OTHER PARTY
WITH SUFFICIENT RIGHTS TO REFERENCE AND USE IN ASSOCIATION WITH EXERCISING ITS
RIGHTS AND PERFORMING ITS OBLIGATIONS UNDER THIS AGREEMENT, ALL OF SUCH PARTY'S,
ITS AFFILIATES' AND SUBLICENSEES' DATA, REGULATORY FILINGS AND MATERIAL
REGULATORY COMMUNICATIONS ASSOCIATED WITH ANY SUBMISSIONS OF INDS, MAAS,
MARKETING APPROVALS OR OTHER APPROVALS FOR THE PRODUCT IN THE GSK TERRITORY AND
IN THE SEPRACOR TERRITORY, RESPECTIVELY. IT IS UNDERSTOOD THAT SUCH RIGHTS AND
ACCESS SHALL BE LIMITED RESPECTIVELY TO SEPRACOR'S, ITS AFFILIATE'S AND
SUBLICENSEES' COMMERCIALIZATION OF THE PRODUCT IN THE SEPRACOR TERRITORY AND TO
GSK'S, ITS AFFILIATE'S AND SUBLICENSEE'S COMMERCIALIZATION OF THE PRODUCT IN THE
GSK TERRITORY.
5.13.
REGULATORY CO-OPERATION. WITHOUT LIMITING SECTION 5.11
ABOVE, IN THE EVENT THAT EITHER PARTY RECEIVES ENQUIRIES FROM A REGULATORY
AUTHORITY IN THEIR RESPECTIVE TERRITORY, REGARDING FILINGS OR COMMUNICATIONS
MADE, OR ACTIVITIES BEING UNDERTAKEN IN THE OTHER PARTY'S
CONFIDENTIAL
RESPECTIVE TERRITORY, THE OTHER PARTY SHALL PROVIDE ALL REASONABLE CO-OPERATION
TO ENABLE THE ORIGINAL PARTY TO RESPOND TO THE REGULATORY AUTHORITY'S ENQUIRIES.
5.14.
REPORTING: ADVERSE DRUG REACTIONS.
(A)
SEPRACOR AND GSK SHALL BE RESPONSIBLE FOR FILING ALL REPORTS
REQUIRED TO BE FILED IN ORDER TO MAINTAIN ANY IND, MAA AND/OR ANY MARKETING
APPROVALS GRANTED FOR THE PRODUCT IN THE SEPRACOR TERRITORY OR THE GSK
TERRITORY, RESPECTIVELY, INCLUDING REPORTING OF ADVERSE DRUG EXPERIENCES;
PROVIDED, HOWEVER, THAT DURING THE TRANSITION PERIOD, SEPRACOR SHALL BE
RESPONSIBLE FOR SUCH FILINGS IN THE GSK TERRITORY.
(B)
THE PARTIES SHALL BE RESPONSIBLE TO ENSURE THAT THEIR RESPECTIVE
AFFILIATES AND SUBLICENSEES COMPLY WITH ALL SUCH REPORTING OBLIGATIONS.
(C)
THE PARTIES WILL EXCHANGE ALL PHARMACOVIGILANCE RELEVANT
INFORMATION PURSUANT TO A SEPARATE PHARMACOVIGILANCE AGREEMENT TO BE EXECUTED
WITHIN NINETY (90) DAYS OF THE EFFECTIVE DATE (THE "PHARMACOVIGILANCE
AGREEMENT"). THE STANDARDS SET FORTH IN THE PHARMACOVIGILANCE AGREEMENT SHALL BE
NO LESS STRINGENT THAN THOSE SET FORTH IN THE ICH GUIDELINES AND SHALL PROVIDE,
AMONG OTHER THINGS, THAT:
(I)
THE PARTIES WILL COMPLY WITH REGULATORY REQUIREMENTS FOR THE
REPORTING OF SAFETY DATA IN ACCORDANCE WITH STANDARDS STIPULATED IN THE ICH
GUIDELINES, AND ALL APPLICABLE REGULATORY AND LEGAL REQUIREMENTS REGARDING THE
MANAGEMENT OF SAFETY DATA;
(II)
THE PARTIES WILL EXCHANGE RELEVANT SAFETY DATA WITHIN APPROPRIATE
TIMEFRAMES AND IN AN APPROPRIATE FORMAT TO ENABLE THEM TO MEET BOTH EXPEDITED
AND PERIODIC LOCAL AND INTERNATIONAL REGULATORY REPORTING REQUIREMENTS AND TO
FACILITATE APPROPRIATE SAFETY REVIEWS; AND
(III)
SEPRACOR SHALL BE THE HOLDER OF THE WORLD-WIDE SAFETY DATABASE
FOR ALL ADVERSE EVENTS.
(D)
FURTHERMORE, SEPRACOR COMMITS TO THE ESTABLISHMENT OF
PHARMACOVIGILANCE SYSTEMS IN COMPLIANCE WITH APPLICABLE REGULATORY REQUIREMENTS
AND TO DEMONSTRATE COMPREHENSIVELY THOSE SYSTEMS, PARTICULARLY THEIR SYSTEM FOR
PRODUCING PSURS, TO GSK PRIOR TO THE END OF THE TRANSITION PERIOD. IN THE EVENT
THAT GSK HAS ANY REASONABLE CONCERNS AFTER SUCH DEMONSTRATION, GSK AND SEPRACOR
WILL CO-OPERATE IN GOOD FAITH TO RESOLVE SUCH CONCERNS.
(E)
PRIOR TO THE END OF THE TRANSITION PERIOD, SEPRACOR SHALL
ESTABLISH A SEPARATE PHARMACOVIGILANCE AGREEMENT WITH EACH THIRD PARTY TO WHICH
SEPRACOR HAS GRANTED RIGHTS TO PROMOTE, MARKET AND SELL THE PRODUCT IN THE
SEPRACOR TERRITORY, OR PART THEREOF.