Common Stock
($0.01 par value per Share)
UBS Securities
LLC
SG Cowen & Co., LLC
First Albany Capital Inc.
Susquehanna Financial Group, LLLP
as Managing
Underwriters
c/o UBS
Securities LLC
299 Park Avenue
New York, New York 10171-0026
Iomai
Corporation, a Delaware corporation (the “ Company
”), proposes to issue and sell to the underwriters named in
Schedule A annexed hereto (the “
Underwriters ”), for whom you are acting as
representative, an aggregate of [___] shares (the “ Firm
Shares ”) of common stock, $0.01 par value per share (the
“ Common Stock ”), of the Company. In addition,
solely for the purpose of covering over-allotments, the Company
proposes to grant to the Underwriters the option to purchase from
the Company up to an additional [___] shares of Common Stock (the
“ Additional Shares ”). The Firm Shares and the
Additional Shares are hereinafter collectively sometimes referred
to as the “ Shares .” The Shares are described
in the Prospectus which is referred to below.
The
Company hereby acknowledges that, in connection with the proposed
offering of the Shares, it has requested UBS Financial Services
Inc. (“ UBS-FinSvc ”) to administer a directed
share program (the “ Directed Share Program ”)
under which up to [___] Firm Shares, or [5]% of the Firm Shares to
be purchased by the Underwriters (the “ Reserved
Shares ”), shall be reserved for sale by UBS-FinSvc at
the initial public offering price to the Company’s officers,
directors, employees and consultants and other persons having a
relationship with the Company as designated by the Company (the
“ Directed Share Participants ”) as part of the
distribution of the Shares by the Underwriters, subject to the
terms of this Agreement, the applicable rules, regulations and
interpretations of the National Association of Securities Dealers,
Inc. (the “ NASD ”) and all other applicable
laws, rules and regulations. The number of Shares available for
sale to the general public will be reduced to the extent that
Directed Share Participants purchase Reserved Shares. The
Underwriters may offer any Reserved Shares not purchased by
Directed Share Participants to the general public on the same basis
as the other Shares being issued and sold hereunder. The Company
has supplied UBS-FinSvc with the names, addresses and telephone
numbers of the individuals or other entities which the Company has
designated to be participants in the Directed Share Program. It is
understood that any number of those so designated to participate in
the Directed Share Program may decline to do so.
The
Company has prepared and filed, in accordance with the provisions
of the Securities Act of 1933, as amended, and the rules and
regulations thereunder (collectively, the
“
Act ”), with the Securities and Exchange Commission
(the “ Commission ”) a registration statement on
Form S-1 (File No. 333-128765) under the Act, including a
prospectus, relating to the Shares.
Except
where the context otherwise requires, “ Registration
Statement ,” as used herein, means the registration
statement, as amended at the time of such registration
statement’s effectiveness for purposes of Section 11 of
the Act, as such section applies to the respective Underwriters
(the “ Effective Time ”), including (i) all
documents filed as a part thereof, (ii) any information
contained in a prospectus filed with the Commission pursuant to
Rule 424(b) under the Act and deemed, pursuant to Rule 430A or
Rule 430C under the Act, to be part of the registration
statement at the Effective Time, and (iii) any registration
statement filed to register the offer and sale of Shares pursuant
to Rule 462(b) under the Act.
The
Company has furnished to you, for use by the Underwriters and by
dealers in connection with the offering of the Shares, copies of
one or more preliminary prospectuses relating to the Shares. Except
where the context otherwise requires, “ Preliminary
Prospectus ,” as used herein, means each such preliminary
prospectus, in the form so furnished.
Except
where the context otherwise requires, “ Prospectus
,” as used herein, means the prospectus filed by the Company
with the Commission pursuant to Rule 424(b) under the Act on or
before the second business day after the date hereof (or such
earlier time as may be required under the Act), or, if no such
filing is required, the final prospectus included in the
Registration Statement at the time it became effective under the
Act, in each case in the form furnished by the Company to you for
use by the Underwriters and by dealers in connection with the
offering of the Shares.
“
Permitted Free Writing Prospectuses ,” as used herein,
means the documents listed on Schedule B attached
hereto and each “road show” (as defined in
Rule 433 under the Act), if any, related to the offering of
the Shares contemplated hereby that is a “written
communication” (as defined in Rule 405 under the Act)
(each such road show, a “ Road Show
”).
“
Disclosure Package ,” as used herein, means any
Preliminary Prospectus together with any combination of one or more
of the Permitted Free Writing Prospectuses, if any.
As
used in this Agreement, “ business day ” shall
mean a day on which the New York Stock Exchange (the “
NYSE ”) is open for trading. The terms
“herein,” “hereof,” “hereto,”
“hereinafter” and similar terms, as used in this
Agreement, shall in each case refer to this Agreement as a whole
and not to any particular section, paragraph, sentence or other
subdivision of this Agreement. The term “or,” as used
herein, is not exclusive.
