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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
December 7, 2006 (December 6, 2006)
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
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DELAWARE
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000-50633
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94-3291317 |
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(State or other jurisdiction of
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(Commission File Number)
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(IRS Employer |
incorporation)
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Identification No.) |
280 East Grand Avenue
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
650-624-3000
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
ITEM 8.01. OTHER EVENTS.
As previously reported on a Current
Report on Form 8-K filed by Cytokinetics, Incorporated (the
Company) with the Securities and
Exchange Commission (SEC) on December 7, 2006, on December 6, 2006, the Company entered into a
Placement Agent Agreement (the Placement Agreement), between the Company and Lazard Capital
Markets LLC, JMP Securities LLC and Rodman & Renshaw, LLC, as placement agents, relating to the
issuance and sale by the Company of 5,285,715 shares of common stock of the Company, par value
$0.001 per share, to the signatories to the Subscription Agreements (as defined below) at a price
of $7.00 per share.
In connection with the offering, the Company entered into subscription agreements, dated December
6, 2006 (the Subscription Agreements), between the Company and the investor signatories thereto.
The Company is making the issuance and sale pursuant to a shelf registration statement on Form S-3
(Registration No. 333-125786), declared effective by the SEC on July 14, 2005 (the Original
Filing), and the registration statement on Form S-3 (Registration No. 333-138306) filed with the
SEC in connection with the Original Filing pursuant to Rule 462(b) under the Securities Act of
1933, as amended, on October 30, 2006 (along with the Original Filing, collectively, the Shelf
Registration Statement).
A copy of the Placement Agreement and the form of Subscription Agreement are attached to this
Current Report on Form 8-K as Exhibit 1.1 and Exhibit 10.68, respectively.
On December 7, 2006,
the Company filed a Rule 424(b)(5) prospectus supplement (the Prospectus)
with the SEC in connection with the Shelf Registration Statement, containing the risk factors
attached to this Current Report on Form 8-K as Exhibit 99.1.
This
Current Report on Form 8-K is being filed for the purpose of incorporating the risk factors from the
Prospectus and the other exhibits listed below by reference into this report and into the
Registration Statement on Form S-3 declared effective by the SEC on December 2, 2005 (SEC File No.:
333-129786) and into the Shelf Registration Statement.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits.
The
following Exhibits are filed as part of this Current Report on Form
8-K:
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Exhibit No. |
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Description |
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1.1
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Placement Agent Agreement, dated as of December 6, 2006, between the
Company and Lazard Capital Markets LLC, JMP Securities LLC and Rodman
& Renshaw, LLC, as placement agents. |
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5.1
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Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. |
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10.68
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Form of Subscription Agreement, dated as of December 6, 2006, between
the Company and the investor signatories thereto. |
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99.1
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Information from Prospectus. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CYTOKINETICS, INCORPORATED
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By: |
/s/ Sharon Surrey-Barbari |
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Sharon Surrey-Barbari |
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Senior Vice President, Finance and Chief Financial
Officer |
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Date: December 7, 2006
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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1.1
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Placement Agent Agreement, dated as of December 6, 2006, between the
Company and Lazard Capital Markets LLC, JMP Securities LLC and Rodman
& Renshaw, LLC, as placement agents. |
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5.1
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Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. |
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10.68
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Form of Subscription Agreement, dated as of December 6, 2006,
between the Company and the investor signatories thereto. |
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99.1
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Information from Prospectus. |
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exv1w1
Exhibit 1.1
5,285,715 Shares
CYTOKINETICS, INCORPORATED
Common Stock
PLACEMENT AGENT AGREEMENT
December 6, 2006
Lazard Capital Markets LLC
JMP Securities LLC
Rodman & Renshaw, LLC
c/o Lazard Capital Markets LLC
30 Rockefeller Plaza
New York, New York 10020
Dear Sirs:
1. Introduction. Cytokinetics, Incorporated, a Delaware corporation (the Company),
proposes to issue and sell to the purchasers, pursuant to the terms of this Placement Agent
Agreement (this Agreement) and the Subscription Agreements in the form of Exhibit A
attached hereto (the Subscription Agreements) entered into with the purchasers identified therein
(each a Purchaser and collectively, the Purchasers), up to an aggregate of 5,285,715 shares of
common stock, $0.001 par value per share (the Common Stock) of the Company. The aggregate of
5,285,715 shares so proposed to be sold is hereinafter referred to as the Stock. The Company
hereby confirms its agreement with Lazard Capital Markets LLC (LCM), JMP Securities LLC (JMP)
and Rodman & Renshaw, LLC (Rodman, and together with LCM and JMP, the Placement Agents) to act
as Placement Agents in accordance with the terms and conditions hereof. LCM is acting as the
representative of the Placement Agents and in such capacity is hereinafter referred to as the
Representative.
2. Agreement to Act as Placement Agents; Placement of Securities. On the basis of
the representations, warranties and agreements of the Company herein contained, and subject to all
the terms and conditions of this Agreement:
2.1 The Company hereby authorizes the Placement Agents to act as its exclusive agents to
solicit offers for the purchase of all or part of the Stock from the Company in connection with
the proposed offering of the Stock (the Offering). Until the Closing Date (as defined in
Section 4 hereof), the Company shall not, without the prior written consent of the
Representative, solicit or accept offers to purchase Stock otherwise than through the Placement
Agents. LCM may utilize the expertise of Lazard Frères & Co. LLC in connection with LCMs
placement agent activities.
2.2 The Placement Agents agree, as agents of the Company, to use their best efforts to
solicit offers to purchase the Stock from the Company on the terms and subject to the conditions
set forth in the Prospectus (as defined below). The Placement Agents shall use commercially
reasonable efforts to assist the Company in obtaining performance by each Purchaser whose offer
to purchase Stock has been solicited by the Placement Agents and accepted by the Company, but
the
Placement Agents shall not, except as otherwise provided in this Agreement, be obligated to
disclose the identity of any potential purchaser or have any liability to the Company in the
event any such purchase is not consummated for any reason. Under no circumstances will the
Placement Agents be obligated to underwrite or purchase any Stock for their own accounts and, in
soliciting purchases of Stock, the Placement Agents shall act solely as the Companys agents and
not as principals. Notwithstanding the foregoing and except as otherwise provided in
Section 2.3, it is understood and agreed that the Placement Agents (or their affiliates)
may, solely at their discretion and without any obligation to do so, purchase Stock as
principals.
2.3 Subject to the provisions of this Section 2, offers for the purchase of Stock
may be solicited by the Placement Agents as agents for the Company at such times and in such
amounts as the Placement Agents deem advisable. Each Placement Agent shall communicate to the
Company, orally or in writing, each reasonable offer to purchase Stock received by it as agent
of the Company. The Company shall have the sole right to accept offers to purchase the Stock
and may reject any such offer, in whole or in part. Each Placement Agent shall have the right,
in its discretion reasonably exercised, with notice to the Company, to reject any offer to
purchase Stock received by it, in whole or in part, and any such rejection shall not be deemed a
breach of its agreement contained herein.
2.4 The Stock is being sold to the Purchasers at a price of $7.00 per share. The purchases
of the Stock by the Purchasers shall be evidenced by the execution of Subscription Agreements by
each of the Purchasers and the Company.
2.5 As compensation for services rendered, on the Closing Date (as defined in Section
4 hereof) the Company shall pay to the Placement Agents by wire transfer of immediately
available funds to an account or accounts designated by the Representative, an amount equal to
five percent (5%) of the gross proceeds received by the Company from the sale of the Stock on
such Closing Date.
2.6 No Stock which the Company has agreed to sell pursuant to this Agreement shall be
deemed to have been purchased and paid for, or sold by the Company, until such Stock shall have
been delivered to the Purchaser thereof against payment by such Purchaser. If the Company shall
default in its obligations to deliver Stock to a Purchaser whose offer it has accepted, the
Company shall indemnify and hold the Placement Agents harmless against any loss, claim, damage
or expense arising from or as a result of such default by the Company in accordance with the
procedures set forth in Section 8(c) herein.
3. Representations and Warranties of the Company. The Company represents and
warrants to, and agrees with, the Placement Agents and the Purchasers that:
(a) The Company has prepared and filed in conformity with the requirements of the
Securities Act of 1933, as amended (the Securities Act), and published rules and
regulations thereunder (the Rules and Regulations) adopted by the Securities and Exchange
Commission (the Commission) a shelf Registration Statement (as hereinafter defined) on
Form S-3 (File No. 333-125786), which became effective as of July 15, 2005 (the Effective
Date), including a base prospectus relating to the Stock (the Base Prospectus), and such
amendments and supplements thereto as may have been required to the date of this Agreement.
The term Registration Statement as used in this Agreement means the registration statement
(including all exhibits, financial schedules and all documents and information deemed to be
a part of the Registration Statement pursuant to Rule 430A under the Securities Act), as
amended and as consolidated with the Registration Statement on Form S-3 (No. 333-138306) or
supplemented to the date of this Agreement, including the Base Prospectus. The Registration
Statement is effective under the Securities Act and no stop order preventing or suspending
the effectiveness of the Registration Statement or suspending or preventing the use of the
Prospectus has been issued by the Commission and no proceedings for that purpose have been
to the best knowledge of the Company instituted or are threatened by the Commission. The
Company, if required by the Rules
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and Regulations of the Commission, will file the Prospectus (as defined below), with
the Commission pursuant to Rule 424(b) of the Rules and Regulations. The term Prospectus
as used in this Agreement means the Prospectus, in the form in which it is to be filed with
the Commission pursuant to Rule 424(b) of the Rules and Regulations, or, if the Prospectus
is not to be filed with the Commission pursuant to Rule 424(b), the Prospectus in the form
included as part of the Registration Statement as of the Effective Date, except that if any
revised prospectus or prospectus supplement shall be provided to the Representative by the
Company for use in connection with the offering and sale of the Stock which differs from the
Prospectus (whether or not such revised prospectus or prospectus supplement is required to
be filed by the Company pursuant to Rule 424(b) of the Rules and Regulations), the term
Prospectus shall refer to such revised prospectus or prospectus supplement, as the case
may be, from and after the time it is first provided to the Representative for such use. Any
preliminary prospectus or prospectus subject to completion included in the Registration
Statement or filed with the Commission pursuant to Rule 424 under the Securities Act is
hereafter called a Preliminary Prospectus. Any reference herein to the Registration
Statement, any Preliminary Prospectus or the Prospectus shall be deemed to refer to and
include the documents incorporated by reference therein pursuant to Item 12 of Form S-3
which were filed under the Securities Exchange Act of 1934, as amended (the Exchange Act),
on or before the last to occur of the Effective Date, the date of the Preliminary
Prospectus, or the date of the Prospectus, and any reference herein to the terms amend,
amendment, or supplement with respect to the Registration Statement, any Preliminary
Prospectus or the Prospectus shall be deemed to refer to and include (i) the filing of any
document under the Exchange Act after the Effective Date, the date of such Preliminary
Prospectus or the date of the Prospectus, as the case may be, which is incorporated by
reference and (ii) any such document so filed. If the Company has filed an abbreviated
registration statement to register additional Stock pursuant to Rule 462(b) under the Rules
(the 462(b) Registration Statement), then any reference herein to the Registration
Statement shall also be deemed to include such 462(b) Registration Statement.
(b) As of the Applicable Time (as defined below) and as of the Closing Date, neither
(i) any General Use Free Writing Prospectus (as defined below) issued at or prior to the
Applicable Time, and the Pricing Prospectus (as defined below) and the information included
on Schedule A hereto, all considered together (collectively, the General Disclosure
Package), nor (ii) any individual Limited Use Free Writing Prospectus (as defined below),
if any, issued prior to the Effective Time, when considered together with the General
Disclosure Package, included or will include, any untrue statement of a material fact or
omitted or as of the Closing Date will omit, to state a material fact necessary in order to
make the statements therein, in the light of the circumstances under which they were made,
not misleading; provided, however, that the Company makes no representations or warranties
as to information contained in or omitted from any Issuer Free Writing Prospectus, in
reliance upon, and in conformity with, written information furnished to the Company through
the Representative by or on behalf of any Placement Agent specifically for inclusion
therein, which information the parties hereto agree is limited to the Placement Agents
Information (as defined in Section 18). As used in this paragraph (b) and
elsewhere in this Agreement:
Applicable Time means 8:00 P.M., New York time, on the date of this Agreement.
Pricing Prospectus means the Preliminary Prospectus, if any, and the Base Prospectus, each
as amended and supplemented immediately prior to the Applicable Time, including any document
incorporated by reference therein and any prospectus supplement deemed to be a part thereof.
Issuer Free Writing Prospectus means any issuer free writing prospectus, as defined in
Rule 433 under the Securities Act relating to the Stock in the form filed or required to be
filed with the
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Commission or, if not required to be filed, in the form retained in the Companys records
pursuant to Rule 433(g) under the Securities Act.
General Use Free Writing Prospectus means any Issuer Free Writing Prospectus that is
identified on Schedule A to this Agreement.
Limited Use Free Writing Prospectuses means any Issuer Free Writing Prospectus that is not
a General Use Free Writing Prospectus.
(c) No order preventing or suspending the use of any Preliminary Prospectus, any Issuer
Free Writing Prospectus or the Prospectus relating to the Offering has been issued by the
Commission, and no proceeding for that purpose or pursuant to Section 8A of the Securities
Act has been to the best knowledge of the Company instituted or threatened by the
Commission, and each Preliminary Prospectus, if any, at the time of filing thereof,
conformed in all material respects to the requirements of the Securities Act and the Rules
and Regulations, and unless otherwise corrected, modified or supplemented did not contain an
untrue statement of a material fact or omit to state a material fact required to be stated
therein or necessary to make the statements therein, in the light of the circumstances under
which they were made, not misleading; provided, however, that the Company makes no
representations or warranties as to information contained in or omitted from any Preliminary
Prospectus, in reliance upon, and in conformity with, written information furnished to the
Company through the Representative by or on behalf of any Placement Agent specifically for
inclusion therein, which information the parties hereto agree is limited to the Placement
Agents Information (as defined in Section 18).
(d) At the time the Registration Statement became effective, at the date of this
Agreement and at the Closing Date, the Registration Statement conformed and will conform in
all material respects to the requirements of the Securities Act and the Rules and
Regulations and did not and will not contain any untrue statement of a material fact or omit
to state any material fact required to be stated therein or necessary to make the statements
therein not misleading; the Prospectus, at the time the Prospectus was issued and at the
Closing Date, conformed and will conform in all material respects to the requirements of the
Securities Act and the Rules and Regulations and did not and will not contain an untrue
statement of a material fact or omit to state a material fact necessary in order to make the
statements therein, in light of the circumstances under which they were made, not
misleading; provided, however, that the foregoing representations and warranties in this
paragraph (d) shall not apply to information contained in or omitted from the
Registration Statement or the Prospectus in reliance upon, and in conformity with, written
information furnished to the Company through the Representative by or on behalf of any
Placement Agent specifically for inclusion therein, which information the parties hereto
agree is limited to the Placement Agents Information (as defined in Section 18).
(e) Each Issuer Free Writing Prospectus, if any, as of its issue date and at all
subsequent times through the completion of the public offer and sale of the Stock or until
any earlier date that the Company notified or notifies the Representative as described in
Section 5(e), did not, does not and will not include any information that
conflicted, conflicts or will conflict with the information contained in the Registration
Statement, Pricing Prospectus or the Prospectus, including any document incorporated by
reference therein and any prospectus supplement deemed to be a part thereof that has not
been superseded or modified, or includes an untrue statement of a material fact or omitted
or would omit to state a material fact required to be stated therein or necessary in order
to make the statements therein, in the light of the circumstances under which they were
made, not misleading. The foregoing sentence does not apply to statements in or omissions
from any Issuer Free Writing Prospectus in reliance upon, and in conformity with, written
information furnished to the Company through the Representative by
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or on behalf of any Placement Agent specifically for inclusion therein, which
information the parties hereto agree is limited to the Placement Agents Information (as
defined in Section 18).
(f) The documents incorporated by reference in the Prospectus, when they became
effective or were filed with the Commission, as the case may be, conformed in all material
respects to the requirements of the Securities Act or the Exchange Act, as applicable, and
the rules and regulations of the Commission thereunder and none of such documents contained
any untrue statement of a material fact or omitted to state any material fact required to be
stated therein or necessary to make the statements therein in light of the circumstances
under which they were made not misleading; and any further documents so filed and
incorporated by reference in the Prospectus, when such documents become effective or are
filed with the Commission, as the case may be, will conform in all material respects to the
requirements of the Securities Act or the Exchange Act, as applicable, and the rules and
regulations of the Commission thereunder and will not contain any untrue statement of a
material fact or omit to state any material fact required to be stated therein or necessary
to make the statements therein in light of the circumstances under which they were made not
misleading.
(g) The Company has not, directly or indirectly, distributed and will not distribute
any offering material in connection with the Offering other than any Preliminary Prospectus,
the Prospectus, the documents incorporated by reference therein and other materials, if any,
permitted under the Securities Act and consistent with Section 5(b) below. The
Company will file with the Commission all Issuer Free Writing Prospectuses, if any, in the
time and manner required under Rules 163(b)(2) and 433(d) under the Securities Act.
(h) The Company has been duly organized and is validly existing as a corporation in
good standing (or the foreign equivalent thereof) under the laws of its jurisdiction of
organization. The Company is duly qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which its ownership or lease of property or the
conduct of its business requires such qualification and has all power and authority
necessary to own or hold its properties and to conduct the business in which it is engaged,
except where the failure to so qualify or have such power or authority (i) would not have,
singularly or in the aggregate, a material adverse effect on the condition (financial or
otherwise), results of operations, assets, business or prospects of the Company, or (ii)
impair in any material respect the ability of the Company to perform its obligations under
this Agreement or to consummate any transactions contemplated by the Agreement, the General
Disclosure Package or the Prospectus (any such effect as described in clauses (i) or (ii), a
Material Adverse Effect). The Company has no subsidiaries and does not own more than 5%
of the equity interest or control, directly or indirectly, any corporate, association or
other entity.
(i) The Company has the full right, power and authority to enter into this Agreement,
each of the Subscription Agreements and that certain Escrow Agreement (the Escrow
Agreement) dated as of the date hereof by and among the Company, the Placement Agents and
the escrow agent named therein, and to perform and to discharge its obligations hereunder
and thereunder; and each of this Agreement and each of the Subscription Agreements has been
duly authorized, executed and delivered by the Company, and constitutes a valid and binding
obligation of the Company enforceable in accordance with its terms, except (i) as limited by
laws of general application relating to bankruptcy, insolvency and the relief of debtors;
(ii) as limited by rules of law governing specific performance, injunctive relief or other
equitable remedies and by general principles of equity; and (iii) to the extent any
indemnification provisions contained therein may further be limited by applicable laws and
principles of public policy.
(j) The Stock to be issued and sold by the Company to the Purchasers hereunder and
under the Subscription Agreements has been duly and validly authorized and, when issued and
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delivered against payment therefor as provided herein and the Subscription Agreements,
will be duly and validly issued, fully paid and nonassessable and free of any preemptive or
similar rights and will conform to the description thereof contained in the General
Disclosure Package and the Prospectus.
(k) The Company has an authorized capitalization as set forth in the Pricing
Prospectus, and all of the issued shares of capital stock of the Company have been duly and
validly authorized and issued, are fully paid and non-assessable, have been issued in
compliance with federal and state securities laws, and conform to the description thereof
contained in the General Disclosure Package and the Prospectus. As of September 30, 2006,
there were 37,793,573 shares of Common Stock issued and outstanding and no shares of
Preferred Stock, par value $0.001 of the Company issued and outstanding and 4,427,980 shares
of Common Stock were issuable upon the exercise of all options, warrants and convertible
securities outstanding as of such date. Since such date, the Company has not issued any
securities, other than Common Stock of the Company issued pursuant to the exercise of stock
options previously outstanding under the Companys stock option plans or the issuance of
restricted Common Stock pursuant to employee stock purchase plans. None of the outstanding
shares of Common Stock was issued in violation of any preemptive rights, rights of first
refusal or other similar rights to subscribe for or purchase securities of the Company.
There are no authorized or outstanding shares of capital stock, options, warrants,
preemptive rights, rights of first refusal or other rights to purchase, or equity or debt
securities convertible into or exchangeable or exercisable for, any capital stock of the
Company or any of its subsidiaries other than those described above or accurately described
in the General Disclosure Package. The description of the Companys stock option, stock
bonus and other stock plans or arrangements, and the options or other rights granted
thereunder, as described in the General Disclosure Package and the Prospectus, accurately
and fairly present the information required to be shown with respect to such plans,
arrangements, options and rights in all material respects.
(l) [Reserved].
(m) The execution, delivery and performance of this Agreement, the Subscription
Agreements and the Escrow Agreement by the Company, the issue and sale of the Stock by the
Company and the consummation of the transactions contemplated hereby and thereby will not
(with or without notice or lapse of time or both) conflict with or result in a breach or
violation of any of the terms or provisions of, constitute a default under, give rise to any
right of termination or other right or the cancellation or acceleration of any right or
obligation or loss of a benefit under, or give rise to the creation or imposition of any
lien, encumbrance, security interest, claim or charge upon any property or assets of the
Company pursuant to, (i) any indenture, mortgage, deed of trust, loan agreement or other
agreement or instrument to which the Company is a party or by which the Company is bound or
to which any of the property or assets of the Company is subject, (ii) result in any
violation of the provisions of the charter or by-laws (or analogous governing instruments,
as applicable) of the Company or (iii) result in any violation of any law, statute, rule,
regulation, judgment, order or decree of any court or governmental agency or body, domestic
or foreign, having jurisdiction over the Company or any of its properties or assets, except
with respect to clauses (i) and (iii) where, any such conflict, breach, violation, default
or right would not reasonably be expected to have a Material Adverse Effect.
(n) Except for the registration of the Stock under the Securities Act and such
consents, approvals, authorizations, registrations or qualifications as may be required
under the Exchange Act and applicable state or foreign securities laws, the National
Association of Securities Dealers, Inc. and the Nasdaq Global Market (Nasdaq GM) in
connection with the offering and sale of the Stock by the Company, no consent, approval,
authorization or order of, or filing, qualification or registration with, any court or
governmental agency or body, foreign or domestic, which has not been made, obtained or taken
and is not in full force and effect, is
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required for the execution, delivery and performance of this Agreement, the
Subscription Agreements and the Escrow Agreement by the Company, the offer or sale of the
Stock or the consummation of the transactions contemplated hereby or thereby.
(o) To the Companys knowledge, PricewaterhouseCoopers LLP, who have certified certain
financial statements and related schedules included or incorporated by reference in the
Registration Statement, the General Disclosure Package and the Prospectus, and have audited
the Companys internal control over financial reporting and managements assessment thereof,
is an independent registered public accounting firm as required by the Securities Act and
the Rules and Regulations and the Public Company Accounting Oversight Board (United States)
(the PCAOB). Except as disclosed in the Registration Statement and as pre-approved in
accordance with the requirements set forth in Section 10A of the Exchange Act,
PricewaterhouseCoopers LLP have not been engaged by the Company to perform any prohibited
activities (as defined in Section 10A of the Exchange Act).
(p) The financial statements, together with the related notes and schedules, included
or incorporated by reference in the General Disclosure Package, the Prospectus and in the
Registration Statement fairly present in all material respects the financial position and
the results of operations and changes in financial position of the Company at the respective
dates or for the respective periods therein specified. Such statements and related notes
and schedules have been prepared in accordance with the generally accepted accounting
principles in the United States (GAAP) applied on a consistent basis throughout the
periods involved except as may be set forth in the related notes included or incorporated by
reference in the General Disclosure Package (provided that non-year-end financial statements
are subject to normal recurring year-end audit adjustments and do not contain all footnotes
required by GAAP). The financial statements, together with the related notes and schedules,
included or incorporated by reference in the General Disclosure Package and the Prospectus
comply in all material respects with the Securities Act, the Exchange Act, and the Rules and
Regulations and the rules and regulations under the Exchange Act. No other financial
statements or supporting schedules or exhibits are required by the Securities Act or the
Rules and Regulations to be described, or included or incorporated by reference in the
Registration Statement, the General Disclosure Package or the Prospectus. There is no pro
forma or as adjusted financial information which is required to be included in the
Registration Statement, the General Disclosure Package, or and the Prospectus or a document
incorporated by reference therein in accordance with the Securities Act and the Rules and
Regulations which has not been included or incorporated as so required.
(q) The Company has not sustained, since the date of the latest unaudited financial
statements included or incorporated by reference in the General Disclosure Package, any
material loss or interference with its business from fire, explosion, flood or other
calamity, whether or not covered by insurance, or from any labor dispute or court or
governmental action, order or decree, otherwise than as set forth or contemplated in the
General Disclosure Package; and, since such date, there has not been any change in the
capital stock (other than as a result of the grant or exercise of stock options or the offer
to sell shares of Common Stock and award shares of restricted Common Stock pursuant to the
Company stock plans in the ordinary course) or long-term debt of the Company or any Material
Adverse Effect.
