Joint Manufacturing Plan Clause Samples

Joint Manufacturing Plan. In the case where either Party supplies Licensed Compound and/or Co-Developed Product to the other Party in accordance with Section 6.1, the Parties shall prepare through the JMC a manufacturing plan with respect to such supplied Licensed Compound and/or Co-Developed Product (the “Joint Manufacturing Plan”). As applicable, the then-current Joint Manufacturing Plan shall be updated [***], with the [***] updated Joint Manufacturing Plan being prepared by the JMC no later than two (2) months prior to [***] to which such [***] Joint Manufacturing Plan relates (i.e., [***]). The Joint Manufacturing Plan may be updated or amended more often as the Parties deem appropriate.

Joint Manufacturing Plan. The initial Joint Manufacturing Plan (including the Manufacturing Data) shall be prepared jointly by the Parties and submitted to the JMC for its review (and ultimately submitted to the JSC for its review and approval) prior to [***], including to reflect the allocation of responsibilities between the Parties as set forth in this Article 7 (the “Initial Joint Manufacturing Plan”). The Initial Joint Manufacturing Plan shall be effective from the date approved by the JSC until amended and updated by the JMC, and approved by the JSC, in accordance with this Agreement. Subject to Section 8.3.1(f), until the Initial Joint Manufacturing Plan is approved by the JSC, BioNTech shall, under the direction of the JMC, conduct the Manufacturing activities for Licensed Antibody or the Licensed Product in accordance with BioNTech’s normal practices during the [***] period immediately prior to the Effective Date, and otherwise in accordance with the terms of this Agreement.

Joint Manufacturing Plan. Within [***] ([***]) days following the Effective Date, the Parties will jointly prepare and agree upon in good faith a reasonably detailed written plan with respect to CMC development activities, Manufacturing and supply of Licensed Product for use in clinical trials (the “Joint Manufacturing Plan”). The Joint Manufacturing Plan will be submitted to the JMC for review and discussion, with ultimate approval by the JSC. Such plan must be consistent with the Initial Development Outline and will include anticipated timelines, budget, strategy, and the respective roles and responsibilities of each Party with respect to the activities covered by such plan. Such Joint Manufacturing Plan will also include customary supply terms applicable to each Party with respect to its activities set forth in Section 8.04 (Clinical Supply) below. [***] in accordance with Section 9.02(b) (Development and CMC Development Costs; Certain Payments [***]).

Joint Manufacturing Plan. 7.2.1 Until the Technology Transfer Completion, the Parties shall collaborate with respect to the CMC activities, manufacturing and supply of Compound and Product for the Licensed Territory (excluding manufacturing and supply for commercial use for the Licensed Territory) under a “Joint Manufacturing Plan”, which shall set forth anticipated timelines, budget, CMC-related development such as formulation, analytical and process development, and scale-up, stability, packaging and shipping studies and related regulatory activities, strategy, and specific commitments of each Party. The Joint Manufacturing Plan shall also include the anticipated quantities for use in conducting all (pre-)clinical trials to be conducted by Astellas in the Licensed Territory, and activities relating to manufacturing technology transfer. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXECUTION VERSION 7.2.2 The Manufacturing Coordinators shall be responsible for drafting the Joint Manufacturing Plan for approval by the JSC. Any material amendment of the Joint Manufacturing Plan, including (a) changes of the latest JSC-approved manufacturing plans or CMC studies, which (i) require additional budget that is not pre-approved by either Party and/or (ii) lead to any delay in timeline and (b) additional manufacturing plans and/or additional CMC studies which are not approved by the JSC, will be discussed and approved by JSC in accordance with ARTICLE II. The Manufacturing Coordinators of each Party shall provide updates to JSC regarding such Party’s activities under the Joint Manufacturing Plan. [***] shall [***] with respect to [***] relating to Compounds and Products [***] Territory under the Joint Manufacturing Plan, and [***] shall [***] with respect to [***] relating to Compounds and Products [***] Territory under the Joint Manufacturing Plan, as further described under ARTICLE II.

Joint Manufacturing Plan