Exhibit 1.1
34,972,678 Shares
Warrants to Purchase 12,240,437 Shares
AVANIR PHARMACEUTICALS
Common Stock
PLACEMENT AGENCY AGREEMENT
March 26, 2008
Piper
Jaffray & Co.
U.S. Bancorp Center
800 Nicollet Mall
Minneapolis, Minnesota 55402
Ladies
and Gentlemen:
Avanir Pharmaceuticals, a California
corporation (the “ Company ”), proposes, subject
to the terms and conditions stated herein, to issue and sell to
certain investors (each an “ Investor ” and,
collectively, the “ Investors ”), (i) up to
34,972,678 shares (the “ Shares ”) of the
Company’s Class A common stock, no par value per share (the
“ Common Stock ”), and (ii) warrants to
purchase up to 12,240,437 shares of Common Stock (the “
Warrants ” and together with the Shares, the “
Securities ”). The shares of Common Stock issuable
upon exercise of the Warrants are hereinafter referred to as the
“ Warrant Shares ”. The Company desires to
engage Piper Jaffray & Co. as its exclusive placement agent
(the “ Placement Agent ”) in connection with
such issuance and sale. The Securities are more fully described in
the Registration Statements (as hereinafter defined).
The Company has prepared and filed in
conformity with the requirements of the Securities Act of 1933, as
amended (the “ Securities Act ”), and the
published rules and regulations thereunder (the “ Rules
and Regulations ”) adopted by the Securities and Exchange
Commission (the “ Commission ”) (i) a
Registration Statement on Form S-3 (No. 333-125979) (the
“ First Registration Statement ” ) and (ii) a
Registration Statement on Form S-3 (No. 333-149125) (the
“ Second Registration Statement ” ), relating to
the Securities and the offering thereof from time to time in
accordance with Rule 415 of the Rules and Regulations, and
such amendments thereof as may have been required. The First
Registration Statement includes a prospectus dated August 3,
2005 (the “ First Base Prospectus ”). The Second
Registration Statement includes a prospectus dated
February 19, 2008 (the “ Second Base Prospectus
” and together with the First Base Prospectus, the “
Base Prospectuses ”). The Company has filed each of
the Base Prospectuses with the Commission and has filed with, or
transmitted for filing to, or shall promptly hereafter file with or
transmit for filing to the Commission, a prospectus supplement
relating to the Securities in accordance with Rule 424(b) under the
Act (the “ Final Prospectus Supplement ”). The
term “ Registration Statements ” as used in this
Agreement means (i) the First Registration Statement
(including all exhibits, financial schedules and all documents and
information deemed to be a part of the First Registration Statement
(through incorporation by reference or otherwise)), as amended, at
the time and on the date it became effective, including the
information (if any) contained in the form of final prospectus
filed with the Commission pursuant to Rule 424(b) of the Rules and
Regulations and deemed to be part thereof at the time of
effectiveness pursuant to Rule 430A of the Rules and
Regulations, and (ii) the Second Registration Statement
(including all exhibits, financial schedules and all documents
and
information deemed to be a part of the Second Registration
Statement (through incorporation by reference or otherwise)), as
amended, at the time and on the date it became effective, including
the information (if any) contained in the form of final prospectus
filed with the Commission pursuant to Rule 424(b) of the Rules and
Regulations and deemed to be part thereof at the time of
effectiveness pursuant to Rule 430A of the Rules and
Regulations. The date a Registration Statement became effective is
referred to herein as the “ Effective Date ”.
The term “ Prospectus ” as used in this
Agreement means the Base Prospectuses together with the Final
Prospectus Supplement. Any preliminary prospectus or prospectus
subject to completion included in the Registration Statements or
filed with the Commission pursuant to Rule 424 under the
Securities Act is hereafter called a “ Preliminary
Prospectus. ” As used herein, the terms “Base
Prospectuses,” “Prospectus,” “Registration
Statements,” “Preliminary Prospectus” and
“Final Prospectus Supplement” shall include any
documents incorporated by reference therein; and any reference to
any amendment or supplement to the Registration Statements or the
Prospectus shall be deemed to refer to and include any document
filed under the Securities Exchange Act of 1934, as amended (the
“ Exchange Act ”), after the date of either of
the Base Prospectuses by the Company with the Commission and 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 Statements, any Preliminary Prospectus or the
Prospectus shall be deemed to refer to and include the filing of
any document under the Exchange Act before or after the applicable
Effective Date, the date of such Preliminary Prospectus or the date
of the Prospectus, as the case may be, which is incorporated by
reference into such amendment or supplement, but excluding any
documents or information furnished to the Commission under
Item 2.02 or Item 7.01 of any Current Report on Form 8-K.
If the Company has filed one or more abbreviated registration
statements to register additional Shares and Warrants pursuant to
Rule 462(b) under the Rules and Regulations (each a “
Rule 462(b) Registration Statement
”), then any reference herein to the term “
Registration Statements ” shall also be deemed to
include any such Rule 462(b) Registration Statement. The Company
hereby confirms that the Placement Agent, in connection with
its duties in such capacity, is authorized to distribute or cause
to be distributed the Prospectus (as from time to time amended or
supplemented if the Company furnishes amendments or supplements
thereto to such Placement Agent).
