Cadence Pharmaceuticals, Inc.
As filed with the Securities and Exchange Commission on
August 30, 2006
Registration
No. 333-135821
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
to
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
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
August 30, 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 and Fever |
We are developing IV APAP in the U.S. market for the
treatment of acute pain and fever. 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
1
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 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 studying pain in both adult and pediatric
subjects and fever in pediatric subjects, 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 prevention 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. However, despite the favorable, statistically
significant results for prevention of LCSI and catheter
colonization, the
2
study did not show statistical significance for the primary
endpoint, the prevention of CRBSIs. After in-licensing omiganan,
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 endpoint of
prevention of LCSIs. The 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. 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. |
3
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 net loss was $7.5 million in 2005, and
as of June 30, 2006, we had an accumulated deficit of
$44.3 million. 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. 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
our planned clinical development programs will be sufficient to
support NDA submissions or 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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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; 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. A Notice of Allowance is a notice issued by the U.S.
Patent and Trademark Office to an
intent-to-use
application once all steps of the application process have been
completed. Once the Notice of Allowance has been issued, the
applicant has six months to file a statement of use or an
extension, showing that it is using the mark in commerce, in
order for the U.S. Patent and Trademark Office to issue a
certificate of registration. 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 88,182,195 shares outstanding as
of June 30, 2006, and excludes:
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5,769,471 shares of common stock issuable upon the exercise
of options outstanding as of June 30, 2006 at a weighted
average exercise price of $0.38 per share; |
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385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of June 30, 2006 at a weighted
average exercise price of $1.00 per share; and |
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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 1,678,789 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). |
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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 six-month periods ended
June 30, 2005 and 2006, and for the period from
May 26, 2004 (inception) through June 30, 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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Six Months Ended | |
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(Inception) | |
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Through | |
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Year Ended | |
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June 30, | |
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Through | |
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December 31, | |
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December 31, | |
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June 30, | |
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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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$ |
2,402 |
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$ |
32,374 |
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$ |
40,734 |
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Marketing
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41 |
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240 |
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142 |
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317 |
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598 |
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General and administrative
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877 |
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1,412 |
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540 |
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1,488 |
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3,777 |
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Total operating expenses
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3,151 |
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7,778 |
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3,084 |
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34,179 |
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45,109 |
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Loss from operations
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(3,151 |
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(7,778 |
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(3,084 |
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(34,179 |
) |
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(45,109 |
) |
Other income (expense):
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Interest income
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9 |
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255 |
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14 |
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553 |
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818 |
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Interest expense
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(44 |
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(44 |
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Total other income
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9 |
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255 |
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14 |
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509 |
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774 |
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Net loss
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$ |
(3,142 |
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$ |
(7,523 |
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$ |
(3,070 |
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$ |
(33,670 |
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|
$ |
(44,335 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share(1)
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.68 |
) |
|
$ |
(6.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share(1)
|
|
|
3,658 |
|
|
|
4,624 |
|
|
|
4,527 |
|
|
|
4,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share(1)
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share(1)
|
|
|
|
|
|
|
20,649 |
|
|
|
|
|
|
|
58,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 June 30, 2006 | |
|
|
| |
|
|
|
|
Pro Forma | |
|
|
Actual | |
|
As Adjusted(1) | |
|
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
42,881 |
|
|
$ |
|
|
Working capital
|
|
|
38,676 |
|
|
|
|
|
Total assets
|
|
|
46,355 |
|
|
|
|
|
Long-term debt, less current portion
|
|
|
5,968 |
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(44,335 |
) |
|
|
|
|
Total stockholders equity
|
|
|
35,628 |
|
|
|
|
|
|
|
(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. |
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 conduct six clinical trials to provide the FDA with
data to support multiple dose efficacy for soft tissue surgery,
efficacy for fever and safety in adults and children, based on
the preliminary feedback we received from the FDA in our meeting
in August 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 secondary endpoints of
the trial: the prevention of LCSIs and catheter colonization,
which is the growth of microorganisms on the portion of the
catheter below the skin
8
surface. However, the trial did not show statistical
significance for the primary endpoint, the prevention of
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 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; |
|
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|
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:
|
|
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|
|
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 |
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|
|
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. 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.
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If BMS breaches the underlying agreement under which we
sublicense the rights to our IV APAP product candidate, we could
lose the ability to develop and commercialize IV APAP.
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
breach by BMS, and otherwise 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 the license from SCR Pharmatop to
BMS could result indirectly in our loss of exclusive rights to
our IV APAP product candidate and may lead to a complete
termination of our product development and any commercialization
efforts for IV APAP.
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-
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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.
We currently have what we believe are adequate clinical supplies
of our omiganan product candidate. We entered into a clinical
supply agreement with Lawrence Laboratories, an affiliate of
BMS, under which Lawrence Laboratories has manufactured a single
batch of clinical supplies of IV APAP and a single batch of
placebo. With these batches, we believe we will have adequate
clinical supplies of our IV APAP product candidate and placebo.
The term of the clinical supply agreement generally extends
until the earlier of the receipt by us of regulatory approval
for IV APAP or December 31, 2008. In addition, the clinical
supply agreement could terminate upon mutual written consent of
the parties, the termination of the IV APAP agreement or our
dissolution. The clinical supply agreement may also be
terminated by either party upon written notice to the other
party of an uncured, material breach. We 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
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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 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
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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. Although we have employment
agreements with our senior management, these agreements are
terminable at will at any time with or without notice and,
therefore, we may not be able to retain their services as
expected.
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.
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.
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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. For example, BMS markets IV APAP in Europe and other
countries principally under the brand name Perfalgan. Although
Perfalgan is not labeled for sale in the United States and we
have an exclusive license from BMS and its licensor to develop
and sell our product candidate in the United States, it is
possible that hospitals and other users may in the future seek
to import Perfalgan rather than purchase IV APAP in the
United States for
cost-savings or other
reasons. We would not receive any revenues from the importation
and sale of Perfalgan into the United States.
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.
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 a single-agent 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
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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 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
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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 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 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.
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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
23
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.
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.
24
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 $33.7 million for the first
six months of 2006. The net loss for the first six 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 June 30,
2006, we had an accumulated deficit of $44.3 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.
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.
25
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 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 significant increased costs as a result of
operating as a public company, and our management will be
required to devote substantial time to new compliance
initiatives.
As a public company, we will incur significant legal, accounting
and other expenses that we did not incur as a private company.
In addition, the Sarbanes-Oxley Act, as well as rules
subsequently implemented by the SEC and the Nasdaq Global
Market, have imposed various new requirements on public
companies, including requiring establishment and maintenance of
effective disclosure and financial controls and changes in
corporate governance practices. Our management and other
personnel will need to devote a substantial amount of time to
these new compliance initiatives. Moreover, these rules and
regulations will increase our legal and financial compliance
costs and will make some activities more
time-consuming and
costly. For example, we expect these rules and regulations to
make it more difficult and more expensive for us to obtain
director and officer liability insurance, and we may be required
to accept reduced policy limits and coverage or incur
substantially higher costs to obtain the same or similar
coverage. As a result, it may be more difficult for us to
attract and retain qualified persons to serve on our board of
directors, our board committees or as executive officers.
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The Sarbanes-Oxley Act requires, among other things, that we
maintain effective internal controls for financial reporting and
disclosure controls and procedures. In particular, commencing in
fiscal 2008, we must perform system and process evaluation and
testing of our internal controls over financial reporting to
allow management and our independent registered public
accounting firm to report on the effectiveness of our internal
controls over financial reporting, as required by
Section 404 of the Sarbanes-Oxley Act. Our testing, or the
subsequent testing by our independent registered public
accounting firm, may reveal deficiencies in our internal
controls over financial reporting that are deemed to be material
weaknesses. Our compliance with Section 404 will require
that we incur substantial accounting expense and expend
significant management efforts. We currently do not have an
internal audit group, and we will need to hire additional
accounting and financial staff with appropriate public company
experience and technical accounting knowledge. Moreover, if we
are not able to comply with the requirements of Section 404
in a timely manner, or if we or our independent registered
public accounting firm identifies deficiencies in our internal
controls over financial reporting that are deemed to be material
weaknesses, the market price of our stock could decline and we
could be subject to sanctions or investigations by Nasdaq, the
SEC or other regulatory authorities, which would require
additional financial and management resources.
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;
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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.
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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.
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
29
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 June 30, 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 available for resale in the public market as described
in the Shares Eligible for Future Sale section of
this prospectus. As a result of the lock-up agreements between
our underwriters and our security holders 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 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, beginning
180 days after the date of this prospectus; |
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shares
will be eligible for sale, upon exercise of outstanding
warrants, upon the expiration of the lock-up agreements,
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. |
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Moreover, after this offering, holders of approximately
83,555,455 shares of common stock and the holders of warrants to
purchase 385,000 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. 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. 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.
30
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, securities class action
litigation has often been brought against a company following a
decline in the market price of its securities. This risk is
especially relevant for us because biotechnology and
biopharmaceutical companies have experienced significant stock
price volatility in recent years. 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.
31
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; |
|
|
|
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; |
|
|
|
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; |
|
|
|
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; |
|
|
|
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; |
|
|
|
our reliance on third parties to conduct our clinical trials and
manufacture our product candidates; |
|
|
|
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; |
|
|
|
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
profitability, 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. |
32
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.
33
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:
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|
|
|
approximately $58.0 million to fund clinical trials for
IV APAP and omiganan 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 NDA filings
for IV APAP and omiganan.
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.
34
CAPITALIZATION
The following table sets forth our capitalization as of
June 30, 2006:
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|
|
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.
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|
As of June 30, 2006 | |
|
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| |
|
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|
|
Pro Forma | |
|
|
Actual | |
|
as Adjusted(1) | |
|
|
| |
|
| |
|
|
(In thousands, except share | |
|
|
and par value amounts) | |
Cash and cash equivalents
|
|
$ |
42,881 |
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, less current portion
|
|
$ |
5,968 |
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
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
|
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|
5 |
|
|
|
|
|
Common stock, $0.0001 par value; actual
100,000,000 shares authorized; 8,551,740 shares issued
and outstanding; pro forma as adjusted
100,000,000 shares
authorized; shares
issued and outstanding
|
|
|
1 |
|
|
|
|
|
Additional paid-in capital
|
|
|
79,954 |
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(44,335 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
35,628 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$ |
41,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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. |
35
The number of pro forma as adjusted common shares shown as
issued and outstanding in the table is based on the number of
shares of our common stock outstanding as of June 30, 2006,
and excludes:
|
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|
|
|
5,769,471 shares of common stock issuable upon the exercise
of options outstanding as of June 30, 2006 at a weighted
average exercise price of $0.38 per share; |
|
|
|
|
|
385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of June 30, 2006 at a weighted
average exercise price of $1.00 per share; and |
|
|
|
|
|
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
1,678,789 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). |
|
36
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 June 30, 2006, our
historical net tangible book value was $35.6 million, or
$0.40 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 June 30, 2006, after giving effect to the
conversion of all outstanding shares of our preferred stock into
79,630,455 shares of our common stock. 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 June 30, 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:
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|
Assumed initial public offering price per share
|
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|
|
|
$ |
|
|
|
Historical net tangible book value per share as of June 30,
2006
|
|
$ |
0.40 |
|
|
|
|
|
|
Increase per share attributable to investors purchasing shares
in this offering
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
37
The following table summarizes, as of June 30, 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:
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|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
Shares Purchased | |
|
Total Consideration | |
|
|
|
|
| |
|
| |
|
Average Price | |
|
|
Number | |
|
Percent | |
|
Amount | |
|
Percent | |
|
Per Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing stockholders before this offering
|
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|
88,182,195 |
|
|
|
|
% |
|
$ |
79,742,641 |
|
|
|
|
% |
|
$ |
0.90 |
|
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 June 30, 2006. As of
June 30, 2006, there were:
|
|
|
|
|
|
5,769,471 shares of common stock issuable upon the exercise
of options outstanding as of June 30, 2006 at a weighted
average exercise price of $0.38 per share; |
|
|
|
|
|
385,000 shares of common stock issuable upon the exercise
of warrants outstanding as of June 30, 2006 at a weighted
average exercise price of $1.00 per share; and |
|
|
|
|
|
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
1,678,789 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). |
|
38
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 six-month periods ended June 30, 2005 and 2006, the
period from May 26, 2004 (inception) through
June 30, 2006 and the balance sheet data as of
June 30, 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) | |
|
|
|
Six Months Ended | |
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
June 30, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
2,233 |
|
|
$ |
6,126 |
|
|
$ |
2,402 |
|
|
$ |
32,374 |
|
|
$ |
40,734 |
|
|
Marketing
|
|
|
41 |
|
|
|
240 |
|
|
|
142 |
|
|
|
317 |
|
|
|
598 |
|
|
General and administrative
|
|
|
877 |
|
|
|
1,412 |
|
|
|
540 |
|
|
|
1,488 |
|
|
|
3,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,151 |
|
|
|
7,778 |
|
|
|
3,084 |
|
|
|
34,179 |
|
|
|
45,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,151 |
) |
|
|
(7,778 |
) |
|
|
(3,084 |
) |
|
|
(34,179 |
) |
|
|
(45,109 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
9 |
|
|
|
255 |
|
|
|
14 |
|
|
|
553 |
|
|
|
818 |
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(44 |
) |
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
9 |
|
|
|
255 |
|
|
|
14 |
|
|
|
509 |
|
|
|
774 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142 |
) |
|
$ |
(7,523 |
) |
|
$ |
(3,070 |
) |
|
$ |
(33,670 |
) |
|
$ |
(44,335 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share(1)
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.68 |
) |
|
$ |
(6.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share(1)
|
|
|
3,658 |
|
|
|
4,624 |
|
|
|
4,527 |
|
|
|
4,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share(1)
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share(1)
|
|
|
|
|
|
|
20,649 |
|
|
|
|
|
|
|
58,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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. |
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
As of | |
|
|
| |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents and securities available-for-sale
|
|
$ |
4,271 |
|
|
$ |
15,025 |
|
|
$ |
42,881 |
|
Working capital
|
|
|
4,161 |
|
|
|
14,405 |
|
|
|
38,676 |
|
Total assets
|
|
|
4,536 |
|
|
|
15,769 |
|
|
|
46,355 |
|
Long-term debt, less current portion
|
|
|
|
|
|
|
|
|
|
|
5,968 |
|
Deficit accumulated during the development stage
|
|
|
(3,142 |
) |
|
|
(10,665 |
) |
|
|
(44,335 |
) |
Total stockholders equity
|
|
|
4,422 |
|
|
|
14,623 |
|
|
|
35,628 |
|
40
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 June 30, 2006, we had
an accumulated deficit of $44.3 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.
41
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
Period from | |
|
|
May 26, 2004 | |
|
|
|
|
|
May 26, 2004 | |
|
|
(Inception) | |
|
|
|
Six Months Ended | |
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
June 30, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
June 30, | |
Product Candidate |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
IV APAP
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
25,698 |
|
|
$ |
25,698 |
|
Omiganan
|
|
|
2,001 |
|
|
|
4,802 |
|
|
|
1,850 |
|
|
|
5,038 |
|
|
|
11,841 |
|
Unallocated
|
|
|
232 |
|
|
|
1,324 |
|
|
|
552 |
|
|
|
1,638 |
|
|
|
3,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,233 |
|
|
$ |
6,126 |
|
|
$ |
2,402 |
|
|
$ |
32,374 |
|
|
$ |
40,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
42
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
43
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 assumptions used in the Black-Scholes model were
6.06-6.08 years for the expected term, 70% for the expected
volatility, 4.36-5.08% for the risk free rate and 0% for
dividend yield for the six months ended June 30, 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 SEC 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 June 30, 2006, we had approximately $1.5 million
of unrecognized share-based compensation costs related to
nonvested equity awards. As of June 30, 2006, we had
outstanding vested options to purchase 341,768 shares of
our common stock and unvested options to purchase
5,427,703 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 applied 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.
44
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 (stages 1 and 2 as
defined in the AICPA guidance) where the preferences of the
preferred stockholders, in particular the liquidation
preferences, are very meaningful. We utilized an asset-based
approach for enterprise value and allocated such value to
preferred and common stock based on the current value method. We
did not obtain a contemporaneous independent valuation prior to
2006 as we were focused on product development and fund raising
and believed our board of directors, all of whom are related
parties, had the requisite experience in valuing early stage
companies. Subsequent to our licensing of IV APAP but prior
to the initiation of our initial public offering process on
June 14, 2006, based on a contemporaneous independent
valuation performed by an unrelated valuation specialist, we
allocated additional enterprise value to our common stock with
an increase in the common stock valuation to $0.34 per
share. The increase in our common stock valuation primarily
related to the licensing of IV APAP and the advancement of our
business model. Subsequent to the initiation of our initial
public offering process, based on a contemporaneous independent
valuation performed by an unrelated valuation specialist, we
increased our common stock valuation to $0.80 per share.
The increase in our common stock valuation primarily related to
the prospect of an initial public offering.
Equity instruments issued to non-employees are recorded at their
fair value as determined in accordance with
SFAS No. 123(R) 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 six months ended June 30, 2006 and
2005 |
Research and Development Expenses. Research and
development expenses increased to $32.4 million for the six
months ended June 30, 2006 from $2.4 million for the
comparable period during 2005. This increase of
$30.0 million primarily was due to:
|
|
|
|
|
|
an increase of $25.7 million in our IV APAP program
primarily as a result of a $25.0 million license fee which
was immediately expensed as in-process research and development; |
|
|
|
|
|
an increase of $3.2 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 $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 clinical
and regulatory efforts related to both omiganan and IV APAP. |
|
Marketing Expenses. Marketing expenses increased to
$0.3 million for the six months ended June 30, 2006
from $0.1 million for the comparable period during 2005.
This increase of $0.2 million primarily was due to higher
market research and branding and personnel costs in 2006.
General and Administrative Expenses. General and
administrative expenses increased to $1.5 million for the
six months ended June 30, 2006 from $0.5 million for
the comparable period during 2005. This increase of
$1.0 million primarily was due to legal fees related to the
IV APAP license agreement and our new facility lease, other
professional fees and consulting fees.
Interest Income. Interest income increased to $553,000
for the six months ended June 30, 2006 from $14,000 for the
comparable period during 2005. This increase of $539,000
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 $44,000
for the six months ended June 30, 2006 from zero for the
comparable period during 2005. This increase of $44,000 was
primarily due to non-cash
45
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.
|
|
|
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
June 30, 2006, we received net proceeds of approximately
$79.5 million from the sale of shares of our preferred and
common stock as follows:
|
|
|
|
|
|
from July 2004 to June 2006, we issued and sold a total of
8,551,740 shares of common stock for aggregate net proceeds
of $0.6 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.
46
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.
As of June 30, 2006, we had $42.9 million in cash and
cash equivalents. We have invested a substantial portion of our
available cash funds in 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
$31.1 million in the six months ended June 30, 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
47
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 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:
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Payments Due by Period |
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Less Than | |
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1 Year | |
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1 - 3 Years |
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4-5 Years |
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After 5 Years |
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(In thousands) |
Long-term debt obligations(1)
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$ |
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$ |
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$ |
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$ |
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$ |
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Operating lease obligations(2)
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147 |
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147 |
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License obligations(3)
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Total
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$ |
147 |
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$ |
147 |
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$ |
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$ |
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$ |
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(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. |
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(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. |
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(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.
48
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
Quantitative and Qualitative Disclosures About Market Risk
Our cash and cash equivalents as of June 30, 2006 consisted
primarily of cash and money market funds. 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.
49
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
and Phase III development for the treatment of fever in the
first half of 2007. 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 and fever. We are
developing IV APAP in the U.S. market for the
treatment of acute pain and fever. 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 |
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CVCs have become an important part of medical care, they can
give rise to dangerous and 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 prevention of LCSIs 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, the
prevention of LCSIs. 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, |
51
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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, 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,
52
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. 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.
53
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 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 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,
excluding the treatment of fever in adults, 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 and Fever |
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
54
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 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
55
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.
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.
Fever is an increase in internal body temperature above its
normal range of 98.6 degrees Fahrenheit. A significant
fever is usually defined as an oral or ear temperature of
greater than 102 degrees Fahrenheit or a rectal temperature
of greater than 103 degrees Fahrenheit. Very high fevers
may cause hallucinations, confusion, irritability, convulsions
or death. Fever is most often an important immune system
response to a viral or bacterial infection since most viruses
and bacteria cannot thrive in hot environments. White blood
cells release substances called pyrogens that act on the
hypothalamus in the brain to raise body temperature.
Hospitalized patients are at especially high risk for developing
fever given the potential exposure to various infectious
microorganisms, invasive procedures and medications. Surgery is
the most common source of fever in the hospital setting, and
published incidence rates range from 14% to 91% of
post-operative patients. Infections such as wound infections,
urinary tract infections and pneumonia are the next most
frequent causes. However, deep venous thrombosis, pulmonary
emboli, myocardial infarction and medications are also important
potential sources of fever. Many patients also present with
fever upon arrival at the hospital due to community-acquired
infections, underlying diseases, including cancer and HIV,
severe sunburn, and often the origin of a fever is unknown.
Fever is also the most common reason parents bring their
children to the emergency rooms of hospitals. Pediatric fever is
particularly worrisome as approximately 4% of children under age
five experience fever-induced seizures, or febrile seizures. The
signs of febrile seizures, which occur when a childs
temperature rises or falls rapidly, include loss of
consciousness and convulsions.
56
Acetaminophen, ibuprofen and aspirin are the most commonly used
medications to treat fever. The use of ibuprofen, an NSAID, and
aspirin are limited due to gastrointestinal side-effects and the
risk of bleeding. Ibuprofen is not approved for children under
six months of age and is not recommended for patients that are
dehydrated or vomiting continuously. Aspirin is contraindicated
in children and teenagers with viral infections due to the risk
of acquiring Reyes syndrome, a potentially fatal disease.
In the United States, acetaminophen, ibuprofen and aspirin are
not available in intravenous dosage form. However, oral delivery
of medications is often not possible for hospitalized patients
that are unconscious, sedated, fasting, experiencing nausea and
vomiting or are otherwise unable to take medications by mouth.
Rectal delivery of medications is sometimes possible; however,
drug absorption is often erratic, resulting in unpredictable
levels of efficacy. Rectal delivery in infants is further
complicated by frequent bowel movements which may lead to
difficulty determining the amount of medication delivered. It is
often more convenient to administer medications in intravenous
dosage form, particularly for patients that currently have an
intravenous line in place. We believe that the availability
of IV APAP in the United States would offer a significant
new treatment option for hospitalized patients with fever.
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
57
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 principally 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
ready-to-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, a more convenient
dosage form for some patients 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.
58
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 |
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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 |
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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.
59
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, and the treatment of fever. We are seeking approval for
use in both adults and children for these indications. Our
proposed development plan to support this indication integrates
the existing body of intravenous propacetamol data, IV APAP data
and the data generated by clinical studies of IV APAP 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.
In August 2006, we met with the FDA to discuss the clinical
trial requirements for submission of a 505(b)(2) NDA for
IV APAP. Based on the preliminary feedback from the FDA, we
intend to conduct six clinical trials to provide the FDA with
additional data to support multiple dose efficacy for soft
tissue surgery, efficacy for fever and safety in adults and
children. These trials include:
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Phase III trial in female patients with moderate-to-severe pain
following total abdominal hysterectomy: this trial will be a
randomized, placebo-controlled, double-blind, multi-center study
to assess the efficacy and safety of single and multiple doses
of IV APAP. |
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Phase III trial in adults with fever: this trial will be a
randomized, controlled, double-blind study to assess the
efficacy and safety of single and multiple doses of IV APAP. |
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Pharmacokinetic study in adult subjects: this trial will be a
randomized, single center study to assess the pharmacokinetics
of single and multiple doses of IV APAP compared to oral
acetaminophen in adults. |
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Pharmacokinetic study in pediatric subjects: this trial will be
a randomized, single center study to assess the pharmacokinetics
of single and multiple doses of IV APAP compared to oral
acetaminophen in children. |
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Safety study in adult subjects: this trial will be an
open-label, multi-center study to assess the safety of single
and multiple doses of IV APAP in adults. |
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Safety study in pediatric subjects: this trial will be an
open-label, multi-center study to assess the safety of single
and multiple doses of IV APAP in children. |
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Total enrollment of the six clinical trials will be determined
based on additional input expected from the FDA. We intend to
initiate the abdominal hysterectomy Phase III trial and the
adult pharmacokinetic study in the fourth quarter of 2006. We
intend to initiate the other clinical trials in the first half
of 2007.
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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
61
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.
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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 prevention 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
62
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.
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-
63
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 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
prevention 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 | |
|
|
|
|
| |
|
|
Variable |
|
10% povidone-iodine | |
|
omiganan | |
|
p-value | |
|
|
| |
|
| |
|
| |
Catheter colonization present
|
|
|
232/583 (39.8)% |
|
|
|
180/578 (31.1)% |
|
|
|
0.002 |
|
64
Treatment with omiganan also resulted in a statistically
significant prevention 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).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Treatment Arm | |
|
|
|
|
| |
|
|
Variable |
|
10% povidone-iodine | |
|
omiganan | |
|
p-value | |
|
|
| |
|
| |
|
| |
LCSI present
|
|
|
48/699 (6.9)% |
|
|
|
24/693 (3.5)% |
|
|
|
0.004 |
|
Despite these favorable, statistically significant results for
the prevention of LCSI and catheter colonization, the study did
not show statistical significance for the primary endpoint: the
prevention 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Treatment Arm | |
|
|
|
|
| |
|
|
Outcome |
|
10% povidone-iodine | |
|
omiganan | |
|
p-value | |
|
|
| |
|
| |
|
| |
Failure
|
|
|
18/699 (2.6)% |
|
|
|
15/693 (2.2)% |
|
|
|
0.622 |
|
Success
|
|
|
635/699 (90.8)% |
|
|
|
630/693 (90.9)% |
|
|
|
|
|
Indeterminate
|
|
|
46/699 (6.6)% |
|
|
|
48/693 (6.9)% |
|
|
|
|
|
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.
|
|
|
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
65
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
prevention in LCSIs, catheter colonization and CRBSIs compared
to a profile of omiganan that demonstrates a statistically
significant prevention 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
prevention 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 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
66
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.
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 events of default that relate to our territory
and would entitle BMS to terminate the Pharmatop license
agreement. The events of default include Pharmatops
inability to maintain specified claims under listed patents, the
marketing by a third party of a parenterally-administered
product containing acetaminophen, subject to certain conditions,
or a successful third party action that deprives Pharmatop of
its rights to specified patents. 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.
Either BMS or Pharmatop may terminate the license agreement
between them upon delivery of written notice after an uncured
failure by the other party to perform any of its material
obligations under the license agreement. BMS may generally
terminate the agreement upon written notice to Pharmatop within
a specified period so long as all payments due under the
agreement to Pharmatop are current. Pharmatop may terminate the
agreement upon specified written notice if BMS opposes any of
the listed patent applications or challenges the validity or
enforceability of any of the listed licensed patents. BMS is
also entitled to terminate the Pharmatop agreement upon the
occurrence of events of default that relate to the territory
described above.
67
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. 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
In February 2006, we entered into a clinical supply agreement
with Lawrence Laboratories, an affiliate of BMS, under which
Lawrence Laboratories has manufactured clinical supplies of IV
APAP and
68
placebo. Under the terms of the agreement, Lawrence Laboratories
is obligated to supply us with this single batch of IV APAP and
a single batch of placebo at specified prices. With these
batches, we believe we will have adequate clinical supplies of
our IV APAP product candidate and placebo. The term of the
clinical supply agreement generally extends until the earlier of
the receipt by us of regulatory approval for IV APAP or
December 31, 2008. In addition, the clinical supply
agreement terminates upon mutual written consent of the parties,
the termination of the IV APAP agreement or our dissolution.
Either party may also terminate the clinical supply agreement
upon written notice of an uncured, material breach by the other
party. 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.
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:
|
|
|
|
|
Morphine is the leading product for the treatment of acute
post-operative pain, and is available generically from several
manufacturers; |
|
|
|
DepoDur, currently marketed by Endo Pharmaceuticals, is an
extended release injectable formulation of morphine; and |
|
|
|
other injectable opioids, including fentanyl, meperidine and
hydromorphone, each of which is available generically from
several manufacturers. |
|
|
|
|
|
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.,
69
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; |
|
|
|
Neosporin, a topical antibacterial ointment containing
polymyxin, neomycin and bacitracin, available generically from
several manufacturers; |
|
|
|
Bactroban, a topical antibacterial containing mupirocin,
available generically from several manufacturers; and |
|
|
|
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
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
70
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 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.
71
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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
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
72
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.
|
|
|
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 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.
73
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.
|
|
|
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.
74
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.
75
MANAGEMENT
Executive Officers and Directors
The following table sets forth certain information about our
executive officers and directors as of July 15, 2006:
|
|
|
|
|
|
|
Name |
|
Age | |
|
Position |
|
|
| |
|
|
Theodore R. Schroeder
|
|
|
51 |
|
|
President, Chief Executive Officer and Director |
James B. Breitmeyer, M.D., Ph.D.
|
|
|
52 |
|
|
Executive Vice President, Development and Chief Medical Officer |
William S. Craig, Ph.D.
|
|
|
56 |
|
|
Senior Vice President, Pharmaceutical Development and
Manufacturing |
Kenneth R. Heilbrunn, M.D.
|
|
|
48 |
|
|
Senior Vice President, Clinical Development |
William R. LaRue
|
|
|
55 |
|
|
Senior Vice President, Chief Financial Officer, Treasurer and
Secretary |
Richard E. Lowenthal
|
|
|
40 |
|
|
Vice President, Regulatory Affairs and Quality Assurance |
Mike A. Royal, M.D., J.D.
|
|
|
52 |
|
|
Vice President, Clinical Development, Analgesics |
David A. Socks
|
|
|
31 |
|
|
Vice President, Business Development |
Cam L. Garner(1)
|
|
|
58 |
|
|
Chairman of the Board of Directors |
Brian G. Atwood(2)
|
|
|
53 |
|
|
Director |
Samuel L. Barker, Ph.D.
|
|
|
63 |
|
|
Director |
Michael A. Berman, M.D.(2)(3)
|
|
|
63 |
|
|
Director |
James C. Blair, Ph.D.(1)
|
|
|
67 |
|
|
Director |
Alan D. Frazier(1)(3)
|
|
|
54 |
|
|
Director |
Alain B. Schreiber, M.D.(2)
|
|
|
51 |
|
|
Director |
Christopher J. Twomey(3)
|
|
|
46 |
|
|
Director |
|
|
|
|
(1) |
Member of the Compensation Committee. |
|
(2) |
Member of the Nominating/ Corporate Governance Committee. |
|
(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.
James B. Breitmeyer, M.D., Ph.D. has served as our
Executive Vice President, Development and Chief Medical Officer
since August 2006. From December 2001 to August 2006,
Dr. Breitmeyer served as Chief Medical Officer and Vice
President, Pharmaceutical Operations of Applied Molecular
Evolution, a wholly-owned subsidiary of Eli Lilly and Company, a
global pharmaceutical company. From February 2000 to July 2001,
Dr. Breitmeyer was the President and Chief Executive
Officer of the Harvard Clinical
76
Research Institute. Prior to February 2000, Dr. Breitmeyer
held various positions of increasing responsibility including
Senior Vice President and Chief Medical Officer of Serono
International S.A., a global biopharmaceutical company. Dr.
Breitmeyer holds a B.A. in chemistry from the University of
California, Santa Cruz, and an M.D. and Ph.D. from Washington
University School of Medicine.
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.
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
77
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).
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 I, LLC, Versant Ventures
II, LLC and Versant Ventures III, LLC (Versant Ventures), a
venture capital firm focusing on healthcare that he co-founded.
Prior to 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
78
Corporation, ForteBio, FivePrime Therapeutics, Inc., Saegis
Pharmaceuticals, Helicos Biosciences Corp. and Spaltudaq
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.
Samuel L. Barker, Ph.D. has served as a member of our
board of directors since August 2006. In March 2001, Dr. Barker
co-founded Clearview Projects, Inc., a provider of partnering
and transaction services to biopharmaceutical companies, and
served as its President and Chief Executive Officer from July
2003 until his retirement in November 2004. Dr. Barker served in
a series of leadership positions at Bristol-Myers Squibb Company
until his initial retirement in 1999. His positions at
Bristol-Myers Squibb included service as Executive Vice
President, Worldwide Franchise Management and Strategy during
1998, President, United States Pharmaceuticals from 1992 to
1997, and President, Bristol-Myers Squibb Intercontinental
Commercial Operations from 1990 to 1992. Prior to 1990, Dr.
Barker held executive positions in research and development,
manufacturing, finance, business development and sales and
marketing at Squibb Pharmaceuticals. Dr. Barker also serves on
the board of directors of AtheroGenics, Inc., a pharmaceutical
company, and Lexicon Genetics Incorporated, a biopharmaceutical
company, where he serves as chairman. Dr. Barker holds a B.S.
from Henderson State College, an M.S. from the University of
Arkansas and a Ph.D. from Purdue 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.
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.
79
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 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 Drs. Berman and
Schreiber and Mr. Schroeder. Our Class II directors,
whose terms will expire at the 2008 annual meeting of
stockholders, will be Dr. Blair and Messrs. Frazier and Twomey.
Our Class III directors, whose terms will expire at the
2009 annual meeting of stockholders, will be Dr. Barker and
Messrs. Atwood and Garner.
Pursuant to a voting agreement originally entered into in July
2004 and most recently amended in August 2006 by and among us
and certain of our stockholders, Drs. Barker, Berman, Blair
and Schreiber and Messrs. Atwood, Frazier, Garner,
Schroeder and Twomey 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 SEC and the Nasdaq
Stock Market, Inc.
80
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
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; |
81
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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 an annual retainer of $25,000 for
each non-employee director. We will also pay an additional
annual retainer to the non-employee director serving as
(i) the chairman of our Audit Committee equal to $10,000,
and (ii) the chairman of our Compensation Committee or our
Nominating/ Corporate Governance Committee equal to $4,000. We
will pay an additional annual retainer to non-employee directors
(other than the chairman) serving on the Audit Committee equal
to $5,000 and to non-employee directors (other than the
chairman) serving on the Compensation Committee or the
Nominating/Corporate Governance Committee equal to $2,000. We
will pay additional cash compensation to the non-employee
director serving as the chairman of our board of directors equal
to $100,000 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 a non-qualified option to purchase 25,000 shares of
our common stock (subject to adjustment as provided in the 2006
plan described below) 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 a
non-qualified option to purchase 12,500 shares of common
stock (subject to adjustment as provided in the 2006 plan
described below).
The initial options granted to non-employee directors described
above will vest in thirty-six (36) equal monthly installments on
the first day of each calendar month 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 twelve equal
monthly installments on the first day of each calendar month
following the date of grant, subject to the directors
continuing service on our board of directors 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.
82
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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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. |
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. In August 2006, Dr. James B. Breitmeyer joined us
as our Executive Vice President, Development and Chief Medical
Officer at an annual salary of $330,000.
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 SEC 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.
83
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Potential Realizable | |
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Annual Rates of | |
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% of | |
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Exercise | |
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5% | |
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10% | |
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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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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 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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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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on Exercise | |
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Realized | |
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Exercisable | |
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Unexercisable | |
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Unexercisable | |
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Theodore R. Schroeder
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1,000,000 |
(1) |
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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, James B.
Breitmeyer, M.D., Ph.D., our Executive Vice President,
Development and Chief Medical 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.
84
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
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.
85
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 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.
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Employee Benefit and Stock Plans
In August 2006, our board of directors approved our 2006
corporate bonus plan. Pursuant to the 2006 corporate bonus plan,
our board of directors designated for each executive officer a
target bonus amount, expressed as a percentage of his or her
base salary (40% for our chief executive officer, 30% for our
executive vice presidents and senior vice presidents and 25% 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, options, or a
combination of the foregoing. 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. The use of corporate performance 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 be evaluated
according to 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 performance goals. The compensation
committee is responsible for approving any bonuses to our
executive officers pursuant to the 2006 incentive plan.
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2006 Equity Incentive Award Plan |
In August 2006, our board of directors approved our 2006
Equity Incentive Award Plan, or the 2006 plan, which was
approved by our stockholders in August 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. In
addition, the number of shares initially reserved under the 2006
plan will be increased by (i) the number of shares of
common stock available for issuance and not subject to options
granted under our 2004 equity incentive award plan as of the
effective date of the 2006 plan, and (ii) the number of
shares of common stock related to options granted under our 2004
equity incentive award plan that are repurchased, forfeited,
expired or are cancelled on or after the effective date of the
2006 plan. The total number of shares described in clauses (i)
and (ii) of the preceding sentence shall not
exceed shares
of our common stock. 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 lesser of:
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4% of our outstanding common stock on the applicable January 1;
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a lesser amount determined by our board of directors. |
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Notwithstanding the evergreen provision, the 2006
plan also provides for an aggregate limit of 20,000,000 shares
of common stock which may be issued under the 2006 plan over the
course of its ten-year term. 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
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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 1,000,000.
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 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 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. The maximum amount of
any such bonuses to a covered employee within the
meaning of Section 162(m) of the Code shall not exceed
$1,000,000 for any fiscal year during the term of the 2006 plan. |
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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 |
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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.
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
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 June 30, 2006, options
to purchase 4,081,740 shares of common stock had been
exercised (30,000 shares of which were repurchased by us),
options to purchase 5,769,471 shares of common stock
were outstanding and 1,678,789 shares of common stock
remained available for grant. As of June 30, 2006, the
outstanding options were exercisable at a weighted average
exercise price of approximately $0.38 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.
