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Exhibit 99.1
3,000,000 SHARES OF COMMON STOCK, PAR VALUE $0.01 PER SHARE
CLINICAL DATA, INC.
UNDERWRITING AGREEMENT
July 17, 2007
BEAR, STEARNS & CO. INC.
As Representative of the
several Underwriters named in
Schedule I attached hereto (the "Representative")
c/o Bear, Stearns & Co. Inc.
383 Madison Avenue
New York, New York 10179
Ladies/Gentlemen:
Clinical Data, Inc., a corporation organized and existing under
the
laws of the State of Delaware (the "Company"), proposes, subject
to the terms
and conditions stated herein, to issue and sell to the several
underwriters
named in Schedule I hereto (the "Underwriters") an aggregate of
3,000,000 shares
(the "Firm Shares") of its Common Stock, par value $0.01 per
share, (the "Common
Stock"), and, for the sole purpose of covering over-allotments
in connection
with the sale of the Firm Shares, at the option of the
Underwriters, up to an
additional 450,000 shares (the "Additional Shares") of Common
Stock. The Firm
Shares and any Additional Shares purchased by the Underwriters
are referred to
herein as the "Shares". Bear, Stearns & Co. Inc. ("Bear
Stearns") is acting as
lead manager (the "Lead Manager") in connection with the
offering and sale of
the Shares contemplated herein (the "Offering").
1. Representations and Warranties of the Company. The
Company
represents and warrants to, and agrees with, each of the
Underwriters that:
(a) The Company has filed with the Securities and Exchange
Commission
(the "Commission") a registration statement under the Securities
Act of 1933, as
amended (the "Securities Act"), relating to the Shares, on Form
S-3 (No.
333-143883) (the initial filing and all pre-effective amendments
thereto
collectively being referred to as the "Initial Registration
Statement"); and
such Initial Registration Statement, and any post-effective
amendment thereto,
each in the form previously delivered to you, have been declared
effective by
the Commission, in such form. Other than a registration
statement, if any,
increasing the size of the Offering (a "Rule 462(b) Registration
Statement")
filed pursuant to Rule 462(b) under the Securities Act, which
will become
effective upon filing, no other document with respect to the
Initial
Registration Statement has heretofore been filed with the
Commission. The
various parts of the Initial Registration Statement and the
462(b) Registration
Statement, if any, including all exhibits
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thereto and including (i) the information contained in the form
of final
prospectus filed with the Commission pursuant to Rule 424(b)
under the
Securities Act in accordance with Section 4(a) hereof and deemed
by virtue of
430B under the Securities Act to be part of the Initial
Registration Statement
at the time it became effective under the Securities Act with
respect to the
Underwriters, and (ii) the documents incorporated by reference
in the prospectus
contained in the Initial Registration Statement at the time such
part of the
Initial Registration Statement becomes effective, each as
amended at the time
such part of the Initial Registration Statement or the Rule
462(b) Registration
Statement, if any, became or hereafter becomes effective under
the Securities
Act with respect to the Underwriters, are hereafter collectively
referred to as
the "Registration Statement." Any reference to any amendment to
the Registration
Statement shall be deemed to refer to and include any annual
report of the
Company filed pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act
of 1934, as amended (the "Exchange Act"), after the effective
date of the
Initial Registration Statement that is incorporated by reference
therein. No
stop order suspending the effectiveness of the Initial
Registration Statement,
any post-effective amendment thereto or the Rule 462(b)
Registration Statement,
if any, has been issued and no proceeding for that purpose has
been initiated or
threatened by the Commission.
The final prospectus supplement together with the base
prospectus
included in the Initial Registration Statement, in the form in
which it has most
recently been filed with the Commission on or prior to the date
of this
Agreement (the "Basic Prospectus") relating to the Shares, in
the form first
filed with the Commission pursuant to Rule 424(b) under the
Securities Act, is
hereafter referred to as the "Prospectus". Any preliminary
prospectus supplement
together with the Basic Prospectus included in the Initial
Registration
Statement or filed with the Commission pursuant to Rule 424
under the Securities
Act is hereafter referred to as a "Preliminary Prospectus;" and
the Preliminary
Prospectus relating to the Shares, as amended or supplemented
immediately prior
to the Applicable Time (as defined below), is hereafter referred
to as the
"Pricing Prospectus". Any "issuer free writing prospectus" (as
defined in Rule
433 under the Securities Act) relating to the Shares is
hereafter referred to as
an "Issuer Free Writing Prospectus"; and the Pricing Prospectus,
as supplemented
by the public offering price of the Shares, the number of Shares
offered and the
Issuer Free Writing Prospectuses, if any, attached and listed in
Annex IV
hereto, taken together, are hereafter referred to collectively
as the "Pricing
Disclosure Package". Any reference herein to any Preliminary
Prospectus or the
Prospectus shall be deemed to refer to and include the documents
incorporated by
reference therein pursuant to Item 12 of Form S- 3 that were
filed under the
Exchange Act on or before the date of such Preliminary
Prospectus or Prospectus,
as the case may be; and any reference herein to any "amendment"
or "supplement"
to any Preliminary Prospectus or the Prospectus shall be deemed
to refer to and
include (i) the filing of any document under the Exchange Act
after the date of
such Preliminary Prospectus or Prospectus, as the case may be,
which is
incorporated therein by reference and (ii) any such document so
filed.
