“Hazardous Substance” means (i) any material, substance or waste that is listed, regulated, classified or defined as hazardous, toxic or as a pollutant, or gives rise to liability under any Environmental Law, and (ii) any petroleum compounds or products or byproducts, asbestos, per- or polyfluoroalkyl substances, toxic mold, radiation or radioactive materials, ethylene oxide or polychlorinated biphenyls.
“Health Care Laws” means all Laws relating to the use, manufacture, import, export, research, development, production, testing, approval, processing, reporting, packaging, labeling, storage, commercial distribution, marketing, advertising, selection, sale, payment for, regulation of, coverage and reimbursement of any Company Products, medical devices and other relevant medical products, including, but not limited to, 42 U.S.C. § 1320a-7b(b) (the Anti-Kickback Statute); 42 U.S.C. § 1320a-7a (the Civil Monetary Penalties Statute); 42 U.S.C. § 1395nn (the Stark Law); 42 U.S.C. § 1320a-7 (the Exclusion Statute); 31 U.S.C. §§ 3729 et seq. (the False Claims Act); 8 U.S.C. § 220 (the Eliminating Kickbacks in Recovery Act); the Clinical Laboratory Improvement Amendments of 1988 (Public Law 100—578) and any Laws concerning the operation of a clinical laboratory or toxicology laboratory; the Animal Welfare Act (7 U.S.C. §§ 2131–2156), 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); HIPAA; the federal Controlled Substances Act, 21 U.S.C. § 31, and all requirements to maintain Drug Enforcement Agency Registration; Regulatory Laws, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”); Laws regulating medical device manufacturer marketing conduct, compliance program requirements, and interactions with and members of the health care industry, including the so-called federal “sunshine” law or Open Payments law (42 U.S.C. § 1320a-7h); Laws relating to unfair competition or trade practices, false, deceptive, unfair or misleading advertising or promotional practices, or violations of consumer protections, including the Federal Trade Commission Act; Laws relating to Health Care Permits; and all Laws relating to the practice of medicine, the corporate practice of medicine, fee splitting, professional licensure; any and all applicable laws governing, regulating or pertaining to the payment for health care related items or services including state all-payor Laws; Laws regulating the billing, coding, documentation, and submission of claims and collection of accounts receivable and reporting and refunding of overpayments for health care services, items, and supplies, including the No Surprises Act of the 2021 Consolidated Appropriations Act, Pub. L. No. 116-260 and Laws relating to any Government Healthcare Program or other Programs; HIPAA; all comparable federal and state Laws to all of the statutes and laws listed or referenced above; and all regulations or rules promulgated pursuant to all of the statutes and laws listed or referenced above.
“HIPAA” means the United States Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d through 1329d-8), as amended by the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5), and all applicable implementing regulations, including its implementing regulations codified at 45 C.F.R. Parts 160, 162, and 164.
“Indebtedness” means, with respect to any Person, without duplication, as of the date of determination, means (i) all indebtedness, liabilities and obligations, now existing or hereafter arising, for money borrowed by a Person (including any principal, premium, accrued and unpaid interest, related expenses, prepayment penalties, commitment and other fees), (ii) any contingent liability for or guaranty by a Person of any such obligation of any other Person (including the pledge of any collateral or grant of any security interest by a Person or such Person’s Subsidiaries in any property as security for any such liability, guaranty or obligation) or (iii) liabilities pursuant to or in connection with letters of credit or banker’s acceptances or similar items (in each case to the extent drawn), in the case of (i) through (iii), whether or not any of the foregoing is evidenced by any note, indenture, guaranty or agreement, but excluding all trade payables incurred in the ordinary course of business.
“Intellectual Property” means all rights arising in any jurisdiction throughout the world and all rights arising under, provided by, or associated with any of the following: (i) patents and patent applications, including any renewals, reissuances, modifications, continuations, continuations-in-part, revisions, divisionals, reexaminations, substitutions, extensions and foreign counterparts thereof; (ii) trademarks, service marks, trade dress, logos, trade names and other designations of source or origin, together with the goodwill symbolized by any of the foregoing; (iii) internet domain names, social media accounts, uniform resource locators (URLs), and other identifiers and locators associated with Internet addresses and sites; (iv) copyrights and works of authorship (including in Software as a work of authorship); (v) trade secrets and industrial secret rights, and intellectual property rights in algorithms, models, methodologies, inventions, know-how, data (including pharmacological, toxicological, non-clinical, pre-clinical and clinical data, analytical and quality control data, manufacturing data and descriptions, market data, financial data or descriptions), databases, data collections, data sets, curated data content, devices, assays,