SECTION 6.6) AND (B) MATERIAL SCHEDULED INTERNAL MEETINGS, IN EACH
CASE REGARDING CLINICAL TRIALS AND REGISTRATION EFFORTS (IN EACH CASE, TO THE
EXTENT NYCOMED IS EXPRESSLY AUTHORIZED TO ENGAGE IN SUCH ACTIVITIES BY TMC
HEREUNDER) AND PROMOTIONAL, MARKETING, SALES, DETAILING AND DISTRIBUTION
ACTIVITIES RELATING TO THE PRODUCT.
6.4.
TRANSFER OF REGULATORY FILINGS AND APPROVALS. THE PARTIES SHALL
USE COMMERCIALLY REASONABLE EFFORTS TO COMPLETE THE TRANSFER OF ALL REGULATORY
FILINGS SET FORTH ON SCHEDULE 6.4
(INCLUDING APPROVALS THAT MAY RESULT
THEREFROM DURING THE TRANSITION PERIOD) AND APPROVALS SET FORTH ON SCHEDULE 6.4
TO TMC OR TMC'S DESIGNEE ON THE TRANSITION DATE OR, WITH RESPECT TO ANY
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GIVEN REGULATORY FILING OR APPROVAL, UPON SUCH EARLIER DATE AS TMC MAY REQUEST,
PROVIDED THAT SUCH EARLIER DATE IS REASONABLY PRACTICABLE. TO THE EXTENT THAT
TMC EXPRESSLY AUTHORIZES NYCOMED TO MAKE ADDITIONAL REGULATORY FILINGS DURING
THE TRANSITION PERIOD, THE PARTIES SHALL UPDATE SCHEDULE 6.4 ACCORDINGLY.
6.5.
MAINTENANCE AND REGISTRATION EFFORTS. DURING THE TRANSITION
PERIOD, NYCOMED SHALL CONTINUE TO MAINTAIN THE APPROVALS SET FORTH ON SCHEDULE
6.4 AND ANY APPROVALS THAT MAY RESULT FROM THE REGULATORY FILINGS SET FORTH ON
SCHEDULE 6.4 UNTIL SUCH TIME AS SUCH APPROVALS AND REGULATORY FILINGS ARE
TRANSFERRED TO TMC OR TMC'S DESIGNEE PURSUANT TO SECTION 6.4. AS OF THE
EFFECTIVE DATE, NYCOMED SHALL NO LONGER BE OBLIGATED OR HAVE THE RIGHT TO PURSUE
NEW APPROVALS WITH RESPECT TO THE PRODUCT OTHER THAN IN SUPPORT OF REGULATORY
FILINGS SET FORTH ON SCHEDULE 6.4; PROVIDED, HOWEVER, THAT TMC MAY, AT ANY TIME
DURING THE TRANSITION PERIOD, DIRECT NYCOMED TO WITHDRAW OR, IF PRACTICAL, TO
CEASE TO ACTIVELY PURSUE, ANY SUCH REGULATORY FILING(S) PENDING FURTHER
INSTRUCTION FROM TMC. SUBJECT TO THE FOREGOING AND SUBJECT TO SECTION 6.6,
DURING THE TRANSITION PERIOD, NYCOMED SHALL CONTINUE TO USE COMMERCIALLY
REASONABLE EFFORTS TO SEEK APPROVALS WITH RESPECT TO SUCH REGULATORY FILINGS,
EXCEPT TO THE EXTENT THAT THE APPLICABLE REGULATORY FILING IS TRANSFERRED TO TMC
OR A TMC DESIGNEE IN ACCORDANCE WITH SECTION 6.4, IN WHICH EVENT TMC OR SUCH
DESIGNEE SHALL BE RESPONSIBLE FOR THE CONDUCT OF ANY SUCH ACTIVITIES. IN THE
EVENT TMC OR A TMC DESIGNEE ASSUMES SUCH RESPONSIBILITY, NYCOMED SHALL ASSIST
TMC OR SUCH DESIGNEE IN SEEKING SUCH APPROVALS BY SUPPLYING TMC OR SUCH DESIGNEE
WITH COPIES OF ALL RELEVANT DOCUMENTS AND COMMUNICATIONS, AND INFORMING TMC OR
SUCH DESIGNEE OF THE STATUS OF THE APPLICABLE REGULATORY FILINGS. THE PARTIES
AGREE THAT DURING THE TRANSITION PERIOD, OR UNTIL SUCH EARLIER TIME AS TMC OR A
TMC DESIGNEE MAY ASSUME RESPONSIBILITY FOR SUCH ACTIVITIES, NYCOMED'S ACTIVITIES
WITH RESPECT TO SEEKING THE FOREGOING APPROVALS SHALL BE SUBJECT TO REASONABLE
COORDINATION WITH TMC; PROVIDED, HOWEVER, THAT NYCOMED SHALL NOT BE REQUIRED TO
TAKE ANY ACTION THAT NYCOMED DETERMINES IN GOOD FAITH WOULD JEOPARDIZE ITS
STANDING AND REPUTATION WITH ANY GOVERNMENTAL AUTHORITY OR VIOLATE ANY
APPLICABLE PROVISION OF LAW, STATUTE, RULE OR REGULATION.
6.6.
COMMUNICATIONS WITH GOVERNMENTAL AUTHORITIES.
6.6.1.
IN ADDITION TO ITS OBLIGATIONS UNDER THE NEW AGREEMENTS AND THE
QUALITY AGREEMENTS, DURING THE TRANSITION PERIOD: