REGENERON PHARMACEUTICALS,
INC.
COMMON STOCK, $0.001 PAR VALUE
PER SHARE
Morgan Stanley
& Co. Incorporated
1585 Broadway
New York, New York 10036
REGENERON
PHARMACEUTICALS, INC., a New York corporation (the “
Company ”), proposes to issue and sell to you (the
“ Underwriter ”) the number of shares of its
common stock, $0.001 par value per share, set forth in
Schedule I hereto (the “ Shares ”). The
shares of common stock, $0.001 par value 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 on Form S-3 (the file number of which is set forth in
Schedule I hereto), relating to the securities (the “
Shelf Securities ”), including the Shares, to be
issued from time to time by the Company. The registration statement
as amended to the date of this Agreement, including the information
(if any) deemed to be part of the registration statement at the
time of effectiveness pursuant to Rule 430A or Rule 430B
under the Securities Act of 1933, as amended (the “
Securities Act ”), is hereinafter referred to as the
“ Registration Statement ,” and the related
prospectus covering the Shelf Securities dated February 10,
2005 in the form first used to confirm sales of the Shares (or in
the form first made available to the Underwriter by the Company to
meet requests of purchasers pursuant to Rule 173 under the
Securities Act) is hereinafter referred to as the “ Basic
Prospectus. ” The Basic Prospectus, as supplemented by
the prospectus supplement specifically relating to the Shares in
the form first used to confirm sales of the Shares (or in the form
first made available to the Underwriter by the Company to meet
requests of purchasers pursuant to Rule 173 under the
Securities Act) is hereinafter referred to as the “
Prospectus ,” and the term “ preliminary
prospectus ” means any preliminary form of the
Prospectus. For purposes of this Agreement, “ free writing
prospectus ” has the meaning set forth in Rule 405
under the Securities Act, “ Time of Sale Prospectus
” means the Basic Prospectus together with the final term
sheet identified in Schedule I 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,” “Basic Prospectus,”
“preliminary prospectus,” “Time of Sale
Prospectus” and “Prospectus” shall include the
documents, if any, incorporated by reference therein. The terms
“ supplement ,” “ amendment
,” and “ amend ” as used herein with
respect to the Registration Statement, the Basic Prospectus, the
Time of Sale Prospectus, any
preliminary
prospectus or free writing prospectus, if any, shall include all
documents subsequently filed by the Company with the Commission
pursuant to the Securities Exchange Act of 1934, as amended (the
“ Exchange Act ”), that are deemed to be
incorporated by reference therein.
1.
Representations and Warranties . The Company represents and
warrants to and agrees with the Underwriter that:
(a) Registration Statement Effective; Eligibility. 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
threatened by the Commission.
(b) Compliance with Form; Disclosure. (i) Each
document, if any, filed or to be filed pursuant to the Exchange Act
and incorporated by reference in the Time of Sale Prospectus or the
Prospectus complied or will comply when so filed in all material
respects with the Exchange Act and the applicable rules and
regulations of the Commission thereunder, (ii) each part of
the Registration Statement, when such part became effective, did
not contain, and each such part, 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,
(iii) the Registration Statement as of the date hereof does
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, (iv) 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, (v) 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,
(vi) each 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
(vii) 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 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
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the Underwriter
furnished to the Company in writing by such Underwriter expressly
for use therein.
(c) Free
Writing Prospectuses. 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 I hereto forming part of the Time of Sale Prospectus,
and electronic road shows, if any, each 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) Incorporated Documents . The documents incorporated
or deemed to be incorporated by reference in the Registration
Statement, the Time of Sale Prospectus and the Prospectus, at the
time they were or hereafter are filed with the Commission (or, in
the case of the Time of Sale Prospectus, first used, and, in the
case of the Prospectus, for so long as a prospectus is required to
be delivered in connection with the sale of the Shares), complied
and will comply in all material respects with the requirements of
the 1934 Act and the rules and regulations of the Commission
thereunder (the “ 1934 Act Regulations ”) and,
when read together with the other information in (i) the Time
of Sale Prospectus, at the time the Registration Statement became
effective and at the time of each sale of Shares in the offering
when the Prospectus is not yet available to prospective purchasers,
and (ii) the Prospectus at the time the Prospectus was issued
and at the Closing Time, in each case, did not and will not contain
an untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the
statements therein not misleading.