The Company was not an "ineligible issuer" (as defined in Rule
405
under the Securities Act) as of the eligibility determination
date for purposes
of Rules 164 and 433 under the Securities Act with respect to
the offering of
the Shares contemplated hereby.
All references in this Agreement to the Registration Statement,
the
Rule 462(b) Registration Statement, any Preliminary Prospectus,
the Pricing
Prospectus, Issuer Free Writing Prospectus or the Prospectus, or
any amendments
or supplements to any of the foregoing, shall
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be deemed to include any copy thereof filed with the Commission
pursuant to its
Electronic Data Gathering, Analysis and Retrieval System.
(b) The Registration Statement complies and the Prospectus and
any
further amendments or supplements to the Registration Statement
or the
Prospectus will comply in all material respects with the
applicable provisions
of the Securities Act, the Exchange Act and the rules and
regulations of the
Commission thereunder (the "Rules and Regulations"), and do not
and will not, as
of the applicable effective date as to each part of the
Registration Statement
and as of the applicable filing date as to the Prospectus and
any amendment
thereof or supplement thereto, contain an untrue statement of a
material fact or
omit to state a material fact required to be stated therein or
necessary in
order to make the statements therein (i) in the case of the
Registration
Statement, not misleading and (ii) in the case of the
Prospectus, in light of
the circumstances under which they were made, not misleading;
provided, however,
that this representation and warranty shall not apply to any
information
contained in or omitted from the Registration Statement or the
Prospectus or any
amendment thereof or supplement thereto in reliance upon and in
conformity with
information furnished in writing to the Company by or on behalf
of any
Underwriter through Bear Stearns specifically for use therein.
The parties
hereto agree that such information provided by or on behalf of
any Underwriter
through Bear Stearns consists solely of the material referred to
in Section 16
hereof.
(c) No order preventing or suspending the use of any
Preliminary
Prospectus or any Issuer Free Writing Prospectus has been issued
by the
Commission, and each Preliminary Prospectus, at the time of
filing thereof,
complied in all material respects with the applicable provisions
of the
Securities Act, the Exchange Act and the Rules and Regulations,
and did not
contain an untrue statement of a material fact or omit to state
a material fact
required to be stated therein or necessary to make the
statements therein, in
light of the circumstances under which they were made, not
misleading; provided,
however, that this representation and warranty shall not apply
to any
information contained in or omitted from any Preliminary
Prospectus in reliance
upon and in conformity with information furnished in writing to
the Company by
or on behalf of any Underwriter through Bear Stearns
specifically for use
therein. The parties hereto agree that such information provided
by or on behalf
of any Underwriter through Bear Stearns consists solely of the
material referred
to in Section 16 hereof.
(d) For purposes of this Agreement, the "Applicable Time" is the
time
of first sale of the Shares in connection with the Offering. The
Pricing
Disclosure Package, as of the Applicable Time, did not, and as
of the Closing
Date and the Additional Closing Date, if any (each as
hereinafter defined), 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,
in light of the circumstances under which they were made, not
misleading. Each
Issuer Free Writing Prospectus complies in all material respects
with the
applicable provisions of the Securities Act and the Rules and
Regulations, and
does not include information that conflicts with the information
contained in
the Registration Statement, the Pricing Prospectus or the
Prospectus, and each
Issuer Free Writing Prospectus not listed in Annex IV hereto, as
supplemented by
and taken together with the Pricing Disclosure Package, as of
the Applicable
Time, did not, and as of the Closing Date and the Additional
Closing Date, if
any, 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, in light of the circumstances under which
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they were made, not misleading. No representation and warranty
is made in this
Section 1(d) with respect to any information contained in or
omitted from the
Pricing Disclosure Package or any Issuer Free Writing Prospectus
in reliance
upon and in conformity with information furnished in writing to
the Company by
or on behalf of any Underwriter through Bear Stearns
specifically for use
therein. The parties hereto agree that such information provided
by or on behalf
of any Underwriter through Bear Stearns consists solely of the
material referred
to in Section 16 hereof.
(e) Deloitte & Touche LLP, who have certified the
consolidated
financial statements and supporting schedules and information of
the Company and
its subsidiaries that are included or incorporated by reference
in the
Registration Statement, the Pricing Prospectus or the Prospectus
are independent
public accountants as required by the Securities Act, the
Exchange Act and the
Rules and Regulations.
