TO BE CONSIDERED AS A POSSIBLE SUPPLIER OF
THE COMBINATION PRODUCT, IT SHALL SUBMIT A CONFIDENTIAL WRITTEN PROPOSAL TO THE
JV FOR CONSIDERATION BY THE JCC ALONGSIDE WRITTEN PROPOSALS SUBMITTED BY
RECOGNIZED, RELIABLE AND SUFFICIENTLY CAPITALIZED THIRD PARTIES AND/OR THE
SUPPLY TERMS PERTAINING TO THE INITIAL SUPPLIER.
ANY PROPOSAL SUBMITTED BY A
POSSIBLE SUPPLIER SHALL INCLUDE AN OFFER TO PERFORM ANY REQUIRED TABLETING,
BLISTERING, PACKAGING, LABELING, ANALYTICAL TESTING AND STORAGE ACTIVITIES WITH
RESPECT TO COMMERCIAL SUPPLIES OF THE COMBINATION PRODUCT.
THE JCC SHALL SELECT
A PERSON TO SUPPLY THE JV WITH COMMERCIAL SUPPLIES OF THE COMBINATION PRODUCT ON
THE BASIS OF PRICE, QUALITY, RELIABILITY, GMP COMPLIANCE, SECURITY OF SUPPLY AND
OTHER RELEVANT COMMERCIAL CONSIDERATIONS.
IF A THIRD PARTY IS SELECTED AS A
SUPPLIER, THE JCC SHALL DESIGNATE A MEMBER PARTY TO MANAGE THE RELATIONSHIP WITH
THAT SUPPLIER. ANY SUPPLY CONTRACT BETWEEN THE JV AND GILEAD OR BMS AS SUPPLIER
SHALL BE NEGOTIATED ON AN ARM'S-LENGTH BASIS AND SHALL CONTAIN SUCH TERMS AND
CONDITIONS AS ARE CUSTOMARY IN THE PHARMACEUTICAL INDUSTRY, MODIFIED AS
APPROPRIATE FOR THE COMBINATION PRODUCT.
(B)
THE JCC, DIRECTLY OR THROUGH A DESIGNATED
MEMBER PARTY, AND IN COORDINATION WITH THE JDC, SHALL MONITOR MANUFACTURING
CAPACITY OF, AND FORECASTS AND ORDERS FOR, THE COMBINATION PRODUCT SUBMITTED TO
THE RELEVANT SUPPLIER(S) TO ENSURE THAT ADEQUATE COMMERCIAL SUPPLIES OF THE
COMBINATION PRODUCT WILL BE AVAILABLE TO MEET THE DEMAND THEREFOR AS PROJECTED
BY THE JCC IN COMMERCIAL UNIT VOLUME FORECASTS.
THE JCC SHALL PREPARE [*]
ROLLING UNIT VOLUME FORECASTS AT LEAST [*] BEFORE THE COMMENCEMENT OF EACH
FORECAST PERIOD, AND SHALL UPDATE SUCH UNIT VOLUME FORECASTS ON A [*] BASIS, OR
AS THE JCC DEEMS NECESSARY AND APPROPRIATE.
(C)
IN CONNECTION WITH THE MANUFACTURE BY THE
SUPPLIER OF THE COMMERCIAL SUPPLY OF THE COMBINATION PRODUCT FOR THE JV, GILEAD
AND BMS EACH SHALL SUPPLY TO THE JV QUANTITIES OF FTC AND TDF, IN THE CASE OF
GILEAD, AND EFV, IN THE CASE OF BMS, AND IN EACH CASE IN THE FORM OF BULK ACTIVE
PHARMACEUTICAL INGREDIENT, PURSUANT TO AND IN ACCORDANCE WITH THEIR RESPECTIVE
SUPPLY AGREEMENTS.
IN CONSIDERATION OF SUCH SUPPLY, THE JV SHALL PAY TO GILEAD
AND BMS, RESPECTIVELY, THE GILEAD TRANSFER PRICE AND THE BMS TRANSFER PRICE.
THE JDC SHALL MONITOR ORDERS UNDER THE RESPECTIVE SUPPLY AGREEMENTS TO ASSURE
CONSISTENCY IN THE QUANTITIES OF FTC, TDF AND EFV ORDERED BY THE JV THEREUNDER.
41
SECTION 5.
COMMERCIALIZATION ACTIVITIES
5.1
CO-PROMOTION OBLIGATIONS.
(A)
GILEAD AND BMS EACH SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO PERFORM IN THE TERRITORY THE COMMERCIALIZATION ACTIVITIES
THAT SUCH MEMBER PARTY IS REQUIRED TO PERFORM UNDER THE COMMERCIALIZATION PLAN
IN ACCORDANCE WITH THE COMMERCIALIZATION BUDGET AS APPLICABLE TO SUCH
ACTIVITIES, FOR SO LONG AS THERE IS A COMMERCIALIZATION PLAN IN EFFECT.
EACH
MEMBER PARTY SHALL BE REQUIRED, DURING THE INITIAL LAUNCH PERIOD AND (TO THE
EXTENT THERE IS A [*] APPLICABLE THERETO) THE SUBSEQUENT LAUNCH PERIOD, TO [*]
PER CALENDAR QUARTER, AND TAKE THE OTHER ACTIONS, APPLICABLE TO IT AS SPECIFIED
IN THE COMMERCIALIZATION PLAN.
SUBJECT