HALOZYME THERAPEUTICS,
INC.
Common Stock ($.001 par
value)
JEFFERIES &
COMPANY, INC.
520 Madison Avenue
New York, New York 10022
Introductory. Halozyme Therapeutics, Inc., a Delaware
corporation (the “ Company ”), proposes to issue
and sell to Jefferies & Company, Inc. as sole underwriter
(“ Jefferies ” or the “ Underwriter
”) an aggregate of 6,150,000 shares (a “ Share
” and, collectively, the “ Shares ”) of
common stock, $0.001 par value per share (the “ Common
Stock ”) of the Company.
The Company has
prepared and filed with the Securities and Exchange Commission (the
“ Commission ”) a shelf registration statement
on Form S-3 (File No. 333-155787), and has prepared a base
prospectus (the “ Base Prospectus ”) to be used
in connection with the public offering and sale of the Shares. Such
registration statement, as amended, including the financial
statements, exhibits and schedules thereto, in the form in which it
was declared effective by the Commission under the Securities Act
of 1933, as amended, and the rules and regulations promulgated
thereunder (collectively, the “ Securities Act
”), including all documents incorporated or deemed to be
incorporated by reference therein and any 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, as amended, and the rules and regulations promulgated
thereunder (collectively, the “ Exchange Act ”),
is called the “ Registration Statement .” Any
registration statement filed by the Company pursuant to Rule 462(b)
under the Securities Act is called the “ Rule 462(b)
Registration Statement ” and, from and after the date and
time of filing of the Rule 462(b) Registration Statement (if any)
the term “Registration Statement” shall include the
Rule 462(b) Registration Statement. Such prospectus, in the form
first used by the Underwriter to confirm sales of the Shares or in
the form first made available to the Underwriter by the Company to
meet requests of purchasers pursuant to Rule 173 under the
Securities Act, is called the “ Prospectus. ”
The preliminary prospectus supplement dated June 22, 2009
describing the Shares and the offering thereof, together with the
Base Prospectus, is called the “ Preliminary Prospectus
Supplement, ” and the Preliminary Prospectus Supplement
and any other preliminary prospectus supplement to the Base
Prospectus that describes the Shares and the offering thereof and
is used prior to the filing of the Prospectus (as defined below),
together with the Base Prospectus, is called a “
preliminary prospectus .” As used herein, the term
“ Prospectus ” shall mean the final prospectus
supplement to the Base Prospectus that describes the Shares and the
offering thereof (the “ Final Prospectus Supplement
”), together with the Base Prospectus, in the form first used
by the Underwriter to confirm sales of the Shares or in the form
first made available to the Underwriter by the Company to meet
requests of purchasers pursuant to Rule 173
under the
Securities Act. As used herein, “ Applicable Time
” is 5:00 p.m. (New York time) on June 23, 2009. As used
herein, “ Time of Sale Prospectus ” means the
Preliminary Prospectus Supplement, as amended or supplemented
immediately prior to the Applicable Time, together with the free
writing prospectuses, if any, identified in Schedule A
hereto, and each “road show” (as defined in
Rule 433 under the Securities Act), if any, related to the
offering of the Shares contemplated hereby that is a “written
communication” (as defined in Rule 405 under the
Securities Act) (each such road show, a “ Road Show
”). As used herein, the terms “Registration
Statement,” “Rule 462(b) Registration
Statement”, “Preliminary Prospectus Supplement,”
“Base Prospectus,” “Time of Sale
Prospectus” and “Prospectus” shall include the
documents incorporated and deemed to be incorporated by reference
therein. All references in this Agreement to amendments or
supplements to the Registration Statement, the Rule 462(b)
Registration Statement, the Preliminary Prospectus Supplement, the
Base Prospectus, the Time of Sale Prospectus or the Prospectus
shall be deemed to mean and include the filing of any document
under the Exchange Act which is or is deemed to be incorporated by
reference in the Registration Statement, the Rule 462(b)
Registration Statement, the Preliminary Prospectus Supplement, the
Base Prospectus, the Time of Sale Prospectus or the Prospectus, as
the case may be. All references in this Agreement to (i) the
Registration Statement, the 462(b) Registration Statement, the
Preliminary Prospectus Supplement, the Base Prospectus or the
Prospectus, or any amendments or supplements to any of the
