CMC Development definition

CMC Development means Development activities related to the composition, manufacture and specification of drug substance and drug product intended to assure the proper identification, quality, purity and strength of the drug, including: test method development and stability testing, process development, drug substance development, process validation, process scale-up, formulation development, quality assurance and quality control development.

CMC Development means all research and development activities conducted in respect of the Manufacture of Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale-up, qualification and validation, quality assurance and quality control processes and techniques.

CMC Development means test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, technology transfer and other related activities directed to establishing Manufacturing for a Product.

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.

More Definitions of CMC Development

CMC Development means all research and development activities conducted in respect of the Manufacture of COVID Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale-up, qualification and validation, quality assurance and quality control processes and techniques.

CMC Development means all research and development activities conducted in respect of the Manufacture of the Licensed Vaccines, including chemistry, manufacturing and control (CMC), test method development and stability testing, process development, manufacturing scale-up, qualification and validation, and any other activity necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining Regulatory Approvals to successfully Manufacture the Licensed Vaccines for use in the Field.

CMC Development means, other than CMC Effort, those activities performed by or on behalf of Xxxxx to develop the information that is or is anticipated to become a part of the CMC section of a regulatory submission document for a Licensed Product.

CMC Development means all activities relating to the manufacturing of the Compound and Product for the supply of clinical and commercial quantities of Product, including test method development and stability testing, formulation, process development, manufacturing [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. EXECUTION VERSION

CMC Development means CD34 Composition Process Development and Product Process Development. For clarity, CMC Development does not include iPSC Generation or Cell Bank Process Development.

CMC Development means, as applicable for a particular Collaboration Product, CMC Step 1 and CMC Step 3. “CMC Develop” shall have a correlative meaning.

CMC Development means the Development activities related to the composition, manufacture, and specification of the drug substance and the drug product intended to assure the proper identification, quality, purity and strength of the drug, including, but not limited to: test method development and stability testing, process development, drug substance development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development.