Exhibit 1.1
Myriad Genetics, Inc.
3,000,000 Shares of Common
Stock
Underwriting
Agreement
February 8, 2007
J.P. Morgan Securities
Inc.
277 Park Avenue
New York, New York 10172
Ladies and Gentlemen:
Myriad Genetics, Inc., a Delaware
corporation (the “Company”), proposes to issue and sell
to you (the “Underwriter”) 3,000,000 shares of Common
Stock, par value $0.01 per share, of the Company (the
“Underwritten Shares”) and, at the option of the
Underwriter, up to an additional 450,000 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 Stock, including
the Shares, will have attached thereto rights (the
“Rights”) to purchase from the Company, upon the
occurrence of certain events, a unit consisting of one
one-hundredth of a share of the Company’s Series A
Junior Participating Preferred Stock, $0.01 par value per share, at
a purchase price of $300.00 per unit. The Rights are to be issued
pursuant to a Rights Agreement, dated July 17, 2001, which was
subsequently amended by an Agreement of Substitution and Amendment
of Common Shares Rights Agreement dated as of August 16, 2002
(the “Rights Agreement”).
The Company hereby confirms its
agreement with the Underwriter 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. 333-123914)
including a prospectus (the “base prospectus”) (which
prospectus was a single prospectus combining the prospectuses from
the aforementioned registration statement and the Company’s
previously filed and effective registration statement (File
No. 333-73124) pursuant to Rule 429 under the Securities Act),
for the registration of the Shares and Rights. Such registration
statements, as amended at the time they became effective, including
the information, if any, deemed pursuant to Rule 430A, 430B or
430C under the Securities Act to be part of the registration
statement at the time of its effectiveness (“Rule 430
Information”) and contained in any supplement or
post-effective amendment thereto, are referred to herein as the
“Registration Statements”; and as used herein, and the
term “Prospectus” means the base prospectus together
with the prospectus supplement specifically relating to the Shares
and Rights filed with the Commission pursuant to Rule 424(b) under
the Securities Act 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 Statements” shall be deemed to
include such Rule 462 Registration Statement. Any reference in
this Agreement to the Registration Statements 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
under the Securities Act, as of the effective date of the
Registration Statement or the date of the Prospectus, as the case
may be and any reference to “amend,”
“amendment” or “supplement” with respect to
the Registration Statements or the Prospectus shall be deemed to
refer to and include any documents filed after such date under the
Securities Exchange Act of 1934, as amended, and the rules and
regulations of the Commission thereunder (collectively, the
“Exchange Act”) that are deemed to be incorporated by
reference therein. Capitalized terms used but not defined herein
shall have the meanings given to such terms in the Registration
Statements 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 base prospectus and any
“free-writing prospectus” (as defined pursuant to Rule
405 under the Securities Act) listed on Annex B hereto.
2. Purchase of the Shares by the
Underwriter . (a) The Company agrees to issue and sell the
Shares to the Underwriter as provided in this Agreement, and the
Underwriter, on the basis of the representations, warranties and
agreements set forth herein and subject to the conditions set forth
herein, agrees to purchase from the Company the Underwritten Shares
at a price per share (the “Purchase Price”) of
$35.15.
In addition, the Company agrees to
issue and sell the Option Shares to the Underwriter as provided in
this Agreement, and the Underwriter, 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 from the Company the Option Shares at the Purchase
Price.
The Underwriter 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 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. 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
Underwriter intends to make a public offering of the Shares as soon
after the effectiveness of this Agreement as in the judgment of the
Underwriter is advisable, and initially to offer the Shares on the
terms set forth in the Prospectus.
The Company acknowledges and agrees that the
Underwriter may offer and sell Shares to or through any of its
affiliates.
(c) Payment for the Shares shall be
made by wire transfer in immediately available funds to the account
specified by the Company to the Underwriter in the case of the
Underwritten Shares, at the offices of Wilson Sonsini
Goodrich & Rosati, Professional Corporation at 10:00 a.m.
New York City time on February 13, 2007, or at such other time
or place on the same or such other date, not later than the fifth
business day thereafter, as the Underwriter 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 Underwriter in the
written notice of the Underwriter’s 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 Underwriter
of the Shares to be purchased on such date in definitive form
registered in the name of the Underwriter, 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 Underwriter 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 Underwriter is 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, the Underwriter is not advising the
Company nor 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
Underwriter shall have no responsibility or liability to the
Company with respect thereto. Any review by the Underwriter of the
Company, the transactions contemplated hereby or other matters
relating to such transactions will be performed solely for the
benefit of the Underwriter and shall not be on behalf of the
Company.
