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.
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

  • No Debarred, Disqualified, Disciplined, or Excluded Individual or Debarred Entity has performed or rendered, or will perform or render, any services or assistance relating to activities of the Company.

  • OraSure further covenants, represents and warrants that if, during the Term, OraSure, or any of its employees, agents or Third Party Providers performing activities or services hereunder, becomes or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added to FDA’s Disqualified and Restricted Lists, OraSure shall immediately notify AbbVie.

  • Neither the Company, nor any of its Subsidiaries nor any of their respective agents or employees has been, and is not currently a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) (“ Debarred Entity”) from submitting or assisting in the submission of any drug application, or an employee, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity.

  • Describe any changes to the 401(k) plan that were initiated during the test year or in the months subsequent to the test year.

  • Neither the Company nor, to the knowledge of the Stockholders, any of its Affiliates, officers, directors, employees or agents, has ever been or are currently the subjects of proceedings to render them, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual, a Convicted Entity or Convicted Individual, or a Disqualified Individual.


More Definitions of Debarred Entity

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 has been debarred by the FDA pursuant to Title 21 of the United States Code Section 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.
Debarred Entity has the meaning specified in Section 8.6.
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 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 for purposed of this Section 7.1(e) means 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 an employee, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity.