subject to any Similar Law, or (iv) any entity whose underlying assets are considered to include “plan assets” (as defined by the regulations of the Department of Labor, as amended by Section 3(42) of ERISA) of any such employee benefit plan, plan, account or arrangement, or a Person acting on behalf of such a Client.
“Filing” means any registration, petition, statement, application, schedule, form, declaration, notice, notification, report, submission or other filing.
“GAAP” means United States generally accepted accounting principles.
“Governmental Authority” means any transnational, domestic or foreign federal, state or local governmental, regulatory or administrative authority, department, court, agency, bureau, office, board, instrumentality, commission or official, including any political subdivision thereof, or any non-governmental self-regulatory agency, commission or authority, and any individual, body or entity exercising or having the authority to exercise under the Applicable Laws thereof any executive, legislative, judicial, regulatory or administrative functions of or pertaining to government, including any Taxing Authority, board of trade, federal revenue offices, securities exchanges commission, stock exchange, and any court, arbitrator or arbitration panel with proper authority and jurisdiction under such Applicable Laws.
“Group” means a “group” as defined in Section 13(d) of the Securities Exchange Act.
“Hazardous Substance” means any substance, material or waste that is listed, defined, designated or classified as hazardous, toxic, radioactive, dangerous or a “pollutant” or “contaminant” or words of similar meaning under any Applicable Law relating to the environment or natural resources or that is otherwise regulated, or for which liability may be imposed, by any Governmental Authority with jurisdiction over Environmental Laws.
“Health Care Laws” means all Applicable Laws, if and to the extent applicable to the Company and its Subsidiaries, relating in any way to: (a) the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, labeling, packaging, marketing, promoting, commercializing, distribution, import, export, storage, service, record keeping, traceability, training, reporting (including medical device reporting, adverse event and incident reporting, field alert reporting, and any other reporting required by Applicable Laws), handling, provision, or payment for, health care services, equipment, supplies, materials, Medical Devices, biologics, combination products, or precursors, ingredients, or components of Medical Devices, biologics, combination products, Products, goods, or services related to the Company or its Subsidiaries; (b) required Health Care Permits; (c) quality, safety certification, and accreditation standards and requirements related to the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, promoting, labeling, packaging, marketing, commercializing, distribution, import, export, storage, service, handling, provision, or payment for health care services, equipment, supplies, materials, Medical Devices, biologics, precursors, ingredients, or components of Medical Devices, biologics, combination products, Products, goods, or services related to the Company or its Subsidiaries; (d) the Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and its implementing regulations, including those relating to the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, labeling, packaging, marketing, promotion, commercializing, distribution, import, export, storage, service, handling, provision, or payment for health care services, equipment, supplies, Medical Devices, biologics, precursors, ingredients, materials, or components of Medical Devices, biologics, combination products, Products, goods, or services related to the Company or its Subsidiaries including all applicable rules and requirements of the FDA and the Federal Trade Commission; (e) the Quality System Regulation as set forth in 21 C.F.R. Part 820; (f) the standards for the manufacture, processing, packaging, testing, transportation, handling and holding of Medical Devices and biologics as set forth in the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), as amended (the “FDC Act”) and applicable regulations promulgated by the FDA (including, for example, 21 C.F.R. Parts 11) and such standards of good manufacturing practices as are required by applicable Governmental Authorities; (g) all Applicable Laws pertaining to the standards for clinical studies and trials for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting (including all applicable requirements relating to protection of human subjects), as set forth in the FDC Act and applicable regulations promulgated by the FDA (including, for example, 21 C.F.R. Parts 11, 50, 54, 56, and 812) and such standards of good clinical practice (including all applicable requirements relating to protection of human subjects) as are required by any other applicable Governmental Authority; (h) the standards for conducting non-clinical laboratory studies, as set forth in the FDC Act and applicable regulations promulgated by the