3. Representations and Warranties
of the Company . The Company represents and warrants to the
Underwriter that:
(a) [intentionally left
blank]
(b) Time of Sale Information
. The Time of Sale Information, at the Time of Sale did not, and at
the Closing Date and as of the Additional Closing Date, as the case
may be, 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 the Underwriter furnished to the Company in writing by
the Underwriter 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 in the Prospectus, the Company
(including its agents and representatives, other than the
Underwriter in its 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 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 document not
constituting a prospectus pursuant to Section 2(a)(10)(a) of
the Securities Act or 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 Underwriter.
Each such Issuer Free Writing Prospectus complied in all material
respects with the Securities Act, has been filed in accordance with
the Securities Act (to the extent required thereby) and, when taken
together with the Prospectus accompanying, or delivered prior to
delivery of, such Issuer Free Writing Prospectus, did not, and at
the Closing Date and as of the Additional Closing Date, as the case
may be, 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 the
Underwriter furnished to the Company in writing by the Underwriter
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 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 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 the Underwriter
furnished to the Company in writing by the Underwriter expressly
for use in the Registration Statement and the Prospectus and any
amendment or supplement thereto.
(e) Incorporated Documents.
The documents incorporated by reference in the Registration
Statements, Prospectus or the Time of Sale Information, when they
became effective or were filed with the Commission, as the case may
be, conformed in all material respects to the requirements of the
Securities Act or the Exchange Act, as applicable, and none of such
documents contained any untrue statement of a material fact or
omitted to state a material fact required to be stated therein or
necessary to make the statements therein, in the light of the
circumstances under which they were made, not misleading; and any
further documents so filed and incorporated by reference in the
Registration Statements, the Prospectus or the Time of Sale
Information, when such documents become effective or are filed with
the Commission, as the case may be, will conform in all material
respects to the requirements of the Act or the Exchange Act, as
applicable, 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 to make the statements therein, in the light of the
circumstances under which they were made, not
misleading.
(f) Financial Statements. The
financial statements and the related notes thereto of the Company
and its consolidated subsidiaries included or incorporated by
reference in the Registration Statements, the Time of Sale
Information and the Prospectus comply in all material respects with
the applicable requirements of the Securities Act and 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 United States generally accepted accounting
principles (“GAAP”) applied on a consistent basis
throughout the periods covered thereby, and the supporting
schedules included or incorporated by reference in the Registration
Statements present fairly the information required to be stated
therein; and the other financial information included or
incorporated by reference in the Registration Statements, 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.
(g) No Material Adverse
Change. Since the date of the most recent audited financial
statements of the Company included or incorporated by reference in
the Registration Statements, the Time of Sale Information and the
Prospectus, (i) there has not been any change in the capital
stock (other than upon the issuance of shares of Common Stock
pursuant to the Company’s stock option plans and employee
stock purchase plan as in existence on the date hereof and pursuant
to its currently outstanding options or in accordance with the
terms of the employee stock purchase plan, in each case as
described in the Prospectus, all of which issuances have been or
will be made in compliance with the applicable federal and state
securities laws) 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 in clauses (i), (ii) and (iii) as
otherwise disclosed in the Registration Statements, the Time of
Sale Information and the Prospectus.
(h) 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 21.1 to the Company’s Annual Report on
Form 10-K for the fiscal year ended June 30,
2006.
(i) 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 preemptive 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
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 description thereof contained in the Registration
Statements, 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 described in the Registration Statements, 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.
(j) Due Authorization. The
Company has full right, power and authority to execute and deliver
this Agreement and to perform its obligations hereunder; and all
action required to be taken
for the due and proper authorization, execution
and delivery of this Agreement and the consummation by it of the
transactions contemplated hereby has been duly and validly
taken.
(k) Underwriting Agreement.
This Underwriting Agreement (this “Agreement”) has been
duly authorized, executed and delivered by the Company.
(l) The Shares. The Shares
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; the Rights Agreement has been duly
authorized, executed and delivered by the Company and constitutes a
valid and legally binding agreement of the Company enforceable
against the Company in accordance with its terms, except as
enforceability may be limited by applicable bankruptcy, insolvency
or similar laws affecting creditors’ rights generally or by
equitable principles relating to enforceability; and the Rights
have been duly authorized by the Company and, when issued upon
issuance of the Shares, will be validly issued, and the
Series A Junior Participation Preferred Stock of the Company
has been duly authorized by the Company and validly reserved for
issuance upon the exercise in accordance with the terms of the
Rights Agreement, will be validly issued, fully paid and
non-assessable.
(m) 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 applicable to the Company or
its subsidiaries, 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.
