FOLLOWING RECEIPT BY THE JPT OF A
WRITTEN PROPOSAL IN ACCORDANCE WITH SECTION 4.3(A)(I) RELATING THERETO, SUCH
PARTY (THE "BUY-IN PARTY") MAY OBTAIN ACCESS TO AND USE OF THE CLINICAL DATA
GENERATED PURSUANT TO THE RELEVANT CLINICAL TRIAL OR DEVELOPMENT ACTIVITY IN
ACCORDANCE WITH THE FOLLOWING PROCEDURE:
AT LEAST ON A *** BASIS, THE PARTY
PARTICIPATING IN A CLINICAL TRIAL OR DEVELOPMENT ACTIVITY PURSUANT TO
SECTION 4.3(B) SHALL UPDATE THE BUY-IN PARTY ON THE STATUS OF SUCH CLINICAL
TRIAL OR DEVELOPMENT ACTIVITY, INCLUDING A SUMMARY OF RELEVANT DATA.
AT ANY
TIME, THE BUY-IN PARTY MAY PROVIDE THE OTHER PARTY WITH NOTICE OF ITS ELECTION
TO PARTICIPATE IN SUCH CLINICAL TRIAL OR DEVELOPMENT ACTIVITY, AND PROMPTLY
THEREAFTER THE OTHER PARTY SHALL PROVIDE THE BUY-IN PARTY WITH AN INVOICE FOR
*** OF THE DEVELOPMENT COSTS INCURRED BY THE OTHER PARTY IN THE GENERATION OF
SUCH CLINICAL DATA AS OF THE DATE OF THE BUY-IN PARTY'S WRITTEN REQUEST, WHICH
INVOICE THE BUY-IN PARTY SHALL PAY WITHIN *** AFTER RECEIPT.
THEREAFTER, TO THE
EXTENT THE DEVELOPMENT ACTIVITY HAS NOT BEEN COMPLETED, THE BUY-IN PARTY SHALL
BE RESPONSIBLE FOR *** OF THE DEVELOPMENT COSTS INCURRED BY THE OTHER PARTY.
SUCH PAYMENT SHALL ENTITLE THE BUY-IN PARTY TO USE ONLY THE DATA SO PAID FOR.
THE OTHER PARTY SHALL, AS APPLICABLE, PROVIDE COPIES OF, AND/OR A RIGHT OF
REFERENCE OR USE OF, THE REQUESTED CLINICAL DATA TO THE BUY-IN PARTY PROMPTLY
AFTER RECEIPT OF THE INVOICED AMOUNT.
(II)
IN THE EVENT NOVARTIS IS THE BUY-IN PARTY
AND HAS EXERCISED THE BUY-IN RIGHT WITH RESPECT TO A CLINICAL TRIAL THAT WOULD
QUALIFY FOR A MILESTONE SET FORTH IN SECTION
34
*** Confidential material redacted and filed separately with the Commission.
8.2, THEN IN ADDITION TO THE DEVELOPMENT COSTS SET FORTH IN
SECTION 4.3(A)(I) ABOVE, INCYTE SHALL INVOICE NOVARTIS FOR THE APPLICABLE
MILESTONE PAYMENT(S) SET FORTH IN SECTION 8.2 AND NOVARTIS SHALL PAY SUCH
MILESTONE PAYMENT(S) IN ACCORDANCE WITH SECTION 8.2(I).
(III)
FOR THE AVOIDANCE OF DOUBT, THE BUY-IN RIGHT
PURSUANT TO THIS SECTION 4.3(C) DOES NOT INCLUDE THE RIGHT TO OPERATIONAL
PARTICIPATION IN THE CONDUCT OF THE CLINICAL TRIAL OR DEVELOPMENT ACTIVITY
UNLESS, AT THE SOLE DISCRETION OF THE PARTY THAT INITIATED THE CLINICAL TRIAL OR
DEVELOPMENT ACTIVITY, SUCH PARTY GRANTS OPERATIONAL PARTICIPATION TO THE BUY-IN
PARTY.
(IV)
IN THE EVENT THE BUY-IN PARTY FAILS TO MEET
ANY PAYMENT OBLIGATION PURSUANT TO THIS SECTION 4.3(C), AND SUCH FAILURE
CONTINUES FOR *** AFTER THE ORIGINAL DUE DATE OF THE PAYMENT, UNTIL SUCH
DELINQUENCY IS CURED, THE DATA GENERATED PURSUANT TO THE CLINICAL TRIAL OR
DEVELOPMENT ACTIVITY SHALL NOT BE SHARED WITH THE BUY-IN PARTY.
IN THE EVENT
SUCH DELINQUENCY IS NOT CURED WITHIN ***, THE BUY-IN PARTY'S NOTICE OF ELECTION
TO PARTICIPATE SHALL BE CONSIDERED VOID.
(D)
RIGHTS TO DATA AND
DOCUMENTATION.
WITH RESPECT TO ANY JOINT DEVELOPMENT ACTIVITIES:
(I)
SUBJECT TO SECTION 4.3(C), EACH PARTY
SHALL HAVE THE RIGHT TO POSSESS, RETAIN AND USE ALL CLINICAL AND NON-CLINICAL
DATA AND RELATED REGULATORY DOCUMENTATION CONTROLLED BY EITHER