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EXHIBIT 1.1
VANDA PHARMACEUTICALS INC.
5,750,000 Shares of Common Stock
Underwriting Agreement
__________, 2006
J.P. Morgan Securities Inc.
Banc of America
Securities LLC
Thomas Weisel
Partners
As
Representatives of the
several
Underwriters listed
in Schedule 1
hereto
c/o J.P. Morgan Securities Inc.
277 Park Avenue
New York, New York 10172
Ladies and Gentlemen:
Vanda
Pharmaceuticals Inc., a Delaware corporation (the "Company"),
proposes to issue and sell to the several Underwriters listed in
Schedule 1
hereto (the "Underwriters"), for whom you are acting as
representatives (the
"Representatives"), an aggregate of 5,750,000 shares of Common
Stock, par value
$0.001 per share, of the Company (the "Underwritten Shares" and, at
the option
of the Underwriters, up to an additional 862,500 shares of Common
Stock of the
Company (the "Option Shares"). The Underwritten Shares and the
Option Shares are
herein referred to as the "Shares"). The shares of Common Stock of
the Company
to be outstanding after giving effect to the sale of the Shares are
herein
referred to as the "Stock".
The
Company hereby confirms its agreement with the several
Underwriters
concerning the purchase and sale of the Shares, as follows:
1.
Registration Statement. The Company has prepared and filed with
the
Securities and Exchange Commission (the "Commission") under the
Securities Act
of 1933, as amended, and the rules and regulations of the
Commission thereunder
(collectively, the "Securities Act"), a registration statement
(File No.
333-130759) including a prospectus, relating to the Shares. Such
registration
statement, as amended at the time it becomes effective, including
the
information, if any, deemed pursuant to Rule 430A under the
Securities Act to be
part of the registration statement at the time of its effectiveness
("Rule 430A
Information"), is referred to herein as the "Registration
Statement"; and as
used herein, the term "Preliminary Prospectus" means each
prospectus filed with
the Commission pursuant to Rule 424(a) under the Securities Act
(including
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the prospectus included in the Registration Statement at the time
of its
effectiveness that omits Rule 430A Information (the "Pricing
Prospectus")), and
the term "Prospectus" means the prospectus in the form first used
(or made
available upon request of purchasers pursuant to Rule 173 under the
Securities
Act) in connection with confirmation of sales of the Shares. If the
Company has
filed an abbreviated registration statement 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. Capitalized terms used but not defined
herein shall
have the meanings given to such terms in the Registration Statement
and the
Prospectus.
At or
prior to the time when sales of the Shares were first made (the
"Time of Sale"), the Company had prepared the following
information
(collectively with the pricing information set forth on Annex B,
the "Time of
Sale Information"): the Pricing Prospectus and each "free-writing
prospectus"
(as defined pursuant to Rule 405 under the Securities Act) listed
on Annex B
hereto (including any and all documents incorporated by reference
therein, by
hyperlink, legend or otherwise, in each case in accordance with the
applicable
rules of the Commission). If, subsequent to the date of this
Agreement, the
Company and the Underwriters have determined that such information
included an
untrue statement of material fact or omitted a statement of
material fact
necessary to make the information therein, in the light of the
circumstances
under which it was made, not misleading and have agreed to provide
an
opportunity to purchasers of the Shares to terminate their old
purchase
contracts and enter into new purchase contracts, then "Time of Sale
Information"
will refer to the information available to purchasers at the time
of entry into
the first such new purchase contract.
2.
Purchase of the Shares by the Underwriters. (a) The Company agrees
to
issue and sell the Shares to the several Underwriters as provided
in this
Agreement, and each Underwriter, on the basis of the
representations, warranties
and agreements set forth herein and subject to the conditions set
forth herein,
agrees, severally and not jointly, to purchase from the Company the
respective
number of Underwritten Shares set forth opposite such Underwriter's
name in
Schedule 1 hereto at a price per share the "Purchase Price" of $
.
