“FDA” means the U.S. Food and Drug Administration.
“FDCA” means the U.S. Federal Food, Drug, and Cosmetic Act.
“FTC” means the U.S. Federal Trade Commission.
“GAAP” is defined in Section 4.6(b) of this Agreement.
“Good Clinical Practices” means with respect to the Company, the then current standards for clinical trials for pharmaceuticals (including all applicable requirements relating to protection of human subjects) promulgated or endorsed by any applicable Governmental Body, including those of the United States, as set forth in the FDCA, or other comparable Law of any comparable foreign Governmental Body.
“Good Laboratory Practices” means with respect to the Company, the then current standards, practices and procedures for pharmaceutical laboratories promulgated or endorsed by any applicable Governmental Body, including those of the United States, as set forth in the FDCA, or other comparable Law of any comparable foreign Governmental Body.
“Good Manufacturing Practices” means with respect to the Company, the then current standards mandated by applicable Law of any applicable Governmental Body as in effect at the time of the manufacture, relating to the manufacturing, development, processing, storing, packaging, repackaging, testing, packing, labeling, relabeling, commercial and clinical distribution, transportation, importing, exporting, handling and holding of drug products, as set forth in the FDCA, or other comparable Law of any comparable foreign Governmental Body.
“Governmental Authorization” means any (a) permit, license, certificate, franchise, permission, variance, clearance, registration, qualification or authorization issued, granted, given or otherwise made available by or under the authority of any Governmental Body or pursuant to any Law or (b) right under any Contract with any Governmental Body.
“Governmental Body” means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; or (c) governmental or quasi-governmental authority of any nature including any governmental division, department, agency, commission, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or Entity and any court, arbitrator or other tribunal.
“Hazardous Materials” means any waste, material, or substance that is listed, regulated or defined under any Environmental Law and includes any pollutant, chemical substance, hazardous substance, hazardous waste, special waste, solid waste, asbestos, mold, radioactive material, polychlorinated biphenyls, petroleum or petroleum-derived substance or waste.
“Healthcare Laws” means any Law of any Governmental Body applicable to the Company that relates to: (i) research, investigation, development, quality, safety, efficacy and manufacturing of pharmaceutical products; (ii) Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices; (iii) investigational use; (iv) manufacturing facilities compliance and approval; (v) with respect to pharmaceutical products, safety surveillance, mandated reporting of incidents, occurrences, diseases and events record keeping and filing of required reports with the applicable Governmental Body; (vi) the import into, or export out of, the U.S. of drugs and materials and technology related to pharmaceutical products; (vii) protection against biosafety risk; (viii) the oversight of pharmaceutical or other interventional or non-interventional research studies, including medical and research record retention; and (x) human and animal subjects protection in research.
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
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