Exhibit 1.1
9,259,254 Shares
and
Warrants to Purchase 3,703,701
Shares
ACUSPHERE, INC.
Common Stock
($.01 par value)
PLACEMENT AGENT AGREEMENT
December 6, 2006
COWEN AND COMPANY, LLC
1221 Avenue of the Americas
New York, New York 10020
Dear Sirs:
1.
INTRODUCTION . Acusphere, Inc., a Delaware corporation
(the “ Company ”), proposes to issue and sell to
the purchasers, pursuant to the terms of the Subscription
Agreements in the form of Exhibit A attached hereto (the
“ Subscription Agreements ”) entered into with
the purchasers identified therein (each a “ Purchaser
” and collectively, the “ Purchasers ”),
up to an aggregate of 9,259,254 units (the “ Units
”), each consisting of (i) one share (the “
Share ,” collectively the “ Shares
”) of common stock, $0.01 par value per share (the “
Common Stock ”) of the Company and (ii) one warrant
(the “ Warrant ,” collectively the “
Warrants ”) to purchase .4 shares of Common Stock. The
shares issuable upon the exercise of the Warrants are referred to
herein as the “ Warrant Shares .” The Warrant
Shares, together with the Shares and the Warrants, are referred to
herein as the “ Securities .” The Company hereby
confirms its agreement with Cowen and Company, LLC to act as
Placement Agent (“ Cowen , or the “ Placement
Agent ”) in accordance with the terms and conditions of
this Placement Agent Agreement (this “ Agreement
”).
2.
AGREEMENT TO ACT AS PLACEMENT AGENT; PLACEMENT OF
SECURITIES. On the basis of the representations,
warranties and agreements of the Company herein contained, and
subject to all the terms and conditions of this
Agreement:
(I)
The Company hereby authorizes the Placement Agent to act as its
sole agent to solicit offers for the purchase of all or part of the
Units from the Company in connection with the proposed offering of
the Units (the “ Offering ”). Until the Closing
Date (as defined in Section 4 hereof), the Company shall
not, without the prior written consent of the Placement Agent,
solicit or accept offers to purchase Units, Common Stock or
Warrants otherwise than through the Placement Agent.
(II)
The Placement Agent agrees, as agent of the Company, to use its
reasonable efforts to solicit offers to purchase the Units from the
Company on the terms and subject to the conditions set forth in the
Prospectus (as defined below). The Placement Agent shall use
reasonable efforts to assist the Company in selling Units to each
Purchaser whose offer to purchase the Units was solicited by the
Placement Agent and accepted by the Company, but the Placement
Agent shall not, except as otherwise provided in the Agreement, be
obligated to disclose the identity of any potential purchaser or
have any liability to the Company in the event any such purchase is
not consummated for any reason. Under no circumstances will the
Placement Agent be obligated to underwrite or purchase any Units
for its own account and, in soliciting purchases of Units, the
Placement Agent shall act solely as the Company’s agent and
not as principal. Notwithstanding the foregoing and except as
otherwise provided in Section 2(II) , it is understood and
agreed that the Placement Agent (or its affiliates) may, solely at
its discretion and without any obligation to do so, purchase the
Units as principal.
(III)
Subject to the provisions of this Section 2 , offers for the
purchase of Units may be solicited by the Placement Agent as agent
for the Company at such times and in such amounts as the Placement
Agent deems advisable. The Placement Agent shall communicate to the
Company, orally or in writing, each reasonable offer to purchase
Units received by it as agent of the Company. The Company shall
have the sole right to accept offers to purchase the Units and may
reject any such offer, in whole or in part. The Placement Agent
shall have the right, in its discretion, without notice to the
Company, to reject any offer to purchase Units received by it, in
whole or in part, and any such rejection shall not be deemed a
breach of this Agreement.
(IV)
The Units are being sold to the Purchasers at a price of $2.75 per
Unit. The purchases of the Units by the Purchasers shall be
evidenced by the execution of Subscription Agreements by each of
the Purchasers and the Company.
(V)
As compensation for services rendered, on the Closing Date (as
defined in Section 4 hereof), the Company shall pay to the
Placement Agent by wire transfer of immediately available funds to
an account or accounts designated by the Placement Agent, on such
Closing Date, an aggregate amount equal to six percent (6%) of the
gross proceeds received by the Company from the sale of the Units
on such Closing Date.
