Exhibit
1.1
2,103,000
SHARES
ADVANCED MAGNETICS,
INC.
COMMON STOCK , $0.01 PAR
VALUE PER SHARE
UNDERWRITING
AGREEMENT
December 7,
2006
December 7, 2006
To the Managers named in Schedule I
hereto
for
the Underwriters named in Schedule II hereto
Ladies and Gentlemen:
ADVANCED MAGNETICS, INC., a Delaware corporation
(the “ Company ”), proposes to issue
and sell to the several underwriters named in Schedule II hereto
(the “ Underwriters ”), for whom you
are acting as managers (the “Managers”), the number of
shares of its common stock, $0.01 par value per share, set forth in
Schedule I hereto (the “ Firm Shares
”). The Company also proposes to issue and sell to the
several Underwriters not more than the number of additional shares
of its common stock, $0.01 par value per share, set forth in
Schedule I hereto (the “ Additional Shares
”) if and to the extent that you, as Managers of the
offering, shall have determined to exercise, on behalf of the
Underwriters, the right to purchase such shares of common stock
granted to the Underwriters in Section 2 hereof. The Firm
Shares and the Additional Shares are hereinafter collectively
referred to as the “ Shares. ” The
shares of common stock, $0.01 par value per share of the Company to
be outstanding after giving effect to the sales contemplated hereby
are hereinafter referred to as the “ Common
Stock. ” If the firm or firms listed in Schedule II
hereto include only the Managers listed in Schedule I hereto, then
the terms “Underwriters” and “Managers” as
used herein shall each be deemed to refer to such firm or
firms.
The Company has filed with the Securities and
Exchange Commission (the “ Commission
”) a registration statement, including a prospectus, (the
file number of which is set forth in Schedule I hereto) on Form
S-3, relating to the securities (the “ Shelf
Securities ”), including the Shares, to be issued
from time to time by the Company. The registration statement as
amended to the date of this Agreement, including the information
(if any) deemed to be part of the registration statement at the
time of effectiveness pursuant to Rule 430A or Rule 430 B
under the Securities Act of 1933, as amended (the “
Securities Act ”), is hereinafter referred
to as the “ Registration Statement ”,
and the related prospectus covering the Shelf Securities dated
August 11, 2006 in the form first used to confirm sales of the
Shares (or in the form first made available to the Underwriters by
the Company to meet requests of purchasers pursuant to Rule 173
under the Securities Act) is hereinafter referred to as the “
Basic Prospectus. ” If the Company has filed
or files an abbreviated registration statement to register
additional shares of Common Stock pursuant to Rule 462(b) (the
“ Rule 462 Registration Statement ”)
under the Securities Act, then any reference herein to
the term
“Registration Statement” shall be deemed to include
such Rule 462 Registration Statement. The Basic Prospectus, as
supplemented by the prospectus supplement specifically relating to
the Shares in the form first used to confirm sales of the Shares
(or in the form first made available to the Underwriters by the
Company to meet requests of purchasers pursuant to Rule 173 under
the Securities Act) is hereinafter referred to as the “
Prospectus ,” and the term “
preliminary prospectus ” means any
preliminary form of the Prospectus. For purposes of this Agreement,
“ free writing prospectus ” has the
meaning set forth in Rule 405 under the Securities Act, “
Time of Sale Prospectus ” means the Basic
Prospectus, as supplemented by the preliminary prospectus
supplement, together with the free writing prospectuses, if any,
each identified in Schedule I hereto, and “ broadly
available road show ” means a “bona fide
electronic road show” as defined in Rule 433(h)(5) under the
Securities Act that has been made available without restriction to
any person. As used herein, the terms “Registration
Statement,” “Basic Prospectus,”
“preliminary prospectus,” “Time of Sale
Prospectus” and “Prospectus” shall include the
documents, if any, incorporated by reference therein. The terms
“ supplement ,” “
amendment ,” and “
amend ” as used herein with respect to the
Registration Statement, the Basic Prospectus, the Time of Sale
Prospectus, any preliminary prospectus or free writing prospectus
shall include all documents subsequently filed by the Company with
the Commission pursuant to the Securities Exchange Act of 1934, as
amended (the “ Exchange Act ”), that
are deemed to be incorporated by reference therein.
