Exhibit 1.1
EXECUTION VERSION
Dendreon
Corporation
Common Stock
UNDERWRITING
AGREEMENT
dated December 6, 2005
Banc of America Securities
LLC
UNDERWRITING
AGREEMENT
December 6, 2005
BANC OF AMERICA SECURITIES LLC
9 West 57 th Street
New York, NY 10019
As Representative of the several
Underwriters
Ladies and Gentlemen:
Introductory
. Dendreon Corporation, a Delaware
corporation (the “Company), proposes to issue and sell to the
several underwriters named in Schedule A (the
“Underwriters”) an aggregate of 10,000,000 shares (the
“Firm Shares”) of its Common Stock, par value $0.001
per share (the “Common Stock”). In addition, the
Company has granted to the Underwriters an option to purchase up to
an additional 1,500,000 shares (the “Optional Shares”)
of Common Stock, as provided in Section 2. The Firm Shares
and, if and to the extent such option is exercised, the Optional
Shares, are collectively called the “Shares”. Banc of
America Securities LLC (“BAS”) has agreed to act as
representative of the several Underwriters (in such capacity, the
“Representative”) in connection with the offering and
sale of the Shares.
The Company hereby confirms its
agreements with the Underwriters as follows:
Section 1. Representations and
Warranties of the Company. The Company hereby represents,
warrants and covenants to each Underwriter as follows:
(a) The Company has prepared and
filed with the Securities and Exchange Commission (the
“Commission”) a registration statement on Form S-3
(File No. 333-127521), which contains a base prospectus (the
“Base Prospectus”), to be used in connection with the
public offering and sale of the Shares. Such registration
statement, including the financial statements, exhibits and
schedules included or incorporated therein, in the form in which it
was declared effective by the Commission under the Securities Act
of 1933 and the rules and regulations promulgated thereunder
(collectively, the “Securities Act”), including any
required information deemed to be a part thereof at the time of
effectiveness pursuant to Rule 430B under the Securities Act or the
Securities Exchange Act of 1934 and the rules and regulations
promulgated thereunder (collectively, the “Exchange
Act”), is called the “Registration Statement.”
Any preliminary prospectus supplement to the Base Prospectus that
describes the Shares and the offering thereof and is used prior to
filing of the Final Prospectus is called, together with the Base
Prospectus, a “preliminary prospectus.” The term
“Prospectus” shall mean the final prospectus relating
to the Shares that is first filed pursuant to Rule 424(b) after the
date and time that this Agreement is executed and delivered by the
parties hereto (the “Execution Time”). 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 under the Securities Act; any reference to
any amendment or supplement to any preliminary prospectus or the
Prospectus shall be deemed to refer to and include any documents
filed after the date of such preliminary prospectus or
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Prospectus, as the case may be, under the
Exchange Act, and incorporated by reference in such preliminary
prospectus or Prospectus, as the case may be; and any reference to
any amendment to the Registration Statement shall be deemed to
refer to and include any annual report of the Company filed
pursuant to Section 13(a) or 15(d) of the Exchange Act after
the effective date of the Registration Statement that is
incorporated by reference in the Registration Statement. Any
further documents so filed and incorporated by reference in the
Prospectus or any further amendment or supplement thereto, 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.
(b) Compliance with Registration
Requirements . The Registration Statement has been declared
effective by the Commission under the Securities Act. The Company
has complied to the Commission’s satisfaction with all
requests of the Commission for additional or supplemental
information. No stop order suspending the effectiveness of the
Registration Statement is in effect and no proceedings for such
purpose have been instituted or are pending or, to the best
knowledge of the Company, are contemplated or threatened by the
Commission.
