AND MAINTAIN THE GLOBAL SAFETY DATABASES FOR EACH LICENSED
PRODUCT (THE "GLOBAL SAFETY DATABASE") INTO WHICH IT SHALL ENTER INFORMATION ON
ALL SERIOUS ADVERSE EVENTS AND SUSPECTED REACTIONS CONCERNING THE LICENSED
PRODUCT OCCURRING ANYWHERE IN THE WORLD AND REPORTED TO EITHER OF THE PARTIES.
SUCH DATABASE SHALL COMPLY IN ALL MATERIAL RESPECTS WITH ALL LAWS
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REASONABLY APPLICABLE TO PHARMACOVIGILANCE ANYWHERE WHERE THE LICENSED PRODUCTS
ARE BEING OR HAVE BEEN DEVELOPED OR COMMERCIALIZED.
4.6
MANUFACTURE AND SUPPLY.
(A)
AS SOON AS REASONABLY PRACTICABLE AFTER THE EFFECTIVE DATE, INCYTE
AND LILLY SHALL AGREE UPON AN APPROPRIATE MANUFACTURING TRANSFER PLAN AND INCYTE
SHALL USE COMMERCIALLY REASONABLE EFFORTS TO TRANSITION THE RESPONSIBILITY FOR
MANUFACTURING LICENSED COMPOUND AND LICENSED PRODUCT TO LILLY IN ACCORDANCE WITH
SUCH PLAN.
LILLY SHALL HAVE THE OPTION, EXERCISABLE WITHIN *** FOLLOWING THE
EFFECTIVE DATE, TO OBTAIN INCYTE'S EXISTING INVENTORY OF LICENSED PRODUCT AND
ANY RELATED RAW MATERIALS OR SUPPLIES AT A PRICE EQUAL TO *** OF INCYTE'S
OUT-OF-POCKET COSTS FOR SUCH INVENTORY OF LICENSED PRODUCT.
LILLY MAY EXERCISE
SUCH OPTION BY WRITTEN NOTICE TO INCYTE DURING SUCH *** PERIOD. IN ADDITION, TO
THE EXTENT INCYTE HAS CONTRACTS WITH THIRD PARTY CONTRACT MANUFACTURERS OR
OTHERS RELATING TO ITS MANUFACTURING OPERATIONS FOR LICENSED COMPOUNDS AND
LICENSED PRODUCTS, IF LILLY SO REQUESTS, INCYTE WILL USE ITS COMMERCIALLY
REASONABLE EFFORTS TO ASSIGN SUCH AGREEMENTS TO LILLY OR OTHERWISE FACILITATE
LILLY'S EFFORTS TO CONTINUE TO UTILIZE SUCH MANUFACTURERS OR SUPPLIERS.
(B)
WITHOUT LIMITING THE FOREGOING, IF LILLY DOES NOT ASSUME DIRECT
RESPONSIBILITIES FOR THE MANUFACTURE OF LICENSED COMPOUND AND LICENSED PRODUCT
WITHIN *** AFTER THE EFFECTIVE DATE, INCYTE WILL INVOICE LILLY FOR ALL
OUT-OF-POCKET COSTS INCURRED BY INCYTE AFTER THE EFFECTIVE DATE FOR THE
MANUFACTURE AND SUPPLY OF LICENSED COMPOUND AND LICENSED PRODUCT FOR LILLY AS
WELL AS INCYTE'S FTES REQUIRED TO MANAGE AND SUPERVISE SUCH MANUFACTURE AND
SUPPLY.
(C)
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, INCYTE
SHALL NOT CONDUCT ANY MANUFACTURING RELATED ACTIVITIES FOLLOWING THE EFFECTIVE
DATE WITHOUT THE EXPRESS WRITTEN CONSENT OF LILLY, EXCEPT FOR THOSE ACTIVITIES
INCIDENTAL TO THE TRANSFER OF MANUFACTURING RESPONSIBILITY TO LILLY IN
ACCORDANCE WITH THE MANUFACTURING TRANSFER PLAN CONTEMPLATED ABOVE.
IF
REQUESTED BY LILLY AND AGREED TO BY INCYTE, INCYTE SHALL SUPPLY LILLY WITH
CLINICAL SUPPLIES OF LICENSED PRODUCT UNDER THE TERMS OF A MUTUALLY ACCEPTABLE
MANUFACTURING AGREEMENT, QUALITY AGREEMENT, AND MANUFACTURING REQUIREMENTS
DOCUMENT RELATING TO INCYTE'S ACTIVITIES, ALL UPON COMMERCIALLY REASONABLE TERMS
CONSISTENT WITH THIS AGREEMENT.
ARTICLE V
COMMERCIALIZATION
5.1
COMMERCIALIZATION DILIGENCE.
DURING THE TERM, LILLY SHALL BE
SOLELY RESPONSIBLE FOR COMMERCIALIZING LICENSED PRODUCTS IN THE TERRITORY FOR
USE IN THE FIELD.
(A)
LILLY SHALL USE COMMERCIALLY REASONABLE EFFORTS, AT ITS EXPENSE,
TO COMMERCIALIZE LICENSED PRODUCTS IN THE FIELD IN THE TERRITORY AFTER RECEIPT
OF REGULATORY APPROVAL THEREFOR.
NOTWITHSTANDING THE FOREGOING, LILLY SHALL
(I) COMMERCIALIZE *** AFTER RECEIPT OF THE RELEVANT REGULATORY APPROVAL;
(II) COMMERCIALIZE *** IN AT LEAST ***
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AFTER