Debarred Person definition
Debarred Person shall have the meaning set forth in Section 12.1(g).
Debarred Person means a Person that is: (a) debarred from or disqualified under the Act or any other governmental program; (b) on any of the FDA clinical investigator enforcement lists (including, the (i) Disqualified/Totally Restricted List, (ii) Restricted List and (iii) Adequate Assurances List); or (c) excluded from participation in any governmental healthcare program or other federal or state program, convicted of an offense under 42 U.S.C § 1320a-7, or otherwise deemed ineligible for participation in health care or federal or state programs.
Debarred Person has the meaning set forth in Section 3.05 (Restricted Transfers);
Examples of Debarred Person in a sentence
It shall not engage, in any capacity in connection with this Agreement any Debarred Person to perform any of such Party’s obligations under this Agreement.
Each Party shall inform the other Party in writing [***] if it or any person engaged by it or any of its Affiliates who is performing any obligations under this Agreement is a Debarred Person, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to each Party’s knowledge, is threatened, pursuant to which a Party, any of its Affiliates or any such person performing obligations hereunder or thereunder may become a Debarred Person.
More Definitions of Debarred Person
Debarred Person means any person (i) debarred or suspended under Section 306 of the FD&C ACT or (ii) listed in the Department of Health and Human Services List of Excluded Individuals/Entities or the General Services Administration’s Listing of Parties excluded from Federal Procurement and Non-Procurement Programs. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
Debarred Person has the meaning set forth in Section 8.1.6.
Debarred Person has the meaning given such term in Article 10.
Debarred Person shall have the meaning set forth in Section 13.1(f). 1.69 “Debtor” shall have the meaning set forth in Section 12.2(d). 1.70 “Develop” or “Development” means all Research and clinical drug development activities in connection with obtaining Regulatory Approval in the applicable country or regulatory jurisdiction for any product (including any Companion Diagnostic), in each case, whether alone or for use together, or in combination, with another active agent or pharmaceutical or other product, including test method development and stability testing, assay development and toxicology (including GLP toxicology studies), formulation, quality assurance/quality control development, technical development, process development, manufacturing scale-up, development-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, statistical analysis, report writing, non-clinical and clinical studies, packaging development, regulatory affairs, and the preparation, filing and prosecution of NDAs, ▇▇▇▇ and other applications for Regulatory Approval for such pharmaceutical or other product, as well as all regulatory activities related to any of the foregoing. For clarity, Development shall not include Manufacturing nor the conduct of any post-approval Clinical Trial. 1.71 “Development Breach” shall have the meaning set forth in Section 4.1(c). 1.72 “Development Costs” means the [**]. 1.73 “Development and Regulatory Milestone Event” shall have the meaning set forth in Section 9.2(a). 1.74 “Development and Regulatory Milestone Payment” shall have the meaning set forth in Section 9.2(a). 1.75 “Development Update” shall have the meaning set forth in Section 5.3. 1.76 “[**]” [**]. 1.77 “Disease Indication” means, [**]. 1.78 “Disclosing Party” shall have the meaning set forth in Section 11.1(a).
Debarred Person has the meaning provided in Section 13.3.
Debarred Person means any person subject to limitations or any form of endorsement imposed upon clinical investigators or clinical study sites by the European Medicines Evaluation Agency (EMEA), the US Food and Drug Administration (FDA) (including persons required to be listed under Section 306(k)(2) of the Act), or any Regulatory Authority or other recognized national, multi-national, or industry body.
Debarred Person means any person subject to limitations or any form of endorsement imposed upon clinical investigators or clinical study sites by