foregoing, shall include any copy thereof filed with the Commission
pursuant to its Electronic Data Gathering, Analysis and Retrieval
System (“ EDGAR ”) and (ii) the Prospectus
shall be deemed to include the “ electronic Prospectus
” provided for use in connection with the offering of the
Shares as contemplated by Section 3(a)(k) of this
Agreement. All references in this Agreement to financial statements
and schedules and other information which are “
contained ,” “ included ” or
“ stated ” in the Registration Statement, the
Rule 462(b) Registration Statement, the Preliminary Prospectus
Supplement, the Base Prospectus, the Time of Sale Prospectus or the
Prospectus (and all other references of like import) shall be
deemed to mean and include all such financial statements and
schedules and other information which is or is deemed to be
incorporated by reference in the Registration Statement or the
Prospectus, as the case may be; and all references in this
Agreement to amendments or supplements to the Registration
Statement, the Rule 462(b) Registration Statement, the Preliminary
Prospectus Supplement, the Base Prospectus, the Time of Sale
Prospectus or the Prospectus, as the case may be, and all
references in this Agreement to amendments or supplements to the
Registration Statement, the Rule 462(b) Registration Statement, the
Preliminary Prospectus Supplement, the Base Prospectus, the Time of
Sale Prospectus or the Prospectus shall be deemed to mean and
include the filing of any document under the Exchange Act which is
or is deemed to be incorporated by reference in the Registration
Statement, the Rule 462(b) Registration Statement, the Preliminary
Prospectus, any preliminary prospectus, the Base Prospectus, the
Time of Sale Prospectus or the Prospectus, as the case may
be.
In the event that
the Company has only one subsidiary, then all references herein to
“subsidiaries” of the Company shall be deemed to refer
to such single subsidiary, mutatis mutandis
.
The Company hereby
confirms its agreements with the Underwriter as follows:
Section 1. Representations and Warranties of the
Company.
The
Company hereby represents, warrants and covenants to the
Underwriter, as of the date of this Agreement and as of the Closing
Date (as hereinafter defined), and covenants with the Underwriter,
as follows:
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(a) Compliance
with Registration Requirements. The Registration Statement and
any Rule 462(b) Registration Statement have 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 or any Rule 462(b) 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, 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 Underwriter for use
in connection with the offer and sale of the Shares. Each of the
Registration Statement, any Rule 462(b) Registration Statement and
any post-effective amendment thereto, at the time it became
effective and as of the Closing Date (as defined in
Section 2 ), complied and will comply in all material
respects with the Securities Act and Exchange 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 to
make the statements therein not misleading. As of the Applicable
Time, the Time of Sale Prospectus did not, and at the time of each
sale of the Shares and at the Closing Date (as defined in
Section 2 ), the Time of Sale Prospectus, as then
amended or supplemented by the Company, if applicable, will not,
contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements therein, in the
light of the circumstances under which they were made, not
misleading. The Prospectus, as amended or supplemented, as of its
date and as of the Closing Date, 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
three immediately preceding sentences do not apply to statements in
or omissions from the Registration Statement, any Rule 462(b)
Registration Statement, or any post-effective amendment thereto, or
the Prospectus or the Time of Sale Prospectus, or any amendments or
supplements thereto, made in reliance upon and in conformity with
information relating to the Underwriter furnished to the Company in
writing by Jefferies expressly for use therein, it being understood
and agreed that the only such information furnished by Jefferies to
the Company consists of the information described in
Section 9(b) below. There are no contracts or other
documents required to be described in the Time of Sale Prospectus
or the Prospectus or to be filed as exhibits to the Registration
Statement which have not been described or filed as
required.
The
Company is not an “ineligible issuer” in connection
with the offering of the Shares pursuant to Rules 164, 405 and
433 under the Securities Act.
