Common use of GMP Regulations Clause in Contracts

GMP Regulations. “GMP Regulations” means the applicable Legal Requirements for current Good Manufacturing Practices promulgated by the FDA under the FDCA, the European Medicines Agency or under the European Union guide to Good Manufacturing Practice for medical products and any other applicable Governmental Body in each jurisdiction where the Company or a third party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Effective Time.

GMP Regulations. “GMP Regulations” means the applicable Legal Requirements Laws and guidances for current Good Manufacturing Practices promulgated by the FDA under the FDCAFDCA or PHS Act, the European Medicines Agency or under the European Union guide guidelines to Good Manufacturing Practice for medical medicinal products and any other applicable Governmental Body in each jurisdiction where the Company or a third party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Effective Time.

GMP Regulations. “GMP Regulations” means shall mean the applicable Legal Requirements for current Good Manufacturing Practices for human biopharmaceutical products promulgated by the FDA under the FDCAFDA Act and the Public Health Service Act, the European Medicines Agency 42 U.S.C. § 201 et seq., or under the European Union guide to Good Manufacturing Practice for medical products and by any other applicable Governmental Body under similar Legal Requirements in each jurisdiction where the Company or a third party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Effective TimeTime (including, for example, 21 C.F.R. Parts 210 and 211).