Amendment to the Development Plan Clause Samples

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.

Related to Amendment to the Development Plan

  • Amendment, Etc Upon request of the Pass Through Trustee and approval by an Action of Investors, the Escrow Agent and Paying Agent shall enter into an amendment to this Agreement, so long as such amendment does not adversely affect the rights or obligations of the Escrow Agent or the Paying Agent, provided that upon request of the Pass Through Trustee and without any consent of the Investors, the Escrow Agent and Paying Agent shall enter into an amendment to this Agreement for any of the following purposes: (1) to correct or supplement any provision in this Agreement which may be defective or inconsistent with any other provision herein or to cure any ambiguity or correct any mistake or to modify any other provision with respect to matters or questions arising under this Agreement, provided that any such action shall not materially adversely affect the interests of the Investors; or (2) to comply with any requirement of the SEC, applicable law, rules or regulations of any exchange or quotation system on which the Certificates are listed or any regulatory body; or (3) to evidence and provide for the acceptance of appointment under this Agreement of a successor Escrow Agent, successor Paying Agent or successor Pass Through Trustee.

  • Amendment Terms All revisions to this Agreement may only be made by written amendment executed by both parties and approved by the Office of the Attorney General prior to the end date of this Agreement.

  • Amendment to this Agreement No provision of this Agreement may be changed, discharged or terminated orally, but only by an instrument in writing signed by the party against which enforcement of the change, discharge or termination is sought.

  • Amendment to the Agreement Pursuant to Section 8.3 of the Agreement, Section 2.1 of the Agreement is hereby amended and restated in its entirety to read as follows:

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.