The
Company has prepared and filed, in accordance with Section 12
of Securities Exchange Act of 1934, as amended, and the rules and
regulations thereunder (collectively, the “ Exchange
Act ”), a registration statement (as amended, the “
Exchange Act Registration Statement ”) on Form 8-A
(File No. [___]) under the Exchange Act to register, under Section
12(g) of the Exchange Act, the class of securities consisting of
the Common Stock.
- 2 -
The
Company and the Underwriters agree as follows:
1. Sale
and Purchase . Upon the basis of the representations and
warranties and subject to the terms and conditions herein set
forth, the Company agrees to issue and sell to the respective
Underwriters and each of the Underwriters, severally and not
jointly, agrees to purchase from the Company the number of Firm
Shares set forth opposite the name of such Underwriter in
Schedule A attached hereto, subject to adjustment in
accordance with Section 8 hereof, in each case at a purchase
price of $[___] per Share. The Company is advised by you that the
Underwriters intend (i) to make a public offering of their
respective portions of the Firm Shares as soon after the effective
date of the Registration Statement as in your judgment is advisable
and (ii) initially to offer the Firm Shares upon the terms set
forth in the Prospectus. You may from time to time increase or
decrease the public offering price after the initial public
offering to such extent as you may determine.
In
addition, the Company hereby grants to the several Underwriters the
option (the “Over-Allotment Option”) to purchase, and
upon the basis of the representations and warranties and subject to
the terms and conditions herein set forth, the Underwriters shall
have the right to purchase, severally and not jointly, from the
Company, ratably in accordance with the number of Firm Shares to be
purchased by each of them, all or a portion of the Additional
Shares as may be necessary to cover over-allotments made in
connection with the offering of the Firm Shares, at the same
purchase price per share to be paid by the Underwriters to the
Company for the Firm Shares. The Over-Allotment Option may be
exercised by UBS Securities LLC (“ UBS ”) on
behalf of the several Underwriters at any time and from time to
time on or before the thirtieth day following the date of the
Prospectus, by written notice to the Company. Such notice shall set
forth the aggregate number of Additional Shares as to which the
Over-Allotment Option is being exercised and the date and time when
the Additional Shares are to be delivered (any such date and time
being herein referred to as an “ additional time of
purchase ”); provided , however , that no
additional time of purchase shall be earlier than the “time
of purchase” (as defined below) nor earlier than the second
business day after the date on which the Over-Allotment Option
shall have been exercised nor later than the tenth business day
after the date on which the Over-Allotment Option shall have been
exercised. The number of Additional Shares to be sold to each
Underwriter shall be the number which bears the same proportion to
the aggregate number of Additional Shares being purchased as the
number of Firm Shares set forth opposite the name of such
Underwriter on Schedule A hereto bears to the total
number of Firm Shares (subject, in each case, to such adjustment as
you may determine to eliminate fractional shares), subject to
adjustment in accordance with Section 8 hereof.
2.
Payment and Delivery . Payment of the purchase price for the
Firm Shares shall be made to the Company by Federal Funds wire
transfer against delivery of the certificates for the Firm Shares
to you through the facilities of The Depository Trust Company
(“ DTC ”) for the respective accounts of the
Underwriters. Such payment and delivery shall be made at
10:00 A.M., New York City time, on [closing date] (unless
another time shall be agreed to by you and the Company or unless
postponed in accordance with the provisions of Section 8
hereof). The time at which such payment and delivery are to be made
is hereinafter sometimes called “ the time of purchase
.” Electronic transfer of the Firm Shares shall be made to
you at the time of purchase in such names and in such denominations
as you shall specify.
- 3 -
Payment
of the purchase price for the Additional Shares shall be made at
the additional time of purchase in the same manner and at the same
office as the payment for the Firm Shares. Electronic transfer of
the Additional Shares shall be made to you at the additional time
of purchase in such names and in such denominations as you shall
specify.
Deliveries
of the documents described in Section 6 hereof with respect to
the purchase of the Shares shall be made at the offices of Dewey
Ballantine LLP at 1301 Avenue of the Americas, New York, New York
10019, at 9:00 A.M., New York City time, on the date of the closing
of the purchase of the Firm Shares or the Additional Shares, as the
case may be.
3.