Each preliminary prospectus and the
Prospectus when filed complied in all material respects with the
Securities Act and the rules thereunder and, if filed by electronic
transmission pursuant to EDGAR (except as may be permitted by
Regulation S-T under the Securities Act), was identical to the copy
thereof delivered to the Underwriters for use in connection with
the offer and sale of the Shares. Each of the Registration
Statement and any post-effective amendment thereto, at the time it
became effective and at the date hereof, complied and will comply
in all material respects with the Securities Act and did not and
will not contain any untrue statement of a material fact or omit to
state a material fact required to be stated therein or necessary in
order to make the statements therein not misleading. The
Prospectus, as amended or supplemented, as of its date, at the date
hereof, at the time of any filing pursuant to Rule 424(b), at
the Closing Date (as defined herein) and at any Subsequent Closing
Date (as defined herein), did not and will not contain any untrue
statement of a material fact or 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. The
representations and warranties set forth in the two immediately
preceding sentences do not apply to statements in or omissions from
the Registration Statement or any post-effective amendment thereto,
or the Prospectus, or any amendments or supplements thereto, made
in reliance upon and in conformity with information relating to any
Underwriter furnished to the Company in writing by the
Representative expressly for use therein, it being understood and
agreed that the only such information furnished by the
Representative consists of the information described as such in
Section 8 hereof. There is no contract or other document
required to be described in the Prospectus or to be filed as
exhibits to the Registration Statement which has not been described
or filed as required.
(c) Documents Incorporated by
Reference . 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.
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(d) Disclosure Package. The
term “Disclosure Package” shall mean (i) the Base
Prospectus, the preliminary prospectus supplement, as amended or
supplemented (ii) the issuer free writing prospectuses as
defined in Rule 433 of the Securities Act (each, an “Issuer
Free Writing Prospectus”), if any, identified in Schedule
B hereto, (iii) any other free writing prospectus that the
parties hereto shall hereafter expressly agree in writing to treat
as part of the Disclosure Package and (iv) the information set
forth in Schedule C attached hereto. As of 8:00 p.m.
(Eastern time) on the date of this Agreement (the “Initial
Sale Time”), the Disclosure Package did not contain any
untrue statement of a material fact or omit to state any material
fact necessary in order to make the statements therein, in the
light of the circumstances under which they were made, not
misleading. The preceding sentence does not apply to statements in
or omissions from the Disclosure Package based upon and in
conformity with written information furnished to the Company by any
Underwriter through the Representative specifically for use
therein, it being understood and agreed that the only such
information furnished by or on behalf of any Underwriter consists
of the information described as such in Section 8
hereof.
(e) Company Not Ineligible
Issuer. At the earliest time after the filing of the
Registration Statement relating to the Shares that the Company or
another offering participant made a bona fide offer (within
the meaning of Rule 164(h)(2)) of the Securities Act, the Company
was not and is not an Ineligible Issuer (as defined in Rule 405 of
the Securities Act), without taking account of any determination by
the Commission pursuant to Rule 405 of the Securities Act that it
is not necessary that the Company be considered an Ineligible
Issuer.
(f) Issuer Free Writing
Prospectus . Each Issuer Free Writing Prospectus will not, as
of the date issued, include any information that conflicts or will
conflict with the information then contained in the Registration
Statement, including any document that is, or will be at such time,
incorporated by reference therein that has not been superseded or
modified. The foregoing sentence does not apply to statements in or
omissions from any Issuer Free Writing Prospectus based upon and in
conformity with written information furnished to the Company by any
Underwriter through the Representative specifically for use
therein, it being understood and agreed that the only such
information furnished by any Underwriter consists of the
information described in Section 8 hereof.
(g) Distribution of Offering
Material By the Company . The Company has not distributed and
will not distribute, prior to the later of the last Subsequent
Closing Date (as defined below) and the completion of the
Prospectus Delivery Period (as defined below), any offering
material in connection with the offering and sale of the Shares
other than a preliminary prospectus, the Prospectus, any Issuer
Free Writing Prospectus reviewed and consented to by the
Representative or included in Schedule B hereto or the
Registration Statement.
(h) The Underwriting
Agreement . This Agreement has been duly authorized, executed
and delivered by, and is a valid and binding agreement of, the
Company, enforceable against the Company in accordance with its
terms, subject to the effect of public policy on the enforceability
of provisions relating to indemnification or
contribution.
