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.

GLP Toxicology Studies means toxicology studies, conducted on a Product Candidate in accordance with GLP, that are intended to assess the onset, severity, and duration of toxic effects of the Product Candidate, their dose dependency and degree of reversibility (or irreversibility).

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.

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.

• A Product Development Plan for each Collaboration Compound for which AstraZeneca elects to commence GLP Toxicology Studies shall be prepared and approved as provided in Section 5.1.

• ALNYLAM shall fund and be responsible for conducting all research and development of MERCK RNAi Novel Targets for discovery and development of RNAi Therapeutic Products as set forth herein and in the workplan developed pursuant to Section 2.14.1 through the completion of IND-Enabling GLP Toxicology Studies, at which time MERCK may exercise its Opt-In Right as set forth below.

• Except as set forth in any Program Plan or Supply Agreement, MTEM shall not conduct any GLP Toxicology Studies or perform any other Development activities or Manufacturing activities with respect to any SLT-A Fusion Proteins prior to the expiration of all Option Periods hereunder, and then only with respect to Targets other than the Takeda Targets that have not been [***] Replacement Target or otherwise terminated as a Takeda Target .

• 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.

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.

GLP Toxicology Studies a means toxicology studies conducted in accordance with then current Good Laboratory Practice Standards promulgated or endorsed by the FDA or in the case of foreign jurisdictions, comparable regulatory standards promulgated or endorsed by the applicable equivalent regulatory authority.

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.

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".

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.

GLP Toxicology Studies shall have the meaning set forth in Section 3.2 of the Agreement. ​

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. KUCTC-Reata Confidential [***]