(r) Except as set forth in the General Disclosure Package, there is no legal or
governmental action, suit, claim or proceeding pending to which the Company is a party or of
which any property or assets of the Company is the subject which is required to be described
in the Registration Statement, the General Disclosure Package or the Prospectus or a
document incorporated by reference therein and is not described therein, or which,
singularly or in the aggregate, if determined adversely to the Company would reasonably be
expected to have a Material Adverse Effect or prevent the consummation of the transactions
contemplated hereby;
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and to the Companys knowledge, no such proceedings are threatened or contemplated by
governmental authorities or threatened by others.
(s) The Company is not in (i) violation of its charter or by-laws (or analogous
governing instrument, as applicable), (ii) default in any respect, and no event has occurred
which, with notice or lapse of time or both, would constitute such a default, in the due
performance or observance of any term, covenant or condition contained in any material
indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument
to which it is a party or by which it is bound or to which any of its property or assets is
subject or (iii) violation in any respect of any law, ordinance, governmental rule,
regulation or court order, decree or judgment to which it or its property or assets may be
subject except, in the case of clauses (ii) and (iii) of this paragraph (s), for any
violations or defaults which, singularly or in the aggregate, would not have a Material
Adverse Effect.
(t) The Company possesses all licenses, certificates, authorizations and permits issued
by, and has made all declarations and filings with, the appropriate local, state, federal or
foreign regulatory agencies or bodies which are necessary or desirable for the ownership of
its properties or the conduct of its business as described in the General Disclosure Package
and the Prospectus (collectively, the Governmental Permits) except where any failures to
possess or make the same, singularly or in the aggregate, would not reasonably be expected
to have a Material Adverse Effect. The Company is in compliance with all such Governmental
Permits and all such Governmental Permits are valid and in full force and effect, except
where the lack of compliance or validity or the failure to be in full force and effect would
not, singularly or in the aggregate, reasonably be expected to have a Material Adverse
Effect. All such Governmental Permits are free and clear of any material restriction or
condition that are in addition to, or materially different from those normally applicable to
similar licenses, certificates, authorizations and permits. The Company has not received
notification of any revocation or modification (or proceedings related thereto) of any such
Governmental Permit except as would not reasonably be expected to have a Material Adverse
Effect.
(u) The Company is not or, after giving effect to the offering of the Stock and the
application of the proceeds thereof as described in the General Disclosure Package and the
Prospectus, will become an investment company within the meaning of the Investment Company
Act of 1940, as amended, and the rules and regulations of the Commission thereunder.
(v) Neither the Company nor, to the Companys knowledge, any of the Companys officers,
directors or affiliates has taken or will take, directly or indirectly, any action designed
or intended to stabilize or manipulate the price of any security of the Company, or which
caused or resulted in, or which might in the future reasonably be expected to cause or
result in, stabilization or manipulation of the price of any security of the Company.
(w) Except as disclosed in the Registration Statement and Prospectus, the Company owns,
possesses, licenses or has other rights to use the patents and patent applications,
copyrights, trademarks, service marks, trade names, technology, know-how (including trade
secrets and other unpatented and/or unpatentable proprietary rights) and other intellectual
property (or could acquire such intellectual property upon commercially reasonable terms)
necessary to conduct its business in the manner in which it is being conducted and in the
manner in which it is contemplated to be conducted as set forth in the Prospectus
(collectively, the Company Intellectual Property); except as disclosed in the Registration
Statement and Prospectus, to the Companys knowledge, none of the patents owned or licensed
by the Company is unenforceable or invalid, and, to the Companys knowledge, none of the
patent applications owned or licensed by the Company would be unenforceable or invalid if
issued as patents; each of the compounds currently in clinical studies, i.e., the compounds
designated SB-743921, CK-1827452 and SB-715992, falls within the scope of at least one claim
in the patents and/or applications assigned to
8
the Company; the Company is not obligated to pay a royalty, grant a license, or provide
other consideration to any third party in connection with the Company Intellectual Property
other than as disclosed in the Prospectus; except as disclosed in the Registration Statement
and Prospectus, the Company has not received any written notice of violation or conflict
with rights of others with respect to the Company Intellectual Property; except as disclosed
in the Registration Statement and Prospectus, there are no pending or to the Companys
knowledge, threatened actions, suits, proceedings or claims by others that the Company is
infringing any patent, trade secret, trade mark, service mark, copyright or other
intellectual property or proprietary right; and except as disclosed in the Registration
Statement and Prospectus, the products or processes of the Company referenced in the
Prospectus do not, to the knowledge of the Company, violate or conflict with any
intellectual property or proprietary right of any third person, or any discovery, invention,
product or process that is the subject of a patent application filed by any third person.
(x) The preclinical and clinical trials conducted by or on behalf of the Company that
are described in the Prospectus were and, if still pending, are being conducted in all
material respects in accordance with procedures and controls pursuant to accepted
professional scientific standards and all applicable local, state and federal and foreign
laws, rules, regulations and published guidance, including, but not limited to, the Federal
Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58
and 312; the descriptions of the results of such studies, tests and trials contained in the
Prospectus are accurate and complete in all material respects; the Company is not aware of
any studies, tests or trials the results of which reasonably call into question the clinical
trial results described or referred to in the Prospectus when viewed in the context in which
such results are described and the clinical state of development; and the Company has not
received any written notices or correspondence from the U.S. Food and Drug Administration or
any foreign, state or local governmental body exercising comparable authority requiring the
termination or suspension of any preclinical or clinical trials conducted by or on behalf of
the Company.
(y) Other than liens on personal or other property securing indebtedness of the Company
in the ordinary course and as described in the Prospectus, the Company has good and
marketable title in fee simple to, or has valid rights to lease or otherwise use, all items
of real or personal property which are material to the business of the Company, free and
clear of all liens, encumbrances, security interests, claims and defects that do not,
singularly or in the aggregate, materially affect the value of such property and do not
interfere with the use made and proposed to be made of such property by the Company and all
of the leases and subleases material to the business of the Company and under which the
Company holds properties described in the General Disclosure Package and the Prospectus, are
in full force and effect, and the Company has not received any written notice of any
material claim of any sort that has been asserted by anyone adverse to the rights of the
Company under any of the leases or subleases mentioned above, or affecting or questioning
the rights of the Company to the continued possession of the leased or subleased premises
under any such lease or sublease.
(z) No labor dispute with the employees of the Company exists or, to the Companys
knowledge, is imminent, and the Company has not received written notice of any existing or
imminent labor disturbance by the employees of any of its principal suppliers,
manufacturers, customers or contractors, that would reasonably be expected, singularly or in
the aggregate, to have a Material Adverse Effect. The Company is not aware that any key
employee or significant group of employees of the Company plans to terminate employment with
the Company.
(aa) No prohibited transaction (as defined in Section 406 of the Employee Retirement
Income Security Act of 1974, as amended, including the regulations and published
interpretations thereunder (ERISA), or Section 4975 of the Internal Revenue Code of 1986,
as amended from time to time (the Code)) or accumulated funding deficiency (as defined
in Section 302 of ERISA) or any of the events set forth in Section 4043(b) of ERISA (other
than
9
events with respect to which the thirty (30)-day notice requirement under Section 4043
of ERISA has been waived) has occurred or would reasonably be expected to occur with respect
to any employee benefit plan of the Company that would, singularly or in the aggregate, be
reasonably expected to have a Material Adverse Effect. Each employee benefit plan of the
Company is in compliance in all material respects with applicable law, including ERISA and
the Code. The Company has not incurred and would not reasonably be expected to incur
liability under Title IV of ERISA with respect to the termination of, or withdrawal from,
any pension plan (as defined in ERISA). Each pension plan for which the Company would have
any liability that is intended to be qualified under Section 401(a) of the Code is so
qualified, and nothing has occurred, whether by action or by failure to act, that would,
singularly or in the aggregate, be reasonably expected to cause the loss of such
qualification.
(bb) The Company is in compliance with all foreign, federal, state and local rules,
laws and regulations relating to the use, treatment, storage and disposal of hazardous or
toxic substances or waste and protection of health and safety or the environment which are
applicable to its business, except where the failure to comply would not, singularly or in
the aggregate, reasonably be expected to have a Material Adverse Effect. There has been no
storage, generation, transportation, handling, treatment, disposal, discharge, emission, or
other release of any kind of toxic or other wastes or other hazardous substances by, due to,
or caused by the Company (or, to the Companys knowledge, any other entity for whose acts or
omissions the Company is or may otherwise be liable) upon any of the property now or
previously leased by the Company in violation of any law, statute, ordinance, rule,
regulation, order, judgment, decree or permit, except for any violation which would not
have, singularly or in the aggregate with all such violations and liabilities, a Material
Adverse Effect; and there has been no disposal, discharge, emission or other release of any
kind onto such property or into the environment surrounding such property of any toxic or
other wastes or other hazardous substances with respect to which the Company has knowledge,
except for any such disposal, discharge, emission, or other release of any kind which would
not have, singularly or in the aggregate with all such discharges and other releases, a
Material Adverse Effect.
(cc) The Company (i) has timely filed all necessary federal, state, local and foreign
tax returns, and all such returns were true, complete and correct, (ii) has paid all
federal, state, local and foreign taxes, assessments, governmental or other charges due and
payable for which it is liable, including, without limitation, all sales and use taxes and
all taxes which the Company is obligated to withhold from amounts owing to employees,
creditors and third parties, and (iii) does not have any tax deficiency or claims
outstanding or assessed or, to the best of its knowledge, proposed against any of them,
except those, in each of the cases described in clauses (i), (ii) and (iii) of this
paragraph (cc), that would not, singularly or in the aggregate, reasonably be
expected to have a Material Adverse Effect. The Company has not engaged in any transaction
which to the Companys knowledge a corporate tax shelter or could be characterized as such
by the Internal Revenue Service or any other taxing authority. The accruals and reserves on
the books and records of the Company in respect of tax liabilities for any taxable period
not yet finally determined are adequate to meet any assessments and related liabilities for
any such period, and since September 30, 2006 the Company has not incurred any liability for
taxes other than in the ordinary course.
(dd) The Company carries, or is covered by, insurance policies in such amounts and
covering such risks as, to the Companys knowledge, are adequate for the conduct of its
business and the value of its properties and to the knowledge of the Company is customary
for companies engaged in similar businesses in similar industries. The Company has no
reason to believe that it will not be able (i) to renew its existing insurance coverage as
and when such policies expire or (ii) to obtain comparable coverage as may be necessary or
appropriate to conduct its business as
10
now conducted. The Company has not been denied any insurance coverage that it has
sought or for which it has applied.
(ee) The Company maintains a system of internal controls over financial reporting (as
such term is defined in Rule 13a 15(f) under the Exchange Act) that complies with the
requirements of the Exchange Act and has been designed by the Companys principal executive
officer and principal financial officer, or under his supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements in accordance with generally accepted accounting principles. Except as described
in the General Disclosure Package, since the end of the Companys most recent audited fiscal
year, there as been (A) no material weakness in the Companys internal control over
financial reporting (whether or not remediated) and (B) no change in the Companys internal
control over financial reporting that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
(ff) The minute books of the Company have been made available to the Placement Agents
and counsel for the Placement Agents, and such books contain a complete and accurate summary
of all meetings and actions of the board of directors (including each board committee) and
shareholders of the Company (or analogous governing bodies and interest holders, as
applicable), since April 29, 2004 through the date of the latest meeting and action.
(gg) There is no franchise, lease, contract, agreement or document required by the
Securities Act or by the Rules and Regulations to be described in the General Disclosure
Package and in the Prospectus or a document incorporated by reference therein or to be filed
as an exhibit to the Registration Statement or a document incorporated by reference therein
which is not described or filed therein as required; and all descriptions of any such
franchises, leases, contracts, agreements or documents contained in the Registration
Statement or in a document incorporated by reference therein are accurate descriptions of
such documents in all material respects. Other than as described in the General Disclosure
Package, no such franchise, lease, contract or agreement has been suspended or terminated
for convenience or default by the Company or any of the other parties thereto, and the
Company has not received notice nor does the Company have any other knowledge of any such
pending or threatened suspension or termination, except for such pending or threatened
suspensions or terminations that would not reasonably be expected to, singularly or in the
aggregate, have a Material Adverse Effect.
(hh) No relationship, direct or indirect, exists between or among the Company on the
one hand, and the directors, officers, stockholders (or analogous interest holders),
customers or suppliers of the Company or any of its affiliates on the other hand, which is
required to be described in the General Disclosure Package and the Prospectus or a document
incorporated by reference therein and which is not so described.
(ii) No person or entity has the right to require registration of shares of Common
Stock or other securities of the Company because of the filing or effectiveness of the
Registration Statement or the sale of the Stock, except for persons and entities who have
expressly waived such right in writing or who have been given timely and proper written
notice and have failed to exercise such right within the time or times required under the
terms and conditions of such right. Except as described in the General Disclosure Package,
there are no persons with registration rights or similar rights to have any securities
registered by the Company under the Securities Act.
(jj) The Company does not own any margin securities as that term is defined in
Regulation U of the Board of Governors of the Federal Reserve System (the Federal Reserve
Board), and none of the proceeds of the sale of the Stock will be used, directly or
indirectly, for the purpose of purchasing or carrying any margin security, for the purpose
of reducing or retiring any indebtedness which was originally incurred to purchase or carry
any margin security or for
11
any other purpose which might cause any of the Stock to be considered a purpose
credit within the meanings of Regulation T, U or X of the Federal Reserve Board.
(kk) Except for payments contemplated by this Agreement, the Registration Statement,
the General Disclosure Package or the Prospectus, the Company is not a party to any
contract, agreement or understanding with any person that would give rise to a valid claim
against the Company or the Placement Agents for a brokerage commission, finders fee or like
payment in connection with the offering and sale of the Stock.
(ll) No forward-looking statement (within the meaning of Section 27A of the Securities
Act and Section 21E of the Exchange Act) contained in either the General Disclosure Package
or the Prospectus has been made or reaffirmed without a reasonable basis or has been
disclosed other than in good faith.
(mm) The Company is subject to and in compliance in all material respects with the
reporting requirements of Section 13 or Section 15(d) of the Exchange Act. The Common Stock
is registered pursuant to Section 12(g) of the Exchange Act and is listed on the Nasdaq GM,
and the Company has taken no action designed to, or reasonably likely to have the effect of,
terminating the registration of the Common Stock under the Exchange Act or delisting the
Common Stock from the Nasdaq GM, nor has the Company received any notification that the
Commission or the National Association of Securities Dealers, Inc. (NASD) is contemplating
terminating such registration or listing. No consent, approval, authorization or order of,
or filing, notification or registration with, the Nasdaq GM is required for the listing and
trading of the Stock on the Nasdaq GM.
(nn) The Company is in material compliance with all applicable provisions of the
Sarbanes-Oxley Act of 2002 and all rules and regulations promulgated thereunder or
implementing the provisions thereof (the Sarbanes-Oxley Act) that are currently in effect.
(oo) The Company is in compliance in all material respects with all applicable
corporate governance requirements set forth in the Nasdaq Global Marketplace Rules that are
currently in effect.
(pp) There are no transactions, arrangements or other relationships between and/or
among the Company, any of its affiliates (as such term is defined in Rule 405 of the
Securities Act) and any unconsolidated entity, including, but not limited to, any structure
finance, special purpose or limited purpose entity that would reasonably be expected to
materially affect the Companys liquidity or the availability of or requirements for its
capital resources required to be described in the General Disclosure Package and the
Prospectus or a document incorporated by reference therein which have not been described as
required.
(qq) There are no outstanding loans, advances (except normal advances for business
expenses in the ordinary course of business) or guarantees or indebtedness by the Company to
or for the benefit of any of the officers or directors of the Company, or any of their
respective family members, except as disclosed in the Registration Statement, the General
Disclosure Package and the Prospectus.
(rr) The statistical and market related data included in the Registration Statement,
the General Disclosure Package and the Prospectus are based on or derived from sources that
the Company believes to be reliable and accurate, and such data agree with the sources from
which they are derived.
(ss) To the Companys knowledge, neither the Company nor any of its affiliates (within
the meaning of NASD Conduct Rule 2720(b)(1)(a)) directly or indirectly controls, is
controlled by, or is under common control with, or is an associated person (within the
meaning of Article I, Section 1(ee) of the By-laws of the NASD) of, any member firm of the
NASD.
12
(tt) No approval of the shareholders of the Company under the rules and regulations of
Nasdaq (including Rule 4350 of the Nasdaq Global Marketplace Rules) is required for the
Company to issue and deliver to the Purchasers the Stock.
Any certificate signed by or on behalf of the Company and delivered to any Placement Agent or to
counsel for the Placement Agents shall be deemed to be a representation and warranty by the Company
to the Placement Agents and the Purchasers as to the matters covered thereby.
4. The Closing. The time and date of closing and delivery of the documents required
to be delivered to the Placement Agents pursuant to Sections 5 and 7 hereof shall
be at 10:00 A.M., New York time, on December 12, 2006 (the Closing Date) at the office of Wilson
Sonsini Goodrich & Rosati PC, 650 Page Mill Road, Palo Alto, CA 94304.
5. FURTHER AGREEMENTS OF THE COMPANY. The Company agrees with the Placement Agents
and the Purchasers:
(a) To prepare the Prospectus in a form approved by the Representative containing
information previously omitted at the time of effectiveness of the Registration Statement in
reliance on rules 430A, 430B and 430C and to file such Prospectus pursuant to Rule 424(b)
under the Securities Act not later than the second business (2nd) day following the
execution and delivery of this Agreement or, if applicable, such earlier time as may be
required by Rule 430A of the Rules and Regulations; to notify the Representative promptly of
the Companys intention to file or prepare any supplement or amendment to any Registration
Statement or to the Prospectus in connection with this Offering and to provide a draft of
any such amendment or supplement to the Registration Statement, the General Disclosure
Package or to the Prospectus to the Representative within an amount of time that is
reasonably practical to review under the circumstances and prior to filing; to advise the
Representative, promptly after it receives notice thereof, of the time when any amendment to
any Registration Statement has been filed in connection with the Offering or becomes
effective or any supplement to the General Disclosure Package or the Prospectus or any
amended Prospectus has been filed in connection with the Offering and to furnish the
Representative copies thereof; to file promptly all material required to be filed by the
Company with the Commission pursuant to Rule 433(d) or 163(b)(2), as the case may be; to
file within the time periods prescribed by the Exchange Act, including any extension
thereof, all reports and any definitive proxy or information statements required to be filed
by the Company with the Commission pursuant to Section 13(a), 13(c), 14 or 15(d) of the
Exchange Act subsequent to the date of the Prospectus and for so long as the delivery of a
prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Securities
Act) is required in connection with the Offering; to advise the Representative, promptly
after it receives notice thereof, of the issuance by the Commission of any stop order or of
any order preventing or suspending the use of any Preliminary Prospectus, any Issuer Free
Writing Prospectus or the Prospectus, of the suspension of the qualification of the Stock
for offering or sale in any jurisdiction, of the initiation or threatening of any proceeding
for any such purpose, or of any request by the Commission for the amending or supplementing
of the Registration Statement, the General Disclosure Package or the Prospectus or for
additional information; and, in the event of the issuance of any stop order or of any order
preventing or suspending the use of any Preliminary Prospectus, any Issuer Free Writing
Prospectus or the Prospectus or suspending any such qualification, and promptly to use its
best efforts to obtain the withdrawal of such order.
(b) The Company represents and agrees that, unless it obtains the prior consent of the
Representative, and each Placement Agent represents and agrees that, unless it obtains the
prior consent of the Representative and the Company, it has not made and will not, make any
offer relating to the Stock that would constitute a free writing prospectus as defined in
Rule 405 under the Securities Act unless the prior written consent of the Representative has
been received (each, a Permitted Free Writing Prospectus); provided that the prior written
consent of the
13
Representative hereto shall be deemed to have been given in respect of the Issuer Free
Writing Prospectus included in Schedule A hereto. The Company represents that it
has treated and agrees that it will treat each Permitted Free Writing Prospectus as an
Issuer Free Writing Prospectus, comply with the requirements of Rules 164 and 433 under the
Securities Act applicable to any Issuer Free Writing Prospectus, including the requirements
relating to timely filing with the Commission, legending and record keeping and will not
take any action that would result in any Placement Agent or the Company being required to
file with the Commission pursuant to Rule 433(d) under the Securities Act a free writing
prospectus prepared by or on behalf of such Placement Agent that such Placement Agent
otherwise would not have been required to file thereunder.
(c) If at any time when a Prospectus relating to the Stock is required to be delivered
under the Securities Act, any event occurs or condition exists as a result of which the
Prospectus, as then amended or supplemented, would include any untrue statement of a
material fact or omit to state a material fact necessary in order to make the statements
therein, in light of the circumstances under which they were made, not misleading, or the
Registration Statement, as then amended or supplemented, would include any untrue statement
of a material fact or omit to state a material fact necessary to make the statements therein
not misleading, or if for any other reason it is necessary at any time to amend or
supplement any Registration Statement or the Prospectus to comply with the Securities Act or
the Exchange Act, the Company will promptly notify the Representative, and upon the
Representatives request, the Company will promptly prepare and file with the Commission, at
the Companys expense, an amendment to the Registration Statement or an amendment or
supplement to the Prospectus that corrects such statement or omission or effects such
compliance and will deliver to the Placement Agents, without charge, such number of copies
thereof as the Placement Agents may reasonably request. The Company consents to the use of
the Prospectus or any amendment or supplement thereto by the Placement Agents.
(d) If the General Disclosure Package is being used to solicit offers to buy the Stock
at a time when the Prospectus is not yet available to prospective purchasers and any event
shall occur as a result of which, in the judgment of the Company or in the reasonable
opinion of the Representative, it becomes necessary to amend or supplement the General
Disclosure Package in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading, or to make the statements therein
not conflict with the information contained or incorporated by reference in the Registration
Statement then on file and not superseded or modified, or if it is necessary at any time to
amend or supplement the General Disclosure Package to comply with any law, the Company
promptly will either (i) prepare, file with the Commission (if required) and furnish to the
Placement Agents and any dealers an appropriate amendment or supplement to the General
Disclosure Package or (ii) prepare and file with the Commission an appropriate filing under
the Exchange Act which shall be incorporated by reference in the General Disclosure Package
so that the General Disclosure Package as so amended or supplemented will not, in the light
of the circumstances under which they were made, be misleading or conflict with the
Registration Statement then on file, or so that the General Disclosure Package will comply
with law.
(e) If at any time following issuance of an Issuer Free Writing Prospectus in
connection with the Offering there occurred or occurs an event or development as a result of
which such Issuer Free Writing Prospectus conflicted or will conflict with the information
contained in the Registration Statement, Pricing Prospectus or Prospectus, including any
document incorporated by reference therein and any prospectus supplement deemed to be a part
thereof and not superseded or modified or included or would include an untrue statement of a
material fact or omitted or would omit to state a material fact required to be stated
therein or necessary in order to make the statements therein, in the light of the
circumstances under which
14
they were made, not misleading, the Company has promptly notified or will promptly
notify the Representative (and the Representative and Placement Agents agree to cease any
such use promptly upon such notification) so that any use of the Issuer Free Writing
Prospectus may cease until it is amended or supplemented and has promptly amended or will
promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to
eliminate or correct such conflict, untrue statement or omission. The foregoing sentence
does not apply to statements in or omissions from any Issuer Free Writing Prospectus in
reliance upon, and in conformity with, written information furnished to the Company by the
Representative by or on behalf of any Placement Agent specifically for inclusion therein,
which information the parties hereto agree is limited to the Placement Agents Information
(as defined in Section 18).
(f) To the extent not available on the Commissions EDGAR system, furnish promptly to
the Placement Agents and to counsel for the Placement Agents a signed copy of the
Registration Statement as originally filed with the Commission, and of each amendment
thereto filed with the Commission, including all consents and exhibits filed therewith.
(g) To the extent not available on the Commissions EDGAR system, to deliver promptly
to the Representative in New York City such number of the following documents as the
Representative shall reasonably request: (i) conformed copies of the Registration Statement
as originally filed with the Commission (in each case excluding exhibits), (ii) each
Preliminary Prospectus, if any (iii) any Issuer Free Writing Prospectus, (iv) the Prospectus
(the delivery of the documents referred to in clauses (i), (ii), (iii) and (iv) of this
paragraph (g) to be made not later than 10:00 A.M., New York time, on the business
day following the execution and delivery of this Agreement), (v) conformed copies of any
amendment to the Registration Statement (excluding exhibits), (vi) any amendment or
supplement to the General Disclosure Package or the Prospectus (the delivery of the
documents referred to in clauses (v) and (vi) of this paragraph (g) to be made not
later than 10:00 A.M., New York City time, on the business day following the date of such
amendment or supplement) and (vii) any document incorporated by reference in the General
Disclosure Package or the Prospectus (excluding exhibits thereto) (the delivery of the
documents referred to in clause (vi) of this paragraph (g) to be made not later than
10:00 A.M., New York City time, on the business day following the date of such document).
