PARTY AND
GENERATED IN THE COURSE OF SUCH DEVELOPMENT ACTIVITIES IN ORDER TO DEVELOP,
OBTAIN REGULATORY APPROVAL FOR AND COMMERCIALIZE JAK LICENSED PRODUCTS IN THE
JAK FIELD IN SUCH PARTY'S TERRITORY IN ACCORDANCE WITH THE TERMS OF THIS
AGREEMENT.
FOR THE AVOIDANCE OF DOUBT, NOVARTIS' RIGHT TO POSSESS, RETAIN AND
USE PRE-CLINICAL AND CLINICAL DATA RELATED TO JAK LICENSED COMPOUNDS AND JAK
LICENSED PRODUCTS AND CONTROLLED BY INCYTE THAT EXIST AS OF THE EFFECTIVE DATE
OR THAT ARE GENERATED FROM STUDY INCB018424-256 FOR ALL POLYCYTHEMIA VERA
FILINGS TO A REGULATORY AUTHORITY FOR JAK LICENSED COMPOUNDS AND JAK LICENSED
PRODUCTS, SHALL NOT BE SUBJECT TO SECTION 4.3(C);
(II)
EACH PARTY HEREBY GRANTS TO THE OTHER
PARTY A RIGHT OF REFERENCE OR USE TO ANY AND ALL SUCH REGULATORY DOCUMENTATION,
AND AGREES TO SIGN, AND CAUSE ITS AFFILIATES TO SIGN, FROM TIME TO TIME,
PROMPTLY UPON REQUEST, ANY INSTRUMENTS REASONABLY REQUESTED BY SUCH OTHER PARTY
IN ORDER TO EFFECT SUCH GRANT;
(III)
EACH PARTY SHALL MAINTAIN COMPLETE AND
ACCURATE RECORDS OF ALL RESULTS, DATA, DEVELOPMENT COSTS AND DEVELOPMENTS MADE
PURSUANT TO ITS EFFORTS UNDER THE DEVELOPMENT PLAN.
SUCH RECORDS SHALL
APPROPRIATELY REFLECT ALL WORK DONE AND RESULTS ACHIEVED IN THE PERFORMANCE OF
DEVELOPMENT ACTIVITIES IN SUFFICIENT DETAIL AND IN GOOD SCIENTIFIC MANNER
APPROPRIATE FOR PATENT AND REGULATORY PURPOSES; AND
(IV)
IN ANY AGREEMENT BETWEEN EITHER PARTY AND A
CLINICAL RESEARCH ORGANIZATION RELATED TO A JOINT DEVELOPMENT ACTIVITY, THE
CONTRACTING PARTY SHALL USE REASONABLE EFFORTS TO NAME THE OTHER PARTY AS A
THIRD PARTY BENEFICIARY FOR THE PURPOSE OF RECEIVING DATA DERIVED FROM CLINICAL
TRIALS RELATED TO SUCH JOINT DEVELOPMENT ACTIVITY FROM SUCH CLINICAL RESEARCH
ORGANIZATION IN THE EVENT OF A BANKRUPTCY EVENT OF SUCH PARTY.
35
*** Confidential material redacted and filed separately with the Commission.
4.4
c-MET Licensed Compound Co-Development
Option.
(A)
WITHIN *** PRIOR TO THE
ANTICIPATED INITIATION OF A PHASE III STUDY FOR THE C-MET LICENSED COMPOUND
INCB28060, NOVARTIS SHALL NOTIFY INCYTE OF SUCH ANTICIPATED INITIATION AND SHALL
PROVIDE INCYTE WITH THE FOLLOWING INFORMATION:
ALL MATERIAL PRE-CLINICAL AND
CLINICAL DATA AND RELATED ANALYSIS AND REGULATORY INFORMATION SUBMITTED TO ANY
REGULATORY AUTHORITIES PRIOR TO THE APPLICABLE TIME-PERIOD MENTIONED ABOVE, AND
NOVARTIS' THEN CURRENT DEVELOPMENT PLANS AND BUDGETS WITH RESPECT TO SUCH C-MET
LICENSED COMPOUND.
INCYTE SHALL HAVE THE OPTION, EXERCISABLE BY (A) PROVIDING
NOVARTIS WRITTEN NOTICE WITHIN *** AFTER RECEIPT OF SUCH INFORMATION AND
(B) CO-FUNDING *** OF NOVARTIS' GLOBAL DEVELOPMENT COSTS FOR SUCH C-MET LICENSED
COMPOUND INCURRED AFTER THE DATE OF SUCH NOTICE.
(B)
IF INCYTE TIMELY DELIVERS SUCH
NOTICE, WITHIN *** FOLLOWING THE END OF EACH CALENDAR QUARTER AFTER INCYTE HAS
DELIVERED SUCH NOTICE, NOVARTIS SHALL PREPARE AND DELIVER TO INCYTE A QUARTERLY
REPORT DETAILING ITS DEVELOPMENT COSTS INCURRED DURING SUCH PERIOD WITH RESPECT
TO SUCH C-MET LICENSED COMPOUND.
NOVARTIS SHALL SUBMIT ANY SUPPORTING
INFORMATION REASONABLY REQUESTED BY INCYTE RELATED TO SUCH DEVELOPMENT COSTS
INCLUDED IN ITS REPORT WITHIN *** AFTER ITS RECEIPT OF SUCH REQUEST.
NOVARTIS
SHALL ISSUE AN INVOICE TO INCYTE FOR *** OF THE