definiens: shall mean ( i ) any animal drug or veterinary medicinal product or component that is subject to the regulatory authority of theFDA pursuant to the Federal Food, Drug, and Cosmetic Act and subsequent amending statutes ( 21 U.S.C. Chapter 9 ), the Public Health Service Act andsubsequent amending statutes ( 42 U.S.C. Chapter 6A ), any subsequent statutes administered by the FDA and any regulations promulgated or otherwiseissued by the FDA, ( ii ) any vaccine or other veterinary biologic that is subject to the regulatory authority of the USDA, via the Animal and Plant HealthInspection Service Center for Veterinary Biologics, pursuant to the Virus- Serum - Toxin - Act ( 21 U.S.C. Chapter 5 ), and any subsequent amendingstatutes and regulations promulgated thereunder and ( iii ) any animal drug or veterinary medicinal product or component or vaccine or other veterinarybiologic that is subject to the regulatory authority of a Regulatory Authority outside of the United States, in each case of the Company or any CompanySubsidiary