1. Representations and Warranties
. The Company represents and
warrants to and agrees with each of the Underwriters
that:
(a) Registration Statement Effective;
Eligibility. The
Registration Statement has become effective; no stop order
suspending the effectiveness of the Registration Statement is in
effect, and no proceedings for such purpose are pending before or
threatened by the Commission.
(b) Compliance with Form; Disclosure.
(i) Each document, if any, filed or
to be filed pursuant to the Exchange Act and incorporated by
reference in the Time of Sale Prospectus or the Prospectus complied
or will comply when so filed in all material respects with the
Exchange Act and the applicable rules and regulations of the
Commission thereunder, (ii) each part of the Registration
Statement, when such part became effective, did not contain, and
each such part, as amended or supplemented, if applicable, will not
contain any untrue statement of a material fact or omit to state a
material fact required to be stated therein or necessary to make
the statements therein not misleading, (iii) the Registration
Statement as of the date hereof does not contain any untrue
statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the statements
therein not misleading, (iv) the Registration Statement and the
Prospectus comply, and as amended or supplemented, if
applicable,
will comply in all material respects with the Securities Act and
the applicable rules and regulations of the Commission
thereunder, (v) the Time of Sale Prospectus does not, and at the
time of each sale of the Shares in connection with the offering
when the Prospectus is not yet available to prospective purchasers
and at the Closing Date (as defined in Section 4), the Time of Sale
Prospectus, as then amended or supplemented by the Company, if
applicable, will not, contain any untrue statement of a material
fact or omit to state a material fact necessary to make the
statements therein, in the light of the circumstances under which
they were made, not misleading, (vi) each broadly available road
show, if any, when considered together with the Time of Sale
Prospectus, does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the
statements therein, in the light of the circumstances under which
they were made, not misleading and (vii) the Prospectus does not
contain and, as amended or supplemented, if applicable, will not
contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements therein, in the
light of the circumstances under which they were made, not
misleading, except that the representations and warranties set
forth in this paragraph do not apply to statements or omissions in
the Registration Statement, the Time of Sale Prospectus or the
Prospectus based upon information relating to any Underwriter
furnished to the Company in writing by such Underwriter through the
Managers expressly for use therein.
(c) Free Writing Prospectuses.
The Company is not an
“ineligible issuer” in connection with the offering
pursuant to Rules 164, 405 and 433 under the Securities Act. Any
free writing prospectus that the Company is required to file
pursuant to Rule 433(d) under the Securities Act has been, or will
be, filed with the Commission in accordance with the requirements
of the Securities Act and the applicable rules and regulations of
the Commission thereunder. Each free writing prospectus that the
Company has filed, or is required to file, pursuant to Rule 433(d)
under the Securities Act or that was prepared by or behalf of or
used or referred to by the Company complies or will comply in all
material respects with the requirements of the Securities Act and
the applicable rules and regulations of the Commission thereunder.
Except for the free writing prospectuses, if any, identified in
Schedule I hereto forming part of the Time of Sale Prospectus, and
electronic road shows, if any, each furnished to you before first
use, the Company has not prepared, used or referred to, and will
not, without your prior consent, prepare, use or refer to, any free
writing prospectus.
(d) Preliminary Prospectuses.
Each preliminary prospectus filed as
part of the registration statement as originally filed or as part
of any amendment thereto, or filed pursuant to Rule 424 under
the Securities Act, complied when so filed in all material respects
with the Securities Act and the applicable rules and regulations of
the Commission thereunder.
(e) Due Incorporation. The Company has been duly incorporated and is
validly existing as a corporation in good standing under the laws
of the State of Delaware, with the corporate power and authority to
own its properties and to conduct its business as currently being
carried on and as described in the Registration Statement, the Time
of Sale Prospectus and the Prospectus. The Company is duly
qualified to transact business as a foreign corporation and is in
good standing under the laws of each other jurisdiction in which
its ownership or leasing of property or the conduct of its business
requires such qualification, except where the failure to be so
qualified and in good standing would not, individually or in the
aggregate, result in any material adverse effect upon, or change
in, the general affairs, business, operations, properties,
financial condition, or results of operations of the Company taken
as a whole (a “ Material Adverse Effect
”)
(f) Subsidiaries. The Company has no significant subsidiaries (as
such term is defined in Rule 1-02(w) of Regulation S-X promulgated
by the Commission) and does not own any beneficial interest,
directly or indirectly, in any corporation, partnership, joint
venture or other business entity.
