Exhibit 1.1
__________ SHARES
AMICUS THERAPEUTICS, INC.
COMMON STOCK, PAR VALUE $0.01 PER SHARE
UNDERWRITING AGREEMENT
____________, 2007
_______________, 2007
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇ & Co.
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
4 World Financial center
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇▇▇
As representatives of the several Underwriters
to be named in the within mentioned Agreement
Ladies and Gentlemen:
Amicus Therapeutics, Inc., a Delaware corporation (the "COMPANY"),
confirms its agreements with ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated ("▇▇▇▇▇▇
▇▇▇▇▇▇▇") and ▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated ("▇▇▇▇▇▇▇
▇▇▇▇▇") and each of the Underwriters named in Schedule I hereto (the
"UNDERWRITERS") for whom ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇ are acting as
representatives (in such capacity "REPRESENTATIVES") with respect to the
Company's proposal to issue and sell to the Underwriters _________ shares of its
Common Stock, par value $0.01 per share (the "FIRM SHARES"). The Company also
proposes to issue and sell to the several Underwriters not more than an
additional ______________ shares of its Common Stock, par value $0.01 per share
(the "ADDITIONAL SHARES") if and to the extent that you, as Representatives,
shall have determined to exercise, on behalf of the Underwriters, the right to
purchase such shares of common stock granted to the Underwriters in Section 2
hereof. The Firm Shares and the Additional Shares are hereinafter collectively
referred to as the "SHARES." The shares of Common Stock, par value $0.01 per
share of the Company to be outstanding after giving effect to the sales
contemplated hereby are hereinafter referred to as the "COMMON STOCK."
The Company has filed with the Securities and Exchange Commission (the
"COMMISSION") a registration statement, including a prospectus, relating to the
Shares. The registration statement as amended at the time it becomes effective,
including the information (if any) deemed to be part of the registration
statement at the time of effectiveness pursuant to Rule 430A under the
Securities Act of 1933, as amended (the "SECURITIES ACT"), is hereinafter
referred to as the "REGISTRATION STATEMENT"; the prospectus in the form first
used to confirm sales of Shares (or in the form first made available to the
Underwriters by the Company
to meet requests of purchasers pursuant to Rule 173 under the Securities Act) is
hereinafter referred to as the "PROSPECTUS." If the Company has filed an
abbreviated registration statement to register additional shares of Common Stock
pursuant to Rule 462(b) under the Securities Act (the "RULE 462 REGISTRATION
STATEMENT"), then any reference herein to the term "REGISTRATION STATEMENT"
shall be deemed to include such Rule 462 Registration Statement.
For purposes of this Underwriting Agreement (this "AGREEMENT"), "FREE
WRITING PROSPECTUS" has the meaning set forth in Rule 405 under the Securities
Act, "TIME OF SALE PROSPECTUS" means the preliminary prospectus together with
the free writing prospectuses, if any, each identified in Schedule II hereto,
and "BROADLY AVAILABLE ROAD SHOW" means a "bona fide electronic road show" as
defined in Rule 433(h)(5) under the Securities Act that has been made available
without restriction to any person. As used herein, the terms "Registration
Statement," "preliminary prospectus," "free writing prospectus," "Time of Sale
Prospectus" and "Prospectus" shall include the documents, if any, incorporated
by reference therein.
1. Representations and Warranties. The Company represents and warrants to
and agrees with each of the Underwriters that:
(a) The Registration Statement has become effective; no stop order
suspending the effectiveness of the Registration Statement is in effect, and no
proceedings for such purpose are pending before or, to the knowledge of the
Company, threatened by the Commission.
(b) (i) The Registration Statement, when it became effective, did not
contain and, as amended or supplemented, if applicable, will not contain any
untrue statement of a material fact or omit to state a material fact required to
be stated therein or necessary to make the statements therein not misleading,
(ii) the Registration Statement and the Prospectus comply and, as amended or
supplemented, if applicable, will comply in all material respects with the
Securities Act and the applicable rules and regulations of the Commission
thereunder, (iii) the Time of Sale Prospectus does not, and at the time of each
sale of the Shares in connection with the offering when the Prospectus is not
yet available to prospective purchasers and at the Closing Date (as defined in
Section 4), the Time of Sale Prospectus, as then amended or supplemented by the
Company, if applicable, will not, contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements therein,
in the light of the circumstances under which they were made, not misleading,
(iv) the broadly available road show, if any, when considered together with the
Time of Sale Prospectus, does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements therein,
in the light of the circumstances under which they were made, not misleading and
(v) the Prospectus does not contain and, as amended or supplemented, if
applicable, will not contain any untrue statement of a material fact or omit to
state a material fact necessary to make the statements therein, in the light of
the circumstances under
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which they were made, not misleading, except that the representations and
warranties set forth in this paragraph do not apply to statements or omissions
in the Registration Statement, the Time of Sale Prospectus or the Prospectus
based upon information relating to any Underwriter furnished to the Company in
writing by such Underwriter through you expressly for use therein. Any
statistical and market-related data included in the Registration Statement, the
Time of Sale Prospectus and the Prospectus are based on or derived from sources
that the Company believes to be reliable and accurate, and the Company has
obtained the written consent to the use of such data from such sources.
(c) The Company is not an "ineligible issuer" in connection with the
offering pursuant to Rules 164, 405 and 433 under the Securities Act. Any free
writing prospectus that the Company is required to file pursuant to Rule 433(d)
under the Securities Act has been, or will be, filed with the Commission in
accordance with the requirements of the Securities Act and the applicable rules
and regulations of the Commission thereunder. Each free writing prospectus that
the Company has filed, or is required to file, pursuant to Rule 433(d) under the
Securities Act or that was prepared by or behalf of or used or referred to by
the Company complies or will comply in all material respects with the
requirements of the Securities Act and the applicable rules and regulations of
the Commission thereunder. Except for the free writing prospectuses, if any,
identified in Schedule II hereto, and electronic road shows, if any, furnished
to you before first use, the Company has not prepared, used or referred to, and
will not, without your prior consent, prepare, use or refer to, any free writing
prospectus.
(d) The Company has been duly incorporated, is validly existing as a
corporation in good standing under the laws of the jurisdiction of its
incorporation, has the corporate power and authority to own its property and to
conduct its business as described in the Time of Sale Prospectus and is duly
qualified to transact business and is in good standing in each jurisdiction in
which the conduct of its business or its ownership or leasing of property
requires such qualification, except to the extent that the failure to be so
qualified or be in good standing would not have a material adverse effect on the
Company.
(e) The Company has no subsidiaries.
(f) This Agreement has been duly authorized, executed and delivered by the
Company.
(g) The authorized capital stock of the Company conforms as to legal
matters to the description thereof contained in each of the Time of Sale
Prospectus and the Prospectus. No person is entitled to preemptive or similar
rights to acquire any securities of the Company, except rights that are not
triggered by the issuance of the Shares and that terminate upon the Closing Date
(as defined herein). There are no outstanding securities convertible into or
exchangeable for, or warrants, rights or options to purchase from the Company,
or obligations of the Company to issue, any shares of its Common Stock or any
other
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class of shares of capital stock of the Company, except as set forth in the
Prospectus. Except as described in the Time of Sale Prospectus, there are no
contracts, agreements or understandings between the Company and any person
granting such person the right to require the Company to file a registration
statement under the Securities Act with respect to any securities of the Company
or to require the Company to include such securities with the Shares registered
pursuant to the Registration Statement.
(h) The shares of Common Stock outstanding prior to the issuance of the
Shares have been duly authorized and are validly issued, fully paid and
non-assessable.
(i) The Shares have been duly authorized and, when issued and delivered in
accordance with the terms of this Agreement, will be validly issued, fully paid
and non-assessable, and the issuance of such Shares will not be subject to any
preemptive or similar rights.
(j) The Company is not in violation of its certificate of incorporation or
by-laws or in default in the performance or observance of any obligation,
agreement, covenant or condition contained in any of the agreements filed as an
exhibit to the Registration Statement or any other material contract, indenture,
mortgage, deed of trust, loan or credit agreement, note, lease or other
agreement or instrument to which the Company is a party or by which it may be
bound, or to which any of the property or assets of the Company is subject
(collectively, "AGREEMENTS AND INSTRUMENTS"); and the execution, delivery and
performance of this Agreement and the consummation of the transactions
contemplated herein and in the Registration Statement (including the issuance
and sale of the Securities and the use of the proceeds from the sale of the
Securities as described in the Prospectus under the caption "Use of Proceeds")
and compliance by the Company with its obligations hereunder have been duly
authorized by all necessary corporate action and do not and will not, whether
with or without the giving of notice or passage of time or both, conflict with
or constitute a breach of, or default or Repayment Event (as defined below)
under, or result in the creation or imposition of any lien, charge or
encumbrance upon any property or assets of the Company or any subsidiary
pursuant to, the Agreements and Instruments, nor will such action result in any
violation of the provisions of the certificate of incorporation or by-laws of
the Company or any applicable law, statute, rule, regulation, judgment, order,
writ or decree of any government, government instrumentality or court, domestic
or foreign, having jurisdiction over the Company or any of its assets,
properties or operations. As used herein, a "REPAYMENT EVENT" means any event or
condition which gives the holder of any note, debenture or other evidence of
indebtedness (or any person acting on such holder's behalf) the right to require
the repurchase, redemption or repayment of all or a portion of such indebtedness
by the Company.
(k) There has not occurred any material adverse change, or any development
involving a prospective material adverse change, in the condition,
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financial or otherwise, or in the earnings, business or operations of the
Company from that set forth in the Time of Sale Prospectus.
(l) There are no legal or governmental proceedings pending or, to the
knowledge of the Company, threatened to which the Company is a party or to which
any of the properties of the Company is subject (i) other than proceedings
accurately described in all material respects in the Time of Sale Prospectus and
proceedings that would not have a material adverse effect on the Company, or on
the power or ability of the Company to perform its obligations under this
Agreement or to consummate the transactions contemplated by the Time of Sale
Prospectus or (ii) that are required to be described in the Registration
Statement or the Prospectus and are not so described; and there are no statutes,
regulations, contracts or other documents that are required to be described in
the Registration Statement or the Prospectus or to be filed as exhibits to the
Registration Statement that are not described or filed as required.