(f) Subsequent to the respective dates as of which information
is
given in the Registration Statement and the Pricing Prospectus,
except as
disclosed in the Pricing Prospectus, (i) the Company has not
declared or paid
any dividends, or made any other distributions of any kind, on
or in respect of
its capital stock, except for dividends declared and/or paid on
the Company's
Series A voting convertible preferred stock in the ordinary
course, (ii) there
has not been any change in the capital stock or material
increase in the
long-term or short-term debt of the Company or any of its
subsidiaries listed in
Exhibit A hereto (each, a "Subsidiary" and, collectively, the
"Subsidiaries"),
(iii) neither the Company nor any Subsidiary has sustained any
material loss or
interference with its business or properties from fire,
explosion, flood,
hurricane, accident or other calamity, whether or not covered by
insurance, or
from any labor dispute or any legal or governmental proceeding,
and (iv) there
has not been any material adverse change or any development
involving a
prospective material adverse change, whether or not arising from
transactions in
the ordinary course of business, in the business, management,
condition
(financial or otherwise), results of operations, stockholders'
equity,
properties or prospects of the Company and the Subsidiaries,
individually or
taken as a whole (a "Material Adverse Change"). Since the date
of the latest
balance sheet included, or incorporated by reference, in the
Registration
Statement and the Pricing Prospectus, neither the Company nor
any Subsidiary has
incurred or undertaken any liabilities or obligations, whether
direct or
indirect, liquidated or contingent, matured or unmatured, or
entered into any
transactions, including any acquisition or disposition of any
business or asset,
which are material to the Company and the Subsidiaries,
individually or taken as
a whole, except for liabilities, obligations and transactions
which are
disclosed in the Registration Statement and in the Pricing
Prospectus.
(g) The issued and outstanding capital stock of the Company is
as set
forth in the Pricing Prospectus, under the caption
"Capitalization" (other than
for subsequent issuances pursuant to employee benefit plans or
issuances upon
the exercise of outstanding options or warrants) and all of the
issued and
outstanding shares of capital stock of the Company have been
duly and validly
authorized and are fully paid and non-assessable and were issued
in compliance
with all applicable state, federal and foreign securities laws
and not in
violation of or subject to any preemptive or similar right that
entitles any
person to acquire from the Company or any subsidiary any Common
Stock or other
equity security of the Company or any security convertible into,
or exercisable
or exchangeable for, Common Stock or any other such security
(any "Relevant
Security"), except for such rights as may have been fully
satisfied or waived
prior
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to the effectiveness of the Registration Statement. All of the
issued shares of
capital stock of or other ownership interests in each Subsidiary
have been duly
and validly authorized and issued and are fully paid and
non-assessable and,
except as set forth in the Pricing Prospectus, are owned
directly or indirectly
by the Company free and clear of any lien, charge, mortgage,
pledge, security
interest, claim, equity, trust or other encumbrance,
preferential arrangement,
defect or restriction of any kind whatsoever (any "Lien").
(h) The Shares to be delivered on the Closing Date and the
Additional
Closing Date (as hereinafter defined), if any, have been duly
and validly
authorized and, when issued and delivered in accordance with
this Agreement,
will be duly and validly issued, fully paid and non-assessable,
will have been
issued in compliance with all applicable state, federal and
foreign securities
laws and will not have been issued in violation of or subject to
any preemptive
or similar right that entitles any person to acquire any
Relevant Security from
the Company. The Common Stock and the Shares conform to the
descriptions thereof
contained in the Registration Statement, the Pricing Prospectus
and the
Prospectus. Except as disclosed in the Pricing Prospectus, the
Company has no
outstanding warrants, options to purchase, or any preemptive
rights or other
rights to subscribe for or to purchase, or any contracts or
commitments to issue
or sell, any Relevant Security. Except as disclosed in the
Pricing Prospectus,
no holder of any Relevant Security has any rights to require
registration under
the Securities Act of any Relevant Security in connection with
the offer and
sale of the Shares contemplated hereby, and any such rights so
disclosed have
either been fully complied with by the Company or effectively
waived by the
holders thereof.
(i) The Subsidiaries are the only "subsidiaries" of the
Company
(within the meaning of Rule 405 under the Securities Act). The
Company and each
Subsidiary has been duly organized and is validly existing as a
corporation,
partnership or limited liability company in good standing under
the laws of its
jurisdiction of organization. Each of the Company and each
Subsidiary is duly
qualified to do business and is in good standing as a foreign
corporation,
partnership or limited liability company in each jurisdiction in
which the
character or location of its properties (owned, leased or
licensed) or the
nature or conduct of its business makes such qualification
necessary, except for
those failures to be so qualified or in good standing which
(individually and in
the aggregate) could not reasonably be expected to have a
material adverse
effect on (i) the business, management, condition (financial or
otherwise),
results of operations, stockholders' equity, properties or
prospects of the
Company and the Subsidiaries, taken as a whole; or (ii) the
ability of the
Company to consummate the Offering or any other transactions
contemplated by
this Agreement or the Pricing Prospectus (a "Material Adverse
Effect").
(j) The Company and each Subsidiary has all requisite power
and
authority, and all necessary consents, approvals,
authorizations, orders,
registrations, qualifications, licenses, filings and permits of,
with and from
all judicial, regulatory and other legal or governmental
agencies and bodies and
all third parties, foreign and domestic (individually a
"Consent" and
collectively, the "Consents"), to own, lease and operate its
properties and
conduct its business as it is now being conducted and as
disclosed in the
Registration Statement and the Pricing Prospectus, and each such
Consent is
valid and in full force and effect, except in each case as could
not reasonably
be expected to have a Material Adverse Effect. Neither the
Company nor any
Subsidiary has received notice of any investigation or
proceedings which, if
decided adversely to the Company or any such Subsidiary, could
reasonably be
expected to
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result in, the revocation of, or imposition of a materially
burdensome
restriction on, any such Consent.