(e) Independent Accountants . The accountants who
certified the financial statements and supporting schedules
included in the Registration Statement are independent public
accountants as required by the 1933 Act and the rules and
regulations of the Commission under the Securities Act (the “
1933 Act Regulations ”).
(f) Financial Statements . The financial statements
included in the Registration Statement, the Time of Sale Prospectus
and the Prospectus, together with the related schedules and notes,
present fairly the respective financial positions of the Company at
the dates indicated and the statement of operations,
stockholders’ equity and cash flows of the Company for the
periods specified;
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said financial
statements have been prepared in conformity with generally accepted
accounting principles (“ GAAP ”) applied on a
consistent basis throughout the periods involved. The supporting
schedules, if any, included in the Registration Statement present
fairly in accordance with GAAP the information required to be
stated therein. The selected financial data included in the
Prospectus present fairly the information shown therein and have
been compiled on a basis consistent with that of the audited
financial statements included in the Registration Statement. All
disclosures in the Registration Statement, the Time of Sale
Prospectus or the Prospectus regarding “non-GAAP financial
measures” (as such term is defined by the rules and
regulations of the Commission) comply with Regulation G under
the Exchange Act and Item 10(e) of Regulation S-K of the 1933
Act Regulations, to the extent applicable.
(g) No
Material Adverse Change in Business . Since the respective
dates as of which information is given in the Registration
Statement and the Prospectus, except as otherwise stated therein,
(A) there has been no material adverse change or a development
known to the Company involving a prospective material adverse
change, in the condition, financial or otherwise, or in the
earnings or business affairs of the Company, whether or not arising
in the ordinary course of business (a “ Material Adverse
Effect ”), (B) there have been no transactions
entered into by the Company, other than those in the ordinary
course of business, which are material with respect to the Company,
and (C) there has been no dividend or distribution of any kind
declared, paid or made by the Company on any class of its capital
stock.
(h) Good
Standing of the Company . The Company has been duly organized
and is validly existing as a corporation in good standing under the
laws of the State of New York and has corporate power and authority
to own, lease and operate its properties and to conduct its
business as described in the Time of Sale Prospectus and the
Prospectus and to enter into and perform its obligations under this
Agreement; and the Company is duly qualified as a foreign
corporation to transact business and is in good standing in each
jurisdiction in which such qualification is required, whether by
reason of ownership or leasing of property or the conduct of
business, except where the failure so to qualify or be in good
standing would not result in a Material Adverse Effect.
(i) Subsidiaries . The Company has no
subsidiaries.
(j) Capitalization . The authorized, issued and
outstanding capital stock of the Company is as set forth in the
condensed balance sheet at September 30, 2006 of the Company
included in the Time of Sale Prospectus and the Prospectus (except
for subsequent issuances, if any, pursuant to this Agreement,
pursuant to reservations, agreements or employee benefit plans
referred to in the Time of Sale Prospectus and the Prospectus or
pursuant to the exercise of convertible securities or options
referred to in the Time of Sale Prospectus and the Prospectus). The
shares of issued and outstanding capital
4
stock of the
Company have been duly authorized and validly issued and are fully
paid and non-assessable; none of the outstanding shares of capital
stock of the Company was issued in violation of the preemptive or
other similar rights of any securityholder of the
Company.
(k) Authorization of Agreement . This Agreement has
been duly authorized, executed and delivered by the
Company.
(l) Authorization and Description of Securities . The
Shares to be purchased by the Underwriter from the Company have
been duly authorized for issuance and sale to the Underwriter
pursuant to this Agreement and, when issued and delivered by the
Company pursuant to this Agreement against payment of the
consideration set forth herein, will be validly issued, fully paid
and non-assessable; the Common Stock conforms to all statements
relating thereto contained in the Time of Sale Prospectus and the
Prospectus and such description conforms to the rights set forth in
the instruments defining the same; and no holder of the Shares will
be subject to personal liability by reason of being such a holder;
and the issuance of the Shares are not subject to the preemptive or
other similar rights of any securityholder of the
Company.
