benefit of Tenant a subordination, non-disturbance and attornment agreement from the Holder in
connection with such future instrument. Notwithstanding such subordination, Tenants right to
quiet possession of the Premises shall not be disturbed if Tenant is not in default beyond
applicable notice and grace periods and so long as Tenant shall pay the rent and observe and
perform all of the provisions of this Lease, unless this Lease is otherwise terminated pursuant to
its terms. If any Holder shall elect to have this Lease and any Options granted hereby prior to
the lien of its mortgage, deed of trust or ground lease, and shall give written notice thereof to
Tenant, this Lease and such Options shall be deemed prior to such mortgage, deed of trust, or
ground lease, whether this Lease or such Options are dated prior or subsequent to the date of said
mortgage, deed of trust or ground lease or the date of recording thereof.
26. Estoppel Certificate.
26.1 |
|
Landlords and Tenants Obligations. Within ten (10) business days following written request
from one party, the other party shall execute and deliver to the requesting party an estoppel
certificate, in a form substantially similar to the form of Exhibit F attached
hereto, certifying: (a) the Commencement Date of this Lease; (b) that this Lease is unmodified
and in full force and effect (or, if modified, that this Lease is in full force and effect as
modified, and stating the date and nature of such modifications); (c) the date to which the
rent and other sums payable under this Lease have been paid; (d) that there are not, to the
best of the responding partys knowledge, any defaults under this Lease by either Landlord or
Tenant, except as specified in such certificate; and (e) such other matters as are reasonably
requested by the requesting party. Any such estoppel certificate delivered pursuant to this
Section 26.1 may be relied upon by any mortgagee, beneficiary, Transferee (including a
Permitted Transferee), purchaser or prospective purchaser of any portion of the Site, as well
as their assignees. |
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26.2 |
|
Failure to Deliver. The failure by the responding party to deliver such estoppel certificate
within such time shall constitute a default hereunder without the applicability of the notice
and cure periods specified in Section 23.1 above and shall be conclusive upon the
responding party that: (a) this Lease is in full force and effect without modification, except
as may be represented by the requesting party; (b) there are no uncured defaults in Landlords
or Tenants performance (other than the responding partys failure to deliver the estoppel
certificate); and (c) not more than one (1) months rental has been paid in advance. |
27. [Intentionally Deleted]
28. Modification and Cure Rights of Landlords Mortgagees and Lessors.
28.1 |
|
Modifications. If, in connection with Landlords obtaining or entering into any financing or
ground lease for any portion of the Building or Site, the lender or ground lessor shall
request modifications to this Lease, Tenant shall, within ten (10) business days after request
therefor, execute an amendment to this Lease including such modifications, provided such
modifications are reasonable, do not increase the obligations of Tenant hereunder, or
adversely affect the leasehold estate created hereby or Tenants rights hereunder. |
24
28.2 |
|
Cure Rights. In the event of any default on the part of Landlord, Tenant will give notice by
registered or certified mail to any beneficiary of a deed of trust or mortgagee covering the
Premises or ground lessor of Landlord whose address shall have been furnished to Tenant, and
shall offer such beneficiary, mortgagee or ground lessor a reasonable opportunity to cure the
default (including with respect to any such beneficiary or mortgagee, time to obtain
possession of the Premises, subject to this Lease and Tenants rights hereunder, by power of
sale or a judicial foreclosure, if such should prove necessary to effect a cure). |
29. Quiet Enjoyment. Landlord covenants and agrees with Tenant that, so long as Tenant
performs all of the covenants and provisions on Tenants part to be observed and performed under
this Lease (including payment of rent hereunder), Tenant shall have the right to use and occupy the
Premises in accordance with and subject to the terms and conditions of this Lease as against all
persons claiming by, through or under Landlord.
30. Transfer of Landlords Interest. The term Landlord as used in this Lease, so far as
covenants or obligations on the part of the Landlord are concerned, shall be limited to mean and
include only the owner or owners, at the time in question, of the fee title to, or a lessees
interest in a ground lease of, the Site. In the event of any transfer or conveyance of any such
title or interest (other than a transfer for security purposes only), the transferor shall be
automatically relieved of all covenants and obligations on the part of Landlord contained in this
Lease accruing after the date of such transfer or conveyance provided that such transferee
expressly assumes Landlords obligations hereunder. Landlord and Landlords transferees and
assignees shall have the absolute right to transfer all or any portion of their respective title
and interest in the Site, the Building, the Premises and/or this Lease without the consent of
Tenant, and such transfer or subsequent transfer shall not be deemed a violation on Landlords part
of any of the terms and conditions of this Lease.
31. Limitation on Liability
31.1 |
|
Limitation on Landlords Liability. Notwithstanding anything contained in this Lease to the
contrary, the obligations of Landlord under this Lease (including any actual or alleged breach
or default by Landlord) do not constitute personal obligations of the individual partners,
directors, officers, members or shareholders of Landlord or Landlords partners, and Tenant
shall not seek recourse against the individual partners, directors, officers, members or
shareholders of Landlord or against Landlords partners or any other persons or entities
having any interest in Landlord, or any of their personal assets for satisfaction of any
liability with respect to this Lease. In addition, in consideration of the benefits accruing
hereunder to Tenant and notwithstanding anything contained in this Lease to the contrary,
Tenant hereby covenants and agrees for itself and all of its successors and assigns that the
liability of Landlord for its obligations under this Lease (including any liability as a
result of any actual or alleged failure, breach or default hereunder by Landlord), shall be
limited solely to, and Tenants and its successors and assigns sole and exclusive remedy
shall be against, Landlords interest in the Project, and no other assets of Landlord. |
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31.2 |
|
Limitation on Tenants Liability. Notwithstanding anything contained in this Lease to the
contrary, the obligations of Tenant under this Lease (including any actual or alleged breach
or default by Tenant) do not constitute personal obligations of the individual directors,
officers or shareholders of Tenant, and Landlord shall not seek recourse against the
individual directors, officers or shareholders of Tenant or any other persons or entities
having any interest in Tenant, or any of their personal assets for satisfaction of any
liability with respect to this Lease. |
32. Miscellaneous.
32.1 |
|
Governing Law. This Lease shall be governed by, and construed pursuant to, the laws of the
State of California. |
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32.2 |
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Successors and Assigns. Subject to the provisions of Section 30 above, and except as
otherwise provided in this Lease, all of the covenants, conditions and provisions of this
Lease shall be binding upon, and shall inure to the benefit of, the parties hereto and their
respective heirs, personal representatives and permitted successors and assigns; provided,
however, no rights shall inure to the benefit of any Transferee of Tenant unless the Transfer
to such Transferee is made in compliance with the provisions of Section 14, and no
options or other rights which are expressly made personal to the original Tenant hereunder or
in any rider attached hereto shall be assignable to or exercisable by anyone other than the
original Tenant and any Permitted Transferee under this Lease. |
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32.3 |
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No Merger. The voluntary or other surrender of this Lease by Tenant or a mutual termination
thereof shall not work as a merger and shall, at the option of Landlord, either (a) terminate
all or any existing subleases, or (b) operate as an assignment to Landlord of Tenants
interest under any or all such subleases. |
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32.4 |
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Professional Fees. If either Landlord or Tenant should bring suit against the other with
respect to this Lease, including for unlawful detainer or any other relief against the other
hereunder, then all costs and expenses incurred by the prevailing party therein (including,
without limitation, its actual appraisers, accountants, attorneys and other professional
fees and court costs), shall be paid by the other party. |
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32.5 |
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Waiver. The waiver by either party of any breach by the other party of any term, covenant or
condition herein contained shall not be deemed to be a waiver of any subsequent breach of the
same or any other term, covenant and condition herein contained, nor shall any custom or
practice which may become established between the parties in the administration of the terms
hereof be deemed a waiver of, or in any way affect, the right of any party to insist upon the
performance by the other in strict accordance with said terms. No waiver of any default of
either party hereunder shall be implied from any acceptance by Landlord or delivery by Tenant
(as the case may be) of any rent or other payments due hereunder or any omission by the
non-defaulting party to take any action on account of such default if such default persists or
is repeated, and no express waiver shall affect defaults other
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than as specified in said waiver. The subsequent acceptance of rent hereunder by Landlord
shall not be deemed to be a waiver of any preceding breach by Tenant of any term, covenant or
condition of this Lease other than the failure of Tenant to pay the particular rent so
accepted, regardless of Landlords knowledge of such preceding breach at the time of
acceptance of such rent. |
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32.6 |
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Terms and Headings. The words Landlord and Tenant as used herein shall include the
plural as well as the singular. Words used in any gender include other genders. The Section
headings of this Lease are not a part of this Lease and shall have no effect upon the
construction or interpretation of any part hereof. Any deletion of language from this Lease
prior to its execution by Landlord and Tenant shall not be construed to raise any presumption,
canon of construction or implication, including, without limitation, any implication that the
parties intended thereby to state the converse of the deleted language. |
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32.7 |
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Time. Time is of the essence with respect to performance of every provision of this Lease in
which time or performance is a factor. All references in this Lease to days shall mean
calendar days unless specifically modified herein to be business days. |
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32.8 |
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Prior Agreements; Amendments. This Lease (and the Exhibits attached hereto) contain all of
the covenants, provisions, agreements, conditions and understandings between Landlord and
Tenant concerning the Premises and any other matter covered or mentioned in this Lease, and no
prior agreement or understanding, oral or written, express or implied, pertaining to the
Premises or any such other matter shall be effective for any purpose. No provision of this
Lease may be amended or added to except by an agreement in writing signed by the parties
hereto or their respective successors in interest. The parties acknowledge that all prior
agreements, representations and negotiations are deemed superseded by the execution of this
Lease to the extent they are not expressly incorporated herein. |
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32.9 |
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Severability. The invalidity or unenforceability of any provision of this Lease (except for
Tenants obligation to pay Monthly Basic Rent and Excess Expenses under Sections 3 and
4 hereof) shall in no way affect, impair or invalidate any other provision hereof, and
such other provisions shall remain valid and in full force and effect to the fullest extent
permitted by law. |
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Recording. Except as otherwise provided in this Lease, neither this Lease, nor any
memorandum, affidavit or other writing with respect thereto, shall be recorded by Tenant or by
anyone acting through, under or on behalf of Tenant, and the recording thereof in violation of
this provision shall make this Lease null and void at Landlords election. |
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32.11 |
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Exhibits. All Exhibits attached to this Lease are hereby incorporated in this Lease as
though set forth at length herein. |
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32.12 |
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Accord and Satisfaction. No payment by Tenant or receipt by Landlord of a lesser amount
than the rent payment herein stipulated shall be deemed to be other than on account of the
rent, nor shall any endorsement or statement on any check or any letter accompanying any check
or payment as rent be deemed an accord and satisfaction, and Landlord may accept such check or
payment without prejudice to Landlords right to recover the balance of such rent or pursue
any other remedy provided in this Lease. Tenant agrees that each of the foregoing covenants
and agreements shall be applicable to any covenant or agreement either expressly contained in
this Lease or imposed by any statute or at common law. |
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32.13 |
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Financial Statements. Upon ten (10) days prior written request from Landlord (which
Landlord may make at any time during the Term but no more often than once in any calendar
year), Tenant shall deliver to Landlord a current financial statement of Tenant. Such
statements shall be prepared in accordance with generally acceptable accounting principles and
certified as true in all material respects by Tenant (if Tenant is an individual) or by an
authorized officer of Tenant (if Tenant is a corporation or limited liability company) or a
general partner or CFO of Tenant (if Tenant is a partnership). |
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32.14 |
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No Partnership. Landlord does not, in any way or for any purpose, become a partner of
Tenant in the conduct of its business, or otherwise, or joint venturer or a member of a joint
enterprise with Tenant by reason of this Lease. |
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32.15 |
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Force Majeure. In the event that either party hereto shall be delayed or hindered in or
prevented from the performance of any act required hereunder by reason of strikes, lock-outs,
labor troubles, inability to procure materials, failure of power, governmental moratorium or
other governmental action or inaction (including failure, refusal or delay in issuing permits,
approvals and/or authorizations), injunction or court order, riots, insurrection, war, fire,
earthquake, flood or other natural disaster or other reason of a like nature not the fault of
the party delaying in performing work or doing acts required under the terms of this Lease
(but excluding delays due to financial inability) (herein collectively, Force Majeure
Delays), then performance of such act shall be excused for the period of the delay and the
period for the performance of any such act shall be extended for a period equivalent to the
period of such delay. The provisions of this Section 32.15 shall not apply to nor
operate to excuse Tenant from the payment of Monthly Basic Rent, Operating Expenses,
additional rent or any other payments strictly in accordance with the terms of this Lease. |
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32.16 |
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Counterparts. This Lease may be executed in one or more counterparts, each of which shall
constitute an original and all of which shall be one and the same agreement. |
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32.17 |
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Nondisclosure of Lease Terms. Tenant acknowledges and agrees that the terms of this Lease
are confidential and constitute proprietary information of Landlord. Disclosure of the terms
could adversely affect the ability of Landlord to negotiate other leases and impair Landlords
relationship with other tenants. Accordingly, Tenant
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agrees that it, and its partners, officers, directors, employees, agents and attorneys, shall
not intentionally and voluntarily disclose the terms and conditions of this Lease to any
newspaper or other publication or any other person, including without limitation, any other
tenant or apparent prospective tenant of the Building or other portion of the Project, or
real estate agent, either directly or indirectly, without the prior written consent of
Landlord, which Landlord may withhold in its sole discretion, provided, however, that Tenant
may disclose the terms to prospective subtenants or assignees under this Lease. |
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32.18 |
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Independent Covenants. This Lease shall be construed as though the covenants herein between
Landlord and Tenant are independent and not dependent and Tenant hereby expressly waives the
benefit of any statute to the contrary and agrees that if Landlord fails to perform its
obligations set forth herein, Tenant shall not be entitled to make any repairs or perform any
acts hereunder at Landlords expense or to any setoff of the Rent or other amounts owing
hereunder against Landlord; provided, however, that the foregoing shall in no way impair the
right of Tenant to commence a separate action against Landlord for any violation by Landlord
of the provisions hereof so long as notice is first given to Landlord and any holder of a
mortgage or deed of trust covering the Building, Project or any portion thereof, of whose
address Tenant has theretofore been notified, and an opportunity is granted to Landlord and
such holder to correct such violations as provided above. |
33. Lease Execution.
33.1 |
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Tenants Authority. If Tenant executes this Lease as a limited liability company,
partnership or corporation, then Tenant represents and warrants that: (a) Tenant is a duly
organized and validly existing limited liability company, partnership or corporation, as the
case may be, and is qualified to do business in the state in which the Premises are located;
(b) such persons and/or entities executing this Lease are duly authorized to execute and
deliver this Lease on Tenants behalf in accordance with the Tenants operating agreement (if
Tenant is a limited liability company), Tenants partnership agreement (if Tenant is a
partnership), or a duly adopted resolution of Tenants board of directors and Tenants by-laws
(if Tenant is a corporation); and (c) this Lease is binding upon Tenant in accordance with its
terms. Concurrently with Tenants execution and delivery of this Lease to Landlord and/or at
any time during the Lease Term within ten (10) days of Landlords request, Tenant shall
provide to Landlord a copy of any documents reasonably requested by Landlord evidencing
Tenants representations and warranties hereunder. |
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33.2 |
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Joint and Several Liability. If more than one person or entity executes this Lease as
Tenant: (a) each of them is and shall be jointly and severally liable for the covenants,
conditions, provisions and agreements of this Lease to be kept, observed and performed by
Tenant; and (b) the act or signature of, or notice from or to, any one or more of them with
respect to this Lease shall be binding upon each and all of the persons and entities executing
this Lease as Tenant with the same force and effect as if each and all of them had so acted or
signed, or given or received such notice. |
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33.3 |
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Building Name and Signage. Landlord shall have the right at any time to designate and/or
change the name and/or address of the Project, the Building and/or any other building in the
Project, and to install, affix and maintain any and all signs on the exterior and on the
interior of the Project, the Building and/or any other building in the Project, as Landlord
may, in Landlords sole discretion, desire. Tenant shall not use the name of the Project, the
Building or any other building in the Project, or use pictures or illustrations of the
Project, the Building or any other building in the Project, in advertising or other publicity,
without the prior written consent of Landlord, which Landlord may withhold in its sole
discretion. |
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33.4 |
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Landlords Title; Air Rights. Landlords title is and always shall be paramount to the title
of Tenant. Nothing herein contained shall empower Tenant to do any act which can, shall or
may encumber the title of Landlord. No rights to any view or to light or air over any
property, whether belonging to Landlord or any other person, are granted to Tenant by this
Lease. |
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33.5 |
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Time of Essence. Time is of the essence of this Lease and each of its provisions. |
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33.6 |
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No Option. The submission of this Lease for examination or execution by Tenant does not
constitute a reservation of or option for the Premises and this Lease shall not become
effective as a Lease until it has been executed by Landlord and delivered to Tenant. |
34. Waiver of Jury Trial. EACH PARTY HEREBY WAIVES ANY RIGHT TO A TRIAL BY JURY IN ANY
ACTION SEEKING SPECIFIC PERFORMANCE OF ANY PROVISION OF THIS LEASE, FOR DAMAGES FOR ANY BREACH
UNDER THIS LEASE, OR OTHERWISE FOR ENFORCEMENT OF ANY RIGHT OR REMEDY HEREUNDER (EACH A
DISPUTE AND COLLECTIVELY, THE DISPUTES).
35. Consent to Judicial Reference. If and to the extent that Section 34
immediately above is determined by a court of competent jurisdiction to be unenforceable or is
otherwise not applied by any such court, each of Landlord and Tenant hereby consents and agrees
that (a) any and all Disputes shall be heard by a referee in accordance with the general reference
provisions of California Code of Civil Procedure Section 638, sitting without a jury in the County
of San Diego, California, (b) such referee shall hear and determine all of the issues in any
Dispute (whether of fact or of law), including issues pertaining to a provisional remedy as
defined in California Code of Civil Procedure Section 1281.8, including without limitation,
entering restraining orders, entering temporary restraining orders, issuing temporary and permanent
injunctions and appointing receivers, and shall report a statement of decision; provided that, if
during the course of any Dispute, any party desires to seek such a provisional remedy at a time
when a referee has not yet been appointed or is otherwise unavailable to hear the request for such
provisional remedy, then such party may apply to the San Diego County Superior Court for such
provisional relief, and (c) pursuant to California Code of Civil Procedure Section 640(a), judgment
may be entered upon the decision of such referee in the same manner as if the Dispute had been
tried directly
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by a court. The parties shall use their respective commercially reasonable and good faith efforts
to agree upon and select such referee, provided that such referee must be a retired California
state or federal judge, and further provided that if the parties cannot agree upon a referee, the
referee shall be appointed by the Presiding Judge of the San Diego County Superior Court. Each
party hereto acknowledges that this consent and agreement is a material inducement to enter into
this Agreement, the Loan Documents and all other agreements and instruments provided for herein or
therein, and that each will continue to be bound by and to rely on this consent and agreement in
their related future dealings. The parties shall share the cost of the referee and reference
proceedings equally; provided that, the referee may award attorneys fees and
reimbursement of the referee and reference proceeding fees and costs to the prevailing party,
whereupon all referee and reference proceeding fees and charges will be payable by the
non-prevailing party (as so determined by the referee). Each party hereto further warrants and
represents that it has reviewed this consent and agreement with legal counsel of its own choosing,
or has had an opportunity to do so, and that it knowingly and voluntarily gives this consent and
enters into this agreement having had the opportunity to consult with legal counsel. This consent
and agreement is irrevocable, meaning that it may not be modified either orally or in writing, and
this consent and agreement shall apply to any subsequent amendments, renewals, supplements, or
modifications to this Agreement or any other agreement or document entered into between the parties
in connection with this Agreement. In the event of litigation, this Agreement may be filed as
evidence of either or both parties consent and agreement to have any and all Disputes heard and
determined by a referee under California Code of Civil Procedure Section 638.
36. ERISA. Tenant represents and warrants to Landlord that: (i) Tenant is not an employee
pension benefit plan subject to the provisions of Title IV of the Employee Retirement Income
Security Act of 1974, as amended (ERISA) or subject to the minimum funding standards under Part
3, Subtitle B, Title I of ERISA or Section 412 of the Internal Revenue Code or Section 302 of
ERISA, and none of its assets constitutes or will constitute assets of any such employee benefit
plan subject to Part 4, Subtitle B, Title I of ERISA; (ii) Tenant is not a governmental plan
within the meaning of Section 3(32) of ERISA and the funds used by Tenant to satisfy its
obligations under the Lease are not subject to State statutes regulating investments of and
fiduciary obligations with respect to governmental plans; (iii) The assets of Tenant do no
constitute plan assets of one or more employee benefit plans within the meaning of 29 C.F.R.
2510.3-101; and (iv) Tenant is not The Prudential Insurance Company of America, a separate account
of Prudential or an affiliate of Prudential as defined in Section IV(b) of Prohibited Transaction
Exemption 90-1 granted by the U.S. Department of Labor.
37. Option.
37.1 Grant of Option. Landlord hereby grants to Tenant the option to extend the term of this Lease
for a five (5) year period (the Option) commencing on the date the prior term expires (the
Option Period) upon each and all of the following terms and conditions:
(a) |
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Tenant gives to Landlord, and Landlord actually receives, on a date which is prior to the
date that the Option Period would commence (if exercised) by at least nine (9) and not more
than twelve (12) months, a written notice of exercise of the option to extend this Lease for
said additional term, time being of the essence. If said notification of the exercise of said
option is not so given and received, this option shall automatically expire; |
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All of the terms and conditions of this Lease shall apply, except that Tenant shall have no
further option to extend the term of this Lease; |
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Any prior Tenant that has not been expressly released from liability under this Lease
expressly reaffirms in writing the extension of its liability for the term of the Option; and |
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The Monthly Basic Rent for each month of the Option Period shall be the Fair Market Rent (as
defined below) of the Premises as of the commencement of the Option Period. |
37.2 Effect of Default.
(a) Tenant shall have no right to exercise the Option, notwithstanding any provision in the grant
of the Option to the contrary, (i) during the time commencing from the date Landlord gives to
Tenant a notice of default pursuant to Sections 23.1(b) or 23.1(c) (or the
date of the default if notice is not required pursuant to the terms of this Lease) and
continuing until the default alleged in said notice of default is cured, or (ii) during the
period of time commencing on the day after a monetary obligation to Landlord is due from
Tenant and unpaid (without any necessity for notice thereof to Tenant) continuing until the
obligation is paid, or (iii) at any time after an event of default described in Sections
23.1(a), 23.1(d), 23.1(e) or 23.1(f) (without any necessity of
Landlord to give notice of such default to Tenant), or (iv) in the event that Landlord has
given to Tenant three or more notices of default under Section 23.1(b), where a late
charge has become payable under Section 23.7 for each of such defaults, or Section
23.1(c), whether or not the defaults are cured, during the 12 month period prior to the
time that Tenant intends to exercise the Option.
(b) All rights of Tenant under the provisions of the Option shall terminate and be of no further
force or effect, notwithstanding Tenants due and timely exercise of the Option, if, after such
exercise and during the term of this Lease, (i) Tenant fails to pay to Landlord a monetary
obligation of Tenant for a period of 30 days after such obligation becomes due (without any
necessity of Landlord to give notice thereof to Tenant), or (ii) Tenant fails to commence to cure a
default specified in Section 23.1(c) within 30 days after the date that Landlord gives
notice to Tenant of such default and/or Tenant fails thereafter to diligently prosecute said cure
to completion, (iii) Tenant commits a default described in Sections 23.1(a),
23.1(d), 23.1(e) or 23.1(f) (without any necessity of Landlord to give
notice of such default to Tenant), or (iv) Landlord gives to Tenant three or more notices of
default under Section 23.1(b), where a late charge becomes payable under Section
23.7 for each such default, or Section 23.1(c), whether or not the defaults are cured
or (v) Tenant commits a default under this Lease where this Lease provides that no notice or cure
period is afforded the Tenant.
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37.3 Personal to Tenant. The Option is personal to Tenant and may not be exercised or be assigned,
voluntarily or involuntarily, by or to any person or entity other than Tenant. The Option is not
assignable separate and apart from this Lease.
37.4 Fair Market Rent.
(a) The term Fair Market Rent as used in this Lease is defined to mean the rent, including all
escalations, at which tenants are leasing non-sublease, non-encumbered, non-equity space comparable
in size and quality to the Premises for the Option Period the San Diego, California metropolitan
area, giving appropriate consideration to the annual rental rates per square foot and the standard
of measurement by which the square footage is measured. In determining Fair Market Rent it shall
be assumed that:
(i) The Premises are in excellent condition and repair and there shall be no deduction for
depreciation, obsolescence or deferred maintenance (but less reasonable wear and tear as long as
maintained by Tenant in accordance with this Lease);
(ii) The Premises would be leased for the Option Period by a tenant with the credit standing
of Tenant, as the same exists at that time;
(iii) The Premises would be leased on the same terms of this Lease insofar as the obligations
for repair, maintenance, insurance and real estate taxes existed as of the expiration of the
original term of this Lease.
(iv) No deduction shall be given nor consideration given to allowances for real estate
brokerage commissions.
(v) The Premises will be used for its highest and best use.
(vi) An minimum annual rent escalation of three percent (3%) would be applicable.
(vii) The Base Year set forth in the Basic Lease Information will be adjusted to correspond
with the first year of the extended term.
(b) Landlord shall initially determine the Fair Market Rent in each instance, and shall give Tenant
notice (the Market Rent Notice) of such determination and the basis on which such determination
was made on or before the 60th day prior to the date on which such determination is to take effect,
or as soon thereafter as is reasonably practicable.
(c) In the event that Tenant notifies Landlord in writing, on or before the 20th business day
following any Market Rent Notice, that Tenant disagrees with the applicable determination, Landlord
and Tenant shall negotiate in good faith to resolve such dispute within 10 business days thereafter
(The 30th business day after any Market Rent Notice is referred to herein as the Outside Agreement
Date). If not resolved by the Outside Agreement Date each party shall submit to the other its
determination of Fair Market Rent and the dispute shall be submitted to arbitration in accordance
with the procedures outlined in the following subsection (d). Until any such dispute is resolved,
any applicable payments due under this Lease shall correspond to Landlords determination and, if
Tenants determination becomes the final determination, Landlord shall refund any overpayments to
Tenant, within 5 business days following the final resolution of the dispute.
(d) The arbitration procedures referred to in subsection (c) are:
(i) Landlord and Tenant shall each appoint one (1) arbitrator who shall by profession be a
licensed real estate broker or appraiser who shall have been active over the five (5) year period
ending on the date of such appointment in the leasing or appraising of properties similar to the
Premises in the surrounding area of San Diego County. The determination of the arbitrators shall
be limited solely to the issue of whether Landlords or Tenants submitted Fair Market Rent for the
Premises is the closest to the actual Fair Market Rent for the Premises as determined by the
arbitrators, taking into account the requirements of this subparagraph regarding the same. Each
such arbitrator shall be appointed within 15 days after the Outside Agreement Date. Landlord and
Tenant may not consult with either such arbitrator prior to resolution.
(ii) The two arbitrators so appointed shall within fifteen (15) days of the date of the
appointment of the last appointed arbitrator, meet and attempt to reach a decision as to whether
the parties shall use Landlords or Tenants submitted Fair Market Rent, and shall notify Landlord
and Tenant of their decision, if any.
(iii) If the two arbitrators are unable to reach a decision, the two (2) arbitrators shall,
within thirty (30) days of the date of the appointment of the last appointed arbitrator, agree upon
and appoint a third arbitrator who shall be a broker who shall be qualified under the same criteria
set forth hereinabove for qualification of the initial two (2) arbitrators.
(iv) The three (3) arbitrators shall, within thirty (30) days of the appointment of the third
arbitrator, reach a decision as to whether the parties shall use Landlords or Tenants submitted
Fair Market Rent, and shall notify Landlord and Tenant thereof.
(v) The decision of the majority of the three (3) arbitrators shall be binding upon Landlord
and Tenant.
(vi) If either Landlord or Tenant fails to appoint an arbitrator within fifteen (15) days
after the Outside Agreement Date, the arbitrator appointed by one (1) of them shall reach a
decision, notify Landlord and Tenant thereof, and such arbitrators decision shall be binding upon
Landlord and Tenant.
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(vii) If the two (2) arbitrators fail to agree upon and to appoint a third arbitrator, then
the appointment of the third arbitrator shall be dismissed, and the matter to be decided shall be
forthwith submitted to arbitration under the provisions of the American Arbitration Association,
but subject to the instructions set forth in this Lease.
(viii) The cost of arbitration shall be paid by Landlord and Tenant equally.
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IN WITNESS WHEREOF, the parties have executed this Lease as of the day and year first above
written.
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TENANT: |
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LANDLORD: |
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CADENCE PHARMACEUTICALS, INC,
a Delaware corporation |
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PRENTISS/COLLINS DEL MAR HEIGHTS LLC,
a Delaware limited liability company |
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By: |
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Cognac High Bluffs LLC, |
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*By: |
/s/ Theodore R. Schroeder |
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a Delaware limited liability company, |
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Print Name: |
Theodore R. Schroeder |
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its managing member |
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President
& CEO |
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By: |
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The Prudential Insurance Company of America, |
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a New Jersey corporation, |
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*By: |
/s/ David A. Socks |
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its sole member |
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David
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V.P.
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& Corporate Secretary |
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/s/ Darin Bright |
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Name:
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Darin
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Title:
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Vice
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If Tenant is a California corporation, then one of the following alternative requirements must be
satisfied:
(i) This Lease must be signed by two (2) officers of such corporation: one being the chairman
of the board, the president or a vice president, and the other being the secretary, an assistant
secretary, the chief financial officer or an assistant treasurer. If one (1) individual is signing
in two (2) of the foregoing capacities, that individual must sign twice; once as one officer and
again as the other officer.
(ii) If there is only one (1) individual signing in two (2) capacities, or if the two (2)
signatories do not satisfy the requirements of (A) above, then Tenant shall deliver to Landlord a
certified copy of a corporate resolution in a form reasonably acceptable to Landlord authorizing
the signatory(ies) to execute this Lease.
If Tenant is a corporation incorporated in a state other than California, then Tenant shall deliver
to Landlord a certified copy of a corporate resolution in a form reasonably acceptable to Landlord
authorizing the signatory(ies) to execute this Lease.
S-1
EXHIBIT A
PROJECT SITE PLAN
A-1
EXHIBIT B-1
12481 PREMISES
High Bluff Ridge
12481 High Bluff Drive
2nd Floor
B-1-1
EXHIBIT B-2
12531 PREMISES
High Bluff Ridge
12531 High Bluff Driver
1st Floor
B-2-1
EXHIBIT C
WORK LETTER AGREEMENT
This Work Letter Agreement (Work Letter Agreement) sets forth the terms and conditions
relating to the construction of improvements for the 12481 Premises. All references in this Work
Letter Agreement to the Lease shall mean the relevant portions of the Lease to which this Work
Letter Agreement is attached as Exhibit C.
SECTION 1.
BASE, SHELL AND CORE
Landlord has constructed, through its contractor, the base, shell and core of the 12481
Premises and the Building (collectively, the Base, Shell and Core), and Tenant shall accept the
Base, Shell and Core in its current As-Is condition existing as of the date of the Lease and the
Commencement Date, subject to the terms of the Lease. Landlord shall install in the 12481 Premises
certain Tenant Improvements (as defined below) pursuant to the provisions of this Work Letter
Agreement. Except for the Tenant Improvement work described in this Work Letter Agreement and
except for the Tenant Improvement Allowance set forth below and except as otherwise provided in the
Lease, Landlord shall not be obligated to make or pay for any alterations or improvements to the
12481 Premises, the Building or the Project.
SECTION 2.
TENANT IMPROVEMENTS
2.1 Tenant Improvement Allowance. Tenant shall be entitled to a one-time tenant
improvement allowance (the Tenant Improvement Allowance) in the amount of up to, but not
exceeding Fifty-Five Dollars ($55.00) per usable square foot of the 12481 Premises (i.e., up to One
Million One Hundred Ninety Thousand Five Hundred Thirty Dollars ($1,190,530) based on a usable
square footage for the 12481 Premises of 21,646 square feet for purposes of this Work Letter
Agreement), for the costs relating to the initial design and construction of Tenants improvements
which are permanently affixed to the 12481 Premises (the Tenant Improvements), which costs shall
include all hard and soft costs, including project management, but excluding data cabling, security
systems and fees for consultants other than the Architect and Engineers (as defined below). In no
event shall Landlord be obligated to make disbursements pursuant to this Work Letter Agreement in a
total amount which exceeds the Tenant Improvement Allowance. Tenant shall not be entitled to
receive any cash payment or credit against rent or otherwise for any portion of the Tenant
Improvement Allowance which is not used to pay for the Tenant Improvement Allowance Items (as such
term is defined below).
2.2 Disbursement of the Tenant Improvement Allowance. Except as otherwise set forth
in this Work Letter Agreement, the Tenant Improvement Allowance shall be disbursed by Landlord
(each of which disbursement shall be made pursuant to Landlords standard disbursement process),
only for the following items and costs (collectively, the Tenant Improvement Allowance Items):
2.2.1 Payment of the fees of the Architect and the Engineers, as those terms are defined
in Section 3.1 of this Work Letter Agreement (provided, however, that only an amount not to
exceed Three and 00/100 Dollars ($3.00) per usable square foot of the 12481 Premises (i.e., up to
Sixty Four Thousand Nine Hundred Thirty Eight and No/100 Dollars ($64,938.00) based on a usable
square footage of 21,646 square feet for the 12481 Premises for purposes of this Work Letter
Agreement) may be deducted from the Tenant Improvement Allowance to pay for such fees), and payment
of the fees incurred by, and the cost of documents and materials supplied by, Tenant or Landlord
and Tenants or Landlords consultants in connection with the preparation and review of the
Construction Drawings, as that term is defined in Section 3.1 of this Work Letter
Agreement;
2.2.2 The payment of plan check, permit and license fees relating to construction of the
Tenant Improvements;
2.2.3 The cost of construction of the Tenant Improvements, including, without limitation,
contractors fees and general conditions, testing and inspection costs, costs of utilities, trash
removal, parking and hoists, and the costs of after-hours freight elevator usage;
2.2.4 The cost of any changes in the Base, Shell and Core when such changes are required by
the Construction Drawings (including if such changes are due to the fact that such work is prepared
on an unoccupied basis), such cost to include all direct architectural and/or engineering fees and
expenses incurred in connection therewith;
2.2.5 The cost of any changes to the Construction Drawings or Tenant Improvements required by
any applicable laws;
2.2.6 Sales and use taxes and Title 24 fees related to the Tenant Improvements;
2.2.7 Landlords Supervision Fee, as that term is defined in Section 4.3.2 of this
Work Letter Agreement; and
2.2.8 All other costs to be expended by Landlord in connection with the construction of the
Tenant Improvements.
2.3 Specifications for Building Standard Improvements. Landlord has established
specifications (the Specifications) for the Building standard components to be used in the
construction of the Tenant Improvements in the
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12481 Premises which Specifications have been received by Tenant. Unless otherwise agreed to
by Landlord, the Tenant Improvements shall comply with or exceed the Specifications.
SECTION 3.
CONSTRUCTION DRAWINGS
3.1 Selection of Architect/Construction Drawings. Tenant shall retain an
architect/space planner (the Architect) approved by Landlord, which approval shall not be
unreasonably withheld, conditioned or delayed, to prepare the Construction Drawings. Tenant shall
retain engineering consultants reasonably approved by Landlord, which approval shall not be
unreasonably withheld, conditioned or delayed (the Engineers ), to prepare all plans and
engineering working drawings relating to the structural, mechanical, electrical, plumbing, HVAC,
life-safety, and sprinkler work in the 12481 Premises. The plans and drawings to be prepared by
Architect and the Engineers hereunder shall be known collectively as the Construction Drawings.
All Construction Drawings shall comply with the drawing format and specifications determined by
Landlord, and shall be subject to Landlords approval, which approval shall not be unreasonably
withheld, conditioned or delayed. Tenant and Architect shall verify, in the field, the dimensions
and conditions as shown on the relevant portions of the base building plans, and Tenant and
Architect shall be solely responsible for the same, and Landlord shall have no responsibility in
connection therewith. Landlords review of the Construction Drawings as set forth in this
Section 3, shall be for its sole purpose and shall not imply Landlords review of the same,
or obligate Landlord to review the same, for quality, design, compliance with applicable laws or
other applicable laws or other like matters. Accordingly, notwithstanding that any Construction
Drawings are reviewed by Landlord or its space planner, architect, engineers and consultants, and
notwithstanding any advice or assistance which may be rendered to Tenant by Landlord or Landlords
space planner, architect, engineers, and consultants, Landlord shall have no liability whatsoever
in connection therewith and shall not be responsible for any omissions or errors contained in the
Construction Drawings.
3.2 Final Space Plan. On or before the date set forth in Schedule 1, attached
hereto, Tenant and Architect shall prepare the final space plan for Tenant Improvements in the
12481 Premises (the Final Space Plan), which Final Space Plan shall include a layout and
designation of all offices, rooms and other partitioning, their intended use, and equipment to be
contained therein, and shall deliver the Final Space Plan to Landlord for Landlords approval,
which approval shall not be unreasonably withheld, conditioned or delayed.
3.3 Final Working Drawings. On or before the date set forth in Schedule 1, Tenant,
Architect and the Engineers shall complete the architectural and engineering drawings for the 12481
Premises, and Architect shall compile a fully coordinated set of architectural, structural,
mechanical, electrical and plumbing working drawings in a form which is complete to allow
subcontractors to bid on the work and to obtain all applicable permits (collectively, the Final
Working Drawings), and shall submit the same to Landlord for Landlords approval, which approval
shall not be unreasonably withheld, conditioned or delayed.
3.4 Approved Working Drawings. On or before the date set forth therefor in Schedule
1, Tenant shall submit the Final Working Drawings approved by Landlord (the Approved Working
Drawings) to the applicable local governmental agency for all applicable building permits
necessary to allow Contractor, as that term is defined in Section 4.1 of this Work Letter
Agreement, to commence and fully complete the construction of the Tenant Improvements
(collectively, the Permits), and, in connection therewith, Tenant shall coordinate with Landlord
in order to allow Landlord, at Landlords option, to take part in all phases of the permitting
process, and shall supply Landlord, as soon as possible, with all plan check numbers and dates of
submittal. Notwithstanding the foregoing, Tenant hereby agrees that neither Landlord nor
Landlords consultants shall be responsible for obtaining any building permit or certificate of
occupancy for the 12481 Premises and that the obtaining of the same shall be Tenants
responsibility; provided, however, that Landlord shall, in any event, cooperate with Tenant in
executing permit applications and performing other ministerial acts reasonably necessary to enable
Tenant to obtain any such permit or certificate of occupancy. No changes, modifications or
alterations in the Approved Working Drawings may be made without the prior written consent of
Landlord, provided that Landlord may not unreasonably withhold, condition or delay its consent.,
3.5 Time Deadlines. Landlord and Tenant shall cooperate with Architect, the Engineer,
and each other to complete all phases of the Construction Drawings and the permitting process and
to receive the permits, and with Contractor, for approval of the Cost Proposal, as that term is
defined in Section 4.2 below, in accordance with the dates set forth in Schedule 1. Tenant
shall meet with Landlord on a weekly (or such other basis as Landlord shall determine) to discuss
Tenants progress in connection with the same. Certain of applicable dates for approval of items,
plans and drawings as described in this Section 3, Section 4, below, and in this
Work Letter Agreement are set forth and further elaborated upon in Schedule 1 (the Time
Deadlines), attached hereto. Tenant agrees to comply with the Time Deadlines, subject to Force
Majeure.
SECTION 4.
CONSTRUCTION OF THE TENANT IMPROVEMENTS
4.1 Contractor. A contractor, under the supervision of and selected by Landlord,
shall construct the Tenant Improvements (the Contractor); provided, however that one (1) of the
following contractors will be recommended by Tenant for Landlords selection and once selected
shall be deemed approved by Tenant: Pacific Building Group, Bycor, Burger Construction, Bilbro and
Roel.
4.2 Cost Proposal. After the Approved Working Drawings are signed by Landlord and
Tenant, Landlord shall provide Tenant with a cost proposal in accordance with the Approved Working
Drawings, which cost proposal shall include, as nearly as possible, the cost of all Tenant
Improvement Allowance Items to be incurred by Tenant in connection
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with the construction of the Tenant Improvements (the Cost Proposal). Notwithstanding the
foregoing, portions of the cost of the Tenant Improvements may be delivered to Tenant as such
portions of the Tenant Improvements are priced by Contractor (on an individual item-by-item or
trade-by-trade basis), even before the Approved Working Drawings are completed (the Partial Cost
Proposal). Tenant shall approve and deliver the Cost Proposal to Landlord within five (5)
business days of the receipt of the same (or, as to a Partial Cost Proposal, within two (2)
business days of receipt of the same). The date by which Tenant must approve and deliver the Cost
Proposal, or the last Partial Cost Proposal to Landlord, as the case may be, shall be known
hereafter as the Cost Proposal Delivery Date. The total of all Partial Cost Proposals, if any,
shall be known as the Cost Proposal.
4.3 Construction of Tenant Improvements by Landlords Contractor under the Supervision of
Landlord.
4.3.1 Over-Allowance Amount. On the Cost Proposal Delivery Date and throughout the
construction process, Tenant shall deliver to Landlord cash in an amount (the Over-Allowance
Amount) equal to the difference between (i) the amount of the Cost Proposal and (ii) the amount of
the Tenant Improvement Allowance (less any portion thereof already disbursed by Landlord, or in the
process of being disbursed by Landlord, on or before the Cost Proposal Delivery Date). Tenant
shall deliver the Over-Allowance Amount in the following manner: 50% of the Over-Allowance Amount
on the Cost Proposal Delivery Date, 35% of the Over-Allowance Amount upon completion of dry-wall
taping, and the remaining 15% of the Over-Allowance Amount upon Substantial Completion (as defined
in Section 5 of this Work Letter). The Over-Allowance Amount shall be disbursed by
Landlord prior to the disbursement of any then remaining portion of the Tenant Improvement
Allowance, and such disbursement shall be pursuant to the same procedure as the Tenant Improvement
Allowance. In the event that, after the Cost Proposal Date, any revisions, changes, or
substitutions shall be made to the Construction Drawings or the Tenant Improvements, any additional
costs which arise in connection with such revisions, changes or substitutions shall be added to the
Cost Proposal and shall be paid by Tenant to Landlord immediately upon Landlords request to the
extent such additional costs increase any existing Over-Allowance Amount or result in an
Over-Allowance Amount. Following completion of the Tenant Improvements, Landlord shall deliver to
Tenant a final cost statement which shall indicate the final costs of the Tenant Improvement
Allowance Items, and if such cost statement indicates that Tenant has underpaid or overpaid the
Over-Allowance Amount, then within ten (10) business days after receipt of such statement, Tenant
shall deliver to Landlord the amount of such underpayment or Landlord shall return to Tenant the
amount of such overpayment, as the case may be.
4.3.2 Landlord Supervision. After Landlord selects the Contractor, Landlord shall
independently retain Contractor to construct the Tenant Improvements in accordance with the
Approved Working Drawings and the Cost Proposal and Landlord shall supervise the construction by
Contractor, and Tenant shall pay a construction supervision and management fee (the Landlords
Supervision Fee) to Landlord in an amount equal to the product of (i) three percent (3%) and (ii)
an amount equal to the Tenant Improvement Allowance plus the Over-Allowance Amount (as such
Over-Allowance Amount may increase pursuant to the terms of this Work Letter Agreement).
4.3.3 Contractors Warranties and Guaranties. Landlord hereby assigns to Tenant all
warranties and guaranties by Contractor relating to the Tenant Improvements, which assignment shall
be on a non-exclusive basis such that the warranties and guarantees may be enforced by Landlord
and/or Tenant, and Tenant hereby waives all claims against Landlord relating to, or arising out of
the construction of, the Tenant Improvements.
4.3.4 Tenants Covenants. Tenant hereby indemnifies Landlord for any loss, claims,
damages or delays arising from the actions of Architect and the Engineers on the 12481 Premises or
in the Building. Within ten (10) days after completion of construction of the Tenant Improvements,
Landlord shall cause a Notice of Completion to be recorded in the office of the Recorder of the
County in which the Building is located in accordance with Section 3093 of the Civil Code of the
State of California or any successor statute and furnish a copy thereof to Landlord upon
recordation, failing which, Landlord may itself execute and file the same on behalf of Tenant as
Tenants agent for such purpose. In addition, Tenant, immediately after the Substantial Completion
of the 12481 Premises, shall have prepared and delivered to the Building management office a copy
of the as built plans and specifications (including all working drawings) for the Tenant
Improvements, together with a computer disk containing the Approved Working Drawings in AutoCAD
format.
SECTION 5.
SUBSTANTIAL COMPLETION
5.1 Substantial Completion. For purposes of the Lease, including for purposes of
determining the Commencement Date (as set forth in Section 1.7 of the Summary to the
Lease), Substantial Completion of the 12481 Premises shall occur upon satisfaction of
both of the following conditions: (a) the completion of the construction of the Tenant
Improvements in the 12481 Premises pursuant to the Approved Working Drawings, with the exception of
the any punchlist items, and (b) the issuance by the City Building Inspector of a temporary
certificate of occupancy or certificate of occupancy.
5.2 Tenant Delays. To the extent there are any delays in Substantial Completion of
the 12481 Premises as a direct, indirect, partial, or total result of any of the following
(collectively, Tenant Delays):
5.2.1 Tenants failure to comply with the Time Deadlines (except as a result of Force
Majeure);
5.2.2 Tenants failure to timely approve any matter requiring Tenants approval, including a
Partial Cost Proposal or the Cost Proposal (except as a result of Force Majeure);
5.2.3 a breach by Tenant of the terms of this Work Letter Agreement or the Lease;
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5.2.4 changes in any of the Construction Drawings because the same do not comply with
applicable laws;
5.2.5 Tenants request for changes in the Approved Working Drawings;
5.2.6 Tenants requirement for materials, components, finishes or improvements which are not
available in a reasonable time (based upon the anticipated date of the Commencement Date set forth
in Section 1.7 of the Summary) or which are different from, or not included in, the
Specifications;
5.2.7 changes to the Base, Shell and Core required by the Approved Working Drawings;
5.2.8 any changes in the Construction Drawings and/or the Tenant Improvements required by
applicable laws if such changes are directly attributable to Tenants use of the 12481 Premises or
Tenants specialized tenant improvement(s); or
5.2.9 any other acts or omissions of Tenant, or its agents, or employees;
then, notwithstanding anything to the contrary set forth in the Lease and regardless of the actual
date of the Substantial Completion of the 12481 Premises, the Commencement Date (as set forth in
Section 1.7 of the Summary) shall be deemed to be the date the Commencement Date would have
occurred if no Tenant Delays, as set forth above, had occurred.
SECTION 6.
MISCELLANEOUS
6.1 Tenants Entry Into the 12481 Premises Prior to Substantial Completion. Subject
to the terms hereof and provided that Tenant and its agents do not interfere with, or delay,
Contractors work in the Building and the 12481 Premises, at Landlords reasonable discretion,
Landlord and Contractor shall allow Tenant access to the 12481 Premises prior to the Substantial
Completion of the 12481 Premises for the purpose of Tenant installing overstandard equipment or
fixtures (including Tenants data and telephone equipment and furniture) in the 12481 Premises.
Prior to Tenants entry into the 12481 Premises as permitted by the terms of this Section
6.1, Tenant shall submit a schedule to Landlord and Contractor, for their approval, which
schedule shall detail the timing and purpose of Tenants entry. In connection with any such entry,
Tenant acknowledges and agrees that Tenants employees, agents, contractors, consultants, workmen,
mechanics, suppliers and invitees shall fully cooperate, work in harmony and not, in any manner,
interfere with Landlord or Landlords Contractor, agents or representatives in performing work in
the Building and the 12481 Premises, or interfere with the general operation of the Building and/or
the Project. If at any time any such person representing Tenant shall not be cooperative or shall
otherwise cause or threaten to cause any such disharmony or interference, including, without
limitation, labor disharmony, and Tenant fails to immediately institute and maintain corrective
actions as directed by Landlord, then Landlord may revoke Tenants entry rights upon twenty-four
(24) hours prior written notice to Tenant. Tenant acknowledges and agrees that any such entry
into and occupancy of the 12481 Premises or any portion thereof by Tenant or any person or entity
working for or on behalf of Tenant shall be deemed to be subject to all of the terms, covenants,
conditions and provisions of the Lease, excluding only the covenant to pay rent (until the
occurrence of the Commencement Date). Tenant further acknowledges and agrees that Landlord shall
not be liable for any injury, loss or damage which may occur to any of Tenants work made in or
about the 12481 Premises in connection with such entry or to any property placed therein prior to
the Commencement Date, the same being at Tenants sole risk and liability. Tenant shall be liable
to Landlord for any damage to any portion of the 12481 Premises, including the Tenant Improvement
work, caused by Tenant or any of Tenants employees, agents, contractors, consultants, workmen,
mechanics, suppliers and invitees. In the event that the performance of Tenants work in
connection with such entry causes extra costs to be incurred by Landlord or requires the use of any
Building services, Tenant shall promptly reimburse Landlord for such extra costs and/or shall pay
Landlord for such Building services at Landlords standard rates then in effect. In addition,
Tenant shall hold Landlord harmless from and indemnify, protect and defend Landlord against any
loss or damage to the Building or 12481 Premises and against injury to any persons caused by
Tenants actions pursuant to this Section 6.1.
6.2 Tenants Representative. Tenant has designated Steve Shupp of Cushman & Wakefield
as its sole representative with respect to the matters set forth in this Work Letter Agreement,
who, until further notice to Landlord, shall have full authority and responsibility to act on
behalf of the Tenant as required in this Work Letter Agreement.
6.3 Landlords Representative. Landlord has designated Steven Stewart as its sole
representative with respect to the matters set forth in this Work Letter Agreement, who, until
further notice to Tenant, shall have full authority and responsibility to act on behalf of the
Landlord as required in this Work Letter Agreement.
