definiens: shall mean the federa l Anti - kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the Physician Payment Sunshine Act ( 42 U.S.C. § 1320a-7 h ), the civil False Claims Act ( 31 U.S.C. § § 3729 e t seq . ), the criminal False Claims Act ( 42 U.S.C. § 1320a-7b ( a ) ), all criminal laws relating to health care fra ud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provis ions under the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ) ( ), the exclusion laws ( 42 U.S.C. § 1320a-7 ), the civil mon etary penalties law ( 42 U.S.C. § 1320a-7a ), HIPAA, as amended by the Health Information Technology for Ec onomic and Clinical Health Act ( 42 U.S.C. § § 17921 et seq . ), the patient privacy, data security and breac h notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § § 301 et seq . ), Medica re ( Title XVIII of the Social Security Act ), Medica i d ( Title XIX of the Social Security Act ), the regulations pr omulgated pursuant to such laws, and any other simi lar local, state or federal law and regulations . The Company h as not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspond ence, communication or notice from the FDA or any o ther governmental or regulatory authority alleging or as serting noncompliance with any Health Care Laws app licable to the Company . The Company is not a party to nor h as any ongoing reporting obligations pursuant to an y corporate integrity agreements, deferred prosecution agreemen ts, monitoring agreements, consent decrees, settlem ent orders, plans of correction or similar agreements with or i mposed by any governmental or regulatory authority