enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any operation or activity is in violation of any Health Care Laws and, to the Company’s knowledge, any such Governmental Entity or third party is considering or threatening such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, except where such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action would not, singly or in the aggregate, result in a Material Adverse Effect; (iv) and except as would not singularly or in the aggregate, result in a Material Adverse Effect, neither the Company nor its subsidiaries has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Governmental Licenses and the Company has no knowledge that any such Governmental Entity is considering such action; (v) 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 as would not, singly or in the aggregate, result in a Material Adverse Effect; (vi) neither the Company nor its subsidiaries or any of their respective directors, officers, or to the Company’s knowledge, any of its employees or agents is or has engaged in activities which are cause for, or has been convicted of any federal civil or criminal activity or engaged in any conduct that are cause for false claims liability or civil penalties or would result in mandatory or permissive debarment, suspension or exclusion from any federal or state government health care program, including Medicare and Medicaid, or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding, or other similar action by any Governmental Entity that could reasonably be expected to result in debarment, suspension, or exclusion; and (vii) the Company is not a party to and the Company does not have 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 Entity. Additionally, neither the Company, the officers or directors nor, to the Company’s knowledge, any of its employees, has been excluded, suspended or debarred from participation in any U.S. federal health care program, human research study, clinical trial or clinical registry.
(xl) Research Studies and Clinical Trials. The research studies and trials 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 local, state and federal laws, rules and regulations of the FDA and comparable medical device regulatory agencies outside of the United States (the FDA and any comparable regulatory agencies, together with applicable institutional review boards, ethics review boards, and ethics committees, collectively, the “Regulatory Authorities”) and any and all applicable Health Care Laws; the descriptions of the results of such research studies, clinical trials and clinical registries described in the Registration Statement, the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are materially inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities or any other Governmental Entity requiring or threatening (i) the termination or suspension or clinical hold of any studies or trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the
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