Common use of Joint Development Plans Clause in Contracts

Joint Development Plans. (i) Within (x) [***] days after the Merck Participation Election Date for the PCV Program, or (y) subject to the last sentence of this Section 4.3(c)(i), [***] days after the date of the Merck Participation Election Notice for a given Joint SAV Program, the Parties shall agree on the Collaboration Activities of the Parties with respect to the applicable Joint Development Program and set forth such activities and a [***] year rolling budget therefor (such budget to be on a study-by-study or activity-by-activity basis) in a joint development plan (each, a “Joint Development Plan and Budget”), the initial draft of which shall be prepared by [***]. The purpose of the Joint Development Plan and Budget for the applicable Program is to set forth the specific Development activities to be performed by the Parties in support of such Joint Development Program, [***]. Each Joint Development Plan and Budget for the applicable Program shall set forth activities that are similar in nature to those contained in the applicable POC Plan. Notwithstanding anything herein to the contrary, if the Parties fail to mutually agree on a Joint Development Plan and Budget for a given Joint SAV Program within [***] days after the date of the Merck Participation Election Notice for such Joint SAV Program, then Moderna shall deliver written notice (together with an invoice) to Merck that the SAV Participation Election Payment for such Joint SAV Program is due and either (1) Merck may pay the SAV Participation Election Payment for such Joint SAV Program within [***] Business Days after receipt of such notice, and the Parties will continue to diligently work to mutually agree on a Joint Development Plan and Budget for such Joint SAV Program, or (2) if Merck does not make such payment under clause (1), then [***]. (ii) Either Party may propose at any meeting of the JDC amendments to the Joint Development Plan and Budget for the applicable Program; provided, however, if such amendments involve an Additional Study or series of related Additional Studies, the inclusion of such Additional Study(ies) shall be in accordance with Section 4.4. Notwithstanding the foregoing, at a minimum, no later than [***] days prior to the start of a Calendar Year, the Parties shall propose an updated budget for any ongoing studies or activities under the then-current Joint Development Plan and Budget for the applicable Joint Development Program for the upcoming Calendar Year for the JDC’s review and JSC’s approval. (iii) The Parties have agreed to engage in the Joint Development Programs on the terms and conditions set forth in this Agreement, under the oversight of the JDC and JSC and in accordance with the applicable Development Plans. Each Party shall use its respective Commercially Reasonable Efforts to perform the activities allocated to it pursuant to the Development Plans [***] in accordance with the terms of this Agreement and within the timelines set forth in the Development Plans and [***], respectively, and to achieve the goals and deliverables set forth in the Development Plans and [***], including [***]. Subject to the foregoing and the terms and conditions of this Agreement (including compliance with the Development Plans and [***] and any applicable Clinical Supply Agreement), each Party (and not the JSC) shall be responsible for managing its own Development and Manufacturing efforts within the scope of the activities allocated to it pursuant to the Development Plans and [***] and for making decisions with respect to its day-to-day conduct in support of such Development efforts.