6.4 Time of the Essence in This Work Letter Agreement. Unless otherwise indicated,
all references herein to a number of days shall mean and refer to calendar days. In all
instances where Tenant is required to approve or deliver an item, if no written notice of approval
is given or the item is not delivered within the stated time period, at Landlords sole option, at
the end of said period the item shall automatically be deemed approved or delivered by Tenant and
the next succeeding time period shall commence.
6.5 Tenants Lease Default. Notwithstanding any provision to the contrary contained
in the Lease, so long as an event of default by Tenant, beyond all applicable notice and cure
periods, as described in Section 23 of the Lease or any default by Tenant, beyond all
applicable notice and cure periods under this Work Letter Agreement, has occurred at any time on or
before the Substantial Completion of the 12481 Premises and is continuing, then (i) in addition to
all other rights and remedies granted to Landlord pursuant to the Lease, at law and/or in equity,
Landlord shall have the right to withhold payment of all or any portion of the Tenant Improvement
Allowance and/or Landlord may cause Contractor to
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cease the construction of the 12481 Premises (in which case, Tenant shall be responsible for
any delay in the Substantial Completion of the 12481 Premises caused by such work stoppage as set
forth in Section 5.2 of this Work Letter Agreement), and (ii) all other obligations of
Landlord under the terms of this Work Letter Agreement shall be forgiven until such time as such
default is cured pursuant to the terms of the Lease (in which case, Tenant shall be responsible for
any delay in the Substantial Completion of the 12481 Premises caused by such inaction by Landlord).
In addition, if the Lease is terminated prior to the Commencement Date for any reason due to a
default by Tenant of Tenants obligations under the Lease or under this Work Letter Agreement
(except for obligations of Tenant that cannot, as a practical matter, take effect until Tenant
takes possession of the Premises), in addition to any other remedies available to Landlord under
the Lease, at law and/or in equity, Tenant shall pay to Landlord, as additional rent under the
Lease, within five (5) days of receipt of a statement therefor, any and all costs incurred by
Landlord (including any portion of the Tenant Improvement Allowance disbursed by Landlord) and not
reimbursed or otherwise paid by Tenant through the date of such termination in connection with the
Tenant Improvements to the extent planned, installed and/or constructed as of such date of
termination, including, but not limited to, any costs related to the removal of all or any portion
of the Tenant Improvements and restoration costs related thereto.
[Signatures on following page]
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IN WITNESS WHEREOF, the parties have executed this Work Letter Agreement as of the day and year
first above written.
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TENANT: |
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LANDLORD: |
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CADENCE PHARMACEUTICALS, INC,
a Delaware corporation |
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PRENTISS/COLLINS DEL MAR HEIGHTS LLC,
a Delaware limited liability company |
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By: |
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Cognac High Bluffs LLC, |
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*By: |
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a Delaware limited liability company, |
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Print Name: |
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its managing member |
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By: |
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The Prudential Insurance Company of America, |
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a New Jersey corporation, |
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*By: |
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its sole member |
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By: |
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Name:
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Title:
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C-6
SCHEDULE 1
TIME DEADLINES
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Dates |
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Actions to be Performed |
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May 9, 2006
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Final Space Plan to be completed by Tenant and
delivered to Landlord. |
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2.
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June 4, 2006
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Tenant to deliver Final Working Drawings to Landlord. |
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3.
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June 4, 2006
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Tenant to submit Approved Working Drawings to the
City of San Diego for all applicable building
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4.
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Five (5)
business days after
the receipt of the
Cost Proposal by
Tenant.
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Tenant to approve Cost Proposal and deliver Cost
Proposal to Landlord. |
C-7
EXHIBIT D
FORM OF COMMENCEMENT NOTICE
This Commencement Notice is delivered this day of , 2006, by
PRENTISS/COLLINS DEL MAR HEIGHTS, LLC, a California limited liability company (Landlord) to
CADENCE PHARMACEUTICALS, INC. (Tenant), pursuant to the provisions of Section 2.1 of that
certain Office Lease (the Lease) dated , 2006 , by and between Landlord and Tenant
covering certain space in the Building known as 12481 & 12531 High Bluff Ridge. All terms used
herein with their initial letter capitalized shall have the meaning assigned to such terms in the
Lease.
Gentlemen:
In accordance with the above-referenced Lease, we wish to advise and/or confirm as follows:
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That the Building, the Premises, the Parking Facilities, and all other improvements required
to be constructed and furnished by Landlord in accordance with the terms of the Lease have
been accepted by Tenant as being substantially complete and that there is no deficiency in
construction. |
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That Tenant has accepted and is in possession of the Premises, and acknowledges that under
the provisions of the Lease, the Term of the Lease is for Six (6) years, with One (1) options
to renew for Five (5) years each, and commenced upon the Commencement Date of [SEPTEMBER 15,
2006] and is currently scheduled to expire on [SEPTEMBER 30, 2012], subject to earlier
termination as provided in the Lease. |
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That in accordance with the Lease, rental payment has commenced (or shall commence) on
[SEPTEMBER 15, 2006]. |
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If the Commencement Date of the Lease is other than the first day of the month, the first
billing will contain a pro rata adjustment. Each billing thereafter, with the exception of
the final billing, shall be for the full amount of the monthly installment as provided for in
the Lease. |
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Rent is due and payable in advance on the first day of each and every month during the Term
of the Lease. Your rent checks should be made payable to Prentiss/Collins Del Mar Heights
LLC, at P.O. Box 100555 Pasadena, California 91189-0555. |
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The exact number of rentable square feet within the 12481 Premises is square feet.
The exact number of usable square feet within the 12481 Premises is square feet.
The exact number of rentable square feet within the 12531 Premises is square feet. The
exact number of usable square feet within the 12531 Premises is square feet. |
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Tenants Percentage, as adjusted based upon the exact number of Rentable Square Feet within
the 12481 Premises, is %. |
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IN WITNESS WHEREOF, this instrument has been duly executed by Landlord as of the date first
written above. |
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LANDLORD: |
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PRENTISS/COLLINS DEL MAR HEIGHTS LLC,
a Delaware limited liability company |
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By: |
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Cognac High Bluffs LLC,
a Delaware limited liability company,
its managing member |
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By: |
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The Prudential Insurance Company of America,
a New Jersey corporation,
its sole member |
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By: |
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Name: |
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Title: |
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[Signatures continue on following page]
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ACKNOWLEDGED AND AGREED TO THIS DAY
OF , 2006, BY TENANT: |
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CADENCE PHARMACEUTICALS, INC,
a Delaware corporation |
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*By: |
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Print Name: |
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Print Title:
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*By: |
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Print Name: |
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Print Title: |
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SAMPLE ONLY [NOT FOR EXECUTION]
EXHIBIT E
RULES AND REGULATIONS
Notwithstanding anything to the contrary contained in this Exhibit E, if any rule or
regulation is in conflict with any term, covenant or condition of the Lease, the Lease shall
prevail. In addition, no rule or regulation, or any subsequent amendment thereto shall in any way
alter, reduce or adversely affect any of Tenants rights or increase Tenants obligations under
this Lease. Following a written request from Tenant, Landlord shall use commercially reasonable
efforts to enforce the rules and regulations in a non-discriminatory manor against Tenant and other
tenants of the Site.
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No sign, advertisement, name or notice shall be installed or displayed on any part of the
outside or inside of the Building without the prior written consent of Landlord. Landlord
shall have the right to remove, at Tenants expense and without notice, any sign installed or
displayed in violation of this rule. All approved signs or lettering on doors and walls shall
be printed, painted, affixed or inscribed at the expense of Tenant by a person approved by
Landlord, using materials and in a style and format approved by Landlord. |
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Tenant shall not place anything or allow anything to be placed near the glass of any window,
door, partition or wall which may appear unsightly from outside the Premises. No awnings or
other projection shall be attached to the outside walls of the Building without the prior
written consent of Landlord. No curtains, blinds, shades or screens shall be attached to or
hung in, or used in connection with, any window or door of the Premises, other than Building
standard materials, without the prior written consent of Landlord. |
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Tenant shall not obstruct any sidewalks, halls, passages, exits, entrances, elevators,
escalators or stairways of the Building. The halls, passages, exits, entrances, elevators,
escalators and stairways are not for the general public, and Landlord shall in all cases
retain the right to control and prevent access thereto of all persons whose presence in the
judgment of Landlord would be prejudicial to the safety, character, reputation and interests
of the Building and its tenants; provided, that nothing herein contained shall be construed to
prevent such access to persons with whom any tenant normally deals in the ordinary course of
its business, unless such persons are engaged in illegal activities. Tenant and no employee,
invitee, agent, licensee or contractor of Tenant shall go upon or be entitled to use any
portion of the roof of the Building. |
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The directory of the Building will be provided exclusively for the display of the name and
location of tenants only, and Landlord reserves the right to exclude any other names
therefrom. |
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All cleaning and janitorial services for the Building and the Premises shall be provided
exclusively through Landlord or Landlords janitorial contractors in accordance with the
provisions of Section 18.1(d) of the Lease. No person or persons other than those
approved by Landlord shall be employed by Tenant or permitted to enter the Building for the
purpose of cleaning the same. Tenant shall not cause any unnecessary labor by carelessness or
indifference to the good order and cleanliness of the Premises. Landlord shall not in any way
be responsible to Tenant for loss of property on the Premises, however occurring, or for any
damage to Tenants property by the janitors or any other employee or any other person. |
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Landlord will furnish Tenant, free of charge, with two keys to each door lock in the Premises
and 24-hour access cards to the Building for each of Tenants employees. Landlord may impose
a reasonable charge for any additional keys or replacement access cards. Tenant may not make
or have made additional keys, and Tenant shall not alter any lock or install a new additional
lock or bolt on any door or window of its Premises. Tenant, upon termination of its tenancy,
shall deliver to Landlord the keys of all doors which have been furnished to, or otherwise
procured by Tenant, and, in the event of loss of any keys, shall pay Landlord the cost of
replacing the same or of changing the lock or locks opened by such lost key if Landlord shall
deem it necessary to make such change. |
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Electric wires, telephones, telegraphs, burglar alarms or other similar apparatus shall not
be installed in the Premises except with the approval and under the direction of Landlord.
The location of telephones, call boxes and any other equipment affixed to the Premises shall
be subject to the approval of Landlord. Any installation of telephones, telegraphs, electric
wires or other electric apparatus made without permission shall be removed by Tenant at
Tenants own expense. No machines other than standard office machines, such as typewriters
and calculators, photo copiers, personal computers and word processors, UL listed kitchenette
appliances, and vending machines permitted by the Lease, shall be used in the Premises without
the approval of Landlord. |
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No furniture, freight, or equipment of any kind shall be brought into the Building without
prior notice to Landlord and all moving of the same into or out of the Building shall be done
at such time and in such manner as Landlord shall designate. No furniture, equipment or
merchandise shall be received in the Building or carried up or down in the elevator, except
between such hours as shall be designated by Landlord. Deliveries during normal office hours
shall be limited to normal office supplies and other small items. No deliveries shall be made
which impede or interfere with other tenants or the operation of the Building. |
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Tenant shall not place a load upon any floor of the Premises which exceeds the load per
square foot which such floor was designed to carry and which is allowed by law. Landlord
shall have the right to reasonably prescribe the weight and size of all unusually heavy
equipment, materials, furniture or other property brought into the Building. Heavy objects,
if such objects are considered necessary by Tenant, as reasonably determined by Landlord,
shall stand on such platforms as determined by Landlord to be necessary to properly distribute
the weight. Business machines and mechanical equipment which cause noise or vibration that
may be transmitted to the structure of the Building or to any space therein to such a degree
as to be objectionable to Landlord or to any tenants in the Building, shall be placed and
maintained by Tenant, at Tenants expense, on vibration eliminators or other devices
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sufficient to eliminate noise or vibration. Landlord will not be responsible for loss of, or
damage to, any such equipment or other property from any cause, and all damage done to the
Building by maintaining or moving such equipment or other property shall be repaired at the
expense of Tenant. Landlord acknowledges and agrees that Tenant may use and maintain
fire-rated storage and filing cabinets that are heavier in nature than typical filing
systems. |
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Tenant shall not use or keep in the Premises any kerosene, gasoline or inflammable or
combustible fluid or material other than those limited quantities necessary for the operation
or maintenance of office equipment. Tenant shall not use or permit to be used in the Premises
any foul or noxious gas or substance, or permit or allow the Premises to be occupied or used
in a manner offensive or objectionable to Landlord or other occupants of the Project by reason
of noise, odors or vibrations, nor shall Tenant bring into or keep in or about the Premises
any birds or animals. |
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Tenant shall not use any method of heating or air-conditioning other than that supplied by
Landlord. |
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Tenant shall not waste electricity, water or air-conditioning and agrees to cooperate fully
with Landlord to assure the most effective operation of the Buildings heating and
air-conditioning and to comply with any governmental energy-saving rules, laws or regulations
of which Tenant has actual notice, and shall not adjust controls other than room thermostats
installed for Tenants use. Tenant shall keep corridor doors closed and shall close window
coverings at the end of each business day. |
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Landlord reserves the right from time to time, in Landlords sole and absolute discretion,
exercisable without prior notice and without liability to Tenant, to: (a) name or change the
name of the Building, Site or Project; (b) change the address of the Building or Project,
and/or (c) install, replace or change any signs in, on or about the Common Areas, the Building
or Site (except for Tenants signs, if any, which are expressly permitted by the Lease). |
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Landlord reserves the right to exclude from the Building between the hours of 6:00 p.m. and
7:00 a.m., or such other hours as may be established from time to time by Landlord, and on
legal holidays, any person unless that person is known to the person or employee in charge of
the Building and has a pass or is properly identified. Landlord shall not be liable for
damages for any error with regard to the admission to or exclusion from the Building of any
person. Tenant shall be responsible for all persons for whom it requests passes and shall be
liable to Landlord for all acts of such persons. Landlord reserves the right to prevent
access to the Building in case of invasion, mob, riot, public excitement or other commotion by
closing the doors or by other appropriate action. |
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Tenant shall close and lock all doors of its Premises and entirely shut off all water faucets
or other water apparatus, and, except with regard to Tenants computers and other equipment
which reasonably require electricity on a 24-hour basis, all electricity, gas or air outlets
before Tenant and its employees leave the Premises. Tenant shall be responsible for any
damage or injuries sustained by other tenants or occupants of the Building or by Landlord for
noncompliance with this rule. |
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The toilet rooms, toilets, urinals, wash bowls and other apparatus shall not be used for any
purpose other than that for which they were constructed, and no foreign substances of any kind
whatsoever shall be thrown therein. |
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Tenant shall not sell, or permit the sale at retail, of newspapers, magazines, periodicals,
theater tickets, or any other goods or merchandise to the general public in or on the
Premises. Tenant shall not make any room-to-room solicitation of business from other tenants
in the Project. Tenant shall not use the Premises for any business or activity other than
that specifically provided for in the Lease. |
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Tenant shall not install any radio or television antenna, loudspeaker or other device on the
roof or exterior walls of the Building. Tenant shall not interfere with radio or television
broadcasting or reception from or in the Building or elsewhere. |
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Except as expressly permitted in the Lease, Tenant shall not mark, drive nails, screw or
drill into the partitions, window mullions, woodwork or plaster, or in any way deface the
Premises or any part thereof, except to install normal wall hangings. Tenant shall repair any
damage resulting from noncompliance under this rule. |
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Tenant shall not install, maintain or operate upon the Premises any vending machines without
the prior written consent of Landlord, which shall not be unreasonably withheld. |
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Canvassing, soliciting and distribution of handbills or any other written material, and
peddling in and around the Project or the Building are expressly prohibited, and each tenant
shall cooperate to prevent same. |
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Landlord reserves the right to exclude or expel from the Project and/or the Building any
person who, in Landlords judgment, is intoxicated or under the influence of liquor or drugs
or who is in violation of any of the Rules and Regulations of the Project or Building. |
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Tenant shall store all its trash and garbage within its Premises. Tenant shall not place in
any trash box or receptacle any material which cannot be disposed of in the ordinary and
customary manner of trash and garbage disposal. All garbage and refuse disposal shall be made
in accordance with directions reasonably issued from time to time by Landlord. |
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The Premises shall not be used for the storage of merchandise held for sale to the general
public, or for lodging or for manufacturing of any kind. No cooking shall be done or
permitted by Tenant on the Premises, except that |
E-2
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use by Tenant of Underwriters Laboratory-approved equipment for brewing coffee, tea, hot
chocolate and similar beverages shall be permitted and the use of a microwave shall be
permitted, provided that such equipment and use is in accordance with all applicable federal,
state, county and city laws, codes, ordinances, rules and regulations. |
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Tenant shall not use in any space, or in the public halls of the Building, any hand trucks
except those equipped with rubber tires and side guards, or such other material-handling
equipment as Landlord may approve. Tenant shall not bring any other vehicles of any kind into
the Building. |
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Tenant agrees that it shall comply with all fire and security regulations that may be issued
from time to time by Landlord, and Tenant also shall provide Landlord with the name of a
designated responsible employee to represent Tenant in all matters pertaining to such fire or
security regulations. Tenant shall cooperate fully with Landlord in all matters concerning
fire and other emergency procedures. |
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Tenant assumes any and all responsibility for protecting its Premises from theft, robbery and
pilferage. Such responsibility shall include keeping doors locked and other means of entry to
the Premises closed. |
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28. |
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Landlord may waive any one or more of these Rules and Regulations for the benefit of Tenant
or any other tenant, but no such waiver by Landlord shall be construed as a waiver of such
Rules and Regulations in favor of Tenant or any other such tenant, nor prevent Landlord from
thereafter enforcing any such Rules and Regulations against any and all of the tenants in the
Building. |
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These Rules and Regulations are in addition to, and shall not be construed to in any way
modify or amend, in whole or in part, the terms, covenants, agreements and conditions of any
lease of premises in the Project or Building. |
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Landlord reserves the right to make such other and reasonable Rules and Regulations as, in
its judgment, may from time to time be needed for safety, security, care and cleanliness of
the Project and/or Building and for the preservation of good order therein. Tenant agrees to
abide by all such Rules and Regulations hereinabove stated and any additional rules and
regulations which are adopted. |
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Tenant shall be responsible for the observance of all of the foregoing rules by Tenants
employees, agents, clients, customers, invitees or guests. |
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32. |
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Tenant shall not lay linoleum, tile, carpet or other similar floor covering so that the same
shall be affixed to the floor of the Premises in any manner except by a paste, or other
material which may easily be removed with water, the use of cement or other similar adhesive
materials being expressly prohibited. The method of affixing any such linoleum, tile, carpet
or other similar floor covering shall be subject to the approval of Landlord. The expense of
repairing any damage resulting from a violation of this rule shall be borne by Tenant. |
PARKING RULES AND REGULATIONS
In addition to the parking provisions contained in the Lease to which this Exhibit E is
attached, the following rules and regulations shall apply with respect to the use of the Buildings
parking facilities.
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Every parker is required to park and lock his/her own vehicle. All responsibility for damage
to or loss of vehicles is assumed by the parker and Landlord shall not be responsible for any
such damage or loss by water, fire, defective brakes, the act or omissions of others, theft,
or for any other cause. |
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Tenant shall not park or permit its employees to park in any parking areas designated by
Landlord as areas for parking by visitors to the Project. Tenant shall not leave vehicles in
the parking areas overnight nor park any vehicles in the parking areas other than automobiles,
motorcycles, motor driven or non-motor driven bicycles or four wheeled trucks. |
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Parking stickers or any other device or form of identification supplied by Landlord as a
condition of use of the parking facilities shall remain the property of Landlord. Such
parking identification device must be displayed as requested and may not be mutilated in any
manner. The serial number of the parking identification device may not be obliterated.
Devices are not transferable and any device in the possession of an unauthorized holder will
be void. |
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No overnight or extended term storage of vehicles shall be permitted. |
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Vehicles must be parked entirely within painted stall lines of a single parking stall. |
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All directional signs and arrows must be observed. |
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The speed limit within all parking areas shall be five (5) miles per hour. |
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Parking is prohibited: (a) in areas not striped for parking; (b) in aisles; (c) where no
parking signs are posted; (d) on ramps; (e) in cross-hatched areas; and (f) in reserved
spaces and in such other areas as may be designated by Landlord or Landlords parking
operator. |
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Loss or theft of parking identification devices must be reported to the Management Office
immediately, and a lost or stolen report must be filed by the Tenant or user of such parking
identification device at the time. Landlord has the right to exclude any vehicle from the
parking facilities that does not have an identification device. |
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Any parking identification devices reported lost or stolen found on any unauthorized car will
be confiscated and the illegal holder will be subject to prosecution. |
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Washing, waxing, cleaning or servicing of any vehicle in any area not specifically reserved
for such purpose is prohibited. |
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The parking operators, managers or attendants are not authorized to make or allow any
exceptions to these rules and regulations. |
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Tenants continued right to park in the parking facilities is conditioned upon Tenant abiding
by these rules and regulations and those contained in this Lease. Further, if the Lease
terminates for any reason whatsoever, Tenants right to park in the parking facilities shall
terminate concurrently therewith. |
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Tenant agrees to sign a parking agreement with Landlord or Landlords parking operator within
five (5) days of request, which agreement shall provide the manner of payment of monthly
parking fees for covered reserved parking spaces and otherwise be consistent with the Lease
and these rules and regulations. |
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Landlord reserves the right to refuse the sale or use of monthly stickers or other parking
identification devices to any tenant or person who willfully refuse to comply with these rules
and regulations and all city, state or federal ordinances, laws or agreements. |
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Landlord reserves the right to establish and change parking fees, and to modify and/or adopt
such other reasonable and non-discriminatory rules and regulations for the parking facilities
as it deems necessary for the operation of the parking facilities. Landlord may refuse to
permit any person who violates these rules to park in the parking facilities, and any
violation of the rules shall subject the vehicle to removal, at such vehicle owners expense. |
E-4
EXHIBIT F
SAMPLE FORM OF TENANT ESTOPPEL CERTIFICATE
The undersigned hereby certifies to , and , a
corporation as follows:
1. |
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Attached hereto is a true, correct and complete copy of that certain Office Lease dated
, 2006 between PRENTISS/COLLINS DEL MAR HEIGHTS LLC, a Delaware limited
liability company (Landlord), and CADENCE PHARMACEUTICALS, INC, a Delaware corporation
(Tenant) (the Lease), which demises Premises which are located at 12481 & 12531 High Bluff
Drive, San Diego, CA 92130. To the undersigneds best knowledge, the Lease is now in full
force and effect, and the Lease has not been amended, modified or supplemented, except as set
forth in Section 6 below. |
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The term of the Lease commenced on , 2006. |
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The term of the Lease is currently scheduled to expire on September 30, 2012. |
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Tenant has no option to renew or extend the Term of the Lease except: One option to renew
the lease for a period of Five (5) years. |
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Tenant has no preferential right to purchase the Premises or any portion of the Building or
Site upon which the Premises are located, and Tenant has no rights or options to expand into
other space in the Building. |
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The Lease has: (Initial One) |
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( )
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not been amended, modified, supplemented, extended, renewed or assigned. |
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( )
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been amended, modified, supplemented, extended, renewed or assigned by the
following described agreements, copies of which are attached hereto: &n
bsp; . |
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Tenant has accepted and is now in possession of the Premises and has not sublet, assigned or
encumbered the Lease, the Premises or any portion thereof except as follows:
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The current Monthly Basic Rent is $ ; and current monthly parking charges are
$ . |
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Tenants Percentage is %, and Tenants Percentage of Operating Expenses currently
payable by Tenant is $ per month, which amount is Landlords current estimate of
Tenants Percentage of Operating Expenses in excess of the Operating Expenses incurred in
calendar year . |
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The amount of security deposit (if any) is $ . No other security deposits have
been made. |
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All rental payments payable by Tenant have been paid in full as of the date hereof. No rent
under the Lease has been paid for more than thirty (30) days in advance of its due date. |
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All work required to be performed by Landlord under the Lease has been completed and has been
accepted by Tenant, and all tenant improvement allowances have been paid in full. |
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To the best of the undersigneds knowledge, as of the date hereof, there are no defaults on
the part of Landlord or Tenant under the Lease. |
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To the undersigneds knowledge, as of the date hereof, Tenant has no defense as to its
obligations under the Lease and claims no set-off or counterclaim against Landlord. |
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Tenant has no right to any concession (rental or otherwise) or similar compensation in
connection with renting the space it occupies, except as expressly provided in the Lease. |
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All insurance required of Tenant under the Lease has been provided by Tenant and all premiums
have been paid. |
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There has not been filed by or against the undersigned a petition in bankruptcy, voluntary or
otherwise, any assignment of creditors, any petition seeking reorganization or arrangement
under the bankruptcy laws of the United States or any state thereof, or any other action
brought pursuant to such bankruptcy laws with respect to the undersigned. |
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Tenant pays rent due Landlord under the Lease to Landlord and does not have any knowledge of
any other person who has any right to such rents by collateral assignment or otherwise. |
The foregoing certification is made with the knowledge that is about to [FUND A LOAN TO
LANDLORD/TENANT OR PURCHASE THE BUILDING FROM LANDLORD OR TAKE AN ASSIGNMENT FROM TENANT], and that
is relying upon the representations herein made in [FUNDING SUCH LOAN OR PURCHASING THE BUILDING OR
TAKING SUCH ASSIGNMENT].
F-1
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Dated: , 20 . |
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TENANT
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By: |
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Print Name: |
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Its: |
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F-2
EXHIBIT G
FORM OF LETTER OF CREDIT
(On Letterhead of Issuing Bank)
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Date: (Insert Date)
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Credit Number: (Insert Number) |
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Expiration Date: (Insert Date) |
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Beneficiary:
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Applicant: (Insert Identification of Tenant) |
(Insert Identification of Landlord)
Ladies/Gentlemen:
We hereby establish our irrevocable letter of credit (the Credit) in favor of Beneficiary,
in the aggregate amount of Dollars U.S. Currency ($ ).
All or any part of the Credit is available by sight draft or drafts drawn on us by you. Such
draft or drafts must be accompanied by a statement, signed by an officer or agent of Beneficiary,
to the effect that the amount drawn herewith represents funds which Beneficiary is entitled to draw
from this Credit pursuant to that certain Office Space Lease dated ___ by and between
Beneficiary, as landlord, and Applicant, as tenant.
All documents presented to us in connection with any demand for payment hereunder, as well as
all notices and other communications to us in respect of this Credit, shall be in writing and shall
make specific reference to this Credit by number. All drafts must be marked Drawn under
(Insert Name of Issuing Bank) Credit No. (Insert Number).
We hereby agree that drafts drawn under and in compliance with the terms of this Credit will
be honored upon presentation and delivery of drafts as specified, without inquiry by us into the
accuracy of any of the statements contained in any of such drafts, if presented at this office,
(Insert Address of Issuing Bank as Shown on Letterhead). We further acknowledge and agree
that: (a) this Credit shall permit partial draws and, in the event you elect to draw upon less
than the full stated amount hereof, the stated amount of this Credit shall be automatically reduced
by the amount of such partial draw; and (b) you shall be entitled to assign your interest in this
Credit from time to time without our approval and without charge.
This Credit is subject to the Uniform Customs and Practice for Documentary Credits (1993
revision) ICC Publication No. 500. This Credit is transferable in accordance with ICC Publication
500. The transfer fee payable in connection with such transfer, if any, shall be paid by
Applicant.
This Credit will be automatically renewed for a one year period upon the expiration date set
forth above and upon each anniversary of such date, unless we notify you in writing by registered
mail, at least thirty (30) days prior to such expiration date or at least thirty (30) days prior to
the expiration of the period for which this Credit is renewed, that we elect not to so renew this
Credit. Upon renewal, we will notify you in writing that this Credit has been automatically
renewed.
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(INSERT IDENTIFICATION OF AND
EXECUTION BY ISSUING BANK) |
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G-1
HIGH BLUFF RIDGE AT DEL MAR
OFFICE LEASE
LANDLORD:
PRENTISS/COLLINS DEL MAR HEIGHTS, LLC,
a California limited liability company
TENANT:
CADENCE PHARMACEUTICALS, INC.,
a Delaware corporation
TABLE
OF CONTENTS
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Page |
1. |
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Premises |
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1 |
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1.1 |
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Premises |
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1 |
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1.2 |
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Landlords Reservation of Rights |
|
1 |
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1.3 |
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Measurement of Premises, Building and/or the Project |
|
1 |
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1.4 |
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Project |
|
1 |
2. |
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Term |
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1 |
3. |
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Rent |
|
1 |
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3.1 |
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Basic Rent |
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1 |
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3.2 |
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Additional Rent |
|
2 |
4. |
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Common Areas; Operating Expenses |
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2 |
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4.1 |
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Definitions; Tenants Rights |
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2 |
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4.2 |
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Landlords Reserved Rights |
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2 |
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4.3 |
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Excess Expenses |
|
2 |
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4.4 |
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Definition of Operating Expenses |
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3 |
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4.5 |
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Definition of Real Property Taxes and Assessments |
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5 |
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4.6 |
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Estimate Statement |
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5 |
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4.7 |
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Actual Statement |
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6 |
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4.8 |
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No Release |
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6 |
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4.9 |
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Audit Rights |
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6 |
5. |
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Security Deposit |
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7 |
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5.1 |
|
Letter of Credit |
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7 |
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5.2 |
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Scheduled Decreases |
|
8 |
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5.3 |
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Transfer of Letter of Credit |
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8 |
6. |
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Use |
|
8 |
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6.1 |
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General |
|
8 |
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6.2 |
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Parking |
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9 |
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6.3 |
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Signs and Auctions |
|
9 |
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6.4 |
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Hazardous Materials |
|
9 |
7. |
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Payments and Notices |
|
10 |
8. |
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Brokers |
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10 |
9. |
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Surrender; Holding Over |
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10 |
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9.1 |
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Surrender of Premises |
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10 |
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9.2 |
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Hold Over With Landlords Consent |
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11 |
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9.3 |
|
No Effect on Landlords Rights |
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11 |
10. |
|
Taxes on Tenants Property |
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11 |
11. |
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Condition of Premises; Repairs |
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11 |
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11.1 |
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Condition of Premises |
|
11 |
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11.2 |
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Landlords Repair Obligations |
|
11 |
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11.3 |
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Tenants Repair Obligations |
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12 |
12. |
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Alterations |
|
12 |
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12.1 |
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Tenant Changes; Conditions |
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12 |
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12.2 |
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Removal of Tenant Changes and Tenant Improvements |
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13 |
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12.3 |
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Removal of Personal Property |
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13 |
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12.4 |
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Tenants Failure to Remove |
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13 |
13. |
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Liens |
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13 |
14. |
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Assignment and Subletting |
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13 |
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14.1 |
|
Restriction on Transfer |
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13 |
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14.2 |
|
Permitted Controlled Transfers |
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14 |
i
TABLE
OF CONTENTS
(continued)
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Page |
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14.3 |
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Landlords Options |
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14 |
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14.4 |
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Additional Conditions; Excess Rent |
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14 |
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14.5 |
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Reasonable Disapproval |
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15 |
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14.6 |
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No Release |
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15 |
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14.7 |
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Administrative and Attorneys Fees |
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16 |
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14.8 |
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Material Inducement |
|
16 |
15. |
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Entry by Landlord |
|
16 |
16. |
|
Utilities and Services |
|
16 |
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16.1 |
|
Standard Utilities and Services |
|
16 |
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16.2 |
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Tenants Obligations |
|
17 |
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16.3 |
|
Failure to Provide Services |
|
17 |
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16.4 |
|
Abatement of Rent When Tenant Is Prevented From Using Premises |
|
17 |
17. |
|
Indemnification and Exculpation |
|
18 |
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17.1 |
|
Tenants Assumption of Risk and Waiver |
|
18 |
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17.2 |
|
Tenants Indemnification of Landlord |
|
18 |
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17.3 |
|
Reciprocal Indemnity |
|
18 |
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17.4 |
|
Survival; No Release of Insurers |
|
18 |
18. |
|
Damage or Destruction |
|
18 |
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18.1 |
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Landlords Rights and Obligations |
|
18 |
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18.2 |
|
Abatement of Rent |
|
19 |
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18.3 |
|
Inability to Complete |
|
19 |
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18.4 |
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Damage Near End of Term |
|
19 |
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18.5 |
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Tenants Termination Right |
|
19 |
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18.6 |
|
Waiver of Termination Rights |
|
19 |
19. |
|
Eminent Domain |
|
19 |
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19.1 |
|
Substantial Taking |
|
19 |
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19.2 |
|
Partial Taking; Abatement of Rent |
|
19 |
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19.3 |
|
Condemnation Award |
|
20 |
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19.4 |
|
Temporary Taking |
|
20 |
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19.5 |
|
Waiver of Termination Right |
|
20 |
20. |
|
Tenants Insurance |
|
20 |
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20.1 |
|
Types of Insurance |
|
20 |
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20.2 |
|
Requirements |
|
20 |
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20.3 |
|
Effect on Insurance |
|
21 |
21. |
|
Landlords Insurance |
|
21 |
22. |
|
Waiver of Claims; Waiver of Subrogation |
|
21 |
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22.1 |
|
Mutual Waiver of Parties |
|
21 |
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22.2 |
|
Waiver of Insurers |
|
21 |
23. |
|
Tenants Default and Landlords Remedies |
|
21 |
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23.1 |
|
Tenants Default |
|
21 |
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23.2 |
|
Landlords Remedies; Termination |
|
22 |
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23.3 |
|
Landlords Remedies; Re-Entry Rights |
|
22 |
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23.4 |
|
Continuation of Lease |
|
22 |
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23.5 |
|
Landlords Right to Perform |
|
23 |
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23.6 |
|
Interest |
|
23 |
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23.7 |
|
Late Charges |
|
23 |
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23.8 |
|
Rights and Remedies Cumulative |
|
23 |
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23.9 |
|
Tenants Waiver of Redemption |
|
23 |
ii
TABLE
OF CONTENTS
(continued)
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Page |
|
|
23.10 |
|
Costs Upon Default and Litigation |
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23 |
24. |
|
Landlords Default |
|
23 |
25. |
|
Subordination |
|
24 |
26. |
|
Estoppel Certificate |
|
24 |
|
|
26.1 |
|
Landlords and Tenants Obligations |
|
24 |
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26.2 |
|
Failure to Deliver |
|
24 |
27. |
|
[Intentionally Deleted] |
|
24 |
28. |
|
Modification and Cure Rights of Landlords Mortgagees and Lessors |
|
24 |
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28.1 |
|
Modifications |
|
24 |
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28.2 |
|
Cure Rights |
|
25 |
29. |
|
Quiet Enjoyment |
|
25 |
30. |
|
Transfer of Landlords Interest |
|
25 |
31. |
|
Limitation on Liability |
|
25 |
|
|
31.1 |
|
Limitation on Landlords Liability |
|
25 |
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31.2 |
|
Limitation on Tenants Liability |
|
25 |
32. |
|
Miscellaneous |
|
25 |
|
|
32.1 |
|
Governing Law |
|
25 |
|
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32.2 |
|
Successors and Assigns |
|
25 |
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32.3 |
|
No Merger |
|
25 |
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|
32.4 |
|
Professional Fees |
|
25 |
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|
32.5 |
|
Waiver |
|
25 |
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|
32.6 |
|
Terms and Headings |
|
26 |
|
|
32.7 |
|
Time |
|
26 |
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|
32.8 |
|
Prior Agreements; Amendments |
|
26 |
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|
32.9 |
|
Severability |
|
26 |
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32.10 |
|
Recording |
|
26 |
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32.11 |
|
Exhibits |
|
26 |
|
|
32.12 |
|
Accord and Satisfaction |
|
26 |
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|
32.13 |
|
Financial Statements |
|
26 |
|
|
32.14 |
|
No Partnership |
|
26 |
|
|
32.15 |
|
Force Majeure |
|
26 |
|
|
32.16 |
|
Counterparts |
|
26 |
|
|
32.17 |
|
Nondisclosure of Lease Terms |
|
26 |
|
|
32.18 |
|
Independent Covenants |
|
27 |
33. |
|
Lease Execution |
|
27 |
|
|
33.1 |
|
Tenants Authority |
|
27 |
|
|
33.2 |
|
Joint and Several Liability |
|
27 |
|
|
33.3 |
|
Building Name and Signage |
|
27 |
|
|
33.4 |
|
Landlords Title; Air Rights |
|
27 |
|
|
33.5 |
|
Time of Essence |
|
27 |
|
|
33.6 |
|
No Option |
|
27 |
34. |
|
Waiver of Jury Trial |
|
27 |
35. |
|
Consent to Judicial Reference |
|
27 |
36. |
|
ERISA |
|
28 |
37. |
|
Option |
|
28 |
|
|
37.1 |
|
Grant of Option |
|
28 |
|
|
37.2 |
|
Effect of Default |
|
28 |
|
|
37.3 |
|
Personal to Tenant |
|
29 |
|
|
37.4 |
|
Fair Market Rent |
|
29 |
iii
exv10w10
EXHIBIT
10.10
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
COLLABORATION AND LICENSE AGREEMENT
between
MICROLOGIX BIOTECH INC.
and
STRATA PHARMACEUTICALS INC.
Dated: July 30, 2004
TABLE OF CONTENTS
|
|
|
|
|
Article 1 DEFINITIONS |
|
|
1 |
|
Section 1.1 Acceptance for Filing |
|
|
1 |
|
Section 1.2 Act |
|
|
1 |
|
Section 1.3 Affiliate |
|
|
2 |
|
Section 1.4 Applicable Law(s) |
|
|
2 |
|
Section 1.5 Approval Letter |
|
|
2 |
|
Section 1.6 Books and Records |
|
|
2 |
|
Section 1.7 CFR |
|
|
2 |
|
Section 1.8 cGMP |
|
|
2 |
|
Section 1.9 Collaboration |
|
|
2 |
|
Section 1.10 Commercially Reasonable Efforts |
|
|
3 |
|
Section 1.11 Common Shares |
|
|
3 |
|
Section 1.12 Competent Authority(ies) |
|
|
3 |
|
Section 1.13 Compound |
|
|
3 |
|
Section 1.14 Confidential Information |
|
|
3 |
|
Section 1.15 Control |
|
|
4 |
|
Section 1.16 Costs |
|
|
4 |
|
Section 1.17 CRBSI |
|
|
4 |
|
Section 1.18 Development |
|
|
4 |
|
Section 1.19 Development Plan(s) |
|
|
4 |
|
Section 1.20 Development Subcontract |
|
|
4 |
|
Section 1.21 DMF |
|
|
5 |
|
Section 1.22 Europe |
|
|
5 |
|
Section 1.23 Exclusivity Fee |
|
|
5 |
|
Section 1.24 Exclusivity Period |
|
|
5 |
|
Section 1.25 Extended Field |
|
|
5 |
|
Section 1.26 FDA |
|
|
5 |
|
Section 1.27 Field |
|
|
5 |
|
Section 1.28 First Commercial Sale |
|
|
5 |
|
Section 1.29 First Phase III Study |
|
|
6 |
|
Section 1.30 GAAP |
|
|
6 |
|
Section 1.31 Good Clinical Practices or GCP |
|
|
6 |
|
Section 1.32 Governmental Approval(s) |
|
|
6 |
|
Section 1.33 IMS Data |
|
|
6 |
|
Section 1.34 Improvements |
|
|
6 |
|
Section 1.35 IND(s) |
|
|
6 |
|
Section 1.36 Know-How |
|
|
7 |
|
Section 1.37 knowledge or best of its knowledge |
|
|
7 |
|
Section 1.38 Labelled or Labelling |
|
|
7 |
|
Section 1.39 LCSI |
|
|
7 |
|
Section 1.40 Major European Market Country |
|
|
7 |
|
Section 1.41 manufacture(d) or manufacturing |
|
|
7 |
|
Section 1.42 Manufacturing Development Costs |
|
|
7 |
|
Section 1.43 Market Price |
|
|
7 |
|
- 2 -
|
|
|
|
|
Section 1.44 Marketing Authorization |
|
|
7 |
|
Section 1.45 MBI 594AN |
|
|
8 |
|
Section 1.46 Micrologix Know-How |
|
|
8 |
|
Section 1.47 Micrologix Patent Rights or Micrologix Patent |
|
|
8 |
|
Section 1.48 Micrologix Technology |
|
|
8 |
|
Section 1.49 NDA |
|
|
8 |
|
Section 1.50 Negotiation Period |
|
|
8 |
|
Section 1.51 Net Sales |
|
|
8 |
|
Section 1.52 Notification Period |
|
|
9 |
|
Section 1.53 packaging |
|
|
9 |
|
Section 1.54 Patent Rights |
|
|
9 |
|
Section 1.55 Phase III Study |
|
|
10 |
|
Section 1.56 Phase IV Study |
|
|
10 |
|
Section 1.57 Post Marketing Commitments |
|
|
10 |
|
Section 1.58 Pricing and Reimbursement Approvals |
|
|
10 |
|
Section 1.59 Prime Rate of Interest |
|
|
10 |
|
Section 1.60 Product |
|
|
10 |
|
Section 1.61 Promotional Material(s) |
|
|
11 |
|
Section 1.62 raw materials and components |
|
|
11 |
|
Section 1.63 Regulations |
|
|
11 |
|
Section 1.64 Reimbursable Costs |
|
|
11 |
|
Section 1.65 Representatives |
|
|
11 |
|
Section 1.66 Royalty Term |
|
|
11 |
|
Section 1.67 Second Phase III Study |
|
|
12 |
|
Section 1.68 Subcontractors |
|
|
12 |
|
Section 1.69 Territory |
|
|
12 |
|
Section 1.70 Third Party |
|
|
12 |
|
Section 1.71 Trading Day |
|
|
12 |
|
Section 1.72 U.S. or the United States |
|
|
12 |
|
Section 1.73 U.S. Dollar Equivalent |
|
|
12 |
|
Section 1.74 U.S. PTO |
|
|
12 |
|
Section 1.75 Valid Claim |
|
|
12 |
|
|
|
|
|
|
Article 2 PRODUCT DEVELOPMENT |
|
|
13 |
|
Section 2.1 Objectives |
|
|
13 |
|
Section 2.2 Collaboration Guidelines; Amendments to the Development Plan(s) |
|
|
13 |
|
Section 2.3 Development |
|
|
14 |
|
Section 2.4 Joint Development Management Committee |
|
|
15 |
|
Section 2.5 Technology Transfer |
|
|
17 |
|
|
|
|
|
|
Article 3 LICENSE |
|
|
18 |
|
Section 3.1 License Terms |
|
|
18 |
|
Section 3.2 Micrologixs Reservation of Rights |
|
|
18 |
|
Section 3.3 Third Party Licensees of Micrologix |
|
|
18 |
|
Section 3.4 Work Product and Intellectual Property |
|
|
18 |
|
Section 3.5 Sublicenses |
|
|
19 |
|
- 3 -
|
|
|
|
|
Section 3.6 Certain Improvements |
|
|
20 |
|
Section 3.7 Exclusive Option to Extend Field |
|
|
21 |
|
|
|
|
|
|
Article 4 ADDITIONAL PAYMENTS |
|
|
22 |
|
Section 4.1 License Fee |
|
|
22 |
|
Section 4.2 Product Milestone Payments |
|
|
23 |
|
Section 4.3 Milestones for a Second Phase III |
|
|
23 |
|
Section 4.4 Milestones for the First Phase III |
|
|
24 |
|
Section 4.5 Burns or Surgical Infections milestones |
|
|
24 |
|
Section 4.6 Commercial Milestone Payments |
|
|
24 |
|
Section 4.7 Royalties |
|
|
24 |
|
|
|
|
|
|
Article 5 COMMERCIALIZATION OF THE PRODUCT |
|
|
27 |
|
Section 5.1 Marketing Efforts |
|
|
27 |
|
Section 5.2 Marketing Update |
|
|
27 |
|
Section 5.3 Manufacturing |
|
|
28 |
|
Section 5.4 Patent Marking |
|
|
31 |
|
|
|
|
|
|
Article 6 REGULATORY COMPLIANCE |
|
|
32 |
|
Section 6.1 Ownership and Maintenance of Governmental Approvals |
|
|
32 |
|
Section 6.2 Rights of Reference |
|
|
32 |
|
Section 6.3 Adverse Drug Event Reporting and Post Marketing Surveillance |
|
|
33 |
|
Section 6.4 Post Marketing Commitments |
|
|
35 |
|
Section 6.5 Assistance |
|
|
35 |
|
Section 6.6 Compliance |
|
|
35 |
|
Section 6.7 General Regulatory Matters |
|
|
36 |
|
|
|
|
|
|
Article 7 PATENTS |
|
|
37 |
|
Section 7.1 Maintenance of Patents or Marks |
|
|
37 |
|
Section 7.2 Cooperation and Procedures Relative to Actions Brought Under Section 7.3 and Section 7.4 |
|
|
38 |
|
Section 7.3 Prosecution of Infringement |
|
|
40 |
|
Section 7.4 Infringement Claimed by Third Parties |
|
|
41 |
|
Section 7.5 Co-operation with Other Licensees |
|
|
41 |
|
|
|
|
|
|
Article 8 CONFIDENTIALITY |
|
|
42 |
|
Section 8.1 Confidentiality |
|
|
42 |
|
Section 8.2 Publicity Review |
|
|
44 |
|
|
|
|
|
|
Article 9 REPRESENTATIONS, WARRANTIES AND COVENANTS |
|
|
44 |
|
Section 9.1 Corporate Power |
|
|
44 |
|
Section 9.2 Due Authorization |
|
|
44 |
|
Section 9.3 Binding Obligation/No Conflict |
|
|
45 |
|
Section 9.4 Ownership of Micrologix Technology |
|
|
45 |
|
- 4 -
|
|
|
|
|
Section 9.5 Patent and Other Intellectual Property Rights Proceedings |
|
|
46 |
|
Section 9.6 Micrologixs Additional Warranties |
|
|
46 |
|
Section 9.7 Stratas Additional Warranties |
|
|
47 |
|
Section 9.8 Pre-Clinical and Clinical Studies Prior to Effective Date |
|
|
47 |
|
Section 9.9 Debarment |
|
|
47 |
|
Section 9.10 Limitation on Warranties |
|
|
47 |
|
|
|
|
|
|
Article 10 INDEMNIFICATION AND INSURANCE |
|
|
48 |
|
Section 10.1 Strata Indemnified by Micrologix |
|
|
48 |
|
Section 10.2 Micrologix Indemnified by Strata |
|
|
48 |
|
Section 10.3 Prompt Notice Required |
|
|
49 |
|
Section 10.4 Indemnitor May Settle |
|
|
49 |
|
Section 10.5 Insurance |
|
|
50 |
|
|
|
|
|
|
Article 11 ADDITIONAL COVENANTS OF THE PARTIES |
|
|
51 |
|
Section 11.1 Micrologix Covenant Not To Compete |
|
|
51 |
|
Section 11.2 Launch of Competitive Product by Strata |
|
|
51 |
|
Section 11.3 Limitation To The Territory |
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51 |
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Section 11.4 Records and Audits |
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52 |
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Section 11.5 Marketing Expenses |
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54 |
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Section 11.6 Further Actions |
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54 |
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Article 12 PRODUCT RECALL |
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54 |
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Section 12.1 Product Recalls or Withdrawal |
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54 |
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Section 12.2 Recall Costs |
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54 |
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Section 12.3 Notification Of Complaints |
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55 |
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Section 12.4 Notification Of Threatened Action |
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55 |
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Article 13 TERM AND TERMINATION |
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55 |
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Section 13.1 Term |
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55 |
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Section 13.2 Termination by Either Party |
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55 |
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Section 13.3 Termination by Strata |
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56 |
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Section 13.4 Termination by Micrologix |
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57 |
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Section 13.5 Effect of Termination |
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57 |
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Section 13.6 Remedies |
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61 |
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Section 13.7 License Following Expiration |
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61 |
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Article 14 DISPUTE RESOLUTION/DAMAGES |
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61 |
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Section 14.1 Disputes |
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61 |
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Section 14.2 Performance to Continue |
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62 |
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Section 14.3 Determination of Patents and Other Intellectual Property |
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62 |
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Section 14.4 Injunctive Relief |
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63 |
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Section 14.5 No Consequential Damages |
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63 |
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Section 14.6 Attorneys Fees |
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63 |
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Article 15 MISCELLANEOUS |
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63 |
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Section 15.1 No Solicitation |
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63 |
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Section 15.2 Assignment; Binding Effect |
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64 |
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Section 15.3 Force Majeure |
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64 |
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Section 15.4 Governing Law |
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64 |
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Section 15.5 Waiver |
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65 |
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Section 15.6 Severability |
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65 |
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Section 15.7 No Right to Use Names |
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65 |
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Section 15.8 Notices |
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65 |
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Section 15.9 Independent Contractors |
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66 |
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Section 15.10 Rules of Construction |
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66 |
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Section 15.11 Entire Agreement; Amendment |
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66 |
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Section 15.12 Counterparts; Facsimile |
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66 |
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Section 15.13 Interpretation |
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67 |
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Exhibit A Development Plan |
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Exhibit B Patents |
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Exhibit C Inventory |
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Exhibit D Governmental Approvals |
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (this Agreement) is made as of July 30, 2004 (the
Effective Date) by and between Micrologix Biotech Inc., a British Columbia corporation having its
offices at BC Research Complex, 3650 Wesbrook Mall, Vancouver, BC, Canada V6S 2L2 (Micrologix)
and Strata Pharmaceuticals Inc., a corporation having its offices at 10923 Coverhurst Way, San
Diego, California 92130, USA (Strata). Micrologix and Strata are sometimes referred to
collectively herein as the Parties or singly as a Party.
R E C I T A L S
WHEREAS, Micrologix has developed and owns or controls certain proprietary technology, patents,
patent applications, and know-how relating to Micrologixs proprietary Compound (as defined below);
WHEREAS, on June 2, 2004, the Parties signed a term sheet (the Term Sheet), whereby Strata paid
Micrologix the Exclusivity Fee, in exchange for, among other things, Micrologixs agreement to
negotiate solely and exclusively with Strata with respect to any license to the Compound and the
Micrologix Technology for development and commercialization in the Field in the Territory (as such
terms are defined herein); and
WHEREAS, Micrologix wishes to grant to Strata, and Strata wishes to obtain from Micrologix, an
exclusive license under the Micrologix Technology to use, market, advertise, promote, distribute,
offer for sale, sell, manufacture, have manufactured, export and import, and co-develop with and/or
in addition to Micrologix, the Compound in the Field in the Territory, or have the foregoing done
on its behalf, subject to the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing Recitals and the mutual covenants and agreements
contained herein, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below:
Section 1.1 Acceptance for Filing
means notification from the FDA indicating receipt of an NDA submission in the United States or
equivalent marketing application pursuant to Applicable Laws in each country in the Territory.
