Examples of CMC Development in a sentence
Prior to the Opt-In/Out Date, Protagonist will lead CMC Development in preparation for the submission of the Rusfertide NDA to the FDA, with guidance from and in consultation with Takeda, in accordance with and as set forth in its Joint Global Development Plan.
After the Opt-In/Out Date, Takeda shall be primarily responsible for CMC Development for the Licensed Products for the Territory, including, with respect to CMC Development for Rusfertide for the United States, the CMC Development activities set forth in Schedule 6.1.
The Joint Manufacturing Working Group shall consist of an equal (and agreed upon) number of representatives from each of the Parties, each being an employee of such Party and having appropriate technical credentials, experience, knowledge, and authority within such Party’s organization for service on the Joint Manufacturing Working Group to oversee and make decisions regarding CMC Development activities and other Manufacturing matters under this Agreement.
Prior to the Opt-In/Out Date, except for the activities set forth in Schedule 4.1(a)(B), unless mutually agreed in writing by the Parties, no CMC Development for the Licensed Products for life cycle management purposes or otherwise will be undertaken by either Party or its Affiliates.