(i) Authorization of the
Shares . The Shares to be purchased by the Underwriters from
the Company have been duly authorized for issuance and sale
pursuant to this Agreement
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and, when issued and delivered by the Company to
the Underwriters pursuant to this Agreement on the Closing Date or
any Subsequent Closing Date, will be validly issued, fully paid and
nonassessable.
(j) No Transfer Taxes . There
are no transfer taxes or other similar fees or charges under
federal law or the laws of any state, or any political subdivision
thereof, required to be paid in connection with the execution and
delivery of this Agreement or the issuance by the Company or sale
by the Company of the Shares.
(k) No Applicable Registration or
Other Similar Rights . There are no persons with registration
or other similar rights to have any equity or debt securities
registered for sale under the Registration Statement or included in
the offering contemplated by this Agreement, except for such rights
as have been duly waived.
(l) No Material Adverse
Change . Except as otherwise disclosed in the Disclosure
Package, subsequent to the respective dates as of which information
is given in the Disclosure Package: (i) there has been no
material adverse change, or any development that could reasonably
be expected to result in a material adverse change, in the
condition, financial or otherwise, or in the earnings, business,
properties, operations or prospects, whether or not arising from
transactions in the ordinary course of business, of the Company and
its subsidiary, considered as one entity (any such change is called
a “Material Adverse Change”); (ii) the Company and
its subsidiary, considered as one entity, have not incurred any
material liability or obligation, indirect, direct or contingent,
nor entered into any material transaction or agreement; and
(iii) there has been no dividend or distribution of any kind
declared, paid or made by the Company or, except for dividends paid
to the Company, its subsidiary on any class of capital stock or
repurchase or redemption by the Company or its subsidiary of any
class of capital stock.
(m) Independent Registered Public
Accounting Firm . Ernst & Young LLP, who have
expressed their opinion with respect to the financial statements
(which term as used in this Agreement includes the related notes
thereto) and supporting schedules filed with the Commission as a
part of the Registration Statement and included in the Disclosure
Package and the Prospectus, are an independent public accounting
firm with respect to the Company as required by the Securities Act
and the Exchange Act and the applicable published rules and
regulations thereunder.
(n) Preparation of the Financial
Statements . The financial statements filed with the Commission
as a part of or incorporated by reference in the Registration
Statement and included or incorporated by reference in the
Disclosure Package and the Prospectus present fairly the
consolidated financial position of the Company and its subsidiary
as of and at the dates indicated and the results of their
operations and cash flows for the periods specified. The supporting
schedules included or incorporated by reference in the Registration
Statement present fairly the information required to be stated
therein. Such financial statements and supporting schedules comply
as to form with the applicable accounting requirements of the
Securities Act and have been prepared in conformity with generally
accepted accounting principles applied on a consistent basis
throughout the periods involved, except as may be expressly stated
in the related notes thereto. No other financial statements or
supporting schedules are required to be included or incorporated by
reference in the Registration Statement. The financial data set
forth in each of
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the preliminary prospectus and the Prospectus
under the captions “Summary—Summary Consolidated
Financial Data” and “Capitalization” fairly
present the information set forth therein on a basis consistent
with that of the audited financial statements contained in the
Registration Statement.
(o) Incorporation and Good
Standing of the Company and its Subsidiary . Each of the
Company and its subsidiary has been duly incorporated and is
validly existing as a corporation in good standing under the laws
of the jurisdiction of its incorporation and has corporate power
and authority to own or lease, as the case may be, and operate its
properties and to conduct its business as described in the
Disclosure Package and the Prospectus and, in the case of the
Company, to enter into and perform its obligations under this
Agreement. Each of the Company and its subsidiary is duly qualified
as a foreign corporation to transact business and is in good
standing in each jurisdiction in which such qualification is
required, whether by reason of the ownership or leasing of property
or the conduct of business, except for such jurisdictions where the
failure to so qualify or to be in good standing would not,
individually or in the aggregate, result in a material adverse
effect, on the condition, financial or otherwise, or on the
earnings, business, properties, operations or prospects, whether or
not arising from transactions in the ordinary course of business,
of the Company and its subsidiary, considered as one entity (a
“Material Adverse Effect”). All of the issued and
outstanding shares of capital stock of the subsidiary have been
duly authorized and validly issued, are fully paid and
nonassessable and are owned by the Company directly, free and clear
of any security interest, mortgage, pledge, lien, encumbrance or
claim. The Company does not own or control, directly or indirectly,
any corporation, association or other entity other than the
subsidiary listed in Exhibit 21 to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31,
2003.
