definiens: means, to the extent related to the conduct of [COMPANY] ’s business or Keryx’sbusiness, as applicable, as of the date hereof, the FDCA, Medicare ( Title XVIII of the Social Security Act ) andMedicaid ( Title XIX of the Social Security Act ), the federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the CivilMonetary Penalty Law ( 42 U.S.C. § 1320a-7a ), the civil False Claims Act ( 31 U.S.C. § § 3729 et seq . ), theadministrative False Claims 91Law ( 42 U.S.C. § 1320a-7b(a ) ), the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d etseq . ), as amended by the Health Information Technology for Economic and Clinical Health Act ( 42 U.S.C. § § 17921 etseq . ) and the exclusion laws ( 42 U.S.C. § 1320a-7 ), the Prescription Drug Marketing Act of 1987, the Sunshine / OpenPayments Law ( 42 U.S.C. § 1320a-7h ), all regulations or guidance promulgated pursuant to such Laws, and any otherfederal, state or non - U.S