In
addition, the Company agrees to issue and sell the Option Shares to
the
several Underwriters as provided in this Agreement, and the
Underwriters, on the
basis of the representations, warranties and agreements set forth
herein and
subject to the conditions set forth herein, shall have the option
to purchase,
severally and not jointly, from the Company the Option Shares at
the Purchase
Price.
If any
Option Shares are to be purchased, the number of Option Shares
to
be purchased by each Underwriter shall be the number of Option
Shares which
bears the same ratio to the aggregate number of Option Shares being
purchased as
the number of Underwritten Shares set forth opposite the name of
such
Underwriter in Schedule 1 hereto (or such number increased as set
forth in
Section 9 hereof) bears to the aggregate number of Underwritten
Shares being
purchased from the Company by the several Underwriters, subject,
however, to
such adjustments to eliminate any fractional Shares as the
Representatives in
their sole discretion shall make.
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The
Underwriters may exercise the option to purchase the Option Shares
at
any time in whole, or from time to time in part, on or before the
thirtieth day
following the date of this Agreement, by written notice from the
Representatives
to the Company. Such notice shall set forth the aggregate number of
Option
Shares as to which the option is being exercised and the date and
time when the
Option Shares are to be delivered and paid for which may be the
same date and
time as the Closing Date (as hereinafter defined) but shall not be
earlier than
the Closing Date nor later than the tenth full business day (as
hereinafter
defined) after the date of such notice (unless such time and date
are postponed
in accordance with the provisions of Section 9 hereof). Any such
notice shall be
given at least two Business Days prior to the date and time of
delivery
specified therein.
(b) The
Company understands that the Underwriters intend to make a
public
offering of the Shares as soon after the effectiveness of this
Agreement as in
the judgment of the Representatives is advisable, and initially to
offer the
Shares on the terms set forth in the Prospectus. The Company
acknowledges and
agrees that the Underwriters may offer and sell Shares to or
through any
affiliate of an Underwriter and that any such affiliate may offer
and sell
Shares purchased by it to or through any Underwriter.
(c)
Payment for the Shares shall be made by wire transfer in
immediately
available funds to the account specified by the Company to the
Representatives
in the case of the Underwritten Shares, at the offices of Davis
Polk & Wardwell
at 10:00 A.M. New York City time on _____, 2006 or at such other
time or place
on the same or such other date, not later than the fifth business
day
thereafter, as the Representatives and the Company may agree upon
in writing or,
in the case of the Option Shares, on the date and at the time and
place
specified by the Representatives in the written notice of the
Underwriters'
election to purchase such Option Shares. The time and date of such
payment for
the Underwritten Shares is referred to herein as the "Closing Date"
and the time
and date for such payment for the Option Shares, if other than the
Closing Date,
are herein referred to as the "Additional Closing Date".
Payment
for the Shares to be purchased on the Closing Date or the
Additional Closing Date, as the case may be, shall be made against
delivery to
the Representatives for the respective accounts of the several
Underwriters of
the Shares to be purchased on such date in definitive form
registered in such
names and in such denominations as the Representatives shall
request in writing
not later than two full business days prior to the Closing Date or
the
Additional Closing Date, as the case may be, with any transfer
taxes payable in
connection with the sale of the Shares duly paid by the Company.
The
certificates for the Shares will be made available for inspection
and packaging
by the Representatives at the office of J.P. Morgan Securities Inc.
set forth
above not later than 1:00 P.M., New York City time, on the business
day prior to
the Closing Date or the Additional Closing Date, as the case may
be.
(d) The Company
acknowledges and agrees that the Underwriters are acting
solely in the capacity of an arm's length contractual counterparty
to the
Company with respect to the offering of Shares contemplated hereby
(including in
connection with determining the terms of the offering) and not as a
financial
advisor or a fiduciary to, or an agent of, the Company or any other
person.
Additionally, neither the Representatives nor any other Underwriter
is advising
the
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Company or any other person as to any legal, tax, investment,
accounting or
regulatory matters in any jurisdiction. The Company shall consult
with its own
advisors concerning such matters and shall be responsible for
making its own
independent investigation and appraisal of the transactions
contemplated hereby,
and the Underwriters shall have no responsibility or liability to
the Company
with respect thereto. Any review by the Underwriters of the
Company, the
transactions contemplated hereby or other matters relating to such
transactions
will be performed solely for the benefit of the Underwriters and
shall not be on
behalf of the Company.
