UNDERWRITER" FOR AN
INVESTMENT COMPANY, WITHIN THE MEANING OF THE INVESTMENT COMPANY ACT OF 1940, AS
AMENDED.
3.10
SUBSIDIARIES.
THE COMPANY HAS NO SUBSIDIARIES AND NO EQUITY
INTERESTS OR INVESTMENTS IN ANY PARTNERSHIP, TRUST OR OTHER ENTITY OR
ORGANIZATION.
FOR PURPOSES OF THIS AGREEMENT, "SUBSIDIARY" SHALL MEAN AN ENTITY
OF WHICH A PERSON OWNS OR CONTROLS, DIRECTLY OR INDIRECTLY, MORE THAN TWENTY
PERCENT (20%) OF THE VOTING STOCK OF SUCH ENTITY.
3.11
BROKERAGE.
THERE ARE NO CLAIMS FOR BROKERAGE COMMISSIONS OR
FINDER'S FEES OR SIMILAR COMPENSATION IN CONNECTION WITH THE TRANSACTIONS
CONTEMPLATED BY THIS AGREEMENT OR THE RESEARCH AGREEMENT BASED ON ANY
ARRANGEMENT MADE BY OR ON BEHALF OF THE COMPANY, AND THE COMPANY AGREES TO
INDEMNIFY AND HOLD THE PURCHASER HARMLESS AGAINST ANY COSTS OR DAMAGES INCURRED
AS A RESULT OF ANY SUCH CLAIM.
3.12
INTELLECTUAL PROPERTY.
EXCEPT AS DISCLOSED IN THE SEC FILINGS, AND
EXCEPT FOR MATTERS WHICH ARE NOT REASONABLY LIKELY TO HAVE A MATERIAL ADVERSE
EFFECT, THE COMPANY OWNS OR CONTROLS THE INTELLECTUAL PROPERTY RIGHTS NECESSARY
FOR THE CONDUCT OF ITS BUSINESS AS NOW CONDUCTED. TO THE COMPANY'S KNOWLEDGE,
THE CONDUCT OF ITS BUSINESS AS CURRENTLY CONDUCTED DOES NOT MATERIALLY INFRINGE
UPON THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
3.13
FDA APPROVAL
(A)
ALL CLINICAL TRIALS CONDUCTED BY OR FOR THE BENEFIT OF THE
COMPANY, AND THAT HAVE OR WILL BE SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION
(THE "FDA") AS A BASIS FOR REGULATORY APPROVAL, HAVE BEEN, OR ARE BEING,
CONDUCTED IN MATERIAL COMPLIANCE WITH THE APPLICABLE REQUIREMENTS OF "GOOD
CLINICAL PRACTICE," INFORMED CONSENT, AND ALL APPLICABLE REQUIREMENTS RELATING
TO PROTECTION OF HUMAN SUBJECTS CONTAINED IN 21 C.F.R.;
(B)
ALL MANUFACTURING OPERATIONS CURRENTLY CONDUCTED BY OR FOR THE
BENEFIT OF THE COMPANY FOR THE MANUFACTURE OF DRUGS FOR HUMAN USE HAVE BEEN AND
ARE BEING CONDUCTED IN MATERIAL COMPLIANCE WITH THE FDA'S APPLICABLE CURRENT
"GOOD MANUFACTURING PRACTICE" REGULATIONS;
(C)
THE COMPANY HAS NOT RECEIVED ANY NOTICE THAT THE FDA HAS
COMMENCED, OR THREATENED TO INITIATE, ANY ACTION TO WITHDRAW APPROVAL OF ANY
AUTHORIZATION NEEDED TO CONDUCT ITS BUSINESS AS CURRENTLY CONDUCTED; AND
4
(D)
THE COMPANY HAS NO PRODUCT ON CLINICAL HOLD NOR HAS THE COMPANY
RECEIVED WRITTEN NOTICE INDICATING THAT ANY PRODUCT WILL BE SUBJECT TO A
CLINICAL HOLD.
SECTION 4
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER
The Purchaser hereby represents and warrants to the Company as of the Effective
Date and as of the Closing Date, as applicable, as follows:
4.1
AUTHORIZATION
(A)
THE PURCHASER HAS ALL REQUISITE POWER AND AUTHORITY TO EXECUTE AND
DELIVER THIS AGREEMENT, TO PURCHASE THE SHARES HEREUNDER AND TO CARRY OUT AND
PERFORM ITS OBLIGATIONS UNDER THE TERMS OF THIS AGREEMENT. ALL ACTION ON THE
PART OF THE PURCHASER NECESSARY FOR THE AUTHORIZATION, EXECUTION, DELIVERY AND
PERFORMANCE OF THIS AGREEMENT, AND THE PERFORMANCE OF ALL OF THE PURCHASER'S
OBLIGATIONS UNDER THIS AGREEMENT, HAS BEEN TAKEN OR WILL BE TAKEN PRIOR TO THE
CLOSING.
(B)
THIS AGREEMENT, WHEN EXECUTED AND DELIVERED BY THE PURCHASER, WILL
CONSTITUTE A