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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
GLP Toxicology Studies means toxicology studies, conducted on a Licensed Candidate in accordance with GLP, that are intended to assess the onset, severity, and duration of toxic effects of the Licensed Candidate, their dose dependency and degree of reversibility (or irreversibility).
Sample 1Sample 2

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.

  • 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.

  • 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.

  • 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 .

  • Completion of GLP Toxicology Studies for the first Product: $ 500,000 2.

  • Selvita has the right to assume all of Felicitex’s rights (including intellectual property other than Patents or Know-How Controlled by Affiliates of Felicitex, contractual, development and commercial rights) for any Clinical Candidate for the one-time milestone payment to Felicitex of [**] at any time after the selection of a Clinical Candidate by the JSC and prior to the initiation of GLP Toxicology Studies.

  • In such case, the Program Compound(s) for which Felicitex has initiated GLP Toxicology Studies shall constitute Optioned Compound(s) and within ten (10) Business Days of the initiation of such GLP Toxicology Studies, Felicitex shall provide written notice to Selvita of the Option exercised by Felicitex through initiation of GLP Toxicology Studies.

  • Precision shall be responsible for Manufacture of Licensed Products to support Pre-Clinical Development up to and including the conduct of GLP Toxicology Studies pursuant to the applicable Research Plans with respect to such Licensed Products.


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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1Sample 2
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".
Sample 1Sample 2
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.
Sample 1
GLP Toxicology Studies shall have the meaning set forth in Section 3.2 of the Agreement. ​
Sample 1

Related to GLP Toxicology Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.