(VI)
No Units which the Company has agreed to sell pursuant to
Subscription Agreements shall be deemed to have been purchased and
paid for, or sold by the Company, until such Units shall have been
delivered to the Purchaser thereof against payment by such
Purchaser. If the Company shall default in its obligations to
deliver Units to a Purchaser whose offer it has accepted, the
Company shall indemnify and hold the Placement Agent harmless
against any loss, claim, damage or expense arising from or as a
result of such default by the Company in accordance with the
procedures set forth in Section 8(III) herein.
3.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
(I)
The Company represents and warrants to, and agrees with, the
Placement Agent and the Purchasers that:
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(a) The Company has
prepared and filed in conformity with the requirements of the
Securities Act of 1933, as amended (the “ Securities
Act ”), and published rules and regulations thereunder
(the “ Rules and Regulations ”) adopted by the
Securities and Exchange Commission (the “ Commission
”) a “shelf” Registration Statement on Form S-3
(File No. 333-134263), which became effective on June 1, 2006 (the
“ Effective Date ”), including a base prospectus
relating to the Securities (the “ Base Prospectus
”), and such amendments and supplements thereto as may have
been required to the date of this Agreement. The term “
Registration Statement ” as used in this Agreement
means the registration statement (including all exhibits, financial
schedules and all documents and information deemed to be a part of
the Registration Statement pursuant to Rule 430A under the
Securities Act), as amended and/or supplemented to the date of this
Agreement, including the Base Prospectus. The Registration
Statement is effective under the Securities Act and no stop order
preventing or suspending the effectiveness of the Registration
Statement or suspending or preventing the use of the Prospectus has
been issued by the Commission and no proceedings for that purpose
have been instituted or, to the Knowledge (as defined herein) of
the Company, are threatened by the Commission. The Company, if
required by the Rules and Regulations of the Commission, will file
the Prospectus (as defined below), with the Commission pursuant to
Rule 424(b) of the Rules and Regulations. The term “
Prospectus ” as used in this Agreement means the
Prospectus, in the form in which it is to be filed with the
Commission pursuant to Rule 424(b) of the Rules and Regulations,
or, if the Prospectus is not to be filed with the Commission
pursuant to Rule 424(b), the Prospectus in the form included as
part of the Registration Statement as of the Effective Date, except
that if any revised prospectus or prospectus supplement shall be
provided to the Placement Agent by the Company for use in
connection with the offering and sale of the Units which differs
from the Prospectus (whether or not such revised prospectus or
prospectus supplement is required to be filed by the Company
pursuant to Rule 424(b) of the Rules and Regulations), the term
“ Prospectus ” shall refer to such revised
prospectus or prospectus supplement, as the case may be, from and
after the time it is first provided to the Placement Agent for such
use. Any preliminary prospectus or prospectus subject to completion
included in the Registration Statement or filed with the Commission
pursuant to Rule 424(a) of the Rules and Regulations is hereafter
called a “ Preliminary Prospectus .” Any
reference herein to the Registration Statement, any Preliminary
Prospectus or the Prospectus shall be deemed to refer to and
include the documents incorporated by reference therein and any
reference herein to the terms “amend,”
“amendment,” or “supplement” with respect
to the Registration Statement, any Preliminary Prospectus or the
Prospectus shall be deemed to refer to and include (i) the filing
of any document under the Exchange Act of 1934, as amended (the
“ Exchange Act ”), after the Effective Date, the
date of such Preliminary Prospectus or the date of the Prospectus,
as the case may be, which is incorporated by reference in the
Registration Statement, any Preliminary Prospectus or the
Prospectus and (ii) any such document so filed and incorporated by
reference. If the Company has filed an abbreviated registration
statement to register additional Securities pursuant to Rule 462(b)
under the Rules and Regulations (the “ 462(b) Registration
Statement ”), then any reference herein to the
Registration Statement shall also be deemed to include such 462(b)
Registration Statement.
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(b) As of the Applicable
Time (as defined below) and as of the Closing Date, neither
(i) any General Use Free Writing Prospectus (as defined below)
issued at or prior to the Applicable Time, and the Pricing
Prospectus (as defined below), all considered together
(collectively, the “ General Disclosure Package
”), (ii) any individual Limited Use Free Writing Prospectus
(as defined below), nor (iii) any bona fide electronic road show
(as defined in Rule 433(h)(5) of the Rules and Regulations that has
been made available without restriction to any person), when
considered together with the General Disclosure Package, included
or will include, any untrue statement of a material fact or omitted
or as of the Closing Date will omit, to state a material fact
necessary in order to make the statements therein, in the light of
the circumstances under which they were made, not misleading;
provided, however , that the Company makes no
representations or warranties as to information contained in or
omitted from any Issuer Free Writing Prospectus (as defined below),
in reliance upon, and in conformity with, written information
furnished to the Company by the Placement Agent specifically for
inclusion therein, which information the parties hereto agree is
limited to the Placement Agent’s Information (as defined in
Section 18) . As used in this paragraph (b) and elsewhere in
this Agreement:
“ Applicable Time
” means 5:00 P.M., New York time, on the date of this
Agreement.