(h) To make generally available to its shareholders as soon as practicable, but in any
event not later than eighteen (18) months after the effective date of each Registration
Statement (as defined in Rule 158(c) under the Securities Act), an earnings statement of the
Company (which need not be audited) complying with Section 11(a) of the Securities Act and
the Rules and Regulations (including, at the option of the Company, Rule 158); and to
furnish to its shareholders as soon as practicable after the end of each fiscal year an
annual report (including a balance sheet and statements of income, shareholders equity and
cash flows of the Company and its consolidated subsidiaries certified by independent public
accountants) and as soon as practicable after each of the first three fiscal quarters of
each fiscal year (beginning with the first fiscal quarter after the effective date of such
Registration Statement), consolidated summary financial information of the Company for such
quarter in reasonable detail.
(i) To take promptly from time to time such actions as the Representative may
reasonably request to qualify the Stock for offering and sale under the securities or Blue
Sky laws of such jurisdictions (domestic or foreign) as the Representative may designate and
to continue such qualifications in effect, and to comply with such laws, for so long as
required to permit the offer and sale of Stock in such jurisdictions; provided that the
Company shall not be obligated to qualify as foreign corporations in any jurisdiction in
which they are not so qualified or to file a general consent to service of process in any
jurisdiction.
(j) To the extent not available on the Commissions EDGAR system, upon request, during
the period of five (5) years from the date hereof, to deliver to the Placement Agents, (i)
as
15
soon as they are available, copies of all reports or other communications furnished to
shareholders, and (ii) as soon as they are available, copies of any reports and financial
statements furnished or filed with the Commission or any national securities exchange or
automatic quotation system on which the Stock is listed or quoted.
(k) That the Company will not, for a period of ninety (90) days from the date of the
Prospectus, (the Lock-Up Period) without the prior written consent of LCM, directly or
indirectly offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of,
any shares of Common Stock or any securities convertible into or exercisable or exchangeable
for Common Stock, other than (i) the Companys sale of the Stock hereunder, (ii) the
issuance of restricted Common Stock or options to acquire Common Stock pursuant to the
Companys employee benefit plans, qualified stock option plans or other employee
compensation plans as such plans are in existence on the date hereof and described in the
Prospectus, and (iii) Common Stock or securities convertible into or exercisable or
exchangeable for shares of Common Stock pursuant to a strategic partnership, joint venture,
merger, collaboration, lending or similar arrangement, or in connection with the acquisition
or license by the Company of any business, products or technologies, provided however, that
such shares may not be traded by the recipient during the Lock-Up Period. The Company will
cause each executive officer, director, shareholder, optionholder and warrantholder listed
in Schedule B to furnish to the Representative, prior to the Closing Date, a letter,
substantially in the form of Exhibit B hereto. The Company also agrees that during
such period, the Company will not file any registration statement, preliminary prospectus or
prospectus, or any amendment or supplement thereto, under the Securities Act for any such
transaction or which registers, or offers for sale, Common Stock or any securities
convertible into or exercisable or exchangeable for Common Stock, except for a registration
statement on Form S-8 relating to employee benefit plans. The Company hereby agrees that
(i) if it issues an earnings release or material news, or if a material event relating to
the Company occurs, during the last seventeen (17) days of the Lock-Up Period, or (ii) if
prior to the expiration of the Lock-Up Period, the Company announces that it will release
earnings results during the sixteen (16)-day period beginning on the last day of the Lock-Up
Period, the restrictions imposed by this paragraph (k) or the letter shall continue
to apply until the expiration of the eighteen (18)-day period beginning on the issuance of
the earnings release or the occurrence of the material news or material event.
(l) To supply the Representative with copies of all correspondence to and from, and all
documents issued to and by, the Commission in connection with the registration of the Stock
under the Securities Act or the Registration Statement, any Preliminary Prospectus or the
Prospectus, or any amendment or supplement thereto or document incorporated by reference
therein.
(m) Prior to the Closing Date, not to issue any press release or other communication
directly or indirectly or hold any press conference with respect to the Company, its
condition, financial or otherwise, or earnings, business affairs or business prospects
(except for routine oral communications regarding the Companys business in the ordinary
course of its business and consistent with the past practices of the Company and of which
the Representative is notified), without the prior written consent of the Representative,
unless in the judgment of the Company and its counsel, and after notification to the
Representative, such press release or communication is required by law.
(n) Until the Representative shall have notified the Company of the completion of the
offering of the Stock, that the Company will not, and will cause its affiliated purchasers
(as defined in Regulation M under the Exchange Act) not to, either alone or with one or more
other persons, bid for or purchase, for any account in which it or any of its affiliated
purchasers has a beneficial interest, any Stock, or attempt to induce any person to purchase
any Stock; and not to,
16
and to cause its affiliated purchasers not to, make bids or purchase for the purpose of
creating actual, or apparent, active trading in or of raising the price of the Stock.
(o) To apply the net proceeds from the sale of the Stock as set forth in the
Registration Statement, the General Disclosure Package and the Prospectus under the heading
Use of Proceeds.
(p) To use commercially reasonable efforts to effect and maintain the quotation of the
Stock on the Nasdaq GM.
(q) To use reasonable best efforts to assist the Representative with any filings with
the NASD and obtaining clearance from the NASD as to the amount of compensation allowable or
payable to the Placement Agents effect and maintain the quotation of the Stock on the Nasdaq
GM.
(r) To use commercially reasonable efforts to do and perform all things required to be
done or performed under this Agreement by the Company prior to the Closing Date and to
satisfy all conditions precedent to the delivery of the Stock.
6. Payment of Expenses. The Company agrees to pay, or reimburse if paid by the
Placement Agents, whether or not the transactions contemplated hereby are consummated or this
Agreement is terminated: (a) the costs incident to the authorization, issuance, sale, preparation
and delivery of the Stock to the Purchasers and any taxes payable in that connection; (b) the costs
incident to the Registration of the Stock under the Securities Act; (c) the costs incident to the
preparation, printing and distribution of the Registration Statement, the Base Prospectus, any
Preliminary Prospectus, any Issuer Free Writing Prospectus, the General Disclosure Package, the
Prospectus, any amendments, supplements and exhibits thereto or any document incorporated by
reference therein and the costs of printing, reproducing and distributing any transaction document
by mail, telex or other means of communications; (d) subject to the limit set forth in (i) below,
the reasonable and documented fees and expenses incurred in connection with securing any required
review by the NASD of the terms of the sale of the Stock and any filings made with the NASD; (e)
any applicable listing, quotation or other fees; (f) the fees and expenses of qualifying the Stock
under the securities laws of the several jurisdictions as provided in Section 5(i) and of
preparing, printing and distributing wrappers, Blue Sky Memoranda; (g) the cost of preparing and
printing stock certificates; (h) all fees and expenses of the registrar and transfer agent of the
Stock; (i) the reasonable and documented fees, disbursements and expenses of counsel to the
Placement Agents not to exceed, along with any fees and expenses incurred in connection with (d)
above, $40,000 and (j) all other costs and expenses incident to the offering of the Stock or the
performance of the obligations of the Company under this Agreement (including, without limitation,
the fees and expenses of the Companys counsel and the Companys independent accountants and the
travel and other reasonable, documented expenses incurred by Company personnel in connection with
any road show including, without limitation, any expenses advanced by the Placement Agents on the
Companys behalf (which will be promptly reimbursed)); provided that, except to the extent
otherwise provided in this Section 6 and in Sections 8 and 10, the
Placement Agents shall pay its own costs and expenses.
7. Conditions to the Obligations of the Placement Agents and the Purchasers, and the Sale
of the Stock. The respective obligations of the Placement Agents hereunder and the Purchasers
under the Subscription Agreements, and the Closing of the sale of the Stock, are subject to the
accuracy, when made and on the Applicable Time and on the Closing Date, of the representations and
warranties of the Company contained herein, to the accuracy of the statements of the Company made
in any certificates pursuant to the provisions hereof, to the performance by the Company of its
obligations hereunder, and to each of the following additional terms and conditions:
(a) No stop order suspending the effectiveness of the Registration Statement or any
part thereof, preventing or suspending the use of any Base Prospectus, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing Prospectus or any part thereof
shall have been issued and no proceedings for that purpose or pursuant to Section 8A under
the
17
Securities Act shall have been initiated or threatened by the Commission, and all
requests for additional information on the part of the Commission (to be included or
incorporated by reference in the Registration Statement or the Prospectus or otherwise)
shall have been complied with to the reasonable satisfaction of the Representative; each
Issuer Free Writing Prospectus, if any, and the Prospectus shall have been filed with the
Commission within the applicable time period prescribed for such filing by, and in
compliance with, the Rules and Regulations and in accordance with Section 5(a); and
the NASD shall have raised no objection to the fairness and reasonableness of the terms of
this Agreement or the transactions contemplated hereby.
(b) The Placement Agents shall not have discovered and disclosed to the Company on or
prior to the Closing Date that the Registration Statement or any amendment or supplement
thereto contains an untrue statement of a fact which, in the opinion of counsel for the
Placement Agents, is material or omits to state any fact which, in the opinion of such
counsel, is material and is required to be stated therein or is necessary to make the
statements therein not misleading, or that the General Disclosure Package, any Issuer Free
Writing Prospectus or the Prospectus or any amendment or supplement thereto contains an
untrue statement of fact which, in the opinion of such counsel, is material or omits to
state any fact which, in the opinion of such counsel, is material and is necessary in order
to make the statements, in the light of the circumstances in which they were made, not
misleading.
(c) All corporate proceedings and other legal matters incident to the authorization,
form and validity of each of this Agreement, the Subscription Agreements, the Escrow
Agreement, the Stock, the Registration Statement, the General Disclosure Package, each
Issuer Free Writing Prospectus, if any, and the Prospectus and all other legal matters
relating to this Agreement and the transactions contemplated hereby shall be reasonably
satisfactory in all material respects to counsel for the Placement Agents, and the Company
shall have furnished to such counsel all documents and information that they may reasonably
request to enable them to pass upon such matters.
(d) Wilson Sonsini Goodrich & Rosati, P.C. shall have furnished to the Placement Agents
an opinion letter in substantially the form attached hereto as Exhibit C, addressed
to the Placement Agents and dated the Closing Date.
(e) Wilson Sonsini Goodrich & Rosati, P.C. shall have furnished to the Placement Agents
an opinion letter regarding certain intellectual property matters in substantially the form
attached hereto as Exhibit D, addressed to the Placement Agents and dated the
Closing Date.
(f) Wilson Sonsini Goodrich & Rosati, P.C. shall have furnished to the Placement Agents
a statement of negative assurances in substantially the form attached hereto as Exhibit E,
addressed to the Placement Agents and dated the Closing Date.
(g) The Placement Agents shall have received from Thelen Reid Brown Raysman & Steiner
LLP, counsel for the Placement Agents, such opinion or opinions, dated the Closing Date,
with respect to such matters as the Placement Agents may reasonably require, and the Company
shall have furnished to such counsel such documents as they request for enabling them to
pass upon such matters.
(h) At the time of the execution of this Agreement, the Representative shall have
received from PricewaterhouseCoopers LLP a letter, addressed to the Placement Agents and to
the Companys Board of Directors, executed and dated such date, in form and substance
reasonably satisfactory to the Placement Agents (i) confirming that they are an independent
registered accounting firm with respect to the Company within the meaning of the Securities
Act and the Rules and Regulations and PCAOB and (ii) stating the conclusions and findings of
such firm, of the type ordinarily included in accountants comfort letters to
underwriters, with respect to the financial statements and certain financial information
contained or incorporated by reference in the Registration Statement, the General Disclosure
Package and the Prospectus.
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(i) On the Closing Date, the Representative shall have received a letter (the
Bring-Down Letter) from PricewaterhouseCoopers LLP addressed to the Placement Agents and
to the Companys Board of Directors and dated the Closing Date confirming, as of the date of
the Bring-Down Letter (or, with respect to matters involving changes or developments since
the respective dates as of which specified financial information is given in the General
Disclosure Package and the Prospectus, as the case may be, as of a date not more than three
(3) business days prior to the date of the Bring-Down Letter), the conclusions and findings
of such firm, of the type ordinarily included in accountants comfort letters to
underwriters, with respect to the financial information and other matters covered by its
letter delivered to the Representative concurrently with the execution of this Agreement
pursuant to paragraph (h) of this Section 7.
(j) The Company shall have furnished to the Representative and the Purchasers a
certificate, dated the Closing Date, of its Chairman of the Board, its President or a Vice
President and its chief financial officer stating that (i) since the date of the final
prospectus supplement, no event has occurred which should have been set forth in a
supplement or amendment to the Registration Statement, the General Disclosure Package or the
Prospectus, (ii) to their knowledge as of the Closing Date, the representations and
warranties of the Company in this Agreement are true and correct in all material respects,
except that any such representation or warranty shall be true and correct in all respects
where such representation or warranty is qualified with respect to materiality, and the
Company has complied with all agreements and satisfied all conditions on its part to be
performed or satisfied hereunder at or prior to the Closing Date, and (iv) there has not
been, subsequent to the date of the most recent unaudited financial statements included or
incorporated by reference in the General Disclosure Package, any material adverse change in
the financial position or results of operations of the Company, or any Material Adverse
Effect.
(k) Since the date of the latest unaudited financial statements included in the General
Disclosure Package or incorporated by reference in the General Disclosure Package as of the
date hereof, (i) the Company shall not have sustained any loss or interference with its
business from fire, explosion, flood or other calamity, whether or not covered by insurance,
or from any labor dispute or court or governmental action, order or decree, otherwise than
as set forth in the General Disclosure Package, and (ii) there shall not have been any
change in the capital stock or long-term debt of the Company, or any change, or any
development involving a prospective change, in or affecting the business, general affairs,
management, financial position, stockholders equity or results of operations of the
Company, otherwise than as set forth in the General Disclosure Package, the effect of which,
in any such case described in clause (i) or (ii) of this paragraph (k), is, in the
judgment of the Placement Agent, so material and adverse as to make it impracticable or
inadvisable to proceed with the sale or delivery of the Stock on the terms and in the manner
contemplated in the General Disclosure Package.
(l) No action shall have been taken and no law, statute, rule, regulation or order
shall have been enacted, adopted or issued by any governmental agency or body which would
prevent the issuance or sale of the Stock or materially and adversely affect the business or
operations of the Company; and no injunction, restraining order or order of any other nature
by any federal or state court of competent jurisdiction shall have been issued which would
prevent the issuance or sale of the Stock or materially and adversely affect the business or
operations of the Company.
(m) Subsequent to the execution and delivery of this Agreement there shall not have
occurred any of the following: (i) trading in securities generally on the New York Stock
Exchange, Nasdaq GM or the American Stock Exchange or in the over-the-counter market, or
trading in any securities of the Company on any exchange or in the over-the-counter market,
shall have been suspended or materially limited, or minimum or maximum prices or maximum
range for prices shall have been established on any such exchange or such market by the
Commission, by such exchange or market or by any other regulatory body or governmental
authority having jurisdiction, (ii) a banking moratorium shall have been declared by Federal
or state authorities or
19
a material disruption has occurred in commercial banking or securities settlement or
clearance services in the United States, (iii) the United States shall have become engaged
in hostilities, other than current hostilities, or the subject of an act of terrorism, or
there shall have been an outbreak of or escalation in hostilities involving the United
States, or there shall have been a declaration of a national emergency or war by the United
States or (iv) there shall have occurred such a material adverse change in general economic,
political or financial conditions (or the effect of international conditions on the
financial markets in the United States shall be such) as to make it, in the judgment of the
Representative, impracticable or inadvisable to proceed with the sale or delivery of the
Stock on the terms and in the manner contemplated in the General Disclosure Package and the
Prospectus.
(n) The Representative shall have received the written agreements, substantially in the
form of Exhibit B hereto, of the executive officers, directors, shareholders,
optionholders and warrantholders of the Company listed in Schedule B to this
Agreement.
(o) The Company shall have entered into Subscription Agreements with each of the
Purchasers and such agreements shall be in full force and effect.
(p) The Company shall have entered into the Escrow Agreement and such agreement shall
be in full force and effect.
(q) The Representative shall have received clearance from the NASD as to the amount of
compensation allowable or payable to the Placement Agents as described in the Pricing
Prospectus.
(r) Prior to the Closing Date, the Company shall have furnished to the Representative
such further information, opinions, certificates, letters or documents as the Representative
shall have reasonably requested.
All opinions, letters, evidence and certificates mentioned above or elsewhere in this
Agreement shall be deemed to be in compliance with the provisions hereof only if they are in form
and substance reasonably satisfactory to counsel for the Placement Agents.
8. INDEMNIFICATION AND CONTRIBUTION.
(a) The Company shall indemnify and hold harmless each Placement Agent, its affiliates
and each of its and their respective directors, officers, members, employees,
representatives and agents (including, without limitation Lazard Frères & Co. LLC, (which
will provide services to LCM) and its affiliates, and each of its and their respective
directors, officers, members, employees, representatives and agents and each person, if any,
who controls Lazard Frères & Co. LLC within the meaning of Section 15 of the Securities Act
or Section 20 of the Exchange Act) and each person, if any, who controls any Placement Agent
within the meaning of Section 15 of the Securities Act of or Section 20 of the Exchange Act
(collectively the Placement Agent Indemnified Parties, and each a Placement Agent
Indemnified Party) against any loss, claim, damage, expense or liability whatsoever (or any
action, investigation or proceeding in respect thereof), joint or several, to which such
Placement Agent Indemnified Party may become subject, under the Securities Act or otherwise,
insofar as such loss, claim, damage, expense, liability, action, investigation or proceeding
arises out of or is based upon (A) any untrue statement or alleged untrue statement of a
material fact contained in any Preliminary Prospectus, any Issuer Free Writing Prospectus,
any issuer information filed or required to be filed pursuant to Rule 433(d) of the Rules
and Regulations, any Registration Statement or the Prospectus, or in any amendment or
supplement thereto or document incorporated by reference therein, or (B) the omission or
alleged omission to state in any Preliminary Prospectus, any Issuer Free Writing Prospectus,
any issuer information filed or required to be filed pursuant to Rule 433(d) of the Rules
and Regulations, any Registration Statement or the Prospectus, or in any amendment or
supplement thereto or document incorporated by reference therein, a material fact
required to be
20
stated therein or necessary to make the statements therein not misleading or
(C) any breach of the representations and warranties of the Company contained herein or
failure of the Company to perform its obligations hereunder or pursuant to any law (provided
that the Company shall not be liable in the case of any matter covered by this subclause (C)
to the extent that it is determined in a final judgment by a court of competent jurisdiction
that such loss, claim, damage, expense or liability resulted directly from any such act or
failure to act undertaken or omitted to be taken by such Placement Agent through its gross
negligence or willful misconduct), and shall reimburse the Placement Agent Indemnified Party
promptly upon demand for any legal fees or other expenses reasonably incurred by that
Placement Agent Indemnified Party in connection with investigating, or preparing to defend,
or defending against, or appearing as a third party witness in respect of, or otherwise
incurred in connection with, any such loss, claim, damage, expense, liability, action,
investigation or proceeding, as such fees and expenses are incurred; provided, however, that
the Company shall not be liable in any such case to the extent that any such loss, claim,
damage, expense or liability arises out of or is based upon an untrue statement or alleged
untrue statement in, or omission or alleged omission from any Preliminary Prospectus, any
Registration Statement or the Prospectus, or any such amendment or supplement thereto, or
any Issuer Free Writing Prospectus made in reliance upon and in conformity with written
information furnished to the Company by the Representative by or on behalf of any Placement
Agent specifically for use therein, which information the parties hereto agree is limited to
the Placement Agents Information (as defined in Section 18). This indemnity
agreement is not exclusive and will be in addition to any liability, which the Company might
otherwise have and shall not limit any rights or remedies which may otherwise be available
at law or in equity to each Placement Agent Indemnified Party.
(b) Each Placement Agent, severally and not jointly, shall indemnify and hold harmless
the Company and its directors, its officers who signed the Registration Statement and each
person, if any, who controls the Company within the meaning of Section 15 of the Securities
Act or Section 20 of the Exchange Act (collectively the Company Indemnified Parties and
each a Company Indemnified Party) against any loss, claim, damage, expense or liability
whatsoever (or any action, investigation or proceeding in respect thereof), joint or
several, to which such Company Indemnified Party may become subject, under the Securities
Act or otherwise, insofar as such loss, claim, damage, expense, liability, action,
investigation or proceeding arises out of or is based upon (i) any untrue statement or
alleged untrue statement of a material fact contained in any Preliminary Prospectus, any
Issuer Free Writing Prospectus, any issuer information filed or required to be filed
pursuant to Rule 433(d) of the Rules and Regulations, any Registration Statement or the
Prospectus, or in any amendment or supplement thereto, or (ii) the omission or alleged
omission to state in any Preliminary Prospectus, any Issuer Free Writing Prospectus, any
issuer information filed or required to be filed pursuant to Rule 433(d) of the Rules and
Regulations, any Registration Statement or the Prospectus, or in any amendment or supplement
thereto, a material fact required to be stated therein or necessary to make the statements
therein not misleading, but in each case only to the extent that the untrue statement or
alleged untrue statement or omission or alleged omission was made in reliance upon and in
conformity with written information furnished to the Company by the Representative by or on
behalf of any Placement Agent specifically for use therein, which information the parties
hereto agree is limited to the Placement Agents Information as defined in Section
18, and shall reimburse the Company promptly upon demand for any legal or other expenses
reasonably incurred by such party in connection with investigating or preparing to defend or
defending against or appearing as third party witness in connection with any such loss,
claim, damage, liability, action, investigation or proceeding, as such fees and expenses are
incurred. This indemnity agreement is not exclusive and will be in addition to any
liability, which the Placement Agent might otherwise have and shall not limit any rights or
remedies which may otherwise be
available at law or in equity to each Company Indemnified Party. Notwithstanding the
provisions
21
of this Section 8(b), in no event shall any indemnity by the Placement Agent
under this Section 8(b) exceed the total compensation received by such Placement Agent in
accordance with Section 2.5.
(c) Promptly after receipt by an indemnified party under this Section 8 of
notice of the commencement of any action, the indemnified party shall, if a claim in respect
thereof is to be made against an indemnifying party under this Section 8, notify
such indemnifying party in writing of the commencement of that action; provided, however,
that the failure to notify the indemnifying party shall not relieve it from any liability
which it may have under this Section 8 except to the extent it has been materially
prejudiced by such failure; and, provided, further, that the failure to notify an
indemnifying party shall not relieve it from any liability which it may have to an
indemnified party otherwise than under this Section 8. If any such action shall be
brought against an indemnified party, and it shall notify the indemnifying party thereof,
the indemnifying party shall be entitled to participate therein and, to the extent that it
wishes, jointly with any other similarly notified indemnifying party, to assume the defense
of such action with counsel reasonably satisfactory to the indemnified party. After notice
from the indemnifying party to the indemnified party of its election to assume the defense
of such action, except as provided herein, the indemnifying party shall not be liable to the
indemnified party under Section 8 for any legal or other expenses subsequently
incurred by the indemnified party in connection with the defense of such action other than
reasonable costs of investigation; provided, however, that any indemnified party shall have
the right to employ separate counsel in any such action and to participate in the defense of
such action but the fees and expenses of such counsel (other than reasonable costs of
investigation) shall be at the expense of such indemnified party unless (i) the employment
thereof has been specifically authorized in writing by the Company in the case of a claim
for indemnification under Section 8(a) or Section 2.6 or the Placement
Agents in the case of a claim for indemnification under Section 8(b), (ii)
representation of both parties by the same counsel would be inappropriate due to actual or
potential conflicts of interests between them (which such judgment shall be made in good
faith), or (iii) the indemnifying party has failed to assume the defense of such action and
employ counsel reasonably satisfactory to the indemnified party within a reasonable period
of time after notice of the commencement of the action or the indemnifying party does not
diligently defend the action after assumption of the defense, in which case, if such
indemnified party notifies the indemnifying party in writing that it elects to employ
separate counsel at the expense of the indemnifying party, the indemnifying party shall not
have the right to assume the defense of (or, in the case of a failure to diligently defend
the action after assumption of the defense, to continue to defend) such action on behalf of
such indemnified party and the indemnifying party shall be responsible for legal or other
expenses subsequently incurred by such indemnified party in connection with the defense of
such action; provided, however, that the indemnifying party shall not, in connection with
any one such action or separate but substantially similar or related actions in the same
jurisdiction arising out of the same general allegations or circumstances, be liable for the
reasonable fees and expenses of more than one separate firm of attorneys at any time for all
such indemnified parties (in addition to any local counsel), which firm shall be designated
in writing by LCM if the indemnified parties under this Section 8 consist of any
Placement Agent Indemnified Party or by the Company if the indemnified parties under this
Section 8 consist of any Company Indemnified Parties. Subject to this Section
8(c), the amount payable by an indemnifying party under Section 8 shall include,
but not be limited to, (x) reasonable legal fees and expenses of counsel to the indemnified
party and any other expenses in investigating, or preparing to defend or defending against,
or appearing as a third party witness in respect of, or otherwise incurred in connection
with, any action, investigation, proceeding or claim, and (y) all amounts paid in settlement
of any of the foregoing. No indemnifying party shall, without the prior written consent of
the indemnified parties, settle or compromise or consent to the entry of judgment with
respect to any pending or threatened action
or any claim whatsoever, in respect of which indemnification or contribution could be
sought
22
under this Section 8 (whether or not the indemnified parties are actual or
potential parties thereto), unless such settlement, compromise or consent (i) includes an
unconditional release of each indemnified party in form and substance reasonably
satisfactory to such indemnified party from all liability arising out of such action or
claim and (ii) does not include a statement as to or an admission of fault, culpability or a
failure to act by or on behalf of any indemnified party. Subject to the provisions of the
following sentence, no indemnifying party shall be liable for settlement of any pending or
threatened action or any claim whatsoever that is effected without its written consent
(which consent shall not be unreasonably withheld or delayed), but if settled with its
written consent, if its consent has been unreasonably withheld or delayed or if there be a
judgment for the plaintiff in any such matter, the indemnifying party agrees to indemnify
and hold harmless any indemnified party from and against any loss or liability by reason of
such settlement or judgment. In addition, if at any time an indemnified party shall have
requested that an indemnifying party reimburse the indemnified party for fees and expenses
of counsel, such indemnifying party agrees that it shall be liable for any settlement of the
nature contemplated herein effected without its written consent if (i) such settlement is
entered into more than forty-five (45) days after receipt by such indemnifying party of the
request for reimbursement, (ii) such indemnifying party shall have received notice of the
terms of such settlement at least thirty (30) days prior to such settlement being entered
into and (iii) such indemnifying party shall not have reimbursed such indemnified party in
accordance with such request prior to the date of such settlement.
