Debarred Entity definition

Debarred Entity is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Debarred Entity has the meaning set forth in Section 7.2.4.

Debarred Entity shall have the meaning set forth in Section 7.1(e).

Examples of Debarred Entity in a sentence

Until the earlier of (a) the end of the Option Period and (b) the execution of the Asset Purchase Agreement, Prelude shall inform Incyte in writing immediately if it or any Person who is performing services for Prelude under the V617F Program becomes or is the subject of a proceeding that could lead to it or such Person becoming a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual.
Prelude shall not use in any capacity, in connection with the V617F Program, any Person who has ever been, is currently, or is the subject of a proceeding that could lead to such Person becoming a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual.

More Definitions of Debarred Entity

Debarred Entity has the meaning set forth in Section 13.2(iii).

Debarred Entity has the meaning set forth in Section 5.1(h)(ii).

Debarred Entity has the meaning given in Article 9.2(c).

Debarred Entity means a corporation, partnership or association that is or has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.

Debarred Entity means an individual or firm that has been declared ineligible in accordance with the World Bank sanctions procedures to be awarded a World Bank financed contract for the periods indicated at: http://web.worldbank.org/external/default/main?theSitePK=84266&content MDK=64069844&menuPK=116730&pagePK=64148989&piPK=64148984;

Debarred Entity is a Person (other than an individual) that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b), or by another Regulatory Agency pursuant to a comparable statute, from submitting or assisting in the submission of any application for any [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. abbreviated or other drug application or generation or preparation of any data with respect thereto, or any affiliate of such Person.

Debarred Entity means a Person (other than an individual) that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) or any applicable non-U.S. equivalent.