In the past five (5) years, either the Company nor any of its subsidiaries has received any written notification or correspondence of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, governmental or regulatory authority or third party of potential or actual non-compliance by, or liability of, the Company or its subsidiaries under any applicable Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, which singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a Material Adverse Effect on the Company and its subsidiaries, taken as a whole.
Except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company and its subsidiaries, taken as a whole, (i) the Company and its subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and (ii) all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company or any of its subsidiaries or controlled affiliates, or to the Company’s knowledge, any other affiliate, or any director, officer, or employee thereof, or, to the Company’s knowledge, any agent or representative of the Company or of any of its subsidiaries or affiliates, has been excluded, suspended, disqualified or debarred from participation in any U.S. federal health care program or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could result in debarment, suspension, disqualification or exclusion, or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. § 335a or comparable foreign law. In the past five (5) years, the Company has not received any warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or assert noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws, which singly or in the aggregate, would reasonably be expected to have a Material Adverse Effect on the Company and its subsidiaries, taken as a whole.
(xl) Compliance by Suppliers. To the knowledge of Company, the manufacturing facilities and operations of its manufacturers and suppliers, with respect to the manufacturing or supply of the Company’s products, are operated in compliance with all Health Care Laws, except as would not reasonably be expected to result in a Material Adverse Effect on the Company and its subsidiaries, taken as a whole.
(xli) Safety Notices. (i) There have been no warnings, investigator notices, safety alerts or other written notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s or any of its subsidiaries’ products (“Safety Notices”), and (ii) there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company’s or any of its subsidiaries’ products, (y) a change in labeling of any of the Company’s or any of its subsidiaries’ products, or (z) a termination or suspension of testing of any of the Company’s or any of its subsidiaries’ products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
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