Supplier and all Related Persons # are not currently excluded, debarred, or otherwise ineligible to participate in the federal health care programs as defined in 42 U.S.C. § 1320a-7b(f) (“Federal Health Care Programs”) or generally from federal procurement and non-procurement programs; # have not been convicted of a criminal offense related to the provision of health care items or services but not yet been excluded, debarred, or otherwise declared ineligible to participate in the Federal Health Care Programs, or generally from federal procurement and non-procurement programs; # are not under investigation or otherwise aware of any circumstances that may result in such exclusion from participation in the Federal Health Care Programs, or generally from federal procurement and non-procurement programs; # shall at all times maintain accurate and complete accounting and other financial records in accordance with the applicable Laws of the country in which any Services are to be performed; # shall, in their performance under this Agreement and in connection with their activities in relation thereto, ensure that no payments of money or anything of value shall be offered, promised or paid, directly or indirectly, to any foreign official, or public or political officer, to induce such official or officer to use their influence with a foreign government or instrumentality to obtain an improper business advantage for [[OUTSET:Organization]]; # shall report immediately to [[OUTSET:Organization]] any information that may indicate there has been a payment of money or anything of value offered, promised or paid, directly or indirectly, to any foreign official, or public or political officer as described above (an “Improper Payment”); # shall, upon [[OUTSET:Organization]]’s request, certify that they have no knowledge of an Improper Payment; # agree that [[OUTSET:Organization]] may suspend or terminate this Agreement upon confirming information and validating the facts to conclude that Supplier has made or offered an Improper Payment; and # agree that payments shall be made to government officials or political parties only purposes permitted by applicable Law, which shall first be fully disclosed in writing to [[OUTSET:Organization]].

Exclusion and Debarment. Advisor represents and warrants that Advisor is not currently: # excluded, debarred, suspended or otherwise ineligible to participate in any governmental healthcare program, including any Federal health care programs as defined in 42 U.S.C. § 1320a-7b(f), or from federal procurement or nonprocurement activities as defined in Executive Order 12689 (collectively “Ineligible”); or # debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), as amended, or subject to any similar sanction pursuant to any similar state or foreign law or regulation (collectively “Debarred”) or # convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible (“Convicted”). If Advisor becomes Ineligible, Debarred or Convicted, or subject to any investigation or proceeding with respect thereto, during the term of this Agreement, Advisor will notify Stoke promptly, and in any event no later than two (2) business days after receiving notification of the Ineligibility, Debarment, Conviction or related investigation or proceeding. Upon receipt of such notice, or if Stoke becomes aware of any existing or threatened Ineligibility, Debarment or Conviction, Stoke shall have the right to terminate this Agreement immediately, without liability or indemnity.

Debarment; Exclusion. Consultant represents and warrants that neither Consultant, Consultant’s group practice (if applicable), nor any person or entity authorized to assist Consultant in the performance of the Consulting Services has ever been and is not currently debarred, suspended, or excluded from, proposed for debarment, suspension, or exclusion from, or otherwise ineligible for the award of contracts by any federal agency or participation in any federal health care program. Consultant’s representation and warranty hereunder includes, but is not limited to, debarment under [Section 306(a) or (b)])] of the federal Food, Drug, and Cosmetic Act, exclusion from participation in any federal health care program (as defined in 42 U.S.C. § 1320a–7b(f)) under 42 U.S.C. § 1320a-7(a) or (b), or exclusion by any federal government agency from receiving federal contracts or federally approved subcontracts under the Federal Acquisition Regulations (FAR) or supplements thereto.

Debarment. Each Party represents, warrants and covenants to the other Party that neither it nor its officers, employees, agents, consultants or any other person used by such Party in the performance of the respective research and Development activities under this Agreement is: # debarred or disqualified under the U.S. Federal Food, Drug and Cosmetic Act; # listed by any government or regulatory agencies as ineligible to participate in any government healthcare programs or government procurement or non-procurement programs (as that term is defined in 42 U.S.C. § 1320a-7b(f)), or excluded, debarred, suspended or otherwise made ineligible to participate in any such program; or # convicted of a criminal offense related to the provision of healthcare items or services, or is subject to any such pending action. Each Party shall not during the Term knowingly, employ or use, directly or indirectly, including through Affiliates the services of any such person. In the event that either Party becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to such Party, directly or indirectly, including through Affiliates or Sublicensees, which directly or indirectly relate to activities contemplated under this Agreement, such Party shall promptly notify the other Party in writing and such Party shall cease employing, contracting with, or retaining any such person to perform any such services.

