CMC definition
Examples of CMC in a sentence
Without limiting the provisions of Section 5.7, each Party shall promptly provide the other Party with copies of all results and information (including Research Program Results) generated by or on behalf of such Party relating to the Clinical Study; provided, however, that in no event shall Moderna be obligated to provide to Immatics any information relating to the Manufacturing of any Product Candidate (including, for clarity, the Moderna CMC Data).
Each such report will contain sufficient detail so that the Client can understand and fully implement and exploit on its own the information described therein, including such information as is required for the CMC section of the investigational new drug (IND) or biological license application (BLA) for such Product and the master Batch record.
The CMC meetings shall be attended by SMEs from all functional areas including quality, regulatory and supply chain sectors to (i) receive an update / track progress, (ii) supervise the work performed by ▇▇▇▇▇▇▇ and/or a sub-contracter appointed by ▇▇▇▇▇▇▇ in accordance with the terms of the Agreement; (iii) advise if there are any changes that need to be undertaken; and (iv) for such other purposes as the Client may decide from time to time.