(m) Each preliminary prospectus filed as part of the registration
statement as originally filed or as part of any amendment thereto, or filed
pursuant to Rule 424 under the Securities Act, complied when so filed in all
material respects with the Securities Act and the applicable rules and
regulations of the Commission thereunder.
(n) The Company is not, and after giving effect to the offering and sale
of the Shares and the application of the proceeds thereof as described in the
Prospectus will not be, required to register as an "investment company" as such
term is defined in the Investment Company Act of 1940, as amended.
(o) The Company (i) is in compliance with any and all applicable foreign,
federal, state and local laws and regulations relating to the protection of
human health and safety, the environment or hazardous or toxic substances or
wastes, pollutants or contaminants ("ENVIRONMENTAL LAWS"), (ii) has received all
permits, licenses or other approvals required of them under applicable
Environmental Laws to conduct their respective businesses and (iii) is in
compliance with all terms and conditions of any such permit, license or
approval, except where such noncompliance with Environmental Laws, failure to
receive required permits, licenses or other approvals or failure to comply with
the terms and conditions of such permits, licenses or approvals would not,
singly or in the aggregate, have a material adverse effect on the Company.
(p) There are no costs or liabilities associated with Environmental Laws
(including, without limitation, any capital or operating expenditures required
for clean-up, closure of properties or compliance with Environmental Laws or any
permit, license or approval, any related constraints on operating activities and
any potential liabilities to third parties) which would, singly or in the
aggregate, have a material adverse effect on the Company, except to the extent
disclosed in the Prospectus.
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(q) Subsequent to the respective dates as of which information is given in
each of the Registration Statement, the Time of Sale Prospectus and the
Prospectus, (i) the Company has not incurred any material liability or
obligation, direct or contingent, nor entered into any material transaction
except to the extent incurred in the ordinary course of business; (ii) the
Company has not purchased any of its outstanding capital stock (except in
connection with the departure of an employee or consultant and pursuant to the
terms of an existing agreement between such person and the Company), nor
declared, paid or otherwise made any dividend or distribution of any kind on its
capital stock other than ordinary and customary dividends; and (iii) there has
not been any material change in the capital stock, short-term debt or long-term
debt of the Company, except in each case as described in each of the
Registration Statement, the Time of Sale Prospectus and the Prospectus,
respectively.
(r) All United States federal income tax returns of the Company required
by law to be filed have been filed and all taxes shown by such returns or
otherwise assessed, which are due and payable, have been paid, except
assessments against which appeals have been or will be promptly taken and as to
which adequate reserves have been provided. The United States federal income tax
returns of the Company through the fiscal year ended December 31, 2006 have been
settled and no assessment in connection therewith has been made against the
Company. The Company has filed all other tax returns that are required to have
been filed by it pursuant to applicable foreign, state, local or other law
except insofar as the failure to file such returns would not result in a
Material Adverse Effect, and has paid all taxes due pursuant to such returns or
pursuant to any assessment received by the Company, except for such taxes, if
any, as are being contested in good faith and as to which adequate reserves have
been provided. The charges, accruals and reserves on the books of the Company in
respect of any income and corporation tax liability for any years not finally
determined are adequate to meet any assessments or re-assessments for additional
income tax for any years not finally determined, except to the extent of any
inadequacy that would not result in a Material Adverse Effect.
(s) The Company has good and marketable title in fee simple to all real
property, if any, and good and marketable title to all personal property owned
by it which is material to the business of the Company, in each case free and
clear of all liens, encumbrances and defects except such as are described in the
Time of Sale Prospectus or such as do not 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; and any real property and buildings held under lease by
the Company are held by them under valid, subsisting and enforceable leases with
such exceptions as are not material and do not interfere with the use made and
proposed to be made of such property and buildings by the Company, in each case
except as described in the Time of Sale Prospectus.
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(t) The Company owns or has valid, binding and enforceable licenses or
other rights to the patents and patent applications, copyrights, trademarks,
service marks, trade names, service names and trade secrets reasonably necessary
or used in any material respect to conduct the business of the Company in the
manner described in the Prospectus (collectively, the "COMPANY INTELLECTUAL
PROPERTY"), except as enforceability may be limited by bankruptcy and other
similar laws affecting the rights of creditors generally and general principles
of equity; the Company is not obligated to pay a royalty, grant a license, or
provide other consideration to any third party in connection with the Company
Intellectual Property other than as disclosed in the Registration Statement
(including the exhibits thereto); except as disclosed in the Prospectus, (i) the
Company has not received any notice of infringement or conflict with asserted
rights of others with respect to any Company Intellectual Property, (ii) the
discoveries, inventions, products or processes of the Company referred to in the
Prospectus do not, to the knowledge of the Company, infringe, interfere or
conflict with any right or valid patent claim of any third party, and (iii) no
third party has any ownership right in or to any Company Intellectual Property
that is owned by the Company, other than any co-owner of any patent constituting
Company Intellectual Property who is listed on the records of the United States
Patent and Trademark Office (the "PTO") and any co-owner of any patent
application constituting Company Intellectual Property who is named in such
patent application, and, to the knowledge of the Company, no third party has any
ownership right in or to any Company Intellectual Property that is licensed to
the Company, other than any licensor to the Company of such Company Intellectual
Property.
(u) All patent applications owned by the Company and filed with the PTO or
any foreign or international patent authority (the "COMPANY PATENT
Applications") have been duly and properly filed; the Company has complied with
its duty of candor and disclosure to the PTO for the Company Patent
Applications; the Company is not aware of any facts required to be disclosed to
the PTO that were not disclosed to the PTO and which would preclude the grant of
a patent for the Company Patent Applications; and the Company has no knowledge
of any facts which would preclude it from having clear title to the Company
Patent Applications that have been identified by the Company as being
exclusively owned by the Company.
(v) No material labor dispute with the employees of the Company exists,
except as described in the Time of Sale Prospectus, or, to the knowledge of the
Company, is imminent; and the Company is not aware of any existing, threatened
or imminent labor disturbance by the employees of any of its principal
suppliers, manufacturers or contractors that could have a material adverse
effect on the Company.
(w) The Company is insured by insurers of recognized financial
responsibility against such losses and risks and in such amounts as are prudent
and customary in the businesses in which it is engaged. The Company has never
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been refused any insurance coverage sought or applied for and the Company has no
reason to believe that it will not be able to renew its existing insurance
coverage as and when such coverage expires or obtain similar coverage from
similar insurers as may be necessary to continue its business at a cost that
would not have a material adverse effect on the Company, except as described in
the Time of Sale Prospectus.
(x) The Company possesses all certificates, authorizations and permits
issued by the appropriate federal, state or foreign regulatory authorities
necessary to conduct its business, including without limitation all such
certificates, authorizations and permits required by the United States Food and
Drug Administration (the "FDA") or any other federal, state or foreign agencies
or bodies engaged in the regulation of pharmaceuticals or biohazardous
materials, and the Company has not received any notice of proceedings relating
to the revocation or modification of any such certificate, authorization or
permit which, singly or in the aggregate, if the subject of an unfavorable
decision, ruling or finding, would have a material adverse effect on the
Company, except as described in the Time of Sale Prospectus.
(y) The studies, tests and preclinical and clinical trials conducted by or
on behalf of the Company that are described in the Registration Statement and
the Prospectus were and, if still pending, are, to the Company's knowledge,
being conducted in all material respects in accordance with experimental
protocols, procedures and controls pursuant to, where applicable, accepted
professional and scientific standards for products or product candidates
comparable to those being developed by the Company; the descriptions of the
results of such studies, tests and trials contained in the Registration
Statement and the Prospectus do not contain any misstatement of a material fact
or omit to state a material fact necessary to make such statements not
misleading; the Company has no knowledge of any studies, tests or trials not
described in the Registration Statement and the Prospectus the results of which
reasonably call into question the results of the studies, tests and trials
described in the Registration Statement or Prospectus; and the Company has not
received any notices or correspondence from the FDA or any foreign, state or
local governmental body exercising comparable authority or any Institutional
Review Board or comparable authority requiring the termination, suspension or
material modification of any studies, tests or preclinical or clinical trials
conducted by or on behalf of the Company which termination, suspension or
material modification would reasonably be expected to have a material adverse
effect on the Company.
(z) The Company has taken all necessary actions to ensure that, upon the
effectiveness of the Registration Statement, it will be in compliance with all
provisions of the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 and all rules and regulations
promulgated thereunder or implementing the provisions thereof (the
"▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act") that are then in effect and which the Company is required
to comply with as of the effectiveness of the Registration Statement, and is
actively taking
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steps to ensure that it will be in compliance with other provisions of the
▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act not currently in effect, upon the effectiveness of such
provisions, or which will become applicable to the Company at all times after
the effectiveness of the Registration Statement. The Company maintains a system
of internal accounting controls sufficient to provide reasonable assurance 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 generally accepted
accounting principles and to maintain asset accountability; (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
the existing assets at reasonable intervals and appropriate action is taken with
respect to any differences. Except as described in the Time of Sale Prospectus,
since the end of the Company's most recent audited fiscal year, there has been
(i) no material weakness in the Company's internal control over financial
reporting (whether or not remediated) and (ii) no change in the Company's
internal control over financial reporting that has materially affected, or is
reasonably likely to materially affect, the Company's internal control over
financial reporting.
(aa) Except as described in the Time of Sale Prospectus, the Company has
not sold, issued or distributed any shares of Common Stock during the six-month
period preceding the date hereof, including any sales pursuant to Rule 144A
under, or Regulation D or S of, the Securities Act, other than shares issued
pursuant to employee benefit plans, qualified stock option plans or other
employee compensation plans or pursuant to outstanding options, rights or
warrants.
(bb) Each material contract, agreement and license to which the Company is
bound is valid, binding, enforceable, and in full force and effect against the
Company, and to the knowledge of the Company, each other party thereto, except
as enforceability may be limited by bankruptcy and other similar laws affecting
the rights of creditors generally and general principles of equity. Neither the
Company nor, to the Company's knowledge, any other party is in breach or default
in any material respect with respect to any such contract, agreement and
license, and, to the Company's knowledge, no event has occurred which with
notice or lapse of time would constitute a material breach or default, or permit
termination, modification, or acceleration, under any such contract, agreement
or license. No party has repudiated any material provision of any such contract,
agreement or license.
