COUNTRIES WHERE THE PARTIES HAVE MUTUALLY
AGREED TO EARLIER TRANSFER RESPONSIBILITY TO GSK. SEPRACOR SHALL NOT HOWEVER
INITIATE THE FILING OF ANY NEW MAA, OR INITIATE ANY INTERACTION, WITH ANY
REGULATORY AUTHORITIES (OTHER THAN THE EMEA) WITHIN THE GSK TERRITORY RELATED TO
THE PRODUCT WITHOUT THE PRIOR APPROVAL OF GSK. SEPRACOR SHALL PROVIDE GSK WITH
REASONABLE ADVANCE NOTICE OF ANY MEETINGS WITH ANY SUCH REGULATORY AUTHORITY
(INCLUDING ANY ORAL HEARINGS) ABOUT THE PRODUCT, IF PRACTICABLE, AND GSK SHALL
HAVE THE RIGHT, BUT NOT THE OBLIGATION, TO ATTEND AND PARTICIPATE IN SUCH
MEETINGS WHERE LEGALLY PERMISSIBLE. IN ADDITION, SEPRACOR SHALL PROMPTLY PROVIDE
GSK WITH COPIES OF ALL MATERIAL CORRESPONDENCE FROM ANY SUCH REGULATORY
AUTHORITIES (INCLUDING ANY ASSESSMENT REPORTS) RELATED TO THE PRODUCT IN THE GSK
TERRITORY, AND SHALL PROVIDE GSK WITH DRAFT COPIES OF ALL MATERIAL
CORRESPONDENCE INTENDED FOR ANY SUCH REGULATORY AUTHORITIES (INCLUDING ANY
RESPONSE DOCUMENTS) FOR REVIEW AND AGREES TO CONSIDER IN GOOD FAITH ANY COMMENTS
GSK MAY HAVE WITH RESPECT TO ANY SUCH REGULATORY FILINGS OR INTERACTIONS WITH
RESPECT TO THE PRODUCT. WHERE THE PARTIES HAVE AGREED TO TRANSFER RESPONSIBILITY
CONFIDENTIAL
TO GSK FOR ANY COUNTRY IN THE GSK TERRITORY BEFORE THE EXPIRATION OR TERMINATION
OF THE TRANSITION PERIOD, SECTIONS 4.2(D), 5.1 AND 5.14 SHALL APPLY MUTATIS
MUTANDIS.
(D)
SUBJECT TO OBTAINING ALL REQUIRED CONSENTS OR APPROVALS FROM ALL
RELEVANT REGULATORY AUTHORITIES, AS SOON AS REASONABLY PRACTICABLE FOLLOWING THE
EXPIRATION OR TERMINATION OF THE TRANSITION PERIOD, SEPRACOR SHALL TRANSFER TO
GSK ALL MARKETING APPROVALS AND/OR MAAS FOR THE PRODUCT IN THE GSK TERRITORY
(EXCEPT FOR DMFS), WITH SEPRACOR TO INVOICE GSK FOR ONE-HALF OF ANY
OUT-OF-POCKET COSTS FOR SO DOING. IN ADDITION, SEPRACOR AGREES TO PROMPTLY
EXECUTE, ACKNOWLEDGE AND DELIVER SUCH FURTHER INSTRUMENTS, AND TO DO ALL SUCH
OTHER REASONABLE ACTS, AS MAY BE NECESSARY IN ORDER TO CARRY OUT THE TRANSFER OF
SUCH MARKETING APPROVALS AND/OR MAAS, AS THE CASE MAY BE RELATED TO THE PRODUCT
IN THE GSK TERRITORY.
(E)
WITHIN [**] FOLLOWING THE EFFECTIVE DATE, GSK AND SEPRACOR SHALL
PROVIDE FOR REVIEW BY THE JSC AN OUTLINE SHOWING IN REASONABLE DETAIL GSK'S
PROVISIONAL PLANS FOR FILING MARKETING AUTHORIZATION APPLICATIONS AND OBTAINING
MARKETING APPROVALS IN THE GSK TERRITORY, WITH A PARTICULAR FOCUS ON THE OVERALL
STRATEGY AND TIMELINE OF MATERIAL SUBMISSIONS AND FILINGS (IF ANY) DURING THE
TRANSITION PERIOD AND HOW THE VARIOUS REGULATORY INTERACTIONS WILL BE MANAGED
DURING THE TRANSITION PERIOD.
4.3.
REQUIRED STUDIES (EMEA). IN THE EVENT THAT THE EMEA
REQUIRES OR REQUESTS IN WRITING THAT REQUIRED STUDIES (OTHER THAN THOSE ALREADY
INITIATED BY SEPRACOR AS OF THE EFFECTIVE DATE) TO BE PERFORMED AS A CONDITION
OF, OR IN CONNECTION WITH, GRANTING MARKETING APPROVAL, GSK SHALL HAVE THE
RIGHT, AT ITS ABSOLUTE DISCRETION, TO PERFORM OR HAVE PERFORMED SUCH REQUIRED
STUDIES AT GSK'S EXPENSE. IF GSK DECIDES TO PERFORM OR HAVE PERFORMED SUCH
REQUIRED STUDIES, THE JSC WILL REVIEW AND DISCUSS WHICH OF THE PARTIES SHOULD
UNDERTAKE SUCH REQUIRED STUDIES. SEPRACOR WILL PROVIDE ALL REASONABLE INCIDENTAL
ASSISTANCE TO GSK AND/OR ITS AFFILIATES IF