GLP Tox Study definition

GLP Tox Study means, with respect to a Compound, a study conducted in a species using applicable regulatory good laboratory practices for the purposes of assessing the onset, severity, and duration of toxic effects and their dose dependency with the goal of establishing a safety profile required for a regulatory submission supporting the dosing of human subjects as outlined in appropriate ICH guidance. For the avoidance of doubt, preliminary toxicology studies are not regarded as a GLP Tox Study.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

GLP Tox Study means, with respect to a Product, a study conducted in accordance with GLP for the purposes of assessing the efficacy, safety or the onset, severity, and duration of toxic effects and their dose dependency to establish a profile sufficient to support the filing of an investigational new drug application.

GLP Tox Study means a study in accordance with the Good Laboratory Practice (GLP) to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for a product.

Examples of GLP Tox Study in a sentence

For the purposes of this Section 4.3.7, “Significant Study” shall mean any GLP Tox Study or Clinical Study.
Additional Backup Compounds may be progressed through a GLP Tox Study at Roche’s sole discretion and expense (including any supply thereof) as part of the Research Plan and under the supervision of the JRC, provided that BPM will have the right to conduct (or have conducted) any such GLP Tox Study, and if BPM elects such right then Roche shall reimburse BPM for any personnel costs, Allocable Overhead or Out of Pocket Expenses incurred by BPM with respect thereto.
A GLP Tox Study shall be started for a Product containing a Degronimid for which the JRD has determined that CCS Achieved has been reached.
For the avoidance of doubt, preliminary toxicology studies are not regarded as a GLP Tox Study.
The Parties shall form a Joint Development Committee (“JDC”) within [***] after the Initiation of the GLP Tox Study in the first species for a given Target to oversee all activities of a Phase I Plan of a Phase I Completed Original Product as well as clinical development of any C4T Co-Dev Products.

More Definitions of GLP Tox Study

GLP Tox Study means, with respect to a Product, a study conducted in a species using applicable GLP for the purposes of assessing the efficacy, safety or the onset, severity, and duration of toxic effects and their dose dependency with the goal of establishing a profile sufficient to support the filing of an IND.

GLP Tox Study means a toxicology study of the relationship between dose and its effects on the exposed animal, where (a) the study is to be conducted in accordance with GLP standards and (b) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Product in Clinical Studies.

GLP Tox Study means a toxicology study of the relationship between dose and its effects on an exposed animal (or its anticipated effects on humans where no animal is used in such a study, such as an organ-on-a-chip), where (i) the study is to be conducted in accordance with Good Laboratory Practices and (ii) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Compound in Clinical Studies.

GLP Tox Study means a non-clinical study conducted in accordance with GLP to characterize the toxicity profile of a drug by identifying its physiological impact through non-human testing, which may include an assessment of dose and reversibility of any adverse effects.

GLP Tox Study means a toxicology study of a product (a) that is conducted in compliance with GLP regulations in an animal species appropriate to satisfy applicable regulatory requirements, (b) that is otherwise designed to satisfy applicable regulatory requirements and (c) the data and results from which are intended to support the filing of an IND for such product with the applicable Regulatory Authority. 11 [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.

GLP Tox Study means, with respect to a Molecule, Clinical Candidate or a Product, an in vivo

GLP Tox Study means, with respect to a Licensed Compound, any preclinical GLP toxicology study of such Licensed Compound.