Exhibit 1.1
3,285,715 SHARES
ENZO BIOCHEM, INC.
COMMON STOCK
PLACEMENT
AGENT AGREEMENT
December 14, 2006
LAZARD CAPITAL MARKETS LLC
30 Rockefeller Plaza
New York, New York 10020
Dear Sirs:
1.
INTRODUCTION. ENZO
BIOCHEM, INC., a New York corporation (the
"COMPANY"), proposes
to issue and sell to the purchasers, pursuant to the terms
of this Placement
Agent Agreement (this "AGREEMENT") and the Subscription
Agreements in
the form of EXHIBIT A attached hereto (the "SUBSCRIPTION
AGREEMENTS") entered
into with the purchasers identified therein (each a
"PURCHASER" and collectively, the "PURCHASERS"), up to an aggregate
of 3,285,715
shares of common
stock, $0.01 par value
per share (the "COMMON
STOCK") of the
Company. The aggregate of 3,285,715 shares so proposed to be sold
is hereinafter
referred to as the
"STOCK." The Company
hereby confirms
its agreement with
Lazard Capital Markets
LLC to act as Placement Agent ("LCM," or the
"PLACEMENT
AGENT") in accordance with the terms and conditions hereof.
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:
2.1 The
Company hereby
authorizes the Placement Agent to
act as its exclusive agent to solicit offers for the purchase of
all or
part of the Stock from the Company in connection with the proposed
offering of the Stock
(the "OFFERING").
Until the Closing Date (as
defined in SECTION 4 hereof), the Company shall not, without the
prior
written consent of the
Placement Agent, solicit or accept offers to
purchase Stock
otherwise than through the Placement
Agent. LCM may
utilize the expertise
of Lazard Freres &
Co. LLC in connection
with
LCM's placement agent activities.
2.2 The
Placement Agent agrees, as agent of the Company,
to use its
commercially
reasonable
efforts to solicit offers to
purchase the Stock
from the Company
on the terms and
subject to the
conditions set
forth in the Prospectus (as defined below). The
Placement Agent shall use commercially reasonable efforts to assist
the
Company in obtaining
performance
by each Purchaser whose offer to
purchase Stock has been solicited by the Placement
Agent and accepted
by the Company, but
the Placement Agent shall not, except as otherwise
provided in this
Agreement, be
obligated to disclose
the identity of
any potential
purchaser or have any liability to the Company in
the
event any such
purchase is not
consummated for any
reason. Under no
circumstances will the
Placement Agent be obligated to underwrite
or
purchase any Stock for its own account and, in soliciting
purchases of
Stock, 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 2.3, it is understood and agreed that the
Placement
Agent (or its affiliates) may, solely at its discretion and
<PAGE>
without any obligation
to do so, purchase Stock as principal on the
same terms as the other Purchasers.
2.3 Subject to
the provisions
of this SECTION 2,
offers
for the purchase of Stock 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
Stock received by it
as agent of the Company. The Company shall have
the sole right to accept offers to purchase the Stock and may reject
any such offer, in whole or in part. The Placement Agent shall have
the
right, in its discretion reasonably exercised, without notice to the
Company, to reject any offer to purchase Stock received by it, in
whole
or in part, and any such rejection shall not be deemed a breach of
its
agreement contained herein.
2.4 The Stock
is being sold to the
Purchasers at a price
of $14.00 per share. The purchases of the Stock by the Purchasers
shall
be evidenced by the execution of Subscription Agreements by each of
the
Purchasers and the Company.
2.5 As
compensation for services rendered, on the Closing
Date (as defined in
SECTION 4 hereof), the
Company shall pay to the
Placement Agent by
wire transfer of immediately available funds to an
account or accounts
designated by the
Placement Agent,
an aggregate
amount equal to five and one half percent (5.5%) of the gross proceeds
received by the
Company from the sale of the Stock on such Closing
Date.
2.6 No
Stock which the Company has agreed to sell
pursuant to this
Agreement shall be
deemed to have been purchased and
paid for, or sold by
the Company,
until such
Stock shall have been
delivered to the Purchaser thereof against payment by such
Purchaser.