(k) This Agreement has been duly and validly authorized,
executed and
delivered by the Company.
(l) The issue and sale of the Shares, the compliance by the
Company
with this Agreement and the consummation of the transactions
herein contemplated
do not and will not (i) conflict with or result in a breach or
violation of any
of the terms and provisions of, or constitute a default (or an
event which with
notice or lapse of time, or both, would constitute a default)
under, or result
in the creation or imposition of any Lien upon any property or
assets of the
Company or any Subsidiary pursuant to, any indenture, mortgage,
deed of trust,
loan agreement or other agreement, instrument, franchise,
license or permit to
which the Company or any Subsidiary is a party or by which the
Company or any
Subsidiary or their respective properties, operations or assets
may be bound or
(ii) violate or conflict with any provision of the certificate
or articles of
incorporation, by-laws, certificate of formation, limited
liability company
agreement, partnership agreement or other organizational
documents of the
Company or any Subsidiary, or (iii) violate or conflict with any
statute, law,
rule, regulation, ordinance, directive, judgment, decree or
order of any
judicial, regulatory or other legal or governmental agency or
body, domestic or
foreign.
(m) No Consent of, with or from any judicial, regulatory or
other
legal or governmental agency or body or any third party, foreign
or domestic, is
required for the execution, delivery and performance of this
Agreement or
consummation of the transactions contemplated by this Agreement,
except the
registration under the Securities Act of the Shares and such
Consents as may be
required under state securities or blue sky laws or the by-laws
and rules of the
National Association of Securities Dealers, Inc. (the "NASD") in
connection with
the purchase and distribution of the Shares by the Underwriters,
each of which
has been obtained and is in full force and effect.
(n) Except as disclosed in the Registration Statement, the
Pricing
Prospectus and the Prospectus, there is no judicial, regulatory,
arbitral or
other legal or governmental proceeding or other litigation or
arbitration,
domestic or foreign, pending to which the Company or any
Subsidiary is a party
or of which any property, operations or assets of the Company or
any Subsidiary
is the subject which, individually or in the aggregate, if
determined adversely
to the Company or any Subsidiary, could reasonably be expected
to have a
Material Adverse Effect; to the Company's knowledge, no such
proceeding,
litigation or arbitration is threatened or contemplated; and the
defense of all
such proceedings, litigation and arbitration against or
involving the Company or
any Subsidiary could not reasonably be expected to have a
Material Adverse
Effect.
(o) The Company's financial statements, including the notes
thereto,
and the supporting schedules included or incorporated by
reference in the
Registration Statement, the Pricing Prospectus and the
Prospectus present
fairly, in all material respects, the financial position as of
the dates
indicated and the cash flows and results of operations for the
periods specified
of the Company and its consolidated subsidiaries; and except as
otherwise stated
in the Registration Statement, the Pricing Prospectus and the
Prospectus, said
financial statements have
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been prepared in conformity with United States generally
accepted accounting
principles applied on a consistent basis throughout the periods
involved. No
other financial statements or supporting schedules are required
to be included
in the Registration Statement, the Pricing Prospectus or the
Prospectus by the
Securities Act, the Exchange Act or the Rules and Regulations.
The other
financial and statistical information included or incorporated
by reference in
the Registration Statement, the Pricing Prospectus and the
Prospectus are
accurately presented in all material respects and have been
prepared on a basis
consistent with that of the financial statements that are
included or
incorporated by reference in the Registration Statement, the
Pricing Prospectus
and the Prospectus and the books and records of the respective
entities
presented therein.
(p) The statistical, industry-related and market-related data
included
in the Registration Statement, the Pricing Prospectus and the
Prospectus are
based on or derived from sources which the Company reasonably
and in good faith
believes are reliable and accurate, and such data agree with the
sources from
which they are derived.
(q) The Common Stock has been registered pursuant to Section
12(b) of
the Exchange Act. The shares of Common Stock are listed on The
Nasdaq Global
Market ("Nasdaq"), and the Company has taken no action designed
to, or likely to
have the effect of, terminating the registration of the Common
Stock under the
Exchange Act or de-listing the Common Stock from Nasdaq, nor has
the Company
received any notification that the Commission or Nasdaq is
contemplating
terminating such registration or listing.
(r) The Company and its Subsidiaries maintain a system of
internal
accounting and other controls sufficient to provide reasonable
assurances that
(i) transactions are executed in accordance with management's
general or
specific authorizations, (ii) transactions are recorded as
necessary to permit
preparation of financial statements in conformity with United
States generally
accepted accounting principles and to maintain accountability
for assets, (iii)
access to assets is permitted only in accordance with
management's general or
specific authorization, and (iv) the recorded accounting for
assets is compared
with existing assets at reasonable intervals and appropriate
action is taken
with respect to any differences.