(p) Capitalization and Other
Capital Stock Matters . The authorized, issued and outstanding
capital stock of the Company is as set forth in each of the
Disclosure Package and the Prospectus under the column headed
“Actual” under the caption “Capitalization”
as of the date(s) specified, and after giving effect to the sale of
the Shares, as specified under the column headed “As
Adjusted” (other than for subsequent issuances, if any,
pursuant to employee benefit plans described in the Disclosure
Package and the Prospectus or upon exercise of outstanding options,
warrants or other rights to receive shares described in the
Disclosure Package and the Prospectus, as the case may be). The
Common Stock (including the Shares) conforms in all material
respects to the description thereof contained in the Prospectus.
All of the issued and outstanding shares of Common Stock have been
duly authorized and validly issued, are fully paid and
nonassessable and have been issued in compliance with federal and
state securities laws. None of the outstanding shares of Common
Stock were 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
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 its subsidiary other than those accurately described in
the Disclosure Package and the Prospectus. The description of the
Company’s stock option, stock bonus and other stock plans or
arrangements, and the options or other rights granted thereunder,
set forth or incorporated by reference in each of the Disclosure
Package and the Prospectus accurately and fairly presents the
information required to be shown with respect to such plans,
arrangements, options and rights.
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(q) Listing . The Shares have
been accepted for quotation on the Nasdaq Stock Market, Inc.,
subject only to official notice of issuance.
(r) Non-Contravention of Existing
Instruments; No Further Authorizations or Approvals Required .
Neither the Company nor its subsidiary is (i) in violation or
in default (or, with the giving of notice or lapse of time, would
be in default) under (“Default”) its charter or
by-laws, (ii) in Default under any indenture, mortgage, loan
or credit agreement, deed of trust, note, contract, franchise,
lease or other agreement, obligation, condition, covenant or
instrument to which the Company or such subsidiary is a party or by
which it may be bound, or to which any of the property or assets of
the Company or its subsidiary is subject (each, an “Existing
Instrument”), or (iii) in violation of any statute, law,
rule, regulation, judgment, order or decree of any court,
regulatory body, administrative agency, governmental body,
arbitrator or other authority having jurisdiction over the Company
or such subsidiary or any of its properties, as applicable, except
with respect to clauses (ii) and (iii) only, for such
Defaults or violations as would not, individually or in the
aggregate, have a Material Adverse Effect. The Company’s
execution, delivery and performance of this Agreement and
consummation of the transactions contemplated hereby, by the
Disclosure Package and by the Prospectus (i) have been duly
authorized by all necessary corporate action and will not result in
any Default under the charter or by-laws of the Company or its
subsidiary, (ii) will not conflict with or constitute a breach
of, or Default under, or result in the creation or imposition of
any lien, charge or encumbrance upon any property or assets of the
Company or its subsidiary pursuant to, or require the consent of
any other party to, any Existing Instrument, and (iii) will
not result in any violation of any statute, law, rule, regulation,
judgment, order or decree applicable to the Company or its
subsidiary of any court, regulatory body, administrative agency,
governmental body, arbitrator or other authority having
jurisdiction over the Company or its subsidiary or any of its or
their properties. No consent, approval, authorization or other
order of, or registration or filing with, any court or other
governmental or regulatory authority or agency is required for the
Company’s execution, delivery and performance of this
Agreement and consummation of the transactions contemplated hereby,
by the Disclosure Package and by the Prospectus, except such as
have been obtained or made by the Company and are in full force and
effect under the Securities Act, applicable state securities or
blue sky laws.