“ Pricing Prospectus
” means the Preliminary Prospectus, if any, and the Base
Prospectus, each as amended and supplemented immediately prior to
the Applicable Time, including any document incorporated by
reference therein and any prospectus supplement deemed to be a part
thereof.
“ Issuer Free Writing
Prospectus ” means any “issuer free writing
prospectus,” as defined in Rule 433 of the Rules and
Regulations 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) of the Rules and Regulations.
“ General Use Free Writing
Prospectus ” means any Issuer Free Writing Prospectus
that is identified on Schedule A to this
Agreement.
“ Limited Use Free Writing
Prospectuses ” means any Issuer Free Writing Prospectus
that is not a General Use Free Writing Prospectus.
(c) No order preventing
or suspending the use of any Preliminary Prospectus, any Issuer
Free Writing Prospectus or the Prospectus relating to the proposed
offering of the Units has been issued by the Commission, and no
proceeding for that purpose or pursuant to Section 8A of the
Securities Act has been instituted or, to the Company’s
Knowledge, threatened by the Commission, and each Preliminary
Prospectus, if any, at the time of filing thereof, conformed in all
material respects to the requirements of the Securities Act and the
Rules and Regulations, and did not contain an untrue statement of a
material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein, in the
light of the circumstances under which they were made, not
misleading; provided, however , that the Company makes no
representations or warranties as to information contained in or
omitted from any Preliminary Prospectus, in reliance upon, and in
conformity with, written information furnished to the Company by
the Placement Agent specifically for inclusion therein, which
information the parties hereto agree is limited to the Placement
Agent’s Information (as defined in Section 18
).
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(d) At the time the
Registration Statement became or becomes effective, at the date of
this Agreement and at the Closing Date, the Registration Statement
conformed and will conform in all material respects to the
requirements of the Securities Act and the Rules and Regulations
and did not and will not contain any untrue statement of a material
fact or omit to state any material fact required to be stated
therein or necessary to make the statements therein, in light of
the circumstances under which they were made, not misleading; the
Prospectus, at the time the Prospectus was issued and at the
Closing Date, conformed and will conform in all material respects
to the requirements of the Securities Act and the Rules and
Regulations and did not and will not contain an untrue statement of
a material fact or omit to state a material fact necessary in order
to make the statements therein, in light of the circumstances under
which they were made, not misleading; provided ,
however , that the foregoing representations and warranties
in this paragraph (d) shall not apply to information contained in
or omitted from the Registration Statement or the Prospectus in
reliance upon, and in conformity with, written information
furnished to the Company by the Placement Agent specifically for
inclusion therein, which information the parties hereto agree is
limited to the Placement Agent’s Information (as defined in
Section 18 ).
(e) Each Issuer Free
Writing Prospectus, if any, as of its issue date and at all
subsequent times through the completion of the offer and sale of
the Units or until any earlier date that the Company notified or
notifies the Placement Agent as described in Section 5(I)(e)
, did not, does not and will not include any information that
conflicted, conflicts or will conflict with the information
contained in the Registration Statement, Pricing Prospectus or the
Prospectus, including any document incorporated by reference
therein and any prospectus supplement deemed to be a part thereof
that has not been superseded or modified, or includes an untrue
statement of a material fact or omitted or would omit to state a
material fact required to be stated therein or necessary in order
to make the statements therein, in the light of the circumstances
prevailing at the subsequent time, not misleading. The foregoing
sentence does not apply to statements in or omissions from any
Issuer Free Writing Prospectus in reliance upon, and in conformity
with, written information furnished to the Company by the Placement
Agent specifically for inclusion therein, which information the
parties hereto agree is limited to the Placement Agent’s
Information (as defined in Section 18 ).
(f) The documents
incorporated by reference in the Prospectus, when they became
effective or were filed with the Commission, as the case may be,
conformed in all material respects to the requirements of the
Securities Act or the Exchange Act, as applicable, and the rules
and regulations of the Commission thereunder and none of such
documents contained any untrue statement of a material fact or
omitted to state any material fact required to be stated therein or
necessary to make the statements therein not misleading; and any
further documents so filed and incorporated by reference in the
Prospectus, when such documents become effective or are filed with
the Commission, as the case may be, will conform in all material
respects to the requirements of the Securities Act or the Exchange
Act, as applicable, and the rules and regulations of the Commission
thereunder and will not contain any untrue statement of a material
fact or
5
omit to state any material fact
required to be stated therein or necessary to make the statements
therein not misleading.
