foreign laws or regulations promulgated pursuant to such laws, including, without limitation, the FDA current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s or its subsidiaries’ products, each as amended from time to time and the regulations promulgated thereunder. Neither the Company nor its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging a violation of any Health Care Laws in any material respect and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as would not, singly or in the aggregate, result in a Material Adverse Effect, neither the Company nor its subsidiaries has received any unresolved FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from any Governmental Authority alleging or asserting non-compliance with any Health Care Laws. The Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), except, in each case, where the failure to do so would not, singly or in the aggregate, result in a Material Adverse Effect. None of the Company, its subsidiaries or, to the Company’s knowledge, any of their respective directors, officers, employees or agents has engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive debarment, suspension or exclusion from Medicare, Medicaid, or any other state or federal health care program, clinical trial or clinical registry or, to the Company’s knowledge, is otherwise subject to an inquiry, investigation, proceeding or other similar action by any Governmental Authority that could reasonably be expected to result in debarment, suspension, or exclusion. Neither the Company nor 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 an Governmental Authority.
(xl) Research and Clinical Studies, Clinical Trials and Clinical Registries. The research and clinical studies, clinical trials and clinical registries conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with all applicable Health Care Laws of the FDA, Health Canada, and comparable medical device regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies, clinical trials and clinical registries are accurate and not misleading in all material respects with respect to the portions of such studies, clinical trials and clinical registries being described; the Company has no knowledge of any other studies, clinical trials or clinical registries not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries has received any written notices, correspondence or other communications from the Regulatory Authorities or any other Governmental Authority requiring or threatening (i) the termination or suspension or clinical hold of any studies, clinical trials or clinical registries that are described in, or the results of which are referred to in, the Registration Statement, the General
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