(s) No Material Actions or
Proceedings . There are no legal or governmental actions, suits
or proceedings pending or, to the best of the Company’s
knowledge, threatened (i) against or affecting the Company or
its subsidiary, (ii) which has as the subject thereof any
officer or director of, or property owned or leased by, the Company
or its subsidiary or (iii) relating to environmental or
discrimination matters, where in any such case (A) there is a
reasonable possibility that such action, suit or proceeding might
be determined adversely to the Company or such subsidiary and
(B) any such action, suit or proceeding, if so determined
adversely, would reasonably be expected to have a Material Adverse
Effect or adversely affect the consummation of the transactions
contemplated by this Agreement.
(t) Labor Matters . No labor
problem or dispute with the employees of the Company or its
subsidiary exists or, to the Company’s knowledge, is
threatened or imminent.
(u) Intellectual Property
Rights . The Company and its subsidiary own, possess, license
or have other rights to use, on reasonable terms, all patents,
patent applications, trade and
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service marks, trade and service mark
registrations, trade names, copyrights, licenses, inventions, trade
secrets, technology, know-how and other intellectual property
(collectively, the “Intellectual Property”) necessary
for the conduct of the Company’s business as now conducted or
as proposed in each of the Disclosure Package and the Prospectus to
be conducted. Except as set forth in the Disclosure Package and the
Prospectus (a) no party has been granted an exclusive license
to use any portion of such Intellectual Property owned by the
Company; (b) to the Company’s knowledge, there is no
material infringement by third parties of any such Intellectual
Property owned by or exclusively licensed to the Company;
(c) to the Company’s knowledge, there is no pending or
threatened action, suit, proceeding or claim by others challenging
the Company’s rights in or to any material Intellectual
Property, and the Company is unaware of any facts which would form
a reasonable basis for any such claim; (d) there is no pending
or threatened action, suit, proceeding or claim by others
challenging the validity or scope of any such Intellectual
Property, and the Company is unaware of any facts which would form
a reasonable basis for any such claim; and (e) there is no
pending or threatened action, suit, proceeding or claim by others
that the Company’s business as now conducted infringes or
otherwise violates any patent, trademark, copyright, trade secret
or other proprietary rights of others, and the Company is unaware
of any other fact which would form a reasonable basis for any such
claim.
(v) All Necessary Permits,
etc . The Company and its subsidiary possess such valid and
current licenses, certificates, authorizations or permits issued by
the appropriate state, federal or foreign regulatory agencies or
bodies necessary to conduct their respective businesses, and
neither the Company nor its subsidiary has received any notice of
proceedings relating to the revocation or modification of, or
non-compliance with, any such license, certificate, authorization
or permit which, singly or in the aggregate, if the subject of an
unfavorable decision, ruling or finding, could have a Material
Adverse Effect.
(w) Title to Properties . The
Company and its subsidiary has good and marketable title to all the
properties and assets reflected as owned in the financial
statements referred to in Section 1(n) above (or elsewhere in
the Disclosure Package and the Prospectus), in each case free and
clear of any security interests, mortgages, liens, encumbrances,
equities, claims and other defects, except such as do not
materially and adversely affect the value of such property and do
not materially interfere with the use made or proposed to be made
of such property by the Company or such subsidiary. The real
property, improvements, equipment and personal property held under
lease by the Company or its subsidiary are held under valid and
enforceable leases, with such exceptions as are not material and do
not materially interfere with the use made or proposed to be made
of such real property, improvements, equipment or personal property
by the Company or such subsidiary.
(x) Tax Law Compliance . The
Company and its consolidated subsidiary have filed all necessary
federal, state, local and foreign income and franchise tax returns
in a timely manner and have paid all taxes required to be paid by
any of them and, if due and payable, any related or similar
assessment, fine or penalty levied against any of them, except for
any taxes, assessments, fines or penalties as may be being
contested in good faith and by appropriate proceedings, or such
taxes, assessments, fines or penalties that could not reasonably be
expected to have a Material Adverse Effect. The Company has made
appropriate provisions in the applicable financial statements
referred to in Section 1(n) above in respect of all federal,
state, local and
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foreign income and franchise taxes for all
current or prior periods as to which the tax liability of the
Company or its consolidated subsidiary has not been finally
determined.
