requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, Health Care Laws). None of the Company, the Subsidiaries, the Managed Practice or any of its respective officers, directors, employees or, to the Companys knowledge, agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, TRICARE or any other state or federal healthcare program (collectively, the Programs). Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, none of the Company, any of the Subsidiaries or the Managed Practice has received any notification, correspondence or any other written or, to the Companys knowledge, oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (Action) from any governmental authority, including, without limitation, the FDA, the EMA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration, CMS, HHSs Office of Inspector General, the United States Department of Justice and state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company, the Subsidiaries or the Managed Practice under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, be material to the Company, its Subsidiaries or the Managed Practice. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, to the Companys knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company, the Subsidiaries or the Managed Practice under any Health Care Laws. Except as set forth in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, none of the Company, any of its Subsidiaries or the Managed Practice is a party to, and has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental or regulatory authority. Additionally, none of the Company, its Subsidiaries, the Managed Practice or any of its respective employees, officers or directors, nor to the Companys knowledge, any of its agents, has been excluded, suspended or debarred from participation in any 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 statements with respect to Health Care Laws and the Companys, the Subsidiaries and the Managed Practices compliance therewith included in the Preliminary Prospectus, in the Time of Sale Disclosure Package and in the Prospectus fairly summarize the matters therein described.
(xx) Third-Party Payor Programs. Each of the Company, its Subsidiaries and the Managed Practice meets all Program requirements and conditions of participation and are a party to valid participation or other agreements required for payment by such Programs and other third-party payor programs in which the Company is a participant. There are no material suspensions, offsets, overpayments or recoupments of any Program or material third-party payor payments being sought, requested or claimed, or to the Companys knowledge, threatened against the Company, any Subsidiary or the