Exhibit 1.1
_______________ Shares
BioMimetic Therapeutics, Inc.
Common Stock
($0.001 Par Value)
UNDERWRITING AGREEMENT
_________, 2006
Deutsche Bank Securities Inc.
Pacific Growth Equities, LLC
First Albany Capital Inc.
A.G. Edwards & Sons, Inc.
As Representatives of the
Several Underwriters
c/o
Deutsche Bank Securities Inc.
60 Wall Street, 4th Floor
New York, New York 10005
Ladies and Gentlemen:
BioMimetic Therapeutics, Inc., a Delaware corporation (the
"Company"),
proposes to sell to the several underwriters (the "Underwriters")
named in
Schedule I hereto for whom you are acting as representatives (the
"Representatives") an aggregate of __________ shares (the "Firm
Shares") of the
Company's common stock, $0.001 par value (the "Common Stock"). The
respective
amounts of the Firm Shares to be so purchased by the several
Underwriters are
set forth opposite their names in Schedule I hereto. The Company
also proposes
to sell at the Underwriters' option an aggregate of up to
__________ additional
shares of the Company's Common Stock (the "Option Shares") as set
forth below.
As the Representatives, you have advised the Company (a) that you
are
authorized to enter into this Agreement on behalf of the several
Underwriters,
and (b) that the several Underwriters are willing, acting severally
and not
jointly, to purchase the numbers of Firm Shares set forth opposite
their
respective names in Schedule I, plus their pro rata portion of the
Option Shares
if you elect to exercise the over-allotment option in whole or in
part for the
accounts of the several Underwriters. The Firm Shares and the
Option Shares (to
the extent the aforementioned option is exercised) are herein
collectively
called the "Shares."
Deutsche Bank Securities Inc. ("DBSI") has agreed to reserve up to
___________ of the Shares to be purchased by it under this
Agreement for sale to
the Company's directors, officers, employees and business
associates and other
parties related to the Company (collectively, "Participants"), as
set forth in
the Prospectus (as defined below) under the heading "Underwriting"
(the
"Directed Share Program"). The Shares to be sold by DBSI and its
affiliates
pursuant to the Directed Share Program are referred to hereinafter
as the
"Directed Shares." Any Directed Shares not orally confirmed for
purchase by any
Participants by the end of the business day on which this Agreement
is executed
will be offered to the public by the Underwriters as set forth in
the
Prospectus.
In consideration of the mutual agreements contained herein and of
the
interests of the parties in the transactions contemplated hereby,
the parties
hereto agree as follows:
1.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company represents and warrants to each of the Underwriters as
follows:
(a) A registration statement on Form S-1 (File No. 333-131718) with
respect to the Shares has been prepared by the Company in
conformity with the
requirements of the Securities Act of 1933, as amended (the "Act"),
and the
rules and regulations (the "Rules and Regulations") of the
Securities and
Exchange Commission (the "Commission") thereunder and has been
filed with the
Commission. Copies of such registration statement, including any
amendments
thereto, the preliminary prospectuses (meeting the requirements of
the Rules and
Regulations) contained therein and the exhibits and financial
statements, as
finally amended and revised, have heretofore been delivered by the
Company to
you. Such registration statement, together with any registration
statement filed
by the Company pursuant to Rule 462(b) under the Act, is herein
referred to as
the "Registration Statement," which shall be deemed to include all
information
omitted therefrom in reliance upon Rules 430A, 430B or 430C under
the Act and
contained in the Prospectus referred to below, has become effective
under the
Act and no post-effective amendment to the Registration Statement
has been filed
as of the date of this Agreement. "Prospectus" means the form of
prospectus
first filed with the Commission pursuant to and within the time
limits described
in Rule 424(b) under the Act. Each preliminary prospectus included
in the
Registration Statement prior to the time it becomes effective is
herein referred
to as a "Preliminary Prospectus." The Company has prepared and
filed, in
accordance with Section 12 of the Securities and Exchange Act of
1934, as
amended (the "Exchange Act"), a registration statement (as may be
amended prior
to the time of execution of this Agreement, the "Exchange Act
Registration
Statement") on Form 8-A (File No. [____]) under the Exchange Act to
register,
under Section 12(g) of the Exchange Act, the class of securities
consisting of
the Common Stock.
(b) As of the Applicable Time (as defined below) and as of the
Closing Date or the Option Closing Date, as the case may be,
neither (i) the
General Use Free Writing Prospectus(es) (as defined below) issued
at or prior to
the Applicable Time, the Statutory Prospectus (as defined below)
and the
information included on Schedule II 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
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Disclosure Package, included or will include any untrue statement
of a material
fact or omitted or 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 or on behalf of any
Underwriter
through the Representatives, specifically for use therein, it being
understood
and agreed that the only such information is that described in
Section 13
herein. As used in this subsection and elsewhere in this Agreement:
"Applicable Time" means ______ [a/p]m (New York time) on the date
of this
Agreement or such other time as agreed to by the Company and the
Representatives.
"Statutory Prospectus" as of any time means the Preliminary
Prospectus
relating to the Shares that is included in the Registration
Statement
immediately prior to that time.
"Issuer Free Writing Prospectus" means any "issuer free writing
prospectus," as defined in Rule 433 under the Act, relating to the
Shares 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 Act.
"General Use Free Writing Prospectus" means any Issuer Free Writing
Prospectus that is identified on Schedule III to this Agreement.