(m) Absence of Defaults and Conflicts . The Company is
not in violation of its charter or by-laws or in default in the
performance or observance of any obligation, agreement, covenant or
condition contained in any 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
”) except for such defaults that would not result in a
Material Adverse Effect; and the execution, delivery and
performance of this Agreement by the Company and the consummation
by the Company of the transactions contemplated herein and in the
Prospectus (including the issuance and sale of the Shares and the
use of the proceeds from the sale of the Shares as described in the
Time of Sale Prospectus and 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 pursuant to, the Agreements and Instruments (except for
such conflicts, breaches or defaults or liens, charges or
encumbrances that would not result in a Material Adverse Effect),
nor will such action result in any violation of the provisions of
the charter 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 except for any such violation that could
not be expected to result in a Material Adverse Effect. As used
herein, a “ Repayment
5
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.
(n) Absence of Labor Dispute . No labor dispute with
the employees of the Company exists or, to the knowledge of the
Company, is imminent, and the Company is not aware of any existing
or imminent labor disturbance by the employees of any of its
principal suppliers, manufacturers, customers or contractors,
which, in either case, may reasonably be expected to result in a
Material Adverse Effect.
(o) Absence of Proceedings . There is no action, suit,
proceeding, inquiry or investigation before or brought by any court
or governmental agency or body, domestic or foreign, now pending,
or, to the knowledge of the Company, threatened, against or
affecting the Company, which is required to be disclosed in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus (other than as disclosed therein), or which might
reasonably be expected to result in a Material Adverse Effect, or
which might reasonably be expected to materially and adversely
affect the properties or assets thereof or the consummation of the
transactions contemplated in this Agreement or the performance by
the Company of its obligations hereunder; the aggregate of all
pending legal or governmental proceedings to which the Company is a
party or of which any of its property or assets is the subject
which are not described in the Registration Statement, the Time of
Sale Prospectus and the Prospectus including ordinary routine
litigation incidental to the business, could not reasonably be
expected to result in a Material Adverse Effect.
(p) Accuracy of Exhibits . There are no contracts or
documents which are required to be described in the Registration
Statement, the Time of Sale Prospectus and the Prospectus or the
documents incorporated by reference therein or to be filed as
exhibits thereto which have not been so described and filed as
required.
(q) Possession of Intellectual Property . The Company
owns or possesses, or will use its best efforts to acquire on
reasonable terms, adequate patents, patent rights, licenses,
inventions, copyrights, know-how (including trade secrets and other
unpatented and/or unpatentable proprietary or confidential
information, systems or procedures), trademarks, service marks,
trade names or other intellectual property (collectively, “
Intellectual Property ”) necessary to carry on the
business now operated by them. Except as disclosed in the Time of
Sale Prospectus and the Prospectus, (i) there is no litigation
or other proceeding pending or, to the Company’s knowledge,
threatened and no claims are presently being asserted by any third
party challenging or questioning the ownership, validity,
enforceability of the Company’s right to use or own any
Intellectual Property or asserting that the use of any Intellectual
Property by the Company or
6
the operation
of the business of the Company infringes upon or misappropriates
the Intellectual Property of any third party, other than
infringements which would not be reasonably likely to have a
Material Adverse Effect, and (ii) the Company is not otherwise
aware of any infringement of or conflict with asserted rights of
others with respect to any Intellectual Property or of any facts or
circumstances which would render any Intellectual Property invalid
or inadequate to protect the interest of the Company therein, and
which infringement or conflict (if the subject of any unfavorable
decision, ruling or finding) or invalidity or inadequacy, singly or
in the aggregate, would result in a Material Adverse
Effect.
(r) Absence of Further Requirements . No filing with,
or authorization, approval, consent, license, order, registration,
qualification or decree of, any court or governmental authority or
agency is necessary or required for the performance by the Company
of its obligations hereunder, in connection with the offering,
issuance or sale of the Shares hereunder or the consummation of the
transactions contemplated by this Agreement, except such as have
been already obtained or as may be required under the Securities
Act or state securities laws.