(cc) There are no outstanding loans, advances (except normal advances for
business expenses in the ordinary course of business) or guarantees or
indebtedness by the Company to or for the benefit of any of the executive
officers or directors of the Company, except as disclosed in the Time of Sale
Prospectus or the Prospectus.
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2. Agreements to Sell and Purchase. The Company hereby agrees to sell to
the several Underwriters, and each Underwriter, upon the basis of the
representations and warranties herein contained, but subject to the conditions
hereinafter stated, agrees, severally and not jointly, to purchase from the
Company the respective numbers of Firm Shares set forth in Schedule I hereto
opposite its name at $______ a share (the "PURCHASE PRICE").
On the basis of the representations and warranties contained in this
Agreement, and subject to its terms and conditions, the Company agrees to sell
to the Underwriters the Additional Shares, and the Underwriters shall have the
right to purchase, severally and not jointly, up to an aggregate _______________
Additional Shares at the Purchase Price. You may exercise this right on behalf
of the Underwriters in whole or from time to time in part by giving written
notice not later than 30 days after the date of this Agreement. Any exercise
notice shall specify the number of Additional Shares to be purchased by the
Underwriters and the date on which such shares are to be purchased. Each
purchase date must be at least one business day after the written notice is
given and may not be earlier than the closing date for the Firm Shares nor later
than ten business days after the date of such notice. Additional Shares may be
purchased as provided in Section 4 hereof solely for the purpose of covering
over-allotments made in connection with the offering of the Firm Shares. On each
day, if any, that Additional Shares are to be purchased (an "OPTION CLOSING
DATE"), each Underwriter agrees, severally and not jointly, to purchase the
number of Additional Shares (subject to such adjustments to eliminate fractional
shares as you may determine) that bears the same proportion to the total number
of Additional Shares to be purchased on such Option Closing Date as the number
of Firm Shares set forth in Schedule I hereto opposite the name of such
Underwriter bears to the total number of Firm Shares.
3. Terms of Public Offering. The Company is advised by you that the
Underwriters propose to make a public offering of their respective portions of
the Shares as soon after the Registration Statement and this Agreement have
become effective as in your judgment is advisable. The Company is further
advised by you that the Shares are to be offered to the public initially at
$_____________ a share (the "PUBLIC OFFERING PRICE") and to certain dealers
selected by you at a price that represents a concession not in excess of $______
a share under the Public Offering Price, and that any Underwriter may allow, and
such dealers may reallow, a concession, not in excess of $_____ a share, to any
Underwriter or to certain other dealers.
4. Payment and Delivery. Payment for the Firm Shares shall be made to the
Company in Federal or other funds immediately available in New York City against
delivery of such Firm Shares for the respective accounts of the several
Underwriters at 10:00 a.m., New York City time, on ___________, 2007 or at such
other time on the same or such other date, not later than ___________, 2007, as
shall be designated in writing by you. The time and date of such payment are
hereinafter referred to as the "CLOSING DATE."
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Payment for any Additional Shares shall be made to the Company in Federal
or other funds immediately available in New York City against delivery of such
Additional Shares for the respective accounts of the several Underwriters at
10:00 a.m., New York City time, on the date specified in the corresponding
notice described in Section 2 or at such other time on the same or on such other
date, in any event not later than ___________, 2007, as shall be designated in
writing by you.
The Firm Shares and Additional Shares shall be registered in such names
and in such denominations as you shall request in writing not later than one
full business day prior to the Closing Date or the applicable Option Closing
Date, as the case may be. The Firm Shares and Additional Shares shall be
delivered to you on the Closing Date or an Option Closing Date, as the case may
be, for the respective accounts of the several Underwriters, with any transfer
taxes payable in connection with the transfer of the Shares to the Underwriters
duly paid, against payment of the Purchase Price therefor.
5. Conditions to the Underwriters' Obligations. The obligations of the
Company to sell the Shares to the Underwriters and the several obligations of
the Underwriters to purchase and pay for the Shares on the Closing Date are
subject to the condition that the Registration Statement shall have become
effective not later than _____ (New York City time) on the date hereof.
The several obligations of the Underwriters are subject to the following
further conditions:
(a) Subsequent to the execution and delivery of this Agreement and prior
to the Closing Date:
(i) there shall not have occurred any downgrading, nor shall any
notice have been given of any intended or potential downgrading or of any
review for a possible change that does not indicate the direction of the
possible change, in the rating accorded any of the securities of the
Company by any "nationally recognized statistical rating organization," as
such term is defined for purposes of Rule 436(g)(2) under the Securities
Act; and
(ii) there shall not have occurred any change, or any development
involving a prospective change, in the condition, financial or otherwise,
or in the earnings, business or operations of the Company from that set
forth in the Time of Sale Prospectus as of the date of this Agreement
that, in the Representatives' judgment, is material and adverse and that
makes it, in the Representatives' judgment, impracticable to market the
Shares on the terms and in the manner contemplated in the Time of Sale
Prospectus.
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(b) The Underwriters shall have received on the Closing Date a
certificate, dated the Closing Date and signed by the chief executive officer
and chief financial officer of the Company, to the effect that there has been no
occurrence or notice of any of the events referred to in Section 5(a)(i) above
and to the effect that the representations and warranties of the Company
contained in this Agreement are true and correct as of the Closing Date, that
the Company has complied with all of the agreements and satisfied all of the
conditions on its part to be performed or satisfied hereunder on or before the
Closing Date, and that no stop order suspending effectiveness of the
Registration Statement has been issued and no proceedings for such purpose
instituted or pending or contemplated by the SEC.
The officers signing and delivering such certificate may rely upon the
best of his or her knowledge as to proceedings threatened.
(c) The Underwriters shall have received on the Closing Date an opinion of
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ LLP, outside counsel for the Company, dated the Closing Date,
to the effect that:
(i) the Company has been incorporated, is validly existing as a
corporation in good standing under the laws of the State of Delaware, has
the corporate power and authority necessary to own its property and to
conduct the business in which it is engaged as described in the Time of
Sale Prospectus, and is qualified to do business and is in good standing
as a foreign corporation in the State of New Jersey;
(ii) the authorized capital stock of the Company conforms in all
material respects as to legal matters to the description thereof contained
under the caption "Description of Capital Stock" of each of the Time of
Sale Prospectus and the Prospectus;
(iii) based solely upon our review of the restated charter and
copies of the Company's corporate minutes and stock records which are in
our possession, after giving effect to the filing of the restated charter,
the shares of Common Stock outstanding prior to the issuance of the Shares
have been duly authorized and are validly issued, fully paid and
non-assessable;
(iv) the Shares have been duly authorized and, when issued and
delivered in accordance with the terms of this Agreement, will be validly
issued, fully paid and non-assessable, and the issuance of the Shares to
the Underwriters is not subject to any preemptive or similar rights under
the Delaware General Corporation Law, the restated charter or the by-laws
of the Company or any document filed as an exhibit to the Registration
Statement;
12
(v) this Agreement has been duly authorized, executed and delivered
by the Company;
(vi) the execution and delivery by the Company of, and the
performance by the Company of its obligations under, this Agreement will
not (a) violate any law, rule or regulation applicable to the Company or
any existing provision of the restated charter or by-laws of the Company
or, (b) to our knowledge, result in a breach of or constitute a default
under, or give rise to a right of termination by any party to, any of the
agreements filed as an exhibit to the Registration Statement or (c)
violate any judgment, order or decree of any governmental body, agency or
court that, to our knowledge, has jurisdiction over the Company; and no
consent, approval, authorization or order of, or qualification with, any
governmental body or agency is required for the due execution and delivery
by the Company of this Agreement and the issuance and sale of the Shares,
except such as may be required by the securities or Blue Sky laws of the
various states in connection with the offer and sale of the Shares and
except for the registration of the Shares under the Securities Act and any
consents, approvals, authorizations, orders or qualifications as may be
required under the rules and regulations of the Nasdaq Global Market or
the National Association of Securities Dealers;
(vii) the statements included in (A) the Time of Sale Prospectus and
the Prospectus under the caption "Description of Capital Stock," (B) the
Prospectus under the caption "Underwriters" and (C) the Registration
Statement in Items 14 and 15, in each case insofar as such statements
purport to summarize certain legal matters or documents referred to
therein, fairly summarize the matters described therein in all material
respects;
(viii) to our knowledge, except as described in the Time of Sale
Prospectus and the Prospectus, there are no legal or governmental
proceedings pending or threatened to which the Company is a party that are
required under the Securities Act to be described in the Registration
Statement or the Prospectus that are not so described;
(ix) the Company is not, and after giving effect to the offering and
sale of the Shares and the application of the proceeds thereof as
described in the Prospectus will not be, required to register as an
"investment company" within the meaning of the Investment Company Act of
1940, as amended, and the rules and regulations of the Commission
thereunder.
In addition, such counsel will include the following negative assurance
sin a separate letter:
13
(i) We have participated in conferences with officers and other
representatives of the Company, in-house counsel for the Company, special
intellectual property counsel to the Company, special regulatory counsel
to the Company, you, and counsel for the Underwriters, at which
conferences the contents of the Registration Statement and the Prospectus
and related matters were discussed.
(ii) On the basis of and subject to the foregoing, (a) the
Registration Statement, as of the effective date thereof, and the
Prospectus, as of its date, (except for the financial statements,
financial schedules and other financial data, and accounting information
included or incorporated by reference therein or in the exhibits to the
Registration Statement (collectively, the "Financial Data") as to which we
express no comment) appeared on their face to be appropriately responsive
in all material respects to the requirements of the Securities Act and the
applicable rules and regulations of the Commission thereunder, and (b)
nothing has come to our attention that has caused us to believe that, (1)
at the time the Registration Statement became effective, the Registration
Statement (except for the Financial Data as to which we express no
comment) contained any untrue statement of a material fact or omitted to
state a material fact required to be stated therein or necessary to make
the statements therein not misleading, (2) the Time of Sale Prospectus
(except for the Financial Data as to which we express no comment) as of
the date of this Agreement or as amended or supplemented, if applicable,
as of the Closing Date contained or contains any untrue statement of a
material fact or omitted or omits 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 or (3) the Prospectus (except
for the Financial Data as to which we express no comment) as of its date
or as amended or supplemented, if applicable, as of the Closing Date
contained or contains any untrue statement of a material fact or omitted
or omits to state a material fact necessary in order to make the
statements therein, in the light of the circumstances under which they
were made, not misleading.
