CLINICAL
TRIAL COMMENCED BY INCYTE PRIOR TO THE EFFECTIVE DATE, AND AGREES TO SIGN, AND
CAUSE ITS AFFILIATES TO SIGN, ANY INSTRUMENTS REASONABLY REQUESTED BY LILLY IN
ORDER TO EFFECT SUCH GRANT.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 4.1 IS INTENDED TO IMPLY THE EXISTENCE OF ANY PARTICULAR DATA,
INFORMATION, DRUG MASTER FILE OR OTHER REGULATORY DOCUMENTATION.
(D)
APPLICABILITY OF BANKRUPTCY CODE.
FOR THE AVOIDANCE OF DOUBT,
RIGHTS GRANTED UNDER THIS ARTICLE IV SHALL BE DEEMED TO BE LICENSE OF RIGHTS TO
"INTELLECTUAL PROPERTY" AS DEFINED IN SECTION 101 (35A) OF THE BANKRUPTCY CODE
AND SHALL OTHERWISE BE SUBJECT TO SECTION 2.3.
4.2
CONDUCT OF DEVELOPMENT ACTIVITIES.
(A)
GENERALLY.
(I)
EXCEPT AS PROVIDED IN SECTION 4.2(A)(II), FROM AND AFTER THE
EFFECTIVE DATE, LILLY WILL, SUBJECT TO THE TERMS OF THIS AGREEMENT, BE
RESPONSIBLE, AT ITS EXPENSE, FOR THE DEVELOPMENT OF LICENSED PRODUCTS IN THE
FIELD IN THE TERRITORY.
WITHOUT LIMITING THE FOREGOING, EXCEPT AS PROVIDED IN
SECTION 4.2(A)(II), LILLY SHALL BE RESPONSIBLE FOR ALL OUT-OF-POCKET COSTS,
INCLUDING COSTS FOR CONTRACT RESEARCH ORGANIZATIONS AND DRUG SUBSTANCE AND DRUG
PRODUCT COSTS, ASSOCIATED WITH STUDIES 28050-103, 102 AND 110 (THE "ONGOING
STUDIES") THAT ARE INCURRED AFTER THE EFFECTIVE DATE, IT BEING UNDERSTOOD THAT
INCYTE SHALL BE RESPONSIBLE FOR ALL COSTS
20
*** Confidential material redacted and filed separately with the Commission.
INCURRED PRIOR TO THE EFFECTIVE DATE, WHETHER BILLED PRIOR TO THE EFFECTIVE DATE
OR THEREAFTER.
INCYTE SHALL TRANSFER THE ONGOING STUDIES TO LILLY WITHIN ***
AFTER THE EFFECTIVE DATE.
INCYTE SHALL INVOICE LILLY FOR INCYTE'S OUT-OF-POCKET
COSTS INCURRED AFTER THE EFFECTIVE DATE AND FTE COSTS IN CONNECTION WITH THE
MANAGEMENT AND SUPERVISION OF SUCH ONGOING STUDIES AFTER THE EFFECTIVE DATE.
(II)
INCYTE SHALL CONTINUE TO ADVANCE, AT ITS EXPENSE, ALL CLINICAL
DEVELOPMENT CONDUCTED BY INCYTE FOR THE INITIAL LEAD COMPOUND THROUGH THE
COMPLETION OF THE ONGOING PHASE IIA TRIAL, STUDY INCB28050-201 (THE "INCYTE
PHASE IIA STUDY").
(III)
THE DEVELOPMENT OF LICENSED PRODUCTS SHALL BE GOVERNED BY
DEVELOPMENT PLANS THAT DESCRIBE THE PROPOSED OVERALL PROGRAM OF DEVELOPMENT FOR
LICENSED PRODUCTS (THE "DEVELOPMENT PLAN"); INCLUDING:
A.
OVERALL GOALS OF THE PROGRAM;
B.
THE ACTIVITIES TO BE PERFORMED (INCLUDING ALL CLINICAL TRIALS AND
REGULATORY APPROVALS REQUIRED FOR MANUFACTURING, MARKETING AND SELLING LICENSED
PRODUCTS IN THE TERRITORY), AS WELL AS THE CHARACTERIZATION OF STUDIES;
C.
A DETAILED BUDGET OF DEVELOPMENT COSTS, INCLUDING THE OVERALL
COSTS FOR EACH STUDY, ANNUALIZED OVER THE COURSE OF EACH SUCH STUDY
("DEVELOPMENT BUDGET");
D.
ANTICIPATED TIMELINES FOR PERFORMANCE; AND
E.
SPECIFIC DELIVERABLES.
(IV)
A CURRENT DRAFT OF A SUMMARY DEVELOPMENT PLAN FOR THE INITIAL LEAD
COMPOUND IS ATTACHED HERETO AS EXHIBIT C (THE "INITIAL DEVELOPMENT PLAN").
LILLY SHALL HAVE THE SOLE RIGHT AND RESPONSIBILITY FOR PREPARING THE
DEVELOPMENT PLAN FOR EACH LICENSED PRODUCT IN THE FIELD IN THE TERRITORY.
EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, WITH RESPECT TO LICENSED PRODUCT
IN THE FIELD IN THE TERRITORY, ALL DECISIONS WITH RESPECT TO THE CREATION,
MODIFICATION AND IMPLEMENTATION OF THE INITIAL DEVELOPMENT PLAN, ALL OTHER
DEVELOPMENT PLANS AND ALL DEVELOPMENT