3.
Representations and Warranties of the Company. The Company
represents
and warrants to each Underwriter that:
(a)
Preliminary Prospectus. No order preventing or suspending the use
of
any Preliminary Prospectus has been issued by the Commission, and
each
Preliminary Prospectus, at the time of filing thereof, complied in
all material
respects with the Securities Act and did not contain any 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, in the light of
the
circumstances under which they were made, not misleading; provided
that the
Company makes no representation and warranty with respect to any
statements or
omissions made in reliance upon and in conformity with information
relating to
any Underwriter furnished to the Company in writing by such
Underwriter through
the Representatives expressly for use in any Preliminary
Prospectus.
(b) Time
of Sale Information. The Time of Sale Information, at the Time
of
Sale did not, and at the Closing Date will not, contain any untrue
statement of
a material fact or omit to state a material fact necessary in order
to make the
statements therein, in the light of the circumstances under which
they were
made, not misleading; provided that the Company makes no
representation and
warranty with respect to any statements or omissions made in
reliance upon and
in conformity with information relating to any Underwriter
furnished to the
Company in writing by such Underwriter through the Representatives
expressly for
use in such Time of Sale Information. No statement of material fact
included in
the Prospectus has been omitted from the Time of Sale Information
and no
statement of material fact included in the Time of Sale Information
that is
required to be included in the Prospectus has been omitted
therefrom.
(c) Issuer
Free Writing Prospectus. Other than any Preliminary Prospectus
and the Prospectus, the Company (including its agents and
representatives, other
than the Underwriters in their capacity as such) has not made,
used, prepared,
authorized, approved or referred to and will not prepare, make,
use, authorize,
approve or refer to any "written communication" (as defined in Rule
405 under
the Securities Act) that constitutes an offer to sell or
solicitation of an
offer to buy the Shares (each such written communication by the
Company or its
agents and representatives (other than a communication referred to
in clause (i)
below) an "Issuer Free Writing Prospectus") other than (i) any
written
communication not constituting a prospectus pursuant to the
Securities Act or
any rule under the Securities Act (including without limitation
Rule 134 under
the Securities Act) or (ii) the documents listed on Annex B hereto
and other
written communications approved in writing in advance by the
Representatives.
Each Issuer Free Writing Prospectus complied in all material
respects with the
Securities Act, has been filed in
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accordance with the Securities Act (to the extent required thereby)
and, when
taken together with the Preliminary Prospectus accompanying, or
delivered prior
to delivery of, such Issuer Free Writing Prospectus, did not, and
at the Closing
Date will not, contain any untrue statement of a material fact or
omit to state
a material fact necessary in order to make the statements therein,
in the light
of the circumstances under which they were made, not misleading;
provided that
the Company makes no representation and warranty with respect to
any statements
or omissions made in each such Issuer Free Writing Prospectus in
reliance upon
and in conformity with information relating to any Underwriter
furnished to the
Company in writing by such Underwriter through the Representatives
expressly for
use in any Issuer Free Writing Prospectus.
(d)
Registration Statement and Prospectus. The Registration Statement
has
been declared effective by the Commission. No order suspending the
effectiveness
of the Registration Statement has been issued by the Commission and
no
proceeding for that purpose or pursuant to Section 8A of the
Securities Act
against the Company or related to the offering has been initiated
or threatened
by the Commission; as of the applicable effective date of the
Registration
Statement and any amendment thereto, the Registration Statement (as
amended or
supplemented as of such date) complied and will comply in all
material respects
with the Securities Act, and did not and will not contain any
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 not
misleading; and
as of the date of the Prospectus and any amendment or supplement
thereto and as
of the Closing Date and as of the Additional Closing Date, as the
case may be,
the Prospectus (as amended or supplemented as of such date) will
not contain any
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, in the
light of the circumstances under which they were made, not
misleading; provided
that the Company makes no representation and warranty with respect
to any
statements or omissions made in reliance upon and in conformity
with information
relating to any Underwriter furnished to the Company in writing by
such
Underwriter through the Representatives expressly for use in the
Registration
Statement and the Prospectus and any amendment or supplement
thereto.