The opinion and negative assurances letter described in this Section 5(c)
shall be rendered to the Underwriters at the request of the Company and shall so
state therein.
(d) The Underwriters shall have received on the Closing Date an opinion of
▇▇▇▇▇ ▇▇▇▇▇ LLP, special intellectual property counsel to the Company, dated the
Closing Date, substantially in the form of Exhibit A hereto.
(e) The Underwriters shall have received on the Closing Date an opinion of
▇▇▇▇▇, ▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇, P.C., special Food and Drug Administration counsel to
the Company, dated the Closing Date, substantially in the form of Exhibit B
hereto.
14
(f) The Underwriters shall have received on the Closing Date an opinion
and negative assurances letter of Ropes & ▇▇▇▇ LLP, counsel for the
Underwriters, dated the Closing Date, covering the matters referred to in
clauses 5(c)(iv), 5(c)(v), 5(c)(vii) (but only as to the statements in each of
the Time of Sale Prospectus and the Prospectus under "Underwriters") and the
paragraph following Section 5(c)(ix) above.
With respect to the negative assurances set forth above, such counsel may
state that their opinion and belief is based upon their participation in the
preparation of the Registration Statement, the Time of Sale Prospectus and
Prospectus and any amendments or supplements thereto and review and discussion
of the contents thereof, but are without independent check or verification,
except as specified.
(g) The Underwriters shall have received, on each of the date hereof and
the Closing Date, a letter dated the date hereof or the Closing Date, as the
case may be, in form and substance satisfactory to the Underwriters, from Ernst
& Young, independent public accountants, containing statements and information
of the type ordinarily included in accountants' "comfort letters" to
underwriters with respect to the financial statements and certain financial
information contained in the Registration Statement, the Time of Sale Prospectus
and the Prospectus; provided that the letter delivered on the Closing Date shall
use a "cut-off date" not earlier than the date hereof.
(h) The "lock-up" agreements, each substantially in the form of Exhibit C
hereto, between you and certain shareholders, officers and directors of the
Company relating to sales and certain other dispositions of shares of Common
Stock or certain other securities, delivered to you on or before the date
hereof, shall be in full force and effect on the Closing Date.
(i) The NASD shall have confirmed that it has not raised any objection
with respect to the fairness and reasonableness of the underwriting terms and
arrangements.
The several obligations of the Underwriters to purchase Additional Shares
hereunder are subject to the delivery to you on the applicable Option Closing
Date of such documents as you may reasonably request with respect to the good
standing of the Company, the due authorization and issuance of the Additional
Shares to be sold on such Option Closing Date and other matters related to the
issuance of such Additional Shares.
6. Covenants of the Company. The Company covenants with each Underwriter
as follows:
(a) To furnish to you, without charge, _____ signed copies of the
Registration Statement (including exhibits thereto) and for delivery to each
other Underwriter a conformed copy of the Registration Statement (without
exhibits
15
thereto) and to furnish to you in New York City, without charge, prior to 10:00
a.m. New York City time on the business day next succeeding the date of this
Agreement and during the period mentioned in Section 6(e) or 6(f) below, as many
copies of the Time of Sale Prospectus, the Prospectus and any supplements and
amendments thereto or to the Registration Statement as you may reasonably
request.
(b) Before amending or supplementing the Registration Statement, the Time
of Sale Prospectus or the Prospectus, to furnish to you a copy of each such
proposed amendment or supplement and not to file any such proposed amendment or
supplement to which you reasonably object, and to file with the Commission
within the applicable period specified in Rule 424(b) under the Securities Act
any prospectus required to be filed pursuant to such Rule.
(c) To furnish to you a copy of each proposed free writing prospectus to
be prepared by or on behalf of, used by, or referred to by the Company and not
to use or refer to any proposed free writing prospectus to which you reasonably
object.
(d) Not to 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 Securities Act a free writing prospectus prepared by or on behalf of the
Underwriter that the Underwriter otherwise would not have been required to file
thereunder.
(e) If the Time of Sale Prospectus is being used to solicit offers to buy
the Shares at a time when the Prospectus is not yet available to prospective
purchasers and any event shall occur or condition exist as a result of which it
is necessary to amend or supplement the Time of Sale Prospectus in order to make
the statements therein, in the light of the circumstances, not misleading, or if
any event shall occur or condition exist as a result of which the Time of Sale
Prospectus conflicts with the information contained in the Registration
Statement then on file, or if, in the opinion of counsel for the Underwriters,
it is necessary to amend or supplement the Time of Sale Prospectus to comply
with applicable law, forthwith to prepare, file with the Commission and furnish,
at its own expense, to the Underwriters and to any dealer upon request, either
amendments or supplements to the Time of Sale Prospectus so that the statements
in the Time of Sale Prospectus as so amended or supplemented will not, in the
light of the circumstances when the Time of Sale Prospectus is delivered to a
prospective purchaser, be misleading or so that the Time of Sale Prospectus, as
amended or supplemented, will no longer conflict with the Registration
Statement, or so that the Time of Sale Prospectus, as amended or supplemented,
will comply with applicable law.
(f) If, during such period after the first date of the public offering of
the Shares as in the opinion of the Representatives or in the opinion of counsel
for the Underwriters the Prospectus (or in lieu thereof the notice referred to
in Rule
16
173(a) of the Securities Act) is required by law to be delivered in connection
with sales by an Underwriter or dealer, any event shall occur or condition exist
as a result of which it is necessary to amend or supplement the Prospectus in
order to make the statements therein, in the light of the circumstances when the
Prospectus (or in lieu thereof the notice referred to in Rule 173(a) of the
Securities Act) is delivered to a purchaser, not misleading, or if, in the
opinion of the Representatives or in the opinion of counsel for the
Underwriters, it is necessary to amend or supplement the Prospectus to comply
with applicable law, forthwith to prepare, file with the Commission and furnish,
at its own expense, to the Underwriters and to the dealers (whose names and
addresses you will furnish to the Company) to which Shares may have been sold by
you on behalf of the Underwriters and to any other dealers upon request, either
amendments or supplements to the Prospectus so that the statements in the
Prospectus as so amended or supplemented will not, in the light of the
circumstances when the Prospectus (or in lieu thereof the notice referred to in
Rule 173(a) of the Securities Act) is delivered to a purchaser, be misleading or
so that the Prospectus, as amended or supplemented, will comply with law.
(g) To endeavor to qualify the Shares for offer and sale under the
securities or Blue Sky laws of such jurisdictions as you shall reasonably
request.
(h) To make generally available to the Company's security holders and to
you as soon as practicable an earning statement covering a period of at least
twelve months beginning with the first fiscal quarter of the Company occurring
after the date of this Agreement which shall satisfy the provisions of Section
11(a) of the Securities Act and the rules and regulations of the Commission
thereunder.
(i) Whether or not the transactions contemplated in this Agreement are
consummated or this Agreement is terminated, to pay or cause to be paid all
expenses incident to the performance of its obligations under this Agreement,
including: (i) the fees, disbursements and expenses of the Company's counsel
(including but not limited to the Company's outside corporate, regulatory and
intellectual property counsel) and the Company's accountants in connection with
the registration and delivery of the Shares under the Securities Act and all
other fees or expenses in connection with the preparation and filing of the
Registration Statement, any preliminary prospectus, the Time of Sale Prospectus,
the Prospectus, any free writing prospectus prepared by or on behalf of, used
by, or referred to by the Company and amendments and supplements to any of the
foregoing, including all printing costs associated therewith, and the mailing
and delivering of copies thereof to the Underwriters and dealers, in the
quantities hereinabove specified, (ii) all costs and expenses related to the
transfer and delivery of the Shares to the Underwriters, including any transfer
or other taxes payable thereon, (iii) the cost of printing or producing any Blue
Sky or Legal Investment memorandum in connection with the offer and sale of the
Shares under state securities laws and all expenses in connection with the
qualification of
17
the Shares for offer and sale under state securities laws as provided in Section
6(g) hereof, including filing fees and the reasonable fees and disbursements of
counsel for the Underwriters in connection with such qualification and in
connection with the Blue Sky or Legal Investment memorandum, (iv) all filing
fees and the reasonable fees and disbursements of counsel to the Underwriters
incurred in connection with the review and qualification of the offering of the
Shares by the National Association of Securities Dealers, Inc., (v) all fees and
expenses in connection with the preparation and filing of the registration
statement on Form 8-A relating to the Common Stock and all costs and expenses
incident to listing the Shares on the Nasdaq Global Market, (vi) the cost of
printing certificates representing the Shares, (vii) the costs and charges of
any transfer agent, registrar or depositary, (viii) the costs and expenses of
the Company relating to investor presentations on any "road show" undertaken in
connection with the marketing of the offering of the Shares, including, without
limitation, expenses associated with the preparation or dissemination of any
electronic roadshow, expenses associated with the production of road show slides
and graphics, fees and expenses of any consultants engaged in connection with
the road show presentations with the prior approval of the Company, travel and
lodging expenses of the representatives and officers of the Company and any such
consultants, and the cost of any aircraft chartered in connection with the road
show, (ix) the document production charges and expenses associated with printing
this Agreement, and (x) all other costs and expenses incident to the performance
of the obligations of the Company hereunder for which provision is not otherwise
made in this Section. It is understood, however, that except as provided in this
Section, Section 8 entitled "Indemnity and Contribution" and the last paragraph
of Section 10 below, the Underwriters will pay all of their costs and expenses,
including fees and disbursements of their counsel, stock transfer taxes payable
on resale of any of the Shares by them and any advertising expenses connected
with any offers they may make.
