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 - Kickba ck Statute ( 42 U.S.C. § 1320a-7b(b ) ), the U.S. Civi l False Claims Act ( 31 U.S.C. § § 3729 et seq . ), the Federal False Statements Law ( 42 U.S.C. § 1320a-7b(a ) ), al l criminal laws relating to health care fraud and abuse, inclu ding but not limited to 18 U.S.C. § § 286 and 287, and the health care fraud criminal provisions under the U.S. Healt h Insurance Portability and Accountability Act of 1 996 ( ) ( 42 U.S.C. § § 1320d et seq . ), the Civil M onetary Penalties Law ( 42 U.S.C. § 1320a-7a ), the e xclusion laws ( 42 U.S.C. § 1320a-7 ), the Medicare statute ( T itle XVIII of the Social Security Act ), and the Med icaid statute ( Title XIX of the Social Security Act ) and the regu lations promulgated pursuant to such statutes ; ( iii ) HIPAA, as amended by the Health Information Technology for Ec onomic and Clinical Health Act ( 42 U.S.C. Section 1 7921 et seq . ), and the regulations promulgated thereunde r ; ( iv ) the U.S. Physician Payments Sunshine Act ( 4 2 U.S.C. § 1320a-7h ), and the regulations promulgated thereund er ; and ( v ) any and all other applicable health car e laws and regulation applicable to the ownership, testing, de velopment, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, pro motion, sale, offer for sale, storage, import, expo rt or disposal of any product under development by the Company