All references in this Agreement to
financial statements and schedules and other information which is
“contained,” “included” or
“stated” in the Registration Statements or the
Prospectus (or other references of like import) shall be deemed to
mean and include all such financial statements and schedules and
other information which is incorporated by reference in the
Registration Statements or the Prospectus, as the case may be; and
all references in this Agreement to amendments or supplements to
the Registration Statements or the Prospectus shall be deemed to
mean and include the filing of any document under the Exchange Act
on or before the Closing Date (as defined herein), which is
incorporated by reference in the Registration Statements or the
Prospectus, as the case may be.
For purposes of this Agreement, all
references to the Registration Statements, any Rule 462(b)
Registration Statement, the Base Prospectuses, any Preliminary
Prospectus, the Prospectus or any amendment or supplement to any of
the foregoing shall be deemed to include the copy filed with the
Commission pursuant to its Electronic Data Gathering, Analysis and
Retrieval System ( “EDGAR” ).
1. Agreement to Act as
Placement Agent; Delivery and Payment . On the basis of the
representations, warranties and agreements of the Company herein
contained, and subject to the terms and conditions set forth in
this Agreement:
(a) The
Company hereby engages the Placement Agent to act as its exclusive
placement agent in connection with the issuance and sale, by the
Company, of Securities to the Investors and the Placement Agent
hereby agrees, as an agent of the Company, to use its best efforts
to solicit offers to purchase the Securities from the Company upon
the terms and conditions set forth in the Prospectus. The Company
expressly acknowledges and agrees that this Agreement shall not
give rise to a
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commitment by the Placement Agent or any of its affiliates to
underwrite or purchase any of the Securities or otherwise provide
any financing, and the Placement Agent shall have no authority to
bind (and agrees not to purport to bind) the Company in respect of
the sale of any Securities.
(b) Concurrently
with the execution and delivery of this Agreement, the Company, the
Placement Agent and JP Morgan Chase, as escrow agent (the “
Escrow Agent ”), shall enter into an escrow agreement,
dated as of the date hereof (the “ Escrow Agreement
”) pursuant to which an escrow account will be established,
at the Company’s expense, for the benefit of the Company and
the Investors (the “ Escrow Account ”). Prior to
the Closing Date, (i) each Investor will deposit in the Escrow
Account an amount equal to $1.14375 per unit (each unit consisting
of one Share and a Warrant to purchase 0.35 shares of Common Stock)
multiplied by the number of units to be purchased by such Investor
(the “ Purchase Amount ”), and (ii) the
Escrow Agent will notify the Company and the Placement Agent in
writing of the amount of funds deposited in the Escrow
Account.
(c) Upon
the occurrence of the Closing (as hereinafter defined), the Company
shall pay to the Placement Agent, by wire transfer of immediately
available funds payable to the order of the Placement Agent, to an
account designated by the Placement Agent, an aggregate of six
percent (6.0%) of the gross proceeds received by the Company from
its sale of the Securities at such Closing to all Investors other
than those Investors whose names are set forth on Schedule
II attached hereto (the “ Agency Fee
”).
(d) Payment
of the purchase price for, and delivery of, the Securities shall be
made at a closing (the “ Closing ”) at the
offices of Goodwin Procter LLP, counsel for the Company, located at
4365 Executive Drive, Suite 300, San Diego, California at
10:00 a.m., local time, on April 4, 2008 or at such other
time and date as the Investor and the Company determine pursuant to
Rule 15c6-1(a) under the Exchange Act (such date of payment and
delivery being herein referred to as the “ Closing
Date ”), and upon satisfaction of the conditions set
forth in this Agreement and the Subscription Agreements (as defined
below), the Company shall deliver the Securities, which shall be
registered in the name or names and shall be in such denominations
as the Placement Agent may request at least one business day before
the Closing Date, to the Investors, which delivery, with respect to
the Shares, may be made through the facilities of the Depository
Trust Company, and the Escrow Agent will disburse the aggregate
funds in the Escrow Account to the Company reduced by an amount
equal to the sum of the aggregate Agency Fee payable to the
Placement Agent and the Placement Agent’s bona fide estimate
of the amount, if any, of expenses for which the Placement Agent is
entitled to reimbursement pursuant hereto, with such amounts being
delivered to the Placement Agent, by wire in federal (same day)
funds, as provided in the Escrow Agreement. All such actions taken
at the Closing shall be deemed to have occurred simultaneously.
Each of the Company and the Placement Agent hereby agree to deliver
to the Escrow Agent a Closing Notice in the form attached as
Exhibit C to the Escrow Agreement at least one day prior to
the Closing Date. At least one day prior to the Closing Date,
the Placement Agent shall submit to the Company its bona fide
estimate of the amount, if any, of expenses for which such
Placement Agent is entitled to reimbursement pursuant hereto. If
the Company shall default in its obligations to deliver Securities
to an Investor whose offer it has accepted, the Company shall
indemnify and hold the Placement Agent harmless against any loss,
claim or damage arising from or as a result of such default by the
Company.