The Company also covenants with each Underwriter that, without the prior
written consent of the Representatives on behalf of the Underwriters, it will
not, during the period ending 180 days after the date of the Prospectus, (1)
offer, pledge, sell, contract to sell, sell any option or contract to purchase,
purchase any option or contract to sell, grant any option, right or warrant to
purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any
shares of Common Stock or any securities convertible into or exercisable or
exchangeable for Common Stock or (2) enter into any swap or other arrangement
that transfers to another, in whole or in part, any of the economic consequences
of ownership of the Common Stock, whether any such transaction described in
clause (1) or (2) above is to be settled by delivery of Common Stock or such
other securities, in cash or otherwise or (3) file any registration statement
with the Commission relating to the offering of any shares of Common Stock or
any securities convertible into or exercisable or exchangeable for Common Stock.
18
The restrictions contained in the preceding paragraph shall not apply to
(a) the Shares to be sold hereunder, (b) the issuance by the Company of shares
of Common Stock upon the exercise of an option or warrant or the conversion of a
security outstanding on the date hereof of which the Underwriters have been
advised in writing, or (c) the issuance or granting by the Company of equity
incentives authorized under any of its equity incentive or stock purchase plans
as of the date of this Agreement provided that any recipient of such issuance or
grant executes a "lock-up" agreement substantially in the form of Exhibit C
hereto. Notwithstanding the foregoing, if (1) during the last 17 days of the
180-day restricted period the Company issues an earnings release or material
news or a material event relating to the Company occurs; or (2) prior to the
expiration of the 180-day restricted period, the Company announces that it will
release earnings results during the 16-day period beginning on the last day of
the 180-day period, the restrictions imposed by this agreement shall continue to
apply until the expiration of the 18-day period beginning on the issuance of the
earnings release or the occurrence of the material news or material event. The
Company shall promptly notify the Representatives of any earnings release, news
or event that may give rise to an extension of the initial 180-day restricted
period.
7. Covenants of the Underwriters. Each Underwriter severally covenants
with the Company not to take any action that would result in the Company being
required to file with the Commission under Rule 433(d) a free writing prospectus
prepared by or on behalf of such Underwriter that otherwise would not be
required to be filed by the Company thereunder, but for the action of the
Underwriter
8. Indemnity and Contribution. (a) The Company agrees to indemnify and
hold harmless each Underwriter, each person, if any, who controls any
Underwriter within the meaning of either Section 15 of the Securities Act or
Section 20 of the Securities Exchange Act of 1934, as amended (the "EXCHANGE
ACT"), and each affiliate of any Underwriter within the meaning of Rule 405
under the Securities Act from and against any and all losses, claims, damages
and liabilities (including, without limitation, any legal or other expenses
reasonably incurred in connection with defending or investigating any such
action or claim) caused by any untrue statement or alleged untrue statement of a
material fact contained in the Registration Statement or any amendment thereof,
any preliminary prospectus, the Time of Sale Prospectus, any issuer free writing
prospectus as defined in Rule 433(h) of the Securities Act, any Company
information that the Company has filed, or is required to file, pursuant to Rule
433(d) of the Securities Act, or the Prospectus or any amendment or supplement
thereto, or caused by any omission or alleged omission to state therein a
material fact required to be stated therein or necessary to make the statements
therein not misleading, except insofar as such losses, claims, damages or
liabilities are caused by any such untrue statement or omission or alleged
untrue statement or omission based upon information relating to any Underwriter
furnished to the Company in writing by such Underwriter through you expressly
for use therein.
19
(b) Each Underwriter agrees, severally and not jointly, to indemnify and
hold harmless the Company, its directors, its officers who sign the Registration
Statement and each person, if any, who controls the Company within the meaning
of either Section 15 of the Securities Act or Section 20 of the Exchange Act to
the same extent as the foregoing indemnity from the Company to such Underwriter,
but only with reference to information relating to such Underwriter furnished to
the Company in writing by such Underwriter through you expressly for use in the
Registration Statement, any preliminary prospectus, the Time of Sale Prospectus,
any issuer free writing prospectus or the Prospectus or any amendment or
supplement thereto.
(c) In case any proceeding (including any governmental investigation)
shall be instituted involving any person in respect of which indemnity may be
sought pursuant to Section 8(a) or 8(b), such person (the "INDEMNIFIED PARTY")
shall promptly notify the person against whom such indemnity may be sought (the
"INDEMNIFYING PARTY") in writing and the indemnifying party, upon request of the
indemnified party, shall retain counsel reasonably satisfactory to the
indemnified party to represent the indemnified party and any others the
indemnifying party may designate in such proceeding and shall pay the fees and
disbursements of such counsel related to such proceeding. In any such
proceeding, any indemnified party shall have the right to retain its own
counsel, but the fees and expenses of such counsel shall be at the expense of
such indemnified party unless (i) the indemnifying party and the indemnified
party shall have mutually agreed to the retention of such counsel or (ii) the
named parties to any such proceeding (including any impleaded parties) include
both the indemnifying party and the indemnified party and representation of both
parties by the same counsel would be inappropriate due to actual or potential
differing interests between them. It is understood that the indemnifying party
shall not, in respect of the legal expenses of any indemnified party in
connection with any proceeding or related proceedings in the same jurisdiction,
be liable for the fees and expenses of more than one separate firm (in addition
to any local counsel) for all such indemnified parties and that all such fees
and expenses shall be reimbursed as they are incurred. Such firm shall be
designated in writing by the Representatives, in the case of parties indemnified
pursuant to Section 8(a), and by the Company, in the case of parties indemnified
pursuant to Section 8(b). The indemnifying party shall not be liable for any
settlement of any proceeding effected without its written consent, but if
settled with such consent or if there be a final judgment for the plaintiff, the
indemnifying party agrees to indemnify the indemnified party from and against
any loss or liability by reason of such settlement or judgment. Notwithstanding
the foregoing sentence, if at any time an indemnified party shall have requested
an indemnifying party to reimburse the indemnified party for fees and expenses
of counsel as contemplated by the second and third sentences of this paragraph,
the indemnifying party agrees that it shall be liable for any settlement of any
proceeding effected without its written consent if (i) such settlement is
entered into more than 30 days after receipt by such indemnifying party of the
aforesaid request and (ii) such indemnifying party shall not have reimbursed the
20
indemnified party in accordance with such request prior to the date of such
settlement. No indemnifying party shall, without the prior written consent of
the indemnified party, effect any settlement of any pending or threatened
proceeding in respect of which any indemnified party is or could have been a
party and indemnity could have been sought hereunder by such indemnified party,
unless such settlement (i) includes an unconditional release of such indemnified
party from all liability on claims that are the subject matter of such
proceeding and (ii) does not include a statement as to or an admission of fault,
culpability or a failure to act, by or on behalf of any indemnified party.
(d) To the extent the indemnification provided for in Section 8(a) or 8(b)
is unavailable to an indemnified party or insufficient in respect of any losses,
claims, damages or liabilities referred to therein, then each indemnifying party
under such paragraph, in lieu of indemnifying such indemnified party thereunder,
shall contribute to the amount paid or payable by such indemnified party as a
result of such losses, claims, damages or liabilities (i) in such proportion as
is appropriate to reflect the relative benefits received by the Company on the
one hand and the Underwriters on the other hand from the offering of the Shares
or (ii) if the allocation provided by clause 8(d)(i) above is not permitted by
applicable law, in such proportion as is appropriate to reflect not only the
relative benefits referred to in clause 8(d)(i) above but also the relative
fault of the Company on the one hand and of the Underwriters on the other hand
in connection with the statements or omissions that resulted in such losses,
claims, damages or liabilities, as well as any other relevant equitable
considerations. The relative benefits received by the Company on the one hand
and the Underwriters on the other hand in connection with the offering of the
Shares shall be deemed to be in the same respective proportions as the net
proceeds from the offering of the Shares (before deducting expenses) received by
the Company and the total underwriting discounts and commissions received by the
Underwriters, in each case as set forth in the table on the cover of the
Prospectus, bear to the aggregate Public Offering Price of the Shares. The
relative fault of the Company on the one hand and the Underwriters on the other
hand shall be determined by reference to, among other things, whether the untrue
or alleged untrue statement of a material fact or the omission or alleged
omission to state a material fact relates to information supplied by the Company
or by the Underwriters and the parties' relative intent, knowledge, access to
information and opportunity to correct or prevent such statement or omission.
The Underwriters' respective obligations to contribute pursuant to this Section
8 are several in proportion to the respective number of Shares they have
purchased hereunder, and not joint.
(e) The Company and the Underwriters agree that it would not be just or
equitable if contribution pursuant to this Section 8 were determined by pro rata
allocation (even if the Underwriters were treated as one entity for such
purpose) or by any other method of allocation that does not take account of the
equitable considerations referred to in Section 8(d). The amount paid or payable
by an indemnified party as a result of the losses, claims, damages and
liabilities referred
21
to in Section 8(d) shall be deemed to include, subject to the limitations set
forth above, any legal or other expenses reasonably incurred by such indemnified
party in connection with investigating or defending any such action or claim.
Notwithstanding the provisions of this Section 8, no Underwriter shall be
required to contribute any amount in excess of the amount by which the total
price at which the Shares underwritten by it and distributed to the public were
offered to the public exceeds the amount of any damages that such Underwriter
has otherwise been required to pay by reason of such untrue or alleged untrue
statement or omission or alleged omission. No person guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the Securities Act)
shall be entitled to contribution from any person who was not guilty of such
fraudulent misrepresentation. The remedies provided for in this Section 8 are
not exclusive and shall not limit any rights or remedies which may otherwise be
available to any indemnified party at law or in equity.
(f) The indemnity and contribution provisions contained in this Section 8
and the representations, warranties and other statements of the Company
contained in this Agreement shall remain operative and in full force and effect
regardless of (i) any termination of this Agreement, (ii) any investigation made
by or on behalf of any Underwriter, any person controlling any Underwriter or
any affiliate of any Underwriter or by or on behalf of the Company, its officers
or directors or any person controlling the Company and (iii) acceptance of and
payment for any of the Shares.
