Common use of Updating and Amending Development Plan and Development Budget; Additional Development Activities Clause in Contracts

Updating and Amending Development Plan and Development Budget; Additional Development Activities. (a) Licensee shall have the right to initiate and lead discussions for (i) any revisions to a Development Plan or (ii) the development of any new Development Plan for any additional indications. On or before September 30th of each Calendar Year during the Term, Licensee shall submit to the JCC any proposed revisions to a Development Plan or proposals for a new Development Plan, and the JCC shall review, update and approve amendments to or new proposals for such Development Plan, which shall cover the Territory Development Activities to be conducted during the upcoming Calendar Year. (b) The JCC shall, on at least a Calendar Quarter basis, review and update, as appropriate, each then-current Development Plan to reflect any material changes, reprioritizations of, or additions to such Development Plan. Notwithstanding the foregoing, from time to time during the Term, either Party may submit to the JCC any proposed expansion or other material amendment of the Development Plan to cover additional Territory Development Activities (or otherwise amend the Territory Development Activities) with respect to the Product for use in the Field in the Territory for the JCC’s review and approval. Once approved by the JCC, each amended Development Plan shall become effective and supersede the previous Development Plan as of the date of such approval or at such other time as decided by the JCC. For the avoidance of doubt, no timelines included in any Development Plan may be altered, or this Agreement amended, without the consent of both Parties. (c) With respect to the Development Budget, such budget shall be included within the Development Plan and provided to the JCC for its review; provided, however, that such budget shall be developed and finalized, and thereafter revised, in Licensee’s sole discretion.

Updating and Amending Development Plan and Development Budget; Additional Development Activities. (a) Licensee shall have the right to initiate and lead discussions for (i) any revisions to a Development Plan or (ii) the development of any new Development Plan for any additional indications. On or before September 30th of each Calendar Year [***] during the Term, Licensee shall submit to the JCC any proposed revisions to a Development Plan or proposals for a new Development Plan, and the JCC JDC shall review, update and approve amendments to or new proposals for such the Development Plan, Plan (including the Development Budget contained therein) which shall cover the Territory Development Activities to be conducted during the upcoming Calendar Year. (b) The JCC , and the JDC shall, on at least a Calendar Quarter [***] basis, review and update, as appropriate, each the then-current Development Plan (including the Development Budget) to reflect any material changes, reprioritizations of, or additions to such the Development Plan. Notwithstanding the foregoing, from time to time during the Term, either Party may submit to the JCC JDC any proposed expansion or other material amendment of the Development Plan to cover additional Territory Development Activities (or otherwise amend the Territory Development Activities) with respect to the Product for use in the Field in the Territory for the JCCJDC’s review and approval. Once approved by the JCCJDC, each amended Development Plan (including the Development Budget contained therein) shall become effective and supersede the previous Development Plan and Development Budget as of the date of such approval or at such other time as decided by the JCCJDC. For the avoidance of doubt, no timelines included in any Development Plan may be altered, or this Agreement amended, without the consent of both PartiesCERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. (c) With respect to the Development Budget, such budget shall be included within the Development Plan and provided to the JCC for its review; provided, however, that such budget shall be developed and finalized, and thereafter revised, in Licensee’s sole discretion.