Any
free writing prospectus that the Company is required to file
pursuant to Rule 433(d) under the Securities Act has been, or will
be, filed with the Commission in accordance with the requirements
of the Securities Act. Each free writing prospectus that the
Company has filed, or is required to file, pursuant to Rule 433(d)
under the Securities Act or that was prepared by or behalf of or
used or referred to by the Company complies or will comply in all
material respects with the requirements of Rule 433 under the
Securities Act including timely filing with the Commission or
retention where required and legending, and each such free writing
prospectus, as of its issue date and at all subsequent times
through the completion of the public offer and sale of the Shares
did not, does not and will not include any information that
conflicted, conflicts with or will conflict with the information
contained in the
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Registration
Statement, the Prospectus or any preliminary prospectus, including
any document incorporated by reference therein. Except for the free
writing prospectuses, if any, identified in Schedule A
hereto, and electronic road shows, if any, furnished to you before
first use, the Company has not prepared, used or referred to, and
will not, without your prior consent, prepare, use or refer to, any
free writing prospectus.
(b) Offering
Materials Furnished to Underwriter . The Company has delivered
to the Underwriter a complete copy of the Registration Statement,
each amendment thereto and any Rule 462(b) Registration Statement
and of each consent and certificate of experts filed as a part
thereof, and conformed copies of the Registration Statement, each
amendment thereto and any Rule 462(b) Registration Statement
(without exhibits) and the Preliminary Prospectus Supplement, the
Time of Sale Prospectus, the Prospectus, as amended or
supplemented, and any free writing prospectus reviewed and
consented to by the Underwriter, in such quantities and at such
places as the Underwriter has reasonably requested.
(c)
Distribution of Offering Material By the Company . The
Company has not distributed and will not distribute, prior to the
completion of the Underwriter’s distribution of the Shares,
any offering material in connection with the offering and sale of
the Shares other than the Preliminary Prospectus Supplement, the
Time of Sale Prospectus, the Prospectus, any free writing
prospectus reviewed and consented to by the Underwriter or the
Registration Statement.
(d) The
Underwriting Agreement . The Company has the full right, power
and authority to enter into this Agreement and to perform and to
discharge its obligations hereunder and this Agreement has been
duly authorized, executed and delivered by, and is a valid and
binding agreement of, the Company, enforceable in accordance with
its terms, except as rights to indemnification hereunder may be
limited by applicable law and except as the enforcement hereof may
be limited by bankruptcy, insolvency, reorganization, moratorium or
other similar laws relating to or affecting the rights and remedies
of creditors or by general equitable principles.
(e) Corporate
Records. All minute books of the Company and its subsidiaries
existing since January 1, 2007, including all existing records
of all meetings and actions of the board of directors (including
Audit, Compensation, Nominating and Governance and other board
committees) and stockholders of the Company from January 1,
2007 through the date of the latest meeting and action
(collectively, “ Corporate Records ”) have been
made available or otherwise described to the Underwriter and
counsel for the Underwriter. All such Corporate Records are
complete and accurately reflect, in all material respects, all
transactions referred to in such Corporate Records. There are no
material transactions, agreements or other actions of the Company
and its subsidiaries that are not properly approved or recorded in
the Corporate Records.
(f)
Authorization of the Shares . The Shares have been duly
authorized for issuance and sale pursuant to this Agreement and,
when issued and delivered by the Company pursuant to this
Agreement, will be validly issued, fully paid and nonassessable,
and the issuance and sale of the Shares is not subject to any
preemptive rights, rights of first refusal or other similar rights
to subscribe for or purchase the Shares.
(g) 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,
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except for
persons and entities who have waived such rights or who have been
given timely and proper written notice and have failed to exercise
such rights within the time or times required under the terms and
conditions of such rights.