(e)
Financial Statements. The financial statements and the related
notes
thereto of the Company and its consolidated subsidiaries included
in the
Registration Statement, the Time of Sale Information and the
Prospectus comply
in all material respects with the applicable requirements of the
Securities Act
and the Securities Exchange Act of 1934, as amended, and the rules
and
regulations of the Commission thereunder (collectively, the
"Exchange Act"), as
applicable, and present fairly the financial position of the
Company and its
subsidiaries as of the dates indicated and the results of their
operations and
the changes in their cash flows for the periods specified; such
financial
statements have been prepared in conformity with generally accepted
accounting
principles applied on a consistent basis throughout the periods
covered thereby,
and the supporting schedules included in the Registration Statement
present
fairly the information required to be stated therein; and the other
financial
information included in the Registration Statement, the Time of
Sale Information
and the Prospectus has been derived from the accounting records of
the Company
and its subsidiaries and presents fairly the information shown
thereby; and the
pro forma financial information and the related notes thereto
included in the
Registration Statement, the Time of Sale Information and the
Prospectus have
been prepared
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in accordance with the applicable requirements of the Securities
Act and the
Exchange Act, as applicable, and the assumptions underlying such
pro forma
financial information are reasonable and are set forth in the
Registration
Statement, the Time of Sale Information and the Prospectus.
(f) No
Material Adverse Change. Since the date of the most recent
financial statements of the Company included in the Registration
Statement, the
Time of Sale Information and the Prospectus, and except, in the
case of clauses
(i) and (ii) below, for issuances of options to purchase the
Company's Common
Stock, and issuances of Common Stock made upon the exercise of
options, pursuant
to its Second Amended and Restated Management Equity Plan (i) there
has not been
any change in the capital stock or long-term debt of the Company or
any of its
subsidiaries, or any dividend or distribution of any kind declared,
set aside
for payment, paid or made by the Company on any class of capital
stock, or any
material adverse change, or any development involving a prospective
material
adverse change, in or affecting the business, properties,
management, financial
position, stockholders' equity, results of operations or prospects
of the
Company and its subsidiaries taken as a whole; (ii) neither the
Company nor any
of its subsidiaries has entered into any transaction or agreement
that is
material to the Company and its subsidiaries taken as a whole or
incurred any
liability or obligation, direct or contingent, that is material to
the Company
and its subsidiaries taken as a whole; and (iii) neither the
Company nor any of
its subsidiaries has sustained any material loss or interference
with its
business from fire, explosion, flood or other calamity, whether or
not covered
by insurance, or from any labor disturbance or dispute or any
action, order or
decree of any court or arbitrator or governmental or regulatory
authority,
except in each case as otherwise disclosed in the Registration
Statement, the
Time of Sale Information and the Prospectus.
(g)
Organization and Good Standing. The Company and each of its
subsidiaries have been duly organized and are validly existing and
in good
standing under the laws of their respective jurisdictions of
organization, are
duly qualified to do business and are in good standing in each
jurisdiction in
which their respective ownership or lease of property or the
conduct of their
respective businesses requires such qualification, and have all
power and
authority necessary to own or hold their respective properties and
to conduct
the businesses in which they are engaged, except where the failure
to be so
qualified or have such power or authority would not, individually
or in the
aggregate, have a material adverse effect on the business,
properties,
management, financial position, stockholders' equity, results of
operations or
prospects of the Company and its subsidiaries taken as a whole (a
"Material
Adverse Effect"). The Company does not own or control, directly or
indirectly,
any corporation, association or other entity other than the
subsidiaries listed
in Exhibit 21 to the Registration Statement.