"Limited Use Free Writing Prospectus" means any Issuer Free Writing
Prospectus that is not a General Use Free Writing Prospectus.
"Material Adverse Effect" means the occurrence, either individually
or in
the aggregate, of any material adverse effect on the earnings,
business,
management, properties, assets, rights, operations, condition
(financial or
otherwise) or prospects of the Company and of the Subsidiary taken
as a whole.
(c) The Company has been duly organized and is validly existing as
a
corporation in good standing under the laws of the State of
Delaware, with
corporate power and authority to own or lease its properties and
conduct its
business as described in the Registration Statement, the General
Disclosure
Package and the Prospectus. The subsidiary of the Company as listed
in Exhibit
21.1 to Item 16(a) of the Registration Statement (the "Subsidiary")
has been
duly organized and is validly existing as a corporation in good
standing under
the laws of the jurisdiction of its incorporation, with corporate
power and
authority to own or lease its properties and conduct its business
as described
in the Registration Statement, the General Disclosure Package and
the
Prospectus. The Subsidiary is the only subsidiary, direct or
indirect, of the
Company. The Company and the Subsidiary are duly qualified to
transact business
in all jurisdictions in which the conduct of their business
requires such
qualification, except where the failure to qualify or be in good
standing would
not result in a Material Adverse Effect. The outstanding shares of
capital stock
of the Subsidiary have been duly authorized and validly issued, are
fully paid
and non-assessable and are owned by the Company free and clear of
all liens,
encumbrances and equities and claims; and no options, warrants or
other rights
to
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purchase, agreements or other obligations to issue or other rights
to convert
any obligations into shares of capital stock or ownership interests
in the
Subsidiary are outstanding.
(d) The information set forth under the captions "Capitalization"
and "Description of Capital Stock" in the Registration Statement
and the
Prospectus (and any similar section or information contained in the
General
Disclosure Package) is true and correct, in all material respects,
as of its
date. All of the Shares conform to the description thereof
contained in the
Registration Statement, the General Disclosure Package and the
Prospectus. The
form of certificates for the Shares conforms to the corporate law
of the
jurisdiction of the Company's incorporation.
(e) The outstanding shares of Common Stock of the Company have been
duly authorized and validly issued and are fully paid and
non-assessable; the
Shares to be issued and sold by the Company have been duly
authorized and when
issued and paid for as contemplated herein will be validly issued,
fully paid
and non-assessable; and no preemptive rights of stockholders exist
with respect
to any of the Shares or the issue and sale thereof, which rights
have not been
waived. Neither the filing of the Registration Statement nor the
offering or
sale of the Shares as contemplated by this Agreement gives rise to
any rights,
other than those which have been waived or satisfied, for or
relating to the
registration of any shares of Common Stock. Prior to the time of
purchase, all
outstanding shares of Series A-1 convertible, redeemable preferred
stock, par
value $0.001 per share, Series A-2 convertible, redeemable
preferred stock, par
value $0.001 per share, Series B convertible, redeemable preferred
stock, par
value $0.001 per share and Series C convertible, redeemable
preferred stock, par
value $0.001 per share, of the Company shall convert into the
number of shares
of Common Stock, and shall convert in the manner, set forth in the
Registration
Statement and the Prospectus; prior to the date hereof the Company
has duly
effected and completed a [x]-for-[x] stock split of the Common
Stock in the
manner set forth in the Registration Statement and the Prospectus;
the Restated
Certificate of Incorporation of the Company and the Amended and
Restated By-Laws
of the Company, each in the form filed as an exhibit to the
Registration
Statement, have been heretofore duly authorized and approved in
accordance with
the Delaware General Corporation Law and shall become effective and
in full
force and effect on or before the time of purchase; and the Shares
are duly
listed, and admitted and authorized for trading, subject to
official notice of
issuance and evidence of satisfactory distribution, on the Nasdaq
National
Market.
(f) The Commission has not issued an 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 Shares, and no
proceeding
for that purpose or pursuant to Section 8A of the Act has been
instituted or, to
the Company's knowledge, threatened by the Commission. The
Registration
Statement contains, and the Prospectus and any amendments or
supplements thereto
will contain, all statements which are required to be stated
therein by, and
will conform to, the requirements of the Act and the Rules and
Regulations. The
Registration Statement and any amendment thereto do not contain,
and will not
contain, any untrue statement of a material fact and do not omit,
and will not
omit, to state a material fact required to be stated therein or
necessary to
make the statements therein not misleading. The Prospectus and any
amendments
and supplements thereto do not contain, and will not contain, any
untrue
statement of a material fact; and do not omit, and will not omit,
to state a
material fact necessary in order to make the
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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 the
Registration Statement or the Prospectus, or any such amendment or
supplement,
in reliance upon, and in conformity with, written information
furnished to the
Company by or on behalf of any Underwriter through the
Representatives,
specifically for use therein, it being understood and agreed that
the only such
information is that described in Section 13 herein.
(g) Each Issuer Free Writing Prospectus, as of its issue date and
at
all subsequent times through the completion of the public offer and
sale of the
Shares, did not, does not and will not include any information that
conflicted,
conflicts or will conflict with the information contained in the
Registration
Statement or the Prospectus.
(h) The Company has not, directly or indirectly, distributed and
will not distribute any offering material in connection with the
offering and
sale of the Shares other than any Preliminary Prospectus, the
Prospectus and
other materials, if any, permitted under the Act and consistent
with Section
4(b) below. The Company will file with the Commission all Issuer
Free Writing
Prospectuses in the time required under Rule 433(d) under the Act.
