ACTION OR BY FAILURE TO ACT, WHICH WOULD CAUSE THE LOSS OF
SUCH QUALIFICATION.
12
(RR)
STATISTICAL OR MARKET-RELATED DATA.
ANY STATISTICAL,
INDUSTRY-RELATED AND MARKET-RELATED DATA INCLUDED OR INCORPORATED BY REFERENCE
IN THE REGISTRATION STATEMENT, THE DISCLOSURE PACKAGE AND THE PROSPECTUS, ARE
BASED ON OR DERIVED FROM SOURCES THAT THE COMPANY REASONABLY AND IN GOOD FAITH
BELIEVES TO BE RELIABLE AND ACCURATE, AND SUCH DATA AGREE WITH THE SOURCES FROM
WHICH THEY ARE DERIVED.
(SS)
CLINICAL STUDIES.
THE CLINICAL, PRE-CLINICAL AND OTHER STUDIES AND
TESTS CONDUCTED BY OR ON BEHALF OF OR SPONSORED BY THE COMPANY OR IN WHICH THE
COMPANY OR PRODUCTS OR PRODUCT CANDIDATES HAVE PARTICIPATED THAT ARE DESCRIBED
IN THE REGISTRATION STATEMENT, THE DISCLOSURE PACKAGE AND THE PROSPECTUS WERE
AND, IF STILL PENDING, ARE BEING CONDUCTED IN ACCORDANCE IN ALL MATERIAL
RESPECTS WITH ALL STATUTES, LAWS, RULES AND REGULATIONS, AS APPLICABLE
(INCLUDING, WITHOUT LIMITATION, THOSE ADMINISTERED BY THE FDA OR BY ANY FOREIGN,
FEDERAL, STATE OR LOCAL GOVERNMENTAL OR REGULATORY AUTHORITY PERFORMING
FUNCTIONS SIMILAR TO THOSE PERFORMED BY THE FDA) AND WITH STANDARD MEDICAL AND
SCIENTIFIC RESEARCH PROCEDURES.
THE DESCRIPTIONS IN THE REGISTRATION STATEMENT,
THE DISCLOSURE PACKAGE AND THE PROSPECTUS OF THE RESULTS OF SUCH STUDIES AND
TESTS ARE ACCURATE AND COMPLETE IN ALL MATERIAL RESPECTS AND FAIRLY PRESENT THE
PUBLISHED DATA DERIVED FROM SUCH STUDIES AND TESTS.
THE COMPANY HAS NOT
RECEIVED ANY NOTICES OR OTHER CORRESPONDENCE FROM THE FDA OR ANY OTHER FOREIGN,
FEDERAL, STATE OR LOCAL GOVERNMENTAL OR REGULATORY AUTHORITY PERFORMING
FUNCTIONS SIMILAR TO THOSE PERFORMED BY THE FDA WITH RESPECT TO ANY ONGOING
CLINICAL OR PRE-CLINICAL STUDIES OR TESTS REQUIRING THE TERMINATION, SUSPENSION
OR MATERIAL MODIFICATION OF SUCH STUDIES OR TESTS, WHICH SUCH TERMINATION,
SUSPENSION OR MATERIAL MODIFICATION WOULD REASONABLY BE EXPECTED TO RESULT IN A
MATERIAL ADVERSE EFFECT.
THE COMPANY IS IN COMPLIANCE WITH ALL APPLICABLE
FEDERAL, STATE, LOCAL AND FOREIGN LAWS, REGULATIONS, ORDERS AND DECREES
GOVERNING ITS BUSINESS AS PRESCRIBED BY THE FDA, OR ANY OTHER FEDERAL, STATE OR
FOREIGN AGENCIES OR BODIES, INCLUDING THOSE BODIES AND AGENCIES ENGAGED IN THE
REGULATION OF PHARMACEUTICALS OR BIOHAZARDOUS SUBSTANCES OR MATERIALS, EXCEPT
WHERE NONCOMPLIANCE WOULD NOT, SINGLY OR IN THE AGGREGATE, RESULT IN A MATERIAL
ADVERSE EFFECT.
Any certificate signed by any officer of the Company and delivered to the
Placement Agent or to counsel for the Placement Agent in connection with the
offering of the Shares shall be deemed a representation and warranty by the
Company to the Placement Agent and the Investors as to the matters covered
thereby.
3.
COVENANTS.
THE COMPANY COVENANTS AND AGREES WITH THE
PLACEMENT AGENT AS FOLLOWS:
(A)
REPORTING OBLIGATIONS; EXCHANGE ACT COMPLIANCE.
THE COMPANY WILL
(I) FILE THE PROSPECTUS WITH THE COMMISSION WITHIN THE TIME PERIODS SPECIFIED BY
RULE 424(B) AND RULES 430A AND 430B, AS APPLICABLE UNDER THE SECURITIES ACT,
(II) FILE ANY ISSUER FREE WRITING PROSPECTUS TO THE EXTENT REQUIRED BY RULE 433
UNDER THE SECURITIES ACT, IF APPLICABLE, (III) FILE PROMPTLY ALL REPORTS AND ANY
DEFINITIVE PROXY OR INFORMATION STATEMENTS REQUIRED TO