GLP Toxicology Study definition

GLP Toxicology Study means a toxicology study that is conducted in compliance with GLP and is required to meet the requirements for filing an IND.

GLP Toxicology Study means an animal pharmacology and toxicology study conducted using cGLP that is used to assess whether a Licensed Product is reasonably safe for initial testing in humans and to support an IND.

GLP Toxicology Study. GLP Toxicology Study means a toxicology study that is conducted in compliance with the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the U.S. to the extent applicable to the relevant toxicology study, as they may be updated from time to time) and is required to meet the requirements for filing an IND.

Examples of GLP Toxicology Study in a sentence

• Initiation of the first GLP Toxicology Study for a T1 Licensed Product $30,000,000 (Thirty Million Dollars) [***] [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

• Each Active Compound which meets the criteria set forth in Exhibit 2.3 to the satisfaction of the Research Committee may be recommended by the Research Committee to Dainippon which shall have the right to select from those so recommended the Active Compound for the GLP Toxicology Study and further development and commercialization under the License Agreement.

• For clarity, for each Licensed Compound approved by the JSC for advancement into Development under Section 2.3.4(a), a set of Development activities will be conducted prior to the Initiation of a GLP Toxicology Study, as exemplified in Exhibit C.

• If Gilead has not previously delivered a Preclinical Milestone Payment Notice for a Licensed Program, Gilead will be deemed to have delivered the Preclinical Milestone Payment Notice for such Licensed Program and the Evaluation Period for such Licensed Program shall be deemed to have expired upon the initiation of any GLP Toxicology Study with respect to any Program DART or Licensed Product from such Licensed Program.

• The Parties shall pursue the Development of at least one Licensed Compound in accordance with a Development Plan and the remainder of this Article II, including seeking to pursue the Initiation of a GLP Toxicology Study.

More Definitions of GLP Toxicology Study

GLP Toxicology Study means a GLP study of the toxicological effects of a product.

GLP Toxicology Study means the study to be undertaken by OncoMed with respect to OMP21M18.

GLP Toxicology Study means a toxicology study in accordance with then current “Good Laboratory Practices” (as such term is defined from time to time by the U.S. Food and Drug Administration), or comparable standards or requirements of Regulatory Authorities outside of the United States, which study is required to meet the requirements for filing an application with applicable Regulatory Authorities to initiate human clinical trials involving such product, including an Investigational New Drug application filed with the U.S. Food and Drug Administration or any foreign equivalent thereof.

GLP Toxicology Study means, with respect to a Compound or Product, an in vivo toxicology study that is conducted in compliance with then-current Good Laboratory Practices.

GLP Toxicology Study means an in vivo toxicology study designed to be no less than [***] ([***]) days in duration, that is conducted in compliance with GLP and is required to meet the requirements for filing an IND.

GLP Toxicology Study means a toxicology study conducted in animals in accordance with current good laboratory practice, to the extent applicable, as required by the FDA under 21 CFR Part 58 and all applicable FDA rules, regulations, orders and guidance, or applicable requirements with respect thereto under current good laboratory practices prescribed by the European Community, the Organization for Economic Cooperation and Development Council (OECD), and the ICH Guidelines.

GLP Toxicology Study means [the three (3) month toxicology] study for the PRN2246 Product identified in the EDP.