(d) If the indemnification provided for in this Section 8 is unavailable or
insufficient to hold harmless an indemnified party under Section 8(a) or Section
8(b), then each indemnifying party shall, in lieu of indemnifying such indemnified
party, contribute to the amount paid, payable or otherwise incurred by such indemnified
party as a result of such loss, claim, damage, expense or liability (or any action,
investigation or proceeding in respect thereof), as incurred, (i) in such proportion as
shall be appropriate to reflect the relative benefits received by the Company on the one
hand and the Placement Agents on the other hand from the offering of the Stock, or (ii) if
the allocation provided by clause (i) of this Section 8(d) is not permitted by
applicable law, in such proportion as is appropriate to reflect not only the relative
benefits referred to in clause (i) of this Section 8(d) but also the relative fault
of the Company on the one hand and the Placement Agents on the other with respect to the
statements, omissions, acts or failures to act which resulted in such loss, claim, damage,
expense or liability (or any action, investigation or proceeding in respect thereof) as well
as any other relevant equitable considerations. The relative benefits received by the
Company on the one hand and the Placement Agents on the other with respect to such offering
shall be deemed to be in the same proportion as the total net proceeds from the offering of
the Stock purchased under this Agreement (before deducting expenses) received by the Company
bear to the total discounts and commissions received by the Placement Agents in connection
with the Offering, in each case as set forth in the table on the cover page of the
Prospectus. The relative fault of the Company on the one hand and the Placement Agents on
the other shall be determined by reference to, among other things, whether the untrue or
alleged untrue statement of a material fact or the omission or alleged omission to state a
material fact relates to information supplied by the Company on the one hand or the
Placement Agents on the other, the intent of the parties and their relative knowledge,
access to information and opportunity to correct or prevent such untrue statement, omission,
act or failure to act; provided that the parties hereto agree that the written information
furnished to the Company by the Representative by or on behalf of any Placement Agent for
use in any Preliminary Prospectus, any Registration Statement or the Prospectus, or in any
amendment or supplement thereto, consists solely of the Placement Agents Information as
defined in Section 18. The Company and the Placement Agents agree that it would not
be just and equitable if contributions pursuant to this Section 8(d) were to be
determined by pro rata allocation or by any other method of allocation that does not
take into account the equitable considerations referred to herein. The amount paid or
payable by
23
an indemnified party as a result of the loss, claim, damage, expense, liability,
action, investigation or proceeding referred to above in this Section 8(d) shall be
deemed to include, for purposes of this Section 8(d), any legal or other expenses
reasonably incurred by such indemnified party in connection with investigating, preparing to
defend or defending against or appearing as a third party witness in respect of, or
otherwise incurred in connection with, any such loss, claim, damage, expense, liability,
action, investigation or proceeding. Notwithstanding the provisions
of this Section 8(d), no Placement Agent shall be required to contribute any amount in excess of the
total compensation received by such Placement Agent in accordance with Section 2.5
less the amount of any damages which such Placement Agent has otherwise paid or become
liable to pay by reason of any untrue or alleged untrue statement, omission or alleged
omission, act or alleged act or failure to act or alleged failure to act. No person guilty
of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act)
shall be entitled to contribution from any person who was not guilty of such fraudulent
misrepresentation. The Placement Agents obligations to contribute as provided in this
Section 8(d) are several in proportion to their respective placement obligations and not
joint.
9. Termination. The obligations of the Placement Agents and the Purchasers hereunder
and under the Subscription Agreements may be terminated by the Representative, in its absolute
discretion by notice given to the Company prior to delivery of and payment for the Stock if, prior
to that time, any of the events described in Sections 7(k), Section 7(l) or
7(m) have occurred or if the Purchasers shall decline to purchase the Stock for any reason
permitted under this Agreement or the Subscription Agreements.
10. Reimbursement of Placement Agents Expenses. Notwithstanding anything to the
contrary in this Agreement, if (a) this Agreement shall have been terminated pursuant to
Section 9, (b) the Company shall fail to tender the Stock for delivery to the Purchasers
for any reason not permitted under this Agreement, (c) the Purchasers shall decline to purchase the
Stock for any reason permitted under this Agreement or (d) the sale of the Stock is not consummated
because any condition to the obligations of the Purchasers or the Placement Agents set forth herein
is not satisfied or because of the refusal, inability or failure on the part of the Company to
perform any agreement herein or to satisfy any condition or to comply with the provisions hereof,
then in addition to the payment of amounts in accordance with Section 6, the Company shall
reimburse the Placement Agents for the reasonable and documented fees and expenses of the Placement
Agents counsel and for such other out-of-pocket expenses as shall have been reasonably incurred by
them in connection with this Agreement and the proposed purchase of the Stock, and upon demand the
Company shall pay the full amount thereof to the Placement Agents.
11. Authority of the representative. Each of JMP and Rodman consents and agrees
that LCM will act as Representative of the Placement Agents under this Agreement and with respect
to the sale of the Stock. Accordingly, each of JMP and Rodman authorizes LCM to manage the
Offering and the sale of the Stock and to take such action in connection therewith as LCM in its
sole discretion deems appropriate or desirable, consistent with the provisions of each Agreement
Among Underwriters previously entered into between and among LCM, JMP and Rodman, taking into
account that the Offering of the Stock will be in the form of a best efforts placement and not a
firm commitment underwriting. Each of JMP and Rodman agrees that any action taken under this
Agreement by the Representative shall be binding upon all of the Placement Agents.
12. Absence of Fiduciary Relationship. The Company acknowledges and agrees that:
(a) the Placement Agents responsibility to the Company is solely contractual in
nature, the Placement Agents have been retained solely to act as Placement Agents in
connection with the Offering and no fiduciary, advisory or agency relationship between the
Company and the Placement Agents has been created in respect of any of the transactions
contemplated by this
Agreement, irrespective of whether the Placement Agents or Lazard Frères & Co. LLC have
advised or are advising the Company on other matters;
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(b) the price of the Stock set forth in this Agreement was established by the Company
following discussions and arms-length negotiations with the Placement Agents, and the
Company is capable of evaluating and understanding, and understands and accepts, the terms,
risks and conditions of the transactions contemplated by this Agreement;
(c) it has been advised that the Placement Agents and Lazard Frères & Co. LLC and their
affiliates are engaged in a broad range of transactions which may involve interests that
differ from those of the Company and that the Placement Agents have no obligation to
disclose such interests and transactions to the Company by virtue of any fiduciary, advisory
or agency relationship; and
(d) it waives, to the fullest extent permitted by law, any claims it may have against
the Placement Agents for breach of fiduciary duty or alleged breach of fiduciary duty and
agrees that the Placement Agents shall have no liability (whether direct or indirect) to the
Company in respect of such a fiduciary duty claim or to any person asserting a fiduciary
duty claim on behalf of or in right of the Company, including stockholders, employees or
creditors of the Company.
13. Successors; Persons Entitled to Benefit of Agreement. This Agreement shall inure
to the benefit of and be binding upon the Placement Agents, the Company, and their respective
successors and assigns. This Agreement shall also inure to the benefit of Lazard Frères & Co. LLC,
the Purchasers, and each of their respective successors and assigns, which shall be third party
beneficiaries hereof. Nothing expressed or mentioned in this Agreement is intended or shall be
construed to give any person, other than the persons mentioned in the preceding sentences, any
legal or equitable right, remedy or claim under or in respect of this Agreement, or any provisions
herein contained, this Agreement and all conditions and provisions hereof being intended to be and
being for the sole and exclusive benefit of such persons and for the benefit of no other person;
except that the representations, warranties, covenants, agreements and indemnities of the Company
contained in this Agreement shall also be for the benefit of the Placement Agent Indemnified
Parties and the indemnities of the several Placement Agents shall be for the benefit of the Company
Indemnified Parties. It is understood that the Placement Agents responsibility to the Company is
solely contractual in nature and the Placement Agents do not owe the Company, or any other party,
any fiduciary duty as a result of this Agreement.
14. Survival of Indemnities, Representations, Warranties, etc. The respective
indemnities, covenants, agreements, representations, warranties and other statements of the Company
and the Placement Agents, as set forth in this Agreement or made by them respectively, pursuant to
this Agreement, shall remain in full force and effect, regardless of any investigation made by or
on behalf of the Placement Agents, the Company, the Purchasers or any person controlling any of
them and shall survive delivery of and payment for the Stock. Notwithstanding any termination of
this Agreement, including without limitation any termination pursuant to Sections 9 or
10, the indemnity and contribution agreements contained in Section 8 and the
covenants, representations, warranties set forth in this Agreement shall not terminate and shall
remain in full force and effect at all times.
15. Notices. All statements, requests, notices and agreements hereunder shall be in
writing, and:
(a) if to the Placement Agents, shall be delivered or sent by mail, facsimile
transmission or overnight courier to Lazard Capital Markets LLC, Attention: General
Counsel, 30 Rockefeller Plaza, New York, New York 10020, Fax: 212-830-3615; and
(b) if to the Company, shall be delivered or sent by mail, facsimile transmission or
overnight courier to: Cytokinetics, Inc., Attention: Chief Financial Officer, 280 E. Grand
Ave., South San Francisco, CA 94080, Fax: (650) 624-3200.
provided, however, that any notice to a Placement Agent pursuant to Section 8 shall be
delivered or sent by mail, telex or facsimile transmission to such Placement Agent at its address
set forth in its acceptance telex to the Placement Agents, which address will be supplied to any
other party hereto by the
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Representative upon request. Any such statements, requests, notices or
agreements shall take effect at the time of receipt thereof, except that any such statement,
request, notice or agreement delivered or sent by email shall take effect at the time of
confirmation of receipt thereof by the recipient thereof.
16. Definition of Certain Terms. For purposes of this Agreement, business day
means any day on which the New York Stock Exchange, Inc. is open for trading.
17. Governing Law, Agent For Service and Jurisdiction. This Agreement shall be
governed by and construed in accordance with the laws of the State of New York, including without
limitation Section 5-1401 of the New York General Obligations Law. No legal proceeding may be
commenced, prosecuted or continued in any court other than the courts of the State of New York
located in the City and County of New York or in the United States District Court for the Southern
District of New York, which courts shall have jurisdiction over the adjudication of such matters,
and the Company and the Placement Agents each hereby consent to the jurisdiction of such courts and
personal service with respect thereto. The Company and the Placement Agents each hereby consent to
personal jurisdiction, service and venue in any court in which any legal proceeding arising out of
or in any way relating to this Agreement is brought by any third party against the Company or the
Placement Agents. The Company and the Placement Agents each hereby waive all right to trial by
jury in any legal proceeding (whether based upon contract, tort or otherwise) in any way arising
out of or relating to this Agreement. The Company agrees that a final judgment in any such legal
proceeding brought in any such court shall be conclusive and binding upon the Company and the
Placement Agents and may be enforced in any other courts in the jurisdiction of which the Company
is or may be subject, by suit upon such judgment.
18. Placement Agents Information. The parties hereto acknowledge and agree that,
for all purposes of this Agreement, the Placement Agents Information consists solely of the
following information in the Prospectus: (i) the last paragraph on the front cover page concerning
the terms of the offering by the Placement Agent; and (ii) the statements concerning the Placement
Agent contained in the first paragraph under the heading Plan of Distribution.
19. Partial Unenforceability. The invalidity or unenforceability of any section,
paragraph, clause or provision of this Agreement shall not affect the validity or enforceability of
any other section, paragraph, clause or provision hereof. If any section, paragraph, clause or
provision of this Agreement is for any reason determined to be invalid or unenforceable, there
shall be deemed to be made such minor changes (and only such minor changes) as are necessary to
make it valid and enforceable.
20. General. This Agreement constitutes the entire agreement of the parties to this
Agreement and supersedes all prior written or oral and all contemporaneous oral agreements,
understandings and negotiations with respect to the subject matter hereof. In this Agreement, the
masculine, feminine and neuter genders and the singular and the plural include one another. The
section headings in this Agreement are for the convenience of the parties only and will not affect
the construction or interpretation of this Agreement. This Agreement may be amended or modified,
and the observance of any term of this Agreement may be waived, only by a writing signed by the
Company and the Placement Agents.
21. Counterparts. This Agreement may be signed in any number of counterparts, each
of which shall be an original, with the same effect as if the signatures thereto and hereto were
upon the same instrument and such signatures may be delivered by facsimile.
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If the foregoing is in accordance with your understanding of the agreement between the Company
and the Placement Agents, kindly indicate your acceptance in the space provided for that purpose
below.
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Very truly yours,
CYTOKINETICS, INCORPORATED
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By: |
/s/ Sharon Surrey-Barbari |
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Name: |
Sharon Surrey-Barbari |
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Title: |
Senior Vice President, Finance and Chief
Financial Officer |
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Accepted as of the date
first above written:
LAZARD CAPITAL MARKETS LLC
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By: |
/s/ David
G. McMillan, Jr. |
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Name: |
David G. McMillan, Jr. |
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Managing Director |
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JMP SECURITIES LLC
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/s/ Stephen Ortiz |
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Name: |
Stephen Ortiz |
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Title: |
Managing Director |
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RODMAN & RENSHAW, LLC
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/s/ John Borer |
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Name: |
John Borer |
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Title: |
CEO |
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27
SCHEDULE A
Issuer Free Writing Prospectus
Final Pricing Terms, dated December 6, 2006
SCHEDULE B
David Morgans
Jay Trautman
Robert Blum
Andrew Wolff
David Cragg
Sharon Surrey-Barbari
James Sabry
Mark McDade
Michael Schmertzler
Sevin Rosen Fund VI L.P.
Sevin Rosen VI Affiliates Fund L.P.
Sevin Rosen Fund VII L.P.
Sevin Rosen Fund VIII L.P.
Sevin Rosen VII Affiliates Fund L.P.
Sevin Rosen VIII Affiliates Fund L.P.
Sevin Rosen Bayless Management Company
The Dow Family Trust
Credit Suisse First Boston Equity Partners L.P.
Credit Suisse First Boston Equity Partners (Bermuda) L.P.
Credit Suisse First Boston U.S. Executive Advisors L.P.
EMA Partners Fund 2000 L.P.
EMA Private Equity Fund 2000 L.P.
Mayfield IX
Mayfield Associates Fund IV
Cell Trust
Cell Trust II
A Grant Heidrich & Jeanette Heidrich Community Property Family Trust
James Spudich
Charles Homcy
EXHIBIT A
SUBSCRIPTION AGREEMENT
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, CA 94080
Gentlemen:
The undersigned (the Investor) hereby confirms its agreement with you as follows:
1. This Subscription Agreement (this Agreement) is made as of the date set forth below
between Cytokinetics, Incorporated, a Delaware corporation (the Company), and the Investor.
2. The Company has authorized the sale and issuance to certain investors of up to an aggregate
of 5,285,715 shares (the Shares) of its Common Stock, par value $0.001 per share (the Common
Stock), subject to adjustment by the Companys Board of Directors, or a committee thereof, for a
purchase price of $7.00 per share (the Purchase Price).
3. The offering and sale of the Shares (the Offering) are being made pursuant to (1) an
effective Registration Statement on Form S-3 (including the Prospectus contained therein (the Base
Prospectus), the Registration Statement) filed by the Company with the Securities and Exchange
Commission (the Commission), (2) if applicable, certain free writing prospectuses (as that term
is defined in Rule 405 under the Securities Act of 1933, as amended (the Act)), that have or will
be filed with the Commission and delivered to the Investor on or prior to the date hereof and (3) a
Prospectus Supplement (the Prospectus Supplement and together with the Base Prospectus, the
Prospectus) containing certain supplemental information regarding the Shares and terms of the
Offering that will be filed with the Commission and delivered to the Investor (or made available to
the Investor by the filing by the Company of an electronic version thereof with the Commission).
4. The Company and the Investor agree that the Investor will purchase from the Company and the
Company will issue and sell to the Investor the Shares of Common Stock set forth below for the
aggregate purchase price set forth below. The Shares shall be purchased pursuant to the Terms and
Conditions for Purchase of Shares attached hereto as Annex I and incorporated herein by
this reference as if fully set forth herein. The Investor acknowledges that the Offering is not
being underwritten by the placement agents (the Placement Agents) named in the Prospectus
Supplement and that there is no minimum offering amount.
5. The manner of settlement of the Shares purchased by the Investor shall be determined by
such Investor as follows (check one):
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Delivery by electronic book-entry at The Depository Trust Company (DTC), registered in
the Investors name and address as set forth below, and released by Mellon Investor Services
LLC, the Companys transfer agent (the Transfer Agent), to the Investor at the Closing. NO
LATER THAN ONE (1) BUSINESS DAY AFTER THE EXECUTION OF THIS AGREEMENT BY THE INVESTOR AND THE
COMPANY, THE INVESTOR SHALL: |
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DIRECT THE BROKER-DEALER AT WHICH THE ACCOUNT OR ACCOUNTS TO BE CREDITED
WITH THE SHARES ARE MAINTAINED TO SET UP A DEPOSIT/WITHDRAWAL AT CUSTODIAN (DWAC)
INSTRUCTING THE TRANSFER AGENT TO CREDIT SUCH ACCOUNT OR ACCOUNTS WITH THE SHARES,
AND |
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REMIT BY WIRE TRANSFER THE AMOUNT OF FUNDS EQUAL TO THE AGGREGATE
PURCHASE PRICE FOR THE SHARES BEING PURCHASED BY THE INVESTOR TO THE FOLLOWING
ACCOUNT: |
THE CITIBANK PRIVATE BANK
666 Fifth Avenue, 5th Floor
New York, NY 10103
ABA # 021-000-089
Account Name: Thelen Reid Brown Raysman & Steiner LLP, escrow
agent for the account of Cytokinetics, Incorporated
Account Number: 9970183443
OR
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Delivery versus payment (DVP) through DTC (i.e., the
Company shall deliver Shares registered in the Investors
name and address as set forth below and released by the
Transfer Agent to the Investor at the Closing directly to
the account(s) at Lazard Capital Markets LLC (LCM)
identified by the Investor and simultaneously therewith
payment shall be made from such account(s) to the Company
through DTC). NO LATER THAN ONE (1) BUSINESS DAY AFTER
THE EXECUTION OF THIS AGREEMENT BY THE INVESTOR AND THE
COMPANY, THE INVESTOR SHALL: |
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NOTIFY LCM OF THE ACCOUNT OR ACCOUNTS AT LCM TO BE CREDITED WITH THE
SHARES BEING PURCHASED BY SUCH INVESTOR, AND |
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CONFIRM THAT THE ACCOUNT OR ACCOUNTS AT LCM TO BE CREDITED WITH THE
SHARES BEING PURCHASED BY THE INVESTOR HAVE A MINIMUM BALANCE EQUAL TO THE AGGREGATE
PURCHASE PRICE FOR THE SHARES BEING PURCHASED BY THE INVESTOR. |
IT IS THE INVESTORS RESPONSIBILITY TO (A) MAKE THE NECESSARY WIRE TRANSFER OR CONFIRM THE
PROPER ACCOUNT BALANCE IN A TIMELY MANNER AND (B) ARRANGE FOR SETTLEMENT BY WAY OF DWAC OR DVP IN A
TIMELY MANNER. IF THE INVESTOR DOES NOT DELIVER THE AGGREGATE PURCHASE PRICE FOR THE SHARES OR
DOES NOT MAKE PROPER ARRANGEMENTS FOR SETTLEMENT IN A TIMELY MANNER, THE SHARES MAY NOT BE
DELIVERED AT CLOSING TO THE INVESTOR OR THE INVESTOR MAY BE EXCLUDED FROM THE CLOSING
ALTOGETHER.
6. The Investor represents that, except as set forth below, (a) it has had no position, office or
other material relationship within the past three years with the Company or persons known to it to
be
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affiliates of the Company, (b) it is not a NASD member or an Associated Person (as such term is
defined under the NASD Membership and Registration Rules Section 1011) as of the Closing, and (c)
neither the Investor nor any group of Investors (as identified in a public filing made with the
Commission) of which the Investor is a part in connection with the Offering of the Shares,
acquired, or obtained the right to acquire, 20% or more of the Common Stock (or securities
convertible into or exercisable for Common Stock) or the voting power of the Company on a
post-transaction basis. Exceptions:
(If no exceptions, write none. If left blank, response will be deemed to be none.)
7. The Investor represents that it has received (or otherwise had made available to it by the
filing by the Company of an electronic version thereof with the Commission) the Base Prospectus,
dated June 14, 2005, which is a part of the Companys Registration Statement, the documents
incorporated by reference therein and any free writing prospectus (collectively, the Disclosure
Package), prior to or in connection with the receipt of this Agreement. The Investor acknowledges
that, prior to the delivery of this Agreement to the Company, the Investor will receive certain
additional information regarding the Offering, including pricing information (the Offering
Information). Such information may be provided to the Investor by any means permitted under the
Act, including the Prospectus Supplement, a free writing prospectus and oral communications.
8. No offer by the Investor to buy Shares will be accepted and no part of the Purchase Price will
be delivered to the Company until the Investor has received the Offering Information and the
Company has accepted such offer by countersigning a copy of this Agreement, and any such offer may
be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to the
Company (or a Placement Agent on behalf of the Company) sending (orally, in writing or by
electronic mail) notice of its acceptance of such offer. An indication of interest will involve no
obligation or commitment of any kind until the Investor has been delivered the Offering Information
and this Agreement is accepted and countersigned by or on behalf of the Company.
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Number of Shares: |
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Purchase Price Per Share: $ |
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Aggregate Purchase Price: $ |
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Please confirm that the foregoing correctly sets forth the agreement between us by signing in
the space provided below for that purpose.
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Dated as of: December __, 2006 |
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INVESTOR |
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By: |
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Print Name: |
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Title: |
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Address: |
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Agreed and Accepted
this ___day of December, 2006
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CYTOKINETICS, INCORPORATED |
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ANNEX I
TERMS AND CONDITIONS FOR PURCHASE OF SHARES
1. Authorization and Sale of the Shares. Subject to the terms and conditions of this
Agreement, the Company has authorized the sale of the Shares.
2. Agreement to Sell and Purchase the Shares; Placement Agents.
2.1 At the Closing (as defined in Section 3.1), the Company will sell to the Investor,
and the Investor will purchase from the Company, upon the terms and conditions set forth herein,
the number of Shares set forth on the last page of the Agreement to which these Terms and
Conditions for Purchase of Shares are attached as Annex I (the Signature Page) for the
aggregate purchase price therefor set forth on the Signature Page.
2.2 The Company proposes to enter into substantially this same form of Subscription Agreement
with certain other investors (the Other Investors) and expects to complete sales of Shares to
them. The Investor and the Other Investors are hereinafter sometimes collectively referred to as
the Investors, and this Agreement and the Subscription Agreements executed by the Other Investors
are hereinafter sometimes collectively referred to as the Agreements.
2.3 Investor acknowledges that the Company has agreed to pay Lazard Capital Markets LLC
(LCM), JMP Securities LLC and Rodman & Renshaw, LLC (the Placement Agents) a fee (the
Placement Fee) in respect of the sale of Shares to the Investor.