(h)
Capitalization. The Company has an authorized capitalization as
set
forth in the Registration Statement, the Time of Sale Information
and the
Prospectus under the heading "Capitalization"; all the outstanding
shares of
capital stock of the Company have been duly and validly authorized
and issued
and are fully paid and non-assessable and are not subject to any
pre-emptive or
similar rights; except as described in or expressly contemplated by
the Time of
Sale Information and the Prospectus, there are no outstanding
rights (including,
without limitation, pre-emptive rights), warrants or options to
acquire, or
instruments convertible into or exchangeable for, any shares of
capital stock or
other equity interest in the Company or any of its subsidiaries, or
any
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contract, commitment, agreement, understanding or arrangement of
any kind
relating to the issuance of any capital stock of the Company or any
such
subsidiary, any such convertible or exchangeable securities or any
such rights,
warrants or options; the capital stock of the Company conforms in
all material
respects to the descriptions thereof contained in the Registration
Statement,
the Time of Sale Information and the Prospectus; and all the
outstanding shares
of capital stock or other equity interests of each subsidiary of
the Company
have been duly and validly authorized and issued, are fully paid
and
non-assessable and except as otherwise described in the
Registration Statement,
the Time of Sale Information and the Prospectus are owned directly
or indirectly
by the Company, free and clear of any lien, charge, encumbrance,
security
interest, restriction on voting or transfer or any other claim of
any third
party.
(i) Due
Authorization. The Company has full right, power and authority
to
execute and deliver this Agreement and to perform its obligations
hereunder and
thereunder; and all action required to be taken for the due and
proper
authorization, execution and delivery of this Agreement and the
consummation of
the transactions contemplated thereby has been duly and validly
taken.
(j) Underwriting
Agreement. This Agreement has been duly authorized,
executed and delivered by the Company.
(k) The
Shares. The Shares to be issued and sold by the Company
hereunder
have been duly authorized by the Company and, when issued and
delivered and paid
for as provided herein, will be duly and validly issued and will be
fully paid
and nonassessable and will conform to the descriptions thereof in
the Time of
Sale Information and the Prospectus; and the issuance of the Shares
is not
subject to any preemptive or similar rights.
(l) No
Violation or Default. Neither the Company nor any of its
subsidiaries is (i) in violation of its charter or by-laws or
similar
organizational documents; (ii) in default, and no event has
occurred that, with
notice or lapse of time or both, would constitute such a default,
in the due
performance or observance of any term, covenant or condition
contained in any
indenture, mortgage, deed of trust, loan agreement or other
agreement or
instrument to which the Company or any of its subsidiaries is a
party or by
which the Company or any of its subsidiaries is bound or to which
any of the
property or assets of the Company or any of its subsidiaries is
subject; or
(iii) in violation of any law or statute or any judgment, order,
rule or
regulation of any court or arbitrator or governmental or regulatory
authority,
except, in the case of clauses (ii) and (iii) above, for any such
default or
violation that would not, individually or in the aggregate, have a
Material
Adverse Effect.
(m) No
Conflicts. The execution, delivery and performance by the
Company
of each of the Transaction Documents, the issuance and sale of the
Shares and
the consummation of the transactions contemplated by the
Transaction Documents
will not (i) conflict with or result in a breach or violation of
any of the
terms or provisions of, or constitute a default under, or result in
the creation
or imposition of any lien, charge or encumbrance upon any property
or assets of
the Company or any of its subsidiaries pursuant to, any indenture,
mortgage,
deed of trust, loan agreement or other agreement or instrument to
which the
Company or any of its subsidiaries is a party or by which the
Company or any of
its subsidiaries is bound or to which any of the property
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or assets of the Company or any of its subsidiaries is subject,
(ii) result in
any violation of the provisions of the charter or by-laws or
similar
organizational documents of the Company or any of its subsidiaries
or (iii)
result in the violation of any law or statute or any judgment,
order, rule or
regulation of any court or arbitrator or governmental or regulatory
authority
having jurisdiction over the Company or any of its subsidiaries,
except, in the
case of clauses (i) and (iii) above, for any such conflict, breach
or violation
that would not, individually or in the aggregate, have a Material
Adverse
Effect.