If the Company shall default in its obligations to deliver Stock to a
Purchaser whose offer
it has accepted, the
Company shall indemnify and
hold the Placement 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(c)
herein.
3.
REPRESENTATIONS AND
WARRANTIES
OF THE COMPANY.
The Company
represents and
warrants to, and agrees with, the Placement Agent and the
Purchasers that:
(a) The
Company has prepared and filed in conformity with
the requirements
of the Securities Act of 1933, as amended (the
"SECURITIES ACT"), and published rules and regulations thereunder (the
"RULES AND
REGULATIONS")
adopted by the Securities and Exchange
Commission (the
"COMMISSION")
a "shelf" Registration Statement (as
hereinafter defined)
on Form S-3 (File No.
333-138417), which
became
effective as of December 8, 2006 (the "EFFECTIVE DATE"), including a
base prospectus relating to the Stock (the "BASE PROSPECTUS"), and
such
amendments and
supplements
thereto as may have
been required to
the
date of this Agreement. The term "REGISTRATION STATEMENT" as used in
this Agreement
means the registration statement (including all
exhibits, financial
schedules and all documents and information deemed
to be a part of the Registration Statement pursuant to Rule 430A
under
the Securities Act), as amended and/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 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
<PAGE>
prospectus supplement
shall be provided to
the Placement Agent by the
Company for use in
connection with the
offering and sale of the Stock
which differs
from the Prospectus (whether or not such revised
prospectus or
prospectus
supplement
is required to be filed by the
Company pursuant to Rule 424(b) of the Rules and Regulations), the
term
"PROSPECTUS" shall
refer to such
revised prospectus or prospectus
supplement, as the
case may be, from and
after the time it is first
provided to
the 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 under the Securities Act is hereafter called a "PRELIMINARY
PROSPECTUS." Any reference herein to the Registration Statement, any
Preliminary Prospectus
or the Prospectus
shall be deemed to
refer to
and include the documents incorporated by reference therein
pursuant to
Item 12 of Form S-3 which were filed under the Securities
Exchange Act
of 1934, as amended
(the "EXCHANGE ACT"), on or before the last to
occur of the Effective Date, the date of the Preliminary
Prospectus, or
the date of the
Prospectus, and any
reference herein to the terms
"amend," "amendment,"
or "supplement" with respect to the Registration
Statement, any Preliminary Prospectus or the Prospectus shall be
deemed
to refer to and
include (i) the
filing of any document under the
Exchange Act after the
Effective Date,
the date of such
Preliminary
Prospectus or the date of the Prospectus, as the case may be, which is
incorporated by
reference and (ii) any such document so filed. If the
Company has filed an
abbreviated
registration statement
to register
additional
Stock pursuant to Rule 462(b) under the
Rules (the "462(b)
REGISTRATION STATEMENT"), then any reference herein to the
Registration
Statement shall also
be deemed to include
such 462(b) Registration
Statement.
(b) As of the
Applicable
Time (as defined
below) and as
of the Closing Date, neither (i) any General Use Free Writing
Prospectus (as
defined below) issued at or prior to the
Applicable
Time, and the Pricing Prospectus (as defined below) and the
information
included on SCHEDULE A hereto, all considered together (collectively,
the "GENERAL DISCLOSURE PACKAGE"), nor (ii) any individual Limited
Use
Free Writing
Prospectus (as defined below), when considered together
with the General
Disclosure Package,
included or will
include, any
untrue statement
of a material
fact or omitted or as
of the Closing
Date will omit, to state a material fact necessary in order to make
the
statements therein, in
the light of the circumstances under which they
were made, not misleading; PROVIDED, HOWEVER, that the Company
makes no
representations or warranties as to information contained in or
omitted
from any Issuer Free
Writing Prospectus, in reliance upon, and in
conformity with,
written information
furnished to the
Company 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 17). As used in this PARAGRAPH (b)
and elsewhere in this Agreement:
"APPLICABLE TIME"
means 7:00 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(h) under the Securities Act
relating to the Stock
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.
"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.