91
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 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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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.
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PRINCIPAL STOCKHOLDERS
The following table sets forth information about the beneficial
ownership of our common stock at August 28, 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 SEC. 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
88,342,195 shares of common stock outstanding on
August 28, 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 August 28, 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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Common Stock | |
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Beneficially | |
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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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13.9 |
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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.(6)
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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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94
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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(7)
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4,043,740 |
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4.5 |
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James B. Breitmeyer, M.D., Ph.D.(8)
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705,000 |
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* |
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William S. Craig, Ph.D.(9)
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705,303 |
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* |
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Kenneth R. Heilbrunn, M.D.(10)
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650,000 |
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* |
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William R. LaRue(11)
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899,000 |
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1.0 |
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Richard E. Lowenthal(12)
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564,000 |
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* |
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Mike A. Royal, M.D., J.D.(13)
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375,000 |
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* |
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David A. Socks(14)
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1,692,728 |
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1.9 |
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Cam L. Garner(15)
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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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Samuel L. Barker, Ph.D.(16)
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100,000 |
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* |
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Michael A. Berman, M.D.(17)
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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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13.9 |
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Christopher J. Twomey(18)
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100,000 |
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* |
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Executive officers and directors as a group (16 persons)(19)
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67,672,084 |
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71.2 |
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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 110,000 shares of common stock
owned by Domain Associates, L.L.C. Of the 110,000 shares
owned by Domain Associates, 86,875 will be subject to our right
of repurchase within 60 days of August 28, 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, 17,500 will be
subject to our right of repurchase within 60 days of
August 28, 2006. Also includes 60,000 shares
Dr. Schreiber has the right to acquire pursuant to
outstanding options which are immediately exercisable, 55,000 of
which would be subject to our right of repurchase within
60 days of August 28, 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, 87,500 of which would be subject to our right of
repurchase within 60 days of August 28, 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
95
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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, 87,500 of which would
be subject to our right of repurchase within 60 days of
August 28, 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. The voting and disposition of the shares held by Technology
Partners Fund VII, L.P. and Technology Partners Affiliates
VII is determined by TP Management VII, L.L.C., which is the
general partner of each of these Technology Partners funds. John
E. Ardell III, Ira Ehrenpreis, James Glasheen, Sheila Mutter and
Roger J. Quy share voting and dispositive authority over the
shares held by Technology Partners. |
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(6) |
The voting and disposition of the shares held by BB Biotech
Ventures II, L.P. is determined by its general partner, BB
Biotech Ventures GP (Guernsey) Limited. Christopher Wilfred
Cochrane, Benedict Peter Goronwy Morgan and Hans Jorg Graf, in
their capacities as directors of the general partner, share
voting and dispositive authority over the shares held by BB
Biotech Ventures. |
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(7) |
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 August 28, 2006. Also
includes 1,000,000 unvested shares acquired by
Mr. Schroeder upon the early exercise of stock options,
609,375 of which will be subject to our right of repurchase
within 60 days of August 28, 2006. |
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(8) |
Includes 705,000 shares Dr. Breitmeyer 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 August 28, 2006. |
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(9) |
Includes 705,303 shares Dr. Craig has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 537,595 of which would be subject to our right of
repurchase within 60 days of August 28, 2006. |
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(10) |
Includes 650,000 shares Dr. Heilbrunn has the right to
acquire pursuant to outstanding options that are immediately
exercisable, 518,750 of which would be subject to our right of
repurchase within 60 days of August 28, 2006. |
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(11) |
Includes 44,000 shares acquired by Mr. LaRue upon
exercise of stock options, 30,250 of which will be subject to
our right of repurchase within 60 days of August 28,
2006. These 44,000 shares are held by a trust for the
benefit of Mr. LaRues family. Also includes
855,000 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 August 28, 2006. |
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(12) |
Includes 564,000 shares acquired by Mr. Lowenthal upon
the exercise of stock options, 426,500 of which will be subject
to our right of repurchase within 60 days of
August 28, 2006. These 564,000 shares are held of
record by a trust for the benefit of Mr. Lowenthals
family. |
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(13) |
Includes 375,000 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 August 28, 2006. |
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(14) |
Includes 842,728 shares Mr. Socks has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 790,645 of which would be subject to our right of
repurchase within 60 days of August 28, 2006. |
|
footnotes continued on the following page
96
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(15) |
Includes 2,293,740 shares acquired by Mr. Garner upon
the exercise of stock options, 2,058,414 of which will be
subject to our right of repurchase within 60 days of
August 28, 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. |
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(16) |
Includes 100,000 shares Dr. Barker has the right to acquire
pursuant to outstanding options which are immediately
exercisable, 91,667 of which would be subject to our right of
repurchase within 60 days of August 28, 2006. |
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(17) |
Includes 100,000 shares Dr. Berman has the right to
acquire pursuant to outstanding options which are immediately
exercisable, 90,000 of which would be subject to our right of
repurchase within 60 days of August 28, 2006. |
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(18) |
Includes 100,000 shares acquired by Mr. Twomey upon
exercise of stock options, 91,667 of which would be subject to
our right of repurchase within 60 days of August 28,
2006. These 100,000 shares are held of record by a trust
for the benefit of Mr. Twomeys family. |
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(19) |
Includes 6,636,771 shares of common stock subject to
outstanding options which are immediately exercisable, 6,237,397
of which would be subject to our right of repurchase within
60 days of August 28, 2006. Includes
4,161,740 shares of common stock acquired upon the exercise
of options, 3,320,581 of which will be subject to our right of
repurchase within 60 days of August 28, 2006. |
|
footnotes continued on the following page
97
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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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.(6)
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3,000,000 |
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4,000,000 |
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Cam L. Garner(7)
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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. |
|
(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. |
|
(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
98
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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. The voting
and disposition of the shares held by Technology Partners
Fund VII, L.P. and Technology Partners Affiliates VII is
determined by TP Management VII, L.L.C., which is the general
partner of each of these Technology Partners funds. John E.
Ardell III, Ira Ehrenpreis, James Glasheen, Sheila Mutter and
Roger J. Quy share voting and dispositive authority over the
shares held by Technology Partners. |
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(6) |
The voting and disposition of the shares held by BB Biotech
Ventures II, L.P. is determined by its general partner, BB
Biotech Ventures GP (Guernsey) Limited. Christopher Wilfred
Cochrane, Benedict Peter Goronwy Morgan and Hans Jorg Graf, in
their capacities as directors of the general partner, share
voting and dispositive authority over the shares held by BB
Biotech Ventures. |
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(7) |
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 |
|
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. |
|
(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.
Barker, Berman, Blair and Schreiber and
Messrs. Atwood, Frazier, Garner and Schroeder. Pursuant
99
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. Drs. Barker and
Berman and Mr. Twomey were selected to serve on our board of
directors as representatives of our common stock and preferred
stock, as designated by a majority of our common and preferred
stockholders.
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. |
|
|
|
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. |
|
|
|
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. |
|
|
|
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 12 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. |
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In August 2006, we granted to Dr. Barker an option to
purchase 100,000 shares of our common stock at an exercise price
of $0.80 per share, vesting over 12 calendar quarters from
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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 Mr. LaRue and Dr. Royal an option
to purchase 705,000 and 300,000, respectively, shares of
our common stock at an exercise price of $0.80 per share.
In August 2006, we granted to Dr. Breitmeyer an option to
purchase 705,000 shares of our common stock at an exercise
price of $0.80 per share. Also in August 2006, we granted
to each of Mr. LaRue and Dr. Royal an option to
purchase 150,000 and 75,000 shares of our common stock at
an exercise price of $.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, James B.
Breitmeyer, M.D., Ph.D., our Executive Vice President,
Development and Chief Medical 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. 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, Windamere III, LLC, a limited liability company
affiliated with our former director, Scott L. Glenn, 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 settled with shares of
our Series A-1 preferred stock.
In May 2005, we executed an engagement letter with Clearview
Projects, Inc., or Clearview, a provider of partnering and
transaction services to biopharmaceutical companies.
Dr. Barker is a founder of Clearview and served as its
President and Chief Executive Officer from July 2003 until
November 2004. Under the terms of the engagement letter, we made
retainer payments and reimbursed expenses to Clearview totaling
$205,341 in 2005 and made retainer and success fee payments
totaling $375,000 from January 2006 through the conclusion of
Clearviews engagement in March 2006. The success fee was
related to our in-license of rights to IV APAP from BMS in
March 2006.
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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 June 30, 2006, there were 8,551,740 shares of
common stock outstanding, held of record by
15 stockholders. This amount excludes our outstanding
shares of preferred stock as of June 30, 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 June 30, 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 June 30, 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
102
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
103
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 deterring 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
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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.
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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; |
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shares
will be eligible for sale, upon exercise of outstanding
warrants, 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
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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.
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 2006 Equity Incentive Award
Plan. 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 SEC.
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.
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Warrants
As of June 30, 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 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 June 30, 2006, options to purchase a total of
5,769,471 shares of our common stock were outstanding, of
which 5,419,165 were exercisable. All of the shares subject to
options are subject to the terms of the
lock-up agreements with
the underwriters. An additional 1,678,789 shares of common
stock were available for future option grants under our stock
plan.
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MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS TO
NON-U.S. HOLDERS
This section summarizes 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 ARE URGED TO
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
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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.
110
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.
EACH PROSPECTIVE INVESTOR IS URGED TO 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.
111
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.
|
|
|
|
|
|
|
Number | |
|
|
of Shares | |
Underwriter |
|
| |
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
|
|
|
|
|
Deutsche Bank Securities Inc.
|
|
|
|
|
Pacific Growth Equities, LLC
|
|
|
|
|
JMP Securities LLC
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share | |
|
Without Option | |
|
With Option | |
|
|
| |
|
| |
|
| |
Public offering price
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
Underwriting discount
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
Proceeds, before expenses, to us
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
The expenses of the offering, not including the underwriting
discount, are estimated at
$ and
are payable by us.
112
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
|
|
|
|
|
offer, pledge, sell or contract to sell any common stock, |
|
|
|
sell any option or contract to purchase any common stock, |
|
|
|
purchase any option or contract to sell any common stock, |
|
|
|
grant any option, right or warrant for the sale of any common
stock, |
|
|
|
lend or otherwise dispose of or transfer any common stock, |
|
|
|
request or demand that we file a registration statement related
to the common stock, or |
|
|
|
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
|
|
|
|
|
the valuation multiples of publicly traded companies that the
representatives believe to be comparable to us, |
|
|
|
our financial information, |
|
|
|
the history of, and the prospects for, our company and the
industry in which we compete, |
|
|
|
an assessment of our management, its past and present
operations, and the prospects for, and timing of, our future
revenues, |
|
|
|
the present state of our development, and |
113
|
|
|
|
|
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.
114
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 SEC 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.
115
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 | |
|
|
| |
|
June 30, | |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
4,271,229 |
|
|
$ |
8,025,285 |
|
|
$ |
42,881,305 |
|
|
|
|
|
|
Securities available-for-sale
|
|
|
|
|
|
|
7,000,000 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
3,854 |
|
|
|
526,173 |
|
|
|
438,274 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
4,275,083 |
|
|
|
15,551,458 |
|
|
|
43,319,579 |
|
|
|
|
|
Property and equipment, net
|
|
|
108,735 |
|
|
|
117,740 |
|
|
|
770,693 |
|
|
|
|
|
Restricted cash
|
|
|
|
|
|
|
|
|
|
|
1,581,130 |
|
|
|
|
|
Other assets
|
|
|
152,159 |
|
|
|
100,000 |
|
|
|
683,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
4,535,977 |
|
|
$ |
15,769,198 |
|
|
$ |
46,354,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
68,509 |
|
|
$ |
715,781 |
|
|
$ |
1,860,993 |
|
|
|
|
|
|
Accrued liabilities
|
|
|
45,965 |
|
|
|
430,220 |
|
|
|
1,749,955 |
|
|
|
|
|
Current portion of long-term debt
|
|
|
|
|
|
|
|
|
|
|
1,032,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
114,474 |
|
|
|
1,146,001 |
|
|
|
4,643,405 |
|
|
|
|
|
Deferred rent
|
|
|
|
|
|
|
|
|
|
|
116,309 |
|
|
|
|
|
Long-term debt, less current portion
|
|
|
|
|
|
|
|
|
|
|
5,967,543 |
|
|
|
|
|
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 June 30, 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 June 30, 2006 (unaudited), respectively; no
shares, 17,675,347 shares and 17,675,347 shares issued
and outstanding at December 31, 2004 and 2005 and
June 30, 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 June 30, 2006
(unaudited); 53,870,000 shares issued and outstanding at
June 30, 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 June 30, 2006
(unaudited), respectively; 4,680,000 shares,
7,616,000 shares and 8,551,740 shares issued and
outstanding at December 31, 2004 and 2005 and June 30,
2006 (unaudited), respectively; 88,182,195 shares issued
and outstanding pro forma (unaudited)
|
|
|
468 |
|
|
|
762 |
|
|
|
855 |
|
|
|
8,818 |
|
|
Additional paid-in capital
|
|
|
7,562,463 |
|
|
|
25,472,308 |
|
|
|
79,953,466 |
|
|
|
79,953,466 |
|
|
Stock subscription receivable
|
|
|
|
|
|
|
(187,600 |
) |
|
|
|
|
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(3,142,237 |
) |
|
|
(10,664,849 |
) |
|
|
(44,334,734 |
) |
|
|
(44,334,734 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
4,421,503 |
|
|
|
14,623,197 |
|
|
|
35,627,550 |
|
|
$ |
35,627,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
4,535,977 |
|
|
$ |
15,769,198 |
|
|
$ |
46,354,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 | |
|
Six Months Ended June 30, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
|
(Unaudited) | |
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
2,233,357 |
|
|
$ |
6,126,226 |
|
|
$ |
2,401,589 |
|
|
$ |
32,373,970 |
|
|
$ |
40,733,553 |
|
|
Marketing
|
|
|
41,114 |
|
|
|
240,361 |
|
|
|
142,501 |
|
|
|
316,541 |
|
|
|
598,016 |
|
|
General and administrative
|
|
|
877,146 |
|
|
|
1,411,810 |
|
|
|
539,914 |
|
|
|
1,487,980 |
|
|
|
3,776,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,151,617 |
|
|
|
7,778,397 |
|
|
|
3,084,004 |
|
|
|
34,178,491 |
|
|
|
45,108,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,151,617 |
) |
|
|
(7,778,397 |
) |
|
|
(3,084,004 |
) |
|
|
(34,178,491 |
) |
|
|
(45,108,505 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
9,380 |
|
|
|
255,785 |
|
|
|
13,996 |
|
|
|
552,501 |
|
|
|
817,666 |
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(43,895 |
) |
|
|
(43,895 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
9,380 |
|
|
|
255,785 |
|
|
|
13,996 |
|
|
|
508,606 |
|
|
|
773,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(3,070,008 |
) |
|
$ |
(33,669,885 |
) |
|
$ |
(44,334,734 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.68 |
) |
|
$ |
(6.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
|
|
|
3,658,356 |
|
|
|
4,623,517 |
|
|
|
4,526,865 |
|
|
|
4,974,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute pro forma basic and diluted net loss per
share
|
|
|
|
|
|
|
20,648,526 |
|
|
|
|
|
|
|
58,711,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30, 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 for cash between $0.10 and
$0.34 per share in January through June (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
935,740 |
|
|
|
93 |
|
|
|
281,099 |
|
|
|
|
|
|
|
|
|
|
|
281,192 |
|
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 |
|
Employee stock- based compensation recognized under SFAS
No. 123(R) (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,861 |
|
|
|
|
|
|
|
|
|
|
|
116,861 |
|
Net loss and comprehensive loss (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,669,885 |
) |
|
|
(33,669,885 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 (unaudited)
|
|
|
8,085,108 |
|
|
$ |
809 |
|
|
|
17,675,347 |
|
|
$ |
1,767 |
|
|
|
53,870,000 |
|
|
$ |
5,387 |
|
|
|
8,551,740 |
|
|
$ |
855 |
|
|
$ |
79,953,466 |
|
|
$ |
|
|
|
$ |
(44,334,734 |
) |
|
$ |
35,627,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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) | |
|
|
|
|
|
(Inception) | |
|
|
Through | |
|
Year Ended | |
|
Six Months Ended June 30, | |
|
Through | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
|
(Unaudited) | |
|
(Unaudited) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(3,070,008 |
) |
|
$ |
(33,669,885 |
) |
|
$ |
(44,334,734 |
) |
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
8,389 |
|
|
|
36,876 |
|
|
|
15,771 |
|
|
|
28,862 |
|
|
|
74,127 |
|
|
|
Stock-based compensation
|
|
|
811 |
|
|
|
|
|
|
|
|
|
|
|
116,861 |
|
|
|
117,672 |
|
|
|
Non-cash interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,665 |
|
|
|
41,665 |
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
(56,013 |
) |
|
|
(470,160 |
) |
|
|
(260,033 |
) |
|
|
59,799 |
|
|
|
(466,374 |
) |
|
|
|
Accounts payable, accrued liabilities and deferred rent
|
|
|
114,474 |
|
|
|
1,031,527 |
|
|
|
1,157,612 |
|
|
|
2,310,041 |
|
|
|
3,456,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,074,576 |
) |
|
|
(6,924,369 |
) |
|
|
(2,156,658 |
) |
|
|
(31,112,657 |
) |
|
|
(41,111,602 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(100,000 |
) |
|
|
(7,000,000 |
) |
|
|
|
|
|
|
|
|
|
|
(7,100,000 |
) |
Maturities of marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000,000 |
|
|
|
7,000,000 |
|
Restricted cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,581,130 |
) |
|
|
(1,581,130 |
) |
Purchases of property and equipment
|
|
|
(117,124 |
) |
|
|
(45,881 |
) |
|
|
(10,719 |
) |
|
|
(681,815 |
) |
|
|
(844,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(217,124 |
) |
|
|
(7,045,881 |
) |
|
|
(10,719 |
) |
|
|
4,737,055 |
|
|
|
(2,525,950 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net
|
|
|
22,500 |
|
|
|
106,000 |
|
|
|
109,000 |
|
|
|
456,609 |
|
|
|
585,109 |
|
Proceeds from sale of preferred stock, net of issuance costs
|
|
|
7,540,429 |
|
|
|
17,618,306 |
|
|
|
13,661,958 |
|
|
|
53,775,013 |
|
|
|
78,933,748 |
|
Borrowings under debt agreements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000,000 |
|
|
|
7,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
7,562,929 |
|
|
|
17,724,306 |
|
|
|
13,770,958 |
|
|
|
61,231,622 |
|
|
|
86,518,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents
|
|
|
4,271,229 |
|
|
|
3,754,056 |
|
|
|
11,603,581 |
|
|
|
34,856,020 |
|
|
|
42,881,305 |
|
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 |
|
|
$ |
15,874,810 |
|
|
$ |
42,881,305 |
|
|
$ |
42,881,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants in connection with loan and security
agreement
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
313,572 |
|
|
$ |
313,572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 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
June 30, 2006, the statements of operations and cash flows
for the six months ended June 30, 2005 and 2006 and the
period from May 26, 2004 (inception) through
June 30, 2006 and the statement of stockholders
equity for the six months ended June 30, 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
June 30, 2006 and results of operations and cash flows for
the six months ended June 30, 2005 and 2006. The results of
operations for the six months ended June 30, 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
June 30, 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
June 30, 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 June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 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 June 30, 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. Leasehold improvements are
amortized over the shorter of their useful lives or the terms of
the related leases.
|
|
|
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
June 30, 2006.
F-8
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 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 the
Companys 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 June 30, 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 six months ended June 30, 2006, the Company
recorded $116,861, or $0.02 per share, of stock-based
compensation expense as a result of the adoption of SFAS
No. 123(R). Of this amount,
F-9
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
the Company allocated $20,339, $84 and $96,438 to research and
development, sales and marketing and general and administrative
expenses, respectively, 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 six months ended June 30, 2006 using the
Black-Scholes option pricing model:
|
|
|
|
|
Employee Stock Options
|
|
|
|
|
Risk-free interest rate
|
|
|
4.36 5.08 |
% |
Dividend yield
|
|
|
0.00 |
% |
Expected life of options (years)
|
|
|
6.06 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 Securities and Exchange Commission (SEC) 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 six months ended June 30, 2006 was
$0.29 per share.
As of June 30, 2006, the Company has approximately
$1,479,000 of unrecognized stock-based compensation costs
related to the non-vested balance of the 5,549,211 stock options
granted during the six months ended June 30, 2006 and
expects to recognize such compensation over a weighted average
period of 3.71 years.
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
F-10
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
disclosures required by SFAS No. 123, the estimated
fair value of the options was amortized on a straight-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(R) 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
June 30, 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 June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
May 26, 2004 | |
|
|
|
|
|
|
|
|
(Inception) | |
|
|
|
|
|
|
Through | |
|
Year Ended | |
|
Six Months Ended June 30, | |
|
|
December 31, | |
|
December 31, | |
|
| |
|
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
Historical
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,142,237 |
) |
|
$ |
(7,522,612 |
) |
|
$ |
(3,070,008 |
) |
|
$ |
(33,669,885 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
3,680,548 |
|
|
|
5,277,468 |
|
|
|
4,770,055 |
|
|
|
7,826,825 |
|
|
Weighted average unvested common shares subject to repurchase
|
|
|
(22,192 |
) |
|
|
(653,951 |
) |
|
|
(243,190 |
) |
|
|
(2,852,825 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
3,658,356 |
|
|
|
4,623,517 |
|
|
|
4,526,865 |
|
|
|
4,974,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.86 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.68 |
) |
|
$ |
(6.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss used above
|
|
|
|
|
|
$ |
(7,522,612 |
) |
|
|
|
|
|
$ |
(33,669,885 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share
|
|
|
|
|
|
$ |
(0.36 |
) |
|
|
|
|
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used above
|
|
|
|
|
|
|
4,623,517 |
|
|
|
|
|
|
|
4,974,000 |
|
Pro forma adjustments to reflect assumed weighted average effect
of conversion of preferred stock
|
|
|
|
|
|
|
16,025,009 |
|
|
|
|
|
|
|
53,737,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma shares used to compute basic and diluted net loss per
share
|
|
|
|
|
|
|
20,648,526 |
|
|
|
|
|
|
|
58,711,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
53,737,140 |
|
Common stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,345,271 |
|
Common stock subject to repurchase
|
|
|
22,192 |
|
|
|
653,951 |
|
|
|
243,190 |
|
|
|
2,852,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,683,322 |
|
|
|
16,678,960 |
|
|
|
8,328,298 |
|
|
|
57,935,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
|
|
3. |
Property and Equipment |
Property and equipment are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
|
|
| |
|
June 30, | |
|
|
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 |
|
|
|
186,006 |
|
Furniture and equipment
|
|
|
5 years |
|
|
|
60,733 |
|
|
|
94,982 |
|
|
|
94,982 |
|
Manufacturing equipment
|
|
|
7 years |
|
|
|
|
|
|
|
|
|
|
|
122,500 |
|
Construction in-process
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
437,281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,124 |
|
|
|
160,100 |
|
|
|
841,915 |
|
Less accumulated depreciation
|
|
|
|
|
|
|
(8,389 |
) |
|
|
(42,360 |
) |
|
|
(71,222 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
108,735 |
|
|
$ |
117,740 |
|
|
$ |
770,693 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4. |
Related Party Transactions |
From September 2004 through August 2005, the Company paid
Mr. Cam L. Garner $5,000 per month plus qualified
business expenses for his services as chairman of the
Companys board of directors under the terms of a
consulting agreement between the Company and a limited liability
company affiliated with Mr. Garner. The agreement expired
on August 31, 2005. From September 2005 to February 2006,
the Company continued to pay Mr. Garner $5,000 per
month for his services as chairman of the Companys board
of directors. In March 2006, Mr. Garners monthly
compensation for his services as chairman of the Companys
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 six months ended June 30, 2005 and 2006 and the period
from May 26, 2004 (inception) through June 30,
2006, the Company expensed $20,000, $60,000, $30,000, $43,333,
and $123,333, respectively for payments to Mr. Garner for
services as chairman of the Companys board of directors.
The unpaid balance as of December 31, 2004 and 2005 and
June 30, 2006 was $20,000, $10,000 and $8,333, respectively.
During 2004, a stockholder 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 accounted for in accordance with the SEC SAB Topic 5T
(SAB No. 79), Accounting for Expenses or Liabilities
Paid by Principal Stockholder(s), which requires the Company
to record expenses for services paid by stockholders for the
benefit of the Company as if such expenses had been paid
directly by the Company. The 531,915 shares of Series A-1
preferred stock issued in settlement of the $500,000 advance
were valued at $0.94 per share, the price paid by new
Series A-1 investors. The transaction was recorded as a $500,000
cash investment in Series A-1 preferred stock by the stockholder
and a corresponding cash payment of $500,000 for operating
expenses.
|
|
|
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. In
F-13
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
June 2006, the Company drew down $7,000,000 under the loan
and security agreement with Silicon Valley Bank and Oxford
Finance Corporation and has no further credit available under
this agreement. 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 are 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 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.
As of December 31, 2005 and June 30, 2006, the
sublessor held a security deposit of $50,685. 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 amount of
$1,581,130. The letter of credit is collateralized by a
certificate of deposit in the same amount that is classified as
restricted cash in the accompanying 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. Rent
expense was $67,579, $190,911, $89,542, $274,231 and $309,174
for the period from May 26, 2004 (inception) through
December 31, 2004, the year ended December 31, 2005,
the six months ended June 30, 2005 and 2006 and the period
from May 26, 2004 (inception) through June 30,
2006, respectively. As of June 30, 2006, future minimum
payments under the operating leases total $186,999, $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.
|
|
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
F-14
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
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 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 a
conversion ratio of
one-to-one, subject to
adjustment for stock splits, certain capital reorganizations and
dilutive stock issuances. As of June 30, 2006, there have
been no adjustments to the conversion ratios of any series of
preferred stock. 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.
F-15
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
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 June 30, 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 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 June 30, 2006, respectively, the
2004 Plan had 4,500,000 and 11,500,000 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 contemporaneously by the
Companys board of directors all of whom are related
parties. From May 26, 2004 (inception) through February
2006 the valuations were performed by the Companys board
of directors who have experience in valuing early stage
companies. Beginning in
F-16
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
March 2006 the board of directors established the fair value of
the Companys common stock based on contemporaneous
independent valuations of the Companys common stock
performed by an unrelated valuation specialist.
The Company has applied 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 the Companys licensing of IV APAP but
prior to the initiation of the Companys initial public
offering process on June 14, 2006, based on a
contemporaneous independent valuation performed by an unrelated
valuation specialist, the Company allocated additional
enterprise value to its common stock with an increase in the
common stock valuation to $0.34 per share. Subsequent to
the initiation of the initial public offering process, based on
a contemporaneous independent valuation performed by an
unrelated valuation specialist, the Company increased its common
stock valuation to $0.80 per share.
At December 31, 2005 and June 30, 2006, respectively,
a total of 228,000 and 1,678,789 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
|
|
|
5,549,211 |
|
|
$ |
0.43 |
|
Exercised
|
|
|
(935,740 |
) |
|
$ |
0.30 |
|
|
|
|
|
|
|
|
Balance at June 30, 2006
|
|
|
5,769,471 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
|
| |
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Average | |
Exercise |
|
Number | |
|
Contractual | |
|
Exercise | |
|
Number | |
|
Exercise | |
Price |
|
Outstanding | |
|
Life (in years) | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.10
|
|
|
1,156,000 |
|
|
|
9.24 |
|
|
$ |
0.10 |
|
|
|
989,521 |
|
|
$ |
0.10 |
|
F-17
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 | |
|
|
| |
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Average | |
|
Weighted | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Remaining | |
|
Average | |
Exercise |
|
Number | |
|
Contractual | |
|
Exercise | |
|
Number | |
|
Contractual | |
|
Exercise | |
Price |
|
Outstanding | |
|
Life (in years) | |
|
Price | |
|
Exercisable | |
|
Life (in years) | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
$0.10
|
|
|
1,017,000 |
|
|
|
8.72 |
|
|
$ |
0.10 |
|
|
|
852,394 |
|
|
|
8.69 |
|
|
$ |
0.10 |
|
$0.34
|
|
|
3,714,471 |
|
|
|
9.86 |
|
|
$ |
0.34 |
|
|
|
3,561,771 |
|
|
|
9.86 |
|
|
$ |
0.34 |
|
$0.80
|
|
|
1,038,000 |
|
|
|
9.96 |
|
|
$ |
0.80 |
|
|
|
1,005,000 |
|
|
|
9.96 |
|
|
$ |
0.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,769,471 |
|
|
|
9.68 |
|
|
$ |
0.38 |
|
|
|
5,419,165 |
|
|
|
9.70 |
|
|
$ |
0.39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, March 31, 2006, and
June 30, 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, 15,000 and
5,534,211, respectively. All such grants had both a fair value
and exercise price of $0.10 for periods through March 31,
2006. During the quarterly period ended June 30, 2006, both
the fair value and exercise price of 4,496,211 and 1,038,000
option grants was $0.34 and $0.80, respectively.
As of December 31, 2005 and June 30, 2006,
respectively, 186,813 and 341,768 of the outstanding options
under the 2004 plan were vested and 2,767,875 and 3,440,257 of
the options exercised were subject to repurchase by the Company
since they were unvested.
The aggregate fair value of options that vested during the six
months ended June 30, 2006 was approximately $12,000. The
aggregate intrinsic value of options exercised during the six
months ended June 30, 2006 was approximately $360,000.
The aggregate intrinsic value of options outstanding and options
exercisable as of June 30, 2006 was approximately
$2,421,000 and $2,235,000, respectively.
|
|
|
Shares Reserved For Future Issuance |
The following shares of common stock are reserved for future
issuance:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
June 30, | |
|
|
2005 | |
|
2006 | |
|
|
| |
|
| |
Conversion of preferred stock
|
|
|
25,760,455 |
|
|
|
79,630,455 |
|
Common stock options granted and outstanding
|
|
|
1,156,000 |
|
|
|
5,769,471 |
|
Preferred stock warrants outstanding
|
|
|
|
|
|
|
385,000 |
|
Common stock options reserved for future issuance
|
|
|
228,000 |
|
|
|
1,678,789 |
|
|
|
|
|
|
|
|
|
|
|
27,144,455 |
|
|
|
87,463,715 |
|
|
|
|
|
|
|
|
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
F-18
Cadence Pharmaceuticals, Inc.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS (Continued)
(Information as of June 30, 2006 and thereafter and for
the six months ended
June 30, 2005 and 2006 and the period from May 26,
2004 (inception)
through June 30, 2006 is unaudited)
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 June 30, 2006, the Company had
not elected to make any contributions to the plan.
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 June 30, 2006, we
granted stock options to purchase 9,851,211 shares of
our common stock at exercise prices from $0.10 to $0.80 per
share to our employees, consultants and directors under our 2004
equity incentive award plan. Since our inception through
June 30, 2006, we issued and sold an aggregate of
4,081,740 shares of our common stock to our employees,
consultants and directors at prices from $0.10 to $0.34 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 at $0.10 per share resulting in a
net of 4,051,740 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(1) |
|
|
Restated Certificate of Incorporation of the Registrant, as
currently in effect |
|
3.2 |
|
|
Certificate of Amendment to Restated Certificate of
Incorporation of the Registrant, as currently in effect |
|
3.3 |
|
|
Form of Amended and Restated Certificate of Incorporation of the
Registrant, to be in effect upon completion of the offering |
|
3.4(1) |
|
|
Amended and Restated Bylaws of the Registrant, as currently in
effect |
|
3.5 |
|
|
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(1) |
|
|
Amended and Restated Investor Rights Agreement dated
February 21, 2006 |
|
4.3(1) |
|
|
Warrant issued by Registrant in February 2006 to Silicon Valley
Bank |
|
4.4(1) |
|
|
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#(1) |
|
|
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 |
|
|
Form of Amended and Restated Restricted Common Stock Purchase
Agreement |
|
10.7# |
|
|
2006 Corporate Bonus Plan |
|
10.8(1) |
|
|
Sublease dated August 31, 2004 by and between the
Registrant and Townsend and Townsend and Crew, LLP |
|
10.9(1) |
|
|
Lease dated May 12, 2006 by and between the Registrant and
Prentiss/ Collins Del Mar Heights LLC |
|
10.10(1) |
|
|
Collaboration and License Agreement dated July 30, 2004 by
and between the Registrant and Migenix Inc. (formerly Micrologix
Biotech Inc.) |
|
10.11(1) |
|
|
IV APAP Agreement (US and Canada) dated February 21, 2006
by and between the Registrant and Bristol-Myers Squibb Company |
|
10.12(1) |
|
|
License Agreement dated December 23, 2002 by and among SCR
Pharmatop and Bristol-Myers Squibb Company |
|
10.13(1) |
|
|
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(1) |
|
|
Power of Attorney |
|
24.2 |
|
|
Power of Attorney |
|
|
|
|
* |
To be filed by amendment. |
|
|
(1) |
Filed with the Registrants Registration Statement on Form
S-1 on July 17, 2006. |
II-3
|
|
|
|
|
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. |
|
(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
Amendment No. 1 to Registration Statement on
Form S-1 to be
signed on its behalf by the undersigned, thereunto duly
authorized, in San Diego, California on the
30th
day of August, 2006.
|
|
|
CADENCE PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Theodore R. Schroeder
|
|
|
|
|
|
Theodore R. Schroeder |
|
President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, as
amended, this Amendment No. 1 to 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) |
|
August 30, 2006 |
|
/s/ William R. LaRue
William
R. LaRue |
|
Senior Vice President, Chief Financial Officer,
Treasurer and Secretary (Principal Financial and Accounting
Officer) |
|
August 30, 2006 |
|
*
Cam
L. Garner |
|
Chairman of the Board of Directors |
|
August 30, 2006 |
|
*
Brian
G. Atwood |
|
Director |
|
August 30, 2006 |
|
*
Samuel
L. Barker, Ph.D. |
|
Director |
|
August 30, 2006 |
|
*
Michael
A. Berman, M.D. |
|
Director |
|
August 30, 2006 |
|
*
James
C. Blair, Ph.D. |
|
Director |
|
August 30, 2006 |
|
*
Alan
D. Frazier |
|
Director |
|
August 30, 2006 |
II-5
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
*
Alain
B. Schreiber, M.D. |
|
Director |
|
August 30, 2006 |
|
*
Christopher
J. Twomey |
|
Director |
|
August 30, 2006 |
|
*By: |
|
/s/ Theodore R. Schroeder
Theodore
R. Schroeder
Attorney-in-Fact |
|
|
|
|
II-6
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
1.1* |
|
|
Form of Underwriting Agreement |
|
3.1(1) |
|
|
Restated Certificate of Incorporation of the Registrant, as
currently in effect |
|
3.2 |
|
|
Certificate of Amendment to Restated Certificate of
Incorporation of the Registrant, as currently in effect |
|
3.3 |
|
|
Form of Amended and Restated Certificate of Incorporation of the
Registrant, to be in effect upon completion of the offering |
|
3.4(1) |
|
|
Amended and Restated Bylaws of the Registrant, as currently in
effect |
|
3.5 |
|
|
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(1) |
|
|
Amended and Restated Investor Rights Agreement dated
February 21, 2006 |
|
4.3(1) |
|
|
Warrant issued by Registrant in February 2006 to Silicon Valley
Bank |
|
4.4(1) |
|
|
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#(1 |
) |
|
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 |
|
|
Form of Amended and Restated Restricted Common Stock Purchase
Agreement |
|
10.7# |
|
|
2006 Corporate Bonus Plan |
|
10.8(1) |
|
|
Sublease dated August 31, 2004 by and between the
Registrant and Townsend and Townsend and Crew, LLP |
|
10.9(1) |
|
|
Lease dated May 12, 2006 by and between the Registrant and
Prentiss/ Collins Del Mar Heights LLC |
|
10.10( |
1) |
|
Collaboration and License Agreement dated July 30, 2004 by
and between the Registrant and Migenix Inc. (formerly Micrologix
Biotech Inc.) |
|
10.11( |
1) |
|
IV APAP Agreement (US and Canada) dated February 21, 2006
by and between the Registrant and Bristol-Myers Squibb Company |
|
10.12( |
1) |
|
License Agreement dated December 23, 2002 by and among SCR
Pharmatop and Bristol-Myers Squibb Company |
|
10.13(1 |
) |
|
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(1) |
|
|
Power of Attorney |
|
24.2 |
|
|
Power of Attorney |
|
|
* |
To be filed by amendment. |
|
|
(1) |
Filed with the Registrants Registration Statement on Form
S-1 on July 17, 2006. |
|
|
|
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. |
|
Exhibit 3.2
EXHIBIT
3.2
CERTIFICATE OF AMENDMENT
OF
RESTATED CERTIFICATE OF INCORPORATION
OF
CADENCE PHARMACEUTICALS, INC.
Cadence Pharmaceuticals, Inc. (the Corporation), formerly known as Strata Pharmaceuticals, Inc., originally filed its Certificate of Incorporation with the Secretary of State of Delaware on May 26, 2004, and is organized and existing under the General Corporation Law of the State of Delaware, hereby certifies as follows:
1. That the Board of Directors of said Corporation duly adopted resolutions proposing and
declaring advisable the following amendment of the Restated Certificate of Incorporation (the
Certificate) of said Corporation. The resolution setting forth the proposed amendment is as
follows:
RESOLVED, that the Certificate be amended by changing Section 4(b)(i) of Article IV thereof so
that, as amended, said Section shall be and read in its entirety as follows:
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 three (3) 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.