Section 1.2 Act
means the Federal Food Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.) in the United States
and any other comparable, applicable legislation in any other country in the Territory.
- 2 -
Section 1.3 Affiliate
means any company or entity controlled by, controlling or under common control with a Party. As
used in this Section 1.3, control means (a) that an entity or company owns, directly or
indirectly, fifty percent (50%) or more of the voting stock of another entity, or (b) that an
entity, person or group has the actual ability to control and direct the management of the entity,
whether by contract or otherwise.
Section 1.4 Applicable Law(s)
means the Act, Regulations and all other applicable laws, rules, regulations and guidelines within
the Territory that apply to the import, export, research and development, manufacture, marketing,
distribution or sale of the Product in the Field in the Territory or the performance of either
Partys obligations under this Agreement (including disclosure obligations as required by the
United States Securities and Exchange Commission or other comparable exchange or securities
commission having authority over a Party) to the extent applicable and relevant to such Party.
Section 1.5 Approval Letter
means a letter issued by the FDA indicating approval of a product for commercialization, as defined
in 21 CFR § 314.105 in the United States, or equivalent letter issued by the applicable Competent
Authority in any other country in the Territory, pursuant to Applicable Laws in each country in the
Territory.
Section 1.6 Books and Records
means, in whatever media, any and all books and records, documents, reports and accounts in
connection with or relative to: any Reimbursable Costs, any costs Strata or Micrologix is obligated
to reimburse or pay to the other Party under this Agreement; the Development; the Development Plan;
as well as any other books and records as may be required from time to time by Applicable Laws or
this Agreement. Books and Records shall not include any market research and competitive reports,
marketing reports and data.
Section 1.7 CFR
means the United States Code of Federal Regulations in the United States and any other comparable,
applicable code of regulations in any other country in the Territory.
Section 1.8 cGMP
means the current good manufacturing protocols as defined in 21 CFR § 210 and § 211 in the United
States or other comparable, applicable regulations in other countries in the Territory.
Section 1.9 Collaboration
means the activities of the Parties carried out in performance of, and the relationship between the
Parties established by this Agreement.
- 3 -
Section 1.10 Commercially Reasonable Efforts
means, except as otherwise explicitly set forth in this Agreement, [***] shall be fairly determined based upon
relevant factors, including [***]. Except as expressly set out in this Agreement, Commercially
Reasonable Efforts, as applied to development and commercialization efforts, shall be as applied
to, and assessed upon, [***], and therefore, Strata shall not be required to:
(a) [***]; or
(b) [***];
except as may be required in respect of the Product and uses of the Product when using Commercially
Reasonable Efforts [***]. In addition to the foregoing, during the [***] immediately following the
Effective Date, when assessing whether Commercially Reasonable Efforts have been applied by a Party
to an obligation under this Agreement other than the obligations set out in Section 2.1(b), in
addition to the foregoing considerations, the Parties shall take into account [***].
Section 1.11 Common Shares
means common shares in the capital of Micrologix.
Section 1.12 Competent Authority(ies)
means collectively the entities in each country in the Territory responsible for: (i) the
regulation of medicinal products intended for human use, including the FDA; or (ii) the
establishment, maintenance and/or protection of rights related to the Micrologix Patent Rights, or
any other successor entities thereto.
Section 1.13 Compound
means [***].
Section 1.14 Confidential Information
means any and all information (including the Micrologix Technology) of a Party relating to any
trade secret, Reimbursable Costs, Books and Records, process, method, compound, research project,
work in process, future development, scientific, engineering, manufacturing, marketing, sales,
business plan, financial or personnel matter relating to the disclosing Party, its present or
future products, sales, suppliers, customers, employees, investors or business, whether in oral,
written, graphic or electronic form. Confidential Information shall not include any information
which the receiving Party can prove by competent evidence:
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(a) |
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is now, or hereafter becomes, through no act or failure to act on the part of
the receiving Party, generally known or available; |
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(b) |
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is known by the receiving Party at the time of receiving such information, as
evidenced by its written records maintained in the ordinary course of business; |
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(c) |
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is hereafter furnished to the receiving Party by a Third Party, as a matter of
right and without restriction on disclosure; |
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(d) |
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is independently developed by the receiving Party, as evidenced by its written
records, without knowledge of, and without the aid, application or use of, the
disclosing Partys Confidential Information; or |
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(e) |
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is the subject of a written permission to disclose provided by the disclosing
Party. |
Section 1.15 Control
means the possession of the ability to grant a license or sublicense as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party, licensee or
sublicensee or the payment of any material licensing fees or royalties to any Third Party, licensee
or sublicensee.
Section 1.16 Costs
means any and all costs, expenses, fees (including attorneys fees and costs), charges, monies,
license fees, upfront fees and royalties paid in connection with any proceeding, action, suit or
claim and/or paid to any Third Party.
Section 1.17 CRBSI
means catheter related blood stream infection.
Section 1.18 Development
means work conducted under the Development Plan(s) and as set out in Section 2.3.
Section 1.19 Development Plan(s)
means the detailed plan(s) related to the research and the development (including work to obtain
Governmental Approvals, including Marketing Authorizations), and the budget therefor as amended
from time to time pursuant to which the Parties shall conduct the Development under the terms of
this Agreement. The initial Development Plan is attached hereto as Exhibit A.
Section 1.20 Development Subcontract
has the meaning set out in Section 2.1.
- 5 -
Section 1.21 DMF
means drug master file.
Section 1.22 Europe
means the European Union as of the Effective Date, European Union Candidate Countries (namely,
Bulgaria, Croatia, Romania and Turkey), and the following European Countries: Albania, Andorra,
Belarus, Bosnia-Herzegovina, Former Yugoslav Republic of Macedonia, Iceland, Liechtenstein,
Moldova, Monaco, Norway, Russia, San Marino, Serbia & Montenegro, Switzerland, Ukraine, and Vatican
City.
Section 1.23 Exclusivity Fee
means the $200,000 payment made by Strata to Micrologix under the Term Sheet which Micrologix
acknowledges it received in two $100,000 payments, the first on June 3, 2004 and the second on July
6, 2004.
Section 1.24 Exclusivity Period
has the meaning set out in Section 3.7(b).
Section 1.25 Extended Field
has the meaning set out in Section 3.7(a).
Section 1.26 FDA
means the United States Food and Drug Administration in the United States and any other comparable,
applicable administrative agency in any other country in the Territory, or any successor entity
thereto.
Section 1.27 Field
means any or all of the following: [***]. For the avoidance of doubt, the Field specifically excludes [***].
Section 1.28 First Commercial Sale
means (a) with respect to a country in the Territory, the first sale for use, consumption or resale
of the Product by Strata, its sublicensees or its Affiliates in such country (excluding any sales
for clinical trials or other non-commercial purposes) and (b) with respect to the Territory, the
First Commercial Sale in any country within the Territory. A sale to a sublicensee or an Affiliate
shall
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not constitute a First Commercial Sale unless the sublicensee or Affiliate is the end user of the
Product.
Section 1.29 First Phase III Studymeans the Phase III Study for the Product completed prior to
the Effective Date, namely #226-98-002.
Section 1.30 GAAP
means United States generally accepted accounting principles, as consistently applied in the
Territory.
Section 1.31 Good Clinical Practices or GCP
means good clinical practices as defined in 21 CFR § 50 et seq., § 56 et seq., and § 312 et seq. in
the United States or other comparable, applicable regulations in other countries in the Territory.
Section 1.32 Governmental Approval(s)
means any and all permits, licenses and authorizations, including Marketing Authorizations required
by any Competent Authority as a prerequisite to the development, manufacturing, packaging,
marketing and selling of the Product in the Field in the Territory; excluding however import
permits.
Section 1.33 IMS Data
means the data reported from IMS Health Incorporated of Plymouth Meeting, PA, or any successor to
IMS Health Incorporated or any other independent reporting service used by Strata to provide
information related to the marketing of the Product and other pharmaceutical products.
Section 1.34 Improvements
means, subject to Section 3.6, any and all developments, derivative works, enhancements,
modifications, inventions or discoveries relating to the Compound, the Product, for use in the
Field and under the Control of Micrologix or developed, created or acquired by Micrologix at any
time during the Term, whether patentable or not, and shall include, but not be limited to,
developments, inventions or discoveries intended to enhance the safety or efficacy of the Product
and all intellectual property rights related thereto.
Section 1.35 IND(s)
means an investigational new drug application as defined in 21 C.F.R. Section 312 et seq for the
FDA in the United States or equivalent application to the Competent Authorities of other countries
in the Territory, to commence clinical testing of a drug in humans, as defined by the FDA in the
United States, or other applicable Competent Authority, as the same may be amended, supplemented or
replaced from time to time.
- 7 -
Section 1.36 Know-How
means any and all know-how, trade secrets, inventions, data, processes, techniques, procedures,
compositions, devices, methods, formulas, protocols, any and all pre-clinical and clinical data,
and information, whether or not patentable, which are not generally publicly known, including but
not limited to any and all chemical, biochemical, toxicological, and scientific research
information, whether in written, electronic, graphic or video form or any other form or format.
Section 1.37 knowledge or best of its knowledge
means, with respect to each Party, the actual knowledge of the senior officers of such Party,
without the duty of inquiry.
Section 1.38 Labelled or Labelling
means any and all labels and other written, printed or graphic matter, including artwork, upon (a)
the Product or any container utilized with the Product; (b) packaging; or (c) the package inserts.
Section 1.39 LCSI
means local catheter site infection.
Section 1.40 Major European Market Country
means France, Germany and United Kingdom.
Section 1.41 manufacture(d) or manufacturing
means the storage, handling, assembly, production, processing, Labelling, testing, disposition,
packaging and quality control of raw materials and components and the Product.
Section 1.42 Manufacturing Development Costs
has the meaning set out in Section 5.3(f).
Section 1.43 Market Price
of the Common Shares means the U.S. Dollar Equivalent of the weighted average of the trading prices
of the Common Shares on The Toronto Stock Exchange, for the five consecutive Trading Days ending on
the last Trading Day prior to the Effective Date.
Section 1.44 Marketing Authorization
means all necessary and appropriate regulatory approvals, including NDAs and Pricing and
Reimbursement Approvals, where applicable, to allow the Product to be marketed and sold in the
Field in a particular country in the Territory.
- 8 -
Section 1.45 MBI 594AN
means [***].
Section 1.46 Micrologix Know-How
means any and all Know-How related to the Compound or the Product, including research and
development and clinical studies hereunder and other obligations of Micrologix hereunder, and which
is under the Control of Micrologix as of the Effective Date and any and all Improvements thereto,
which is not covered by the Micrologix Patent Rights, but is necessary or useful to the use,
development, manufacture, marketing, promotion, distribution, sale and/or commercialization of the
Product in the Territory for use in the Field.
Section 1.47 Micrologix Patent Rights or Micrologix Patent
means any and all Patent Rights that claim Micrologixs proprietary technology for the Product or
the Compound which is under the Control of Micrologix as of the Effective Date and any and all
Patent Rights covering Improvements thereto, which are necessary or useful to the use, development,
manufacture, marketing, promotion, distribution, sale and/or commercialization of the Product in
the Territory for use in the Field. The Micrologix Patent Rights as of the Effective Date are set
forth on Exhibit B. Any Micrologix Patent Rights issued after the Effective Date shall be added
to Exhibit B.
Section 1.48 Micrologix Technology
means the Micrologix Patent Rights and the Micrologix Know-How.
Section 1.49 NDA
means a New Drug Application, and all amendments and supplements thereto, for regulatory approval
by the FDA as defined in 21 CFR § 314.50 et seq., as such act or regulations may be amended,
supplemented or replaced from time to time, to commence commercial sale of the Product in the
United States and any other comparable term and act as applicable with regard to a new drug
application and all amendments, supplements or replacements to such act or regulations in any other
country in the Territory.
Section 1.50 Negotiation Period
has the meaning set out in Section 3.7(c).
Section 1.51 Net Sales
means collectively, the gross amount invoiced by Strata, its sublicensees, or its Affiliates for
sales of the Product to a Third Party (excluding sales among Strata and a sublicensee or Affiliate
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- 9 -
of Strata for resale, but including the subsequent final sales to Third Parties by such
sublicensees or Affiliates), less the following as they pertain to the Product:
(a) [***].
(b) [***].
The Product shall be considered sold when billed out or invoiced.
No deductions shall be made from Net Sales for items (a) and (b) above except to the extent of
amounts for such items actually granted or paid with respect to the Product; provided that a Party
may reconcile all such amounts within a given calendar quarter regardless of when such amounts were
actually granted or paid.
No deductions shall be made from Net Sales [***].
Components of Net Sales shall be determined in the ordinary course of business using the accrual
method of accounting in accordance with GAAP, provided that a Party may reconcile all such amounts
within a given calendar quarter regardless of when such amounts were actually granted or paid.
In the event a Party transfers Product to a Third Party in a bona fide arms length transaction,
for consideration, in whole or in part, other than cash or to a Third Party in other than a bona
fide arms length transaction, the Net Sales price for such Product shall be deemed to be the
standard invoice price then being invoiced by a Party in an arms length transaction with similar
customers.
Notwithstanding anything herein to the contrary, the transfer of a Product to a Third Party without
consideration to Strata in connection with the development or testing of a Product shall not be
considered a sale of a Product under this Agreement.
Section 1.52 Notification Period
has the meaning set out in Section 3.7(c).
Section 1.53 packaging
means any and all containers, cartons, shipping cases, inserts, package inserts or other similar
material used in packaging or accompanying the Product.
Section 1.54 Patent Rights
means any and all rights under patents and patent applications, and any and all patents issuing
therefrom (including utility, model and design patents and certificates of invention), together
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-10-
with any and all substitutions, extensions (including supplemental protection certificates),
registrations, confirmations, reissues, divisionals, continuations, continuations-in-part,
re-examinations, renewals, and foreign counterparts of the foregoing and all supplements and
modifications thereto.
Section 1.55 Phase III Study
means that portion of the clinical development program that provides for human clinical trials,
performed after preliminary evidence suggesting dose and effectiveness of a Product has been
obtained, which is intended to gather the additional information about the effectiveness and safety
that is needed to evaluate the overall benefit-risk relationship of the Product and to provide
adequate basis for labelling, performed in accordance with the U.S.A. Federal Food, Drug and
Cosmetic Act and applicable regulations promulgated thereunder (including 21 CFR Part 312), as
amended from time to time.
Section 1.56 Phase IV Study
means, as applicable, a study or program, designed to: (a) obtain additional safety or efficacy
data in support of the Product; or (b) determine effectiveness for additional labelled indications,
in either case commenced after Governmental Approval of the Product in the subject country in the
Territory.
Section 1.57 Post Marketing Commitments
means any post-approval commitments required by the FDA in the United States or any other Competent
Authority in any other country in the Territory.
Section 1.58 Pricing and Reimbursement Approvals
means any pricing and reimbursement approvals which must be obtained before placing the Product on
the market in the Field in any country in the Territory in which such approval is required.
Section 1.59 Prime Rate of Interest
means the prime rate of interest published from time to time in The Wall Street Journal as the
prime rate; provided, however that if The Wall Street Journal does not publish the Prime Rate of
Interest, then the term Prime Rate of Interest shall mean the rate of interest publicly announced
by Bank of America, N.A., as its prime rate, base rate, reference rate or the equivalent of such
rate, whether or not such bank makes loans to customers at, above, or below said rate.
Section 1.60 Product
means any and all pharmaceutical formulations containing any and all concentrations, sizes of
volume, configurations and combinations of the Compound.
-11-
Section 1.61 Promotional Material(s)
has the meaning set out in Section 6.6(a).
Section 1.62 raw materials and components
means any and all raw materials and components (such as bulk drug, chemicals, containers, closures,
packaging, Labelling, etc.) needed to manufacture the Product.
Section 1.63 Regulations
means regulations, statutes, rules, guidelines and procedures promulgated by the FDA or other
Competent Authority pursuant to the Act or other Applicable Laws, including current Good Clinical
Practices, current Good Manufacturing Practices, as well as those regulations currently contained
in Title 21 of the CFR.
Section 1.64 Reimbursable Costsmeans the fees and costs owed by Strata pursuant to Section 2.5.
Reimbursable Costs do not include [***]. Marketing Authorizations will be paid for by Strata in accordance with
Section 2.3(c).
Section 1.65 Representatives
means, in respect of a Party, its Affiliates, licensees, sublicensees, and their respective
employees, agents, consultants, Subcontractors, and other representatives.
Section 1.66 Royalty Term
means the period of time commencing on the First Commercial Sale of the Product in a particular
country in the Territory and ending on the expiration of the last to expire of the Micrologix
Patent Rights containing Valid Claims covering such Product in such country in the Territory;
provided, however, that with respect to a country in the Territory in which a Micrologix Patent has
not been issued at the time of the First Commercial Sale in that country, the Royalty Term shall
commence on the First Commercial Sale in such country and continue for the greater of (i) the
period in which a Valid Claim covering such Product exists in the United States; or (ii) if a
Micrologix Patent is subsequently issued in such country, for the period of time in which a Valid
Claim covering such Product exists in such country. The Royalty Term shall apply on a
country-by-country basis. Notwithstanding anything to the contrary provided in this Section 1.66,
if no Valid Claim covering such Product exists in a given country in the Territory, then the
Royalty Term in such country shall be for a period of ten (10) years from the date of the First
Commercial Sale in that country.
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Section 1.67 Second Phase III Study
means a Phase III Study to support a Marketing Authorization for a LCSI, and if reasonably prudent
to pursue same, for CRBSI.
Section 1.68 Subcontractors
means Third Parties engaged to perform obligations of the Parties as permitted by this Agreement.
Section 1.69 Territory
means North America (including the United States, Canada and Mexico) and Europe, and as may be
expanded or reduced pursuant to the terms of this Agreement.
Section 1.70 Third Party
means any entity, other than Micrologix or Strata.
Section 1.71 Trading Day
means any day on which the Toronto Stock Exchange is open for business.
Section 1.72 U.S. or the United States
means the 50 states of the United States of America, its territories or possessions, and the
District of Columbia and Puerto Rico.
Section 1.73 U.S. Dollar Equivalent
means the equivalent amount of U.S. dollars calculated from Canadian currency using the Bank of
Canada noon rate for such conversion as reported on the Bank of Canadas website on the business
day prior to the applicable date.
Section 1.74 U.S. PTO
means the Unites States Patent and Trademark Office or any successor entity thereto.
Section 1.75 Valid Claim
means a claim of an issued and unexpired Micrologix Patent that, with respect to a specific country
in the Territory: (i) has not been revoked, declared unenforceable or unpatentable, or held invalid
by a court or other governmental agency of competent jurisdiction that is unappealable or
unappealed within the time allowed for appeal, (ii) has not been admitted to be rendered invalid or
unenforceable through reissue, disclaimer or otherwise, and (iii) has not been finally cancelled,
withdrawn, abandoned, allowed to lapse, or rejected by any governmental agency of competent
jurisdiction.
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ARTICLE 2
PRODUCT DEVELOPMENT
Section 2.1 Objectives.
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(a) |
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Pursuant to the Development Plan(s) and under the oversight of the JDMC,
Strata, (along with the collaboration and assistance of Micrologix as described in any
applicable development subcontract (Development Subcontract)), shall use Commercially
Reasonable Efforts to obtain Marketing Authorizations for the Product in the Field in
the Territory. |
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(b) |
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Strata shall use Commercially Reasonable Efforts: |
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(i) |
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to submit a protocol and request a special protocol assessment
for the Second Phase III Study in the US, in sufficient time to obtain feedback
from the FDA, on or before the end of the [***]; and |
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(ii) |
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within [***] after receiving satisfactory feedback from the FDA
on such protocol, provided that Strata has secured an adequate supply of
Product ready for use in human trials, enrol a patient in the Second Phase III
Study; |
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(iii) |
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within [***] after filing an NDA in the US, provided that no
Competent Authority in Europe requires an additional phase III clinical study
in order to file a common technical document in Europe, file a common technical
document in Europe. |
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(c) |
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After receiving satisfactory feedback from the FDA on the protocol referred to
in Section 2.1(b)(ii), Strata shall use Commercially Reasonable Efforts to [***]. |
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(d) |
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In addition, in its absolute discretion, Strata may file an NDA and seek
Marketing Authorization for CRBSI based on [***]. |
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(e) |
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Strata shall use Commercially Reasonable Efforts to market and sell the Product
as contemplated hereunder. |
Section 2.2 Collaboration Guidelines; Amendments to the Development Plan(s).
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(a) |
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In all matters related to the Collaboration, the Parties shall strive to
balance as best they can the legitimate interests and concerns of the Parties and to
realize the economic potential of the Product. |
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(b) |
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Any Development Plan may only be modified by the JDMC. The Development Plan(s)
and any modifications thereto, as each may be approved by the JDMC in |
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accordance with this Section 2.2(b), shall be incorporated into this Agreement as
though fully set forth herein and without requiring formal or additional amendment
to this Agreement. |
Section 2.3 Development.
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(a) |
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Strata shall have responsibility for the Development under the oversight and
based on the Development Plan, including a timeline, as approved by the JDMC. In
addition to any other responsibilities as may be provided in the Development Plan(s),
Strata shall: |
|
(i) |
|
use Commercially Reasonable Efforts to develop the Product in
accordance with the Development Plan(s) and as otherwise in accordance with the
terms and conditions of this Agreement; |
|
|
(ii) |
|
use Commercially Reasonable Efforts to secure the Marketing
Authorizations, in accordance with the Development Plan(s) and/or otherwise in
accordance with Article 6; |
|
|
(iii) |
|
promptly advise Micrologix of any issues of which Strata
becomes aware that materially and adversely affect Stratas ability to develop
the Product or meet the timelines on the critical path set out in the
Development Plan(s); |
|
|
(iv) |
|
use Commercially Reasonable Efforts to manufacture or have
manufactured the Compound and the Product to supply the Product to carry out
the Development Plan(s). |
|
(b) |
|
Strata may from time to time and where appropriate, engage Micrologix to
perform regulatory, clinical and other development work pursuant to a Development
Subcontract consistent with the provisions of this Article 2. |
|
|
(c) |
|
Strata shall pay [***] of the Reimbursable Costs incurred by
Micrologix, including those arising under Section 2.5. Micrologix shall invoice Strata
for such Reimbursable Costs on a quarterly basis within forty-five (45) days after the
end of each calendar quarter and such invoices shall be accompanied by the appropriate
documentation, including a listing of expenditures, in reasonably specific detail.
Strata shall pay such invoices within thirty (30) days after receipt of the invoice.
Micrologix shall keep Books and Records as necessary to document the inclusion of the
out-of-pocket and internal costs within the Reimbursable Costs including time sheets,
invoices, etc. Pursuant to Section 11.4, Strata has the right to inspect such Books
and Records upon request and |
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*** |
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during normal business hours, and Micrologix shall provide copies of such Books and
Records to Strata. |
|
(d) |
|
Notwithstanding anything to the contrary contained in this Agreement, if the
Second Phase III Study is commenced, Strata shall not terminate such study except on
notice to Micrologix: |
|
(i) |
|
at any time within [***] after
Stratas receipt of any interim results or the executive summary following
database lock of the LCSI endpoint; |
|
|
(ii) |
|
if Strata elects to continue such study by enrolling patients
thereafter, at any time within [***] after Stratas receipt of any subsequent
interim results or the executive summary following database lock of the CRBSI
endpoint; |
|
|
|
unless Strata terminates this Agreement for Micrologixs breach pursuant to Section
13.2. |
Section 2.4 Joint Development Management Committee.
|
(a) |
|
Creation of JDMC; Scope. Within ten (10) days after the Effective Date, the
Parties will form a Joint Development Management Committee (JDMC), which shall
oversee, review and coordinate the Development under the Development Plan(s) and
otherwise under the terms and conditions of this Agreement. The JDMC may delegate
certain responsibilities to the Parties. The JDMC shall be responsible for (i)
coordinating the Parties respective duties and efforts under this Article 2; (ii)
overseeing the Development, including responsibility for all regulatory strategies
involving Marketing Authorizations, meetings with the FDA and other Competent
Authorities, review of draft submissions to the FDA and other Competent Authorities, as
well as shelf-life and other manufacturing issues; (iii) making all decisions related
to development, clinical trials and budgets in connection with the Development and the
Development Plan(s); (iv) managing the Development conducted under the Development
Plan(s); (v) coordinating the Parties respective obligations under Section 2.3(a) and
Section 2.3(b); (vi) managing the manufacturing development for the Compound referred
to in Section 5.3(a)(i)(C); (vii) monitoring the progress and results of such work, all
based on the principles of prompt, diligent and commercially reasonable development of
the Product consistent with generally accepted practices in the pharmaceutical
industry; and (viii) performing any Post Marketing Commitments. Any changes to any
Development Plan shall be approved in advance by the JDMC. Notwithstanding the
foregoing and anything to the contrary in this Agreement, the JDMC shall have a
consulting role only in regard to, and no right to vote upon, any matters relating to
burns and surgical |
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*** |
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|
|
infections indications for the Product. The JDMC shall not have any
responsibilities in connection with: (i) any Phase IV Study; (ii) any
commercialization or marketing activities in connection with the Product; or (iii)
subject to Section 2.4(a)(vi), any manufacturing of commercial supplies of the
Compound or the Product. Subject to the obligations to make Commercially Reasonable
Efforts set out in Section 2.1 and Section 2.3 of this Agreement: (i) any such
commercialization, marketing and manufacturing activities shall be the sole right
and responsibility of Strata; and (ii) any Phase IV Study(ies) shall be the sole
right and responsibility, but not obligation, of Strata. |
|
(b) |
|
Membership. The JDMC shall be comprised of three (3) voting representatives of
each of Micrologix and Strata. Each Party may change its representatives on the JDMC
at any time upon written notice to the other Party. Strata shall select one (1) member
of the JDMC to act as the chairperson of the JDMC and Micrologix shall select one
member of the JDMC to act as the secretary of the JDMC. |
|
|
(c) |
|
Meetings of the JDMC. The JDMC shall meet on a quarterly basis or at such
other frequency and at such time (and place, as applicable) as agreed to by the members
of the JDMC or upon the reasonable request of either Party. Such meetings may be
conducted in person or via teleconference. The JDMC Secretary will be responsible for
calling meetings, preparing and circulating an agenda in advance of each meeting, and
preparing and issuing minutes of each meeting within thirty (30) days thereafter. Any
such agenda or minutes shall be approved by the other Party in advance of any issuance.
A reasonable number of additional representatives of a Party may attend meetings of
the JDMC in a non-voting observer capacity. |
|
|
(d) |
|
Decisions of the JDMC. A quorum of the JDMC shall be deemed to be present at
any meeting of the JDMC if at least two (2) JDMC members or their designees of each
Party are present at such meeting in person or by telephone. If a quorum exists at any
meeting, a majority vote of the members of the JDMC present at such meeting is required
to take any action on behalf of the JDMC. In the event that any vote within the JDMC
results in a tie, Strata shall have the tie-breaking vote, which shall be exercised in
good faith, and make the final determination. Such final determination shall be
binding upon the Parties. |
|
|
(e) |
|
Limitation of Powers. The JDMC shall not have the right to amend or interpret
this Agreement. Issues regarding the interpretation of this Agreement shall be
referred to the respective Chief Executive Officers of each Party, or their designees
(who must be members of a Partys senior management), as provided in Section 14.1. The
actions or decisions of the JDMC shall not substitute for either Partys ability to
exercise any right set forth herein or excuse the performance of any obligation set
forth herein. |
|
|
(f) |
|
Liaisons. Each Party will designate an individual to serve as the liaison
between the Parties to undertake and coordinate any day-to-day communications as may be |
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|
|
required between the Parties relating to their respective activities under this
Agreement. Each Party may change such liaison from time to time during the Term
upon written notice thereof to the other Party. |
Section 2.5 Technology Transfer.
|
(a) |
|
Micrologix shall, upon Stratas request, transfer to or make available to
Strata the then most-current version of all relevant Micrologix Know-How to enable
Stratas reasonably capable personnel to understand such Micrologix Know-How as
reasonably necessary to undertake the manufacture, development and commercialization of
the Compound and generally any Product in the Field under this Agreement. Such transfer
shall include: |
|
(i) |
|
transfer of the results of the clinical trials conducted prior
to and as of the Effective Date relating to the Product to Strata (including
all regulatory information, clinical data, hard-copy CRFs and reports together
with any patient samples (such as blood samples, microbiology samples, and
tissue samples), if available, without regard to the condition of such
samples); |
|
|
(ii) |
|
transfer of any communications with the FDA and the minutes of
any meetings with the FDA relating to the Product to Strata; |
|
|
(iii) |
|
transfer of the data and results of any CMC related activities
incident to Section 2.5(a)(i) and Section 2.5(a)(ii); |
|
|
(iv) |
|
coordination of communication between Strata and the clinical
trial groups that conducted the clinical trials referred to in Section
2.5(a)(i) prior to and as of the Effective Date; and |
|
|
(v) |
|
providing Strata reasonable access to Micrologix personnel with
relevant clinical and regulatory expertise to explain the information
transferred pursuant to Section 2.5(a)(i), Section 2.5(a)(ii) and Section
2.5(a)(iii). |
|
(b) |
|
Micrologix shall update the Micrologix Know-How related to the Compound and
Products previously transferred to Strata regularly at JDMC meetings. |
|
|
(c) |
|
Micrologix shall work cooperatively with and provide reasonable assistance to
Strata upon Stratas request, under the oversight of the JDMC, to prepare the first NDA
filing in the United States pursuant to a Development Subcontract. |
|
|
(d) |
|
Strata shall pay for the maintenance by Micrologix of the certain Governmental
Approvals in connection with the research and development of the Product pursuant to
Section 6.7(b) and the services of Micrologix personnel provided pursuant to this
Section 2.5, as follows: |
|
(i) |
|
For the first three months from the Effective Date, Strata
shall pay to Micrologix Micrologixs documented out-of-pocket costs of
providing such services. |
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|
(ii) |
|
Commencing after the expiry of three months from the Effective
Date, Strata shall pay to Micrologix the hourly rate of [***] ($[***]) per hour, plus the documented out-of-pocket costs of
providing such services. |
|
|
(iii) |
|
Strata is responsible for, and will pay all reasonable,
documented, actual travel and associated accommodation expenses of Micrologix
personnel who, at Stratas request, travels to provide transition support under
this Section. |
ARTICLE 3
LICENSE
Section 3.1 License Terms.
Subject to the terms and conditions of this Agreement, Micrologix hereby grants to Strata an
exclusive, royalty-bearing license under the Micrologix Technology to use, market, advertise,
promote, distribute, offer for sale, sell, make, manufacture, have manufactured, export and import,
and develop the Product in the Territory for use in the Field with the right to sublicense (as
provided in Section 3.5), and/or assign (as provided Section 15.2) the foregoing.
Section 3.2 Micrologixs Reservation of Rights.
Except as otherwise licensed to Strata hereunder and subject to Section 11.1, Micrologix may
exploit the Micrologix Technology for any purpose, including to use, develop, market, advertise,
promote, distribute, offer for sale, make, manufacture, sell, export and import the Product:
|
(a) |
|
outside the Territory; and |
|
|
(b) |
|
inside the Territory but outside the Field. |
Section 3.3 Third Party Licensees of Micrologix.
In the event that Micrologix or a licensee of Micrologix develops and/or markets a Product outside
the Territory but inside the Field, Micrologix shall use Commercially Reasonable Efforts to work
cooperatively with Strata to coordinate the development and marketing activities of Micrologix or
such licensee of Micrologix with the development and marketing activities hereunder.
Section 3.4 Work Product and Intellectual Property.
|
(a) |
|
Strata acknowledges that it shall have no right, title or interest in or to the
Micrologix Technology except as set forth in this Agreement. Nothing in this Agreement
shall be construed to grant Strata any rights or license to any |
|
|
|
*** |
|
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|
|
intellectual property of Micrologix other than as expressly set forth in this
Agreement. |
|
(b) |
|
Except as set forth in Section 5.2 and the termination Sections of this
Agreement |
|
(i) |
|
Micrologix acknowledges that it shall have no right, title or
interest in or to any data, inventions, discoveries, improvements, derivative
works, and/or any other work product, whether patentable or not, developed
hereunder by Strata or on behalf of Strata by its Representatives (Strata Work
Product). |
|
|
(ii) |
|
Nothing herein shall be construed to grant Micrologix any
rights or license to the Strata Work Product or any other intellectual property
of Strata (collectively, Strata Intellectual Property). Strata reserves all
rights in and to any such Strata Work Product and the Strata Intellectual
Property. |
Section 3.5 Sublicenses.
|
(a) |
|
Strata shall have the right to sublicense rights granted in Section 3.1 to its
Affiliates. Strata shall cause its Affiliates to comply with and be bound by those
terms and conditions of Strata under this Agreement that by their terms are intended to
obligate Strata or its Affiliates commercializing the Product as permitted hereunder,
including Section 3.4, Section 3.5, Article 5, Article 6, Article 7, Article 8, Article
9, Article 10, Article 11 (excluding however Section 11.1), Article 12 and Section
14.5. Notwithstanding the foregoing, Strata shall remain primarily responsible for
complying with such applicable terms and conditions. A breach by any such Affiliate of
any such obligation shall constitute a breach by Strata of this Agreement and shall
entitle Micrologix to exercise its rights hereunder, in addition to any other rights
and remedies to which Micrologix may be entitled. |
|
|
(b) |
|
Strata shall also have the right to sublicense rights granted in Section 3.1 to
Third Parties, subject to the following: Strata shall give Micrologix prompt notice of
the execution of any sublicense. Within ten (10) calendar days after execution of a
sublicensing agreement, Strata shall provide Micrologix with a copy thereof (provided
that Strata shall be permitted to redact the financial terms and other confidential
information in such agreement). Each sublicense shall contain covenants by the
sublicensee for such sublicensee to observe and perform materially the same terms and
conditions as those set out for Strata in this Agreement to the extent applicable. In
the event Strata grants sublicenses to others to sell Product, such sublicenses shall
include an obligation for the sublicensee to account for and report its Net Sales on
the same basis as if such sales were Net Sales by Strata, and Micrologix shall receive
royalties from Strata in the same amounts as if the Net Sales of the sublicensee were
Net Sales of Strata. In the event that Strata becomes aware of a material breach of
any such sublicense by the sublicensee, Strata shall promptly notify Micrologix of the
particulars of same and use its Commercially Reasonable Efforts to enforce the |
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|
|
terms of such sublicense. Upon the request of Micrologix, Strata shall act
reasonably in considering any request of Micrologix for Strata to terminate such
sublicense for cause, but Strata shall have the final and sole right and
responsibility and decision making authority with respect to any such sublicense
(provided that Strata acts reasonably in such regard). |
|
|
(c) |
|
The terms of this Section 3.5 shall apply to each subsequent sublicensee or
sub-sublicensee, as if same were Stratas original sublicensee. |
|
|
(d) |
|
Micrologix will, upon request by any sublicensee of Strata, provide such
sublicensee with a letter whereby Micrologix agrees that if Micrologix gives notice of
default to Strata pursuant to Section 13.2 or Section 13.4, then, prior to any
termination of this Agreement, Micrologix will give such sublicensee written notice of
such default or intention to terminate this Agreement, and in the event of any breach
or default by Strata, which may be cured pursuant to Section 13.2 or Section 13.4, will
for 60 days from the date of such notice to the sublicensee, give the sublicensee the
opportunity to cure such default or breach on the terms provided in Section 13.2 or
Section 13.4, mutatis mutandis. Further, such letter shall evidence Micrologixs
agreement that if this Agreement is terminated, and provided that the sublicense
between Strata and the sublicensee is in good standing at such time, Micrologix will
then grant to the sublicensee a license of the same rights conferred on the sublicensee
by the sublicense agreement on substantially those same terms and conditions as are
contained in this Agreement as would correspond to the sublicense rights granted in the
sublicense agreement, on the financial terms set out in the relevant sublicense
agreement. |
Section 3.6 Certain Improvements.
|
(a) |
|
When Micrologix enters into any agreement or other arrangement with a Third
Party or licensee or sublicensee that may result in the development, creation or
acquisition by Micrologix of any developments, derivative works, enhancements,
modifications, inventions or discoveries relating to the Compound or the Product for
use in the Field (collectively, Certain Improvements), Micrologix will use
Commercially Reasonable Efforts not to limit or otherwise restrict Micrologixs ability
to grant a license or sublicense to any such Certain Improvements as provided for
herein without violating the terms of any such agreement or other arrangement. |
|
|
(b) |
|
If Micrologix develops, creates or acquires any developments, derivative works,
enhancements, modifications, inventions or discoveries relating to the Compound or the
Product for use in the Field, where the grant of a license or sublicense to same as
provided for herein requires the payment of material licensing fees or royalties to any
Third Party, licensee or sublicensee, then Micrologix shall in a timely fashion offer
to Strata in writing a license or sublicense to the rights to such developments,
derivative works, enhancements, modifications, inventions or
|
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|
|
discoveries. Within a reasonable period of time (but not to exceed [***] after receipt of Micrologixs offer), Strata shall either accept the license or
sublicense of same and pay to Micrologix the amount of such material licensing fees
or royalties owed by Micrologix to such Third Party due to Stratas activities under
such license or sublicense, or advise Micrologix that Strata does not wish to obtain
such rights. |
|
(i) |
|
Micrologix, using Commercially Reasonable Efforts, fails to
obtain the ability to grant a license or sublicense as provided for in Section
3.6(a) without violating the terms of any such agreement or other arrangement,
then the rights to any such Certain Improvements shall be excluded from the
definition of Improvements under this Agreement; or |
|
|
(ii) |
|
Strata advises Micrologix that Strata does not wish to obtain
the rights referred to in Section 3.6(b), or if Strata fails to notify
Micrologix within a reasonable period of time (not to exceed [***] as noted
above) that it accepts such license or sublicense, then such rights shall be
excluded from the definition of Improvements under this Agreement; or |
|
|
(iii) |
|
Strata advises Micrologix that Strata does wish to obtain the
rights referred to in Section 3.6(b) within a reasonable period of time (not to
exceed [***] as noted above) and pays such licensing fees or royalties, then
such rights shall be included in the definition of Improvements under this
Agreement without further formality. |
Section 3.7 Exclusive Option to Extend Field.
|
(a) |
|
Subject to the terms and conditions of this Section, Micrologix hereby grants
to Strata the right of first negotiation to obtain an exclusive license under the
Micrologix Technology to use, market, advertise, promote, distribute, offer for sale,
sell, make, manufacture, have manufactured, export and import, and develop the Product
to reduce or eliminate the nasal carriage of infectious organisms (the Extended
Field) in the Territory. |
|
|
(b) |
|
From the Effective Date and for a period of [***] thereafter (the Exclusivity
Period), Micrologix shall notify Strata in writing prior to any: |
|
(i) |
|
use, marketing, advertising, promotion, distribution, offer for
sale, sale, making, manufacturing, having manufactured, exporting, importing or
developing the Product or the Compound for the Extended Field in all or any
part of the Territory for itself or through its Affiliates, or |
|
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|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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(ii) |
|
grant to any Third Party any rights to do any of the foregoing. |
|
(c) |
|
Strata shall have a period of [***] from its receipt of a notice described
in Section 3.7(b) (the Notification Period) to notify Micrologix in writing if Strata
is interested in obtaining such license for the Extended Field for such territory. If,
by the end of the Notification Period, Micrologix receives written notice from Strata
that it desires to obtain such a license, then Micrologix and Strata for a period of
[***] or such longer period of time as mutually agreed to by the Parties in writing
(the Negotiation Period) shall negotiate in good faith, on an exclusive basis, a
definitive license agreement(s) for an exclusive license to the Extended Field upon
such terms and conditions as are mutually agreeable to the Parties. |
|
|
(d) |
|
If the Parties fail to execute such definitive license agreement(s) as
described in Section 3.7(c), by the end of the Negotiation Period or if Strata fails to
give notice of its interest in obtaining a license to the Extended Field before the
expiry of the Notification Period, then Stratas right of first negotiation with
respect to the Extended Field shall terminate; provided, however, that if Micrologix
disposes of rights to the Micrologix Technology for the Extended Field to a Third Party
prior to the end of the Exclusivity Period, then the financial terms of such
transaction shall not be substantially less favorable to Micrologix in the aggregate
than the best terms offered to Strata by Micrologix in writing during the Negotiation
Period. If, prior to the end of the Exclusivity Period, Micrologix desires to offer a
Third Party rights to the Extended Field on financial terms substantially less
favorable to Micrologix in the aggregate than the best terms offered to Strata by
Micrologix in writing during the Negotiation Period, then Micrologix shall first offer
such terms to Strata, and if within [***] of such offer, Strata informs Micrologix that
it is prepared to enter into an agreement with Micrologix in accordance with such
terms, Micrologix shall conclude such agreement with Strata upon such terms. If no
such statement is made by Strata within said [***], Micrologix shall be free to enter
into an agreement in accordance with such terms with a Third Party. |
ARTICLE 4
ADDITIONAL PAYMENTS
Section 4.1 License Fee.
|
(a) |
|
Upfront Payment to Micrologix. In partial consideration for the licenses
granted under Section 3.1, Strata shall pay to Micrologix a one-time, non-refundable
license fee equal to One and One Half Million Dollars ($1,500,000) one business day
after the Effective Date by wire transfer of immediately available funds to an account
designated in writing by Micrologix to Strata prior |
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*** |
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to the Effective Date (the Upfront Fee). Strata may deduct the Exclusivity Fee
from the Upfront Fee. |
|
(b) |
|
Upfront Equity Investment in Micrologix. Strata shall purchase from Micrologix
on the Effective Date such number of Common Shares as equals Five Hundred Thousand
Dollars ($500,000), based on the Market Price plus a [***] ([***]) premium, and as issued pursuant to a separate stock purchase agreement. |
Section 4.2 Product Milestone Payments.
Strata shall pay to Micrologix, as licensing fees, the following non-refundable milestone payments
as follows:
|
(a) |
|
for milestones referred to in Section 4.3 and Section 4.4, |
|
(i) |
|
if Strata can make the payment respecting such milestone within
45 days of the date on which Strata receives a copy of the applicable letter or
notice from the FDA in the U.S. or from a foreign equivalent in the Territory,
Strata shall pay to Micrologix such milestone within [***] of achieving such
milestone; |
|
|
(ii) |
|
if Strata cannot make the payment respecting such milestone
within [***] of the date on which Strata receives a copy of the applicable
letter or notice from the FDA in the U.S. or from a foreign equivalent in the
Territory, Strata shall: |
|
(A) |
|
within [***] of achieving such milestone,
notify Micrologix in writing that it cannot make the payment respecting
such milestone; and |
|
|
(B) |
|
provided that Micrologix receives such notice
within the period for the receipt of same, Strata shall pay to
Micrologix such milestone within [***] of achieving such milestone,
[***]. |
|
(b) |
|
for milestones referred to in Section 4.5, [***] after Strata receives a copy
of the applicable letter or notice from the FDA in the U.S. or from a foreign
equivalent in the Territory. |
Section 4.3 Milestones for a Second Phase III.
For NDA Filings and Marketing Authorizations for either LCSI or CRBSI based upon a second Phase III
trial, the following milestones shall apply:
|
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*** |
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Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions. |
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[***]
Section 4.4 Milestones for the First Phase III.
For an NDA Filing and Marketing Authorization for CRBSI based upon the First Phase III Study, the
following milestones shall apply; provided however that notwithstanding anything in this Agreement
to the contrary, the milestone for receipt of [***] in the United States in this Section 4.4 shall
only be payable when the milestone for [***] in the United States in this Section 4.4 becomes
payable:
[***]
The CRBSI milestones set forth in Section 4.3 and Section 4.4 regarding the CRBSI indication in the
United States are alternative milestones and as such only one milestone shall be due and payable
for [***] and [***], as applicable, under Section 4.3 and Section 4.4, but not both.
Section 4.5 Burns or Surgical Infections milestones.
For Marketing Authorizations for burns or surgical infection indications, the following milestones
shall apply:
[***]
Section 4.6 Commercial Milestone Payments.
Strata shall pay to Micrologix, as additional licensing fees, the following one-time,
non-refundable milestone payments within [***] following the end of the calendar quarter in which the relevant
commercial milestone is achieved.