9. Termination. The Underwriters may terminate this Agreement by notice
given by the Representatives to the Company, if after the execution and delivery
of this Agreement and prior to the Closing Date (i) trading generally shall have
been suspended or materially limited on, or by, as the case may be, any of the
New York Stock Exchange, the American Stock Exchange or the Nasdaq Global
Market, (ii) trading of any securities of the Company shall have been suspended
on any exchange or in any over-the-counter market, (iii) a material disruption
in securities settlement, payment or clearance services in the United States
shall have occurred, (iv) any moratorium on commercial banking activities shall
have been declared by Federal or New York State authorities, (v) there shall
have occurred any outbreak or escalation of hostilities, or any change in
financial markets or any calamity or crisis that, in your judgment, is material
and adverse and which, singly or together with any other event specified in this
clause (v), makes it, in the Representatives' judgment, impracticable or
inadvisable to proceed with the offer, sale or delivery of the Shares on the
terms and in the manner contemplated in the Time of Sale Prospectus or the
Prospectus, or (vi) there shall have occurred any change, or any development
involving a prospective change, in the condition, financial or otherwise, or in
the earnings, business or operations of the Company from that set forth in the
Time of Sale Prospectus as of the date of this Agreement that, in the
Representatives' judgment, is material
22
and adverse and that makes it, in the Representatives' judgment, impracticable
to market the Shares on the terms and in the manner contemplated in the Time of
Sale Prospectus.
10. Effectiveness; Defaulting Underwriters. This Agreement shall become
effective upon the execution and delivery hereof by the parties hereto.
If, on the Closing Date or an Option Closing Date, as the case may be, any
one or more of the Underwriters shall fail or refuse to purchase Shares that it
has or they have agreed to purchase hereunder on such date, and the aggregate
number of Shares which such defaulting Underwriter or Underwriters agreed but
failed or refused to purchase is not more than one-tenth of the aggregate number
of the Shares to be purchased on such date, the other Underwriters shall be
obligated severally in the proportions that the number of Firm Shares set forth
opposite their respective names in Schedule I bears to the aggregate number of
Firm Shares set forth opposite the names of all such non-defaulting
Underwriters, or in such other proportions as you may specify, to purchase the
Shares which such defaulting Underwriter or Underwriters agreed but failed or
refused to purchase on such date; provided that in no event shall the number of
Shares that any Underwriter has agreed to purchase pursuant to this Agreement be
increased pursuant to this Section 10 by an amount in excess of one-ninth of
such number of Shares without the written consent of such Underwriter. If, on
the Closing Date, any Underwriter or Underwriters shall fail or refuse to
purchase Firm Shares and the aggregate number of Firm Shares with respect to
which such default occurs is more than one-tenth of the aggregate number of Firm
Shares to be purchased on such date, and arrangements satisfactory to you and
the Company for the purchase of such Firm Shares are not made within 36 hours
after such default, this Agreement shall terminate without liability on the part
of any non-defaulting Underwriter or the Company. In any such case either you or
the Company shall have the right to postpone the Closing Date, but in no event
for longer than seven days, in order that the required changes, if any, in the
Registration Statement, in the Time of Sale Prospectus, in the Prospectus or in
any other documents or arrangements may be effected. If, on an Option Closing
Date, any Underwriter or Underwriters shall fail or refuse to purchase
Additional Shares and the aggregate number of Additional Shares with respect to
which such default occurs is more than one-tenth of the aggregate number of
Additional Shares to be purchased on such Option Closing Date, the
non-defaulting Underwriters shall have the option to (i) terminate their
obligation hereunder to purchase the Additional Shares to be sold on such Option
Closing Date or (ii) purchase not less than the number of Additional Shares that
such non-defaulting Underwriters would have been obligated to purchase in the
absence of such default. Any action taken under this paragraph shall not relieve
any defaulting Underwriter from liability in respect of any default of such
Underwriter under this Agreement.
If this Agreement shall be terminated by the Underwriters, or any of them,
because of any failure or refusal on the part of the Company to comply with the
23
terms or to fulfill any of the conditions of this Agreement, or if for any
reason the Company shall be unable to perform its obligations under this
Agreement, the Company will reimburse the Underwriters or such Underwriters as
have so terminated this Agreement with respect to themselves, severally, for all
out-of-pocket expenses (including the fees and disbursements of their counsel)
reasonably incurred by such Underwriters in connection with this Agreement or
the offering contemplated hereunder.
11. Entire Agreement. (a) This Agreement, together with any
contemporaneous written agreements and any prior written agreements (to the
extent not superseded by this Agreement) that relate to the offering of the
Shares, represents the entire agreement between the Company and the Underwriters
with respect to the preparation of any preliminary prospectus, the Time of Sale
Prospectus, the Prospectus, the conduct of the offering, and the purchase and
sale of the Shares.
(b) The Company acknowledges that in connection with the offering of the
Shares: (i) the Underwriters have acted at arms length, are not agents of, and
owe no fiduciary duties to, the Company or any other person, (ii) the
Underwriters owe the Company only those duties and obligations set forth in this
Agreement and prior written agreements (to the extent not superseded by this
Agreement), if any, and (iii) the Underwriters may have interests that differ
from those of the Company. The Company waives to the full extent permitted by
applicable law any claims it may have against the Underwriters arising from an
alleged breach of fiduciary duty in connection with the offering of the Shares.
12. Counterparts. This Agreement may be signed in two or more
counterparts, each of which shall be an original, with the same effect as if the
signatures thereto and hereto were upon the same instrument.
13. Applicable Law. This Agreement shall be governed by and construed in
accordance with the internal laws of the State of New York.
14. Headings. The headings of the sections of this Agreement have been
inserted for convenience of reference only and shall not be deemed a part of
this Agreement.
15. Notices. All communications hereunder shall be in writing and
effective only upon receipt and if to the Underwriters shall be delivered,
mailed or sent to you in care of the Representatives, at the addresses specified
above, with a copy to the Legal Department; and if to the Company shall be
delivered, mailed or sent to ▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇,
Attention: ▇▇▇▇▇▇▇ ▇ ▇▇▇▇▇▇, Esq., with a copy to ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ LLP, ▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, Attention: ▇▇▇▇▇ ▇▇▇▇, Esq.
24
[ Signature Page Follows ]
Very truly yours,
AMICUS THERAPEUTICS, INC.
By:
-----------------------------------
Name:
Title:
Accepted as of the date hereof
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇
Incorporated
Acting severally on behalf of themselves
and the several Underwriters named
in Schedule I hereto.
By: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
By:
-------------------------------
Name:
Title:
By: ▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ &
▇▇▇▇▇ Incorporated
By:
-------------------------------
Name:
Title:
SCHEDULE I
NUMBER OF
UNDERWRITER SHARES
----------- ---------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated..........
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇
Incorporated...................
▇.▇. ▇▇▇▇▇▇ Securities Inc.................
Lazard Capital Markets LLC.................
Pacific Growth Equities, LLC...............
---------
Total................................
=========
I-1
SCHEDULE II
TIME OF SALE PROSPECTUS
1. Preliminary Prospectus issued [date]
2. [identify all free writing prospectuses filed by the Company under Rule
433(d) of the Securities Act]
3. [free writing prospectus containing a description of terms that does not
reflect final terms, if the Time of Sale Prospectus does not include a
final term sheet]
4. [orally communicated pricing information to be included on Schedule II if
a final term sheet is not used] [to be discussed]
II-1
EXHIBIT A
FORM OF OPINION OF ▇▇▇▇▇ & ▇▇▇▇▇ LLP
[SEE ATTACHED]
A-1
[FORM OF OPINION of ▇▇▇▇▇ & ▇▇▇▇▇ LLP]
_______ ___, 2007
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇▇▇▇ ▇▇▇▇▇ & Co.
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
as Representatives of the several Underwriters
c/o Morgan ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Re: Opinion of Patent Counsel to Amicus Therapeutics, Inc.
Dear Ladies and Gentlemen:
We have been retained by the Amicus Therapeutics, Inc. (the "Company"), as
special intellectual property counsel to review the information relating to the
Company's intellectual property contained in specified sections of the (i) the
Registration Statement on Form S-1 (Registration No. 333-_______ ) filed by the
Company under the Securities Act of 1933, as amended (the "1933 Act"), [as
amended by _______], at the time it became effective under the 1933 Act (the
"Registration Statement") and (ii) the prospectus, dated __________ ___, 2007,
in the form filed by the Company under Section 424(b)(4) of the 1933 Act (the
"Prospectus") [to be confirmed when the Prospectus is filed]. We have not been
retained or engaged by the Company to pass upon any other information in the
Registration Statement or the Prospectus, nor have we acted as counsel to the
Company in any other capacity in connection with the offer and sale of the
securities described in the Registration Statement or the Prospectus. This
opinion is provided to you at the request of the Company pursuant to Section
5(d) of the
Underwriting Agreement dated ______, 2007 (the "
Underwriting
Agreement") [to be confirmed when the
Underwriting Agreement is finalized],
among the Company and the several Underwriters named in Schedule I thereto.
Capitalized terms used herein and not otherwise defined shall have the meaning
ascribed to such terms in the
Underwriting Agreement.
A-2
In our capacity as special intellectual property counsel to the Company
and in the course of our representation, we have reviewed the following sections
(the "Sections") under the captions "RISK FACTORS -- Risks Related to Our
Intellectual Property" and "BUSINESS -- Intellectual Property" in the
Registration Statement, the Prospectus and the Time of Sale Prospectus, except
for any free writing prospectus not listed on attached Schedule A:
RISK FACTORS
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
IF WE ARE UNABLE TO OBTAIN AND MAINTAIN PROTECTION FOR THE INTELLECTUAL
PROPERTY RELATING TO OUR TECHNOLOGY AND PRODUCTS, THE VALUE OF OUR
TECHNOLOGY AND PRODUCTS WILL BE ADVERSELY AFFECTED.
IF WE FAIL TO COMPLY WITH OUR OBLIGATIONS IN OUR INTELLECTUAL PROPERTY
LICENSES WITH THIRD PARTIES, WE COULD LOSE LICENSE RIGHTS THAT ARE
IMPORTANT TO OUR BUSINESS.
IF WE ARE UNABLE TO PROTECT THE CONFIDENTIALITY OF OUR PROPRIETARY
INFORMATION AND KNOW-HOW, THE VALUE OF OUR TECHNOLOGY AND PRODUCTS COULD
BE ADVERSELY AFFECTED.
