definiens: means all federal, state and local laws, and the rules, regulations, guidelines and guidances of all Agencies, in effect from time to time, appli cable to the marketing, promotion, distribution and sale of the Product in the Territory, including, to the extent applicable, ( i ) the American Medical Association Guidelines on Gifts to Physicians from Industry, ( ii ) the PhRMA Code on Interactions with Healthcare Professionals, ( iii ) t he Health Insurance Portability and Accountability Act of 1996, including the Privacy Standards ( 45 C.F.R. Parts 16 0 and 164 ), as amended by the American Recovery and Reinvestment Act of 2009 and any regulations promul gated thereunder, ( iv ) the Social Security Act and any regulations promulgated thereunder, ( v ) the Act, ( v i ) the PDMA, and ( vii ) state and federal anti - kickb ack statutes, false claims statutes, statutes that gove rn price reporting and reimbursement, and statutes that govern marketing disclosure and physician payments, and al l rules and regulations promulgated thereunder, in each case in the Territory