U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C.
Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7) and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by
the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated pursuant to such statutes; (iv) the Patient Protection and Affordable Care Act (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act (Public Law 111-152); (v) Medicare (Title XVIII of the Social Security Act); (vi) Medicaid (Title XIX
of the Social Security Act); and (vii) any and all other applicable health care laws and regulations. Except as otherwise disclosed in the Registration Statement or Prospectus, neither the Company nor, to the knowledge of the Company, any of
its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that
any product operation or activity is in material violation of any Health Care Laws, and, to the Companys knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. To the
Companys knowledge, neither the Company nor any of its subsidiaries have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any
other state health care program or federal health care program. Except as otherwise disclosed in the Registration Statement or Prospectus, 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, except as otherwise disclosed in the Registration Statement or Prospectus, none of the Company, any of its subsidiaries or any of their respective employees, officers or directors has been excluded, suspended or debarred from
participation in any U.S. federal health care 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.
(qq) Except as otherwise disclosed in the Registration Statement or Prospectus, neither
the Company nor any of its subsidiaries has sent or received any communication regarding termination of, or intent not to renew, any of the contracts or agreements referred to or described in the Prospectus or any free writing prospectus, or
referred to or described in, or filed as an exhibit to, the Registration Statement, and no such termination or non-renewal has been threatened by the Company or any of its subsidiaries or, to the
Companys knowledge, any other party to any such contract or agreement, which threat of termination or non-renewal has not been rescinded as of the date hereof.
(rr) The preclinical tests and clinical trials, and other studies (collectively, studies) being conducted by or, to
the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance
with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act (collectively, FFDCA) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the
protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly
presents, in all material respects, the data derived from such studies, and, except as otherwise disclosed in the Registration Statement or Prospectus, the Company and its subsidiaries have no knowledge of any other studies the results of which are
inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; except as otherwise disclosed in the Registration Statement or Prospectus, the Company and its subsidiaries
have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or
medical
16