Company; (iv) each description of any studies, tests or preclinical and clinical trials conducted by or on behalf of or sponsored by the Company contained in the Registration Statement, Disclosure Package and the Prospectus is accurate and complete in all material respects and fairly presents the data about and derived from such studies, tests and trials; (v) all testing, manufacturing, packaging, processing, labeling, distribution, marketing, promotion, storage, import, export or disposal of the Company’s or its subsidiaries’ products by the Company, its subsidiaries or to the Company’s knowledge, their suppliers, vendors or partners have been conducted in compliance with all applicable laws, rules and regulations, including applicable Health Care Laws; (vi) neither the Company nor any subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory authority or third party alleging that any product, operation, or activity is in violation of any Health Care Laws or Governmental Licenses and the Company has no knowledge that any such governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vii) neither the Company nor any subsidiary has received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any governmental or regulatory authority alleging or asserting noncompliance with any applicable laws or regulations, including the Health Care Laws, or the terms of any Governmental Licenses; (viii) (A) the Company and each subsidiary has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Governmental Licenses, (B) all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), and (C) the Company is not aware of any reasonable basis for any material liability with respect to such filings; and (D) neither the Company nor its subsidiaries have, and to the knowledge of the Company, the Company’s officers, employees and agents have not, made any untrue statement of a material fact or fraudulent statement to any governmental or regulatory authority or failed to disclose a material fact required to be disclosed to any governmental or regulatory authority; (ix) the Company is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental agency; and (x) neither the Company or any of its subsidiaries or their employees, officers, directors or, to the Company’s knowledge, agents, has been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute), Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute) and any other law governing or pertaining to a government healthcare program; the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347, 1349 and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act,
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