Representations and Warranties of the Company . The Company
represents and warrants to and agrees with each of the Underwriters
that:
(a) the
Registration Statement has heretofore become effective under the
Act or, with respect to any registration statement to be filed to
register the offer and sale of Shares pursuant to Rule 462(b) under
the Act, will be filed with the Commission and become effective
under the Act no later than 10:00 P.M., New York City time, on
the date of determination of the public offering price for the
Shares; no stop order of the Commission preventing or suspending
the use of any Preliminary Prospectus or Permitted Free Writing
Prospectus or the effectiveness of the Registration Statement has
been issued, and no proceedings for such purpose have been
instituted or, to the Company’s knowledge, are contemplated
by the Commission; the Exchange Act Registration Statement has
become effective as provided in Section 12 of the Exchange
Act;
(b) the
Registration Statement complied when it became effective, complies
as of the date hereof and, as amended or supplemented, at the time
of purchase, each additional time of purchase, if any, and at all
times during which a prospectus is required by the Act to be
delivered (whether physically or through compliance with
Rule 172 under the Act or any similar rule) in connection with
any sale of Shares, will comply, in all material respects, with the
requirements of the Act; the Registration Statement did not, as of
the Effective Time, contain an untrue statement of a material fact
or omit to state a material fact required to be stated therein or
necessary to make the statements therein not misleading; each
Preliminary Prospectus complied, at the time it was filed with the
Commission, and complies as of the date hereof, in all material
respects with the requirements of the Act; at no time during the
period that begins on the earlier of the date of such Preliminary
Prospectus and the date such Preliminary Prospectus was filed with
the Commission and ends at the time of purchase did or will any
Preliminary Prospectus, as then amended or supplemented, include an
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, and at no time during such period did or will any
Preliminary Prospectus, as then amended or supplemented, together
with any combination of one or more of the then issued Permitted
Free Writing Prospectuses, if any, include an 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
- 4 -
circumstances
under which they were made, not misleading; the Prospectus will
comply, as of its date, the date that it is filed with the
Commission, the time of purchase, each additional time of purchase,
if any, and at all times during which a prospectus is required by
the Act to be delivered (whether physically or through compliance
with Rule 172 under the Act or any similar rule) in connection
with any sale of Shares, in all material respects, with the
requirements of the Act (including, without limitation, Section
10(a) of the Act); at no time during the period that begins on the
earlier of the date of the Prospectus and the date the Prospectus
is filed with the Commission and ends at the later of the time of
purchase, the latest additional time of purchase, if any, and the
end of the period during which a prospectus is required by the Act
to be delivered (whether physically or through compliance with
Rule 172 under the Act or any similar rule) in connection with
any sale of Shares did or will the Prospectus, as then amended or
supplemented, include an 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; at no time during the period that
begins on the date of such Permitted Free Writing Prospectus and
ends at the time of purchase did or will any Permitted Free Writing
Prospectus include an untrue statement of a material fact or, when
taken together with the Disclosure Package, 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 , however , that the Company
makes no representation or warranty with respect to any statement
contained in the Registration Statement, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing Prospectus
in reliance upon and in conformity with information concerning an
Underwriter and furnished in writing by or on behalf of such
Underwriter through you to the Company expressly for use in the
Registration Statement, such Preliminary Prospectus, the Prospectus
or such Permitted Free Writing Prospectus;
(c) prior to the
execution of this Agreement, the Company has not, directly or
indirectly, offered or sold any Shares by means of any
“prospectus” (within the meaning of the Act) or used
any “prospectus” (within the meaning of the Act) in
connection with the offer or sale of the Shares, in each case other
than the Preliminary Prospectuses and the Permitted Free Writing
Prospectuses, if any; the Company has not, directly or indirectly,
prepared, used or referred to any Permitted Free Writing Prospectus
except in compliance with Rules 164 and 433 under the Act;
assuming that such Permitted Free Writing Prospectus is accompanied
or preceded by the most recent Preliminary Prospectus that contains
a price range or the Prospectus, as the case may be, and that such
Permitted Free Writing Prospectus is so sent or given after the
Registration Statement was filed with the Commission (and after
such Permitted Free Writing Prospectus was, if required pursuant to
Rule 433(d) under the Act, filed with the Commission), the sending
or giving, by any Underwriter, of any Permitted Free Writing
Prospectus will satisfy the provisions of Rule 164 or
Rule 433 (without reliance on subsections (b), (c) and
(d) of Rule 164); the Preliminary Prospectus dated [date]
is a prospectus that, other than by reason of Rule 433 or
Rule 431 under the Act, satisfies the requirements of
Section 10 of the Act, including a price range where required
by rule; neither the Company nor the Underwriters are disqualified,
by reason of subsection (f) or (g) of Rule 164 under
the Act, from using, in connection with the offer and sale of the
Shares, “free writing
- 5 -
prospectuses” (as defined in Rule 405
under the Act) pursuant to Rules 164 and 433 under the Act;
the Company is not an “ineligible issuer” (as defined
in Rule 405 under the Act) as of the eligibility determination
date for purposes of Rules 164 and 433 under the Act with
respect to the offering of the Shares contemplated by the