(s) The Company maintains a system of internal control over
financial
reporting (as such term is defined in Rule 13a-15(f) under the
Exchange Act)
that complies with the requirements of the Exchange Act and has
been designed by
the Company's principal executive officer and principal
financial officer, or
under their supervision, to provide reasonable assurance
regarding the
reliability of financial reporting and the preparation of
financial statements
for external purposes in accordance with generally accepted
accounting
principles. Except as disclosed in the Registration Statement,
the Pricing
Prospectus and the Prospectus, the Company's internal control
over financial
reporting is effective and the Company is not aware of any
material weaknesses
in its internal control over financial reporting. Since the date
of the latest
audited financial statements included or incorporated by
reference in the
Registration Statement, the Pricing Prospectus and the
Prospectus, there has
been 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.
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(t) The Company maintains "disclosure controls and procedures"
(as
such term is defined in Rule 13a-15(e) under the Exchange Act)
that comply with
the requirements of the Exchange Act; such disclosure controls
and procedures
have been designed to ensure that material information relating
to the Company
and its subsidiaries is made known to the Company's principal
executive officer
and principal financial officer by others within those entities;
and such
disclosure controls and procedures are effective.
(u) The Company is in compliance in all material respects with
all
applicable provisions of the Sarbanes-Oxley Act of 2002 and all
rules and
regulations promulgated thereunder or implementing the
provisions thereof (the
"Sarbanes-Oxley Act") and is taking commercially reasonable
steps to ensure that
it will be in compliance in all material respects with other
provisions of the
Sarbanes-Oxley Act not currently in effect, upon the
effectiveness of such
provisions.
(v) Neither the Company nor any of its affiliates (within the
meaning
of Rule 144 under the Securities Act) has taken, directly or
indirectly, any
action which constitutes or is designed to cause or result in,
or which could
reasonably be expected to constitute, cause or result in, the
stabilization or
manipulation of the price of any security to facilitate the sale
or resale of
the Shares.
(w) Neither the Company nor any of its affiliates (within the
meaning
of Rule 144 under the Securities Act) has, prior to the date
hereof, made any
offer or sale of any securities which could be "integrated"
(within the meaning
of the Securities Act and the Rules and Regulations) with the
offer and sale of
the Shares pursuant to the Registration Statement.
(x) The statements set forth in the Registration Statement,
the
Pricing Prospectus and Prospectus under the caption "Description
of Capital
Stock", insofar as it purports to constitute a summary of the
terms of the
Common Stock, and under the caption "Underwriting", insofar as
they purport to
describe the provisions of the laws and documents referred to
therein, are
accurate, complete and fair in all material respects.
(y) The Company is subject to the reporting requirements of
Section 13
or 15(d) of the Exchange Act and files periodic reports with the
Commission, and
the conditions for use of Form S-3 to register and offer the
Shares under the
Securities Act have been satisfied. The documents incorporated
or deemed to be
incorporated by reference in the Pricing Prospectus and the
Prospectus, at the
time they were or hereafter are filed with the Commission,
complied and will
comply in all material respects with the requirements of the
Securities Act, the
Exchange Act and the Rules and Regulations and, when read
together with the
other information in the Pricing Prospectus or the Prospectus,
as applicable, do
not contain an untrue statement of a material fact or omit to
state a material
fact required to be stated therein or necessary to make the
statements therein,
in the light of the circumstances under which they were made,
not misleading.
(z) The Company is not and, at all times up to and including
consummation of the transactions contemplated by this Agreement,
and after
giving effect to application of the net proceeds of the Offering
as described in
the Registration Statement, the Pricing Prospectus and the
Prospectus, will not
be, required to register as an "investment company" under
the
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Investment Company Act of 1940, as amended, and is not and will
not be an entity
"controlled" by an "investment company" within the meaning of
such act.
(aa) Except as disclosed in the Registration Statement, the
Pricing
Prospectus and the Prospectus, there are no contracts,
agreements or
understandings between the Company and any person that would
give rise to a
valid claim against the Company or any Underwriter for a
brokerage commission,
finder's fee or other like payment in connection with the
transactions
contemplated by this Agreement or, to the Company's knowledge,
any arrangements,
agreements, understandings, payments or issuances with respect
to the Company or
any of its officers, directors, shareholders, partners,
employees, Subsidiaries
or affiliates that may affect the Underwriters' compensation as
determined by
the NASD.
(bb) The Company and each Subsidiary owns or leases all such
properties as are necessary to the conduct of its business as
presently operated
and as proposed to be operated as described in the Registration
Statement, the
Pricing Prospectus and the Prospectus. The Company and the
Subsidiaries have
good and marketable title in fee simple to all real property and
good and valid
title to all personal property owned by them, in each case free
and clear of any
and all Liens except such as are described in the Registration
Statement, the
Pricing Prospectus and the Prospectus or such as do not
(individually or in the
aggregate) materially affect the value of such property or
materially interfere
with the use made or proposed to be made of such property by the
Company and the
Subsidiaries; and any real property and buildings held under
lease or sublease
by the Company and the Subsidiaries are held by them under
valid, subsisting and
enforceable leases with such exceptions as are not material to,
and do not
materially interfere with, the use made and proposed to be made
of such property
and buildings by the Company and the Subsidiaries. Neither the
Company nor any
Subsidiary has received any notice of any claim adverse to its
ownership of any
real or personal property or of any claim against the continued
possession of
any real property, whether owned or held under lease or sublease
by the Company
or any Subsidiary.
