No Debarred or Disqualified Persons. The Provider certifies that it will not engage, directly or indirectly, any person (including the Investigator) to perform services under this Agreement if (a) that person is debarred by any regulatory authority or to the Provider’s knowledge is threatened with debarment by a pending proceeding, action, or investigation, or (b) that person is otherwise disqualified under Applicable Law (including local law), or to the Provider’s knowledge is threatened with such disqualification by a pending proceeding, action, or investigation, from participating in the Study. The Provider certifies that it will immediately 7.4 Žádné vyloučené nebo diskvalifikované osoby. Poskytovatel potvrzuje, že nebude najímat, přímo nebo nepřímo, žádnou osobu (včetně Zkoušejícího) pro provádění služeb podle této Smlouvy, pokud (a) tato osoba bude vyloučena jakýmkoli regulačním úřadem nebo která bude podle poskytovatele ohrožena vyloučením v rámci probíhajícího řízení, aktivity nebo hodnocení, nebo (b) tato osoba bude jinak diskvalifikována podle Příslušných právních předpisů (včetně lokálního zákona) nebo která bude podle poskytovatele ohrožena takovou diskvalifikací v rámci probíhajícího řízení, aktivity nebo vyšetřování z účasti ve Studii. notify GWWO in writing if any such debarment, exclusion, or disqualification occurs, or if any such debarment, exclusion, or disqualification proceeding, action, or investigation is commenced or, to the Provider’s knowledge, is threatened, with respect to any such person. Poskytovatel potvrzuje, že bude okamžitě písemně informovat GWWO, pokud takový zákaz, vyloučení nebo diskvalifikace nastane, nebo pokud jakýkoli takový zákaz, vyloučení nebo diskvalifikační řízení, aktivita nebo vyšetřování bude zahájeno nebo pokud je podle informací poskytovatele ohroženo s ohledem na jakoukoli takovou osobu.
No Debarred or Disqualified Persons. AFP represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform any activities relating to the manufacture or supply of Product if such a person (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successor provisions or by the applicable regulatory authority in any country or jurisdiction outside the United States under comparable regulations, or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or its successor provisions or by the applicable regulatory authority in any other country or jurisdiction outside the United States under comparable regulations. In addition, AFP represents and warrants that it has not engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. If, during the term of this Agreement, AFP or any person employed or retained by it to perform any activities relating to the manufacture or supply of Product (i) comes under investigation by the FDA or by the applicable regulatory authority in any country or jurisdiction outside the United States for a debarment action or disqualification, (ii) is debarred or disqualified, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, AFP shall immediately notify MannKind of same.
No Debarred or Disqualified Persons. Distributor warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform services under this Agreement if such person is (i) debarred by either the U.S. Food and Drug Administration under 21 U.S.C. § 335(a) or any equivalent law or regulation in the Territory, or (ii) disqualified as described in 21 C.F.R. § 812.119, or any equivalent law or regulation in the Territory. In the event that Distributor becomes aware of the debarment or disqualification of any person providing services to Distributor which relate to services being provided under this Agreement, Distributor agrees to notify Conor immediately.
No Debarred or Disqualified Persons. Eagle and MDCO shall not, and Eagle shall require that the Third Party Manufacturer shall not, employ, contract with or retain, any person, directly or indirectly, to perform any services under this Agreement if such person: (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successor provisions, (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or its successor provisions, or (c) is otherwise debarred or the subject of debarment or other disciplinary proceedings by any [*] = 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. Regulatory Authority anywhere in the world. In addition, Eagle and MDCO each represents and warrants that it has not engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. If, during the Term, Eagle, MDCO or any Person employed or retained by them, or employed or retained by the Third Party Manufacturer, to perform under this Agreement (i) comes under investigation by the FDA or other Regulatory Authority for a debarment action or disqualification, (ii) is debarred or disqualified or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, Eagle or MDCO, as the case may be, shall immediately notify the other Party of same.
No Debarred or Disqualified Persons. Vical represents and warrants that is not debarred under the United States Federal Food, Drug and Cosmetic Act or comparable laws in any other country or jurisdiction, and it does not, and will not during the Term, employ or use the services of any person or entity who is debarred, in connection with the performance of activities pursuant to this Agreement. In the event that Vical becomes aware of the debarment or threatened debarment of any person or entity providing services to Vical which directly or indirectly relate to activities under this Agreement, Astellas shall be immediately notified in writing.
No Debarred or Disqualified Persons. Novasep represents and warrants to Celladon as of the Effective Date that neither Novasep nor any of its Affiliates, nor, to Novasep’s knowledge, any of their respective employees, (i) is under investigation for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a, or by the EMA or the Regulatory Authority of any European Union member state under any foreign equivalent thereof, or (ii) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70, or by the EMA or the Regulatory Authority of any European Union member state under any foreign equivalent thereof. Novasep further represents and warrants that neither it nor any of its Affiliates, nor, to Novasep’s knowledge, any of their respective employees, has engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. Novasep hereby covenants that neither Novasep nor any of its Affiliates will employ, contract with, or retain any person directly or indirectly to perform any services or other activities under this Agreement if such person (A) is under investigation for debarment or is presently debarred by the FDA, the EMA or the Regulatory Authority of any European Union member state, or (B) has a disqualification hearing pending or has been disqualified by the FDA, the EMA or the Regulatory Authority of any European Union member state. If, during the Term, Novasep, its Affiliate or any person employed or retained by Novasep or its Affiliate to perform any Development Services or any of the activities contemplated by Article 4 hereof (x) comes under investigation by the FDA, EMA or any other Regulatory Authority for a debarment action or disqualification, (y) is debarred or disqualified by the FDA, EMA or any other Regulatory Authority, or (z) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, Novasep shall immediately notify Celladon of same, and Celladon shall have the right to terminate this Agreement immediately upon written notice to Novasep.
No Debarred or Disqualified Persons. Kureha represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform any services under this Agreement if such a person is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successor provisions. Kureha further represents and warrants that it has not engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. If, during the Term, Kureha or any person employed or retained by it to perform work on the manufacture of Clinical Supply (i) comes under investigation by the FDA for a debarment action or disqualification, (ii) is debarred or disqualified, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, Kureha shall immediately, upon becoming aware of such investigations, conduct or activity, notify Ocera of same.
No Debarred or Disqualified Persons. Institution warrants that neither Investigator nor any Study Team Member has been debarred by the Regulatory Authority, disqualified or otherwise found by any Regulatory Authority to have violated any statue, rule or regulation concerning the 8. PROHLÁŠENÍ A ZÁRUKY
No Debarred or Disqualified Persons. The Provider certifies that it will not engage, directly or indirectly, any person (including the Investigator) to perform services under this Agreement if (a) that person is debarred by any regulatory authority or to the Provider’s knowledge is threatened with debarment by a pending proceeding, action, or investigation, or (b) that person is otherwise disqualified under Applicable Law (including local law), or to the Provider’s knowledge is threatened with such disqualification by a pending proceeding, action, or investigation, from participating in the Study. The Provider certifies that it will immediately notify the Sponsor in writing if any such debarment, exclusion, or disqualification occurs, or if any such debarment, exclusion, or disqualification proceeding, action, or investigation is commenced or, to the Provider’s knowledge, is threatened, with respect to any such person.
No Debarred or Disqualified Persons. Alfacell and Par shall not, and Alfacell shall require that the Third Party Manufacturer not, employ, contract with or retain, any person, directly or indirectly, to perform any services under this Agreement if such person: (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successor provisions, or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or its