2. That thereafter, pursuant to a resolution of the Board of Directors and in lieu of a
meeting of stockholders, the stockholders gave their approval of said amendment by written consent
in accordance with the provisions of Section 228 of the General Corporation Law of the State of
Delaware.
3. That the aforesaid amendment was duly adopted in accordance with the provisions of Sections
242 and 228 of the General Corporation Law of the State of Delaware.
4. That said amendment shall be executed, filed and recorded in accordance with Section 103 of
the General Corporation Law of the State of Delaware.
IN WITNESS WHEREOF, Cadence Pharmaceuticals, Inc. has caused this Certificate of Amendment to
be signed by an authorized officer thereof, this 30th day of August, 2006.
|
|
|
|
|
|
|
Cadence Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
/s/ William R. LaRue |
|
|
|
|
|
By:
|
|
William R. LaRue |
|
|
Title:
|
|
Senior Vice President, Chief Financial
Officer, Treasurer and Secretary |
Exhibit 3.3
EXHIBIT
3.3
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
CADENCE PHARMACEUTICALS, INC.
Cadence
Pharmaceuticals, Inc. (the Corporation), a corporation organized and existing under and by virtue of the General
Corporation Law of the State of Delaware (the DGCL), DOES HEREBY CERTIFY:
1. The name of the Corporation is Cadence Pharmaceuticals, Inc. The Corporations
original Certificate of Incorporation was filed on May 26, 2004.
2. That by action taken by the Board of Directors at a meeting held on August 23, 2006,
resolutions were duly adopted setting forth a proposed amendment and restatement of the Certificate
of Incorporation of the Corporation, declaring said amendment and restatement to be advisable and
directing its officers to submit said amendment and restatement to the stockholders of the
Corporation for consideration thereof. The resolution setting forth the proposed amendment and
restatement is as follows:
THEREFORE, BE IT RESOLVED, that the Certificate of Incorporation of the Corporation is hereby
amended to read in its entirety as follows, subject to the required consent of the stockholders of
the Corporation:
FIRST: The name of the Corporation (hereinafter the Corporation) is Cadence
Pharmaceuticals, Inc.
SECOND: The address, including street, number, city and county, of the registered
office of the Corporation in the State of Delaware is 2711 Centerville Road, Suite 400, in the City
of Wilmington, County of New Castle; and the name of the Registered Agent of the Corporation at
such address is Corporation Service Company.
THIRD: The nature of the business or purposes to be conducted or promoted is to engage
in any lawful act or activity for which corporations may be organized under the General Corporation
Law of the State of Delaware (the DGCL).
FOURTH: The Corporation is authorized to issue two classes of stock to be designated,
respectively, Common Stock, par value $0.0001 per share (Common Stock) and Preferred Stock, par
value $0.001 per share (Preferred Stock). The total number of shares the Corporation shall have
the authority to issue is one hundred ten million (110,000,000) shares, one hundred million
(100,000,000) shares of which shall be Common Stock and ten million (10,000,000) shares of which
shall be Preferred Stock.
(1) Common Stock. The voting, dividend and liquidation rights of the holders of the Common
Stock are subject to and qualified by the rights of the holders of the Preferred Stock of any
series as may be designated by the Board of Directors upon any issuance of the Preferred Stock or
any series. The holders of the Common Stock are entitled to one vote for each share held at all
meetings of stockholders. There shall be no cumulative voting. Dividends may be declared and paid
on the Common Stock from funds lawfully available therefor as and when determined by the Board of
Directors and subject to any preferential dividend rights of any then outstanding Preferred Stock.
Upon the dissolution or liquidation of the Corporation, whether voluntary or involuntary, holders
of the Corporation will be entitled to receive ratably all assets of the Corporation available for
distribution to stockholders, subject to any preferential rights of any then outstanding Preferred
Stock.
(2) Preferred Stock. Shares of Preferred Stock may be issued from time to time in one or more
series, each of such series to have such terms as stated in the resolution or resolutions providing
for the establishment of such series adopted by the Board of Directors of the Corporation as
hereinafter provided. Authority is hereby expressly granted to the Board of Directors of the
Corporation to issue, from time to time, shares of Preferred Stock in one or more series, and, in
connection with the establishment of any such series by resolution or resolutions, to determine and
fix such voting powers, full or limited, or no voting powers, and such other powers, designations,
preferences and relative, participating, optional and other special rights, and the qualifications,
limitations and restrictions thereof, if any, including, without limitation, dividend rights,
conversion rights, redemption privileges and liquidation preferences, as shall be stated in such
resolution or resolutions, all to the fullest extent permitted by the DGCL. Without limiting the
generality of the foregoing, the resolution or resolutions providing for the establishment of any
series of Preferred Stock may, to the extent permitted by law, provide that such series shall be
superior to, rank equally with or be junior to the Preferred Stock of any other series. The
powers, preferences and relative, participating, optional and other special rights of each series
of Preferred Stock, and the qualifications, limitations or restrictions thereof, if any, may be
different from those of any and all other series at any time outstanding. Except as otherwise
expressly provided in the resolution or resolutions providing for the establishment of any series
of Preferred Stock, no vote of the holders of shares of Preferred Stock or Common Stock shall be a
prerequisite to the issuance of any shares of any series of the Preferred Stock authorized by and
complying with the conditions of this Certificate of Incorporation.
FIFTH: (1) The business and affairs of the Corporation shall be managed by or under
the direction of a Board of Directors having that number of directors set out in the Bylaws of the
Corporation as adopted or as set forth from time to time by a duly adopted amendment thereto by the
Board of Directors or stockholders of the Corporation.
(2) No director (other than directors elected by one or more series of Preferred Stock) may be
removed from office by the stockholders except for cause and, in addition to any other vote
required by law, upon the affirmative vote of not less than
662/3% of the total voting power of all
outstanding securities of the Corporation then entitled to vote generally in the election of
directors, voting together as a single class.
(3) The directors of the Corporation, other than directors elected by one or more series of
Preferred Stock, shall be divided into three classes, designated Class I, Class II and Class III.
Each class shall consist, as nearly as may be possible, of one-third of the total number of
directors (other than directors elected by one or more series of Preferred Stock) constituting the
entire Board of Directors. Each director (other than directors elected by one or more series of
Preferred Stock) shall serve for a term ending on the date of the third annual meeting of
stockholders next following the annual meeting at which such director was elected, provided that
directors initially designated as Class I directors shall serve for a term ending on the date of
the 2007 annual meeting, directors initially designated as Class II directors shall serve for a
term ending on the date of the 2008 annual meeting and directors initially designated as Class III
directors shall serve for a term ending on the date of the 2009 annual meeting. Notwithstanding the
foregoing, each director shall hold office until such directors successor shall have been duly
elected and qualified or until such directors earlier death, resignation or removal. If the number
of directors (other than directors elected by one or more series of Preferred Stock) is changed,
any increase or decrease shall be apportioned among the classes so as to maintain the number of
directors in each class as nearly equal as possible, but in no event will a decrease in the number
of directors shorten the term of any incumbent director. Vacancies on the Board of Directors
resulting from death, resignation, removal or otherwise and newly created directorships resulting
from any increase in the number of
2
directors (other than directors elected by one or more series of Preferred Stock) may be
filled solely by a vote of a majority of the directors then in office (although less than a quorum)
or by a sole remaining director, and each director so elected shall hold office for a term that
shall coincide with the remaining term of the class to which such director shall have been elected.
Whenever the holders of one or more classes or series of Preferred Stock shall have the right,
voting separately as a class or series, to elect directors, the nomination, election, term of
office, filling of vacancies, removal and other features of such directorships shall not be
governed by this Article FIFTH unless otherwise provided for in the certificate of designation for
such classes or series.
SIXTH: The Corporation is to have perpetual existence.
SEVENTH: The following provisions are inserted for the management of the business and
the conduct of the affairs of the Corporation and for the further definition of the powers of the
Corporation and its directors and stockholders:
(1) The Board of Directors is expressly authorized to make, adopt, amend, alter, rescind or
repeal the Bylaws of the Corporation. Notwithstanding the foregoing, the stockholders may adopt,
amend, alter, rescind or repeal the Bylaws with, in addition to any other vote required by law, the
affirmative vote of the holders of not less than
662/3% of the total voting power of all outstanding
securities of the Corporation then entitled to vote generally in the election of directors, voting
together as a single class.
(2) Elections of directors need not be by written ballot unless the Bylaws of the Corporation
so provide.
(3) Any action required or permitted to be taken at any annual or special meeting of
stockholders may be taken only upon the vote of stockholders at an annual or special meeting duly
noticed and called in accordance with the DGCL and may not be taken by written consent of
stockholders without a meeting.
(4) Special meetings of the stockholders of the Corporation for any purpose or purposes may be
called at any time by the Chairman of the Board of Directors or the President or at the written
request of a majority of the members of the Board of Directors and may not be called by any other
person; provided, however, that if and to the extent that any special meeting of
stockholders may be called by any other person or persons specified in any provisions of the
Certificate of Incorporation or any amendment thereto or any certificate filed under Section 151(g)
of the DGCL, then such special meeting may also be called by the person or persons, in the manner,
at the times and for the purposes so specified.
EIGHTH: (a) Subject to Article EIGHTH (c), the Corporation shall indemnify and hold
harmless any person who is or was 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, 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 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
3
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) Subject to Article EIGHTH (c), the Corporation shall indemnify and hold harmless any
person who is or was 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, employee benefit plan 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; except
that no 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 the State 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 person is fairly and reasonably entitled to indemnity for
such expenses which the Court of Chancery of the State of Delaware or such other court shall deem
proper.
(c) Any indemnification under this Article EIGHTH (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 or other person entitled to indemnification under this Article EIGHTH is
proper in the circumstances because he or she has met the applicable standard of conduct set forth
in Article EIGHTH (a) or Article EIGHTH (b), as the case may be. Such determination shall be made,
with respect to an officer or director, (i) by the Board of Directors by a majority vote of
directors who were not parties to such action, suit or proceeding, even if constituting less than a
quorum, (ii) by a committee of directors who were not parties to such action, suit or proceeding
even if constituting less than a quorum, (iii) if there are no such directors, or if such directors
so direct, by independent legal counsel in a written opinion or (iv) by the stockholders. To the
extent, however, that a present or former director or officer of the Corporation has been
successful on the merits or otherwise in defense of any action, suit or proceeding referred to in
Article EIGHTH (a) or Article EIGHTH (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, without the necessity of authorization in the
specific case.
(d) Notwithstanding any contrary determination in the specific case under Article EIGHTH (c),
and notwithstanding the absence of any determination thereunder, any present or former director or
officer of the Corporation may apply to the Court of Chancery of the State of Delaware for
indemnification to the extent otherwise permissible under Article EIGHTH (a) and Article EIGHTH
(b). The basis of such indemnification by a court shall be a determination by such court that
indemnification of such person is proper in the circumstances because he or she has met the
applicable standards of conduct set forth in Article EIGHTH (a) or Article EIGHTH (b), as the case
may be. Neither a contrary determination in the specific case under Article EIGHTH (c) nor the
absence of any determination thereunder shall be a defense to such application or create a
presumption that such person seeking indemnification has not met any applicable standard of
conduct. Notice of any application for indemnification pursuant to this Article EIGHTH (d) shall
be given to the Corporation promptly upon the filing of such application. If successful, in whole
or in part, such person seeking indemnification in the Court of Chancery of the State of Delaware
shall also be entitled to be paid the expense of prosecuting such application.
4
(e) Expenses incurred by a person who is or was a director or officer of the Corporation in
defending or investigating a threatened or pending 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 person 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 EIGHTH.
(f) The indemnification and advancement of expenses provided by or granted pursuant to this
Article EIGHTH 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, contract,
vote of stockholders or disinterested directors or pursuant to the direction (howsoever embodied)
of any court of competent jurisdiction or otherwise, both as to action in his or her official
capacity and as to action in another capacity while holding such office, it being the policy of the
Corporation that indemnification of the persons specified in Article EIGHTH (a) and Article EIGHTH
(b) shall be made to the fullest extent permitted by law. The provisions of this Article EIGHTH
shall not be deemed to preclude the indemnification of any person who is not specified in Article
EIGHTH (a) or Article EIGHTH (b) but whom the Corporation has the power or obligation to indemnify
under the provisions of the DGCL or otherwise.
(g) The Corporation may 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, officer, employee or agent of another corporation, partnership, joint venture, trust,
employee benefit plan 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 or the obligation to indemnify him or her against such
liability under the provisions of this Article EIGHTH or Section 145 of the DGCL.
(h) For purposes of this Article EIGHTH, 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 the 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, officer, employee or agent of another
corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, shall
stand in the same position under the provisions of this Article EIGHTH 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. For purposes of this Article EIGHTH,
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
any service as a director, officer, employee or agent of the Corporation which imposes duties on,
or involves services by, such person 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 Article EIGHTH. For purposes of any determination under Article EIGHTH (c), a person
shall be deemed to have acted in good faith in a manner he or she reasonably believed to be in or
not opposed to the best interests of the Corporation, or, with respect to any criminal action or
proceeding, to have had no reasonable cause to believe his or her conduct was unlawful, if his or
her action is based on the records or books of account of the Corporation or another enterprise, or
on information supplied to him or her by the officers of the Corporation or another enterprise in
the course of their duties, or on the advice of legal counsel for the Corporation or another
enterprise or on information or records given or reports made to the Corporation or another
enterprise by an independent certified public accountant or by an appraiser or other expert
selected with reasonable care by the Corporation or another enterprise. The term another
5
enterprise as used in this Article EIGHTH (h) shall mean any other corporation or any partnership,
joint venture, trust, employee benefit plan or other enterprise of which such person is or was
serving at the request of the Corporation as a director, officer, employee or agent. The
provisions of this Article EIGHTH (h) shall not be deemed to be exclusive, or to limit in any way,
the circumstances in which a person may be deemed to have met the applicable standard of conduct
set forth in Article EIGHTH (a) or (b), as the case may be.
(i) The indemnification and advancement of expenses provided by, or granted pursuant to, this
Article EIGHTH shall, unless otherwise provided when authorized or ratified, continue as to a
person who has ceased to be a director or officer of the Corporation and shall inure to the benefit
of the heirs, executors and administrators of such a person.
(j) Notwithstanding anything contained in this Article EIGHTH to the contrary, except for
proceedings to enforce rights to indemnification (which shall be governed by Article EIGHTH (d)),
the Corporation shall not be obligated to indemnify any person in connection with a proceeding (or
part, thereof) initiated by such person unless such proceeding (or part thereof) was authorized or
consented to by the Board of Directors of the Corporation.
(k) The Corporation may, to the extent authorized from time to time by the Board of Directors,
provide rights to indemnification and to the advancement of expenses to employees and agents of the
Corporation similar to those conferred in this Article EIGHTH to directors and officers of the
Corporation.
NINTH: 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, provided that
this Article shall not eliminate or limit the liability of a director (i) for any breach of his or
her 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 the law, (iii) under
Section 174 of the DGCL or (iv) for any transaction from which the director derives an improper
personal benefit.
If the DGCL is hereafter amended to authorize corporate action further limiting or eliminating
the personal liability of directors, then the liability of the director to the Corporation shall be
limited or eliminated to the fullest extent permitted by the DGCL, as so amended from time to time.
Any amendment, repeal or modification of this Article shall be prospective only, and shall not
adversely affect any right or protection of a director of the Corporation under this Article NINTH
in respect of any act or omission occurring prior to the time of such amendment, repeal or
modification.
TENTH: Each reference in this Certificate of Incorporation to any provision of the
DGCL refers to the specified provision of the DGCL, as the same now exists or as it may hereafter
be amended or superseded.
ELEVENTH: The Corporation reserves the right at any time and from time to time to
amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the
manner now or hereafter prescribed by the laws of the State of Delaware; and all rights conferred
on stockholders, directors or any other persons herein are granted subject to this reservation;
provided, however, that no amendment, alteration, change or repeal may be made to Article FIFTH,
SEVENTH, EIGHTH, NINTH or ELEVENTH without the affirmative vote of the holders of at least 662/3% of
the outstanding voting stock of the corporation, voting together as a single class.
6
3. That said Amended and Restated Certificate of Incorporation has been consented to and
authorized by the holders of a majority of the issued and outstanding stock entitled to vote in
accordance with the provisions of Section 228 of the DGCL.
4. That said Amended and Restated Certificate of Incorporation was duly adopted in accordance
with the applicable provisions of Sections 242 and 245 of the DGCL.
7
IN WITNESS WHEREOF, Cadence Pharmaceuticals, Inc. has caused this Certificate to be signed by
Theodore R. Schroeder, its President and Chief Executive Officer and William R. LaRue, its Senior
Vice President, Chief Financial Officer, Treasurer and Secretary,
this ___ day of 2006.
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Cadence Pharmaceuticals, Inc.,
a Delaware corporation
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By: |
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Name: |
William R. LaRue |
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Title: |
Senior Vice President, Chief Financial Officer, Treasurer and Secretary |
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ATTEST
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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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8
Exhibit 3.5
EXHIBIT
3.5
AMENDED AND RESTATED
BYLAWS
OF
CADENCE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
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PAGE |
ARTICLE I. OFFICES |
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1 |
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Section 1.
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REGISTERED OFFICES
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1 |
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Section 2.
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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.
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PLACE OF MEETINGS
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Section 2.
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ANNUAL MEETING OF STOCKHOLDERS
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1 |
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Section 3.
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QUORUM; ADJOURNED MEETINGS AND NOTICE THEREOF
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1 |
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Section 4.
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VOTING
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Section 5.
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PROXIES
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Section 6.
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SPECIAL MEETINGS
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2 |
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Section 7.
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NOTICE OF STOCKHOLDERS MEETINGS
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2 |
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Section 8.
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FIXING DATE FOR DETERMINATION OF STOCKHOLDERS OF RECORD
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3 |
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Section 9.
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NOTICE OF STOCKHOLDER BUSINESS AND NOMINATIONS
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3 |
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Section 10.
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MAINTENANCE AND INSPECTION OF STOCKHOLDER LIST
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6 |
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Section 11.
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STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING
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ARTICLE III. DIRECTORS |
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Section 1.
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THE NUMBER OF DIRECTORS
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Section 2.
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VACANCIES
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Section 3.
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POWERS
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Section 4.
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PLACE OF DIRECTORS MEETINGS
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Section 5.
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REGULAR MEETINGS
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Section 6.
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SPECIAL MEETINGS
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Section 7.
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QUORUM
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Section 8.
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ACTION WITHOUT MEETING
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Section 9.
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TELEPHONIC MEETINGS
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Section 10.
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COMMITTEES OF DIRECTORS
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Section 11.
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MINUTES OF COMMITTEE MEETINGS
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Section 12.
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COMPENSATION OF DIRECTORS
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ARTICLE IV. OFFICERS |
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Section 1.
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OFFICERS
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Section 2.
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ELECTION OF OFFICERS
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Section 3.
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SUBORDINATE OFFICERS
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Section 4.
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COMPENSATION OF OFFICERS
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Section 5.
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TERM OF OFFICE; REMOVAL AND VACANCIES
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Section 6.
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POWERS AND DUTIES OF OFFICERS
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ARTICLE V. INDEMNIFICATION OF EMPLOYEES AND AGENTS |
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ARTICLE VI. CERTIFICATES OF STOCK |
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Section 1.
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CERTIFICATES
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Section 2.
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SIGNATURES ON CERTIFICATES
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Section 3.
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STATEMENT OF STOCK RIGHTS, PREFERENCES, PRIVILEGES
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Section 4.
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LOST CERTIFICATES
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Section 5.
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TRANSFERS OF STOCK
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Section 6.
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REGISTERED STOCKHOLDERS
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ARTICLE VII. GENERAL PROVISIONS |
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Section 1.
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CHECKS
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Section 2.
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FISCAL YEAR
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Section 3.
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CORPORATE SEAL
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Section 4.
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MANNER OF GIVING NOTICE
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Section 5.
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WAIVER OF NOTICE
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ARTICLE VIII. AMENDMENTS |
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ii
AMENDED AND RESTATED
BYLAWS
OF
CADENCE PHARMACEUTICALS, INC.
ARTICLE I.
OFFICES
Section 1. REGISTERED OFFICES. The registered office shall be in the City of Wilmington, County of New
Castle, 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 (the Board) 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. 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 time designated by the Board. At each annual meeting directors shall be elected, 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.
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 and entitled to vote on a particular question shall decide such question
brought before such meeting, unless the question is one upon which by express provision of the
statutes, the Certificate of Incorporation or these Bylaws, a different
1
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 stock 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. Each stockholder shall have one vote for each share of stock
having voting power, registered in his name on the books of the corporation on the record date set
by the Board as provided in Article II, Section 8 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
Chairman of the Board or the President and shall be called by the President or the Secretary at the
request in writing of a majority of the members of the Board. 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 deemed given when deposited in the United States mail,
postage prepaid, directed to the stockholder at his address as it appears on the records of the
corporation.
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Section 8. FIXING DATE FOR DETERMINATION OF STOCKHOLDERS OF RECORD. In order that the corporation may
determine the stockholders entitled to notice of, or to vote at, any meeting of 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 may fix a record date, which record date shall not precede the
date upon which the resolution fixing the record date is adopted by the Board, and which record
date: (a) in the case of determination of stockholders entitled to vote at any meeting of
stockholders or adjournment thereof, shall, unless otherwise required by law, not be more than
sixty nor less than ten days before the date of such meeting; and (b) in the case of any other
action, shall not be more than sixty days prior to such other action. If no record date is fixed:
(i) the record date for determining stockholders entitled to notice of or to vote at a meeting of
stockholders shall be at the close of business on the day next preceding the day on which notice is
given, or, if notice is waived, at the close of business on the day next preceding the day on which
the meeting is held; and (ii) the record date for determining stockholders for any other purpose
shall be at the close of business on the day on which the Board adopts the resolution relating
thereto. 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
may fix a new record date for the adjourned meeting.
Section 9. NOTICE OF STOCKHOLDER BUSINESS AND NOMINATIONS.
(a) Nominations of persons for election to the Board of the corporation and the proposal of
business to be considered by the stockholders may be made at an annual meeting of stockholders (i)
pursuant to the corporations notice of meeting (or any supplement thereto), (ii) by or at the
direction of the Board or (iii) by any stockholder of the corporation who was a stockholder of
record at the time notice provided for in this Section 9 is given to the Secretary of the
corporation, who is entitled to vote at the meeting and who complies with the notice procedures in
this Section 9.
(b) For nominations or other business to be properly brought before an annual meeting by a
stockholder pursuant to clause (iii) of paragraph (a) of this Section 9, the stockholder must have
given timely notice thereof in writing to the Secretary of the corporation, and any such proposed
business other than the nominations of persons for election to the Board must constitute a proper
matter for stockholder action. To be timely, a stockholders notice shall be delivered to the
Secretary at the principal executive offices of the corporation not later than the close of
business on the ninetieth day nor earlier than the close of business on the one hundred twentieth
day prior to the first anniversary of the preceding years annual meeting; provided, however, that
in the event that the date of the annual meeting is more than thirty days before or more than sixty
days after such anniversary date, notice by the stockholder to be timely must be so delivered not
earlier than the close of business on the one hundred twentieth day prior to such annual meeting
and not later than the close of business on the later of the ninetieth day prior to such annual
meeting or the tenth day following the earlier of (i) the day on which notice of the meeting was
mailed or (ii) the date public announcement of the date of such meeting is first made by the
corporation. In no event shall the public announcement of an adjournment or postponement of an
annual meeting commence a new time period (or extend any time period) for the giving of a
stockholders notice as described above. Such stockholders notice shall set forth:
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(A) as to each
person whom the stockholder proposes to nominate for election or re-election as a director, all
information relating to such person that is required to be disclosed in solicitations of proxies
for election of directors in an election contest, or is otherwise required, in each case
pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended (the
Exchange Act), and Rule 14a-101 thereunder (including such persons written consent to being
named in the proxy statement as a nominee and to serving as a director if elected); (B) as to any
other business that the stockholder proposes to bring before the meeting, a brief description of
the business desired to be brought before the meeting, the text of the proposal or business
(including the text of any resolutions proposed for consideration and, in the event that such
business includes a proposal to amend the Bylaws, the language of the proposed amendment), the
reasons for conducting such business at the meeting and any material interest in such business of
such stockholder and the beneficial owner, if any, on whose behalf the nomination or proposal is
made; and (C) as to the stockholder giving the notice and the beneficial owner, if any, on whose
behalf the nomination or proposal is made, (I) the name and address of such stockholder and of such
beneficial owner, as they appear on the corporations books, (II) the class and number of shares of
capital stock of the corporation which are owned beneficially and of record by such stockholder and
such beneficial owner, (III) a representation that the stockholder is a holder of record of stock
of the corporation entitled to vote at such meeting and intends to appear in person or by proxy at
the meeting to propose such business or nomination and (IV) a representation whether the
stockholder or the beneficial owner, if any, intends or is part of a group which intends (y) to
deliver a proxy statement and/or form of proxy to holders of at least the percentage of the
corporations outstanding capital stock required to approve or adopt the proposal or elect the
nominee and/or (z) otherwise to solicit proxies from stockholders in support of such proposal or
nomination. The foregoing notice requirements shall be deemed satisfied by a stockholder if the
stockholder has notified the corporation of his or her intention to present a proposal at an annual
meeting in compliance with Rule 14a-8 (or any successor thereof) promulgated under the Exchange Act
and such stockholders proposal has been included in a proxy statement that has been prepared by
the corporation to solicit proxies for such annual meeting. The corporation may require any
proposed nominee to furnish such other information as it may reasonably require to determine the
eligibility of such proposed nominee to serve as a director of the corporation.
(c) Only such business shall be conducted at a special meeting of stockholders as shall have
been brought before the meeting pursuant to the corporations notice of meeting. Nominations of
persons for election to the Board may be made at a special meeting of stockholders at which
directors are to be elected pursuant to the corporations notice of meeting (i) by or at the
direction of the Board or (ii) provided that the Board has determined that directors shall be
elected at such meeting, by any stockholder of the corporation who is a stockholder of record at
the time the notice provided for in this Section 9 is delivered to the Secretary of the
corporation, who is entitled to vote at the meeting and who complies with the notice procedures set
forth in this Section 9. In the event the corporation calls a special meeting of stockholders for
the purpose of electing one or more directors to the Board, any such stockholder entitled to vote
in such election of directors may nominate a person or persons (as the case may be) for election to
such position(s) as specified in the corporations notice of meeting, if the stockholders notice
required by paragraph (b) of this Section 9 shall be delivered to the Secretary at the principal
executive offices of the corporation not earlier than the close of business on the one hundred
twentieth day prior to such special meeting and not later than the close of business on the later
of
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(i) the ninetieth day prior to such special meeting or (ii) the tenth day following the day on
which public announcement is first made of the date of the special meeting and of the nominees
proposed by the Board to be elected at such meeting. In no event shall the public announcement
of an adjournment or postponement of a special meeting commence a new time period (or extend
any time period) for the giving of a stockholders notice as described above.
(d)
(i) Only such persons who are nominated in accordance with the procedures set forth in this
Section 9 shall be eligible to be elected at an annual or special meeting of stockholders of the
corporation to serve as directors, and only such business shall be conducted at a meeting of
stockholders as shall have been brought before the meeting in accordance with the procedures set
forth in this Section 9. Except as otherwise provided by law, the chairman of the meeting shall
have the power and duty (A) to determine whether a nomination or any business proposed to be
brought before the meeting was made or proposed, as the case may be, in accordance with the
procedures set forth in this Section 9 (including whether the stockholder or beneficial owner, if
any, on whose behalf the nomination or proposal is made solicited (or is part of a group which
solicited) or did not so solicit, as the case may be, proxies in support of such stockholders
nominee or proposal in compliance with such stockholders representation as required by paragraph
(b) of this Section 9) and (B) if any proposed nomination or business was not made or proposed in
compliance with this Section 9, to declare that such nomination shall be disregarded or that such
proposed business shall not be transacted. Notwithstanding the foregoing provisions of this
Section 9, if the stockholder (or a qualified representative of the stockholder) does not appear at
the annual or special meeting of stockholders of the corporation to present a nomination or
business, such nomination shall be disregarded and such proposed business shall not be transacted,
notwithstanding that proxies in respect of such vote may have been received by the corporation.
(ii) For purposes of this Section 9, public announcement shall include disclosure in a press
release reported by PRNewswire, Business Wire, the Dow Jones News Service, Associated Press or
comparable national news service or in a document publicly filed by the corporation with the
Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.
(iii) Notwithstanding the foregoing provisions of this Section 9, a stockholder shall also
comply with all applicable requirements of the Exchange Act and the rules and regulations
promulgated thereunder with respect to the matters set forth in this Section 9. Nothing in this
Section 9 shall be deemed to affect any rights (A) of stockholders to request inclusion of
proposals in the corporations proxy statement pursuant to Rule 14a-8 under the Exchange Act or (B)
of the holders of any series of preferred stock of the corporation to elect directors pursuant to
any applicable provisions of the Certificate of Incorporation.
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Section 10. 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 11. 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 not be taken without a meeting.
ARTICLE III.
DIRECTORS
Section 1. THE NUMBER OF DIRECTORS. The number of directors which shall constitute the whole Board shall
be not less than three nor more than fifteen. The actual number of directors shall be fixed 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 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 may be
removed, for cause, from the Board at any meeting of stockholders by not less than 66 2/3% of the
outstanding stock of the Corporation.
Section 2. VACANCIES. Vacancies on the Board 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 solely by a vote of a majority of
the directors then in office, although less than a quorum, or by a sole remaining director, and
each director so elected shall hold office for a term that shall coincide with the remaining term
of the class to which such director shall have been elected. 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 (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.
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Section 3. POWERS. The property and business of the corporation shall be managed by or under the
direction of its Board. In addition to the powers and authorities by these Bylaws expressly
conferred upon them, the Board may exercise all such powers of the corporation and do all such
lawful acts and things as are not by statute, by the Certificate of Incorporation or by these
Bylaws directed or required to be exercised or done by the stockholders.
Section 4. PLACE OF DIRECTORS MEETINGS. The directors may hold their meetings, 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 may be held without notice at such time and
place as shall from time to time be determined by the Board.
Section 6. SPECIAL MEETINGS. Special meetings of the Board may be called by the Chairman of the Board or
the President on forty-eight hours notice to each director, either personally, by mail, electronic
mail or by telegram; special meetings shall be called by the President or the Secretary in like
manner and on like notice on the written request of two directors, unless the Board consists of
only one director, in which case special meetings shall be called by the 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 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, 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, the
directors present thereat 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, or of any
committee thereof, may be taken without a meeting, if all members of the Board 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 or committee.
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Section 9. TELEPHONIC MEETINGS. Unless otherwise restricted by the Certificate of Incorporation or these
Bylaws, members of the Board, or any committee designated by the Board, may participate in a
meeting of the Board, 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 may, by resolution passed by a majority of the whole Board,
designate one or more committees, each such committee to consist of one or more of the directors of
the corporation. The Board 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, she or they constitute a
quorum, may unanimously appoint another member of the Board 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, shall have and may exercise all the powers and authority of the Board in
the management of the business and affairs of 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 when required.
Section 12. COMPENSATION OF DIRECTORS. Unless otherwise restricted by the Certificate of Incorporation or
these Bylaws, the Board 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 and may be
paid a fixed sum for attendance at each meeting of the Board 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 and shall include a
President, a Secretary and a Chief Financial Officer or Treasurer. The corporation may also have at
the discretion of the Board such other officers as are desired, including 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
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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, at its first meeting after each annual meeting of
stockholders, shall choose the officers of the corporation.
Section 3. SUBORDINATE OFFICERS. The Board 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.
Section 4. COMPENSATION OF OFFICERS. The salaries of all officers and agents of the corporation shall be
fixed by the Board.
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 may be removed at any time by the affirmative vote of a majority of the Board. If the
office of any officer or officers becomes vacant for any reason, the vacancy shall be filled by the
Board.
Section 6. POWERS AND DUTIES OF OFFICERS. The officers of the corporation shall have such powers and
duties in the management of the corporation as may be prescribed in a resolution by the Board and,
to the extent not so provided, as generally pertain to their respective offices, subject to the
control of the Board.
ARTICLE V.
INDEMNIFICATION OF EMPLOYEES AND
AGENTS
The corporation may indemnify every person who is or was 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 counsel
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.
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ARTICLE VI.
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 President or a Vice President and
by the Secretary or an Assistant Secretary, or the 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 class, the powers, designations,
preferences and relative, participating, optional or other special rights of each class of stock or
series thereof and the qualification, 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 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 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 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.
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Section 6. 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, except as expressly provided by the
laws of the State of Delaware.
ARTICLE VII.
GENERAL PROVISIONS
Section 1. CHECKS. All checks or demands for money and notes of the corporation shall be signed by such
officer or officers as the Board may from time to time designate.
Section 2. FISCAL YEAR. The fiscal year of the corporation shall be fixed by resolution of the Board.
Section 3. CORPORATE SEAL. The corporate seal shall have inscribed thereon the name of the corporation
and shall be in such form as may be approved from time to time by the Board.
Section 4. MANNER OF GIVING NOTICE. Whenever, under the law, the Certificate of Incorporation or 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 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, telecopier
or other means of communication permitted by law.
Section 5. WAIVER OF NOTICE. Whenever any notice is required to be given under the law, the Certificate of Incorporation or
these Bylaws, a waiver thereof via electronic mail or 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. Attendance of a person at a meeting shall constitute a waiver of notice of such
meeting, except when the person attends a meeting for the express purpose of objecting, at the
beginning of the meeting, to the transaction of any business because the meeting is not lawfully
called or convened. Neither the business to be transacted at nor the purpose of any regular or
special meeting of the stockholders, directors or members of a committee of directors need be
specified in any written waiver of notice.
ARTICLE VIII.
AMENDMENTS
These Bylaws may be altered, amended or repealed or new Bylaws may be adopted by the
stockholders or by the Board in accordance with the terms of the Certificate of Incorporation. If
the power to adopt, amend or repeal Bylaws is conferred upon the Board by the Certificate of
Incorporation, it shall not divest or limit the power of the stockholders to adopt, amend or repeal
Bylaws.
* * * * *
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Exhibit 10.1
EXHIBIT
10.1
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (Agreement) is made as of , 2006 by
and between Cadence Pharmaceuticals, Inc., a Delaware corporation (the Company), and
(Indemnitee).
RECITALS
WHEREAS, highly competent persons have become more reluctant to serve corporations as
directors or in other capacities unless they are provided with adequate protection through
insurance and adequate indemnification against inordinate risks of claims and actions against them
arising out of their service to and activities on behalf of the corporation;
WHEREAS, the Board of Directors of the Company (the Board) has determined that, in
order to attract and retain qualified individuals, the Company will attempt to maintain on an
ongoing basis, at its sole expense, liability insurance to protect persons serving the Company and
its subsidiaries from certain liabilities. Although the furnishing of such insurance has been a
customary and widespread practice among United States-based corporations and other business
enterprises, the Company believes that, given current market conditions and trends, such insurance
may be available to it in the future only at higher premiums and with more exclusions. At the same
time, directors, officers and other persons in service to corporations or business enterprises are
being increasingly subjected to expensive and time-consuming litigation relating to, among other
things, matters that traditionally would have been brought only against the Company or business
enterprise itself. The certificate of incorporation and bylaws of the Company require
indemnification of the officers and directors of the Company. Indemnitee may also be entitled to
indemnification pursuant to the General Corporation Law of the State of Delaware (DGCL).
The certificate of incorporation, bylaws and the DGCL expressly provide that the indemnification
provisions set forth therein are not exclusive and thereby contemplate that contracts may be
entered into between the Company and members of the Board, officers and other persons with respect
to indemnification;
WHEREAS, the uncertainties relating to such insurance and to indemnification have increased
the difficulty of attracting and retaining such persons;
WHEREAS, the Board has determined that the increased difficulty in attracting and retaining
such persons is detrimental to the best interests of the Companys stockholders and that the
Company should act to assure such persons that there will be increased certainty of such protection
in the future;
WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate
itself to indemnify, and to advance expenses on behalf of, such persons to the fullest extent
permitted by applicable law so that they will serve or continue to serve the Company free from
undue concern that they will not be so indemnified;
WHEREAS, this Agreement is a supplement to and in furtherance of the certificate of
incorporation and bylaws of the Company and any resolutions adopted pursuant thereto and shall not
be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder;
and
WHEREAS, Indemnitee does not regard the protection available under the Companys certificate
of incorporation, bylaws and insurance as adequate in the present circumstances and may not be
willing to serve as an officer or director without adequate protection, and the Company desires
Indemnitee to serve
in such capacity. Indemnitee is willing to serve, to continue to serve and to take on
additional service for or on behalf of the Company on the condition that he or she be so
indemnified.
NOW, THEREFORE, in consideration of the promises and the covenants contained herein, the
Company and Indemnitee do hereby covenant and agree as follows:
1. Services to the Company. Indemnitee will serve or continue to serve as an officer,
director or key employee of the Company for so long as Indemnitee is duly elected or appointed or
until Indemnitee tenders his or her resignation.
2. Definitions. As used in this Agreement:
(a) Beneficial Owner shall have the meaning given to such term in Rule 13d-3 under
the Exchange Act; provided, however, that Beneficial Owner shall exclude any Person
otherwise becoming a Beneficial Owner by reason of the stockholders of the Company approving a
merger of the Company with another entity.
