
| -7- or any department, commission, board, public or private arbitral body, agency, bureau, official or other regulatory, administrative or judicial authority thereof. “Healthcare Laws” means, collectively, any and all applicable state, federal, national, and foreign healthcare Laws which govern the Target Business and Business Products, including but not limited to: (i) the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.); (ii) all healthcare fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. § 3729 et seq.), the federal Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the federal health care program exclusion law (42 U.S.C. § 1320a-7a), the criminal false statements law (42 U.S.C. §1320a-7b(a)), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to health care fraud and abuse, including but not limited to the health care fraud statutes set forth at 18 U.S.C. §§ 286, 287, 1035, 1347 and 1349; and the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C § 1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. § 1921 et seq.); (iii) the Medicare and Medicaid statutes (Titles XVIII and XIX of the Social Security Act) and any other Law governing a government sponsored or funded healthcare programs; (iv) requirements applicable to medical device advertising under the Federal Trade Commission Act; (v) all implementing regulations of the preceding Laws; (vi) the EU Medical Devices Directives (Directives 93/42/EEC and 90/385/EEC), Regulation (EU) 2017/745, including their implementing national Laws, (vii) any analogous Laws of any applicable jurisdiction; and (viii) any other state, federal, national or foreign Laws which regulate kickbacks, recordkeeping, claims process, documentation requirements, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government healthcare programs, quality, safety, licensure or any other aspect of testing, manufacture, distributing, sale, promotion or marketing of medical devices. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder. “Information” means documented and undocumented information, including any technical information, and other data and drawings of whatever kind in whatever medium, specifications, techniques, network configurations and architectures, Software, APIs, subroutines, techniques, user interfaces, URLs, works of authorship, algorithms, formulae, protocols, schematics, compositions, processes, designs, bills of material, sketches, photographs, graphs, drawings, samples, non-patented inventions, discoveries, developments and ideas, build instructions, Software code (in any form, including source code and executable or object code), build scripts, test scripts, databases and data collections, past and current manufacturing and distribution methods and processes, tooling requirements, current and anticipated customer requirements, price lists, part lists, customer lists, market studies, business plans, database technologies, systems, structures, architectures, improvements, devices, concepts, methods and information, RTL, GDSII files, whether embodied in Software or otherwise, inventions (whether or not patentable), discoveries, improvements, and technology, breadboards, netlists, mask works, mask sets, wafers, test methodologies, verilog files, emulation and simulation reports, test vectors and hardware development tools, and any and all instantiations of the foregoing in any form and embodied in any media, however documented and whether or not embodied in any tangible form, and any and all notes, analysis, compilations, studies, summaries, and other material containing or based, in |