(s) Possession of Licenses and Permits . The Company
possesses such permits, licenses, approvals, consents and other
authorizations (collectively, “ Governmental Licenses
”) issued by the appropriate federal, state, local or foreign
regulatory agencies or bodies necessary to conduct the business now
operated by them; the Company is in compliance with the terms and
conditions of all such Governmental Licenses, except where the
failure so to comply would not, singly or in the aggregate, have a
Material Adverse Effect; all of the Governmental Licenses are valid
and in full force and effect, except when the invalidity of such
Governmental Licenses or the failure of such Governmental Licenses
to be in full force and effect would not have a Material Adverse
Effect; and the Company has not received any notice of proceedings
relating to the revocation or modification of any such Governmental
Licenses which, singly or in the aggregate, if the subject of an
unfavorable decision, ruling or finding, would result in a Material
Adverse Effect.
(t) Title
to Property . The Company has good and marketable title to all
real property owned by the Company and good title to all other
properties owned by it, in each case, free and clear of all
mortgages, pledges, liens, security interests, claims, restrictions
or encumbrances of any kind except such as (a) are described
in the Time of Sale Prospectus and the Prospectus or (b) do
not, singly or in the aggregate, materially affect the value of
such property and do not interfere with the use made and proposed
to be made of such property by the Company; and all of the leases
and subleases material to the business of the Company considered as
one enterprise, and under which the Company holds properties
described in the Time of Sale Prospectus and the Prospectus, are in
full force and effect, and the Company has no notice of any
material claim of any sort that has been asserted by anyone adverse
to the rights of the Company any of the leases or subleases
mentioned above, or affecting or questioning the rights of
the
7
Company to the
continued possession of the leased or subleased premises under any
such lease or sublease.
(u) Environmental Laws . Except as described in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus and except as would not, singly or in the aggregate,
result in a Material Adverse Effect, (A) the Company is not in
violation of any federal, state, local or foreign statute, law,
rule, regulation, ordinance, code, policy or rule of common law or
any judicial or administrative interpretation thereof, including
any judicial or administrative order, consent, decree or judgment,
relating to pollution or protection of human health, the
environment (including, without limitation, ambient air, surface
water, groundwater, land surface or subsurface strata) or wildlife,
including, without limitation, laws and regulations relating to the
release or threatened release of chemicals, pollutants,
contaminants, wastes, toxic substances, hazardous substances,
petroleum or petroleum products (collectively, “ Hazardous
Materials ”) or to the manufacture, processing,
distribution, use, treatment, storage, disposal, transport or
handling of Hazardous Materials (collectively, “
Environmental Laws ”), (B) the Company has all
permits, authorizations and approvals required under any applicable
Environmental Laws and are each in compliance with their
requirements, (C) there are no pending or threatened
administrative, regulatory or judicial actions, suits, demands,
demand letters, claims, liens, notices of noncompliance or
violation, investigation or proceedings relating to any
Environmental Law against the Company and (D) there are no
events or circumstances that might reasonably be expected to form
the basis of an order for clean-up or remediation, or an action,
suit or proceeding by any private party or governmental
body.
(v) Investment Company Act . The Company is not, and
upon the issuance and sale of the Shares as herein contemplated and
the application of the net proceeds therefrom as described in the
Time of Sale Prospectus and the Prospectus will not be, an
“investment company” or an entity controlled by an
“investment company” as such terms are defined in the
Investment Company Act of 1940, as amended (the “ 1940
Act ”).
(w) FDA
and PTO Proceedings . To the Company’s knowledge, except
as disclosed in the Time of Sale Prospectus and the Prospectus,
there are no rulemaking or similar proceedings before the U.S. Food
and Drug Administration, the U.S. Patent and Trademark Office or
the European Patent Office which affect or involve the Company or
any of the processes or products which the Time of Sale Prospectus
and the Prospectus disclose the Company to have de
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