Governmental Authority shall mean (a) any government, (b) any governmental or regulatory entity, body, department, commission, subdivision, board, administrative agency or instrumentality, (c) any court, tribunal, judicial body, or an arbitrator or arbitration panel, or (d) any non-governmental self-regulatory agency, securities exchange, commission or authority, in each of (a) through (d) whether supranational, national, federal, state, county, municipal, provincial, and whether local, domestic or foreign. Governmental Authority includes the FDA, FTC and any other domestic or foreign entity that regulates or has jurisdiction over the quality, identity, strength, purity, safety, efficacy, research, development, testing, production, manufacturing, packaging, labeling, storage, transport, marketing, advertising, promotion, distribution, sale, storage, pricing, prescription, import or export of any Company Product.
Hazardous Substance shall mean any material, substance or waste that is defined, classified, characterized or otherwise regulated as hazardous, toxic, a pollutant, a contaminant, radioactive or words of similar meaning or effect, including petroleum and its by-products, asbestos, polychlorinated biphenyls, per- and polyfluoroalkyl substances (including PFAs, PFOA, PFOS, Gen X, and PFBs), radon, mold, urea formaldehyde insulation, silica, chlorofluorocarbons, and all other ozone-depleting substances.
Health Care Laws shall mean all applicable Laws relating to human health and safety, the provision of healthcare, and the quality, identity, strength, purity, safety, efficacy, research, development, testing, production, manufacturing, packaging, labeling, storage, transport, marketing, advertising, promotion, distribution, sale, pricing, prescription, import or export of the Company Products, including the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) (the FFDCA), the Public Health Service Act (42 U.S.C. § 201 et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Stark Law (42 U.S.C. § 1395nn), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Statements Law (42 U.S.C. § 1320a-7b(a)), the exclusion Laws (42 U.S.C. § 1320a-7), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), laws relating to the claims made or promotional or marketing efforts undertaken by or on behalf of the Company or any of its Subsidiaries for prescription drugs or controlled substances, laws relating to the privacy, security, integrity, accuracy, management, processing, exchange, disclosure, transmission, storage or other protection of information about or belonging to individuals, including actual or prospective participants in the Companys Health Care Programs or other lines of business, including HIPAA and any other applicable Laws relating to medical information, the federal Medicare and Medicaid statutes, laws related to billing or claims for reimbursement for health care items and services submitted to any third party payor, laws relating to consumer protection or unfair trade practices, including any state unfair and deceptive trade acts, each of their state, local, foreign and international counterparts or equivalents, in each case as amended, their implementing regulations or rules, in each case any formal applicable guidance documents promulgated thereunder, and all applicable requirements and conditions of each Company Regulatory Permit.
HIPAA means the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, their implementing regulations or rules and any formal applicable guidance documents promulgated thereunder.