No Debarment. In the course of the Development of Products, such Party has not used prior to the Effective Date and shall not use, during the Term, any employee, agent or independent contractor who has been debarred by any Regulatory Authority, or, to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.

No Debarment. Each Party hereby certifies to the other that it has not used, and will not use the services of any person disqualified, debarred, banned, subject to debarment or convicted of a crime for which a person could be debarred by the FDA under 21 U.S.C. 335a, as amended (or subject to a similar sanction of any other Regulatory Authority), in any capacity in connection with any of the services or work provided under any Combined Therapy Trial and that this certification may be relied upon in any applications to the FDA or any other Regulatory Authority. It is understood and agreed that this certification imposes a continuing obligation upon each Party to notify the other promptly of any change in the truth of this certification. Upon request by a Party, the other Party agrees to provide a list of persons used to perform the services or work provided under any activities conducted for or on behalf of such Party or any of its Affiliates pursuant to this Agreement who, within the five years preceding the Effective Date, or subsequent to the Effective Date, were or are convicted of one of the criminal offenses required by 21 U.S.C. 335a, as amended, to be listed in any application for approval of an abbreviated application for drug approval.

No Debarment. Neither such Party nor any of its Affiliates is debarred or disqualified under the Act or comparable applicable Laws outside the U.S.; and

No Debarment. Neither Provider nor any of Provider Personnel to Provider’s knowledge:

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.

No Debarment. Neither it nor any of its respective Affiliates has been Debarred by the FDA, is not subject to any similar sanction of other Governmental Authorities in the Territory, and, to its knowledge, neither it nor any of its respective Affiliates has used or engaged, in any capacity, in connection with this Agreement or any ancillary agreements (if any), any Person who either has been Debarred by such a Regulatory Authority.

No Debarment. Neither such Party, nor any Affiliate of such Party, has been debarred by any regulatory authority, including under [Section 306] of the FD&C Act, is under investigation for debarment action by any regulatory authority, has been disqualified as an investigator pursuant to [Section 306] of the FD&C Act (or similar applicable Law outside of the U.S.), has a disqualification hearing pending, or is currently employing or using any person that has been so debarred or disqualified by any regulatory authority to perform any of such Party’s obligations under this Agreement.

No Debarment. In the course of the Research, Development, Manufacture and Commercialization of the Compounds and Collaboration Products, neither Party nor its Affiliates shall use any employee or consultant (including of any sublicensee), who has been debarred or disqualified by any Regulatory Authority, or, to such Party’s or its Affiliates’ knowledge, is the subject of debarment or disqualification proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its Affiliates’ employees or consultants has been debarred or is the subject of debarment or disqualification proceedings by any Regulatory Authority.

No Debarment. Each Party hereby represents, warrants and covenants (on behalf of itself and its Affiliates) that it nor any of its Affiliates will not and has not employed or otherwise used in any capacity the services of any person debarred in performing any activities under or in connection with this Agreement under [Section 335a] of Title 21 of United States Code or by the FDA, or under any analogous laws under the Applicable Laws or by any Regulatory Authority in the Territory. Each Party will immediately notify the other Party in writing if any such debarment occurs or comes to its attention, and will, with respect to any person or entity so debarred, promptly remove such person or entity from performing any activities related to or in connection with the Territory Development Plans or this Agreement.

No Debarment. Neither it nor any of its Affiliates, nor its or their respective employees, have been Debarred or are subject to Debarment.