(b) A Change in Control shall be deemed to occur upon the earliest to occur after
the date of this Agreement of any of the following events:
(i) Acquisition of Stock by Third Party. Any Person (as defined below) is or
becomes the Beneficial Owner, directly or indirectly, of securities of the Company
representing twenty percent (20%) or more of the combined voting power of the Companys then
outstanding securities;
(ii) Change in Board of Directors. During any period of two (2) consecutive
years (not including any period prior to the execution of this Agreement), individuals, who
at the beginning of such period constitute the Board, and any new director (other than a
director designated by a person who has entered into an agreement with the Company to effect
a transaction described in Sections 2(b)(i), 2(b)(iii) or 2(b)(iv)) whose election by the
Board or nomination for election by the Companys 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 period or whose election or nomination for election was previously so
approved, cease for any reason to constitute at least a majority of the members of the
Board;
(iii) Corporate Transactions. The effective date of a merger or consolidation
of the Company with any other entity, other than a merger or consolidation which would
result in the voting securities of the Company outstanding immediately prior to such merger
or consolidation continuing to represent (either by remaining outstanding or by being
converted into voting securities of the surviving entity) more than 50.1% of the combined
voting power of the voting securities of the surviving entity outstanding immediately after
such merger or consolidation and with the power to elect at least a majority of the board of
directors or other governing body of such surviving entity;
(iv) Liquidation. The approval by the stockholders of the Company of a
complete liquidation of the Company or an agreement or series of agreements for the sale or
disposition by the Company of all or substantially all of the Companys assets; or
(v) Other Events. There occurs any other event of a nature that would be
required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or a
response to any similar item on any similar schedule or form) promulgated under the Exchange
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Act (as defined below), whether or not the Company is then subject to such reporting
requirement.
(c) Corporate Status describes the status of a person who is or was a director,
officer, trustee, general partner, managing member, fiduciary, employee or agent of the Company or
of any other Enterprise (as defined below) which such person is or was serving at the request of
the Company.
(d) Disinterested Director means a director of the Company who is not and was not a
party to the Proceeding in respect of which indemnification is sought by Indemnitee.
(e) Enterprise shall mean the Company and any other corporation, limited liability
company, partnership, joint venture, trust, employee benefit plan or other enterprise of which
Indemnitee is or was serving at the request of the Company as a director, officer, trustee, general
partner, managing member, fiduciary, employee or agent.
(f) Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
(g) Expenses shall include all reasonable attorneys fees, retainers, court costs,
transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and
binding costs, telephone charges, postage, delivery service fees and all other disbursements or
expenses of the type customarily incurred in connection with prosecuting, defending, preparing to
prosecute or defend, investigating, being or preparing to be a witness in, or otherwise
participating in, a Proceeding. Expenses also shall include expenses incurred in connection with
any appeal resulting from any Proceeding, including, without limitation, the premium, security for
and other costs relating to any cost bond, supersedeas bond or other appeal bond or its equivalent.
Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of
judgments or fines against Indemnitee.
(h) Independent Counsel means a law firm, or a member of a law firm, that is
experienced in matters of corporation law and neither presently is, nor in the past five years has
been, retained to represent: (i) the Company or Indemnitee in any matter material to either such
party (other than with respect to matters concerning Indemnitee under this Agreement, or of other
indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding
giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term
Independent Counsel shall not include any person who, under the applicable standards of
professional conduct then prevailing, would have a conflict of interest in representing either the
Company or Indemnitee in an action to determine Indemnitees rights under this Agreement. The
Company agrees to pay the reasonable fees and expenses of the Independent Counsel referred to above
and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages
arising out of or relating to this Agreement or its engagement pursuant hereto.
(i) Person shall have the meaning set forth in Sections 13(d) and 14(d) of the
Exchange Act; provided, however, that Person shall exclude (i) the Company, (ii)
any trustee or other fiduciary holding securities under an employee benefit plan of the Company and
(iii) any corporation owned, directly or indirectly, by the stockholders of the Company in
substantially the same proportions as their ownership of stock of the Company.
(j) The term Proceeding shall include any threatened, pending or completed action,
suit, arbitration, alternate dispute resolution mechanism, investigation, formal or informal,
inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether
brought in the right of the Company or otherwise and whether of a civil, criminal, administrative
or investigative nature,
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in which Indemnitee was, is or will be involved as a party, witness or otherwise by reason of
the fact that Indemnitee is or was a director or officer of the Company, by reason of any action
taken (or failure to act) by him or her or of any action (or failure to act) on his or her part
while acting as a director or officer of the Company, or by reason of the fact that he or she is or
was serving at the request of the Company as a director, officer, trustee, general partner,
managing member, fiduciary, employee or agent of any other Enterprise, in each case whether or not
serving in such capacity at the time any liability or Expense is incurred for which
indemnification, reimbursement or advancement of Expenses can be provided under this Agreement.
(k) References to other enterprise shall include employee benefit plans; references
to fines shall include any excise tax assessed with respect to any employee benefit plan;
references to serving at the request of the Company shall include any service as a
director, officer, employee or agent of the Company which imposes duties on, or involves services
by, such director, officer, employee or agent 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 best interests 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 Company as referred to in this Agreement.
3. Indemnity in Third-Party Proceedings. The Company shall indemnify Indemnitee in accordance
with the provisions of this Section 3 if Indemnitee is, or is threatened to be made, a party to or
a participant (as a witness or otherwise) in any Proceeding, other than a Proceeding by or in the
right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee
shall be indemnified against all Expenses, judgments, fines, penalties and amounts paid in
settlement (including all interest, assessments and other charges paid or payable in connection
with or in respect of such Expenses, judgments, fines, penalties and amounts paid in settlement)
actually and reasonably incurred by Indemnitee or on his or her behalf in connection with such
Proceeding or any claim, issue or matter therein, if Indemnitee 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 Company and, in
the case of a criminal proceeding, he or she had no reasonable cause to believe that his or her
conduct was unlawful.
4. Indemnity in Proceedings by or in the Right of the Company. The Company shall indemnify
Indemnitee in accordance with the provisions of this Section 4 if Indemnitee is, or is threatened
to be made, a party to or a participant (as a witness or otherwise) in any Proceeding by or in the
right of the Company to procure a judgment in its favor. Pursuant to this Section 4, Indemnitee
shall be indemnified against all Expenses actually and reasonably incurred by Indemnitee or on his
or her behalf in connection with such Proceeding or any claim, issue or matter therein, if
Indemnitee 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 Company. No indemnification for Expenses shall be made under
this Section 4 in respect of any claim, issue or matter as to which Indemnitee shall have been
finally adjudged by a court to be liable to the Company, unless and only to the extent that any
court in which the Proceeding was brought or the Delaware Court of Chancery shall determine upon
application that, despite the adjudication of liability but in view of all the circumstances of the
case, Indemnitee is fairly and reasonably entitled to indemnification.
5. Indemnification for Expenses of a Party Who is Wholly or Partly Successful.
Notwithstanding any other provisions of this Agreement, to the extent that Indemnitee is a party to
(or a participant in) and is successful, on the merits or otherwise, in any Proceeding or in
defense of any claim, issue or matter therein, in whole or in part, the Company shall indemnify
Indemnitee against all Expenses actually and reasonably incurred by him or her in connection
therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the
merits or otherwise, as to one or more but less than all claims, issues or matters in such
Proceeding, the Company shall indemnify Indemnitee against all
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Expenses actually and reasonably incurred by him or her or on his or her behalf in connection
with each successfully resolved claim, issue or matter. If Indemnitee is not wholly successful in
such Proceeding, the Company also shall indemnify Indemnitee against all Expenses reasonably
incurred in connection with a claim, issue or matter related to any claim, issue or matter on which
Indemnitee was successful. For purposes of this Section and without limitation, the termination of
any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be
deemed to be a successful result as to such claim, issue or matter.
6. Indemnification For Expenses of a Witness. Notwithstanding any other provision of this
Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a witness in any
Proceeding to which Indemnitee is not a party, he shall be indemnified against all Expenses
actually and reasonably incurred by him or her or on his or her behalf in connection therewith.
7. Additional Indemnification.
(a) Notwithstanding any limitation in Sections 3, 4 or 5, the Company shall indemnify
Indemnitee to the fullest extent permitted by law if Indemnitee is a party to or threatened to be
made a party to any Proceeding (including a Proceeding by or in the right of the Company to procure
a judgment in its favor) against all Expenses, judgments, fines, penalties and amounts paid in
settlement (including all interest, assessments and other charges paid or payable in connection
with or in respect of such Expenses, judgments, fines, penalties and amounts paid in settlement)
actually and reasonably incurred by Indemnitee in connection with the Proceeding. No indemnity
shall be made under this Section 7(a) on account of Indemnitees conduct which constitutes a breach
of Indemnitees duty of loyalty to the Company or its stockholders or is an act or omission not in
good faith or which involves intentional misconduct or a knowing violation of the law.
(b) For purposes of Section 7(a), the meaning of the phrase to the fullest extent
permitted by law shall include, but not be limited to:
(i) the fullest extent permitted by the provision of the DGCL that authorizes or
contemplates additional indemnification by agreement or the corresponding provision of any
amendment to or replacement of the DGCL; and
(ii) the fullest extent authorized or permitted by any amendments to or replacements of
the DGCL adopted after the date of this Agreement that increase the extent to which a
corporation may indemnify its officers and directors.
8. Exclusions. Notwithstanding any other provision in this Agreement, the Company shall not
be obligated under this Agreement to indemnify Indemnitee in connection with any claim made against
Indemnitee:
(a) for which payment has actually been received by or on behalf of Indemnitee under any
insurance policy or other indemnity provision, except with respect to any excess beyond the amount
actually received under any insurance policy or other indemnity provision;
(b) for an accounting of profits made from the purchase and sale (or sale and purchase) by
Indemnitee of securities of the Company within the meaning of Section 16(b) of the Exchange Act or
similar provisions of state statutory law or common law; or
(c) except as otherwise provided in Sections 13(d)-(f) hereof, prior to a Change in Control,
in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee,
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including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the
Company or its directors, officers, employees or other indemnitees, unless (i) the Board of
Directors of the Company authorized the Proceeding (or any part of any Proceeding) prior to its
initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to
the powers vested in the Company under applicable law.
9. Advances of Expenses; Defense of Claim.
(a) Notwithstanding any provision of this Agreement to the contrary, the Company shall advance
the Expenses incurred by Indemnitee in connection with any Proceeding within ten (10) days after
the receipt by the Company of a statement or statements requesting such advances from time to time,
whether prior to or after final disposition of any Proceeding. Advances shall be unsecured and
interest free. Advances shall be made without regard to Indemnitees ability to repay the expenses
and without regard to Indemnitees ultimate entitlement to indemnification under the other
provisions of this Agreement. Advances shall include any and all reasonable Expenses incurred
pursuing an action to enforce this right of advancement, including Expenses incurred preparing and
forwarding statements to the Company to support the advances claimed. Indemnitee shall qualify for
advances solely upon the execution and delivery to the Company of an undertaking providing that
Indemnitee undertakes to repay the advance to the extent that it is ultimately determined that
Indemnitee is not entitled to be indemnified by the Company. This Section 9(a) shall not apply to
any claim made by Indemnitee for which indemnity is excluded pursuant to Section 8.
(b) The Company will be entitled to participate in the Proceeding at its own expense.
(c) The Company shall not settle any action, claim or Proceeding (in whole or in part) which
would impose any Expense, judgment, fine, penalty or limitation on Indemnitee without Indemnitees
prior written consent.
10. Procedure for Notification and Application for Indemnification.
(a) Within sixty (60) days after the actual receipt by Indemnitee of notice that he or she is
a party to or a participant (as a witness or otherwise) in any Proceeding, Indemnitee shall submit
to the Company a written notice identifying the Proceeding. The omission by Indemnitee to notify
the Company will not relieve the Company from any liability which it may have to Indemnitee (i)
otherwise than under this Agreement and (ii) under this Agreement unless and only to the extent
that the Company can establish that such omission to notify resulted in actual prejudice to the
Company.
(b) Indemnitee shall thereafter deliver to the Company a written application to indemnify
Indemnitee in accordance with this Agreement. Such application(s) may be delivered from time to
time and at such time(s) as Indemnitee deems appropriate in his or her sole discretion. Following
such a written application for indemnification by Indemnitee, Indemnitees entitlement to
indemnification shall be determined in accordance with Section 11(a) of this Agreement.
11. Procedure Upon Application for Indemnification.
(a) Upon written request by Indemnitee for indemnification pursuant to Section 10(b), a
determination, if required by applicable law, with respect to Indemnitees entitlement thereto
shall be made in the specific case: (i) by a majority vote of the Disinterested Directors, even if
constituting less than a quorum of the Board; or (ii) if so requested by Indemnitee, in his or her
sole discretion, by Independent Counsel in a written opinion to the Board, a copy of which shall be
delivered to Indemnitee. If it is so determined that Indemnitee is entitled to indemnification,
payment to Indemnitee
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shall be made within ten (10) days after such determination. Indemnitee shall reasonably
cooperate with the person, persons or entity making such determination with respect to Indemnitees
entitlement to indemnification, including providing to such person, persons or entity upon
reasonable advance request any documentation or information which is not privileged or otherwise
protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary
to such determination. Any costs or Expenses (including attorneys fees and disbursements)
incurred by Indemnitee in so cooperating with the person, persons or entity making such
determination shall be borne by the Company (irrespective of the determination as to Indemnitees
entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee
harmless therefrom.
(b) In the event the determination of entitlement to indemnification is to be made by
Independent Counsel pursuant to Section 11(a) hereof, the Independent Counsel shall be selected as
provided in this Section 11(b). If a Change in Control shall not have occurred, the Independent
Counsel shall be selected by the Board of Directors, and the Company shall give written notice to
Indemnitee advising him of the identity of the Independent Counsel so selected and the basis for
the Board determination that such counsel qualified as Independent Counsel. If a Change in Control
shall have occurred, the Independent Counsel shall be selected by Indemnitee (unless Indemnitee
shall request that such selection be made by the Board of Directors, in which event the preceding
sentence shall apply), and Indemnitee shall give written notice to the Company advising it of the
identity of the Independent Counsel so selected. In either event, Indemnitee or the Company, as
the case may be, may, within 10 days after such written notice of selection shall have been
received, deliver to the Company or to Indemnitee, as the case may be, a written objection to such
selection; provided, however, that such objection may be asserted only on the
ground that the Independent Counsel so selected does not meet the requirements of Independent
Counsel as defined in Section 2 of this Agreement, and the objection shall set forth with
particularity the factual basis of such assertion. Absent a proper and timely objection, the
person so selected shall act as Independent Counsel. If such written objection is so made and
substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and
until such objection is withdrawn or a court of competent jurisdiction has determined that such
objection is without merit. If, within 20 days after submission by Indemnitee of a written request
for indemnification pursuant to Section 10(b) hereof, no Independent Counsel shall have been
selected and not objected to, either the Company or Indemnitee may petition a court of competent
jurisdiction (the Court) for resolution of any objection which shall have been made by
the Company or Indemnitee to the others selection of Independent Counsel and/or for the
appointment as Independent Counsel of a person selected by the Court or by such other person as the
Court shall designate, and the person with respect to whom all objections are so resolved or the
person so appointed shall act as Independent Counsel under Section 11(a) hereof. Upon the due
commencement of any judicial proceeding or arbitration pursuant to Section 13(a) of this Agreement,
Independent Counsel shall be discharged and relieved of any further responsibility in such capacity
(subject to the applicable standards of professional conduct then prevailing).
(c) The Company agrees to pay the reasonable fees of Independent Counsel and to fully
indemnify such Independent Counsel against any and all Expenses, claims, liabilities and damages
arising out of or relating to this Agreement or its engagement pursuant hereto.
12. Presumptions and Effect of Certain Proceedings.
(a) In making a determination with respect to entitlement to indemnification hereunder, the
person or persons or entity making such determination shall presume that Indemnitee is entitled to
indemnification under this Agreement if Indemnitee has submitted a request for indemnification in
accordance with Section 10(b) of this Agreement, and the Company shall have the burden of proof to
overcome that presumption in connection with the making by any person, persons or
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entity of any determination contrary to that presumption. Neither the failure of the Company
(including by the Board or Independent Counsel) to have made a determination prior to the
commencement of any action pursuant to this Agreement that indemnification is proper in the
circumstances because Indemnitee has met the applicable standard of conduct, nor an actual
determination by the Company (including by the Board or Independent Counsel) that Indemnitee has
not met such applicable standard of conduct, shall be a defense to the action or create a
presumption that Indemnitee has not met the applicable standard of conduct.
(b) If the person, persons or entity empowered or selected under Section 11 of this Agreement
to determine whether Indemnitee is entitled to indemnification shall not have made a determination
within sixty (60) days after receipt by the Company of the request therefor, the requisite
determination of entitlement to indemnification shall be deemed to have been made and Indemnitee
shall be entitled to such indemnification, absent (i) a misstatement by Indemnitee of a material
fact, or an omission of a material fact necessary to make Indemnitees statement not materially
misleading, in connection with the request for indemnification or (ii) a prohibition of such
indemnification under applicable law; provided, however, that such 60-day period
shall be extended for a reasonable time, not to exceed an additional thirty (30) days, if the
person, persons or entity making the determination with respect to entitlement to indemnification
in good faith requires such additional time for the obtaining or evaluating of documentation and/or
information relating thereto.
(c) The termination of any Proceeding or of any claim, issue or matter therein, by judgment,
order, settlement or conviction, or upon a plea of nolo contendere or its
equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself
adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee
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 Company or, with respect to any criminal Proceeding, that
Indemnitee had reasonable cause to believe that his or her conduct was unlawful.
(d) For purposes of any determination of good faith, Indemnitee shall be deemed to have acted
in good faith if Indemnitees action is based on the records or books of account of the Enterprise,
including financial statements, or on information supplied to Indemnitee by the officers of the
Enterprise in the course of their duties, or on the advice of legal counsel for the Enterprise or
on information or records given or reports made to the Enterprise by an independent certified
public accountant or by an appraiser or other expert selected by the Enterprise. The provisions of
this Section 12(d) shall not be deemed to be exclusive or to limit in any way the other
circumstances in which Indemnitee may be deemed or found to have met the applicable standard of
conduct set forth in this Agreement.
(e) The knowledge and/or actions, or failure to act, of any other director, trustee, partner,
managing member, fiduciary, officer, agent, advisor or employee of the Enterprise shall not be
imputed to Indemnitee for purposes of determining the right to indemnification under this
Agreement.
13. Remedies of Indemnitee.
(a) In the event that (i) a determination is made pursuant to Section 11 of this Agreement
that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of
Expenses is not timely made pursuant to Section 9 of this Agreement, (iii) no determination of
entitlement to indemnification shall have been made pursuant to Section 11(a) of this Agreement
within the time period specified in Section 12(b) of this Agreement, (iv) payment of
indemnification is not made pursuant to Section 5, 6, 7 or the last sentence of Section 11(a) of
this Agreement within ten (10) days after receipt by the Company of a written request therefor or
(v) payment of indemnification pursuant to Section 3 or
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Section 4 of this Agreement is not made within ten (10) days after a determination has been
made that Indemnitee is entitled to indemnification, Indemnitee shall be entitled to an
adjudication by a court of his or her entitlement to such indemnification or advancement of
Expenses. Alternatively, Indemnitee, at his or her option, may seek an award in arbitration to be
conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American
Arbitration Association. The Company shall not oppose Indemnitees right to seek any such
adjudication or award in arbitration.
(b) In the event that a determination shall have been made pursuant to Section 11(a) of this
Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or
arbitration commenced pursuant to this Section 13 shall be conducted in all respects as a
de novo trial or arbitration on the merits, and Indemnitee shall not be prejudiced
by reason of that adverse determination. In any judicial proceeding or arbitration commenced
pursuant to this Section 13, the Company shall have the burden of proving Indemnitee is not
entitled to indemnification or advancement of Expenses, as the case may be, and the Company may not
refer to or introduce into evidence any determination pursuant to Section 11(a) of this Agreement
adverse to Indemnitee for any purpose. If Indemnitee commences a judicial proceeding or
arbitration pursuant to this Section 13, Indemnitee shall not be required to reimburse the Company
for any advances pursuant to Section 9 until a final determination is made with respect to
Indemnitees entitlement to indemnification (as to which all rights of appeal have been exhausted
or lapsed).
(c) If a determination shall have been made pursuant to Section 11(a) of this Agreement that
Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any
judicial proceeding or arbitration commenced pursuant to this Section 13, absent (i) a misstatement
by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitees
statement not materially misleading, in connection with the request for indemnification or (ii) a
prohibition of such indemnification under applicable law.
(d) In the event that Indemnitee, pursuant to this Section 13, seeks a judicial adjudication
of or an award in arbitration to enforce his or her rights under, or to recover damages for breach
of, this Agreement, Indemnitee shall be entitled to recover from the Company, and shall be
indemnified by the Company against, any and all Expenses actually and reasonably incurred by him or
her in such judicial adjudication or arbitration. If it shall be determined in said judicial
adjudication or arbitration that Indemnitee is entitled to receive part but not all of the
indemnification or advancement of Expenses sought, Indemnitee shall be entitled to recover from the
Company, and shall be indemnified by the Company against, any and all Expenses reasonably incurred
by Indemnitee in connection with such judicial adjudication or arbitration.
(e) The Company shall be precluded from asserting in any judicial proceeding or arbitration
commenced pursuant to this Section 13 that the procedures and presumptions of this Agreement are
not valid, binding and enforceable and shall stipulate in any such court or before any such
arbitrator that the Company is bound by all the provisions of this Agreement.
(f) The Company shall indemnify Indemnitee to the fullest extent permitted by law against all
Expenses and, if requested by Indemnitee, shall (within ten (10) days after the Companys receipt
of such written request) advance such Expenses to Indemnitee, which are incurred by Indemnitee in
connection with any judicial proceeding or arbitration brought by Indemnitee for (i)
indemnification or advances of Expenses by the Company under this Agreement or any other agreement
or provision of the Companys certificate of incorporation or bylaws now or hereafter in effect or
(ii) recovery or advances under any insurance policy maintained by any person for the benefit of
Indemnitee, regardless of whether Indemnitee ultimately is determined to be entitled to such
indemnification, advance or insurance recovery, as the case may be.
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14. Non-exclusivity; Survival of Rights; Insurance; Subrogation.
(a) The rights of indemnification and to receive advancement of Expenses as provided by this
Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be
entitled under applicable law, the Companys certificate of incorporation, the Companys bylaws,
any agreement, a vote of stockholders, a resolution of directors or otherwise. No amendment,
alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right
of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in
his Corporate Status prior to such amendment, alteration or repeal. The parties hereto intend
that, to the extent that a change in Delaware law, whether by statute or judicial decision, permits
greater indemnification or advancement of Expenses than would be afforded currently under the
Companys bylaws and this Agreement, the Indemnitee shall enjoy by this Agreement the greater
benefits so afforded by such change. No right or remedy herein conferred is intended to be
exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in
addition to every other right and remedy given hereunder or now or hereafter existing at law, in
equity or otherwise. The assertion or employment of any right or remedy hereunder or otherwise,
shall not prevent the concurrent assertion or employment of any other right or remedy.
(b) To the extent that the Company maintains an insurance policy or policies providing
liability insurance for directors, officers, trustees, partners, managing members, fiduciaries,
employees or agents of the Company or of any other Enterprise which such person serves at the
request of the Company, Indemnitee shall be covered by such policy or policies in accordance with
its or their terms to the maximum extent of the coverage available for any such director, trustee,
partner, managing member, fiduciary, officer, employee or agent under such policy or policies. If,
at the time the Company receives notice from any source of a Proceeding as to which Indemnitee is a
party or a participant (as a witness or otherwise), the Company has director and officer liability
insurance in effect, the Company shall give prompt notice of such Proceeding to the insurers in
accordance with the procedures set forth in the respective policies. The Company shall thereafter
take all necessary or desirable action to cause such insurers to pay, on behalf of Indemnitee, all
amounts payable as a result of such Proceeding in accordance with the terms of such policies.
(c) In the event of any payment under this Agreement, the Company shall be subrogated to the
extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers
required and take all action necessary to secure such rights, including execution of such documents
as are necessary to enable the Company to bring suit to enforce such rights.
(d) The Company shall not be liable under this Agreement to make any payment of amounts
otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the
extent that Indemnitee has otherwise actually received such payment under any insurance policy,
contract, agreement or otherwise.
(e) The Companys obligation to indemnify or advance Expenses hereunder to Indemnitee who is
or was serving at the request of the Company as a director, officer, trustee, partner, managing
member, fiduciary, employee or agent of any other Enterprise shall be reduced by any amount
Indemnitee has actually received as indemnification or advancement of expenses from such
Enterprise.
15. Duration of Agreement. This Agreement shall continue until and terminate upon the later
of: (a) ten (10) years after the date that Indemnitee shall have ceased to serve as a director or
officer of the Company or as a director, officer, trustee, partner, managing member, fiduciary,
employee or agent of any other corporation, partnership, joint venture, trust, employee benefit
plan or other enterprise which
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Indemnitee served at the request of the Company; or (b) one (1) year after the final
termination of any Proceeding (including any rights of appeal thereto) then pending in respect of
which Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of
any Proceeding commenced by Indemnitee pursuant to Section 13 of this Agreement relating thereto
(including any rights of appeal of any Section 13 Proceeding).
16. Severability. If any provision or provisions of this Agreement shall be held to be
invalid, illegal or unenforceable for any reason whatsoever: (a) the validity, legality and
enforceability of the remaining provisions of this Agreement (including, without limitation, each
portion of any Section of this Agreement containing any such provision held to be invalid, illegal
or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be
affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law;
(b) such provision or provisions shall be deemed reformed to the extent necessary to conform to
applicable law and to give the maximum effect to the intent of the parties hereto; and (c) to the
fullest extent possible, the provisions of this Agreement (including, without limitation, each
portion of any Section of this Agreement containing any such provision held to be invalid, illegal
or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to
give effect to the intent manifested thereby.
17. Enforcement and Binding Effect.
(a) The Company expressly confirms and agrees that it has entered into this Agreement and
assumed the obligations imposed on it hereby in order to induce Indemnitee to serve as a director
or officer of the Company, and the Company acknowledges that Indemnitee is relying upon this
Agreement in serving as a director or officer of the Company.
(b) This Agreement constitutes the entire agreement between the parties hereto with respect to
the subject matter hereof and supersedes all prior agreements and understandings, oral, written and
implied, between the parties hereto with respect to the subject matter hereof.
(c) The indemnification and advancement of expenses provided by or granted pursuant to this
Agreement shall apply to Indemnitees service as an officer, director or key employee of the
Company prior to the date of this Agreement.
(d) The indemnification and advancement of expenses provided by or granted pursuant to this
Agreement shall continue as to a person who has ceased to be a director, officer, employee or agent
and shall inure to the benefit of the heirs, executors and administrators of such a person.
18. Modification and Waiver. No supplement, modification or amendment of this Agreement shall
be binding unless executed in writing by the parties hereto. No waiver of any of the provisions of
this Agreement shall be deemed or shall constitute a waiver of any other provisions of this
Agreement nor shall any waiver constitute a continuing waiver.
19. Notice by Indemnitee. Indemnitee agrees promptly to notify the Company in writing upon
being served with any summons, citation, subpoena, complaint, indictment, information or other
document relating to any Proceeding or matter which may be subject to indemnification or
advancement of Expenses covered hereunder. The failure of Indemnitee to so notify the Company
shall not relieve the Company of any obligation which it may have to Indemnitee under this
Agreement or otherwise, except as provided in Section 10(a).
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20. Notices. All notices, requests, demands and other communications under this Agreement
shall be in writing and shall be deemed to have been duly given (a) if delivered by hand and if
receipt is acknowledged in writing by the party to whom said notice or other communication shall
have been directed or (b) if mailed by certified or registered mail with postage prepaid, on the
third business day after the date on which it is so mailed:
(a) If to Indemnitee, at the address indicated on the signature page of this Agreement, or
such other address as Indemnitee shall provide in writing to the Company.
(b) If to the Company to:
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, California 92130
Attn.: Secretary
or to any other address as may have been furnished to Indemnitee in writing by the Company.
21. Contribution. To the fullest extent permissible under applicable law, if the
indemnification provided for in this Agreement is unavailable to Indemnitee for any reason
whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount
incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to
be paid in settlement and/or for Expenses, in connection with any claim relating to an
indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in
light of all of the circumstances of such Proceeding in order to reflect: (i) the relative benefits
received by the Company and Indemnitee as a result of the event(s) and/or transaction(s) giving
rise to such Proceeding; and/or (ii) the relative fault of the Company (and its directors,
officers, employees and agents) and Indemnitee in connection with such event(s) and/or
transaction(s).
22. Applicable Law and Consent to Jurisdiction. This Agreement and the legal relations among
the parties shall be governed by, and construed and enforced in accordance with, the laws of the
State of Delaware, without regard to its conflict of laws rules. Except with respect to any
arbitration commenced by Indemnitee pursuant to Section 13(a) of this Agreement, the Company and
Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising
out of or in connection with this Agreement shall be brought only in the Chancery Court of the
State of Delaware (the Delaware Court) and not in any other state or federal court in the
United States of America or any court in any other country, (ii) consent to submit to the exclusive
jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in
connection with this Agreement, (iii) appoint, to the extent such party is not a resident of the
State of Delaware, irrevocably Corporation Service Company, 2711 Centerville Road, Suite 400, in
the City of Wilmington, County of New Castle, as its agent in the State of Delaware as such partys
agent for acceptance of legal process in connection with any such action or proceeding against such
party with the same legal force and validity as if served upon such party personally within the
State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding
in the Delaware Court and (v) waive and agree not to plead or to make any claim that any such
action or proceeding brought in the Delaware Court has been brought in an improper or inconvenient
forum.
23. Identical Counterparts. This Agreement may be executed in one or more counterparts, each
of which shall for all purposes be deemed to be an original but all of which together shall
constitute one and the same Agreement. Only one such counterpart signed by the party against whom
enforceability is sought needs to be produced to evidence the existence of this Agreement.
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24. Miscellaneous. Use of the masculine pronoun shall be deemed to include usage of the
feminine pronoun where appropriate. The headings of the sections and paragraphs of this Agreement
are inserted for convenience only and shall not be deemed to constitute part of this Agreement or
to affect the construction thereof.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be signed as of the day and year
first above written.
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CADENCE PHARMACEUTICALS, INC., |
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INDEMNITEE |
a Delaware corporation |
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Name:
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[NAME] |
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Title: |
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Address: |
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14
Exhibit 10.2
EXHIBIT 10.2
EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT (this Agreement) is entered into by and between Cadence
Pharmaceuticals, Inc., a Delaware corporation (the Company), and [NAME]
(Executive), and shall be effective as of July 7, 2006 (the Effective Date).
WHEREAS, the Company desires to employ Executive, and Executive desires to commence or
continue employment with the Company, on the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual promises herein contained, the parties agree as
follows:
1. Definitions. As used in this Agreement, the following terms shall have the
following meanings:
(a) Board. Board means the Board of Directors of the Company.
(b) Bonus. Bonus means an amount equal to the average of the bonuses
awarded to Executive for each of the three (3) fiscal years prior to the date of termination, or
such lesser number of years as may be applicable if Executive has not been employed for three (3)
full years on the date of termination. For purposes of determining Executives Bonus, to the
extent Executive received no bonus in a year due to a failure to meet the applicable performance
objectives, such year will still be taken into account (using zero (0) as the applicable bonus) in
determining Executives Bonus for purposes of Section 4. If any portion of the bonuses awarded
to Executive consisted of securities or other property, the fair market value thereof shall be
determined in good faith by the Board.
(c) Cause. Cause means any of the following:
(i) the commission of an act of fraud, embezzlement or dishonesty by Executive that has a
material adverse impact on the Company or any successor or affiliate thereof;
(ii) a conviction of, or plea of guilty or no contest to, a felony by Executive;
(iii) any unauthorized use or disclosure by Executive of confidential information or trade
secrets of the Company or any successor or affiliate thereof that has a material adverse impact on
any such entity;
(iv) Executives gross negligence, insubordination or material violation of any duty of
loyalty to the Company or any other material misconduct on the part of Executive;
(v) Executives ongoing and repeated failure or refusal to perform or neglect of Executives
duties as required by this Agreement, which failure, refusal or neglect
continues for fifteen (15) days following Executives receipt of written notice from the Board
[ALL OFFICERS EXCEPT CEO: or the Companys Chief Executive Officer (the CEO) or the
President] stating with specificity the nature of such failure, refusal or neglect; or
(vi) Executives breach of any material provision of this Agreement; provided,
however, that prior to the determination that Cause under this Section 1(c) has occurred,
the Company shall (w) provide to Executive in writing, in reasonable detail, the reasons for the
determination that such Cause exists, (x) other than with respect to clause (v) above which
specifies the applicable period of time for Executive to remedy his or her breach, afford Executive
a reasonable opportunity to remedy any such breach, (y) provide the Executive an opportunity to be
heard prior to the final decision to terminate the Executives employment hereunder for such
Cause and (z) make any decision that such Cause exists in good faith.
The foregoing definition shall not in any way preclude or restrict the right of the Company or
any successor or affiliate thereof to discharge or dismiss Executive for any other acts or
omissions, but such other acts or omissions shall not be deemed, for purposes of this Agreement, to
constitute grounds for termination for Cause.
(d) Change of Control. 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. Code means the Internal Revenue Code of 1986, as amended from
time to time, and the Treasury Regulations and other interpretive guidance issued thereunder.
(f) Good Reason. Good Reason means the occurrence of any of the following
events or conditions without Executives written consent and the failure of the Company or any
successor or affiliate to cure such event or condition within thirty (30) days after receipt of
written notice from Executive:
(i) a change in Executives position or responsibilities[ALL OFFICERS EXCEPT CEO: other than a
change in Executives reporting relationship,] that, in Executives reasonable judgment, represents
a substantial and material reduction in the position or responsibilities as in effect immediately
prior thereto; the assignment to Executive of any duties or responsibilities [ALL OFFICERS EXCEPT
CEO: other than a change in Executives
2
reporting relationship,] that, in Executives reasonable judgment, are materially inconsistent
with such position or responsibilities; or any removal of Executive from or failure to reappoint or
reelect Executive to any of such positions, except in connection with the termination of
Executives employment for Cause, as a result of his or her Permanent Disability or death, or by
Executive other than for Good Reason;
(ii) a material reduction in Executives annual base salary, except in connection with a
general reduction in the compensation of the Companys or any successors or affiliates personnel
with similar status and responsibilities;
(iii) the Companys or any successors or affiliates requiring Executive (without Executives
consent) to be based at any place outside a 50-mile radius of his or her place of employment as of
the Effective Date, except for reasonably required travel on the Companys or any successors or
affiliates business that is not materially greater than such travel requirements prior to the
Effective Date;
(iv) the Companys or any successors or affiliates failure to provide Executive with
compensation and benefits substantially equivalent (in terms of benefit levels and/or reward
opportunities) to those provided for under each material employee benefit plan, program and
practice as in effect immediately prior to the Effective Date; or
(v) any material breach by the Company or any successor or affiliate of its obligations to
Executive under this Agreement.
(g) Permanent Disability. Executives Permanent Disability shall be deemed
to have occurred if Executive shall become physically or mentally incapacitated or disabled or
otherwise unable fully to discharge his or her duties hereunder for a period of ninety (90)
consecutive calendar days or for one hundred twenty (120) calendar days in any one hundred eighty
(180) calendar-day period. The existence of Executives Permanent Disability shall be determined
by the Company on the advice of a physician chosen by the Company and the Company reserves the
right to have the Executive examined by a physician chosen by the Company at the Companys expense.
(h) Stock Awards. Stock Awards means all stock options, restricted stock
and such other awards granted pursuant to the Companys stock option and equity incentive award
plans or agreements and any shares of stock issued upon exercise thereof.
2. Services to Be Rendered.
(a) Duties and Responsibilities. Executive shall serve as [TITLE] of the Company. In
the performance of such duties, Executive shall report directly to the [ ALL OFFICERS EXCEPT
CEO : CEO or President] [CEO ONLY: Board] and shall be subject to the direction of the
[ALL OFFICERS EXCEPT CEO : CEO or President] [CEO ONLY: Board] and to such limits upon
Executives authority as the Board or the CEO or President may from time to time impose. [ ALL
OFFICERS EXCEPT CEO : In the event of the CEOs or Presidents incapacity or unavailability,
Executive shall report directly to the CEO or be subject
3
to the direction of the Board or its designee.] Executive hereby consents to serve as an
officer and/or director of the Company or any subsidiary or affiliate thereof without any
additional salary or compensation, if so requested by the [ ALL OFFICERS EXCEPT CEO : CEO
or President] [CEO ONLY: Board]. Executive shall be employed by the Company on a full time basis.
Executives primary place of work shall be the Companys facility in San Diego, California, or such
other location within San Diego County as may be designated by the [ALL OFFICERS EXCEPT CEO: CEO or
President] [CEO ONLY: Board] from time to time. Executive shall also render services at such
other places within or outside the United States as the [ALL OFFICERS EXCEPT CEO: CEO or President]
[CEO ONLY: Board] may direct from time to time. Executive shall be subject to and comply with the
policies and procedures generally applicable to senior executives of the Company to the extent the
same are not inconsistent with any term of this Agreement.