Registration Statement; the parties hereto agree and understand
that the content of any and all “road shows” (as
defined in Rule 433 under the Act) related to the offering of
the Shares contemplated hereby is solely the property of the
Company; the Company has caused there to be made available at least
one version of a “ bona fide electronic road
show” (as defined in Rule 433 under the Act) in a manner
that, pursuant to Rule 433(d)(8)(ii) under the Act, causes the
Company not to be required, pursuant to Rule 433(d) under the Act,
to file, with the Commission, any Road Show;
(d) as of the date
of this Agreement, the Company has an authorized and outstanding
capitalization as set forth in the sections of the Registration
Statement, the Preliminary Prospectuses and the Prospectus entitled
“Capitalization” and “Description of capital
stock” (and any similar sections or information, if any,
contained in any Permitted Free Writing Prospectus), and, as of the
time of purchase and any additional time of purchase, as the case
may be, the Company shall have an authorized and outstanding
capitalization as set forth in the sections of the Registration
Statement and the Prospectus entitled “Capitalization”
and “Description of capital stock” (and any similar
sections or information, if any, contained in any Permitted Free
Writing Prospectus) (subject, in each case, to the issuance of
shares of Common Stock upon exercise of stock options and warrants
disclosed as outstanding in the Registration Statement (excluding
the exhibits thereto), each Preliminary Prospectus and the
Prospectus and the grant of options under existing stock option and
stock purchase plans described in the Registration Statement
(excluding the exhibits thereto), each Preliminary Prospectus and
the Prospectus); all of the issued and outstanding shares of
capital stock, including the Common Stock, of the Company have been
duly authorized and validly issued and are fully paid and
non-assessable, have been issued in compliance, in all material
respects, with all applicable securities laws and were not issued
in violation of any preemptive right, resale right, right of first
refusal or similar right; prior to the time of purchase, all
outstanding shares of Series B preferred stock, par value
$0.01 per share, and Series C preferred stock, par value $0.01
per share, of the Company shall convert into shares of Common Stock
in the manner described in the Registration Statement (excluding
the exhibits thereto), each Preliminary Prospectus and the
Prospectus; prior to the date hereof, the Company has duly effected
and completed a 13-for-1 reverse stock split of the Common Stock in
the manner described in the Registration Statement (excluding the
exhibits thereto), each Preliminary Prospectus and the Prospectus;
and the Amended and Restated Certificate of Incorporation of the
Company and the Amended and Restated Bylaws of the Company, each in
the form filed as an exhibit to the Registration Statement, have
been heretofore duly authorized and approved in accordance with the
Delaware General Corporation Law and shall become effective and in
full force and effect at or before the time of purchase; the Shares
are duly listed, and admitted and authorized for trading, subject
to official notice of issuance and evidence of satisfactory
distribution, on the Nasdaq National Market (the “
Nasdaq ”);
- 6 -
(e) 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
requisite corporate power and authority to own, lease and operate
its properties and conduct its business as described in the
Registration Statement, the Preliminary Prospectuses, the
Prospectus and the Permitted Free Writing Prospectuses, if any, to
execute and deliver this Agreement and to issue, sell and deliver
the Shares as contemplated herein;
(f) the Company is
duly qualified to do business as a foreign corporation and is in
good standing in each jurisdiction where the ownership or leasing
of its properties 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, have a
material adverse effect on the business, properties, financial
condition, results of operations or prospects of the Company (a
“ Material Adverse Effect ”);
(g) the Company
has no subsidiaries (as defined under the Act); the Company does
not own, directly or indirectly, any shares of stock or any other
equity or long-term debt securities of any corporation or have any
material equity interest in any firm, partnership, joint venture,
association or other entity; complete and correct copies of the
charter and the bylaws of the Company and all amendments thereto
have been delivered to you, and, except as set forth in the
exhibits to the Registration Statement, no changes therein will be
made on or after the date hereof through and including the time of
purchase or, if later, any additional time of purchase, except for
the filing of the Amended and Restated Certificate of
Incorporation, which is described in the Registration Statement,
the Preliminary Prospectus and the Prospectus under the caption
“Description of Capital Stock” (and any similar
sections or information, if any, contained in any Permitted Free
Writing Prospectus);
(h) the Shares
have been duly and validly authorized and, when issued and
delivered against payment therefor as provided herein, will be duly
and validly issued, fully paid and non-assessable and free of
statutory and contractual preemptive rights, rights of first
refusal and similar rights;
(i) the capital
stock of the Company, including the Shares, conforms in all
material respects to each description thereof contained in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any Permitted Free Writing Prospectus; and the certificates for
the Shares are in due and proper form;
(j) this Agreement
has been duly authorized, executed and delivered by the
Company;
(k) 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, constitute a default under or
give the holder of any indebtedness (or a person acting on such
holder’s behalf) the right to require the repurchase,
redemption or repayment of all or a part of such indebtedness
under) (A) its charter or bylaws, or (B) any indenture,
mortgage, deed of trust, bank loan or credit agreement or other
evidence of
- 7 -
indebtedness,
or any license, lease, contract or other agreement or instrument to
which the Company is a party or by the Company or any of its
properties may be bound or affected, or (C) any federal,
