AIDS DRUG ASSISTANCE PROGRAMS,
CORRECTIONAL FACILITIES AND SYSTEMS, MANAGED CARE ORGANIZATIONS AND ALL OTHER
NATIONAL ACCOUNTS IN ALL PAYOR SEGMENTS IN THE TERRITORY, INCLUDING WITHOUT
LIMITATION CONTRACT STRATEGY AND CONTRACT CREATION.
SUCH ACTIVITIES SHALL BE
FURTHER DEFINED IN THE COMMERCIALIZATION PLAN AND SHALL COMPLY WITH SECTION 5.3
AND THE [*].
EXCEPT WITH RESPECT TO PRICING ACTIVITIES, BMS SHALL SHARE IN THE
COMMERCIALIZATION ACTIVITIES IN CORRECTIONAL FACILITIES AND SYSTEMS AND OTHER
NATIONAL ACCOUNTS.
5.5
PERFORMANCE; SUBCONTRACTING.
GILEAD AND BMS
EACH SHALL COMPLY, AND SHALL CAUSE ITS AFFILIATES TO COMPLY, WITH ALL APPLICABLE
LAWS, REGULATIONS AND APPROVALS IN CONDUCTING THEIR RESPECTIVE COMMERCIALIZATION
ACTIVITIES.
EITHER MEMBER PARTY MAY SUBCONTRACT THE PERFORMANCE OF
COMMERCIALIZATION ACTIVITIES ALLOCATED TO IT UNDER THE COMMERCIALIZATION PLAN;
PROVIDED, HOWEVER, THAT THE SUBCONTRACTING MEMBER PARTY SHALL OVERSEE THE
PERFORMANCE BY ITS SUBCONTRACTORS OF SUCH SUBCONTRACTED COMMERCIALIZATION
ACTIVITIES IN A MANNER THAT WOULD BE REASONABLY EXPECTED TO RESULT IN THEIR
TIMELY AND SUCCESSFUL COMPLETION AND SHALL REMAIN RESPONSIBLE FOR THE
PERFORMANCE OF SUCH COMMERCIALIZATION ACTIVITIES IN ACCORDANCE WITH THIS
AGREEMENT AND THE COMMERCIALIZATION PLAN; AND, PROVIDED, FURTHER, THAT NEITHER
GILEAD NOR BMS MAY ENGAGE ANY SUBCONTRACTOR, INCLUDING, WITHOUT LIMITATION, ANY
CONTRACT SALES ORGANIZATION, TO PERFORM ANY DETAILS OF THE COMBINATION PRODUCT.
5.6
CONFLICT AVOIDANCE.
GILEAD AND BMS EACH
AGREES TO ENSURE THAT, DURING THE INITIAL LAUNCH PERIOD, NONE OF ITS FIELD FORCE
EMPLOYEES WHO ENGAGES IN THE MARKETING OF THE COMBINATION PRODUCT SHALL ALSO
MARKET ANY [*] WHICH [*], ANY [*] THAT IS [*] IN THE TERRITORY AS OF [*], OR ANY
[*] THAT IS [*] IN THE TERRITORY AS OF [*].
47
5.7
MARKETING MATERIALS.
(A)
THE JCC SHALL DEVELOP AND APPROVE AN
INITIAL SET OF ADVERTISING AND PROMOTIONAL MATERIALS FOR THE COMBINATION
PRODUCT.
IF THE JCC CANNOT REACH AGREEMENT WITH RESPECT TO SUCH MATERIALS, THE
JEC SHALL ATTEMPT TO RESOLVE ANY DISPUTED ISSUES RELATING TO THE MATERIALS.
IN
THE EVENT THAT THE JCC OR, FOLLOWING A DISPUTE WITHIN THE JCC,
THE JEC SHALL
REACH AGREEMENT WITH RESPECT TO SUCH MATERIALS (AS MODIFIED FROM TIME TO TIME
PURSUANT TO THIS SECTION 5.7, THE "APPROVED MARKETING MATERIALS"), THEN SUBJECT
TO SUBPARAGRAPH (B) BELOW, EACH MEMBER PARTY SHALL USE THE APPROVED MARKETING
MATERIALS (AND ONLY THE APPROVED MARKETING MATERIALS, TOGETHER WITH THE
FDA-APPROVED PRODUCT LABEL AND THE PACKAGE INSERT) IN PROMOTING THE COMBINATION
PRODUCT IN THE TERRITORY FOR AT LEAST THE FIRST TWELVE MONTHS FOLLOWING THE
LAUNCH.
IF EACH OF THE JCC AND THE JEC IS UNABLE TO REACH AGREEMENT ON SUCH
MATERIALS, THEN THE MEMBER PARTIES SHALL PROMOTE THE COMBINATION PRODUCT IN THE
TERRITORY USING ONLY THE FDA-APPROVED PRODUCT LABEL AND THE PACKAGE INSERT FOR
THE COMBINATION PRODUCT.
(B)
EACH MEMBER PARTY MAY PROPOSE INTERIM
UPDATES TO THE APPROVED MARKETING MATERIALS FROM TIME TO TIME, INDEPENDENT OF
THE ANNUAL REVIEWS CONDUCTED PURSUANT TO SECTION 5.7(C).
THE JCC SHALL BE
REQUIRED TO CONSIDER, AND SHALL ADOPT, SUCH UPDATES ONLY IF THEY SATISFY THE
FOLLOWING CONDITIONS:
(I) THE UPDATE IS BASED ON RELEVANT NEW SCIENTIFIC,
MEDICAL OR CLINICAL DATA, RELEVANT NEW REGULATORY