(e) The
sale of the Securities shall be made pursuant to subscription
agreements in the form included as Exhibit A hereto
(the “ Subscription Agreements ”). The Company
shall have the sole right to accept offers to purchase the
Securities and may reject any such offer in whole or in part, and,
except as set forth in Section 4 hereof, in no event shall
fees be payable on any proposed purchase which is rejected for any
reason or which otherwise does not close for any reason.
(f) Prior
to the earlier of (i) the date on which this Agreement is
terminated and (ii) the Closing Date, the Company shall not,
without the prior written consent of the Placement Agent, solicit
or accept offers to purchase Securities of the Company (other than
pursuant to the exercise of options or
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warrants
to purchase shares of Common Stock that are outstanding at the date
hereof) otherwise than through the Placement Agent in accordance
herewith.
2. Representations and
Warranties of the Company . The Company represents and warrants
to the Placement Agent as of the date hereof and as of the Closing
Date, and agrees with the Placement Agent, as follows:
(a)
Registration Statements and Prospectus . The Company and the
transactions contemplated by this Agreement meet the requirements
and comply with the conditions for the use of Form S-3 under the
Securities Act. The offering of the Securities by the Company
complies with the applicable requirements of Rule 415 under
the Securities Act. The Company has complied to the
Commission’s satisfaction with all requests of the Commission
for additional or supplemental information. Each of the
Registration Statements has become effective under the Securities
Act. No stop order preventing or suspending use of the Registration
Statements or the Prospectus or the effectiveness of the
Registration Statements, has been issued by the Commission, and no
proceedings for such purpose have been instituted or are pending
or, to the Company’s knowledge, are contemplated or
threatened by the Commission.
(b)
Compliance with Registration Requirements . Each part of the
Registration Statements and any post-effective amendments thereto,
at the time such part became effective (including each deemed
effective date with respect to the Placement Agent pursuant to
Rule 430B under the Securities Act) and as of the Closing
Date, complied and will comply, in all material respects, with the
requirements of the Securities Act, the Rules and Regulations and
the 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. The Prospectus (or any amendment or
supplement to the Prospectus), at the time of filing or the time of
first use within the meaning of the Rules and Regulations and as of
the Closing Date, complied and will comply, in all material
respects, with the requirements of the Securities Act, the Rules
and Regulations and the Exchange Act 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
the light of the circumstances under which they were made, not
misleading; provided , that the Company makes no
representations or warranties in this paragraph with respect to any
Placement Agent Information (as defined in Section 7
).
(c)
Disclosure Package . As of the Time of Sale (as hereinafter
defined) and as of the Closing Date, neither (A) any Issuer
General Use Free Writing Prospectus(es)(as defined below), if any,
issued at or prior to the Time of Sale, the Statutory Prospectus
(as hereinafter defined) and the information contained on
Schedule III , which will be conveyed orally by the
Placement Agent to the Investors prior to the Time of Sale, all
considered together (collectively, the “Disclosure
Package” ), nor (B) any individual Issuer
Limited-Use Free Writing Prospectus (as hereinafter defined), when
considered together with the Disclosure Package, included or will
include any untrue statement of a material fact or omitted or will
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; provided , that the Company
makes no representations or warranty in this paragraph with respect
to statements in or omissions from the Disclosure Package in
reliance upon, and in conformity with any Placement Agent
Information. No statement of material fact included in the
Prospectus has been omitted from the Disclosure Package and no
statement of material fact included in the Disclosure Package that
is required to be included in the Prospectus has been omitted
therefrom. As used in this paragraph and elsewhere in this
Agreement:
(1) “Time of Sale”
with respect to any Investor, means 6:30 p.m. New York City time on
the date of this Agreement.
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(2) “Statutory
Prospectus” means the Preliminary Prospectus, if any, and
the Base Prospectuses, each as amended and supplemented as of
immediately prior to the Time of Sale, including any document
incorporated by reference therein and any prospectus supplement
deemed to be a part thereof. For purposes of this definition,
information contained in a form of prospectus that is deemed
retroactively to be a part of either of the Registration Statements
pursuant to Rule 430B under the Securities Act shall be
considered to be included in the Statutory Prospectus as of the
actual time that form of prospectus is filed with the Commission
pursuant to Rule 424(b) under the Securities Act.
(3) “Issuer Free Writing
Prospectus” means any “issuer free writing
prospectus,” as defined in Rule 433 under the Securities
Act (“ Rule 433 ”), relating to the
Securities in the form filed or required to be filed with the
Commission or, if not required to be filed, in the form retained in
the Company’s records pursuant to Rule 433(g) under the
Securities Act.
(4) “Issuer General Use Free
Writing Prospectus” means any Issuer Free Writing
Prospectus that is intended for general distribution to prospective
investors as identified on Schedule I hereto, and does
not include a “bona fide electronic road show” as
defined in Rule 433.
(5) “Issuer Limited-Use Free
Writing Prospectus” means any Issuer Free Writing
Prospectus that is not an Issuer General Free Writing Prospectus,
including any “bona fide electronic road show” as
defined in Rule 433, that is made available without
restriction pursuant to Rule 433(d)(8)(ii), even though not
required to be filed with the Commission.