(cc) Each of the Company and each Subsidiary (i) owns or
possesses the
right to use all patents, patent applications, trademarks,
service marks, domain
names, trade names, trademark registrations, service mark
registrations,
copyrights, licenses, formulae, customer lists, and know-how and
other
intellectual property (including trade secrets and other
unpatented and/or
unpatentable proprietary or confidential information, systems or
procedures,
"Intellectual Property") necessary for the conduct of their
respective
businesses as presently conducted and as described in the
Registration
Statement, the Pricing Prospectus and the Prospectus and (ii)
has no reason to
believe that the conduct of their respective businesses does or
will conflict
with, and have not received any notice of any claim of conflict
with, any such
right of others. To the Company's knowledge, all material
technical information
developed by and belonging to the Company or any Subsidiary
which has not been
patented has been kept confidential. Neither the Company nor any
Subsidiary has
granted, licensed or assigned to any other person or entity any
right to
manufacture, have manufactured, assemble or sell the current
products and
services of the Company and its Subsidiaries or those products
and services
described in the Registration Statement, the Pricing Prospectus
and the
Prospectus. There is no infringement by third parties of any
such Intellectual
Property; there is no pending or, to the Company's knowledge,
threatened action,
suit, proceeding or claim by others challenging the Company's or
any
Subsidiary's rights in or to any such Intellectual Property, and
the Company is
unaware of any facts which would
9
<PAGE>
form a reasonable basis for any such claim; and there is no
pending or, to the
Company's knowledge, threatened action, suit, proceeding or
claim by others that
the Company or any Subsidiary infringes or otherwise violates
any patent,
trademark, copyright, trade secret or other proprietary rights
of others, and
the Company is unaware of any other fact which would form a
reasonable basis for
any such claim.
(dd) The Company and the Subsidiaries maintain insurance in
such
amounts and covering such risks as the Company reasonably
considers adequate for
the conduct of its business and the value of its properties and
as is customary
for companies engaged in similar businesses in similar
industries, all of which
insurance is in full force and effect, except where the failure
to maintain such
insurance could not reasonably be expected to have a Material
Adverse Effect.
There are no material claims by the Company or any Subsidiary
under any such
policy or instrument as to which any insurance company is
denying liability or
defending under a reservation of rights clause. The Company
reasonably believes
that it will be able to renew its existing insurance as and when
such coverage
expires or will be able to obtain replacement insurance adequate
for the conduct
of the business and the value of its properties at a cost that
would not have a
Material Adverse Effect.
(ee) Each of the Company and each Subsidiary has accurately
prepared
and timely filed all federal, state, foreign and other tax
returns that are
required to be filed by it and has paid or made provision for
the payment of all
taxes, assessments, governmental or other similar charges,
including without
limitation, all sales and use taxes and all taxes which the
Company or any
Subsidiary is obligated to withhold from amounts owing to
employees, creditors
and third parties, with respect to the periods covered by such
tax returns
(whether or not such amounts are shown as due on any tax
return), except for
such taxes that individually or in the aggregate could not
reasonably be
expected to have a Material Adverse Effect. No deficiency
assessment with
respect to a proposed adjustment of the Company's or any
Subsidiary' federal,
state, local or foreign taxes is pending or, to the best of the
Company's
knowledge, threatened, except for assessments that are being
contested in good
faith. The accruals and reserves on the books and records of the
Company and the
Subsidiaries in respect of tax liabilities for any taxable
period not finally
determined are adequate to meet any assessments and related
liabilities for any
such period and, since March 31, 2007, the Company and the
Subsidiaries have not
incurred any liability for taxes other than in the ordinary
course of its
business. There is no tax lien, whether imposed by any federal,
state, foreign
or other taxing authority, outstanding against the assets,
properties or
business of the Company or any Subsidiary.
(ff) No labor disturbance by the employees of the Company or
any
Subsidiary exists or, to the best of the Company's knowledge, is
imminent and
the Company is not aware of any existing or imminent labor
disturbances by the
employees of any of its or any Subsidiary's principal suppliers,
manufacturers',
customers or contractors, which, in either case (individually or
in the
aggregate), could reasonably be expected to have a Material
Adverse Effect.