state, local or foreign law, regulation or rule or any Nasdaq rule
or regulation, or (D) any decree, judgment or order applicable
to the Company or any of its properties, other than, in the case of
clause (B) for those conflicts, breaches, violations or
defaults that would not, individually or in the aggregate, have a
Material Adverse Effect;
(l) and the
execution, delivery and performance of this Agreement, the issuance
and sale of the Shares and the consummation of the transactions
contemplated hereby will not conflict with, result in any 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 or give the
holder of any indebtedness (or a person acting on such
holder’s behalf) the right to require the repurchase,
redemption or repayment of all or a part of such indebtedness
under) (or result in the creation or imposition of a lien, charge
or encumbrance on any property or assets of the Company pursuant
to) (I) the charter or bylaws of the Company, or (II) 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 the Company or any of its properties may be bound or
affected, or (III) any federal, state, local or foreign law,
regulation or rule or any Nasdaq rule or regulation, or
(IV) any decree, judgment or order applicable to the Company
or any of its properties, other than, in the case of clause
(II) for those conflicts, breaches, violations or defaults
that would not, individually or in the aggregate, have a Material
Adverse Effect;
(m) 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
(including, without limitation, the NASDAQ) or the 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) registration
of the Shares under the Act and the registration of the Common
Stock under the Exchange Act, each of which has been effected (or,
with respect to any registration statement to be filed hereunder
pursuant to Rule 462(b) under the Act, will be effected in
accordance herewith), (ii) the filing of the Amended and
Restated Certificate of Incorporation, which will be effected at or
prior to the time of purchase, (iii) and any necessary
qualification under the securities or blue sky laws of the various
jurisdictions in which the Shares are being offered by the
Underwriters or (iv) under the Conduct Rules of the National
Association of Securities Dealers, Inc. (the “ NASD
”);
(n) except as
described in the Registration Statement (excluding the exhibits
thereto), each Preliminary Prospectus and the Prospectus,
(i) no person has the right, contractual or otherwise, to
cause the Company to issue or sell to it any shares of Common Stock
or shares of any other capital stock or other equity interests of
the Company, (ii) no person has any preemptive rights, resale
rights, rights of first refusal or
- 8 -
other rights to
purchase any shares of Common Stock or shares of any other capital
stock of or other equity interests in the Company and (iii) no
person has the right to act as an underwriter or as a financial
advisor to the Company in connection with the offer and sale of the
Shares; except as described in the Registration Statement
(excluding the exhibits thereto), each Preliminary Prospectus and
the Prospectus, no person has the right, contractual or otherwise,
to cause the Company to register under the Act any shares of Common
Stock or shares of any other capital stock of or other equity
interests in the Company, or to include any such shares or
interests in the Registration Statement or the offering
contemplated thereby;
(o) except as
described in the Registration Statement (excluding the exhibits
thereto), each Preliminary Prospectus and the Prospectus, the
Company has all necessary licenses, authorizations, consents and
approvals and has made all necessary filings required under any
applicable law, regulation or rule, and has obtained all necessary
licenses, authorizations, consents and approvals from other
persons, in order to conduct its business; 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 or any federal, state,
local or foreign law, regulation or rule or any decree, order or
judgment applicable to the Company, except where such violation,
default, revocation or modification would not, individually or in
the aggregate, have a Material Adverse Effect or prevent
consummation of the transactions contemplated hereby;
(p) there are no
actions, suits, claims, investigations or proceedings pending or
threatened or, to the Company’s knowledge, contemplated to
which the Company or any of its respective directors or officers 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
(including, without limitation, the rules and regulations of the
NASDAQ), except any such action, suit, claim, investigation or
proceeding which, if resolved adversely to the Company, would not,
individually or in the aggregate, have a Material Adverse Effect or
prevent consummation of the transactions contemplated
hereby;
(q) Ernst &
Young LLP, whose report on the financial statements of the Company
is included in the Registration Statement, each Preliminary
Prospectus and the Prospectus, are independent registered public
accountants as required by the Act and by the rules of the Public
Company Accounting Oversight Board;
(r) the financial
statements included in the Registration Statement, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing
Prospectus, together with the related notes and schedules, present
fairly in all material respects the consolidated financial position
of the Company as of the dates indicated and the results of
operations and cash flows of the Company for the periods specified
have been prepared in compliance with the requirements of the Act
and in conformity with U.S. generally accepted accounting
principles applied on a consistent basis during the periods
involved;
- 9 -
all pro forma
financial statements or data included in the Registration
Statement, any Preliminary Prospectus, the Prospectus or any
Permitted Free Writing Prospectus comply as to form in all material
respects with the applicable requirements of Regulation S-X of
the Act, including, without limitation, Article 11 thereof,
and the assumptions used in the preparation of such pro forma
financial statements and data are reasonable, the pro forma
adjustments used therein are appropriate to give effect to the
transactions or circumstances described therein and the pro forma
adjustments have been properly applied to the historical amounts in
the compilation of those statements and data; the other financial
