CHAIRPERSON, ON A ROTATING ANNUAL BASIS FROM EACH ANNIVERSARY OF THE EFFECTIVE
DATE.
THE INITIAL JDC MEMBERS AND THE CHAIRPERSON ARE IDENTIFIED IN ANNEX A
HERETO.
(B)
SUBJECT TO THE OVERSIGHT OF THE JEC, THE JDC
SHALL HAVE THE FOLLOWING POWERS AND DUTIES:
(I)
TO (X) REVIEW AND PROPOSE TO THE JEC FOR
ITS APPROVAL EACH ANNUAL UPDATE OF THE DEVELOPMENT PLAN AND DEVELOPMENT BUDGET
AND (Y) REVIEW AND APPROVE EACH INTERIM UPDATE OF THE DEVELOPMENT PLAN AND
DEVELOPMENT BUDGET, IN EACH CASE PROPOSED PURSUANT TO SECTION 3.7;
(II)
TO OVERSEE AND COORDINATE THE PARTIES'
ACTIVITIES UNDER THE DEVELOPMENT PLAN;
(III)
TO OVERSEE AND MANAGE MATTERS RELATING TO
CLINICAL SUPPLY OF THE COMBINATION PRODUCT, INCLUDING, WITHOUT LIMITATION,
MANUFACTURING REQUIREMENTS, INVENTORY PROJECTIONS AND INVENTORY CONTROL;
(IV)
WITH THE ALLIANCE MANAGERS, (X) TO ASSIST IN
COORDINATING SCIENTIFIC INTERACTIONS BETWEEN THE PARTIES DURING THE COURSE OF
IMPLEMENTING THE DEVELOPMENT PLAN AND (Y) TO FACILITATE THE EXCHANGE AMONG THE
PARTIES OF DATA, INFORMATION, MATERIALS AND RESULTS RELATING TO CLINICAL
MANUFACTURING, CLINICAL TRIALS, AND COMMUNICATIONS AND FILINGS WITH REGULATORY
AUTHORITIES FOR THE COMBINATION PRODUCT (IN EACH CASE SOLELY TO THE EXTENT THAT
SUCH
22
DATA, INFORMATION AND MATERIALS ARE REQUIRED TO BE EXCHANGED AMONG THE PARTIES,
OR WITH RESPECT TO WHICH ONE MEMBER PARTY HAS THE RIGHT TO GAIN ACCESS FROM THE
OTHER MEMBER PARTY OR THE JV, PURSUANT TO THIS AGREEMENT OR THE OPERATING
AGREEMENT);
(V)
TO OVERSEE REGULATORY MATTERS FOR THE JV,
INCLUDING, WITHOUT LIMITATION, APPROVING ALL COMBINATION PRODUCT REGULATORY
DOCUMENTATION TO THE EXTENT REQUIRED PURSUANT TO SECTION 3.4, OVERSEEING
GILEAD'S ACTIVITIES AS THE JV'S LIAISON WITH REGULATORY AUTHORITIES IN THE
TERRITORY, AND OVERSEEING THE ACTIVITIES CONDUCTED PURSUANT TO THE SDEA AND
OTHER PHARMACOVIGILANCE AND SAFETY REPORTING;
(VI)
TO OVERSEE THE MEMBER PARTIES' ACTIVITIES
PURSUANT TO THEIR RESPECTIVE SUPPLY AGREEMENTS AND TO OVERSEE AND COORDINATE
WITH THE JCC WITH RESPECT TO MATTERS RELATING TO THE MONITORING OF MANUFACTURING
CAPACITY, FORECASTS AND ORDERS FOR THE ACTIVE PHARMACEUTICAL INGREDIENTS OF THE
COMBINATION PRODUCT;
(VII)
TO RESOLVE
DISPUTES BETWEEN THE MEMBER PARTIES
WITH RESPECT TO (A) ANY REQUIRED APPROVAL OF PUBLICATIONS OR PRESENTATIONS
PURSUANT TO SECTION 3.11(A), AND (B) A MEMBER PARTY'S OBLIGATION UNDER
SECTION 3.6(B), IF ANY, TO PROVIDE THE OTHER MEMBER PARTY WITH ACCESS TO CERTAIN
OF SUCH MEMBER PARTY'S RECORDS, DOCUMENTATION AND DATA;
(VIII)
TO OVERSEE MEDICAL AFFAIRS AND MEDICAL
COMMUNICATIONS ACTIVITIES;
(IX)
TO REVIEW AND APPROVE OR REJECT PROPOSALS
FOR PHASE IV CLINICAL STUDIES OF THE COMBINATION PRODUCT;
(X)
TO PROVIDE UPDATES ON THE JDC'S ACTIVITIES
AND ACHIEVEMENTS TO THE JEC EACH CALENDAR QUARTER;
AND
(XI)
TO PERFORM SUCH OTHER FUNCTIONS AS THE
MEMBER PARTIES MAY MUTUALLY AGREE IN WRITING FROM TIME TO TIME.
2.4
JOINT COMMERCIALIZATION COMMITTEE.
(A)
EACH MEMBER SHALL APPOINT FOUR (4) MEMBERS
OF A JOINT COMMERCIALIZATION OVERSIGHT AND MANAGEMENT COMMITTEE (THE "JOINT
COMMERCIALIZATION COMMITTEE" OR "JCC").
BMS SUB SHALL APPOINT ONE (1) OF THE
MEMBERS DESIGNATED BY BMS SUB, TO SERVE AS CHAIRPERSON OF THE JCC THROUGH THE
FIRST ANNIVERSARY OF THE EFFECTIVE DATE.
THEREAFTER A MEMBER