definiens: means : ( i ) the Federal Food, Drug, and Cosme tic Act ( 21 U.S.C. § § 301 et seq . ), and the regulat ions promulgated thereunder ; ( ii ) all applicable federal, state, local and foreign health care related frau d and abuse laws, including, without limitation, the U.S. Anti- Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the U.S . Civil False Claims Act ( 31 U.S.C. § § 3729 et seq . ), the F ederal False Statements Law ( 42 U.S.C. § 1320a-7b(a ) ), all criminal laws relating to health care fraud and abu se, including but not limited to 18 U.S.C. § § 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountabili ty Act of 1996 ( ), the Civil Monetary Penalties Law ( 42 U.S.C. § 1 320a-7a ), the exclusion laws ( 42 U.S.C. § 1320a-7 ), the Medicare statute ( Title XVIII of the Social Security Act ), and the Medicaid statute ( Tit le XIX of the Social 15 Security Act ) and the regulations promulgated pursu ant to such statutes ; ( iii ) HIPAA, as amended by t he Health Information Technology for Economic and Clinical He alth Act ( 42 U.S.C. Section 17921 et seq . ), and the regulations promulgated thereunder ; ( iv ) the U.S. P hysician Payments Sunshine Act ( 42 U.S.C. § 1320a-7 h ), and the regulations promulgated thereunder ; and ( v ) any and all other applicable health care laws and regu lation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distributi on, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company