definiens: means the laws, rules, statute s, orders, ordinances, regulations, guidance and guidelines, or other requirements of any Government al Authority that may be in effect from time to tim e and that are applicable to a Party or a Party ’s activities u nder this Agreement ( including the marketing, sale, and promotion of pharmaceutical products for human use ), includin g GMP, GLP, GCP, and any other rules, regulations, guidelines, or other requirements of Regulatory Aut horities . For example, in the United States Applica ble Law includes the FFDCA, the Public Health Service Act, the Prescription Drug Marketing Act, the Federal Fa lse Claims Act ( 31 U.S.C. § 3729 et seq . ), the Federal Health C are Program Anti - Kickback Law ( 42 U.S.C. § § 1320a-7b ), the Health Insurance Portability and Accountability Act of 1996, and all rules and regulations 2 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH ( I ) NOT MATERIAL AND ( II ) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED