CMC Development Plan definition

CMC Development Plan means the development plan setting out the CMC and manufacturing process development activities with respect to Licensed Product #1 as set out in Schedule D, and amended by the Joint Manufacturing Committee or the Joint Steering Committee (as applicable) from time to time pursuant to Section 2.8.5.

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CMC Development Plan means the strategic plan for the CMC Development Collaboration, as such plan may be agreed to, approved, amended or updated from time to time in accordance with Section 8.4(a). Each CMC Development Plan will be automatically incorporated into this Agreement by reference and form a part of Exhibit 1.51.

CMC Development Plan means the plan setting forth in reasonable detail the CMC Development activities to be performed by each Party or its Affiliates or designees with respect to the Licensed Compounds and Licensed Products. The initial CMC Development Plan is attached as Schedule 1.39 to this Agreement.

Examples of CMC Development Plan in a sentence

• Each Party shall have day-to-day operational control over the Collaboration CMC Activities allocated to it in the CMC Development Plan.

• Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for [***], at which time any updates shall be appended to the CMC Development Plan and the Manufacturing Plan, as applicable.

• Thereafter, the JMC shall provide to the JSC at least annually for its review and approval an updated version of the CMC Development Plan and the Manufacturing Plan.

• Promptly following the Effective Date, the JMC shall prepare and provide to the JSC for its review and approval an initial CMC Development Plan and an initial Manufacturing Plan.

• The initial CMC Development Plan shall be consistent with the CMC Development and Manufacturing roles and responsibilities chart attached hereto as Schedule 6.1.

More Definitions of CMC Development Plan

CMC Development Plan means, as applicable, a CMC Step 1 Development Plan, CMC Step 1 LGC Reserved Product Development Plan or a CMC Step 3 Development Plan.

CMC Development Plan has the meaning set forth in the Manufacturing Development and Supply Agreement.

CMC Development Plan means the Parties’ written plan for CMC Development and Manufacturing of the Initial Compound and Initial Product during the Development Term, as amended from time to time, which shall include the budget and timelines described in Article 4. The initial CMC Development Plan is attached hereto a s Exhibit F. For clarity, the CMC Development Plan may be expanded to include additional Compounds or Products, if the Clinical Development Plan is so expanded upon mutual agreement of the Parties in accordance with Section 4.2(b).

CMC Development Plan means the written plan for manufacturing CDC Cells and CDC Products in the Field by the Parties under FDA and EMA regulations an initial draft of which is attached as CMC Development Plan Schedule, attached hereto, and which may be amended from time to time in accordance with the terms of this Agreement.

CMC Development Plan shall have the meaning provided in Section 4.10(a).

CMC Development Plan means for the purposes of this Agreement, the development plan attached to this Agreement as Exhibit D.

CMC Development Plan means the development plan, including a detailed budget, setting forth the deliverables (including the Final CMC Development Report) to be provided by Eisai with respect to chemistry, manufacturing and controls for the Existing Licensed Product, attached hereto as Schedule 1.25, as will be finalized by the Parties in accordance with Section 3.1.3(a), and as may be amended from time to time by the Parties in accordance with Section 3.1.3(b).