Debarred Persons Clause Samples

Debarred Persons. Manufacturer represents, warrants and covenants that, to the best of its knowledge, neither it nor any of its affiliated companies performing the Services shall 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 or any other Regulatory Authority for debarment or is presently debarred by the FDA or any other Regulatory Authority pursuant to 21 U.S.C. § 335a or its successor provisions or any similar law in any other country. If, during the Term, any person employed or retained by Manufacturer or any of its affiliated companies to perform any Services (i) comes under investigation by the FDA or any other Regulatory Authority for a debarment action, (ii) is debarred, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned debarment actions, Manufacturer shall immediately notify Artiva of same, and Artiva shall have the right to terminate this Agreement immediately upon written notice to Manufacturer.

Debarred Persons. Patheon covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b) or comparable provisions under the laws and regulations of any other applicable jurisdiction. Patheon represents that it does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Act. If Patheon or any officer, employee or agent of Patheon: (a) becomes debarred; or (b) receives notice of action or threat of action with respect to its debarment, during the term of this Agreement, Patheon agrees to notify Client immediately. If Patheon or any of its officers, employees or agents becomes debarred as set forth in clause (a) above or receives notice of action or threat of action as set forth in clause (b) above, Client will have the right to terminate this Agreement upon written notice to Patheon.

Debarred Persons. Each Party hereby represents, warrants, and covenants to the other Party that (a) neither such Party nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 of the FFDCA or any similar law in any country or other jurisdiction in the Territory or listed on either Excluded List, and (b) neither Manufacturer nor any of its Affiliates will use in any capacity, including as officer, director, managing employee, or any other way, in connection with the Manufacturing Services or the operation of the Manufacturing Site, any Person who has been debarred pursuant to Section 306 of the FFDCA or any similar law in any country or other jurisdiction in the Territory, or who is the subject of a conviction described in such section or listed on either Excluded List. Manufacturer shall inform Acorda in writing promptly if it or any Person who is performing the Manufacturing Services or operating the Manufacturing Site is debarred or is the subject of a conviction described in Section 306 of the FFDCA or any similar law in any country or other jurisdiction in the Territory or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Manufacturer’s knowledge, is threatened, relating to the debarment or conviction Section 306 of the FFDCA or any similar law in any country or other jurisdiction in the Territory, or listing on either Excluded List, of Manufacturer or any Person performing services hereunder.

Debarred Persons. ▇▇▇▇▇▇ covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b).

Debarred Persons. Patheon represents and warrants as of the Effective Date that neither it, nor any of its officers, directors or employees expected to perform Manufacturing Services under this Agreement has been debarred or convicted of a crime which could lead to debarment, under 21 USC §§335(a) and (b), or other applicable Laws. Patheon covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b). Patheon represents that it does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Act.

Debarred Persons. 26 9.4 PERMITS......................................................... 26 9.5

Debarred Persons. Without limiting Section 5.1, in the course of activities performed under this Agreement, neither Party shall use any employee, consultant or contractor: 5.2.1 who has been debarred under 21 U.S.C. § 335(a)-(b) or pursuant to the analogous applicable Laws of any Regulatory Authority; 5.2.2 who, to such Party’s Knowledge, has been charged with, or convicted of, any felony or misdemeanor within the ambit of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(l)-(3), or otherwise pursuant to the analogous applicable Laws of any Regulatory Authority, or is proposed for exclusion, or the subject of exclusion or debarment proceedings by a Regulatory Authority, during the employee’s or consultant’s employment or contract term with such Party; and 5.2.3 who is excluded, suspended or debarred from participation, or otherwise ineligible to participate, in any U.S. or non-U.S. healthcare programs (or who has been convicted of a criminal offense that falls within the scope of 42 U.S.C. §1320a-7 but has not yet been excluded, debarred, suspended, or otherwise declared ineligible), or excluded, suspended or debarred by a Regulatory Authority from participation, or otherwise ineligible to participate, in any procurement or non-procurement programs. Each Party shall notify the other Party promptly, but in no event later than [***] ([***]) Business Days, upon becoming aware that any of its employees or consultants has been excluded, debarred, suspended or is otherwise ineligible, or is the subject of exclusion, debarment or suspension proceedings by any Regulatory Authority.

Debarred Persons. Patheon hereby represents, warrants, and covenants to Client that (a) neither Patheon nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 of the FFDCA or any similar law in any country in the Territory or listed on either Excluded List, and (b) neither Patheon nor any of its Affiliates will use in any capacity, including as officer, director, managing employee, or any other way, 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 any similar law in any country in the Territory, or who is the subject of a conviction described in such section or listed on either Excluded List. Patheon will inform Client in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA or any similar law in any country in the Territory or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Patheon’s knowledge, is threatened, relating to the debarment or conviction Section 306 of the FFDCA or any similar law in any country in the Territory, or listing on either Excluded List, of Patheon or any person performing services hereunder.

Debarred Persons. Patheon covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b) or by Health Canada or any comparable European regulatory authority. Patheon represents that it does not currently have, and covenants that it will not hire, as an officer, an employee or an independent contractor in connection with the Manufacturing any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Federal Food, Drug, and Cosmetic Act (United States) or any comparable Canadian or European law. If Patheon becomes aware of any breaches of the Section, it will promptly notify the Client.