(b) Exclusive Services. Executive shall at all times faithfully, industriously and to
the best of his or her ability, experience and talent perform to the satisfaction of the Board,
[ALL OFFICERS EXCEPT CEO: the CEO and the President] all of the duties that may be assigned to
Executive hereunder and shall devote substantially all of his or her productive time and efforts to
the performance of such duties. Subject to the terms of the Employee Proprietary Information and
Inventions Agreement referred to in Section 5(b), this shall not preclude Executive from devoting
time to personal and family investments or serving on community and civic boards, or participating
in industry associations, provided such activities do not interfere with his or her duties to the
Company, as determined in good faith by the [ALL OFFICERS EXCEPT CEO: CEO or President] [CEO ONLY:
Board] . Executive agrees that he or she will not join any boards, other than community and civic
boards (which do not interfere with his or her duties to the Company), without the prior approval
of the [ALL OFFICERS EXCEPT CEO: CEO or President] [CEO ONLY: Board].
3. Compensation and Benefits. The Company shall pay or provide, as the case may be,
to Executive the compensation and other benefits and rights set forth in this Section 3.
(a) Base Salary. The Company shall pay to Executive a base salary of $[SALARY] per
year, payable in accordance with the Companys usual pay practices (and in any event no less
frequently than monthly). Executives base salary shall be subject to review annually by and at
the sole discretion of the Compensation Committee of the Board or its designee.
(b) Bonus. Executive shall participate in any bonus plan that the Board or its
designee may approve for the senior executives of the Company.
(c) Benefits. Executive shall be entitled to participate in benefits under the
Companys benefit plans and arrangements, including, without limitation, any employee benefit plan
or arrangement made available in the future by the Company to its senior executives, subject to and
on a basis consistent with the terms, conditions and overall administration of such plans and
arrangements. The Company shall have the right to amend or delete any such benefit plan or
arrangement made available by the Company to its senior executives and not otherwise specifically
provided for herein.
4
(d) Expenses. The Company shall reimburse Executive for reasonable out-of-pocket
business expenses incurred in connection with the performance of his or her duties hereunder,
subject to (i) such policies as the Company may from time to time establish, (ii) Executive
furnishing the Company with evidence in the form of receipts satisfactory to the Company
substantiating the claimed expenditures, [ALL OFFICERS EXCEPT CEO: (iii) Executive receiving
advance approval from the CEO or the President in the case of expenses for travel outside of North
America, and (iv) Executive receiving advance approval from the CEO or the President in the case of
expenses (or a series of related expenses) in excess of $10,000.]
(e) Paid Time Off. Executive shall be entitled to such periods of paid time off
(PTO) each year as provided from time to time under the Companys PTO guidelines;
provided that Executive shall be entitled to at least four (4) weeks of PTO per year.
(f) Equity Plans. Executive shall be entitled to participate in any equity or other
employee benefit plan that is generally available to senior executive officers, as distinguished
from general management, of the Company. Except as otherwise provided in this Agreement,
Executives participation in and benefits under any such plan shall be on the terms and subject to
the conditions specified in the governing document of the particular plan.
(g) Stock Award Acceleration.
(i) If Executives employment is terminated by the Company without Cause, by Executive for
Good Reason, or as a result of Executives death or Permanent Disability, the vesting and/or
exercisability of each of Executives outstanding Stock Awards shall be automatically accelerated
on the date of termination as to the number of Stock Awards that would vest over the twelve (12)
month period following the date of termination had Executive remained continuously employed by the
Company during such period.
(ii) The vesting and exercisability of fifty percent (50%) of Executives outstanding Stock
Awards shall be automatically accelerated on the date of a Change of Control.
(iii) With respect to Stock Awards granted prior to the Effective Date, if Executives
employment is terminated by the Company without Cause or by Executive for Good Reason within three
(3) months prior to or twelve (12) months following a Change of Control, the vesting and/or
exercisability of any outstanding unvested portions of such Stock Awards shall be automatically
accelerated on the later of (A) the date of termination or (B) the date of the Change of Control.
(iv) With respect to Stock Awards granted on or after the Effective Date, if Executives
employment is terminated by the Company without Cause or by Executive for Good Reason within three
(3) months prior to or twelve (12) months following a Change of Control, the vesting and/or
exercisability of any outstanding unvested portions of such Stock Awards shall be automatically
accelerated on the later of (A) the date of termination or (B) the date of the Change of Control.
In addition, Executives Stock Awards may be exercised by Executive (or Executives guardian or
legal representative) until the latest of (A) three (3)
5
months after the date of termination, (B) with respect to any portion of the Stock Awards that
become exercisable on the date of a Change of Control pursuant to this Section 3(g)(iv), three (3)
months after the date of the Change of Control, or (C) such longer period as may be specified in
the applicable Stock Award agreement; provided, however, that in no event shall any
Stock Award remain exercisable beyond the original outside expiration date of such Stock Award.
(v) The vesting pursuant to clauses (i), (ii), (iii) and (iv) of this Section 3(g) shall be
cumulative. The foregoing provisions are hereby deemed to be a part of each Stock Award and to
supersede any less favorable provision in any agreement or plan regarding such Stock Award.
4. Termination and Severance. Executive shall be entitled to receive benefits upon
termination of employment only as set forth in this Section 4:
(a) At-Will Employment; Termination. The Company and Executive acknowledge that
Executives employment is and shall continue to be at-will, as defined under applicable law, and
that Executives employment with the Company may be terminated by either party at any time for any
or no reason, with or without notice. If Executives employment terminates for any reason,
Executive shall not be entitled to any payments, benefits, damages, awards or compensation other
than as provided in this Agreement. Executives employment under this Agreement shall be
terminated immediately on the death of Executive.
(b) Termination by Death. If Executives employment is terminated by death,
Executives estate shall be entitled to receive (i) Executives fully earned but unpaid base
salary, through the date of death at the rate then in effect, plus all other amounts to which
Executive is entitled under any compensation plan or practice of the Company at the time of
Executives death, (ii) a lump sum cash payment equal to Executives annual base salary as in
effect immediately prior to the date of death, payable within sixty (60) days following the date of
Executives death, (iii) a lump sum cash payment equal to Executives Bonus for the year in which
Executives death occurs prorated for the period during such year Executive was employed prior to
his or her death, payable within sixty (60) days following the date of Executives death, and (iv)
for the period beginning on the date of death and ending on the date which is twelve (12) full
months following the date of death (or, if earlier, the date on which the applicable continuation
period under COBRA expires), the Company shall reimburse Executives eligible dependents for the
costs associated with continuation coverage for such eligible dependents pursuant to the
Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (COBRA)
(provided that Executives dependents shall be solely responsible for all matters relating
to such continuation of coverage pursuant to COBRA, including, without limitation, election of such
coverage and his or her timely payment of premiums).
(c) Termination for Permanent Disability. If Executives employment is terminated by
the Company as a result of Executives Permanent Disability, Executive shall be entitled to receive
(i) Executives fully earned but unpaid base salary, through the date of termination at the rate
then in effect, plus all other amounts to which Executive is entitled under any compensation plan
or practice of the Company at the time such payments are due, (ii) subject
6
to Executives continued compliance with Section 5, a lump sum cash payment equal to
Executives annual base salary as in effect immediately prior to the date of termination, payable
within sixty (60) days following the effective date of Executives Permanent Disability, (iii)
subject to Executives continued compliance with Section 5, a lump sum cash payment equal to
Executives Bonus for the year in which the date of termination occurs prorated for the period
during such year Executive was employed prior to the date of termination, payable within sixty (60)
days following the effective date of Executives Permanent Disability, (iv) subject to Executives
continued compliance with Section 5, for the period beginning on the date of termination and ending
on the date which is twelve (12) full months following the date of termination (or, if earlier, the
date on which the applicable continuation period under COBRA expires), the Company shall (A)
reimburse Executive for the costs associated with continuation coverage pursuant to COBRA for
Executive and his or her eligible dependents who were covered under the Companys health plans as
of the date of Executives termination (provided that Executive shall be solely responsible
for all matters relating to his or her continuation of coverage pursuant to COBRA, including,
without limitation, his or her election of such coverage and his or her timely payment of
premiums), and (v) the Company shall pay for and provide Executive and such eligible dependents
with a lump sum payment sufficient to pay the premiums for life insurance benefits coverage for the
twelve (12) month period commencing on the date of termination to the extent such Executive and/or
such dependents were receiving such benefits prior to the date of Executives termination, which
payment shall be paid within thirty (30) days of the date of termination.
(d) Termination Without Cause or For Good Reason.
(i) Termination Without Cause or For Good Reason. If Executives employment is
terminated by the Company without Cause or by Executive for Good Reason more than three (3) months
prior to a Change of Control or more than twelve (12) months following a Change of Control,
Executive shall be entitled to receive, in lieu of any severance benefits to which Executive may
otherwise be entitled under any severance plan or program of the Company (other than as provided in
Section 3(g) of this Agreement), the benefits provided below:
(A) the Company shall pay to Executive his or her fully earned but unpaid base salary,
when due, through the date of termination at the rate then in effect, plus all other amounts
to which Executive is entitled under any compensation plan or practice of the Company at the
time of termination;
(B) subject to Executives continued compliance with Section 5, Executive shall be
entitled to receive a lump sum cash payment equal to Executives annual base salary as in
effect immediately prior to the date of termination, payable within thirty (30) days
following the effective date of the Release (as defined below); plus
(C) subject to Executives continued compliance with Section 5, (1) for the period
beginning on the date of termination and ending on the date which is twelve (12) full months
following the date of termination (or, if earlier, the date on which the applicable
continuation period under COBRA expires), the Company shall reimburse Executive for the
costs associated with continuation coverage pursuant to COBRA for
7
Executive and his or her eligible dependents who were covered under the Companys
health plans as of the date of Executives termination (provided that Executive
shall be solely responsible for all matters relating to his or her continuation of coverage
pursuant to COBRA, including, without limitation, his or her election of such coverage and
his or her timely payment of premiums), and (2) the Company shall pay for and provide
Executive and such eligible dependents with a lump sum payment sufficient to pay the
premiums for life insurance benefits coverage for the twelve (12) month period commencing on
the date of termination to the extent such Executive and/or such dependents were receiving
such benefits prior to the date of Executives termination, which payment shall be paid
within thirty (30) days of the date of termination; and
(D) subject to Executives continued compliance with Section 5, Executive shall be
entitled to executive-level outplacement services at the Companys expense, not to exceed
$15,000. Such services shall be provided by a firm selected by the Company.
(E) The payments and benefits provided for in this Section 4(d)(i) shall only be
payable in the event Executives employment is terminated by the Company without Cause or by
Executive for Good Reason more than three (3) months prior to a Change of Control or more
than twelve (12) months following a Change of Control. If Executives employment is
terminated by the Company without Cause or by Executive for Good Reason within three (3)
months prior to or twelve (12) months following a Change of Control, then Executive shall
receive the payments and benefits described in Section 4(d)(ii) in lieu of the payments and
benefits described in this Section 4(d)(i).
(ii) Termination Without Cause or By Executive For Good Reason In Connection With a Change
of Control. If Executives employment is terminated by the Company without Cause or by
Executive for Good Reason within three (3) months prior to or twelve (12) months following a Change
of Control, Executive shall be entitled to receive, in lieu of any severance benefits to which
Executive may otherwise be entitled under any severance plan or program of the Company (other than
as provided in Section 3(g) of this Agreement), the benefits provided below:
(A) the Company shall pay to Executive his or her fully earned but unpaid base salary,
when due, through the date of termination at the rate then in effect, plus all other amounts
to which Executive is entitled under any compensation plan or practice of the Company at the
time of termination;
(B) subject to Executives continued compliance with Section 5, Executive shall be
entitled to receive a lump sum cash payment, payable within thirty (30) days following the
effective date of the Release, equal to the sum of:
(1) Executives annual base salary as in effect immediately prior to
the date of termination, plus
(2) an amount equal to Executives Bonus for
8
the year in which the date of termination occurs prorated for the
period during such year Executive was employed prior to the date of
termination;
(C) subject to Executives continued compliance with Section 5, (1) for the period
beginning on the date of termination and ending on the date which is twelve (12) full months
following the date of termination (or, if earlier, the date on which the applicable
continuation period under COBRA expires), the Company shall reimburse Executive for the
costs associated with continuation coverage pursuant to COBRA for Executive and his or her
eligible dependents who were covered under the Companys health plans as of the date of
Executives termination (provided that Executive shall be solely responsible for all
matters relating to his or her continuation of coverage pursuant to COBRA, including,
without limitation, his or her election of such coverage and his or her timely payment of
premiums), and (2) the Company shall pay for and provide Executive and such eligible
dependents with a lump sum payment sufficient to pay the premiums for life insurance
benefits coverage for the twelve (12) month period commencing on the date of termination to
the extent such Executive and/or such dependents were receiving such benefits prior to the
date of Executives termination, which payment shall be paid within thirty (30) days of the
date of termination; and
(D) subject to Executives continued compliance with Section 5, Executive shall be
entitled to executive-level outplacement services at the Companys expense, not to exceed
$15,000. Such services shall be provided by a firm selected by Executive from a list
compiled by the Company.
(E) The payments and benefits provided for in this Section 4(d)(ii) shall only be
payable in the event Executives employment is terminated by the Company without Cause or by
Executive for Good Reason within three (3) months prior to or twelve (12) months following a
Change of Control. If Executives employment is terminated by the Company without Cause or
by Executive for Good Reason more than twelve (12) months following a Change of Control or
prior to a Change of Control and such Change of Control is not consummated within three (3)
months following such termination, then Executive shall receive the payments and benefits
described in Section 4(d)(i) and shall not be eligible to receive any of the payments and
benefits described in this Section 4(d)(ii).
(e) Termination for Cause, Voluntary Resignation Without Good Reason or Expiration of
Employment Period. If Executives employment is terminated by the Company for Cause or by
Executive without Good Reason (other than as a result of Executives death or Permanent
Disability), the Company shall not have any other or further obligations to Executive under this
Agreement (including any financial obligations) except that Executive shall be entitled to receive
(i) Executives fully earned but unpaid base salary, through the date of termination at the rate
then in effect, and (ii) all other amounts or benefits to which Executive is entitled under any
compensation, retirement or benefit plan or practice of the Company at the time of termination in
accordance with the terms of such plans or practices, including, without limitation, any
continuation of benefits required by COBRA or applicable law. In addition, if Executives
employment is terminated by the Company for Cause or by Executive without Good Reason
9
(other than as a result of Executives death or Permanent Disability), or if the Employment
Period expires, all vesting of Executives unvested Stock Awards previously granted to him or her
by the Company shall cease and none of such unvested Stock Awards shall be exercisable following
the date of such termination. The foregoing shall be in addition to, and not in lieu of, any and
all other rights and remedies which may be available to the Company under the circumstances,
whether at law or in equity.
(f) Delay of Payments. Notwithstanding anything to the contrary in this Section 4,
the parties acknowledge and agree that any payment to be made, or benefit provided, to Executive
pursuant to this Section 4 shall be delayed to the extent necessary for this Agreement and such
payment or benefit to comply with Section 409A of the Code.
(g) Release. As a condition to Executives receipt of any post-termination benefits
described in this Agreement, Executive shall execute and not revoke a general release of
all claims in favor of the Company (the Release) substantially in the form attached
hereto.
(h) Exclusive Remedy. Except as otherwise expressly required by law (e.g., COBRA) or
as specifically provided herein, all of Executives rights to salary, severance, benefits, bonuses
and other amounts hereunder (if any) accruing after the termination of Executives employment shall
cease upon such termination. In the event of a termination of Executives employment with the
Company, Executives sole remedy shall be to receive the payments and benefits described in this
Section 4. In addition, Executive acknowledges and agrees that he or she is not entitled to any
reimbursement by the Company for any taxes payable by Executive as a result of the payments and
benefits received by Executive pursuant to this Section 4, including, without limitation, any
excise tax imposed by Section 4999 of the Code.
(i) No Mitigation. The amount of any payment or benefit provided for in this Section
4 shall not be reduced by any compensation earned by Executive as the result of employment by
another employer or self-employment or by retirement benefits and, as provided in Sections 4(b),
(c) or (d), Executives (or his or her dependents) right to continued healthcare and life
insurance benefits following his or her termination of employment will terminate on the date on
which the applicable continuation period under COBRA expires. In addition, loans, advances or
other amounts owed by Executive to the Company may be offset by the Company against amounts payable
to Executive under this Section 4.
(j) Return of the Companys Property. If Executives employment is terminated for any
reason, or if the Employment Period expires, the Company shall have the right, at its option, to
require Executive to vacate his or her offices prior to or on the effective date of termination and
to cease all activities on the Companys behalf. Upon the termination of his or her employment in
any manner, as a condition to the Executives receipt of any post-termination benefits described in
this Agreement, Executive shall immediately surrender to the Company all lists, books and records
of, or in connection with, the Companys business, and all other property belonging to the Company,
it being distinctly understood that all such lists, books and records, and other documents, are the
property of the Company. Executive shall deliver to the Company a signed statement certifying
compliance with this Section 4(j) prior to the receipt of any post-termination benefits described
in this Agreement.
10
(k) Waiver of the Companys Liability. Executive recognizes that his or her
employment is subject to termination with or without Cause for any reason and therefore Executive
agrees that Executive shall hold the Company harmless from and against any and all liabilities,
losses, damages, costs and expenses, including but not limited to, court costs and reasonable
attorneys fees, which Executive may incur as a result of the termination of Executives
employment. Executive further agrees that Executive shall bring no claim or cause of action
against the Company for damages or injunctive relief based on a wrongful termination of employment.
Executive agrees that the sole liability of the Company to Executive upon termination of this
Agreement shall be that determined by this Section 4. In the event this covenant is more
restrictive than permitted by laws of the jurisdiction in which the Company seeks enforcement
thereof, this covenant shall be limited to the extent permitted by law.
5. Certain Covenants.
(a) Noncompetition. Except as may otherwise be approved by the Board, during the term
of Executives employment, Executive shall not have any ownership interest (of record or
beneficial) in, or have any interest as an employee, salesman, consultant, officer or director in,
or otherwise aid or assist in any manner, any firm, corporation, partnership, proprietorship or
other business that engages in any county, city or part thereof in the United States and/or any
foreign country in a business which competes directly or indirectly (as determined by the Board)
with the Companys business in such county, city or part thereof, so long as the Company, or any
successor in interest of the Company to the business and goodwill of the Company, remains engaged
in such business in such county, city or part thereof or continues to solicit customers or
potential customers therein; provided, however, that Executive may own, directly or
indirectly, solely as an investment, securities of any entity which are traded on any national
securities exchange if Executive (x) is not a controlling person of, or a member of a group which
controls, such entity; or (y) does not, directly or indirectly, own one percent (1%) or more of any
class of securities of any such entity.
(b) Confidential Information. Executive and the Company have entered into the
Companys standard employee proprietary information and inventions agreement (the Employee
Proprietary Information and Inventions Agreement). Executive agrees to perform each and every
obligation of Executive therein contained.
(c) Solicitation of Employees. Executive shall not during the term of Executives
employment and for the applicable severance period for which Executive receives severance benefits
following any termination hereof pursuant to Section 4(c) or (d) above (regardless of whether
Executive receives such severance benefits in a lump sum payment or over the length of the
severance period) (the Restricted Period), directly or indirectly, solicit or encourage
to leave the employment of the Company or any of its affiliates, any employee of the Company or any
of its affiliates.
(d) Solicitation of Consultants. Executive shall not during the term of Executives
employment and for the Restricted Period, directly or indirectly, hire, solicit or encourage to
cease work with the Company or any of its affiliates any consultant then under contract with the
Company or any of its affiliates within one year of the termination of such consultants engagement
by the Company or any of its affiliates.
11
(e) Rights and Remedies Upon Breach. If Executive breaches or threatens to commit a
breach of any of the provisions of this Section 5 (the Restrictive Covenants), the
Company shall have the following rights and remedies, each of which rights and remedies shall be
independent of the other and severally enforceable, and all of which rights and remedies shall be
in addition to, and not in lieu of, any other rights and remedies available to the Company under
law or in equity:
(i) Specific Performance. The right and remedy to have the Restrictive Covenants
specifically enforced by any court having equity jurisdiction, all without the need to post a bond
or any other security or to prove any amount of actual damage or that money damages would not
provide an adequate remedy, it being acknowledged and agreed that any such breach or threatened
breach will cause irreparable injury to the Company and that money damages will not provide
adequate remedy to the Company; and
(ii) Accounting and Indemnification. The right and remedy to require Executive (i) to
account for and pay over to the Company all compensation, profits, monies, accruals, increments or
other benefits derived or received by Executive or any associated party deriving such benefits as a
result of any such breach of the Restrictive Covenants; and (ii) to indemnify the Company against
any other losses, damages (including special and consequential damages), costs and expenses,
including actual attorneys fees and court costs, which may be incurred by them and which result
from or arise out of any such breach or threatened breach of the Restrictive Covenants.
(f) Severability of Covenants/Blue Pencilling. If any court determines that any of
the Restrictive Covenants, or any part thereof, is invalid or unenforceable, the remainder of the
Restrictive Covenants shall not thereby be affected and shall be given full effect, without regard
to the invalid portions. If any court determines that any of the Restrictive Covenants, or any
part thereof, are unenforceable because of the duration of such provision or the area covered
thereby, such court shall have the power to reduce the duration or area of such provision and, in
its reduced form, such provision shall then be enforceable and shall be enforced. Executive hereby
waives any and all right to attack the validity of the Restrictive Covenants on the grounds of the
breadth of their geographic scope or the length of their term.
(g) Enforceability in Jurisdictions. The Company and Executive intend to and do
hereby confer jurisdiction to enforce the Restrictive Covenants upon the courts of any jurisdiction
within the geographical scope of such covenants. If the courts of any one or more of such
jurisdictions hold the Restrictive Covenants wholly unenforceable by reason of the breadth of such
scope or otherwise, it is the intention of the Company and Executive that such determination not
bar or in any way affect the right of the Company to the relief provided above in the courts of any
other jurisdiction within the geographical scope of such covenants, as to breaches of such
covenants in such other respective jurisdictions, such covenants as they relate to each
jurisdiction being, for this purpose, severable into diverse and independent covenants.
(h)
Definitions. For purposes of this Section 5, the term
Company means not
only Cadence Pharmaceuticals, Inc., but also any company, partnership or entity which,
12
directly or indirectly, controls, is controlled by or is under common control with Cadence
Pharmaceuticals, Inc.
6. Insurance. The Company shall have the right to take out life, health, accident,
key-man or other insurance covering Executive, in the name of the Company and at the Companys
expense in any amount deemed appropriate by the Company. Executive shall assist the Company in
obtaining such insurance, including, without limitation, submitting to any required examinations
and providing information and data required by insurance companies.
7. Arbitration. Any dispute, claim or controversy based on, arising out of or
relating to Executives employment or this Agreement shall be settled by final and binding
arbitration in San Diego, California, before a single neutral arbitrator in accordance with the
National Rules for the Resolution of Employment Disputes (the Rules) of the American
Arbitration Association, and judgment on the award rendered by the arbitrator may be entered in any
court having jurisdiction. Arbitration may be compelled pursuant to the California Arbitration Act
(Code of Civil Procedure §§ 1280 et seq.). If the parties are unable to agree upon
an arbitrator, one shall be appointed by the AAA in accordance with its Rules. Each party shall
pay the fees of its own attorneys, the expenses of its witnesses and all other expenses connected
with presenting its case; however, Executive and the Company agree that, to the extent
permitted by law, the arbitrator may, in his or her discretion, award reasonable attorneys fees to
the prevailing party. Other costs of the arbitration, including the cost of any record or
transcripts of the arbitration, AAAs administrative fees, the fee of the arbitrator, and all other
fees and costs, shall be borne by the Company. This Section 7 is intended to be the exclusive
method for resolving any and all claims by the parties against each other for payment of damages
under this Agreement or relating to Executives employment; provided, however, that neither this
Agreement nor the submission to arbitration shall limit the parties right to seek provisional
relief, including without limitation injunctive relief, in any court of competent jurisdiction
pursuant to California Code of Civil Procedure § 1281.8 or any similar statute of an applicable
jurisdiction. Seeking any such relief shall not be deemed to be a waiver of such partys right to
compel arbitration. Both Executive and the Company expressly waive their right to a jury trial.
8. General Relationship. Executive shall be considered an employee of the Company
within the meaning of all federal, state and local laws and regulations including, but not limited
to, laws and regulations governing unemployment insurance, workers compensation, industrial
accident, labor and taxes.
9. Miscellaneous.
(a) Modification; Prior Claims. This Agreement and the Employee Proprietary
Information and Inventions Agreement set forth the entire understanding of the parties with respect
to the subject matter hereof, supersede all existing agreements between them concerning such
subject matter [ALL OFFICERS EXCEPT CEO AND VICE PRESIDENT, BUSINESS DEVELOPMENT: including that
certain offer letter dated [OFFER LETTER DATE] between the Company and Executive], and may be
modified only by a written instrument duly executed by each party. [VICE PRESIDENT, CLINICAL
DEVELOPMENT ONLY: Notwithstanding the foregoing, this Agreement does not supersede
13
the third paragraph of the Offer Letter that relates to Executives relocation benefits, which
paragraph shall remain in effect during Executives employment with the Company.]
(b) Assignment; Assumption by Successor. The rights of the Company under this
Agreement may, without the consent of Executive, be assigned by the Company, in its sole and
unfettered discretion, to any person, firm, corporation or other business entity which at any time,
whether by purchase, merger or otherwise, directly or indirectly, acquires all or substantially all
of the assets or business of the Company. The Company will require any successor (whether direct
or indirect, by purchase, merger or otherwise) to all or substantially all of the business or
assets of the Company expressly to assume and to agree to perform this Agreement in the same manner
and to the same extent that the Company would be required to perform it if no such succession had
taken place; provided, however, that no such assumption shall relieve the Company
of its obligations hereunder. As used in this Agreement, the Company shall mean the
Company as hereinbefore defined and any successor to its business and/or assets as aforesaid which
assumes and agrees to perform this Agreement by operation of law or otherwise.
(c) Survival. The covenants, agreements, representations and warranties contained in
or made in Sections 4, 5, 7 and 9 of this Agreement shall survive any termination of Executives
employment.
(d) Third-Party Beneficiaries. This Agreement does not create, and shall not be
construed as creating, any rights enforceable by any person not a party to this Agreement.
(e) Waiver. The failure of either party hereto at any time to enforce performance by
the other party of any provision of this Agreement shall in no way affect such partys rights
thereafter to enforce the same, nor shall the waiver by either party of any breach of any provision
hereof be deemed to be a waiver by such party of any other breach of the same or any other
provision hereof.
(f) Section Headings. The headings of the several sections in this Agreement are
inserted solely for the convenience of the parties and are not a part of and are not intended to
govern, limit or aid in the construction of any term or provision hereof.
(g) Notices. All notices, requests and other communications hereunder shall be in
writing and shall be delivered by courier or other means of personal service (including by means of
a nationally recognized courier service or professional messenger service), or sent by telex or
telecopy or mailed first class, postage prepaid, by certified mail, return receipt requested, in
all cases, addressed to:
If to the Company or the Board prior to September 15, 2006:
Cadence Pharmaceuticals, Inc.
12730 High Bluff Drive, Suite 410
San Diego, CA 92130
Attention: Secretary
If to the Company or the Board on or after September 15, 2006:
14
Cadence Pharmaceuticals, Inc.
12481 High Bluff Drive, Suite 200
San Diego, CA 92130
Attention: Secretary
If to Executive:
All notices, requests and other communications shall be deemed given on the date of actual receipt
or delivery as evidenced by written receipt, acknowledgement or other evidence of actual receipt or
delivery to the address. In case of service by telecopy, a copy of such notice shall be personally
delivered or sent by registered or certified mail, in the manner set forth above, within three
business days thereafter. Any party hereto may from time to time by notice in writing served as
set forth above designate a different address or a different or additional person to which all such
notices or communications thereafter are to be given.
(h) Severability. All Sections, clauses and covenants contained in this Agreement are
severable, and in the event any of them shall be held to be invalid by any court, this Agreement
shall be interpreted as if such invalid Sections, clauses or covenants were not contained herein.
(i) Governing Law and Venue. This Agreement is to be governed by and construed in
accordance with the laws of the State of California applicable to contracts made and to be
performed wholly within such State, and without regard to the conflicts of laws principles thereof.
Except as provided in Sections 5 and 7, any suit brought hereon shall be brought in the state or
federal courts sitting in San Diego, California, the parties hereto hereby waiving any claim or
defense that such forum is not convenient or proper. Each party hereby agrees that any such court
shall have in personam jurisdiction over it and consents to service of process in any manner
authorized by California law.
(j) Non-transferability of Interest. None of the rights of Executive to receive any
form of compensation payable pursuant to this Agreement shall be assignable or transferable except
through a testamentary disposition or by the laws of descent and distribution upon the death of
Executive. Any attempted assignment, transfer, conveyance, or other disposition (other than as
aforesaid) of any interest in the rights of Executive to receive any form of compensation to be
made by the Company pursuant to this Agreement shall be void.
(k) Gender. Where the context so requires, the use of the masculine gender shall
include the feminine and/or neuter genders and the singular shall include the plural, and vice
versa, and the word person shall include any corporation, firm, partnership or other form of
association.
15
(l) Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
Agreement.
(m) Construction. The language in all parts of this Agreement shall in all cases be
construed simply, according to its fair meaning, and not strictly for or against any of the parties
hereto. Without limitation, there shall be no presumption against any party on the ground that
such party was responsible for drafting this Agreement or any part thereof.
(n) Withholding and other Deductions. All compensation payable to Executive hereunder
shall be subject to such deductions as the Company is from time to time required to make pursuant
to law, governmental regulation or order.
(o) Code Section 409A. This Agreement shall be interpreted, construed and
administered in a manner that satisfies the requirements of Sections 409A of the Code.
Notwithstanding any provision of this Agreement to the contrary, the Company may adopt such
amendments to this Agreement or adopt other policies and procedures (including amendments, policies
and procedures with retroactive effect), or take any other actions, that the Company determines are
necessary to comply with the requirements of Section 409A of the Code.
(Signature Page Follows)
16
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth
above.
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CADENCE PHARMACEUTICALS, INC. |
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Name:
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Title: |
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[Name of Executive] |
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SIGNATURE PAGE TO EMPLOYMENT AGREEMENT
Schedule to Exhibit 10.2: The Form of Employment Agreement was entered into with the following
executive officers with their respective titles, addresses, salaries and original offer letter
dates listed below:
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Name |
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Title |
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Salary |
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Offer Letter Date |
Theodore R. Schroeder |
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President and Chief Executive Officer |
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$ |
300,000 |
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None |
James B. Breitmeyer, M.D., Ph.D. |
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Executive Vice President, Development and Chief Medical Officer |
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$ |
330,000 |
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July 31, 2006 |
William S. Craig, Ph.D. |
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Senior Vice President, Pharmaceutical Development and Manufacturing |
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$ |
231,000 |
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October 7, 2004 |
Kenneth R. Heilbrunn, M.D. |
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Senior Vice President, Clinical Development |
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$ |
315,000 |
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March 17, 2005 |
William R. LaRue |
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Senior Vice President and Chief Financial Officer |
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$ |
265,000 |
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April 7, 2006 |
Richard E. Lowenthal |
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Vice President, Regulatory Affairs and Quality Assurance |
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$ |
231,000 |
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November 4, 2004 |
Mike A. Royal, M.D., J.D. |
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Vice President, Clinical Development |
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$ |
275,000 |
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April 17, 2006 |
David A. Socks |
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Vice President, Business Development |
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$ |
200,000 |
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None |
EXHIBIT 10.4
EXHIBIT
10.4
CADENCE PHARMACEUTICALS, INC.
DIRECTOR COMPENSATION POLICY
Non-employee members of the board of directors (the Board) of Cadence Pharmaceuticals, Inc.
(the Company) shall be eligible to receive cash and equity compensation commencing on the first
date upon which the Company is subject to the reporting requirements of Section 13 or 15(d)(2) of
the Exchange Act (the Public Trading Date) as set forth in this Director Compensation Policy.
The cash compensation and option grants described in this Director Compensation Policy shall be
paid or be made, as applicable, automatically and without further action of the Board, to each
member of the Board who is not an employee of the Company or any parent or subsidiary of the
Company (each, an Independent Director) who may be eligible to receive such cash compensation or
options, unless such Independent Director declines the receipt of such cash compensation or options
by written notice to the Company. This Director Compensation Policy shall remain in effect until
it is revised or rescinded by further action of the Board. All share numbers set forth in this
policy give effect to the reverse stock split to be implemented by the Company in connection with
its initial public offering.
1. Cash Compensation.
Each Independent Director shall be eligible to receive an annual retainer of $25,000 for
service on the Board. In addition, an Independent Director serving as:
(i) chairman of the Audit Committee shall be eligible to receive an additional annual retainer
of $10,000 for such service;
(ii) members (other than the chairman) of the Audit Committee shall be eligible to receive an
additional annual retainer of $5,000 for such service;
(iii) chairman of the Compensation Committee or the Nominating/Corporate Governance Committee
shall be eligible to receive an additional annual retainer of $4,000 for such service; and
(iv) members (other than the chairman) of the Compensation Committee or the
Nominating/Corporate Governance Committee shall be eligible to receive an additional annual
retainer of $2,000 for such service.
The annual retainers shall be paid by the Company in quarterly installments or more frequently
as deemed advisable by the officers of the Company for administrative or other reasons.
2. Equity Compensation. The options described below shall be granted under and shall
be subject to the terms and provisions of the Companys 2006 Equity Incentive Award Plan (the 2006
Plan) and shall be granted subject to the execution and delivery of option agreements, including
attached exhibits, in substantially the same forms previously approved by the Board, setting forth
the vesting schedule applicable to such options and such other terms as may be required by the 2006
Plan.
(a) Initial Options. A person who was initially elected or appointed to the Board
less than twelve (12) months prior to the Public Trading Date or who is initially elected or
appointed to the Board following the Public Trading Date, and who was or is an Independent Director
at the time of such initial election or appointment, shall be eligible to receive a non-qualified
stock option to purchase 25,000 shares of common stock (subject to adjustment as provided in the
2006 Plan) on the later of the Public Trading Date and the date of such initial election or
appointment (each, an Initial Option).
(b) Subsequent Options. A person who is an Independent Director automatically shall
be eligible to receive a non-qualified stock option to purchase 12,500 shares of common stock
(subject to adjustment as provided in the 2006 Plan) on the date of each annual meeting of the
Companys stockholders after the Public Trading Date. An Independent Director elected for the
first time to the Board at an annual meeting of stockholders shall only receive an Initial Option
in connection with such election, and shall not receive a Subsequent Option on the date of such
meeting as well. The option grants described in this clause shall be referred to as Subsequent
Options.
(c) Termination of Employment of Employee Directors. Members of the Board who are
employees of the Company or any parent or subsidiary of the Company who subsequently terminate
their employment with the Company and any parent or subsidiary of the Company and remain on the
Board will not receive an Initial Option grant pursuant to clause 2(a) above, but to the extent
that they are otherwise eligible, will be eligible to receive, after termination from employment
with the Company and any parent or subsidiary of the Company, Subsequent Options as described in
clause 2(b) above.
(d) Terms of Options Granted to Independent Directors.
(i) Exercise Price. The per share exercise price of each option granted to an
Independent Director shall equal 100% of the Fair Market Value (as defined in the 2006 Plan) of a
share of common stock on the date the option is granted.
(ii) Vesting. Initial Options granted to Independent Directors shall become
exercisable in thirty-six equal monthly installments of 1/36 of the shares subject to such option
on the first day of each calendar month following the date of the Initial Option grant, such that
each Initial Option shall be 100% vested on the first day of the 36th month following
the date of grant, subject to the directors continuing service on the Board through such dates.
Subsequent Options granted to Independent Directors shall become vested in twelve equal monthly
installments of 1/12 of the shares subject to such option on the first day of each calendar month
following the date of the Subsequent Option Grant, subject to a directors continuing service on
the Board through such dates. The term of each option granted to an Independent Director shall be
ten years from the date the option is granted. No portion of an option which is unexercisable at
the time of an Independent Directors termination of membership on the Board shall thereafter
become exercisable.
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EXHIBIT 10.5
EXHIBIT
10.5
CADENCE PHARMACEUTICALS, INC.
2006 EQUITY INCENTIVE AWARD PLAN
ARTICLE 1
PURPOSE
The purpose of the Cadence Pharmaceuticals, Inc. 2006 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,
and Consultants 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, and Consultants upon whose judgment,
interest, and special effort the successful conduct of the Companys operation is largely
dependent.
All numbers of shares of Stock set forth in the Plan give effect to the reverse stock split to
be implemented by the Company in connection with its initial public offering.
ARTICLE 2
DEFINITIONS AND CONSTRUCTION
Wherever the following terms are used in the Plan they shall have the meanings specified
below, unless the context clearly indicates otherwise. The singular pronoun shall include the
plural where the context so indicates.
2.1 Award means an Option, a Restricted Stock award, a Stock Appreciation Right
award, a Performance Share award, a Performance Stock Unit award, a Dividend Equivalents award, a
Stock Payment award, a Deferred Stock award, a Restricted Stock Unit award, an Other Stock-Based
Award, a Performance Bonus Award, or a Performance-Based Award granted to a Participant pursuant to
the Plan.
2.2 Award Agreement means any written agreement, contract, or other instrument or
document evidencing an Award.