(d)
Conflict with Registration Statements . Each Issuer Free
Writing Prospectus, as of its issue date and at all subsequent
times through the completion of the offering and sale of the
Securities or until any earlier date that the Company notified or
notifies the Placement Agent, did not, does not and will not
include any information that conflicted, conflicts or will conflict
with the information contained in the Registration Statements, any
Statutory 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 included an untrue statement of a material fact or
omitted to state a material fact required to be stated therein or
necessary in order to make the statements therein not misleading;
provided, that the Company makes no representations or warranty in
this paragraph with respect to any Placement Agent
Information.
(e)
Distributed Materials . The Company has not, directly or
indirectly, distributed and will not distribute any prospectus or
other offering material in connection with the offering and sale of
the Securities other than the Disclosure Package or the Prospectus,
and other materials, if any, permitted under the Securities Act to
be distributed and consistent with Section 3 below. The
Company will file with the Commission all Issuer Free Writing
Prospectuses required to be filed in the time required under Rule
433(d) under the Securities Act. The Company has satisfied or will
satisfy the conditions in Rule 433 under the Securities Act to
avoid a requirement to file with the Commission any electronic road
show. The parties hereto agree and understand that the content of
any and all “road shows” related to the offering of the
Securities contemplated hereby is solely the property of the
Company.
(f)
Not an Ineligible Issuer . (1) At the earliest time
after the filing of the Registration Statements that the Company or
another offering participant made a bona fide offer (within the
meaning of Rule 164(h)(2) under the Securities Act) of the
Securities and (2) at the date hereof, the
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Company
was not and is not an “ineligible issuer,” as defined
in Rule 405 under the Securities Act, without taking account
of any determination by the Commission pursuant to Rule 405
that it is not necessary that the Company be considered an
ineligible issuer, including, without limitation, for purposes of
Rules 164 and 433 under the Securities Act with respect to the
offering of the Securities as contemplated by the Registration
Statements.
(g)
Incorporated Documents . The documents incorporated by
reference in the Disclosure Package and 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 were
filed on a timely basis with the Commission and none of such
documents contained an untrue statement of a material fact or
omitted to state a material fact necessary to make the statements
therein, in the light of the circumstances under which they were
made, not misleading.
(h)
Due Incorporation . The Company has been duly incorporated
and is validly existing as a corporation in good standing under the
laws of its jurisdiction of incorporation, with the corporate power
and authority to own its properties and to conduct its business as
currently being carried on and as described in the Registration
Statements, the Disclosure Package and the Prospectus and is duly
qualified to transact business as a foreign corporation in good
standing under the laws of each other jurisdiction in which its
ownership or leasing of property or the conduct of its business
requires such qualification, except where the failure to be so
qualified and in good standing (i) would not, individually or
in the aggregate, result in any material adverse effect upon, or
change in, the general affairs, business, operations, prospects,
properties, financial condition, or results of operations of the
Company taken as a whole or (ii) would not impair in any material
respect the ability of the Company to perform its obligations under
this Agreement or to consummate any transactions contemplated by
this Agreement, the Disclosure Package or the Prospectus (any such
effect as described in clauses (i) or (ii), a “
Material Adverse Effect ”).
(i)
Capitalization . All of the issued and outstanding shares of
capital stock of the Company, including the outstanding shares of
Common Stock, have been duly authorized and validly issued and are
fully paid and nonassessable, have been issued in compliance with
all federal and state securities laws, were not issued in violation
of or subject to any preemptive rights or other rights to subscribe
for or purchase or acquire any securities of the Company that have
not been waived in writing.
(j)
The Securities . The Shares have been duly and validly
authorized by the Company and, when issued, delivered and paid for
in accordance with the terms of this Agreement and the Subscription
Agreements, will have been duly and validly issued and will be
fully paid and nonassessable and will not be subject to any
statutory or contractual preemptive rights or other rights to
subscribe for or purchase or acquire any shares of Common Stock of
the Company, which have not been waived or complied with and will
conform in all material respects to the description thereof
contained in the Disclosure Package and the Prospectus and such
description conforms in all material respects to the rights set
forth in the instruments defining the same. The Warrants conform,
or when issued will conform, to the description thereof contained
in the Disclosure Package and the Prospectus and have been duly and
validly authorized by the Company and upon delivery to the
Investors at the Closing Date will be valid and binding obligations
of the Company, enforceable in accordance with their terms, except
as such enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the rights and
remedies of creditors generally or subject to general principles of
equity. The Warrant Shares initially issuable upon exercise of the
Warrants conform, or when issued will conform, to the description
thereof contained in the Disclosure Package and the Prospectus and
have been duly authorized and reserved for issuance and when issued
in accordance with the terms thereof will be validly issued, fully
paid and nonassessable.
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(k)
Description of Capital Stock . The capital stock of the
Company, including the Common Stock, conforms as to legal matters
to the description thereof, if any, contained in the Registration
Statements, the Statutory Prospectus and the Prospectus, and as of
the date thereof, the Company had authorized capital stock as set
forth therein. The Securities are in due and proper form and the
holders of the Securities will not be subject to personal liability
by reason of being such holders.