(g) The Company has not,
directly or indirectly, distributed and will not distribute any
offering material in connection with the offering and sale of the
Units other than any Preliminary Prospectus, the Prospectus and
other materials, if any, permitted under the Securities Act and
consistent with Section 5(I)(b) below. The Company will file
with the Commission all Issuer Free Writing Prospectuses (other
than a “road show,” as described in Rule 433(d)(8) of
the Rules and Regulations), if any, in the time and manner required
under Rules 163(b)(2) and 433(d) of the Rules and
Regulations.
(h) The Company is
existing as a corporation in Delaware and each of its subsidiaries
(as defined in Section 16 ) have been duly incorporated and
are validly existing as corporations or other legal entities in
good standing (or the foreign equivalent thereof) under the laws of
their respective jurisdictions of organization. The Company and
each of its subsidiaries are duly qualified to do business and are
in good standing as foreign corporations or other legal entities in
each jurisdiction in which their respective ownership or lease of
property or the conduct of their respective businesses require such
qualification and have all power and authority (corporate or other)
necessary to own or hold their respective properties and to conduct
the businesses in which they are engaged, except where the failure
to so qualify or have such power or authority (i) would not have,
singularly or in the aggregate, a material adverse effect on the
condition (financial or otherwise), results of operations, assets,
business or prospects of the Company and its subsidiaries taken as
a whole, or (ii) impair in any material respect the ability of the
Company to perform its obligations under this Agreement or to
consummate any transactions contemplated by the Agreement, the
General Disclosure Package or the Prospectus (any such effect as
described in clauses (i) or (ii), a “ Material Adverse
Effect ”). The Company owns or controls, directly or
indirectly, only the following corporations, partnerships, limited
liability partnerships, limited liability companies, associations
or other entities: Acusphere Securities Corporation, a
Massachusetts corporation and Acusphere Limited, an entity
organized in the United Kingdom.
(i) The Company
has the full right, power and authority to enter into this
Agreement, each of the Subscription Agreements and that certain
Escrow Agreement (the “ Escrow Agreement ”)
dated as of the date hereof by and among the Company, the Placement
Agent and the escrow agent named therein, and to perform and to
discharge its obligations hereunder and thereunder; and each of
this Agreement, each of the Subscription Agreements and the Escrow
Agreement has been duly authorized, executed and delivered by the
Company, and constitutes a valid and binding obligation of the
Company enforceable in accordance with its terms.
(j) The Shares to
be issued and sold by the Company to the Purchasers under the
Subscription Agreements and the Warrant Shares, which are issuable
upon exercise of the Warrants, have been duly and validly
authorized and, when issued and delivered against payment therefor,
will be duly and validly issued, fully paid and nonassessable and
free
6
of any preemptive or similar rights
and will conform to the description thereof contained in the
General Disclosure Package and the Prospectus.
(k) All of the issued
shares of capital stock of the Company have been duly and validly
authorized and issued, are fully paid and non-assessable, have been
issued in compliance with federal and state securities laws, and
conform to the description thereof contained in the General
Disclosure Package and the Prospectus. As of December 5, 2006,
there were 28,830,922 shares of Common Stock issued and outstanding
and 730,000 shares of Preferred Stock issued and outstanding and
12,350,807 shares of Common Stock were issuable upon the exercise
of all options, warrants and convertible securities outstanding as
of such date. Since such date, the Company has not issued any
securities, other than Common Stock of the Company issued pursuant
to the exercise of warrants previously outstanding or stock options
previously outstanding under the Company’s stock option plans
or the issuance of restricted Common Stock pursuant to employee
stock purchase plans. All of the Company’s options, warrants
and other rights to purchase or exchange any securities for shares
of the Company’s capital stock have been duly authorized and
validly issued in compliance with federal and state securities
laws. None of the outstanding shares of Common Stock was issued in
violation of any preemptive rights, rights of first refusal or
other similar rights to subscribe for or purchase securities of the
Company. There are no authorized or outstanding shares of capital
stock, options, warrants, preemptive rights, rights of first
refusal or other rights to purchase, or equity or debt securities
convertible into or exchangeable or exercisable for, any capital
stock of the Company or any of its subsidiaries other than those
described above or accurately described in the General Disclosure
Package. The description of the Company’s stock option, stock
bonus and other stock plans or arrangements, and the options or
other rights granted thereunder, as described in the General
Disclosure Package and the Prospectus, accurately and fairly
present the information required to be shown therein with respect
to such plans, arrangements, options and rights.