[***]
Section 4.7 Royalties.
|
(a) |
|
Royalty Payment. During the Royalty Term, Strata shall owe and pay to
Micrologix the following royalties on Net Sales: |
|
(i) |
|
[***]% of Net Sales, on aggregate Net Sales in each calendar
year which does not exceed [***] ($[***]); |
|
|
(ii) |
|
[***]% of Net Sales, on aggregate Net Sales in each calendar
year which is greater than [***] ($[***]) but does not exceed [***] ($[***]);
and |
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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|
(iii) |
|
[***]% of Net Sales, on aggregate Net Sales in each calendar year which
is greater than [***]($[***]). |
|
(b) |
|
Reductions in Royalty Rates. Stratas royalty obligation under Section 4.7(a)
shall be [***] in the manner herein described: |
|
(i) |
|
In the event (and for the period that) a non-proprietary
version or versions of the Product enters the market in a country in the
Territory in any calendar quarter during the Term, [***]. For the purposes of
this Section, non-proprietary means a product containing the amino acid
sequence [***] for use in the Field which does not infringe a Valid Claim. The
[***] shall be effective beginning on the first calendar quarter of the launch
of such generic product. The royalty rate shall be adjusted quarterly and
shall be reconciled quarterly at such time as the applicable IMS Data has been
made available to Strata. |
|
|
(ii) |
|
Any such [***] in Section 4.7(b)(i) shall be credited against
the next payment(s) owed Micrologix. [***]. |
|
(c) |
|
Certain Recoveries. If Micrologix owes Strata Micrologixs share of the Costs
pursuant to Section 7.3, Section 7.4 or Section 10.4, Strata shall recover such amounts
[***]. The Parties acknowledge and agree that the maximum amount of any such [***]
in accordance with Section 7.3, Section 7.4 and Section 10.4 from any royalty payments
due Micrologix hereunder in a given quarter shall not exceed [***] of the royalty
payment owed in such quarter (the [***]). Any amounts in excess of [***] for any
quarter(s) shall be [***] against subsequent quarterly royalty payments owed to
Micrologix, subject to the [***] limitation for any such subsequent quarter, [***]. |
|
|
(d) |
|
After Royalty Term. After the expiration of the Royalty Term in any relevant
country, Strata shall have no further obligation to pay royalties to Micrologix in such
country. |
|
|
(e) |
|
Payment of Royalties and Reports. Within [***] of the end of each calendar
quarter following the First Commercial Sale, Strata shall provide Micrologix with a
written report, in a form to be agreed between the parties, acting reasonably,
accompanied by full payment of all royalties accrued and owing to Micrologix during
such quarter, of: (i) Net Sales during such quarter and cumulative Net Sales for the
current calendar year; (ii) deductions from Net Sales; (iii) withholding taxes, if any,
required by Applicable Laws to be deducted with
respect to such sales; (iv) the dates of the First Commercial Sale of the Product in
any country in the Territory during the reporting period; (v) the exchange rates, if
any used to determine the amount of United States dollars; and (vi) the calculation |
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*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
- 26 -
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of the royalties owed (collectively, the Royalty Statement). The Royalty
Statement shall be in reasonably specific detail, on a country-by-country basis, and
segmented according to sales by Strata, each Affiliate and each sublicensee. |
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(f) |
|
Exchange Rate; Manner and Place of Payment. All payments hereunder shall be
payable in United States dollars. With respect to each month in each calendar quarter,
whenever conversion of payments from any foreign currency shall be required, such
conversion shall be made at the rate of exchange reported in The Wall Street Journal on
the last business day of such month within the applicable calendar quarter. All
payments owed under this Agreement shall be made by wire transfer to a bank account
designated in writing by the receiving Party. |
|
|
(g) |
|
Late Payments. In the event that any payments due hereunder are not made when
due, each such payment shall accrue interest from the date due until paid at the Prime
Rate of Interest. The payment of such interest shall not limit or otherwise be deemed
to be in satisfaction of a Party exercising any other rights it may have under this
Agreement arising from the other Partys failure to make such payment when due. |
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(h) |
|
Taxes. All taxes levied on account of the payments accruing to either Party
(the Receiving Party) under this Agreement shall be paid by the Receiving Party for
its own account, including taxes levied thereon as income to the Receiving Party. If
provision is made under Applicable Laws for withholding, such tax shall be deducted
from the payment made by the other Party paid to the proper taxing authority and a
receipt of payment of the tax secured and promptly delivered to the Receiving Party,
provided that it is understood that if this Agreement is assigned by Strata, Micrologix
should be no worse off than if this Agreement was made and remained with a United
States company and the payments to Micrologix were made from the United States to
Canada. Each Party agrees to assist the other Party in claiming exemption from such
deductions or withholdings under any double taxation or similar agreement or treaty
from time to time in force. |
|
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(i) |
|
Prohibited Payments. Notwithstanding any other provision of this Agreement, if
either Party is prevented from paying any payments by virtue of the Applicable Laws of
the country from which the payment is to be made, then such payment may be paid by
depositing funds in the currency in which it accrued to the Receiving Partys account
in a bank acceptable to the Receiving Party in the country whose currency is involved. |
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(j) |
|
Non-Monetary Consideration. In the event Strata, its sublicensee(s) or its
Affiliate(s) receive any non-monetary consideration in connection with the sale of the
Product, the Net Sales of such Product shall be calculated based on the fair market
value of such other consideration. Strata shall disclose the terms of such
arrangement to Micrologix and the Parties shall endeavour in good faith to agree on
such fair market value as promptly as possible. |
- 27 -
|
(k) |
|
Manufacturing Development Costs. Strata shall recover Manufacturing
Development Costs owed by Micrologix pursuant to Section 5.3(f) [***]. |
ARTICLE 5
COMMERCIALIZATION OF THE PRODUCT
Section 5.1 Marketing Efforts.
|
(a) |
|
Subject to Section 2.4(a) and Section 5.3(f), Strata shall: (i) have the
exclusive right, at its cost, to make, manufacture, market, advertise, promote, sell,
distribute, and commercialize the Product in the Field in the Territory; (ii) be solely
responsible using Commercially Reasonable Efforts, for the making, manufacture,
marketing, advertising promotion, sale, distribution and commercialization of the
Product in the Field in the Territory; and (iii) have the sole responsibility and
decision making authority using Commercially Reasonable Efforts with regard to any and
all aspects of the making, manufacturing, marketing, advertising, promotion, sale,
distribution and commercialization of the Product in the Field in the Territory,
including all Labelling, marketing plans, marketing strategy, pricing decisions, and
the nature and type of advertising and marketing materials, including all Promotional
Materials. |
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(b) |
|
Subject to the terms of this Agreement, Strata agrees to: (i) use Commercially
Reasonable Efforts to market, advertise, promote, sell, distribute, and commercialize
the Product in the Field in the Territory; and (ii) commence commercial sales of the
Product in each country in the Territory within six (6) months after receiving a copy
of each of the relevant Marketing Authorization. |
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(c) |
|
Strata shall promptly advise Micrologix of any issues of which Strata becomes
aware that materially and adversely affect Stratas ability to market or sell the
Product in the Territory. In such event, senior executives of Strata and Micrologix
shall meet and in good faith discuss what actions should be taken in light of such
issues. If the Parties cannot resolve any such issue, either Party may invoke the
dispute resolution procedure in Article 14. |
|
|
(d) |
|
Strata shall provide Micrologix prompt notice of the following events during
the Term: (i) the First Commercial Sale of Product in each country in the Territory,
if and when such occurrence takes place; and (ii) when any milestone referred to in
Section 4.3, Section 4.4, Section 4.5, or Section 4.6 has occurred. |
Section 5.2 Marketing Update.
|
(a) |
|
Following receipt of an Approval Letter from the FDA for the Product or an
equivalent letter from a Competent Authority, Strata shall provide Micrologix on |
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*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
- 28 -
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|
an annual basis during the Term, through the JDMC or otherwise, with reports in reasonable
detail describing Stratas material marketing efforts with respect to the Product in
the Territory during the preceding year and forecasts and plans for such efforts for
the following year. |
|
|
(b) |
|
Strata agrees to consider Micrologixs input and comments that Micrologix may
provide related to any such report for any applicable period; provided, however, Strata
shall have the right to either accept or reject such input and/or comments in whole or
in part in Stratas sole discretion for any reason whatsoever, and Strata shall have
the final and sole right and responsibility and decision-making authority for all
matters related to any such report(s). |
Section 5.3 Manufacturing.
|
(a) |
|
Unless Strata is prevented, restricted, interfered with or delayed in making
such sales by reason of: (i) Force Majeure; or (ii) otherwise due to any breach of this
Agreement by Micrologix; Strata shall use Commercially Reasonable Efforts to: |
|
(i) |
|
identify, select, qualify, and enter into definitive
agreement(s) with Third Party(ies) to: |
|
(A) |
|
manufacture commercial supplies of the Product
for use in the Field in the Territory; and |
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(B) |
|
supply raw materials and components for such
commercial supply, including the Compound; and |
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|
(C) |
|
conduct manufacturing and process development
activities, including manufacturing scale up and start up process
development, and analytical and quality assurance and control method
development, and activities related to the foregoing, for the Compound;
and |
|
|
(D) |
|
conduct manufacturing and process development
activities, including manufacturing scale up and start up process
development, and analytical and quality assurance and control method
development, and activities related to the foregoing, for the Product
(excluding the Compound) for use in the Field in the Territory; and |
|
(ii) |
|
manufacture or have manufactured adequate supplies of the
Product for use in the Field in the Territory. |
|
(b) |
|
Strata shall use its Commercially Reasonable Efforts to resolve any shelf-life,
regulatory and other manufacturing issues respecting the Product. |
|
|
(c) |
|
Strata agrees that: (i) Micrologix and its Representatives shall be entitled to
contract directly with any Third Party with whom Strata has entered into such |
- 29 -
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|
|
definitive agreement(s) under Section 5.3(a) and (ii) such definitive agreement(s)
shall not contain any contractual provision that would prohibit Micrologix and its
Representatives from contracting directly or otherwise having access to any such Third
Party(ies) as part of either manufacturing any product for use outside the Territory or
any product for use inside the Territory, but outside the Field. Strata further agrees
that, if there is any Strata Intellectual Property developed by Strata or such Third
Party(ies) in the course of the activities described in Section 5.3(a), Micrologix
shall have a non-exclusive, royalty free license to use such Strata Intellectual
Property as part of either manufacturing any product for use outside the Territory or
any product for use inside the Territory, but outside the Field. Strata will use
Commercially Reasonable Efforts not to limit or restrict Stratas ability to grant
Micrologix such license as provided for herein without violating the terms of any
agreement or other arrangement with any such Third Party. The Parties acknowledge that
if Strata is required to pay material license fees or royalties to any such Third
Party(ies) in order to grant Micrologix such license to use the Strata Intellectual
Property, then Strata shall in a timely fashion offer to Micrologix in writing a
license or sublicense to such Strata Intellectual Property. Within a reasonable period
of time (but not to exceed [***] after receipt of Stratas offer), Micrologix
shall either accept the license or sublicense of same and pay to Strata the amount of
such material licensing fees or royalties, or advise Strata that Micrologix does not
wish to obtain such rights. |
|
|
(d) |
|
In the event that: |
|
(i) |
|
Strata, using Commercially Reasonable Efforts, fails to obtain
the ability to grant a license or sublicense as provided for in Section 5.3(c)
without violating the terms of any such agreement or other arrangement, then
Strata shall have no obligation to grant such license to Micrologix under
Section 5.3(c); or |
|
|
(ii) |
|
Micrologix advises Strata that Micrologix does not wish to
obtain the rights referred to in Section 5.3(c), or if Micrologix fails to
notify Strata within a reasonable period of time (not to exceed [***] as noted
above) that it accepts such license or sublicense, then Strata shall have no
obligation to grant such license or sublicense to Micrologix under Section
5.3(c); or |
|
|
(iii) |
|
Micrologix advises Strata that Micrologix does wish to obtain
the rights referred to in Section 5.3(c) within a reasonable period of time
(not to exceed [***] as noted above) and pays such licensing fees or royalties
then Strata shall be deemed to have granted such license or sublicense to
Micrologix under Section 5.3(c) without further formality. |
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
- 30 -
|
(e) |
|
If Strata manufactures the Product itself, rather than through Third Part(ies),
Strata will provide reasonable technical assistance, at Micrologixs cost and expense
to provide Micrologix and its Representatives the technology and Know How necessary to
permit Micrologix or its Representatives to manufacture or have manufactured any
product for use outside the Territory or any product for use inside the Territory, but
outside the Field. |
|
|
(f) |
|
Strata and Micrologix shall share in the manufacturing development costs for
the Compound. Strata shall recover such costs from Micrologix as set forth in Section
4.7(k) for [***] of Stratas documented out-of-pocket costs of conducting the
activities set out in Section 5.3(a)(i)(C) up to a maximum of [***] (the Manufacturing
Development Costs). |
|
|
(g) |
|
Transfer of Micrologix Compound and Product Inventory. |
|
(i) |
|
Subject to Section 5.3(g)(vi), at the request of Strata, such
request to be made within six (6) months after the Effective Date, Micrologix
shall make available to Strata at Micrologixs documented out-of-pocket cost,
all or any part of Micrologixs inventory of MBI 226 GMP Inventory as set
out in Exhibit C conforming to the specifications mutually agreed upon by the
Parties to the extent such inventory has not been used or dedicated for use by
Micrologix for other purposes. |
|
|
(ii) |
|
Subject to Section 5.3(g)(vi), at the request of Strata, such
request to be made within six (6) months after the Effective Date, Micrologix
shall make available to Strata at [***] of
Micrologixs documented out-of-pocket cost, all or any part of Micrologixs
inventory of MBI 266 Reference Standard as set out in Exhibit C to the
extent such inventory has not been used or dedicated for use by Micrologix for
other purposes. |
|
|
(iii) |
|
At the request(s) of Strata, such request(s) to be made within
twelve (12) months after the Effective Date, Micrologix shall make available to
Strata at [***] of Micrologixs documented out-of-pocket cost, all or any part
of Micrologixs inventory of MBI 226 non-GMP Inventory, all for use as
contemplated hereunder, as set out in Exhibit C. |
|
|
(iv) |
|
As soon as practical, and in any event before the expiry of
three (3) months from after the Effective Date, Micrologix shall transfer to
Strata at [***], all of Micrologixs inventory of MBI 266 1.0% Gel Inventory,
on an as is basis, all for use as contemplated hereunder, as set out in
Exhibit C. |
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
- 31 -
|
(v) |
|
Pursuant to Micrologix making Compound available to Strata in
Section 5.3(g)(i), Micrologix shall cause its Representative to release or
re-release such Compound to Strata with all release documentation including all
certificates of analyses confirming the identity, strength, quality and purity
of the lots of Compound, certificates of compliance confirming that the same
lots of Compound were manufactured, tested, stored and supplied in compliance
with cGMPs and all Applicable Laws, each such certificate signed by an
authorized signatory of Micrologixs Representative, any deviation or
discrepancy reports pertaining to Compound relating to deviations that may
require reporting to the FDA, and all such other documentation and information
as is reasonably required by Strata. |
|
|
(vi) |
|
With respect to the inventories that are made available by
Micrologix pursuant to Section 5.3(g)(i) and Section 5.3(g)(ii), until the
expiry of three (3) months from the Effective Date, Micrologix will not use or
dedicate for use any of such inventory. Thereafter, until the expiry of six (6)
months from the Effective Date, Micrologix will not use or dedicate for use any
of such inventory without first giving Strata ten (10) days prior written
notice of same. If Strata gives notice in writing within such period of its
intention to purchase such inventory, Micrologix shall sell such inventory to
Strata and same shall not be used or dedicated for use by Micrologix. If Strata
gives notice in writing within such period that it does not intend to purchase
such inventory, or if Strata fails to give notice within such period,
Micrologix may use or dedicate such inventory, and same shall not be sold to
Strata. |
|
(h) |
|
Co-negotiation for Commercial Supply of the Compound. In the event that both
Parties require commercial supplies of the Compound and it is in the best interests of
each Party to obtain a single source of supply for both Parties, the Parties
acknowledge that they intend to approach jointly and co-negotiate with Third Party
suppliers for the manufacture of commercial supplies of the Compound. Any such
co-negotiation shall be under the oversight of the JDMC. The Parties acknowledge and
agree that any benefits from any economies of scale recognized from such co-negotiation
for commercial supplies of the Compound shall be shared by the Parties. Nothing in this
Section will oblige either Party to enter into any agreement with any Third Party, or
restrict either Partys ability to enter into any agreement with a Third Party without
the other Party. |
Section 5.4 Patent Marking.
Each Party shall use Commercially Reasonable Efforts to ensure that where permissible under
Applicable Law(s) and provided there is adequate space available on any such packaging, such Party
shall identify by number any applicable Micrologix Patent Rights and applicable patent rights
within the Strata Intellectual Property with any reasonable patent marking notification(s).
- 32 -
ARTICLE 6
REGULATORY COMPLIANCE
Section 6.1 Ownership and Maintenance of Governmental Approvals.
|
(a) |
|
Strata will own all Marketing Authorizations for each country in the Territory
for use in the Field. Without limiting the generality of the foregoing, Strata shall
prepare and submit in its own name and at its expense the NDA with the FDA in the U.S.
and any other equivalent application with the Competent Authorities in other countries
in the Territory. Without acting as a limitation to any other provision under this
Agreement, Strata shall maintain a current and valid DMF on the Compound and the
Product, whether as an independent document or as part of the NDA, which it shall keep
up to date at all times during the Term and shall cause any Subcontractor to similarly
maintain the same or grant the Subcontractor reference rights to Stratas DMF for the
Product. |
|
|
(b) |
|
Other than those required to be maintained by Micrologix under Section 6.7(b),
Strata shall secure and maintain in good standing, at its sole cost and expense, any
and all Governmental Approvals (including, Marketing Authorizations, licenses, permits
and consents, facility licenses and permits required by Applicable Laws or by the
applicable Competent Authorities) necessary and/or required for Strata to perform its
obligations under this Agreement and use Commercially Reasonable Efforts at its cost
and expense to secure and maintain any variations and renewals thereof. |
|
|
(c) |
|
Excluding Marketing Authorizations and subject to Section 6.7(b), Micrologix
shall secure and maintain, at its sole cost and expense, any and all Governmental
Approvals (including, licenses, permits and consents, facility licenses and permits
required by Applicable Laws or by the applicable Competent Authorities) necessary
and/or required for Micrologix to perform its obligations under this Agreement and any
Development Subcontract and use Commercially Reasonable Efforts, at its cost and
expense to secure and maintain any variations or renewals thereof. |
Section 6.2 Rights of Reference.
|
(a) |
|
For the Products in the Field in the Territory, Micrologix shall grant and
hereby grants to Strata and its Representatives (subject to the terms of Section 3.5),
a free-of-charge right to reference and use and have full access to all Governmental
Approvals and all other regulatory documents owned or Controlled by Micrologix to the
extent relating to the Compound, the Product, and MBI 594AN, including
any IND, any NDA and any DMF (whether as an independent document or as part of any
NDA, and all chemistry, manufacturing and controls information), and any
supplements, amendments or updates to the foregoing. |
|
|
(b) |
|
For use outside the Territory, or for any Product for use inside the Territory
but outside the Field, Strata shall grant and hereby grants to Micrologix and its |
- 33 -
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|
|
Representatives a free-of-charge right to reference and use and have full access to all
Governmental Approvals and all regulatory documents owned or Controlled by Strata to
the extent relating to the Compound or the Product, including any NDA and DMF (whether
as an independent document or as part of any NDA, and all chemistry, manufacturing and
controls information), and any supplements, amendments or updates to the foregoing. |
|
|
(c) |
|
For the Products in the Field in the Territory, Micrologix shall make
Commercially Reasonable Efforts to grant or have granted to Strata (subject to the
terms of Section 3.5), a free-of-charge right of reference and use and have full access
to all Governmental Approvals and all other regulatory documents owned or Controlled by
Fujisawa Healthcare, Inc. or by any Third Party licensee of Micrologix to the extent
related to the Compound, the Product, and MBI 594AN, including any IND, any NDA and any
DMF (whether as an independent document or as part of any NDA, and all chemistry,
manufacturing and controls information), and any supplements, amendments or updates to
the foregoing. |
|
|
(d) |
|
For use outside the Territory, or for any Product for use inside the Territory
but outside the Field, Strata shall make Commercially Reasonable Efforts to grant or
have granted to Micrologix and its Representatives a free-of-charge right of reference
and use and have full access to all Governmental Approvals and all other regulatory
documents owned or Controlled by any Third Party licensee of Strata to the extent
related to the Compound or the Product, including any IND, any NDA and any DMF (whether
as an independent document or as part of any NDA, and all chemistry, manufacturing and
controls information), and any supplements, amendments or updates to the foregoing.
Such rights of reference, use and access shall survive termination of this Agreement. |
|
|
(e) |
|
For avoidance of doubt, no transfer by a Party of Control in respect of any
Governmental Approvals or other regulatory documents referred to in this Section shall
limit the rights of the other Party to the most current version of same up to the time
of such transfer. |
Section 6.3 Adverse Drug Event Reporting and Post Marketing Surveillance.
|
(a) |
|
Each Party, on behalf of itself, its Affiliates and any permitted sublicensees,
shall advise the other Party, by telephone or facsimile, promptly but in no event later
than seventy-two (72) hours or such shorter time period as may be required by a
Competent Authority after a Party, its Affiliates and/or sublicensees becomes aware of
any serious adverse drug event (as defined in 21 CFR Section 312.32(a) or its
equivalent under Applicable Law(s) as the same may be amended,
supplemented or replaced from time to time) (a SADE) involving the Product or the
Compound. Such advising Party shall provide the other Party with a written report
delivered by confirmed facsimile of any SADE, stating the full facts known to such
Party, including customer name, address, telephone number, batch, lot and serial
numbers, and other information as required by Applicable Laws. After receipt by the
Parties of an Approval Letter in any country, Strata |
- 34 -
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|
|
shall have full responsibility
in such country for: (i) monitoring such SADEs; (ii) data collection activities that
occur between Strata and the patient or medical professional, as appropriate,
including any follow-up inquiries which Strata deems necessary or appropriate; and
(iii) meeting the requirements of the Competent Authorities, including the
submission of SADE individual reports and periodic reports as necessary. As the
holder of the Marketing Authorizations, any reporting (and follow-up thereto) to the
Competent Authorities relating to the Compound and the Product in the Field in the
Territory shall remain the responsibility of Strata. |
|
|
(b) |
|
In the event either Party requires information regarding SADEs with respect to
reports required to be filed by it in order to comply with Applicable Laws, including
obligations to report SADEs to the Competent Authorities, each Party agrees to provide
such information to the other in sufficient time to enable each Party to report such
SADEs to the Competent Authorities in accordance with Applicable Laws. |
|
|
(c) |
|
If the report of an SADE causes a Competent Authority to request a Labelling
revision and/or any other corrective action, or if Strata believes it is necessary to
have a Labelling revision or conduct a post marketing surveillance program as a result
of an SADE, then Strata shall determine all of the material terms and conditions of
such Labelling revision, corrective action or post marketing surveillance program in
consultation with the applicable Competent Authority. Upon Stratas request, Micrologix
will cooperate with Strata with respect to any of the foregoing. The costs of such
Labelling revision, corrective action or post marketing surveillance program shall be
borne one hundred percent (100%) by Strata. Notwithstanding the foregoing, however,
the Parties agree that if any such Labelling revision or corrective action or post
marketing surveillance program is due to the negligence or willful misconduct in the
conduct by Micrologix and/or its Representatives of the pre-clinical and clinical
research and development activities in connection with the Product prior to and after
the Effective Date, then, in such event, the costs of any such Labelling revision,
corrective action, or post marketing surveillance program, as the case may be, shall be
borne one hundred percent (100%) by Micrologix. Subject to Section 5.3 and Section 6.2,
the Parties agree that Strata shall own the results and underlying data from any Phase
IV Study. |
|
|
(d) |
|
Within thirty (30) days of the filing of each report with the FDA on drug
related adverse events associated with the Compound as may be required under Applicable
Laws, each Party will provide to the other Party particulars of such adverse events. |
- 35 -
Section 6.4 Post Marketing Commitments.If the FDA or other Competent Authority requires a Post Marketing
Commitment for the Product, then Strata shall use Commercially Reasonable Efforts to implement such
Post Marketing Commitment at Stratas expense.
Section 6.5 Assistance.
Each Party shall provide reasonable assistance to the other at the others request, in connection
with their obligations pursuant to this Article 6, the requesting Party shall reimburse all of the
other Partys reasonable documented out-of-pocket costs of such assistance, subject to the
allocation of costs determined pursuant to this Article 6.
Section 6.6 Compliance.
Subject to the other terms and conditions of this Agreement, the Parties agree to the following
general compliance provisions:
|
(a) |
|
Strata shall be responsible for compliance in all material respects with
Applicable Laws and the Governmental Approvals relating to its activities under the
Development, the making, manufacturing, marketing, advertising, promoting, selling,
distributing, and commercializing the Product, including the maintenance of the
Marketing Authorizations and other requirements of a Competent Authority applicable
thereto, obtaining and holding all necessary permits and any other requirements
relating to its activities under the Development, the making, manufacture, import,
export, storage, sale and distribution of the Product. Any and all Labelling, packaging
and artwork and any and all proposed change to any such Labelling, packaging and/or
artwork shall be determined by Strata, which shall have the sole right and
decision-making authority with respect thereto. Strata shall have the sole right and
decision making authority with respect to any and all advertising, sales and marketing
materials (collectively the Promotional Material(s)) and shall be responsible for all
interactions with the Competent Authorities in connection with such Promotional
Materials. Strata shall submit any required changes to the Labelling, packaging and/or
artwork to the Competent Authorities in a timely fashion at Stratas expense. |
|
|
(b) |
|
Micrologix shall be responsible for compliance in all material respects with
Applicable Laws and Governmental Approvals relating to Development to be conducted by
Micrologix pursuant to any Development Subcontract. Strata shall be responsible for
compliance in all material respects with Applicable Laws and Governmental Approvals
relating to the Development to be conducted by Strata. Each Party shall cause their
respective Subcontractors to comply with this Section 6.6(b). |
|
|
(c) |
|
As provided in this Agreement with regard to each Partys obligations
hereunder, Strata and Micrologix (as the case may be) shall each comply in all material
respects with all Applicable Laws within the Territory, including the provision of
information by Strata and Micrologix to each other necessary for Micrologix and
Strata, as the case may be, to comply with any applicable reporting requirements |
- 36 -
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|
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and Governmental Approvals required; and maintaining any and all licenses, permits and
consents necessary and/or required for complying with such Partys obligations under
this Agreement. During the Term, each Party agrees to execute and deliver to the
other Party any certifications that may be required by Applicable Laws, including
any debarment certification. |
|
|
(d) |
|
Each Party shall promptly notify the other Party of any written or oral notices
received from, or inspections by, the FDA, or other Competent Authority, which
materially impact the Product, the Development and/or the Marketing Authorizations, and
shall promptly inform the other Party of any responses to such written notices or
inspections and the resolution of any issue raised by the FDA or other Competent
Authority. |
Section 6.7 General Regulatory Matters.
|
(a) |
|
Subject to Micrologixs obligations under Section 6.7(b) and Applicable Laws
during the period in which it is the IND holder, Strata shall have all regulatory
responsibility with respect to and relative to the Product and has the sole right and
decision making authority with respect to all such regulatory matters, including
without limitation reaching agreement on all regulatory matters with the FDA and/or any
other Competent Authority. |
|
|
(b) |
|
The Parties acknowledge that Micrologix, as of the Effective Date, owns and
holds certain Governmental Approvals in connection with the research and development of
the Product, including without limitation the IND listed in Exhibit D. Micrologix
shall be responsible for the filing and maintenance in good standing of all such
Governmental Approvals, with costs and expenses associated therewith to be included in
Reimbursable Costs. During the time that Micrologix is the holder of the IND,
Micrologix shall comply with all Applicable Laws applicable to the holder of the IND,
including, without limitation, process, track and report all IND Safety Reports (as
defined by the FDA). Upon Stratas request, such request to be made as soon as
reasonably possible, Micrologix shall transfer to Strata, without any additional
consideration, those Governmental Approvals (including without limitation the IND)
requested by Strata. |
|
|
(c) |
|
During the time that Micrologix is the holder of such Governmental Approvals,
Strata shall be entitled to attend any and all meetings and participate in telephone
calls with the Competent Authorities, including without limitation any meeting
preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the
FDA. During such time as Micrologix is the holder of such Governmental Approvals,
subject to Micrologixs obligations under Section 6.7(b) and Applicable Laws during the
period of time in which it is the IND holder: |
|
(i) |
|
Strata has the sole right and decision making authority for all
regulatory matters with respect to or relative to the Product. |
- 37 -
|
(ii) |
|
While it is still the holder of the IND in the United States,
Micrologix shall give Strata no less than three (3) business days notice
following the scheduling of any such meeting and/or telephone call with the FDA
and/or other Competent Authority (or such shorter period of time, if the
meeting and/or telephone call is scheduled within such three (3) business days
and in such event such notice shall be in sufficient time so that Strata shall
be able to attend and/or participate in such meeting and/or telephone call). |
|
|
(iii) |
|
Micrologix shall provide Strata copies of any materials
relating to any regulatory matter prior to their presentation to the FDA or
other Competent Authority during the Development, so that Strata shall have an
opportunity to review and comment thereon. |
|
|
(iv) |
|
The JDMC shall approve all such materials prior to
presentation. |
ARTICLE 7
PATENTS
Section 7.1 Maintenance of Patents or Marks.
|
(a) |
|
Micrologix shall, at Micrologixs expense and on a timely basis in each country
in the Territory: (i) use Commercially Reasonable Efforts to obtain Micrologix Patent
Rights in all countries in the Territory; (ii) pay all fees and file all documentation
and other materials required by any Competent Authority in each applicable country to
maintain and/or renew Micrologix Patent Rights; and (iii) shall use Commercially
Reasonable Efforts to otherwise maintain the Micrologix Patent Rights in all countries
in which Strata has the right and elects to exercise any or all of its rights hereunder
related to the Product; provided however, that upon written request by Micrologix,
Strata shall, at no cost or expense to Strata, provide such reasonable assistance as
may be necessary to enable Micrologix to comply with the administrative formalities
necessary to register or maintain any Micrologix Patent Rights. |
|
|
(b) |
|
In the event Micrologix intends to abandon the prosecution or maintenance of
all or any part of Micrologix Patent Rights claiming the Product or the Compound (which
it shall only be permitted to do in the event it has a bona fide belief that obtaining
or maintaining rights are not possible using Commercially Reasonable Efforts),
Micrologix shall notify Strata no less than [***] (or such shorter period of time
if there is a shorter period of time required by a Competent Authority) prior to the
date it intends to abandon the prosecution or maintenance, as applicable, of any such
Micrologix Patent Rights. |
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|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
- 38 -
|
(c) |
|
In the event Micrologix notifies Strata within the period provided in Section
7.1(b), Strata has the right but not the obligation to assume such prosecution and/or
maintenance and shall notify Micrologix if, and when, Strata wishes to assume the
responsibility for prosecuting and maintaining such Micrologix Patent Rights, as
applicable, whereupon Micrologix shall permit Strata, at Stratas expense, to take over
such prosecution and/or maintenance, as applicable, and Micrologix shall cooperate in
any such transfer of responsibilities and rights as necessary or prudent for the
benefit of Strata to prosecute and/or maintain the foregoing rights. Thereafter,
Strata shall have the right but not the obligation to prosecute or maintain any such
Micrologix Patent Right, as the case may be, at its expense; provided that Strata keep
Micrologix reasonably informed of the progress of any such prosecution. Micrologix
shall have the right to review all such pending applications and other proceedings and
make recommendations to Strata concerning them and their conduct, but the final
decision with respect thereto shall rest with Strata, provided that Strata acts
reasonably. |
|
|
(d) |
|
Each Party shall make available to the other Party or its authorized attorneys,
agents or representatives, its employees, agents or consultants necessary or
appropriate to enable the other Party to file, prosecute and maintain its patent
applications covering the Product for a reasonable period of time sufficient for the
other Party to obtain the assistance it needs from such personnel. Micrologix shall
provide Strata with copies of all material correspondence, documentation and/or
submissions provided to, and received from, U.S. PTO and comparable Competent
Authorities that may materially affect Stratas rights under this Agreement. |
Section 7.2 Cooperation and Procedures Relative to Actions Brought Under Section 7.3 and
Section 7.4.
|
(a) |
|
The Parties shall reasonably cooperate with each other with respect to any
litigation, action, suit, claim or other proceeding under Section 7.3 or Section 7.4
(an Article 7 Proceeding). Without limiting the generality of the foregoing, the
Non-Litigating Party (as hereinafter defined) agrees to cooperate reasonably in any
Article 7 Proceeding, as may be requested by or necessary to the Litigating Party (as
hereinafter defined) including, joining any Article 7 Proceeding as a party, executing
all necessary documents, supplying essential documentary evidence and making available
essential witnesses then in its employment or engaged as a consultant. |
|
|
(b) |
|
The Party prosecuting any Article 7 Proceeding under Section 7.3 or controlling
the defence of any Article 7 Proceeding under Section 7.4 shall be referred to in this
context, as the Litigating Party). The other Party in this context shall be referred
to as the Non-Litigating Party. Except as provided in Section 7.2(e) or Section
7.4(b), the Litigating Party shall have the right to control any Article 7 Proceeding.
In addition, the Litigating Party shall have the right to control the settlement or
compromise of any Article 7 Proceeding and may so settle or compromise without the
Non-Litigating Partys prior written consent, provided |
- 39 -
|
|
|
that the terms of any such settlement or compromise: (i) does not materially impair
the Non-Litigating Partys rights hereunder (including each Partys rights in the
Micrologix Technology or the validity or enforceability thereof); (ii) would not
require the Non-Litigating Party to be subject to an injunction or to make a
monetary payment or would restrict the claims in or admit any invalidity or
unenforceability of the Micrologix Patent Rights; (iii) provide for the
unconditional release of the Non-Litigating Party; and (iv) expressly state that
neither the fact of settlement, nor the settlement agreement shall constitute or be
construed or interpreted, as, an admission by the Non-Litigating Party of any issue,
fact, allegation or any other aspect of the claim being settled. In all other cases,
the Litigating Party may not settle any Article 7 Proceeding without the prior
written consent of the Non-Litigating Party, which consent shall not be unreasonably
withheld or delayed. The Non-Litigating Party may not pay or voluntarily permit the
determination of any liability which is subject to any such Article 7 Proceeding
while the Litigating Party is negotiating the settlement thereof or contesting the
matter, except with the prior written consent of the Non-Litigating Party, which
consent shall not be unreasonably withheld or delayed. |
|
|
(c) |
|
Upon learning of any actual, contemplated or threatened Article 7 Proceeding
involving any of the Micrologix Patent Rights that claims the Product or the Compound,
each Party shall promptly notify the other Party of such and shall, upon request,
provide to the other Party an assessment of the status of any such proceeding. |
|
|
(d) |
|
To the extent any cooperation provided by Micrologix hereunder requires
Micrologix to disclose information that would be deemed Micrologix Confidential
Information (other than any information which shall become the property and right of
Strata under Section 3.4), Strata shall treat such information in accordance with
Section 8.1. |
|
|
(e) |
|
The Parties acknowledge and agree that circumstances may arise in which a Party
hereto may desire to protect its interests by joining or intervening in litigation or
other proceeding involving the Micrologix Patent Rights, which proceeding has neither
been brought by that Party nor levied against that Party. Accordingly, neither Party
shall object or oppose any effort by the other Party, at its own expense, to join or
intervene in such litigation or other proceedings involving the Micrologix patent
Rights. In the event the Non-Litigating Party seeks to join or intervene in any
litigation or other proceeding where such joining or intervention is neither requested
by nor necessary to the Litigating Party, then (i) the Litigating Partys right to
control the litigation under Section 7.3 or Section 7.4 (as the case may be) shall not
be extended to the conduct of the Non-Litigating Party after intervention or joining;
and (ii) notwithstanding anything to the contrary contained in Section 7.3 and Section
7.4, the Non-Litigating Party shall bear its own costs associated with its involvement
in any such litigation or other proceeding after intervening or joining. |
- 40 -
Section 7.3 Prosecution of Infringement.
|
(a) |
|
During the Term, each Party shall give prompt notice to the other of any Third
Party act which may infringe one or more claims of the Micrologix Patent Rights that
claims the Product or the Compound. |
|
(b) |
|
Infringement within the Field. |
|
(i) |
|
Strata may (but shall have no obligation to do so) prosecute
any Article 7 Proceeding under this Section 7.3 against such Third Party
infringement of any claims of Micrologix Patent Rights where such infringement
primarily relates to such Third Party activities in the Field in the Territory
in accordance with the terms of Section 7.2 and this Section 7.3 and in such
event Strata shall become the Litigating Party. |
|
|
(ii) |
|
In the event Strata fails to institute any Article 7 Proceeding
and terminate any Third Party infringement of the claims of Micrologix Patent
Rights that the claim the Product or the Compound within thirty (30) days of
the later of: (i) receiving notification from Micrologix of any such
infringement or (ii) sending notice to Micrologix of such action, Micrologix
may take (but shall have no obligation to do so) such action as it deems
appropriate, including the filing of a lawsuit against such Third Party. In
such event Micrologix shall promptly notify Strata of any such Article 7
Proceeding and shall become the Litigating Party. |
(c) Infringement outside the Field.
|
(i) |
|
Micrologix may (but shall have no obligation to do so)
prosecute any Article 7 Proceeding under this Section 7.3 against such Third
Party infringement of any claims of Micrologix Patent Rights where such
infringement does not primarily relate to such Third Party activities in the
Field in the Territory in accordance with the terms of Section 7.2 and this
Section 7.3 and in such event Micrologix shall become the Litigating Party. |
|
|
(ii) |
|
In the event Micrologix fails to institute any Article 7
Proceeding and terminate any Third Party infringement of the claims of
Micrologix Patent Rights that claim the Product or the Compound within thirty
(30) days of the later of: (i) receiving notification from Strata of any such
infringement or (ii) sending notice to Strata of such action, Strata may take
(but shall have no obligation to do so) such action as it deems appropriate,
including the filing of a lawsuit against such Third Party. In such event
Strata shall promptly notify Micrologix of any such Article 7 Proceeding and
shall become the Litigating Party.
|
- 41 -
|
(d) |
|
Micrologix and Strata shall share all Costs in connection with any Article 7
Proceeding under this Section 7.3, on the basis of [***] % paid by the
Litigating Party and [***]% paid by the Non-Litigating Party, provided that Micrologix
and Strata shall first recover their respective actual documented out-of-pocket Costs,
or equitable proportions thereof, associated with any Article 7 Proceeding under
this Section 7.3, or settlement thereof from any recovery made by the Litigating
Party. Any excess amount recovered by the Litigating Party shall be shared between
Strata and Micrologix on the basis of [***]% to the Litigating Party and [***]% to
the Non-Litigating Party. In the event there is no recovery from a Third Party or if
any such recovery does not cover all of the Costs of the Litigating and/or
Non-Litigating Party, as the case may be, then the Parties agree to share any such
unrecovered Costs on the basis of [***]% to the Litigating Party and [***]% to the
Non-Litigating Party. If Strata is the Litigating Party, Strata shall recover such
amounts by [***]. |
Section 7.4 Infringement Claimed by Third Parties.
|
(a) |
|
In the event a Third Party commences, or threatens to commence, any Article 7
Proceeding against a Party to this Agreement alleging infringement of a Third Partys
intellectual property rights by the making, manufacture, use, sale, offer for sale,
export and/or import by Strata, its Affiliates or sublicensees of the Product, the
Party against whom such proceeding is threatened or commenced shall give prompt notice
to the other Party (Infringement Notice). |
|
|
(b) |
|
Strata shall control the defense and settlement of any such Article 7
Proceeding under this Section 7.4 in accordance with the terms of Section 7.2 and this
Section 7.4 and shall become the Litigating Party; provided that, in the event that the
validity and enforceability of the claims of Micrologix Patent Rights are in issue in
any such Article 7 Proceeding under this Section 7.4, Micrologix may (but shall have no
obligation to do so) control the defense and settlement of any such Article 7
Proceeding under this Section 7.4 in accordance with the terms of Section 7.2 and this
Section 7.4 solely to the extent that such defense and settlement relates to validity
and enforceability of the claims of the Micrologix Patent Rights. |
|
|
(c) |
|
Micrologix shall be liable for its own Costs in connection with any Article 7
Proceeding under this Section 7.4. |
Section 7.5 Co-operation with Other Licensees.
Strata acknowledges that Micrologix may grant to licensees rights in the Micrologix Technology in
the Territory in respect of fields outside the Field, and may grant to other licensees rights
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 42 -
outside the Territory. If Micrologix grants such rights to other licensees, in the event of any
litigation in respect of:
|
(a) |
|
fields outside of the Field that may reasonably affect Stratas use of the
Micrologix Technology in the Field or the use or sale of Products by Strata; or |
|
|
(b) |
|
the Field that may reasonably affect Micrologix or one or more of Micrologixs
licensees use of the Micrologix Technology outside the Field or the making,
manufacture, use or sale of products outside the Field by Micrologix or one or more
other such licensee(s); |
then Micrologix, Strata and such other licensee(s) will use good faith efforts to determine jointly
the course of action, if any, necessary or appropriate to prosecute or defend the litigation.
Micrologix will use Commercially Reasonable Efforts to include in its other license agreements,
provisions that allow the participation of Strata as contemplated herein. If Micrologix is unable
to include in any such other license agreement such provisions, then with respect to the licensee
under such other license agreement, Strata shall not be bound by the terms and conditions of this
Section 7.5.
ARTICLE 8
CONFIDENTIALITY
Section 8.1 Confidentiality.
|
(a) |
|
During the Term and for a period of five (5) years thereafter, each Party shall
maintain all Confidential Information of the other Party as confidential and shall not
disclose any such Confidential Information to any Third Party or use any such
Confidential Information for any purpose, except (i) as expressly authorized by this
Agreement or with the prior written consent of the other Party, which consent shall not
be unreasonably withheld or delayed, (ii) as required by Applicable Laws or court order
of a court of competent jurisdiction (provided that the disclosing Party shall first
notify the other Party to afford the other Party, for a period of ten (10) business
days or such lesser period as may be provided by Applicable Law, an opportunity to seek
whatever protective relief it deems appropriate, and the disclosing Party shall use
Commercially Reasonable Efforts to obtain confidential treatment of any such
information required to be disclosed), (iii) to its Representatives to accomplish the
purposes of this Agreement, so long as such Representatives are under an obligation of
confidentiality no less stringent than as set forth herein, (iv) to bona fide potential
investors and their respective advisors during financing or an acquisition, merger or
other like reorganization, so long as such investors and advisors are under an
obligation of confidentiality no less stringent than as set forth herein, except as
otherwise provided herein, and (v) as is required to exercise its rights and perform
its obligations under this Agreement, so long as the recipients of such information are
under an obligation of confidentiality no less stringent than as set forth herein.
Each Party may use such Confidential Information only to the extent required to
accomplish the purposes of this Agreement.
|
- 43 -
|
(b) |
|
Notwithstanding any provision to the contrary herein or in any confidentiality
or nondisclosure agreement between the Parties, from time to time, either Party may
disclose to bona fide potential investors and their respective advisors during
financing or an acquisition, merger or other like reorganization the following
Confidential Information: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
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|
(iii) |
|
[***]; |
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|
(iv) |
|
[***]; |
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|
(v) |
|
[***]; |
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|
(vi) |
|
[***]; |
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|
(vii) |
|
[***]; |
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|
(viii) |
|
this Agreement, in the form as redacted and filed with the SEC and available
for disclosure, as may be modified by SEC filings, press releases or other
public disclosures, or if not filed with the SEC, as executed with the
financial particulars in Article 4 redacted to the extent not publicly
disclosed; and |
|
|
(ix) |
|
such additional information and materials as may be agreed-to
by the Parties; |
all without obtaining written agreement of confidence and non-use from the
recipient. The disclosing Party remains liable to the other Party for any use or
disclosure made of such information by such investors and advisors, as if such
investors and advisors were bound by the terms of this Article 8. No information
disclosed pursuant to this Section 8.1(b) that becomes generally known or available,
directly or indirectly as a result of a disclosure permitted by this Section, shall
be excluded from the definition of Confidential Information pursuant to the
exclusion set out in Section 1.14(a).
|
(c) |
|
Each Party shall use at least the same standard of care as it uses to protect
its own Confidential Information to ensure that it and its Affiliates and
Representatives do not disclose or make any unauthorized use of the other Partys
Confidential Information. Each Party shall be responsible for any breach of this
Agreement by its Representatives. Each Party shall promptly notify the other Party
upon |
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*** |
|
Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 44 -
discovery of any unauthorized use or disclosure of the other Partys Confidential
Information.
|
(d) |
|
Micrologix acknowledges and agrees that the Micrologix Know-How licensed to
Strata has value to Strata in being maintained as confidential. Therefore, Micrologix
shall keep the Micrologix Know-How confidential as if it were Confidential Information
of Strata as set forth in this Article 8. |
Section 8.2 Publicity Review.
The Parties agree that the public announcement of the execution of this Agreement shall be in the
form of a press release to be mutually agreed upon by the Parties on or before the Effective Date
and thereafter each Party shall be entitled to make or publish any public statement consistent with
the contents thereof. Thereafter, except as allowed in the preceding sentence, the Parties will
jointly discuss and agree, based on the principles of this Section 8.2, on any statement to the
public regarding this Agreement or any aspect of this Agreement, and the results of clinical
studies conducted as part of the Development, subject in each case to disclosure otherwise required
by Applicable Laws. When a Party elects to make any such statement or disclosure required under
Applicable Law, it will give the other Party at least five (5) business days notice to review and
comment on such statement, unless the applicable Competent Authority requires disclosure such that
a Party is prohibited by Applicable Law to provide such advance review by the other Party (in which
case it shall be disclosed according to such requirement and notice will be provided as soon as
possible). The terms of this Agreement may also be disclosed to Competent Authorities, including
the United States Securities and Exchange Commission or any other exchange or securities commission
having authority over a Party, where required by Applicable Law, with redaction of financial
information not otherwise required to be disclosed under Applicable Laws in which event the
disclosing Party shall provide in advance of submission to the other Party for review and comment a
copy of such redactions made to this Agreement.
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
Section 9.1 Corporate Power.
Each Party hereby represents, warrants and covenants that such Party is, and will remain through
the Term, duly organized and validly existing under the laws of the state of its incorporation and
has full corporate power and authority to enter into this Agreement and to carry out the provisions
hereof.
Section 9.2 Due Authorization.
Each Party hereby represents and warrants that such Party is duly authorized to execute and deliver
this Agreement and covenants to perform its obligations hereunder.
- 45 -
Section 9.3 Binding Obligation/No Conflict.
Each Party hereby represents, warrants and covenants that: (i) this Agreement is a legal and valid
obligation binding upon it and is enforceable in accordance with its terms; and (ii) the execution,
delivery and performance of this Agreement by such Party does not, and will not during the Term,
conflict with any agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor to the best knowledge of each Party as of the Effective Date,
violate any Applicable Laws.
Section 9.4 Ownership of Micrologix Technology.
Micrologix represents, warrants, and covenants, as the case may be, that:
|
(a) |
|
as of the Effective Date and during the Term, it is and shall remain the sole
owner of all right, title and interest in and to the Micrologix Technology, subject to
Micrologixs ability to license and assign as permitted hereunder; and, to the best of
the knowledge of Micrologix as of the Effective Date, no Representative of Micrologix
or any Third Party has any rights to the Micrologix Technology; |
|
|
(b) |
|
as of the Effective Date, it has not granted and will not grant after the
Effective Date any license under the Micrologix Technology for any product in the
Territory for use in the Field to any Third Party, and is under no obligation to grant
any such license, except to Strata, and there are, and will be, no rights granted to
any Third Party and/or no agreements, either written or oral, regarding either the
Micrologix Technology which are inconsistent or in conflict with this Agreement; |
|
|
(c) |
|
as of the Effective Date, there are no outstanding liens, judgments,
injunctions, decrees, rulings, security interests, or other encumbrances on the
Micrologix Technology, and through the Term, there shall be no liens, judgments,
injunctions, decrees, rulings, security interests, or any other encumbrances (other
than security interests filed by Micrologixs lender(s) and licensee(s) in the ordinary
course of business) on the Micrologix Technology which could materially affect Stratas
interests in the Micrologix Technology; |
|
|
(d) |
|
as of the Effective Date and during the Term, it has taken and will take
Commercially Reasonable Efforts to ensure that all Micrologix Know-How has been and
will continue to be fully protected and maintained in accordance with appropriate
procedures for its protection; |
|
|
(e) |
|
(i) as of the Effective Date, Micrologix has made available to Strata all
material information in its possession or Control relating to the Product in the Field;
and (ii) as of the Effective Date, to the best of Micrologixs knowledge, all art that
Micrologix believes to be material to the patentability of any claims within the
Micrologix Patent Rights claiming the Product or the Compound has been cited by
Micrologix to the U.S. PTO for U.S. patent rights or to the comparable Competent
Authority in such other jurisdictions in the Territory that require disclosure of
material information in possession or Control of the patentee; and |
- 46 -
|
(f) |
|
Exhibit B is a true, complete and current listing of the Micrologix Patents
as of the Effective Date. |
Section 9.5 Patent and Other Intellectual Property Rights Proceedings.
As of the Effective Date, Micrologix represents and warrants that:
|
(a) |
|
to the best of its knowledge, no patent within the Micrologix Patent Rights, or
patent application with regard to the Micrologix Patent Rights, as the case may be, is
the subject of any pending interference, opposition, cancellation or other protest
proceeding, or judicial proceeding; |
|
|
(b) |
|
to the best of its knowledge, the Micrologix Technology and any process,
procedure or method used to manufacture the Compound and the Product do not infringe,
interfere with, or misappropriate the intellectual property rights of any Third Party; |
|
|
(c) |
|
to the best of its knowledge, the practice of the Micrologix Patent Rights and
any process, procedure or method used to manufacture the Compound and the Product in
the Territory do not and will not infringe, interfere with, or misappropriate any
intellectual property rights of any Third Party; |
|
|
(d) |
|
there has been no lapse of any claims within the Micrologix Patents in the
Territory; |
|
|
(e) |
|
Micrologix has not received any: (i) notices or communications that the
development, making, manufacture, use, marketing, advertising, promoting, distributing,
offer for sale, selling, importation or exportation of the Compound or the Product or
use of the Micrologix Technology would infringe or misappropriate any intellectual
property rights of any Third Party; or (ii) allegation regarding the legality,
enforceability, or validity of the Micrologix Technology, other than those made by the
U.S. PTO or other comparable Competent Authorities in other countries in the
prosecution of the Micrologix Patent Rights and previously disclosed to Strata; |
|
|
(f) |
|
Micrologix is not aware of any Third Party having infringed or misappropriated
the Micrologix Technology and has not sent any notices or communications to any Third
Party that the activities of such Third Party infringe or misappropriate the Micrologix
Technology. |
Section 9.6 Micrologixs Additional Warranties.
As of the Effective Date, Micrologix represents and warrants that:
|
(a) |
|
Exhibit D is a true, complete and current listing of the regulatory filings
relating to Product or Compound owned or Controlled by Micrologix as of the Effective
Date, including, all INDs; and |
- 47 -
|
(b) |
|
Micrologix has not deliberately withheld any material information or data known
to Micrologix relating to: |
|
(i) |
|
the results of preclinical and clinical studies of the Compound
and the Product conducted by or on behalf of Micrologix; |
|
|
(ii) |
|
Micrologixs ongoing clinical development activities in the
United States for the Product, including the status of all such studies; and |
|
|
(iii) |
|
the manufacturing, testing and release of the Compound and
Product, including CMC information therefor. |
Section 9.7 Stratas Additional Warranties.
As of the Effective Date, Strata represents and warrants that upon completion of transactions
related to this Agreement, which transactions are conditional only upon the execution and delivery
of this Agreement, Strata shall be entitled to receive proceeds of a financing of not less than $5
million.
Section 9.8 Pre-Clinical and Clinical Studies Prior to Effective Date.
Micrologix represents and warrants that all of the pre-clinical and clinical trials related to the
Product prior to the Effective Date have been conducted in accordance with Applicable Laws.
Section 9.9 Debarment.
During the Term, neither of the Parties shall knowingly utilize any employee, representative,
agent, assistant or associate who has been debarred by the FDA pursuant to 21 U.S.C. Section 335a
(a) or (b) of the Act in connection with any of the activities to be carried out under this
Agreement. Micrologix further represents and warrants that, as of the Effective Date, to the best
of its knowledge, none of the entities, laboratories or clinical sites participating in the
clinical studies prior to the Effective Date had been debarred at the relevant time.
Section 9.10 Limitation on Warranties.
|
(a) |
|
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT: |
|
(i) |
|
NOTHING HEREIN SHALL BE CONSTRUED AS A REPRESENTATION OR
WARRANTY BY MICROLOGIX TO STRATA THAT THE MICROLOGIX TECHNOLOGY IS NOT
INFRINGED BY ANY THIRD PARTY, OR THAT THE PRACTICE OF SUCH RIGHTS DOES NOT
INFRINGE ANY PUBLISHED INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. |
|
|
(ii) |
|
NEITHER PARTY MAKES ANY WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, WITH
RESPECT TO THE PRODUCT. |
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|
(b) |
|
NEITHER PARTY MAKES ANY OTHER WARRANTIES HEREUNDER, EXPRESS OR IMPLIED,
INCLUDING WARRANTIES CONCERNING THE SUCCESS OF THE DEVELOPMENT PROGRAM, THE SUCCESS OF
THE MARKETING AND COMMERCIALIZATION OF THE PRODUCT OR THE COMMERCIAL UTILITY OF THE
PRODUCT. |
ARTICLE 10
INDEMNIFICATION AND INSURANCE
Section 10.1 Strata Indemnified by Micrologix.
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(a) |
|
Micrologix shall indemnify, defend and hold Strata, and its Representatives (in
respect of each Party, its Indemnitees), harmless from and against any Third Party
liabilities, obligations, damages, losses, claims, encumbrances, costs or expenses
(including attorneys fees) (any or all of the foregoing herein referred to as Loss)
insofar as a Loss or actions in respect thereof, occurred subsequent to the Effective
Date (except as provided in Section 10.1(a)(iii) below), and arises out of or is based
upon: |
|
(i) |
|
any breach by Micrologix of its representations, warranties,
covenants, obligations or agreements under this Agreement; or |
|
|
(ii) |
|
the negligence or willful misconduct of Micrologix and/or any
of Micrologixs Indemnitees, including violation of Applicable Laws in their
performance under this Agreement; or |
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(iii) |
|
Micrologixs (or any Subcontractors) conduct of the
pre-clinical and clinical research and development activities in connection
with the Product prior to and after the Effective Date; provided however,
Micrologixs duty to indemnify under this Section 10.1(a)(iii) shall not
include product liability claims unless Micrologixs liability for same arises
pursuant to Section 10.1(a)(i) or Section 10.1(a)(ii). |
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(b) |
|
Micrologixs obligations to indemnify Strata hereunder shall not apply to the
extent any such Loss arises out of or is based on the: |
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(i) |
|
inactions or actions of Strata or its Indemnitees for which
Strata is obligated to indemnify Micrologix under Section 10.2; or |
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(ii) |
|
negligence or willful misconduct of Strata and/or its Indemnitees. |
Section 10.2 Micrologix Indemnified by Strata.
