Additional Indications Development Clause Samples

Additional Indications Development. As contemplated under Section 3.2.2 (Amendments to Joint Development Plans), each Party may propose (the “Proposing Party”) for addition under the applicable then-current Joint Development Plan (and corresponding Joint Development Budget) Development of a Licensed Product for the Profit-Share Territory in an Indication not included in such then-current Joint Development Plan (“Additional Indications Development”). In such a case, the Proposing Party will prepare a proposed amendment to the applicable then-current Joint Development Plan (and corresponding Joint Development Budget) for the applicable Licensed Product setting forth the additional Indication proposed to be included for Development for the Profit-Share Territory, the proposed Development activities to be conducted in furtherance of such Indication, the proposed Development Lead Party designations as between the Parties for the performance thereof and the proposed budget of FTE Costs and Out-of-Pocket Costs associated with the performance of such additional Development activities (each, an “Additional Development Proposal”). The Proposing Party will submit each Additional Development Proposal to the JDC to review and discuss and then the JDC will submit each Additional Development Proposal (as may be revised by the JDC) to the JSC to review, discuss and determine whether to approve in accordance with Section 2.3.2.1 (Specific Responsibilities of the JDC). As soon as reasonably practicable, but in no event more than [**] following such time as the JSC approves an Additional Development Proposal, the Parties, through the JDC, will prepare an amendment to the applicable Joint Development Plan to contemplate the Development of such Additional Indications Development that is consistent with such approved Additional Development Proposal, and submit such amendment to the JSC to review, discuss and determine whether to approve. If the JSC cannot reach consensus on approving any aspect of an Additional Development Proposal or the update to the Joint Development Plan related thereto (e.g., the additional Indication proposed to be included for Development and Regulatory Approval, [**].