and statistical data contained in the Registration Statement, any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing Prospectus are accurately presented and prepared on a basis
consistent with the financial statements and books and records of
the Company; there are no financial statements (historical or pro
forma) that are required to be included in the Registration
Statement, any Preliminary Prospectus or the Prospectus that are
not included as required; the Company does not have any material
liabilities or obligations, direct or contingent (including any
off-balance sheet obligations), not described in the Registration
Statement (excluding the exhibits thereto), each Preliminary
Prospectus and the Prospectus; and all disclosures contained in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any Permitted Free Writing 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 of Regulation S-K under the Act,
to the extent applicable;
(s) subsequent to
the respective dates as of which information is given in the
Registration Statement, the Preliminary Prospectuses, the
Prospectus and the Permitted Free Writing Prospectuses, if any, in
each case excluding any amendments or supplements to the foregoing
made after the execution of this Agreement, there has not been
(i) any material adverse change, or any development involving
a prospective material adverse change, in the business, properties,
management, financial condition or results of operations of the
Company, (ii) any transaction which is material to the
Company, (iii) any obligation or liability, direct or
contingent (including any off-balance sheet obligations), incurred
by the Company, which is material to the Company, (iv) any
change in the capital stock or outstanding indebtedness of the
Company or (v) any dividend or distribution of any kind
declared, paid or made on the capital stock of the
Company;
(t) the Company
has obtained for the benefit of the Underwriters the agreement (a
“ Lock-Up Agreement ”), substantially in the
form set forth as Exhibit A hereto, of (i) each of
its directors and “officers” (within the meaning of
Rule 16a-1(f) under the Exchange Act); (ii) holders of an
aggregate of over [ 95% ] of the outstanding and
issuable shares of capital stock of the Company; and
(iii) each Directed Share Participant;
(u) the Company is
not, and any time during which a prospectus is required by the Act
to be delivered (whether physically or through compliance with
Rule 172 under the Act or any similar rule) in connection with
any sale of Shares will not be, and, after
- 10 -
giving effect
to the offering and sale of the Shares, will not be an
“investment company” or an entity
“controlled” by an “investment company,” as
such terms are defined in the Investment Company Act of 1940, as
amended (the “ Investment Company Act
”);
(v) the Company
owns all property (real and personal) described in the Registration
Statement, any Preliminary Prospectus, the Prospectus or any
Permitted Free Writing Prospectus as being owned by any of them,
free and clear of all liens, claims, security interests or other
encumbrances, other than those disclosed in the Registration
Statement and Prospectus; all the property described in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any Permitted Free Writing Prospectus as being held under lease
by the Company is held thereby under valid, subsisting and
enforceable leases;
(w) 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, service
names, copyrights, trade secrets and other proprietary information
described in the Registration Statement, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing Prospectus
as being owned or licensed by it or which are, to the
Company’s knowledge, necessary for the conduct of its
business as currently conducted or as proposed to be conducted
(including the commercialization of products or services described
in the Registration Statement, any Preliminary Prospectus, the
Prospectus or any Permitted Free Writing Prospectus as under
development) (collectively, “ Intellectual Property
”) except where the failure to own, license or have such
rights would not, individually or in the aggregate, have a Material
Adverse Effect; (i) there are no third parties who have or, to the
Company’s knowledge after due inquiry, will be able to
establish rights to any Intellectual Property, except for, and to
the extent of, the ownership rights of the owners of the
Intellectual Property which the Registration Statement (excluding
the exhibits thereto), each Preliminary Prospectus and the
Prospectus disclose is licensed to the Company; (ii) there is
no infringement by third parties of any Intellectual Property;
(iii) there is no pending or threatened action, suit,
proceeding or claim by others challenging the Company’s
rights in or to any Intellectual Property, and the Company is
unaware of any facts which would form a reasonable basis for any
such action, suit, proceeding or claim; (iv) there is no
pending or threatened action, suit, proceeding or claim by others
challenging the validity, enforceability or scope of any
Intellectual Property, and the Company is unaware of any facts
which would form a reasonable basis for any such action, suit,
proceeding or claim; (v) there is no pending or threatened
action, suit, proceeding or claim by others that the Company
infringes or otherwise violates any patent, trademark, tradename,
service name, copyright, trade secret or other proprietary rights
of others, and the Company is unaware of any facts which would form
a reasonable basis for any such action, suit, proceeding or claim;
(vi) the Company has complied with the terms of any agreement
pursuant to which Intellectual Property has been licensed to the
Company, and all such agreements are in full force and effect;
(vii) the sale of any product or potential product described
in the Registration Statement or Prospectus by the Company would
not be held to infringe any claims in any patents of third parties;
(viii) there is no patent or patent application that contains
claims that interfere with the issued or pending claims of any of
the Intellectual
- 11 -
Property or
that challenges the validity, enforceability or scope of any of the
Intellectual Property; (ix) there is no prior art that renders
any patent application owned by the Company of the Intellectual
Property unpatentable that has not been disclosed to the U.S.
