definiens: means ( a ) all Laws enforced by the FDA and other Governmental Entities andcomparable state regulatory authorities and Governmental Entities outside the United States, concerned with thequality, identity, strength, purity, safety, efficacy, marketing, developing or manufacturing of the Company Products orParent Products, as appropriate, ( b ) the FDA Act and the regulations promulgated thereunder, ( c ) the Public HealthService Act ( 42 U.S.C. § 201 et seq . ), and the regulations promulgated thereunder, ( d ) all federal and state fraud andabuse laws, including the Federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the civil False Claims Act ( 31U.S.C. § 3729 et seq . ), the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), the Anti - Inducement Law ( 42U.S.C. § 1320a-7a(a)(5 ) ), the exclusion laws ( 42 U.S.C. § 1320a-7 ), and the regulations promulgated pursuant to suchstatutes, ( e ) the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § § 1320d et seq . ), theregulations promulgated thereunder and comparable state laws, ( f ) the Controlled Substances Act ( 21 U.S.C. § 801 etseq . ), ( f ) Titles XVIII ( 42 U.S.C. § 1395 et seq . ) and XIX ( 42 U.S.C. § 1396 et seq . ) of the Social Security Act and theregulations promulgated thereunder and ( g ) the Clinical Laboratories Improvement Amendments ( 42 U.S.C. § 263a etseq . )