(h) No Material
Adverse Change . Except as otherwise disclosed in the Time of
Sale Prospectus, subsequent to the respective dates as of which
information is given in Time of Sale Prospectus: (i) there has
been no material adverse change, or any development that would
reasonably be expected to result in a material adverse change, in
the condition, financial or otherwise, or in the earnings,
business, operations or prospects, whether or not arising from
transactions in the ordinary course of business, of the Company and
its subsidiaries, considered as one entity (any such change is
called a “ Material Adverse Change ”);
(ii) the Company and its subsidiaries, considered as one
entity, have not incurred any material liability or obligation,
indirect, direct or contingent, not in the ordinary course of
business nor entered into any material transaction or agreement not
in the ordinary course of business; 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 or other
subsidiaries, any of its subsidiaries on any class of capital stock
or repurchase or redemption by the Company or any of its
subsidiaries of any class of capital stock.
(i) Independent
Accountants . 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 Preliminary Prospectus
Supplement, the Prospectus and Time of Sale Prospectus (each, an
“ Applicable Prospectus ” and collectively, the
“ Applicable Prospectuses ”), are independent
public or certified public accountants as required by the
Securities Act and the Exchange Act.
(j) Preparation
of the Financial Statements . The financial statements filed
with the Commission as a part of the Registration Statement and
included in the Preliminary Prospectus Supplement, the Time of Sale
Prospectus and the Prospectus present fairly the consolidated
financial position of the Company and its subsidiaries as of and at
the dates indicated and the results of their operations and cash
flows for the periods specified. The supporting schedules included
in the Registration Statement present fairly the information
required to be stated therein. Such financial statements and
supporting schedules 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 in the
Registration Statement or any Applicable Prospectus. The financial
data set forth in each Applicable Prospectus fairly present the
information set forth therein on a basis consistent with that of
the audited financial statements contained in the Registration
Statement and each Applicable Prospectus. To the Company’s
knowledge, no person who has been suspended or barred from being
associated with a registered public accounting firm, or who has
failed to comply with any sanction pursuant to Rule 5300
promulgated by the Public Company Accounting Oversight Board, has
participated in or otherwise aided the preparation of, or audited,
the financial statements, supporting schedules or other financial
data filed with the Commission as a part of the Registration
Statement and included in any Applicable Prospectus.
(k)
Company’s Accounting System . The Company and each of
its subsidiaries make and keep accurate books and records and
maintain a system of internal accounting controls sufficient to
provide reasonable assurance that (i) transactions are
executed in accordance
5
with
management’s general or specific authorization;
(ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with generally
accepted accounting principles and to maintain accountability for
assets; (iii) access to assets is permitted only in accordance
with management’s general or specific authorization; and
(iv) the recorded accountability for assets is compared with
existing assets at reasonable intervals and appropriate action is
taken with respect to any differences. There has not been and is no
material weakness in the Company’s internal control over
financial reporting (whether or not remediated) and since
December 31, 2008, there has been no change in the
Company’s internal control over financial reporting that has
materially affected, or is reasonably likely to materially affect,
the Company’s internal control over financial reporting
except as disclosed in the Registration Statement and the
Prospectus.
(l)
Incorporation and Good Standing of the Company and its
Subsidiaries . Each of the Company and its subsidiaries
(i) has been duly incorporated or organized, as the case may
be, and is validly existing as a corporation, partnership or
limited liability company, as applicable, in good standing under
the laws of the jurisdiction of its incorporation or organization
and has the power and authority (corporate or other) to own, lease
and operate its properties and to conduct its business as described
in each Applicable Prospectus and, in the case of the Company, to
enter into and perform its obligations under this Agreement; and
(ii) is duly qualified as a foreign corporation, partnership
or limited liability company, as applicable, to transact business
and is in good standing in each jurisdiction where qualification is
required, whether by reason of the ownership or leasing of property
or the conduct of business, except where the failure to be so
qualified or in good standing or have such power or authority would
not reasonably be expected to result, singularly or in the
aggregate, in a Material Adverse Change. All of the issued and
outstanding capital stock or other equity or ownership interests of
each subsidiary have been duly authorized and validly issued, are
fully paid and nonassessable and are owned by the Company, directly
or through subsidiaries, free and clear of any security interest,
mortgage, pledge, lien, encumbrance or adverse claim. The Company
does not own or control, directly or indirectly, any corporation,
association or other entity other than (x) the subsidiaries
listed in Exhibit 21 to the Registration Statement and
(y) such other entities omitted from Exhibit 21 which,
when such omitted entities are considered in the aggregate as a
single subsidiary, would not constitute a “significant
subsidiary” within the meaning of Rule 1-02(w) of
Regulation S-X.
