U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), TRICARE (10 U.S.C. Sections 1071 et seq.), any state corporate practice or fee-splitting prohibitions, and any state or federal anti-markup or comparable laws or regulations, the regulations promulgated pursuant to such laws, and any other state, federal or foreign law, accreditation standards, regulation, memorandum, opinion letter or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs, biologics and medical devices (including diagnostic products and laboratory developed tests), kickbacks, patient or program charges, recordkeeping, claims process, documentation 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 SEC Reports, 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 SEC Reports, 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 SEC Reports, 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 SEC Reports fairly summarize the matters therein described.
(mm) Shell Company. The Company is not an ineligible issuer (as defined in Rule 405 promulgated under the Securities Act).
(nn) No Additional Agreements. The Company does not have any agreement or understanding with any Purchaser with respect to the transactions contemplated by the Transaction Documents other than as specified in the Transaction Documents or any written agreement regarding the confidentiality and use of confidential information.
(oo) Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company or the Subsidiaries, or in which the Company or the Subsidiaries have participated, that are described in the SEC Reports, or the results of which are referred to in the SEC