(l)
No Registration Rights . Except as otherwise described in
the Disclosure Package, there are no preemptive rights or other
rights to subscribe for or to purchase, or any restriction upon the
voting of transfer of, any shares of Common Stock pursuant to the
Company’s charter, by-laws or any agreement or other
instrument to which the Company is a party or by which the Company
is bound. There are no contracts, agreements or understandings
between the Company and any person granting such person the right
(other than rights which have been waived in writing in connection
with the transactions contemplated by this Agreement or otherwise
satisfied) to require the Company to file a registration statement
under the Securities Act with respect to any securities of the
Company owned or to be owned by such person or to require the
Company to include such securities in the securities registered
pursuant to the Registration Statements or in any securities being
registered pursuant to any other registration statement filed by
the Company under the Securities Act.
(m)
Subsidiaries . The Company has no significant subsidiaries
(as such term is defined in Rule 1-02(w) of Regulation S-X
promulgated by the Commission).
(n)
Due Authorization and Enforceability . The Company has the
full right, power and authority to enter into this Agreement, each
of the Subscription Agreements and the Escrow Agreement, and to
perform and discharge its obligations hereunder and thereunder; and
each of this Agreement, the Escrow Agreement and each Subscription
Agreement has been duly authorized, executed and delivered by the
Company, and constitutes a valid, legal and binding obligation of
the Company, enforceable against the Company in accordance with its
terms, except as rights to indemnity hereunder may be limited by
federal or state securities laws and except as such enforceability
may be limited by applicable bankruptcy, insolvency, reorganization
or similar laws affecting the rights of creditors generally and
subject to general principles of equity.
(o)
No Conflict . The execution, delivery and performance by the
Company of this Agreement each Subscription Agreement and the
Escrow Agreement and the consummation of the transactions herein
contemplated, including the issuance and sale by the Company of the
Securities and the issuance of the Warrant Shares upon due exercise
of the Warrants in accordance with their terms, will not conflict
with or result in a breach or violation of, or constitute a default
under (nor constitute any event which with notice, lapse of time or
both would result in any breach or violation of or constitute a
default under) (i) the provisions of the charter or by-laws of
the Company, (ii) any material indenture, mortgage, deed of
trust, bank loan or credit agreement or other evidence of
indebtedness, or any license, lease, contract or other agreement or
instrument to which the Company is a party or by which it or any of
its properties may be bound or affected, or (iii) any federal,
state, local or foreign law, regulation or rule or any decree,
judgment or order applicable to the Company.
(p)
No Consents Required . No approval, authorization, consent
or order of or filing with any federal, state, local or foreign
governmental or regulatory commission, board, body, authority or
agency, or of or with any self-regulatory organization or other
non-governmental regulatory authority (including, without
limitation, the National Association of Securities Dealers
Automated Quotation (“ Nasdaq ”) Global Market,
or approval of the stockholders of the Company (including such as
may be required pursuant to Rule 4350 of the Nasdaq
Marketplace Rules), is required in connection with the execution,
delivery and performance of this Agreement, the Subscription
Agreements and the Escrow
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Agreement by the Company, the issuance and sale of the Securities
and the issuance of the Warrant Shares upon due exercise of the
Warrants in accordance with their terms, or the consummation by the
Company of the transactions contemplated hereby other than
(i) as may be required under the Securities Act, (ii) any
necessary qualification of the Securities under the securities or
blue sky laws of the various jurisdictions in which the Securities
are being offered by the Placement Agent and (iii) under the
rules and regulations of the Financial Industry Regulatory
Authority (“ FINRA ”).
(q)
No Violation . The Company is not in breach or violation of
or in default (nor has any event occurred which with notice, lapse
of time or both would result in any breach or violation of, or
constitute a default) (i) under the provisions of its charter
or bylaws or (ii) in the performance or observance of any
term, covenant, obligation, agreement or condition contained in any
indenture, mortgage, deed of trust, bank loan or credit agreement
or other evidence of indebtedness, or any license, lease, contract
or other agreement or instrument to which the Company is a party or
by which it or any of its properties may be bound or affected, or
(iii) in the performance or observance 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 any of its 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
governmental or regulatory authority performing functions similar
to those performed by the FDA), except, with respect to clauses
(ii) and (iii) above, to the extent any such
contravention has been waived or would not result in a Material
Adverse Effect.
(r)
Absence of Material Changes. Subsequent to the respective
dates as of which information is given in the Disclosure Package
(and taking into account any updates included within the Disclosure
Package), (a) the Company has not 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,
(b) the Company has not incurred any material liability or
obligation, direct or contingent, or entered into any material
transaction not in the ordinary course of business; (c) the
Company has not purchased any of the Company’s outstanding
capital stock, or declared, paid or otherwise made any dividend or
distribution of any kind on the Company’s capital stock; and
(d) there has not been any change in the capital stock (other
than a change in the number of outstanding shares of Common Stock
due to the issuance of shares upon the exercise of outstanding
options or warrants or the conversion of convertible indebtedness),
or material change in the short-term debt or long-term debt of the
Company (other than upon conversion of convertible indebtedness) or
any issue of options, warrants, convertible securities or other
rights to purchase the capital stock (other than grants of stock
options under the Company’s equity incentive plans existing
on the date hereof) of the Company, or any Material Adverse
Effect.