(m)
Capitalization and Other Capital Stock Matters . The
authorized, issued and outstanding capital stock of the Company is
as set forth in each Applicable Prospectus under the caption
“Capitalization” (other than for subsequent issuances,
if any, pursuant to employee benefit plans described in the Time of
Sale Prospectus or upon the exercise of outstanding options or
warrants described in each Applicable Prospectus). The Shares
conform in all material respects to the description thereof
contained in the Time of Sale Prospectus. All of the issued and
outstanding Shares 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 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
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 accurately
described in each Applicable 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 in each Applicable Prospectus accurately and fairly
presents the information required to be shown with respect
to
6
such plans,
arrangements, options and rights. All of the outstanding shares of
capital stock of the Company’s subsidiaries have been duly
authorized and validly issued, are fully paid and non-assessable
and, except to the extent set forth in each Applicable Prospectus,
are owned directly by the Company, free and clear of any claim,
lien encumbrance, security interest, defect or restriction upon
voting or transfer or any other claim of any kind.
(n) Trading;
Exchange Account Registration; Stockholder Approval . The
Shares are registered pursuant to Section 12(b) of the Exchange Act
and are listed on the NASDAQ Global Market under the symbol
“HALO,” and the Company has taken no action designed
to, or likely to have the effect of, terminating the registration
of the Shares under the Exchange Act or delisting the Shares from
the NASDAQ Global Market, nor has the Company received any
notification that the Commission or the NASDAQ Global Market is
contemplating terminating such registration or listing. The Company
is in compliance with all applicable corporate governance
requirements set forth in the NASDAQ Global Marketplace Rules that
are currently in effect. No approval of the stockholders of the
Company under the rules and regulations of the NASDAQ Global Market
is required for the Company to issue and deliver the Shares to the
Underwriter. Any certificate signed by or on behalf of the Company
and delivered to the Underwriter or to counsel for the Underwriter
shall be deemed to be a representation and warranty by the Company
to the Underwriter as to the matters covered thereby.
(o)
Non-Contravention of Existing Instruments; No Further
Authorizations or Approvals Required . Neither the Company nor
any of its subsidiaries is (i) in violation of its charter or
by-laws, partnership agreement or operating agreement or similar
organizational document, as applicable, (ii) is in default
(or, with the giving of notice or lapse of time, would be in
default) (“ Default ”) under any indenture,
mortgage, loan or credit agreement, note, contract, franchise,
lease or other instrument to which the Company or any of its
subsidiaries is a party or by which it or any of them may be bound
(including, without limitation, any credit agreement, indenture,
pledge agreement, security agreement or other instrument or
agreement evidencing, guaranteeing, securing or relating to
indebtedness of the Company or any of its subsidiaries ), or to
which any of the property or assets of the Company or any of its
subsidiaries is subject (each, an “ Existing
Instrument ”), or (iii) in violation in any respect
of any statute, law, rule, regulation, ordinance, judgment, order
or decree of any court, regulatory body, administrative agency,
governmental body, arbitrator or other authority having
jurisdiction over the Company or its subsidiaries, or any of their
properties, as applicable (including, without limitation, those
administered by the Food and Drug Administration of the U.S.