(y) Company Not an
“Investment Company” . The Company is not, and
after receipt of payment for the Shares and the application of the
proceeds thereof as contemplated under the caption “Use of
Proceeds” in each of the preliminary prospectus and the
Prospectus will not be, required to register as an
“investment company” within the meaning of the
Investment Company Act of 1940, as amended.
(z) Insurance . Each of the
Company and its subsidiary is insured by recognized, financially
sound and reputable institutions with policies in such amounts and
with such deductibles and covering such risks as are generally
deemed adequate and customary for their businesses. All policies of
insurance and fidelity or surety bonds insuring the Company or its
subsidiary or their respective businesses, assets, employees,
officers and directors are in full force and effect; the Company
and its subsidiary are in compliance with the terms of such
policies and instruments in all material respects; and there are no
claims by the Company or its subsidiary under any such policy or
instrument as to which any insurance company is denying liability
or defending under a reservation of rights clause. The Company has
no reason to believe that it or any subsidiary will not be able
(i) to renew its existing insurance coverage as and when such
policies expire or (ii) to obtain comparable coverage from
similar institutions as may be necessary or appropriate to conduct
its business as now conducted and at a cost that would not have a
Material Adverse Effect.
(aa) No Restrictions on
Dividends . No subsidiary of the Company is currently
prohibited, directly or indirectly, from paying any dividends to
the Company, from making any other distribution on such
subsidiary’s capital stock, from repaying to the Company any
loans or advances to such subsidiary from the Company or from
transferring any of such subsidiary’s property or assets to
the Company, except as described in or contemplated by the
Disclosure Package and the Prospectus.
(bb) No Price Stabilization or
Manipulation . The Company has not taken and will not take,
directly or indirectly, any action designed to or that might be
reasonably expected to cause or result in stabilization or
manipulation of the price of the Common Stock to facilitate the
sale or resale of the Shares. The Company acknowledges that the
Underwriters may engage in passive market making transactions in
the Shares on the Nasdaq Stock Market, Inc. in accordance with
Regulation M under the Exchange Act.
(cc) Related Party
Transactions . There are no business relationships or
related-party transactions involving the Company or its subsidiary
or any other person required to be described in the preliminary
prospectus or the Prospectus that have not been described as
required.
(dd) Internal Controls and
Procedures . The Company maintains (i) effective internal
control over financial reporting as defined in Rule 13a-15 under
the Exchange Act, and (ii) a system of internal accounting
controls sufficient to provide reasonable assurance that
(A) transactions are executed in accordance with
management’s general or specific authorizations;
(B) transactions are recorded as necessary to permit
preparation of financial statements in conformity with generally
accepted accounting principles and to maintain asset
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accountability; (C) access to assets is
permitted only in accordance with management’s general or
specific authorization; and (D) the recorded accountability
for assets is compared with the existing assets at reasonable
intervals and appropriate action is taken with respect to any
differences.
(ee) No Material Weakness in
Internal Controls . Except as disclosed in the Disclosure
Package and the Prospectus or in any document incorporated by
reference therein, since the end of the Company’s most recent
audited fiscal year, there has been (i) to the Company’s
knowledge, no material weakness in the Company’s internal
control over financial reporting (whether or not remediated) and
(ii) no change in the Company’s internal control over
financial reporting that has materially adversely affected, or is
reasonably likely to materially adversely affect, the
Company’s internal control over financial
reporting.
(ff) Earnings Statement . The
Company agrees with each of the Underwriters to make generally
available to its stockholders as soon as practicable, but in any
event not later than 16 months after the date hereof, an
earnings statement covering a period of at least 12 months
beginning after the date hereof and otherwise satisfying
Section 11(a) of the Securities Act.
