GMP

GMP. As relevant to the Products, the principles and guidelines of good manufacturing practice as contained (a) with respect to any Product intended for use or sale in the European Union, in either directive 91/356/EEC (medicinal products for human use) or directive 91/412/EEC (medicinal products for veterinary use), as such principles and guidelines are interpreted and expanded in "The Rules Governing Medicinal Products in the European Community, Volume IV. Good Manufacturing Practice for medicinal... Products" and/or amended from time to time, and any reasonably equivalent successors to such guidelines and principles or (b) with respect to Product intended for use or sale in any other portion of the Territory, any equivalent guidelines or regulations. View More

GMP. Means material that (a) has been manufactured under conditions of current good manufacturing practices for bulk excipients as set forth in U.S. Pharmacopoeia <1078> as of the Effective Date or any successor thereto.

GMP. ICH Q7 requirements as amended from time to time.

GMP. Shall mean good manufacturing practice as required by FDA regulations.

GMP. Shall mean current good manufacturing practice regulations promulgated by the FDA and other regulatory agencies.

GMP. Means applicable current good manufacturing practices and regulations and other accepted standards governing manufacturing and testing practices of intermediates, drug substances, active pharmaceutical ingredients and finished pharmaceutical drug and biologic products, including without limitation (a) the regulations promulgated by the Japan Ministry of Health, Labour and Welfare and (b) any comparable Applicable Law promulgated by any applicable Authority having jurisdiction over the... Manufacture of Product; in each case as in effect as of the Effective Date and as amended, promulgated or accepted by any applicable Authority from time to time, including GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice). View More

GMP. Shall mean the then-current standards for the manufacture of pharmaceutical product or biological therapeutic product as set forth in the FD&C Act, as amended, and applicable regulations and guidances promulgated thereunder, including, without limitation, 21 C.F.R. Parts 210, 211, and 312, and the equivalent regulations and requirements in jurisdictions outside the United States.

GMP. Means good manufacturing practice promulgated by the MHRA or EMEA, including, without limitation, Directive 2003/94/EC, Directive 2004/27/EC, Directive 91/412/EEC and all applicable directives, rules and regulations, policies and guidelines in effect at a given time.

GMP. Shall mean good manufacturing practices as required by the rules and regulations of the applicable Regulatory Authority.

GMP. Means the current good manufacturing practices for bulk excipients as set forth in: (i) 21 C.F.R. parts 210 and 211 of the U.S. Code of Federal Regulations; (ii) the International Conference on Harmonization (ICH) Guide Q7; and LICENSE AND SUPPLY AGREEMENT PAGE 2 Portions of this Exhibit, indicated by the mark "[***]," were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant's application requesting confidential... treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. (iii) U.S. Pharmacopoeia <1078>; as of the Effective Date or as may be amended or re-enacted from time to time and as interpreted in accordance with then-current industry standards and FDA policies. View More