(s)
Permits . The Company possesses, and is operating in
compliance in all material respects with, all necessary franchises,
licenses, grants, permits, easements, authorizations, consents,
certificates and orders of any governmental or self-regulatory body
required for the conduct of its business and all such franchises,
licenses, grants, permits, easements, authorizations, consents,
certificates and orders are valid and in full force and effect. The
Company has made all necessary material filings required under any
federal, state, local or foreign law, regulation or rule
(including, without limitation, those from the FDA, and any other
foreign, federal, state or local government or regulatory
authorities performing functions similar to those performed by the
FDA), in order to conduct its business. The Company has not
received notice of any proceedings relating to revocation or
modification of, any such franchise, license, grant, permit,
easement, authorization, consent, certificate or order, except
where such violation, default or proceeding would not, individually
or in the aggregate, have a Material Adverse Effect.
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(t)
Legal Proceedings . There are no legal or governmental
proceedings pending or, to the Company’s knowledge,
threatened or contemplated to which the Company is or would be a
party or of which any of its properties is or would be subject at
law or in equity, before or by any federal, state, local or foreign
governmental or regulatory commission, board, body, authority or
agency, or before or by any self-regulatory organization or other
non-governmental regulatory authority (including, without
limitation, Nasdaq), except (i) as described in the
Registration Statements, the Prospectus, and the Disclosure
Package, (ii) any such proceeding, which if resolved adversely
to the Company, would not result in a judgment, decree or order
having, individually or in the aggregate, a Material Adverse Effect
or (iii) any such proceeding that would not prevent or
materially and adversely affect the ability of the Company to
consummate the transactions contemplated hereby. The Disclosure
Package contains in all material respects the same description of
the foregoing matters contained in the Prospectus.
(u)
Statutes; Contracts . There are no statutes or regulations
applicable to the Company or contracts or other documents of the
Company which are required to be described in the Registration
Statements, the Disclosure Package or the Prospectus or filed as
exhibits to the Registration Statements by the Securities Act or by
the Rules and Regulations which have not been so described or
filed.
(v)
Good Title to Property . The Company has good and valid
title to all property (whether real or personal) described in the
Registration Statements, the Disclosure Package and the Prospectus
as being owned by it, in each case free and clear of all liens,
claims, security interests, other encumbrances or defects except
such as are described in the Registration Statements, the
Disclosure Package and the Prospectus and those that would not,
individually or in the aggregate materially affect the value of
such property and do not materially interfere with the use made and
proposed to be made of such property by the Company. All of the
property described in the Registration Statements, the Disclosure
Package and the Prospectus as being held under lease by the Company
is held thereby under valid, subsisting and enforceable leases,
without any liens, restrictions, encumbrances or claims, except
those that, individually or in the aggregate, are not material
and do not materially interfere with the use made and proposed to
be made of such property by the Company.
(w)
Intellectual Property Rights . The Company owns, or has
obtained valid and enforceable licenses for, or other rights to
use, the inventions, patent applications, patents, trademarks (both
registered and unregistered), tradenames, copyrights, trade secrets
and other proprietary information described in the Registration
Statements, the Disclosure Package and the Prospectus as being
owned or licensed by it or which are necessary for the conduct of
its business, except where the failure to own, license or have such
rights would not, individually or in the aggregate, result in a
Material Adverse Effect (collectively, “ Intellectual
Property ”); except as described in the Registration
Statements, the Disclosure Package and the Prospectus
(i) there are no third parties who have or, to the
Company’s knowledge, will be able to establish rights to any
Intellectual Property, except for the ownership rights of the
owners of the Intellectual Property which is licensed to the
Company; (ii) to the Company’s knowledge, there is no
infringement by third parties of any Intellectual Property;
(iii) there is no pending or, to the Company’s
knowledge, threatened action, suit, proceeding or claim by others
challenging the Company’s rights in or to, or the validity,
enforceability, or scope of, any Intellectual Property owned by or
licensed to the Company, and the Company is unaware of any facts
which could form a reasonable basis for any such claim;
(iv) there is no pending or, to the Company’s knowledge,
threatened action, suit, proceeding or claim by others that the
Company infringes or otherwise violates any patent, trademark,
copyright, trade secret or other proprietary rights of others, and
the Company is unaware of any facts which could form a reasonable
basis for any such claim; (v) to the Company’s
knowledge, there is no patent or patent application that contains
claims that interfere with the issued or pending claims of any of
the Intellectual Property; and (vi) to the Company’s
knowledge, each issued patent was validly issued under the laws
of
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the
country that issued it; except in each case of (i) through
(vi) above, where any such exceptions would not, individually
or in the aggregate, have a Material Adverse Effect.
