CMC Development definition

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 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

• The Parties acknowledge the merit of publishing Development Data regarding the COVID Products (other than CMC Development Data) in searchable, peer-reviewed scientific literature in accordance with international scientific publishing practices and standards (including regarding the recognition of contribution and authorship).

• With regard to CMC Development and Manufacturing, CureVac shall contribute the necessary sections for such filings.

• 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.

• 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.

• EXHIBIT D Summary of Phase 2 Clinical and CMC Development Budget [ * ] [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

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.