2.3 Board means the Board of Directors of the Company.
2.4 Change in Control means and includes each of the following:
(a) A transaction or series of transactions (other than an offering of Stock to the general
public through a registration statement filed with the Securities and Exchange Commission) whereby
any person or related group of persons (as such terms are used in Sections 13(d) and 14(d)(2)
of the Exchange Act) (other than the Company, any of its subsidiaries, an employee benefit plan
maintained by the Company or any of its subsidiaries or a person that, prior to such transaction,
directly or indirectly controls, is controlled by, or is
under common control with, the Company) directly or indirectly acquires beneficial ownership
(within the meaning of Rule 13d-3 under the Exchange Act) of securities of the Company possessing
more than 50% of the total combined voting power of the Companys securities outstanding
immediately after such acquisition; or
(b) During any period of two consecutive years, individuals who, at the beginning of such
period, constitute the Board together with any new director(s) (other than a director designated by
a person who shall have entered into an agreement with the Company to effect a transaction
described in Section 2.4(a) or Section 2.4(c)) whose election by the Board or nomination for
election by the Companys 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 thereof; or
(c) The consummation by the Company (whether directly involving the Company or indirectly
involving the Company through one or more intermediaries) of (x) a merger, consolidation,
reorganization, or business combination or (y) a sale or other disposition of all or substantially
all of the Companys assets or (z) the acquisition of assets or stock of another entity, in each
case other than a transaction:
(i) Which results in the Companys voting securities outstanding immediately before the
transaction continuing to represent (either by remaining outstanding or by being converted into
voting securities of the Company or the person that, as a result of the transaction, controls,
directly or indirectly, the Company or owns, directly or indirectly, all or substantially all of
the Companys assets or otherwise succeeds to the business of the Company (the Company or such
person, the Successor Entity)) directly or indirectly, at least a majority of the
combined voting power of the Successor Entitys outstanding voting securities immediately after the
transaction, and
(ii) After which no person or group beneficially owns voting securities representing 50% or
more of the combined voting power of the Successor Entity; provided, however, that no person or
group shall be treated for purposes of this Section 2.4(c)(ii) as beneficially owning 50% or more
of combined voting power of the Successor Entity solely as a result of the voting power held in the
Company prior to the consummation of the transaction.
2.5
Code means the Internal Revenue Code of 1986, as
amended.
2.6 Committee means the committee of the Board described in Article 12.
2.7 Consultant means any consultant or adviser if:
(a) The consultant or adviser renders bona fide services to the Company or any Parent or
Subsidiary;
(b) The services rendered by the consultant or adviser are not in connection with the offer or
sale of securities in a capital-raising transaction and do not directly or indirectly promote or
maintain a market for the securities of the Company or of any Parent or Subsidiary; and
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(c) The consultant or adviser is a natural person.
2.8 Covered Employee means an Employee who is, or could be, a covered employee
within the meaning of Section 162(m) of the Code.
2.9 Deferred Stock means a right to receive a specified number of shares of Stock
during specified time periods pursuant to Article 8.
2.10 Disability means disability, as such term is defined in Section 22(e)(3) of
the Code.
2.11 Dividend Equivalents means a right granted to a Participant pursuant to Article
8 to receive the equivalent value (in cash or Stock) of dividends paid on Stock.
2.12 Effective Date shall have the meaning set forth in Section 13.1.
2.13 Eligible Individual means any person who is an Employee, a Consultant or a
member of the Board, as determined by the Committee.
2.14 Employee means any officer or other employee (as defined in accordance with
Section 3401(c) of the Code) of the Company or of any Parent or Subsidiary.
2.15 Exchange Act means the Securities Exchange Act of 1934, as amended.
2.16 Fair Market Value means, as of any given date, the fair market value of a share
of Stock on the date determined by such methods or procedures as may be established from time to
time by the Committee. Unless otherwise determined by the Committee, the Fair Market Value of a
share of Stock as of any date shall be the closing sales price for a share of Stock as reported on
the NASDAQ National Market (or on any national securities exchange on which the Stock is then
listed) for the date or, if no such prices are reported for that date, the average of the high and
low trading prices on the next preceding date for which such prices were reported.
2.17 Incentive Stock Option means an Option that is intended to meet the
requirements of Section 422 of the Code or any successor provision thereto.
2.18 Independent Director means a member of the Board who is not an Employee of the
Company or of any Parent or Subsidiary.
2.19 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.
2.20 Non-Qualified Stock Option means an Option that is not intended to be an
Incentive Stock Option.
2.21 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.
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2.22 Other Stock-Based Award means an Award granted or denominated in Stock or units
of Stock pursuant to Section 8.7 of the Plan.
2.23 Parent means any parent corporation, as defined in Section 424(e) of the Code
and any applicable regulations promulgated thereunder, of the Company or any other entity which
beneficially owns, directly or indirectly, a majority of the outstanding voting stock or voting
power of the Company.
2.24 Participant means any Eligible Individual who, as a member of the Board,
Consultant or Employee, has been granted an Award pursuant to the Plan.
2.25 Performance-Based Award means an Award granted to selected Covered Employees
pursuant to Articles 6 and 8, but which is subject to the terms and conditions set forth in Article
9. All Performance-Based Awards are intended to qualify as Qualified Performance-Based
Compensation.
2.26 Performance Bonus Award has the meaning set forth in Section 8.8.
2.27 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), economic value-added (as determined by the Committee), sales or revenue, net income
(either before or after taxes), operating earnings, cash flow (including, but not limited to,
operating cash flow and free cash flow), cash flow return on capital, return on net assets, return
on stockholders equity, return on assets, return on capital, stockholder returns, return on sales,
gross or net profit margin, productivity, expense, margins, operating efficiency, customer
satisfaction, working capital, earnings per share of Stock, 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. To the extent an Award is intended to be
Qualified Performance-Based Compensation, the Committee shall, within the time prescribed by
Section 162(m) of the Code, define in an objective fashion the manner of calculating the
Performance Criteria it selects to use for such Performance Period for such Participant.
2.28 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. To the extent an Award is intended to be Qualified Performance-Based
Compensation, the Committee, in its discretion, may, within the time prescribed by Section 162(m)
of the Code, 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 (a) in the event of, or
in anticipation of, any unusual or extraordinary corporate item, transaction, event, or
development, or (b) 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.
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2.29 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.
2.30 Performance Share means a right granted to a Participant pursuant to Article 8,
to receive Stock, the payment of which is contingent upon achieving certain Performance Goals or
other performance-based targets established by the Committee.
2.31 Performance Stock Unit means a right granted to a Participant pursuant to
Article 8, to receive Stock, the payment of which is contingent upon achieving certain Performance
Goals or other performance-based targets established by the Committee.
2.32 Plan means this Cadence Pharmaceuticals, Inc. 2006 Incentive Award Plan, as it
may be amended from time to time.
2.33 Public Trading Date means the first date upon which Stock is listed (or
approved for listing) upon notice of issuance on any securities exchange or designated (or approved
for designation) upon notice of issuance as a national market security on an interdealer quotation
system.
2.34 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.
2.35 Restricted Stock means Stock awarded to a Participant pursuant to Article 6
that is subject to certain restrictions and may be subject to risk of forfeiture.
2.36 Restricted Stock Unit means an Award granted pursuant to Section 8.6.
2.37 Securities Act shall mean the Securities Act of 1933, as amended.
2.38 Stock means the common stock of the Company, par value $0.0001 per share, and
such other securities of the Company that may be substituted for Stock pursuant to Article 11.
2.39 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.
2.40 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.
2.41 Subsidiary means any subsidiary corporation as defined in Section 424(f) of
the Code and any applicable regulations promulgated thereunder or any other entity of which a
5
majority of the outstanding voting stock or voting power is beneficially owned directly or
indirectly by the Company.
ARTICLE 3
SHARES SUBJECT TO THE PLAN
3.1 Number of Shares.
(a) Subject to Article 11 and Section 3.1(b), the aggregate number of shares of Stock which
may be issued or transferred pursuant to Awards under the Plan shall be the sum of: (i) 2,100,000
shares of Stock; plus (ii) the number of shares of Stock remaining available for issuance and not
subject to awards granted under the Cadence Pharmaceuticals, Inc. 2004 Equity Incentive Award Plan
(the Existing Plan) as of the Effective Date; plus (iii) with respect to awards granted
under the Existing Plan on or before the Effective Date that expire or are canceled without having
been exercised in full or shares of Stock that are forfeited or repurchased pursuant to the terms
of awards granted under the Existing Plan, the number of shares of Stock subject to each such award
as to which such award was not exercised prior to its expiration or cancellation or which are
forfeited or repurchased by the Company. The aggregate number of shares of Stock authorized for
issuance under the Existing Plan was [ ] shares of Stock and, accordingly, the total number
of shares of Stock under clauses (ii) and (iii) in the preceding sentence shall not exceed
[ ] shares of Stock. In addition, subject to Article 11, commencing on January 1, 2008, and
on each January 1 thereafter during the term of the Plan, the number of shares of Stock which shall
be made available for sale under the Plan shall be increased by that number of shares of Stock
equal to the least of: (i) 4% of the Companys outstanding shares of Stock on the applicable
January 1; and (ii) a lesser number of shares of Stock as determined by the Board. Accordingly,
the number of shares of Stock which shall be available for sale under the Plan shall be subject to
increase under the preceding sentence only on January 1, 2008 and on each subsequent January 1
through and including January 1, 2016. Notwithstanding anything in this Section 3.1(a) to the
contrary, the number of shares of Stock that may be issued or transferred pursuant to Awards under
the Plan shall not exceed an aggregate of 20,000,000 shares of Stock, subject to Article 11. In
order that the applicable regulations under the Code relating to Incentive Stock Options be
satisfied, the maximum number of shares of Stock that may be delivered upon exercise of Incentive
Stock Options shall be the number specified in the preceding sentence, and, if necessary to satisfy
such regulations, such maximum limit shall apply to the number of shares of Stock that may be
delivered in connection with each other type of Award under the Plan (applicable separately to each
type of Award).
(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.
6
The payment of Dividend Equivalents in conjunction with any outstanding Awards shall not be
counted against the shares of Stock available for issuance under the Plan.
3.2 Stock Distributed. Any shares of Stock distributed pursuant to an Award may
consist, in whole or in part, of authorized and unissued Stock, treasury Stock or 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, the maximum number of shares of Stock with
respect to one or more Awards that may be granted to any one Participant during any fiscal year of
the Company (measured from the date of any grant) shall be 1,000,000; provided, however, that the
foregoing limitation shall not apply prior to the Public Trading Date and, following the Public
Trading Date, the foregoing limitation shall not apply until the earliest of: (a) the first
material modification of the Plan (including any increase in the number of shares of Stock reserved
for issuance under the Plan in accordance with Section 3.1); (b) the issuance of all of the shares
of Stock reserved for issuance under the Plan; (c) the expiration of the Plan; (d) the first
meeting of stockholders at which members of the Board are to be elected that occurs after the close
of the third calendar year following the calendar year in which occurred the first registration of
an equity security of the Company under Section 12 of the Exchange Act; or (e) such other date
required by Section 162(m) of the Code and the rules and regulations promulgated thereunder.
ARTICLE 4
ELIGIBILITY AND PARTICIPATION
4.1 Eligibility. Each Eligible Individual shall be eligible to be granted one or more
Awards pursuant to the Plan.
4.2 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 Eligible Individual shall have any right
to be granted an Award pursuant to this Plan.
4.3 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 limitations on the number of shares of Stock (a) issued or transferred pursuant to Awards under
the Plan, as detailed in Section 3.1, and (b) issued or transferred pursuant to Awards granted to
any one Participant during any fiscal year of the Company, as detailed in Section 3.3 of the Plan.
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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 times
at which an Option may be exercised in whole or in part. 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: (i) cash, (ii)
promissory note bearing interest at no less than such rate as shall then preclude the imputation of
interest under the Code, (iii) shares of Stock held for such period of time as may be required by
the Committee in order to avoid adverse accounting consequences and having a Fair Market Value on
the date of delivery equal to the aggregate exercise price of the Option or exercised portion
thereof, or (iv) other property acceptable to the Committee (including through the 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), and the methods by which shares of Stock shall be delivered or deemed to be
delivered to Participants. Notwithstanding any other provision of the Plan to the contrary, no
Participant who is a member of the Board or an executive officer of the Company within the
meaning of Section 13(k) of the Exchange Act shall be permitted to pay the exercise price of an
Option in any method which would violate Section 13(k) of the Exchange Act.
(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. The terms of any Incentive Stock Options granted
pursuant to the Plan must comply with the conditions and limitations contained in Section 13.2 and
this Section 5.2.
(a) Eligibility. Incentive Stock Options may be granted only to Employees.
(b) Exercise Price. The exercise price per share of Stock shall be set by the
Committee; provided that subject to Section 5.2(e) the exercise price for any Incentive Stock
Option shall not be less than 100% of the Fair Market Value on the date of grant.
8
(c) Expiration. Subject to Section 5.2(e), an Incentive Stock Option may not be
exercised to any extent by anyone after the tenth anniversary of the date it is granted, unless an
earlier time is set in the Award Agreement.
(d) 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.
(e) 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 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.
(f) Notice of Disposition. The Participant shall give the Company prompt notice of
any disposition of shares of Stock acquired by exercise of an Incentive Stock Option within (i) two
years from the date of grant of such Incentive Stock Option or (ii) one year after the transfer of
such shares of Stock to the Participant.
(g) Right to Exercise. During a Participants lifetime, an Incentive Stock Option may
be exercised only by the Participant.
5.3 Substitution of Stock Appreciation Rights. The Committee may provide in the Award
Agreement evidencing the grant of an Option that the Committee, in its sole discretion, shall have
to right to substitute a Stock Appreciation Right for such Option at any time prior to or upon
exercise of such Option, subject to the provisions of Section 7.2 hereof; provided that such Stock
Appreciation Right shall be exercisable with respect to the same number of shares of Stock for
which such substituted Option would have been exercisable.
5.4 Paperless Exercise. In the event that the Company establishes, for itself or
using the services of a third party, an automated system for the exercise of Options, such as a
system using an internet website or interactive voice response, then the paperless exercise of
options by a Participant may be permitted through the use of such an automated system.
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 written Restricted Stock Award Agreement.
6.2 Issuance and Restrictions. Restricted Stock shall be subject to such restrictions
on
9
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 (a) 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 (b) 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 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 Stock Appreciation Rights.
(a) A Stock Appreciation Right (SAR) shall have a term set by the Committee. A SAR
shall be exercisable in such installments as the Committee may determine. A SAR shall cover such
number of shares of Stock as the Committee may determine. The exercise price per share of Stock
subject to each SAR shall be set by the Committee; provided, however, that the Committee in its
sole and absolute discretion may provide that the SAR may be exercised subsequent to a termination
of employment or service, as applicable, or following a Change in Control of the Company, or
because of the Participants retirement, death or disability, or otherwise.
(b) A SAR shall entitle the Participant (or other person entitled to exercise the SAR pursuant
to the Plan) to exercise all or a specified portion of the SAR (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 SAR from the Fair Market
Value of a share of Stock on the date of exercise of the SAR by the number of shares of Stock with
respect to which the SAR shall have been exercised, subject to any limitations the Committee may
impose.
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7.3 Payment and Limitations on Exercise.
(a) Payment of the amounts determined under Section 7.2(b) above shall be in cash, in Stock
(based on its Fair Market Value as of the date the SAR is exercised) or a combination of both, as
determined by the Committee.
(b) To the extent any payment under Section 7.2(b) is effected in Stock it shall be made
subject to satisfaction of all provisions of Article 5 above pertaining to Options.
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 shall be denominated in a number 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 Performance Stock Units. Any Participant selected by the Committee may be granted
one or more Performance Stock Unit awards which shall be denominated in units of value including
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.
8.3 Dividend Equivalents.
(a) 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.
(b) Dividend Equivalents granted with respect to Options or SARs that are intended to be
Qualified Performance-Based Compensation shall be payable, with respect to pre-exercise periods,
regardless of whether such Option or SAR is subsequently exercised.
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8.4 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 of
Stock or the number of options or other rights to purchase shares of Stock subject to a Stock
Payment 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.
8.5 Deferred Stock. Any Participant selected by the Committee may be granted an award
of Deferred Stock in the manner determined from time to time by the Committee. The number of
shares of Deferred Stock 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 Deferred Stock award will not be issued until the Deferred Stock award has
vested, pursuant to a vesting schedule or performance criteria set by the Committee. Unless
otherwise provided by the Committee, a Participant awarded Deferred Stock shall have no rights as a
Company stockholder with respect to such Deferred Stock until such time as the Deferred Stock Award
has vested and the Stock underlying the Deferred Stock Award has been issued.
8.6 Restricted Stock Units. The Committee is authorized to make Awards of Restricted
Stock Units to any Participant selected by the Committee in such amounts and subject to such terms
and conditions as determined by the Committee. At the time of grant, the Committee shall specify
the date or dates on which the Restricted Stock Units shall become fully vested and nonforfeitable,
and may specify such conditions to vesting as it deems appropriate. At the time of grant, the
Committee shall specify the maturity date applicable to each grant of Restricted Stock Units which
shall be no earlier than the vesting date or dates of the Award and may be determined at the
election of the grantee. On the maturity date, the Company shall, subject to Section 10.5(b),
transfer to the Participant one unrestricted, fully transferable share of Stock for each Restricted
Stock Unit scheduled to be paid out on such date and not previously forfeited. The Committee shall
specify the purchase price, if any, to be paid by the grantee to the Company for such shares of
Stock.
8.7 Other Stock-Based Awards. Any Participant selected by the Committee may be
granted one or more Awards that provide Participants with shares of Stock or the right to purchase
shares of Stock or that have a value derived from the value of, or an exercise or conversion
privilege at a price related to, or that are otherwise payable in 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.
8.8 Performance Bonus Awards. Any Participant selected by the Committee may be
granted one or more Performance-Based Awards in the form of a cash bonus (a Performance Bonus
Award) payable upon the attainment of Performance Goals that are established by the Committee
and relate to one or more of the Performance Criteria, in each case on a specified date
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or dates or over any period or periods determined by the Committee. Any such Performance
Bonus Award paid to a Covered Employee shall be based upon objectively determinable bonus formulas
established in accordance with Article 9. The maximum amount of any Performance Bonus Award
payable to a Covered Employee with respect to any fiscal year of the Company shall not exceed
$1,000,000.
8.9 Term. Except as otherwise provided herein, the term of any Award of Performance
Shares, Performance Stock Units, Dividend Equivalents, Stock Payments, Deferred Stock, Restricted
Stock Units or Other Stock-Based Award shall be set by the Committee in its discretion.
8.10 Exercise or Purchase Price. The Committee may establish the exercise or purchase
price, if any, of any Award of Performance Shares, Performance Stock Units, Deferred Stock, Stock
Payments, Restricted Stock Units or Other Stock-Based Award; provided, however, that such price
shall not be less than the par value of a share of Stock on the date of grant, unless otherwise
permitted by applicable state law.
8.11 Exercise Upon Termination of Employment or Service. An Award of Performance
Shares, Performance Stock Units, Dividend Equivalents, Deferred Stock, Stock Payments, Restricted
Stock Units and Other Stock-Based Award shall only be exercisable or payable while the Participant
is an Employee, Consultant or a member of the Board, as applicable; provided, however, that the
Committee in its sole and absolute discretion may provide that an Award of Performance Shares,
Performance Stock Units, Dividend Equivalents, Stock Payments, Deferred Stock, Restricted Stock
Units or Other Stock-Based Award may be exercised or paid subsequent to a termination of employment
or service, as applicable, or following a Change in Control of the Company, or because of the
Participants retirement, death or disability, or otherwise; provided, however, that any such
provision with respect to Performance Shares or Performance Stock Units shall be subject to the
requirements of Section 162(m) of the Code that apply to Qualified Performance-Based Compensation.
8.12 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.
8.13 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 other than Options and SARs and that are granted pursuant to Articles 6 and 8 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 contained in Articles 6 or 8; provided, however, that the
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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.
9.2 Applicability. This Article 9 shall apply only to those Covered Employees
selected by the Committee to receive Performance-Based Awards. 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 (90) 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, (a)
designate one or more Covered Employees, (b) select the Performance Criteria applicable to the
Performance Period, (c) establish the Performance Goals, and amounts of such Awards, as applicable,
which may be earned for such Performance Period, and (d) 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. Unless otherwise provided in the applicable
Award Agreement, a Participant must be employed by the Company or a Parent or Subsidiary on the day
a Performance-Based Award for such Performance Period is paid to the Participant. Furthermore, 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.
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.
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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 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, a Parent,
or a Subsidiary, or shall be subject to any lien, obligation, or liability of such Participant to
any other party other than the Company, a Parent, or a 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 shall 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, a Parent, or a 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 or her 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
15
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) Notwithstanding anything herein to the contrary, 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.
(b) Notwithstanding any other provision of the Plan, unless otherwise determined by the
Committee or required by any applicable law, rule or regulation, the Company shall not deliver to
any Participant certificates evidencing shares of Stock issued in connection with any Award and
instead such shares of Stock shall 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, distribution of Company assets to stockholders
(other than normal cash dividends), or any other corporate event affecting the Stock or the share
price of the Stock, the Committee may make such proportionate adjustments, if any, as the Committee
in its discretion may deem appropriate to reflect such changes with respect to1
(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
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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 in
Control), or of changes in applicable laws, regulations or accounting 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, is hereby authorized to take any one or more of the following actions
wherever 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:
(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; and
(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 Restricted Stock
or Deferred Stock 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 in Control. Notwithstanding Section 11.1, and except
as may otherwise be provided in any applicable Award Agreement or other written agreement entered
into between the Company, a Parent, a Subsidiary, or other Company affiliate and a Participant, if
a Change in Control occurs and a Participants Awards are not converted, assumed, or replaced by a
successor entity, then immediately prior to the Change in Control such
17
Awards shall become fully exercisable and all forfeiture restrictions on such Awards shall
lapse. Upon, or in anticipation of, a Change in Control, the Committee may cause any and all
Awards outstanding hereunder to terminate at a specific time in the future, including but not
limited to the date of such Change in Control, 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. In the event that the terms of any agreement between the Company, a Parent, a
Subsidiary, or other Company affiliate and a Participant contains provisions that conflict with and
are more restrictive than the provisions of this Section 11.2, this Section 11.2 shall prevail and
control and the more restrictive terms of such agreement (and only such terms) shall be of no force
or effect.
11.3 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
kind of shares or other securities 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.
11.4 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.
ARTICLE 12
ADMINISTRATION
12.1 Committee. Unless and until the Board delegates administration of the Plan to a
Committee as set forth below, the Plan shall be administered by the full Board, and for such
purposes the term Committee as used in this Plan shall be deemed to refer to the Board. The
Board, at its discretion or as otherwise necessary to comply with the requirements of Section
162(m) of the Code, Rule 16b-3 promulgated under the Exchange Act or to the extent required by any
other applicable rule or regulation, shall delegate administration of the Plan to a Committee. The
Committee shall consist solely of two or more members of the Board each of whom is a Non-Employee
Director, and with respect to awards that are intended to be Performance-Based Awards, an outside
director within the meaning of Section 162(m) of the Code. Notwithstanding the foregoing: (a) the
full Board, acting by a majority of its members in office, shall conduct the general administration
of the Plan with respect to all Awards granted to Independent Directors and for purposes of such
Awards the term Committee as used in this Plan shall be deemed to refer to the Board and (b) the
Committee may delegate its authority hereunder to the extent permitted by Section 12.5.
Appointment of Committee members shall be effective upon acceptance of appointment. The Board may
abolish the Committee at any time
18
and revest in the Board the administration of the Plan. 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.
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 of any Parent or Subsidiary, the Companys independent certified public accountants, or
any executive compensation consultant or other professional retained by the Company or any Parent
or Subsidiary 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;
(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
19
(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.
12.5 Delegation of Authority. To the extent permitted by applicable law, the
Committee may from time to time delegate to a committee of one or more members of the Board or one
or more officers of the Company the authority to grant or amend Awards to Participants other than
(a) senior executives of the Company who are subject to Section 16 of the Exchange Act, (b) Covered
Employees, or (c) officers of the Company (or members of the Board) to whom authority to grant or
amend Awards has been delegated hereunder. Any delegation hereunder shall be subject to the
restrictions and limits that the Committee specifies at the time of such delegation, and the
Committee may at any time rescind the authority so delegated or appoint a new delegatee. At all
times, the delegatee appointed under this Section 12.5 shall serve in such capacity at the pleasure
of the Committee.
12.6 Amendment or Exchange of Awards. The Committee may (i) amend any Award to reduce
the per share exercise price of such an Award below the per share exercise price as of the date the
Award is granted and (ii) grant an Award in exchange for, or in connection with, the cancellation
or surrender of an Award having a higher per share exercise price.
ARTICLE 13
EFFECTIVE AND EXPIRATION DATE
13.1 Effective Date. The Plan is effective as of the day prior to the Public Trading
Date (the Effective Date).
13.2 Expiration Date. The Plan will expire on, and no Incentive Stock Option or other
Award may be granted pursuant to the Plan after, the tenth anniversary of the date this Plan is
approved by the Board. 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.
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 (a) 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, and (b) stockholder approval is
required for any amendment to the Plan that increases the number of shares of Stock available under
the Plan.
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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 Eligible Individual 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 Eligible Individuals, Participants or any other persons uniformly.
15.2 No Stockholders Rights. Except as otherwise provided herein, a Participant shall
have none of the rights of a stockholder with respect to shares of Stock covered by any Award until
the Participant becomes the record owner of such shares of Stock.
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 FICA
obligation) 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 (or such other period as may be determined by the Committee) after such
shares of Stock were acquired by the Participant from the Company) in order to satisfy the
Participants federal, state, local and foreign income and payroll tax liabilities with respect to
the issuance, vesting, exercise or payment of the Award shall be limited to the number of shares of
Stock 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 income tax and payroll tax purposes that are applicable to such
supplemental 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 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.
21
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 of Stock or whether such fractional shares of Stock 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 of 1933, as amended, any of the shares of
Stock paid pursuant to the Plan. If the shares of Stock paid pursuant to the Plan may in certain
circumstances be exempt from registration pursuant to the Securities Act of 1933,
22
as amended, the Company may restrict the transfer of such shares of Stock in such manner as it
deems advisable to ensure the availability of any such exemption.
15.13 Section 409A. To the extent that the Committee determines that any Award
granted under the Plan is subject to Section 409A of the Code, the Award Agreement evidencing such
Award shall incorporate the terms and conditions required by Section 409A of the Code. To the
extent applicable, the Plan and Award Agreements shall be interpreted in accordance with Section
409A of the Code and Department of Treasury regulations and other interpretive guidance issued
thereunder, including without limitation any such regulations or other guidance that may be issued
after the adoption of the Plan. Notwithstanding any provision of the Plan to the contrary, in the
event that following the adoption of the Plan the Committee determines that any Award may be
subject to Section 409A of the Code and related Department of Treasury guidance (including such
Department of Treasury guidance as may be issued after the adoption of the Plan), the Committee may
adopt such amendments to the Plan and the applicable Award Agreement or adopt other policies and
procedures (including amendments, policies and procedures with retroactive effect), or take any
other actions, that the Committee determines are necessary or appropriate to (a) exempt the Award
from Section 409A of the Code and/or preserve the intended tax treatment of the benefits provided
with respect to the Award, or (b) comply with the requirements of Section 409A of the Code and
related Department of Treasury guidance.
15.14 Governing Law. The Plan and all Award Agreements shall be construed in
accordance with and governed by the laws of the State of Delaware.
23
CADENCE PHARMACEUTICALS, INC.
2006 EQUITY INCENTIVE AWARD PLAN
STOCK OPTION GRANT NOTICE AND
STOCK OPTION AGREEMENT
STOCK OPTION GRANT NOTICE
Cadence Pharmaceuticals, Inc., a Delaware corporation (the Company), pursuant to its 2006
Equity Incentive Award Plan (the Plan), hereby grants to the holder listed below (Participant),
an option to purchase the number of shares of the Companys common stock, par value $0.0001
(Stock), set forth below (the Option). This Option is subject to all of the terms and
conditions set forth herein and in the Stock Option Agreement attached hereto as Exhibit A
(the Stock Option Agreement) and the Plan, which are incorporated herein by reference. Unless
otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in
this Grant Notice and the Stock Option Agreement.
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Participant: |
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Grant Date: |
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Exercise Price per Share:
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$
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Total Exercise Price:
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$
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Total Number of Shares
Subject to the Option:
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shares |
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Type of Option:
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o Incentive Stock Option
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Vesting Schedule:
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[To be specified in individual agreements]
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By his or her signature, the Participant agrees to be bound by the terms and conditions of the
Plan, the Stock Option Agreement and this Grant Notice. The Participant has reviewed the Stock
Option Agreement, the Plan and this Grant Notice in their entirety, has had an opportunity to
obtain the advice of counsel prior to executing this Grant Notice and fully understands all
provisions of this Grant Notice, the Stock Option Agreement and the Plan. Participant hereby
agrees to accept as binding, conclusive and final all decisions or interpretations of the Committee
upon any questions arising under the Plan or relating to the Option.
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CADENCE PHARMACEUTICALS, INC. |
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PARTICIPANT |
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By:
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By: |
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Print Name:
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Title: |
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EXHIBIT A
TO STOCK OPTION GRANT NOTICE
STOCK OPTION AGREEMENT
Pursuant to the Stock Option Grant Notice (the Grant Notice) to which this Stock Option
Agreement (this Agreement) is attached, Cadence Pharmaceuticals, Inc., a Delaware corporation
(the Company), has granted to the Participant an Option under the Companys 2006 Equity Incentive
Award Plan (the Plan) to purchase the number of shares of Stock indicated in the Grant Notice.
ARTICLE I.
GENERAL
1.1 Defined Terms. Wherever the following terms are used in this Agreement they
shall have the meanings specified below, unless the context clearly indicates otherwise.
Capitalized terms not specifically defined herein shall have the meanings specified in the Plan and
the Grant Notice.
(a) Administrator shall mean the Committee responsible for conducting the general
administration of the Plan in accordance with Article 12 of the Plan; provided that if the
Participant is an Independent Director, Administrator shall mean the Board.
(b) Termination of Consultancy shall mean the time when the engagement of the Participant as
a Consultant to the Company or to a Parent or Subsidiary is terminated for any reason, with or
without cause, including, but not by way of limitation, by resignation, discharge, death or
retirement, but excluding: (a) terminations where there is a simultaneous employment or continuing
employment of the Participant by the Company or any Parent or Subsidiary, and (b) terminations
where there is a simultaneous reestablishment of a consulting relationship or continuing consulting
relationship between the Participant and the Company or any Parent or Subsidiary. The
Administrator, in its absolute discretion, shall determine the effect of all matters and questions
relating to Termination of Consultancy, including, but not by way of limitation, the question of
whether a particular leave of absence constitutes a Termination of Consultancy. Notwithstanding
any other provision of the Plan, the Company or any Parent or Subsidiary has an absolute and
unrestricted right to terminate a Consultants service at any time for any reason whatsoever, with
or without cause, except to the extent expressly provided otherwise in writing.
(c) Termination of Directorship shall mean the time when the Participant, if he or she is or
becomes an Independent Director, ceases to be a Director for any reason, including, but not by way
of limitation, a termination by resignation, failure to be elected, death or retirement. The
Board, in its sole and absolute discretion, shall determine the effect of all matters and questions
relating to Termination of Directorship with respect to Independent Directors.
(d) Termination of Employment shall mean the time when the employee-employer relationship
between the Participant 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 retirement; but excluding: (a) terminations where there is a
simultaneous reemployment or continuing employment of the Participant by the Company or any Parent
or Subsidiary, and (b) terminations where there is a simultaneous establishment of a consulting
relationship or continuing consulting relationship between the Participant and the Company or any
Parent or Subsidiary. The Administrator, in its absolute discretion, shall determine the effect of
all matters and questions relating to Termination of Employment, including, but not by way of
limitation, the question of
B-1
whether a particular leave of absence constitutes a Termination of Employment; provided,
however, that, if this Option is an Incentive Stock Option, unless otherwise determined by the
Administrator 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 Employment 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.
(e) Termination of Services shall mean the Participants Termination of Consultancy,
Termination of Directorship or Termination of Employment, as applicable.
1.2 Incorporation of Terms of Plan. The Option is subject to the terms and conditions
of the Plan which are incorporated herein by reference. In the event of any inconsistency between
the Plan and this Agreement, the terms of the Plan shall control.
ARTICLE II.
GRANT OF OPTION
2.1 Grant of Option. In consideration of the Participants past and/or continued
employment with or service to the Company or a Parent or Subsidiary 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 Participant 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 the Plan, the Grant Notice and 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 Exercise Price. The exercise price of the shares of Stock subject to the Option
shall be as set forth in the Grant Notice, without commission or other charge; provided, however,
that the price per share of the shares of Stock subject to the Option shall not be less than 100%
of the Fair Market Value of a share of Stock on the Grant Date. Notwithstanding the foregoing, if
this Option is designated as an Incentive Stock Option and the Participant owns (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), the price per share of the shares
of Stock subject to the Option shall not be less than 110% of the Fair Market Value of a share of
Stock on the Grant Date.
2.3 Consideration to the Company. In consideration of the grant of the Option by the
Company, the Participant agrees to render faithful and efficient services to the Company or any
Parent or Subsidiary. Nothing in the Plan, the Grant Notice, or this Agreement shall confer upon
the Participant any right to continue in the employ or service of the Company or any Parent or
Subsidiary or shall interfere with or restrict in any way the rights of the Company and any Parent
or Subsidiary, which rights are hereby expressly reserved, to discharge or terminate the services
of the Participant 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 or a Parent or
Subsidiary and the Participant.
B-2
ARTICLE III.
PERIOD OF EXERCISABILITY
3.1 Commencement of Exercisability.
(a) Subject to Sections 3.2, 3.3, 5.8 and 5.10, the Option shall become vested and 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 vested and exercisable at the date of the
Participants Termination of Employment, Termination of Directorship or Termination of Consultancy
shall thereafter become vested and exercisable, except as may be otherwise provided by the
Administrator or as set forth in a written agreement between the Company and the Participant.
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 vested and
exercisable pursuant to the vesting schedule set forth in the Grant Notice shall remain vested and
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;
(b) If this Option is designated as an Incentive Stock Option and the Participant 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 Grant Date;
(c) The expiration of [three months] from the date of the Participants Termination of
Services, unless such termination occurs by reason of the Participants death or Disability; or
(d) The expiration of [one year] from the date of the Participants Termination of Services by
reason of the Participants death or Disability.
[The Participant acknowledges that an Incentive Stock Option exercised more that three months
after the Participants Termination of Employment, other than by reason of death or Disability,
will be taxed as a Non-Qualified Stock Option.]
3.4 Special Tax Consequences. The Participant acknowledges that, to the extent that
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, including the Option, are exercisable for the
first time by the Participant in any calendar year exceeds $100,000, the Option and such other
options shall be Non-Qualified Stock Options to the extent necessary to comply with the limitations
imposed by Section 422(d) of the Code. The Participant further acknowledges that the rule set
forth in the preceding sentence shall be applied by taking the Option and other incentive stock
options into account in the order in which they were granted, as determined under Section 422(d)
of the Code and the Treasury Regulations thereunder.
B-3
ARTICLE IV.
EXERCISE OF OPTION
4.1 Person Eligible to Exercise. Except as provided in Section 5.2(b), during
the lifetime of the Participant, only the Participant may exercise the Option or any portion
thereof. After the death of the Participant, any exercisable portion of the Option may, prior to
the time when the Option becomes unexercisable under Section 3.3, be exercised by the Participants
personal representative or by any person empowered to do so under the deceased the Participants
will or under the then applicable 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 any third party administrator or
other person or entity designated by the Company) 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 a form specified by the Administrator, stating that the Option or
portion thereof is thereby exercised, such notice complying with all applicable rules established
by the Administrator;
(b) The receipt by the Company of full payment for the shares of Stock with respect to which
the Option or portion thereof is exercised, including payment of any applicable withholding tax,
which may be in one or more of the forms of consideration permitted under Section 4.4;
(c) Any other written representations as may be required in the Administrators reasonable
discretion to evidence compliance with the Securities Act or any other applicable law, rule, or
regulation; and
(d) In the event the Option or portion thereof shall be exercised pursuant to Section 4.1 by
any person or persons other than the Participant, appropriate proof of the right of such person or
persons to exercise the Option.
Notwithstanding any of the foregoing, the Company shall have the right to specify all conditions of
the manner of exercise, which conditions may vary by country and which may be subject to change
from time to time.
4.4 Method of Payment. Payment of the exercise price shall be by any of the
following, or a combination thereof, at the election of the Participant:
(a) Cash;
(b) Check;
(c) With the consent of the Administrator, 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
B-4
to the Company in satisfaction of the aggregate exercise price; provided, that payment of such
proceeds is then made to the Company upon settlement of such sale;
(d) With the consent of the Administrator, surrender of other shares of Stock which (A) in the
case of shares of Stock acquired from the Company, have been owned by the Participant for more than
six (6) months on the date of surrender, and (B) have a Fair Market Value on the date of surrender
equal to the aggregate exercise price of the shares of Stock with respect to which the Option or
portion thereof is being exercised;
(e) With the consent of the Administrator, surrendered shares of Stock issuable upon the
exercise of the Option having a Fair Market Value on the date of exercise equal to the aggregate
exercise price of the shares of Stock with respect to which the Option or portion thereof is being
exercised; or
(f) With the consent of the Administrator, property of any kind which constitutes good and
valuable consideration.
4.5 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 of Stock or issued shares of Stock which have then been reacquired by the Company.
Such shares of Stock shall be fully paid and nonassessable. The Company shall not be required to
issue or deliver 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 of Stock to listing on all stock exchanges on which such
Stock is then listed;
(b) The completion of any registration or other qualification of such shares of Stock 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 Administrator shall, in its absolute
discretion, deem necessary or advisable;
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Administrator shall, in its absolute discretion, determine to be necessary or
advisable;
(d) The receipt by the Company of full payment for such shares of Stock, including payment of
any applicable withholding tax, which may be in one or more of the forms of consideration permitted
under Section 4.4; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Administrator may from time to time establish for reasons of administrative convenience.