Patent and Trademark Office; and (x) the product candidates
described in the Registration Statement, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing Prospectus
as under development by the Company fall within the scope of the
claims of one or more patents owned by, or exclusively licensed to,
the Company;
(x) the Company is
not engaged in any unfair labor practice; except for matters which
would not, individually or in the aggregate, have a Material
Adverse Effect, (i) there is (A) no unfair labor practice
complaint pending or, to the Company’s knowledge after due
inquiry, threatened against the Company before the National Labor
Relations Board, and no grievance or arbitration proceeding arising
out of or under collective bargaining agreements is pending or
threatened, (B) no strike, labor dispute, slowdown or stoppage
pending or, to the Company’s knowledge after due inquiry,
threatened against the Company and (C) no union representation
dispute currently existing concerning the employees of the Company,
and (ii) to the Company’s knowledge after due inquiry,
(A) no union organizing activities are currently taking place
concerning the employees of the Company and (B) there has been
no violation of any federal, state, local or foreign law relating
to discrimination in the hiring, promotion or pay of employees, any
applicable wage or hour laws or any provision of the Employee
Retirement Income Security Act of 1974 (“ ERISA
”) or the rules and regulations promulgated thereunder
concerning the employees of the Company;
(y) the Company
and its properties, assets and operations each is in compliance
with, and holds all permits, authorizations and approvals required
under, Environmental Laws (as defined below), except to the extent
that failure to so comply or to hold such permits, authorizations
or approvals would not, individually or in the aggregate, have a
Material Adverse Effect; there are no past, present or, to the
Company’s knowledge after due inquiry, reasonably anticipated
future events, conditions, circumstances, activities, practices,
actions, omissions or plans that could reasonably be expected to
give rise to any material costs or liabilities to the Company
under, or to interfere with or prevent compliance by the Company
with, Environmental Laws; except as would not, individually or in
the aggregate, have a Material Adverse Effect, the Company
(i) is not the subject of any investigation, (ii) has not
received any notice or claim, (iii) is not a party to or
affected by any pending or threatened action, suit or proceeding,
(iv) is not bound by any judgment, decree or order or
(v) has not entered into any agreement, in each case relating
to any alleged violation of any Environmental Law or any actual or
alleged release or threatened release or cleanup at any location of
any Hazardous Materials (as defined below) (as used herein, “
Environmental Law ” means any federal, state, local or
foreign law, statute, ordinance, rule, regulation, order, decree,
judgment, injunction, permit, license, authorization or other
binding requirement, or common law, relating to health, safety or
the protection, cleanup or restoration of the environment or
natural resources, including those relating to the distribution,
processing, generation, treatment, storage, disposal,
transportation, other handling or release or threatened release of
Hazardous Materials, and “ Hazardous Materials ”
means any
- 12 -
material
(including, without limitation, pollutants, contaminants, hazardous
or toxic substances or wastes) that is regulated by or may give
rise to liability under any Environmental Law);
(z) no tax returns
required to be filed by the Company are delinquent, and all taxes
and other assessments of a similar nature (whether imposed directly
or through withholding) including any interest, additions to tax or
penalties applicable thereto due or claimed to be due from such
entities have been timely paid, other than those being contested in
good faith and for which adequate reserves have been
provided;
(aa) the Company
maintains insurance covering its properties, operations, personnel
and businesses as the Company reasonably deems adequate; such
insurance insures against such losses and risks to an extent which
is adequate in accordance with customary industry practice to
protect the Company and its business; all such insurance is fully
in force on the date hereof and will be fully in force at the time
of purchase and any additional time of purchase;
(bb) the Company
has not sustained since the date of the last audited financial
statements included in the Registration Statement, the Preliminary
Prospectus and the Prospectus any loss or interference with its
business from fire, explosion, flood or other calamity, whether or
not covered by insurance, or from any labor dispute or court or
governmental action, order or decree;
(cc) the Company
has not sent or received any communication regarding termination
of, or intent not to renew, any of the contracts or agreements
referred to or described in any Preliminary Prospectus, the
Prospectus or any Permitted Free Writing Prospectus, or referred to
or described in, or filed as an exhibit to, the Registration
Statement, and no such termination or non-renewal has been
threatened by the Company or, to the Company’s knowledge
after due inquiry, any other party to any such contract or
agreement;
(dd) the Company
maintains a system of internal accounting controls sufficient to
provide reasonable assurance 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;
(ee) the Company
has established and maintains and evaluates “disclosure
controls and procedures” (as such term is defined in
Rule 13a-15 and 15d-15 under the Exchange Act) and
“internal control over financial reporting” (as such
term is defined in Rule 13a-15 and 15d-15 under the Exchange
Act); such disclosure controls and procedures are designed to
ensure that material information relating to the Company
is
- 13 -
made known to
the Company’s Chief Executive Officer and its Chief Financial
Officer by others within the Company, and such disclosure controls
and procedures are effective in all material respects to perform
the functions for which they were established; the Company’s
independent auditors and the Audit Committee of the Board of
Directors of the Company have been advised of: (i) any
significant deficiencies in the design or operation of internal
