HEREBY OTHER THAN THOSE SPECIFICALLY SET FORTH IN
PARAGRAPH 4 OF THE SECURITIES PURCHASE AGREEMENT, SECTION 4 OF THIS AGREEMENT,
AND IN THE INVESTOR QUESTIONNAIRE.
3.27
ACKNOWLEDGMENT REGARDING THE INVESTORS' PURCHASE OF
SECURITIES.
THE COMPANY ACKNOWLEDGES AND AGREES THAT EACH OF THE INVESTORS IS
ACTING SOLELY IN THE CAPACITY OF AN ARM'S LENGTH PURCHASER WITH RESPECT TO THIS
AGREEMENT AND THE TRANSACTIONS CONTEMPLATED HEREBY.
THE COMPANY FURTHER
ACKNOWLEDGES THAT NO INVESTOR IS ACTING AS A FINANCIAL ADVISOR OR
10
FIDUCIARY OF THE COMPANY (OR IN ANY SIMILAR CAPACITY WITH RESPECT TO THE
COMPANY) WITH RESPECT TO THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED HEREBY
AND ANY ADVICE GIVEN BY ANY PURCHASER OR ANY OF THEIR RESPECTIVE REPRESENTATIVES
OR AGENTS TO THE COMPANY IN CONNECTION WITH THIS AGREEMENT AND THE TRANSACTIONS
CONTEMPLATED HEREBY IS MERELY INCIDENTAL TO SUCH INVESTOR'S PURCHASE OF THE
SECURITIES.
THE COMPANY FURTHER REPRESENTS TO EACH INVESTOR THAT THE COMPANY'S
DECISION TO ENTER INTO THIS AGREEMENT HAS BEEN BASED ON THE INDEPENDENT
EVALUATION OF THE TRANSACTIONS CONTEMPLATED HEREBY BY THE COMPANY AND ITS
REPRESENTATIVES.
3.28
FDA.
AS TO EACH PRODUCT SUBJECT TO THE JURISDICTION
OF THE U.S. FOOD AND DRUG ADMINISTRATION ("FDA") UNDER THE FEDERAL FOOD, DRUG
AND COSMETIC ACT, AS AMENDED, AND THE REGULATIONS THEREUNDER ("FDCA") THAT IS
MANUFACTURED, PACKAGED, LABELED, TESTED, DISTRIBUTED, SOLD, AND/OR MARKETED BY
THE COMPANY (EACH A "PRODUCT"), SUCH PRODUCT IS BEING MANUFACTURED, PACKAGED,
LABELED, TESTED, DISTRIBUTED, SOLD AND/OR MARKETED BY THE COMPANY IN COMPLIANCE
WITH ALL APPLICABLE REQUIREMENTS UNDER FDCA AND SIMILAR LAWS, RULES AND
REGULATIONS RELATING TO REGISTRATION, INVESTIGATIONAL USE, PREMARKET CLEARANCE,
LICENSURE, OR APPLICATION APPROVAL, GOOD MANUFACTURING PRACTICES, GOOD
LABORATORY PRACTICES, GOOD CLINICAL PRACTICES, PRODUCT LISTING, QUOTAS,
LABELING, ADVERTISING, RECORD KEEPING AND FILING OF REPORTS, AND IN ALL OTHER
RESPECTS, EXCEPT WHERE THE FAILURE TO BE IN COMPLIANCE WOULD NOT HAVE A MATERIAL
ADVERSE EFFECT.
THERE IS NO PENDING, COMPLETED OR, TO THE COMPANY'S KNOWLEDGE,
THREATENED, ACTION (INCLUDING ANY LAWSUIT, ARBITRATION, OR LEGAL OR
ADMINISTRATIVE OR REGULATORY PROCEEDING, CHARGE, COMPLAINT, OR INVESTIGATION)
AGAINST THE COMPANY AND THE COMPANY HAS NOT RECEIVED ANY NOTICE, WARNING LETTER
OR OTHER COMMUNICATION FROM THE FDA OR ANY OTHER GOVERNMENTAL ENTITY, WHICH
(I) CONTESTS THE PREMARKET CLEARANCE, LICENSURE, REGISTRATION, OR APPROVAL OF,
THE USES OF, THE DISTRIBUTION OF, THE MANUFACTURING OR PACKAGING OF, THE TESTING
OF, THE SALE OF, OR THE LABELING AND PROMOTION OF ANY PRODUCT, (II) WITHDRAWS
ITS APPROVAL OF, REQUESTS THE RECALL, SUSPENSION, OR SEIZURE OF, OR WITHDRAWS OR
ORDERS THE WITHDRAWAL OF ADVERTISING OR SALES PROMOTIONAL MATERIALS RELATING TO,
ANY PRODUCT, (III) IMPOSES A CLINICAL HOLD ON ANY CLINICAL INVESTIGATION BY THE
COMPANY, (IV) ENJOINS PRODUCTION AT ANY FACILITY OF THE COMPANY, (V) ENTERS OR
PROPOSES TO ENTER INTO A CONSENT DECREE OF PERMANENT INJUNCTION WITH THE
COMPANY, OR (VI) OTHERWISE ALLEGES ANY VIOLATION OF ANY LAWS, RULES OR
REGULATIONS BY THE COMPANY, AND WHICH, EITHER INDIVIDUALLY OR IN THE AGGREGATE,
WOULD NOT BE REASONABLY EXPECTED TO HAVE A MATERIAL ADVERSE EFFECT.
THE
PROPERTIES, BUSINESS AND OPERATIONS OF THE COMPANY HAVE