GSK WISHES TO UNDERTAKE THE REQUIRED
STUDIES ITSELF, OR VIA ITS AFFILIATES OR ANY SUB-CONTRACTOR. SEPRACOR SHALL
PROVIDE SUCH ASSISTANCE FREE OF CHARGE, UNLESS OTHERWISE AGREED IN WRITING BY
GSK. IN THE EVENT THAT GSK NOTIFIES SEPRACOR THAT IT DOES NOT DESIRE TO INCUR
SUCH EXPENSE, AT ANY TIME AFTER SUCH NOTIFICATION SEPRACOR MAY, BUT SHALL NOT BE
OBLIGATED TO, TERMINATE THE AGREEMENT WITH RESPECT TO THE EUROPEAN UNION (BUT
NOT THE REST OF THE GSK TERRITORY) UPON SIXTY (60) DAYS WRITTEN NOTICE. FOR THE
AVOIDANCE OF DOUBT, A DECISION NOT TO PURSUE SUCH MARKETING APPROVAL BY GSK
SHALL NOT BE DEEMED A FAILURE TO EXERCISE ITS COMMERCIALLY REASONABLE EFFORTS.
IN THE EVENT THAT SEPRACOR BELIEVES THAT THE USE OF THE RESULTS OF ANY REQUIRED
STUDY COULD BE OF MATERIAL BENEFIT TO SEPRACOR IN THE SEPRACOR TERRITORY, FOR
EXAMPLE, IF THE REQUIRED STUDY WERE THE DEVELOPMENT OF A [**] OF THE PRODUCT,
THE PARTIES SHALL [**], TAKING INTO ACCOUNT THE COSTS OF ANY ASSISTANCE WHICH
MAY HAVE BEEN PROVIDED BY SEPRACOR UNDER THIS SECTION.
4.4.
REPORTING: ADVERSE DRUG REACTIONS. DURING THE TRANSITION
PERIOD, SEPRACOR SHALL, IN ACCORDANCE WITH SECTION 5.14, BE RESPONSIBLE FOR
FILING ALL REPORTS REQUIRED TO BE FILED IN ORDER TO MAINTAIN ANY IND, MAA AND/OR
ANY MARKETING APPROVALS FILED OR GRANTED FOR THE PRODUCT IN THE GSK TERRITORY,
INCLUDING REPORTING OF ADVERSE DRUG EXPERIENCES.
CONFIDENTIAL
ARTICLE V.
REGULATORY MATTERS AND DEVELOPMENT ACTIVITIES
5.1.
REGULATORY MATTERS.
(A)
FOLLOWING THE TRANSITION PERIOD AND FOR THE TERM OF THIS
AGREEMENT, GSK SHALL RETAIN ALL RIGHT, TITLE AND INTEREST IN AND TO ALL
MARKETING AUTHORIZATION APPLICATIONS AND MARKETING APPROVALS FOR THE PRODUCT IN
THE GSK TERRITORY, SUBJECT TO THE LICENSES GRANTED TO SEPRACOR PURSUANT TO
SECTION 5.12 AND THE ASSIGNMENT AND TRANSFER OF SUCH MARKETING AUTHORIZATION
APPLICATIONS AND MARKETING APPROVALS PURSUANT TO SECTION 15.2(B).
(B)
UPON EXPIRATION OR TERMINATION OF THE TRANSITION PERIOD, GSK SHALL
HAVE SOLE RESPONSIBILITY FOR LIAISING WITH AND MANAGING ALL INTERACTIONS WITH
REGULATORY AUTHORITIES IN RELATION TO THE PRODUCT IN THE GSK TERRITORY IN
CONNECTION WITH ANY AND ALL REGULATORY FILINGS. GSK SHALL PROVIDE SEPRACOR WITH
REASONABLE ADVANCE WRITTEN NOTICE OF ANY MEETINGS WITH THE REGULATORY
AUTHORITIES RELATED TO THE PRODUCT IN MAJOR MARKETS OF THE GSK TERRITORY AND
SEPRACOR SHALL HAVE THE RIGHT, BUT NOT THE OBLIGATION, TO ATTEND AND PARTICIPATE
IN SUCH MEETINGS IN THE MAJOR MARKETS WHERE LEGALLY PERMISSIBLE. NOTWITHSTANDING
THE FOREGOING, GSK SHALL PROVIDE SEPRACOR WITH A COPY OF ANY REGULATORY
SUBMISSION AND OTHER SUBSTANTIVE WRITTEN MATERIAL TO BE SENT TO ANY REGULATORY
AUTHORITY IN THE GSK TERRITORY FOR REVIEW AND AGREES TO CONSIDER IN GOOD FAITH
ANY PROMPT COMMENTS SEPRACOR MAY HAVE WITH RESPECT TO ANY SUCH REGULATORY
FILINGS OR INTERACTIONS.
(C)
SEPRACOR SHALL PROVIDE GSK WITH ALL REASONABLE ASSISTANCE, IN A
TIMELY MANNER, TO SUPPORT GSK'S ACTIVITIES IN SEEKING AND MAINTAINING MARKET
APPROVAL IN THE GSK TERRITORY. WITHOUT LIMITING THE ABOVE, SEPRACOR ACCEPTS THAT
SUCH ASSISTANCE MAY EXTEND TO OBTAINING CERTIFICATES OF PHARMACEUTICAL PRODUCT
ON BEHALF OF GSK.
(D)
FOLLOWING