DESIGNATED BY
GILEAD SUB AND THEN A MEMBER DESIGNATED BY BMS SUB SHALL SERVE ALTERNATELY AS
CHAIRPERSON, ON A ROTATING ANNUAL BASIS FROM EACH ANNIVERSARY OF THE EFFECTIVE
DATE.
THE INITIAL JCC MEMBERS AND THE CHAIRPERSON ARE IDENTIFIED IN ANNEX A
HERETO.
(B)
SUBJECT TO THE OVERSIGHT OF THE JEC, THE JCC
SHALL HAVE THE FOLLOWING POWERS AND DUTIES:
(I)
TO OVERSEE AND COORDINATE THE PARTIES
ACTIVITIES UNDER THE COMMERCIALIZATION PLAN;
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(II)
TO (X) REVIEW AND PROPOSE TO THE JEC FOR
ITS APPROVAL EACH ANNUAL UPDATE OF THE COMMERCIALIZATION PLAN AND
COMMERCIALIZATION BUDGET AND (Y) REVIEW AND APPROVE EACH INTERIM UPDATE OF THE
COMMERCIALIZATION PLAN AND COMMERCIALIZATION BUDGET, IN EACH CASE PROPOSED
PURSUANT TO SECTION 5.11(C);
(III)
TO OVERSEE GILEAD'S ACTIVITIES PURSUANT TO
THE SERVICES AGREEMENT;
(IV)
TO DEVELOP AND APPROVE (X) INITIAL MARKETING
MATERIALS FOR THE COMBINATION PRODUCT FOR THE TERRITORY, AND (Y) UPDATES TO SUCH
MATERIALS FROM TIME TO TIME AS MAY BE REASONABLY NECESSARY OR APPROPRIATE, ALL
IN ACCORDANCE WITH SECTION 5.7;
(V)
TO DEVELOP AND APPROVE UNIT VOLUME FORECASTS
FOR USE IN PREPARATION OF COMMERCIALIZATION PLANS AND COMMERCIALIZATION BUDGETS
AND (REGARDLESS OF WHETHER THERE IS A COMMERCIALIZATION PLAN OR
COMMERCIALIZATION BUDGET) FOR USE IN PLANNING FOR MANUFACTURE OF THE COMBINATION
PRODUCT, PLANNING FOR COMMERCIALIZATION ACTIVITIES AND FOR THE MEMBER PARTIES'
OWN FINANCIAL PLANNING PURPOSES;
(VI)
TO COORDINATE WITH THE JDC WITH RESPECT TO
MANUFACTURING AND LABELING MATTERS;
(VII)
TO (X) DETERMINE HOW THE JV WILL RESPOND TO
REQUESTS FROM HEALTH CARE PROVIDERS OR FROM INDIVIDUAL PATIENTS WHO HAVE OR MAY
OBTAIN PRESCRIPTIONS FOR THE COMBINATION PRODUCT BUT ARE UNABLE TO AFFORD IT,
AND (Y) TO ESTABLISH THE APPROPRIATE PROCEDURES AND RESPONSE TIMES THAT SHALL
APPLY IN RESPONDING TO SUCH REQUESTS, IN EACH CASE ((X) AND (Y)) IN ACCORDANCE
WITH SECTION 5.2(A);
(VIII)
TO MAKE RECOMMENDATIONS TO THE JEC WITH RESPECT TO
COST ALLOCATION PROPOSALS;
(IX)
TO MAINTAIN ONE SUPPLIER AND ONE OR MORE
ALTERNATE SUPPLIERS PURSUANT TO SECTION 4.2(A) FOR MANUFACTURE OF COMMERCIAL
SUPPLIES OF THE COMBINATION PRODUCT;
(X)
OVERSEE AND COORDINATE WITH THE JDC WITH
RESPECT TO MATTERS RELATING TO THE MANUFACTURING AND LABELING OF THE COMBINATION
PRODUCT FOR COMMERCIAL SUPPLY, INCLUDING, IN THE CASE OF MANUFACTURING, WITH
RESPECT TO QUALITY CONTROL MATTERS, AND THE MONITORING OF MANUFACTURING
CAPACITY, FORECASTS AND ORDERS FOR THE COMBINATION PRODUCT TO ENSURE ADEQUATE
COMMERCIAL SUPPLY TO MEET THE DEMAND THEREFOR IN THE TERRITORY AS PROJECTED BY
THE JCC AND APPROVED BY THE JEC;
(XI)
TO RESOLVE DISPUTES BETWEEN THE MEMBER
PARTIES WITH RESPECT TO A MEMBER PARTY'S OBLIGATION, IF ANY, PURSUANT TO
SECTION 5.10 TO PROVIDE THE OTHER MEMBER PARTY WITH ACCESS TO CERTAIN OF SUCH
MEMBER PARTY'S RECORDS, DOCUMENTATION AND DATA;
(XII)
TO PROVIDE UPDATES ON THE JCC'S ACTIVITIES AND
ACHIEVEMENTS TO THE JEC EACH CALENDAR QUARTER; AND
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(XIII)
TO PERFORM SUCH OTHER FUNCTIONS AS THE MEMBER
PARTIES MAY MUTUALLY AGREE IN WRITING FROM TIME TO TIME.
2.5
JOINT FINANCE COMMITTEE.
(A)
EACH MEMBER SHALL APPOINT TWO (2) MEMBERS
OF A JOINT FINANCE COMMITTEE