The Company
has satisfied or will satisfy the conditions in Rule 433 under the
Act to avoid
a requirement to file with the Commission any electronic road show.
(i) (i) At the time of the initial filing of the Registration
Statement and (ii) as of the date hereof (with such date being used
as the
determination date for purposes of this clause(ii)), the Company
was not and is
not an "ineligible issuer" (as defined in Rule 405 under the Act,
without taking
into account any determination by the Commission pursuant to Rule
405 under the
Act that it is not necessary that the Company be considered an
ineligible
issuer), including, without limitation, for purposes of Rules 164
and 433 under
the Act with respect to the offering of the Shares as contemplated
by the
Registration Statement.
(j) The financial statements of the Company and the consolidated
financial statements of the Company and Subsidiary, as applicable,
together with
related notes and schedules as set forth in the Registration
Statement, the
General Disclosure Package and the Prospectus, present fairly the
financial
position and the results of operations and cash flows of the
Company and the
consolidated Subsidiary, as applicable, at the indicated dates and
for the
indicated periods. Such financial statements and related schedules
have been
prepared in accordance with generally accepted principles of
accounting
("GAAP"), consistently applied throughout the periods involved,
except as
disclosed therein, and all adjustments necessary for a fair
presentation of
results for such periods have been made. The summary and selected
financial and
consolidated financial data included in the Registration Statement,
the General
Disclosure Package and the Prospectus present fairly the
information shown
therein and such data has been compiled on a basis consistent with
the financial
statements presented therein and the books and records of the
Company. The pro
forma financial statements and other pro forma financial
information included in
the Registration Statement, the General Disclosure Package and the
Prospectus
present fairly the information shown therein, have been prepared in
accordance
with the Commission's rules and guidelines with respect to pro
forma financial
statements, have been properly compiled on the pro forma bases
described
therein, and, in the opinion of the
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Company, the assumptions used in the preparation thereof are
reasonable and the
adjustments used therein are appropriate to give effect to the
transactions or
circumstances referred to therein. The Registration Statement, the
General
Disclosure Package and the Prospectus do not contain "non-GAAP
financial
measures" (as such term is defined by the Rules and Regulations).
The Company
and the Subsidiary do not have any material liabilities or
obligations, direct
or contingent (including any off-balance sheet obligations or any
"variable
interest entities" within the meaning of Financial Accounting
Standards Board
Interpretation No. 46), not disclosed in the Registration
Statement, the General
Disclosure Package and the Prospectus. There are no financial
statements
(historical or pro forma) that are required to be included in the
Registration
Statement, the General Disclosure Package or the Prospectus that
are not
included as required.
(k) Ernst & Young LLP, who have certified the financial
statements
filed with the Commission as part of the Registration Statement,
the General
Disclosure Package and the Prospectus, is an independent registered
public
accounting firm with respect to the Company and the Subsidiary
within the
meaning of the Act and the applicable Rules and Regulations and the
Public
Company Accounting Oversight Board (United States) (the "PCAOB").
(l) Neither the Company nor the Subsidiary is aware of (i) any
material weakness in its internal control over financial reporting
or (ii)
change in internal control over financial reporting that has
materially
affected, or is reasonably likely to materially affect, the
Company's internal
control over financial reporting.
(m) Solely to the extent that the Sarbanes-Oxley Act of 2002, as
amended, and the rules and regulations promulgated by the
Commission and the
Nasdaq National Market thereunder (the "Sarbanes-Oxley Act") has
been applicable
to the Company, there is and has been no failure on the part of the
Company to
comply in all material respects with any provision of the
Sarbanes-Oxley Act.
The Company has taken all necessary actions to ensure that it is in
compliance
with all provisions of the Sarbanes-Oxley Act that are in effect
and with which
the Company is required to comply and is actively taking steps to
ensure that it
will be in compliance with other provisions of the Sarbanes-Oxley
Act not
currently in effect or which will become applicable to the Company.
(n) There is no action, suit, claim or proceeding pending or, to
the
knowledge of the Company, threatened against the Company or the
Subsidiary
before any court or administrative agency or otherwise, except as
set forth in
the Registration Statement, the General Disclosure Package and the
Prospectus.
(o) The Company and the Subsidiary have good title to all of the
properties and assets reflected in the consolidated financial
statements
hereinabove described or described in the Registration Statement,
the General
Disclosure Package and the Prospectus, subject to no lien,
mortgage, pledge,
charge or encumbrance of any kind except those reflected in such
financial
statements or described in the Registration Statement, the General
Disclosure
Package and the Prospectus, and except as would not, individually
or in the
aggregate have a Material Adverse Effect. The Company and the
Subsidiary occupy
their leased properties under valid and binding leases conforming
in all
material respects to the description thereof set forth in the
Registration
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Statement, the General Disclosure Package and the Prospectus with
such
exceptions as are not material and do not interfere with the use
made of such
property.
(p) The Company and the Subsidiary have filed all Federal, State,
local and foreign tax returns which have been required to be filed
and have paid
all taxes indicated by such returns and all assessments received by
them or any
of them to the extent that such taxes have become due and are not
being
contested in good faith and for which an adequate reserve for
accrual has been
established in accordance with GAAP. All tax liabilities have been
adequately
provided for in the financial statements of the Company, and the
Company does
not know of any actual or proposed additional material tax
assessments.
