Good Manufacturing Practice Requirements shall mean the
applicable requirements set forth in the quality systems regulations for drugs contained in 21 C.F.R. Parts 210, 211, 600 and 610 and comparable standards of other applicable Governmental Body.
Government Official shall mean any officer or employee of a Governmental Body or any department, agency or
instrumentality thereof, including state-owned entities, or of a public organization or any Person acting in an official capacity for or on behalf of any such Governmental Body, department, agency, or instrumentality or on behalf of any such public
organization.
Governmental Authorization shall mean 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 Legal Requirement or (b) right under any
Contract with any Governmental Body.
Governmental Body shall mean: (a) any nation, state, commonwealth,
province, territory, county, municipality, district or other jurisdiction of any nature; (b) any federal, state, local, municipal, foreign or other government; or (c) any 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.
Governmental Program shall mean any Governmental
Program as defined in 42 U.S.C. §1320a-7b(f), including Medicare, Medicaid, CHAMPVA, TRICARE, the United States Department of Veteran Affairs, and all other health care reimbursement programs funded
or regulated by any Governmental Body.
Hazardous Materials shall mean 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, per- and polyfluoroalkyl substances, petroleum or petroleum-derived substance or waste.
Healthcare Laws shall mean any and all federal, state, local, or foreign Legal Requirements applicable to the
Company related to the nonclinical and clinical research, investigation, development, design, manufacturing, packaging, labeling, marketing, advertising, promotion, import, export, testing, sale, sampling, distribution, use, and commercialization of
healthcare products (and components thereof), including (i) the United States Federal Food, Drug and Cosmetics Act, 21 U.S.C. §§ 301 et seq; (ii) the Federal Health Care Program Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); (iii) the Federal Physician Payments Sunshine Act, 42 U.S.C. §1320a-7h; (iv) the Federal Health Insurance Portability and Accountability Act of 1996
(HIPAA), 42 U.S.C. § 1320d; (v) the False Claims Act, 31 U.S.C. §§ 3729-3733; (vi) Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; (vii) the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; (viii) the Exclusions Law, 42 U.S.C. § 1320a-7; (ix) Legal Requirements governing the protection of
human research subjects; 15 U.S.C. §§ 41-58; (x) the Controlled Substances Act, 21 U.S.C. § 801 et seq., (xi) Legal Requirements governing the manufacture, possession, and distribution of
controlled substances; and state board of pharmacy Legal Requirements; and (xii) any applicable implementing regulations promulgated thereunder, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements,
and Good Clinical Practice Requirements.