(x)
Financial Statements . The financial statements of the
Company, together with the related schedules and notes thereto, set
forth or incorporated by reference in the Registration Statements,
the Disclosure Package and the Prospectus comply in all material
respects with the applicable requirements of the Securities Act and
the Exchange Act, as applicable, and present fairly in all material
respects (i) the financial condition of the Company, taken as
a whole, as of the dates indicated and (ii) the consolidated
results of operations, stockholders’ equity and changes in
cash flows of the Company, taken as a whole, for the periods
therein specified; and such financial statements and related
schedules and notes thereto have been prepared in conformity with
United States generally accepted accounting principles,
consistently applied throughout the periods involved (except as
otherwise stated therein and subject, in the case of unaudited
financial statements, to the absence of footnotes and normal
year-end adjustments). There are no other financial statements
(historical or pro forma) that are required to be included in the
Registration Statements, the Disclosure Package and the Prospectus;
and the Company does not have any material liabilities or
obligations, direct or contingent (including any off-balance sheet
obligations), not disclosed in the Registration Statements, the
Disclosure Package and the Prospectus; and all disclosures
contained in the Registration Statements, the Disclosure Package
and the Prospectus regarding “non-GAAP financial
measures” (as such term is defined by the rules and
regulations of the Commission) comply with Regulation G of the
Exchange Act and Item 10(e) of Regulation S-K of the
Commission, to the extent applicable, and present fairly the
information shown therein and the Company’s basis for using
such measures.
(y)
Independent Accountants . To the Company’s knowledge,
KMJ Corbin & Company, LLP, who have certified certain of the
financial statements of the Company, is (i) an independent
public accounting firm within the meaning of the Securities Act and
the Rules and Regulations, (ii) a registered public accounting
firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act
of 2002 (the “ Sarbanes-Oxley Act ”)), and
(iii) not in violation of the auditor independence
requirements of the Sarbanes-Oxley Act.
(z)
Taxes . The Company has timely filed all federal, state,
local and foreign income and franchise tax returns (or timely filed
applicable extensions therefore) that have been required to be
filed and are not in default in the payment of any taxes which were
payable pursuant to said returns or any assessments with respect
thereto, other than any which the Company is contesting in good
faith and for which adequate reserves have been provided and
reflected in the Company’s financial statements included in
the Registration Statements, the Disclosure Package and the
Prospectus. The Company does not have any tax deficiency that has
been or, to the knowledge of the Company, might be asserted or
threatened against it that would result in a Material Adverse
Effect.
(aa)
Nasdaq; Exchange Act Registration . The Common Stock is
registered pursuant to Section 12(b) or 12(g) of the Exchange Act
and is accepted for quotation on the Nasdaq Global Market, and the
Company has taken no action designed to terminate the registration
of the Common Stock under the Exchange Act or delisting the Common
Stock from the Nasdaq Global Market, nor, except as disclosed in
the Disclosure Package and the Prospectus, has the Company received
any notification that the Commission or FINRA is contemplating
terminating such registration or listing. Except as disclosed in
the Disclosure Package and the Prospectus, the Company has complied
in all material respects with the applicable requirements of the
Nasdaq Global Market for maintenance of inclusion of the Common
Stock thereon. The Company has filed an application to include the
Shares and Warrant Shares on the Nasdaq Global Market.
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(bb)
Accounting Controls . The Company maintains a system of
internal accounting controls sufficient to provide reasonable
assurances that (i) transactions are executed in accordance
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. Except as described in the
Registration Statements, in the Disclosure Package and in the
Prospectus, since the most recent audit of the effectiveness of the
Company’s internal control over financial reporting, there
has been (i) 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 affected, or
is reasonably likely to materially affect, the Company’s
internal control over financial reporting.
(cc)
Disclosure Controls . The Company has established, maintains
and evaluates “disclosure controls and procedures” (as
such term is defined in Rule 13a-15(e) and 15d-15(e) under the
Exchange Act), which (i) are designed to ensure that material
information relating to the Company is made known to the
Company’s principal executive officer and its principal
financial officer by others within those entities, particularly
during the periods in which the periodic reports required under the
Exchange Act are being prepared, (ii) have been evaluated for
effectiveness as of the end of the last fiscal period covered by
the Registration Statements; and (iii) such disclosure
controls and procedures are effective to perform the functions for
which they were established. There are no significant deficiencies
and material weaknesses in the design or operation of internal
controls which could adversely affect the Company’s ability
to record, process, summarize, and report financial data to
management and the Board of Directors. The Company is not aware
of any fraud, whether or not material, that involves
management or other employees who have a role in the
Company’s internal controls; and since the date of the most
recent evaluation of such disclosure controls and procedures, there
have been no significant changes in internal controls or in other
factors that could significantly affect internal controls,
including any corrective actions with regard to significant
deficiencies and material weaknesses.
(dd)
Sarbanes-Oxley Act . The Company, and to its knowledge, all
of the Company’s directors or officers, in their capacities
as such, is in compliance in all material respects with all
applicable effective provisions of the Sarbanes-Oxley Act and any
related rules and regulations promulgated by the Commission.
(ee)
Minute Books . Copies of the contents of the minute books of
the Company since October 1, 2004 have been made available to
the Placement Agent and counsel for the Placement Agent, and such
books (i) contain a complete 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 that time through the date
of the latest meeting and action, and (ii) accurately in all
material respects reflect all transactions referred to in such
minutes.