(q) Since the respective dates as of which information is given in
the Registration Statement, the General Disclosure Package and the
Prospectus,
as each may be amended or supplemented, there has not been (i) any
material
adverse change or any development involving a prospective material
adverse
change in the earnings, business, management, properties, assets,
rights,
operations, condition (financial or otherwise) or prospects of the
Company and
the Subsidiary taken as a whole, whether or not occurring in the
ordinary course
of business, (ii) any material transaction entered into or any
material
transaction that is probable of being entered into by the Company
or the
Subsidiary, other than transactions in the ordinary course of
business and
changes and transactions described in the Registration Statement,
the General
Disclosure Package and the Prospectus, as each may be amended or
supplemented,
(iii) any change in the capital stock (other than changes resulting
from
conversion of the outstanding convertible preferred stock, a stock
split or the
grant or exercise of outstanding stock options) or outstanding
indebtedness of
the Company or (iv) any dividend or distribution of any kind
declared, paid or
made on the capital stock of the Company. The Company and the
Subsidiary have no
material contingent obligations which are not disclosed in the
Company's
financial statements which are included in the Registration
Statement, the
General Disclosure Package and the Prospectus.
(r) Neither the Company nor the Subsidiary is or with the giving of
notice or lapse of time or both, will be, in violation of or
default under (i)
its Restated Certificate of Incorporation and Restated By-Laws,
(ii) any
agreement, lease, contract, indenture or other instrument or
obligation to which
it is a party or by which it, or any of its properties, is bound,
(iii) any
federal, state, local or foreign law, regulation or rule, (iv) any
rule or
regulation of any self-regulatory organization or other
non-governmental
regulatory authority (including, without limitation, the rules and
regulations
of the Nasdaq National Market, or (v) any decree, judgment or order
applicable
to the Company or any of its properties; except, in the case of
clauses (ii) -
(v) of this section, for such violation or defaults that would not
have a
Material Adverse Effect. The execution and delivery of this
Agreement and the
consummation of the transactions herein contemplated and the
fulfillment of the
terms hereof will not conflict with or result in a breach of any of
the terms or
provisions of, or constitute a default under, any indenture,
mortgage, deed of
trust or other agreement or instrument to which the Company or any
Subsidiary is
a party or by which the Company or any Subsidiary or any of their
respective
properties is bound, or of the Restated Certificate of
Incorporation or By-laws
of the Company or any law, order, rule or regulation judgment,
order, writ or
decree applicable to the Company or any Subsidiary of any court or
of any
government, regulatory body or administrative agency or other
governmental body
having jurisdiction.
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(s) The execution and delivery of, and the performance by the
Company of its obligations under, this Agreement has been duly and
validly
authorized by all necessary corporate action on the part of the
Company, and
this Agreement has been duly executed and delivered by the Company.
(t) Each approval, consent, order, authorization, designation,
declaration or filing by or with any regulatory, administrative or
other
governmental body necessary in connection with the execution and
delivery by the
Company of this Agreement and the consummation of the transactions
herein
contemplated (except such additional steps as may be required by
the Commission,
the National Association of Securities Dealers, Inc. (the "NASD")
or such
additional steps as may be necessary to qualify the Shares for
public offering
by the Underwriters under state securities or Blue Sky laws) has
been obtained
or made and is in full force and effect.
(u) The Company has all necessary licenses, authorizations,
consents
and approvals and has made all necessary filings required under any
federal,
state, local or foreign law, regulation or rule, and has obtained
all necessary
licenses, authorizations, consents and approvals from other
persons, in order to
conduct its business, except where the absence of such license,
authorization,
consent, approval or filing would not, individually or in the
aggregate, have a
Material Adverse Effect. The Company is not in violation of, or in
default
under, and has not received notice of any proceedings relating to
revocation or
modification of, any such license, authorization, consent or
approval or any
federal, state, local or foreign law, regulation or rule or any
decree, order or
judgment applicable to the Company, except where such violation,
default,
revocation or modification would not, individually or in the
aggregate, have a
Material Adverse Effect.
