GLP Toxicology Studies definition

GLP Toxicology Studies means, with respect to a Licensed Product, animal studies conducted in accordance with GLP and intended to support an IND for such Licensed Product.
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GLP Toxicology Studies means all toxicology studies that meet the requirements set forth in 21 CFR Part 58 pertaining to good laboratory practice for use or intended for use in an IND and are required to be included in the filing of an IND, but excluding toxicology studies performed in the course of evaluating compounds prior to selection of a development candidate.
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GLP Toxicology Studies means toxicology studies, conducted on an Agreement Compound in accordance with GLP, that are intended to assess the onset, severity, and duration of toxic effects of such Agreement Compound, their dose dependency and degree of reversibility (or irreversibility).
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Examples of GLP Toxicology Studies in a sentence

  • If and when AstraZeneca decides to commence GLP Toxicology Studies for a Collaboration Compound, AstraZeneca shall notify Targacept in writing and the JDC shall prepare or direct the preparation of, and approve a Product Development Plan for such Collaboration Compound.

  • In addition, the Product for use in GLP Toxicology Studies will be manufactured and supplied solely by Sutro pursuant to a separate supply agreement (the “Product Supply Agreement”), in sufficient quantities and quality (as mutually agreed by the Parties and set forth in a supply plan) at a transfer price of [*] to permit Merck to conduct the GLP Toxicology Studies.

  • After the completion of GLP Toxicology Studies, BIND and Amgen shall cooperate to transition the Manufacturing of Licensed Candidates and Licensed Products to a mutually acceptable Third Party manufacturer; provided that, if the Parties are unable to so agree, Amgen may select either Patheon or Xxxxxx as the Third Party manufacturer.

  • An initial draft plan and budget for the IND Enabling GLP Toxicology Studies are included in the Collaboration Plan.

  • In the event Regeneron exercises the Option, Regeneron will generate and present to the JRC in writing the proposed protocols and design for, and each Party’s designated responsibilities for the conduct of, IND Enabling GLP Toxicology Studies and the Collaboration Clinical Trial for any Licensed Products that were the subject of the activities previously conducted pursuant to the Collaboration Plan.


More Definitions of GLP Toxicology Studies

GLP Toxicology Studies means the preclinical toxicology studies carried out in accordance with Good Laboratory Practices described in the U.S. Federal Register dated December 22, 1988, as amended, or the Japanese or European equivalent, which are intended to enable the filing of an IND.
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GLP Toxicology Studies means preclinical toxicology studies carried out in accordance with Good Laboratory Practices described in the U.S. Federal Register dated December 22, 1988, as amended, which are intended to enable the filing of an IND. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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GLP Toxicology Studies. Inactive Derived Compound", "IND", "NDA", "Licensed Back-Up Compound", "Licensed Compound", "Regulatory Approval(s)", "Research Committee", "Research Program", "Research Term", "RiboGene Know-How", "RiboGene Patents", " RiboGene Substances", "RiboGene Technology", "Tail End Period", and "Targets".
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GLP Toxicology Studies means a non-clinical toxicology study conducted according to Good Laboratory Practices guidelines promulgated by the FDA, and intended to support submission of an IND. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. KUCTC-Reata Confidential [***]
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GLP Toxicology Studies means the preclinical toxicology and biosafety studies of novel drugs and biologics in compliance with the then current Good Laboratory Practice Standards (“GLP”) promulgated or endorsed by the FDA in the United States (or in the case of foreign jurisdictions, comparable regulatory standards), as each may be amended from time to time.
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GLP Toxicology Studies means a toxicology study conducted under Good Laboratory Practice regulations, and [****]. Notwithstanding the foregoing, if Amgen initiates a Phase 1 Trial with a Program Product comprised of or including PRX-13038 (or any hydrates, anhydrates, solvates, salt forms, free acids, complexes, conjugates, polymorphs, in all forms, presentations and formulations thereof) then there will be [****] under this Section 7.4.2(b) thereafter.
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GLP Toxicology Studies shall have the meaning set forth in Section 3.2 of the Agreement. ​
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