<PAGE>
(c) No
order preventing or suspending the use of any
Preliminary
Prospectus, any Issuer
Free Writing Prospectus or the
Prospectus
relating to the
Offering has been issued by the Commission,
and no proceeding
for that purpose or pursuant to Section 8A of the
Securities Act has been instituted or threatened by the Commission,
and
each Preliminary Prospectus, 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 17).
(d) At
the time the Registration Statement became
effective, at the date
of this Agreement and
at the Closing Date, the
Registration Statement
conformed and will conform in all material
respects to the
requirements of the
Securities Act and the
Rules and
Regulations and did not and will not contain any untrue
statement of a
material fact or omit
to state any material fact required to be stated
therein or necessary to make the statements therein not misleading;
the
Prospectus, at the
time the Prospectus
was issued and at the
Closing
Date, conformed
and will conform in all material respects to the
requirements of the
Securities Act and the Rules and Regulations and
did not and will not contain an untrue statement of a material fact
or
omit to state a material fact necessary in order to make the
statements
therein, in light of
the circumstances under which they were made, not
misleading; PROVIDED,
HOWEVER, that the
foregoing representations and
warranties in this
PARAGRAPH (d) shall not apply to information
contained in
or omitted from the Registration Statement or the
Prospectus in
reliance upon, and in conformity with, written
information
furnished to
the Company 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 17).
(e) Each
Issuer Free Writing
Prospectus,
if any, as of
its issue date and at all subsequent times through the completion of
the public offer and
sale of the Stock or until any earlier date that
the Company notified
or notifies the
Placement Agent as
described in
SECTION 5(e), did not,
does not and will not
include any
information
that conflicted,
conflicts or will conflict with the information
contained
in the Registration
Statement,
Pricing Prospectus or the
Prospectus, including
any document
incorporated by reference therein
and any prospectus
supplement deemed to be a part thereof that has not
been superseded
or modified, or includes an untrue statement of a
material fact or
omitted or would omit to state a material fact
required to be
stated therein or necessary in order to make the
statements therein, in the light of the circumstances 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 17).
(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
<PAGE>
requirements of the
Securities Act or the Exchange Act, as applicable,
and the rules and regulations of the Commission thereunder and will
not
contain any untrue
statement of a
material fact or omit
to state any
material fact
required to be stated
therein or necessary
to make the
statements therein not misleading.
(g) The
Company
has not, directly or indirectly,
distributed and will not distribute any offering material in
connection
with the Offering other than any Preliminary Prospectus, the
Prospectus
and other materials,
if any, permitted under the Securities Act and
consistent with
SECTION 5(b) below. The Company will file with the
Commission all Issuer
Free Writing
Prospectuses, if any,
in the time
and manner
required under Rule 433(d) under the Securities Act.
(h) The
Company and each of its Subsidiaries (as defined
below) has been duly organized and is validly existing as a
corporation
or other legal
entity in good
standing (or the foreign equivalent
thereof) under the laws of its respective jurisdiction of
organization.
The Company
and each of its Subsidiaries is duly qualified to do
business and is in
good standing
as a foreign
corporation
or other
legal entity in each jurisdiction in which its respective
ownership or
lease of property or the conduct of its respective business requires
such qualification and has all power and authority (corporate or
other)
necessary to own or hold its respective properties and to conduct the
business in which it is engaged, except where the failure to so
qualify
or have such power or authority (i) would not have, singularly or in
the aggregate, a material adverse effect on the condition
(financial or
otherwise), results of
operations,
assets or business of
the Company
and its Subsidiaries,
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: Enzo Clinical
Labs, Inc., a New York
corporation,
Enzo Life Sciences,
Inc., a New
York corporation, Enzo
Therapeutics, Inc., a
New York corporation and
Enzo Realty,
LLC, a New York limited liability company, each, a
"SUBSIDIARY" and together "SUBSIDIARIES".
(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 and
each of the Subscription Agreements has been duly authorized,
executed
and delivered
by the Company, and constitutes a valid and binding
obligation of the Company enforceable in accordance with its
terms.
(j) The Stock
to be issued and sold by the Company to the
Purchasers hereunder
and under the
Subscription
Agreements has
been
duly and validly
authorized and,
when issued and
delivered against
payment therefor as
provided herein and the Subscription Agreements,
will be duly and validly issued, fully paid and nonassessable and
free
of any preemptive or similar rights and will conform to the
description
thereof contained in the General Disclosure Package and the
Prospectus.