(gg) No "prohibited transaction" (as defined in either Section
406 of
the Employee Retirement Income Security Act of 1974, as amended,
including the
regulations and published interpretations thereunder ("ERISA")
or Section 4975
of the Internal Revenue Code of 1986, as amended from time to
time (the
"Code")), "accumulated funding deficiency" (as
10
<PAGE>
defined in Section 302 of ERISA) or other event of the kind
described in Section
4043(b) of ERISA (other than events with respect to which the
30-day notice
requirement under Section 4043 of ERISA has been waived) has
occurred with
respect to any employee benefit plan for which the Company or
any Subsidiary
would have any liability which could (individually or in the
aggregate)
reasonably be expected to have a Material Adverse Effect; each
employee benefit
plan for which the Company or any Subsidiary would have any
liability is in
compliance in all material respects with applicable law,
including (without
limitation) ERISA and the Code; the Company has not incurred and
does not expect
to incur liability under Title IV of ERISA with respect to the
termination of,
or withdrawal from any "pension plan"; and each plan for which
the Company would
have any liability that is intended to be qualified under
Section 401(a) of the
Code is so qualified and nothing has occurred, to the knowledge
of the Company,
whether by action or by failure to act, which could cause the
loss of such
qualification.
(hh) There has been no storage, generation, transportation,
handling,
use, treatment, disposal, discharge, emission, contamination,
release or other
activity involving any kind of hazardous, toxic or other wastes,
pollutants,
contaminants, petroleum products or other hazardous or toxic
substances,
chemicals or materials ("Hazardous Substances") by, due to, on
behalf of, or
caused by the Company or any Subsidiary (or, to the Company's
knowledge, any
other entity for whose acts or omissions the Company is or may
be liable) upon
any property now or previously owned, operated, used or leased
by the Company or
any Subsidiary, or upon any other property, which would be a
violation of or
give rise to any liability under any applicable law, rule,
regulation, order,
judgment, decree or permit, common law provision or other
legally binding
standard relating to pollution or protection of human health and
the environment
("Environmental Law"), except for violations and liabilities
which, individually
or in the aggregate, could not reasonably be expected to have a
Material Adverse
Effect. There has been no disposal, discharge, emissions,
contamination or other
release of any kind at, onto or from any such property or into
the environment
surrounding any such property of any Hazardous Substances with
respect to which
the Company or any Subsidiary has knowledge, except as could
not, individually
or in the aggregate, reasonably be expected to have a Material
Adverse Effect.
Neither the Company nor any Subsidiary has agreed to assume,
undertake or
provide indemnification for any liability of any other person
under any
Environmental Law, including any obligation for cleanup or
remedial action,
except as could not, individually or in the aggregate,
reasonably be expected to
have a Material Adverse Effect. There is no pending or, to the
best of the
Company's knowledge, threatened administrative, regulatory or
judicial action,
claim or notice of noncompliance or violation, investigation or
proceedings
relating to any Environmental Law against the Company or any
Subsidiary except
as could not, individually or in the aggregate, reasonably be
expected to have a
Material Adverse Effect. No property of the Company or any
Subsidiary is subject
to any Lien under any Environmental Law. Neither the Company nor
any Subsidiary
is subject to any order, decree, agreement or other
individualized legal
requirement related to any Environmental Law except as could
not, individually
or in the aggregate, reasonably be expected to have a Material
Adverse Effect.
(ii) None of the Company, any Subsidiary or, to the
Company's
knowledge, any of its employees or agents, has at any time
during the last five
years (i) made any unlawful contribution to any candidate for
foreign office, or
failed to disclose fully any such contribution in violation of
law, or (ii) made
any payment to any federal or state governmental officer or
official, or other
person charged with similar public or quasi-public duties, other
than payments
11
<PAGE>
required or permitted by the laws of the United States of any
jurisdiction
thereof. The operations of the Company and each Subsidiary are
and have been
conducted at all times in compliance with applicable financial
record-keeping
and reporting requirements of the Currency and Foreign
Transactions Reporting
Act of 1970, as amended, the money laundering statutes of all
applicable
jurisdictions, the rules and regulations thereunder and any
related or similar
rules, regulations or guidelines issued, administered or
enforced by any
governmental agency (collectively, the "Money Laundering Laws")
and no action,
suit or proceeding by or before any court or governmental
agency, authority or
body or any arbitrator involving the Company or any Subsidiary
with respect to
the Money Laundering Laws is pending or, to the knowledge of the
Company,
threatened. Neither the Company nor any Subsidiary nor, to the
knowledge of the
Company, any director, officer, agent, employee or affiliate of
the Company or
any Subsidiary is currently subject to any U.S. sanctions
administered by the
Office of Foreign Assets Control of the U.S. Treasury Department
("OFAC"); and
the Company will not directly or indirectly use the proceeds of
the offering, or
lend, contribute or otherwise make available such proceeds to
any subsidiary,
joint venture partner or other person or entity, for the purpose
of financing
the activities of any person currently subject to any U.S.
sanctions
administered by OFAC.
(jj) Neither the Company nor any Subsidiary (i) is in violation
of its
certificate or articles of incorporation, by-laws, certificate
of formation,
limited liability company agreement, partnership agreement or
other
organizational documents, (ii) is in default under, and no event
has occurred
which, with notice or lapse of time or both, would constitute a
default under or
result in the creation or imposition of any Lien upon any
property or assets of
the Company or any Subsidiary pursuant to, any indenture,
mortgage, deed of
trust, loan agreement or other agreement or instrument to which
it is a party or
by which it is bound or to which any of its property or assets
is subject, or
(iii) is in violation of any statute, law, rule, regulation,
ordinance,
directive, judgment, decree or order of any judicial, regulatory
or other legal
or governmental agency or body, foreign or domestic, except (in
the case clauses
(ii) and (iii) above) for violations or defaults that could not
(individually or
in the aggregate) reasonably be expected to have a Material
Adverse Effect.
