CMC Development definition

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 chemistry, Manufacturing and controls development activities with respect to the Molecules and Products, including active pharmaceutical ingredient and formulation development, test method development, Manufacture/testing of active pharmaceutical ingredient and formulations (including placebos) for use in Clinical Studies, quality assurance, quality control development, development of the Manufacturing Process for the Products, scale-up, Manufacturing Process validation, including validation batches, Manufacturing Improvements, and qualification and validation of Third Party contract manufacturers.

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

• 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.

• ACI shall not have the right to subcontract its Development activities (including CMC Development activities) to a Third Party without the prior written approval of Takeda (it being understood that any Third Parties listed on Schedule ‎3.4 shall be deemed approved by Xxxxxx as of the Effective Date with respect to the performance of those activities listed in Schedule ‎3.4 for each such Third Party).

• Each Party (or its Affiliate) may subcontract the performance of any of its CMC Development or Manufacturing activities with respect to the Licensed Compounds or Licensed Products in accordance with Section 3.3.2; -51- provided that the applicable Subcontractor(s) satisfy any subcontractor criteria established by the JMC.

• As contemplated under Section 2.2, the JDC shall oversee CMC Development and the establishment of Manufacturing sources and Licensed Product supply chains pursuant to the CMC Plan, subject to the provisions of this ARTICLE 8.

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 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 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 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 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.

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, 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.