No Debarred Individuals. As of the Effective Date, Takeda has not employed and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of Takeda, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA or TPDHC.
No Debarred Individuals. As of the Effective Date, SPI has not employed and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of SPI, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA or TPDHC.
No Debarred Individuals. Morphic will not engage, in any capacity in connection with this Agreement, any person who has been debarred by FDA, is the subject of a conviction described in 21 U.S.C. 335a, or is subject to any similar sanction. Morphic will promptly inform Xxxxxxx in writing if it or any person performing activities under this Agreement is debarred or is the subject of a conviction described in 21 U.S.C. 335a, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened relating to the debarment of conviction of Morphic or any such person performing activities in connection with this Agreement. Upon written request from Xxxxxxx, Morphic will, within ten (10) days, provide written confirmation that it has complied with the foregoing obligation.
No Debarred Individuals. Each Party agrees that it shall not engage, in any capacity in connection with this Agreement, any Person who has been debarred by FDA, is the subject of a conviction described in 21 U.S.C. 335a, or is subject to any similar sanction. Each Party shall promptly inform the other Party in writing if such Party or any Person performing activities under this Agreement on such Party’s behalf is debarred or is the subject of a conviction described in 21 U.S.C. 335a, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened relating to the debarment of conviction of such Party or any such Person performing activities in connection with this Agreement on such Party’s behalf. Upon written request from the other Party, a Party shall, within [ * ], provide written confirmation that it has complied with the foregoing obligation.
No Debarred Individuals. Each Party agrees that it shall not engage, in any capacity in connection with this Agreement, any person who has been debarred by FDA, is the subject of a conviction described in 21 U.S.C. 335a, or is subject to any similar sanction, and in the case of Xxxxxxx, Xxxxxxx represents and warrants to Licensee that neither Xxxxxxx nor any of its Affiliates engaged any such person in connection with a Program prior to the Effective Date. Each Party shall promptly inform the other Party in writing if such Party or any person performing activities under this Agreement on such Party’s behalf is debarred or is the subject of a conviction described in 21 U.S.C. 335a, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened relating to the debarment of conviction of such Party or any such person performing activities in connection with this Agreement on such Party’s behalf. Upon written request from the other Party, a Party shall, within ten (10) days, provide written confirmation that it has complied with the foregoing obligation.
No Debarred Individuals. Xxxxxxx agrees that it shall not engage, in any capacity in connection with this Agreement, any person who has been debarred by FDA, is the subject of a conviction described in 21 U.S.C. 335a, or is subject to any similar sanction. Xxxxxxx shall promptly inform TRACON in writing if Xxxxxxx or any person performing activities under this Agreement on Xxxxxxx’x behalf is debarred or is the subject of a conviction described in 21 U.S.C. 335a, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened relating to the debarment of conviction of Xxxxxxx or any such person performing activities in connection with this Agreement on Xxxxxxx’x behalf. Upon written request from TRACON, Xxxxxxx shall, within ten (10) days, provide written confirmation that it has complied with the foregoing obligation.
No Debarred Individuals. Licensee will not engage, in any capacity in connection with this Agreement, any person who has been debarred by FDA, is the subject of a conviction described in 21 U.S.C. § 335a or is subject to any similar sanction. Licensee will promptly inform Xxxxxxx in writing if it or any person performing activities under this Agreement is debarred or is the subject of a conviction described in 21 U.S.C. § 335a, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened relating to the debarment of conviction of Licensee or any such person performing activities in connection with this Agreement. Upon written request from Xxxxxxx, Licensee will, within [***], provide written confirmation that it has complied with the foregoing obligation.
No Debarred Individuals or Entities ATP represents and warrants for itself and its agents, that ATP has never been and is not currently, and is not using, and shall not use, in any capacity, in connection with any of the Services performed by ATP or its agents hereunder, the services of.
(i) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) (a “Debarred Individual”) from providing services in any capacity to a person that has an approved or pending drug product application, or an employer, employee or partner of a Debarred Individual; or
(ii) a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) (a “Debarred Entity”) from submitting or assisting in the submission of an abbreviated new drug application, or an employee, partner, shareholder, member, subsidiary or affiliate or a Debarred Entity.
No Debarred Individuals. As of the Effective Date, SPI has not employed and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of SPI, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA or TPDHC. (e) Disclosure. SPI has disclosed to Takeda all information (if any of such information has been superceded by any additional information which has been disclosed to Takeda by SPI, all such information with such supersession) that is material to the Development and Commercialization of the Product, and the information disclosed to Takeda is, in its all material aspects, true and correct. Further, as of the Effective Date, SPI has not recognized any fact which prevents Takeda or SPI from the performance of this Agreement, including without limitation, notice from any third party which alleges, challenges or questions the right of Takeda under this Agreement.
No Debarred Individuals. To the best of its knowledge as of the Effective Date and as far as related to the Research Program, it has neither employed nor used a contractor or consultant that has employed, any individual or entity debarred by a regulatory authority in any other country or countries of the Territory, or, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of a regulatory authority in any other country or countries of the Territory.
