Definition of CMC Development Plan


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 pursuant to Section 3.2.2, including the budget and timelines described in Section 3.2.1(b). The initial CMC Development Plan is attached hereto as Exhibit B.


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 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 as 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).

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.
Each Party shall use Diligent Efforts to conduct and complete the Collaboration CMC Activities allocated to it in the CMC Development Plan in accordance with the CMC Development Plan (including the timelines set forth therein).
From time to time during the Development Term, either Party may submit proposed amendments to the Clinical Development Plan to the JSC for review and approval, and either Party or the JMC may submit proposed amendments to the CMC Development Plan to the JSC for review and approval.
During the pendency of such discussion, each Party may suspend or delay any Collaboration Activity allocated to it under the Clinical Development Plan or CMC Development Plan to the extent such activity is affected by such Material Safety Issue.
If the JSC approves such proposed amendment in accordance with Section 2.1.4(c), the Clinical Development Plan or CMC Development Plan, as applicable, shall be deemed amended to reflect such amendment and such amended Clinical Development Plan or CMC Development Plan, as applicable, shall become effective and supersede the previous Clinical Development Plan or CMC Development Plan, as applicable, as of the date of such approval.



More definitions of CMC Development Plan

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 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.