WITHIN [***] ([***])[***] AFTER EXPIRATION OF THE RESEARCH
TERM, SYNTA SHALL HAVE THE OPTION, NOT THE OBLIGATION, TO PERFORM THE
DEVELOPMENT ACTIVITIES DESCRIBED IN SECTION 2.4.1.
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.
14
(B)
ROCHE SHALL HAVE NO RIGHT TO DEVELOP OR COMMERCIALIZE ANY
LICENSED COMPOUND (OTHER THAN ANY ACTIVITIES THAT MAY BE ASSIGNED TO ROCHE UNDER
THE RESEARCH PLAN) UNLESS AND UNTIL SUCH LICENSED COMPOUND HAS BEEN NOMINATED BY
THE JRDC, AND APPROVED BY THE JSC, FOR ADVANCEMENT INTO DEVELOPMENT HEREUNDER.
2.4.
DEVELOPMENT.
THE PARTIES SHALL PURSUE THE
DEVELOPMENT OF AT LEAST ONE LICENSED COMPOUND IN ACCORDANCE WITH A DEVELOPMENT
PLAN AND THE REMAINDER OF THIS ARTICLE II, INCLUDING SEEKING TO PURSUE THE
INITIATION OF A GLP TOXICOLOGY STUDY.
FOR CLARITY, FOR EACH LICENSED COMPOUND
APPROVED BY THE JSC FOR ADVANCEMENT INTO DEVELOPMENT UNDER SECTION 2.3.4(A), A
SET OF DEVELOPMENT ACTIVITIES WILL BE CONDUCTED PRIOR TO THE INITIATION OF A GLP
TOXICOLOGY STUDY, AS EXEMPLIFIED IN EXHIBIT C.
AS OF THE EXECUTION DATE, THE
PARTIES AGREE THAT [***] IS ANTICIPATED TO BE THE FIRST LICENSED COMPOUND.
2.4.1.
FIRST LICENSED COMPOUND.
FOR THE RELEVANT FIRST LICENSED COMPOUND,
SYNTA (ITSELF OR THROUGH AN AFFILIATE OR A THIRD PARTY) SHALL, IN ACCORDANCE
WITH THE DEVELOPMENT PLANS: CONDUCT PRE-IND DEVELOPMENT, PHASE 1 CLINICAL
TRIALS, AND OTHER NONCLINICAL DEVELOPMENT ACTIVITIES THAT ARE TYPICALLY
PERFORMED DURING EACH OF THE FOREGOING DEVELOPMENT STAGES, AND SHALL HAVE THE
RIGHT, AT SYNTA'S OPTION, TO CONDUCT A PHASE 2A CLINICAL TRIAL FOR AN INDICATION
OTHER THAN RHEUMATOID ARTHRITIS, PROVIDED, THAT SUCH INDICATION IS PART OF THE
DEVELOPMENT PLAN.
2.4.2.
OTHER LICENSED COMPOUNDS.
EXCEPT AS MUTUALLY AGREED BY THE PARTIES
OR AS SET FORTH IN SECTION 2.4.1, AND SUBJECT TO OVERSIGHT BY THE JRDC AND THE
JSC, ROCHE SHALL BE SOLELY RESPONSIBLE FOR THE DEVELOPMENT OF LICENSED COMPOUNDS
AND LICENSED PRODUCTS IN THE FIELD AND IN THE TERRITORY IN ACCORDANCE WITH THE
DEVELOPMENT PLAN AND THE TERMS AND CONDITIONS OF THIS AGREEMENT; PROVIDED,
HOWEVER, THAT FOR LICENSED COMPOUNDS OTHER THAN THE FIRST LICENSED COMPOUND, THE
JRDC SHALL DECIDE WHICH PARTY SHALL CONDUCT DEVELOPMENT FOR SUCH LICENSED
COMPOUND; PROVIDED, FURTHER, THAT THE JRDC AND JSC CANNOT REQUIRE SYNTA TO
UNDERTAKE SUCH RESPONSIBILITY UNLESS SYNTA AGREES TO DO SO.
PRIOR TO THE
INITIATION OF EACH STAGE OF ACTIVITY TO BE SO CONDUCTED BY SYNTA WITH RESPECT TO
ANY LICENSED COMPOUND, THE PARTIES SHALL DISCUSS AND UNDERTAKE TO FINALIZE THE
ANTICIPATED SCOPE, DESIGN, CONTENT, CRITERIA, PROTOCOLS, BUDGET AND OTHER TERMS
ASSOCIATED WITH THE CONDUCT OF DEVELOPMENT FOR SUCH LICENSED COMPOUND AND SHALL
UPDATE THE DEVELOPMENT PLAN TO REFLECT SUCH AGREEMENT.
2.4.3.
DEVELOPMENT PLANS.
FOR THE FIRST LICENSED COMPOUND, THE INITIAL
DEVELOPMENT PLANS THROUGH AND INCLUDING ONE PHASE 2A CLINICAL TRIAL WITH RESPECT
THERETO ARE ATTACHED HERETO AS EXHIBIT C AND EXHIBIT D (AS MAY BE AMENDED FROM
TIME TO TIME UPON