MUTUAL AGREEMENT OF THE PARTIES, THE "DEVELOPMENT PLANS,"
INCLUDING THE "DEVELOPMENT PLAN - PRE-IND" AND "DEVELOPMENT PLAN - PHASE 1 AND
PHASE 2A," RESPECTIVELY).
THE PARTIES AGREE AND ACKNOWLEDGE THAT THESE INITIAL
DEVELOPMENT PLANS REFLECT, AS OF THE EXECUTION DATE, SYNTA'S GOOD FAITH
ESTIMATES OF DEVELOPMENT ACTIVITIES AND THE TIMING, INTERNAL COSTS, AND EXTERNAL
COSTS ASSOCIATED WITH SUCH ACTIVITIES, ALL OF WHICH MAY BE SUBJECT TO CHANGE.
WITH RESPECT TO THE FURTHER DEVELOPMENT OF THE RELEVANT FIRST LICENSED COMPOUND
OR FOLLOWING THE APPROVAL FOR ADVANCEMENT INTO DEVELOPMENT OF ANY SUBSEQUENT
LICENSED COMPOUND, SYNTA AND ROCHE, UNDER THE GUIDANCE OF THE JRDC, SHALL
PREPARE INITIAL OR UPDATED DEVELOPMENT PLANS DIRECTED TO
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
15
DEVELOPMENT ACTIVITIES IN THE TERRITORY FOR SUCH LICENSED COMPOUND FOR THE NEXT
TWELVE (12) MONTH PERIOD.
AN UPDATED DEVELOPMENT PLAN FOR EACH SUBSEQUENT
TWELVE (12) MONTH PERIOD WILL BE PREPARED BY SYNTA AND ROCHE AT LEAST [***]
([***]) DAYS PRIOR TO THE BEGINNING OF EACH SUCH SUBSEQUENT TWELVE (12) MONTH
PERIOD.
THE DEVELOPMENT PLAN SHALL BE CONSISTENT WITH THE TERMS AND CONDITIONS
OF THIS AGREEMENT, AND SHALL BE SUBJECT TO REVIEW AND APPROVAL BY THE JRDC AND
THE JSC.
THE DEVELOPMENT PLAN SHALL SPECIFY, AMONG OTHER THINGS, (A) KEY
OBJECTIVES, (B) DEVELOPMENT AND RELATED MANUFACTURING ACTIVITIES TO BE PERFORMED
WITH RESPECT TO A LICENSED COMPOUND, INCLUDING INITIATION OF CLINICAL TRIALS,
(C) THE PARTY RESPONSIBLE FOR PERFORMANCE OF AN ACTIVITY, (D) THE NUMBER AND
TYPES OF FTES TO BE ASSIGNED TO SPECIFIC ACTIVITIES BY SYNTA, (E) ANTICIPATED
COSTS TO BE INCURRED UNDER THE DEVELOPMENT PLANS (THE "BUDGET") FOR THE
APPLICABLE TWELVE (12) MONTH PERIOD, AND (F) DEVELOPMENT TIMELINES.
FOR THE
SAKE OF CLARITY, NEITHER THE INITIAL DEVELOPMENT PLANS ATTACHED HERETO, NOR ANY
SUBSEQUENT DEVELOPMENT PLAN ONCE AGREED BY THE PARTIES, MAY BE AMENDED EXCEPT BY
MUTUAL AGREEMENT OF THE PARTIES.
2.5.
DEVELOPMENT COSTS.
2.5.1.
GENERAL.
ROCHE SHALL PAY ITS OWN DEVELOPMENT EXPENSES IN CARRYING
OUT EACH DEVELOPMENT PLAN, AND SHALL PAY SYNTA FOR ALL DEVELOPMENT COSTS
INCURRED PURSUANT TO EACH DEVELOPMENT PLAN AND THE APPLICABLE BUDGET AS SET
FORTH BELOW.
2.5.2.
AUDIT RIGHTS.
ROCHE SHALL HAVE THE RIGHT TO AUDIT SYNTA TO VERIFY
ALL OF SYNTA'S DEVELOPMENT COSTS INCURRED PURSUANT TO A DEVELOPMENT PLAN AND THE
BUDGET.
(A)
SYNTA SHALL KEEP, AND SHALL REQUIRE ITS AFFILIATES TO
KEEP, FOR [***] ([***]) YEARS, FULL, TRUE AND ACCURATE BOOKS OF ACCOUNT
CONTAINING ALL PARTICULARS THAT MAY BE NECESSARY FOR THE PURPOSE OF CALCULATING
ALL DEVELOPMENT COSTS UNDER THIS AGREEMENT. SUCH BOOKS OF ACCOUNTS SHALL BE KEPT
AT SYNTA'S OR THE RELEVANT AFFILIATE'S PRINCIPAL PLACE OF BUSINESS. AT THE
EXPENSE OF ROCHE, ROCHE HAS THE RIGHT TO ENGAGE AN INDEPENDENT, CERTIFIED PUBLIC
ACCOUNTANT MUTUALLY ACCEPTABLE TO BOTH PARTIES TO PERFORM, ON BEHALF OF ROCHE,
AN AUDIT OF SUCH BOOKS AND RECORDS OF SYNTA AND ITS