(g) Capitalization. All of the issued and outstanding shares of
capital stock of the Company, including the outstanding shares of
Common Stock, have been duly authorized and validly issued and are
fully paid and nonassessable, have been issued in compliance with
all federal and state securities laws, were not issued in violation
of any preemptive right or other rights to subscribe for or to
purchase or acquire any securities of the Company that have not
been waived in writing.
(h) The Shares. The Shares have been duly and validly authorized
by the Company and, when issued, delivered and paid for in
accordance with the terms of this Agreement, will have been duly
and validly issued and will be fully paid and nonassessable and
will not be subject to any statutory or contractual preemptive
rights or other rights to subscribe for or to purchase or acquire
any shares of Common Stock of the Company.
(i) No Registration Rights. Neither the filing of the Registration Statement
nor the offering or sale of the Shares as contemplated by this
Agreement gives rise to any rights, other than those which have
been waived or satisfied, for or relating to the registration of
any shares of Common Stock or other securities of the
Company
(j) Description of Capital Stock.
The capital stock of the Company, including the Shares, conforms as
to legal matters to the description thereof, if any, contained in
the Registration Statement, the Time of Sale Prospectus and the
Prospectus, and as of the date thereof, the Company had authorized
and
outstanding
capital stock as set forth therein. The certificates for the Shares
are in due and proper form and the holders of the Shares will not
be subject to personal liability by reason of being such
holders.
(k) Due Authorization and Enforceability
. This Agreement has been duly
authorized, executed and delivered by the Company, and constitutes
a valid, legal and binding obligation of the Company, enforceable
against the Company in accordance with its terms, except as rights
to indemnity hereunder may be limited by federal or state
securities laws and except as such enforceability may be limited by
applicable bankruptcy, insolvency, reorganization or similar laws
affecting the rights of creditors generally and subject to general
principles of equity.
(l) No Violation. The Company is not in breach or violation of or
in default under (nor has any event occurred which with notice,
lapse of time or both would result in any breach or violation of,
or constitute a default) (i) under the provisions of its charter or
bylaws or (ii) in the performance or observance of any term,
covenant, obligation, agreement or condition contained in any
indenture, mortgage, deed of trust, bank loan or credit agreement
or other evidence of indebtedness, or any license, lease, contract
or other agreement or instrument to which the Company is a party or
by which it or any of its properties may be bound or affected, or
(iii) any statute, law, rule, regulation, ordinance, judgment,
order or decree of any court, regulatory body, administrative
agency, governmental body, arbitrator or other authority having
jurisdiction over the Company or any of its properties, as
applicable (including, without limitation, those administered by
the Food and Drug Administration of the U.S. Department of Health
and Human Services (the “ FDA ”) or by
any foreign, federal, state or local governmental or regulatory
authority performing functions similar to those performed by the
FDA), except, with respect to clauses (ii) and (iii) above, to the
extent any such contravention would not result in a Material
Adverse Effect.
(m) No Conflict. The execution, delivery and performance by the
Company of this Agreement and the consummation of the transactions
herein contemplated, including the issuance and sale by the Company
of the Shares, will not conflict with or result in a breach or
violation of, or constitute a default under (nor constitute any
event which with notice, lapse of time or both would result in any
breach or violation of or constitute a default under) (i) the
provisions of the charter or by-laws of the Company, (ii) any
material indenture, mortgage, deed of trust, bank loan or credit
agreement or other evidence of indebtedness, or any license, lease,
contract or other agreement or instrument to which the Company is a
party or by which it or any of its properties may be bound or
affected, or (iii) any federal, state, local or foreign law,
regulation or rule or any decree, judgment or order applicable to
the Company.
(n) No Consents Required. No approval, authorization, consent or order of
or filing with any federal, state, local or foreign governmental or
regulatory commission, board, body, authority or agency, or of or
with any self-regulatory organization or other non-governmental
regulatory authority, or approval of the stockholders of the
Company, is required in connection with the issuance and sale of
the Shares or the consummation by the Company of the transactions
contemplated hereby other than (i) as may be required under the
Securities Act, (ii) any necessary qualification of the Shares
under the securities or blue sky laws of the various jurisdictions
in which the Shares are being offered and (iii) under the rules and
regulations of the National Association of Securities Dealers, Inc.