(n) No
Consents Required. No consent, approval, authorization, order,
registration or qualification of or with any court or arbitrator or
governmental
or regulatory authority is required for the execution, delivery and
performance
by the Company of each of the Transaction Documents, the issuance
and sale of
the Shares and the consummation of the transactions contemplated by
the
Transaction Documents, except for the registration of the Shares
under the
Securities Act and such consents, approvals, authorizations, orders
and
registrations or qualifications as may be required under applicable
state
securities laws or applicable rules and regulations of the Nasdaq
National
Market in connection with the purchase and distribution of the
Shares by the
Underwriters.
(o) Legal
Proceedings. Except as described in the Registration Statement,
the Time of Sale Information and the Prospectus, there are no
legal,
governmental or regulatory investigations, actions, suits or
proceedings pending
to which the Company or any of its subsidiaries is or may be a
party or to which
any property of the Company or any of its subsidiaries is or may be
the subject
that, individually or in the aggregate, where there is a reasonable
possibility
that such action might be determined adversely to the Company or
any of its
subsidiaries, could reasonably be expected to have a Material
Adverse Effect or
materially and adversely affect the ability of the Company to
perform its
obligations under the Transaction Documents; no such
investigations, actions,
suits or proceedings are threatened or, to the knowledge of the
Company,
contemplated by any governmental or regulatory authority or
threatened by
others; and (i) there are no current or pending legal, governmental
or
regulatory actions, suits or proceedings that are required under
the Securities
Act to be described in the Registration Statement that are not so
described in
the Registration Statement, the Time of Sale Information and the
Prospectus and
(ii) there are no statutes, regulations or contracts or other
documents that are
required under the Securities Act to be filed as exhibits to the
Registration
Statement or described in the Registration Statement or the
Prospectus that are
not so filed as exhibits to the Registration Statement or described
in the
Registration Statement, the Time of Sale Information and the
Prospectus.
(p)
Independent Accountants. PricewaterhouseCoopers LLP, who have
certified certain financial statements of the Company and its
subsidiaries are
an independent registered public accounting firm with respect to
the Company and
its subsidiaries within the applicable rules and regulations
adopted by the
Commission and the Public Company Accounting Oversight Board
(United States) and
as required by the Securities Act.
(q) Title
to Real and Personal Property. The Company and its subsidiaries
have good and marketable title in fee simple to, or have valid
rights to lease
or otherwise use, all items of
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real and personal property that are material to the respective
businesses of the
Company and its subsidiaries, in each case free and clear of all
liens,
encumbrances, claims and defects and imperfections of title except
those that
(i) do not materially interfere with the use made and proposed to
be made of
such property by the Company and its subsidiaries or (ii) could not
reasonably
be expected, individually or in the aggregate, to have a Material
Adverse
Effect.
(r) Title
to Intellectual Property. The Company and its subsidiaries own
or possess adequate rights to use all material patents, patent
applications,
trademarks, service marks, trade names, trademark registrations,
service mark
registrations, copyrights, licenses and know-how (including trade
secrets and
other unpatented and/or unpatentable proprietary or confidential
information,
systems or procedures) (collectively, "Intellectual Property") that
is used in
the conduct of their business (as now conducted and as proposed to
be conducted
in the Time of Sale Information) and except where the failure to
own, license or
possess such rights would not, individually or in the aggregate,
have a Material
Adverse Effect; and to the knowledge of the Company, without having
conducted
any special investigation or patent search, the conduct of their
respective
businesses (as now conducted and as proposed to be conducted in the
Time of Sale
Information) does not conflict in any material respect with any
such rights of
others. The Company and its subsidiary have not received any
written notice of
any claim of infringement or conflict with any intellectual
property of others.
