Common use of Development Plan; Updates; Amendments Clause in Contracts

Development Plan; Updates; Amendments. (a) The Development Plan shall include all material Development activities to be performed by Licensee in the Territory for the Development of the Licensed Compound and Licensed Products, including: (i) all Territory-specific Trials and Territory-specific PoC Trials; (ii) all material Development activities to be performed by Licensee in the Territory as part of a Global Trial; (iii) a plan for preparing and submitting Regulatory Filings in the Territory and obtaining and maintaining Regulatory Approvals for Licensed Products in the Territory; (iv) all other material Development activities that are required to seek, obtain and maintain Regulatory Approvals in the Territory for the Initial Indications and any Additional Indications approved by the JSC; and (v) [***]. (b) The initial Development Plan is attached hereto as Schedule 3.2.1. The Development Plan (including estimated timelines and estimated budgets) may be updated and amended from time to time only with the approval of the JSC, as described in this Section 3.2.1. To the extent that the initial Development Plan as of the Effective Date does not include all of the items listed in Section 3.2.1(a), the Parties will cooperate through the JSC, JDC and JFC in good faith to amend such Development Plan to include such further detail. (c) The JDC shall review the Development Plan (including milestones and estimated timelines and estimated budgets) at least annually and prepare any recommended updates. The JDC shall submit all such updates to the JSC for review and approval. ​ (d) Either Party may submit a proposed update or amendment to the Development Plan to the JDC from time to time, including changes to the Territory-specific Trials and Territory-specific PoC Trials or proposal for new Territory-specific Trials and Territory-specific PoC Trials. The JDC shall discuss such proposal at its next meeting, and submit such proposal to the JSC for review and approval together with a recommendation as to whether to approve such update or amendment.

Development Plan; Updates; Amendments. (a) The Development Plan shall include all material Development activities to be performed by Licensee in the Territory for the Development of the Licensed Compound and Licensed Products, including: (i) all Territory-specific Trials and Territory-specific PoC Trials; (ii) all material Development activities to be performed by Licensee in the Territory as part of a Global Trial; (iii) a plan for preparing and submitting Regulatory Filings in the Territory and obtaining and maintaining Regulatory Approvals for Licensed Products in the Territory; (iv) all other material Development activities that are required to seek, obtain and maintain Regulatory Approvals in the Territory for the Initial Indications and any Additional Indications approved by the JSC; and (v) [***]. (b) The initial Development Plan is attached hereto as Schedule 3.2.13. 2.1. The Development Plan (including estimated timelines and estimated budgets) may be updated and amended from time to time only with the approval of the JSC, as described in this Section 3.2.1. To the extent that the initial Development Plan as of the Effective Date does not include all of the items listed in Section 3.2.1(a), the Parties will cooperate through the JSC, JDC and JFC in good faith to amend such Development Plan to include such further detail. (c) The JDC shall review the Development Plan (including milestones and estimated timelines and estimated budgets) at least annually and prepare any recommended updates. The JDC shall submit all such updates to the JSC for review and approval. ​. (d) Either Party may submit a proposed update or amendment to the Development Plan to the JDC from time to time, including changes to the Territory-specific Trials and Territory-specific PoC Trials or proposal for new Territory-specific Trials and Territory-specific PoC Trials. The JDC shall discuss such proposal at its next meeting, and submit such proposal to the JSC for review and approval together with a recommendation as to whether to approve such update or amendment.