Exclusion and Debarment. Advisor represents and warrants that Advisor is not currently: # excluded, debarred, suspended or otherwise ineligible to participate in any governmental healthcare program, including any Federal health care programs as defined in 42 U.S.C. § 1320a-7b(f), or from federal procurement or nonprocurement activities as defined in Executive Order 12689 (collectively “Ineligible”); or # debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), as amended, or subject to any similar sanction pursuant to any similar state or foreign law or regulation (collectively “Debarred”) or # convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible (“Convicted”). If Advisor becomes Ineligible, Debarred or Convicted, or subject to any investigation or proceeding with respect thereto, during the term of this Agreement, Advisor will notify Stoke promptly, and in any event no later than two (2) business days after receiving notification of the Ineligibility, Debarment, Conviction or related investigation or proceeding. Upon receipt of such notice, or if Stoke becomes aware of any existing or threatened Ineligibility, Debarment or Conviction, Stoke shall have the right to terminate this Agreement immediately, without liability or indemnity.

Debarment and Exclusion. Consultant represents and warrants that: # it is not debarred under [subsections 306(a) or (b)])] of the Federal Food, Drug, and Cosmetic Act [US Generic Drug Enforcement Act of 1992; 21 USC 335a [(a) or (b)]] or similar local laws or regulations and that Consultant has not and will not use in any capacity the services of any person debarred under such law with respect to the Services; and # it is not excluded from any federal health care program, including but not limited to Medicare and Medicaid. Consultant will notify Trevi immediately if either of these representations needs to be amended in light of new information.

Exclusion and Debarment. Advisor represents and warrants that Advisor is not currently: # excluded, debarred, suspended or otherwise ineligible to participate in any governmental healthcare program, including any Federal health care programs as defined in 42 U.S.C. § 1320a-7b(f), or from federal procurement or nonprocurement activities as defined in Executive Order 12689 (collectively “Ineligible”); or # debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), as amended, or subject to any similar sanction pursuant to any similar state or foreign law or regulation (collectively “Debarred”) or # convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible (“Convicted”). If Advisor becomes Ineligible, Debarred or Convicted, or subject to any investigation or proceeding with respect thereto, during the term of this Agreement, Advisor will notify Stoke promptly, and in any event no later than two (2) business days after receiving notification of the Ineligibility, Debarment, Conviction or related investigation or proceeding. Upon receipt of such notice, or if Stoke becomes aware of any existing or threatened Ineligibility, Debarment or Conviction, Stoke shall have the right to terminate this Agreement immediately, without liability or indemnity.

Neither the Company nor any Affiliates, directors, officers, managers or any “Principal” (as defined in FAR 2.101), nor, to Seller’s Knowledge, any employees of the Company, have been debarred, proposed for debarment or suspended from participation in the award of Government Contracts (it being understood that debarment and suspension do not include ineligibility to bid for certain contracts due to generally applicable bidding requirements); nor subject to any indictment, lawsuit, subpoena, civil investigative demand, discovery request, administrative proceeding, voluntary disclosure, consent decree, judgment, deferred prosecution agreement, Claim, dispute, mediation, arbitration or settlement concerning any material violation of any requirement pertaining to a Government Contract or Government Bid; nor are any of them listed on the List of Parties Excluded from Federal Procurement and Nonprocurement Programs.

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.

Debarment. Each Party hereby represents, warrants and covenants to the other Party as of the Effective Date that no such Party nor any of its Affiliates has been debarred or is subject to debarment and neither such Party nor any of its Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement any party who has been debarred pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or who is the subject of a conviction described in such section. Each Party will inform the other Party in writing immediately if it or any party who is performing activities hereunder is debarred or is the subject of a conviction described in [Section 306], or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to such Party’s knowledge, is threatened, relating to the debarment or conviction of such Party or any party performing activities hereunder.