IF WE INFRINGE OR ARE ALLEGED TO INFRINGE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES, IT WILL ADVERSELY AFFECT OUR BUSINESS.
BUSINESS
INTELLECTUAL PROPERTY -- PATENTS AND TRADE SECRETS
INTELLECTUAL PROPERTY -- LICENSE AGREEMENTS
Specifically, based on facts known to us at this time and without having
made a special investigation, we are of the opinion as to the Company's patents
or patent applications prosecuted or being prosecuted by us that are owned or
exclusively licensed by the Company (the "Owned Patents") and patents and patent
applications owned by third parties that we have not prosecuted and that have
been licensed to the Company (collectively with the Owned Patents, the
"Patents", listed in the attached Schedule B) that:
(i) Except as disclosed in the Registration Statement, the Prospectus
and the Time of Sale Prospectus, to our knowledge, no person or
entity has asserted any ownership rights in any of the Patents other
than the owner identified in the records in the United States Patent
and Trademark Office ("USPTO"). In addition, we have filed and
A-3
recorded an assignment in the USPTO for each of the Owned Patents
that is a non-provisional patent application or issued patent, in
which the named inventor(s) of such Owned Patents assigned their
rights in those Owned Patents to the Company or the Company's
Licensor, as appropriate; or if the assignment has not been executed
we believe the Company is entitled to receive the assignment and the
inventor(s) will provide the assignment. To our knowledge, no liens
have been filed against any of the Patents in the USPTO.
(ii) We have filed and prosecuted each of the Owned Patents in accordance
with the patent statutes and the USPTO Rules of Practice.
(iii) We have complied and are continuing to comply on an ongoing basis
with the required duty of candor and good faith in dealing with the
USPTO with respect to the patents or patent applications prosecuted
or being prosecuted by us, including the duty to disclose to the
USPTO all information known to us to be material to the
patentability of each of the Owned Patents.
In the course of our assistance in the preparation and review of the
Sections, we have participated in conferences with officers and other
representatives of the Company, at which the contents of the Sections were
discussed, and although we are not passing upon and do not assume any
responsibility for the accuracy, completeness or fairness of the statements in
the Sections, on the basis of the foregoing, nothing has come to our attention
that has caused us to believe that (i) as of the effective date of the
Registration Statement, the Sections contained any untrue statement of a
material fact or omitted to state any material fact necessary to make the
statements in the Sections not misleading, (ii) as of the date of the Prospectus
or as of the date hereof, the Sections contained or contain any untrue statement
of a material fact or omitted or omit to state any material fact necessary in
order to make the statements in the Sections, in the light of the circumstances
under which they were made, not misleading, or (iii) as of the date of the Time
of Sale Prospectus, the Sections contained or contain any untrue statement of a
material fact or omitted or omit to state any material fact necessary in order
to make the statements in the Sections, in the light of the circumstances under
which they were made, not misleading. Except as set forth in the Prospectus,
there is no claim, action, proceeding or litigation relating to the Patents or
patent rights of others that is pending or threatened against the Company before
any court, governmental or administrative agency or body of which we are aware.
To the extent the statements made in the Sections constitute summaries of
law, documents or legal proceedings, in our opinion, such statements accurately
summarize in all material respects the provisions of the laws, documents and
proceedings referred to therein.
A-4
Phrases herein such as "to our knowledge," "known to us," or "of which we
are aware," and those with equivalent wording, refer to the conscious awareness
of information by the lawyers of this Firm who have prepared this opinion,
without any independent investigation by any lawyer of this Firm.
We assume no obligation to advise you of any changes in the foregoing
subsequent to the delivery of this letter. This letter has been prepared solely
for your use in connection with the closing on the date hereof of the sale of
the Company's Common Stock as contemplated by the Prospectus, and shall not be
relied upon, quoted in whole or in part or otherwise be referred to, nor be
filed with or furnished to any government agency or other person or entity,
without prior written consent of this firm.
Sincerely,
A-5
SCHEDULE A -- FREE WRITING PROSPECTUSES REVIEWED
A-6
SCHEDULE B -- PATENTS
[table of patents licensed by or assigned to Amicus; to be prepared]
A-7
EXHIBIT B
FORM OF OPINION OF ▇▇▇▇▇, ▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇, P.C.
[SEE ATTACHED]
B-1
DIRECT DIAL (▇▇▇) ▇▇▇-▇▇▇▇
[CLOSING DATE]
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇ & Co.
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
4 World Financial Center
New York, New York 1080
As Representatives of the several Underwriters
Re: Opinion of FDA Regulatory Counsel to Amicus Therapeutics, Inc.
Ladies and Gentlemen:
This opinion letter is being furnished to you at the request of Amicus
Therapeutics, Inc. (the "Company"), a Delaware corporation, pursuant to Section
5(e) of the
Underwriting Agreement dated _______________ between you and the
Company (the "
Underwriting Agreement"), relating to the public offering by the
Company of 5,000,000 shares of the Company's common stock, par value $0.01 per
share (the "Offering"). Capitalized terms not otherwise defined herein shall
have the meanings set forth in the
Underwriting Agreement.
We have been retained by the Company to act as U.S. Food and Drug
Administration ("FDA") regulatory counsel for the limited purpose of reviewing
the information relating to FDA regulatory matters contained in certain sections
of the Company's Registration Statement on Form S-1 (File No. 333.141700), which
was filed with the Securities and Exchange Commission ("SEC") on __________ (the
B-2
"Registration Statement") and final Prospectus dated ____________________ (the
"Prospectus") specified below. We have not been retained by the Company or
anyone else to pass upon any other information in the Registration Statement or
Prospectus.
For purposes of this opinion letter, "FDA Laws", laws that we specialize
in, shall mean the Federal Food, Drug, and Cosmetic Act (the "FDC Act") set
forth at 21 U.S.C. Section 301 et seq., the regulations promulgated under the
authority of the FDC Act, the enforcement of the FDC Act by the FDA, and
judicial and administrative decisions under the FDC Act.
In connection with this opinion letter, at your direction, we have
reviewed and relied upon only the Officer's Certificate, dated ___________,
signed by ______________, [title], certifying certain facts relating to the
Company (the "Officer's Certificate") and attached here as Attachment A, and
information in the Registration Statement and Prospectus pertaining to FDA
regulatory matters under the following captions (collectively referred to herein
as the "Designated Regulatory Provisions"):
RISK FACTORS
RISKS RELATED TO THE DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCT CANDIDATES
INITIAL RESULTS FROM A CLINICAL TRIAL DO NOT ENSURE THAT THE TRIAL WILL BE
SUCCESSFUL AND SUCCESS IN EARLY STAGE CLINICAL TRIALS DOES NOT ENSURE
SUCCESS IN LATER-STAGE CLINICAL TRIALS.
IF OUR PRECLINICAL STUDIES DO NOT PRODUCE POSITIVE RESULTS, IF OUR
CLINICAL TRIALS ARE DELAYED OR IF SERIOUS SIDE EFFECTS ARE IDENTIFIED
DURING DRUG DEVELOPMENT, WE MAY EXPERIENCE DELAYS, INCUR ADDITIONAL COSTS
AND ULTIMATELY BE UNABLE TO COMMERCIALIZE OUR PRODUCT CANDIDATES.
If we are unable to obtain adequate reimbursement from governments or
third party payors for any products that we may develop or if we are
unable to obtain acceptable prices for those products, our prospects for
generating revenue and achieving profitability will suffer.
RISKS RELATED TO OUR DEPENDENCE ON THIRD PARTIES
USE OF THIRD PARTIES TO MANUFACTURE OUR PRODUCT CANDIDATES MAY INCREASE
THE RISK THAT WE WILL NOT HAVE SUFFICIENT QUANTITIES OF OUR PRODUCT
CANDIDATES OR SUCH QUANTITIES AT AN ACCEPTABLE COST, AND CLINICAL
DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCT CANDIDATES COULD BE
DELAYED, PREVENTED OR IMPAIRED.
B-3
WE RELY ON THIRD PARTIES TO CONDUCT OUR CLINICAL TRIALS AND THOSE THIRD
PARTIES MAY NOT PERFORM SATISFACTORILY, INCLUDING FAILING TO MEET
ESTABLISHED DEADLINES FOR THE COMPLETION OF SUCH TRIALS.
RISKS RELATED TO REGULATORY APPROVAL OF OUR PRODUCT CANDIDATES
IF WE ARE NOT ABLE TO OBTAIN AND MAINTAIN REQUIRED REGULATORY APPROVALS,
WE WILL NOT BE ABLE TO COMMERCIALIZE OUR PRODUCT CANDIDATES, AND OUR
ABILITY TO GENERATE REVENUE WILL BE MATERIALLY IMPAIRED.
OUR PRODUCT CANDIDATES MAY CAUSE UNDESIRABLE SIDE EFFECTS OR HAVE OTHER
PROPERTIES THAT COULD DELAY OR PREVENT THEIR REGULATORY APPROVAL OR
COMMERCIALIZATION.
WE MAY NOT BE ABLE TO OBTAIN ORPHAN DRUG EXCLUSIVITY FOR OUR PRODUCT
CANDIDATES. IF OUR COMPETITORS ARE ABLE TO OBTAIN ORPHAN DRUG EXCLUSIVITY
FOR THEIR PRODUCTS THAT ARE THE SAME DRUG AS OUR PRODUCT CANDIDATES, WE
MAY NOT BE ABLE TO HAVE COMPETING PRODUCTS APPROVED BY THE APPLICABLE
REGULATORY AUTHORITY FOR A SIGNIFICANT PERIOD OF TIME.
ANY PRODUCT FOR WHICH WE OBTAIN MARKETING APPROVAL COULD BE SUBJECT TO
RESTRICTIONS OR WITHDRAWAL FROM THE MARKET AND WE MAY BE SUBJECT TO
PENALTIES IF WE FAIL TO COMPLY WITH REGULATORY REQUIREMENTS OR IF WE
EXPERIENCE UNANTICIPATED PROBLEMS WITH OUR PRODUCTS, WHEN AND IF ANY OF
THEM ARE APPROVED.
