“Ex-Im Laws” means all applicable Laws relating to export, re-export and transfer controls, including the U.S. Export Administration Act, U.S. Export Administration Regulations, U.S. Arms Export Control Act, U.S. International Traffic in Arms Regulations, and their respective implementing rules and regulations administered by the U.S. State Department, U.S. Commerce Department, the Export and Import Permits Act (Canada), the Export Control List and other similar export control Laws or restrictions applicable to the Company, its subsidiaries, and their operations from time to time, and all applicable customs and import Laws administered by Canada Border Services Agency, Global Affairs Canada, Customs Border Protection or any other relevant Government Entity.
“Government Entity” means any United States, Canadian or foreign governmental authority, including any national, federal, territorial, state, provincial, commonwealth, province, territory, county, municipal, district, local governmental jurisdiction of any nature or any other governmental, government-appointed professional association or college, self-regulatory or quasi-governmental authority of any nature (including any governmental department, division, agency, bureau, office, branch, court, commission, tribunal, or other governmental instrumentality) or any political or other subdivision or part of any of the foregoing.
“Government Official” means any officer or employee of a government or any department, agency or instrumentality thereof, or of a public international organization, or any person acting in an official capacity or on behalf of any such government, department, agency or instrumentality or for, or on the behalf of, such public international organization, including directors, officers, managers, employees and other agents of any enterprise owned directly or indirectly by a government or public international organization.
“Government Payment Program” means any plan or program providing health care benefits, whether directly through insurance or otherwise, that is funded directly, in whole or part, by a Government Entity, whether pursuant to one or more contracts with the applicable Government Entity or otherwise, including Medicare, Medicaid, state CHIP programs, TRICARE, Medicare Advantage, managed Medicaid, and similar or successor programs with or for the benefit of any Government Entity, and any other federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)).
“Hazardous Substance(s)” means any materials, substances, pollutants, or contaminants, including any hazardous, toxic, dangerous, flammable, explosive, infectious or radioactive substances or wastes that are regulated by, defined, declared, or controlled in or under, or may give rise to standards of conduct or liability pursuant to, any Environmental Laws or order from a Governmental Authority, including any petroleum products or byproducts, asbestos, lead, polychlorinated biphenyls or related waste, per- and poly-fluoroalkyl substances, mold, or radon.
“Health Care Laws” means any health care law applicable to the operations of the Company, including: (a) the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7, 1320a-7a, and 1320a-7b of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes and any comparable self-referral or fraud and abuse Laws promulgated by any state and any equivalent law in any jurisdiction where the Company operates; (b) the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., the regulations promulgated thereunder, and any sub-regulatory guidance document or binding action of or by the FDA, and the Food and Drugs Act (Canada), the regulations promulgated thereunder and any sub-regulatory guidance document or binding action of or by Health Canada; (c) any Laws of any Government Entity that is the foreign, federal, state or local equivalent of the FDA or Health Canada; (e) any Laws applicable to the hiring of employees or acquisition of services or supplies from Persons excluded from participation in Government Payment Programs; (f) any laws applicable to the licensing or operation of a pharmacy including the Health Professions Act, RSBC 1996, c. 183, Pharmacy Operations and Drug Scheduling Act, SBC 2003, C-77, Pharmacy Operations General Regulation, BC Reg 43/2018, Pharmacy and Pharmacy Disciplines Act, 1996, SS 1996, c P-9.1, Pharmacy Act, 1991, S.O. 1991, c. 36, Drug and Pharmacies Regulation Act, R.S.O. 1990, c. H.4, Drug and Pharmacies Regulation Act, O. Reg. 264/16, and any regulations promulgated thereunder and any sub-regulatory guidance document or professional code of conduct, as applicable, in each province.
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