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(a) |
|
Strata shall indemnify, defend and hold harmless Micrologix and its Indemnitees
from and against any Loss insofar as such Loss or actions in respect thereof occurred
subsequent to the Effective Date, and arises out of or is based upon: |
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(i) |
|
any breach by Strata of its representations, warranties,
covenants, obligations or agreements under this Agreement; or |
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(ii) |
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the negligence or willful misconduct of Strata and/or any of
Stratas Indemnitees, including any violation of Applicable Law in their
performance under this Agreement; or |
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(iii) |
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Stratas or its Indemnitees making, manufacture, marketing,
sale, distribution, storage or promotion of the Product, including any injury
or death to any person or damage to any property caused by any Product provided
by Strata or its Indemnitees, whether by reason of breach of warranty,
negligence, product defect or otherwise, and regardless of the form in which
any such claim is made. |
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(b) |
|
Stratas obligations to indemnify Micrologix hereunder shall not apply to the
extent any such Loss arises out of or is based on the: |
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(i) |
|
inactions or actions of Micrologix or its Indemnitees for which
Micrologix is obligated to indemnify Strata under Section 10.1; or |
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|
(ii) |
|
the negligence or willful misconduct of Micrologix and/or its
Indemnitees. |
Section 10.3 Prompt Notice Required.
No claim for indemnification hereunder shall be valid unless notice of the matter which may give
rise to such claim is given in writing by the Party seeking indemnification (the Indemnified
Party) to the persons against whom indemnification may be sought (the Indemnitor) as soon as
reasonably practicable after such Indemnified Party becomes aware of such claim. Such notice shall
state that the Indemnitor is required to indemnify the Indemnified Party and its Indemnitees for a
Loss and shall specify the amount of Loss, if available, and relevant details thereof. The
Indemnitor shall notify Indemnified Party no later than thirty (30) days from such notice of its
intention to assume the defense of any such claim. Failure of the Indemnified Party to notify
Indemnitor within such notice period shall not relieve Indemnitor of any liability hereunder,
except to the extent the Indemnitor reasonably demonstrates that the defense of such Third Party
claim is prejudiced by such failure.
Section 10.4 Indemnitor May Settle.
The Indemnitor shall, at its expense, have the right to settle and defend any action which may be
brought in connection with all matters for which indemnification is available. In such event the
Indemnified Party shall cooperate with the Indemnitor as reasonably requested by the Indemnitor in
connection with such action; provided that the Indemnified Party shall have the right to fully
participate in such defence at its own expense. The defence by the Indemnitor of any such actions
shall not be deemed a waiver by the Indemnitor of its right to assert a claim with respect to the
responsibility of the Indemnified Party with respect to the Loss in question. The Indemnitor shall
have the right to settle or compromise any claim against the Indemnified Party without the consent
of the Indemnified Party provided that the terms of any settlement or compromise: (a) does not
materially impair the Indemnified Partys rights hereunder (including
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each Partys rights in the Micrologix Technology); (b) would not require the Indemnified Party to be subject to an injunction
or to make a monetary payment or would restrict the claims in or admit any invalidity or
unenforceability of the Micrologix Patent Rights; (c) provide for the unconditional release of the
Indemnified Party; and (d) expressly state that neither the fact of settlement nor the settlement
agreement shall constitute, or be construed or interpreted as, an admission by the Indemnified
Party of any issue, fact, allegation or any other aspect of the claim being settled. In all other cases, the Indemnitor may not settle any such action without the prior
written consent of the Indemnified Party, which consent shall not be unreasonably withheld or
delayed. No Indemnified Party shall pay or voluntarily permit the determination of any liability
which is subject to any such action while the Indemnitor is negotiating the settlement thereof or
contesting the matter, except with the prior written consent of the Indemnitor, which consent shall
not be unreasonably withheld or delayed. If the Indemnitor fails to give Indemnified Party notice
of its intention to defend any such action as provided herein, the Indemnified Party involved shall
have the right to assume the defence thereof with counsel of its choice and defend, settle or
otherwise dispose of such action. If Strata is the Indemnified Party in such case, Strata shall
recover its Costs by deducting its Costs from any royalty payments or any other amounts payable to
Micrologix hereunder in accordance with Section 4.7(c).
Section 10.5 Insurance.
Each Party shall, at its sole cost and expense, obtain and keep in force during the Term and for a
period of not less than three (3) years after termination, cancellation or expiration of this
Agreement the following insurance: (a) general liability insurance, including blanket contractual
liability coverage with bodily injury, death and property damage with limits of $[***] per occurrence and $[***] in
the aggregate within six months after the Effective Date; and (b) clinical studies and product
liability insurance with bodily injury death and property damage limits of not less than $[***] per occurrence and
$[***] in the aggregate; provided, however, each Partys obligation to maintain such product
liability insurance shall not commence until immediately prior to the First Commercial Sale of the
Product in the first country in the Territory and each Partys obligation to maintain such clinical
studies insurance shall not commence until immediately prior to the first human dosing by such
Party. Upon execution of this Agreement, and upon the other Partys request thereafter, each Party
shall furnish the other with a certificate of insurance signed by an authorized representative of
such Partys insurance underwriter evidencing the insurance coverage required by this Agreement and
providing for at least thirty (30) days prior written notice to the other Party of any
cancellation, termination or reduction of such insurance coverage. Each Party shall use its
Commercially Reasonable Efforts to cause Third Parties engaged by a Party to perform its
obligations under this Agreement to maintain such types of insurance coverages and for such period
of time as are customary for such Third Parties given the nature of the services to be provided.
|
|
|
*** |
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Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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ARTICLE 11
ADDITIONAL COVENANTS OF THE PARTIES
Section 11.1 Micrologix Covenant Not To Compete.
Micrologix hereby covenants and agrees, and shall cause its Affiliates to agree, not to, in whole
or in part, develop, in-license, market, make, manufacture or have manufactured, sell, promote,
distribute or have marketed, have sold or have distributed any product in the Territory in the
Field (in this Section, a Section 11.1 Competitive Product) during the Term and for a period of
[***] thereafter. Notwithstanding the foregoing, if Micrologix acquires an entity or all or
substantially all of the assets of an entity during such period of time and such entity distributes
or such assets include a Section 11.1 Competitive Product, Micrologix or its Affiliate shall have
[***] in which to divest itself of such Section 11.1 Competitive Product or to otherwise cease
distribution of such Section 11.1 Competitive Product, and Micrologix shall not be in breach of
this Section 11.1 if it so divests or ceases distribution within such [***] period. Strata and
Micrologix hereby agree that the covenants set forth in this Section 11.1 are a material and
substantial part of the transactions contemplated by this Agreement.
Section 11.2 Launch of Competitive Product by Strata.
Strata hereby agrees that in the event Strata and/or its Affiliates develop, in-license, market,
sell, promote, distribute or have marketed, or have sold any product in the Field in a particular
country in the Territory that is not a Product hereunder (in this Section, a Competitive Product)
during the Term, directly for themselves or by a Third Party, licensee or sublicensee on behalf of
Strata and/or its Affiliates, then pursuant to Section 13.4, Stratas rights with respect to such
country under this Agreement shall terminate and revert to Micrologix. No termination pursuant to
this Section shall terminate this Agreement with respect to any other country in the Territory.
Notwithstanding the foregoing, if Strata or an Affiliate acquires an entity or all or substantially
all of the assets of an entity during such period of time and such entity distributes or such
assets include a Competitive Product, Strata, or its Affiliate(s), shall have [***] in which to divest itself of
such Competitive Product or to otherwise cease distribution of such Competitive Product, and Strata
shall not be in violation of this Section 11.2 if it so divests or ceases distribution within such
[***] period. The Parties mutually agree that Stratas (or Affiliates) commercialization, as
described above, of any Competitive Product shall not be deemed a breach of this Agreement, and
Micrologix sole recourse for such an event shall be that as described in this Section 11.2 only.
|
|
Section 11.3 Limitation To The Territory. |
Strata hereby covenants that it will not directly or indirectly, without the prior written
authorization of Micrologix: (i) promote or actively solicit the sale of the Product or advertise
the Product, outside of the Territory; (ii) purchase or cause to be purchased Product which Strata
has represented, directly or indirectly, as being for the purpose of sale in a specific country in
the
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*** |
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Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 52 -
Territory for sale in any other country outside the Territory; (iii) contact any of Micrologixs
suppliers or vendors of the Product or element thereof for the purpose of causing the Product to be
sold outside the Territory; (iv) knowingly sell or distribute for resale the Product purchased
hereunder to a Third Party who intends to sell the Product outside of the Territory; and (vi)
knowingly sell or distribute for resale Product purchased from a Third Party outside the Territory
for resale in the Territory.
Section 11.4 Records and Audits.
|
(a) |
|
Each Party shall keep or cause to be kept true, accurate and complete Books and
Records as are required to determine, in a manner consistent with accrual method of
accounting in accordance with GAAP, any sums or credits due under this Agreement during
the Term and for a period of three years thereafter or as otherwise required to comply
with Applicable Laws. Without limiting the generality of the foregoing, the Parties
agree that such Books and Records shall include the following: |
|
(i) |
|
Strata shall keep such Books and Records to permit Micrologix
to confirm the completeness and accuracy of (A) the information presented in
each Royalty Statement and all payments due hereunder; (B) the calculation of
Net Sales; (C) any payments due Micrologix under this Agreement; and (D) any
other payment obligations of Strata hereunder. |
|
|
(ii) |
|
Micrologix shall keep such Books and Records to permit Strata
to confirm the completeness and accuracy of (A) Reimbursable Costs; (B) any
payments due Strata under this Agreement; and (C) any other obligations of
Micrologix hereunder. |
|
(b) |
|
With regard to sums or credits due or related reports, at the request (and
expense) of the requesting Party, the other Party shall permit the requesting Party
and/or such requesting Partys independent certified public accountant selected by such
Party and reasonably acceptable to the other Party to audit and/or inspect only those
Books and Records of the other Party as may be necessary to determine, with respect to
any calendar year ending no more than three years prior to such Partys request, the
completeness and accuracy of any reports made and/or any sums or credits due under this
Agreement. Any such independent accounting firm shall be subject to the
confidentiality provisions of this Agreement. Such inspection shall be conducted
during the Partys normal business hours, no more than once in any twelve (12) month
period and upon at least thirty (30) days prior written notice by the requesting Party.
If such requesting Party concludes that such payments were underpaid during the
periods reviewed by such requesting Party and/or its accountants, the other Party shall
pay the requesting Party the amount of any such underpayments, plus interest at a rate
equal to the Prime Rate of Interest, within thirty (30) days of the date the requesting
Party delivers to the other Party the report so concluding that such payments were
underpaid. If such requesting Party and/or its accounting firm concludes that such
payments were overpaid during such period, the Party shall pay to the other Party the
amount of |
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|
|
|
any such overpayments, without interest, within thirty (30) days of the date the
requesting Party delivers to the other Party the report so concluding that such
payments were overpaid. The requesting Party shall bear the full cost of such audit
unless such audit discloses an underpayment by more than [***] of
the amount due during such period. In such case, the other Party shall bear the
full cost of such audit. |
|
|
(c) |
|
In the event the non-requesting Party does not agree with the conclusions of
such report under Section 11.4(b), (whether such payments were underpaid or overpaid),
then such Party shall notify the other Party within thirty (30) days after receipt of
such report. Thereafter, the Parties shall in good faith try and resolve such
differences. If the Parties are unable to reach a mutual agreement within fifteen (15)
days after the date of notice then independent auditors of each Party shall meet and
select an independent accounting firm (being an accounting firm not used by either
Party) to make the final determination within fifteen (15) days thereafter. The
determination of such independent accounting firm shall be binding and conclusive on
the Parties, and the cost of such firm shall be borne by the Party against whom the
determination by such firm is made. |
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|
(d) |
|
Micrologix shall, upon prior, reasonable notice by Strata and during normal
business hours, allow Strata or its Representative to inspect and audit Micrologixs
facilities, equipment, personnel and operating procedures (and of any Subcontractor, as
applicable) used to develop the Product and any Books and Records related thereto to
confirm compliance with the terms and conditions of this Agreement, including
compliance with Applicable Laws and Governmental Approvals; provided that Strata shall
use Commercially Reasonable Efforts to ensure that such inspection and audit shall not
interfere with Micrologixs (or its Subcontractors, as applicable) normal operations.
However, notwithstanding the foregoing, Strata shall be permitted to inspect and audit
as provided above immediately on notice in the event of a bona fide belief that
(i) an Applicable Law is being, or may be, violated or (ii) there is, or may be, an
SADE or imminent and otherwise material harm to the public due to the Product. Without
limiting anything else under this Agreement, if any of the obligations of Micrologix is
performed by a Subcontractor, then Micrologix shall cause any such Subcontractor to
comply with the terms and conditions of this Section 11.4(d). If any inspection or
audit hereunder reveals that Micrologix (or its Subcontractor(s) or other
Representatives) is not in compliance in all material respects with the terms and
conditions of this Agreement, Applicable Laws, or/and applicable Governmental
Approvals, Micrologix, at its sole cost, shall use Commercially Reasonable Efforts to
promptly correct (and, as applicable, cause its Subcontractor(s) to use Commercially
Reasonable Efforts to promptly correct) any such deficiencies to ensure compliance as
required hereunder. Micrologix |
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*** |
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Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 54 -
shall keep Strata informed on a regular, on-going and periodic basis as to the
status of any such deficiencies and such corrections.
Section 11.5 Marketing Expenses.
Strata covenants and agrees that, except as otherwise specified in this Agreement, Strata shall be
solely responsible for the cost and implementation of any and all marketing, sales, promotional and
related activities concerning or related to the marketing, sale, distribution and promotion of the
Product under this Agreement.
Section 11.6 Further Actions.
Upon the terms and subject to the conditions hereof, each of the Parties shall use its Commercially
Reasonable Efforts to take, or cause to be taken, all appropriate action and do, or cause to be
done, all things necessary or advisable under Applicable Laws or otherwise to consummate and make
effective the transactions contemplated by this Agreement.
ARTICLE 12
PRODUCT RECALL
Section 12.1 Product Recalls or Withdrawal.
If at any time or from time to time during the Term: (a) any Competent Authority of any country in
the Territory requests Strata to recall or withdraw the Product; (b) a court of competent
jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a
voluntary recall or withdrawal of the Product is contemplated by Strata (individually or
collectively, a Recall), then Strata shall carry out any Recall in the Territory in as
expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product
and the goodwill and reputation of the Parties. Strata shall in all events be responsible for
conducting any Recall in the Territory, market withdrawals or corrections with respect to the
Product in the Territory. Strata shall maintain records of all sales and distribution of Product
and customers sufficient to adequately administer a Recall for the period required by Applicable
Law. Micrologix shall cooperate as reasonably requested by Strata in connection with any such
Recall. Strata will be responsible for complying with all Applicable Laws and Governmental
Approvals during the Recall and will be responsible for all interactions with appropriate Competent
Authorities, including, the FDA Office of Compliance in the U.S. and the appropriate FDA local
district office(s) in the U.S. Strata shall be responsible for preparing and timely submitting any
reports any other documentation required by the Competent Authorities in connection with any such
Recall.
Section 12.2 Recall Costs.
Strata shall be responsible for conducting any Recall of the Product in the Territory and the cost
and expense therefor shall be paid by Strata, unless such Recall is due to, prior to or during the
Development: (i) any breach by Micrologix of its representations, warranties, covenants,
obligations or agreements under this Agreement; or (ii) the negligence or willful misconduct of
Micrologix and/or any of Micrologixs Representatives under this Agreement, including violation of
Applicable Laws in their performance under this Agreement; in which case all such
- 55 -
costs and
expenses, to the extent same are reasonable, shall be borne and paid solely by Micrologix. In such
event, Micrologix will reimburse Strata for any such costs and expenses paid by Strata within
thirty (30) days of its receipt of a reasonably detailed invoice(s) for such costs and expenses
from Strata.
Section 12.3 Notification Of Complaints.
During the Term and for a period of four (4) years after the termination, expiration or
cancellation of this Agreement or for such longer period as may be required by Applicable Law(s),
each Party agrees to (a) notify the other Party immediately of all available material information
concerning any complaint, product defect reports, and similar notices received by either Party with
respect to the Product, whether or not determined to be attributable to the Product and (b) with
respect to an SADE, comply with the provisions of Section 6.6. Strata shall define and implement
appropriate and necessary regulatory compliance procedures for product defect reporting, including
action plans and an SOP and will handle all product complaints in the Territory. In connection
with any such product complaint Micrologix shall cooperate as reasonably requested by Strata.
Strata, at its sole cost and expense, will have the responsibility for preparing and submitting any
reports to the Competent Authorities, including FDA field alerts.
Section 12.4 Notification Of Threatened Action.
During the Term and, for a period of four years after the termination, expiration or cancellation
of this Agreement or for such longer period as may be required by Applicable Law(s), each Party
agrees to immediately notify the other Party of any information it receives regarding any
threatened or pending action, inspection or communication by or from a concerned Competent
Authority which may affect the safety or efficacy claims of the Product or the continued marketing
or distribution of the Product. Upon receipt of such information, the Parties shall consult with
each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action,
provided that, subject to Micrologixs obligation under Section 6.1 and Applicable Laws during the
Period Micrologix is the IND holder, Strata shall have the final decision making authority with
respect thereto.
ARTICLE 13
TERM AND TERMINATION
Section 13.1 Term.
This Agreement shall become effective on the Effective Date and shall expire on the date of the
expiration of the last to expire Royalty Term in any country in the Territory (the Term), unless
earlier terminated as provided in Section 13.2, Section 13.3 or Section 13.4.
Section 13.2 Termination by Either Party.
Either Party may terminate this Agreement (in its entirety or on a country by country basis as
hereinafter provided) prior to the expiration of the Term upon the occurrence of any of the
following:
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(a) |
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upon or after the cessation of operations of the other Party or the bankruptcy,
dissolution or winding up of the other Party (other than dissolution or winding up for
the purposes or reconstruction or amalgamation which includes an assignment permitted
by this Agreement) or the filing of any involuntary petition for bankruptcy,
dissolution, liquidation or winding up of the affairs of the other Party which is not
dismissed within ninety (90) days after the date on which it is filed or commenced, and
in the case of any of the foregoing events, the non-defaulting Party may terminate the
Agreement in its entirety; or |
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(b) |
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upon or after the breach of any material provision of this Agreement by the
allegedly breaching Party if the allegedly breaching Party has not cured such breach
within sixty (60) days after written notice thereof by the non-breaching Party, the
non-breaching Party may, at its sole option, terminate this Agreement with respect to
the particular country in the Territory that is the subject of such breach, and this
Agreement shall remain in effect as it applies to all other countries; provided,
however, that if such breach and failure to cure occurred in the United States, the
non-breaching Party may terminate this Agreement in its entirety, and if such breach
and failure to cure occurred in a Major European Market Country, the non-breaching
Party may terminate this Agreement in respect of the whole of Europe. For the
avoidance of doubt, performance of the development and commercialization obligations
required to be performed in accordance with Commercially Reasonable Efforts hereunder
are evaluated based upon the Territory as a whole as set out in Section 1.10. |
Section 13.3 Termination by Strata.
Strata may terminate this Agreement in its entirety, or on a country-by-country basis prior to the
expiration of the Term as follows:
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(a) |
|
subject to Section 2.3(d), prior to issuance of a Marketing Authorization in
the US, at any time on written notice to Micrologix if it is determined by Strata in
good faith, acting reasonably and in accordance with prudent scientific and business
judgment and otherwise in accordance with generally accepted practices in the
pharmaceutical industry, that the Product is not reasonably expected to demonstrate
safety or efficacy; or |
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(b) |
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if the Second Phase III Study is commenced, at any time on written notice to
Micrologix if Strata exercises its right to terminate such study pursuant to Section
2.3(d); or |
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(c) |
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if the Second Phase III Study is not commenced, or after the completion of the
Second Phase III Study, at any time upon one hundred twenty (120) days prior written
notice to Micrologix. |
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Section 13.4 Termination by Micrologix.
Micrologix may terminate this Agreement in its entirety or on a country by country basis prior to
the expiration of the Term upon thirty (30) days prior written notice if Strata conducts any of the
activities respecting a Competitive Product in a particular country as set forth in Section 11.2.
Section 13.5 Effect of Termination.
|
(a) |
|
Payment Obligations. If this Agreement is terminated by either Party pursuant
to Section 13.2, Section 13.3 or Section 13.4, subject to the rights and obligations of
Strata related to selling off Product inventory as provided in Section 13.5(b)(ii) and
Section 13.5(b)(iii) and to pay Reimbursable Costs and certain wind down costs as set
forth in Sections Section 13.5(b)(iv)(A), Strata shall not be obligated to pay any
other wind down costs, milestone payments and/or other monies to Micrologix under this
Agreement, other than payments due and owing prior to the effective date of
termination. |
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(b) |
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Termination by Either Party. Upon the early termination of this Agreement by
either Party pursuant to Section 13.2, Section 13.3 or Section 13.4, the following
shall occur: |
|
(i) |
|
Subject to Section 13.7, Strata, its sublicensees and
Affiliates (as the case may be) shall have no right to practice within the
Micrologix Patent Rights or use any of the Micrologix Technology, and all
rights, title or interest in, or other incidents of ownership under, the
Micrologix Technology shall revert to and become the sole property of
Micrologix, and the licenses granted to Strata under Section 3.1 shall
automatically terminate. |
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(ii) |
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Notwithstanding Section 13.5(b)(i), provided that this
Agreement is terminated other than: (A) by Micrologix due to the breach of
Strata pursuant to Section 13.2 or Section 13.4; or (B) by Strata pursuant to
Section 13.3; Strata may, in its sole discretion, elect to sell-off or
distribute, as applicable, its existing inventory of Product to which the
termination pertains in accordance with the terms set forth in Section
13.5(b)(iii), after the effective date of termination, by notifying Micrologix
of its decision within thirty (30) days after the date it receives a notice of
termination by Micrologix or the date it provides a notice of termination to
Micrologix, as the case may be. |
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(iii) |
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If Strata elects pursuant to Section 13.5(b)(ii) to sell-off
or distribute, as applicable, its existing inventory, it shall not, either
directly or indirectly, use or permit the use of the Product except as set
forth under this Section 13.5(b)(iii) and shall proceed as follows: |
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(A) |
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continue to comply with its royalty obligations
for the Product to Micrologix under Article 4; |
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(B) |
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continue to sell off or distribute, as
applicable, existing inventory of Product until such time as the
inventory is depleted but in no event more than six (6) months after
the applicable notice of termination. At the expiration of such
period, Strata shall sell all existing inventory of Product to
Micrologix. In such case, Micrologix shall pay to Strata the full
amount of the actual cost paid by Strata, or Stratas documented
out-of-pocket costs, as applicable, for such remaining inventory of
Product; |
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(C) |
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if Strata does not elect pursuant to Section
13.5(b)(ii) to sell-off or distribute, as applicable, any existing
inventory of Product, or if this Agreement is terminated by Micrologix
under Section 13.2 or Section 13.4 for Stratas breach, or by Strata
pursuant to Section 13.3, Strata shall, at Micrologixs election,
either: |
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(1) |
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sell all existing inventory of
Product to Micrologix at Stratas actual cost of acquisition, or
Stratas documented out-of-pocket costs, as applicable; or |
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(2) |
|
destroy all remaining inventory
of Product in accordance with Applicable Laws and provide
Micrologix with written proof of destruction sufficient to
comply with Applicable Laws. |
|
|
|
In either case, Micrologix shall pay to Strata the actual cost paid
by Strata for such remaining inventory of Product; |
|
|
(D) |
|
if Strata sells any inventory of Product to
Micrologix pursuant to this Section 13.5(b)(iii), it shall warrant that
such inventory of Product has been stored in material compliance with
the applicable specifications therefor, Governmental Approvals and all
Applicable Laws, has not been adulterated within the meaning of
Applicable Laws and has otherwise been maintained by Strata according
to such specifications, Governmental Approvals and Applicable Laws; and |
|
|
(E) |
|
any sales of Product made by Strata to
Micrologix pursuant to this Section 13.5(b)(iii) shall be made by
Strata within thirty (30) days after the date it becomes obligated to
do so and shall be shipped to Micrologix appropriately packaged and
stored. All transportation costs in connection with such sale,
including insurance, freight and duties, and all reasonable costs of
re-working the Product so that such Product is in saleable form, shall
be shared equally by Strata and Micrologix. Amounts owed by either
Party to the other pursuant to this Section 13.5(b)(iii) for the
Product shall be paid by such Party within ten (10) days after receipt
by a Party of a
|
- 59 -
|
|
|
reasonably detailed invoice from the other Party for
the amount so owing to it by the other Party under this Section
13.5(b)(iii). |
|
(iv) |
|
if this Agreement is terminated prior to the completion of the
Development and the payment therefor: |
|
(A) |
|
by Micrologix pursuant to Section 13.2 for
Stratas breach or pursuant to Section 13.4, or by Strata pursuant to
Section 13.3(a) or Section 13.3(b), Strata shall, at Micrologixs
election, pay Micrologixs reasonable, wind-down costs under any
Development Subcontract provided that Micrologix uses Commercially
Reasonable Efforts to minimize, or if possible eliminate, such costs. |
|
|
(B) |
|
by Strata pursuant to Section 13.2 due to the
breach of Micrologix, Strata shall have no obligation to pay for any
wind-down costs, milestone payments and/or any other monies due and
owing from and after the effective date of such termination under this
Agreement. |
|
(v) |
|
if this Agreement is terminated by Micrologix pursuant to
Section 13.2 for Stratas breach or pursuant to Section 13.4, or by Strata
pursuant to Section 13.3(a) or Section 13.3(b), to the extent of its legal
right to do so, Strata shall immediately assign or transfer to Micrologix any
Governmental Approvals and trademarks for the Product held in the name of or
Controlled by Strata, if any, in any country in the Territory. |
|
|
(vi) |
|
to the extent of its legal right to do so, Strata shall, at
Micrologixs request, grant Micrologix a worldwide royalty-bearing, license
under any Strata Work Product necessary to use, market, advertise, promote,
distribute, offer for sale, sell, make, manufacture, have manufactured, export
and import, and develop Products with the right to sublicense and assign the
foregoing, in consideration of such reasonable royalties on net sales by
Micrologix or Product to be negotiated in good faith between Micrologix and
Strata at such time, and if the Parties cannot agree on such license and
royalties, either Party may refer the matter to arbitration pursuant to Article
14. Nothing in this Section shall cause a royalty to be payable in respect of
rights obtained by Micrologix pursuant to Section 5.3 or Section 6.2. |
|
|
(vii) |
|
if this Agreement is terminated by Strata pursuant to Section
13.2 due to the breach of Micrologix, to the extent of its legal right to do
so, Strata shall immediately assign or transfer to Micrologix any Governmental
Approvals and trademarks for the Product held in the name of or Controlled by
Strata, if any, in any country in the Territory, in consideration of such
reasonable royalties on net sales by Micrologix of Product to be negotiated in
good faith between Micrologix and Strata at |
- 60 -
|
|
|
such time, and if the Parties
cannot agree on such license and royalties, either Party may refer the matter
to arbitration pursuant to Article 14. Nothing in this Section shall cause a
royalty to be payable in respect of rights obtained by Micrologix pursuant to
Section 6.2. |
|
(viii) |
|
at the sole option and request of Micrologix, which request shall be made no
more than sixty (60) days after the effective date of termination, if
Micrologix chooses to permit Third Party sublicenses related to the Product to
survive termination of this Agreement, Strata will cooperate reasonably to
facilitate the transfer of Third Party sublicenses from Strata to Micrologix or
its designee. |
|
|
(ix) |
|
except as otherwise provided in this Agreement, expiration or
termination of this Agreement shall not relieve the Parties of any obligation
accruing prior to such expiration or termination. Except as set forth below or
elsewhere in this Agreement, the obligations and rights of the Parties under
Article 1 (as needed), Section 3.4, Section 4.7(b)(ii), Section 4.7(c), Section
5.3(c), Section 5.3(e) (for a one year period after expiration or termination
of this Agreement, in respect of the manufacture of Product for use in the
Field in the Territory), Section 6.2(b), Section 7.2, Section 7.4, Article 8,
Article 9, Article 10, Article 12, Article 13, Article 14 and Article 15, and
any other that by its terms is intended to survive, shall survive expiration or
termination of this Agreement. |
|
|
(x) |
|
subject to the provision of Section 13.7, within thirty (30)
days following the expiration or termination of this Agreement, each Party
shall return to the other Party, or destroy, upon the written request of the
other Party, any and all Confidential Information of the other Party in its
possession and upon a Partys request, such destruction (or delivery) shall be
confirmed in writing to such Party by a responsible officer of the other Party,
except for such Confidential Information which the receiving Party is required
to keep under Applicable Laws, in which event such Confidential Information
shall be held subject to the terms and conditions of Article VIII. |
|
(c) |
|
Termination on a Country-by-Country Basis. In the event any termination under
this Agreement relates solely to one or more countries in the Territory as permitted
herein, then this Agreement and the license contained in Section 3.1 shall only be
terminated to the extent it applies to such country or countries in the Territory and
this Agreement shall remain in effect as it applies to all other countries in the
Territory. |
|
|
(d) |
|
Bankruptcy Rights. In the event this Agreement is terminated or rejected by a
Party or its receiver or trustee under applicable bankruptcy laws due to such Partys
bankruptcy, then all rights and licenses granted under or pursuant to this Agreement by
such Party to the other Party are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code in the United States |
- 61 -
|
|
|
and other comparable
Applicable Law in any other country in the Territory (collectively Other Bankruptcy
Laws), licenses of rights to intellectual property as defined under Section 101(52)
of the United State Bankruptcy Code. The Parties agree that all intellectual property
rights licensed hereunder, including any patents or patent applications of a Party in
any country covered by the license grants under this Agreement, are part of the
intellectual property as defined in Section 101(52) of the United States Bankruptcy
Code, subject to protections afforded the non-terminating Party under Section 365(n) of
United States Bankruptcy Code or Other Bankruptcy Laws. |
Section 13.6 Remedies.
All of the non-breaching Partys remedies shall be cumulative, and the exercise of one remedy
hereunder by the non-defaulting Party shall not be deemed to be an election of remedies. These
remedies shall include the non-breaching Partys other rights of recovery for such breach with or
without terminating this Agreement.
Section 13.7 License Following Expiration.
Upon expiration of each of the applicable Royalty Terms in each country in the Territory, Strata
shall thereafter have an irrevocable, non-exclusive, royalty-free license in such country, with the
right to sublicense, to use, develop, market, advertise, promote, distribute, make, manufacture,
have manufactured, offer for sale, sell, export and import the Product for use in the Field in the
Territory. Upon request by Strata, Micrologix shall continue to allow Strata to manufacture and
sell the Product under the Micrologix Technology pursuant to a separate agreement to be negotiated
in good faith between the Parties.
ARTICLE 14
DISPUTE RESOLUTION/DAMAGES
Section 14.1 Disputes.
The Parties recognize that disputes as to certain matters may from time to time arise during the
Term which relate to either Partys rights and/or obligations hereunder or to the interpretation,
performance, breach, or termination of this Agreement, (a Dispute). It is the objective of the
Parties to establish procedures to facilitate the resolution of a Dispute in an expedient manner by
mutual cooperation and without resort to litigation. To accomplish this objective, the Parties
agree to follow the procedures set forth in this Article 14 if and when a Dispute arises under this
Agreement. The Parties acknowledge and agree that nothing under this Article 14 shall in any way
affect, alter, negate or modify Stratas tie-breaking vote in the JDMC under Section 2.4(d).
Subject to Section 11.4(c), a Dispute among the Parties will be resolved as recited in this Article
14. Any Disputes relating to this Agreement shall be promptly presented to the Chief Executive
Officers of Micrologix and Strata, or their respective designees (who must be members of a Partys
senior management) for resolution. From the date of referral of a Dispute to the Chief Executive
Officers or their designees of the Parties and until such time as any matter has been resolved by
the Parties or has been finally settled by arbitration hereunder, the running of the cure periods
(if any) as to which a Party must cure a breach that is part of the subject matter of
- 62 -
any Dispute
shall be suspended. In the event that the Chief Executive Officers of Micrologix and Strata, or
their respective designees, cannot after good faith negotiations resolve the Dispute within 10 days
(or such other period of time as mutually agreed to by the Parties in writing) of being requested
by a Party to resolve a Dispute, the Parties agree that such Dispute shall be resolved by binding
arbitration in accordance with this Section 14.1.
If a Party intends to begin arbitration to resolve such Dispute, such Party shall provide written
notice (the Arbitration Notice) to the other Party informing such other Party of such intention
and the issues to be resolved. Any arbitration hereunder shall be conducted pursuant to the
Commercial Arbitration Rules of the American Arbitration Association (AAA), including the
Supplementary Procedures for Large Complex Disputes (the AAA Rule) except as modified herein.
The arbitration shall be conducted by a panel of three (3) arbitrators (the Panel) to be mutually
agreed upon by the Parties and appointed by the AAA. The arbitrators shall be industry experts
experienced in the issues comprising the Dispute and shall have no past, present or anticipated
future affiliation with either Party. If the Parties are unable to agree upon all or any number of
the three (3) mutually acceptable arbitrators within thirty (30) days after the filing of the
Arbitration Notice, the AAA shall promptly appoint the arbitrator(s) to complete the Panel in
accordance with the criteria set forth in this Section 14.1. The arbitration shall take place in
Denver, Colorado. The Panel shall apply the laws of the State of Delaware, without regard to its
conflicts of laws provisions. The Panel shall issue appropriate protective orders to protect each
Partys Confidential Information. If a Party can demonstrate to the Panel that the complexity of
the issue or other reasons warrant the extension of one or more timetables in the AAA Rules, the
Panel may extend such timetables but in no event shall the proceeding extend more than twelve (12)
months from the date of filing of the Arbitration Notice with the AAA. The Panels decision shall
be in writing. The Panel shall have the authority to award any remedy allowed by law or in equity,
including compensatory damages, pre-judgment interest and to grant final, complete, interim, or
interlocutory relief, including specific performance, injunctions and other equitable relief, but
not punitive or other damages set forth in Section 14.5 and each Party shall be deemed to have
waived any right to such excluded damages. Each Party shall bear its own costs, fees and expenses
in the arbitration and shall share equally the Panels fees, unless the Panel determines that its
fees are to be paid by the non-prevailing Party.
Section 14.2 Performance to Continue.
Each Party shall continue to perform its obligations under this Agreement pending final resolution
of any Dispute arising out of or related to this Agreement; including continuing the Development,
provided, however, that a Party may suspend performance of its obligations during any period in
which the other Party fails or refuses to perform its obligations.
Section 14.3 Determination of Patents and Other Intellectual Property.
Notwithstanding the foregoing, any dispute relating to the determination of validity of claims,
infringement or claim interpretation relating to Micrologixs Patents shall be submitted
exclusively to the federal courts.
- 63 -
Section 14.4 Injunctive Relief.
Nothing in this Agreement shall prevent either Party from seeking a temporary restraining order or
injunction against the other Party as required to prevent such other Partys misuse of the
intellectual property or Confidential Information of the other Party seeking such temporary
restraining order or injunction. In addition nothing in this Agreement shall prevent Strata from
seeking a temporary restraining order or injunction against Micrologix to prevent any breach by
Micrologix under Section 11.1. The Parties understand and agree that because of the difficulty in
measuring economic losses to the non breaching Party as a result of a breach of the covenants set
forth in this Agreement respecting intellectual property and Confidential Information and because
of the immediate and irreparable damage that may be caused to the non breaching Party for which
monetary damages would not be a sufficient remedy, the Parties agree that the non breaching Party
will be entitled to seek specific performance, temporary and permanent injunctive relief, and such
other equitable remedies to which it may then be entitled against the breaching Party. This
Section 14.4 shall not limit any other legal or equitable remedies that the non breaching Party may
have against the breaching Party.
Section 14.5 No Consequential Damages.
EXCEPT WITH REGARD TO DAMAGES ARISING UNDER SECTION 8.1(B) AND EACH PARTYS DUTY TO INDEMNIFY THE
OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES RECOVERED BY A THIRD
PARTY AS PROVIDED UNDER ARTICLE 10, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY
INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES INCURRED BY EITHER PARTY UNDER
THIS AGREEMENT OR OTHERWISE.
Section 14.6 Attorneys Fees.
In the event of any claim hereunder related to either Partys infringement of the intellectual
property rights of the other Party or the misuse of Confidential Information of the other Party,
the prevailing party in any such dispute shall pay the reasonable legal fees and costs related
thereto.
ARTICLE 15
MISCELLANEOUS
Section 15.1 No Solicitation.
Neither Party nor its Affiliates (collectively, the Initiating Group) shall, directly or through
its representatives, solicit for employment any officer, director, employee or consultant of the
other Party or its subsidiaries or Affiliates (collectively, the Other Group) with whom the
Initiating
Group has contact in connection with, or who otherwise is known by the Initiating
- 64 -
Group to participate in, the transactions contemplated by this Agreement for a period of [***]. The Initiating
Group shall not be precluded from hiring any such person who has been terminated by the Other Group
prior to commencement of employment discussions between such person and the Initiating Group or its
representatives. Solicitation shall not include any generalized public advertisement or any other
solicitation by the Initiating Group or its representatives that is not specifically directed
toward any such employee of the Other Group or toward any group of such employees of the Other
Group.
Section 15.2 Assignment; Binding Effect.
Except as otherwise provided in this Agreement, neither this Agreement nor any of the rights,
interests or obligations hereunder shall be assigned by any of the Parties hereto (whether by
operation of Applicable Laws or otherwise) without the prior written consent of the other Party,
which consent shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, either
Party may sell, transfer or assign its rights under this Agreement to any Third Party, as part of a
sale or transfer of substantially all of a Partys assets; provided that such Third Party agrees in
writing to be bound by the terms and conditions of this Agreement. Subject to the preceding
sentence, this Agreement shall be binding upon and shall inure to the benefit of the Parties hereto
and their respective permitted successors and assigns. Notwithstanding anything contained in this
Agreement to the contrary, nothing herein, expressed or implied, is intended to confer on any
person other than the Parties hereto or their Representatives, respective heirs, successors,
executors, administrators and assigns any rights, remedies, obligations or liabilities under or by
reason of this Agreement. Any purported assignment, sale, transfer, delegation or other
disposition by a Party, except as permitted herein, shall be null and void.
Section 15.3 Force Majeure.
Neither Party shall be held liable or responsible to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party, including fire, flood, embargo, war, act of war (whether
war be declared or not), act of terrorism, failure of supplier, insurrection, riot, civil
commotion, strike, lockout or other labour disturbance, act of God (a Force Majeure); provided
that the Party whose performance is delayed or prevented shall provide prompt notice of the Force
Majeure to the other Party. Performance shall be excused so long as the condition constituting
Force Majeure continues and the non-performing Party uses good faith diligent efforts to mitigate,
avoid or end such delay of failure in performance as soon as practicable.
Section 15.4 Governing Law.
This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the
State of Delaware, except that no conflict of laws provision shall be applied to make the laws of
any other jurisdiction applicable to this Agreement.
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*** |
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Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 65 -
Section 15.5 Waiver.
Except as specifically provided for herein, the waiver from time to time by either of the Parties
of any of their rights or their failure to exercise any remedy shall not operate or be construed as
a continuing waiver of same or of any other of such Partys rights or remedies provided in this
Agreement.
Section 15.6 Severability.
In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity,
legality and enforceability of the remaining provisions shall not in any way be affected or
impaired thereby.
Section 15.7 No Right to Use Names.
Except as otherwise provided herein, no right, express or implied, is granted by the Agreement to
use in any manner the name Micrologix, Strata or any other trade name or trademark of the other
Party or its Affiliates in connection with the performance of the Agreement.
Section 15.8 Notices.
All notices and other communications provided for hereunder shall be in writing and shall be mailed
by first-class, registered or certified mail, postage paid, or delivered personally, by overnight
delivery service or by facsimile, computer mail or other electronic means, with confirmation of
receipt, addressed as follows:
|
|
|
If to Micrologix:
|
|
Micrologix Biotech Inc. |
|
|
BC Research Complex |
|
|
3650 Wesbrook Mall |
|
|
Vancouver, BC Canada V6S 2L2 |
|
|
Attention: President |
|
|
|
With a copy to:
|
|
Farris, Vaughan, Wills & Murphy |
|
|
2600 700 West Georgia Street |
|
|
Vancouver, BC Canada V7Y 1B3 |
|
|
Attention: James Hatton |
|
|
|
If to Strata:
|
|
Strata Pharmaceuticals, Inc. |
|
|
10923 Cloverhurst Way
San Diego, California 92130 |
|
|
Attention: CEO |
|
|
|
With copies to:
|
|
Morrison & Foerster LLP |
|
|
3811 Valley Centre Drive, Suite 500 |
|
|
San Diego, California 92130-2332 |
|
|
Attention: Jay de Groot |
- 66 -
Notice so given shall be deemed given and received (a) if by mail on the fourth day after posting;
(b) by cable, telegram, telex or personal delivery on the date of actual transmission, with
evidence of transmission acceptance, or (as the case may be) personal or other delivery; and (c) if
by overnight delivery courier, on the next business day following the day such notice is delivered
to the overnight delivery courier service.
Section 15.9 Independent Contractors.
The activities and resources of each Party shall be managed by such Party, acting independently and
in its individual capacity. It is expressly agreed that Micrologix and Strata shall be independent
contractors and that the relationship between the two Parties shall not constitute a partnership or
agency of any kind. Neither Micrologix nor Strata shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall be binding on the
other Party, without the prior written consent of the other Party.
Section 15.10 Rules of Construction.
The Parties hereto agree that they have been represented by counsel during the negotiation and
execution of this Agreement and, therefore, waive the application of any law, regulation, holding
or rule of construction providing that ambiguities in an agreement or other document will be
construed against the Party drafting such agreement or document.
Section 15.11 Entire Agreement; Amendment.
This Agreement (including the Exhibits attached hereto) sets forth all of the covenants, promises,
agreements, warranties, representations, conditions and understandings between the Parties hereto
with respect to the subject matter hereof and supersedes and terminates all prior agreements and
understandings between the Parties, including the Letter Agreement. There are no covenants,
promises, agreements, warranties, representations conditions or understandings, either oral or
written, between the Parties other than as set forth herein. No subsequent alteration, amendment,
change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to
writing and signed by the respective authorized officers of the Parties. Purchase orders, purchase
order releases, confirmations, acceptances and similar documents submitted by a Party in conducting
the activities contemplated under this Agreement are for administrative purposes only and shall not
add to or modify the terms of the Agreement. To the extent of any conflict or inconsistency
between this Agreement and any such document, the terms of this Agreement shall govern.
Section 15.12 Counterparts; Facsimile.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same instrument. This Agreement
may be signed and delivered to the other Party by facsimile signature; such transmission will be
deemed a valid signature.
- 67 -
Section 15.13 Interpretation.
The Section headings contained in this Agreement are for reference purposes only and shall not
affect the meaning or interpretation of this Agreement. Except where the context clearly requires
to the contrary: (i) each reference in this Agreement to a designated Section or Exhibit is to
the corresponding Section or Exhibit of or to this Agreement; (ii) instances of gender or
entity-specific usage (e.g., his her its person or individual) shall not be interpreted
to preclude the application of any provision of this Agreement to any individual or entity; (iii)
including shall mean including, without limitation; (iv) references to Applicable Laws shall
mean such Applicable Laws in effect during the Term (taking into account any amendments thereto
effective at such time without regard to whether such amendments were enacted or adopted after the
Effective Date); (v) references to $ or dollars shall mean the lawful currency of the United
States; (vi) references to Federal or federal shall be to laws, agencies or other attributes of
the United States (and not to any State or locality thereof); (vii) references to days shall mean
calendar days, unless it is expressly stated as business days; and (viii) the English language
version of this Agreement shall govern all questions of interpretation relating to this Agreement,
notwithstanding that this Agreement may have been translated into, and executed in, other
languages.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly
authorized officers as of the Effective Date.
|
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Micrologix Biotech Inc. |
|
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Strata Pharmaceuticals, Inc. |
|
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By:
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/s/ James DeMesa |
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By: |
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/s/ Theodore R. Schroeder |
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Name: |
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James DeMesa |
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Name: |
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Theodore R. Schroeder |
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Title: |
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President and CEO |
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Title: |
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President and Chief Executive Officer |
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- 68 -
EXHIBIT A
DEVELOPMENT PLANS
Please refer to the following documents:
|
|
|
Strata Pharmaceuticals Inc. Development Plan, Timeline and Budget for NDA for LCSI Based
on Second Phase III Study, dated July___, 2004; and |
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Strata Pharmaceuticals Inc. Development Plan, Timeline and budget for NDA for CRBSI
Based on First Phase III Study, dated July ___, 2004. |
- 69 -
EXHIBIT B
PATENTS
|
|
|
Country |
|
Application or Patent No. |
USA
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
PCT
|
|
[***] |
Canada
|
|
[***] |
Europe
|
|
[***] |
Belgium
|
|
[***] |
Switzerland
|
|
[***] |
Germany
|
|
[***] |
Spain
|
|
[***] |
France
|
|
[***] |
Great Britain
|
|
[***] |
Hong Kong
|
|
[***] |
Ireland
|
|
[***] |
Italy
|
|
[***] |
Europe
|
|
[***] |
Hong Kong
|
|
[***] |
|
|
|
*** |
|
Certain information on this page has been omitted
and filed separately with the Commission. Confidential
treatment has been requested with respect to the omitted
portions. |
- 70 -
|
|
|
Country |
|
Application or Patent No. |
USA
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
PCT
|
|
[***] |
Canada
|
|
[***] |
Europe
|
|
[***] |
Hong Kong
|
|
[***] |
USA
|
|
[***] |
USA
|
|
[***] |
PCT
|
|
[***] |
CA
|
|
[***] |
Europe
|
|
[***] |
|
|
|
*** |
|
Certain information on this page has been omitted
and filed separately with the Commission. Confidential
treatment has been requested with respect to the omitted
portions. |
- 71 -
EXHIBIT C
INVENTORY
[***]
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*** |
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Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions. |
- 72 -
EXHIBIT D
REGULATORY FILINGS
[***]
|
|
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*** |
|
Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions. |
exv10w11
EXHIBIT 10.11
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
IV APAP AGREEMENT
(US and Canada)
by and between
BRISTOL-MYERS SQUIBB COMPANY
and
CADENCE PHARMACEUTICALS, INC.
