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. For the avoidance of doubt, Governmental Authority includes the FDA and any other
domestic or foreign entity that regulates or has jurisdiction over the development, quality, identity, strength, purity, safety, efficacy, testing, manufacturing, marketing, distribution, sale, storage, pricing, import or export of any Company
Product.
Hazardous Substance shall mean (a) any material, substance or waste that is regulated or that can result
in Liability under Environmental Law and (b) petroleum and its by-products, asbestos, polychlorinated biphenyls, per- and poly-fluorinated substances, radon, mold,
urea formaldehyde insulation, silica, chlorofluorocarbons, and all other ozone-depleting substances.
Health Care Laws shall mean all applicable Laws administered or issued by the U.S. Department of Health and Human Services,
National Health Commission or any similar Governmental Authority relating to the development, testing, manufacture, marketing, distribution or promotion of the Company Products, including: (i) the Federal Food, Drug and Cosmetic Act of 1938
(the FDCA) and other similar Laws in other jurisdictions, (ii) Laws pertaining to health care fraud and abuse, kickbacks and physician self-referral, including state and Federal Anti-Kickback Statutes (42 U.S.C. §§ 1320a-7b(b), et seq. and their implementing regulations) and the related Safe Harbor Regulations, (iii) Laws pertaining to submission of false claims to governmental or private health care payors (31 U.S.C.
§§ 3729, et seq. and its implementing regulations), (iv) the Public Health Service Act of 1944, (v) Laws relating to government health care programs, private health care plans, or the privacy, security and confidentiality of patient health
information, including United States federal and state Laws pertaining to the Medicare and Medicaid programs, (vi) the Social Security Act or regulations of the Office of the Inspector General of the Department of Health and Human Services or
similar Laws, (vii) transparency Laws (including The Physician Payments Transparency Requirements of the Affordable Care Act (codified at 42 U.S.C. § 1320a-7h) and its implementing regulations)
relating to reporting of direct or indirect payments and transfers of value provided to physicians and teaching hospitals and (viii) any and all other comparable state, local, federal or foreign health care Laws.
HSR Act shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or any successor statute, rules and
regulations thereto.
Incidental Contracts shall mean (a) shrink-wrap, click-wrap and off-the-shelf Contracts for commercially available Software or services that are generally available on nondiscriminatory pricing terms and
(b) non-disclosure agreements, consulting services agreements, materials transfer agreements, and other Contracts, in each case (i) in which the grant of rights to use Intellectual Property is
incidental and not material to performance under any such Contract and (ii) that were entered into in the ordinary course of business consistent with past practice.
Intellectual Property shall mean all intellectual property, regardless of form, including: (a) published and
unpublished works of authorship, including audiovisual works, collective works, Software, programs, code (including source code and object code), compilations, derivative works, websites, literary works and mask works (Works of
Authorship); (b) inventions and discoveries, including articles of manufacture, business methods, compositions of matter, improvements, machines, methods, and processes and new uses for any of the preceding items, and including, in
each case, such items associated with preclinical and clinical trials and research and development for regulatory filings, registrations and approvals (Inventions); (c) words, names, symbols, devices, designs, slogans, logos,
trade dress and other designations, and combinations of the preceding items, used to identify or distinguish the origin of a business, good, group, product, or service or to indicate a form of certification (Trademarks); (d) trade
secrets, confidential or proprietary information, including know-how, concepts, methods, processes, designs, schematics, drawings, formulae, technical data, specifications, research and development
information, technology, business plans, including with respect to regulatory filings relating to investigational or approved medicines or medical devices, Drug Master Files (DMFs), and the like
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