(k) The
Company has an authorized capitalization as set
forth in the
Pricing Prospectus, and all of the issued shares of
capital stock of the Company have been duly and validly
authorized and
issued, are
fully paid and non-assessable, have been issued in
compliance with federal and state securities laws, and conform to the
description thereof contained in the General Disclosure Package and
the
Prospectus. As of
October 31, 2006,
there were 32,282,500
shares of
Common Stock issued and outstanding and no shares of Preferred
Stock,
par value $0.01 of the Company issued and outstanding and 2,866,576
shares of Common Stock were issuable upon the exercise of all
options,
warrants and convertible securities outstanding as of
<PAGE>
such date. Since such
date, the Company has not issued any securities,
other than Common Stock of the Company issued pursuant to the exercise
of stock options
previously
outstanding
under the Company's stock
option plans or the
issuance of restricted
Common Stock
pursuant to
employee stock purchase plans. None of the outstanding shares of
Common
Stock was issued in violation of any preemptive rights, rights of
first
refusal or other similar rights to subscribe for or purchase
securities
of the Company.
There are no authorized or outstanding shares of
capital stock,
options, warrants,
preemptive rights,
rights of first
refusal or other
rights to purchase, or equity or debt securities
convertible into or
exchangeable or exercisable for, any capital stock
of the Company or any of its Subsidiaries other than those described
above or accurately
described in the General Disclosure Package. The
description of the 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 with respect to such plans, arrangements, options and
rights.
(l) All the
outstanding
shares of capital
stock of each
Subsidiary 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 Stock by the Company and the
consummation of the transactions contemplated hereby and thereby will
not (with or without
notice or lapse of time or both) conflict with or
result in a breach or violation of any of the terms or provisions of,
constitute a default
under, give rise to
any right of
termination or
other right or the cancellation or acceleration of any right or
obligation or loss of a benefit under, or give rise to the creation
or
imposition of any lien, encumbrance, security interest, claim or
charge
upon any property or assets of the Company or any Subsidiary pursuant
to, any indenture,
mortgage, deed of trust, loan 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 Stock
under the
Securities Act
and such consents, approvals, authorizations,
registrations or
qualifications as may
be required under the Exchange
Act and applicable
state or foreign
securities
laws, the National
Association of Securities Dealers, Inc. and the New York Stock
Exchange
(the "NYSE") in
connection with the
offering and sale of the Stock by
the Company,
no consent, approval, authorization or order of, or
filing, qualification
or registration with,
any court or governmental
agency or body, foreign or domestic, which has not been made,
obtained
or taken and is not in
full force and
effect, is required for the
execution, delivery and performance of this Agreement, the
Subscription
Agreements and the Escrow Agreement by the Company,
the offer or sale
of the Stock
or the consummation of the transactions contemplated
hereby or thereby.
(o) Ernst
& Young LLP, who have certified certain
financial statements
and related schedules included or incorporated by
reference in the Registration Statement, the General Disclosure
Package
and the Prospectus,
and have audited the
Company's internal
control
over financial
reporting and management's assessment thereof, is an
independent registered
public accounting firm as required by the
Securities Act and the Rules and Regulations and the Public
<PAGE>
Company
Accounting Oversight Board (United States) (the "PCAOB"). Ernst
& Young LLP have not been engaged by the Company to perform any "
prohibited activities" (as defined in Section 10A of the Exchange
Act).
