BUT ARE NOT LIMITED TO, ANALYTICS,
CHARACTERIZATION, PROCESS DEVELOPMENT, BIOEQUIVALENCE/CLINICAL, REGULATORY,
INTELLECTUAL PROPERTY/LEGAL, COMMERCIALIZATION AND SUPPLY CHAIN, EACH AS
APPROPRIATE FOR THE STAGE OF DEVELOPMENT OR COMMERCIALIZATION OF THE RELEVANT
PRODUCT) PER THE RELEVANT ANNUAL COLLABORATION PLAN.
THE JOC MAY ALTER THE
FUNCTIONAL COMPOSITION OF AND REPRESENTATION ON A JPT OVER TIME AS APPROPRIATE.
MOMENTA AND SANDOZ MAY EACH CHANGE ITS JPT REPRESENTATIVES AT ANY TIME BY GIVING
WRITTEN NOTICE TO THE OTHER.
ADDITIONAL REPRESENTATIVES OF A PARTY MAY ATTEND
MEETINGS OF THE JPTS ON AN AD HOC INVITED BASIS AS APPROPRIATE.
EACH JPT SHALL
MEET AT LEAST MONTHLY DURING THE COURSE OF THE COLLABORATIVE PROGRAM.
WITHIN
[**] DAYS AFTER EACH MEETING, THE JPT (VIA THE JPTL AND LPL) WILL PROVIDE THE
ALLIANCE MANAGERS WITH A WRITTEN REPORT DESCRIBING THE STATUS OF THE
COLLABORATIVE PROGRAM WITH RESPECT TO THE RELEVANT PRODUCT, INCLUDING, WITHOUT
LIMITATION, A SUMMARY OF THE RESULTS AND PROGRESS TO DATE, THE STATUS OF THE
THEN-CURRENT BUDGET IN THE RELEVANT ANNUAL COLLABORATION PLAN (ACTUALS VS.
ESTIMATES), PROJECT TIMELINES, CRITICAL PATH ISSUES AND ANY OTHER ISSUES
REQUIRING RESOLUTION, PROPOSED SOLUTIONS TO SUCH ISSUES, AND THE AGREED
RESOLUTION OF PREVIOUSLY REPORTED ISSUES.
5.5.
ALLIANCE MANAGERS.
EACH PARTY SHALL APPOINT A SENIOR
REPRESENTATIVE WHO POSSESSES A GENERAL UNDERSTANDING OF THE RELEVANT TECHNICAL,
REGULATORY, COMMERCIAL AND LEGAL ISSUES TO ACT AS ITS ALLIANCE MANAGER (EACH, AN
"AM" OR "ALLIANCE MANAGER").
THE AMS SHALL BE CHARGED WITH CREATING AND
MAINTAINING A COLLABORATIVE AND EFFICIENT WORK ENVIRONMENT WITHIN AND AMONG THE
COMMITTEES.
THE AMS SHALL ENSURE EFFICIENT AND RESPONSIVE COMMUNICATION AMONG
EACH JPT, THE JOC, AND THE JSC.
THE AMS WILL ALSO BE RESPONSIBLE FOR:
(A)
SEEKING CONSENSUS (BOTH INTERNALLY, WITHIN HIS/HER RESPECTIVE PARTY'S
ORGANIZATION, AS WELL AS TOGETHER, BETWEEN THE PARTIES) REGARDING KEY STRATEGY
AND COLLABORATIVE PROGRAM ISSUES; (B) COORDINATING THE VARIOUS ACTIVITIES OF
EACH JPTL AND LPL, IF APPROPRIATE, IN DEVELOPING AND EXECUTING GLOBAL STRATEGIES
AND PLANS FOR THE PRODUCTS; AND (C) IDENTIFYING AND RAISING CROSS-COUNTRY
(WITHIN THE RELEVANT TERRITORY), CROSS-PARTY AND/OR CROSS-FUNCTIONAL DISPUTES TO
THE JOC IN A TIMELY MANNER.
THE JAM WILL BE RESPONSIBLE FOR:
(Y) ASSISTING THE
JOC AND JSC CO-CHAIRS IN SETTING APPROPRIATE MEETING AGENDAS, AND PREPARING
MEETING MINUTES, AS APPROPRIATE, IN A FORMAT AGREED UPON WITH THE JOC AND JSC,
RESPECTIVELY; AND (Z) IN COLLABORATION WITH THE OTHER AM, DRAFTING AND REVISING
ON A REGULAR BASIS A MONTHLY EXECUTIVE SUMMARY OF THE STATUS OF THE
COLLABORATIVE PROGRAM, IN A FORMAT AGREED UPON WITH THE JSC, AND PROVIDING SUCH
SUMMARY TO THE JSC AND JOC.
SANDOZ MAY SELECT THE INITIAL JAM FROM AMONG THE
INITIAL AMS; PROVIDED, HOWEVER, THAT THE JOC MAY CHANGE THE JAM BY SELECTING
FROM BETWEEN THE THEN-CURRENT AMS.
5.6.
JOINT OPERATING COMMITTEE.
THE JOINT OPERATING COMMITTEE ("JOC")
SHALL CONSIST OF SIX (6) MEMBERS, THREE (3) REPRESENTATIVES FROM EACH PARTY,
EACH OF WHOM SHALL HAVE THE AUTHORITY, EXPERIENCE AND SENIORITY SUFFICIENT TO
ENABLE HIM OR HER TO MAKE DECISIONS ON BEHALF OF THE PARTY HE OR SHE REPRESENTS,
AND EACH JOC MEMBER WILL HAVE THE