February 21, 2006
TABLE OF CONTENTS
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ARTICLE I DEFINITIONS |
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1 |
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1.1 Defined Terms |
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1 |
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ARTICLE II GRANT OF U.S. AND CANADIAN RIGHTS AND RELATED TRANSFERS |
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12 |
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2.1 Grant of Sublicense and License |
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12 |
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2.2 No Implied Licenses; Reservation of Rights |
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13 |
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2.3 Rights of Pharmatop |
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14 |
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2.4 Further Sublicenses |
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15 |
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2.5 Delegation of Manufacturing |
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16 |
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2.6 Development and Commercialization Arrangements |
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17 |
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2.7 Improvements |
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17 |
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2.8 Transfer of Regulatory Filings; Communications with Regulatory Authorities |
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18 |
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2.9 Transfer of Data and Transition Arrangements |
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19 |
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2.10 Tech Transfer Plan |
|
|
21 |
|
2.11 Technology Documentation |
|
|
21 |
|
2.12 Technical Assistance |
|
|
22 |
|
2.13 Cooperation |
|
|
23 |
|
2.14 Additional Assistance |
|
|
23 |
|
2.15 Pharmacovigilance; Adverse Event Reporting |
|
|
23 |
|
2.16 Infringement Pharmatop Patents |
|
|
25 |
|
2.17 Infringement BMS Patents |
|
|
27 |
|
2.18 Maintenance of BMS Patents |
|
|
27 |
|
2.19 Noncontravention |
|
|
27 |
|
2.20 Patent Extensions |
|
|
27 |
|
2.21 Data Exclusivity and Orange Book Listings |
|
|
28 |
|
2.22 Notification of Patent Certifications |
|
|
28 |
|
2.23 Audit, Inspection and Review |
|
|
28 |
|
2.24 [***] Covenant; [***]Covenant |
|
|
29 |
|
|
|
|
|
|
ARTICLE III ADDITIONAL COVENANTS |
|
|
30 |
|
3.1 Annual Operating Plan |
|
|
30 |
|
3.2 Development, Commercialization and Financial Reports and Consultations |
|
|
30 |
|
3.3 Development Responsibilities and Costs |
|
|
32 |
|
3.4 Obligations in respect of the Pharmatop License Agreement |
|
|
33 |
|
3.5 Certain Rights and Obligations under the Pharmatop License Agreement |
|
|
33 |
|
3.6 Conduct of Clinical Trials of Products by Cadence in Clinical Study
Countries |
|
|
35 |
|
3.7 Conduct of US or Canadian Clinical Trials of Products by BMS |
|
|
37 |
|
|
|
|
*** |
|
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
ii
|
|
|
|
|
3.8 Existing BMS Suppliers |
|
|
38 |
|
|
|
|
|
|
ARTICLE IV FINANCIAL TERMS |
|
|
38 |
|
4.1 Payments to BMS |
|
|
38 |
|
4.2 Reduction of Certain Milestone Payments |
|
|
39 |
|
4.3 Payments by Cadence to Pharmatop |
|
|
40 |
|
4.4 Manner of Payment |
|
|
41 |
|
4.5 Interest |
|
|
41 |
|
4.6 Expenses; Taxes |
|
|
41 |
|
(a) Expenses |
|
|
41 |
|
(b) Transfer Taxes |
|
|
41 |
|
(b) Tax Withholding |
|
|
41 |
|
4.7 Sales Reports and Royalty and Other Payments |
|
|
41 |
|
4.8 Sales Record Audit |
|
|
42 |
|
|
|
|
|
|
ARTICLE V MUTUAL COVENANTS OF THE PARTIES |
|
|
42 |
|
5.1 Publicity |
|
|
42 |
|
5.2 Confidentiality |
|
|
43 |
|
(a) Confidentiality Obligations |
|
|
43 |
|
(b) Limited Disclosure |
|
|
43 |
|
(c) Authorized Disclosure |
|
|
44 |
|
(d) Employees and Consultants |
|
|
45 |
|
(d) Securities Filings |
|
|
45 |
|
(f) Academic Publications |
|
|
45 |
|
(g) Additional Confidentiality Obligations under the Pharmatop License Agreement |
|
|
46 |
|
5.3 Restrictions Binding on Affiliated Companies and Investors |
|
|
46 |
|
5.4 Alliance Management |
|
|
46 |
|
5.5 Liens |
|
|
46 |
|
5.6 BMS Confidential Disclosure Agreements |
|
|
47 |
|
|
|
|
|
|
ARTICLE VI REPRESENTATIONS AND WARRANTIES |
|
|
47 |
|
6.1 Mutual Representations and Warranties |
|
|
47 |
|
(a) Organization |
|
|
47 |
|
(b) Authorization |
|
|
47 |
|
(c) Binding Agreement |
|
|
47 |
|
(d) No Conflicts; Consents |
|
|
48 |
|
(e) Litigation |
|
|
48 |
|
6.2 Additional Representations of Cadence |
|
|
48 |
|
(a) Financial Statements |
|
|
48 |
|
(b) Absence of Undisclosed Liabilities |
|
|
49 |
|
(c) Absence of Material Adverse Effect |
|
|
49 |
|
(d) Legal Matters |
|
|
50 |
|
(e) Receipt of Financing; Restrictions |
|
|
50 |
|
6.3 BMS Rights |
|
|
50 |
|
6.4 BMS Patents and Know-How |
|
|
51 |
|
6.5 DISCLAIMER |
|
|
52 |
|
iii
|
|
|
|
|
6.6 Limitation of Liability |
|
|
52 |
|
|
|
|
|
|
ARTICLE VII INDEMNIFICATION; ARBITRATION |
|
|
53 |
|
7.1 Mutual Indemnification |
|
|
53 |
|
7.2 Additional Indemnification Obligations of Cadence |
|
|
54 |
|
7.3 Additional Indemnification Obligations of BMS |
|
|
54 |
|
7.4 Conditions to Indemnification; Third Party Claims |
|
|
55 |
|
7.5 Insurance |
|
|
55 |
|
7.6 Arbitration |
|
|
56 |
|
7.7 Pharmatop Arbitration |
|
|
57 |
|
|
|
|
|
|
ARTICLE VIII TERM AND TERMINATION |
|
|
58 |
|
8.1 Term |
|
|
58 |
|
8.2 Automatic Termination |
|
|
58 |
|
8.3 Termination by Either Party |
|
|
58 |
|
8.4 Termination by BMS |
|
|
59 |
|
8.5 Termination by Cadence |
|
|
59 |
|
8.6 Scope of Termination |
|
|
60 |
|
8.7 Effect of Termination |
|
|
60 |
|
8.8 Transition |
|
|
62 |
|
8.9 Survival |
|
|
63 |
|
8.10 Bankruptcy |
|
|
63 |
|
|
|
|
|
|
ARTICLE IX MISCELLANEOUS |
|
|
63 |
|
9.1 Amendments |
|
|
63 |
|
9.2 Counterparts; Facsimile Execution |
|
|
63 |
|
9.3 Cumulative Remedies |
|
|
63 |
|
9.4 Entire Agreement |
|
|
63 |
|
9.5 Schedules |
|
|
63 |
|
9.6 Force Majeure |
|
|
64 |
|
(a) General |
|
|
64 |
|
(b) Definition |
|
|
64 |
|
(c) Duty to Mitigate |
|
|
64 |
|
(d) Suspension
of Certain Obligations |
|
|
64 |
|
9.7 Assignment |
|
|
64 |
|
9.8 Governing Law |
|
|
65 |
|
9.9 Headings |
|
|
65 |
|
9.10 Notices |
|
|
65 |
|
9.11 Severability |
|
|
66 |
|
9.12 No Third Party Beneficiaries |
|
|
66 |
|
9.13 Waivers |
|
|
66 |
|
9.14 Documentary Conventions |
|
|
66 |
|
9.15 Consents and Approvals |
|
|
67 |
|
9.16 Absence of Presumption |
|
|
67 |
|
9.17 Relationship of Parties |
|
|
67 |
|
iv
Schedule 1.1 BMS Patents
Schedule 6.3(a) Pharmatop Patents
v
INDEX OF DEFINED TERMS
|
|
|
|
|
|
|
Section |
|
$ |
|
|
1.1 |
|
Adverse Event |
|
|
1.1 |
|
Affiliated Company |
|
|
1.1 |
|
Agreement |
|
|
Introductory Paragraph |
|
Annual Operating Plan |
|
|
3.1 |
|
[***] |
|
|
3.2 |
(c) |
Applicable Law |
|
|
1.1 |
|
Approval |
|
|
1.1 |
|
Available [***] |
|
|
2.24 |
|
Balance Sheet |
|
|
6.2 |
(b) |
Balance Sheet Date |
|
|
6.2 |
(b) |
Bankruptcy |
|
|
1.1 |
|
BMS |
|
|
Introductory Paragraph |
|
[***] |
|
|
1.1 |
|
BMS Indemnitees |
|
|
7.2 |
|
BMS Know-How |
|
|
1.1 |
|
[***] |
|
|
4.1 |
(g) |
BMS Patent Product |
|
|
1.1 |
|
BMS Patent Royalty Term |
|
|
1.1 |
|
BMS Patents |
|
|
1.1 |
|
[***] Covenant |
|
|
2.24 |
(b) |
BMS Rights |
|
|
1.1 |
|
Business Day |
|
|
1.1 |
|
Cadence |
|
|
Introductory Paragraph |
|
Cadence Claims |
|
|
6.2 |
(d) |
Cadence Indemnitees |
|
|
7.3 |
|
Calendar Quarter |
|
|
1.1 |
|
Calendar Year |
|
|
1.1 |
|
[***] |
|
|
2.1 |
(c)(i) |
[***] |
|
|
2.24 |
(d) |
[***] |
|
|
2.24 |
|
[***] |
|
|
3.2 |
(f) |
Clinical Study Countries |
|
|
1.1 |
|
Clinical Supply Agreement |
|
|
1.1 |
|
Clinical Testing Product |
|
|
1.1 |
|
Confidential Information |
|
|
1.1 |
|
Consent |
|
|
6.1 |
(d) |
Contract Research Organization |
|
|
1.1 |
|
Contracts |
|
|
1.1 |
|
Control |
|
|
1.1 |
|
Controlled |
|
|
1.1 |
|
Controlling |
|
|
1.1 |
|
Covenant Termination Date |
|
|
2.24(c). 1.1 |
|
Derivative |
|
|
1.1 |
|
Development Plan |
|
|
3.3 |
|
Disclosing Party |
|
|
1.1 |
|
Dispute |
|
|
7.6 |
|
Dollar |
|
|
1.1 |
|
Drug Regulatory Authority |
|
|
1.1 |
|
Effective Date |
|
|
Introductory Paragraph |
|
Equivalent Percentage |
|
|
4.1 |
(f) |
Exchange Act |
|
|
1.1 |
|
[***] Date |
|
|
1.1 |
|
[***] Period |
|
|
1.1 |
|
[***] Date |
|
|
2.1 |
(c) |
Execution Date |
|
|
Introductory Paragraph |
|
FDA |
|
|
1.1 |
|
FDCA |
|
|
1.1 |
|
Financial Statements |
|
|
6.2 |
(a) |
Force Majeure |
|
|
9.6 |
(b) |
Governmental Entity |
|
|
1.1 |
|
HSR Act |
|
|
1.1 |
|
ICC |
|
|
7.6 |
(a) |
Improvement |
|
|
1.1 |
|
In Accordance With GAAP |
|
|
6.2 |
(a) |
include |
|
|
9.14 |
|
includes |
|
|
9.14 |
|
including |
|
|
9.14 |
|
IND |
|
|
1.1 |
|
Indemnified Party |
|
|
7.4 |
|
Indemnifying Party |
|
|
7.1 |
|
Indemnitees |
|
|
7.1 |
|
Judgments |
|
|
6.1 |
(d) |
License |
|
|
2.1 |
(a) |
Lien |
|
|
1.1 |
|
Losses |
|
|
7.1 |
|
Material Adverse Effect |
|
|
1.1 |
|
NDA |
|
|
1.1 |
|
NDA Acceptance |
|
|
1.1 |
|
Net Sales |
|
|
1.1 |
|
vi
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions. |
|
|
|
|
|
|
|
Section |
|
[***] Date |
|
|
2.1 |
(c) |
[***] Date |
|
|
2.24 |
(d) |
Organizational Documents |
|
|
1.1 |
|
Other Chemical Entity |
|
|
1.1 |
|
Other Product Data |
|
|
2.9 |
|
Other Reportable Information |
|
|
2.15 |
(e) |
Parties
|
Introductory Paragraph |
|
Party
|
Introductory Paragraph |
|
Patents |
|
|
1.1 |
|
Person |
|
|
1.1 |
|
Pharmatop
|
Background |
|
Pharmatop Know-How |
|
|
1.1 |
|
Pharmatop License Agreement
|
Background |
|
Pharmatop Patent Challenge |
|
|
2.16 |
(a) |
Pharmatop Patents |
|
|
1.1 |
|
Pharmatop Royalty Term |
|
|
1.1 |
|
Previously Disclosed |
|
|
1.1 |
|
Proceedings |
|
|
6.1 |
(e) |
Product |
|
|
1.1 |
|
Product Data |
|
|
1.1 |
|
Qualifying [***] |
|
|
1.1 |
|
Qualifying [***] |
|
|
1.1 |
|
Receiving Party |
|
|
1.1 |
|
Registrational Information |
|
|
1.1 |
|
Regulatory Filings |
|
|
1.1 |
|
[***] Product |
|
|
2.24 |
(b) |
Retained Sum |
|
|
4.2 |
(b) |
Royalties |
|
|
4.1 |
(h) |
Rules |
|
|
7.6 |
(a) |
[***] |
|
|
2.24 |
|
Silicon Valley Loan Agreement |
|
|
6.2 |
(b) |
[***] |
|
|
2.24 |
|
Specified Number of Days |
|
|
8.3 |
|
Sublicense |
|
|
2.1 |
(a) |
Tax |
|
|
1.1 |
|
Tech Transfer Period |
|
|
2.12 |
|
Tech Transfer Plan |
|
|
2.10 |
|
Technology |
|
|
1.1 |
|
Technology Documentation |
|
|
1.1 |
|
Territory |
|
|
1.1 |
|
Third Party |
|
|
1.1 |
|
[***] |
|
|
2.24 |
|
Title 11 |
|
|
8.10 |
|
Transaction Documents |
|
|
1.1 |
|
Transfer Taxes |
|
|
1.1 |
|
[***] |
|
|
2.24 |
|
Valid Claim |
|
|
1.1 |
|
without limitation |
|
|
9.14 |
|
vii
|
|
|
*** |
|
Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions. |
IV APAP AGREEMENT
(US and Canada)
This IV APAP Agreement (US and Canada) (the Agreement) is entered into as of February 21,
2006 (the Execution Date), by and between Bristol-Myers Squibb Company, a Delaware corporation
having an address at 345 Park Avenue, New York, New York 10154 (BMS), and Cadence
Pharmaceuticals, Inc., a Delaware corporation having an address at 12730 High Bluff Drive, San
Diego, California 92130 (Cadence), effective as of March 29, 2006 (the Effective Date).
Cadence and BMS are sometimes collectively referred to herein as the Parties and each
individually as a Party.
BACKGROUND
1. BMS has licensed from SCR Pharmatop, a civil law partnership organized under the laws of
France, having its head offices address at 10, Square St. Florentin, 78150 Le Chesnay, France,
recorded with the Register of Commerce and Companies of Versailles under No. 407552702
(Pharmatop), rights under certain patents and patent applications relating to parenteral
paracetamol (also referred to in the United States as acetaminophen) formulations in the United
States, Canada and Mexico.
2. The License Agreement dated as of December 23, 2002, between Pharmatop and BMS (the
Pharmatop License Agreement) sets forth such rights.
3. BMS desires to sublicense to Cadence BMSs intellectual property rights and related
obligations under the Pharmatop License Agreement to Cadence with respect to the Territory (as
defined below) upon the terms and conditions set forth in this Agreement and to provide for certain
other matters.
AGREEMENT
THEREFORE, the Parties, intending to be legally bound, agree as follows:
ARTICLE
I DEFINITIONS
1.1 Defined Terms. As used in this Agreement, the following terms shall have the
following meanings:
Adverse Event means any untoward medical occurrence in a patient or clinical investigation
subject administered any Product, and which does not necessarily have a causal relationship with
such product. An adverse event can therefore be any unfavorable and unintended sign (including an
abnormal laboratory finding, for example),
symptom or disease temporally associated with the use of a medicinal product, whether or not
considered related to the medicinal product. For the avoidance of doubt, in the U.S. an Adverse
Event shall include an adverse experience or test result in connection with the use of the Product
that requires a written IND safety report in accordance with 21 CFR Part 312.32(c), as amended or
superseded from time to time.
Affiliated Company of a Party means any corporation, firm, partnership or other entity that
directly or indirectly Controls, is Controlled by or is under common Control with such Party at any
time during the term of this Agreement, but only for so long as such entity directly or indirectly
Controls, is Controlled by or is under common Control with such Party.
Agreement has the meaning given to such term in the introductory paragraph hereof.
Annual Operating Plan has the meaning given to such term in Section 3.1 hereof.
[***] has the meaning given to such term in Section 3.2 hereof.
Applicable Law means any applicable federal, state, local or foreign statute, law,
ordinance, rule or regulation, judicial order, or industry standard imposed by regulation or law,
including the laws of the United States and Canada, and regulations promulgated by any other
applicable Governmental Entity or Drug Regulatory Authority.
Approval means, with respect to any Product in any regulatory jurisdiction, approval from
the applicable Drug Regulatory Authority sufficient for the importation, manufacture, distribution,
use and sale of the Product in such jurisdiction in accordance with Applicable Law, including
receipt of pricing and reimbursement approvals, where applicable.
Available [[***] has the meaning set forth in Section 2.24(a).
Balance Sheet has the meaning given to such term in Section 6.2(b) hereof.
Balance Sheet Date has the meaning given to such term in Section 6.2(b) hereof.
Bankruptcy means with respect to a Party the first to occur of:
(i) such Party shall have (A) voluntarily commenced any proceeding or filed any petition seeking
relief under Title 11 of the United States Code, or any other bankruptcy, insolvency or similar law
or any law for the protection of creditors of the United States, any state thereof, or any other
applicable jurisdiction, (B) applied for or consented to the appointment of a receiver, trustee,
custodian, sequestrator, conciliator, administrator or similar official for it or a substantial
part of its property, (C) filed an answer admitting the material allegations of a petition filed
against or in respect of it in any such proceeding, (D) made a general assignment for the benefit
of creditors, (E) admitted in writing its inability, to pay its debts as they become due or (F)
taken corporate action for the purpose of effecting any of the foregoing; or
(ii) an involuntary proceeding shall have been commenced or any involuntary petition
shall have been filed in a court of competent jurisdiction seeking (A) relief in respect of
such Party or of a substantial part of its or their property, under Title 11 of the
|
|
|
*** |
|
Certain information on this page has
been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions. |
2
United
States Code, or any other bankruptcy, insolvency or similar law of the United States, any
state thereof or any other applicable jurisdiction, (B) the appointment of a receiver,
trustee, custodian, sequestrator, conciliator, administrator or similar official for such
Party or all or substantially all of its property or (C) the winding-up or liquidation of
such Party; and such proceeding or petition shall have continued undismissed for 60 days or
an order or decree approving or ordering any of the foregoing shall have continued unstayed
and in effect for 30 days.
BMS has the meaning given to such term in the introductory paragraph hereof.
[***] means (i) [***]and (ii) [***].
BMS Indemnitees has the meaning given to such term in Section 7.2 hereof.
BMS Know-How means formulation and manufacturing know-how that is used by BMS and its
Affiliated Companies as of the Execution Date or during the Supply Term (as defined in the Clinical
Supply Agreement) to make or formulate the Product or the Clinical Testing Products (as defined in
the Clinical Supply Agreement) in the European Union.
BMS Patent Product means any Product for which the manufacture, use, import, sale or offer
for sale in the United States would otherwise infringe a Valid Claim of any of the BMS Patents but
for the license rights granted by BMS in Article 2 hereof.
BMS Patent Royalty Term means the date commencing upon the expiration of the Pharmatop
Royalty Term in the United States and terminating upon the date that the manufacture, use, import,
sale or offer for sale of BMS Patent Products in the United States is no longer covered by any
Valid Claim of a BMS Patent (including any patent term extensions, such as pediatric exclusivity
extensions, as may be available under Applicable Law) or covered by any data or regulatory
exclusivity.
BMS Patents means the Patents listed on Schedule 1.1.
BMS Rights means (i) BMSs rights under the Pharmatop Patents and Pharmatop Know-How with
respect to the Products in the Territory licensed to BMS under the Pharmatop License Agreement
during the term of this Agreement, subject to the
limitations, terms and conditions set forth in the Pharmatop License Agreement and (ii) the
right granted to BMS in Section 2.1 of the Pharmatop License Agreement to make and have made the
Products outside the Territory for use within the Territory.
Business Day means any day other than a Saturday, a Sunday or a United States Federal
holiday.
Cadence has the meaning given to such term in the introductory paragraph hereof.
|
|
|
*** |
|
Certain information on this page has
been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions. |
3
Cadence Claims has the meaning given to such term in Section 6.2(d) hereof.
Cadence Indemnitees has the meaning given to such term in Section 7.3 hereof.
Calendar Quarter means each of the periods of time from (a) January 1 through March 31; (b)
April 1 through June 30; (c) July 1 through September 30; and (d) October 1 through December 31.
Calendar Year means a year that begins on January 1 and ends on December 31.
[***] has the meaning set forth in Section 2.1(c)(i).
[***] has the meaning set forth in Section 2.24(d).
[***] has the meaning set forth in Section 2.24(a).
[***] has the meaning set forth in Section 3.2(f).
Clinical Study Countries means the countries set forth on a list of such countries that has
been Previously Disclosed, as such list is amended from time to time in accordance with the last
paragraph of Section 3.6.
Clinical Supply Agreement means the Clinical Supply Agreement dated as of the Execution Date
between Lawrence Laboratories and Cadence (and BMS, as guarantor).
Clinical Testing Product has the meaning set forth in the Clinical Supply Agreement.
Confidential Information means (a) with respect to a Party and its Affiliated Companies
(collectively, the Receiving Party), all information, Technology and confidential or proprietary
materials which are disclosed by the other Party and its Affiliated Companies (collectively, the
Disclosing Party) to the Receiving Party hereunder or under the Clinical Supply Agreement or that
has previously been disclosed under the Mutual Confidential Disclosure Agreement between the
Parties dated July 6, 2005, as amended, or to any of its employees, consultants, Affiliated
Companies or sublicensees and any information that
is considered Confidential Information for purposes of the Clinical Supply Agreement, (b) the
Product Data, which shall be Confidential Information of BMS to the extent resulting from work,
trials or studies conducted by or on behalf of BMS and which shall be Confidential Information of
Cadence to the extent resulting from work, trials or studies conducted by or on behalf of Cadence,
(c) correspondence with Drug Regulatory Authorities, which shall be Confidential Information of the
Party that conducted such correspondence, and (d) all reports (including any development,
commercialization and/or financial reports), plans (including the Development Plan and the Annual
Operating Plan) and other documents and budgets provided by Cadence and/or its Affiliated Companies
to BMS pursuant to this Agreement, all of which shall be considered Confidential Information of
Cadence except, in each of (a), (b),(c) or (d), to the extent that any such information (i) as of
the date of disclosure is known to the Receiving Party
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or its Affiliated Companies, as demonstrated
by credible written documentation existing and in the possession of the Receiving Party prior to
the date of disclosure, other than by virtue of a prior confidential disclosure to such Receiving
Party; (ii) as of the date of disclosure is in, or subsequently enters, the public domain, through
no fault or omission of the Receiving Party; (iii) is obtained without restriction from a Third
Party having a lawful right to make such disclosure free from any obligation of confidentiality to
the Disclosing Party; or (iv) is independently developed by or for the Receiving Party without
reference to or reliance upon any Confidential Information of the Disclosing Party as demonstrated
by credible written documentation. The amount of the payments made to BMS under this Agreement
shall be Confidential Information of both BMS and Cadence. A Partys Affiliated Company that has
disclosed Confidential Information to a Receiving Party
shall continue to be considered a
Disclosing Party even after it ceases to be an Affiliated Company of such Party. A Partys
Affiliated Company that has received Confidential Information from a Disclosing Party shall
continue to be considered a Receiving Party even after it ceases to be an Affiliated Company of
such Party.
Consent has the meaning given to such term in Section 6.1(d) hereof.
Contract Research Organization means a reputable Third Party research or development
organization one of whose principal businesses is the provision of contract research or development
services to unrelated Persons.
Contracts means all contracts, agreements, commitments and other legally binding
arrangements, whether oral or written.
Control means (a) with respect to any intellectual property (including any Patents or
Technology), the possession by a Party of the ability to grant a license or sublicense of such
intellectual property without violating the terms of, or requiring a consent under, any agreement
or arrangement between such Party and any Third Party and (b) when used with respect to any Person
means the power to direct or cause the direction of the management or policies of such Person,
directly or indirectly, whether through the ownership of voting securities, by contract, or
otherwise. Controlled and Controlling shall have correlative meanings.
Covenant Termination Date has the meaning set forth in Section 2.24(c).
Derivative of paracetamol means any compound whose chemical structure is derived from the
chemical structure for paracetamol through structural modifications and/or chemical changes that
retain those portions of paracetamols chemical structure that are known to contribute materially to the activity, specificity and selectivity of
paracetamol.
Development Plan has the meaning given to such term in Section 3.3 hereof.
Disclosing Party has the meaning given to such term in the definition of Confidential
Information herein.
Dispute has the meaning given to such term in Section 7.6 hereof.
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Dollar or $ means United States dollars, the lawful currency of the United States.
Drug Regulatory Authority means any Governmental Entity with responsibility for granting any
licenses, approvals or authorizations or granting pricing and/or reimbursement approvals necessary
for the marketing and sale of pharmaceutical products in any regulatory jurisdiction.
Effective Date has the meaning given to such term in the introductory paragraph hereof.
Exchange Act means the Securities Exchange Act of 1934, as amended from time to time.
[***] Date means [***] on which (i) [***], (ii) [***] or (iii) [***]; provided that (A)
[***] and (B) [***].
[***] Period means the [***] not include any period during which [***].
[***] Date has the meaning given to such term in Section 2.1(c).
Execution Date has the meaning given to such term in the introductory paragraph hereof.
FDA means the United States Food and Drug Administration or any successor agency.
FDCA means the Federal Food, Drug & Cosmetics Act, 21 U.S.C. 321 et seq., any amendments or
supplements thereto, or any regulations promulgated or adopted thereunder or any successor act
thereof.
Financial Statements has the meaning given to such term in Section 6.2(a) hereof.
Force Majeure has the meaning given to such term in Section 9.6(b) hereof.Governmental
Entity means any Federal, state, local or foreign government or any court of competent
jurisdiction, regulatory or administrative agency or commission or other governmental authority or
instrumentality, domestic or foreign.
HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
ICC has the meaning given to such term in Section 7.6(a) hereof.
Improvement means any adaptation, improvement, enhancement or upgrade with respect to the
formulation and/or manufacture of the Products, whether such Improvement can be protected by patent
or not.
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In Accordance With GAAP has the meaning given to such term in Section 6.2(a) hereof.
IND means an Investigational New Drug Application (as defined in 21 CFR Part 312.3, as
amended or superseded from time to time) that is required to be filed with the FDA before beginning
clinical testing of a Product in human subjects in the United States, or any successor application
or procedure.
Indemnified Party has the meaning given to such term in Section 7.4 hereof.
Indemnifying Party has the meaning given to such term in Section 7.1 hereof.
Indemnitees has the meaning given to such term in Section 7.1 hereof.
Judgments has the meaning given to such term in Section 6.1(d) hereof.
License has the meaning given to such term in Section 2.1(a) hereof.
Lien means any pledge, encumbrance, mortgage, security interest, purchase option, call or
similar right.
Loan Agreement has the meaning given to such term in Section 6.2(b) hereof.
Losses has the meaning given to such term in Section 7.1 hereof.
Material Adverse Effect means, with respect to any applicable representation and warranty of
a Party or to any other matter to which such phrase is applied, a material adverse change in or
effect on (i) such Partys (and its subsidiaries) business, operations, assets, condition
(financial or otherwise) taken as a whole or (ii) such Partys ability to perform its obligations
under any Transaction Document to which it is a party.
NDA means a new drug application or an abbreviated new drug application (as described in 21 CFR
314.50), including any amendments or supplements thereto, filed with
the FDA pursuant to the FDCA and includes any Common Technical Document for the Registration of
Pharmaceuticals for Human Use filed with the FDA or any Drug Regulatory Authority in Canada.
NDA Acceptance means the earlier of (i) the date Cadence receives written notice from the
FDA of acceptance by the FDA of an NDA filed by or on behalf of Cadence or its licensees with
respect to any Product in the United States, or (ii) sixty (60) days following filing of such NDA
with the FDA, provided that Cadence has not received a Notice of Refusal to File from the FDA
with respect to such NDA.
Net Sales means the total revenue invoiced by Cadence, its Affiliated Companies,
sublicensees, co-promotion and co-marketing partners and any other Person selling or promoting
Products on behalf of any such Person from the sale of a Product to independent Third Parties in
the Territory less the following amounts: (a) credits, allowances and rebates to, and chargebacks
from the account of, such customers for spoiled, damaged, out-dated and returned Product;
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(b) trade
discounts, cash discounts, quantity discounts, rebates and other price reduction programs, and
other charge back payments; (c) sales, value-added and other similar taxes (including duties or
other governmental charges levied on, absorbed or otherwise imposed on the sales of Products
including governmental charges otherwise measured by the billing amount); (d) customs duties,
surcharges and other governmental charges incurred in connection with the exportation or
importation of the Product; and (e) bad debts on Product sales written off in accordance with
generally accepted accounting principles, consistently applied. For the purposes of this
definition, samples distributed by Cadence, its Affiliated Companies, sublicensees, co-promotion
and co-marketing partners and any other Person selling or promoting Products on behalf of any such
Person to their customers free of charge, and any Product used or provided for clinical or research
purposes, shall not be included in Net Sales.
When Products are sold for monies other than Dollars, the monies due will first be determined
in the foreign currency of the country in which such Products were sold and then converted into
equivalent Dollars, on a monthly basis, using the applicable U.S. Federal Reserve rate in effect on
the last business day of each calendar month.
In the event that Cadence makes sales of Products to an Affiliated Company, sublicensee,
co-promotion or co-marketing partner or any other person selling or promoting Products on behalf of
any such Person, the calculation of Net Sales shall be based on the greater of (x) the revenue
received by Cadence from its sale of Products to the Affiliated Company, sublicensee, co-promotion
or co-marketing partner or other person selling or promoting Products on behalf of any such Person,
as the case may be, and (y) the revenue received by the Affiliated Company, sublicensee,
co-promotion or co-marketing partner or other person selling or promoting Products on behalf of any
such Person from its sale of Products to Third Parties.
[***] Date has the meaning set forth in Section 2.1(c).
[***] Date has the meaning set forth in Section 2.24(d).
Organizational Documents means, with respect to any Person at any time, such Persons
certificate or articles of incorporation, by-laws, memorandum and articles of association,
certificate of formation of limited liability company, limited liability company agreement, and other similar organizational or constituent documents, as
applicable, in effect at such time.
Other Chemical Entity means any chemical entity that is not parenteral paracetamol or a
Derivative thereof.
Other Reportable Information has the meaning set forth in Section 2.15(e).
Parties has the meaning given to such term in the introductory paragraph hereof.
Party has the meaning given to such term in the introductory paragraph hereof.
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Patents means, to the extent that they have been or are filed or issued in the Territory:
(a) patents and patent applications existing as of the Execution Date and/or at any time
thereafter; and (b) any divisionals, continuations, substitutions, continuations-in-part,
extensions, renewals, re-examinations or reissues of such patents and/or applications as of the
Execution Date and/or at any time thereafter.
Person means any individual, firm, corporation, partnership, limited liability company,
trust, joint venture, governmental authority or other entity.
Pharmatop has the meaning given to such term in Background.
Pharmatop Know-How means the Know-How (as such term is defined in the Pharmatop License
Agreement) licensed to BMS under the Pharmatop License Agreement.
Pharmatop License Agreement has the meaning given to such term in Background.
Pharmatop Patent Challenge has the meaning given to such term in Section 2.16(a).
Pharmatop Patents means the Licensed Patents (as such term is defined in the Pharmatop
License Agreement) filed or issued in the Territory and licensed to BMS under the Pharmatop License
Agreement.
Pharmatop Royalty Term means, with respect to each country in the Territory on a
country-by-country basis, the date commencing with the date of first commercial sale of a Product
in such country, and terminating upon the latest of (a) the date that is ten (10) years after such
first commercial sale in such country, (b) the date that the manufacture, use and sale of a Product
in such country is no longer covered by any Valid Claim of a Pharmatop Patent in such country
(including any patent term extensions, such as pediatric exclusivity extensions, as may be
available under Applicable Law) or (c) the date that the obligation of BMS to pay royalties to
Pharmatop (or any successor licensor), pursuant to the Pharmatop License Agreement, terminates.
Previously Disclosed means with respect to any document or information, a document or
information set forth in a mutually agreed letter or memorandum delivered by Cadence or BMS to the other contemporaneously with the execution of this
Agreement which identifies such document or information as Previously Disclosed for purposes of
this Agreement.
Proceedings has the meaning given to such term in Section 6.1(e) hereof.
Product means (i) any parenterally administered dosage form containing paracetamol (or any
Derivative thereof) alone or in combination with one or more other drugs (as defined, as of
December 23, 2002, in Section 201 of the FDCA), and for which the manufacture, use or sale in a
country in the Territory (x) would otherwise infringe any of the Pharmatop Patents or BMS Patents
but for the license rights granted by BMS in Article 2 hereof, and/or (y) incorporates or uses to
any material extent any Pharmatop Know-How and/or (ii) any parenterally administered dosage form
containing paracetamol (or any Derivative thereof) alone or in combination with
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one or more other
drugs (as defined, as of December 23, 2002, in Section 201 of the FDCA) that is manufactured by a
process that incorporates or uses to any material extent any BMS Know-How. When used with respect
to any jurisdiction outside the Territory, Product shall refer to any parenterally administered
dosage form containing paracetamol (or any Derivative thereof) alone or in combination with one or
more other drugs (as defined, as of December 23, 2002, in Section 201 of the FDCA).
Product Data means data, information and conclusions resulting from any analytical,
galenical, stability, toxicology or pharmacokinetic work and/or clinical studies and/or clinical
trials relating to, or conducted by or on behalf of BMS or Cadence and filed in support of,
Approval of Products in the United States.
Qualifying [***] means a [***], with respect to which [***].
Qualifying [***] means any [***] (i) [***], (ii) [***], and (iii) [***].
Receiving Party has the meaning given to such term in the definition of Confidential
Information herein.
Registrational Information has the meaning set forth in the Pharmatop License Agreement.
Regulatory Filings means, collectively, any and all INDs, NDAs or any other filings
(including any foreign equivalents) as may be required by any Drug Regulatory Authority for the
development, manufacture or commercialization of Products, as applicable.
[***] Product has the meaning given to such term in Section 2.24(b) hereof.
Royalties has the meaning given to such term in Section 4.1(h) hereof.
Rules has the meaning given to such term in Section 7.6(a) hereof.
[***] has the meaning given to such term in Section 2.24(a).
[***] has the meaning set forth in Section 2.24(a).
Specified Number of Days has the meaning given to such term in Section 8.3.
Sublicense has the meaning given to such term in Section 2.1(a) hereof.
Tax means all taxes, charges, fees, levies or other assessments, and all estimated payments
thereof, including income, excise, license, severance, stamp, occupation, premium, profits,
windfall profits, customs duties, capital stock, employment, disability, registration, alternative
or add-on minimum, property, sales, use, value added, environmental, franchise, payroll, transfer,
gross receipts, withholding, social security or similar unemployment taxes, and any other tax of
any kind whatsoever, imposed by any federal, state, local or foreign
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governmental authority,
including any interest, penalties and additions to tax relating to such taxes, charges, fees,
levies or other assessments.
Tech Transfer Period has the meaning given to such term in Section 2.12 hereof.
Tech Transfer Plan has the meaning given to such term in Section 2.10 hereof.
Technology means and includes all inventions, discoveries, Improvements, trade secrets,
know-how, processes, procedures, research records, records of inventions, test information, market
surveys and other similar proprietary methods, materials or property, whether or not patentable,
relating to Products, including (a) samples of, methods of production or use of, and structural and
functional information pertaining to, chemical compounds, proteins or other biological substances,
(b) data, formulations, techniques and know-how (including any negative results), and (c) rights
under patents, patent applications and copyrights.
Technology Documentation means a written description of the BMS Know-How.
Territory means the United States (including Puerto Rico and all U.S. possessions and
territories) and Canada.
Third Party means any Person other than Cadence, BMS and their respective Affiliated
Companies.
Title 11 has the meaning given to such term in Section 8.10 hereof.
Transaction Documents means this Agreement and the Clinical Supply Agreement.
Transfer Taxes means taxes and assessments imposed upon the transfer, such as transfer,
sales, value added, and stamp taxes, and not Taxes measured by income or gain, but including any
interest, penalties or other additions thereto.
[***] has the meaning set forth in Section 2.24(a).
[***] has the meaning set forth in Section 2.24(a).
Valid Claim means a claim in any unexpired issued Pharmatop Patent or BMS Patent that has
not been held invalid or unenforceable by a non-appealed or unappealable decision by a court or
other appropriate body of competent jurisdiction, and which is not admitted to be invalid through
disclaimer, dedication to the public, and which has not been cancelled or abandoned in accordance
with and as permitted by (i) both the terms of this Agreement and the Pharmatop License Agreement
in the case of the Pharmatop Patents, or (ii) the terms of this Agreement in the case of the BMS
Patents.
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ARTICLE
II GRANT OF U.S. AND CANADIAN RIGHTS AND RELATED TRANSFERS
2.1 Grant of Sublicense and License .
(a) Effective as of the Effective Date and subject to Section 3.4 and the reservation of
rights set forth in Section 2.2 and subject to early termination as provided in Article VIII, BMS
hereby grants to Cadence on behalf of itself and its Affiliated Companies:
(i) subject to the terms, conditions and limitations set forth in the Pharmatop License
Agreement and subject to Section 2.1(c):
(A) an exclusive (even as to BMS), royalty-bearing sublicense under the BMS Rights with
the right to sublicense as provided in Section 2.4, to import, use, sell and offer for sale
Products in the Territory;
(B) an exclusive (even as to BMS) sublicense under the BMS Rights, with the right to
sublicense as provided in Section 2.4, to make and have made the Products in the Territory
solely for (1) import, use, sale and offer for sale within the Territory or (2) import and
use in clinical trials in the Clinical Study Countries as permitted by Section 3.6; and
(C) an exclusive (even as to BMS) sublicense under the BMS Rights, with the right to
sublicense as provided in Section 2.4, to make and have made the Products anywhere in the
world solely for (1) import, use, sale and offer for sale within the Territory, subject to
the limitations set forth in Section 2.1 of the Pharmatop License Agreement (other than the
consent of UPSA S.A., which has been obtained as of the Effective Date) and subject to
Section 3.8, or (2) import or use in Cadences clinical trials in the Clinical Study
Countries as permitted by Section 3.6 hereof;
(ii) a non-exclusive license under the BMS Patents, with the right to sublicense as provided
in Section 2.4, to import, use, sell and offer for sale Products in the Territory; provided,
however, that the license granted in this paragraph shall not grant any right to the composition of
matter of any Other Chemical Entity, or the right to import, use, sell or offer for sale any Other
Chemical Entity or to any use not claimed by the BMS Patents;
(iii) a non-exclusive license under the BMS Patents, with the right to sublicense as provided
in Section 2.4, to make and have made the Products in the Territory solely for import, use, sale
and offer for sale within the Territory; provided, however, that the license granted in this
paragraph shall not grant any right to the composition of matter of any Other Chemical Entity, or
the right to make or have made any Other Chemical Entity or to any use not claimed by the BMS
Patents;
(iv) a non-exclusive license under the BMS Know-How, with the right to sublicense as provided
in Section 2.4, to make and have made the Products anywhere in the world solely for (1) use and
sale within the Territory and (2) import and use in clinical trials in the Clinical Study Countries
as permitted by Section 3.6; and.
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(v) a non-exclusive right to use, copy, translate, display and distribute (subject to any
confidentiality obligations), improve and make derivative works of the BMS Technology Documentation
for the purpose of making and having made the Products consistent with the license set forth above
with respect to the BMS Know-How.
The sublicenses granted in Section 2.1(a)(i) are referred to herein collectively as the
Sublicense), and the licenses granted in Sections 2.1(a)(ii), (iii), (iv) and (v) are referred to
herein collectively as the License).
The Sublicense granted to Cadence hereby shall only permit Cadence to sell Products that are
packaged, finished products ready for use, and the Sublicense shall not extend to any sales in bulk
or of semi-finished products except to permitted sublicensee(s) of Cadence. Except as may be
otherwise agreed in writing by BMS in its sole discretion, the License granted to Cadence hereby
shall only permit Cadence to sell Products that are packaged, finished products ready for use, and
the License shall not extend to any sales in bulk or of semi-finished products except to permitted
sublicensee(s) of Cadence.
(b) Cadence hereby (i) accepts such Sublicense and License, (ii) acknowledges that the
Sublicense rights granted hereunder are subject and subordinate to the rights of Pharmatop under,
and all the terms and conditions of, the Pharmatop License
Agreement and (iii) agrees to comply with all the restrictions of the Pharmatop License
Agreement that relate to the exercise of the rights sublicensed to Cadence hereunder.
(c) If on the [***], then [***]; provided that:
(i) [***] (A) Cadence may [***] and (B) such [***]. Cadence shall provide to BMS
evidence reasonably satisfactory to BMS of the accuracy of such report. Notwithstanding the
foregoing, [***] (A) [***] or (B) [***]. In the event [***] as provided in this Section
2.1(c).
(ii) Such [***].
(iii) Such [***].
Each date, if any, as of which such [***].
(d) Any Affiliated Companies on whose behalf BMS has made any of the foregoing license grants
that hereafter ceases to be an Affiliated Company of BMS shall nevertheless continue to be
obligated under such license grants in accordance with the terms of this Agreement.
2.2 No Implied Licenses; Reservation of Rights .
(a) Cadence shall have no licenses or other rights other than those expressly granted in this
Agreement, and, in particular and without limiting the foregoing, nothing in this
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Agreement shall
be construed to grant Cadence any licenses or other rights in any intellectual property rights,
information or data (i) owned or Controlled by BMS or any of its Affiliated Companies, except as
expressly set forth in this Agreement or (ii) owned or Controlled by Pharmatop or any of its
Affiliated Companies that is not licensed by Pharmatop to BMS under the Pharmatop License
Agreement.
(b) Cadence acknowledges that BMS or one or more of its Affiliated Companies holds certain
license rights from Pharmatop (whether under the Pharmatop License Agreement or otherwise) relating
to countries outside the Territory, and, except for the right of cross-reference provided for in
Section 2.8(d), the rights granted to Cadence under this Agreement do not include any license or
other rights with respect to such other rights of BMS and its Affiliated Companies, all of which
are expressly reserved to BMS and its Affiliated Companies.
(c) Notwithstanding the [***], BMS hereby reserves the non-exclusive, sublicensable right
under the BMS Rights, BMS Patents and BMS Know-How (i) to make and have made the Products in the
Territory for supply to Cadence, or to the extent otherwise necessary or appropriate for BMS or any
of its Affiliated Companies or sublicensees to perform
its obligations, under the Clinical Supply Agreement, (ii) to make and have made the Products
anywhere in the world for import, use, sale and offer for sale outside the Territory and (iii) to
import, make, have made and use Products in the Territory for any non-clinical or clinical research
purpose of BMS and its Affiliated Companies (subject, to the extent applicable, to Section 3.7) or
in support of any Regulatory Filings or other activities outside the Territory (subject, to the
extent applicable, to Section 3.7); provided that the rights reserved pursuant to clause (iii)
above shall not be sublicensable.
(d) BMS is not sublicensing or granting to Cadence, and Cadence acknowledges and agrees that
it is not receiving any rights under Section 2.10 or the proviso of the last sentence of Section
2.3 of the Pharmatop License Agreement, all of which are reserved to BMS.
(e) BMS shall have no licenses or other rights other than those expressly granted in this
Agreement, and, in particular and without limiting the foregoing, nothing in this Agreement shall
be construed to grant BMS any licenses or other rights in any intellectual property rights,
information or data owned or Controlled by Cadence or any of its Affiliated Companies, except as
expressly set forth in this Agreement.
2.3 Rights of Pharmatop .
(a) Nothing in this Agreement shall reduce or limit any of Pharmatops rights under the
Pharmatop License Agreement.
(b) Pharmatop shall have the same right to supervise the activities of Cadence hereunder as
Pharmatop has with respect to BMSs activities under the Pharmatop License Agreement.
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(c) Pharmatop shall have the same rights to audit Cadences (and any of its sublicensees)
activities relevant to this Agreement, and to inspect Cadences (and any sublicensees) facilities
involved in the manufacture of Products, in the same manner as Pharmatop has with respect to BMSs
activities and facilities under the Pharmatop License Agreement.
2.4 Further Sublicenses.
(a) Except as set forth in Section 2.5, the rights licensed to Cadence under Section 2.1 shall
be sublicensable to a Third Party [***] (except to the extent otherwise agreed to by BMS in writing
in its sole discretion, which writing shall, to the extent applicable, specifically waive
compliance with this Section 2.4(a)): (i) such sublicense shall refer to this Agreement and shall
be subject and subordinate to this Agreement and, with respect to the Sublicense, the Pharmatop
License Agreement, (ii) the sublicensee shall assume and agree in writing to be bound by and comply
with the terms and conditions of this Agreement in the same manner as Cadence, and without limiting
the generality of the foregoing to maintain insurance coverage at the same levels and on the same
terms and conditions as set forth in Section 7.5, provide sales reports pursuant to Section 4.7
hereof and keep books and records and permit BMS to review such books and records pursuant to
Section 4.8 hereof, (iii) BMS shall be made an express third party beneficiary of the sublicensees
obligations under such sublicense that relate to compliance
with the terms and conditions of this Agreement with the express right to enforce the same
directly against the sublicensee, (iv) a copy of the proposed sublicense (except that any
confidential financial terms may be redacted) shall be provided to BMS at the time Cadence seeks
BMSs consent to such sublicense as aforesaid, (v) an executed copy of the sublicense (except that
any confidential financial terms may be redacted) shall be provided to BMS promptly after
execution, (vi) each sublicense or other right granted by Cadence with respect to any right
licensed to it hereunder shall terminate immediately upon the termination of the Sublicense or
License from BMS to Cadence with respect to such right; and (vii) such sublicensees shall not have
the right to grant further sublicenses or otherwise transfer any rights sublicensed to them with
respect to the Products except in accordance with and subject to this Section 2.4 and all of the
other terms and conditions of this Agreement. The foregoing shall also apply in the event of any
subsequent amendment or modification of such sublicense agreement. In the event Cadence desires to
effect any such sublicense, it shall provide BMS with such information concerning the proposed
arrangement as BMS may reasonably request. BMS shall use reasonable efforts to provide its
response within [***] ([***])[***] (or, if BMS so requests, [***] ([***])[***]) after receiving
such information. The failure of BMS to consent to or disapprove of such proposed sublicense
within such [***] period shall not constitute a consent to such sublicense.
(b) Cadence may grant sublicenses to its Affiliated Companies under the Sublicense and the
License [***], subject, in the case of a sublicense of rights licensed to Cadence pursuant to the
Sublicense, to compliance with the Pharmatop License, and then shall be sublicensable only as
follows (except to the extent otherwise agreed to by BMS in writing in its sole discretion, which
writing shall, to the extent applicable, specifically waive compliance
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with this Section 2.4(a)):
(i) such sublicense shall be subject and subordinate to this Agreement and, with respect to the
Sublicense, the Pharmatop License Agreement, (ii) such sublicense shall terminate immediately in
the event such Affiliated Company ceases to be an Affiliated Company of Cadence, (iii) an executed
copy of the sublicense shall be provided to BMS promptly after execution, (iv) each sublicense or
other right granted by Cadence with respect to any right licensed to it hereunder shall terminate
immediately upon the termination of the Sublicense or License from BMS to Cadence with respect to
such right and (v) such sublicensees shall not have the right to grant further sublicenses or
otherwise transfer any rights sublicensed to them with respect to the Products except in accordance
with and subject to this Section 2.4 and all of the other terms and conditions of this Agreement.
The foregoing shall also apply in the event of any subsequent amendment or modification of such
sublicense agreement. Without limiting any of Cadences responsibilities under Section 2.4(c),
Cadence shall cause its Affiliated Company to comply with the terms and conditions of this
Agreement in the same manner as Cadence.
(c) Cadence shall be primarily responsible for all payments due and the making of reports
under this Agreement by its sublicensees and for compliance with all applicable terms of this
Agreement, and Cadence shall remain jointly and severally liable with each of its sublicensees
(whether or not such sublicensee is an Affiliated Company of Cadence) for any failure by such
sublicensee to perform, observe or comply with the terms and conditions of this Agreement or the
Pharmatop License Agreement.
(d) Any purported sublicense hereunder not entered into in compliance with this Section 2.4
shall be null and void and without effect.
(e) Cadence or its Affiliated Companies may engage a Third Party, including a contractor,
consultant, or Contract Research Organization, to perform research or development activities with
respect to Products on behalf of Cadence or its Affiliated Companies and such activities shall not
be deemed a sublicense if no rights under the BMS Rights, BMS Patents or BMS Know-How are licensed
or granted; provided, that (i) none of the rights of BMS hereunder are diminished or otherwise
adversely affected as a result of such engagement, (ii) any such Third Party shall enter into an
appropriate written agreement obligating such Third Party to be bound by obligations of
confidentiality and restrictions on use of Confidential Information that are no less restrictive
than the obligations in this Agreement; and (iii) Cadence shall at all times be responsible for the
performance of such Third Party. Cadence shall use all reasonable efforts to cause such Third
Party to agree in writing to assign to Cadence inventions made by such Third Party in performing
such services for Cadence.
2.5 Delegation of Manufacturing. Subject to the scope of the rights granted to
Cadence in the Sublicense and the License and subject to Section 3.8, Cadence may arrange by
written agreement to have the Products manufactured by a Third Party manufacturer without the prior
consent of BMS but subject to compliance with the Pharmatop License Agreement with respect to
sublicensing, if applicable, and subject to clauses (i), (iii), (v), (vi) and (vii) of Section
2.4(a) and the provision to BMS of a copy of the agreement or agreements relating to such
manufacturing arrangement (subject to redaction of confidential financial terms) promptly after the
execution thereof. If the Products are manufactured by a Third Party manufacturer (other than
pursuant to the Clinical Supply Agreement), Cadence shall notify BMS and Pharmatop and shall
provide BMS and Pharmatop with the identity of each such manufacturer
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and provide proof to BMS and
Pharmatop that (a) each such manufacturer has been informed in writing that the products to be made
are subject to the Licensed Patents (as defined in the Pharmatop License Agreement) held by
Pharmatop and (b) each such manufacturer has agreed to manufacture the Products only pursuant to a
written agreement with Cadence and solely for the benefit of Cadence and its sublicensees. In
addition Cadence shall use reasonable efforts to have such Third Party agree in writing to assign
or license to Cadence Improvements made by such Third Party with respect to the manufacture of the
Products, which license if obtained by Cadence shall include the right to sublicense such rights to
BMS and Pharmatop as contemplated by Section 2.7. The above restrictions do not apply to raw
materials, packaging items or other incidental articles from outside suppliers, or to the
performance of packing operations in accordance with customary practices in the pharmaceutical
industry.
2.6 Development and Commercialization Arrangements. Cadence shall not enter into any
co-development or other development collaboration with any Third Party with respect to the Products
without the prior written consent of BMS. The engagement of a Contract Research Organization to
perform research or development services on behalf of Cadence or its Affiliated Companies, which
research is funded entirely by Cadence and its Affiliated Companies (and not indirectly by a Third
Party through Cadence or any of its Affiliated Companies), shall not constitute a co-development or
other development collaboration that requires the consent of
BMS. In the event Cadence enters into any co-promotion or co-marketing arrangement with any
Third Party with respect to the Products or any other arrangement with a Third Party whereby such
Third Party would distribute or commercialize any Product, Cadence shall include in the quarterly
reports provided to BMS pursuant to Section 3.2 information concerning the activities of the other
party to such co-promotion, co-marketing, distribution or commercialization arrangement. In
connection with any arrangement with a Third Party whereby such Third Party would distribute,
co-promote, co-market or otherwise develop or commercialize any Product (or collaborate with
Cadence in the development or commercialization of any Product), Cadence shall comply, and shall
cause such Third Party to comply, with all applicable terms and conditions of this Agreement and
the Pharmatop License Agreement. Cadence shall remain jointly and severally liable with any such
Third Party for any failure by such Third Party to perform, observe or comply with the terms and
conditions of this Agreement or the Pharmatop License Agreement.
2.7 Improvements.
(a) BMS shall inform Cadence in a timely manner of any Improvements made by Pharmatop (or any
Third Party sublicensees of Pharmatop) as to which BMS receives notice pursuant to Section 2.2 or
Article 8 of the Pharmatop License Agreement. If requested by Cadence, BMS will request that
Pharmatop license such Improvements to BMS and, upon receipt of such license, shall sublicense such
Improvements to Cadence on a non-exclusive, [***] basis ([***]), consistent with the license
thereof from Pharmatop and the Pharmatop License Agreement, to the extent not already covered by
the Sublicense.