(l) Except as
previously disclosed to the Placement Agents, all the outstanding
shares of capital stock of each subsidiary of the Company have been
duly authorized and validly issued, are fully paid and
nonassessable and, except to the extent set forth in the General
Disclosure Package or the Prospectus, are owned by the Company
directly or indirectly through one or more wholly-owned
subsidiaries, free and clear of any claim, lien, encumbrance,
security interest, restriction upon voting or transfer or any other
claim of any third party.
(m) The execution, delivery
and performance of this Agreement, the Subscription Agreements and
the Escrow Agreement by the Company, the issue and sale of the
Units by the Company and the consummation of the transactions
contemplated hereby and thereby will not (with or without notice or
lapse of time or both) conflict with or result in a breach or
violation of any of the terms or provisions of, constitute a
default under, give rise to any right of termination or other right
or the cancellation or acceleration of any right or obligation or
loss of a benefit under, or give rise to the creation or imposition
of any lien, encumbrance, security interest, claim or charge upon
any property or assets of the Company or any subsidiary pursuant
to, any indenture, mortgage, deed of trust, loan
7
agreement or other agreement or
instrument to which the Company or any of its subsidiaries is a
party or by which the Company or any of its subsidiaries is bound
or to which any of the property or assets of the Company or any of
its subsidiaries is subject, nor will such actions result in any
violation of the provisions of the charter or by-laws (or analogous
governing instruments, as applicable) of the Company or any of its
subsidiaries or any law, statute, rule, regulation, judgment, order
or decree of any court or governmental agency or body, domestic or
foreign, having jurisdiction over the Company or any of its
subsidiaries or any of their properties or assets.
(n) Except for the
registration of the Shares, Warrants and the Warrant Shares under
the Securities Act and such consents, approvals, authorizations,
registrations or qualifications as may be required under the
Exchange Act and applicable state securities laws, the National
Association of Securities Dealers, Inc. (the “ NASD
”) and the Nasdaq Global Market (the “ Nasdaq GM
”) in connection with the offering and sale of the Units and
the quotation of the Shares on the Nasdaq GM, no consent, approval,
authorization or order of, or filing, qualification or registration
(each an “ Authorization ”) with, any court,
governmental or non-governmental agency or body, foreign or
domestic, which has not been made, obtained or taken and is not in
full force and effect, is required for the execution, delivery and
performance of this Agreement by the Company, the offer or sale of
the Units or the consummation of the transactions contemplated
hereby or thereby; and no event has occurred that allows or results
in, or after notice or lapse of time or both would allow or result
in, revocation, suspension, termination or invalidation of any such
Authorization or any other impairment of the rights of the holder
or maker of any such Authorization. All corporate approvals
(including those of stockholders) necessary for the Company to
consummate the transactions contemplated by this Agreement have
been obtained and are in effect.
(o) Deloitte &
Touche, LLP, who have certified certain financial statements and
related schedules included or incorporated by reference in the
Registration Statement, the General Disclosure Package and the
Prospectus, is an independent registered public accounting firm
within the meaning of Article 2-01 of Regulation S-X and the Public
Company Accounting Oversight Board (United States) (the “
PCAOB ”). Except as disclosed in the Registration
Statement and as pre-approved in accordance with the requirements
set forth in Section 10A of the Exchange Act, Deloitte &
Touche, LLP has not been engaged by the Company to perform any
“prohibited activities” (as defined in Section 10A of
the Exchange Act).
(p) The financial
statements, together with the related notes and schedules, included
or incorporated by reference in the General Disclosure Package, the
Prospectus and in the Registration Statement fairly present, the
financial position and the results of operations and changes in
financial position of the Company and its consolidated subsidiaries
and other consolidated entities at the respective dates or for the
respective periods therein specified. Such statements and related
notes and schedules have been prepared in accordance with generally
accepted accounting principles in the United States (“
GAAP ”) applied on a consistent basis throughout the
periods involved except as may be set forth in the related notes
included or incorporated by reference in the General
Disclosure
8
Package. The financial statements,
together with the related notes and schedules, included or
incorporated by reference in the General Disclosure Package and the
Prospectus comply in all material respects with Regulation S-X as
in effect on the respective dates thereof. No other financial
statements or supporting schedules or exhibits are required by
Regulation S-X to be described, or included or incorporated by
reference in the Registration Statement, the General Disclosure
Package or the Prospectus. There is no pro forma or as adjusted
financial information which is required to be included in the
Registration Statement, the General Disclosure Package, or and the
Prospectus or a document incorporated by reference therein in
accordance with Regulation S-X which has not been included or
incorporated as so required. The summary and selected financial
data included or incorporated by reference in the General
Disclosure Package, the Prospectus and each Registration Statement
fairly present the information shown therein as at their respective
dates and for the respective periods specified and are derived from
the consolidated financial statements set forth or incorporated by
reference from the Registration Statement, the Pricing Prospectus
and the Prospectus and other financial information. All information
contained in the Registration Statement, the General Disclosure
Package and the Prospectus regarding “non-GAAP financial
measures” (as defined in Regulation G) complies with
Regulation G and Item 10 of Regulation S-K, to the extent
possible.