controls which could adversely affect the Company’s ability
to record, process, summarize, and report financial data; and
(ii) any fraud, whether or not material, that involves
management or other employees who have a role in the
Company’s internal controls; any material weaknesses in
internal controls have been identified for the Company’s
auditors; since the date of the most recent evaluation of such
disclosure controls and procedures, there have been no changes in
internal controls that have materially negatively affected, or
could materially negatively affect, internal controls; and the
Company has taken all actions which are reasonably necessary to
ensure that, upon and at all times after filing of the Registration
Statement, the Company and its officers and directors, in their
capacities as such, will be in compliance in all material respects
with the applicable provisions of the Sarbanes-Oxley Act of 2002
(the “ Sarbanes-Oxley Act ”) and the rules and
regulations promulgated thereunder;
(ff) all
statistical or market-related data included in the Registration
Statement, any Preliminary Prospectus, the Prospectus or any
Permitted Free Writing Prospectus are based on or derived from
sources that the Company believes to be reliable and accurate, and
the Company has obtained the written consent to the use of such
data from such sources to the extent required;
(gg) neither the
Company nor, to the Company’s knowledge after due inquiry,
any employee or agent of the Company has made any payment of funds
of the Company or received or retained any funds in violation of
any law, rule or regulation (including, without limitation, the
Foreign Corrupt Practices Act of 1977), which payment, receipt or
retention of funds is of a character required to be disclosed in
the Registration Statement, any Preliminary Prospectus or the
Prospectus;
(hh) the
preclinical tests and clinical trials that are described in, or the
results of which are referred to in, the Registration Statement,
any Preliminary Prospectus, the Prospectus or any Permitted Free
Writing Prospectus were and, if still pending, are being conducted
in accordance with protocols filed with the appropriate regulatory
authorities for each such test or trial, as the case may be; the
description of the results of such tests and trials contained in
the Registration Statement, any Preliminary Prospectus, the
Prospectus or any Permitted Free Writing Prospectus are accurate
and fairly present the data derived from such tests and trials, and
the Company has no knowledge of any other studies or tests the
results of which are inconsistent with, or otherwise call into
question, the results described or referred to in the Registration
Statement, any Preliminary Prospectus, the Prospectus or any
Permitted Free Writing Prospectus; the Company has not received any
notices or other correspondence from the Food and Drug
Administration of the U.S. Department of Health and Human Services
or any committee thereof or from any other U.S. or foreign
government or drug or medical device regulatory agency requiring
the termination, suspension or modification of any clinical trials
that are
- 14 -
described or
referred to in the Registration Statement, any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing
Prospectus; and the Company has operated and currently is in
compliance in all material respects with all applicable rules,
regulations and policies of the U.S. Food and Drug Administration
and comparable foreign drug or medical device regulatory agencies
outside of the United States;
(ii) immediately
after the issuance and sale of the Shares as contemplated hereby,
no shares of preferred stock of the Company shall be issued or
outstanding; and the issuance and sale of the Shares as
contemplated hereby will not cause any holder of any shares of
capital stock, securities convertible into or exchangeable or
exercisable for capital stock or options, warrants or other rights
to purchase capital stock or any other securities of the Company to
have any right to acquire any shares of preferred stock of the
Company;
(jj) the Company
is in compliance with the Marketplace Rules of the NASDAQ,
including, without limitation, the requirements for initial and
continued designation of the Common Stock as a Nasdaq National
Market security;
(kk) except
pursuant to this Agreement, the Company has not incurred any
liability for any finder’s or broker’s fee or
agent’s commission in connection with the execution and
delivery of this Agreement or the consummation of the transactions
contemplated hereby or by the Registration Statement;
(ll) neither the
Company nor any of its directors, officers, affiliates or
controlling persons has taken, directly or indirectly, any action
designed, or which has constituted or might reasonably be expected
to cause or result in, under the Exchange Act or otherwise, the
stabilization or manipulation of the price of any security of the
Company to facilitate the sale or resale of the Shares;
(mm) to the
Company’s knowledge after due inquiry, there are no
affiliations or associations between (i) any member of the
NASD and (ii) the Company or any of the Company’s
officers, directors or 5% or greater security holders or any
beneficial owner of the Company’s unregistered equity
securities that were acquired at any time on or after the 180th day
immediately preceding the date the Registration Statement was
initially filed with the Commission, except as disclosed in the
Registration Statement (excluding the exhibits thereto), the
Preliminary Prospectuses and the Prospectus;
(nn) the
Registration Statement, each Preliminary Prospectus, the Prospectus
and each Permitted Free Writing Prospectus comply, and any further
amendments or supplements thereto will comply, with any applicable
laws or regulations of any foreign jurisdiction in which any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing Prospectus is distributed in connection with the Directed
Share Program; and no approval, authorization, consent or order of
or filing with any governmental or regulatory commission, board,
body, authority or agency, other than those heretofore obtained, is
required in connection with the offering of the Reserved Shares in
any jurisdiction where the Reserved Shares are being offered;
and
- 15 -
(oo) the Company
has not offered, or caused the Underwriters to offer, Shares to any
person pursuant to the Directed
|