2.4 The Company has entered into a Placement Agent Agreement, dated December 6, 2006 (the
Placement Agreement), with the Placement Agents that contains certain representations,
warranties, covenants and agreements of the Company that may be relied upon by the Investor, which
shall be a third party beneficiary thereof.
3. Closings and Delivery of the Shares and Funds.
3.1 Closing. The completion of the purchase and sale of the Shares (the Closing)
shall occur at a place and time (the Closing Date) to be specified by the Company and LCM and of
which the Investors will be notified in advance by the Placement Agents, in accordance with Rule
15c6-1 promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act). At
the Closing, (a) the Company shall cause the Transfer Agent to deliver to the Investor the number
of Shares set forth on the Signature Page registered in the name of the Investor or, if so
indicated on the Investor Questionnaire attached hereto as Exhibit A, in the name of a
nominee designated by the Investor and (b) the aggregate purchase price for the Shares being
purchased by the Investor will be delivered by or on behalf of the Investor to the Company.
3.2 Conditions to the Companys Obligations. (a) The Companys obligation to issue
and sell the Shares to the Investor shall be subject to: (i) the receipt by the Company of the
purchase price for the Shares being purchased hereunder as set forth on the Signature Page and (ii)
the accuracy of the representations and warranties made by the Investor and the fulfillment of
those undertakings of the Investor to be fulfilled prior to the Closing Date.
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(b) Conditions to the Investors Obligations. The Investors obligation to purchase
the Shares will be subject to the accuracy of the representations and warranties made by the
Company and the fulfillment of those undertakings of the Company to be fulfilled prior to the
Closing Date, including without limitation, those contained in this Agreement and the Placement
Agreement, and to the condition that the Placement Agents shall not have: (a) terminated the
Placement Agreement pursuant to the terms thereof or (b) determined that the conditions to the
closing in the Placement Agreement have not been satisfied. The Investors obligations are
expressly not conditioned on the purchase by any or all of the Other Investors of the Shares that
they have agreed to purchase from the Company.
3.3 Delivery of Funds.
(a) Delivery by Electronic Book-Entry at The Depository Trust Company. If the
Investor elects to settle the Shares purchased by such Investor through delivery by electronic
book-entry at DTC, no later than one (1) business day after the execution of this Agreement by
the Investor and the Company, the Investor shall remit by wire transfer the amount of funds
equal to the aggregate purchase price for the Shares being purchased by the Investor to the
following account designated by the Company and the Placement Agents pursuant to the terms of that
certain Escrow Agreement (the Escrow Agreement) dated as of December 6, 2006, by and among the
Company, the Placement Agents and Thelen Reid Brown Raysman & Steiner LLP (the Escrow Agent):
THE CITIBANK PRIVATE BANK
666 Fifth Avenue, 5th Floor
New York, NY 10103
ABA # 021-000-089
Account Name: Thelen Reid Brown Raysman & Steiner LLP, escrow
agent for the account of Cytokinetics, Incorporated
Account Number: 9970183443
Such funds shall be held in escrow until the Closing and delivered by the Escrow Agent on
behalf of the Investors to the Company upon the satisfaction, in the sole judgment of the Placement
Agents, of the conditions set forth in Section 3.2(b) hereof. The Placement Agents shall have no
rights in or to any of the escrowed funds, unless the Placement Agents and the Escrow Agent are
notified in writing by the Company in connection with the Closing that a portion of the escrowed
funds shall be applied to the Placement Fee. The Company and the Investor agree to indemnify and
hold the Escrow Agent harmless from and against any and all losses, costs, damages, expenses and
claims (including, without limitation, court costs and reasonable attorneys fees) (Losses)
arising under this Section 3.3 or otherwise with respect to the funds held in escrow
pursuant hereto or arising under the Escrow Agreement, unless it is finally determined that such
Losses resulted directly from the willful misconduct or gross negligence of the Escrow Agent.
Anything in this Agreement to the contrary notwithstanding, in no event shall the Escrow Agent be
liable for any special, indirect or consequential loss or damage of any kind whatsoever (including
but not limited to lost profits), even if the Escrow Agent has been advised of the likelihood of
such loss or damage and regardless of the form of action.
Investor shall also furnish to the Placement Agents a completed W-9 form (or, in the case of
an Investor who is not a United States citizen or resident, a W-8 form).
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Investor acknowledges that the Escrow Agent acts as counsel to the Placement Agents, and shall
have the right to continue to represent the Placement Agents, in any action, proceeding, claim,
litigation, dispute, arbitration or negotiation in connection with the Offering, and Investor
hereby consents thereto and waives any objection to the continued representation of the Placement
Agents by the Escrow Agent in connection therewith based upon the services of the Escrow Agent
under the Escrow Agreement, without waiving any duty or obligation the Escrow Agent may have to any
other person.
(b) Delivery Versus Payment through The Depository Trust Company. If the Investor
elects to settle the Shares purchased by such Investor by delivery versus payment through DTC,
no later than one (1) business day after the execution of this Agreement by the Investor and
the Company, the Investor shall confirm that the account or accounts at LCM to be credited with
the Shares being purchased by the Investor have a minimum balance equal to the aggregate purchase
price for the Shares being purchased by the Investor.
3.4 Delivery of Shares.
(a) Delivery by Electronic Book-Entry at The Depository Trust Company. If the
Investor elects to settle the Shares purchased by such Investor through delivery by electronic
book-entry at DTC, no later than one (1) business day after the execution of this Agreement by
the Investor and the Company, the Investor shall direct the broker-dealer at which the account
or accounts to be credited with the Shares being purchased by such Investor are maintained, which
broker/dealer shall be a DTC participant, to set up a Deposit/Withdrawal at Custodian (DWAC)
instructing Mellon Investor Services LLC, the Companys transfer agent, to credit such account or
accounts with the Shares by means of an electronic book-entry delivery. Such DWAC shall indicate
the settlement date for the deposit of the Shares, which date shall be provided to the Investor by
the Placement Agents. Simultaneously with the delivery to the Company by the Escrow Agent of the
funds held in escrow pursuant to Section 3.3 above, the Company shall direct its transfer
agent to credit the Investors account or accounts with the Shares pursuant to the information
contained in the DWAC.
(b) Delivery Versus Payment through The Depository Trust Company. If the Investor
elects to settle the Shares purchased by such Investor by delivery versus payment through DTC,
no later than one (1) business day after the execution of this Agreement by the Investor and
the Company, the Investor shall notify LCM of the account or accounts at LCM to be credited
with the Shares being purchased by such Investor. On the Closing Date, the Company shall deliver
the Shares to the Investor directly to the account(s) at LCM identified by Investor and
simultaneously therewith payment shall be made from such account(s) to the Company through DTC.
4. Representations, Warranties and Covenants of the Investor.
The Investor represents and warrants to, and agrees with, the Company and the Placement Agents
that:
4.1 The Investor (a) is knowledgeable, sophisticated and experienced in making, and is
qualified to make decisions with respect to, investments in shares presenting an investment
decision like that involved in the purchase of the Shares, including investments in securities
issued by the Company and investments in comparable companies, (b) has answered all questions on
the Signature Page and the Investor Questionnaire and the answers thereto are true and correct as
of the date hereof
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and will be true and correct as of the Closing Date and (c) in connection with its decision to
purchase the number of Shares set forth on the Signature Page, has received and is relying only
upon the Disclosure Package, the documents incorporated by reference therein and the Offering
Information.
4.2 If the Investor is outside the United States, it will comply with all applicable laws and
regulations in each foreign jurisdiction in which it purchases, offers, sells or delivers Shares or
has in its possession or distributes any offering material, in all cases at its own expense.
4.3 (a) The Investor has full right, power, authority and capacity to enter into this
Agreement and to consummate the transactions contemplated hereby and has taken all necessary action
to authorize the execution, delivery and performance of this Agreement, and (b) this Agreement
constitutes a valid and binding obligation of the Investor enforceable against the Investor in
accordance with its terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium or similar laws affecting creditors and contracting
parties rights generally and except as enforceability may be subject to general principles of
equity (regardless of whether such enforceability is considered in a proceeding in equity or at
law) and except as to the enforceability of any rights to indemnification or contribution that may
be violative of the public policy underlying any law, rule or regulation (including any federal or
state securities law, rule or regulation).
4.4 The Investor understands that nothing in this Agreement, the Prospectus or any other
materials presented to the Investor in connection with the purchase and sale of the Shares
constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and
investment advisors as it, in its sole discretion, has deemed necessary or appropriate in
connection with its purchase of Shares.
4.5 Since the date on which any Placement Agent first contacted such Investor about the
Offering, the Investor has not engaged in any transactions in the securities of the Company
(including, without limitation, any Short Sales involving the Companys securities), and has not
violated its obligations of confidentiality. Each Investor covenants that it will not engage in
any transactions in the securities of the Company (including Short Sales) or disclose any
information about the contemplated offering (other than to its advisors that are under a legal
obligation of confidentiality) prior to the time that the transactions contemplated by this
Agreement are publicly disclosed. Each Investor agrees that it will not use any of the Shares
acquired pursuant to this Agreement to cover any short position in the Common Stock if doing so
would be in violation of applicable securities laws. For purposes hereof, Short Sales include,
without limitation, all short sales as defined in Rule 200 promulgated under Regulation SHO under
the Exchange Act, whether or not against the box, and all types of direct and indirect stock
pledges, forward sales contracts, options, puts, calls, short sales, swaps, put equivalent
positions (as defined in Rule 16a-1(h) under the Exchange Act) and similar arrangements (including
on a total return basis), and sales and other transactions through non-US broker dealers or foreign
regulated brokers.
5. Survival of Representations, Warranties and Agreements; Third Party Beneficiary.
Notwithstanding any investigation made by any party to this Agreement or by the Placement Agents,
all covenants, agreements, representations and warranties made by the Company and the Investor
herein will survive the execution of this Agreement, the delivery to the Investor of the Shares
being purchased and the payment therefor. The Placement Agents and Lazard Fréres & Co.
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shall be third party beneficiaries with respect to the representations, warranties and
agreements of the Investor in Section 4 hereof.
6. Notices. All notices, requests, consents and other communications hereunder will be in
writing, will be mailed (a) if within the domestic United States by first-class registered or
certified airmail, or nationally recognized overnight express courier, postage prepaid, or by
facsimile or (b) if delivered from outside the United States, by International Federal Express or
facsimile, and will be deemed given (i) if delivered by first-class registered or certified mail
domestic, three business days after so mailed, (ii) if delivered by nationally recognized overnight
carrier, one business day after so mailed, (iii) if delivered by International Federal Express, two
business days after so mailed and (iv) if delivered by facsimile, upon electric confirmation of
receipt and will be delivered and addressed as follows:
(a) if to the Company, to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, CA 94080
Attention: Chief Financial Officer
Facsimile: (650) 624-3200
with copies to:
Wilson Sonsini Goodrich & Rosati PC.
650 Page Mill Road
Palo Alto, CA 94304
Attention: Mike ODonnell, Esq.
Facsimile: (650) 493-6811
(b) if to the Investor, at its address on the Signature Page hereto, or at such
other address or addresses as may have been furnished to the Company in writing.
7. Changes. This Agreement may not be modified or amended except pursuant to an instrument
in writing signed by the Company and the Investor.
8. Headings. The headings of the various sections of this Agreement have been inserted for
convenience of reference only and will not be deemed to be part of this Agreement.
9. Severability. In case any provision contained in this Agreement should be invalid,
illegal or unenforceable in any respect, the validity, legality and enforceability of the
remaining provisions contained herein will not in any way be affected or impaired thereby.
10. Governing Law. This Agreement will be governed by, and construed in accordance with,
the internal laws of the State of New York, without giving effect to the principles of
conflicts of law that would require the application of the laws of any other jurisdiction.
11. Counterparts. This Agreement may be executed in two or more counterparts, each of which
will constitute an original, but all of which, when taken together, will constitute but one
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instrument, and will become effective when one or more counterparts have been signed by each
party hereto and delivered to the other parties. The Company and the Investor acknowledge
and agree that the Company shall deliver its counterpart to the Investor along with the
Prospectus Supplement (or the filing by the Company of an electronic version thereof with
the Commission).
12. Confirmation of Sale. The Investor acknowledges and agrees that such Investors receipt
of the Companys counterpart to this Agreement, together with the Prospectus Supplement (or
the filing by the Company of an electronic version thereof with the Commission), shall
constitute written confirmation of the Companys sale of Shares to such Investor.
13. Press Release. The Company and the Investor agree that the Company shall issue a press
release announcing the Offering prior to the opening of the financial markets in New York
City on the business day immediately after the date hereof.
14. Termination. In the event that the Placement Agreement is terminated by the Placement
Agents pursuant to the terms thereof, this Agreement shall terminate without any further
action on the part of the parties hereto.
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Exhibit A
CYTOKINETICS, INCORPORATED
INVESTOR QUESTIONNAIRE
Pursuant to Section 3 of Annex I to the Agreement, please provide us with the
following information:
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The exact name that your Shares are to be registered in. You may
use a nominee name if appropriate: |
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2.
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The relationship between the Investor and the registered holder
listed in response to item 1 above: |
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3.
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The mailing address of the registered holder listed in response to
item 1 above: |
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4.
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The Social Security Number or Tax Identification Number of the
registered holder listed in the response to item 1 above: |
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5.
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Name of DTC Participant (broker-dealer at which the account or
accounts to be credited with the Shares are maintained): |
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6.
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DTC Participant Number: |
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7.
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Name of Account at DTC Participant being credited with the Shares: |
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8.
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Account Number at DTC Participant being credited with the Shares: |
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EXHIBIT B
[Form of Lock-Up]
December 5, 2006
Lazard Capital Markets LLC
JMP Securities LLC
Rodman & Renshaw, LLC
c/o Lazard Capital Markets LLC
30 Rockefeller Plaza
New York, New York 10020
Re: Cytokinetics, Incorporated Public Offering of Shares of Common Stock
Dear Sirs:
In order to induce Lazard Capital Markets LLC (Lazard), to enter in to a certain placement
agent agreement with Cytokinetics, Incorporated, a Delaware corporation (the Company), with
respect to the public offering (the Offering) of shares of the Companys Common Stock, par value
$0.001 per share (Common Stock), the undersigned hereby agrees that for a period (the lock-up
period) of ninety (90) days following the date of the final prospectus filed by the Company with
the Securities and Exchange Commission in connection with such public offering, the undersigned
will not, without the prior written consent of Lazard, directly or indirectly, (i) offer, sell,
assign, transfer, pledge, contract to sell, or otherwise dispose of, any shares of Common Stock or
securities convertible into or exercisable or exchangeable for Common Stock (including, without
limitation, shares of Common Stock or any such securities which may be deemed to be beneficially
owned by the undersigned in accordance with the rules and regulations promulgated under the
Securities Act of 1933, as the same may be amended or supplemented from time to time (such shares
or securities, the Beneficially Owned Shares)), (ii) enter into any swap, hedge or other
agreement or arrangement that transfers in whole or in part, the economic risk of ownership of any
Beneficially Owned Shares, Common Stock or securities convertible into or exercisable or
exchangeable for Common Stock, or (iii) engage in any short selling of any Beneficially Owned
Shares, Common Stock or securities convertible into or exercisable or exchangeable for Common
Stock.
If (i) the Company issues an earnings release or material news or a material event relating to
the Company occurs during the last seventeen (17) days of the lock-up period, or (ii) prior to the
expiration of the lock-up period, the Company announces that it will release earnings results
during the sixteen (16)-day period beginning on the last day of the lock-up period, the
restrictions imposed by this Agreement shall continue to apply until the expiration of the eighteen
(18)-day period beginning on the issuance of the earnings release or the occurrence of the material
news or material event.
Notwithstanding the foregoing, the undersigned may sell or otherwise transfer shares of Common
Stock or Beneficially Owned Shares (i) as a bona fide gift or gifts or pledge, provided that the
undersigned provides prior written notice of such gift or gifts or pledge to Lazard and the donee
or donees or pledgee or pledgees (as the case may be) thereof agree to be bound by the restrictions
set forth herein, (ii) either during the undersigneds lifetime or on death by will or intestacy to
the undersigneds immediate family or to a trust, the beneficiaries of which are exclusively the
undersigned and a member or members of the undersigneds immediate family, provided that the
transferee thereof agrees to be bound by the restrictions set forth herein, or (iii) pursuant to
any 10b-5(1) trading plans in effect as of the date of the date of the Offering or (iv) with the
prior written consent of Lazard. In addition, if the
undersigned is a partnership, limited liability company, trust, corporation or similar entity,
it may distribute the Common Stock or Beneficially Owned Shares to its partners, members or
stockholders; provided, however, that in each such case, prior to any such transfer, each
transferee shall execute a duplicate form of this letter agreement (the Lock-Up Agreement) or
execute an agreement, reasonably satisfactory to Lazard, pursuant to which each transferee shall
agree to receive and hold such Common Stock or Beneficially Owned Shares subject to the provisions
hereof, and there shall be no further transfer except in accordance with the provisions hereof.
For the purposes of this paragraph, immediate family shall mean spouse, domestic partner, lineal
descendant (including adopted children), father, mother, brother or sister of the transferor.
In addition, the undersigned hereby waives, from the date hereof until the expiration of the
ninety (90) day period following the date of the Companys final prospectus, any and all rights, if
any, to request or demand registration pursuant to the Securities Act of 1933, as amended, of any
shares of Common Stock or securities convertible into or exercisable or exchangeable for Common
Stock that are registered in the name of the undersigned or that are Beneficially Owned Shares. In
order to enable the aforesaid covenants to be enforced, the undersigned hereby consents to the
placing of legends and/or stop-transfer orders with the transfer agent of the Common Stock with
respect to any shares of Common Stock, securities convertible into or exercisable or exchangeable
for Common Stock or Beneficially Owned Shares.
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[Signatory]
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By: |
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Name: |
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Title: |
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EXHIBIT C
Form of Wilson Sonsini Goodrich & Rosati, P.C. Opinion Letter
EXHIBIT D
Form of Wilson Sonsini Goodrich & Rosati, P.C. Opinion Letter Regarding Intellectual Property Matters
EXHIBIT E
Form of Wilson Sonsini Goodrich & Rosati, P.C. Statement of Negative Assurances
exv5w1
[Wilson Sonsini Goodrich & Rosati Professional Corporation Letterhead]
Exhibit 5.1
December 7, 2006
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
Re: Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as special counsel for Cytokinetics, Incorporated, a Delaware corporation (the
Company), in connection with the registration under the Securities Act of 1933, as amended (the
Act), of 5,285,715 shares of the Companys common stock, par value $0.001 per share, of the
Company (Common Stock) pursuant to the registration statement on Form S-3 (Registration No.
333-125786), as filed with the Securities and Exchange Commission
(the Commission) under the Act
on June 14, 2005, and the registration statement on Form S-3 (Registration No. 333-138306), as filed
with the Commission under the Act pursuant to Rule
462(b) on October 30, 2006, together with the exhibits thereto each and the documents incorporated
by reference therein each (said registration statements, as they may be amended from time to time,
are herein referred to collectively as the Registration Statement) and the related base
prospectus which forms a part of and is included in the Registration Statement and the related
prospectus supplement in the form filed with the Commission pursuant to Rule 424(b) under the Act
(together, the prospectus).
The Common Stock are to be sold pursuant to a Placement Agent Agreement, dated as of December
6, 2006 (the Placement Agreement), between the Company and Lazard Capital Markets LLC , JMP
Securities LLC and Rodman & Renshaw, LLC, as placement agents, and Subscription Agreements, dated
as of December 6, 2006, between the Company and the investor signatories thereto (the Subscription
Agreements). The Placement Agreement and the form of Subscription Agreement have been filed by the Company as an
exhibit to a Current Report on Form 8-K filed with the Commission on December 7, 2006.
In connection with this opinion, we have examined and relied upon the Registration Statement
and related base prospectus included therein, the prospectus supplement filed with the Commission
pursuant to Rule 424(b) under the Act, the Companys Amended and Restated Certificate of
Incorporation, as amended to date, the Companys Amended and Restated Bylaws, as currently in
effect, the Placement Agreement, the Subscription Agreements and such instruments, documents,
certificates and records that we have deemed relevant and necessary for the basis of our opinions
hereinafter expressed. In such examination, we have assumed: (i) the authenticity of original
documents and the genuineness of all signatures; (ii) the conformity to the originals of all
documents submitted to us as copies; (iii) the truth, accuracy and
Cytokinetics, Incorporated
December 7, 2006
Page 2
completeness of the information, representations and warranties contained in the records,
documents, instruments and certificates we have reviewed; and (iv) the due execution and delivery
of all documents where due execution and delivery are a prerequisite to the effectiveness thereof.
On the basis of the foregoing, and in reliance thereon, we are of the opinion that the shares
of Common Stock, when issued and sold in accordance with the Placement Agreement, the Subscription
Agreements, the Registration Statement and the prospectus, will be validly issued, fully paid and
nonassessable.
Our opinion that any document is legal, valid and binding is qualified as to:
(a) limitations imposed by bankruptcy, insolvency, reorganization, arrangement, fraudulent
conveyance, moratorium or other laws relating to or affecting the rights of creditors generally;
(b) rights to indemnification and contribution, which may be limited by applicable law or
equitable principles; and
(c) general principles of equity, including without limitation concepts of materiality,
reasonableness, good faith and fair dealing, and the possible unavailability of specific
performance or injunctive relief and limitation of rights of acceleration, regardless of whether
such enforceability is considered in a proceeding in equity or at law.
Members of our firm are admitted to the bar in the State of California, and we do not express
any opinion as to the laws of any jurisdiction, other than the federal laws of the United States of
America, laws of the State of California and the General Corporation Law of the State of Delaware
(the DGCL). We are not licensed to practice law in the State of Delaware and, accordingly, our
opinions as to the DGCL are based solely on a review of the official statues of the State of
Delaware and the applicable provisions of the Delaware Constitution and the reported judicial
decisions interpreting such statutes and provisions.
We hereby consent to the filing of this opinion as an exhibit to the above-referenced
Registration Statement and to the use of our name wherever it appears in the Registration Statement
and the related prospectus and prospectus supplement, and in any amendment or supplement thereto.
In giving such consent, we do not believe that we are experts within the meaning of such term as
used in the Act or the rules and regulations of the Commission issued
thereunder with respect to any part of the Registration Statement, including this opinion as
an exhibit or otherwise.
Cytokinetics, Incorporated
December 7, 2006
Page 3
Sincerely,
WILSON SONSINI GOODRICH & ROSATI
Professional Corporation
/s/
Wilson Sonsini Goodrich & Rosati
exv10w68
Exhibit
10.68
SUBSCRIPTION AGREEMENT
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, CA 94080
Gentlemen:
The undersigned (the Investor) hereby confirms its agreement with you as follows:
1. This Subscription Agreement (this Agreement) is made as of the date set forth below
between Cytokinetics, Incorporated, a Delaware corporation (the Company), and the Investor.
2. The Company has authorized the sale and issuance to certain investors of up to an aggregate
of 5,285,715 shares (the Shares) of its Common Stock, par value $0.001 per share (the Common
Stock), subject to adjustment by the Companys Board of Directors, or a committee thereof, for a
purchase price of $7.00 per share (the Purchase Price).
3. The offering and sale of the Shares (the Offering) are being made pursuant to (1) an
effective Registration Statement on Form S-3 (including the Prospectus contained therein (the Base
Prospectus), the Registration Statement) filed by the Company with the Securities and Exchange
Commission (the Commission), (2) if applicable, certain free writing prospectuses (as that term
is defined in Rule 405 under the Securities Act of 1933, as amended (the Act)), that have or will
be filed with the Commission and delivered to the Investor on or prior to the date hereof and (3) a
Prospectus Supplement (the Prospectus Supplement and together with the Base Prospectus, the
Prospectus) containing certain supplemental information regarding the Shares and terms of the
Offering that will be filed with the Commission and delivered to the Investor (or made available to
the Investor by the filing by the Company of an electronic version thereof with the Commission).
4. The Company and the Investor agree that the Investor will purchase from the Company and the
Company will issue and sell to the Investor the Shares of Common Stock set forth below for the
aggregate purchase price set forth below. The Shares shall be purchased pursuant to the Terms and
Conditions for Purchase of Shares attached hereto as Annex I and incorporated herein by
this reference as if fully set forth herein. The Investor acknowledges that the Offering is not
being underwritten by the placement agents (the Placement Agents) named in the Prospectus
Supplement and that there is no minimum offering amount.