(“ NASD ”) or the NASDAQ Global
Market. The Company has full power and authority to enter into this
Agreement and to authorize, issue and sell the Shares as
contemplated by this Agreement.
(o) Absence of Material Changes
. Subsequent to the respective dates
as of which information is given in the Time of Sale Prospectus,
(i) the Company has not incurred any material liability or
obligation, direct or contingent, or entered into any material
transaction not in the ordinary course of business; (ii) the
Company has not purchased any of the Company's outstanding capital
stock, or declared, paid or otherwise made any dividend or
distribution of any kind on the Company's capital stock; and (iii)
there has not been any change in the capital stock (other than a
change in the number of outstanding shares of Common Stock due to
the issuance of shares upon the exercise of outstanding options or
warrants), or material change in the short-term debt or long-term
debt of the Company or any issue of options, warrants, convertible
securities or other rights to purchase the capital stock (other
than grants of stock options under the Company’s stock option
plans existing on the date hereof) of the Company, or any Material
Adverse Effect.
(p) Permits. The Company possesses all necessary licenses,
authorizations, consents and approvals and has made all necessary
filings required under any federal, state, local or foreign law,
regulation or rule (including, without limitation, those from the
FDA, and any other foreign, federal, state or local government or
regulatory authorities performing functions similar to those
performed by the FDA), in order to conduct its business, except
where such failure would not individually or in the aggregate have
a Material Adverse Effect. The Company is not in violation of, or
in default under, or has received notice of any proceedings
relating to revocation or modification of, any such license,
authorization, consent or approval, except where such violation or
default would not individually or in the aggregate have a Material
Adverse Effect. The Company is in compliance with all applicable
federal, state, local and foreign laws, regulations, orders or
decrees, except where noncompliance would not individually or in
the aggregate have a Material Adverse Effect.
(q) Legal Proceedings. There are no legal or governmental proceedings
pending or, to the Company’s knowledge, threatened or
contemplated to which the Company is or would be a party or of
which any of its properties is or would be subject at law or in
equity, before or by any federal, state, local or foreign
governmental or regulatory commission, board, body, authority or
agency, or before or by any self-regulatory organization or other
non-governmental regulatory authority, except (i) as described in
the Registration Statement, the Prospectus, and the Time of Sale
Prospectus, (ii) any such proceeding, which if resolved adversely
to the Company, would not result in a judgment, decree or order
having, individually or in the aggregate, a Material Adverse Effect
or (iii) any such proceeding that would not prevent or materially
and adversely affect the ability of the Company to consummate the
transactions contemplated hereby. The Time of Sale Prospectus
contains in all material respects the same description of the
foregoing matters contained in the Prospectus.
(r) Statutes; Contracts. There are no statutes or regulations applicable
to the Company or contracts or other documents of the Company which
are required to be described in the Registration Statement, the
Time of Sale Prospectus or the Prospectus or filed as exhibits to
the Registration Statement by the Securities Act which have not
been so described or filed.
(s) Independent Accountants.
To the Company's knowledge,
PricewaterhouseCoopers LLP, who have certified certain of the
financial statements of the Company filed with the Commission as
part of any of the Registration Statement, the Time of Sale
Prospectus or the Prospectus, or incorporated by reference therein,
was during the period covered by such financial statements an
independent public accounting firm within the meaning of the
Securities Act.
(t) Financial Statements. The financial statements of the Company,
together with the related schedules and notes thereto, set forth or
incorporated by reference in the Registration Statement, the Time
of Sale Prospectus 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 in all material
respects (i) the financial condition of the Company, taken as a
whole, as of the dates indicated and (ii) the consolidated results
of operations, stockholders’ equity and changes in cash flows
of the Company, taken as a whole, for the periods therein
specified; and such financial statements and related schedules and
notes thereto have been prepared in conformity with United States
generally accepted accounting principles, consistently applied
throughout the periods involved (except as otherwise stated therein
and subject, in the case of unaudited financial statements, to the
absence of footnotes and normal year-end adjustments). There are no
other financial statements (historical or pro forma)
that
are required to
be included in the Registration Statement, the Time of Sale
Prospectus and the Prospectus; and the Company does not have any
material liabilities or obligations, direct or contingent
(including any off-balance sheet obligations), not disclosed in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus; and all disclosures contained in the Registration
Statement, the Time of Sale Prospectus and the Prospectus regarding
“non-GAAP financial measures” (as such term is defined
by the rules and regulations of the Commission) comply with
Regulation G of the Exchange Act and Item 10(e) of Regulation S-K
under the Securities Act, to the extent applicable, and present
fairly the information shown therein and the Company’s basis
for using such measures.