(p) The
financial statements,
together with the
related
notes and schedules,
included or
incorporated
by reference in the
General Disclosure
Package, the Prospectus and in the Registration
Statement fairly
present in all material respects the financial
position and the
results of operations and changes in financial
position of the
Company 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 the generally
accepted
accounting principles
in the United States ("GAAP") applied on a
consistent basis
throughout the periods
involved except as may be set
forth in the related notes included or incorporated by reference in
the
General Disclosure Package. The financial statements, together with
the
related notes and schedules, included or incorporated by reference in
the General
Disclosure
Package and the Prospectus comply in all
material respects with
the Securities
Act, the Exchange Act,
and the
Rules and Regulations and the rules and regulations under the Exchange
Act. No other financial statements or supporting schedules
or exhibits
are required by the Securities Act or the Rules and Regulations to be
described, or included or incorporated by reference in the
Registration
Statement, the General
Disclosure Package or the Prospectus. There is
no pro forma or as adjusted financial information which is required
to
be included in the
Registration
Statement,
the General Disclosure
Package, or and the Prospectus or a document incorporated by reference
therein in
accordance
with the Securities Act and the Rules and
Regulations which has not been included or incorporated as so
required.
The pro forma and pro forma as adjusted financial information and the
related notes included or incorporated by reference in the
Registration
Statement, the General
Disclosure Package and the Prospectus have been
properly compiled
and prepared in accordance with the applicable
requirements of the
Securities Act and the Rules and Regulations and
present fairly the information shown therein, and the assumptions used
in the preparation
thereof are
reasonable and the
adjustments
used
therein are
appropriate
to give effect to the transactions and
circumstances referred to therein.
(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 changes, 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, 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 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
have a Material
Adverse Effect or
prevent the consummation of the
transactions
contemplated hereby;
and to the
best of the
Company's
knowledge, no such
proceedings
are threatened or contemplated by
governmental authorities or threatened by others.
<PAGE>
(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 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 which are
necessary or
desirable for the ownership of its respective properties or the
conduct
of its 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
is 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 Company nor any
subsidiary has received notification of any revocation or
modification
(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.
(u) Neither
the Company nor any of
its Subsidiaries
is
or, after giving effect to the offering of the Stock and the
application of the
proceeds thereof as described in the General
Disclosure Package
and the Prospectus, will become an "investment
company" within the
meaning of the Investment Company Act of 1940, as
amended, and the rules and regulations of the Commission
thereunder.
(v) Neither
the Company,
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 all patents, trademarks, trademark registrations,
service
marks, service mark registrations, trade names, copyrights,
licenses,
inventions, software, databases, know-how, Internet domain names,
trade
secrets and
other unpatented and/or unpatentable proprietary or
confidential information, systems or procedures, and other
intellectual
property (collectively, "INTELLECTUAL PROPERTY") necessary
to carry on
their respective businesses as currently conducted, and as proposed to
be conducted and
described in the General Disclosure Package and the
Prospectus, and the
Company is not aware of any claim to the contrary
or any challenge
by any other person to
the rights of the Company and
its Subsidiaries
with respect to the
foregoing except for
those that
could not have a Material Adverse Effect. The Intellectual Property
licenses described in the General Disclosure Package and the
Prospectus
are valid, binding
upon, and enforceable by or against the parties
thereto in accordance
to their terms. The Company and each of its
Subsidiaries have
complied in all material respects with, and are not,
to the Company's knowledge, in breach nor have received any
asserted or
threatened claim of breach of, any Intellectual Property license, and
the Company has
<PAGE>
no knowledge of any breach or anticipated breach by any other
person to
any
Intellectual
Property license. The Company's and each of its
Subsidiaries'
businesses as
now conducted and as proposed to be
conducted do not and will not, to the Company's knowledge,
infringe or
conflict with any
patents, trademarks,
service marks, trade names,
copyrights, trade
secrets, licenses or
other Intellectual Property or
franchise right of any
person. No claim has been received by the
Company that makes
against the Company or any of its Subsidiaries an
allegation of infringement by the Company or any of its
Subsidiaries of
any patent, trademark,
service mark, trade name, copyright, trade
secret, license in or
other intellectual
property right or
franchise
right of any person.
The Company
and each of its
Subsidiaries
have
taken all reasonable
steps to protect,
maintain and safeguard its
rights in all Intellectual Property, including the execution of
appropriate
nondisclosure
and
confidentiality
agreements.