(kk) The Company has complied with the requirements of Rule 433
under
the Securities Act with respect to each Issuer Free Writing
Prospectus
including, without limitation, all prospectus delivery, filing,
record retention
and legending requirements applicable to any such Issuer Free
Writing
Prospectus. The Company has not (i) distributed any offering
material in
connection with the Offering other than the Pricing Prospectus,
the Prospectus,
and any Issuer Free Writing Prospectus set forth on Annex IV
hereto, or (ii)
filed, referred to, approved, used or authorized the use of any
"free writing
prospectus" as defined in Rule 405 under the Securities Act with
respect to the
Offering or the Shares, except for any Issuer Free Writing
Prospectus set forth
in Annex IV hereto and any electronic road show previously
approved by Bear
Stearns.
(ll) The preclinical tests and clinical trials conducted by or
on
behalf of the Company that are described in, or the results of
which are
referred to in, the Registration Statement, the Pricing
Prospectus and the
Prospectus were and, if still pending, are being conducted in
accordance with
experimental protocols, procedures and controls filed with the
appropriate
regulatory authorities for each such test or trial, as the case
may be; the
description of the results of such tests and trials contained in
the
Registration Statement, the Pricing Prospectus and the
Prospectus are accurate
in all material respects and fairly present the data
12
<PAGE>
derived from such tests and trials, and the Company and the
Subsidiaries have no
knowledge of any other published or otherwise publicly available
studies or
tests the results of which are inconsistent with, or otherwise
call into
question, the results described or referred to in the
Registration Statement,
the Pricing Prospectus and the Prospectus; neither the Company
nor any
Subsidiaries has received any notices or other correspondence
from the Food and
Drug Administration of the U.S. Department of Health (the "FDA")
and Human
Services or any committee thereof or from any other U.S. or
foreign government
or drug or medical device regulatory agency requiring the
termination,
suspension or material modification of any clinical trials
conducted by or on
behalf of the Company that are described in the Registration
Statement, the
Pricing Prospectus and the Prospectus; and the Company and the
Subsidiaries have
each operated and currently are in compliance in all material
respects with all
applicable rules, regulations and policies of the FDA and
comparable foreign
drug or medical device regulatory agencies outside of the United
States.
(mm) To the Company's knowledge, except as disclosed in the
Registration Statement, the Pricing Prospectus and the
Prospectus, there are no
rulemaking or similar proceedings before the FDA, 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 Registration Statement,
the Pricing
Prospectus and the Prospectus disclose the Company to have
developed, to be
developing or to propose to develop or use or propose to use
which, if the
subject of an action unfavorable to the Company, would have a
Material Adverse
Effect.
Any certificate signed by or on behalf of the Company and
delivered to
the Representatives or to counsel for the Underwriters' shall be
deemed to be a
representation and warranty by the Company to each Underwriter
as to the matters
covered thereby.
2. Purchase, Sale and Delivery of the Shares.
(a) On the basis of the representations, warranties, covenants
and
agreements herein contained, but subject to the terms and
conditions herein set
forth, the Company agrees to sell to each Underwriter and each
Underwriter,
severally and not jointly, agrees to purchase from the Company,
at a purchase
price per share of $20.735, the number of Firm Shares set forth
opposite their
respective names on Schedule I hereto together with any
additional number of
Shares which such Underwriter may become obligated to purchase
pursuant to the
provisions of Section 10 hereof.
(b) Payment of the purchase price for, and delivery of
certificates
representing, the Firm Shares shall be made at the office of
Skadden, Arps,
Slate, Meagher & Flom LLP ("Underwriters' Counsel"), or at
such other place as
shall be agreed upon by the Lead Manager and the Company, at
10:00 A.M., New
York City time, on July 23, 2007, or such other time and date as
Bear Stearns
and the Company may agree upon in writing (such time and date of
payment and
delivery being herein called the "Closing Date"). Payment of the
purchase price
for the Firm Shares shall be made by wire transfer in same day
funds to the
Company upon delivery of certificates for the Firm Shares to the
Representatives
through the facilities of The Depository Trust Company for the
respective
accounts of the several Underwriters. Certificates for the Firm
Shares shall be
registered in such name or names and shall be in such
denominations
13
<PAGE>
as the Lead Manager may request. The Company will permit the
Lead Manager to
examine and package such certificates for delivery at least one
full business
day prior to the Closing Date.
(c) In addition, on the basis of the representations,
warranties,
covenants and agreements herein contained, but subject to the
terms and
conditions herein set forth, the Company hereby grants to the
Underwriters,
acting severally and not jointly, the option to purchase up to
450,000
Additional Shares at the same purchase price per share to be
paid by the
Underwriters for the Firm Shares as set forth in Section 2(a)
above, for the
sole purpose of covering over-allotments in the sale of Firm
Shares by the
Underwriters. This option may be exercised at any t
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