(u) No Material Adverse Change.
There has not been any material
adverse change, or to the Company’s knowledge, any
development involving a prospective material adverse change, in the
business, properties, management, financial condition or results of
operations of the Company taken as a whole, from that set forth in
the Time of Sale Prospectus (exclusive of any amendments or
supplements thereto subsequent to the date of this
Agreement).
(v) Not an Investment Company.
The Company is not or, after giving
effect to the offering and sale of the Shares and the application
of the proceeds thereof as described in the Prospectus, will be
required to register as an “investment company” as
defined in the Investment Company Act of 1940, as
amended.
(w) Good Title to Property. The Company has good and valid title to all
property (whether real or personal) described in each of the Time
of Sale Prospectus and the Prospectus as being owned by it, in each
case free and clear of all liens, claims, security interests, other
encumbrances or defects except such as are described in each of the
Time of Sale Prospectus and the Prospectus and those that would
not, individually or in the aggregate materially affect the value
of such property and do not materially interfere with the use made
and proposed to be made of such property by the Company. All of the
property described in each of the Time of Sale Prospectus and the
Prospectus as being held under lease by the Company is held thereby
under valid, subsisting and enforceable leases, without any liens,
restrictions, encumbrances or claims, except those that,
individually or in the aggregate, are not material and do not
materially interfere with the use made and proposed to be made of
such property by the Company.
(x) Intellectual Property Rights.
The Company owns, or has obtained
valid and enforceable licenses for, or other rights to use, the
inventions, patent applications, patents, trademarks (both
registered and unregistered), tradenames, copyrights, trade secrets
and other proprietary information described in each of the Time of
Sale Prospectus and the Prospectus as being owned or licensed by
it
or which are
necessary for the conduct of its business, except where the failure
to own, license or have such rights would not, individually or in
the aggregate, result in a Material Adverse Effect (collectively,
“ Intellectual Property ”); except as
described in the Time of Sale Prospectus and the Prospectus (i)
there are no third parties who have or, to the Company’s
knowledge, will be able to establish rights to any Intellectual
Property, except for the ownership rights of the owners of the
Intellectual Property which is licensed to the Company; (ii) to the
Company’s knowledge, there is no infringement by third
parties of any Intellectual Property; (iii) 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, or the validity, enforceability, or scope of, any
Intellectual Property owned by or licensed to the Company, and the
Company is unaware of any facts which could form a reasonable basis
for any such claim; (iv) except as would not result in a Material
Adverse Effect, there is no pending or, to the Company’s
knowledge, threatened action, suit, proceeding or claim by others
that the Company infringes or otherwise violates any patent,
trademark, copyright, trade secret or other proprietary rights of
others, and the Company is unaware of any facts which could form a
reasonable basis for any such claim; (v) to the Company’s
knowledge, there is no patent or patent application that contains
claims that interfere with the issued or pending claims of any of
the Intellectual Property; and (vi) to the Company’s
knowledge, there is no prior art that may render any patent owned
by the Company invalid, nor is there any prior art known to the
Company that may render any patent application owned by the Company
unpatentable.
(y) Taxes. The Company has timely filed all material
federal, state, local and foreign income and franchise tax returns
(or timely filed applicable extensions therefore) that have been
required to be filed and is not in default in the payment of any
taxes which were payable pursuant to said returns or any
assessments with respect thereto, other than any which the Company
is contesting in good faith and for which adequate reserves have
been provided and reflected in the Company’s financial
statements included in the Registration Statement, the Time of Sale
Prospectus and the Prospectus. The Company has no tax deficiency
that has been or, to the knowledge of the Company, might be
asserted or threatened against it that would result in a Material
Adverse Effect.
(z) Insurance. The Company maintains insurance in such amounts
and covering such risks as is 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
such insurance is fully in force on the date hereof and will be
fully in force as of the Closing Date. The Company has no reason to
believe that it will not be able to renew its existing insurance
coverage as and when such coverage expires or to obtain similar
coverage from similar insurers as may be necessary to continue its
business at a cost that would not have a Material Adverse
Effect.
