(ww) Regulatory Compliance. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company: (i) within the last three (3) years has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from any governmental or regulatory authority alleging or asserting noncompliance with any applicable Health Care Laws (as defined below) or the terms of any Permits required by Health Care Laws, except in each case as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (ii) within the past three (3) years has not 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 Permits and has no knowledge that any such claim, litigation, arbitration, action, suit, investigation or proceeding is threatened, except in each case as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (iii) (a) for the past three (3) years has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Permits, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (b) except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, for the past three (3) years, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct 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 (iv) has not, and to the knowledge of the Company, the Company’s officers, employees and agents have not, within the past three (3) years, 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.
(xx) Compliance with Health Care Laws. The Company is, and at all times in the past three (3) years has been, in compliance in with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims
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