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(b) BMS shall notify Cadence in writing of any Improvements made in whole or in part by its
(and its Affiliated Companies) employees, agents, sublicensees and Third Party manufacturers after
the Effective Date and Controlled and implemented by BMS and its Affiliated Companies. Upon the
request of Cadence, BMS shall grant Cadence a non-exclusive, [***] license to practice and use such
Improvements, including the right to grant sublicenses, anywhere in the world to make and have made
Products solely (i) to import, use, sale and offer for sale within the Territory and (ii) to import
and use in clinical trials in the Clinical Study Countries as permitted by Section 3.6. BMS shall
provide Cadence with such information in BMSs possession as may be reasonably requested by Cadence
in order to practice such Improvements.
(c) Cadence shall notify BMS and Pharmatop in writing of any Improvements made in whole or in
part by its (and its Affiliated Companies) employees, agents, sublicensees and Third Party
manufacturers after the Effective Date and Controlled and implemented by Cadence and its Affiliated
Companies, and Cadence shall license such Improvements to Pharmatop on the basis described in
Article 8 of the Pharmatop License Agreement. In addition, upon the request of BMS, Cadence shall
grant BMS a non-exclusive [***] license to practice and use such Improvements, including the right
to grant sublicenses, anywhere in the world (i) to make and have made the Products in the Territory
for supply to Cadence, or to the extent
otherwise necessary or appropriate for BMS or any of its Affiliated Companies or sublicensees
to perform its obligations, under the Clinical Supply Agreement, (ii) to make and have made the
Products anywhere in the world for import, use, sale and offer for sale outside the Territory and
(iii) to import, make, have made and use Products in the Territory for any non-clinical or clinical
research purpose of BMS and its Affiliated Companies (subject, to the extent applicable, to Section
3.7) or in support of any Regulatory Filings or other activities outside the Territory (subject, to
the extent applicable, to Section 3.7); provided that the rights granted pursuant to clause (iii)
above shall not be sublicensable. Cadence shall provide BMS with such information in Cadences
possession as may be reasonably requested by BMS in order to practice such Improvements.
2.8 Transfer of Regulatory Filings; Communications with Regulatory Authorities .
(a) As of the Effective Date, BMS hereby cedes and assigns to Cadence all right, title and
interest in and to the Regulatory Filings with Drug Regulatory Authorities in the Territory
relating to the Products and shall use reasonable efforts to take any actions with the applicable
Drug Regulatory Authority in the Territory that are necessary to transfer ownership and control of
such Regulatory Filings to Cadence not later than five (5) days after the Effective Date.
(b) During the [***]([***])[***] period following the Effective Date, BMS shall transfer to
Cadence copies of all Regulatory Filings with Drug Regulatory Authorities in the Territory relating
to Products and shall provide Cadence with copies of all material correspondence with Drug
Regulatory Authorities in the Territory relating to Products. Following the Effective Date,
Cadence shall have sole responsibility for (i) communicating with Drug Regulatory Authorities in
the Territory with respect to Products, including responsibility for all Regulatory Filings in the
Territory and all associated official correspondence and informal
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communications, and (ii) subject
to Section 2.15, reporting to Drug Regulatory Authorities in the Territory any Adverse Event
relating to Products in compliance with the requirements of Applicable Law in the Territory. If
BMS maintains such Regulatory Filings and correspondence in electronic form, BMS shall provide such
copies to Cadence in electronic form, but BMS shall have no obligation to reformat or otherwise
alter or modify any materials or to create or recreate any such materials in electronic form in
order to provide them to Cadence.
(c) BMS and its Affiliated Companies and licensees and, subject to the terms of Sections 3.1
and 3.3 of the Pharmatop License Agreement, Pharmatop shall have a right to cross-reference, file
or incorporate by reference any Regulatory Filings in the Territory transferred hereunder or
subsequently made by Cadence and its Affiliated Companies and sublicensees with respect to Products
in the Territory (and any data contained therein) to support Regulatory Filings by BMS and its
Affiliated Companies and licensees for Products outside the Territory.
(d) Cadence and its Affiliated Companies and licensees shall have a right to cross-reference,
file or incorporate by reference any Regulatory Filings made by BMS and its Affiliated Companies
and sublicensees of the BMS Rights with respect to Products outside the Territory (and any data
contained therein) to support Regulatory Filings by Cadence and its
Affiliated Companies and licensees in the Territory (or Regulatory Filings in such additional
jurisdictions where Cadence may in the future acquire rights).
2.9 Transfer of Data and Transition Arrangements . Following the Effective Date:
(a) During the [***] ([***])[***] period following the Effective Date, BMS shall provide to
Cadence a copy of (i) all Product Data, (ii) other written information, data and reports in BMSs
possession that relate exclusively to the Products to the extent such information, data and reports
are necessary (in the reasonable judgment of both BMS and Cadence) to the development of the
Products in the Territory, and (iii) the full Marketing Authorization dossier submitted to Drug
Regulatory Authorities in the EU with respect to the Products (in non-Common Technical Document
format) and the variation dossiers submitted to Drug Regulatory Authorities in the EU with respect
to the Products after the initial Approval, including (1) with respect to Perfalgan (A) copies of
the applicable clinical study reports (and the appendices, tables, listings and graphs therein),
(B) copies of the raw data from the applicable clinical studies included in the Marketing
Authorization Application, (C) to the extent available, rendered PDF copies of such clinical study
reports (and such appendices, tables, listings and graphs) and (D) to the extent available, SAS
data sets containing such raw data and (2) with respect to ProDafalgan, to the extent they exist,
(A) copies of the applicable clinical study reports (and the appendices, tables, listings and
graphs therein), (B) copies of the raw data from the applicable clinical studies included in the
Marketing Authorization Application, (C) rendered PDF copies of such clinical study reports (and
such appendices, tables, listings and graphs) and (D) SAS data sets containing such raw data, but
only to the extent such information, data and reports described in clauses (i), (ii) and (iii)
above are reasonably available to BMS or its Affiliated Companies without undue searching (the
information, data and reports described in clauses (ii) and (iii) above being referred to herein as
Other Product Data); provided,
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however, that the foregoing shall in no event require BMS or its
Affiliated Companies to provide copies of laboratory notebooks or manufacturing run records
required to be maintained by BMS or its Affiliated Companies under Applicable Law. If BMS or its
Affiliated Company maintains such Product Data or Other Product Data in electronic form, BMS shall
provide such copies to Cadence in electronic form, but BMS shall have no obligation to reformat or
otherwise alter or modify any materials or to create or recreate any such materials in electronic
form in order to provide them to Cadence. BMS shall retain ownership of such Product Data and
Other Product Data, may retain a copy of the Product Data and Other Product Data and retains the
right to use and reference such Product Data and Other Product Data for any purpose to the extent
consistent with BMSs other retained rights and the rights granted to Cadence hereunder, including
the right to cross-reference, file or incorporate by reference such Product Data and Other Product
Data and to assign, transfer or license to other Persons any or all of such rights of use and
reference. Cadence shall have the right to use such Product Data and Other Product Data for any
purpose in connection with the exercise of the rights granted to Cadence under this Agreement. In
the event that any such Regulatory Filing is supplemented or modified, BMS shall notify Cadence
that supplements or modifications have been made not later
than [***] ([***])[***] after such supplementation or modification, and BMS shall provide
Cadence with copies thereof upon Cadences request.
(b) Cadence shall notify BMS in writing of the completion of any additional registrational
clinical trials or studies (Phase I Phase III) or large-scale safety studies performed by or on
behalf of Cadence relating to Products within [***]([***])[***] after the final study report
relating to such trial or study has been completed and received all necessary internal Cadence
approvals in accordance with Cadences customary procedures. Cadence shall provide BMS
semi-annually with copies of any such final study reports and copies of the final study reports
relating to any non-registrational clinical trials or studies performed by or on behalf of Cadence
relating to Products that have received all necessary internal Cadence approvals in accordance with
Cadences customary procedures, in each case that have received such necessary approvals in the
preceding semi-annual period, and BMS and its Affiliated Companies and licensees shall have a right
to cross-reference, file or incorporate by reference such final study reports and any existing or
future Regulatory Filings (and any data contained therein) made or maintained by Cadence and its
Affiliated Companies for Products in the Territory (including the foreign equivalent of any NDA
relating to Products) to support Regulatory Filings by BMS and its Affiliated Companies and
licensees for Products outside the Territory and to use such final study reports, Regulatory
Filings and data for other commercially reasonable uses to support commercialization activities
outside the Territory. In the event that any such Regulatory Filing is supplemented or modified,
Cadence shall notify BMS that supplements or modifications have been made not later than
[***]([***])[***] after such supplementation or modification, and Cadence shall provide BMS with
copies thereof upon Cadences request.
(c) BMS shall notify Cadence in writing of the completion of any additional registrational
clinical trials or studies (Phase I Phase III) or large-scale safety studies done within the then
existing label performed by or on behalf of BMS relating to Products within [***]([***])[***] after
the final study report relating to such trial or study has been completed
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and received all
necessary internal BMS approvals in accordance with BMSs customary procedures. BMS shall provide
Cadence semi-annually with copies of any such final study reports and copies of the final study
reports relating to any non-registrational clinical trials or studies performed by or on behalf of
BMS relating to Products that have received all necessary internal BMS approvals in accordance with
BMSs customary procedures, in each case that have received such necessary approvals in the
preceding semi-annual period, and Cadence and its Affiliated Companies and licensees shall have a
right to cross-reference, file or incorporate by reference such final study reports and any
existing or future Regulatory Filings (and any data contained therein) made or maintained by BMS
and its Affiliated Companies for Products outside the Territory (including the foreign equivalent
of any NDA relating to Products) to support Regulatory Filings by Cadence and its Affiliated
Companies and licensees for Products in the Territory and to use such final study reports,
Regulatory Filings and data for other commercially reasonable uses to support commercialization
activities in the Territory.
(d) BMS shall provide Cadence with prompt written notice of any Registrational Information of
Pharmatop made available to BMS pursuant to Article III of the
Pharmatop License Agreement. To the extent permitted by the Pharmatop License Agreement,
Cadence and its Affiliated Companies and licensees shall have a right to cross-reference, file or
incorporate by reference any such Registrational Information to support Regulatory Filings by
Cadence and its Affiliated Companies and licensees for Products in the Territory, provided [***]
reimburses [***] directly (or indirectly through payment to [***]) [***] ([***]) of the [***] to
develop or obtain such Pharmatop Registrational Information consistent with Sections 3.1 and 3.3 of
the Pharmatop License Agreement.
2.10 Tech Transfer Plan. Within [***]([***])[***] of the Effective Date, the Parties
shall meet to develop a technology transfer plan (the Tech Transfer Plan) containing a plan and
schedule for transferring and otherwise providing Cadence access to the BMS Know-How and Technology
Documentation.
2.11 Technology Documentation. Pursuant to the Tech Transfer Plan, BMS shall provide
Cadence with one (1) copy (which may be in paper or electronic form as provided below) of the
Technology Documentation to which BMS or its Affiliated Companies have access to without undue
searching (unless such documents are material to the manufacture of the Products or Clinical
Testing Products in which case BMS shall use all reasonable commercial efforts to locate such
Technology Documentation); provided, however, that the foregoing shall in no event require BMS to
provide copies of laboratory notebooks or manufacturing run records required to be maintained by
BMS under Applicable Law (other than one blank batch record which shall be provided to Cadence).
If BMS maintains such Technology Documentation in electronic form, BMS shall provide such
Technology Documentation to Cadence in electronic form. Otherwise, BMS may provide such Technology
Documentation in paper form. All Technology Documentation shall be in the English language,
reasonably comprehendible and, if any Technology Documentation requires translation, authenticated
translation shall be provided by BMS at no cost to Cadence. BMS shall not have any obligation to
translate any documentation relating to the Pharmatop Know-How. The Technology Documentation at
the
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time provided to Cadence shall be written with sufficient detail and clarity for Cadence, a
Cadence Affiliated Company or a Third Party sublicensee or supplier of Cadence to practice and/or
otherwise utilize the manufacturing processes disclosed thereunder. The Technology Documentation
shall not be used by Cadence for any purpose other than to manufacture the Products and Clinical
Testing Products as permitted under this Agreement and the Clinical Supply Agreement. The
Technology Documentation shall be Confidential Information of BMS, and Cadence shall have full
responsibility and liability to BMS for any unauthorized use or disclosure of such Confidential
Information; provided that Cadence shall have the right to disclose and otherwise provide such
Technology Documentation to one or more Third Party manufacturers and/or suppliers so long as such
Third Parties agree to maintain the confidentiality of such information. BMS shall be responsible
for the cost of providing one (1) set of copies only; provided, however, that BMS shall have no
obligation to reformat or otherwise alter or modify any such materials to the extent provided
consistent with this Section 2.11, or to create materials in electronic form, in order to provide
them to Cadence.
2.12 Technical Assistance. During the period commencing on the Effective Date and
ending on [***] (the Tech Transfer Period), BMS shall provide the technical assistance provided
for in this Section 2.12. During the Tech Transfer Period, BMS shall provide Cadence with the
assistance of up to [***] of BMS employees having knowledge relevant to the Clinical Testing
Products, the Technology Documentation and the BMS Know-How to provide Cadence with a reasonable
level of technical assistance and consultation in connection with the technology transfer and
implementation of the manufacturing processes included in the Technology Documentation for the
purpose of assisting Cadence in assuming the responsibility for manufacturing the Products. The
first [***]([***])[***] of such technical assistance and consultation shall be without charge to
Cadence other than for the reasonable out-of-pocket costs of BMS and its Affiliated Companies. For
technical assistance and consultation in excess of [***]([***])[***], Cadence shall pay BMS for
such technical assistance and consultation at the rate of [***]. [***]. Cadence shall bear [***]
implementing the Technology Documentation, including all costs and expenses it incurs in connection
with such technology transfer, process development, manufacturing scale-up, quality control and
quality assurance. BMS makes no warranty, express or implied, that Cadence shall be able to
successfully implement and use the Technology Documentation. Cadence shall be responsible for
ensuring that its personnel who receive such assistance are appropriately qualified and experienced
for such purpose. At Cadences written request, BMS shall, during the Tech Transfer Period and
upon reasonable prior notice and subject to BMSs customary rules and restrictions with respect to
site visits by non-BMS personnel, permit Cadences technical personnel to visit the facilities
utilized by BMS for the supply of Clinical Testing Products under the Clinical Supply Agreement for
the purpose of personally observing the production of the Clinical Testing Products. The time of
BMS employees expended in connection with any such visit (but not visits contemplated by the
Clinical Supply Agreement) shall be charged against the [***] of technical assistance and
consultation to be provided by BMS hereunder and compensated as provided in this Section 2.12. BMS
shall not have any obligation to provide any such technical assistance or consultation following
the expiration of the Tech Transfer Period.
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2.13 Cooperation. The Parties shall cooperate to implement processes to ensure a
close, cooperative working relationship between the Parties and their respective technical
personnel in order to facilitate the technology transfer assistance contemplated above.
2.14 Additional Assistance. In the event Cadence desires any additional technical
assistance or consultation, Cadence may request such additional technical assistance or
consultation from BMS. BMS shall consider such request in good faith, but BMS shall not have any
obligation to provide any such additional technical assistance or consultation unless BMS agrees in
writing in its sole discretion to provide such additional technical assistance or consultation. In
the event BMS agrees in its sole discretion to provide any such additional technical assistance or
consultation, Cadence shall pay BMS for such additional technical assistance or consultation at a
rate equal to [***].
2.15 Pharmacovigilance; Adverse Event Reporting. Subject to the terms of this
Agreement, and within [***] ([***])[***] after the Effective Date of this Agreement, BMS and
Cadence (under the guidance of their respective Pharmacovigilance Departments, or equivalent
thereof) shall in good faith define and finalize the responsibilities the Parties shall employ to
protect patients and promote their well-being in their respective territories. These
responsibilities shall include mutually acceptable guidelines and procedures for the receipt,
investigation, recordation, communication, and exchange (as between the Parties) of adverse event
reports, pregnancy reports, and any other information concerning the safety of the Product. Such
guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliated
Companies to fulfill, local and international regulatory reporting obligations to government
authorities. Furthermore, such agreed procedures shall be consistent with relevant International
Council for Harmonization guidelines, except where said guidelines may conflict with existing local
regulatory safety reporting requirements, in which case local reporting requirements shall prevail.
Until such guidelines and procedures are set forth in an agreement between the Parties,
hereafter referred to as the Safety Data Exchange Agreement, the terms of paragraphs (a) (d) and
(f) below, of this Section, shall apply. Following the execution of the Safety Data Exchange
Agreement, paragraphs (a) (d) and (f) shall have no further force or effect.
(a) Each Party shall notify the other Party as soon as practicable, but not later than
[***]([***])[***] after it receives information about the initiation of any investigation, review
or inquiry by any Drug Regulatory Authority concerning the safety of the Product.
(b) Individual Case Safety Reports and pregnancy reports which come to the attention of either
Party shall be notified to the other Party, in English, in the form of a source document or CIOMS
Form by secure email or fax within [***]([***])[***] of receipt.
(c) Each Party is responsible for complying with all applicable investigational and
post-marketing safety reporting regulations with respect to the use of the Product in the territory
in which its affiliated companies, its sublicensees, its agents, or its contractors promotes
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the
Product, as subject to the terms of this Agreement. This includes the submission of expedited and
periodic reports to the appropriate Drug Regulatory Authority(s).
(d) All information to be reported to a Party under this Section shall be sent as follows (or
to such other address, contact person, telephone number, facsimile number or e-mail address as may
be specified in writing to the other Party):
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Bristol-Myers Squibb Company |
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Global Pharmacovigilance |
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Adverse Event Processing |
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311 Pennington-Rocky Hill Road |
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Mail Stop HW 19-1.01
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FAX Number: 609-818-3804 |
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(ii)
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To Cadence, at: |
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Cadence Pharmaceuticals, Inc. |
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12730 High Bluff Drive, Suite 410 |
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San Diego, CA 92130 |
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Attention: Vice President, Regulatory Affairs and Quality Assurance |
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Telephone: [***] |
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Facsimile: 858-436-1401 |
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(e) A Partys costs incurred in connection with receiving, investigating, recording,
reviewing, communicating, and exchanging Adverse Events and Other Reportable Information shall be
borne solely by such Party. As used herein, Other Reportable Information means any communication
or other information that questions the purity, identity, potency or quality of the Product and all
reports of Product exposure during pregnancy and Product overdose whether or not resulting in an
Adverse Event.
(f) If any Drug Regulatory Authority (1) should contact Cadence with respect to the improper
development, use, distribution, manufacture or commercialization of any Product, (2) conducts, or
gives notice of its intent to conduct, an inspection at Cadences facilities, or (3) takes, or
gives notice of its intent to take, any other regulatory action with respect to any activity of
Cadence that could reasonably be expected to adversely affect any development or commercialization
activities of any Product under this Agreement, then Cadence shall promptly notify BMS of such
contact or notice. Cadence shall provide BMS with copies of all pertinent information and
documentation issued by any such Drug Regulatory Authority within two (2) Business Days of receipt
and copies of any responses to such Drug Regulatory
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Authority that pertain to the Products promptly
after the submission thereof to such Drug Regulatory Authority.
2.16 Infringement Pharmatop Patents.
(a) In the event either Party becomes aware that the Pharmatop Patents (or their inventorship)
have become the subject to an administrative or judicial action, suit or challenge by a Third Party
(including any reexamination or other proceeding challenging the validity or enforceability of the
Pharmatop Patents) with respect to the Territory (to the extent relating to the Territory, a
Pharmatop Patent Challenge), such Party shall promptly notify the other Party and BMS and Cadence
shall consult with each other in order to attempt to determine the appropriate response to such
Pharmatop Patent Challenge. If Pharmatop undertakes the defense thereof, Cadence shall have the
right, to the extent permitted by the Pharmatop License Agreement, to participate and be
represented in any such Pharmatop Patent Challenge by its own counsel [***]. To the extent Cadence
is not permitted by the Pharmatop License Agreement to participate directly in such Pharmatop
Patent Challenge, BMS shall (i) consult with Cadence during the defense of such Pharmatop Patent
Challenge and (ii) if requested by Cadence, participate in such Pharmatop Patent Challenge [***]
and cooperate with Cadence, [***], to arrange for the interests of the Parties (including Cadence)
to be represented in such Pharmatop Patent Challenge.
If Pharmatop does not defend any such Pharmatop Patent Challenge, BMS shall provide written
notice to Cadence promptly after receiving notice of Pharmatops decision not to defend and shall
consult with Cadence concerning the defense of such Pharmatop Patent Challenge. BMS shall use
reasonable efforts (in light of relevant time and other deadlines) to determine whether it will
defend such Pharmatop Patent Challenge and, if BMS elects not to defend such Pharmatop Patent
Challenge, shall use reasonable efforts to provide Cadence with sufficient notice to permit Cadence
to defend such Pharmatop Patent Challenge as permitted by Section 6.3 of the Pharmatop License
Agreement and as set forth in this Section 2.16.
If BMS elects to defend against any such Pharmatop Patent Challenge as permitted by Section
6.3 of the Pharmatop License Agreement, BMS shall consult with Cadence during the defense of such
Pharmatop Patent Challenge and BMS shall permit Cadence to participate and be represented in any
such Pharmatop Patent Challenge by its own counsel [***].
The Parties shall reasonably assist Pharmatop and the other Party in the defense of any
Pharmatop Patent Challenge. In the event the Party defending such Pharmatop Patent Challenge
requests the assistance of the other Party, [***] shall reimburse the [***] for its [***] incurred
in connection with such assistance. BMS shall not, without the written consent of Cadence, consent
to the entry into any such settlement agreement by Pharmatop, that would restrict the scope, or
adversely affect the enforceability or validity of, any of the Pharmatop Patents in the Territory.
If neither Pharmatop nor BMS elects to defend against a Pharmatop Patent Challenge, then BMS
shall provide written notice to Cadence promptly after the later of BMS
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receiving notice of such
decision by Pharmatop or such decision by BMS (in accordance with the last sentence of the second
paragraph of this Section 2.16(a)) and, to the extent permitted by the
Pharmatop License Agreement, Cadence shall have the right to defend [***] any such Pharmatop
Patent Challenge in accordance with Section 6.3(b) of the Pharmatop License Agreement, and BMS
shall be entitled to participate and be represented in any such Pharmatop Patent Challenge by its
own counsel [***]. Cadence shall not enter into any settlement agreement with respect to such
Pharmatop Patent Challenge, without the written consent of Pharmatop to the extent required by the
Pharmatop License Agreement, and the written consent of BMS. If Cadence is not permitted by the
Pharmatop License Agreement to defend such Pharmatop Patent Challenge, then at the written request
of Cadence, BMS shall defend such action, suit or challenge as provided above, at [***].
(b) In the event either Party becomes aware of any infringement of a Valid Claim in the
Territory under the Pharmatop Patents, such Party shall promptly notify the other Party and BMS and
Cadence shall consult with each other and with Pharmatop in order to attempt to end such
infringement, consistent with the Pharmatop License Agreement and shall take all appropriate action
to do so. BMS shall have the right in the first instance, but not the obligation, to initiate
legal action against an infringing party. Cadence shall reasonably assist BMS and Pharmatop in any
action or proceeding prosecuted against the infringing Person by BMS or Pharmatop. If neither
Pharmatop nor BMS prosecutes a legal action against the infringing Person (or if Pharmatop or BMS
ceases to pursue or withdraws from such action), Cadence may initiate and prosecute such action (or
substitute itself for Pharmatop or BMS in such action) at its own expense to the extent permitted
by and in accordance with Section 6.5 of the Pharmatop License Agreement. Cadence shall not enter
into a settlement agreement concerning such action, suit or challenge without the written consent
of BMS.
If neither Pharmatop nor BMS prosecutes a legal action against the infringing Person (or if
Pharmatop or BMS ceases to pursue or withdraws from such action) and Cadence is not permitted by
Section 6.5 of the Pharmatop License Agreement to initiate and prosecute such action (or substitute
itself for Pharmatop or BMS in such action), then at the written request of Cadence, BMS shall
initiate and prosecute such action at the expense of Cadence and shall not, without the written
consent of Cadence, enter into a settlement agreement with such infringing Person that would
restrict the scope, or adversely affect the enforceability or validity of, any of the Pharmatop
Patents in the Territory.
(c) Subject to the rights of Pharmatop set forth in the Pharmatop License Agreement, in the
event either Party recovers any damages or other sums in such action in relation to any
infringement of a Valid Claim under a Pharmatop Patent in the Territory or in settlement thereof,
such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses
incurred by the Parties in connection therewith, including attorneys fees, subject to any
allocation due to Pharmatop pursuant to the Pharmatop License Agreement. If such recovery (after
giving effect to any allocation due to Pharmatop pursuant to the Pharmatop License Agreement) is
insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion
to the total of such costs and expenses incurred by each
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Party. If after such reimbursement any
funds shall remain from such damages or other sums recovered (after giving effect to any allocation
due to Pharmatop pursuant to the Pharmatop
License Agreement), such funds shall be shared [***] ([***]) by Cadence and [***] ([***]) by
BMS. In the event any such action involves patent rights outside the Territory, Cadence shall be
entitled to share only in the portion of any recovery that relates to infringement of any Pharmatop
Patents in the Territory and shall not have any right to share in any recovery with respect to
rights outside the Territory.
2.17 Infringement BMS Patents.
(a) In the event the BMS Patents (or their inventorship) become the subject to an
administrative or judicial challenge by a Third Party with respect to the Territory, BMS shall
notify Cadence of such challenge within [***]([***])[***] of receipt of notice of such challenge.
BMS shall have the right, but not the obligation, to defend such action, suit or challenge, and BMS
shall notify Cadence of its decision regarding whether or not it will defend such action, suit or
challenge. If BMS decides in its sole discretion to enter into any settlement agreement with
respect to such action, suit or proceeding, BMS shall notify Cadence of such intent. If such
settlement restricts the scope, or adversely affects the license to the BMS Patents granted to
Cadence under Section 2.1, Cadence shall have the right, but not the obligation, to enter into
discussions with BMS for the purpose of renegotiating the terms of said license in view of such
settlement.
(b) If BMS does not defend any such action, suit or challenge and Cadence disagrees with BMSs
decision, Cadence shall have the right, but not the obligation, to (i) enter into discussion with
BMS for the purpose of renegotiating the terms of the license to the BMS Patents granted to Cadence
under Section 2.1 or (ii) notwithstanding Article 8 of this Agreement, terminate the License
granted under Sections 2.1(a)(ii) (v) subject to the confidentiality provisions set forth in
Sections 5.2 and 5.3.
2.18 Maintenance of BMS Patents. In the event BMS determines that it no longer
desires to maintain any of the BMS Patents, BMS shall notify Cadence in writing of the BMS Patents
that it no longer desires to maintain, and Cadence shall have the right to retain counsel of its
own choosing to prosecute and maintain such BMS Patents and to make all maintenance and other
payments as may be necessary to maintain such BMS Patents in effect.
2.19 Noncontravention. Neither BMS nor Cadence shall be required to take any action
pursuant to Section 2.16, 2.17, 2.21 and 2.22 that it determines in its sole judgment and
discretion conflicts with or violates any court or government order or decree to which it is then
subject.
2.20 Patent Extensions. Subject to applicable terms of the Pharmatop License
Agreement, BMS and Cadence shall each cooperate with one another to obtain patent term extensions
(including any pediatric exclusivity extensions as may be available) or supplemental protection
certificates or their equivalents in any country in the Territory with respect to a BMS Patent or
Pharmatop Patent in the Territory.
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2.21 Data Exclusivity and Orange Book Listings. Subject to applicable terms of the
Pharmatop License Agreement: (i) with respect to data exclusivity periods in the Territory (such
as those periods listed in the FDAs Orange Book (including any available pediatric extensions))
Cadence, as appropriate, shall use commercially reasonable efforts consistent with its obligations
under Applicable Law in the Territory to seek, maintain and enforce all such data exclusivity
periods available for Products, and (ii) with respect to filings in the FDA Orange Book for issued
patents for a Product, the appropriate Party shall, consistent with its obligations under
Applicable Law in the Territory, list (and update as appropriate) in a timely manner all applicable
Patents required to be filed by it, or that it is permitted to file, under such Applicable Law in
connection with such Product. At least [***] ([***])[***] prior to an anticipated deadline for the
filing of patent listing information for such Patents, the Party making such filing shall notify in
writing and consult with the other Party regarding the content of such filing. In the event of a
dispute between the Parties as to whether a particular Patent can be listed and/or the content of
the filing for such listing, the Parties shall take expedited steps to resolve the dispute as
promptly as possible, including seeking advice of an independent legal counsel to guide their
decision. The other Party shall provide, consistent with its obligations under Applicable Law in
the Territory, reasonable cooperation to the Party making such listing in filing and maintaining
such Orange Book (and foreign equivalent) listings.
2.22 Notification of Patent Certifications. A Party receiving any allegation of
patent invalidity, unenforceability or non-infringement of a Pharmatop Patent or a BMS Patent
pursuant to a paragraph IV patent certification by a Third Party filing an Abbreviated New Drug
Application, an application under §505(b)(2) of the FDCA or other similar patent certification by a
Third Party, and/or any foreign equivalent thereof in connection with a Product in the Territory
shall notify the other Party and shall provide the other Party with copies of all such allegations.
Such notification and copies shall be provided to the other Party within five (5) days after
receipt of such certification. If and to the extent such allegation relates to a Pharmatop Patent,
and subject to the terms of the Pharmatop License Agreement, Cadence shall have the right (but not
the obligation) to contest such patent certification in the Territory and initiate and control
actions with respect thereto in accordance with Section 2.16, and upon request by Cadence, BMS
shall provide reasonable assistance and cooperation at Cadences expense in any actions reasonably
undertaken by Cadence to contest any such patent certification.
2.23 Audit, Inspection and Review. BMS shall have the right [***] during business
hours and upon reasonable prior notice to enter, inspect and evaluate that part of any plant or
other facility that is engaged in the production, preparation, processing or storage of the
Products for compliance with applicable environmental, health and safety regulations, cGMP and
other Applicable Law in the Territory and for compliance with the terms of this Agreement; provided
that such inspections may not be made more than [***] in any [***]; and provided, further, that if
material corrective measures are necessary, BMS may [***] verify the implementation of such
corrective measures. In addition to the other rights of BMS set forth in this Agreement: (i) BMS
shall have the same
right to inspect and review the activities of Cadence hereunder as Pharmatop has with respect
to BMS under the Pharmatop License Agreement, and (ii) BMS shall have the same rights to audit
Cadences (and any of its sublicensees) activities relevant to this
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Agreement, and to inspect
Cadences (and any sublicensees) facilities involved in the manufacture of Products, in the same
manner as Pharmatop has with respect to BMSs activities and facilities under the Pharmatop License
Agreement. Cadence shall cause its sublicensees, suppliers, toll manufacturers and other Third
Parties involved in the production, preparation, processing or storage of the Products to provide
such access to BMS and shall include an appropriate provision in the applicable contract with any
such Third Party providing for such access and shall cause such sublicensees, suppliers, toll
manufacturers and other Third Parties to grant such access to BMS. Cadence shall notify BMS within
[***] ([***])[***] after receipt of any notice of any inquiry, inspection or legal action by any
Drug Regulatory Authority related to any aspect of the production of the Products. Cadence shall
provide to BMS, promptly after receipt by Cadence, a copy of the results of any inspection reports
and/or legal actions with or by any Drug Regulatory Authority in the Territory relating to such
matters. Cadence shall keep BMS informed on an on-going basis as to any proposed responses
regarding corrective or remedial actions to be taken as a result of any such inquiry, inspection or
legal action, including actions relating to plants and facilities of Third Parties.
2.24 [***] Covenant; [***] Covenant.
(a) Certain Definitions. As used herein:
Available [***] means, as of any date, [***] determined In Accordance With GAAP
[***].
[***] means as of any date, [***] determined In Accordance with GAAP [***]:
(1) (A) [***], or
(B) [***], and
(2) (A) [***], (B) [***] and (C) [***],
but only to the extent any such items are not already included in [***].
[***] means, as of any date [***] plus [***], in each case determined In Accordance
With GAAP.
[***] means, as of any date, the [***].
[***] means, as of any date, the [***].
[***] means, as of any date, the [***].
(b) [***] Covenant. Provided that neither [***]:
(A) [***]; or
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(B) [***].
The foregoing covenant is referred to herein as the [***] Covenant. [***] shall be entitled
to temporary and permanent injunctive relief in order to restrain any violation of this Section
2.24(b).
As used herein, the term [***] Product means (i) [***] and/or (ii) [***].
(c) Termination of Covenant. If on [***] Covenant shall immediately terminate without
any action on the part of [***]. Each such date of such termination is referred to herein as a
Covenant Termination Date. In the event [***].
During any period in which [***] shall have the right to (i) [***] and (ii) [***].
(d) Permanent Termination of Covenant; [***]. If [***]
(e) Reinstatement of [***]. As set forth in Section 2.1(c), if and when [***].
ARTICLE
III ADDITIONAL COVENANTS
3.1 Annual Operating Plan. Not later than [***]([***])[***] prior to the beginning of
each Calendar Year, Cadence shall provide to BMS a written operating plan (each an Annual
Operating Plan) setting forth in reasonable detail Cadences plans for the continued development
(including plans for clinical and other studies and plans for obtaining any necessary Approvals in
the Territory) and commercialization of the Products for such Calendar Year, together with the
related budgets therefore and the estimated timelines for completion of key activities. The
initial Annual Operating Plan for 2006 is as Previously Disclosed. Each subsequent Annual
Operating Plan shall include a comparable level of information and detail as set forth in such
Previously Disclosed Annual Operating Plan (and following first commercial sale of the Product in
the Territory, shall include a line item for advertising and promotional expenses). Cadence shall
promptly notify BMS in writing of any material change in any such Annual Operating Plan or of any
material deviation from any Annual Operating Plan.
3.2 Development, Commercialization and Financial Reports and Consultations.
(a) Quarterly Development and Commercialization Reports. Cadence shall provide
quarterly written reports to BMS, within [***]([***])[***]) following the end of each Calendar
Quarter, presenting a summary in reasonable detail of the development and commercialization actions
taken by Cadence relating to the Products in the Territory and results obtained through the end of
such Calendar Quarter and a summary of any material changes to the Development Plan since the last
such quarterly report. The report with respect to commercialization activities shall include,
among other things, the number of full-time equivalent sales representatives assigned to each
Product by Cadence and any co-promotion or
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co-marketing partner or any Third Party with which
Cadence has any other arrangement for such Third Party to market, promote or sell any Product.
(b) [***] Reports. [***]:
(i) [***].
(ii) [***];
(iii) [***].
(c) [***] Statements. If [***] shall be In Accordance With GAAP [***].
(d) Calculations, Notifications and Consultations concerning [***]. If [***]:
(i) [***](A) [***] and (B) [***].
(ii) [***].
(iii) [***].
(e) [***] Reports. If on the [***], if any:
(i) [***], within [***]([***])[***]:
(A) [***],
(B) [***],
(C) [***],
(D) [***],
(E) [***],
(F) [***] Section 3.2(b):
(1) the [***] In Accordance With GAAP.
(2) a [***];
(G) a [***].
(ii) [***]:
(A) within [***]([***])[***]; and
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(B) not later than [***] ([***])[***].
In the event [***].
(f) Standards for Determining [***]. All projections used to determine [***] (i)
[***] (A) [***] and (B) [***] and (ii) [***]. If any calculation of [***].
(g) Presentations concerning Development and Commercialization Activities. In
addition, on reasonable request by BMS, Cadence shall meet with BMS to make presentations
concerning the development and commercialization activities taken relating to the Products and to
permit BMS to ask reasonable questions and receive answers from Cadence with respect to such
matters (including advertising and promotional expenditures and measures of sales effort);
provided, however, that Cadence shall not be required to make more than [***] in any Calendar Year.
[***].
(h) Date of NDA Approval. Cadence shall notify BMS in writing as soon as reasonably
practicable of the expected date of approval by the FDA of the NDA with respect to any Product in
the United States and shall notify BMS of any such Approval not later than [***]([***])[***]
following the date on which Cadence receives written notice of such approval or receives an
approvable letter from the FDA with respect to any such NDA.
(i) Correspondence with Pharmatop. Each Party shall provide to the other Party copies
of all material correspondence and reports provided by it to Pharmatop or by Pharmatop to it after
the Effective Date with respect to the Products in the Territory.
3.3 Development Responsibilities and Costs.
(a) Cadences initial plan (current as of the Execution Date) for the development of the
Products, including the clinical and other studies it contemplates as of the date of this Agreement
in order to obtain Approval of the Products in the United States and related budgets and timelines
as of the Execution Date as the same may be amended from time to time in accordance with Section
3.3(c) (collectively, the Development Plan) has been Previously Disclosed.
(b) Cadence shall have sole responsibility for, and shall bear the cost of the development and
commercialization of the Products in the Territory. Cadence shall develop and commercialize the
Products in compliance with all Applicable Law. Without limiting the foregoing, Cadence shall
cause all Products manufactured, labeled, advertised and sold by it and its Affiliated Companies
and sublicensees or on its or their behalf to comply in all material respects with Applicable Law.
(c) Without limiting Cadences obligations under the Pharmatop License Agreement, Cadence
shall use reasonable commercial efforts to pursue, fund and complete the development of the
Products as set forth in the Development Plan as modified from time to time in accordance with this
Agreement (including obtaining all necessary Approvals in the
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Territory). In the event that the
results of clinical or other studies or communications from Drug Regulatory Authorities require a
material modification to the Development Plan, Cadence shall consult with BMS concerning such
results or communications and potential changes to the Development Plan that would offer a
reasonable prospect for obtaining Approvals on a reasonably expeditious basis. Any modification to
the Development Plan that involves [***]. No such consent by BMS shall relieve Cadence of any
obligation under the Pharmatop License Agreement.
3.4 Obligations in respect of the Pharmatop License Agreement. Notwithstanding any
other provision of this Agreement, Cadence (i) hereby unconditionally assumes and agrees during the
term of this Agreement to perform as and when due all the obligations of BMS under the Pharmatop
License Agreement that relate to the Territory (except (A) to the extent such obligations were
required to be performed by BMS prior to the Effective Date and (B) for any obligation to indemnify
Pharmatop for any breach by BMS of any such obligations prior to the Effective Date), the BMS
Rights or the exercise of the rights sublicensed to Cadence under this Agreement and (ii) shall
comply with all the terms and conditions of the Pharmatop License Agreement that relate to the
Territory, the BMS Rights or the exercise of the rights sublicensed to Cadence under this
Agreement, it being understood that Cadence shall be obligated to perform such obligations and
comply with such terms and conditions in respect of its activities under this Agreement and the
Pharmatop License Agreement but shall not have any obligation to cause BMS to perform such
obligations or to cause BMS to comply with such terms and conditions. Without limiting the
foregoing, Cadence shall be obligated to perform and comply, but shall not have any liability with
respect to any failure by BMS (but not its own failure) to perform and comply, with Section 4.6(a),
Article 10 or Article 12 of the Pharmatop License Agreement. Without limiting any other right or
remedy of BMS under this Agreement and in order to prevent, ameliorate, mitigate or cure a breach
of the Pharmatop License Agreement, in the event that Cadence fails to perform any of such
obligations under the Pharmatop License Agreement (except to the extent that a breach by BMS of its
obligations under this Agreement or the Pharmatop License Agreement or any other act or omission by
BMS prevents such performance by Cadence or any of its Affiliated Companies, sublicensees,
contractors or agents), which failure is not cured within ninety (90) days after written notice
from BMS, BMS may perform such obligation on behalf of Cadence at Cadences expense, and [***]
provided, however, that
this Section 3.4 shall not authorize BMS to control the conduct of any clinical trial or study
under the Development Plan. This Agreement sets forth the obligations of the Parties inter se, and
nothing in this Agreement (including any standard of effort set forth herein) shall limit or modify
the obligations of the Parties assumed under the Pharmatop License Agreement.
3.5 Certain Rights and Obligations under the Pharmatop License Agreement.
(a) BMS shall provide Cadence with copies of written communications received by BMS from
Pharmatop after the Effective Date pursuant to Section 2.2 of the Pharmatop License Agreement with
respect to the results of research and development work performed by Pharmatop and concerning any
inventions or Know-How (as defined in the Pharmatop License Agreement) made by Pharmatop relating
to the Products.
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(b) If Pharmatop provides to BMS a copy of any application, filing or request for review and
comment by BMS, BMS shall provide a copy of each application, filing or request to Cadence promptly
after receipt thereof, and shall give reasonable consideration to any comments of Cadence in any
comments provided by BMS to Pharmatop.
(c) If Pharmatop provides to BMS a quarterly written patent report pursuant to Section 5.1(d)
of the Pharmatop License Agreement, BMS shall provide a copy of such report to Cadence within a
reasonable period of time after receipt thereof, provided that BMS may redact information relating
to Patents outside the Territory.
(d) To the extent that Pharmatop is obligated to indemnify sublicensees of BMS pursuant to
Section 12.1 of the Pharmatop License Agreement and Cadence desires to assert a claim for
indemnification pursuant to such section, Cadence shall have the right, to the extent permitted by
the Pharmatop License Agreement, to assert such claim for indemnification against Pharmatop. In
the event Cadence is not permitted by the Pharmatop License Agreement to assert such claim directly
against Pharmatop, BMS shall cooperate with Cadence (at Cadences expense and subject to Section
7.7 of this Agreement) to permit Cadence to assert such claim, including, if necessary, allowing
Cadence to bring such claim in the name of BMS, unless BMS has a reasonable objection to such
procedure; provided that Cadence shall give BMS written notice of any proposed settlement with
Pharmatop and a reasonable opportunity to review and comment on such proposed settlement, and
Cadence shall not enter into any settlement with Pharmatop that could adversely affect the rights
of BMS hereunder or under the Pharmatop License Agreement without the prior written consent of BMS
in its sole discretion.
(e) To the extent that BMS is permitted to assert against Pharmatop a claim on behalf of
Cadence (as BMSs sublicense) for (i) indemnification and defense pursuant to Section 3.2 of the
Pharmatop License Agreement based on any use made by Pharmatop, its Affiliated Companies or its or
their licensees of the Registrational Information or with respect to the breach of any
representation, warranty or covenant of Pharmatop contained in the Pharmatop License Agreement or
(ii) for specific performance of any covenant of Pharmatop contained in the Pharmatop License
Agreement, BMS shall use reasonable efforts to cooperate with Cadence (at Cadences expense and
subject to Section 7.7 of this Agreement) to permit Cadence to assert such claim or request for
specific performance by Pharmatop, including, if necessary, allowing
Cadence to bring such claim in the name of BMS, unless BMS has a reasonable objection to such
procedure; provided that Cadence shall give BMS written notice of any proposed settlement with
Pharmatop and a reasonable opportunity to review and comment on such proposed settlement, and
Cadence shall not enter into any settlement with Pharmatop that could adversely affect the rights
of BMS hereunder or under the Pharmatop License Agreement without the prior written consent of BMS
in its sole discretion. BMS makes no representation or warranty as to whether BMS is permitted to
assert any such claim on behalf of Cadence.
(f) Whenever Cadence provides any report, notice or other communication to Pharmatop in
compliance with of any of the obligations under the Pharmatop License Agreement assumed by Cadence
pursuant to Section 3.4 (e.g., the obligation to provide quarterly updates pursuant to Section 4.3
of the Pharmatop License Agreement), Cadence shall provide a copy of
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such report or notice to BMS
at least [***] ([***])[***] prior to the time such report, notice or communication is provided to
Pharmatop or, if it is impracticable to provide such copy at least [***]([***])[***]) ahead of
time, Cadence shall provide such copy to BMS as early as practicable prior to the provision thereof
to Pharmatop.
(g) BMS agrees that it shall, if reasonably requested by Cadence and at Cadences expense,
take reasonable efforts to enforce the material obligations of Pharmatop under the Pharmatop
License Agreement as it relates to the Territory, including obligations under Article 5 of the
Pharmatop License Agreement.
(h) BMS covenants that it shall not agree or consent to any amendment, supplement or other
modification to the Pharmatop License Agreement or exercise any other right of agreement or consent
thereunder, in each case as it relates to the Territory, unless Cadence has consented in its sole
discretion in writing to the same.
(i) If Cadence is not in breach of any of its material obligations under this Agreement, BMS
shall not terminate the Pharmatop License Agreement (either unilaterally or by mutual agreement
with Pharmatop) with respect to any country in the Territory without the prior written consent of
Cadence, which consent may be given or withheld in Cadences sole discretion. If Cadence is in
breach of any of its material obligations under this Agreement, BMS may terminate the Pharmatop
License Agreement in its sole discretion. If BMS determines to terminate the Pharmatop Agreement,
BMS shall consult with Cadence in advance to the extent reasonably practical.
(j) BMS shall not market a Competing Product (as defined in the Pharmatop License Agreement)
in any country in the Territory during the Pharmatop Royalty Term for such country without
obtaining a written waiver from Pharmatop of the consequences of such marketing under Section 7.4
of the Pharmatop License Agreement.
(k) Cadence shall provide written notice to BMS of any use by Pharmatop of which Cadence is
aware of any Registrational Information of Cadence as to which BMS has the right [***] from
Pharmatop as contemplated by Sections 3.1 and 3.3 of the Pharmatop License Agreement, and, if
requested by Cadence, BMS shall thereafter request from Pharmatop [***]
contemplated by Sections 3.1 and 3.3 of the Pharmatop License Agreement. If BMS [***] from
Pharmatop for the use by Pharmatop of any Cadence Registrational Information as contemplated by
Section 3.1 and 3.3 of the Pharmatop License Agreement, BMS shall [***] over to Cadence within
[***]([***])[***] after the receipt thereof.
3.6 Conduct of Clinical Trials of Products by Cadence in Clinical Study Countries. In
the event (i) Cadence is unable (or reasonably believes that it will be unable) to recruit in the
Territory sufficient clinical study subjects to conduct clinical trials necessary for Approval of
the Products in the Territory due to US treatment parameters that would significantly delay or
impair Cadences ability to recruit patients or otherwise complete the study on a timely basis and
(ii) Cadence desires to conduct all or a portion of such clinical study in any of the Clinical
Study Countries where BMS retains rights to commercialize the Product, then Cadence shall notify
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BMS in writing and provide BMS with a copy of the clinical trial study design and protocol(s) for
the conduct of such clinical study in the Clinical Study Countries in which it plans to conduct
such study and a statement of the proposed number of patients proposed to be recruited in each city
in such Clinical Study Countries. Cadence shall not conduct any such study without the prior
written consent of BMS and the license provided for below, which consent and license shall not be
unreasonably withheld if: (i) such study design and protocols are reasonably satisfactory to BMS
(and its Affiliated Companies in the Clinical Study Countries) and (ii) such study is lawful to
conduct in the regulatory jurisdictions where such study will be conducted and meets prevailing
ethical standards and guidelines (including BMS internal policies) relating to the conduct of
clinical trials and the use of the Product. In the event BMS consents to the conduct of such study
in a Clinical Study Country, BMS shall cause its applicable Affiliated Companies to grant a limited
license or sublicense to Cadences Affiliated Company in such Clinical Study Country where the BMS
Affiliated Companies have rights to grant such license or sublicense solely for the purpose of
permitting such clinical study solely in accordance with such study design and protocol; provided
that (1) not later than [***] ([***])[***] after [***] during such clinical trial, Cadence shall
provide BMS with a written report of the number of vials of Product administered to patients in
such clinical study in each country outside the Territory where such study is conducted and [***],
and (2) such clinical study shall be subject to such reasonable limitations as may be reasonably
satisfactory to BMS to avoid undue concentration of study subjects in a particular city.
Neither BMS nor any of its Affiliated Companies shall have any duties or responsibilities in
connection with such clinical trial, other than (to the extent applicable) the supply of Clinical
Testing Products pursuant to the Clinical Supply Agreement, except that this provision shall not
affect the obligations of BMS and Cadence to exchange safety information as provided in Section
2.15 and the Safety Data Exchange Agreement to be entered into pursuant to Section 2.15.
In the event Cadence desires to conduct all or a portion of such clinical study in [***], then
Cadence may request that BMS consent to the inclusion of [***] as an additional Clinical Study
Country. In the event (i) Cadence is unable (or reasonably believes that it will be unable)
to recruit in the Territory and the Clinical Study Countries sufficient clinical study
subjects to conduct clinical trials necessary for Approval of the Products in the Territory due to
treatment parameters in the US and the Clinical Study Countries that would significantly delay or
impair Cadences ability to recruit patients or otherwise complete the study on a timely basis and
(ii) Cadence desires to conduct all or a portion of such clinical study in any of the other
countries where BMS retains rights to commercialize the Product, then Cadence may request that BMS
consent to the inclusion of up to [***]([***]) additional countries as Clinical Study Countries;
provided that Cadence may not request the inclusion of more [***]([***]) additional countries as
Clinical Study Countries, including [***], over the term of this Agreement. In the event Cadence
makes such request, BMS shall cause its Alliance Manager to use reasonable efforts to obtain the
necessary internal BMS consents and approvals of the applicable BMS Affiliated Company in the
applicable country to the inclusion of such country as a Clinical Study Country, which consents and
approvals may be given or withheld in the sole discretion of such BMS
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Affiliated Company. In the
event such consents and approvals are obtained, the Parties shall amend the list of Clinical Study
Countries to include such country.
Cadence acknowledges that as of the Effective Date, BMS does not commercialize, and has not
effected the registration of, Products in certain of the Clinical Study Countries and other
countries where Cadence may desire to conduct clinical trials or studies. Nothing in this
Agreement shall obligate BMS or any of its Affiliated Companies (i) to maintain, retain, obtain or
seek any rights in any Clinical Study Country or any other country where Cadence may desire to
conduct clinical trials or studies or (ii) to make, maintain, refile, renew or reinstate any
Regulatory Filing in any such country.