5. The manner of settlement of the Shares purchased by the Investor shall be determined by
such Investor as follows (check one):
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Delivery by electronic book-entry at The Depository Trust Company (DTC), registered in
the Investors name and address as set forth below, and released by Mellon Investor Services
LLC, the Companys transfer agent (the Transfer Agent), to the Investor at the Closing. NO
LATER THAN ONE (1) BUSINESS DAY AFTER THE EXECUTION OF THIS AGREEMENT BY THE INVESTOR AND THE
COMPANY, THE INVESTOR SHALL: |
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DIRECT THE BROKER-DEALER AT WHICH THE ACCOUNT OR ACCOUNTS TO BE CREDITED
WITH THE SHARES ARE MAINTAINED TO SET UP A DEPOSIT/WITHDRAWAL AT CUSTODIAN (DWAC)
INSTRUCTING THE TRANSFER AGENT TO CREDIT SUCH ACCOUNT OR ACCOUNTS WITH THE SHARES,
AND |
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REMIT BY WIRE TRANSFER THE AMOUNT OF FUNDS EQUAL TO THE AGGREGATE
PURCHASE PRICE FOR THE SHARES BEING PURCHASED BY THE INVESTOR TO THE FOLLOWING
ACCOUNT: |
THE CITIBANK PRIVATE BANK
666 Fifth Avenue, 5th Floor
New York, NY 10103
ABA # 021-000-089
Account Name: Thelen Reid Brown Raysman & Steiner LLP, escrow
agent for the account of Cytokinetics, Incorporated
Account Number: 9970183443
OR
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Delivery versus payment (DVP) through DTC (i.e., the
Company shall deliver Shares registered in the Investors
name and address as set forth below and released by the
Transfer Agent to the Investor at the Closing directly to
the account(s) at Lazard Capital Markets LLC (LCM)
identified by the Investor and simultaneously therewith
payment shall be made from such account(s) to the Company
through DTC). NO LATER THAN ONE (1) BUSINESS DAY AFTER
THE EXECUTION OF THIS AGREEMENT BY THE INVESTOR AND THE
COMPANY, THE INVESTOR SHALL: |
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NOTIFY LCM OF THE ACCOUNT OR ACCOUNTS AT LCM TO BE CREDITED WITH THE
SHARES BEING PURCHASED BY SUCH INVESTOR, AND |
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CONFIRM THAT THE ACCOUNT OR ACCOUNTS AT LCM TO BE CREDITED WITH THE
SHARES BEING PURCHASED BY THE INVESTOR HAVE A MINIMUM BALANCE EQUAL TO THE AGGREGATE
PURCHASE PRICE FOR THE SHARES BEING PURCHASED BY THE INVESTOR. |
IT IS THE INVESTORS RESPONSIBILITY TO (A) MAKE THE NECESSARY WIRE TRANSFER OR CONFIRM THE
PROPER ACCOUNT BALANCE IN A TIMELY MANNER AND (B) ARRANGE FOR SETTLEMENT BY WAY OF DWAC OR DVP IN A
TIMELY MANNER. IF THE INVESTOR DOES NOT DELIVER THE AGGREGATE PURCHASE PRICE FOR THE SHARES OR
DOES NOT MAKE PROPER ARRANGEMENTS FOR SETTLEMENT IN A TIMELY MANNER, THE SHARES MAY NOT BE
DELIVERED AT CLOSING TO THE INVESTOR OR THE INVESTOR MAY BE EXCLUDED FROM THE CLOSING
ALTOGETHER.
6. The Investor represents that, except as set forth below, (a) it has had no position, office or
other material relationship within the past three years with the Company or persons known to it to
be
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affiliates of the Company, (b) it is not a NASD member or an Associated Person (as such term is
defined under the NASD Membership and Registration Rules Section 1011) as of the Closing, and (c)
neither the Investor nor any group of Investors (as identified in a public filing made with the
Commission) of which the Investor is a part in connection with the Offering of the Shares,
acquired, or obtained the right to acquire, 20% or more of the Common Stock (or securities
convertible into or exercisable for Common Stock) or the voting power of the Company on a
post-transaction basis. Exceptions:
(If no exceptions, write none. If left blank, response will be deemed to be none.)
7. The Investor represents that it has received (or otherwise had made available to it by the
filing by the Company of an electronic version thereof with the Commission) the Base Prospectus,
dated June 14, 2005, which is a part of the Companys Registration Statement, the documents
incorporated by reference therein and any free writing prospectus (collectively, the Disclosure
Package), prior to or in connection with the receipt of this Agreement. The Investor acknowledges
that, prior to the delivery of this Agreement to the Company, the Investor will receive certain
additional information regarding the Offering, including pricing information (the Offering
Information). Such information may be provided to the Investor by any means permitted under the
Act, including the Prospectus Supplement, a free writing prospectus and oral communications.
8. No offer by the Investor to buy Shares will be accepted and no part of the Purchase Price will
be delivered to the Company until the Investor has received the Offering Information and the
Company has accepted such offer by countersigning a copy of this Agreement, and any such offer may
be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to the
Company (or a Placement Agent on behalf of the Company) sending (orally, in writing or by
electronic mail) notice of its acceptance of such offer. An indication of interest will involve no
obligation or commitment of any kind until the Investor has been delivered the Offering Information
and this Agreement is accepted and countersigned by or on behalf of the Company.
- 3 -
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Number of Shares: |
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Purchase Price Per Share: $ |
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Aggregate Purchase Price: $ |
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Please confirm that the foregoing correctly sets forth the agreement between us by signing in
the space provided below for that purpose.
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Dated as of: December __, 2006 |
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INVESTOR |
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By: |
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Print Name: |
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Title: |
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Address: |
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Agreed and Accepted
this ___day of December, 2006
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CYTOKINETICS, INCORPORATED |
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By: |
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Title: |
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ANNEX I
TERMS AND CONDITIONS FOR PURCHASE OF SHARES
1. Authorization and Sale of the Shares. Subject to the terms and conditions of this
Agreement, the Company has authorized the sale of the Shares.
2. Agreement to Sell and Purchase the Shares; Placement Agents.
2.1 At the Closing (as defined in Section 3.1), the Company will sell to the Investor,
and the Investor will purchase from the Company, upon the terms and conditions set forth herein,
the number of Shares set forth on the last page of the Agreement to which these Terms and
Conditions for Purchase of Shares are attached as Annex I (the Signature Page) for the
aggregate purchase price therefor set forth on the Signature Page.
2.2 The Company proposes to enter into substantially this same form of Subscription Agreement
with certain other investors (the Other Investors) and expects to complete sales of Shares to
them. The Investor and the Other Investors are hereinafter sometimes collectively referred to as
the Investors, and this Agreement and the Subscription Agreements executed by the Other Investors
are hereinafter sometimes collectively referred to as the Agreements.
2.3 Investor acknowledges that the Company has agreed to pay Lazard Capital Markets LLC
(LCM), JMP Securities LLC and Rodman & Renshaw, LLC (the Placement Agents) a fee (the
Placement Fee) in respect of the sale of Shares to the Investor.
2.4 The Company has entered into a Placement Agent Agreement, dated December 6, 2006 (the
Placement Agreement), with the Placement Agents that contains certain representations,
warranties, covenants and agreements of the Company that may be relied upon by the Investor, which
shall be a third party beneficiary thereof.
3. Closings and Delivery of the Shares and Funds.
3.1 Closing. The completion of the purchase and sale of the Shares (the Closing)
shall occur at a place and time (the Closing Date) to be specified by the Company and LCM and of
which the Investors will be notified in advance by the Placement Agents, in accordance with Rule
15c6-1 promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act). At
the Closing, (a) the Company shall cause the Transfer Agent to deliver to the Investor the number
of Shares set forth on the Signature Page registered in the name of the Investor or, if so
indicated on the Investor Questionnaire attached hereto as Exhibit A, in the name of a
nominee designated by the Investor and (b) the aggregate purchase price for the Shares being
purchased by the Investor will be delivered by or on behalf of the Investor to the Company.
3.2 Conditions to the Companys Obligations. (a) The Companys obligation to issue
and sell the Shares to the Investor shall be subject to: (i) the receipt by the Company of the
purchase price for the Shares being purchased hereunder as set forth on the Signature Page and (ii)
the accuracy of the representations and warranties made by the Investor and the fulfillment of
those undertakings of the Investor to be fulfilled prior to the Closing Date.
- 5 -
(b) Conditions to the Investors Obligations. The Investors obligation to purchase
the Shares will be subject to the accuracy of the representations and warranties made by the
Company and the fulfillment of those undertakings of the Company to be fulfilled prior to the
Closing Date, including without limitation, those contained in this Agreement and the Placement
Agreement, and to the condition that the Placement Agents shall not have: (a) terminated the
Placement Agreement pursuant to the terms thereof or (b) determined that the conditions to the
closing in the Placement Agreement have not been satisfied. The Investors obligations are
expressly not conditioned on the purchase by any or all of the Other Investors of the Shares that
they have agreed to purchase from the Company.
3.3 Delivery of Funds.
(a) Delivery by Electronic Book-Entry at The Depository Trust Company. If the
Investor elects to settle the Shares purchased by such Investor through delivery by electronic
book-entry at DTC, no later than one (1) business day after the execution of this Agreement by
the Investor and the Company, the Investor shall remit by wire transfer the amount of funds
equal to the aggregate purchase price for the Shares being purchased by the Investor to the
following account designated by the Company and the Placement Agents pursuant to the terms of that
certain Escrow Agreement (the Escrow Agreement) dated as of December 6, 2006, by and among the
Company, the Placement Agents and Thelen Reid Brown Raysman & Steiner LLP (the Escrow Agent):
THE CITIBANK PRIVATE BANK
666 Fifth Avenue, 5th Floor
New York, NY 10103
ABA # 021-000-089
Account Name: Thelen Reid Brown Raysman & Steiner LLP, escrow
agent for the account of Cytokinetics, Incorporated
Account Number: 9970183443
Such funds shall be held in escrow until the Closing and delivered by the Escrow Agent on
behalf of the Investors to the Company upon the satisfaction, in the sole judgment of the Placement
Agents, of the conditions set forth in Section 3.2(b) hereof. The Placement Agents shall have no
rights in or to any of the escrowed funds, unless the Placement Agents and the Escrow Agent are
notified in writing by the Company in connection with the Closing that a portion of the escrowed
funds shall be applied to the Placement Fee. The Company and the Investor agree to indemnify and
hold the Escrow Agent harmless from and against any and all losses, costs, damages, expenses and
claims (including, without limitation, court costs and reasonable attorneys fees) (Losses)
arising under this Section 3.3 or otherwise with respect to the funds held in escrow
pursuant hereto or arising under the Escrow Agreement, unless it is finally determined that such
Losses resulted directly from the willful misconduct or gross negligence of the Escrow Agent.
Anything in this Agreement to the contrary notwithstanding, in no event shall the Escrow Agent be
liable for any special, indirect or consequential loss or damage of any kind whatsoever (including
but not limited to lost profits), even if the Escrow Agent has been advised of the likelihood of
such loss or damage and regardless of the form of action.
Investor shall also furnish to the Placement Agents a completed W-9 form (or, in the case of
an Investor who is not a United States citizen or resident, a W-8 form).
- 6 -
Investor acknowledges that the Escrow Agent acts as counsel to the Placement Agents, and shall
have the right to continue to represent the Placement Agents, in any action, proceeding, claim,
litigation, dispute, arbitration or negotiation in connection with the Offering, and Investor
hereby consents thereto and waives any objection to the continued representation of the Placement
Agents by the Escrow Agent in connection therewith based upon the services of the Escrow Agent
under the Escrow Agreement, without waiving any duty or obligation the Escrow Agent may have to any
other person.
(b) Delivery Versus Payment through The Depository Trust Company. If the Investor
elects to settle the Shares purchased by such Investor by delivery versus payment through DTC,
no later than one (1) business day after the execution of this Agreement by the Investor and
the Company, the Investor shall confirm that the account or accounts at LCM to be credited with
the Shares being purchased by the Investor have a minimum balance equal to the aggregate purchase
price for the Shares being purchased by the Investor.
3.4 Delivery of Shares.
(a) Delivery by Electronic Book-Entry at The Depository Trust Company. If the
Investor elects to settle the Shares purchased by such Investor through delivery by electronic
book-entry at DTC, no later than one (1) business day after the execution of this Agreement by
the Investor and the Company, the Investor shall direct the broker-dealer at which the account
or accounts to be credited with the Shares being purchased by such Investor are maintained, which
broker/dealer shall be a DTC participant, to set up a Deposit/Withdrawal at Custodian (DWAC)
instructing Mellon Investor Services LLC, the Companys transfer agent, to credit such account or
accounts with the Shares by means of an electronic book-entry delivery. Such DWAC shall indicate
the settlement date for the deposit of the Shares, which date shall be provided to the Investor by
the Placement Agents. Simultaneously with the delivery to the Company by the Escrow Agent of the
funds held in escrow pursuant to Section 3.3 above, the Company shall direct its transfer
agent to credit the Investors account or accounts with the Shares pursuant to the information
contained in the DWAC.
(b) Delivery Versus Payment through The Depository Trust Company. If the Investor
elects to settle the Shares purchased by such Investor by delivery versus payment through DTC,
no later than one (1) business day after the execution of this Agreement by the Investor and
the Company, the Investor shall notify LCM of the account or accounts at LCM to be credited
with the Shares being purchased by such Investor. On the Closing Date, the Company shall deliver
the Shares to the Investor directly to the account(s) at LCM identified by Investor and
simultaneously therewith payment shall be made from such account(s) to the Company through DTC.
4. Representations, Warranties and Covenants of the Investor.
The Investor represents and warrants to, and agrees with, the Company and the Placement Agents
that:
4.1 The Investor (a) is knowledgeable, sophisticated and experienced in making, and is
qualified to make decisions with respect to, investments in shares presenting an investment
decision like that involved in the purchase of the Shares, including investments in securities
issued by the Company and investments in comparable companies, (b) has answered all questions on
the Signature Page and the Investor Questionnaire and the answers thereto are true and correct as
of the date hereof
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and will be true and correct as of the Closing Date and (c) in connection with its decision to
purchase the number of Shares set forth on the Signature Page, has received and is relying only
upon the Disclosure Package, the documents incorporated by reference therein and the Offering
Information.
4.2 If the Investor is outside the United States, it will comply with all applicable laws and
regulations in each foreign jurisdiction in which it purchases, offers, sells or delivers Shares or
has in its possession or distributes any offering material, in all cases at its own expense.
4.3 (a) The Investor has full right, power, authority and capacity to enter into this
Agreement and to consummate the transactions contemplated hereby and has taken all necessary action
to authorize the execution, delivery and performance of this Agreement, and (b) this Agreement
constitutes a valid and binding obligation of the Investor enforceable against the Investor in
accordance with its terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium or similar laws affecting creditors and contracting
parties rights generally and except as enforceability may be subject to general principles of
equity (regardless of whether such enforceability is considered in a proceeding in equity or at
law) and except as to the enforceability of any rights to indemnification or contribution that may
be violative of the public policy underlying any law, rule or regulation (including any federal or
state securities law, rule or regulation).
4.4 The Investor understands that nothing in this Agreement, the Prospectus or any other
materials presented to the Investor in connection with the purchase and sale of the Shares
constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and
investment advisors as it, in its sole discretion, has deemed necessary or appropriate in
connection with its purchase of Shares.
4.5 Since the date on which any Placement Agent first contacted such Investor about the
Offering, the Investor has not engaged in any transactions in the securities of the Company
(including, without limitation, any Short Sales involving the Companys securities), and has not
violated its obligations of confidentiality. Each Investor covenants that it will not engage in
any transactions in the securities of the Company (including Short Sales) or disclose any
information about the contemplated offering (other than to its advisors that are under a legal
obligation of confidentiality) prior to the time that the transactions contemplated by this
Agreement are publicly disclosed. Each Investor agrees that it will not use any of the Shares
acquired pursuant to this Agreement to cover any short position in the Common Stock if doing so
would be in violation of applicable securities laws. For purposes hereof, Short Sales include,
without limitation, all short sales as defined in Rule 200 promulgated under Regulation SHO under
the Exchange Act, whether or not against the box, and all types of direct and indirect stock
pledges, forward sales contracts, options, puts, calls, short sales, swaps, put equivalent
positions (as defined in Rule 16a-1(h) under the Exchange Act) and similar arrangements (including
on a total return basis), and sales and other transactions through non-US broker dealers or foreign
regulated brokers.
5. Survival of Representations, Warranties and Agreements; Third Party Beneficiary.
Notwithstanding any investigation made by any party to this Agreement or by the Placement Agents,
all covenants, agreements, representations and warranties made by the Company and the Investor
herein will survive the execution of this Agreement, the delivery to the Investor of the Shares
being purchased and the payment therefor. The Placement Agents and Lazard Fréres & Co.
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shall be third party beneficiaries with respect to the representations, warranties and
agreements of the Investor in Section 4 hereof.
6. Notices. All notices, requests, consents and other communications hereunder will be in
writing, will be mailed (a) if within the domestic United States by first-class registered or
certified airmail, or nationally recognized overnight express courier, postage prepaid, or by
facsimile or (b) if delivered from outside the United States, by International Federal Express or
facsimile, and will be deemed given (i) if delivered by first-class registered or certified mail
domestic, three business days after so mailed, (ii) if delivered by nationally recognized overnight
carrier, one business day after so mailed, (iii) if delivered by International Federal Express, two
business days after so mailed and (iv) if delivered by facsimile, upon electric confirmation of
receipt and will be delivered and addressed as follows:
(a) if to the Company, to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, CA 94080
Attention: Chief Financial Officer
Facsimile: (650) 624-3200
with copies to:
Wilson Sonsini Goodrich & Rosati PC.
650 Page Mill Road
Palo Alto, CA 94304
Attention: Mike ODonnell, Esq.
Facsimile: (650) 493-6811
(b) if to the Investor, at its address on the Signature Page hereto, or at such
other address or addresses as may have been furnished to the Company in writing.
7. Changes. This Agreement may not be modified or amended except pursuant to an instrument
in writing signed by the Company and the Investor.
8. Headings. The headings of the various sections of this Agreement have been inserted for
convenience of reference only and will not be deemed to be part of this Agreement.
9. Severability. In case any provision contained in this Agreement should be invalid,
illegal or unenforceable in any respect, the validity, legality and enforceability of the
remaining provisions contained herein will not in any way be affected or impaired thereby.
10. Governing Law. This Agreement will be governed by, and construed in accordance with,
the internal laws of the State of New York, without giving effect to the principles of
conflicts of law that would require the application of the laws of any other jurisdiction.
11. Counterparts. This Agreement may be executed in two or more counterparts, each of which
will constitute an original, but all of which, when taken together, will constitute but one
- 9 -
instrument, and will become effective when one or more counterparts have been signed by each
party hereto and delivered to the other parties. The Company and the Investor acknowledge
and agree that the Company shall deliver its counterpart to the Investor along with the
Prospectus Supplement (or the filing by the Company of an electronic version thereof with
the Commission).
12. Confirmation of Sale. The Investor acknowledges and agrees that such Investors receipt
of the Companys counterpart to this Agreement, together with the Prospectus Supplement (or
the filing by the Company of an electronic version thereof with the Commission), shall
constitute written confirmation of the Companys sale of Shares to such Investor.
13. Press Release. The Company and the Investor agree that the Company shall issue a press
release announcing the Offering prior to the opening of the financial markets in New York
City on the business day immediately after the date hereof.
14. Termination. In the event that the Placement Agreement is terminated by the Placement
Agents pursuant to the terms thereof, this Agreement shall terminate without any further
action on the part of the parties hereto.
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Exhibit A
CYTOKINETICS, INCORPORATED
INVESTOR QUESTIONNAIRE
Pursuant to Section 3 of Annex I to the Agreement, please provide us with the
following information:
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The exact name that your Shares are to be registered in. You may
use a nominee name if appropriate: |
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2.
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The relationship between the Investor and the registered holder
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The mailing address of the registered holder listed in response to
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The Social Security Number or Tax Identification Number of the
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5.
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Name of DTC Participant (broker-dealer at which the account or
accounts to be credited with the Shares are maintained): |
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DTC Participant Number: |
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Name of Account at DTC Participant being credited with the Shares: |
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Account Number at DTC Participant being credited with the Shares: |
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exv99w1
Exhibit
99.1
RISK
FACTORS
Our business is subject to various risks, including those
described below. You should carefully consider the following
risks, together with all of the other information included in
this prospectus supplement, the accompanying prospectus and the
documents incorporated by reference before investing in our
common stock. Any of these risks could materially adversely
affect our business, operating results and financial
condition.
Risks Related To
Our Business
Our drug
candidates are in the early stages of clinical testing and we
have a history of significant losses and may not achieve or
sustain profitability and, as a result, you may lose all or part
of your investment.
Our drug candidates are in the early stages of clinical testing
and we must conduct significant additional clinical trials
before we can seek the regulatory approvals necessary to begin
commercial sales of our drugs. We have incurred operating losses
in each year since our inception in 1997 due to costs incurred
in connection with our research and development activities and
general and administrative costs associated with our operations.
We expect to incur increasing losses for at least several years,
as we continue our research activities and conduct development
of, and seek regulatory approvals for, our drug candidates, and
commercialize any approved drugs. If our drug candidates fail in
clinical trials or do not gain regulatory approval, or if our
drugs do not achieve market acceptance, we will not be
profitable. If we fail to become and remain profitable, or if we
are unable to fund our continuing losses, you could lose all or
part of your investment.
We have never
generated, and may never generate, revenues from commercial
sales of our drugs and we may not have drugs to market for at
least several years, if ever.
We currently have no drugs for sale and we cannot guarantee that
we will ever have marketable drugs. We must demonstrate that our
drug candidates satisfy rigorous standards of safety and
efficacy to the U.S. Food and Drug Administration, or FDA,
and other regulatory authorities in the United States and
abroad. We and our partners will need to conduct significant
additional research and preclinical and clinical testing before
we or our partners can file applications with the FDA or other
regulatory authorities for approval of our drug candidates. In
addition, to compete effectively, our drugs must be easy to use,
cost-effective and economical to manufacture on a commercial
scale, compared to other therapies available for the treatment
of the same conditions. We may not achieve any of these
objectives. Ispinesib, our most advanced drug candidate for the
treatment of cancer, SB-743921, our second drug candidate for
the treatment of cancer, and CK-1827452 in both intravenous and
oral formulations, our drug candidates for the treatment of
heart failure, are currently our only drug candidates in
clinical trials and we cannot be certain that the clinical
development of these or any other drug candidate in preclinical
testing or clinical development will be successful, that they
will receive the regulatory approvals required to commercialize
them, or that any of our other research programs will yield a
drug candidate suitable for entry into clinical trials. Our
commercial revenues, if any, will be derived from sales of drugs
that we do not expect to be commercially available for several
years, if at all. The development of any one or all of these
drug candidates may be discontinued at any stage of our clinical
trials programs and we may not generate revenue from any of
these drug candidates.
1
We currently
finance and plan to continue to finance our operations through
the sale of equity and potentially entering into additional
strategic alliances, which may result in additional dilution to
our stockholders or relinquishment of valuable technology
rights, or may cease to be available on attractive terms or at
all.
We have funded all of our operations and capital expenditures
with proceeds from both private and public sales of our equity
securities, strategic alliances with GlaxoSmithKline, or GSK,
AstraZeneca and others, equipment financings, interest on
investments and government grants. We believe that our existing
cash and cash equivalents, future payments from GSK, interest
earned on investments, proceeds from equipment financings and
potential proceeds from our committed equity financing facility,
or CEFF, with Kingsbridge Capital Ltd., or Kingsbridge, will be
sufficient to meet our projected operating requirements for at
least the next 12 months. To meet our future cash
requirements, we may raise funds through public or private
equity offerings or strategic alliances. To the extent that we
raise additional funds by issuing equity securities, our
stockholders may experience additional dilution. To the extent
that we raise additional funds through strategic alliance and
licensing arrangements, we will likely have to relinquish
valuable rights to our technologies, research programs or drug
candidates, or grant licenses on terms that may not be favorable
to us. To the extent that we raise additional funds through debt
financing, if available, such financing may involve covenants
that restrict our business activities. In addition, we cannot
assure you that any such funding, if needed, will be available
on attractive terms, or at all.
Clinical trials
may fail to demonstrate the desired safety and efficacy of our
drug candidates, which could prevent or significantly delay
completion of clinical development and regulatory
approval.
Prior to receiving approval to commercialize any of our drug
candidates, we must demonstrate with substantial evidence from
well-controlled clinical trials, and to the satisfaction of the
FDA and other regulatory authorities in the United States and
abroad, that such drug candidate is both sufficiently safe and
effective. In clinical trials we will need to demonstrate
efficacy for the treatment of specific indications and monitor
safety throughout the clinical development process. None of our
drug candidates have yet demonstrated long-term safety and
efficacy in clinical trials. In addition, for each of our
current preclinical compounds, we must demonstrate satisfactory
chemistry, formulation, stability and toxicity in order to file
an investigational new drug application, or IND, or a foreign
equivalent, that would allow us to advance that compound into
clinical trials. If our preclinical studies, current clinical
trials or future clinical trials are unsuccessful, our business
and reputation will be harmed and our stock price will be
negatively affected.