(q) Neither the Company
nor any of its subsidiaries has sustained, since the date of the
latest audited financial statements included or incorporated by
reference in the General Disclosure Package, any material loss or
interference with its business from fire, explosion, flood or other
calamity, whether or not covered by insurance, or from any labor
dispute or court or governmental action, order or decree, otherwise
than as set forth or contemplated in the General Disclosure
Package; and, since such date, there has not been any change in the
capital stock or long-term debt of the Company or any of its
subsidiaries, or any material adverse change, or any development
involving a prospective material adverse change, in or affecting
the business, assets, general affairs, management, financial
position, prospects, stockholders’ equity or results of
operations of the Company and its subsidiaries taken as a whole,
otherwise than as set forth or contemplated in the General
Disclosure Package.
(r) Except as set
forth in the General Disclosure Package, there is no legal or
governmental action, suit, claim or proceeding pending to which the
Company or any of its subsidiaries is a party or of which any
property or assets of the Company or any of its subsidiaries is the
subject, including any proceeding before the United States Food and
Drug Administration of the U.S. Department of Health and Human
Services (“ FDA ”) or comparable federal, state,
local or foreign governmental bodies (it being understood that the
interaction between the Company and the FDA and such comparable
governmental bodies relating to the clinical development and
product approval process shall not be deemed proceedings for
purposes of this representation), which is required to be described
in the Registration Statement, the General Disclosure Package or
the Prospectus or a document incorporated by reference therein and
is not described therein, or which, singularly or in the aggregate,
if determined adversely to the Company or any of its subsidiaries,
could reasonably be expected to have a Material Adverse Effect
or
9
prevent the consummation of the
transactions contemplated hereby; and to the best of the
Company’s knowledge (“ Knowledge ”), no
such proceedings are threatened or contemplated by governmental
authorities or threatened by others. The Company is in compliance
with all applicable federal, state, local and foreign laws,
regulations, orders and decrees governing its business as
prescribed by the FDA, or any other federal, state or foreign
agencies or bodies with jurisdiction over the activities of the
Company engaged in the regulation of pharmaceuticals or
biohazardous substances or materials, except where noncompliance
would not, singly or in the aggregate, have a Material Adverse
Effect. All preclinical and clinical studies conducted by or on
behalf of the Company to support approval for commercialization of
the Company’s products have been conducted by the Company, or
to the Company’s Knowledge by third parties, in compliance
with all applicable federal, state or foreign laws, rules, orders
and regulations, except for such failure or failures to be in
compliance as could not reasonably be expected to have, singly or
in the aggregate, a Material Adverse Effect.
(s) Neither the Company
nor any of its subsidiaries is in (i) violation of its charter or
by-laws (or analogous governing instrument, as applicable), (ii)
default in any respect, and no event has occurred which, with
notice or lapse of time or both, would constitute such a default,
in the due performance or observance of any term, covenant or
condition contained in any indenture, mortgage, deed of trust, loan
agreement, lease or other agreement or instrument to which it is a
party or by which it is bound or to which any of its property or
assets is subject (including, without limitation, those
administered by the FDA or by any foreign, federal, state or local
governmental or regulatory authority with jurisdiction over the
activities of the Company performing functions similar to those
performed by the FDA) or (iii) violation in any respect of any law,
ordinance, governmental rule, regulation or court order, decree or
judgment to which it or its property or assets may be subject
except, in the case of clauses (ii) and (iii) of this paragraph
(s), for any violations or defaults which, singularly or in the
aggregate, would not have a Material Adverse Effect.
