INCLUDE APPROPRIATE REPRESENTATION FROM ITS [**] AND, IF APPROPRIATE, ITS [**].
ANY REPLACEMENTS OR PROXIES FOR THE FOREGOING PERSONS SHALL BE EQUIVALENTLY
SENIOR PERSONNEL. THE PTC SHALL MEET AT LEAST [**] (IN PERSON OR BY TELEPHONE,
AS MUTUALLY AGREED BY THE PARTIES) AT SUCH TIME AND, WITH RESPECT TO IN-PERSON
MEETINGS, PLACE AS MUTUALLY AGREED UPON BY THE PARTIES, AND AT SUCH OTHER DATES
AS MAY BE AGREED UPON BY THE PARTIES. IN ADDITION, THE PARTIES SHALL CAUSE THEIR
RESPECTIVE MEMBERS OF THE PTC TO MAKE THEMSELVES AVAILABLE, IN PERSON OR BY
TELEPHONE, AS REASONABLY NECESSARY TO CARRY OUT SUCH IMPLEMENTATION. SHOULD THE
PARTIES MUTUALLY AGREE TO DO SO, ADDITIONAL, NON-VOTING MEMBERS MAY BE APPOINTED
TO THE PTC AND OPERATING SUBCOMMITTEES AND PROJECT TEAMS MAY BE APPOINTED BY AND
REPORT TO THE PTC.
6.1.3.
IN THE EVENT THAT A CONSENSUS DECISION CANNOT BE REACHED BY THE
PTC, THEN, EXCEPT TO THE EXTENT INCONSISTENT WITH ANY PROVISION OF THIS
AGREEMENT, THE NEW AGREEMENTS OR THE QUALITY AGREEMENTS, TMC SHALL HAVE FINAL
AUTHORITY FOR ALL DECISIONS WITH RESPECT TO THE PRODUCT, OTHER THAN IN RESPECT
OF PRICING IN EACH COUNTRY IN THE TERRITORY DURING THE TERM OF THE NEW
DISTRIBUTION AGREEMENT WITH RESPECT TO SUCH COUNTRY; PROVIDED, HOWEVER, THAT (A)
THE FOREGOING SHALL NOT BE INTERPRETED TO REQUIRE NYCOMED TO ALLOCATE PERSONNEL
RESOURCES TO THE PERFORMANCE OF THE SERVICES (AS DEFINED IN THE SERVICES
AGREEMENT) BEYOND THE THEN-CURRENT COMMITMENT (AS DEFINED IN THE SERVICES
AGREEMENT); (B) NYCOMED SHALL HAVE NO OBLIGATION TO ACT IN ACCORDANCE WITH TMC'S
DIRECTIONS IF DOING SO WOULD VIOLATE ANY APPLICABLE PROVISION OF LAW, STATUTE,
RULE OR REGULATION, AS DETERMINED BY NYCOMED IN GOOD FAITH, OR WOULD CAUSE
NYCOMED TO BREACH ANY OBLIGATION OWED TO A THIRD PARTY UNDER AN AGREEMENT
ENTERED INTO BY NYCOMED IN GOOD FAITH; (C) NYCOMED SHALL PERFORM AND FUND THE
ACTIVITIES SPECIFIED TO BE
17
performed and funded, respectively, by Nycomed in Schedule 2.1(b) of the
Services Agreement and TMC shall perform and fund the activities specified to be
performed and funded, respectively, by TMC in Schedule 2.1(b) of the Services
Agreement; and (d) the foregoing shall not be interpreted as giving TMC any
authority to amend any provision of any Transaction Agreement.
6.2.
TRANSITION OF ACTIVITIES IN GENERAL. THE PARTIES, VIA THE PTC,
WILL AGREE UPON PROCEDURES TO ENSURE A SMOOTH TRANSITION FROM NYCOMED TO TMC ON
OR BEFORE THE TRANSITION DATE OF THE ACTIVITIES REQUIRED TO BE UNDERTAKEN BY THE
HOLDER OF THE APPROVALS FOR THE PRODUCT, INCLUDING WITHOUT LIMITATION ADVERSE
EXPERIENCE REPORTING, QUARTERLY AND ANNUAL REPORTS WITH GOVERNMENTAL
AUTHORITIES, COMPLAINT AND SAMPLE TRACKING, PRODUCT RECALLS AND COMMUNICATION
WITH HEALTH CARE PROFESSIONALS AND CUSTOMERS. WITHOUT LIMITING THE GENERALITY OF
THE FOREGOING, THE PARTIES WILL COOPERATE WITH EACH OTHER IN A COMMERCIALLY
REASONABLE MANNER TO NOTIFY RELEVANT KEY OPINION LEADERS AND OTHER RELEVANT
PARTIES INTERESTED IN THE PRODUCT OF THE TRANSITION CONTEMPLATED BY THIS
AGREEMENT.
6.3.
PROVISION OF REPORTS, DOCUMENTS AND ACCESS.
6.3.1.
DURING THE TRANSITION PERIOD, NYCOMED SHALL PROVIDE TMC