definiens: shall mean ( a ) the applicable statutes, ordinances, other laws, rules, codes, orders, decrees of courts and regulations of any Go vernmental Authority in the Territory that may be i n effect from time to time that apply to a Party ’s activities or obligations under or in connection with this Agreem ent, including the FD&C Act, the Prescription Drug Marketing Act o f 1987, the Generic Drug Enforcement Act of 1992 ( 2 1 U.S.C. § 335a et seq . ), the Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b et seq . ), the Patient Protecti on and Affordable Care Act ( 42 U.S.C. § 18001 et seq . ), th e Antifraud and Abuse Amendment to the Social Secur ity Act, FCPA, HIPAA, Debarment Laws, and all applicable imp lementing regulations for the foregoing, all as ame nded from time to time ; and ( b ) applicable guidelines co ncerning the advertising and promotion of prescript ion drug products, including the Office of the Inspector Gen eral ’s Compliance Guidance Program issued in 2003, the American Medical Association ( the ) Guidelines on Gifts to Physicians, the Pharmaceu tical Research and Manufacturers of America ( ) Code on Interactions with Healthcare Professiona ls, as hereafter amended from time to time ( the ), the PhRMA Principles on Conduct of Clinical Tri als and Communication of Clinical Trial Results, and the standards set fo rth by the Accreditation Council for Continuing Med ical Education ( ) relating to educating the medical community in t he United States ( ), in each case to the extent applicable to the Pa rties ’ activities hereunder and as may be amended o r supplemented from time to time