definiens: means the Legal Requirements relating to the research, development, testing, manufacture, handling, production, pricing, Labeling, packaging, marketing, promotion, sale, distribution, coverage, or reimbursement of a drug, device, biological or other medical item, supply or service, including the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. § 321 et seq . ), the federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7(b ) ), the civil False Claims Act ( 31 U.S.C. § 3729 etseq . ), the healthcare fraud, false statement and health information privacy and3security provisions of the Health Insurance Portability and Accountability Act of 1996, as amended, the federal healthcareprogram civil money penalty and exclusion authorities, the applicable requirements of Medicare, Medicaid and otherGovernmental Entity healthcare programs, including those of the Veterans Health Administration and U.S. Department ofDefense, or other applicable Legal Requirements relating to private health care plans or the privacy and conﬁdentiality ofpatient health information, and the analogous Legal Requirement of any federal, state, local, or foreign jurisdiction applicableto Seller and the Specified Affiliates