(gg) No Unlawful Contributions or
Other Payments . Neither the Company nor its subsidiary nor, to
the knowledge of the Company, any director, officer, agent,
employee or affiliate of the Company or its subsidiary is aware of
or has taken any action, directly or indirectly, that would result
in a violation by such persons of the FCPA, including, without
limitation, making use of the mails or any means or instrumentality
of interstate commerce corruptly in furtherance of an offer,
payment, promise to pay or authorization of the payment of any
money, or other property, gift, promise to give, or authorization
of the giving of anything of value to any “foreign
official” (as such term is defined in the FCPA) or any
foreign political party or official thereof or any candidate for
foreign political office, in contravention of the FCPA, and the
Company, its subsidiary and, to the knowledge of the Company, its
affiliates have conducted their businesses in compliance with the
FCPA and have instituted and maintain policies and procedures
designed to ensure, and which are reasonably expected to continue
to ensure, continued compliance therewith.
“FCPA” means Foreign
Corrupt Practices Act of 1977, as amended, and the rules and
regulations thereunder.
(hh) Compliance with
Environmental Laws . Except as otherwise disclosed in the
Disclosure Package and the Prospectus (i) neither the Company
nor its subsidiary is in violation of any federal, state, local or
foreign law, regulation, order, permit or other requirement
relating to pollution or protection of human health or the
environment (including, without limitation, ambient air, surface
water, groundwater, land surface or subsurface strata) or wildlife,
including without limitation, laws and regulations relating to
emissions, discharges, releases or threatened releases of
chemicals, pollutants, contaminants, wastes, toxic substances,
hazardous substances, petroleum and petroleum products
(collectively, “Materials of Environmental Concern”),
or otherwise relating to the manufacture, processing, distribution,
use, treatment, storage, disposal, transport or handling of
Materials of Environment Concern (collectively,
“Environmental Laws”), which violation includes, but is
not limited to, noncompliance with any permits or other
governmental authorizations required for the operation of the
business of the Company or its
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subsidiary under applicable Environmental Laws,
or noncompliance with the terms and conditions thereof, nor has the
Company or its subsidiary received any written communication,
whether from a governmental authority, citizens group, employee or
otherwise, that alleges that the Company or its subsidiary is in
violation of any Environmental Law, except as would not,
individually or in the aggregate, have a Material Adverse Effect;
(ii) there is no claim, action or cause of action filed with a
court or governmental authority, no investigation with respect to
which the Company has received written notice, and no written
notice by any person or entity alleging potential liability for
investigatory costs, cleanup costs, governmental responses costs,
natural resources damages, property damages, personal injuries,
attorneys’ fees or penalties arising out of, based on or
resulting from the presence, or release into the environment, of
any Material of Environmental Concern at any location owned, leased
or operated by the Company or its subsidiary, now or in the past
(collectively, “Environmental Claims”), pending or, to
the best of the Company’s knowledge, threatened against the
Company or its subsidiary or any person or entity whose liability
for any Environmental Claim the Company or its subsidiary has
retained or assumed either contractually or by operation of law,
except as would not, individually or in the aggregate, have a
Material Adverse Effect; (iii) to the best of the
Company’s knowledge, there are no past, present or
anticipated future actions, activities, circumstances, conditions,
events or incidents, including, without limitation, the release,
emission, discharge, presence or disposal of any Material of
Environmental Concern, that reasonably could result in a violation
of any Environmental Law, require expenditures to be incurred
pursuant to Environmental Law, or form the basis of a potential
Environmental Claim against the Company or its subsidiary or
against any person or entity whose liability for any Environmental
Claim the Company or its subsidiary has retained or assumed either
contractually or by operation of law, except as would not,
individually or in the aggregate, have a Material Adverse Effect;
and (iv) neither the Company nor its subsidiary is subject to
any pending or threatened proceeding under Environmental Law to
which a governmental authority is a party and which is reasonably
likely to result in monetary sanctions of $100,000 or
more.