(v) To the Company's knowledge, the Company owns, or has obtained
valid and enforceable licenses for, or other legal rights to use,
the
inventions, patent applications, patents, utility models,
industrial property,
trademarks (both registered and unregistered), trade names, service
marks (both
registered and unregistered), service names, copyrights, trade
secrets, customer
lists, designs, manufacturing or other processes, computer
software, systems,
data compilations, research results, know-how or other proprietary
rights and
information described in the Registration Statement, the General
Disclosure
Package and the Prospectus as being owned or licensed by the
Company, or used in
the Company's business as presently conducted with respect to the
research,
development, testing and marketing of GEM 21S, GEM OS1 and GEM OS2
and the other
product candidates (collectively, the "Products") each as described
in the
Registration Statement, the General Disclosure Package and the
Prospectus,
except where the failure to own, license or otherwise enjoy such
rights would
not, individually or in the aggregate, have a Material Adverse
Effect
(collectively, "Intellectual Property"). To the Company's
knowledge, all of such
patents, registered trademarks and registered copyrights owned or
licensed by
the Company have been duly registered in, filed in or issued by the
United
States Patent and Trademark Office, the United States Copyright
Office or the
corresponding offices of other jurisdictions and have been
maintained and
renewed in accordance with all applicable provisions of law and
administrative
regulations in the United States and all such other jurisdictions,
except where
the failure to do so, individually or in the aggregate, would not
have a
Material Adverse Effect. The Company has taken all steps required
in accordance
with sound
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business practice and business judgment to establish and preserve
its ownership
of or rights to all material Intellectual Property. To the
Company's knowledge,
there are no third parties who have or will be able to establish
rights to any
Intellectual Property related to the Products, except for, and to
the extent of,
the ownership rights of the owners of the Intellectual Property
that the
Registration Statement or Prospectus disclose is licensed to the
Company. To the
Company's knowledge, there is no infringement by third parties of
any of the
Intellectual Property. To the Company's knowledge, there is no
pending or
threatened action, suit, proceeding or claim by others challenging
the Company's
rights in or to any Intellectual Property, and the Company is
unaware of any
facts that could form a reasonable basis for any such action, suit,
proceeding
or claim. There is no pending, or to the Company's knowledge,
threatened action,
suit, proceeding or claim by others challenging the validity,
enforceability or
scope of any Intellectual Property, and the Company is unaware of
any facts that
could form a reasonable basis for any such action, suit, proceeding
or claim. To
the Company's knowledge, the Company has not formerly and presently
is not
infringing or violating the Intellectual Property of any other
person. There is
no pending, or to the Company's knowledge, threatened action, suit,
proceeding
or claim by another that the Company infringes or otherwise
violates any
Intellectual Property, and the Company is unaware of any facts that
could form a
reasonable basis for any such action, suit, proceeding or claim. To
the
Company's knowledge, the manufacture, use, sale, offer for sale or
import of any
Product described in the Registration Statement or Prospectus by
the Company
would not infringe any claim of any patent of another, except that
of a licensor
who has granted the Company a license under any such patent. No
proceeding
charging the Company with infringement of any adversely held
Intellectual
Property has been filed. The Company is in compliance with the
terms of all
agreements pursuant to which Intellectual Property has been
licensed to the
Company. All such agreements are in full force and effect and there
is no
default by the Company thereto, and to the Company's knowledge, no
notice of
default thereunder has been threatened against the Company. To the
Company's
knowledge, sublicenses granted to others are now in compliance with
the terms of
all agreements pursuant to which Intellectual Property has been
sublicensed by
the Company. To the Company's knowledge, all such agreements are in
full force
and effect and there is no default by any sublicensee thereto. To
the Company's
knowledge, there is no patent or patent application containing
claims that
interfere with the issued or pending claims of any patent owned by
or licensed
to the Company. The Company is not aware of any fact from which it
could
reasonably be inferred that an individual associated with the
filing and
prosecution of any patent owned by or licensed to the Company
failed to disclose
to the United States Patent and Trademark Office all information
known to that
individual to be material to patentability. The Products described
in the
Registration Statement, the General Disclosure Package or the
Prospectus fall
within the scope of one or more claims of one or more patents owned
by or
licensed to the Company. Upon the making, selling, offering for
sale or
importing into the United States of any product covered by one or
more claims of
a United States patent owned or licensed by the Company, the
Company will comply
with the marking and notice requirements of 35 U.S.C. SS. 287(a).
(w) Neither the Company nor the Subsidiary, nor any of their
respective directors, officers, affiliates or controlling persons,
has taken or
may take, directly or indirectly, any action designed to cause or
result in, or
which has constituted or which might reasonably be expected to
constitute, the
stabilization or manipulation of the price of the shares of Common
Stock to
facilitate the sale or resale of the Shares. The Company
acknowledges that the
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Underwriters may engage in passive market making transactions in
the Shares on
the Nasdaq National Market in accordance with Regulation M under
the Exchange
Act.
(x) Neither the Company nor any Subsidiary is or, after giving
effect to the offering and sale of the Shares contemplated
hereunder, will be an
"investment company" within the meaning of such term under the
Investment
Company Act of 1940 as amended (the "1940 Act"), and the rules and
regulations
of the Commission thereunder.
(y) The Company is not and, after giving effect to the offering and
sale of the Shares, will not be a "holding company" or a
"subsidiary company" of
a "holding company" or an "affiliate" of a "holding company" or of
a "subsidiary
company," as such terms are defined in the Public Utility Holding
Company Act of
1935, as amended (the "Public Utility Holding Company Act").
(z) The Company maintains for it, and if applicable, for the
Subsidiary, a system of internal accounting controls sufficient to
provide
reasonable assurances that (i) transactions are executed in
accordance with
management's general or specific authorization; (ii) transactions
are recorded
as necessary to permit preparation of financial statements in
conformity with
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.
(aa) The Company has established and maintains "disclosure controls
and procedures" (as defined in Rules 13a-15(e) and 15d-15(e) under
the Exchange
Act); the Company's "disclosure controls and procedures" are
reasonably designed
to ensure that all information (both financial and non-financial)
required to be
disclosed by the Company in the reports that it files or submits
under the
Exchange Act is recorded, processed, summarized and reported within
the time
periods specified in the rules and regulations of the Exchange Act,
and that all
such information is accumulated and communicated to the Company's
management as
appropriate to allow untimely decisions regarding required
disclosure and to
make the certifications of the Chief Executive Officer and Chief
Financial
Officer of the Company required under the Exchange Act with respect
to such
reports.
(bb) The statistical, industry-related and market-related data
included in the Registration Statement, the General Disclosure
Package and the
Prospectus are based on or derived from sources which the Company
reasonably and
in good faith believes are reliable and accurate, and the Company
has obtained
the written consent to the use of such data from such sources to
the extent
required.