4.6 Rights as Stockholder. 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 of Stock purchasable
upon the exercise of any part of the Option unless and until such shares of Stock shall have been
issued by the Company to such holder (as evidenced by the appropriate entry on the books of the
Company or of a duly authorized transfer agent of the Company). No adjustment will be made for a
dividend or other right for which the record date is prior to the date the shares of Stock are
issued, except as provided in Section 11.1 of the Plan.
B-5
ARTICLE V.
OTHER PROVISIONS
5.1 Administration. The Administrator shall have the power to interpret the
Plan, the Grant Notice 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
Administrator in good faith shall be final and binding upon Participant, the Company and all other
interested persons. No member of the Committee or the Board shall be personally liable for any
action, determination or interpretation made in good faith with respect to the Plan, the Grant
Notice, this Agreement or the Option.
5.2 Option Not Transferable.
(a) Unless determined otherwise by the Administrator, 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 shares of Stock underlying the Option have been issued, and all restrictions
applicable to such shares of Stock have lapsed. Neither the Option nor any interest or right
therein shall be liable for the debts, contracts or engagements of Participant 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) Unless determined otherwise by the Administrator, during the lifetime of Participant, only
Participant may exercise the Option or any portion thereof. After the death of Participant, any
exercisable portion of the Option may, prior to the time when the Option becomes unexercisable
under Section 3.3, be exercised by Participants personal representative or by any person empowered
to do so under the deceased Participants will or under the then applicable laws of descent and
distribution.
5.3 Adjustments. The Participant acknowledges that the Option is subject to
modification and termination in certain events as provided in this Agreement and Article 11 of the
Plan.
5.4 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 at the address given
beneath the signature of the Companys authorized officer on the Grant Notice, and any notice to be
given to Participant shall be addressed to Participant at the address given beneath Participants
signature on the Grant Notice. By a notice given pursuant to this Section 5.4, 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 Participant shall, if Participant is then deceased, be given to the person
entitled to exercise his or her Option pursuant to Section 4.1 by written notice under this Section
5.4. Any notice shall be deemed duly given when sent via email or when sent by certified mail
(return receipt requested) and deposited (with postage prepaid) in a post office or branch post
office regularly maintained by the United States Postal Service.
5.5 Titles. Titles are provided herein for convenience only and are not to serve as a
basis for interpretation or construction of this Agreement.
B-6
5.6 Governing Law; Severability. The laws of the State of Delaware shall govern the
interpretation, validity, administration, enforcement and performance of the terms of this
Agreement regardless of the law that might be applied under principles of conflicts of laws.
5.7 Conformity to Securities Laws. The Participant acknowledges that the Plan, the
Grant Notice and this Agreement are 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, the Grant Notice and this
Agreement shall be deemed amended to the extent necessary to conform to such laws, rules and
regulations.
5.8 Amendments, Suspension and Termination. To the extent permitted by the Plan, this
Agreement may be wholly or partially amended or otherwise modified, suspended or terminated at any
time or from time to time by the Committee or the Board, provided, that, except as may otherwise be
provided by the Plan, no amendment, modification, suspension or termination of this Agreement shall
adversely effect the Option in any material way without the prior written consent of the
Participant.
5.9 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 in
Section 5.2, this Agreement shall be binding upon Participant and his or her heirs, executors,
administrators, successors and assigns.
5.10 Notification of Disposition. If this Option is designated as an Incentive Stock
Option, Participant 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 of Stock or (b) within one year
after the transfer of such shares of Stock to the Participant. 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 Participant in such disposition or other transfer.
5.11 Limitations Applicable to Section 16 Persons. Notwithstanding any other
provision of the Plan or this Agreement, if Participant is subject to Section 16 of the Exchange
Act, the Plan, the Option and this Agreement 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, this Agreement shall be deemed amended
to the extent necessary to conform to such applicable exemptive rule.
5.12 Not a Contract of Employment. Nothing in this Agreement, the Grant Notice, or
the Plan shall confer upon the Participant any right to continue to serve as an employee or other
service provider of the Company or any Parent or Subsidiary.
5.13 Entire Agreement. The Plan, the Grant Notice and this Agreement (including all
exhibits thereto) constitute the entire agreement of the parties and supersede in their entirety
all prior undertakings and agreements of the Company and Participant with respect to the subject
matter hereof.
5.14 Section 409A. Notwithstanding any other provision of the Plan, this Agreement or
the Grant Notice, the Plan, this Agreement and the Grant Notice shall be interpreted in accordance
with, and
B-7
incorporate the terms and conditions required by, Section 409A of the U.S. Internal Revenue
Code of 1986, as amended (together with any Department of Treasury regulations and other
interpretive guidance issued thereunder, including without limitation any such regulations or other
guidance that may be issued after the date hereof, Section 409A). The Committee may, in its
discretion, adopt such amendments to the Plan, this Agreement or the Grant Notice or adopt other
policies and procedures (including amendments, policies and procedures with retroactive effect), or
take any other actions, as the Committee determines are necessary or appropriate to comply with the
requirements of Section 409A.
B-8
Exhibit 10.6
EXHIBIT 10.6
Cadence Pharmaceuticals, Inc.
Amended and Restated Restricted
Common Stock Purchase Agreement
Table of Contents
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I.
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Purchase of Shares
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1.1 Purchase
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1.2 Payment
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II.
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Securities Law Compliance
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2.1 Restricted Securities
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2.2 Disposition of Shares
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2.3 Restrictive Legends
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III.
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Transfer Restrictions
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3.1 Restriction on Transfer
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3.2 Transferee Obligations
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3.3 Definition of Owner
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3.4 Market Stand-Off Provisions
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IV.
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Right of First Refusal
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4.1 Grant
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4.2 Notice of Intended Disposition
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4.3 Exercise of Right
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4.4 Non-Exercise of Right
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4.5 Partial Exercise of Right
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4.6 Recapitalization
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4.7 Lapse
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V.
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Marital Dissolution or Legal Separation
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5.1 Grant
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5.2 Notice of Decree or Agreement
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5.3 Exercise of the Special Purchase Right
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5.4 Lapse
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VI.
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Repurchase Option
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6.1 Repurchase Option
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6.2 Release of Shares From Repurchase Option
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6.3 Escrow of Shares
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6.4 Tax Consequences
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VII.
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General Provisions
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7.1 Assignment
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7.2 Definitions
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7.3 Notices
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7.4 No Waiver
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VIII.
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Miscellaneous Provisions
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8.1 Purchaser Undertaking
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8.2 Agreement is Entire Contract
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8.3 Governing Law
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8.4 Counterparts
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8.5 Successors and Assigns
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8.6 Amendment and Waiver
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8.7 Arbitration
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8.8 Acknowledgement
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Exhibit A Joint Escrow Instructions
Exhibit B Assignment Separate From Certificate
ii
Amended and Restated Restricted Common Stock Purchase Agreement
This Amended and Restated Restricted Common Stock Purchase Agreement (the
Agreement) is made as of this ___ day of November, 2004, by and between Cadence Pharmaceuticals,
Inc., a Delaware corporation (formerly known as Strata Pharmaceuticals, Inc.) (the Company), and
[PURCHASER] (Purchaser).
Recitals
A. On July 6, 2004, the Purchaser and the Company entered into a Restricted Common Stock
Purchase Agreement (the Prior Agreement) pursuant to which the Purchaser purchased certain shares
of the Companys Common Stock.
B. The Company and the Purchaser desire to amend and restate the Prior Agreement to grant the
Company a Repurchase Option with respect to the Purchasers Shares (as such terms are defined
below).
C. Pursuant to the terms of the Prior Agreement, the Prior Agreement may be amended with the
consent of a majority of the Companys Board of Directors, which consent has been obtained by the
Company, and the Purchaser.
Agreement
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants and
agreements herein contained, the parties, intending to be legally bound, hereby agree as follows:
I. Purchase of Shares
1.1 Purchase. Pursuant to the terms of the Prior Agreement, the Purchaser
purchased, and the Company sold to Purchaser, [NUMBER OF SHARES OF COMMON STOCK] shares of the
Companys Common Stock (the Shares) at a purchase price of $0.001 per share (the Purchase
Price), or $[PURCHASE PRICE] in the aggregate.
1.2 Payment. As of the date of the Prior Agreement, the Purchaser delivered
to the Corporate Secretary of the Company the aggregate Purchase Price payable for the Shares in
cash, cancellation of indebtedness or transfer of property. Concurrently with the execution of
this Agreement, the Purchaser shall deliver to the Corporate Secretary of the Company (i) duly
executed Joint Escrow Instructions (in the form attached hereto as Exhibit A), and (ii) a
duly executed blank Assignment Separate from Certificate (in the form attached hereto as
Exhibit B).
II. Securities Law Compliance
2.1 Restricted Securities.
(a) Purchaser hereby confirms that Purchaser has been informed that the Shares are restricted
securities under the Securities Act of 1933, as amended (1933 Act), and may not
1
be resold or
transferred unless the Shares are first registered under the federal securities laws or unless an
exemption from such registration is available. Accordingly, Purchaser hereby acknowledges that
Purchaser is prepared to hold the Shares for an indefinite period and that Purchaser is aware that
Rule 144 of the Securities and Exchange Commission (SEC) issued under the 1933 Act is not
presently available to exempt the sale of the Shares from the registration requirements of the 1933
Act.
(b) Upon the expiration of the ninety (90)-day period immediately following the date on which
the Company first becomes subject to the reporting requirements of the Securities Exchange Act of
1934, as amended (the Exchange Act), the Shares may be sold (without registration) pursuant to
the applicable requirements of Rule 144. If Purchaser is at the time of such sale an affiliate of
the Company for purposes of Rule 144 or was such an affiliate during the preceding three (3)
months, then the sale must comply with all the requirements of Rule 144 (including the volume
limitation on the number of shares sold, the broker/market-maker sale requirement and the requisite
notice to the SEC). If Purchaser is not at the time of the sale an affiliate of the Company nor
was such an affiliate during the preceding three (3) months, then none of the requirements of Rule
144 (other than the broker/market-maker sale requirement for Shares held for fewer than two (2)
years following payment in cash of the Purchase Price therefor) will be applicable to the sale.
The requirements of Rule 144 are subject to change at any time.
2.2 Disposition of Shares. Subject to the terms of this Agreement,
Purchaser hereby agrees that Purchaser shall make no disposition of the Shares (other than a
permitted transfer under paragraph 3.1) unless and until there is compliance with all of the
following requirements:
(a) Purchaser shall have notified the Company of the proposed disposition and provided a
written summary of the terms and conditions of the proposed disposition;
(b) Purchaser shall have complied with all requirements of this Agreement applicable to the
disposition of the Shares;
(c) Purchaser shall have provided the Company with written assurances, in form and substance
satisfactory to the Company, that (i) the proposed disposition does not require registration of the
Shares under the 1933 Act or (ii) all appropriate action necessary for compliance with the
registration requirements of the 1933 Act or of any exemption from registration available under the
1933 Act (including Rule 144) has been taken; and
(d) Purchaser shall have provided the Company with written assurances, in form and substance
satisfactory to the Company, that the proposed disposition will not result in the contravention of
any transfer restrictions applicable to the Shares.
The Company shall not be required (i) to transfer on its books any Shares which have
been sold or transferred in violation of the provisions of this Article II nor (ii) to
treat as the owner of the Shares, or otherwise to accord voting or dividend rights to, any
transferee to whom the Shares have been transferred in contravention of this Agreement.
2
2.3 Restrictive Legends. In order to reflect the restrictions on
disposition of the Shares, the stock certificates for the Shares will be endorsed with restrictive
legends, including one or more of the following legends:
(a) 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.
(b) 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.
III. Transfer Restrictions
3.1 Restriction on Transfer. Except for the escrow described below in
Article VI, none of the Shares or any beneficial interest therein shall be transferred, assigned,
encumbered or otherwise made the subject of disposition until the release of such Shares from the
Repurchase Option in accordance with the provisions of this Agreement. In addition, the Shares
shall not be transferred, assigned, encumbered or otherwise made the subject of disposition in
contravention of the Companys First Refusal Right under Article IV or Special Purchase Right under
Article V or as otherwise limited herein. The restrictions on transfer set forth under Article IV
and Article V, however, shall not be applicable to (i) a gratuitous transfer of the Shares
made to the [EXECUTIVE OFFICER ONLY: Purchasers] siblings, spouse, lineal descendent or
antecedent, including adopted children and stepchildren, [DIRECTOR ONLY: of the Director (as
defined below)] or to a trust for the exclusive benefit of the [EXECUTIVE OFFICER ONLY: Purchaser]
[DIRECTOR ONLY: Director] or the [EXECUTIVE OFFICER ONLY: Purchasers] [DIRECTOR ONLY: Directors]
siblings, spouse or issue, provided and only if the Purchaser obtains the Companys prior written
consent to such transfer and such transferee agrees to be bound by the terms of this Agreement,
(ii) a transfer of title to the Shares effected pursuant to the Purchasers will or the laws of
intestate succession or (iii) a transfer to the Company in pledge as security for any
purchase-money indebtedness incurred by the Purchaser in connection with the acquisition of the
Shares [DIRECTOR ONLY: or (iv) to any affiliate of the Purchaser].
3.2 Transferee Obligations. Each person (other than the Company) to whom
the Shares are transferred by means of one of the permitted transfers specified in paragraph 3.1
must, as a condition precedent to the validity of such transfer, acknowledge in writing to the
Company that such person is bound by the provisions of this Agreement and that the transferred
shares are subject to (i) the Companys First Refusal Right and Special Purchase Right granted
hereunder and (ii) the market stand-off provisions of paragraph 3.4, to the same extent such Shares
would be so subject if retained by the Purchaser.
3
3.3 Definition of Owner. For purposes of this Agreement, the term Owner
shall include the Purchaser and all subsequent holders of the Shares who derive their chain of
ownership through a permitted transfer from the Purchaser in accordance with paragraph 3.1.
3.4 Market Stand-Off Provisions.
(a) In connection with any underwritten public offering by the Company of its equity
securities pursuant to an effective registration statement filed under the 1933 Act, Owner shall
not sell, make any short sale of, loan, hypothecate, pledge, grant any option for the purchase of,
or otherwise dispose or transfer for value or otherwise agree to engage in any of the foregoing
transactions with respect to, any Shares without the prior written consent of the Company or its
underwriters. Such limitations shall be in effect for such period of time from and after the
effective date of such registration statement as may be requested by the Company or such
underwriters; provided, however, that in no event shall such period exceed one hundred-eighty (180)
days.
(b) Owner shall be subject to the market stand-off provisions of this paragraph 3.4 provided
and only if the executive officers and directors of the Company are also subject to similar
arrangements.
(c) In the event of any stock dividend, stock split, recapitalization or other change
affecting the Companys outstanding Common Stock effected without receipt of consideration, then
any new, substituted or additional securities distributed with respect to the Shares shall be
immediately subject to the provisions of this paragraph 3.4, to the same extent the Shares are at
such time covered by such provisions.
(d) In order to enforce the limitations of this paragraph 3.4, the Company may impose
stop-transfer instructions with respect to the Shares until the end of the applicable stand-off
period.
IV. Right of First Refusal
4.1 Grant. The Company is hereby granted the right of first refusal (the
First Refusal Right), exercisable in connection with any proposed transfer of the Shares. For
purposes of this
Article IV, the term transfer shall include any sale, assignment, pledge, encumbrance or
other disposition for value of the Shares intended to be made by the Owner, but shall exclude any
of the permitted transfers under paragraph 3.1.
4.2 Notice of Intended Disposition. In the event the Owner desires to
accept a bona fide third-party offer for any or all of the Shares (the shares subject to such offer
to be hereinafter called the Target Shares), Owner shall promptly (i) deliver to the Corporate
Secretary of the Company written notice (the Disposition Notice) of the terms and conditions of
the offer, including the purchase price and the identity of the third-party offeror and (ii)
provide satisfactory proof that the disposition of the Target Shares to such third-party offeror
would not be in contravention of the provisions set forth in Articles II and III of this Agreement.
4.3 Exercise of Right. The Company (or its assignees) shall, for a period
of twenty-five (25) days following receipt of the Disposition Notice, have the right to repurchase
any or all
4
of the Target Shares specified in the Disposition Notice upon substantially the same
terms and conditions specified therein. Such right shall be exercisable by delivery of written
notice (the Exercise Notice) to Owner prior to the expiration of the twenty-five (25) day
exercise period. If such right is exercised with respect to all the Target Shares specified in the
Disposition Notice, then the Company (or its assignees) shall effect the repurchase of the Target
Shares, including payment of the purchase price, not more than five (5) business days after
delivery of the Exercise Notice; and at such time Owner shall deliver to the Company the
certificates representing the Target Shares to be repurchased, each certificate to be properly
endorsed for transfer.
4.4 Non-Exercise of Right. In the event the Exercise Notice is not given to
Owner within twenty-five (25) days following the date of the Companys receipt of the Disposition
Notice, Owner shall have a period of thirty (30) days thereafter in which to sell or otherwise
dispose of the Target Shares to the third-party offeror identified in the Disposition Notice upon
terms and conditions (including the purchase price) no more favorable to such third-party offeror
than those specified in the Disposition Notice; provided, however, that any such sale or
disposition must not be effected in contravention of the provisions of Article II of this
Agreement. The acquired shares shall remain subject to (i) the securities law restrictions under
Article II, (ii) the market stand-off provisions of paragraph 3.4, (iii) the Companys First
Refusal Rights hereunder and (iv) Article V.
4.5 Partial Exercise of Right. In the event the Company (or its assignees)
makes a timely exercise of the First Refusal Right with respect to a portion, but not all, of the
Target Shares specified in the Disposition Notice, Owner shall have the option, exercisable by
written notice to the Company delivered within thirty (30) days after the date of the Disposition
Notice, to effect the sale of the Target Shares pursuant to one of the following alternatives:
(a) sale or other disposition of all the Target Shares to the third-party offeror identified
in the Disposition Notice, but in full compliance with the requirements of paragraph 4.4, as if the
Company did not exercise the First Refusal Right hereunder; or
(b) sale to the Company (or its assignees) of the portion of the Target Shares which the
Company (or its assignees) has elected to purchase, such sale to be effected in substantial
conformity with the provisions of paragraph 4.3.
Failure of Owner to deliver timely notification to the Company under this paragraph 4.5 shall
be deemed to be an election by Owner to sell the Target Shares pursuant to alternative (a) above.
4.6 Recapitalization. In the event of any stock dividend, stock split,
recapitalization or other transaction affecting the Companys outstanding Common Stock as a class
effected without receipt of consideration, then any new, substituted or additional securities or
other property which is by reason of such transaction distributed with respect to the Shares shall
be immediately subject to the Companys First Refusal Right hereunder, but only to the extent the
Shares are at the time covered by such right.
4.7 Lapse. The First Refusal Right under this Article IV shall remain in
effect under all circumstances but shall lapse and cease to have effect upon the earliest
to occur of (i) the first
5
date on which shares of the Companys Common Stock are held of record by
more than five hundred (500) persons, (ii) a determination is made by the Companys Board of
Directors that a public market exists for the outstanding shares of the Companys Common Stock,
(iii) an underwritten public offering pursuant to an effective registration statement under the
1933 Act or (iv) a Change of Control (as defined below). However, the market stand-off provisions
of paragraph 4.4 shall continue to remain in full force and effect following the lapse of the First
Refusal Right hereunder.
V. Marital Dissolution or Legal Separation
5.1 Grant. Notwithstanding anything in this Agreement to the contrary, in
connection with the dissolution of Owners marriage or the legal separation of Owner and Owners
spouse, the Company shall have the right (the Special Purchase Right) [DIRECTOR ONLY: if
applicable,] to purchase from Owners spouse, in accordance with the provisions of this Article V,
all or any portion of the Shares which would otherwise be awarded to such spouse in settlement of
any community property or other marital property rights such spouse may have in such shares.
5.2 Notice of Decree or Agreement. Owner shall promptly provide the Company with written notice (the Dissolution Notice) of (i)
the entry of any judicial decree or order resolving the property rights of Owner and Owners spouse
in connection with their marital dissolution or legal separation or (ii) the execution of any
contract or agreement relating to the distribution or division of such property rights. The
Dissolution Notice shall be accompanied by a copy of the actual decree or order of dissolution or
contract or agreement between Owner and Owners spouse which provides for the award to the spouse
of one or more Shares in settlement of any community property or other marital property rights such
spouse may have in such shares.
5.3 Exercise of the Special Purchase Right. The Special Purchase Right
shall be exercisable by delivery of written notice (the Purchase Notice) to Owner and Owners
spouse within forty-five (45) days after the Companys receipt of the Dissolution Notice. The
Purchase Notice shall indicate the number of Shares to be purchased by the Company, the date such
purchase is to be effected (such date to be not less than five (5) business days, nor more than
fifteen (15) business days, after the date of the Purchase Notice) and the fair market value to be
paid for such Shares. Owner (or Owners spouse, to the extent such spouse has physical possession
of the Shares) shall, prior to the close of business on the date specified for the purchase,
deliver to the Company the certificates representing the shares to be purchased. The Company
shall, concurrently with the receipt of the stock certificates, pay to Owners spouse (in cash or
cash equivalents) an amount equal to the fair market value specified for such shares in the
Purchase Notice.
If Owners spouse does not agree with the fair market value specified for the Shares in the
Purchase Notice, then the spouse shall promptly notify the Company in writing of such disagreement
and the fair market value of such Shares shall thereupon be determined by an appraiser of
recognized standing selected by the Company and the spouse. If they cannot agree on an appraiser
within fifteen (15) days after the date of the Purchase Notice, each shall select an appraiser of
recognized standing, and the two (2) appraisers shall designate a third appraiser of recognized
standing whose appraisal shall be determinative of such value. The cost of the
6
appraisal shall be
shared equally by the Company and Owners spouse. The closing shall then be held on the fifteenth
(15th) business day following the completion of such appraisal; provided, however, that if the
appraised value is more than twenty-five percent (25%) greater than the fair market value specified
for the Shares in the Purchase Notice, the Company shall have the right, exercisable prior to the
expiration of such fifteen (15) business-day period, to rescind the exercise of the Special
Purchase Right and thereby revoke its election to purchase the Shares awarded to the spouse.
5.4 Lapse. The Special Purchase Right shall lapse upon the earlier
to occur of (i) the lapse of the First Refusal Right or (ii) the expiration of the exercise period
specified in this Article V, to the extent the Special Purchase Right is not timely exercised in
accordance with such paragraph.
VI. Repurchase Option
6.1 Repurchase Option. In the event of any voluntary or involuntary termination of the [EXECUTIVE OFFICER ONLY:
Purchasers employment by, or services to,] [DIRECTOR ONLY: service of [RELATED DIRECTOR] (the
Director) as a director of] the Company for any or no reason (including death or disability)
before all of the Shares are released from the Companys Repurchase Option (as defined below), the
Company shall, upon the date of such termination (as reasonably fixed and determined by the
Company), have an irrevocable, exclusive option, but not the obligation, for a period of 90 days
from such date to repurchase all or any portion of the Unreleased Shares (as defined below in
paragraph 6.2) at such time (the Repurchase Option) at the original purchase price per share (the
Repurchase Price). The Repurchase Option shall be exercisable by the Company by written notice to
the Purchaser or the Purchasers executor and shall be exercisable by delivery to the Purchaser or
the Purchasers executor of cash, check or wire transfer in an amount equal to the Repurchase Price
times the number of Shares to be repurchased (the Aggregate Repurchase Price). Upon delivery of
such notice and the payment of the Aggregate Repurchase Price, the Company shall become the legal
and beneficial owner of the Shares being repurchased and all rights and interests therein or
relating thereto, and the Company shall have the right to retain and transfer to its own name the
number of Shares being repurchased by the Company.
6.2 Release of Shares From Repurchase Option.
(a) The Shares shall be released from the Companys Repurchase Option pursuant to the
following schedule:
25% of the Shares are immediately released from, and shall
not be subject to, the Repurchase Option. As of July 6,
2004 (the Vesting Commencement Date), the remaining 75% of
the Shares shall be subject to the Repurchase Option.
1/48th of such Shares shall be released from the Repurchase
Option on each monthly anniversary of the Vesting
Commencement Date thereafter, such that all Shares shall be
released from the Repurchase Option on the
7
four (4) year
anniversary of the Vesting Commencement Date.
Any of the Shares which, from time to time, have not yet been released from the Repurchase
Option are referred to herein as Unreleased Shares. The number of Shares released each month
and/or year, as applicable, from the Repurchase Option shall be rounded down to the next whole
number of Option Shares, except in the last month of the four (4) year period when all Unreleased
Shares shall be released from the Repurchase Option.
(b) Upon an Acceleration Event (as defined below), the Repurchase Option shall lapse for 100%
of the Unreleased Shares (if any). An Acceleration Event shall mean any of the following:
(1) The termination by the Company of the [EXECUTIVE OFFICER ONLY: Purchasers employment
with] [DIRECTOR ONLY: Directors service as a director of] the Company for any reason other than
Cause (as defined below). [EXECUTIVE OFFICER
ONLY: Unless otherwise defined in an employment or services agreement between the Purchaser
and the Company (which definition will control),] Cause shall mean dishonesty, fraud, misconduct,
unauthorized use or disclosure of confidential information or trade secrets, or conviction or
confession of a crime punishable by law (except minor violations), in each case as determined by
the Board of Directors of the Company, and its determination shall be conclusive and binding; or
(2) [EXECUTIVE OFFICER ONLY: The termination by the Purchaser of the Purchasers employment
with the Company for Good Reason (as defined below). Unless otherwise defined in an employment or
services agreement between the Purchaser and the Company (which definition will control), Good
Reason shall mean the occurrence of any of the following events or conditions and the failure of
the Company or any successor corporation, as applicable, to cure such event or condition within
thirty (30) days after receipt of written notice from the Purchaser:
(i) a change in the Purchasers position or responsibilities (including reporting
responsibilities) that represents a substantial reduction in the position or responsibilities as in
effect immediately prior thereto; the assignment to the Purchaser of any duties or responsibilities
that are materially inconsistent with such position or responsibilities; or any removal of the
Purchaser from or failure to reappoint or reelect the Purchaser to any of such positions, except in
connection with the termination of the Purchasers employment for Cause, as a result of his or her
disability or death, or by the Purchaser other than for Good Reason;
(ii) a material reduction in the Purchasers annual base salary, except in connection with a
general reduction in the compensation of all personnel of the Company and its parent and
subsidiaries, if any;
(iii) the Company requiring the Purchaser (without the Purchasers consent) to be based at any
place outside a 50-mile radius of his or her principal place of employment with the Company, except
for reasonably required travel on the Companys business;
8
(iv) a material reduction in the Purchasers aggregate benefits (in terms of benefit levels
and/or reward opportunities) provided for under each material employee benefit plan, program and
practice of the Company, except in connection with a general reduction in the benefits of all
personnel of the Company and its parent and subsidiaries, if any; or
(v) any material breach by the Company of its obligations to the Purchaser under any
applicable employment or services agreement between the Purchaser and the Company.]
(c) In the event of a Change of Control, the Repurchase Option shall lapse for (i) [EXECUTIVE
OFFICER ONLY: 50%] [DIRECTOR ONLY: 100%] of the Unreleased Shares (if any) at the time of the
Change of Control [EXECUTIVE OFFICER ONLY: and (ii) the remaining Unreleased Shares (if any) on the
twelve month anniversary of the Change of Control. In the event an Acceleration Event occurs
between the Change of Control and the twelve month
anniversary of the Change of Control the provisions of paragraph 6.2(b) above shall apply.] A
Change of Control shall mean (1) a merger or consolidation of the Company with or into any other
corporation or other entity or person or (2) a sale, lease, exchange or other transfer in one
transaction or a series of related transactions of all or substantially all the Companys
outstanding securities or all or substantially all the Companys assets; provided 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.
(d) Subject to paragraph 6.3, the Shares which have been released from the Repurchase Option
shall be delivered to the Purchaser at the Purchasers request.
6.3 Escrow of Shares. Pursuant to the terms of the Joint Escrow
Instructions attached hereto as Exhibit A, the Shares issued under this Agreement shall be
held by the Escrow Agent (as defined in such Joint Escrow Instructions) along with a stock
assignment executed by the Purchaser in blank in the form attached hereto as Exhibit B.
Notwithstanding the vesting set forth in paragraph 6.2 above, neither the Company nor the Escrow
Agent shall be required to release or issue certificates evidencing the Shares to the Purchaser
more frequently than twice in any calendar year.
6.4 Tax Consequences. The Purchaser has reviewed with the Purchasers own
tax advisors the federal, state, local and foreign tax consequences of the transactions
contemplated by this Agreement. The Purchaser is relying solely on such advisors and not on any
statements or representations of the Company or any of its agents. The Purchaser understands that
the Purchaser (and not the Company) shall be responsible for the Purchasers own tax liability that
may arise as a result of the transactions contemplated by this Agreement.
9
VII. General Provisions
7.1 Assignment. The Company may assign its First Refusal Right under
Article IV and/or its Special Purchase Rights under Article V and/or its Repurchase Option under
Article VI to any person or entity selected by the Companys Board of Directors, including (without
limitation) one or more stockholders of the Company.
7.2 Definitions. For purposes of this Agreement, the following provisions shall be applicable in determining
the parent and subsidiary corporations of the Company:
(1) any corporation (other than the Company) in an unbroken chain of corporations ending with
the Company shall be considered to be a parent corporation of the Company, provided each such
corporation in the unbroken chain (other than the Company) owns, at the time of the determination,
stock possessing fifty percent (50%) or more of the total combined voting power of all classes of
stock in one of the other corporations in such chain, and
(2) each corporation (other than the Company) in an unbroken chain of corporations beginning
with the Company shall be considered to be a subsidiary of the Company, provided each such
corporation (other than the last corporation) in the unbroken chain owns, at the time of the
determination, stock possessing fifty percent (50%) or more of the total combined voting power of
all classes of stock in one of the other corporations in such chain.
7.3 Notices. Any notice required in connection with (i) the First Refusal
Right, Special Purchase Right or the Repurchase Option or (ii) the disposition of any Shares
covered thereby shall be given in writing and shall be deemed effective upon personal delivery or
upon deposit in the United States mail, registered or certified, postage prepaid and addressed to
the party entitled to such notice at the address indicated below such partys signature line on
this Agreement or at such other address as such party may designate by ten (10) days advance
written notice under this paragraph 7.3 to all other parties to this Agreement.
7.4 No Waiver. The failure of the Company (or its assignees) in any
instance to exercise the First Refusal Right, Special Purchase Right or the Repurchase Option shall
not constitute a waiver of any other repurchase right and/or right of first refusal that may
subsequently arise under the provisions of this Agreement or any other agreement between the
Company and the Purchaser or the Purchasers spouse. No waiver of any breach or condition of this
Agreement shall be deemed to be a waiver of any other or subsequent breach or condition, whether of
like or different nature.
VIII. Miscellaneous Provisions
8.1 Purchaser Undertaking. Purchaser hereby agrees to take whatever
additional action and execute whatever additional documents the Company may in its judgment deem
necessary or advisable in order to carry out or effect one or more of the obligations or
restrictions imposed on either the Purchaser or the Shares pursuant to the express provisions of
this Agreement.
8.2 Agreement is Entire Contract. This Agreement constitutes the entire
contract between the parties hereto with regard to the subject matter hereof.
10
8.3 Governing Law. This Agreement shall be governed by, and construed in
accordance with, the laws of the State of California, as such laws are applied to contracts entered
into and performed in such State without resort to that States conflict-of-laws rules.
8.4 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed to be an original, but all of which together shall constitute one and the
same instrument.
8.5 Successors and Assigns. The provisions of this Agreement shall inure to
the benefit of, and be binding upon, the Company and its successors and assigns and the Purchaser
and the Purchasers legal representatives, heirs, legatees, distributees, assigns and transferees
by operation of law, whether or not any such person shall have become a party to this Agreement and
have agreed in writing to join herein and be bound by the terms and conditions hereof.
8.6 Amendment and Waiver. This Agreement shall not be amended nor any
Section hereof waived by the Company in the absence of approval of such amendment or waiver by a
majority of the Companys Board of Directors.
8.7 Arbitration. Any controversy between the parties hereto involving any
claim arising out of or relating to this Agreement shall be finally settled by arbitration in San
Diego, California, in accordance with the then current Employment ADR Rules of the American
Arbitration Association, and judgment upon the award rendered by the arbitrators may be entered in
any court having jurisdiction thereof.
8.8 Acknowledgement. PURCHASER ACKNOWLEDGES AND AGREES THAT THE LAPSING OF
THE REPURCHASE OPTION PURSUANT TO ARTICLE VI HEREOF IS EARNED ONLY BY CONTINUING SERVICE AS AN AT
WILL EMPLOYEE AND/OR DIRECTOR, AS APPLICABLE, OF THE COMPANY (AND NOT THROUGH THE ACT OF BEING
HIRED OR PURCHASING SHARES HEREUNDER). PURCHASER FURTHER ACKNOWLEDGES AND AGREES THAT THIS
AGREEMENT, THE TRANSACTIONS CONTEMPLATED HEREUNDER AND THE REPURCHASE OPTION SCHEDULE SET FORTH
HEREIN DO NOT CONSTITUTE AN EXPRESS OR IMPLIED PROMISE OF CONTINUED ENGAGEMENT AS AN EMPLOYEE
AND/OR DIRECTOR FOR SUCH PERIOD, FOR ANY PERIOD, OR AT ALL, AND SHALL NOT INTERFERE WITH THE
COMPANYS RIGHT TO TERMINATE PURCHASERS EMPLOYMENT AND/OR SERVICE WITH THE COMPANY AT ANY TIME,
WITH OR WITHOUT CAUSE.
[Remainder of Page Intentionally Left Blank]
11
In Witness Whereof, the parties have executed this Agreement on the day and year
first indicated above.
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THE COMPANY:
Cadence Pharmaceuticals, Inc.
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By: |
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Name: |
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Title: |
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Address: |
12730 High Bluff Drive Suite 410 San Diego, CA 92130 |
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PURCHASER:
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By: |
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Name: |
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Address: |
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Schedule to Exhibit 10.6: The form of Amended and Restated Restricted Common Stock Purchase
Agreement above was executed by the following persons or entities with respect to the number of
shares and purchase prices listed:
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NUMBER OF SHARES |
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PURCHASE |
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RELATED |
PURCHASER |
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OF COMMON STOCK |
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PRICE |
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DIRECTOR |
Theodore R. Schroeder |
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1,000,000 |
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$ |
1,000.00 |
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N/A |
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David A. Socks |
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850,000 |
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$ |
850.00 |
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N/A |
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Garner Investments, LLC |
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1,750,000 |
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$ |
1,750.00 |
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Cam L. Garner |
Exhibit 10.7
EXHIBIT 10.7
CONFIDENTIAL
CADENCE PHARMACEUTICALS, INC
2006 Corporate Bonus Plan
Cadence Pharmaceuticals, Inc.
1
CONFIDENTIAL
2006 Corporate Bonus Plan
The Cadence Pharmaceuticals, Inc. (Cadence or the Company) Corporate Bonus Plan (the Plan) is
designed to offer incentive compensation to eligible Employees by rewarding the achievement of
corporate objectives and specifically measured individual objectives that are consistent with and
support overall corporate objectives. Since cooperation between departments and Employees will be
required to achieve corporate objectives that represent a significant portion of the Plan, the Plan
should help foster teamwork and build a cohesive management team.
Purpose of the Plan
The Plan is designed to:
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Encourage high performance by providing an incentive program to achieve overall corporate
objectives and to enhance shareholder value |
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Reward those individuals who significantly impact corporate results |
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Encourage increased teamwork among all disciplines within Cadence |
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Incorporate an incentive program in the Cadence overall compensation program to help attract
and retain Employees, and |
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Incentivize eligible Employees to remain employed by Cadence throughout the Plan year and
until the time incentive awards are paid |
Plan Governance
The Plan
will be governed by the Compensation Committee of the Board of Directors (the Compensation
Committee). The President and / or CEO of Cadence will be responsible for the administration of
the Plan. The Compensation Committee will be responsible for approving any compensation or
incentive awards to officers of the Company. All determinations of the Compensation Committee,
under the Plan, shall be final and binding on all Plan participants.
Eligibility
All exempt Full Time Employees Level 8 (Associate Director) or higher are eligible to participate
in the Plan. To receive an incentive award, a participant: (a) must have
2
CONFIDENTIAL
been in an eligible position for at least three (3) full consecutive months prior to the end
of the Plan year, and must remain employed through the end of the Plan year and until incentive
awards are paid; and (b) must not be on probation at the time bonus determinations are made.
Form of Incentive Award Payments
Incentive award payments may be made in cash, through the issuance of stock or stock options, or by
a combination of cash, stock and/or stock options, at the discretion of the Compensation Committee.
In the event that the Compensation Committee and / or the Board of Directors elect to pay
incentive awards in stock or stock options, the Compensation Committee, in its sole discretion,
will make a determination as to the number of shares of stock or stock options to be issued to each
Plan participant based, in part, upon the overall corporate performance and each participants
individual performance, as described below. The issuance of stock and stock options may also be
subject to the approval of the Companys stockholders, and any stock options issued will be subject
to the terms and conditions of the Companys 2004 Equity Incentive Award Plan, as amended from time
to time by the Company.
