APPLICABLE TO PHARMACOVIGILANCE ANYWHERE WHERE THE LICENSED PRODUCTS
ARE BEING OR HAVE BEEN DEVELOPED OR COMMERCIALIZED. THE PHARMACOVIGILANCE
AGREEMENT SHALL, AMONG OTHER THINGS, GOVERN COOPERATION BETWEEN THE PARTIES THAT
WILL ENABLE EACH OF THEM TO COMPLY WITH ITS RESPECTIVE OBLIGATIONS UNDER
APPLICABLE LAWS WITH REGARD TO ADVERSE EVENT DATA COLLECTION, ANALYSIS AND
REPORTING AND TO ENABLE EACH PARTY TO SATISFY ITS DUTY OF CARE, AND TO GOVERN
THE GLOBAL SAFETY DATABASE.
ARTICLE V
CLINICAL AND COMMERCIAL SUPPLY
5.1
Clinical Supply.
(A)
MANUFACTURE AND SUPPLY OF JAK
LICENSED PRODUCT FOR STUDY 352.
EXCEPT AS SPECIFICALLY PROVIDED IN THAT LETTER
AGREEMENT DATED NOVEMBER 13, 2009, INCYTE SHALL REMAIN RESPONSIBLE FOR THE
SUPPLY OF PRECLINICAL AND CLINICAL MATERIAL OF JAK LICENSED PRODUCT FOR USE IN
THE CONDUCT OF STUDY 352, UNTIL SUCH TIME AS THE JAK JDC DETERMINES THAT
NOVARTIS SHOULD ASSUME RESPONSIBILITY FOR STUDY 352.
WITHIN *** AFTER THE
EFFECTIVE DATE, NOVARTIS SHALL REIMBURSE INCYTE THE OUT-OF-POCKET COSTS FOR THE
SUPPLY OF DRUG SUBSTANCE AND DRUG PRODUCT FOR JAK LICENSED COMPOUNDS AND JAK
LICENSED PRODUCTS AS DESCRIBED IN EXHIBIT C-1 AND THAT HAVE BEEN INCURRED AS OF
THE EFFECTIVE DATE.
40
*** Confidential material redacted and filed separately with the Commission.
(B)
ON-GOING CLINICAL SUPPLY BY
INCYTE.
IN THE EVENT THAT NOVARTIS DETERMINES THAT INCYTE SHOULD PROVIDE THE
SUPPLY OF DRUG SUBSTANCE AND DRUG PRODUCT FOR LICENSED PRODUCT FOR NOVARTIS
DEVELOPMENT ACTIVITIES, THE PARTIES SHALL ENTER INTO A CLINICAL SUPPLY AGREEMENT
IN THE FORM ATTACHED AS EXHIBIT C-2 (THE "CLINICAL SUPPLY AGREEMENT"), UNDER
WHICH INCYTE SHALL:
(I)
USE COMMERCIALLY REASONABLE EFFORTS TO
SUPPLY NOVARTIS WITH SUCH DRUG SUBSTANCE OR DRUG PRODUCT AS REQUESTED IN WRITING
FROM NOVARTIS, INCLUDING API, FORMULATION, CMC AND BLISTER FORMULATION WORK.
NOVARTIS SHALL REIMBURSE INCYTE'S OUT-OF-POCKET COSTS, SUBJECT TO AN AGREED UPON
BUDGET AND PAYMENT SCHEDULE BY THE PARTIES;
(II)
USE COMMERCIALLY REASONABLE EFFORTS TO
MANUFACTURE, HANDLE AND SUPPLY, AND SHALL USE COMMERCIALLY REASONABLE EFFORTS TO
CAUSE ITS THIRD PARTY SUPPLIER(S), AS APPLICABLE, TO MANUFACTURE, HANDLE AND
SUPPLY, ALL SUCH DRUG SUBSTANCE OR DRUG PRODUCT FOR LICENSED COMPOUND AND
LICENSED PRODUCT SUPPLIED BY INCYTE OR ITS AFFILIATE TO NOVARTIS PURSUANT TO THE
CLINICAL SUPPLY AGREEMENT (A) IN ACCORDANCE WITH THEN-CURRENT GOOD MANUFACTURING
PRACTICES, AS DEFINED IN ANY APPLICABLE REGULATORY AUTHORITY'S RULES AND
REGULATIONS, AS THE SAME MAY BE AMENDED FROM TIME TO TIME ("GMP"); (B) IN
COMPLIANCE WITH ALL APPLICABLE LAWS; (C) IN CONFORMANCE WITH ALL SPECIFICATIONS
FOR SUCH DRUG SUBSTANCE OR DRUG PRODUCT AS DETERMINED BY THE PARTIES AND AS
REQUIRED BY REGULATORY AUTHORITIES, INCLUDING SPECIFICATIONS PERTAINING TO
MANUFACTURING METHODS, TESTING, MATERIALS, FACILITIES, RELEASE, LABELING,
PACKAGING, STORAGE, SHIPMENT, AND SHELF-LIFE.
(III)
PROVIDE NOVARTIS WITH ACCESS TO ALL
SUPPLIERS IN INCYTE'S SUPPLY CHAIN, AS PERMITTED UNDER INCYTE'S
AGREEMENT(S) WITH SUCH PARTIES, FOR THE PURPOSES OF AUDITING AND ENSURING
COMPLIANCE WITH GMPS AND HSE ISSUES; AND
(IV)
AT NOVARTIS' REQUEST, INCYTE SHALL USE
REASONABLE EFFORTS TO FACILITATE NEGOTIATIONS BETWEEN NOVARTIS AND INCYTE'S
THIRD PARTY MANUFACTURER(S) THAT MANUFACTURE SUCH DRUG PRODUCT OR DRUG SUBSTANCE
TO ENABLE NOVARTIS TO DISCUSS