(cc) The operations of the Company and the Subsidiary are and have
been conducted at all times in compliance with applicable financial
record-keeping and reporting requirements of the Currency and
Foreign
Transactions Reporting Act of 1970, as amended, applicable money
laundering
statutes and applicable rules and regulations thereunder
(collectively, the
"Money Laundering Laws"), and no action, suit or proceeding by or
before any
court or governmental agency, authority or body or any arbitrator
involving the
Company or the
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Subsidiary with respect to the Money Laundering Laws is pending or,
to the
Company's knowledge, threatened.
(dd) Neither the Company nor, to the Company's knowledge, any
director, officer, agent, employee or affiliate of the Company is
currently
subject to any U.S. sanctions administered by the Office of Foreign
Assets
Control of the U.S. Treasury Department ("OFAC"); and the Company
will not
directly or indirectly use the proceeds of the offering, or lend,
contribute or
otherwise make available such proceeds to any subsidiary, joint
venture partner
or other person or entity, for the purpose of financing the
activities of any
person currently subject to any U.S. sanctions administered by
OFAC.
(ee) The Company and the Subsidiary carry, or are covered by,
insurance 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.
(ff) The Company and each Subsidiary is in compliance in all
material respects with all presently applicable provisions of the
Employee
Retirement Income Security Act of 1974, as amended, including the
regulations
and published interpretations thereunder ("ERISA"); neither the
Company nor the
Subsidiary has ever maintained any "pension plan" (as defined in
ERISA).
(gg) To the Company's knowledge, there are no affiliations or
associations between (i) any member of the NASD and (ii) the
Company or any of
the Company's officers, directors or 5% or greater security holders
or any
beneficial owner of the Company's unregistered equity securities
that were
acquired at any time on or after the 180th day immediately
preceding the date
the Registration Statement was initially filed with the Commission,
except as
set forth in the Registration Statement.
(hh) The Company and its properties, assets and operations is and
has been in compliance with, and holds all permits, authorizations
and approvals
required under, Environmental Laws (as defined below), except to
the extent that
failure to so comply or to hold such permits, authorizations or
approvals would
not, individually or in the aggregate, have a Material Adverse
Effect; there are
no past, present or, to the Company's knowledge, reasonably
anticipated future
events, conditions, circumstances, activities, practices, actions,
omissions or
plans that could reasonably be expected to, individually or in the
aggregate,
have a Material Adverse Effect or to interfere with or prevent
material
compliance by the Company with Environmental Laws; except as would
not,
individually or in the aggregate, have a Material Adverse Effect,
the Company
(i) to the Company's knowledge is not the subject of any
investigation, (ii) has
not received any notice or claim, (iii) is not a party to or
affected by any
pending or to the Company's knowledge threatened action, suit or
proceeding,
nor, to the best of the Company's knowledge, is there any basis for
any such
suit or proceeding, (iv) is not bound by any judgment, decree or
order, (v) has
not entered into any agreement, in each case relating to any
alleged violation
of any Environmental Law or any actual or alleged release or
threatened release
or cleanup at any location of any Hazardous Materials (as defined
below), (vi)
has not arranged for the disposal of any Hazardous Material at, or
transported
any Hazardous Material
- 11 -
to, any site for which the Company is or may be liable except by a
licensed
contractor in accordance with applicable laws, (vii) is not bound
by any lien,
nor is any lien reasonably expected to be recorded on the property
or (viii) to
the Company's knowledge, it does not currently own or lease or has
not
previously owned or leased any property that contains or contained
or includes
or included any asbestos, polychlorinated biphenyls, or any
underground storage
tanks, piping, or sumps (or other underground structures) which
contain or
contained Hazardous Materials or contains or contained any
environmental
conditions (other than resulting from the fact that the property is
located on a
cemetery), including, without limitation, any wetlands or
endangered species,
that will impede use or redevelopment of such property (as used
herein,
"Environmental Law" means any federal, state, local or foreign law,
statute,
ordinance, rule, regulation, order, decree, judgment, injunction,
permit,
license, authorization or other binding requirement, or common law,
relating to
health, safety or the protection, cleanup or restoration of the
environment or
natural resources, including those relating to the distribution,
processing,
generation, treatment, storage, disposal, transportation, other
handling or
release or threatened release of Hazardous Materials, and
"Hazardous Materials"
means any material (including, without limitation, pollutants,
contaminants,
hazardous or toxic substances, wastes, asbestos, silica, mixed
dust, bacteria,
mold or fungi) that is regulated by or may give rise to liability
under any
Environmental Law); other than as set forth on Schedule 1(hh),
there have been
no environmental studies, investigations, reports or assessments
concerning the
Company or any currently or previously owned or leased properties
within its
possession or control.
(ii) There are no relationships or related-party transactions
involving the Company or the Subsidiary or any other person
required to be
described in the Prospectus which have not been described as
required.
(jj) Neither the Company nor the Subsidiary has made any
contribution or other payment to any official of, or candidate for,
any federal,
state or foreign office in violation of any law which violation is
required to
be disclosed in the Prospectus.
(kk) The Company has not failed to file with the applicable
regulatory authorities (including, without limitation, the Food and
Drug
Administration (the "FDA") or any foreign, federal, state or local
governmental
or regulatory authority performing functions similar to those
performed by the
FDA) any required filing, declaration, listing, registration,
report or
submission; all such filings, declarations, listings,
registrations, reports or
submissions were in material compliance with applicable laws when
filed and,
except as referred to or described in the Registration Statement,
the General
Disclosure Package or the Prospectus or which would not have,
individually or in
the aggregate, a Material Adverse Effect, no deficiencies have been
asserted by
any applicable regulatory authority (including, without limitation,
the FDA or
any foreign, federal, state or local governmental or regulatory
authority
performing functions similar to those performed by the FDA) with
respect to any
such filings, declarations, listings, registrations, reports or
submissions that
remain unresolved.
