THE CONTENT OF THE MINUTES, SUCH MINUTES WILL BE
FINALIZED TO REFLECT SUCH DISAGREEMENT.
3.6.
EXPENSES. EACH PARTY SHALL BEAR ALL ITS OWN COSTS,
INCLUDING EXPENSES INCURRED BY THE MEMBERS NOMINATED BY IT IN CONNECTION WITH
THEIR ACTIVITIES AS MEMBERS OF THE JSC.
3.7.
ALLIANCE MANAGERS. PROMPTLY AFTER THE EFFECTIVE DATE,
EACH PARTY SHALL APPOINT AN INDIVIDUAL TO ACT AS THE ALLIANCE MANAGER FOR SUCH
PARTY (THE "ALLIANCE MANAGER"). EACH ALLIANCE MANAGER WHO IS NOT OTHERWISE A
MEMBER OF THE JSC SHALL THEREAFTER BE PERMITTED TO ATTEND MEETINGS OF THE JSC.
THE ALLIANCE MANAGERS SHALL BE THE PRIMARY CONTACT FOR THE PARTIES REGARDING THE
ACTIVITIES CONTEMPLATED BY THIS AGREEMENT AND SHALL FACILITATE ALL SUCH
ACTIVITIES HEREUNDER. EACH PARTY MAY REPLACE ITS ALLIANCE MANAGER WITH AN
ALTERNATIVE REPRESENTATIVE AT ANY TIME WITH PRIOR WRITTEN NOTICE TO THE OTHER
PARTY. THE ALLIANCE MANAGERS SHALL NOT, IN ANY MANNER, TAKE OVER THE ROLE OF THE
JSC AND SHALL NOT HAVE ANY RIGHTS, POWERS OR DISCRETION EXCEPT AS EXPRESSLY
GRANTED TO THE ALLIANCE MANAGERS HEREUNDER. IN NO EVENT SHALL THE ALLIANCE
MANAGERS HAVE ANY POWER TO MODIFY OR AMEND THIS AGREEMENT
CONFIDENTIAL
ARTICLE IV.
TRANSITION ACTIVITIES
4.1.
CURRENT STATUS; GENERAL. PRIOR TO THE EFFECTIVE DATE,
SEPRACOR (ALONE OR WITH THIRD PARTIES) HAS CONDUCTED PRE-CLINICAL AND CLINICAL
STUDIES OF THE PRODUCT, AND ON 23RD JULY 2007 SUBMITTED A MAA FOR THE PRODUCT TO
THE EMEA FOR REVIEW UNDER THE CENTRALIZED PROCEDURE.
4.2.
REGULATORY MATTERS.
(A)
DURING THE TRANSITION PERIOD, SEPRACOR SHALL RETAIN ALL RIGHT,
TITLE AND INTEREST IN AND TO ALL MARKETING AUTHORIZATION APPLICATIONS FOR THE
PRODUCT IN THE GSK TERRITORY, SUBJECT TO THE LICENSES GRANTED TO GSK PURSUANT TO
THIS AGREEMENT.
(B)
DURING THE TRANSITION PERIOD, SEPRACOR SHALL SUPPORT THE MAA FILED
WITH THE EMEA ON 23RD JULY 2007 AND USE ITS COMMERCIALLY REASONABLE EFFORTS TO
OBTAIN APPROVAL FOR THE MAA FROM THE EMEA FOR THE PRODUCT WITH LABELING
CONSISTENT WITH, OR LESS RESTRICTIVE THAN, THE TARGET LABEL. SEPRACOR SHALL BE
RESPONSIBLE FOR LIAISING WITH AND MANAGING ALL INTERACTIONS WITH THE EMEA IN
RELATION TO THE PRODUCT IN CONNECTION WITH SUCH MAA. SEPRACOR SHALL PROVIDE GSK
WITH REASONABLE ADVANCE NOTICE OF ANY MEETINGS WITH THE EMEA (INCLUDING ANY ORAL
HEARINGS), 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 THE EMEA (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 THE EMEA (INCLUDING ANY RESPONSE DOCUMENTS)
FOR REVIEW AND AGREES TO CONSIDER IN GOOD FAITH ANY PROMPT COMMENTS GSK MAY HAVE
WITH RESPECT TO ANY SUCH REGULATORY FILINGS OR INTERACTIONS.
(C)
DURING THE TRANSITION PERIOD, SEPRACOR SHALL REMAIN RESPONSIBLE
FOR LIAISING WITH AND MANAGING ALL INTERACTIONS WITH OTHER REGULATORY
AUTHORITIES IN RELATION TO THE PRODUCT IN CONNECTION WITH A MAA FOR ANY COUNTRY
IN THE GSK TERRITORY, EXCEPT FOR THOSE