(ii) ERISA Compliance . None
of the following events has occurred or exists: (i) a failure
to fulfill the obligations, if any, under the minimum funding
standards of Section 302 of the United States Employee
Retirement Income Security Act of 1974, as amended
(“ERISA”), and the regulations and published
interpretations thereunder with respect to a Plan, determined
without regard to any waiver of such obligations or extension of
any amortization period; (ii) an audit or investigation by the
Internal Revenue Service, the U.S. Department of Labor, the Pension
Benefit Guaranty Corporation or any other federal or state
governmental agency or any foreign regulatory agency with respect
to the employment or compensation of employees by the Company that
could have a material adverse effect on the Company; (iii) any
breach of any contractual obligation, or any violation of law or
applicable qualification standards, with respect to the employment
or compensation of employees of the Company that could have a
Material Adverse Effect. None of the following events has occurred
or is reasonably likely to occur: (i) a material increase in
the aggregate amount of contributions required to be made to all
Plans in the current fiscal year of the Company compared to the
amount of such contributions made in the Company’s most
recently completed fiscal year; (ii) a material increase in
the Company’s “accumulated post-retirement benefit
obligations” (within the meaning of Statement of Financial
Accounting Standards 106) compared to the amount of such
obligations in the Company’s most recently completed fiscal
year; (iii) any event or condition giving rise to a liability
under Title IV of ERISA that could have a Material Adverse Effect;
or (iv) the filing of a claim by one or more
10
employees or former employees of the Company
related to their employment that could have a Material Adverse
Effect. For purposes of this paragraph, the term “Plan”
means a plan (within the meaning of Section 3(3) of ERISA)
subject to Title IV of ERISA with respect to which the Company may
have any liability.
(jj) No Outstanding Loans or
Other Indebtedness . 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, except as disclosed in the Disclosure Package and the
Prospectus.
(kk) Sarbanes-Oxley
Compliance . There is and has been no failure on the part of
the Company and, to the Company’s knowledge, any of the
Company’s directors or officers, in their capacities as such,
to comply with any provision of the Sarbanes-Oxley Act of 2002 and
the rules and regulations promulgated in connection therewith (the
“Sarbanes-Oxley Act”), including Section 402
related to loans and Sections 302 and 906 related to
certifications.
(ll) Subsidiary . Dendreon
San Diego LLC is the only subsidiary of the Company (the
“Subsidiary”).
(mm) Statistical and Market
Related Data . Nothing has come to the attention of the Company
that has caused the Company to believe that the statistical and
market-related data included in each of the Disclosure Package and
the Prospectus is not based on or derived from sources that are
reliable and accurate in all material respects.
(nn) Immunity from
Jurisdiction . Neither the Company nor its subsidiary nor any
of their properties or assets has any immunity from the
jurisdiction of any court or from any legal process (whether
through service or notice, attachment prior to judgment, attachment
in aid of execution or otherwise) under the laws of New
York.
(oo) Compliance with Regulatory
Authorities . The clinical, pre-clinical and other studies and
tests conducted by or on behalf of or sponsored by the Company or
its subsidiary that are described in the Prospectus or the results
of which are referred to in the Prospectus were and, if still
pending, are being conducted in accordance, in all material
respects, with standard medical and scientific research procedures;
the descriptions in the Prospectus of the results of such studies
and tests are accurate and complete in all material respects and
fairly present the data derived from such studies and tests; the
Company and its subsidiary have no knowledge of any other studies
or tests conducted by third parties the results of which contest or
contradict, and have no knowledge of any other studies or tests
conducted by third parties that unsuccessfully attempted to
replicate, the results described or referred to in the Prospectus;
except to the extent disclosed in the Registration Statement and
the Prospectus, the Company and its subsidiary have operated and
currently are in compliance in all material respects with all
applicable rules, regulations and policies of the U.S. Food and
Drug Administration (the “FDA”) and comparable drug
regulatory agencies outside of the United States (collectively, the
“Regulatory Authorities”); and except for the partial
clinical hold p
