Toxicology Study definition

Toxicology Study means the twelve weeks toxicology studies being part of the Phase I Study as described in Schedule 5 attached hereto.
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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.
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Toxicology Study means the IND-enabling GLP toxicology studies for the RDH12 Program, including [***].
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Examples of Toxicology Study in a sentence

  • Praxis will enter into an agreement with CONFIDENTIAL such CMO for the production of the API and finished drug product to be used in the IND-Enabling Toxicology Study, and, if applicable, shall have reserved a manufacturing slot with such CMO for such production (and pay any reservation fees, if applicable), no later than [***].

  • For the purposes of calculating the amount of service credit, the MRC is deemed to cover 30 calendar days or 720 hours.

  • Ionis will submit invoices to Praxis for (a) the amount that is [***] of the total amount of the IND-Enabling Toxicology Costs promptly following Ionis’ execution of the contract with the applicable vendor for any IND-Enabling Toxicology Study, and (b) the remaining amount of such IND-Enabling Toxicology Costs once Ionis sends to Praxis the Draft Report with respect to such IND-Enabling Toxicology Studies.

  • Notwithstanding Section 3.5.2, no Related Party may initiate an IND-Enabling Pharmacology and Toxicology Study unless the Research Milestone for such Target has previously been paid by Agensys.

  • 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 “[***]”.

  • In the event there are either no or one (1) Active Selected Target(s) in the Research Program (e.g., an Active Selected Target has dropped out of the Research Program or an IND-Enabling Pharmacology and Toxicology Study has been initiated for at least two (2) of the Active Selected Targets), Agensys may propose that Ambrx and Agensys enter into up to three (3) material transfer agreements for research purposes only (each, an “MTA”).

  • The Fire Chief may increase the number of members assigned to any special assignment in order to satisfy operational needs.

  • Ionis will provide the Draft Report for the IND-Enabling Toxicology Study to the JSC and to Praxis promptly following Completion of such study.

  • 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.

  • Before commencing any IND-Enabling Toxicology Study, Ionis will provide a good faith detailed estimate of Ionis’ fully burdened cost (i.e., any out-of-pocket expenses to be paid to Third Party service providers and Ionis’ FTE Costs) expected to be incurred in connection with conducting such IND-Enabling Toxicology Study and the Parties will agree, through the JSC, upon a budget for such IND-Enabling Toxicology Study (such JSC-approved costs, the “IND-Enabling Toxicology Costs”).


More Definitions of Toxicology Study

Toxicology Study means the GLP toxicology studies to be conducted as part of the Preclinical Studies with respect to a Primary Development Compound or a Backup Compound, as described in the Annual Research Plan.
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