(t) The Company
and each of its subsidiaries possess all licenses, certificates,
authorizations and permits issued by, and have made all
declarations and filings with, the appropriate local, state,
federal or foreign regulatory agencies or bodies (including,
without limitation, those administered by FDA or by any foreign,
federal, state or local governmental or regulatory authority with
jurisdiction over the activities of the Company performing
functions similar to those performed by the FDA) which are
necessary or desirable for the ownership of their respective
properties or the conduct of their respective businesses as
described in the General Disclosure Package and the Prospectus
(collectively, the “ Governmental Permits ”)
except where any failures to possess or make the same, singularly
or in the aggregate, would not have a Material Adverse Effect. The
Company and its subsidiaries are in compliance with all such
Governmental Permits; all such Governmental Permits are valid and
in full force and effect, except where the validity or failure to
be in full force and effect would not, singularly or in the
aggregate, have a Material Adverse Effect. All such Governmental
Permits are free and clear of any restriction or condition that are
in addition to, or materially different from those normally
applicable to similar licenses, certificates, authorizations and
permits. Neither the
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Company nor any subsidiary has
received notification of any revocation, modification, suspension,
termination or invalidation (or proceedings related thereto) of any
such Governmental Permit and to the Knowledge of the Company, no
event has occurred that allows or results in, or after notice or
lapse of time or both would allow or result in, revocation,
modification, suspension, termination or invalidation (or
proceedings related thereto) of any such Governmental Permit and
the Company has no reason to believe that any such Governmental
Permit will not be renewed. The studies, tests and
preclinical or clinical trials conducted by or on behalf of the
Company that are described in the General Disclosure Package and
the Prospectus (the “ Company Studies and Trials
”) were and, if still pending, are being, conducted in all
material respects in accordance with experimental protocols,
procedures and controls pursuant to, where applicable, accepted
professional scientific standards; the descriptions of the results
of the Company Studies and Trials contained in the General
Disclosure Package and Prospectus are accurate in all material
respects; and except as disclosed by the Disclosure Package and the
Prospectus the Company has not received any notices or
correspondence with 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 have a Material
Adverse Effect.
(u) Neither the Company
nor any of its subsidiaries is or, after giving effect to the
offering of the Units and the application of the proceeds thereof
as described in the General Disclosure Package and the Prospectus,
will become an “investment company” within the meaning
of the Investment Company Act of 1940, as amended, and the rules
and regulations of the Commission thereunder.
(v) Neither the Company,
its subsidiaries nor, to the Company’s Knowledge, any of the
Company’s or its subsidiaries’ officers, directors or
affiliates has taken or will take, directly or indirectly, any
action designed or intended to stabilize or manipulate the price of
any security of the Company, or which caused or resulted in, or
which might in the future reasonably be expected to cause or result
in, stabilization or manipulation of the price of any security of
the Company.
(w) The Company and its
subsidiaries own or possess the right to use (either directly or
through valid licenses) all (i) enforceable patents, trademarks,
service marks, Internet domain name registrations, copyrights,
trade secret rights and other intellectual property rights (“
Intellectual Property Rights ”) material to conduct
their respective businesses as currently conducted, and as proposed
to be conducted and described in the General Disclosure Package and
the Prospectus, except as disclosed therein. The Company and its
subsidiaries have not received written notice of any court
proceeding or material administrative proceeding, which is to their
Knowledge still pending, by any other person challenging the rights
of the Company and its subsidiaries with respect to any material
Intellectual Property Rights owned or used by the Company or its
subsidiaries except as disclosed in the General Disclosure Package.
To the Knowledge of the Company after due inquiry, the Company and
its subsidiaries’ respective businesses as now conducted do
not give rise to any infringement of, any misappropriation of, or
other violation of, any
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valid and enforceable Intellectual
Property Rights of any other person. To the Knowledge of the
Company, all licenses for the use of the Intellectual Property
Rights described in the General Disclosure Package and the
Prospectus are valid, binding upon, and enforceable by or against
the parties thereto in accordance to its terms. The Company has
complied in all material respects with, and is not in breach nor
has received any asserted or threatened claim of breach of any
Intellectual Property license, and the Company has no Knowledge of
any unresolved breach or anticipated breach by any other person to
any such license. Except as described in the General
Disclosure Package, no material claim has been made against the
Company alleging the infringement by the Company of any patent,
trademark, service mark, trade name, copyright, trade secret,
license in or other intellectual property right or franchise right
of any person. The Company has taken all reasonable steps to
protect, maintain and safeguard its material Intellectual Property
Rights, including the execution of appropriate nondisclosure and
confidentiality agreements. The consummation of the transactions
contemplated by this Agreement will not result in the loss or
impairment of or payment of any additional amounts with respect to,
nor require the consent of any other person in respect of, the
Company’s right to own, use, or hold for use any of the
material Intellectual Property Rights as owned, used or held for
use in the conduct of the business as currently
conducted.