Except as described in the Time of Sale Information, (i) to the
Company's
knowledge, without having conducted any special investigation or
patent search,
there are no third parties who have or will be able to establish
rights to any
Intellectual Property of the Company, except for the retained
rights of the
owners of the Intellectual Property which is licensed to the
Company and except
to the extent not reasonably expected, individually or in the
aggregate, to have
a Material Adverse Effect; (ii) there is no pending, or to the
Company's
knowledge, threatened action, suit, proceeding or claim by others
challenging
the Company's rights in or to any Intellectual Property, (iii)
there is no
pending or, to the Company's knowledge, threatened action, suit,
proceeding or
claim by others challenging the validity or scope of any
Intellectual Property,
(iv) there is no pending or, to the Company's knowledge, threatened
action,
suit, proceeding or claim by others that the Company infringes
or
misappropriates any patent, trademark, trade name, service name,
copyright,
trade secret or other proprietary rights of others (v) the Company
is unaware of
any facts which could form a reasonable basis for any such action,
suit,
proceeding or claim as described in items (ii), (iii) and (iv),
except to the
extent not reasonably expected, individually or in the aggregate,
to have a
Material Adverse Effect, and (vi) to the Company's knowledge,
without having
conducted any special investigation or patent search, there is no
patent or
patent application that contains claims that interfere, as such
term is
described in 35 U.S.C. Section 135 and 37 C.F.R. 41.100 to 41.208
with the
issued or pending claims of any of the Intellectual Property.
(s)
Preclinical and Clinical Trials. The preclinical and clinical
trials
described in the Time of Sale Information were and, if still
pending, are being
conducted (to the Company's knowledge, after due inquiry, with
respect to such
studies conducted by third parties) in accordance in all material
respects with
standard medical and scientific research procedures and all
applicable rules,
regulations and policies of the Food and Drug Administration,
including current
Good Clinical Practices and Good Laboratory Practices, and all
applicable
foreign regulatory requirements and standards.
9
<PAGE>
(t) No
Undisclosed Relationships. No relationship, direct or indirect,
exists between or among the Company or any of its subsidiaries, on
the one hand,
and the directors, officers, stockholders, customers or suppliers
of the Company
or any of its subsidiaries, on the other, that is required by the
Securities Act
to be described in the Registration Statement and the Prospectus
and that is not
so described in such documents and in the Time of Sale
Information.
(u)
Investment Company Act. 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 Registration Statement, the Time of Sale
Information and the
Prospectus, will not be required to register as an "investment
company" or an
entity "controlled" by an "investment company" within the meaning
of the
Investment Company Act of 1940, as amended, and the rules and
regulations of the
Commission thereunder (collectively, "Investment Company Act").
(v) Taxes.
The Company and its subsidiaries have paid all federal, state,
local and foreign taxes and filed all tax returns required to be
paid or filed
through the date hereof; and except as otherwise disclosed in the
Registration
Statement, the Time of Sale Information and the Prospectus, there
is no tax
deficiency that has been, or could reasonably be expected to be,
asserted
against the Company or any of its subsidiaries or any of their
respective
properties or assets, in each case, except as would not have a
Material Adverse
Effect.
(w)
Licenses and Permits. The Company and its subsidiaries possess
all
licenses, certificates, permits and other authorizations issued by,
and have
made all declarations and filings with, the appropriate federal,
state, local or
foreign governmental or regulatory authorities that are necessary
for the
ownership or lease of their respective properties or the conduct of
their
respective businesses as described in the Registration Statement,
the Time of
Sale Information and the Prospectus, except where the failure to
possess or make
the same would not, individually or in the aggregate, have a
Material Adverse
Effect; and except as described in the Registration Statement, the
Time of Sale
Information and the Prospectus, neither the Company nor any of its
subsidiaries
has received notice of any revocation or modification of any such
license,
certificate, permit or authorization or has any reason to believe
that any such
license, certificate, permit or authorization will not be renewed
in the
ordinary course.
(x) No
Labor Disputes. No labor disturbance by or dispute with
employees
of the Company or any of its subsidiaries exists or, to the
knowledge of the
Company, is contemplated or threatened and the Company is not aware
of any
existing or imminent labor disturbance by, or dispute with, the
employees of any
of its or its subsidiaries' principal suppliers, contractors or
customers,
except as would not have a Material Adverse Effect.
(y)
Compliance With Environmental Laws. (i) The Company and its
subsidiaries (x) are in compliance with any and all applicable
federal, state,
local and foreign laws, rules, regulations, requirements, decisions
and orders
relating to the protection of human health and safety, the
environment or
hazardous or toxic substances or wastes, pollutants or contam