Department of Health and Human Services (the “ FDA
”) or by any foreign, federal, state or local government or
regulatory authority performing functions similar to those
performed by the FDA), except with respect to clauses (ii) and
(iii), for any violations, breaches or Defaults as would not
reasonably be expected, individually or in the aggregate, to result
in a Material Adverse Change. The Company’s execution,
delivery and performance of this Agreement, consummation of the
transactions contemplated hereby and by each Applicable Prospectus
and the issuance and sale of the Shares (i) have been duly
authorized by all necessary corporate action and will not result in
any violation of the provisions of the charter or by-laws,
partnership agreement or operating agreement or similar
organizational document of the Company or any subsidiary, as
applicable, (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 any of its subsidiaries 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, ordinance, judgment, order or decree of any
court, regulatory body, administrative agency, governmental body,
arbitrator or
7
other authority
having jurisdiction over the Company or its subsidiaries, or any of
their properties, as applicable (including, without limitation,
those administered by the FDA or by any foreign, federal, state or
local government or regulatory authority performing functions
similar to those performed by the FDA) applicable to the Company or
any subsidiary. 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
and by each Applicable 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.
(p) No Material
Actions or Proceedings . There are no legal or governmental
actions, suits or proceedings (including any proceeding before the
FDA or comparable federal, state, local or foreign governmental
bodies) pending or, to the Company’s knowledge, threatened
(i) against the Company or any of its subsidiaries,
(ii) which, to the Company’s knowledge, have as the
subject thereof any officer or director of, or property owned or
leased by, the Company or any of its subsidiaries or (iii) relating
to environmental or discrimination matters, where in any such case
(A) to the Company’s knowledge, there is a substantial
likelihood that such action, suit or proceeding will be determined
adversely to the Company, such subsidiary or such officer or
director, (B) any such action, suit or proceeding, if so determined
adversely, would reasonably be expected to result in a Material
Adverse Change or adversely affect the consummation of the
transactions contemplated by this Agreement and (C) any such
action, suit or proceeding is or would be material in the context
of the sale of Shares. No material labor dispute with the employees
of the Company or any of its subsidiaries, or, to the
Company’s knowledge, with the employees of any principal
supplier, manufacturer, customer or contractor of the Company,
exists or, to the Company’s knowledge, is threatened or
imminent. Neither the Company nor its subsidiaries is aware that
any key employee of the Company or its subsidiaries or significant
group of employees of the Company or its subsidiaries plans to
terminate employment with the Company or its
subsidiaries.
(q)
Intellectual Property Rights . To the Company’s
knowledge, the Company and its subsidiaries own or possess the
right to use all foreign and domestic patents, trademarks,
trademark registrations, service marks, service mark registrations,
trade names, copyrights, licenses, inventions, software, databases,
know-how, Internet domain names, trade secrets and other unpatented
and/or unpatentable proprietary or confidential information,
systems or procedures, and other intellectual property
(collectively, “ Intellectual Property ”) used
in carrying on their respective businesses as currently conducted
and as such businesses are described in the Applicable Prospectus,
and the Company has not received any written notice of any claim to
the contrary or any written challenge by any other person to the
rights of the Company and its subsidiaries with respect to the
foregoing except for those claims and/or challenges that would not
reasonably be expected to result in a Material Adverse Change. The
Intellectual Property licenses described in the Registration
Statement and the Time of Sale Prospectus are valid, binding upon,
and enforceable by or against the Company and to the
Company’s knowledge the other parties thereto in accordance
to their terms except as would not reasonably be expected to result
in a Material Adverse Change and subject to the effect of any
applicable bankruptcy, moratorium, insolvency, reorganization or
other similar law affecting the enforceability of creditors’
rights generally and to the effect of general principles of equity
which may limit the availability of remedies (whether in a
proceeding at law or in equity). The Company and each of its
subsidiaries has complied in all material respects with, and is not
in material breach of nor has the Company received any
written
8
asserted or
written threatened claim of breach of, any Intellectual Property
license, and the Company has no knowledge of any material breach or
anticipated material breach by any other person to any Intellectual
Property license. The Company’s and each of its
subsidiaries’ businesses as now conducted do not, to the
Company’s knowledge, infringe any patents, trademarks,
service marks, trade names, copyrights, trade secrets, licenses or
other Intellectual Property right of any person. The Company has
