No Debarred Person. IgDraSol represents and warrants that it will not employ, contract with, or retain any person directly or indirectly to perform the Services under this Agreement if such person is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, IgDraSol represents and warrants that it has not engaged in any conduct or activity that could lead to any such debarment actions. If during the Term, IgDraSol or any person employed or retained by it to perform the Services (a) comes under investigation by the FDA for a debarment action, (b) is debarred, or (c) engages in any conduct or activity that could lead to debarment, IgDraSol shall immediately notify STI of same.
No Debarred Person. SIEGFRIED represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform the Services under this Agreement [*] under investigation by the FDA for debarment or being presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, SIEGFRIED represents and warrants that, to its best knowledge, it has not engaged in any conduct or activity that could lead to any such debarment actions. If during the term of this Agreement, SIEGFRIED [*] (i) coming under investigation by the FDA for a debarment action, (ii) being debarred, or (iii) engaging in any conduct or activity that could lead to debarment, SIEGFRIED shall immediately notify METABOLEX of same, subject to limitations and disclosure prohibitions pursuant to Applicable Laws, including but not limited to data protection laws.
No Debarred Person. Contractor represents and warrants that it will not employ, contract with, or retain any person directly or indirectly to perform the Services under this Agreement if such person is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, Contractor represents and warrants that it has not engaged in any conduct or activity that could lead to any such debarment actions. If during the Term, Contractor or any person employed or retained by it to perform the Services (i) comes under investigation by the FDA for a debarment action, (ii) is debarred, or (iii) engages in any conduct or activity that could lead to debarment, Contractor shall immediately notify Company of same.
No Debarred Person. Patheon represents and warrants that it shall not employ, contract with, or retain any person or entity directly or indirectly to perform the Services under this Agreement [*] under investigation by the FDA for debarment or being presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, Patheon represents and warrants that, to its best knowledge, it has not engaged in any conduct or activity that could lead to any such debarment actions. If during the term of this Agreement, Patheon or any person or entity employed or retained by it to perform any Services is debarred[*] then in each case Patheon shall immediately notify Metabolex of same. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
No Debarred Person. In the course of the Research, Development, Manufacture and Commercialization of the Products, neither Party nor its Affiliates or sublicensees shall use any employee or consultant who is or has been a Debarred Person, or, to such Party's or its Affiliate's knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its Affiliates' or sublicensees' employees or consultants has become a Debarred Person or is the subject of debarment proceedings by any Regulatory Authority.
No Debarred Person. IsoRay represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform activities under this Agreement if such is debarred by the FDA under 21 U.S.C. § 335a(a) or disqualified as described in 21 C.F.R. § 812.119. In addition, IsoRay represents and warrants that it has not engaged in any conduct or activity which could lead to any such debarment actions. If IsoRay learns during the Term that this representation needs to be amended in light of new information, IsoRay shall promptly notify GT MED TECH of same and shall take prompt action to remedy the situation.
No Debarred Person. Neither ARUP nor any of ARUP’s Workers is debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a, as amended, or any similar state law or regulation (collectively “Debarred”), excluded by the Office of Inspector General pursuant to 42 U.S.C. § 1320a-7, et seq. or any state agency from participation in any federal or state health care program (collectively “Excluded”) or otherwise disqualified or restricted by the FDA pursuant to 21 C.F.R. 312.70 or any other Regulatory Authority (collectively “Disqualified”). ARUP further represents and certifies that, to the best of ARUP’s actual knowledge as of the date of execution of this Agreement, after due inquiry, ARUP, its employees and ARUP’s Workers are not under investigation or otherwise aware of any circumstances which may result in ARUP being Debarred, Excluded or Disqualified. ARUP further represents and certifies that it shall not employ or otherwise use any business or individual that is Debarred, Excluded or Disqualified to perform any portion or portions of the Services hereunder. ARUP further represents and certifies that in connection with the subject matter of this Agreement: (i) none of its ARUP, Its employees or ARUP Workers is a Foreign Official as defined in the U.S. Foreign Corrupt Practices Act, (ii) it will not make, accept or request any payment, either directly or indirectly, of money or other assets to any third party where such payment would constitute violation of any law, including the U.S. Foreign Corrupt Practices Act and the UK Bxxxxxx Xxx 0000, (iii) regardless of legality, it shall neither make, accept nor request any such payment for the purpose of improperly influencing the decisions or actions of any third party, and (iv) it shall report any suspected or actual violation of this Section 8.3 to ArQule upon becoming aware of the same. During the term of this Agreement, ARUP shall immediately notify Sponsor in writing, pursuant to the Notice provisions provided herein, of any change in the status of any representation or certification set forth in this Section 8.3.
No Debarred Person. CRO warrants that it shall not employ, contract with or retain any person directly or indirectly to perform Services under this Agreement if such a person is debarred by the FDA under 21 U.S.C. 335a (Section 306, Federal Food, Drug and Cosmetic Act). In the event that CRO becomes debarred, CRO agrees to notify NovaCardia immediately. CRO hereby certifies that it has not and shall not use in any capacity related to a Study the services of any individual, corporation, partnership, or association which has been debarred under Article 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b). In the event that CRO becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association providing services to CRO which relate to the research conducted under this Agreement, CRO agrees to notify NovaCardia immediately. CRO makes no representation or warranty, either express or implied, that the NovaCardia Product covered by any Task Order can, either during the term of this Agreement or thereafter, be successfully developed or, if so developed, will receive the required approval from any applicable regulatory body. NovaCardia acknowledges that its obligations to pay CRO under this Agreement and the individual Task Orders are dependent upon CRO's performance of the Services as required hereunder and in the Task Orders, and are independent of and shall not be affected by the results of the Studies. NovaCardia acknowledges that the Services provided by CRO under this Agreement are based in part upon information supplied by NovaCardia. CRO does not warrant that the Services will meet any specifications, functions or other standards, except as expressly set forth in the individual Task Orders, this Agreement and any applicable Protocol.
No Debarred Person. Consultant represents and warrants that she is not under investigation by the FDA for debarment or presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, Consultant represents and warrants that she has not engaged in any conduct or activity which could lead to any such debarment actions. If during the term of this Agreement, Consultant (i) comes under investigation by the FDA for a debarment action, (ii) is debarred, or (iii) engages in any conduct or activity that could lead to debarment, Consultant shall immediately notify Company of same.
No Debarred Person. Each Party represents and warrants that it shall not knowingly employ, contract with, or retain any person directly or indirectly in connection with the development work contemplated hereby if such person is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.). In addition, each Party represents and warrants that it will not engage in any conduct or activity which could lead to any such debarment actions. If, during the term of this Agreement, a Party becomes aware that it or any person employed or retained by it to perform development work hereunder (i) has come under investigation by the FDA for a debarment action, (ii) has been debarred, or (iii) has engaged in any conduct or activity that could lead to debarment, such Party shall immediately notify the other Party.
