Debarment and Exclusion Sample Clauses

Debarment and Exclusion. Data User certifies that it is not debarred under subsections 306(a) or (b) of the Federal Food Drug and Cosmetic Act [U.S. Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)], and that it has not and will not use in any capacity the services of any person debarred under such law in performing under this Agreement. Data User further certifies that it is not excluded from any federal health care program, including but not limited to Medicare and Medicaid. Data User will notify Yale immediately if either of these certifications needs to be amended in light of new information.
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Debarment and Exclusion. BGM represents and warrants that neither it, nor any of its employees or agents working on the subject matter of this Agreement, has ever been, is currently, or is the subject of a proceeding that could lead to it becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual. BGM further covenants, represents and warrants that if, during the Term of this Agreement, it, or any of its employees or agents working on Xxxxxx’x behalf, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual, BGM shall immediately notify Xxxxxx, and Xxxxxx shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions shall apply:
Debarment and Exclusion. Each Party represents and warrants that neither such Party, nor any Party employees, agents, subcontractors working on the subject matter hereunder, have ever been, are currently or are the subject of a proceeding that could lead to such Party or such employees, agents or subcontractors becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, nor are they listed on the FDA’s Disqualified/Restricted List. Each Party further covenants, represents and warrants that if, during the Term, Company, or any of Company’s employees, agents or subcontractors working on the subject matter hereunder, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added to FDA’s Disqualified/Restricted List, such Party will immediately notify the other Party, and such other Party will have the right to immediately terminate this Agreement. This provision will survive termination or expiration of this Agreement. For purposes of this provision, the following definitions will apply: (a) a “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application; (b) a “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity; (c) an “Excluded Individual” or “Excluded Entity” is (i) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA); (d) a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense t...
Debarment and Exclusion a) Neurocrine represents and warrants that prior to the Effective Date neither it, nor any of its employees, nor […***…] each of its consultants, or independent contractors or any other person working on its behalf that provided services in connection with an NDA for a Product, were at the time the services were performed a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or after the services were performed, […***…] became a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual due to actions related to the services in connection with an NDA for a Product.
Debarment and Exclusion. CoMFRE represents, warrants and covenants that (a) CoMFRE and Principal Investigator are not currently, have never been, and, to the best of CoMFRE’s knowledge, are not the subject of a proceeding that could lead to CoMFRE or Principal Investigator becoming, as applicable, (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, (iii) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible; and (b) CoMFRE shall not engage, directly or indirectly, any person to perform services under this Membership Agreement if that person has ever been, is currently, or, to the best of CoMFRE’s knowledge, is the subject of a proceeding that could lead to that person becoming, as applicable, any of (i)-(iv) above. In the event that CoMFRE receives notice of, or otherwise becomes aware of, the debarment, proposed debarment or such other exclusion, suspension, restriction or sanction of itself, Principal Investigator, or any person providing services in connection with the performance of this Membership Agreement, CoMFRE shall notify Company immediately and Company shall have the right to immediately terminate this Membership Agreement.
Debarment and Exclusion. Axxxxx represents and warrants that, to the best of its knowledge, neither it, nor any of its employees or agents providing services under this Agreement, has ever been, is currently, or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Individual or Debarred Entity. A “Debarred Individual” is an individual who has been debarred by the U.S. Food and Drug Administration (“FDA”) pursuant to Title 20 Xxxxxx Xxxxxx Code §335a (a) or (b), or by any other competent authority, including, without limitation, any local competent authority, from providing services in any capacity to a person that has an approved or pending drug product application. A “Debarred Entity” is a corporation, partnership or association that has been debarred by FDA pursuant to Title 20 Xxxxxx Xxxxxx Code §335a (a) or (b), or by any other competent authority, including, without limitation, any local competent authority, from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of such a corporation, partnership or association. Axxxxx further covenants, represents and warrants that if, during the term of this Agreement, it becomes aware that it, or any of its employees or agents providing services under this Agreement, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Individual or Debarred Entity, Axxxxx shall immediately notify Abaxis, and Abaxis shall have the right to immediately terminate this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Debarment and Exclusion. CRO certifies that neither it, nor its Affiliates, are debarred under subsections 306(a) or (b) of the U.S. Federal Food Drug and Cosmetic Act (US Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)), and that it has not and will not use in any capacity the services of any person debarred under this law to conduct the Project nor will it permit any Site or Clinical Investigator to do so. CRO further certifies that neither it, nor any of its Affiliates in the United States, are excluded from any federal health care program, including but not limited to Medicare and Medicaid, and it shall require each Clinical Investigator and Site to so certify. CRO will notify Sponsor immediately if either of these certifications needs to be amended in light of new information.
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Debarment and Exclusion. None of OraSure or its employees performing activities or services hereunder, nor to OraSure’s knowledge, any agents or Third Party Providers of OraSure performing activities or services hereunder, are currently, or currently are the subject of a proceeding that could lead to OraSure or such employees, agents, or subcontractors
Debarment and Exclusion. None of AbbVie or its employees performing activities hereunder, nor to AbbVie’s knowledge, any agents or Third Party Providers of AbbVie performing activities hereunder are currently, or currently are the subject of a proceeding that could lead to AbbVie or such employees, agents, or subcontractors becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, nor are they listed on the FDA’s Disqualified and Restricted Lists. AbbVie further covenants, represents and warrants that if, during the Term, AbbVie, or any of its employees, agents or Third Party Providers performing activities hereunder, becomes or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added to FDA’s Disqualified and Restricted Lists, AbbVie shall immediately notify OraSure. The provision of this paragraph regarding notice of acts occurring during the Term shall survive termination or expiration of this Agreement.
Debarment and Exclusion. (a) Each Party hereby represents and warrants that it has not been debarred and is not subject to debarment and that it shall not 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 Act or who is the subject of a conviction described in such section. Each Party shall notify the other Party in writing immediately if it or any of its sales or other Representatives or member of its senior management is debarred or is the subject of a conviction described in Section 306 of the Act, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to the best of that Party’s knowledge, is threatened, relating to the debarment or conviction of that Party or any of its sales or other Representatives or member of that Party’s senior management.
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