To the Knowledge of the Company, all
patent applications filed by the Company and its subsidiaries for
all inventions owned by the Company and its subsidiaries that are
material to the conduct of the businesses of the Company and its
subsidiaries, each in the manner in which it has been and is
contemplated to be conducted as described in the Prospectus, have
been duly and properly filed or caused to be filed with the United
States Patent and Trademark Office (“ PTO ”)
and, in some cases, applicable foreign and international patent
authorities. To the Knowledge of the Company, assignments for all
patents and patent applications, including, without limitation any
continuations, divisionals, continuations-in-part, renewals,
reissues and applications for registration, to the extent such
assignments are required for any such filing, of any of the
foregoing owned by the Company and its subsidiaries (collectively,
the “ Patents ”) that are material to the
conduct of the businesses of the Company and its subsidiaries each
in the manner in which it has been and is contemplated to be
conducted as described in the Prospectus, have been properly
executed and recorded for each named inventor; except where such
failure would not reasonably be expected to have a Material Adverse
Effect. To the Knowledge of the Company, all printed publications
and patent references material to the patentability of the
inventions claimed in the Patents have been disclosed to those
patent offices so requiring pursuant to their respective disclosure
requirements. To the Knowledge of the Company, each of the Company
and the subsidiaries, and their assignors, as applicable, has met
its duty of candor and good faith to the PTO for the Patents. The
Company has no Knowledge of any facts that would preclude the
Company from having clear title to the patents and patent
applications in the Patents.
(x) The Company
and each of its subsidiaries have good and marketable title in fee
simple to, or have valid rights to lease or otherwise use, all
items of real or personal property which are material to the
business of the Company and its subsidiaries taken as a
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whole, in each case free and clear
of all liens, encumbrances, security interests, claims and defects
that do not, singularly or in the aggregate, materially affect the
value of such property and do not interfere with the use made and
proposed to be made of such property by the Company or any of its
subsidiaries; and all of the leases and subleases material to the
business of the Company and its subsidiaries, considered as one
enterprise, and under which the Company or any of its subsidiaries
hold properties described in the General Disclosure Package and the
Prospectus, are in full force and effect, and neither the Company
nor any subsidiary has received any notice of any material claim of
any sort that has been asserted by anyone adverse to the rights of
the Company or any subsidiary under any of the leases or subleases
mentioned above, or affecting or questioning the rights of the
Company or such subsidiary to the continued possession of the
leased or subleased premises under any such lease or
sublease.
(y) There is (A) no
significant unfair labor practice complaint pending against the
Company, or any of its subsidiaries, nor, to the Knowledge of the
Company, threatened against it or any of its subsidiaries, before
the National Labor Relations Board, any state or local labor
relation boards or any foreign labor relations board, and no
significant grievance or significant arbitration proceeding arising
out of or under any collective bargaining agreement is so pending
against the Company or any of its subsidiaries, or, to the
Knowledge of the Company, threatened against it and (B) no labor
disturbance by the employees of the Company or any of its
subsidiaries exists or, to the Company’s Knowledge, is
imminent, and the Company is not aware of any existing or imminent
labor disturbance by the employees of any of its or its
subsidiaries principal suppliers, manufacturers, customers or
contractors, that could reasonably be expected, singularly or in
the aggregate, to have a Material Adverse Effect. The Company is
not aware that any key employee or significant group of employees
of the Company or any subsidiary plans to terminate employment with
the Company or any such subsidiary.
(z) No
“prohibited transaction” (as defined in Section 406 of
the Employee Retirement Income Security Act of 1974, as amended,
including the regulations and published interpretations thereunder
(“ERISA”), or Section 4975 of the Internal Revenue Code
of 1986, as amended from time to time (the “Code”)) or
“accumulated funding deficiency” (as defined in Section
302 of ERISA) or any of the events set forth in Section 4043(b) of
ERISA (other than events with respect to which the thirty (30)-day
notice requirement under Section 4043 of ERISA has been waived) has
occurred or could reasonably be expected to occur with respect to
any employee benefit plan of the Company or any of its subsidiaries
which could, singularly or in the aggregate, have a Material
Adverse Effect. Each employee benefit plan of the Company or any of
its subsidiaries is in compliance in all material respects with
applicable law, including ERISA and the Code. The Company and its
subsidiaries have not incurred and could not reasonably be expected
to incur liability under Title IV of ERISA with respect to the
termination of, or withdrawal from, any pension plan (as defined in
ERISA). Each pension plan for which the Company or any of its
subsidiaries would have any liability that is intended to be
qualified under Section 401(a) of the Code is so qualified, and
nothing has occurred, whether by action or by failure to act, which
could, singularly or in the aggregate, cause the loss of such
qualification.
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