(aa) Accounting Controls. The Company maintains a system of internal
accounting controls sufficient to provide reasonable assurances
that (i) transactions are executed in accordance with
management’s general or specific authorization; (ii)
transactions are recorded as necessary to permit preparation of
financial statements in conformity with 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 accountability for assets is compared with existing assets
at reasonable intervals and appropriate action is taken with
respect to any differences.
(bb) Disclosure Controls. The Company has established, maintains and
evaluates “disclosure controls and procedures” (as such
term is defined in Rule 13a-14(c) and 15d-14(c) under the Exchange
Act), which (i) are designed to ensure that material information
relating to the Company is made known to the Company’s
principal executive officer and its principal financial officer by
others within the Company, particularly during the periods in which
the periodic reports required under the Exchange Act are being
prepared, (ii) have been evaluated for effectiveness as of the end
of the last fiscal period covered by the Registration Statement;
and (iii) such disclosure controls and procedures are effective to
perform the functions for which they were established. There are no
material weaknesses in the design or operation of internal controls
which could adversely affect the Company’s ability to record,
process, summarize, and report financial data to management and the
Board of Directors. The Company is not aware of any fraud, whether
or not material, that involves management or other employees who
have a role in the Company’s internal controls; and since the
date of the most recent evaluation of such disclosure controls and
procedures, there have been no significant changes in internal
controls or in other factors that could significantly affect
internal controls, including any corrective actions with regard to
significant deficiencies and material weaknesses.
(cc) Corrupt Practices. Neither the Company nor, to the Company’s
knowledge, any other person associated with or acting on behalf of
the Company, including without limitation any director, officer,
agent or employee of the Company has, directly or indirectly, while
acting on behalf of the Company (i) used any corporate funds for
unlawful contributions, gifts, entertainment or other unlawful
expenses relating to political activity, (ii) made any unlawful
payment to foreign or domestic government officials or employees or
to foreign or domestic political parties or campaigns from
corporate funds, (iii) violated any provision of the Foreign
Corrupt Practices Act of 1977, as amended or (iv) made any other
unlawful payment.
(dd) No Price Stabilization. Neither the Company nor, to the Company’s
knowledge, any of its officers, directors, affiliates or
controlling persons has taken or will take, directly or indirectly,
any action designed to cause
or result in,
or which has constituted or which might reasonably be expected to
constitute the stabilization or manipulation of the price of any
security of the Company to facilitate the sale or resale of the
Shares.
(ee) No Undisclosed Relationships.
No relationship, direct or indirect,
exists between or among the Company on the one hand and the
directors, officers, stockholders, customers or suppliers of the
Company on the other hand which is required to be described in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus which has not been so described.
(ff) Sarbanes-Oxley Act. The
Company, and to its knowledge after due inquiry, all of the
Company’s directors or officers, in their capacities as such,
is in compliance in all material respects with all applicable
effective provisions of the Sarbanes-Oxley Act of 2002 (the “
Sarbanes-Oxley Act ”) and any related rules
and regulations promulgated by the Commission.
(gg) Brokers Fees. The Company is not a party to any contract,
agreement or understanding with any person (other than this
Agreement) that would give rise to a valid claim against the
Company or the Underwriters for a brokerage commission,
finder’s fee or other like payment in connection with the
offering and sale of the Shares.
(hh) Exchange Act Requirements.
Company has filed in a timely manner
all reports required to be filed pursuant to Sections 13(a), 13(e),
14 and 15(d) of the Exchange Act during the preceding 12 months
(except to the extent that Section 15(d) requires reports to be
filed pursuant to Sections 13(d) and 13(g) of the Exchange Act,
which shall be governed by the next clause of this sentence); and
the Company has filed in a timely manner all reports required to be
filed pursuant to Sections 13(d) and 13(g) of the Exchange Act
since January 1, 2005, except where the failure to timely file
could not reasonably be expected individually or in the aggregate
to have a Material Adverse Effect.
(ii) Ferumoxytol Clinical Trials.
Except as disclosed in the Time of Sale Prospectus, since April
2004, the FDA has not notified the Company of any material
deficiencies relating to the ferumoxytol Phase III iron replacement
therapy clinical trials.
(jj) Compliance with Environmental Laws.
The Company (i) is in compliance
with any and all applicable foreign, federal, state and local laws,
orders, rules, regulations, directives, decrees and judgments
relating to the protection of human health and safety,