(ll) To the Company's knowledge, with regard to GEM 21S, all of the
manufacturing facilities and operations of the Company and its
United States and
foreign suppliers are in compliance in all material respects with
applicable FDA
and comparable regulations, including current Good Manufacturing
Practices
except that as of the date hereof,
- 12 -
the Company is prohibited by the terms of the FDA's approval of the
premarket
application ("PMA") for GEM 21S from utilizing lots of rhPDGF that
were
fermented by Chiron after September 2002, and related compliance
issues at
Chiron remain unresolved.
(mm) The preclinical tests and clinical trials that are described
in, or the results of which are referred to in, the Registration
Statement, the
General Disclosure Package or the Prospectus were and, if still
pending, are to
the Company's knowledge being conducted in all material respects in
accordance
with protocols filed with the appropriate regulatory authorities
for each such
test or trial and in accordance with all statutes, laws, rules and
regulations,
as the case may be, and with standard medical and scientific
research procedures
except where such failure to comply would not have a Material
Adverse Effect;
the description of the results of such tests and trials contained
in the
Registration Statement, the General Disclosure Package or the
Prospectus
accurately presents summaries in all material respects of the data
derived from
such tests and trials, and the Company has no knowledge of any
other studies or
tests the results of which call into question, the clinical results
described or
referred to in the Registration Statement, the General Disclosure
Package or the
Prospectus such that such study or test would result in a Material
Adverse
Effect; the Company has not received any notices or other
correspondence from
the FDA or any committee thereof or from any other U.S. or foreign
government or
drug or medical device regulatory agency requiring the termination
or suspension
of any clinical trials that are described or referred to in the
Registration
Statement, the General Disclosure Package or the Prospectus; and
the Company has
operated and currently is in compliance in all material respects
with all
applicable rules and regulations of the FDA and comparable foreign
drug or
medical device regulatory agencies outside of the United States
except where
such failure to comply would not have a Material Adverse Effect.
(nn) Immediately after the issuance and sale of the Shares as
contemplated hereby, no shares of preferred stock of the Company
shall be issued
or outstanding; and the issuance and sale of the Shares as
contemplated hereby
will not cause any holder of any shares of capital stock,
securities convertible
into or exchangeable or exercisable for capital stock or options,
warrants or
other rights to purchase capital stock or any other securities of
the Company to
have any right to acquire any shares of preferred stock of the
Company.
(oo) Except pursuant to this Agreement, the Company has not
incurred
any liability for any finder's or broker's fee or agent's
commission in
connection with the execution and delivery of this Agreement or the
consummation
of the transactions contemplated hereby or by the Prospectus.
(pp) The Company is not engaged in any unfair labor practice;
except
for matters which would not, individually or in the aggregate, have
a Material
Adverse Effect, (i) there is (A) no unfair labor practice complaint
pending or,
to the Company's knowledge, threatened against the Company before
the National
Labor Relations Board, and no grievance or arbitration proceeding
arising out of
or under collective bargaining agreements is pending or threatened,
(B) no
strike, labor dispute, slowdown or stoppage pending or, to the
Company's
knowledge, threatened against the Company and (C) no union
representation
dispute currently existing concerning the employees of the Company,
and (ii) to
the Company's knowledge, (A) no union organizing activities are
currently taking
place concerning the employees of the Company and
- 13 -
(B) there has been no violation of any federal, state, local or
foreign law
relating to discrimination in the hiring, promotion or pay of
employees or any
applicable wage or hour laws.
(qq) No consent, approval, authorization or order of, or
qualification with, any governmental body or agency, other than
those obtained,
is required in connection with the offering of the Directed Shares
in any
jurisdiction where the Directed Shares are being offered.
(rr) The Company has not offered, or caused DBSI or its affiliates
to offer, Shares to any person pursuant to the Directed Share
Program with the
specific intent to unlawfully influence (i) a customer or supplier
of the
Company to alter the customer's or supplier's level or type of
business with the
Company, or (ii) a trade journalist or publication to write or
publish favorable
information about the Company or its products.
2.
PURCHASE, SALE AND DELIVERY OF THE FIRM SHARES.
(a) On the basis of the representations, warranties and covenants
herein contained, and subject to the conditions herein set forth,
the Company
agrees to sell to the Underwriters and each Underwriter agrees,
severally and
not jointly, to purchase, at a price of $_____ per share, the
number of Firm
Shares set forth opposite the name of each Underwriter in Schedule
I hereof,
subject to adjustments in accordance with Section 9 hereof.
(b) Payment for the Firm Shares to be sold hereunder is to be made
in Federal (same day) funds against delivery of certificates
therefor to the
Representatives for the several accounts of the Underwriters. Such
payment and
delivery are to be made through the facilities of The Depository
Trust Company,
New York, New York at 10:00 a.m., New York time, on the third
business day after
the date of this Agreement or at such other time and date not later
than five
business days thereafter as you and the Company shall agree upon,
such time and
date being herein referred to as the "Closing Date." (As used
herein, "business
day" means a day on which the New York Stock Exchange is open for
trading and on
which banks in New York are open for business and are not permitted
by law or
executive order to be closed.)
