“GAAP” means generally accepted accounting principles in the United States.
“GCP” means ethical and scientific quality standards for designing, conducting, performing, monitoring, auditing, analyzing, recording and reporting trials that involve the participation of human subjects, as promulgated, enforced, or endorsed by any Governmental Authority.
“GLP” means a set of rules and criteria for a quality system, standards, practices, and procedures concerned with the organizational process and the conditions under which non-clinical health and safety studies are planned, performed, monitored, recorded, reported and archived, as promulgated, enforced, or endorsed by any Governmental Authority.
“Government Official” means any official, officer, employee or representative of, or any Person acting in an official capacity for or on behalf of, any Governmental Authority, and includes any official or employee of any directly or indirectly government-owned or -controlled entity, and any officer or employee of a public international organization, as well as any Person acting in an official capacity for or on behalf of any such Governmental Authority, or for or on behalf of any such public international organization.
“Governmental Authority” means any federal, national, state, provincial, local or transnational (in each case whether domestic or foreign) government, court, administrative agency or commission, judicial body or tribunal, arbitrator or arbitration panel, self-regulatory agency (including Nasdaq and NYSE) or other governmental or regulatory authority or instrumentality.
“Hazardous Materials” means any petroleum or petroleum products, explosive or radioactive materials or wastes, asbestos, per- and poly-fluorinated substances, polychlorinated biphenyls and hazardous or toxic materials and any other material, substance or waste that is regulated or may result in liability under any Environmental Law.
“Healthcare Laws” means all applicable Law relating to the procurement, development, research, manufacture, production, packaging, labeling, sterilization, distribution, importation, exportation, handling, quality, safety surveillance, reporting of adverse events and product complaints, recall, reprocessing, commercialization, sale, or promotion of medical and other FDA- or similar Governmental Authority-regulated products, including the Products of Kenvue, the regulation, provision, management or administration of, ordering or arranging for, or payment or reimbursement for, any healthcare items or services, and standards for establishments involved in any such activities, including: the Federal Food, Drug, and Cosmetic Act (21 C.F.R. § 301 et seq.), the U.S. Public Health Service Act (42 U.S.C. § 201 et seq.), and all rules, regulations, product monographs and guidance promulgated thereunder; cGMP, GCP and GLP; the Federal Trade Commission Act (15 U.S.C. §§ 41 et seq.) and all rules, regulations and guidance promulgated thereunder; licensure Laws relating to the regulation, provision or administration of, or payment for, the manufacture, distribution, storage, holding, dispensing and possession of medical and other FDA- or similar Governmental Authority-regulated products; state pharmacy Laws; the False Claims Act (31 U.S.C. §§ 3729-3733); the Exclusion Law, 42 U.S.C. § 1320a-7; the Civil Monetary Penalties Law (42 U.S.C. § 1320 a-7a); the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); the False Claim Law (42 U.S.C. § 1320a-7b(a)); the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); HIPAA; and any applicable Law with respect to healthcare related fraud and abuse, false claims, self-referral, anti-kickback and licensing.
“Healthcare Program” shall mean any U.S. federal health program as defined in 42 U.S.C. § 1320a-7b(f), including Medicare, Medicaid, TRICARE, CHAMPVA and state health care programs (as defined therein), and any health insurance program for the benefit of federal employees, including those under Chapter 89 of Title V, United States Code.
“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, including the Standards for Privacy of Individually Identifiable Health Information (45 CFR Part 160 and Part 164, Subparts A, D and E), the Transactions and Code Set Standards (45 CFR Part 162), and the Security Standards for the Protection of Electronic Protected Health Information (45 CFR Part 164, Subparts A and C), the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009) as set forth at 42 USC §§ 17931 et seq., and their implementing regulations.
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
“Indebtedness” means, with respect to any Person, without duplication, all obligations or undertakings by such Person: (a) for borrowed money (including deposits or advances of any kind to such Person); (b) evidenced by bonds, including performance or surety bonds, debentures, notes or similar instruments; (c) for capitalized leases or to pay the deferred and unpaid purchase price of property or equipment; (d) pursuant to securitization or factoring programs or arrangements; (e) to maintain or cause to be maintained the financing or financial position of others; (f) net cash payment obligations under swaps, options, derivatives or other hedging Contracts that will be payable upon termination thereof (assuming termination on the date of determination); (g) letters of credit, bank guarantees or other similar Contracts entered into by or on behalf of such Person to the extent they have been drawn upon; or (h) pursuant to guarantees or arrangements having the economic effect of a guarantee of any obligations of the type described in the foregoing clauses of any other Person.
“Intellectual Property” means any of the following existing under the Laws of the United States or any other jurisdiction: (a) patents (including all reissues, reexaminations, supplemental examinations, substitutions, renewals and extensions thereof) and patent applications (including provisional non-provisional applications, continuations, divisionals and continuations-in-part); (b) registered and unregistered trademarks, service marks, trade names and other similar indicia or source or origin, pending trademark and service mark registration applications, and intent-to-use registrations or similar reservations of marks, together with the goodwill symbolized by any of the foregoing; (c) registered and unregistered copyrights, applications for registration of copyright and other equivalent rights in works of authorship; (d) internet domain names; (e) trade secrets, know-how, processes, formulae, recipes, methods, techniques, procedures, algorithms, specifications, inventions, ideas, marketing materials, customer and supplier lists, and other rights in proprietary information, in each case, to the extent qualifying as a trade secret under applicable Law (“Trade Secrets”); (f) rights in Software; and (g) all other intellectual property, proprietary, industrial and similar rights, and any registrations, applications for registration and renewals therefor.
“IT Systems” means computers, software, databases, firmware, middleware, servers, workstations, networks, systems, routers, hubs, switches, data communications lines and all other information technology equipment and associated documentation.
“Johnson & Johnson” means Johnson & Johnson, a New Jersey corporation.
“Johnson & Johnson TMA” means that certain Tax Matters Agreement, dated May 3, 2023, by and between Kenvue and Johnson & Johnson.
“Judgment” means any judgment, order, writ, ruling, determination, injunction, decree, award, stipulation or settlement (in each case whether civil, administrative or criminal) of or with any Governmental Authority.