OF ANY DISPUTE INVOLVING THE PRODUCT.
TO THE KNOWLEDGE OF AVANT, THE
INTELLECTUAL PROPERTY IS NOT SUBJECT TO ANY OUTSTANDING INJUNCTION, JUDGMENT,
ORDER, DECREE, RULING, CHARGE, SETTLEMENT OR OTHER DISPOSITION OF DISPUTE.
(K)
TO THE KNOWLEDGE OF AVANT, THERE IS NO PENDING
OR THREATENED ACTION, SUIT, OR PROCEEDING, OR ANY INVESTIGATION OR CLAIM BY ANY
GOVERNMENT AUTHORITY TO WHICH AVANT OR, TO THE KNOWLEDGE OF AVANT, TO WHICH
GAMBLE OR GSK IS A PARTY (I) THAT WOULD BE THE SUBJECT OF A CLAIM FOR
INDEMNIFICATION, IF ANY, BY OR AGAINST AVANT, GAMBLE OR GSK UNDER THE RELATED
LICENSE AGREEMENTS, AND (II) THAT THE MARKETING, SALE OR DISTRIBUTION OF THE
PRODUCT WORLDWIDE, BY GSK OR BY ANY LICENSEE OF GSK OR ANY OTHER CONTRACT PARTY,
PURSUANT TO THE RELATED LICENSE AGREEMENTS DOES OR WILL INFRINGE ON ANY PATENT
OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER PERSON.
TO THE KNOWLEDGE OF
AVANT, THERE ARE NO PENDING U.S., INTERNATIONAL OR FOREIGN PATENT APPLICATIONS
OWNED BY ANY SUCH OTHER PERSON, WHICH, IF ISSUED, WOULD LIMIT OR PROHIBIT, IN
ANY MATERIAL RESPECT, THE USE MANUFACTURE, USE OR SALE OF THE PRODUCT, IN EACH
CASE BY THE APPLICABLE CONTRACT PARTY.
SECTION 3.13
REGULATORY APPROVAL.
(A)
AVANT HAS MADE AVAILABLE TO PRF ALL OF THE
FOLLOWING DOCUMENTS THAT AVANT HAS IN ITS POSSESSION AS OF THE DATE FIRST
WRITTEN ABOVE IN ANY FORM FROM ANY CONTRACT PARTY TO ANY LICENSE AGREEMENT:
(I)
ALL MATERIAL REGULATORY CORRESPONDENCE,
WRITTEN NOTES IN RESPECT OF TELEPHONE COMMUNICATIONS, ELECTRONIC COMMUNICATIONS,
COPIES OF ALL MATERIAL SUBMISSIONS TO ANY ACTIVE REGULATORY FILES REGARDING
PRECLINICAL, CLINICAL, MANUFACTURING OR ADVERSE EVENTS, AND ANY
17
MATERIAL NOTICES AND FORMS RECEIVED BY A CONTRACT PARTY FROM APPROPRIATE
REGULATORY AGENCIES RELATING TO COMPLIANCE, DEVELOPMENTAL (INCLUDING SAFETY,
EFFICACY AND POTENCY), MARKETING PROMOTION OR MANUFACTURING ACTIVITIES, IN EACH
CASE, CONCERNING THE PRODUCT;
(II)
MATERIAL CORRESPONDENCE OR REPORTS FROM
BOTH INTERNAL CORPORATE EMPLOYEES AND NON-GOVERNMENTAL CONSULTANTS RELATING TO
ANY OF THE REGULATORY AND/OR PRODUCT LIABILITY EXPOSURES, MARKETING AND
REIMBURSEMENT STRATEGIES, MANUFACTURING (I.E., ANNUAL AUDIT REPORTS),
PRECLINICAL AND CLINICAL DATA ISSUES CONCERNING THE PRODUCT; AND
(III)
ANY INFORMATION OR COMMUNICATION THAT WOULD
INDICATE THAT ANY REGULATORY AGENCY (A) IS NOT LIKELY TO APPROVE ANY APPLICATION
WITH RESPECT TO THE PRODUCT, (B) IS LIKELY TO REVISE OR REVOKE ANY CURRENT
APPROVAL GRANTED BY ANY REGULATORY AGENCY WITH RESPECT TO THE PRODUCT, OR (C) IS
LIKELY TO PURSUE COMPLIANCE ACTIONS AGAINST AVANT OR ANY CONTRACT PARTY RELATING
TO A LICENSE AGREEMENT.
(B)
TO AVANT'S KNOWLEDGE, GSK POSSESSES ALL
REGULATORY APPROVALS ISSUED OR REQUIRED BY THE APPROPRIATE REGULATORY AGENCIES
NECESSARY TO CONDUCT ITS CURRENT BUSINESS RELATING TO THE PRODUCT, AND NEITHER
AVANT NOR, TO AVANT'S KNOWLEDGE, GSK HAS RECEIVED ANY NOTICE OF PROCEEDINGS
RELATING TO, AND THERE ARE NO FACTS OR CIRCUMSTANCES TO AVANT'S KNOWLEDGE THAT
WOULD LEAD TO, THE REVOCATION, SUSPENSION, TERMINATION OR MODIFICATION OF ANY
SUCH REGULATORY APPROVALS.
(C)
AVANT IS IN MATERIAL COMPLIANCE WITH, AND HAS
MATERIALLY COMPLIED WITH, ALL APPLICABLE FEDERAL, STATE, LOCAL AND FOREIGN LAWS,
RULES, REGULATIONS, STANDARDS, ORDERS