ACCRUED OR CONTINGENT
(WHETHER OR NOT REQUIRED TO BE REFLECTED IN FINANCIAL STATEMENTS IN ACCORDANCE
WITH GAAP), AND WHETHER DUE OR TO BECOME DUE, OTHER THAN (I) LIABILITIES
REFLECTED OR PROVIDED FOR ON THE BALANCE SHEET AS OF JUNE 30, 2004 (THE "COMPANY
BALANCE SHEET") SET FORTH IN THE DISCLOSURE SCHEDULE, (II) LIABILITIES
SPECIFICALLY DESCRIBED IN THIS AGREEMENT OR THE DISCLOSURE SCHEDULE, AND
(III) NORMAL OR RECURRING LIABILITIES INCURRED SINCE JUNE 30, 2004 IN THE
ORDINARY COURSE OF BUSINESS CONSISTENT WITH PAST PRACTICES THAT WOULD NOT
REASONABLY BE EXPECTED TO RESULT IN A MATERIAL ADVERSE EFFECT. THE COMPANY IS
CURRENTLY ELIGIBLE TO REGISTER THE RESALE OF COMMON STOCK PURSUANT TO A
REGISTRATION STATEMENT ON FORM S-3 UNDER THE SECURITIES ACT (A "REGISTRATION
STATEMENT").
3.5
COMPLIANCE. TO THE KNOWLEDGE OF THE COMPANY,
EACH OF THE COMPANY AND ITS SUBSIDIARIES HAS COMPLIED IN ALL MATERIAL RESPECTS
WITH ALL APPLICABLE FEDERAL, STATE, LOCAL AND FOREIGN STATUTES, LAWS AND
REGULATIONS, AND IS NOT IN VIOLATION OF, AND HAS NOT RECEIVED ANY NOTICES OF
VIOLATION WITH RESPECT TO, ANY SUCH STATUTE, LAW OR REGULATION, WITH RESPECT TO
THE CONDUCT, OWNERSHIP OR OPERATION OF ITS BUSINESSES WHICH, INDIVIDUALLY OR IN
AGGREGATE, WOULD HAVE A MATERIAL ADVERSE EFFECT. NOR IS THE COMPANY OR ANY OF
ITS SUBSIDIARIES IN VIOLATION OF ITS CERTIFICATE OF INCORPORATION, BYLAWS OR
OTHER ORGANIZATION DOCUMENTS, AS AMENDED, WHICH VIOLATION, INDIVIDUALLY OR IN
THE AGGREGATE, IS REASONABLY LIKELY TO HAVE A MATERIAL ADVERSE EFFECT.
3.6
REGULATORY COMPLIANCE. THE COMPANY AND ALL OF
ITS SUBSIDIARIES ARE IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH ALL APPLICABLE
STATUTES, RULES AND REGULATIONS OF THE FEDERAL FOOD AND DRUG ADMINISTRATION (THE
"FDA"), AND, TO THE EXTENT APPLICABLE, FOREIGN REGULATORY AUTHORITIES, WITH
RESPECT TO THE CLINICAL TESTING, MANUFACTURE, COLLECTION, LABELING, STORING,
TESTING, OR DISTRIBUTION OF ITS PRODUCTS, INCLUDING CURRENT "GOOD MANUFACTURING
PRACTICES," OR CGMP REGULATIONS, "GOOD CLINICAL PRACTICES" OR CGCP REGULATIONS,
"GOOD LABORATORY PRACTICES" OR CGLP REGULATIONS, AND ALL APPLICABLE REQUIREMENTS
RELATING TO THE PROTECTION OF HUMAN SUBJECTS (E.G., INFORMED CONSENT,
INSTITUTIONAL REVIEW BOARD) FOR ITS CLINICAL TRIALS AS REQUIRED BY THE FDA AND
ANY APPLICABLE CORRESPONDING REQUIREMENTS OF FOREIGN REGULATORY AUTHORITIES.
EACH OF THE COMPANY AND ITS SUBSIDIARIES HAS ALL REQUISITE FDA AND FOREIGN
AUTHORITIES PERMITS, APPROVALS, REGISTRATION, LICENSES OR THE LIKE TO CONDUCT
THE BUSINESS OF THE COMPANY OR THE SUBSIDIARIES, AS APPLICABLE, AS IT IS
CURRENTLY CONDUCTED. THE COMPANY AND EACH SUBSIDIARY IS IN COMPLIANCE WITH ALL
APPLICABLE REGISTRATION AND LISTING
5
REQUIREMENTS SET FORTH AT 21 U.S.C. §360 AND ALL SIMILAR APPLICABLE LAWS AND
REGULATIONS, EXCEPT FOR NONCOMPLIANCE WHICH, INDIVIDUALLY OR IN THE AGGREGATE,
WOULD NOT REASONABLY BE EXPECTED TO HAVE A MATERIAL ADVERSE EFFECT.
Neither the Company nor any Subsidiary is in receipt of notice of, and not
subject to, any adverse inspection, finding of deficiency, finding of
non-compliance, compelled or voluntary recall, investigation, penalty for
corrective or remedial action or other compliance or enforcement action, in each
case relating to any of its products or to the Company's knowledge, to the
facilities in