Neither it nor any of its Affiliates (nor with respect to UroGen, to the knowledge of UroGen, any Person involved in the research or Development of the RTGel Product or a Licensed Product prior to the Effective Date) has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to [Section 306] of the FFDCA or who is the subject of a conviction described in such section. It agrees to inform the other Party in writing promptly if it or any such Person who is performing activities hereunder or thereunder 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 its or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing activities hereunder or thereunder.

Certification. SCI represents, warrants and certifies that neither it, nor its Affiliates, nor any of their respective directors, officers, principals, employees and agents was or is debarred, suspended, proposed for debarment or otherwise determined to be ineligible to participate in the drug industry, federal health care programs under or convicted of a criminal offense related to the provision of health care items or services the United States Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), and that it has not and will not use in any capacity the services of any entity or person debarred under such law with respect to Consulting Services to be performed under this Agreement. In the event that SCI, or any of its affiliates, directors, officers, principals, employees, or agents becomes or is debarred, suspended, proposed for debarment or otherwise determined to be ineligible to participate in the drug industry under such law or convicted of a criminal offense related to the provision of health care items or services, SCI shall notify Therapeutics in writing immediately.

Zai Lab represents that except as disclosed to GSK in writing prior to the commencement of the Agreement, it has not been convicted of or pleaded guilty to a criminal offence, including one involving fraud or corruption, that it is not now, to the best of its knowledge, the subject of any government investigation for such offenses, and that it is not now listed by any government agency as debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs.

Neither any Credit Party nor any Subsidiary of any Credit Party nor any Principal (as defined in Federal Acquisition Regulation 52.209-5) presently is suspended or debarred from bidding on contracts or subcontracts for or with any Governmental Authority. No Credit Party has received written notification of any suspension or debarment actions with respect to any government contract currently have been commenced or threatened in writing against any Credit Party or any Subsidiary of any Credit Party or any of their respective Related Parties.

to interview employees during working hours on the job. If the contractor or subcontractor fails to submit the required records or to make them available, the Federal agency may, after written notice to the contractor, sponsor, applicant, or owner, take such action as may be necessary to cause the suspension of any further payment, advance, or guarantee of funds. Furthermore, failure to submit the required records upon request or to make such records available may be grounds for debarment action pursuant to 29 CFR 5.12.

WuXi represents and warrants that, as of the Effective Date and during the Term of this Agreement, neither # WuXi, nor any of its Affiliates’ employees, officers, subcontractors, or consultants who developed the Antibody and/or the Licensed IP and who have rendered services relating to the Licensed Products under this Agreement, has ever been debarred nor is subject to debarment or convicted of a crime for which an entity or person could be debarred (including by the FDA under 21 U.S.C. § 335a (or subject to a similar sanction of any other Governmental Authority)).

Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. [[Identifier]] (September 10, 1991) and any amendments thereto. Neither the Company nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of the Company, any of its Subsidiaries or, to the knowledge of the Company, any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that # could result in a debarment or exclusion under 21 U.S.C. § 335a, # could result in disqualification under FDA investigator disqualification proceedings, # is subject to FDA’s Application Integrity Policy, # is subject to any enforcement proceeding arising from material false statements to FDA pursuant to 18 U.S.C. § 1001, or # any similar applicable Legal Requirements. To the knowledge of the Company, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, any of its Subsidiaries or any of their respective officers, employees or agents.

Arcus covenants that, as of the Effective Date and during the Term of this Agreement, neither # Arcus, nor any of its or its Affiliates’ employees, officers, subcontractors, consultants, or sublicensees (or their further sublicensees or subcontractors), who will render services relating to the Licensed Products in performing under this Agreement, has ever been debarred nor is subject to debarment or convicted of a crime for which an entity or person could be debarred (including by the FDA under 21 U.S.C. § 335a (or subject to a similar sanction of any other Governmental Authority)); and # Arcus will require language materially similar to that in Section 7.3.4(i) in every sublicense and subcontract agreement under this Agreement.

In the event a party receives a notice from the other party (“Defaulting Party”) or otherwise becomes aware that a debarment, suspension, exclusion, sanction, or declaration of ineligibility action has been brought against the Defaulting Party, which would prevent such Party from performing its obligations and/or on this Agreement; then the party receiving such notice shall have the right to terminate this Agreement immediately; provided that if such event shall occur, the party receiving such notice shall not have such right of termination if the Defaulting Party is disputing and defending such action and the Defaulting Party is otherwise able to perform its obligations and/or Services in the manner required under this Agreement.