The
consummation of the
transactions
contemplated by this
Agreement will
not, to the Company's knowledge, 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 or any of its
Subsidiaries'
right to own, use, or hold for use any of the
Intellectual Property
as owned, used or held for use in the conduct of
the businesses
as currently conducted. The Company and each of its
Subsidiaries has at all times taken reasonable steps to comply with
all
applicable laws
relating to privacy, data protection, and the
collection and use of personal information collected, used, or held
for
use by the Company and
any of its
Subsidiaries in the
conduct of the
Company's and its Subsidiaries businesses. No claims have been
received
by the Company or any of its Subsidiaries alleging a violation of any
person's privacy
or personal information or data rights and the
consummation of the transactions contemplated hereby will not, to the
Company's knowledge, breach or otherwise cause any violation of any
law
related to privacy,
data protection, or the collection and use of
personal information collected, used, or held for use by the
Company or
any of its
Subsidiaries in the
conduct of the Company's or any of its
Subsidiaries'
businesses. The
Company and each of its Subsidiaries
takes reasonable
measures to ensure that such information is protected
against unauthorized access, use, modification, or other
misuse.
(x) 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 prevent the
consummation of the
transactions
contemplated
hereby; and
to the Company's Knowledge, no such proceedings are
threatened or contemplated by governmental authorities or
threatened by
others. The Company
and its Subsidiaries
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 or its Subsidiaries 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 or its Subsidiaries to
support
approval for
commercialization of
the Company's or its
Subsidiaries'
products have been conducted by the Company or its Subsidiaries,
or to
the Company's
knowledge by third parties, in compliance with all
applicable federal,
state, provincial or foreign laws, rules,
orders
and regulations, except for
<PAGE>
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.
(y) The
Company and each of its Subsidiaries has 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,
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, and under which the
Company or any of its Subsidiaries holds 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.
(z) No labor
disturbance by the
employees of the Company
or any of its
Subsidiaries exists
or, to the best of 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.
(aa)
No "prohibited
transaction"
(as defined in
Section
406 of the Employee Retirement Income Security Act of 1974, as
amended,
including the
regulations
and published
interpretations
thereunder
("ERISA"), or Section
4975 of the Internal
Revenue Code of 1986,
as
amended from
time to time (the "CODE")) or "accumulated funding
deficiency" (as
defined in Section 302
of ERISA) or any of the events
set forth
in Section 4043(b) of
ERISA (other than
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.
(bb)
The
Company and its
Subsidiaries are in
compliance
with all foreign,
federal, state and local rules, laws and regulations
relating to the use,
treatment, storage and
disposal of hazardous
or
toxic substances
or waste and
protection of health
and safety or the
environment which are
applicable to their
businesses
("ENVIRONMENTAL
LAWS"), except where
the failure to comply would not, singularly or in
the aggregate,
have a Material Adverse Effect. There has been no
storage, generation,
transportation,
handling, treatment,
disposal,
discharge, emission,
or other release of any kind of toxic or other
wastes or other
hazardous substances by, due to, or caused by the
Company or any of its Subsidiaries (or, to the Company's knowledge,
any
other entity for whose
acts or omissions the Company or any of its
Subsidiaries is or may
otherwise be liable) upon any of the
property
now or previously owned or leased by the Company or any of its
Subsidiaries, or upon
any other property,
in violation of any law,
statute, ordinance, rule, regulation, order, judgment, decree or
permit
or which would, under any law, statute, ordinance,
<PAGE>
rule (including
rule of common
law), regulation, order, judgment,
decree or permit, give rise to any liability, except for any violation
or liability which would not have, singularly or in the aggregate
with
all such violations and liabilities, a Material Adverse Effect; and
there has been no disposal, discharge, emission or other release of
any
kind onto such property or into the environment surrounding such
property of any toxic
or other wastes or
other hazardous
substances
with respect to which
the Company has
knowledge, except for
any such
disposal, discharge, emission, or other release of any kind which
would
not have, singularly
or in the aggregate with all such discharges and
other releases, a
Material Adverse
Effect. In the
ordinary course of
business, the Company
and its Subsidiaries conduct periodic reviews of
the effect of Environmental Laws on their business and assets,
in the
course of which
they identify and evaluate associated costs and
liabilities
(including, without
limitation, any
capital or operating
expenditures required for clean-up, closure of properties or
compliance
with Environmental Laws or Governmental Permits issued thereunder,
any
related
constraints on
operating activities and any potential
liabilities to
third parties). On the basis of such reviews, the
Company and its
Subsidiaries
have reasonably concluded that such
associated costs and liabilities would not have, singularly or in the
aggregate, a Material Adverse Effect.