BUSINESS
OUR LEAD PRODUCT CANDIDATES
AMIGAL FOR FABRY DISEASE -- EXISTING PRODUCTS FOR THE TREATMENT OF FABRY
DISEASE AND POTENTIAL ADVANTAGES OF AMIGAL (THE FIRST AND FOURTH
PARAGRAPHS ONLY)
PLICERA FOR GAUCHER DISEASE -- EXISTING PRODUCTS FOR THE TREATMENT OF
GAUCHER DISEASE AND POTENTIAL ADVANTAGES OF PLICERA (THE FIRST AND FOURTH
PARAGRAPHS ONLY)
AT2220 FOR POMPE DISEASE -- EXISTING PRODUCTS FOR THE TREATMENT OF POMPE
DISEASE AND POTENTIAL ADVANTAGES OF AT2220 (THE FIRST AND THIRD PARAGRAPHS
ONLY)
GOVERNMENT REGULATION
B-4
PHARMACEUTICAL PRICING AND REIMBURSEMENT
We have relied with your approval solely upon our examination of the
Designated Regulatory Provisions.
We have assumed with your approval the accuracy and completeness of all
statements of fact relating to the Company and the status of its products and
you have not asked us to make, and we have not made, any independent
investigations with regard to such matters for purposes of rendering the
opinions herein. We have further assumed that with respect to the laws
identified above, all statutes, judicial and administrative decisions, and rules
and regulations of governmental agencies or self regulatory bodies, applicable
to this opinion letter, are generally available to lawyers practicing in the
area of the FDA laws and are in a format that makes legal research reasonably
feasible.
Further, we have not independently verified, nor do we take any
responsibility for, or are we in any way addressing, any statements of belief
attributable to the Company or whether or not the Company is in compliance with
the FDA Laws.
This opinion is to the best of our knowledge and is based solely on
matters of law as they pertain to FDA Laws, as implemented by FDA, and we
express no opinion as to any other federal, state, local or foreign laws,
statutes, regulations or ordinances.
For purposes of this opinion, the expression "to the best of our
knowledge" means the current actual knowledge of the attorneys in this firm who
have been significantly involved in actively representing the Company, or in
connection with matters related to the Offering, without having conducted any
special investigation of factual matters in connection with this opinion letter.
Based on, subject to, and limited by the foregoing, we are of the opinion
that:
(i) Insofar as the statements in the Designated Regulatory
Provisions of the Registration Statement and Prospectus purport to
describe or summarize applicable provisions of the FDA Laws, such
statements fairly summarize such FDA Laws and are accurate in all
material respects, subject to any qualifications set forth therein;
and
(ii) Nothing has come to our attention which causes us to believe
that the Designated Regulatory Provisions, at the time the
Registration Statement became effective and at all times subsequent
thereto up to and on the Closing Date, contained any untrue
statement of a material fact or omitted to state a material fact
required to be stated therein or necessary to make the statements
therein, in light of the circumstances under which they were made,
not misleading.
* * * *
B-5
This opinion letter is given as of the date hereof and we assume no
obligation to advise you of any changes in the foregoing subsequent to the
delivery of this opinion. This opinion is solely for the information of the
addressee hereof and is not to be quoted in whole or in part or otherwise
referred to, nor is it to be filed with any governmental agency or any other
person without our prior written consent. No one other than the addressee hereof
is entitled to rely on this opinion. This opinion is rendered solely for
purposes of the Offering and should not be relied upon for any other purpose.
Nothing herein should be construed to cause us to be considered "experts" within
the meaning of Section 11 of the Securities Act of 1933, as amended.
B-6
Sincerely,
▇▇▇▇▇, ▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇, P.C.
By: [SIGNATURE OF DIRECTOR]
-----------------------
[PRINTED NAME OF DIRECTOR]
B-7
EXHIBIT C
FORM OF LOCK-UP LETTER
[SEE ATTACHED]
C-1
________________, 2007
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇ & Co.
▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
4 World Financial center
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇▇▇
As Representatives of the several Underwriters
to be named in the within mentioned
Underwriting Agreement
Ladies and Gentlemen:
The undersigned understands that ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ & Co. Incorporated
("▇▇▇▇▇▇ ▇▇▇▇▇▇▇") and ▇▇▇▇▇▇▇ Lynch, Pierce, ▇▇▇▇▇▇ & ▇▇▇▇▇ Incorporated
("▇▇▇▇▇▇▇ ▇▇▇▇▇") propose to enter into an Underwriting Agreement (the
"UNDERWRITING AGREEMENT") in their capacity as representatives of the several
underwriters referred to therein (together with ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇
▇▇▇▇▇, the "UNDERWRITERS") with Amicus Therapeutics, Inc., a Delaware
corporation (the "COMPANY"), providing for the public offering (the "PUBLIC
OFFERING") by the Underwriters of shares (the "SHARES") of the Common Stock,
$0.01 par value per share, of the Company (the "COMMON STOCK").
To induce the Underwriters that may participate in the Public Offering to
continue their efforts in connection with the Public Offering, the undersigned
hereby agrees that, without the prior written consent of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and
▇▇▇▇▇▇▇ ▇▇▇▇▇ on behalf of the Underwriters, it will not, during the period
commencing on the date hereof and ending 180 days after the date of the final
prospectus relating to the Public Offering (the "PROSPECTUS"), (1) offer,
pledge, sell, contract to sell, sell any option or contract to purchase,
purchase any option or contract to sell, grant any option, right or warrant to
purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any
shares of Common Stock or any securities, directly or indirectly, convertible
into or exercisable or exchangeable for Common Stock whether now owned or
hereafter acquired by the undersigned or with respect to which the undersigned
has or hereafter acquires the power of disposition, or (2) enter into any swap
or other arrangement that transfers to another, in whole or in part, any of the
economic consequences of
C-2
ownership of the Common Stock, whether any such transaction described in clause
(1) or (2) above is to be settled by delivery of Common Stock or such other
securities, in cash or otherwise. The foregoing sentence shall not apply to
transactions relating to (a) shares of Common Stock or other securities acquired
in open market transactions after the completion of the Public Offering,
provided that no filing under Section 16(a) of the Securities Exchange Act of
1934, as amended (the "EXCHANGE ACT"), shall be required or shall be voluntarily
made in connection with subsequent sales of Common Stock or other securities
acquired in such open market transactions, (b) transfers of shares of Common
Stock or any security, directly or indirectly, convertible into Common Stock as
a bona fide gift or in connection with estate planning or by intestacy, or (c)
distributions of shares of Common Stock or any security, directly or indirectly,
convertible into Common Stock to limited partners, members, stockholders or
affiliates of the undersigned; provided that in the case of any transfer or
distribution pursuant to clause (b) or (c), (i) each donee or distributee shall
sign and deliver a lock-up letter substantially in the form of this letter and
(ii) no filing under Section 16(a) of the Exchange Act, reporting a reduction in
beneficial ownership of shares of Common Stock, shall be required or shall be
voluntarily made during the restricted period referred to in the foregoing
sentence. In addition, the undersigned agrees that, without the prior written
consent of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇ on behalf of the Underwriters, it
will not, during the period commencing on the date hereof and ending 180 days
after the date of the Prospectus, make any demand on the Company for or exercise
any right with respect to, the registration of any shares of Common Stock or any
security, directly or indirectly, convertible into or exercisable or
exchangeable for Common Stock. The undersigned also agrees and consents to the
entry of stop transfer instructions with the Company's transfer agent and
registrar against the transfer of the undersigned's shares of Common Stock
except in compliance with the foregoing restrictions.
If:
(1) during the last 17 days of the 180-day restricted period, the Company
issues an earnings release or material news or a material event relating to the
Company occurs; or
(2) prior to the expiration of the 180-day restricted period, the Company
announces that it will release earnings results during the 16-day period
beginning on the last day of the 180-day restricted period;
the restrictions imposed by this agreement shall continue to apply until the
expiration of the 18-day period beginning on the issuance of the earnings
release or the occurrence of the material news or material event.
C-3
On or about the date hereof, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇ on behalf of
Underwriters have received or will receive from certain other holders of shares
of Common Stock written agreements setting forth terms similar to this agreement
(the "LOCK-UP AGREEMENTS"). In the event that ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇
on behalf of the Underwriters release for sale or other disposition for value
any shares of Common Stock held by such other holders from the restrictions set
forth in the Lock-Up Agreements, the same percentage of shares of Common Stock
(i.e., percentage as compared to total outstanding share capital) held by the
undersigned shall be immediately and fully released; provided that no shares of
Common Stock held by the undersigned will be so released unless and until more
than 3% of the Company's total outstanding shares of Common Stock in aggregate
have been released from restrictions set forth in the Lock-Up Agreements;
provided further that the undersigned will not be entitled to make any demand
for or exercise any right with respect to the registration of such released
shares of Common Stock until the expiration of this agreement. In the event
that, as a result of the foregoing sentence, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇
release any shares of Common Stock from the restrictions set forth above, they
shall use their commercially reasonable efforts to notify the undersigned within
three business days that the same percentage of shares of Common Stock held by
the undersigned has been released; provided that the failure to give such notice
shall not give rise to any claim against or result in liability to ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, or the Underwriters.
The undersigned understands that the Company and the Underwriters are
relying upon this agreement in proceeding toward consummation of the Public
Offering. The undersigned further understands that this agreement is irrevocable
and shall be binding upon the undersigned's heirs, legal representatives,
successors and assigns.
Whether or not the Public Offering actually occurs depends on a number of
factors, including market conditions. Any Public Offering will only be made
pursuant to an Underwriting Agreement, the terms of which are subject to
negotiation between the Company and the Underwriters and there is no assurance
that the Company and the Underwriters will enter into an Underwriting Agreement
with respect to the Public Offering or that the Public Offering will be
consummated.
C-4
This agreement shall automatically terminate upon the earliest to occur,
if any, of (a) either ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇, on the one hand, or the
Company, on the other hand, advising the other in writing, prior to the
execution of the Underwriting Agreement, that they have determined not to
proceed with the Public Offering, (b) termination of the Underwriting Agreement
before the sale of any Shares to the Underwriters, or (c) October 31, 2007, in
the event that the Underwriting Agreement has not been executed by that date.
Very truly yours,
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(Name)
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(Address)
C-5
