GAAP means generally accepted accounting principles in the United States,
as in effect from time to time, consistently applied.
Governmental Authorization means any authorization, approval,
consent, license, registration, lease, ruling, permit, tariff, certification, Order, privilege, franchise, membership, entitlement, exemption, filing or registration by, with, or issued by, any Governmental Body.
Governmental Body means any federal, national, supranational, foreign, state, provincial, local, county, municipal or other
government, any governmental, regulatory or administrative authority, agency, department, bureau, board, commission or official or any quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or
quasi-governmental authority, or any court, tribunal, judicial or arbitral body.
Government Official means
(i) any official, employee, agent, or representative of, or any Person acting in an official capacity for or on behalf of, any Governmental Body, (ii) any official, employee, agent, or representative of, or any Person acting in an official
capacity for or on behalf of, a company, business, enterprise or other entity owned, in whole or in part, or controlled by any Governmental Body or (iii) any official, employee, agent, or representative of, or any Person acting in an official
capacity for or on behalf of, a public international organization.
Hazardous Substance means any toxic or hazardous
material, substance or waste regulated under any Environmental Laws, including petroleum, any per- or polyfluoroalkyl substances, any polychlorinated biphenyls, radon, and any asbestos.
Health Care Laws mean, collectively, the federal Anti-Kickback Statute (42 U.S.C.
Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the
administrative False Claims Law (42 U.S.C. Section 1320a-7b(a)), the Stark law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C.
Section 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated pursuant to
such laws, and any other state, federal or foreign law, regulation, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing, or distribution of medical devices, kickbacks, patient, or
program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, exclusion of individuals or companies from government health care programs, quality, safety, privacy, security, licensure, or any other aspect
of providing health care or medical products or services.
International Trade Laws means any of the following:
(a) any Laws concerning the importation of merchandise and other items (including technology, services, and software), including but not limited to those administered by U.S. Customs and Border Protection; (b) any Laws concerning the
exportation or re-exportation of items (including technology, services, and software), including but not limited to those administered by the U.S. Department of Commerce or the U.S. Department of State; or
(c) any economic sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (OFAC), the U.S. State Department, the United Nations, Canada, the European Union, the United Kingdom, or any
other applicable economic sanctions.
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