not received any written notice of any claims that have been made
against the Company or any of its subsidiaries alleging the
infringement by the Company or any of its subsidiaries of any
patent, trademark, service mark, trade name, copyright, trade
secret, license in or other intellectual property right of any
person except as disclosed in the Registration Statement and the
Prospectus. The Company and each of its subsidiaries has taken
reasonable steps to protect, maintain and safeguard its rights in
all Intellectual Property owned by the Company or its subsidiaries,
including the execution of appropriate nondisclosure and
confidentiality agreements. The consummation of the transactions
contemplated by this Agreement will not result in the material loss
or impairment of or payment of any material additional amounts with
respect to, nor require the consent of any other person in respect
of, the Company’s or any of its subsidiaries’ right to
own, use, or hold for use any of the Intellectual Property as
owned, used or held for use in the conduct of the businesses as
currently conducted. The Company and each of its subsidiaries has
at all times complied in all material respects with all applicable
laws relating to privacy, data protection, and the collection and
use of personal information collected, used, or held for use by the
Company and any of its subsidiaries in the conduct of the
Company’s and its subsidiaries businesses except as would not
reasonably be expected to result in a Material Adverse Change. The
Company has not received notice of any claims that have been
asserted or threatened against the Company or any of its
subsidiaries alleging a violation of any person’s privacy or
personal information or data rights and the consummation of the
transactions contemplated hereby will not breach or otherwise cause
any violation of any law related to privacy, data protection, or
the collection and use of personal information collected, used, or
held for use by the Company or any of its subsidiaries in the
conduct of the Company’s or any of its subsidiaries’
businesses. The Company and each of its subsidiaries take
reasonable measures to ensure that such personal information is
protected against unauthorized access, use, or other
misuse.
(r) All
Necessary Permits, etc. The Company and each subsidiary possess
such valid and current certificates, authorizations or permits
issued by the appropriate state, federal or foreign regulatory
agencies or bodies necessary to conduct their respective businesses
(including any certificates, authorizations or permits required by
the FDA or comparable federal, state, local or foreign governmental
bodies) except as would not reasonably be expected to result in a
Material Adverse Change, and neither the Company nor any subsidiary
has received, or has any reason to believe that it will receive,
any notice of proceedings relating to the revocation or
modification of, or non-compliance with, any such certificate,
authorization or permit which, singly or in the aggregate, if the
subject of an unfavorable decision, ruling or finding, could result
in a Material Adverse Change.
(s) Compliance
with Laws .
(i) The Company
has not been advised, and has no reason to believe, that it and
each of its subsidiaries are not conducting business in compliance
with all applicable laws, rules and regulations of the
jurisdictions in which it is conducting business, including,
without limitation, the rules and regulations of the FDA or
comparable federal, state, local or foreign
9
governmental
bodies, except where failure to be so in compliance would not
reasonably be expected to result in a Material Adverse
Change.
(ii) The studies,
tests and preclinical or clinical trials conducted by or at the
direction of or sponsored by the Company that are described in the
Registration Statement and the Prospectus (the “ Company
Studies and Trials ”) were and, if still pending, are
being, conducted in all material respects in accordance with all
statutes, laws, rules, regulations, experimental protocols,
procedures and controls (including, without limitation, those
administered by the FDA or by any foreign, federal, state or local
governmental or regulatory authority performing functions similar
to those performed by the FDA) pursuant to, where applicable,
accepted professional scientific standards; the descriptions of the
results of the Company Studies and Trials contained in the
Registration Statement and the Prospectus are accurate in all
material respects; and the Company and its subsidiaries have no
knowledge of other studies and tests the results of which are
materially inconsistent with or otherwise call into question the
results described or referred to in the Applicable Prospectus. The
Company has not received any notices or correspondence from the FDA
or any foreign, state or local governmental body exercising
comparable authority mandating the termination, suspension or
material modification of any Company Studies or Trials that
termination, suspension or material modification would reasonably
be expected to result in a Material Adverse Change. For the
avoidance of doubt, the Company makes no representation or warranty
that the results of any studies, tests or preclinical or clinical
trials conducted by or on behalf of or sponsored by the Company
will be sufficient to obtain governmental approval from the FDA or
any foreign, state or local governmental body exercising comparable
authority.