(cc)
The Company and its Subsidiaries, each (i) has timely
filed all necessary federal, state, local and foreign tax
returns, and
all such returns were
true, complete
and correct,
(ii) has paid all
federal, state, local and foreign taxes, assessments, governmental or
other charges
due and payable for which it is liable, including,
without limitation,
all sales and use taxes and all taxes
which the
Company or any of its
subsidiaries
is obligated to withhold from
amounts owing to employees, creditors and third parties, and (iii)
does
not have any tax
deficiency or claims
outstanding or
assessed or, to
the best of its knowledge, proposed against any of them,
except those,
in each of the cases
described in clauses (i), (ii) and (iii) of this
PARAGRAPH (cc), that would not, singularly or in the aggregate,
have a
Material Adverse Effect. The Company and its Subsidiaries, each has
not
engaged in any transaction that could reasonably be
characterized as a
corporate tax
shelter by the
Internal Revenue Service or any other
taxing authority. The accruals and reserves on the books and
records of
the Company and its
Subsidiaries in respect of tax liabilities for any
taxable period not yet
finally determined are adequate to meet any
assessments and related liabilities for any such period, and since
July
31, 2006, the Company
and its Subsidiaries
each has not incurred
any
liability for taxes other than in the ordinary course.
(dd)
The Company and each of its Subsidiaries carries, or
is covered by, insurance provided by recognized, financially sound and
reputable institutions
with policies in such amounts and covering such
risks as is adequate for the conduct of their respective businesses
and
the value of
their respective properties and as is customary for
companies engaged in
similar businesses
in similar
industries.
The
Company has no reason to believe that it or any Subsidiary
will not be
able (i) to renew its
existing insurance coverage as and when such
policies expire or
(ii) to obtain
comparable coverage
from similar
institutions as may be necessary or appropriate to conduct its
business
as now conducted
and at a cost that
would not result in a Material
Adverse Effect.
Neither the Company nor any of its Subsidiaries have
been denied any
insurance coverage
that they have sought or for which
they have applied.
(ee)
The Company and its
Subsidiaries
each maintains a
system of internal
accounting and other controls sufficient to provide
reasonable assurances
that (i) transactions are executed in accordance
with management's general or specific authorizations; (ii)
transactions
are recorded as necessary to permit preparation of financial
statements
in conformity
with GAAP 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 General Disclosure
Package,
since the end of the Company's most recent audited fiscal year, there
as been (A) no material weakness in the
<PAGE>
Company's internal
control over financial
reporting (whether or not
remediated) and (B) 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.
(ff)
The minute
books of the Company and each of its
Subsidiaries have
been made available to the Placement Agent and
counsel for the
Placement Agent, and
such books (i) contain a complete
summary, in all
material respects, 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), and
each of its Subsidiaries since the time of its
respective incorporation or organization through the date of the
latest
meeting and
action, and (ii) accurately in all material respects
reflect all transactions referred to in such minutes.
(gg)
There is no franchise, lease, contract, agreement or
document required by the Securities Act or by the Rules and
Regulations
to be described in the General Disclosure Package and in the
Prospectus
or a document
incorporated by
reference therein or
to be filed as an
exhibit to the
Registration Statement
or a document
incorporated by
reference therein
which is not described or filed therein as required;
and all descriptions of any such franchises, leases, contracts,
agreements or documents contained in the Registration Statement or
in a
document incorporated
by reference
therein are accurate
and complete
descriptions of such documents in all material respects.
Other than as
described in the General Disclosure Package, no such franchise,
lease,
contract or agreement has been suspended or terminated for
convenience
or default by the
Company or any of its Subsidiaries or any of the
other parties
thereto, and neither the Company nor any of its
Subsidiaries has
received notice nor does the Company have
any other
knowledge of any such pending or threatened suspension or termination,
except for such pending or threatened suspensions or terminations
that
would not reasonably
be expected to,
singularly or