(n) No Conflicts. The
execution, delivery and performance by the Company of this
Agreement, the issuance and sale of the Shares and the consummation
of the transactions contemplated by this Agreement 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 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 applicable to the Company or 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.
(o) 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 this Agreement, the issuance and sale
of the Shares and the consummation of the transactions contemplated
hereby, 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 in connection with the purchase
and distribution of the Shares by the Underwriter.
(p) Legal Proceedings. Except
as described in the Registration Statements, 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, if
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 this Agreement; no such
investigations, actions, suits or proceedings are threatened or, to
the best 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 Statements that
are not so described in the Registration Statements, 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 Statements or described in the Registration Statements
or the Prospectus that are not so filed as exhibits to the
Registration Statements or described in the Registration
Statements, the Time of Sale Information and the
Prospectus.
(q) Independent Accountants.
KPMG LLP, who has certified certain financial statements of the
Company and its subsidiaries and has audited the Company’s
internal control over financial reporting and managements’
assessment thereof, and Ernst & Young LLP are each 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 Accounting
Oversight Board (United States) as required by the Securities
Act.
(r) 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 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.
(s) 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 or unpatentable
proprietary or confidential compounds, genes, information, systems
or procedures) necessary for the conduct of their respective
businesses. The Company has not received any notice of infringement
of or conflict with, and the Company has no knowledge of any
infringement of or conflict with, asserted rights of others with
respect to its intellectual property rights which could reasonably
be expected to result in a Material Adverse Effect; the
discoveries, inventions, products or processes of the Company
referred to in the Registration Statements, the Time of Sale
Information and the Prospectus do not infringe or conflict with any
right or patent of any third party, or any discovery, invention,
product or process which is the subject of a patent application
filed by any third party. Further, except as described in the
Registration Statements, the Time of Sale Information or the
Prospectus, or which would not reasonably be expected to result in
a Material Adverse Effect, the Company is not obligated to pay a
royalty, grant a license or provide other consideration to any
third party in connection with its patents, patent rights,
licenses, inventions, trademarks, service marks, trade names,
copyrights and know-how; and no third party, including any academic
or governmental organization, possesses rights to the
Company’s intellectual property rights which, if exercised,
could enable such third party to develop products competitive with
those of the Company or its subsidiaries and could reasonably be
expected to have a Material Adverse Effect.
(t) Clinical Trials . The
clinical trials conducted by or on behalf of the Company that are
described in the Registration Statements, the Time of Sale
Information and the Prospectus as ongoing, or the results of which
are referred to in the Prospectus, are the only clinical trials
currently being conducted by or on behalf of the Company with
respect to it and its subsidiaries. Nothing has come to the
attention of the Company that has caused the Company to believe
that the studies and tests described in the Registration
Statements, the Time of Sale Information and the Prospectus were
not and, to the extent still pending, are not being conducted in
all material respects in accordance with experimental protocols,
procedures and controls pursuant to accepted professional
scientific standards; the descriptions of the results of such
studies, tests and trials contained in the Registration Statements,
the Time of Sale Information and the Prospectus are consistent in
all material respects with such results. Except as described in the
Registration Statements, the Time of Sale Information and the
Prospectus, no results of any other studies or tests have come to
the attention of the Company that have caused the Company to
believe that such results are materially adverse to the results
described in the Registration Statements, the Time of Sale
Information and the Prospectus of the clinical trials. The Company
has not received any notices or correspondence from the Food and
Drug Administration (the “FDA”) or any other
governmental agency requiring the termination, suspension or
modification of any clinical trials currently conducted by, or on
behalf of, the Company. Nothing has come to the attention of the
Company that has caused the Company to believe that the clinical
trials previously conducted, or now being conducted, by or on
behalf of the Company were not conducted in all material respects
in accordance with experimental protocols, procedures and controls
pursuant to accepted professional scientific standards. The
clinical trials conducted by or on behalf of the Company that are
described in the Registration Statements, the Time of Sale
Information and the Prospectus as ongoing are to the knowledge of
the Company, in all material respects, being conducted
in
compliance with protocols submitted to the FDA
in Investigational New Drug applications filed by the Company, if
required.
(u) 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 Statements and the Prospectus and that is not so
described in such documents and in the Time of Sale
Information.
(v) 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 Statements, 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”).
(w) Public Utility Holding
Company Act. Neither the Company nor any of its subsidiaries is
a “holding company” or a “subsidiary
company” of a holding company or an “affiliate”
thereof within the meaning of the Public Utility Holding Company
Act of 1935, as amended.
(x) 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 Statements, 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, except in any such deficiency as would not, individually or
in the aggregate, have a Material Adverse Effect.
(y) 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 Statements, the Time of Sa
