TO SECTION 2.10, [*] SHALL APPLY (I)
DURING THE SUBSEQUENT LAUNCH PERIOD UNLESS APPROVED BY THE JEC OR JCC AS
APPLICABLE, AS PART OF A COMMERCIALIZATION PLAN UPDATE PURSUANT TO
SECTION 5.11(C), AND (II) AFTER THE SUBSEQUENT LAUNCH PERIOD UNLESS APPROVED BY
THE MEMBER PARTIES.
EACH MEMBER PARTY SHALL BE FREE TO ENGAGE IN [*], AND TO
ENGAGE IN [*] WHEN THERE IS NO LONGER A COMMERCIALIZATION PLAN IN EFFECT, IN
EACH CASE IN ITS SOLE DISCRETION.
(B)
GILEAD AND BMS SHALL SELECT INDEPENDENTLY
THE TARGET PRESCRIBERS TO WHICH EACH SHALL PROMOTE THE COMBINATION PRODUCT.
(C)
IN ACCORDANCE WITH SECTION 2.9(B), GILEAD
AND BMS SHALL EACH CAUSE ITS FIELD FORCE TO USE ONLY THE FDA-APPROVED PRODUCT
LABELS AND INSERTS AND, SUBJECT TO SECTION 5.7, THE APPROVED MARKETING MATERIALS
IN PROMOTING THE COMBINATION PRODUCT, AND TO MAKE ONLY SUCH STATEMENTS AND
CLAIMS REGARDING THE COMBINATION PRODUCT AS ARE CONSISTENT WITH APPLICABLE LAW
AND FDA-APPROVED PRODUCT LABELS AND INSERTS.
GILEAD AND BMS SHALL NOT PROVIDE
OR GIVE ACCESS TO SAMPLES OF THE COMBINATION PRODUCT TO HEALTH CARE
PRACTITIONERS OR PATIENTS IN CONNECTION WITH PROMOTION OF THE COMBINATION
PRODUCT.
(D)
GILEAD AND BMS SHALL EACH DETAIL THE
COMBINATION PRODUCT AND PERFORM ITS OTHER PROMOTIONAL ACTIVITIES UNDER THIS
AGREEMENT IN THE TERRITORY IN STRICT ADHERENCE TO REGULATORY AND PROFESSIONAL
REQUIREMENTS, AND TO ALL APPLICABLE LAW, INCLUDING, TO THE EXTENT APPLICABLE,
THE ACT; THE FDA GUIDANCE FOR INDUSTRY-SUPPORTED SCIENTIFIC AND EDUCATIONAL
ACTIVITIES; THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA CODE ON
INTERACTIONS WITH HEALTHCARE PROFESSIONALS; THE OFFICE OF INSPECTOR GENERAL
COMPLIANCE PROGRAM GUIDANCE FOR PHARMACEUTICAL MANUFACTURERS; THE AMERICAN
MEDICAL ASSOCIATION GUIDELINES ON GIFTS TO PHYSICIANS FROM INDUSTRY; THE
PHARMACEUTICAL MARKETING RESEARCH GROUP GUIDELINES ON MARKET RESEARCH
ACTIVITIES; THE PRESCRIPTION DRUG MARKETING ACT OF 1987, AS AMENDED ("PDMA");
AND ALL FEDERAL, STATE AND LOCAL "FRAUD AND ABUSE," CONSUMER PROTECTION AND
FALSE CLAIMS STATUTES AND REGULATIONS, INCLUDING BUT NOT LIMITED TO THE MEDICARE
AND STATE HEALTH PROGRAMS ANTI-FRAUD AND ABUSE AMENDMENTS OF THE SOCIAL SECURITY
ACT, THE "SAFE HARBOR REGULATIONS" FOUND AT 42 C.F.R. §1001.952 ET SEQ.
AS
AMONG THE PARTIES, EACH MEMBER PARTY SHALL TREAT ITS SALES REPRESENTATIVES
ENGAGED IN DETAILING THE COMBINATION PRODUCT AS ITS (OR ITS AFFILIATE'S) OWN
EMPLOYEES FOR ALL PURPOSES, INCLUDING, WITHOUT LIMITATION, FEDERAL, STATE AND
LOCAL TAX AND EMPLOYMENT LAWS.
(E)
WITHIN [*] AFTER THE END OF EACH CALENDAR
QUARTER (OR PART THEREOF) FALLING WITHIN (I) THE INITIAL LAUNCH PERIOD, (II) (TO
THE EXTENT THERE IS A [*] APPLICABLE THERETO) THE
42
SUBSEQUENT LAUNCH PERIOD, OR (III) ANY PERIOD COMMENCING AFTER THE SUBSEQUENT
LAUNCH PERIOD IF MUTUALLY AGREED BY THE MEMBER PARTIES PURSUANT TO SECTION 2.10
(CLAUSES (I), (II) AND (III) BEING REFERRED TO HEREIN COLLECTIVELY AS THE
"PRODUCT DETAIL PERIOD"), GILEAD AND BMS SHALL EACH FURNISH THE OTHER PARTIES
WITH A WRITTEN REPORT, IN THE FORM SET FORTH IN ANNEX H ATTACHED HERETO, SETTING
OUT THE NUMBER OF DETAILS THAT IT HAS CONDUCTED DURING SUCH CALENDAR QUARTER (OR
PART THEREOF) IN THE TERRITORY.
THE NUMBER SO REPORTED SHALL BE