DEVELOPMENT ACTIVITIES WITH RESPECT TO SUCH LICENSED COMPOUND IN
ACCORDANCE WITH SECTION 2.4, ONCE SYNTA'S ACTIVITIES WITH RESPECT TO A GLP
TOXICOLOGY STUDY OR PHASE 1 CLINICAL TRIALS FOR SUCH LICENSED COMPOUND ARE
COMPLETE, IN ACCORDANCE WITH A TRANSITION PLAN TO BE ESTABLISHED BY THE PARTIES,
INCLUDING THE TRANSFER TO ROCHE OF ANY IND OR OTHER REGULATORY FILINGS WITH
RESPECT TO SUCH LICENSED COMPOUND THAT ARE HELD BY SYNTA IN SYNTA'S NAME.
NOTWITHSTANDING THE FOREGOING, FOR THE FIRST LICENSED COMPOUND, SUCH TRANSITION
SHALL OCCUR PROMPTLY FOLLOWING COMPLETION OF THE FIRST PHASE 2A CLINICAL TRIAL,
IF SUCH CLINICAL TRIAL IS CONDUCTED BY SYNTA, OR PROMPTLY FOLLOWING COMPLETION
OF PHASE 1 CLINICAL TRIALS, IF SYNTA DOES NOT CONDUCT THE FIRST PHASE 2A
CLINICAL TRIAL.
EACH PARTY SHALL CONTINUE TO USE COMMERCIALLY REASONABLE
EFFORTS TO PERFORM CRITICAL DEVELOPMENT ACTIVITIES WHICH MAY BE ASSIGNED TO SUCH
PARTY UNDER THE RELEVANT DEVELOPMENT PLAN, IN A MANNER CONSISTENT WITH THE
TRANSITION PLAN, UNTIL THE COMPLETION OF SUCH TRANSFER OF DEVELOPMENT
RESPONSIBILITY TO ROCHE.
2.7.2.
MANUFACTURING.
UNLESS OTHERWISE AGREED BY THE PARTIES,
CONCURRENTLY WITH THE TRANSFER OF ALL DEVELOPMENT RESPONSIBILITY TO ROCHE WITH
RESPECT TO A LICENSED COMPOUND PURSUANT TO SECTION 2.7.1 ABOVE, (A) SYNTA SHALL
TRANSFER TO ROCHE, AND ROCHE SHALL ASSUME SOLE RESPONSIBILITY FOR, THE
MANUFACTURE OF NON-CLINICAL, CLINICAL AND COMMERCIAL QUANTITIES OF SUCH LICENSED
COMPOUND NECESSARY FOR THE DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY, AT ROCHE'S SOLE COST AND EXPENSE, AND
(B) SYNTA SHALL PROVIDE TO ROCHE REASONABLE TECHNICAL ASSISTANCE, MANUFACTURING
AND ANALYTICAL KNOW-HOW, AND MATERIAL SPECIFICATIONS CONTROLLED BY SYNTA THAT
ARE NECESSARY FOR ROCHE, ITS AFFILIATE OR A THIRD PARTY MANUFACTURER IDENTIFIED
BY ROCHE TO MANUFACTURE SUCH LICENSED COMPOUND.
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.
18
2.7.3.
TECHNOLOGY TRANSFER.
IF ROCHE REQUESTS THAT SYNTA PROVIDE ROCHE
WITH TECHNICAL ASSISTANCE IN TRANSFERRING TECHNOLOGY REQUIRED FOR THE
MANUFACTURE OF A LICENSED COMPOUND AT A MANUFACTURING FACILITY, THEN SYNTA SHALL
PROVIDE FOR EACH SUCH LICENSED COMPOUND ONE (1) VISIT OF UP TO [***] ([***])
[***] IN DURATION OF ONE FULL TIME SYNTA EMPLOYEE'S TIME TO PROVIDE SUCH
SERVICES.
IF ROCHE DESIRES ADDITIONAL TECHNICAL ASSISTANCE, THEN SYNTA, AT ITS
OPTION, SHALL PROVIDE SUCH ASSISTANCE AND ROCHE SHALL COMPENSATE SYNTA ON A TIME
AND MATERIALS BASIS AT THE FTE RATE PER EIGHT (8) HOUR DAY.
SUBJECT TO THE
FOREGOING, SYNTA SHALL ASSIST ROCHE, AS REASONABLY REQUESTED BY ROCHE, IN
(A) CAUSING THE ASSIGNMENT TO ROCHE OF ANY AND ALL APPLICABLE THIRD PARTY
MANUFACTURING AND SUPPLY AGREEMENTS FOR SUCH LICENSED PRODUCT, TO THE EXTENT
ASSIGNABLE AND RELATED TO SUCH LICENSED PRODUCTS, OR (B) TRANSFERRING THE
MANUFACTURING PROCESS FOR SUCH LICENSED PRODUCT TO ROCHE OR TO A THIRD PARTY
CONTRACT MANUFACTURER ENGAGED BY ROCHE.
SUCH ASSISTANCE SHALL INCLUDE ASSISTING
ROCHE BY PROVIDING REASONABLE TECHNICAL AND REGULATORY ASSISTANCE AND
DOCUMENTATION RELATING TO THE