GMP definition

GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

GMP means then-current good manufacturing practices required by the FDA, as set forth in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, for the manufacture and testing of biopharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of biopharmaceutical materials in jurisdictions outside the U.S., that may be in effect from time to time. For clarity, GMP shall include applicable quality guidelines promulgated under the ICH.

GMP means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

Examples of GMP in a sentence

Janux, its Affiliates and its and their respective contractors and consultants have conducted (including the generation, preparation, maintenance and retention of documentation with respect thereto) all Development and Manufacture of the Licensed Compounds and Licensed Products in accordance with Applicable Law (including GLP, GCP, GMP as applicable).
Each Party (and its Affiliates) shall, and shall require that its other Related Parties and its and their respective contractors and consultants, conduct (including the generation, preparation, maintenance and retention of documentation with respect thereto) all Development, Manufacture and other Exploitation of the Licensed Compounds and Licensed Products in accordance with Applicable Law (including GLP, GCP, GMP as applicable).
Such reports, records and documentation shall fully and properly reflect all work done and results achieved in the performance of such Joint Development Activities or other Development activities in good scientific manner and appropriate for regulatory and patent purposes, and shall be prepared and maintained in accordance with Applicable Law, including, to the extent applicable, GLP, GCP and GMP recordkeeping requirements.
Each Party (and its Affiliates) shall, and shall require that its subcontractors, conduct activities under the Joint Development Plan in compliance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP), in good scientific manner and consistent with good business ethics, and each Party will promptly notify the other Party in writing after it becomes aware of any deviations from any of the foregoing.
With respect to any such Licensed Compounds and Licensed Products, Janux hereby represents, warrants and covenants to BMS that such Licensed Compounds and Licensed Products shall (a) be Manufactured in accordance with Applicable Law (including GMP, as applicable), (b) conform to the Product Specifications with respect thereto and (c) if applicable, not be adulterated or misbranded.

More Definitions of GMP

GMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, MHLW regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

GMP means current Good Manufacturing Practices. In the United States, GMP shall be as defined under the rules and regulations of the FDA, as the same may be amended from time to time.

GMP means current Good Manufacturing Practices promulgated by the FDA.

GMP means the then-current good manufacturing practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Parts 210 and 211, as may be amended from time to time, or any successor thereto and foreign equivalents thereof.

GMP means, as to the United States and the European Union, applicable good manufacturing practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices as then in effect in the United States or the European Union.

GMP means all applicable Good Manufacturing Practices including, as applicable, (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601 and 610, (ii) the principles detailed in the ICH Q7 guidelines, and (iii) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time.

GMP or “Good Manufacturing Practices” means the then-current good manufacturing practices required by the FDA, as set forth in the FD&C Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws and regulations applicable to the manufacture and testing of pharmaceutical materials promulgated by other Regulatory Authorities, as they may be updated from time to time.