3.7 Conduct of US or Canadian Clinical Trials of Products by BMS. In the event BMS is
unable (or reasonably believes that it will be unable) to recruit outside the Territory sufficient
clinical study subjects to conduct clinical trials necessary for Approval of the Products in any
jurisdiction outside the Territory due to local treatment parameters that would significantly
delay or impair BMSs ability to recruit patients or otherwise complete the study on a timely basis
and BMS desires to conduct any clinical trials or studies of Products in the Territory, then BMS
shall notify Cadence in writing and provide Cadence with a copy of the clinical trial study design
and protocol(s) for the conduct of such clinical trial in the Territory and a statement of the
proposed number of patients proposed to be recruited in each city in the Territory. BMS shall not
conduct such study without the prior written consent of Cadence, which shall not be unreasonably
withheld if: (i) such study design and protocols are reasonably satisfactory to Cadence; and (ii)
such study is lawful to conduct in the country in the Territory where such study will be conducted
and meets prevailing ethical standards and guidelines (including Cadence internal policies)
relating to the conduct of clinical trials and the use of the Product. In the event Cadence
consents to the conduct of such study in the Territory, BMS may conduct such study solely in
accordance with such study design and protocol; provided that:
(A) if such clinical trial or study will take place prior to the launch of the
Product by Cadence in the country where BMS proposes to conduct such clinical trial or
study, such study is subject to such reasonable limitations designed to avoid impairing
Cadences ability to recruit patients for its own contemporaneous clinical trials; or
(B) if such clinical trial or study will take place after the launch of the
Product by Cadence in the country where BMS proposes to conduct such clinical trial or
study, then (1) not later than [***] ([***])[***] after [***] during such clinical trial,
BMS shall provide Cadence with a written report of the number of vials of Product
administered to patients in such clinical study in each country in the Territory where such
study is [***], and (2) such clinical study shall be subject to such reasonable limitations
as may be reasonably satisfactory to Cadence to avoid undue concentration of study subjects
in a particular city in the Territory.
Neither Cadence nor any of its Affiliated Companies shall have any duties or responsibilities
in connection with such clinical trial by BMS or its Affiliated Companies, except that this
provision shall not affect the obligations of BMS and Cadence to exchange safety
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information as
provided in Section 2.15 and the Safety Data Exchange Agreement to be entered into pursuant to
Section 2.15.
3.8 Existing BMS Suppliers. [***].
ARTICLE
IV FINANCIAL TERMS
4.1 Payments to BMS. In partial consideration of the rights granted to Cadence
hereunder:
(a) On the Effective Date, Cadence shall pay to BMS Twenty-Five Million Dollars ($25,000,000).
(b) Within ten (10) Business Days following the [***], Cadence shall pay to BMS [***]([***]).
Such amount shall be paid only once, regardless of [***].
(c) Within ten (10) Business Days after [***], Cadence shall pay to BMS an amount equal to
[***]([***])[***]; provided, however, that such payment shall not exceed [***]([***]).
(d) Not later than [***]([***][***] following the [***] in which the [***], Cadence shall pay
to BMS [***]([***]); provided, however, if [***], Cadence shall pay such amount to BMS not later
than [***]([***])[***] following the [***].
(e) In addition to the payment provided for in Section 4.1(d) above, not later than
[***]([***][***] following the [***] in which the [***], Cadence shall pay to BMS [***]([***]);
provided, however, if such [***], Cadence shall pay such amount to BMS not later than [***]([***])
[***].
(f) During the Pharmatop Royalty Term, Cadence shall pay to BMS royalties calculated at the
rate of:
(i) [***] of that portion of aggregate Net Sales in each Calendar Year that is [***],
(ii) [***] of that portion of aggregate Net Sales in each Calendar Year that is [***] and up
to and including Net Sales of [***], and
(iii) [***] of that portion of aggregate Net Sales in each Calendar Year that is [***],
with the aggregate amount of Royalties payable pursuant to clauses (i) (iii) above [***] by the
amount of the [***] and any [***] and [***] of this Agreement and the terms of the Pharmatop
License Agreement (which [***] provided for in [***]). In the event the amount of [***] and any
[***] with respect to any [***].
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In the event the royalties payable to Pharmatop are reduced in respect of any Combination
Product (as defined in the Pharmatop License Agreement) sold by Cadence or its Affiliated Companies
or sublicensees in the Territory, the Royalties payable to BMS pursuant to this Section 4.1(f) in
respect of such Combination Product shall be reduced (dollar-for-dollar) by the amount of the
reduction in such royalties payable to Pharmatop.
[***].
(g) During the BMS Patent Royalty Term, Cadence shall pay to BMS royalties calculated at the
rate of:
(i) [***] of that portion of aggregate Net Sales of Products that are BMS Patent Products in
each Calendar Year that is [***],
(ii) [***] of that portion of aggregate Net Sales of Products that are BMS Patent Products in
each Calendar Year that is in [***] and up to and including Net Sales of such Products of [***],
and
(iii) [***] of that portion of aggregate Net Sales of Products that are BMS Patent Products in
each Calendar Year that is [***].
[***].
The Royalties payable by Cadence to BMS pursuant to this Section 4.1(g) shall be [***] for any
Calendar Quarter if:
(i) [***]
(ii) [***]
(iii) [***]
but only to the extent such Royalties are [***] as of the date of such event.
[***].
(h) The royalties payable pursuant to Section 4.1(f) and Section 4.1(g) are referred to herein
as Royalties). Such Royalties shall be paid quarterly as provided in Section 4.7 of this
Agreement.
(i) [***].
4.2 Reduction of Certain Milestone Payments.
(a) If (i) after the Effective Date, a Third Party claim or action challenging the Pharmatop
Patents succeeds so as to deprive Pharmatop (and therefore BMS and Cadence) of any of its rights
under the Pharmatop Patents in the United States or (ii) after the Effective Date, Pharmatop or BMS
is unable to maintain, or a material alteration of the scope or content occurs with respect to, any
of the claims under any of the Pharmatop Patents, in the United States, then
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(1) the payment
provided for in Section 4.1(b) shall, if not yet earned, be reduced to [[***] ([***]) and (2) the
payment provided for in Section 4.1(c) shall, if not yet earned, be reduced by [***].
(b) If a Third Party should market in the United States after the Effective Date a
parenterally-administered liquid solution product, in a stable and readily injectible form, that
(i) contains paracetamol and one or more other analgesic ingredients, (ii) uses any of the
Technology contained within any issued claim of any Pharmatop Patent in such country or any
Pharmatop Know-How, and (iii) is not considered to infringe any Pharmatop Patent or BMS Patent in
such country (whether by judicial determination or settlement, by joint agreement of either BMS and
Pharmatop or BMS and Cadence or by the failure of Pharmatop, BMS and Cadence to prosecute such
Third Party for infringement under Section 6.5 of the Pharmatop License Agreement or Section 2.16
of this Agreement), then (1) the payment provided for in Section 4.1(b) shall, if not yet earned,
be reduced to [***]([***]) and (2) the payment provided for in Section 4.1(c) shall, if not yet
earned, be reduced by [***]; provided that (A) during the pendency of any legal action against such
Third Party with respect to the possible infringement of a Pharmatop Patent or BMS Patent the
amount of such reduction (the Retained Sum) shall be temporarily retained by Cadence until such
litigation ends, (B) if the outcome of the litigation is the invalidation of the Pharmatop Patents
so that the Third Party is free to sell such product in the United States, [***] and (C) if the
outcome of the litigation is not as described in clause (B) above, [***].
(c) The reductions provided for in Sections 4.2(a) and 4.2(b) shall not be [***] and (i) the
aggregate amount of the reduction in the payment provided for in Section 4.1(b) shall not exceed
[***]([***]) and (ii) the aggregate amount of the reduction in the payment provided for in Section
4.1(c) shall not exceed [***].
(d) Notwithstanding the foregoing Sections 4.2(a) and 4.2(b), if aggregate Net Sales during
any Calendar Year [***], then (i) for the [***] such Calendar Year Cadence shall pay to BMS
[***]([***]) of the aggregate amount of the reduction [***], (ii) for the [***] such
Calendar Year Cadence shall pay to BMS an [***]([***]) of the aggregate [***] and (iii) for
the [***] such Calendar Year Cadence shall pay to BMS an [***]([***]) of the aggregate [***]. Such
[***] shall be made not later than [***]([***])[***] following the applicable Calendar Year.
4.3 Payments by Cadence to Pharmatop. In partial consideration of the rights granted
to Cadence hereunder and without limiting any of the other obligations assumed by Cadence under the
Pharmatop License Agreement:
(a) Within ten (10) business days (as such term is used in the Pharmatop License Agreement)
following the [***], Cadence shall pay to Pharmatop [***]([***]) in satisfaction of the obligation
set forth in Section 7.1(b) of the Pharmatop License Agreement.
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(b) Cadence shall pay to Pharmatop all royalties payable to Pharmatop pursuant to the
Pharmatop License Agreement with respect to the Territory in the manner provided for in such
agreement.
(c) If for any period a Guaranteed Payment is due under the Pharmatop License Agreement,
Cadence shall pay to Pharmatop the amount of such Guaranteed Payment in the manner provided for in
the Pharmatop License Agreement.
(d) Cadence shall provide to BMS evidence reasonably satisfactory to BMS of each such payment.
(e) The amount of the payments made to BMS under this Agreement shall be Confidential
Information of BMS and of Cadence. Cadence shall not disclose to Pharmatop in the reports provided
by Cadence to Pharmatop pursuant to the Pharmatop License Agreement or otherwise the amount of any
payments to BMS hereunder.
4.4 Manner of Payment. All payments to be made to BMS or Cadence hereunder shall be
paid in Dollars by wire transfer of immediately available funds to a bank account designated in
writing by the payee not less than [***] ([***])[***] prior to the required payment date.
4.5 Interest. Any payment by Cadence to BMS hereunder not made as and when due shall
bear interest at the rate of [***]([***]) per annum, compounded daily, from the due date to the
date of payment.
4.6 Expenses; Taxes.
(a) Expenses. Except as expressly set forth in this Agreement, all costs and expenses
incurred in connection with the preparation and negotiation of this Agreement and the other
Transaction Documents and the transactions contemplated hereby shall be paid by the Party incurring
such expense. Each Party shall bear the fees and expenses of any agent, broker, investment banker,
finder or other Person engaged by it or any of its Affiliated Companies in connection with the
transactions contemplated by this Agreement and the other Transaction Documents.
(b) Transfer Taxes. Any Transfer Tax, if any, applicable to the transactions contemplated by
this Agreement shall be borne and paid by Cadence.
(c) Tax Withholding. The withholding tax, duties, and other levies (if any) applied by a
government of any country of the Territory on payments made by Cadence to BMS hereunder shall be
borne by BMS. Cadence, its Affiliated Companies and sublicensees shall cooperate with BMS to
enable BMS to claim exemption therefrom under any double taxation or similar agreement in force,
shall provide to BMS proper evidence of payments of withholding tax, and shall assist BMS by
obtaining or providing in as far as possible the required documentation for the purpose of BMSs
tax returns.
4.7 Sales Reports and Royalty and Other Payments. The Royalties payable under Section
4.1 shall be calculated and will be payable quarterly for sales made in each Calendar
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Quarter in the Royalty Term and the BMS Patent Royalty Term, as applicable. Cadence shall
prepare and send to BMS within [***] ([***])[***] after the end of each Calendar Quarter
([***]([***])[***] after the last Calendar Quarter in a Calendar Year to allow for additional time
to determine any adjustments required to be made on an annual basis) a detailed statement, country
by country and by dosage and pharmaceutical form, of the Net Sales (and, during the BMS Patent
Royalty Term, the Net Sales of BMS Patent Products), the calculation of the Royalties payable under
Section 4.1, the calculation of any amounts payable to Pharmatop pursuant to the Pharmatop License
Agreement with respect to the Territory and the calculation of any reduction in the Royalties or
other amounts deducted from the payments to BMS as contemplated by Section 4.1 together with a
description of any facts or circumstances that Cadence believes entitles it to a reduction in, or
deduction from, the Royalties payable under this Agreement as contemplated by Section 4.1 and
information reasonably satisfactory to BMS to permit the calculation of any such reduction or
deduction, accompanied by payment in accordance with Section 4.4 of the Royalties due BMS. Cadence
shall provide to BMS a copy of each statement of Net Sales provided by Cadence to Pharmatop
contemporaneously with the provision of such statement to Pharmatop, which statements shall not
disclose the Royalties or other amounts payable to BMS under this Agreement.
4.8 Sales Record Audit. Cadence shall keep, and shall cause each of its Affiliated
Companies, sublicensees, distributors and agents to keep, full and accurate books of accounting In
Accordance With GAAP containing all particulars that may be necessary for the purpose of
calculating all Royalties payable to BMS. Such books of accounting (including those of Cadences
Affiliated Companies, sublicensees, distributors and agents) shall be kept at their principal place
of business, together with all necessary supporting data. BMS may, on reasonable (but not less
than [***]([***])[***]) written notice to Cadence, have the calculation of the Royalties payable
under Section 4.1 and any calculation or reconciliation statement provided pursuant to Section 4.7
audited at its own expense by an accounting firm selected by BMS that is reasonably acceptable to
Cadence and that is bound by a written agreement of confidentiality to Cadence. The auditors
assignment will be limited to reviewing the accuracy of a calculation or reconciliation statement
sent by Cadence, and to disclosing only if there are any errors in payment and, if an error exists,
the amount of such error(s) and the calculation thereof, and no additional or any other
information. If an audit discloses that the amount of Royalties owed to BMS was understated by
more than [***]([***][***], then [***] must reimburse [***] for the cost of the audit, in addition
to paying the additional Royalties together with interest on the additional amounts, calculated
from the date on which the additional amount should have been paid, as provided in Section 4.5.
Such audit rights may be exercised only once in any given Calendar Year, and any such audit shall
apply [***].
ARTICLE V MUTUAL COVENANTS OF THE PARTIES
5.1 Publicity. Neither Party shall issue any public release or announcement
concerning this Agreement or the transactions contemplated hereby without the prior consent of the
other Party, except to the extent required by Applicable Law or the rules or regulations of any
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United States or foreign securities exchange (or inter-dealer quotation system) or regulatory
commission (in which case such Party shall, to the extent practicable, allow the other Party
reasonable time to comment on such release or announcement in advance of such issuance); provided,
however, that prior to any such disclosure, such Party shall use reasonable efforts to give advance
notice to the other Party of the timing and content of such disclosure. Nothing contained in this
Section 5.1 shall prevent either Party from making internal announcements to its and its Affiliated
Companies employees.
5.2 Confidentiality.
(a) Confidentiality Obligations. Each Party recognizes that the other Partys Confidential
Information constitutes highly valuable and proprietary confidential information and material.
Each Party agrees that until the date that is [***]([***])[***] after the date of disclosure to it
of any given item of Confidential Information, it will keep confidential, and will cause its officers, employees, consultants,
agents, Affiliated Companies and sublicensees to keep confidential, such Confidential Information
disclosed to it by the other Party; provided that if the Pharmatop License Agreement requires a
longer period of confidentiality with respect to any Confidential Information of Pharmatop
disclosed to a Party, such Party shall also observe such longer period of confidentiality in
accordance with the Pharmatop License Agreement. Neither BMS nor Cadence nor any of their
respective employees, consultants, Affiliated Companies or sublicensees shall use Confidential
Information of the other Party for any purpose whatsoever except as otherwise expressly permitted
by this Agreement.
(b) Limited Disclosure. Each Party agrees that any disclosure of the other Partys
Confidential Information to any officer, employee, consultant, agent or Affiliated Company of such
Party, shall be made only if and to the extent necessary to carry out its obligations and
responsibilities, or to exercise its rights, under this Agreement, shall be limited to the maximum
extent possible consistent with such rights and responsibilities, and shall only be made to persons
who are bound by their employment (or other) contract (or, in the case of counsel or other licensed
professionals, by applicable rules of professional conduct) to maintain the confidentiality thereof
and not to use such Confidential Information except as expressly permitted by this Agreement. Each
Party further agrees not to disclose or transfer the other Partys Confidential Information to any
Third Party under any circumstance without the prior written approval from the other Party (such
approval not to be unreasonably withheld, delayed or conditioned if such Confidential Information
is appropriately protected by the recipient), except as otherwise required by law, and except as
otherwise expressly permitted by this Agreement. Each Party shall take such action, and shall
cause its officers, employees, consultants, agents, Affiliated Companies and sublicensees to take
such action, to preserve the confidentiality of the other Partys Confidential Information as it
would customarily take to preserve the confidentiality of its own Confidential Information, using a
level of care that shall not under any circumstances be less than reasonable care. Each of the
Receiving Partys Affiliated Companies shall be bound by the confidentiality obligations set forth
in this Section 5.2 for the entire period
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set forth in Section 5.2(a), including any entity that becomes an Affiliated Company after the
date of the relevant disclosure by the Disclosing Party, whether or not such Affiliated Company
ceases to be an Affiliated Company of the Receiving Party during the term of the confidentiality
obligations hereunder; and the Receiving Party shall be responsible for any unauthorized disclosure
of such Confidential Information by any of its Affiliated Companies to which such Confidential
Information is disclosed, including after such company ceases to be an Affiliated Company.
(c) Authorized Disclosure. The Receiving Party may disclose Confidential Information
belonging to the other Party to the extent (and only to the extent) such disclosure is reasonably
necessary in the following instances:
(i) as reasonably necessary for filing or prosecuting Patents as contemplated by this
Agreement;
(ii) as reasonably necessary for Regulatory Filings and other communications with Drug
Regulatory Authorities as contemplated by this Agreement;
(iii) as reasonably necessary for prosecuting or defending litigation;
(iv) subject to Section 5.2(e) of this Agreement, as reasonably necessary to comply
with Applicable Law (including the rules and regulations of the Securities and Exchange
Commission or any national securities exchange) and with judicial process, if in the
reasonable opinion of the Receiving Partys counsel, such disclosure is necessary for such
compliance; and
(v) in connection with the performance of this Agreement and solely on a reasonable
need to know basis, to Affiliated Companies, potential collaborators (including potential
co-marketing and co-promotion contractors), sublicensees, potential sublicensees, research
collaborators, potential investment bankers, lenders, investors, employees, consultants,
medical professionals participating in the conduct of clinical trials, or agents, each of
whom prior to disclosure must be bound by similar obligations of confidentiality and non-use
at least equivalent in scope to those set forth in this Section 5.2; provided, that in the
case of disclosure to academic researchers and academic institutions, the confidentiality
period hereunder shall be the longest such period as the applicable Party may reasonably
negotiate with such researchers or institutions; and provided, that the Receiving Party
shall remain responsible for any failure by any Person who receives Confidential Information
pursuant to this Section 5.2 to treat such Confidential Information as required under this
Section 5.2;
provided, however, that nothing in this Agreement shall limit or affect the Parties
confidentiality obligations under the Pharmatop License Agreement.
If and whenever any Confidential Information is disclosed in accordance with this Section 5.2,
such disclosure shall not cause any such information to cease to be Confidential Information except
to the extent that such disclosure results in a public disclosure of such information (otherwise
than by breach of this Agreement). With respect to disclosures under Sections 5.2(c)(iii) and
5.2(c)(iv), where reasonably possible, the Receiving Party shall notify the
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Disclosing Party of the Receiving Partys intent to make such disclosure sufficiently prior to
making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it
may deem appropriate to protect the confidentiality of the information, and the Receiving Party
shall further reasonably assist the Disclosing Party to obtain confidential treatment of such
Confidential Information.
The Parties acknowledge that the terms of this Agreement shall be treated as Confidential
Information of both Parties. For the avoidance of doubt, this Section 5.2 shall in no way prevent
a Party from disclosing the existence of this Agreement or any terms of this Agreement in order to
seek legal advice whenever deemed appropriate by such Party or to enforce such Partys rights under
this Agreement, whether through arbitration proceedings, court proceedings or otherwise, or to
defend itself against allegations or claims relating to this Agreement, or to disclose such terms
as it may be advised in written opinion of outside counsel are required to be disclosed to comply
with Applicable Law (a copy of which opinion shall be provided to the other Party).
(d) Employees and Consultants. Each Party hereby represents that all of its employees and any
consultants to such Party or its Affiliated Companies that will have access to the Confidential
Information of the other Party shall be bound by written obligations (or, in the case of counsel or
other licensed professionals, bound by rules of professional conduct) to maintain such information
in confidence consistent with the terms of this Agreement and not to use such information except as
expressly permitted herein. Each Party agrees to enforce confidentiality obligations to which its
employees and consultants (and those of its Affiliated Companies) are obligated with respect to any
such Confidential Information and agrees to be responsible for any breach or violation by such
Persons of any provisions of this Agreement or the Pharmatop License Agreement relating to the
confidentiality or non-use of any such Confidential Information by such Persons.
(e) Securities Filings. In the event either Party proposes to file with the Securities and
Exchange Commission or the securities regulators of any state or other jurisdiction a registration
statement or any other disclosure document which describes or refers to this Agreement under the
Securities Act of 1933, as amended, the Exchange Act, or any other Applicable Law relating to
securities matters, that Party shall notify the other Party of such intention and shall provide
such other Party with a copy of relevant portions of the proposed filing not less than five (5)
Business Days prior to such filing (and any revisions to such portions of the proposed filing a
reasonable time prior to the filing thereof), including any exhibits thereto relating to this
Agreement, and shall use reasonable efforts to obtain confidential treatment of any information
concerning this Agreement that such other Party requests be kept confidential, and shall only
disclose Confidential Information which it is advised by counsel or the Securities and Exchange
Commission is legally required to be disclosed. No such notice shall be required under this
Section 5.2(e) if the substance of the description of or reference to this Agreement contained in
the proposed filing has been included in any previous filing made by either Party hereunder or
otherwise approved by the other Party.
(f) Academic Publications. The Parties recognize that independent investigators have been
engaged, and will be engaged in the future, to conduct clinical trials and studies of the Products.
The Parties recognize that such investigators operate in an academic
45
environment and may release information regarding such studies in a manner consistent with
academic standards and as further provided in this paragraph. In the event that any such
independent investigator of a Party desires to publish any abstract, manuscript or article or make
any presentation (including verbal presentations) or other publication that includes any
Confidential Information of the other Party, such Party shall (i) require such independent
investigator to provide the other Party and its patent counsel the opportunity to review any
proposed abstract, manuscript, article, presentation (including verbal presentations) or other
publication at least thirty (30) days prior to its intended submission for publication or such
presentation and (ii) upon request of the other Party not to submit any such abstract, article or
manuscript for publication or not to make such presentation for such additional reasonable period
of time (but not to exceed an additional thirty (30) days) to enable the other Party to secure
patent protection for any material in such publication which it believes to be patentable or to
consider the implications of publication on eventual commercialization.
(g) Additional Confidentiality Obligations under the Pharmatop License Agreement. The
provisions of this Section 5.2 are in addition to and not in limitation of any applicable
obligation of confidentiality under the Pharmatop License Agreement.
5.3 Restrictions Binding on Affiliated Companies and Investors. Each Party shall
require each of its Affiliated Companies and investors to which Confidential Information of the
other Party is disclosed as permitted hereunder to comply with the covenants and restrictions set
forth in Sections 5.1 and 5.2 as if each such Affiliated Company and each such investor were a
Party to this Agreement and shall be fully responsible for any breach of such covenants and
restrictions by any such Affiliated Company or investor.
5.4 Alliance Management. Each of the Parties shall appoint one senior representative
who possesses a general understanding of development, regulatory and commercialization issues to
act as its Alliance Manager. The role of the Alliance Manager is to act as a single point of
contact between the Parties to assure a successful working relationship. Each Party may change its
designated Alliance Manager from time to time upon written notice to the other Party. Any Alliance
Manager may designate a substitute to temporarily perform the functions of that Alliance Manager.
5.5 Liens.
(a) Cadence shall not during the term of this Agreement (i) grant any Lien (excluding any
permitted sublicenses) with respect to this Agreement or any of the rights licensed or sublicensed
to it under this Agreement or (ii) permit such a lien, security interest or other encumbrance
(excluding any permitted sublicenses) to attach to this Agreement or any of such rights. For sake
of clarity, any breach of this Section 5.5(a) by Cadence that is not cured within ten (10) Business
Days after written notice thereof shall be deemed a material breach of this Agreement.
(b) BMS shall not during the term of this Agreement (i) grant any Lien (excluding any
permitted sublicenses) with respect to any of the BMS Rights, BMS Patents or BMS Know-How that
would prevent BMS from granting the licenses hereunder or performing its obligations under this
Agreement, or (ii) permit such a Lien to attach to the BMS Rights,
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BMS Patents or BMS Know-How. For sake of clarity, any breach of this Section 5.5(b) by BMS
that is not cured within ten (10) Business Days after written notice thereof shall be deemed a
material breach of this Agreement.
5.6 BMS Confidential Disclosure Agreements. Promptly following the Effective Date,
BMS shall assign to Cadence the Confidential Disclosure Agreements executed by BMS and the other
potential sublicensees considered by BMS in connection with the sublicense of the BMS Rights
contemplated hereby, to the extent assignable; provided, however, that if BMS is not permitted by
the terms of such Confidential Disclosure Agreements to so assign them, BMS shall request the other
parties to such Confidential Disclosure Agreement to (i) return or destroy all the confidential
information of BMS relating to the Products and the BMS Rights provided to them by BMS in
connection with such transaction and (ii) certify to BMS that such confidential information has
been returned or destroyed; provided, further, that BMS shall not have any obligation to bring any
suit or take any other action against any such other party to enforce the obligations thereunder.
BMS shall provide to Cadence copies of any such certifications received by BMS.
ARTICLE VI REPRESENTATIONS AND WARRANTIES
6.1 Mutual Representations and Warranties. Each of BMS and Cadence represents and
warrants to the other Party as follows:
(a) Organization. Such Party is a corporation duly organized, validly existing and in good
standing (or subsisting) under the laws of the jurisdiction of its organization, is qualified to do
business and is in good standing (or subsisting) as a foreign corporation or company in each
jurisdiction in which the performance of its obligations under this Agreement requires such
qualification, and has full corporate or company power and authority and possesses all governmental
franchises, licenses, permits, authorizations and approvals (other than the termination or
expiration of any waiting periods under the HSR Act, if applicable) necessary to enable it to
perform its obligations under this Agreement, other than such franchises, licenses, permits,
authorizations and approvals the lack of which, individually or in the aggregate, could not
reasonably be expected to have a Material Adverse Effect.
(b) Authorization. The execution, delivery and performance by such Party of this Agreement
have been duly authorized by all necessary corporate action and do not and will not require any
further consent or approval of its shareholders or members. Such Party has the power and authority
to execute and deliver this Agreement and to perform its obligations hereunder and to grant the
rights and licenses granted (or to be granted) by it in this Agreement.
(c) Binding Agreement. Such Party has duly executed and delivered this Agreement, and this
Agreement (assuming the due authorization, execution and delivery by each other party thereto),
constitutes its legal, valid and binding obligation, enforceable against it in accordance with its
terms, subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization,
moratorium and similar laws and judicial decisions of general applicability relating to or
affecting creditors rights generally and to general principles of equity (regardless of whether
enforceability is sought in equity or at law).
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(d) No Conflicts; Consents. The execution and delivery by such Party of this Agreement do
not, and the consummation of the transactions contemplated by this Agreement do not and will not,
conflict with, or result in any violation of or default (with or without notice or lapse of time,
or both) under, or give rise to a right of termination, cancellation or acceleration of any
obligation or to loss of a material benefit under, or to increased, additional or accelerated
rights or entitlements of any Third Party under, or result in the creation of any Lien upon any of
the assets of such Party under, any provision of (i) its Organizational Documents, (ii) any
Contract to which such Party is a party or by which any of its properties or assets is bound,
except for the rights of Pharmatop under the Pharmatop License Agreement or (iii) any judgment,
order or decree (collectively, Judgments) or any Applicable Law applicable to such Party or its
properties or assets. No consent, approval, license, permit, order or authorization (collectively,
Consent) of, or registration, declaration or filing with, any Governmental Entity (other than any
filing under the HSR Act) or any other Third Party is required to be obtained or made by or with
respect to such Party in connection with the execution, delivery and performance of this Agreement
or the consummation of the transactions contemplated by this Agreement.
(e) Litigation. There are no (a) outstanding Judgments against or affecting such Party, or
(b) claims, actions, suits, proceedings, arbitrations, investigations, inquiries, or hearings or
notices of hearings (collectively, Proceedings) pending or, to the knowledge of such Party,
threatened in writing against or affecting such Party, its Affiliated Companies, by or against any
Governmental Entity or any other Person, that in any manner challenges or seeks to prevent, enjoin,
materially alter or materially delay the transactions contemplated by this Agreement or that,
individually or in the aggregate, could reasonably be expected to have a Material Adverse Effect on
such Party or on the exploitation (including the import, use, manufacture, sale and offer for sale)
of the Products hereunder.
6.2 Additional Representations of Cadence. Without limiting the generality of the
representations and warranties set forth in Section 6.1 above, Cadence represents and warrants to
BMS as follows:
(a)
Financial Statements. True and complete copies of the audited balance sheet of Cadence as of
December 31, 2004, and the related statements of income, shareholders equity and cash flows for
the fiscal year ended on such date, together with the notes thereto and the unaudited consolidated
balance sheets of Cadence and its subsidiaries as of December 31, 2005, and the related statements
of income, shareholders equity and cash flows for the twelve (12) months ended on such date
(collectively, the
Financial Statements) have been Previously Disclosed. The Financial
Statements are In Accordance With GAAP (as defined below). As used herein with respect to any
financial statements,
In Accordance With GAAP means that such financial statements: (i) are in
accordance with the books and records of Cadence and its subsidiaries, if any, (ii) are true and
correct and fairly present in all material respects the financial position, results of operations,
shareholders equity and cash flows of Cadence and its subsidiaries, if any, on a consolidated
basis, if applicable, as of the dates and for the periods indicated, in each case in conformity
with United States generally accepted accounting principles consistently applied during the
applicable periods and (iii) if such financial statements are audited, include all required
footnotes and, if such financial statements are unaudited, include all required footnotes
concerning contingent liabilities, if any. The statements of income included
48
in the Financial Statements do not contain any items of special or nonrecurring income, revenue or
expense and have not been affected by the inclusion of transactions entered into otherwise than on
normal commercial terms or by any other factors rendering such profits for all or any of such
periods exceptionally high or low, except as expressly specified therein. Except as specified in
the Financial Statements or the notes thereto, the balance sheets included in the Financial
Statements do not reflect any write-up or revaluation increasing the book value of any assets. The
books and accounts of Cadence and its subsidiaries are true and complete in all material respects
and fully and fairly reflect all of the transactions of Cadence and its subsidiaries.
(b) Absence of Undisclosed Liabilities. To the knowledge of Cadence, Cadence and its
subsidiaries have no liability of any nature whatsoever (whether known or unknown, due or to become
due, accrued, absolute, contingent, existing, inchoate or otherwise) including any unfunded
obligation under any benefit plan (as defined in ERISA) or liabilities for Taxes, except for (i)
liabilities reflected or reserved against in the consolidated balance sheet of Cadence and its
subsidiaries as of December 31, 2005 (the Balance Sheet Date) included in the Financial
Statements (collectively, the Balance Sheet), or in the notes thereto, (ii) liabilities under the
Loan and Security Agreement among Cadence, Oxford Finance Corporation and Silicon Valley Bank dated
February 17, 2006 (the Loan Agreement), (iii) current liabilities incurred in the ordinary course
of business and consistent with past practice from the Balance Sheet Date to the Effective Date
which, individually and in the aggregate, do not exceed [***] and (iv) liabilities which
individually or in the aggregate would not have a Material Adverse Effect on Cadence. The
collateral pledged by Cadence pursuant to the Loan Agreement does not include any of Cadences
rights in, to or under this Agreement.
(c) Absence of Material Adverse Effect. To the knowledge of Cadence, since the Balance Sheet
Date and through the Effective Date, Cadence and its subsidiaries have not experienced a Material
Adverse Effect and no event or circumstance has occurred or developed which is reasonably likely to
result in such a Material Adverse Effect or which has resulted, or is reasonably likely to result,
in any loss or liability to Cadence and its subsidiaries in excess of [***].
Without limiting the foregoing, since the Balance Sheet Date there has not been, occurred or
arisen: (i) any declaration, setting aside or payment of any dividend or distribution (whether in
cash, stock or property) in respect of capital stock of Cadence or any of its subsidiaries, or any
direct or indirect redemption, purchase or other acquisition of shares of such capital stock or any
split, combination or reclassification of such capital stock (other than redemption of shares
issued pursuant to early-exercised options under Cadences 2004 Equity Incentive Award Plan), (ii)
any Lien on any of the assets or properties of Cadence and its subsidiaries (other than the pledge
of assets pursuant to the Loan Agreement); or (iii) any authorization, approval, agreement or
commitment to do any of the foregoing. The pledge of assets pursuant to the Loan Agreement does
not grant any Lien with respect to this Agreement or any of the rights licensed or sublicensed to
it under this Agreement.
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(d) Legal Matters. Since Cadences date of incorporation (May 26, 2004), there has not been
any, and there is no, claim, action, suit, litigation, investigation, inquiry, review or proceeding
(collectively, Cadence Claims) pending against Cadence or any of its subsidiaries relating to the
business or assets of Cadence or its subsidiaries before or by any court, arbitrator or
Governmental Entity; and to the knowledge of Cadence no such Cadence Claim has been threatened.
Neither Cadence nor any of its subsidiaries is subject to any judgment, decree, writ, injunction,
ruling, award or order of any Governmental Entity or any arbitrator relating to the business or
assets of Cadence and its subsidiaries.
(e) Receipt of Financing; Restrictions. Between the Execution Date and the Effective Date,
Cadence will have received additional financing in an amount that is not less than $50 million from
the sale of equity securities. The holders of the equity securities of Cadence and its
subsidiaries do not have (by virtue of the terms of such equity securities, by contract or
otherwise) any right (mandatory or optional) to require the redemption of any of such equity
securities. On or before the Effective Date, Cadence will have entered into the Loan Agreement
obligating the lender or lenders thereunder to lend to Cadence not less than $7 million, subject to
the terms and conditions set forth therein. Cadence has provided to BMS true and complete copies
of the documents relating to such equity financing and such Loan Agreement.
6.3 BMS Rights.
(a) Pharmatop Patents. As of the Execution Date, BMS represents and warrants to
Cadence as follows with respect to the Pharmatop Patents and Pharmatop Know-How:
(i) Schedule 6.3(a) sets forth a list of all the Pharmatop Patents. To the knowledge
of BMSs in-house patent counsel after reasonable due diligence, (A) the most recent Patent report
provided to BMS pursuant to Section 5.1 of the Pharmatop License Agreement relating to the
Pharmatop Patents has been provided to Cadence, except for information that may have been redacted
relating to Patents outside the Territory, and (B) BMS has not received any written notices of
allowances for the Pharmatop Patents or written notices of interferences proceedings with respect
thereto, except as previously disclosed to Cadence.
(ii) To the knowledge of BMSs in-house patent counsel after reasonable due diligence, there
are no unpaid maintenance, annuity or renewal fees currently overdue for any of the Pharmatop
Patents.
(iii) To the knowledge of BMSs in-house patent counsel, BMS is the sole and exclusive
licensee of the Pharmatop Patents in the Territory.
(iv) BMS has not sublicensed, granted any interest in or options to the Pharmatop Patents to
any Third Party in the Territory and covenants not do so prior to the expiration or termination of
this Agreement, except in the exercise of BMSs retained rights pursuant to Section 2.2.
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(b) To the knowledge of BMSs in-house counsel, BMS is not, nor has it received any notice
that it is, in default (or that with the giving of notice or lapse of time or both it would be in
default) with respect to the BMS Rights under the Pharmatop License Agreement that would permit
Pharmatop to terminate, or exercise a right of rescission, revision or amendment of, the Pharmatop
License Agreement with respect to the Territory and covenants that it shall not take, and shall
cause its Affiliated Companies not to take, any action or omit to take any action after the
Execution Date that would permit Pharmatop to terminate, or exercise a right of rescission,
revision or amendment of, the Pharmatop License Agreement with respect to the Territory, other than
the omission of the performance of obligations assumed by Cadence hereunder.
(c) To the knowledge of BMSs in-house patent counsel, BMS has not received written notice of
any claim, action, suit or litigation alleging that BMSs exploitation (including the import, use,
manufacture, sale and offer for sale) of the BMS Rights for the Product interferes with, infringes,
or misappropriates any intellectual property rights of any Third Party (including written notice of
any claim, action, suit or litigation that BMS must license or refrain from using any intellectual
property rights of any Third Party in order to exploit(including the import, use, manufacture, sale
and offer for sale) any Products. To the knowledge of BMSs in-house patent counsel, BMS has not
received written notice that any claim, action, suit or litigation is pending or threatened which
challenges the legality, validity, enforceability, use or ownership of any BMS Rights.
(d) BMS represents and warrants to Cadence that a true and correct copy of the Pharmatop
License Agreement as of the Effective Date, including any and all amendments, supplements or other
modifications thereto, except for the redaction of certain financial information in Section 7.1
thereof, has been Previously Disclosed. A copy of the Licensor Confirmation provided by Pharmatop
with respect to certain intellectual property and other matters as of February 6, 2006, has been
Previously Disclosed.
(e) To the knowledge of BMS, no circumstances or grounds exist that would entitle Pharmatop to
terminate or exercise a right of rescission, revision, or amendment of the Pharmatop License
Agreement with respect to the Territory, and the execution, delivery and performance of this
Agreement will not constitute such a circumstance or ground.
(f) BMS has protected the Pharmatop Know-How in a manner not materially different from the
manner in which it customarily protects its other proprietary know-how of comparable commercial
value.
6.4 BMS Patents and Know-How. As of the Execution Date, BMS represents and warrants
to Cadence with respect to the BMS Patents and BMS Know-How that to the knowledge of its in-house
patent counsel:
(a) there are no unpaid maintenance, annuity or renewal fees currently overdue for any of the
BMS Patents; and
(b) there are no claims, judgments or settlements against or owed by BMS and no litigation
pending or threatened in writing relating to the BMS Patents; and
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(c) BMS has protected the BMS Know-How in a manner not materially different from the manner in
which it customarily protects its other proprietary know-how of comparable commercial value.
6.5 DISCLAIMER.
(a) EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE VI OR IN
SECTION 5.2(D), BMS MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
WITH RESPECT TO THE BMS RIGHTS, BMS PATENTS OR BMS KNOW-HOW, IMPROVEMENTS, REGISTRATIONAL
INFORMATION, REGULATORY FILINGS, APPROVALS, PRODUCT DATA, OTHER PRODUCT DATA OR REPORTS, STUDIES,
PATENTS, PROCESSES, FORMULATIONS, TECHNIQUES OR OTHER TRADE SECRETS OR CONFIDENTIAL INFORMATION
PROVIDED BY BMS TO CADENCE HEREUNDER OR ANY LICENSE GRANTED BY BMS HEREUNDER, OR WITH RESPECT TO
ANY COMPOUNDS OR PRODUCTS. WITHOUT LIMITING THE FOREGOING, BMS MAKES NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE BMS RIGHTS,
BMS PATENTS OR BMS KNOW-HOW OR ANY LICENSE GRANTED BY BMS HEREUNDER, OR WITH RESPECT TO ANY
COMPOUNDS OR PRODUCTS. FURTHERMORE, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A
REPRESENTATION OR WARRANTY BY BMS THAT ANY OF THE FOREGOING IS VALID OR ENFORCEABLE OR THAT
CADENCES USE THEREOF CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
(b) EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE VI OR IN
SECTION 5.2(D), CADENCE MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, WITH RESPECT TO THE IMPROVEMENTS, REGISTRATIONAL INFORMATION, REGULATORY FILINGS,
APPROVALS, PRODUCT DATA, OTHER PRODUCT DATA OR REPORTS, STUDIES, PATENTS, PROCESSES, FORMULATIONS,
TECHNIQUES OR OTHER TRADE SECRETS OR CONFIDENTIAL INFORMATION PROVIDED BY CADENCE TO BMS HEREUNDER
OR ANY LICENSE GRANTED BY CADENCE HEREUNDER, OR WITH RESPECT TO ANY COMPOUNDS OR PRODUCTS. WITHOUT
LIMITING THE FOREGOING, CADENCE MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO ANY LICENSE GRANTED BY CADENCE HEREUNDER, OR WITH
RESPECT TO ANY COMPOUNDS OR PRODUCTS. FURTHERMORE, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS
A REPRESENTATION OR WARRANTY BY CADENCE THAT ANY OF THE FOREGOING IS VALID OR ENFORCEABLE OR THAT
BMSS USE THEREOF CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY.
6.6 LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE,
(I) NEITHER PARTY SHALL BE LIABLE TO THE
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OTHER (OR TO ANY INDEMNIFIED PARTIES) WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT,
WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR
ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES
(INCLUDING LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS), EXCEPT THAT SUCH
LIMITATION SHALL NOT APPLY TO (A) PUNITIVE OR CONSEQUENTIAL DAMAGES PAID OR PAYABLE TO A THIRD
PARTY BY AN INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION
HEREUNDER, (B) A BREACH OF THE [***] COVENANT, (C) ANY FAILURE BY CADENCE OR ITS AFFILIATED
COMPANIES TO (1) OBSERVE OR COMPLY WITH THE TERMS OF THE PHARMATOP LICENSE AGREEMENT OR (2) PERFORM
ANY OF THE OBLIGATIONS UNDER THE PHARMATOP LICENSE AGREEMENT ASSUMED BY CADENCE HEREUNDER THAT, IN
THE CASE OF EACH OF PART (1) AND (2) OF THIS CLAUSE (C) RESULTS IN A TERMINATION OF THE PHARMATOP
LICENSE AGREEMENT WITH RESPECT TO ANY COUNTRY IN THE TERRITORY OR A TERMINATION OF THE PHARMATOP
LICENSE AGREEMENT IN ITS ENTIRETY, (D) ANY BREACH OF THE PHARMATOP LICENSE AGREEMENT BY BMS OR ITS
AFFILIATED COMPANIES (OTHER THAN WITH RESPECT TO ANY OBLIGATION TO BE PERFORMED BY CADENCE) THAT
RESULTS IN A TERMINATION OF THE PHARMATOP LICENSE AGREEMENT WITH RESPECT TO ANY COUNTRY IN THE
TERRITORY OR A TERMINATION OF THE PHARMATOP LICENSE AGREEMENT IN ITS ENTIRETY OR (E) ANY BREACH OF
[***] OF THIS AGREEMENT BY BMS OR ITS AFFILIATED COMPANIES OR OF [***] OF THIS AGREEMENT BY CADENCE
OR ITS AFFILIATED COMPANIES AS TO WHICH CADENCE OR BMS, AS THE CASE MAY BE, TERMINATES THIS
AGREEMENT PURSUANT TO SECTION 8.3(B) (IT BEING UNDERSTOOD THAT A BREACH OF ANY OF SUCH SECTIONS IS
NOT NECESSARILY A MATERIAL BREACH THAT WOULD PERMIT TERMINATION UNDER SECTION 8.3(B)), AND (II)
EXCEPT AS PROVIDED IN [***] ABOVE, BMS SHALL NOT BE LIABLE IN RESPECT OF ANY BREACH OF ANY
REPRESENTATION OR WARRANTY OF BMS CONTAINED IN THIS AGREEMENT IN AN AMOUNT GREATER THAN THE AMOUNTS
PAID BY CADENCE TO BMS UNDER SECTION 4.1 OF THIS AGREEMENT.
ARTICLE VII INDEMNIFICATION; ARBITRATION
7.1 Mutual Indemnification. Each Party (the Indemnifying Party) shall indemnify,
defend and hold harmless the other Party, its Affiliated Companies and their respective directors,
officers, employees, and agents and their respective successors, heirs and permitted assigns (the
Indemnitees), against any liability, damage, loss or expense (including reasonable attorneys
fees and expenses of litigation) (collectively, but subject to Section 6.6 hereof, Losses)
incurred by or imposed upon the Indemnitees, or any one of them arising out of or resulting from
(or alleged to arise out of or result from) any of the following:
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(i) any breach of any representation or warranty of the Indemnifying Party contained in this
Agreement; and
(ii) any breach of any covenant or agreement of the Indemnifying Party contained in this Agreement.
7.2 Additional Indemnification Obligations of Cadence. Without limiting its
obligations under Section 7.1, Cadence further agrees to indemnify, defend and hold harmless BMS,
its Affiliated Companies and their respective directors, officers, employees, and agents and their
respective successors, heirs and assigns (the BMS Indemnitees), against any Losses payable by the
BMS Indemnitees, or any one of them, to any Third Party arising out of or resulting from (or
alleged to arise out of or result from) (A) any breach of the Pharmatop License Agreement (other
than a breach by Pharmatop) resulting from (i) any failure of Cadence or any of its Affiliated
Companies, sublicensees, contractors or agents to perform, observe or comply with any provision of
the Pharmatop License Agreement that relates to the Territory (except to the extent that a breach
by BMS of its obligations under this Agreement or the Pharmatop License Agreement or any other act
or omission by BMS prevents such performance, observance or compliance by Cadence or its Affiliated
Companies, sublicensees, contractors or agents) or (ii) the exercise by Cadence or its Affiliated
Companies, sublicensees, contractors or agents of the BMS Rights sublicensed to Cadence under this
Agreement, (B) the development of Products by or on behalf of Cadence or any of its Affiliated
Companies or sublicensees for the Territory or any other jurisdiction as to which Cadence or any of
its Affiliated Companies has or may acquire rights with respect to Products, (C) the marketing,
promotion, sale, use, consumption of, or exposure to, Products in the Territory or any such other
jurisdiction, (D) the manufacturing (other than pursuant to the Clinical Supply Agreement) of
Products for sale, use or consumption in the Territory or any such other jurisdiction, (E) the use
by Cadence and its Affiliated Companies or any of its or their sublicensees, contractors or agents
of BMSs Product Data, Other Product Data or Regulatory Filings or other data, information,
records, filings or Confidential Information that BMS provides to Cadence pursuant to this
Agreement or (F) any failure by Cadence and its Affiliated Companies and its and their sublicensees
to comply with Applicable Law in connection with the development and commercialization (including
the manufacture, marketing, promotion and sale) of the Products hereunder.
7.3 Additional Indemnification Obligations of BMS. Without limiting its obligations under
Section 7.1, BMS further agrees to indemnify, defend and hold harmless Cadence, its Affiliated
Companies and their respective directors, officers, employees, and agents and their respective
successors, heirs and assigns (the Cadence Indemnitees), against any Losses payable by the
Cadence Indemnitees, or any one of them, to any Third Party arising out of or resulting from (or
alleged to arise out of or result from) (A) any breach of the Pharmatop License Agreement (other
than a breach by Pharmatop or a failure by Cadence or any of Cadences Affiliated Companies or any
of their sublicensees, contractors or agents to perform, observe or comply with any of the
provisions of the Pharmatop License Agreement, except to the extent that a breach by BMS of its
obligations under this Agreement or the Pharmatop License Agreement or any other act or omission by
BMS prevents such performance, observance or compliance by Cadence or its Affiliated Companies,
sublicensees, contractors or agents) resulting from (i) any failure of BMS or any of its Affiliated
Companies or its or their sublicensees (other than Cadence), contractors or agents to perform,
observe or comply with anyprovision of the Pharmatop License
Agreement
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that relates to the Territory (except to the extent such failure results from any act or omission
of Cadence and its Affiliated Companies, sublicensees contractors and agents to perform, observe or
comply with any provision of the Pharmatop License Agreement that relates to the Territory or with
this Agreement), (B) any breach of the Pharmatop License Agreement by BMS or any of its Affiliated
Companies or its or their sublicensees (other than Cadence), contractors or agents that arises out
of activities of BMS or any of its Affiliated Companies or its or their sublicensees (other than
Cadence) outside the Territory, (C) the exploitation (including the import, use, manufacture, sale
and offer for sale) of the Products by BMS or any of its Affiliated Companies or its or their
sublicensees (other than Cadence), contractors or agents outside the Territory or inside the
Territory pursuant to the rights retained by BMS under this Agreement, (D) the exploitation
(including the import, use, manufacture, sale and offer for sale) of the Products by BMS or any of
its Affiliated Companies or its or their sublicensees (other than Cadence), contractors or agents
inside the Territory prior to the Effective Date or (E) the use by BMS and its Affiliated Companies
or any of its or their sublicensees (other than Cadence), contractors or agents of Cadences
Product Data, Other Product Data or Regulatory Filings or other data, information, records, filings
or Confidential Information that Cadence provides to BMS pursuant to this Agreement.
7.4 Conditions to Indemnification; Third Party Claims. Subject to Article 12 of the
Pharmatop License Agreement, to the extent applicable, a Party seeking indemnification under this
Article VII (the Indemnified Party) with respect to any claim brought by any Third Party shall
give prompt notice of the claim to the Indemnifying Party and, provided that the Indemnifying Party
is not contesting the indemnity obligation, shall permit the Indemnifying Party to control and
assume the defense of any litigation relating to such claim and disposition of any such claim
unless the Indemnifying Party is also a party (or likely to be named a party) to the proceeding in
which such claim is made and the Indemnified Party gives notice to the Indemnifying Party that it
may have defenses to such claim or proceeding that are in conflict with the interests of the
Indemnifying Party, in which case the Indemnifying Party shall not be so entitled to assume the
defense of the case. If the Indemnifying Party does assume the defense of any claim or proceeding,
it (i) shall act diligently and in good faith with respect to all matters relating to the
settlement or disposition of any claim as the settlement or disposition relates to Parties being
indemnified under this Article VII, (ii) shall cause such defense to be conducted by counsel
reasonably acceptable to the Indemnified Party and (iii) shall not settle or otherwise resolve any
claim without prior notice to the Indemnified Party and the consent of the Indemnified Party if
such settlement involves anything other than the payment of money by the Indemnifying Party. The
Indemnified Party shall cooperate with the Indemnifying Party in its defense of any claim for which
the Indemnifying Party has assumed the defense in accordance with this Section 7.4, and shall have
the right (at its own expense) to be present in person or through counsel at all legal proceedings
giving rise to the right of indemnification.
7.5 Insurance. Cadence shall, beginning with the initiation of its first clinical
trial for a Product, maintain at all times thereafter during the term of this Agreement, and until
the later of (i) [***] ([***])[***] after termination or expiration of this Agreement or (ii) the
date that all statutes of limitation covering claims or suits that may be brought for personal
injury based on
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