Example ContractsClausesAbsence of Debarment
Absence of Debarment
Absence of Debarment contract clause examples

August 13, 2021 Master Manufacturing Services Agreement

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

Absence of Debarment. Neither it, nor any of its officers, employees, subcontractors, representatives, agents, consultants or any other person used by either Party in the performance of the Research Activities has been or is # debarred, convicted, or is subject to a pending debarment or conviction, pursuant to Section 306 of the United States Food Drug and Cosmetic Act, 21 U.S.C. § 335a, # listed by any government or regulatory agencies as ineligible to participate in any government healthcare programs (as that term is defined in 42 U.S.C. § 1320a-7b(f)) or government procurement or non-procurement programs, 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 inform the other Party in writing promptly if such Party or any person who is performing Research Activities on behalf of such Party is subject to the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of such Party’s Knowledge, is threatened.

Debarment. [[AstraZeneca:Organization]] and Licensee each represents and warrants to the other, as of the Effective Date, and covenants during the Term of this Agreement, that: neither it nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will knowingly use in any capacity, in connection with the services 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 will inform the other Party in writing promptly if it or any such Person who is performing services 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, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder.

Debarment. Neither Party has ever been, is not currently, nor is it the subject of a proceeding that could lead to it becoming a Debarred Entity, Excluded Entity, or Convicted Entity and it will not use in any capacity, in connection with the obligations to be performed under this Agreement, any person who is a Debarred Individual, Excluded Individual or a Convicted Individual, nor are they listed on the FDA’s Disqualified/Restricted List for clinical investigators. Each Party further covenants that if, during the Term, it becomes a Debarred Entity, Excluded Entity, or Convicted Entity or if any employee or agent performing any of its obligations hereunder becomes a Debarred Individual, Excluded Individual, or a Convicted Individual, or added to FDA’s Disqualified/Restricted List for clinical investigators, then such Party shall immediately notify the other Party. For purposes of this provision, the following definitions shall apply:

Debarment. Neither it nor any of its Affiliates # has been debarred by a Regulatory Authority, # is subject to debarment proceedings by a Regulatory Authority or # will use, in any capacity, in connection with the activities to be performed under this Agreement, any Person that has been debarred, or who is the subject of debarment proceedings by any Regulatory Authority. If either Party learns that a Person performing on its behalf under this Agreement has been debarred by any Regulatory Authority, or has become the subject of debarment proceedings by any Regulatory Authority, such Party shall so promptly notify the other Party and shall prohibit such Person from performing on its behalf under this Agreement.

Debarment. Danforth represents and warrants that it has not been nor is currently: # debarred by the United States Food and Drug Administration (“FDA”), or subject to any similar sanction of the European Medicines Agency (“EMA”) or other applicable authority, or # the subject of an FDA investigation or proceeding of debarment, or the subject of any similar investigation or proceeding by the EMA or other applicable authority. Further, Danforth hereby represents and warrants that it shall not employ or use any individual or entity that has been or is currently so debarred or subject to such investigation or proceeding of debarment in performing the Services. Danforth will immediately notify Company if it, or any individual or entity it employs in performing the Services becomes debarred or subject to an investigating or proceeding of debarment.

Debarment. Neither Party nor any of its Affiliates will use in any capacity, in connection with the Collaboration or the performance of its obligations under this Agreement, any Person that has been Debarred. Each Party agrees to inform the other Party in writing promptly if it learns that it or any Person that is performing activities in the Collaboration or under this Agreement is Debarred or is subject to Debarment, or, to the notifying Party’s Knowledge, if Debarment of the notifying Party or any Person used in any capacity by such Party or any of its Affiliates in connection with the Collaboration or the performance of its other obligations under this Agreement, is threatened.

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.

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