(c) In addition, on the basis of the representations and warranties
herein contained and subject to the terms and conditions herein set
forth, the
Company hereby grants an option to the several Underwriters to
purchase the
Option Shares at the price per share as set forth in the first
paragraph of this
Section 2. The option granted hereby may be exercised in whole or
in part by
giving written notice (i) at any time before the Closing Date and
(ii) only once
thereafter within 30 days after the date of this Agreement, by DBSI
to the
Company setting forth the number of Option Shares as to which the
several
Underwriters are exercising the option and the time and date at
which such
certificates are to be delivered. The time and date at which
certificates for
Option Shares are to be delivered shall be determined by DBSI but
shall not be
earlier than three nor later than 10 full business days after the
exercise of
such option, nor in any event prior to the Closing Date (such time
and date
being herein referred to as the "Option Closing Date"). If the date
of exercise
of the option is three or more days before the Closing Date, the
notice of
exercise shall set the Closing Date as the Option Closing Date. The
number of
Option Shares to be purchased by each Underwriter shall be in the
same
proportion to the total number of Option Shares being purchased as
the number of
Firm Shares being purchased by
- 14 -
such Underwriter bears to the total number of Firm Shares, adjusted
by you in
such manner as to avoid fractional shares. The option with respect
to the Option
Shares granted hereunder may be exercised only to cover
over-allotments in the
sale of the Firm Shares by the Underwriters. DBSI may cancel such
option at any
time prior to its expiration by giving written notice of such
cancellation to
the Company. To the extent, if any, that the option is exercised,
payment for
the Option Shares shall be made on the Option Closing Date in
Federal (same day
funds) through the facilities of The Depository Trust Company in
New York, New
York drawn to the order of the Company.
3.
OFFERING BY THE UNDERWRITERS.
It is understood that the several Underwriters are to make a public
offering of the Firm Shares as soon as the Representatives deem it
advisable to
do so. The Firm Shares are to be initially offered to the public at
the initial
public offering price set forth in the Prospectus. The
Representatives may from
time to time thereafter change the public offering price and other
selling
terms.
It is further understood that you will act as the Representatives
for the Underwriters in the offering and sale of the Shares in
accordance with a
Master Agreement Among Underwriters entered into by you and the
several other
Underwriters.
4.
COVENANTS OF THE COMPANY
The Company covenants and agrees with the several Underwriters
that:
(a) The Company will (A) prepare and timely file with the
Commission
under Rule 424(b) under the Act a Prospectus in a form approved by
the
Representatives containing information previously omitted at the
time of
effectiveness of the Registration Statement in reliance on Rules
430A, 430B or
430C under the Act and (B) not file any amendment to the
Registration Statement
or distribute an amendment or supplement to the General Disclosure
Package or
the Prospectus of which the Representatives shall not previously
have been
advised and furnished with a copy or to which the Representatives
shall have
reasonably objected in writing or which is not in compliance with
the Rules and
Regulations.
(b) The Company will (i) not make any offer relating to the Shares
that would constitute an Issuer Free Writing Prospectus or that
would otherwise
constitute a "free writing prospectus" (as defined in Rule 405
under the Act)
required to be filed by the Company with the Commission under Rule
433 under the
Act unless the Representatives approve its use in writing prior to
first use
(each, a "Permitted Free Writing Prospectus"); provided that the
prior written
consent of the Representatives hereto shall be deemed to have been
given in
respect of the Issuer Free Writing Prospectus(es) included in
Schedule III
hereto, (ii) treat each Permitted Free Writing Prospectus as an
Issuer Free
Writing Prospectus, (iii) comply with the requirements of Rules 164
and 433
under the Act applicable to any Issuer Free Writing Prospectus,
including the
requirements relating to timelv filing with the Commission,
legending and record
keeping and (iv) not take any action that would result in an
Underwriter or the
Company being required to file with the Commission pursuant to Rule
433(d) under
the Act a free writing prospectus prepared
- 15 -
by or on behalf of such Underwriter that such Underwriter otherwise
would not
have been required to file thereunder. The Company will satisfy the
conditions
in Rule 433 under the Act to avoid a requirement to file with the
Commission any
electronic road show.
(c) The Company will advise the Representatives promptly (A) when
the Registration Statement or any post-effective amendment thereto
shall have
become effective, (B) of receipt of any comments from the
Commission, (C) of any
request of the Commission for amendment of the Registration
Statement or for
supplement to the General Disclosure Package or the Prospectus or
for any
additional information, and (D) of the issuance by the Commission
of any stop
order suspending the effectiveness of the Registration Statement or
any order
preventing or suspending the use of any Preliminary Prospectus, any
Issuer Free
Writing Prospectus or the Prospectus, or of the institution of any
proceedings
for that purpose or pursuant to Section 8A of the Act. The Company
will use its
best efforts to prevent the issuance of any such order and to
obtain as soon as
possible the lifting thereof, if issued.
(d) The Company will cooperate with the Representatives in
endeavoring to qualify the Shares for sale under the securities
laws of such
jurisdictions as the Representatives may reasonably have designated
in writing
and will make such applications, file such documents, and furnish
such
information as may be reasonably required for that purpose,
provided the Company
shall not be required to qualify as a foreign corporation or to
file a general
consent to service of process in any jurisdiction where it is not
now so
qualified or required to file such a consent. The Company will,
from time to
time, prepare and file