All of our drug candidates are prone to the risks of failure
inherent in drug development. Preclinical studies may not yield
results that would satisfactorily support the filing of an IND
(or a foreign equivalent) with respect to our potential drug
candidates, and, even if these applications would be or have
been filed with respect to our drug candidates, the results of
preclinical studies do not necessarily predict the results of
clinical trials. Similarly, early-stage clinical trials do not
predict the results of later-stage clinical trials, including
the safety and efficacy profiles of any particular drug
candidate. In addition, there can be no assurance that the
design of our clinical trials is focused on appropriate tumor
types, patient populations, dosing regimens or other variables
which will result in obtaining the desired efficacy data to
support regulatory approval to commercialize the drug. Even if
we believe the data collected from clinical trials of our drug
candidates are promising, such data may not be sufficient to
support approval by the FDA or any other U.S. or foreign
regulatory authority. Preclinical and clinical data can be
interpreted in different ways. Accordingly, FDA officials or
officials from foreign regulatory authorities could interpret
the data in different ways than we or our partners do, which
could delay, limit or prevent regulatory approval.
Administering any of our drug candidates or potential drug
candidates that are the subject of preclinical studies to
animals may produce undesirable side effects, also known as
adverse effects.
2
Toxicities and adverse effects that we have observed in
preclinical studies for some compounds in a particular research
and development program may occur in preclinical studies or
clinical trials of other compounds from the same program.
Potential toxicity issues may arise from the effects of the
active pharmaceutical ingredient, or API, itself or from
impurities or degradants that are present in the API or could
form over time in the formulated drug candidate or the API. Such
toxicities or adverse effects could delay or prevent the filing
of an IND (or a foreign equivalent) with respect to such drug
candidates or potential drug candidates or cause us to cease
clinical trials with respect to any drug candidate. In clinical
trials, administering any of our drug candidates to humans may
produce adverse effects. In clinical trials of ispinesib, the
dose-limiting toxicity was neutropenia, a decrease in the number
of a certain type of white blood cell that results in an
increase in susceptibility to infection. In a Phase I
clinical trial of
SB-743921,
the dose-limiting toxicities observed were: prolonged
neutropenia, with or without fever and with or without
infection; elevated transaminases and hyperbilirubinemia, both
of which are abnormalities of liver function; and hyponatremia,
which is a low concentration of sodium in the blood. In a
Phase I clinical trial of
CK-1827452,
doses that exceeded the maximum tolerated dose of
CK-1827452
were associated with increases in heart rate and declines in
blood pressure. These adverse effects could interrupt, delay or
halt clinical trials of our drug candidates and could result in
the FDA or other regulatory authorities denying approval of our
drug candidates for any or all targeted indications. The FDA,
other regulatory authorities, our partners or we may suspend or
terminate clinical trials at any time. Even if one or more of
our drug candidates were approved for sale, the occurrence of
even a limited number of toxicities or adverse effects when used
in large populations may cause the FDA to impose restrictions
on, or stop, the further marketing of such drugs. Indications of
potential adverse effects or toxicities which may occur in
clinical trials and which we believe are not significant during
the course of such clinical trials may later turn out to
actually constitute serious adverse effects or toxicities when a
drug has been used in large populations or for extended periods
of time. Any failure or significant delay in completing
preclinical studies or clinical trials for our drug candidates,
or in receiving and maintaining regulatory approval for the sale
of any drugs resulting from our drug candidates, may severely
harm our reputation and business.
Clinical trials
are expensive, time consuming and subject to delay.
Clinical trials are very expensive and difficult to design and
implement, especially in the cancer and heart failure
indications that we are pursuing, in part because they are
subject to rigorous requirements. The clinical trial process is
also time consuming. According to industry studies, the entire
drug development and testing process takes on average 12 to
15 years, and the fully capitalized resource cost of new
drug development averages approximately $800 million.
However, individual clinical trials and individual drug
candidates may incur a range of costs or time demands above or
below this average. We estimate that clinical trials of our most
advanced drug candidates will continue for several years, but
they may take significantly longer to complete. The commencement
and completion of our clinical trials could be delayed or
prevented by many factors, including, but not limited to:
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delays in obtaining regulatory or other approvals to commence
and conduct a clinical trial;
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delays in identifying and reaching agreement on acceptable terms
with prospective clinical trial sites;
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slower than expected rates of patient recruitment and
enrollment, including as a result of the introduction of
alternative therapies or drugs by others;
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lack of effectiveness during clinical trials;
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unforeseen safety issues;
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inadequate supply of clinical trial material;
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uncertain dosing issues;
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introduction of new therapies or changes in standards of
practice or regulatory guidance that render our clinical trial
endpoints or the targeting of our proposed indications obsolete;
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inability to monitor patients adequately during or after
treatment; and
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inability or unwillingness of medical investigators to follow
our clinical protocols.
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We do not know whether planned clinical trials will begin on
time, or whether planned or currently ongoing clinical trials
will need to be restructured or will be completed on schedule,
if at all. Significant delays in clinical trials will impede our
ability to commercialize our drug candidates and generate
revenue and could significantly increase our development costs.
We have limited
capacity to carry out our own clinical trials in connection with
the development of our drug candidates and potential drug
candidates, and to the extent we elect to develop a drug
candidate without a strategic partner we will need to expand our
development capacity, and will require additional
funding.
The development of drug candidates is complicated, and the
required resources and experience that we currently have to
carry out such development are limited. Pursuant to our amended
Collaboration and License Agreement with GSK, we are now
responsible for conducting clinical development for our drug
candidates ispinesib and
SB-743921.
Currently, we rely on GSK to conduct pre-clinical and clinical
development for
GSK-923295
and the National Cancer Institute, or NCI, to conduct certain
clinical trials for ispinesib. We cannot engage a strategic
partner for ispinesib or
SB-743921
until GSK elects not to exercise its option to conduct clinical
development for that drug candidate or its option expires. If
GSK elects to terminate its development efforts with respect to
GSK-923295,
or not to exercise its option to conduct clinical development
for either of ispinesib or
SB-743921,
we do not have an alternative strategic partner for these
programs. We do not have a strategic partner for our cardiac
myosin activator drug candidate,
CK-1827452.
For our drug candidates for which we expect to conduct clinical
trials, such as ispinesib,
SB-743921
and
CK-1827452,
we plan to rely on contractors for the manufacture and
distribution of clinical supplies. To the extent we conduct
clinical trials for a drug candidate without support from a
strategic partner, we will need to develop additional skills,
technical expertise and resources necessary to carry out such
development efforts on our own or through the use of other third
parties, such as contract research organizations, or CROs.
If we utilize CROs, we will not have control over many aspects
of their activities, and will not be able to fully control the
amount or timing of resources that they devote to our programs.
These third parties also may not assign as high a priority to
our programs or pursue them as diligently as we would if we were
undertaking such programs ourselves, and therefore may not
complete their respective activities on schedule. CROs may also
have relationships with our competitors and potential
competitors, and may prioritize those relationships ahead of
their relationships with us. Typically, we would prefer to
qualify more than one vendor for each function performed outside
of our control, which could be time consuming and costly. The
failure of CROs to carry out development efforts on our behalf
according to our requirements and FDA or other regulatory
agencies standards and in accordance with applicable laws,
or our failure to properly coordinate and manage such efforts,
could increase the cost of our operations and delay or prevent
the development, approval and commercialization of our drug
candidates. In addition, if a CRO fails to perform as agreed,
our ability to collect damages may be contractually limited.
If we fail to develop the additional skills, technical expertise
and resources necessary to carry out the development of our drug
candidates, or if we fail to effectively manage our CROs
carrying out such development, the commercialization of our drug
candidates will be delayed or prevented.
4
We have no
manufacturing capacity and depend on our strategic partners or
contract manufacturers to produce our clinical trial drug
supplies for each of our drug candidates and potential drug
candidates, and anticipate continued reliance on contract
manufacturers for the development and commercialization of our
potential drugs.
We do not currently operate manufacturing facilities for
clinical or commercial production of our drug candidates or
potential drug candidates. We have limited experience in drug
formulation and manufacturing, and we lack the resources and the
capabilities to manufacture any of our drug candidates on a
clinical or commercial scale. As a result, we will rely on GSK
to be responsible for such activities for the planned
GSK-923295
clinical trial. For ispinesib,
SB-743921,
CK-1827452
and any future drug candidates for which we conduct clinical
development, we expect to rely on a limited number of contract
manufacturers, and, in particular, we expect to rely on
single-source contract manufacturers for the active
pharmaceutical ingredient and the drug product supply for our
clinical trials. We anticipate continued reliance on a limited
number of contract manufacturers. If any of our existing or
future contract manufacturers fail to perform as agreed, it
could delay clinical development or regulatory approval of our
drug candidates or commercialization of our drugs, producing
additional losses and depriving us of potential product
revenues. In addition, if a contract manufacturer fails to
perform as agreed, our ability to collect damages may be
contractually limited.
Our drug candidates require precise, high quality manufacturing.
The failure to achieve and maintain high manufacturing
standards, including the incidence of manufacturing errors,
could result in patient injury or death, product recalls or
withdrawals, delays or failures in product testing or delivery,
cost overruns or other problems that could seriously hurt our
business. Contract drug manufacturers often encounter
difficulties involving production yields, quality control and
quality assurance, as well as shortages of qualified personnel.
These manufacturers are subject to stringent regulatory
requirements, including the FDAs current good
manufacturing practices regulations and similar foreign laws, as
well as ongoing periodic unannounced inspections by the FDA, the
U.S. Drug Enforcement Agency and other regulatory agencies,
to ensure strict compliance with current good manufacturing
practices and other applicable government regulations and
corresponding foreign standards. However, we do not have control
over our contract manufacturers compliance with these
regulations and standards. If one of our contract manufacturers
fails to maintain compliance, the production of our drug
candidates could be interrupted, resulting in delays, additional
costs and potentially lost revenues. Additionally, our contract
manufacturer must pass a preapproval inspection before we can
obtain marketing approval for any of our drug candidates in
development.
If the FDA or other regulatory agencies approve any of our drug
candidates for commercial sale, we will need to manufacture them
in larger quantities. To date, our drug candidates have been
manufactured only in small quantities for preclinical testing
and clinical trials. We may not be able to successfully increase
the manufacturing capacity, whether in collaboration with
contract manufacturers or on our own, for any of our drug
candidates in a timely or economic manner, or at all.
Significant
scale-up of
manufacturing may require additional validation studies, which
the FDA must review and approve. If we are unable to
successfully increase the manufacturing capacity for a drug
candidate, the regulatory approval or commercial launch of any
related drugs may be delayed or there may be a shortage in
supply. Even if any contract manufacturer makes improvements in
the manufacturing process for our drug candidates, we may not
own, or may have to share, the intellectual property rights to
such improvements.
In addition, our existing and future contract manufacturers may
not perform as agreed or may not remain in the contract
manufacturing business for the time required to successfully
produce, store and distribute our drug candidates. If a natural
disaster, business failure, strike or other difficulty occurs,
we may be unable to replace such contract manufacturer in a
timely manner and the production of our drug candidates would be
interrupted, resulting in delays and additional costs.
Switching manufacturers or manufacturing sites may be difficult
and time consuming because the number of potential manufacturers
is limited. In addition, prior to the commercialization of a
drug
5
from any replacement manufacturer or manufacturing site, the FDA
must approve that site. Such approval would require new testing
and compliance inspections. In addition, a new manufacturer or
manufacturing site would have to be educated in, or develop
substantially equivalent processes for, production of our drugs
after receipt of FDA approval. It may be difficult or impossible
for us to find a replacement manufacturer on acceptable terms
quickly, or at all.
We may not be
able to successfully
scale-up
manufacture of our drug candidates in sufficient quality and
quantity, which would delay or prevent us from developing our
drug candidates and commercializing resulting approved drugs, if
any.
To date, our drug candidates have been manufactured in small
quantities for preclinical studies and early-stage clinical
trials. In order to conduct larger scale or late-stage clinical
trials for a drug candidate and for the resulting drug if that
drug candidate is approved for sale, we will need to manufacture
it in larger quantities. We may not be able to successfully
increase the manufacturing capacity for any of our drug
candidates, whether in collaboration with third-party
manufacturers or on our own, in a timely or cost-effective
manner or at all. Significant
scale-up of
manufacturing may require additional validation studies, which
are costly and which the FDA must review and approve. In
addition, quality issues may arise during such
scale-up
activities because of the inherent properties of a drug
candidate itself or of a drug candidate in combination with
other components added during the manufacturing and packaging
process. If we are unable to successfully
scale-up
manufacture of any of our drug candidates in sufficient quality
and quantity, the development, regulatory approval or commercial
launch of that drug candidate may be delayed or there may be a
shortage in supply, which could significantly harm our business.
We depend on GSK
for the conduct, completion and funding of the clinical
development and commercialization of
GSK-923295.
Under our strategic alliance with GSK, as amended, GSK is
responsible for the clinical development and regulatory approval
of our potential drug candidate
GSK-923295
for cancer and other indications. GSK is responsible for filing
applications with the FDA or other regulatory authorities for
approval of
GSK-923295
and will be the owner of any marketing approvals issued by the
FDA or other regulatory authorities for
GSK-923295.
If the FDA or other regulatory authorities approve
GSK-923295,
GSK will also be responsible for the marketing and sale of the
resulting drug. Because GSK is responsible for these functions,
we cannot control whether GSK will devote sufficient attention
and resources to the clinical trials program for
GSK-923295
or will proceed in an expeditious manner. GSK generally has
discretion to elect whether to pursue or abandon the development
of
GSK-923295
and may terminate our strategic alliance for any reason upon six
months prior notice. These decisions are outside our control.
In particular, if the initial clinical results of some of its
early clinical trials do not meet GSKs expectations, GSK
may elect to terminate further development of
GSK-923295
or certain of the potential clinical trials for
GSK-923295,
even if the actual number of patients treated at such time is
relatively small. If GSK abandons
GSK-923295,
it would result in a delay in or prevent us from commercializing
GSK-923295,
and would delay or prevent our ability to generate revenues.
Disputes may arise between us and GSK, which may delay or cause
the termination of any
GSK-923295
clinical trials, result in significant litigation or
arbitration, or cause GSK to act in a manner that is not in our
best interest. If development of
GSK-923295
does not progress for these or any other reasons, we would not
receive further milestone payments from GSK with respect to
GSK-923295.
Even if the FDA or other regulatory agencies approve
GSK-923295,
GSK may elect not to proceed with the commercialization of the
resulting drug. These decisions are outside our control. In such
event, or if GSK abandons development of
GSK-923295
prior to regulatory approval, we would have to undertake and
fund the clinical development of
GSK-923295
or commercialization of the resulting drug, seek a new partner
for clinical development or commercialization, or curtail or
abandon such clinical
6
development or commercialization. If we were unable to do so on
acceptable terms, or at all, our business would be harmed, and
the price of our common stock would be negatively affected.
If we fail to
enter into and maintain successful strategic alliances for
certain of our drug candidates, we may have to reduce or delay
our drug candidate development or increase our
expenditures.
Our strategy for developing, manufacturing and commercializing
certain of our drug candidates currently requires us to enter
into and successfully maintain strategic alliances with
pharmaceutical companies or other industry participants to
advance our programs and reduce our expenditures on each
program. However, we may not be able to negotiate additional
strategic alliances on acceptable terms, if at all. If we are
not able to maintain our existing strategic alliances or
establish and maintain additional strategic alliances, we may
have to limit the size or scope of, or delay, one or more of our
drug development programs or research programs or undertake and
fund these programs ourselves. If we elect to increase our
expenditures to fund drug development programs or research
programs on our own, as we have under the amendment to our
Collaboration and License Agreement with GSK through which we
will be responsible for the clinical development of ispinesib
and
SB-743921,
we will need to obtain additional capital, which may not be
available on acceptable terms, or at all.
The success of
our development efforts depends in part on the performance of
GSK and the NCI, over which we have little or no
control.
Our ability to commercialize drugs that we develop with our
partners and that generate royalties from product sales depends
on our partners abilities to assist us in establishing the
safety and efficacy of our drug candidates, obtaining and
maintaining regulatory approvals and achieving market acceptance
of the drugs once commercialized. Our partners may elect to
delay or terminate development of one or more drug candidates,
independently develop drugs that could compete with ours or fail
to commit sufficient resources to the marketing and distribution
of drugs developed through their strategic alliances with us.
Our partners may not proceed with the development and
commercialization of our drug candidates with the same degree of
urgency as we would because of other priorities they face. In
particular, we are relying on the NCI, a government agency, to
conduct several clinical trials of ispinesib and GSK to conduct
clinical development of
GSK-923295.
There can be no assurance that GSK or the NCI, or both, will not
modify their respective plans to conduct such clinical
development or will proceed with such clinical development
diligently. We have no control over the conduct of clinical
development being conducted by GSK or the NCI, including the
timing of initiation, termination or completion of such clinical
trials, the analysis of data arising out of such clinical trials
or the timing of release of complete data concerning such
clinical trials, which may impact our ability to report on their
results. If our partners fail to perform as we expect, our
potential for revenue from drugs developed through our strategic
alliances, if any, could be dramatically reduced.
Our focus on the
discovery of drug candidates directed against specific proteins
and pathways within the cytoskeleton is unproven, and we do not
know whether we will be able to develop any drug candidates of
commercial value.
We believe that our focus on drug discovery and development
directed at the cytoskeleton is novel and unique. While a number
of commonly used drugs and a growing body of research validate
the importance of the cytoskeleton in the origin and progression
of a number of diseases, no existing drugs specifically and
directly interact with the cytoskeletal proteins and pathways
that our drug candidates seek to modulate. As a result, we
cannot be certain that our drug candidates will appropriately
modulate the targeted cytoskeletal proteins and pathways or
produce commercially viable drugs that safely and effectively
treat cancer, heart failure or other diseases, or that the
results we have seen in preclinical models will translate into
similar results in humans. In addition, even if we are
successful in developing and receiving regulatory approval for a
commercially viable drug for the treatment of one disease
focused on the cytoskeleton, we cannot be certain that we will
also be able
7
to develop and receive regulatory approval for drug candidates
for the treatment of other forms of that disease or other
diseases. If we or our partners fail to develop and
commercialize viable drugs, we will not achieve commercial
success.
Our proprietary
rights may not adequately protect our technologies and drug
candidates.
Our commercial success will depend in part on our obtaining and
maintaining patent and trade secret protection of our
technologies and drug candidates as well as successfully
defending these patents against third-party challenges. We will
only be able to protect our technologies and drug candidates
from unauthorized use by third parties to the extent that valid
and enforceable patents or trade secrets cover them. In the
event that our issued patents and our patent applications, if
granted, do not adequately describe, enable or otherwise provide
coverage of our technologies and drug candidates, including for
example ispinesib,
SB-743921,
GSK-923295
and
CK-1827452,
we would not be able to exclude others from developing or
commercializing these drug candidates and potential drug
candidates. Furthermore, the degree of future protection of 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.
The patent positions of life sciences 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
such companies 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 or 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.
For example:
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we or 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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we or 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 technologies without
infringing our intellectual property rights;
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some or all of our or our licensors pending patent
applications may not result in issued patents;
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our and our licensors issued patents may not provide a
basis for commercially viable drugs or therapies, or may not
provide us with any competitive advantages, or may be challenged
and invalidated by third parties;
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our or our licensors patent applications or patents may be
subject to interference, opposition or similar administrative
proceedings;
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we may not develop additional proprietary technologies or drug
candidates that are patentable; or
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the patents of others may prevent us or our partners from
discovering, developing or commercializing our drug candidates.
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We also rely on trade secrets to protect our technology,
especially where we believe patent protection is not appropriate
or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets,
our or our strategic partners employees, consultants,
contractors or scientific and other advisors may unintentionally
or willfully disclose our information to competitors. In
addition, confidentiality agreements, if any, executed by such
persons may not be enforceable or provide meaningful protection
for our trade secrets or other proprietary information in the
event of unauthorized use or disclosure. If we were to enforce a
claim that a third party had illegally obtained and was using
our trade secrets, our enforcement efforts would be
8
expensive and time consuming, and the outcome would be
unpredictable. In addition, courts outside the United States are
sometimes less willing to protect trade secrets. Moreover, if
our competitors independently develop information that is
equivalent to our trade secrets, it will be more difficult for
us to enforce our rights and our business could be harmed.
If we are not able to defend the patent or trade secret
protection position of our technologies and drug candidates,
then we will not be able to exclude competitors from developing
or marketing competing drugs, and we may not generate enough
revenue from product sales to justify the cost of development of
our drugs and to achieve or maintain profitability.
If we are sued
for infringing intellectual property rights of third parties,
such litigation will be costly and time consuming, and an
unfavorable outcome would have a significant adverse effect on
our business.
Our ability to commercialize drugs depends on our ability to
sell such drugs without infringing the patents or other
proprietary rights of third parties. Numerous U.S. and foreign
issued patents and pending patent applications owned by third
parties exist in the areas that we are exploring. In addition,
because patent applications can take several years to issue,
there may be currently pending applications, unknown to us,
which may later result in issued patents that our drug
candidates may infringe. There could also be existing patents of
which we are not aware that our drug candidates may
inadvertently infringe.
In particular, we are aware of an issued U.S. patent and at
least one pending U.S. patent application assigned to
Curis, Inc., or Curis, relating to certain compounds in the
quinazolinone class. Ispinesib falls into this class of
compounds. The Curis patent claims a method of use for
inhibiting signaling by what is called the hedgehog pathway
using certain such compounds. Curis has pending applications in
Europe, Japan, Australia and Canada with claims covering certain
quinazolinone compounds, compositions thereof
and/or
methods of their use. We are also aware that two of the
Australian applications have been allowed and two of the
European applications have been granted. In Europe, Australia
and elsewhere, the grant of a patent may be opposed by one or
more parties. We have opposed the granting of certain such
patents to Curis in Europe and in Australia. A third party has
also opposed the grant of one of Curis European patents.
Curis or a third party may assert that the sale of ispinesib may
infringe one or more of these or other patents. We believe that
we have valid defenses against the Curis patents if asserted
against us. However, we cannot guarantee that a court would find
such defenses valid or that such oppositions would be
successful. We have not attempted to obtain a license to this
patent. If we decide to obtain a license to these patents, we
cannot guarantee that we would be able to obtain such a license
on commercially reasonable terms, or at all.
Other future products of ours may be impacted by patents of
companies engaged in competitive programs with significantly
greater resources (such as Merck & Co., Inc., or Merck,
Eli Lilly and Company, or Lilly, Bristol-Myers Squibb, or BMS,
Array Biopharma Inc., or Array, and ArQule, Inc., or ArQule).
Further development of these products could be impacted by these
patents and result in the expenditure of significant legal fees.
If a third party claims that our actions infringe on their
patents or other proprietary rights, we could face a number of
issues that could seriously harm our competitive position,
including, but not limited to:
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infringement and other intellectual property claims that, with
or without merit, can be costly and time consuming to litigate
and can delay the regulatory approval process and divert
managements attention from our core business strategy;
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substantial damages for past infringement which we may have to
pay if a court determines that our drugs or technologies
infringe a competitors patent or other proprietary rights;
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a court prohibiting us from selling or licensing our drugs or
technologies unless the holder licenses the patent or other
proprietary rights to us, which it is not required to
do; and
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9
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if a license is available from a holder, we may have to pay
substantial royalties or grant cross licenses to our patents or
other proprietary rights.
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We may become
involved in disputes with our strategic partners over
intellectual property ownership, and publications by our
research collaborators and scientific advisors could impair our
ability to obtain patent protection or protect our proprietary
information, which, in either case, would have a significant
impact on our business.
Inventions discovered under our strategic alliance agreements
become jointly owned by our strategic partners and us in some
cases, and the exclusive property of one of us in other cases.
Under some circumstances, it may be difficult to determine who
owns a particular invention, or whether it is jointly owned, and
disputes could arise regarding ownership of those inventions.
These disputes could be costly and time consuming, and an
unfavorable outcome would have a significant adverse effect on
our business if we were not able to protect or license rights to
these inventions. In addition, our research collaborators and
scientific advisors have contractual rights to publish our data
and other proprietary information, subject to our prior review.
Publications by our research collaborators and scientific
advisors containing such information, either with our permission
or in contravention of the terms of their agreements with us,
may impair our ability to obtain patent protection or protect
our proprietary information, which could significantly harm our
business.
To the extent we
elect to fund the development of a drug candidate or the
commercialization of a drug at our expense, we will need
substantial additional funding.
The discovery, development and commercialization of new drugs
for the treatment of a wide array of diseases is costly. As a
result, to the extent we elect to fund the development of a drug
candidate or the commercialization of a drug at our expense, we
will need to raise additional capital to:
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expand our research and development and technologies;
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fund clinical trials and seek regulatory approvals;
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build or access manufacturing and commercialization capabilities;
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implement additional internal systems and infrastructure;
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maintain, defend and expand the scope of our intellectual
property; and
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hire and support additional management and scientific personnel.
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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
research and development activities;
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the costs and timing of seeking and obtaining regulatory
approvals;
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the costs associated with establishing manufacturing and
commercialization capabilities;
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights;
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the costs of acquiring or investing in businesses, products and
technologies;
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the effect of competing technological and market
developments; and
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the payment and other terms and timing of any strategic
alliance, licensing or other arrangements that we may establish.
