Absence of Debarment. Consultant represents that # neither Consultant nor any Consultant Personnel has been debarred, and to the best of Consultant’s knowledge is not under consideration to be debarred, by the U.S. Food and Drug Administration (“FDA”) from working in or providing consulting services to any pharmaceutical or biotechnology company under [Section 306(a) or 306(b)])] of the federal Food, Drug and Cosmetic Act (codified at 21 U.S.C. §§ 335a(a) and 335a(b)); # no debarred person will in the future be employed by Consultant to perform any services hereunder in connection with any application for approval of a drug by the FDA; and # neither Consultant nor any Consultant Personnel has a conviction on their record for which a person can be debarred as decribed in [Sections 306(a) or 306(b)])] of the federal Food, Drug and Cosmetic Act. Consultant further represents and warrants that should Consultant or any Consultant Personnel be convicted in the future of any act for which a person can be debarred as described in [Sections 306(a) or 306(b)])] of the federal Food, Drug and Cosmetic Act, Consultant shall immediately notify Company of such conviction in writing.

Absence of Debarment. Consultant further represents and warrants that Consultant is not and has not been # debarred or convicted, and is not subject to a pending debarment or conviction, pursuant to section 306 of the United States Food Drug and Cosmetic Act (as amended), 21 U.S.C. § 335a; (ii) (A) listed by any government or regulatory agencies as ineligible to participate in a “Federal Health Care Program” (as that term is defined in 42 U.S.C. 1320a-7b(f)), or in any other government payment program, or # excluded, debarred, suspended or otherwise made ineligible to participate in any such program; # listed on the General Services Administration’s List of parties Excluded from Federal Procurement and Nonprocurement Programs; or # convicted of a criminal offense related to the provision of healthcare items or services, and is not subject to any such pending action. Consultant further represents and warrants # that, to the best of Consultant’s knowledge, Consultant has not engaged in any activity that could lead Consultant to become excluded or debarred as set forth above; and # Consultant does not and will not use in any capacity the services of any person

No Debarment. Consultant represents and warrants that Consultant has not been debarred under Section (a) or (b) of 21 U.S.C. Section 335a and does not appear on the United States Food and Drug debarment list. Consultant represents and warrants that Consultant has not committed any crime or conduct that could result in such debarment or Consultant’s exclusion from any governmental healthcare program. Consultant represents and warrants that, to Consultant’s knowledge, no investigations, claims or proceedings with respect to any such crimes or conduct are pending or threatened against Consultant. Consultant agrees and undertakes to promptly notify Company if Consultant becomes debarred or proceedings have been initiated against Consultant with respect to debarment, whether such debarment or initiation of proceedings occurs during or after the term of this Agreement.

Consultant certifies, represents and warrants that Consultant has not been: # debarred under [subsections (a) or (b)])] of Section 306 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 335a(a) and (b) (the “FD&C Act”), or # excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)) or convicted of a criminal offense related to the provision of health care items or services, but has not yet been debarred. Moreover, if Consultant is subsequently so debarred or excluded, Consultant agrees to immediately notify Company of such debarment or exclusion as provided in Section 20 herein, and this Agreement shall terminate with respect to Consultant as of the date of such debarment or exclusion.

#Compliance with Laws. Consultant represents and warrants that Consultant will render Services in compliance with all applicable laws, rules and regulations, including but not limited to the U.S. Food, Drug and Cosmetic Act, as amended from time to time, and the highest professional standards. Further, Consultant represents and warrants that he has not been, and is not under consideration to be # debarred from providing services pursuant to Section 306 of the United States Federal Food Drug and Cosmetic Act, 21 U.S.C. § 335a; # excluded, debarred or suspended from, or otherwise ineligible to participate in, any federal or state health care program or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. §1320a-7b(f)); # disqualified by any government or regulatory agencies from performing specific services, and is not subject to a pending disqualification proceeding; or # convicted of a criminal offense related to the provision of health care items or services, or under investigation or subject to any such action that is pending.

Sanctions or Debarment. Consultant represents and warrants that Consultant is not and has never been: # sanctioned by the Office of Inspector General (“OIG”) of the Department of Health and Human Services, barred from participating in government health care programs, or convicted of a criminal offense with respect to health care reimbursement; or # debarred under [Section 306(a) or (b)])] of the Federal Food, Drug and Cosmetic Act, or a stockholder in, or otherwise affiliated with any person or entity who has been so debarred. Consultant shall immediately notify Company, in writing, if the foregoing representation becomes untrue, or if Consultant is notified by the OIG, the FDA or other enforcement agency that an investigation of Consultant has begun which could lead to such sanction, debarment or conviction.‬‬