Debarred Individual is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application.
Debarred Individual has the meaning set forth in Section 7.2.3.
Debarred Individual has the meaning given in Article 9.2(c).
Examples of Debarred Individual in a sentence
Company further covenants, represents and warrants to Halozyme as follows: 2.3.1 Company and its Affiliates have never been the subject of a proceeding related to it or its Affiliates becoming a Debarred Entity, Excluded Entity or Convicted Entity and it and its Affiliates will not use in any capacity under this Agreement any person who is a Debarred Individual, Excluded Individual or a Convicted Individual.
More Definitions of Debarred Individual
Debarred Individual is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application; (b) a “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; (c) an “Excluded Individual” or “Excluded Entity” is (i) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA); (d) a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible; and (e) “FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
Debarred Individual has the meaning set forth in Section 5.1(h)(i).
Debarred Individual is an individual who has been debarred pursuant to 21 U.S.C. § 335a (a) or (b).
Debarred Individual has the meaning set forth in Section 9.2.19.
Debarred Individual has the meaning set forth in Section 10.2.13(a)
Debarred Individual has the meaning specified in Section 8.6.
Debarred Individual is an individual who has been debarred by the U.S. Food and Drug Administration (“FDA”) pursuant to Title 21 United States Code § 335a (a) or (b) or by any other competent regulatory authority from providing services in any capacity to a person that has an approved or pending drug product application. A “Debarred Entity” is a corporation, partnership or association that has been debarred by FDA pursuant to Title 21 United States Code § 335a (a) or (b) or by any other competent regulatory authority, from submitting or assisting in the submission of any drug application, or a subsidiary or affiliate of such a corporation, partnership, or association. Service Provider further covenants, represents, and warrants that if, during the term of this Agreement, Service Provider, or any of Service Provider’s employees or agents providing services or products under this Agreement, becomes or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Individual or Debarred Entity, Service Provider shall immediately notify AbbVie, and AbbVie shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement. This information is confidential to AbbVie.