definiens: Applicable Laws " means all laws, rules, regulations, guidance and guidelines that are applicable to the marketing, sale and promotion of pharmaceutical products for human use in the Co - Promotion Territory and that materially affect a Party 's performance under this Agreement, including the United States Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Prescription Drug Marketing Act, Federal Health Care Program Anti­Kickback Law ( 42 U.S.C. ss.1320a-7b ), the Health Insurance Portability and Accountability Act of 1996, and all rules and regulations promulgated thereunder, the Office of Inspector General ( " OIG ' ) Compliance Guidance Program, the Code on Interactions with Healthcare Professionals promulgated by the Pharmaceutical Research and Manufacturers of America ( PhRMA ) and the American Medical Association Guidelines on Gifts to Physicians, as any of the foregoing may be amended