CONTAINED IN ANY SUCH
PORTIONS OF THE DMF AND THUS, NOTWITHSTANDING ANY OTHER PROVISION OF THIS
AGREEMENT, SEPRACOR SHALL HAVE NO OBLIGATION TO DISCLOSE TO GSK OR ANY OF ITS
AFFILIATES OR SUBLICENSEES THE CLOSED PORTIONS OF SUCH DMFS OR ANY INFORMATION
CONTAINED THEREIN. FOR THE AVOIDANCE OF DOUBT, REGULATORY AUTHORITIES IN THE GSK
TERRITORY SHALL HAVE THE RIGHT TO ACCESS THE ENTIRE DMF, INCLUDING ANY CLOSED
PORTIONS.
5.11.
EXCHANGE OF DATA AND KNOW-HOW.
(A)
BY SEPRACOR. SUBJECT TO THE TERMS AND CONDITIONS OF THIS
AGREEMENT, SEPRACOR SHALL PROMPTLY MAKE AVAILABLE TO GSK ALL RELEVANT SEPRACOR
KNOW-HOW RELATING TO THE
CONFIDENTIAL
PRODUCT, INCLUDING ALL DATA FROM ANY AND ALL CLINICAL TRIALS AND PRECLINICAL
STUDIES FOR THE PRODUCT THAT ARE CONTROLLED BY SEPRACOR AS OF THE EFFECTIVE DATE
OR THAT WILL BE OBTAINED BY SEPRACOR THEREAFTER, SUBJECT IN EACH CASE TO SECTION
5.10. SEPRACOR SHALL ALSO USE ITS COMMERCIALLY REASONABLE EFFORTS TO PROVIDE TO
GSK ANY THIRD PARTY MANUFACTURER'S KNOW-HOW WHICH IS NECESSARY FOR GSK TO OBTAIN
MARKETING APPROVAL IN THE GSK TERRITORY,
(B)
NEW DATA. NOTWITHSTANDING SECTIONS 5.10, 5.11(A) AND 5.12, IN THE
EVENT THAT GSK REQUIRES INFORMATION RELATING TO THE BULK TABLETS IN ADDITION TO
THAT PROVIDED BY OR OTHERWISE READILY AVAILABLE TO SEPRACOR TO SUPPORT GSK'S
REGULATORY FILINGS FOR PRODUCT IN THE GSK TERRITORY, SEPRACOR SHALL CONDUCT, AT
GSK'S EXPENSE, SUCH WORK AS IS NECESSARY TO PRODUCE THE NECESSARY CHEMISTRY,
MANUFACTURING AND CONTROLS ("CMC") INFORMATION OR OTHER REGULATORY DOCUMENTATION
REASONABLY REQUIRED TO SUPPORT SUCH REGULATORY FILINGS (PROVIDED THAT GSK SHALL
BE RESPONSIBLE FOR, AT ITS EXPENSE, ANY ADDITIONAL CLINICAL TRIAL WORK REQUIRED
FOR SUCH FILINGS). THE OBLIGATION OF SEPRACOR TO PROVIDE SUCH CMC DATA OR OTHER
REGULATORY DOCUMENTATION REASONABLY REQUIRED TO SUPPORT SUCH REGULATORY FILINGS
WILL INCLUDE, WITHOUT LIMITATION, CMC INFORMATION OR OTHER REGULATORY
DOCUMENTATION REASONABLY REQUIRED TO SUPPORT SUCH REGULATORY FILINGS BEYOND WHAT
WAS REQUIRED FOR THE U.S.A. REGULATORY APPROVAL, TO SUPPORT INITIAL AS WELL AS
FILED REGULATORY SUBMISSIONS FOR PRODUCT IN THE GSK TERRITORY, SUPPORT ON AN
ONGOING BASIS TO DEAL WITH REGULATORY QUESTIONS, PROVISION OF ON-GOING STABILITY
DATA, BATCH ANALYSIS, ETC. FOR LICENSE RENEWALS, CMC DATA FOR VARIATIONS, ANY
RESPONSE TO QUESTIONS RELATING TO RENEWALS AND VARIATIONS, AS WELL AS ANY OTHER
DATA REQUIRED TO MEET ANY REGULATORY INSPECTION REQUIREMENTS. FOR THE AVOIDANCE
OF DOUBT, SEPRACOR'S OBLIGATIONS DO NOT EXTEND TO QUESTIONS REGARDING FINISHING
OPERATIONS PERFORMED BY GSK.
(C)
PROVISION OF DATA TO JSC. UPON REQUEST BY THE JSC, GSK AND
SEPRACOR SHALL PROMPTLY PROVIDE THE JSC WITH SUMMARIES IN REASONABLE DETAIL OF
ALL DATA GENERATED OR OBTAINED IN THE COURSE OF THE PERFORMANCE OF ACTIVITIES
UNDER THE DEVELOPMENT PLAN OR THE SEPRACOR DEVELOPMENT PLAN RESPECTIVELY. FOR
THE AVOIDANCE OF DOUBT, THIS OBLIGATION SHALL NOT EXTEND TO PROVISION OF DATA
NOT RELATED TO THE PRODUCT AND ONLY RELATING TO EXCLUDED PRODUCTS.
5.12.
SHARING OF REGULATORY FILINGS. WITHOUT LIMITING SECTION 5.11
ABOVE, AND WITHOUT PREJUDICE TO THE TERMS OF THE SUPPLY AGREEMENT, GSK AND
SEPRACOR SHALL PERMIT THE OTHER TO ACCESS, AND SHALL PROVIDE THE