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.

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

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.

Examples of CMC Development Plan in a sentence

• Attached hereto as Schedule ‎1.68 is the initial Development Plan (including the initial Development Budget) and attached hereto as Schedule ‎1.39 is the initial CMC Development Plan.

• The Parties shall perform, or cause to be performed, all CMC Development activities in good scientific manner and in compliance with all Applicable Law and, with respect to ACI, by allocating sufficient time, effort, equipment and skilled personnel to complete such CMC Development activities in accordance with the CMC Development Plan.

• Except as set forth in Section ‎7.2.4, ACI shall not initiate or perform any Development activity or any CMC Development activity with respect to a Licensed Compound or Licensed Product that is not set forth in the Development Plan or the CMC Development Plan, as applicable.

• Any CMC Development activities performed by or on behalf of Takeda shall be performed in accordance with the CMC Development Plan.

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

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 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. 1.15 CMC Know-how means the Know-how made, conceived or first reduced to practice by or on behalf of either Party (or its Affiliates), or jointly by or on behalf of the Parties (or their Affiliates), in the conduct of the activities under the CMC Development Plan. 1.16 CMC Patents is defined in Section 4.2.2. 1.17 CMC Technology means the CMC Know-how and CMC Patents. 1.18 Co-Development Activities means the Development and other activities with respect to the Licensed Product #1 in the Field as specified in or reasonably contemplated

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).

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.

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.