Amendment to the Development Plan. The draft Development Plan that is mutually agreed upon by the Parties is attached hereto as Exhibit 5.1(b), and the JSC shall review and approve an initial Development Plan based on such draft at its first meeting after the Effective Date. The JSC shall regularly review the Development Plan and the progress of activities being conducted under the Development Plan. Subject to Section 3.5, the JSC shall update the then-current Development Plan once every Calendar Year, or more or less often as the Parties deem appropriate. If the Parties determine to seek Regulatory Approval for the Combination Therapy in the Initial Territory, and the FDA requires the conduct of a Confirmatory Combination Therapy Trial as a condition for granting accelerated approval under 21 C.F.R. §601 Subpart E for the Combination Therapy in a particular Indication, then the Parties shall update the Development Plan to include the conduct of such Confirmatory Combination Therapy Trial, including the Confirmatory Combination Therapy Trial Budget for the applicable Confirmatory Combination Therapy Trial Activities, to be approved by the JSC. [*****] Subject to Section 3.5, the Development Plan as updated or amended shall (i) be in effect upon JSC’s approval of such Development Plan and (ii) supersede the previous Development Plan for the applicable period. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. [*****].
Amendment to the Development Plan. On a semi-annual basis (no later than March 31 or September 30 of each Calendar Year, commencing on June 30, 2019), or as often as the Parties deem appropriate, the Parties, via JSC, shall update or amend, as appropriate, the then-current Development Plan. Such updates and amendments shall reflect any agreed changes to the then-current agreed-upon Development activities, including proposal of any new indications to be Priority Indications or removal of any existing Priority Indication. Once approved by the JSC, such amended Development Plan shall become effective immediately and supersede the then-current Development Plan immediately prior to such approval. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail.
