SUCH NOTICE IS RECEIVED BY GSK WITHIN THE [**] PERIOD, GSK
SHALL NOT COMMENCE SUCH DEVELOPMENTAL STUDY OR SUPPORT SUCH INVESTIGATOR
SPONSORED CLINICAL STUDY UNTIL MUTUAL AGREEMENT OR RESOLUTION OF ANY DISPUTE HAS
BEEN ACHIEVED IN RESPECT OF THE PERFORMANCE OF SUCH STUDY.
(B)
IF GSK DISPUTES THE ASSESSMENT OF THE [**], GSK MAY REFER THE
DISPUTE TO THE SENIOR EXECUTIVES. THE SENIOR EXECUTIVES SHALL NEGOTIATE IN GOOD
FAITH TO RESOLVE THE DISPUTE WITHIN [**], OR SUCH LONGER PERIOD AS MUTUALLY
AGREED. IF THE SENIOR EXECUTIVES ARE UNABLE TO RESOLVE THE DISPUTE WITHIN SUCH
TIME PERIOD, [**].
(C)
FOR THE AVOIDANCE OF DOUBT, IF SEPRACOR DOES NOT PROVIDE SUCH
WRITTEN NOTICE WITH THE ABOVE STATED PERIOD, SEPRACOR'S APPROVAL WILL BE DEEMED
TO HAVE BEEN RECEIVED.
CONFIDENTIAL
5.8.
DEVELOPMENT ACTIVITIES OF SEPRACOR IN THE GSK TERRITORY.
SEPRACOR SHALL HAVE THE RIGHT, BUT NOT THE OBLIGATION, TO UNDERTAKE FUTURE
DEVELOPMENT WITHIN THE GSK TERRITORY IN SUPPORT OF THE COMMERCIALIZATION OF
PRODUCT IN THE SEPRACOR TERRITORY AND THE RIGHT, BUT NOT THE OBLIGATION, TO
UNDERTAKE FUTURE DEVELOPMENT WITHIN THE GSK TERRITORY OF EXCLUDED PRODUCTS.
HOWEVER, WITH RESPECT TO SEPRACOR STUDIES, SEPRACOR SHALL GENERATE A SEPRACOR
DEVELOPMENT PLAN (THE "SEPRACOR DEVELOPMENT PLAN") WHICH SHALL BE PRESENTED
PROMPTLY TO THE JSC FOR REVIEW TO ENSURE THAT THE SEPRACOR DEVELOPMENT PLAN
TAKES INTO ACCOUNT, AND IS NOT INCONSISTENT WITH, THE BRANDING STRATEGY FOR THE
PRODUCT IN THE GSK TERRITORY. THE SEPRACOR DEVELOPMENT PLAN SHALL INCLUDE
REASONABLY DETAILED INFORMATION REGARDING ALL SUCH ACTIVITIES. IT IS
ACKNOWLEDGED HOWEVER THAT IN RESPECT OF SEPRACOR STUDIES NOT DIRECTLY RELATED TO
THE PRODUCT, THE LEVEL OF INFORMATION THAT WILL BE REQUIRED TO BE DISCLOSED TO
ENABLE APPROPRIATE REVIEW MAY BE LIMITED (EXCEPT IN RESPECT OF MATTERS RELATING
TO SAFETY).
5.9.
CONDUCT OF ACTIVITIES. THE PARTIES SHALL CARRY OUT ALL
PRE-CLINICAL AND CLINICAL STUDIES RELATED TO THE PRODUCT THAT THEY RESPECTIVELY
UNDERTAKE IN THE GSK TERRITORY IN COMPLIANCE WITH ALL APPLICABLE LAWS, RULES AND
REGULATIONS AND IN ACCORDANCE WITH GOOD SCIENTIFIC AND CLINICAL PRACTICES,
APPLICABLE UNDER THE LAWS AND REGULATIONS OF THE RELEVANT COUNTRY IN THE GSK
TERRITORY.
5.10.
DRUG MASTER FILE.
(A)
RESPONSIBILITY FOR MAINTAINING. NOTWITHSTANDING SECTION 5.1(A),
SEPRACOR SHALL BE RESPONSIBLE FOR FILING AND MAINTAINING DRUG MASTER FILES
("DMF") RELATING TO THE PRODUCT AND ACTIVE INGREDIENT CONTAINED IN THE PRODUCT,
WHERE SUCH DMF IS EITHER REQUIRED BY A REGULATORY AUTHORITY OR IT IS DETERMINED
BY THE JSC THAT DMF SUBMISSION IS PREFERABLE TO INCORPORATION OF THE DMF
INFORMATION IN THE APPLICABLE MAA. SEPRACOR SHALL FILE AND MAINTAIN SUCH DMFS IN
ITS OWN NAME, AND/OR IN THE NAME OF ITS RELEVANT SUPPLIERS, AND SHALL PERMIT
GSK, ITS AFFILIATES AND SUBLICENSEES, TO CROSS-REFERENCE SUCH DMFS IN THEIR
REGULATORY FILINGS FOR THE PRODUCT IN THE GSK TERRITORY.
(B)
COSTS. RESPONSIBILITY FOR THE COSTS OF FILING AND MAINTAINING SUCH
DMFS SHALL BE SEPRACOR'S.
(C)
CLOSED PORTIONS. NOTWITHSTANDING ANY OTHER PROVISIONS OF THIS
AGREEMENT, THE DEFINITIONS OF "DATA" AND "SEPRACOR KNOW-HOW" SHALL NOT INCLUDE
THE CLOSED PORTIONS OF ANY SUCH DMF, NOR ANY INFORMATION