Bonus Percentage
Incentive
Awards will be determined by applying a bonus percentage to the base salary of
participants in the Plan. The following bonus percentages will be used for this purpose:
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Grade Level |
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Position Title |
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Bonus Percentage |
12 |
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CEO |
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40% |
11 |
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EVP, SVP, CFO, CMO |
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30% |
10 |
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VP |
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25% |
9 |
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Sr. Director |
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20% |
8 |
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Associate Director, Director, Controller |
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15% |
Corporate and Individual Performance Factors
The President and / or CEO will present to the Compensation Committee a list of the overall
corporate objectives for 2006, which are subject to approval by the Compensation Committee. All
participants in the Plan will then develop a list of key individual objectives, which must be
approved by the responsible Vice President or Senior Vice President and by the President and / or
CEO.
The Plan calls for incentive awards based on the achievement of annual corporate and individual
objectives that have been approved as indicated above.
3
CONFIDENTIAL
The relative weight between corporate and individual performance factors varies based on the
individuals assigned grade level within the organization. The weighting may be reviewed
periodically and may be adjusted, as necessary or appropriate. The weighting for the 2006
performance factors will be as follows:
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Corporate |
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Individual |
President or CEO |
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(Grades 12) |
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100% |
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SVPs/VPs |
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(Grades 10-11) |
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80% |
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20% |
All Others |
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(Grades 8-9) |
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60% |
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40% |
Performance Award Multiplier
The following scale will be used to determine the actual performance award multiplier for incentive
award calculations based upon the measurement of corporate and individual performance objectives.
Separate payment multipliers will be established for both the corporate and the individual
components of each award. The same payment multiplier for the corporate component each
participants annual award shall be used for all Plan participants in any given year. The award
multiplier for the corporate component shall be determined by the Compensation Committee, in its
sole discretion.
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Performance Category |
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Award Multiplier |
1. |
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Performance for the year met or exceeded objectives or was excellent in view of prevailing conditions |
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75% - 150% |
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2. |
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Performance generally met the years objectives or was very acceptable in view of prevailing conditions |
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50% - 75% |
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3. |
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Performance for the year met some, but not all, objectives |
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25% - 50% |
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4. |
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Performance for the year was not acceptable in view of prevailing conditions |
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0% |
Calculation of Cash Incentive Award
The
example below shows a sample cash incentive award calculation under the
Plan, which is determined after the end of the performance period. Step #1: a potential
base bonus award is calculated by multiplying the Employees base salary by their assigned grade
level bonus percentage. Step #2: The calculated potential base bonus amount is then split
between the corporate and individual performance factors by the Employees assigned grade level
(per the weighting above). This calculation establishes specific potential dollar awards for the
performance period for both the individual and corporate performance factor components.
Step #3: After the end of the performance period, corporate and individual award
multipliers will be established using the criteria described above. The corporate
4
CONFIDENTIAL
award multiplier, which is based on overall corporate performance, is used to calculate
corporate performance awards for all Plan participants. This is accomplished by multiplying the
bonus percentage established for each individual at the beginning of the performance period by the
actual corporate award multiplier. The individual award multiplier, which is based on an
individuals performance against objectives, is used in the same way to calculate the actual
individual performance award.
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Example: |
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Step # 1:
Potential Base Bonus Award Calculation |
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Position: |
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Manager | |
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Base salary: |
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$ |
100,000 |
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Bonus percentage: |
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10 |
% |
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Potential base bonus: |
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$ |
10,000 |
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Step # 2:
Split award amount based on Performance Factors |
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Potential corporate performance bonus (50%): |
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5,000 |
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Potential individual performance bonus (50%): |
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5,000 |
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Step #
3: Actual Cash Incentive Award Calculation |
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Assumed payment multipliers based on assessment of corporate and individual performance: |
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Corporate multiplier |
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75 |
%-performance generally met objectives |
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Individual multiplier |
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125 |
%-performance generally exceeded objectives |
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Cash Award: |
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Corporate component |
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3,750 |
($5,000 x 75%) |
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Individual component |
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$ |
6,250 |
($5,000 x 125%) |
Payment of the Incentive Award
Payment of
incentive awards will be made as soon as practicable after the end of the Plan year
but not before the completion and issuance of the Companys year-end audited Financial Statements. Incentive award calculations will be based on
the participants base salary as of December 31, 2006. Participants entitlement
to an incentive award under this Plan does not vest until the awards are actually
paid.
Participants who have been in an eligible position for less than a year, but who hold an eligible
position for at least three months prior to the end of the Plan year and remain continuously
employed through the end of the Plan year, will receive a pro-rata bonus based on the portion of
the Plan year they hold an eligible position. Participants promoted during the year from one Bonus
percentage level to another will have their Incentive Award calculated using their base pay on
December 31, 2006. Providing the promotion occurred after April 30, 2006 but prior to October 1,
2006, the calculation will be pro-rated, based on the number of months at each bonus percentage
level. If the promotion occurred after October 1, 2006, the entire calculation will be based on the
bonus percentage applicable prior to the promotion. For those Employees working less than full time
(40 hours / week), the calculated award will be pro-rated based on the actual average hours worked
per week during the performance period as a
5
CONFIDENTIAL
percent of a full time equivalent. Other than as stated above, incentive awards will not be
pro-rated for partial year service.
Termination
A Plan participant whose employment terminates voluntarily prior to the payment of the incentive
awards, will not be eligible to receive an incentive award. Continued employment until payment of
the incentive award is a condition of vesting. If a participants employment is terminated
involuntarily during the calendar year, or prior to payment of awards, it will be at the absolute
discretion of the Company whether or not an award payment is made.
Compensation Committees Absolute Right to Alter or Abolish the Plan
The Compensation Committee reserves the right in its absolute discretion to abolish the Plan at any
time or to alter the terms and conditions under which incentive compensation will be paid. Such
discretion may be exercised any time before, during, and after the Plan year is completed. No
participant shall have any vested right to receive any compensation hereunder until actual delivery
of such compensation.
Employment Duration/Employment Relationship
This Plan does not, and Cadences policies and practices in administering this Plan do not,
constitute an express or implied contract or other agreement concerning the duration of
any participants employement with the Company. The employment relationship of each participant is at
will and may be terminated at any time by Cadence or by the participant, with or without cause.
6
CONFIDENTIAL
Cadence Pharmaceuticals, Inc.
2006 Bonus Plan
This is to acknowledge that I have received a copy of the 2006 Bonus Plan.
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Name:
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Date: |
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(print) |
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(signature)
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Please return signed copy to Ted Schroeder. |
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7
Exhibit 23.1
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the reference to our firm under the caption Experts and to the use of our
report dated April 21, 2006, in Amendment No. 1 to the Registration Statement (Form
S-1 No. 333-135821) and related
Prospectus of Cadence Pharmaceuticals, Inc. for the registration of
its shares of common stock.
San Diego, California
August 28, 2006
exv24w2
Exhibit 24.2
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that the 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 to the
Registration Statement on Form S-1 (SEC File No. 333-135821), including post-effective amendments
or any abbreviated registration statement and any amendments thereto filed 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.
Corresondence
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12636 High Bluff Drive, Suite 400 |
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San Diego, California 92130-2071 |
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Tel: (858) 523-5400 Fax: (858) 523-5450 |
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www.lw.com |
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FIRM / AFFILIATE OFFICES |
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Brussels
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New York |
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Chicago
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Northern Virginia |
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Frankfurt
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Orange County |
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Hamburg
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Paris |
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Hong Kong
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San Diego |
August 30, 2006
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London
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San Francisco |
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Los Angeles
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Shanghai |
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Milan
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Silicon Valley |
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Moscow
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Singapore |
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Munich
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Tokyo |
Jeffrey Riedler
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New Jersey
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Washington, D.C. |
Assistant Director |
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Division of Corporation Finance |
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File No. 038916-0007 |
Securities and Exchange Commission |
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100 F Street, N.E. |
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Mail Stop 7010 |
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Washington, D.C. 20549 |
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Re:
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Cadence Pharmaceuticals, Inc. |
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Amendment No. 1 to Registration Statement on Form S-1 |
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Filed August 30, 2006 |
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SEC File No. 333-135821 |
Dear Mr. Riedler:
We are in receipt of the Staffs letter dated August 10, 2006 with respect to the
above-referenced Registration Statement. We are responding to the Staffs comments on behalf of
Cadence Pharmaceuticals, Inc. (Cadence or the Company) as set forth below. Simultaneously with
the filing of this letter, Cadence is submitting (by EDGAR) Amendment No. 1 to its Registration
Statement on Form S-1 (the Amendment), responding to the Staffs comments. Courtesy copies of
this letter and the Amendment (specifically marked to show the changes thereto) are being submitted
to the Staff by hand delivery.
Cadences responses set forth in this letter are numbered to correspond to the numbered
comments in the Staffs letter. All terms used but not defined herein have the meanings assigned
to such terms in the Amendment. For ease of reference, we have set forth the Staffs comments and
Cadences response for each item below.
General
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1. |
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We have received your confidential treatment request. Our comments regarding
this request, if any, will be sent under separate cover at a later date. All comments
will need to be resolved prior to effectiveness. |
Cadences Response: Cadence acknowledges the Staffs comment, and looks forward to receiving any
comments the Staff may have on the confidential treatment request.
Jeffrey Riedler
August 30, 2006
Page 2
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2. |
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Please provide us proofs of all graphic, visual, or photographic information
you will provide in the printed prospectus prior to its use, for example in a
preliminary prospectus. Please note we may have comments regarding these materials. |
Cadences Response: The courtesy copy of the Registration Statement previously provided to the
Staff included Cadences corporate logo on the inside front cover and a graph on page 59. Cadence
confirms that it does not intend to use any other graphic, visual or photographic materials in the
prospectus.
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3. |
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Please note that when you file a pre-effective amendment containing
pricing-related information, we may have additional comments. As you are likely aware,
you must file this amendment prior to circulating the prospectus. |
Cadences Response: Cadence acknowledges the Staffs comment and will include pricing-related
information in a pre-effective amendment to the Registration Statement prior to circulating the
preliminary prospectus for the offering.
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4. |
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Please note that when you file a pre-effective amendment that includes your
price range, it must be bona fide. We interpret this to mean your range may not exceed
$2 if you price below $20 and 10% if you price above $20. |
Cadences Response: Cadence acknowledges the Staffs comment and will include a bona fide price
range in a pre-effective amendment to the Registration Statement prior to circulating the
preliminary prospectus for the offering.
Prospectus Summary, page 1
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5. |
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We note the statement in the second full paragraph on page 2 that IV APAP has
undergone six Phase III trials. Please discuss any difficulties or other issues that
have necessitated six Phase III trials rather than just one. If the number of trials
is caused only by multiple indications, disclose that fact. |
Cadences Response: Cadence has revised the Amendment to clarify that the six Phase III trials in
which IV APAP has previously been studied focused on pain and fever in adult and pediatric
subjects and fever in pediatric subjects. Please refer to the revisions on page 2 of the Amendment.
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6. |
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We note you expect to submit a new drug application for IV APAP in the second
half of 2008 if the Phase III trial results are positive. Please state, as you mention
on page 3, that the FDA might require you to perform additional trials. Also state
that you might not ever obtain approval for IV APAP in the United States. |
Cadences Response: Cadence has revised the Amendment under the heading Prospectus Summary Risk
Factors in accordance with the Staffs comment to disclose that Cadence cannot be certain that its
planned clinical trials will be sufficient for regulatory approval or that either of its product
candidates will receive regulatory approval. Cadence believes the most
Jeffrey Riedler
August 30, 2006
Page 3
appropriate location for this cautionary disclosure in the Prospectus Summary Risk Factors
subsection, where Cadence summarizes the most significant risks relating to its business. Please
refer to the revisions on page 4 of the Amendment.
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7. |
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Please explain what the special protocol assessment process is where you use
this term at the bottom of page 2. Also explain what a Notice of Allowance is where
you use this term in the last paragraph on page 4. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
include explanations for the special protocol assessment process and Notice of Allowance. Please
refer to the revisions on pages 3 and 4.
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8. |
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Please disclose in the Risk Factors discussion on pages 3-4 the amount of
your net loss for 2005 and your accumulated deficit. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
include in the Prospectus Summary Risk Factors discussion the amount of Cadences net loss for
2005 and Cadences accumulated deficit as of June 30, 2006. Please refer to the revisions on page
4.
Risk Factors
If Clinical trials of our current or future product candidates . . . , page 8
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9. |
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We note the previous phase III trial for omiganan did not show statistical
significance for the prevention of the primary endpoint: catheter-related bloodstream
infections. Please disclose this fact in the last paragraph on page 2, where you
discuss omiganans previous trials. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
note that the previous phase III clinical trial for omiganan did not show statistical significance
for the primary endpoint, the prevention of catheter-related bloodstream
infections. Please refer to the revisions on page 2 of the Amendment. As described in detail in the
Amendment, Cadence respectfully submits to the Staff that Cadence is targeting a different primary
endpoint in its trial, the prevention of local catheter site infections.
If any of our product candidates for which we receive regulatory approval . . . , page 12
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10. |
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The issue that is discussed in the second bullet point regarding the decreasing
use of 10% povidone-iodine appears to be a material risk by itself. Please include a
new risk factor covering this issue. |
Cadences Response: After considering the merits of a separate risk factor as suggested by the
Staff, Cadence respectfully submits for the Staffs further consideration that the most useful
disclosure to potential investors is a discussion of the decreasing use of 10% povidone-iodine in
Jeffrey Riedler
August 30, 2006
Page 4
the context of two separate risks. Specifically, Cadence directs the Staff to the disclosure under
the risk factors entitled 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 (page 10) and 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 (page 12). Cadence believes the two separate discussions of the
decreasing use of 10% povidone-iodine are helpful, specific examples of these two distinct risk
factors. The potential delay in completion of clinical trials and the potential difficulties in
achieving commercial market acceptance are distinct risks that Cadence believes should be discussed
separately in order to provide potential investors with the appropriate context to understand the
implications of the increasing replacement of 10% povidone-iodine with chlorhexidine in hospitals.
Furthermore, because these two distinct risk factors related to clinical trial timing and
commercial viability apply equally to both of Cadences product candidates (IV APAP and omiganan),
a separate discussion specific only to omiganan would either create unnecessary repetition with the
existing risk factor disclosure, or necessitate a similar separate risk factor for IV APAP.
Accordingly, Cadence respectfully requests that the Staff reconsider this comment given the
disclosure already provided in the Registration Statement under the two risk factors noted above.
Our product candidates may have undesirable side effects . . . , page 14
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11. |
|
Please discuss any side effects or adverse events that have been observed in
the clinical trials of your products to date. |
Cadences Response: Cadence has disclosed in the risk factor identified by the Staff the
undesirable side effects and other characteristics associated with acetaminophen and omiganan. For
example, the risk factor indicates that acetaminophen has the potential to cause liver toxicity and
that drug-related adverse events observed in clinical trials completed to date for omiganan have
all been related to the skin. Please refer to page 14 of the Amendment.
If we breach any of the agreements under which we license rights . . . , page 15
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12. |
|
We note you could lose your rights to IV APAP due to the actions of BMS in its
relationship with SCR Pharmatop, which you presumably cannot control. Please discuss
this issue in a separate risk factor. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 16 of the Amendment.
If the manufacturers upon whom we rely fail to produce . . . , page 16
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13. |
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We note you have contracted with BMS to manufacture clinical supplies of IV
APAP. |
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|
Is this a separate agreement from the agreement currently filed as exhibit
10.11? If it is, please file this agreement as an exhibit. |
Jeffrey Riedler
August 30, 2006
Page 5
Cadences Response: Cadence has previously considered whether the filing of its agreement for
clinical supplies of IV APAP and placebo is a material contract for purposes of Item 601 of
Regulation S-K. Because the agreement provides for only a single
batch of IV APAP and a single batch of placebo, and no long-term
commitment by either party, and because more than sufficient quantities of IV APAP and placebo have already been
manufactured for purposes of all planned clinical trials for this product candidate, Cadence does
not view the agreement as a material contract. Furthermore, Cadence purchases clinical quantities
of its product candidates in the ordinary course of its business and does not view the clinical
quantity supply agreement to be material to Cadence in amount or significance. However, Cadence
would view any subsequent agreement providing for the long-term supply of commercial supplies (as
opposed to clinical supplies) as a material contract and would expect to file as an exhibit any
such supply agreement, if and when Cadence negotiates such an agreement in the future. Cadence has
disclosed in the Registration Statement that it is seeking to establish a source for long-term
supply of commercial quantities of IV APAP.
|
|
|
Please discuss in the Manufacturing section of your Business section on
page 66 the material terms of the manufacturing contract with BMS. |
Cadences Response: As noted above, all quantities of IV APAP and placebo have already been
manufactured, for purposes of all planned clinical trials for IV APAP. Cadence has revised the
Amendment to make clear that the clinical supply agreement provides for only a single batch of
clinical supplies of IV APAP and a single batch of placebo. Cadence has also revised the Amendment to disclose the
termination provisions for the clinical supply agreement. Please refer to the revisions on pages
17 and 69 of the Amendment. However, Cadence would expect to describe the terms of any commercial
supply agreement if and when it negotiates such an agreement in the future.
|
|
|
Please disclose in the risk factor when BMSs manufacturing obligation ends
and the circumstances under which it can be terminated. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 17 of the Amendment.
We will need to increase the size of our organization . . . , page 18
|
14. |
|
Please state how many additional employees you anticipate you will need. Also
state the anticipated additional cost. |
Cadences Response: Cadence respectfully submits to the Staff that any estimate of the number of
additional employees or the anticipated additional costs would be speculative and potentially
misleading. Cadence believes the current disclosure sufficiently advises prospective investors
that Cadence will need to expend resources in its efforts to increase the size of its organization
as its product candidates advance through clinical trials and the company prepares for potential
regulatory approval and commercialization. The additional bullet points in the risk factor
identified by the Staff are intended to provide a specific discussion of tasks Cadence will need to
implement to effectively achieve its development and commercialization goals. The discussion
Jeffrey Riedler
August 30, 2006
Page 6
of each of these tasks provides prospective investors with a general understanding of the
challenges that Cadence will face in managing its future growth. Because the items described in
this risk factor are inherently forward-looking, Cadence does not believe it is possible to provide
a meaningful estimate of the number of additional employees or the anticipated costs of hiring
additional employees at this time. However, Cadence continues to believe this particular risk
factor, even without a specific forecast of additional employees and additional cost, is
significant and worthy of consideration by prospective investors.
We may not be able to manage our business effectively if we are unable . . . , page 18
|
15. |
|
We note the loss of one or more of the members of [your] senior management
team or other key employees could threaten the implementation of your business
strategy. Please identify by name and title all individuals to whom you are referring.
Also state whether you have employment agreements with each of these individuals. |
Cadences Response: Cadence respectfully submits to the Staff that the loss of any one or more of
the members of Cadences senior management team could be a significant loss to Cadence and could
threaten the implementation of Cadences business strategy. Cadence believes that singling out any
one particular member of the senior management team, or a subset of the senior management team,
could lead prospective investors to incorrectly conclude that the loss of services of the
individuals that are not listed in the risk factor may not have a material impact on Cadences
business. Cadence has not specifically listed out the names and titles of each of the members of
the senior management team because they are already listed in the Management section, and a full
recitation of the names and titles could be unnecessarily repetitive. However, as the Staff
requested, Cadence now refers in the risk factor to the employment agreements that are in place
with its senior management. Please refer to page 18 of the Amendment.
Recent proposed legislation may permit re-importation of drugs . . . , page 19
|
16. |
|
So that this risk factor is more specific to your companys situation, please
discuss the possibility of IV APAP being sold in Europe and then re-imported to the
United States. If this were to occur, would your company be entitled to receive any
revenues from these sales? |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to page 20.
The patent rights that we have in-licensed covering IV APAP . . . , page 20
|
17. |
|
Based on this risk factor, it appears there are no patents for the drug
acetaminophen. Please disclose this fact in the first full paragraph on page 2, where
you discuss patent protection. Also disclose on page 2, if true, that the only patents
to which you have rights relate to the process and formulation, and there may be
competing processes and formulations that are not covered by the patents. |
Jeffrey Riedler
August 30, 2006
Page 7
Cadences Response: Cadence respectfully submits to the Staff that the Risk Factors section of
the prospectus summary is the appropriate section for disclosures related to risks as potential
investors would likely first turn to this section for an overview of the risks associated with
Cadences business. Accordingly, Cadence has revised the Risk Factors section of the prospectus
summary in response to the Staffs comment. Please refer to the revisions on page 4 of the
Amendment.
We depend on our licensors for the maintenance . . . , page 21
|
18. |
|
To the extent you are aware that you have any intellectual property that is
being infringed upon or that you have been notified of a third partys belief that you
are infringing on their intellectual property, please revise this risk factor or If we
are sued for infringing intellectual property rights of third parties. . . on page 23,
as applicable, to disclose the situation and potential consequences. |
Cadences Response: Cadence supplementally advises the Staff that it is not aware of any
infringement of its intellectual property by a third party. Further, Cadence has not been notified
by a third party that Cadence is infringing upon any intellectual property rights of such third
party. Accordingly, no revisions have been made to the risk factor referenced in the Staffs
comment.
We will incur increased costs as a result of changes in laws and regulations. . . , page 27
|
19. |
|
As currently worded, this risk factor and We may become involved in securities
class action litigation . . . on page 30 could apply to any public company. Please
revise these two risk factors so they describe your situation more specifically. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on pages 27 and 31 of the Amendment.
Future sales of our common stock may depress our stock price. . . , page 29
|
20. |
|
Please disclose the number of shares subject to lock-up agreements and Rule 144
restrictions, and state when the agreements and restrictions expire. Also, state how
many shares have registration rights and when you are obligated to register the resale
offering. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 30 of the Amendment.
Use of Proceeds, page 33
|
21. |
|
Please describe with more specificity the uses currently described as working
capital, capital expenditures and other general corporate purposes. State the
approximate amount you plan to use on each of these purposes. |
Jeffrey Riedler
August 30, 2006
Page 8
Cadences Response: Cadence has revised the Amendment to provide an approximate dollar amount of
the net proceeds intended to be used to fund clinical trials for its two product candidates and
other research and development activities: $58.0 million. Please refer to page 34 of the
Amendment. Cadence supplementally advises the Staff that this amount represents approximately 80%
of the anticipated net proceeds from the offering, assuming net proceeds of approximately $72.5
million. Page 34 of the Amendment also indicates that any residual proceeds are expected to be
used for working capital, capital expenditures and other general corporate purposes. Because the
residual proceeds are expected to represent not more than approximately 20% of the anticipated net
proceeds, Cadence respectfully submits to the Staff that any additional detail on these general
purposes should not be viewed as material to an investors understanding of the principal uses of
proceeds from the offering. If the ultimate net proceeds realized from the offering is less than
this currently projected amount, the portion allocated to clinical trials and research and
development will represent an even larger percentage of the total net proceeds. Furthermore,
Cadence already discloses to investors that its management will retain broad discretion over the
use of proceeds from the offering in both the Use of Proceeds section and Risk Factors 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. Finally, Cadence draws the Staffs attention to
the revisions in the Amendment which confirm that Cadence anticipates that the net proceeds from
the offering, together with its existing cash and cash equivalents, will allow it to complete the
clinical trials necessary to support NDA filings for IV APAP and omiganan. With this detailed
disclosure concerning the stage of clinical development expected to be achieved from the proceeds
of the offering, coupled with the precise dollar amount for the largest anticipated use of
proceeds, Cadence respectfully submits to the Staff that no further detail is necessary to
adequately inform investors of the material anticipated use of proceeds from the offering.
|
22. |
|
Based on the discussion in the third paragraph of this section, it appears the
development of IV APAP is less predictable than the development of omiganan. Please
clarify why. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 34 of the Amendment. Cadence respectfully submits to the
Staff that since initially filing the Registration Statement on July 17, 2006, Cadence now has more
visibility on the costs associated with the clinical development plan for IV APAP due to the recent
meeting with the FDA on August 14, 2006, as discussed in more detail in the Business section on
page 60 of the Amendment.
|
23. |
|
We note you do not know the total costs for IV APAP. Please state
approximately how much of the funds from this offering you plan to put toward IV APAP.
Also state how much you plan to use on omiganan. |
Cadences Response: Cadence has also revised the Amendment on page 34 to confirm that Cadence
anticipates that the net proceeds from the offering, together with its existing cash and cash
equivalents, will allow it to complete the clinical trials necessary to support NDA filings for IV
APAP and omiganan. Because the anticipated net proceeds from the offering are expected to
Jeffrey Riedler
August 30, 2006
Page 9
allow Cadence to complete clinical development of both IV APAP and omiganan sufficient to support
an NDA submission, and because Cadence discloses an aggregate amount of proceeds to be devoted to
clinical trial and research and development activities, Cadence respectfully submits to the Staff
that the allocation of proceeds between the two development programs is not necessary for investors
to understand the anticipated development stage of Cadence following the offering.
Managements discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 44
|
24. |
|
Please clarify why you had more legal fees, other professional fees, and
consulting fees during the first quarter of 2006 than during the first quarter of 2005.
What business activities were these fees associated with? |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
refer specifically to the IV APAP program and Cadences new facility lease, which were the business
activities that led to an increase of legal fees, other professional fees, and consulting fees
during the first quarter of 2006 than during the first quarter of 2005. Please refer to the
revisions on page 45 of the Amendment.
Business
Our Product Development Programs, page 52
|
25. |
|
We note from footnote (1) to the product development table at the top of page
53 that BMS completed Phase III clinical trials for IV APAP in the United States.
Please clarify why you believe additional clinical trials will be necessary for IV APAP
in the United States. Why are BMSs trials not sufficient? |
Cadences Response: Cadence has revised the Amendment to describe the planned clinical trial
development program for IV APAP in accordance with the Staffs comment. Please refer to the
revisions to the product candidate summary table on page 54 of the Amendment and the discussion of
the recent guidance from the FDA on the planned clinical trials for IV APAP on page 60 of the
Amendment.
Clinical Development History, page 56
|
26. |
|
We note the reference in the penultimate paragraph on page 57 to a phase IV
study. Typically, phase IV studies are done after marketing approval. Therefore,
please clarify why this phase IV study took place. |
Cadences Response: Cadence advises the Staff that because IV APAP has been approved by the
applicable regulatory authorities for marketing in Europe by BMS, the Phase IV study referred to on
page 58 of the Amendment is properly characterized as a post-marketing study.
Jeffrey Riedler
August 30, 2006
Page 10
IV APAP Agreement, page 65
|
27. |
|
We note the agreement will terminate if the BMS-Pharmatop agreement terminates.
Please discuss the term and termination provisions of the BMS-Pharmatop agreement. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 67 of the Amendment.
|
28. |
|
Please explain what the event is that is currently described in the third
paragraph of this section as an event that relates to our territory. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 67 of the Amendment.
Principal Stockholders, page 91
|
29. |
|
Please identify the natural persons who are the beneficial owners of the shares
held by Technology Partners and BB Biotech. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
include the identities of the natural persons who are the beneficial owners of the shares held by
Technology Partners and BB Biotech. Please refer to the revisions on page 96 of the Amendment.
Certain Relationships and Related Party Transactions, page 95
|
30. |
|
Please file as exhibits the agreements underlying all of the transactions
discussed in this section. |
Cadences Response: Cadence has filed as an exhibit the form of amended and restated common stock
purchase agreement underlying an aggregate of 3,600,000 shares of common stock issued to Theodore
R. Schroeder, President and Chief Executive Officer of Cadence, David A. Socks, Vice President,
Business Development of Cadence, and a limited liability company affiliated with Cadences
Chairman, Cam L. Garner. Please refer to Exhibit 10.6 of the Amendment. With respect to the
underlying agreements related to investor rights, indemnification, employment and stock option
grants, please refer to Exhibits 4.2, 10.1, 10.2 and 10.3, respectively, of the Amendment. Cadence
respectfully submits to the Staff that there are no other agreements referenced in the Certain
Relationships and Related Party Transactions section that are material to Cadence in amount or
significance.
|
31. |
|
So that investors can better understand the terms of the preferred stock
issuances, please explain the rights that the Series A-1, A-2, and A-3 preferred stock
entail. |
Jeffrey Riedler
August 30, 2006
Page 11
Cadences Response: Cadence respectfully submits to the Staff that upon the closing of the proposed
initial public offering, all of Cadences preferred stock will convert into shares of common stock.
Please refer to the discussion related to the conversion of the preferred stock in the Description
of Capital Stock section on page 102 of the Amendment. Accordingly, Cadence does not believe a
detailed description of the terms of the preferred stock would be material to potential investors.
Moreover, Cadence respectfully submits to the Staff that the terms of the Series A-1, A-2 and A-3
preferred stock are already discussed in the Notes to Financial Statements in the Convertible
Preferred Stock section on page F-15 of the Amendment.
|
32. |
|
Please state the names of the certain investors who advanced $500,000 to the
company in 2004. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 101 of the Amendment.
Material U.S. Federal Income Tax Considerations to Non-U.S. Holders, page 106
|
33. |
|
Please replace the word certain with all in the first sentence of this
section. Your should describe all material tax considerations. |
Cadences Response: Cadence has revised the Amendment to eliminate the word certain. Please refer
to the revisions on page 101 of the Amendment.
|
34. |
|
[sic] their own tax advisors. We do not object to stating that you urge them
to do so. Similarly revise the last paragraph on page 108. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on pages 109 and 111 of the Amendment.
|
35. |
|
Please delete the first two sentences from the last paragraph on page 108.
These sentences appear to disclaim responsibility for information in your filing. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page 111 of the Amendment.
Notes to Financial Statements, page F-7
4. Related Party Transactions, page F-13
|
36. |
|
Your disclosures indicate that you have issued only 8,085,108 shares of Series
A-1 preferred stock. Many of your disclosures suggest that you issued all of these
shares for cash, while your disclosure here suggests that some of the shares were
instead issued as repayment for advanced pre-operating expenses and an exclusivity fee
due for the collaboration and license agreement with Migenix. Please revise your |
Jeffrey Riedler
August 30, 2006
Page 12
|
|
|
disclosures to resolve this apparent discrepancy. To the extent shares were issued as
repayment, please: |
|
|
|
Disclose the number of these shares and the value assigned to them, as required
by paragraph 11(d) of SFAS 7, |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page F-13 of the Amendment.
|
|
|
Ensure that the amount you disclose as cash flows from financing activities
complies with SFAS 95, and |
Cadences Response: Cadence respectfully submits to the Staff that the cash flows from financing
activities in the Registration Statement as originally filed comply with SFAS 95. In accordance
with the Staff Accounting Bulletin Topic 5T (SAB 79), Accounting for Expense or Liabilities Paid by
Principal Stockholder(s), certain transactions undertaken by a stockholder on behalf of Cadence
were recorded as if they had been transacted directly by Cadence. In particular, 531,915 shares of
Series A-1 preferred stock issued directly to a stockholder in settlement of $500,000 paid on
behalf of Cadence by that stockholder were valued at $0.94 per share, the price
paid by new Series A-1 investors and recorded as a $500,000 cash investment in Series A-1 and a
corresponding cash payment of $500,000 for operating expenses.
|
|
|
Provide the disclosures required by paragraph 32 of SFAS 95 about non-cash
financing activities. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment.
Please refer to the revisions on page F-6 of the Amendment.
6. License Agreements and Acquired Development and Commercialization Rights, page F-14
|
37. |
|
Based on your disclosure, it appears that you allocated only approximately
$0.16 to each share of Migenix stock that you acquired. As it appears that shares of
Migenix stock was then trading at significantly more than $0.16 per share, please tell
us why your allocation of the up-front fee was appropriate or revise your financial
statements to correct the allocation. |
Cadences Response: Cadence respectfully submits to the Staff that it believes the $100,000
valuation of the Migenix stock on the date the shares were acquired was appropriate. In July 2004,
Cadence completed the negotiations with Migenix to in-license rights to omiganan. As a condition to
completing the transaction, Migenix required Cadence to acquire 617,284 shares of Migenix stock at
a stated value of $500,000. The stock of Migenix was and continues to be thinly traded and has been
declining in value consistently since July 2004 from $0.84 at July 31, 2004 to $0.35 at June 30,
2006. Cadence concluded that it could not easily dispose of the shares due to the illiquid market
and to do so could be contrary to maintaining a positive relationship
Jeffrey Riedler
August 30, 2006
Page 13
with its collaborative partner, Migenix. In addition, based on the knowledge of Migenixs
operations, Cadence believed it would be highly unlikely that it would realize the value of the
Migenix equity securities in the foreseeable future. Therefore, with the concurrence of Cadences
audit committee, Cadence allocated $100,000 of the $500,000 stipulated for the Migenix stock to the
cost of the stock and $400,000 as additional cost of obtaining the license since Cadence would not have
acquired the stock had it not been required to do so to complete the
transaction to acquire the license. Based on the lack of liquidity
for the Migenix stock, the
$100,000 was the best estimate of value that Cadence might receive for the shares if it was forced
to sell the shares.
In addition, Cadence does not believe that any alternative accounting would have a material impact
on Cadences financial statements or a readers ability to understand Cadences financial results
or condition.
7. Stockholders Equity, page f-15
Convertible Preferred Stock, page F-15
|
38. |
|
Please disclose how and under what circumstances the initial conversion ratio
is subject to adjustment. In addition, please disclosure whether and by how much it
has been adjusted. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
include how and under what circumstances the initial conversion ratio of the convertible preferred
stock is subject to adjustment and to disclose whether and by how much it has been adjusted. Please
refer to the revisions on page F-15 of the Amendment.
Stock Options, page F-16
|
39. |
|
We noted that you had considered the guidance in the AICPA Practice Aid,
Valuation of Private-Held-Company Securities Issued as Compensation. We also
noted that, subsequent to your licensing of IV APAP and the initiation of your IPO
process, you took into consideration a contemporaneous independent valuation. Please
revise these disclosures to further clarify whether you simply considered it or you
followed it and to what extent. For example, it is unclear whether your consideration
of it solely resulted in your determinations of fair value being contemporaneous or if
the determinations were made in accordance with it. To the extent that you followed
it, please tell us how you followed it and cite the specific paragraphs within it that
support how you determined the fair value of the common stock. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
include further clarification that Cadence engaged an independent valuation specialist to provide a
valuation report taking into consideration the recommendations of the AICPA Practice Aid. Please
refer to the revisions on page F-16 of the Amendment. Cadence reviewed the report of the valuation
specialist and utilized the recommended common stock valuation without adjustment. As required
under Uniform Standards of Professional Appraisal
Jeffrey Riedler
August 30, 2006
Page 14
Practice, the valuation specialist considered the market, income and asset-based approaches in
preparation of its valuation report. Ultimately, the valuation report utilizes a market approach to
determine the common stock valuation and further supports the reasonableness of this valuation by
comparing the implied internal rate of return to published information regarding required rates of
returns on investments in early-stage companies.
|
40. |
|
As you had considered the guidance in the AICPA Practice Aid and as you did not
indicate that you considered a contemporaneous independent valuation prior to your
licensing of IV APAP, please provide the disclosures recommended by paragraphs 179 and
182 of the AICPA Practice Aid to the extent that you have not already provided them. |
Cadences Response: Cadence has revised the Amendment in accordance with the Staffs comment to
expand the disclosures in the financial statements and in Managements Discussion and Analysis of
Financial Condition and Results of Operations to comply with the required disclosures in
paragraphs 179 and 182 of the AICPA Practice Aid. Please refer to the revisions on pages F-17 and
44 of the Amendment.
Item 15. Recent Sales of Unregistered Securities, page II-2
|
41. |
|
We note that a press release dated October 11, 2005 on your website discusses a sale of
$25 million of Series A Preferred Stock. Please explain to us why page 45 of the filing
and this section mention only $17,675,347 during that approximate time period, and revise
your filing as appropriate. |
Cadences Response: Cadence respectfully submits to the Staff that the October 11, 2005 press
release describes the aggregate proceeds from two closings in a single announcement, while the
discussion in Liquidity and Capital Resources section on page 46 of the Amendment provides a more
detailed discussion of the two closings. Pursuant to Cadences amended and restated Series
A-1 and Series A-2 preferred stock purchase agreement dated September 30, 2005, Cadence issued and
sold 8,085,108 shares of Series A-1 preferred stock and 17,675,347 shares of Series A-2 preferred
stock for an aggregate total of $25.1 million. As discussed in the Liquidity and Capital
Resources section on page 46 of the Amendment, the initial sale of the 8,085,108 shares of Series
A-1 preferred stock occurred from July 2004 to August 2004 and the subsequent sale of the Series
A-2 preferred stock occurred from June 2005 to September 2005. Cadence announced the combined
closings from the sale of Series A-1 preferred stock and Series A-2 preferred stock in a single
press release dated October 11, 2005.
* * *
Jeffrey Riedler
August 30, 2006
Page 15
Any comments or questions regarding the foregoing should be directed to the undersigned at
(858) 523-5435. Thank you in advance for your cooperation in connection with this matter.
Very truly yours,
/s/ Cheston J. Larson
Cheston J. Larson
of LATHAM & WATKINS LLP
Enclosures
|
|
|
cc:
|
|
Theodore R. Schroeder, Cadence Pharmaceuticals, Inc. |
|
|
William R. LaRue, Cadence Pharmaceuticals, Inc. |
|
|
David A. Socks, Cadence Pharmaceuticals, Inc. |
|
|
Faye H. Russell, Latham & Watkins LLP |
|
|
Mark B. Weeks, Heller Ehrman LLP |
|
|
Ross L. Burningham, Heller Ehrman LLP |
|
|
Richard Mejia, Jr., Ernst & Young LLP |