(ff) Not an Investment Company . The Company is not,
nor after giving effect to the offering and sale of the Securities
and the application of the proceeds thereof as described in the
Prospectus, will be, (i) required to register as an
“investment company” as defined in the Investment
Company Act of 1940, as amended (the “ Investment Company
Act ”), and the rules and regulations of the Commission
thereunder or (ii) a “business development
company” (as defined in Section 2(a)(48) of the
Investment Company Act).
(gg)
Insurance . The Company maintains insurance in such amounts
and covering such risks as it reasonably considers to be adequate
for the conduct of its business and the value of its properties and
as is customary for companies engaged in similar businesses in
similar industries. All such insurance is fully in force on the
date hereof and will be fully in force as of the Closing Date.
The
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Company
has no reason to believe that it will not be able to renew its
existing insurance coverage as and when such coverage expires or to
obtain similar coverage from similar insurers as may be necessary
to continue its business at a cost that would not have a Material
Adverse Effect.
(hh)
Brokers Fees . The Company is not a party to any contract,
agreement or understanding with any person (other than this
Agreement) that would give rise to a valid claim against the
Company or the Placement Agent for a brokerage commission,
finder’s fee or other like payment in connection with the
offering and sale of the Securities.
(ii)
Integration . The Company has not sold or issued any
securities that would be integrated with the offering of the
Securities contemplated by this Agreement pursuant to the
Securities Act, the Rules and Regulations or the interpretations
thereof by the Commission.
(jj)
Corrupt Practices . Neither the Company nor, to the
Company’s knowledge, any other person associated with or
acting on behalf of the Company, including without limitation any
director, officer, agent or employee of the Company has, directly
or indirectly, while acting on behalf of the Company (i) used
any corporate funds for unlawful contributions, gifts,
entertainment or other unlawful expenses relating to political
activity, (ii) made any unlawful payment to foreign or
domestic government officials or employees or to foreign or
domestic political parties or campaigns from corporate funds,
(iii) violated any provision of the Foreign Corrupt Practices
Act of 1977, as amended or (iv) made any other unlawful
payment.
(kk)
Critical Accounting Policies . The section entitled
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Critical Accounting
Policies and Estimates for Continuing Operations” and
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Critical Accounting
Policies and Estimates for Discontinued Operations” in the
Company’s most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q accurately and fully describes
(A) the accounting policies that the Company believes are the
most important in the portrayal of the Company’s financial
condition and results of operations and that require
management’s most difficult, subjective or complex judgments
(“ Critical Accounting Policies ”); and
(B) the judgments and uncertainties affecting the application
of Critical Accounting Policies.
(ll)
No Price Stabilization . Neither the Company nor, to the
Company’s knowledge, any of its officers, directors,
affiliates or controlling persons has taken or will take, directly
or indirectly, any action designed to cause or result in, or which
has constituted or which might reasonably be expected to constitute
the stabilization or manipulation of the price of any security of
the Company to facilitate the sale or resale of the
Securities.
(mm)
No Undisclosed Relationships . No relationship, direct or
indirect, exists between or among the Company on the one hand and
the directors, officers, stockholders, customers or suppliers of
the Company on the other hand which is required to be described in
the Registration Statements, the Disclosure Package and the
Prospectus which has not been so described.
(nn)
Exchange Act Requirements . The Company has filed in a
timely manner all reports required to be filed pursuant to
Sections 13(a), 13(e), 14 and 15(d) of the Exchange Act during
the preceding 12 months (except to the extent that
Section 15(d) requires reports to be filed pursuant to
Sections 13(d) and 13(g) of the Exchange Act, which shall be
governed by the next clause of this sentence); and the Company has
filed in a timely manner all reports required to be filed pursuant
to Sections 13(d) and 13(g) of the Exchange Act during the
preceding 12 months, except where the failure to timely file
could not reasonably be expected individually or in the aggregate
to have a Material Adverse Effect.
-12-
(oo)
FINRA Affiliations . To the Company’s knowledge, there
are no affiliations or associations between (i) any member of
FINRA and (ii) the Company or any of the Company’s
officers, directors or 5% or greater securityholders or any
beneficial owner of the Company’s unregistered equity
securities that were acquired from the Company at any time on or
after the one hundred eightieth (180th) day immediately preceding
the date either of the Registration Statements was initially filed
with the Commission, except as set forth in the Registration
Statements, the Disclosure Package and the Prospectus.
(pp)
Compliance with Environmental Laws . The Company (a) is
in compliance with any and all applicable foreign, federal, state
and local laws, orders, rules, regulations, directives, decrees and
judgments relating to the protection of human health and safety,
the environment or hazardous or toxic substances or wastes,
pollutants or contaminants (“ Environmental Laws
”), (b) has received all permits, licenses or other
approvals required of them under applicable Environmental Laws to
conduct its business and (c) is in compliance with all terms
and conditions of any such permit, license or approval, except
where such noncompliance with Environmental Laws, failure to
receive required permits, licenses or other approvals or failure to
comply with the terms and conditions of such permits, licenses or
approvals would not, ind
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