BEEN AND ARE BEING
CONDUCTED IN ALL MATERIAL RESPECTS IN ACCORDANCE WITH ALL APPLICABLE LAWS,
RULES AND REGULATIONS OF THE FDA.
THE COMPANY HAS NOT BEEN INFORMED BY THE FDA
THAT THE FDA WILL PROHIBIT THE MARKETING, SALE, LICENSE OR USE IN THE UNITED
STATES OF ANY PRODUCT PROPOSED TO BE DEVELOPED, PRODUCED OR MARKETED BY THE
COMPANY NOR HAS THE FDA EXPRESSED ANY CONCERN AS TO APPROVING OR CLEARING FOR
MARKETING ANY PRODUCT BEING DEVELOPED OR PROPOSED TO BE DEVELOPED BY THE
COMPANY.
3.29
SEC Documents.
The Company has filed in a timely
manner all documents that the Company was required to file under the Exchange
Act during the 12 months preceding the date of this Agreement.
As of their
respective filing dates, the SEC Documents complied in all material respects
with the requirements of the Exchange Act or the Securities Act, as applicable,
and all rules and regulations promulgated thereunder, and to the knowledge of
the Company none of the SEC Documents contained or will contain, and none of the
Transaction Documents contain, any untrue statement of a material fact or
omitted or will omit to state a material fact required to be stated therein or
necessary in order to make the statements made therein, in light of the
circumstances under which they were made, not misleading, as of their
11
respective filing dates or as of the Closing Date, as the case may be, except to
the extent with respect to the SEC Documents corrected by a SEC Document filed
prior to the date of this Agreement.
From and after the date hereof the Company
currently expects to meet each of the eligibility requirements for the use of
Form S-3 in connection with the resale registration of the Securities and the
Warrant Shares as contemplated under Section 6 of this Agreement.
4.
REPRESENTATIONS, WARRANTIES AND
COVENANTS OF THE INVESTOR.
4.1
INVESTOR KNOWLEDGE AND STATUS.
THE INVESTOR
REPRESENTS AND WARRANTS TO, AND COVENANTS WITH, THE COMPANY THAT: (I) THE
INVESTOR IS AN "ACCREDITED INVESTOR" AS DEFINED IN REGULATION D UNDER THE
SECURITIES ACT, IS KNOWLEDGEABLE, SOPHISTICATED AND EXPERIENCED IN MAKING, AND
IS QUALIFIED TO MAKE DECISIONS WITH RESPECT TO, INVESTMENTS IN SECURITIES
PRESENTING AN INVESTMENT DECISION SIMILAR TO THAT INVOLVED IN THE PURCHASE OF
THE SECURITIES, AND HAS REQUESTED, RECEIVED, REVIEWED AND CONSIDERED ALL
INFORMATION IT DEEMED RELEVANT IN MAKING AN INFORMED DECISION TO PURCHASE THE
SECURITIES; (II) THE INVESTOR UNDERSTANDS THAT THE SECURITIES ARE "RESTRICTED
SECURITIES" AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT AND IS
ACQUIRING THE NUMBER OF SECURITIES SET FORTH IN PARAGRAPH 3 OF THE SECURITIES
PURCHASE AGREEMENT TO WHICH THIS ANNEX I IS ATTACHED IN THE ORDINARY COURSE OF
ITS BUSINESS AND FOR ITS OWN ACCOUNT FOR INVESTMENT ONLY, HAS NO PRESENT
INTENTION OF DISTRIBUTING ANY OF SUCH SECURITIES AND HAS NO ARRANGEMENT OR
UNDERSTANDING WITH ANY OTHER PERSONS REGARDING THE DISTRIBUTION OF SUCH
SECURITIES (THIS REPRESENTATION AND WARRANTY NOT LIMITING THE INVESTOR'S RIGHT
TO SELL REGISTRABLE SECURITIES PURSUANT TO A