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Until we can generate a sufficient amount of product revenue to
finance our cash requirements, which we may never do, we expect
to continue to finance our future cash needs primarily through
10
public or private equity offerings, debt financings and
strategic alliances. We cannot be certain that additional
funding will be available on acceptable terms, or at all. If we
are not able to secure additional funding when needed, we may
have to delay, reduce the scope of or eliminate one or more of
our clinical trials or research and development programs or
future commercialization initiatives.
We currently have
no marketing or sales staff, and if we are unable to enter into
or maintain strategic alliances with marketing partners or if we
are unable to develop our own sales and marketing capabilities,
we may not be successful in commercializing our potential
drugs.
We currently have no sales, marketing or distribution
capabilities. To commercialize our drugs that we determine not
to market on our own, we will depend on strategic alliances with
third parties, such as GSK, which have established distribution
systems and direct sales forces. If we are unable to enter into
such arrangements on acceptable terms, we may not be able to
successfully commercialize such drugs.
We plan to commercialize drugs on our own, with or without a
partner, that can be effectively marketed and sold in
concentrated markets that do not require a large sales force to
be competitive. To achieve this goal, we will need to establish
our own specialized sales force and marketing organization with
technical expertise and with supporting distribution
capabilities. Developing such an organization is expensive and
time consuming and could delay a product launch. In addition, we
may not be able to develop this capacity efficiently, or at all,
which could make us unable to commercialize our drugs.
To the extent that we are not successful in commercializing any
drugs ourselves or through a strategic alliance, our product
revenues will suffer, we will incur significant additional
losses and the price of our common stock will decrease.
We expect to
expand our development, clinical research, sales and marketing
capabilities, and as a result, we may encounter difficulties in
managing our growth, which could disrupt our
operations.
We expect to have significant growth in expenditures, the number
of our employees and the scope of our operations, in particular
with respect to those drug candidates that we elect to develop
or commercialize independently or together with a partner. To
manage our anticipated future growth, we must continue to
implement and improve our managerial, operational and financial
systems, expand our facilities and continue to recruit and train
additional qualified personnel. Due to our limited resources, we
may not be able to effectively manage the expansion of our
operations or recruit and train additional qualified personnel.
The physical expansion of our operations may lead to significant
costs and may divert our management and business development
resources. Any inability to manage growth could delay the
execution of our business plans or disrupt our operations.
The failure to
attract and retain skilled personnel could impair our drug
development and commercialization efforts.
Our performance is substantially dependent on the performance of
our senior management and key scientific and technical
personnel, particularly James H. Sabry, M.D., Ph.D.,
our Chief Executive Officer, Robert I. Blum, our President,
Andrew A. Wolff, M.D., F.A.C.C., our Senior Vice President,
Clinical Research and Chief Medical Officer, Sharon A.
Surrey-Barbari, our Senior Vice President, Finance and Chief
Financial Officer, David J. Morgans, Ph.D., our Senior Vice
President of Preclinical Research and Development, Jay K.
Trautman, Ph.D., our Vice President of Research, and David W.
Cragg, our Vice President of Human Resources. The employment of
these individuals and our other personnel is terminable at will
with short or no notice. We carry key person life insurance on
James H. Sabry. The loss of the services of any member of our
senior management, scientific or technical staff may
significantly delay or prevent the achievement of drug
development and other business objectives by diverting
managements attention to transition matters and
identification of suitable replacements,
11
and could have a material adverse effect on our business,
operating results and financial condition. We also rely on
consultants and advisors to assist us in formulating our
research and development strategy. All of our consultants and
advisors are either self-employed or employed by other
organizations, and they may have conflicts of interest or other
commitments, such as consulting or advisory contracts with other
organizations, that may affect their ability to contribute to us.
In addition, we believe that we will need to recruit additional
executive management and scientific and technical personnel.
There is currently intense competition for skilled executives
and employees with relevant scientific and technical expertise,
and this competition is likely to continue. Our inability to
attract and retain sufficient scientific, technical and
managerial personnel could limit or delay our product
development efforts, which would adversely affect the
development of our drug candidates and commercialization of our
potential drugs and growth of our business.
Risks Related To
Our Industry
Our competitors
may develop drugs that are less expensive, safer, or more
effective, which may diminish or eliminate the commercial
success of any drugs that we may commercialize.
We compete with companies that are also developing drug
candidates that focus on the cytoskeleton, as well as companies
that have developed drugs or are developing alternative drug
candidates for cancer and cardiovascular and other diseases for
which our compounds may be useful treatments. For example, if
approved for marketing by the FDA, depending on the approved
clinical indication, our cancer drug candidates such as
ispinesib and SB-743921 could compete against existing cancer
treatments such as paclitaxel, docetaxel, vincristine,
vinorelbine or navelbine and potentially against other novel
cancer drug candidates that are currently in development such as
those that are reformulated taxanes, other tubulin binding
compounds or epothilones. We are also aware that Merck, Lilly,
Array, BMS, ArQule and others are conducting research and
development focused on KSP and other mitotic kinesins. In
addition, BMS, Merck, Novartis, Genentech, Inc. and other
pharmaceutical and biopharmaceutical companies are developing
other approaches to inhibiting mitosis.
With respect to heart failure, if CK-1827452 or any other of our
compounds is approved for marketing by the FDA for heart
failure, that compound could compete against current generically
available therapies, such as milrinone, dobutamine or digoxin or
newer drugs such as nesiritide, as well as potentially against
other novel drug candidates in development such as ularitide,
which is being developed by PDL Biopharma, Inc.,
urocortin II, which is being developed by Neurocrine
Biosciences, Inc., and levosimendan, which is being developed in
the United States by Abbott Laboratories and is commercially
available in a number of countries outside of the United States.
Our competitors may:
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develop drug candidates and market drugs that are less expensive
or more effective than our future drugs;
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commercialize competing drugs before we or our partners can
launch any drugs developed from our drug candidates;
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hold or obtain proprietary rights that could prevent us from
commercializing our products;
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initiate or withstand substantial price competition more
successfully than we can;
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more successfully recruit skilled scientific workers from the
limited pool of available talent;
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more effectively negotiate third-party licenses and strategic
alliances;
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take advantage of acquisition or other opportunities more
readily than we can;
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develop drug candidates and market drugs that increase the
levels of safety or efficacy or alter other drug candidate
profile aspects that our drug candidates will need to show in
order to obtain regulatory approval; or
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introduce therapies or market drugs that render the market
opportunity for our potential drugs obsolete.
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We will compete for market share against large pharmaceutical
and biotechnology companies and smaller companies that are
collaborating with larger pharmaceutical companies, new
companies, academic institutions, government agencies and other
public and private research organizations. Many of these
competitors, either alone or together with their partners, may
develop new drug candidates that will compete with ours. These
competitors may, and in certain cases do, operate larger
research and development programs or have substantially greater
financial resources than we do. Our competitors may also have
significantly greater experience in:
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developing drug candidates;
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undertaking preclinical testing and clinical trials;
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building relationships with key customers and opinion-leading
physicians;
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obtaining and maintaining FDA and other regulatory approvals of
drug candidates;
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formulating and manufacturing drugs; and
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launching, marketing and selling drugs.
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If our competitors market drugs that are less expensive, safer
or more efficacious than our potential drugs, or that reach the
market sooner than our potential drugs, we may not achieve
commercial success. In addition, the life sciences industry is
characterized by rapid technological change. Because our
research approach integrates many technologies, it may be
difficult for us to stay abreast of the rapid changes in each
technology. If we fail to stay at the forefront of technological
change we may be unable to compete effectively. Our competitors
may render our technologies obsolete by advances in existing
technological approaches or the development of new or different
approaches, potentially eliminating the advantages in our drug
discovery process that we believe we derive from our research
approach and proprietary technologies.
The regulatory
approval process is expensive, time consuming and uncertain and
may prevent our partners or us from obtaining approvals to
commercialize some or all of our drug candidates.
The research, testing, manufacturing, selling and marketing of
drug candidates are subject to extensive regulation by the FDA
and other regulatory authorities in the United States and other
countries, which regulations differ from country to country.
Neither we nor our partners are permitted to market our
potential drugs in the United States until we receive approval
of a New Drug Application, or NDA, from the FDA. Neither we nor
our partners have received marketing approval for any of
Cytokinetics drug candidates. Obtaining approval of an NDA
can be a lengthy, expensive and uncertain process. In addition,
failure to comply with the FDA and other applicable foreign and
U.S. regulatory requirements may subject us to
administrative or judicially imposed sanctions. These include
warning letters, civil and criminal penalties, injunctions,
product seizure or detention, product recalls, total or partial
suspension of production, and refusal to approve pending NDAs or
supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is never
guaranteed, and the approval process typically takes several
years and is extremely expensive. The FDA also has substantial
discretion in the drug approval process. Despite the time and
expense exerted, failure can occur at any stage, and we could
encounter problems that cause us to abandon clinical trials or
to repeat or perform additional preclinical testing and clinical
trials. The number and focus of preclinical studies
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and clinical trials that will be required for FDA approval
varies depending on the drug candidate, the disease or condition
that the drug candidate is designed to address, and the
regulations applicable to any particular drug candidate. The FDA
can delay, limit or deny approval of a drug candidate for many
reasons, including, but not limited to:
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a drug candidate may not be safe or effective;
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the FDA may not find the data from preclinical testing and
clinical trials sufficient;
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the FDA might not approve our or our contract
manufacturers processes or facilities; or
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the FDA may change its approval policies or adopt new
regulations.
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If we or our
partners receive regulatory approval for our drug candidates, we
will also be subject to ongoing FDA obligations and continued
regulatory review, such as continued safety reporting
requirements, and we may also be subject to additional FDA
post-marketing obligations, all of which may result in
significant expense and limit our ability to commercialize our
potential drugs.
Any regulatory approvals that we or our partners receive for our
drug candidates may be subject to limitations on the indicated
uses for which the drug may be marketed or contain requirements
for potentially costly post-marketing
follow-up
studies. In addition, if the FDA approves any of our drug
candidates, the labeling, packaging, adverse event reporting,
storage, advertising, promotion and record-keeping for the drug
will be subject to extensive regulatory requirements. The
subsequent discovery of previously unknown problems with the
drug, including adverse events of unanticipated severity or
frequency, or the discovery that adverse effects or toxicities
previously observed in preclinical research or clinical trials
that were believed to be minor actually constitute much more
serious problems, may result in restrictions on the marketing of
the drug, and could include withdrawal of the drug from the
market.
The FDAs policies may change and additional government
regulations may be enacted that could prevent or delay
regulatory approval of our drug candidates. We cannot predict
the likelihood, nature or extent of adverse government
regulation that may arise from future legislation or
administrative action, either in the United States or abroad. If
we are not able to maintain regulatory compliance, we might not
be permitted to market our drugs and our business could suffer.
If physicians and
patients do not accept our drugs, we may be unable to generate
significant revenue, if any.
Even if our drug candidates obtain regulatory approval,
resulting drugs, if any, may not gain market acceptance among
physicians, healthcare payors, patients and the medical
community. Even if the clinical safety and efficacy of drugs
developed from our drug candidates are established for purposes
of approval, physicians may elect not to recommend these drugs
for a variety of reasons including, but not limited to:
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timing of market introduction of competitive drugs;
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clinical safety and efficacy of alternative drugs or treatments;
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cost-effectiveness;
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availability of coverage and reimbursement from health
maintenance organizations and other third-party payors;
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convenience and ease of administration;
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prevalence and severity of adverse side effects;
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other potential disadvantages relative to alternative treatment
methods; or
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insufficient marketing and distribution support.
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If our drugs fail to achieve market acceptance, we may not be
able to generate significant revenue and our business would
suffer.
The coverage and
reimbursement status of newly approved drugs is uncertain and
failure to obtain adequate coverage and reimbursement could
limit our ability to market any drugs we may develop and
decrease our ability to generate revenue.
There is significant uncertainty related to the coverage and
reimbursement of newly approved drugs. The commercial success of
our potential drugs in both domestic and international markets
is substantially dependent on whether third-party coverage and
reimbursement is available for the ordering of our potential
drugs by the medical profession for use by their patients.
Medicare, Medicaid, health maintenance organizations and other
third-party payors are increasingly attempting to contain
healthcare costs by limiting both coverage and the level of
reimbursement of new drugs, and, as a result, they may not cover
or provide adequate payment for our potential drugs. They may
not view our potential drugs as cost-effective and reimbursement
may not be available to consumers or may not be sufficient to
allow our potential drugs to be marketed on a competitive basis.
If we are unable to obtain adequate coverage and reimbursement
for our potential drugs, our ability to generate revenue may be
adversely affected. Likewise, legislative or regulatory efforts
to control or reduce healthcare costs or reform government
healthcare programs could result in lower prices or rejection of
coverage and reimbursement for our potential drugs. Changes in
coverage and reimbursement policies or healthcare cost
containment initiatives that limit or restrict reimbursement for
our drugs may cause our revenue to decline.
We may be subject
to costly product liability claims and may not be able to obtain
adequate insurance.
The use of our drug candidates in clinical trials may result in
adverse effects. We currently maintain product liability
insurance. We cannot predict all the possible harms or adverse
effects that may result from our clinical trials. We may not
have sufficient resources to pay for any liabilities resulting
from a claim excluded from, or beyond the limit of, our
insurance coverage.
In addition, once we have commercially launched drugs based on
our drug candidates, we will face exposure to product liability
claims. This risk exists even with respect to those drugs that
are approved for commercial sale by the FDA and manufactured in
facilities licensed and regulated by the FDA. We intend to
secure limited product liability insurance coverage, but may not
be able to obtain such insurance on acceptable terms with
adequate coverage, or at reasonable costs. There is also a risk
that third parties that we have agreed to indemnify could incur
liability, or that third parties that have agreed to indemnify
us do not fulfill their obligations. Even if we were ultimately
successful in product liability litigation, the litigation would
consume substantial amounts of our financial and managerial
resources and may create adverse publicity, all of which would
impair our ability to generate sales of the affected product as
well as our other potential drugs. Moreover, product recalls may
be issued at our discretion or at the direction of the FDA,
other governmental agencies or other companies having regulatory
control for drug sales. If product recalls occur, they are
generally expensive and often have an adverse effect on the
image of the drugs being recalled as well as the reputation of
the drugs developer or manufacturer.
We may be subject
to damages resulting from claims that we or our employees have
wrongfully used or disclosed alleged trade secrets of their
former employers.
Many of our employees were previously employed at universities
or 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
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former employers. Litigation may be necessary to defend against
these claims. If we fail in defending such claims, in addition
to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel
or their work product could hamper or prevent our ability to
commercialize certain potential drugs, which could severely harm
our business. Even if we are successful in defending against
these claims, litigation could result in substantial costs and
be a distraction to management.
We use hazardous
chemicals and radioactive and biological materials in our
business. Any claims relating to improper handling, storage or
disposal of these materials could be time consuming and
costly.
Our research and development processes involve the controlled
use of hazardous materials, including chemicals and radioactive
and biological materials. Our operations produce hazardous waste
products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from those
materials. Federal, state and local laws and regulations govern
the use, manufacture, storage, handling and disposal of
hazardous materials. We may be sued for any injury or
contamination that results from our use or the use by third
parties of these materials. Compliance with environmental laws
and regulations is expensive, and current or future
environmental regulations may impair our research, development
and production efforts.
In addition, our partners may use hazardous materials in
connection with our strategic alliances. To our knowledge, their
work is performed in accordance with applicable biosafety
regulations. In the event of a lawsuit or investigation,
however, we could be held responsible for any injury caused to
persons or property by exposure to, or release of, these
hazardous materials used by these parties. Further, we may be
required to indemnify our partners against all damages and other
liabilities arising out of our development activities or drugs
produced in connection with these strategic alliances.
Our facilities in
California are located near an earthquake fault, and an
earthquake or other types of natural disasters or resource
shortages could disrupt our operations and adversely affect
results.
Important documents and records, such as hard copies of our
laboratory books and records for our drug candidates and
compounds, are located in our corporate headquarters at a single
location in South San Francisco, California near active
earthquake zones. In the event of a natural disaster, such as an
earthquake or flood, or localized extended outages of critical
utilities or transportation systems, we do not have a formal
business continuity or disaster recovery plan, and could
therefore experience a significant business interruption. In
addition, California from time to time has experienced shortages
of water, electric power and natural gas. Future shortages and
conservation measures could disrupt our operations and cause
expense, thus adversely affecting our business and financial
results.
Risks Related to
Our Common Stock
We expect that
our stock price will fluctuate significantly, and you may not be
able to resell your shares at or above your investment
price.
The stock market, particularly in recent years, has experienced
significant volatility, particularly with respect to
pharmaceutical, biotechnology and other life sciences company
stocks. The volatility of pharmaceutical, biotechnology and
other life sciences company stocks often does not relate to the
operating performance of the companies represented by the stock.
Factors that could cause volatility in the market price of our
common stock include, but are not limited to:
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results from, delays in, or discontinuation of, any of the
clinical trials for our drug candidates for the treatment of
cancer or heart failure, including the current and proposed
clinical trials for ispinesib,
SB-743921
and
GSK-923295
for cancer, and
CK-1827452
for heart failure, and
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including delays resulting from slower than expected or
suspended patient enrollment or discontinuations resulting from
a failure to meet pre-defined clinical end-points;
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developments in establishing new strategic alliances;
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announcements concerning our strategic alliances with GSK or
future strategic alliances;
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announcements concerning clinical trials;
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failure or delays in entering additional drug candidates into
clinical trials;
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failure or discontinuation of any of our research programs;
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issuance of new or changed securities analysts reports or
recommendations;
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market conditions in the pharmaceutical, biotechnology and other
healthcare related sectors;
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actual or anticipated fluctuations in our quarterly financial
and operating results;
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developments or disputes concerning our intellectual property or
other proprietary rights;
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introduction of technological innovations or new commercial
products by us or our competitors;
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issues in manufacturing our drug candidates or drugs;
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market acceptance of our drugs;
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third-party healthcare coverage and reimbursement policies;
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FDA or other U.S. or foreign regulatory actions affecting
us or our industry;
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litigation or public concern about the safety of our drug
candidates or drugs;
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additions or departures of key personnel; or
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volatility in the stock prices of other companies in our
industry.
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These and other external factors may cause the market price and
demand for our common stock to fluctuate substantially, which
may limit or prevent investors from readily selling their shares
of common stock and may otherwise negatively affect the
liquidity of our common stock. In addition, when the market
price of a stock has been volatile, holders of that stock have
instituted securities class action litigation against the
company that issued the stock. If any of our stockholders
brought a lawsuit against us, we could incur substantial costs
defending the lawsuit. Such a lawsuit could also divert our
managements time and attention.
If the ownership
of our common stock continues to be highly concentrated, it may
prevent you and other stockholders from influencing significant
corporate decisions and may result in conflicts of interest that
could cause our stock price to decline.
As of November 30, 2006, our executive officers, directors
and their affiliates beneficially owned or controlled
approximately 30.2% percent of the outstanding shares of our
common stock (after giving effect to the exercise of all
outstanding vested and unvested options and warrants).
Accordingly, these executive officers, directors and their
affiliates, acting as a group, will have substantial influence
over the outcome of corporate actions requiring stockholder
approval, including the election of directors, any merger,
consolidation or sale of all or substantially all of our assets
or any other significant corporate transactions. These
stockholders may also delay or prevent a change of control of
us, even if such a change of control would benefit our other
stockholders. The significant concentration of stock ownership
may adversely affect the trading price of our common stock due
to investors perception that conflicts of interest may
exist or arise.
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Evolving
regulation of corporate governance and public disclosure may
result in additional expenses and continuing
uncertainty.
Changing laws, regulations and standards relating to corporate
governance and public disclosure, including the Sarbanes-Oxley
Act of 2002, new Securities and Exchange Commission regulations
and Nasdaq Global Market, or Nasdaq, rules are creating
uncertainty for public companies. We are presently evaluating
and monitoring developments with respect to new and proposed
rules and cannot predict or estimate the amount of the
additional costs we may incur or the timing of such costs. For
example, compliance with the internal control requirements of
Sarbanes-Oxley Section 404 has to date required the
commitment of significant resources to document and test the
adequacy of our internal control over financial reporting. While
our assessment, testing and evaluation of the design and
operating effectiveness of our internal control over financial
reporting resulted in our conclusion that as of
December 31, 2005 our internal control over financial
reporting was effective, we can provide no assurance as to
conclusions of management or by our independent registered
public accounting firm with respect to the effectiveness of our
internal control over financial reporting in the future. These
new or changed laws, regulations and standards are subject to
varying interpretations, in many cases due to their lack of
specificity, and, as a result, their application in practice may
evolve over time as new guidance is provided by regulatory and
governing bodies. This could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by
ongoing revisions to disclosure and governance practices. We are
committed to maintaining high standards of corporate governance
and public disclosure. As a result, we intend to invest the
resources necessary to comply with evolving laws, regulations
and standards, and this investment may result in increased
general and administrative expenses and a diversion of
management time and attention from revenue-generating activities
to compliance activities. If our efforts to comply with new or
changed laws, regulations and standards differ from the
activities intended by regulatory or governing bodies, due to
ambiguities related to practice or otherwise, regulatory
authorities may initiate legal proceedings against us and our
reputation and business may be harmed.
Volatility in the
stock prices of other companies may contribute to volatility in
our stock price.
The stock market in general, and Nasdaq and the market for
technology companies in particular, have experienced significant
price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of those
companies. Further, there has been particular volatility in the
market prices of securities of early stage and development stage
life sciences companies. These broad market and industry factors
may seriously harm the market price of our common stock,
regardless of our operating performance. In the past, following
periods of volatility in the market price of a companys
securities, securities class action litigation has often been
instituted. A securities class action suit against us could
result in substantial costs, potential liabilities and the
diversion of managements attention and resources.
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
businesses. In addition, the terms of existing or any future
debts may preclude us from paying these dividends.
Our common stock
is thinly traded and there may not be an active, liquid trading
market for our common stock.
There is no guarantee that an active trading market for our
common stock will be maintained on Nasdaq, or that the volume of
trading will be sufficient to allow for timely trades. Investors
may not be able to sell their shares quickly or at the latest
market price if trading in our stock is not active or if trading
volume is limited. In addition, if trading volume in our common
stock is limited, trades of
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relatively small numbers of shares may have a disproportionate
effect on the market price of our common stock.
Risks Related To
The Committed Equity Financing Facility With
Kingsbridge
Our committed
equity financing facility with Kingsbridge may not be available
to us if we elect to make a draw down, may require us to make
additional blackout or other payments to
Kingsbridge, and may result in dilution to our
stockholders.
In October 2005, we entered into the CEFF with Kingsbridge. The
CEFF entitles us to sell and obligates Kingsbridge to purchase,
from time to time over a period of three years, shares of our
common stock for cash consideration up to an aggregate of
$75.0 million, subject to certain conditions and
restrictions. Kingsbridge will not be obligated to purchase
shares under the CEFF unless certain conditions are met, which
include a minimum price for our common stock; the accuracy of
representations and warranties made to Kingsbridge; compliance
with laws; effectiveness of a registration statement registering
for resale the shares of common stock to be issued in connection
with the CEFF and the continued listing of our stock on Nasdaq.
In addition, Kingsbridge is permitted to terminate the CEFF if
it determines that a material and adverse event has occurred
affecting our business, operations, properties or financial
condition and if such condition continues for a period of
10 days from the date Kingsbridge provides us notice of
such material and adverse event. If we are unable to access
funds through the CEFF, or if the CEFF is terminated by
Kingsbridge, we may be unable to access capital on favorable
terms or at all.
We are entitled, in certain circumstances, to deliver a blackout
notice to Kingsbridge to suspend the use of the resale
registration statement and prohibit Kingsbridge from selling
shares under the resale registration statement. If we deliver a
blackout notice in the 15 trading days following the settlement
of a draw down, or if the resale registration statement is not
effective in circumstances not permitted by the agreement, then
we must make a payment to Kingsbridge, or issue Kingsbridge
additional shares in lieu of this payment, calculated on the
basis of the number of shares held by Kingsbridge (exclusive of
shares that Kingsbridge may hold pursuant to exercise of the
Kingsbridge warrant) and the change in the market price of our
common stock during the period in which the use of the
registration statement is suspended. If the trading price of our
common stock declines during a suspension of the resale
registration statement, the blackout or other payment could be
significant.
Should we sell shares to Kingsbridge under the CEFF, or issue
shares in lieu of a blackout payment, it will have a dilutive
effective on the holdings of our current stockholders, and may
result in downward pressure on the price of our common stock. If
we draw down under the CEFF, we will issue shares to Kingsbridge
at a discount of up to 10 percent from the volume weighted
average price of our common stock. If we draw down amounts under
the CEFF when our share price is decreasing, we will need to
issue more shares to raise the same amount than if our stock
price was higher. Issuances in the face of a declining share
price will have an even greater dilutive effect than if our
share price were stable or increasing, and may further decrease
our share price.
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