(iii) Each of the
Company and its subsidiaries has established and administers a
compliance program (including a written compliance policy)
applicable to the Company and its subsidiaries, to assist the
Company, its subsidiaries and their directors, officers and
employees in complying with applicable regulatory guidelines
(including, without limitation, those administered by the FDA and
any other foreign, federal, state or local governmental or
regulatory authority performing functions similar to those
performed by the FDA).
(iv) Exchange
Act Compliance. The documents incorporated or deemed to be
incorporated by reference in the Prospectus, at the time they were
or hereafter are filed with the Commission, complied and will
comply in all material respects with the requirements of the
Exchange Act, and, when read together with the other information in
the Prospectus, at the time the Registration Statement and any
amendments thereto become effective and at the Closing Date will
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 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.
(v)
Sarbanes-Oxley Act Compliance. The Company is in 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.
10
(vi) Tax Law
Compliance. The Company and its subsidiaries have filed all
necessary federal, state and foreign income and franchise tax
returns 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. The Company has made adequate
charges, accruals and reserves in the applicable financial
statements referred to in Section 1(j) above in respect
of all federal, state and foreign income and franchise taxes for
all periods as to which the tax liability of the Company or any of
its subsidiaries has not been finally determined.
(t) Title to
Properties . The Company and each of its subsidiaries has good
and marketable title to all of the real and personal property and
other assets reflected as owned in the financial statements
referred to in Section 1(j) above (or elsewhere in any
Applicable Prospectus), in each case free and clear of any security
interests, mortgages, liens, encumbrances, equities, adverse 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
any 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.
(u) Company Not
an “Investment Company” . The Company has been
advised of the rules and requirements under the Investment Company
Act of 1940, as amended (the “ Investment Company Act
”). The Company is not, and will not be, either after receipt
of payment for the Shares or after the application of the proceeds
therefrom as described under “Use of Proceeds” in each
Applicable Prospectus, an “ investment company ”
within the meaning of Investment Company Act and will conduct its
business in a manner so that it will not become subject to the
Investment Company Act.
(v)
Insurance . Each of the Company and its subsidiaries are
insured by recognized 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
including, but not limited to, policies covering real and personal
property owned or leased by the Company and its subsidiaries
against theft, damage, destruction, acts of vandalism and policies
covering the Company and its subsidiaries for product liability
claims and clinical trial liability claims. 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 result
in a Material Adverse Change. Neither of the Company nor any
subsidiary has been denied any insurance coverage which it has
sought or for which it has applied.
(w) No Price
Stabilization or Manipulation; Compliance with
Regulation M . The Company has not taken, 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 Shares or any other “ reference security
” (as defined in Rule 100 of Regulation M under the
1934 Act (“ Regulation M ”)) whether to
facilitate the sale or resale of the Shares or otherwise, and has
taken no action which would directly or indirectly violate
Regulation M.
11
The Company
acknowledges that the Underwriter may engage in passive market
making transactions in the Shares on the NASDAQ Global Market in
accordance with Regulation M.
(x) Related
Party Transactions . Except with respect to the transactions
contemplated by this Agreement, there are no business relationships
or related-party transactions involving the Company or any of its
subsidiaries or any other person required to be described in each
Applicable Prospectus which have not been described as required.
(The Time of Sale Prospectus contains in all material respects the
same description of the matters set forth in the preceding sentence
contained in the Prospectus.)
(y) S-3
Eligibility. At the time the Registration Statement was
originally declared effective and at the time the Company’s
Annual Report on Form 10-K for the year ended December 31,
2008 (the “ Annual Report ”) was filed with the
Commission, the Company met the then applicable requirements for
use of Form S-3 under the Securities Act. The Company does not meet
the requirements for use of Form S-3 under the Securities Act
specified in Conduct Rule 2710(b)(7)(C)(i) of The Financial
Industry Regulatory Authority Inc. (“ FINRA
”).
(z) FINRA
Matters . There are no affiliations with FINRA among the
Company’s officers, directors, or to the knowledge of the
Company, any five percent or greater stockholder o
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