IND-Enabling Study definition

IND-Enabling Study means a toxicology study (a) that is conducted using applicable GLP, (b) that is conducted in one or more species and that satisfies both applicable regulatory requirements and ▇▇▇▇▇▇▇ internal requirements and (c) the data and results from which are intended to meet the standard necessary for submission thereof as part of an IND with the applicable Regulatory Authority.
View Source
IND-Enabling Study means an in vivo animal study for a Licensed Product designed to provide data that can be used to support a filing of an IND for such Licensed Product. An IND-Enabling Study may include, without limitation, a GLP toxicology study and pharmacokinetic study.
View Source
IND-Enabling Study means a pre-clinical study for which the protocol and results are necessary to prepare a complete IND for a Licensed Product.
View Source

Examples of IND-Enabling Study in a sentence

  • Alnylam, through its Affiliate or a Third Party collaborator, has commenced an IND-Enabling Study for [**] product candidate as set forth in Section 5.2(b) of the Listed Alnylam Third Party Agreement with Isis Pharmaceuticals, Inc.

  • On a Research Program-by-Research Program basis, within [***] following the date on which the complete IND-Enabling Study Reports from the IND-Enabling Studies for at least [***] animal species for such Research Program becomes available to ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ will deliver to the JRC such IND-Enabling Study Report for such Research Program (the date of such delivery, the “IND-Enabling Study Completion Date”).

  • Biocon shall deliver to Equillium the draft and final reports for each IND-Enabling Study and all IND-Enabling CMC Activities promptly following the availability thereof.

  • Biogen will only be obligated to pay the IND-Enabling Study Commencement Fee one time with respect to each Collaboration Target, and after Biogen pays the IND-Enabling Study Commencement Fee for the first Degrader directed to a particular Collaboration Target, Biogen may commence IND-Enabling Studies for any other Degrader directed to such Collaboration Target without paying any additional IND-Enabling Study Commencement Fee.

  • Within [***] days of MAGENTA first initiating an IND-Enabling Study for the first Development Target, MAGENTA will pay a one-time fee in the amount of [***].


More Definitions of IND-Enabling Study

IND-Enabling Study means an acute in vivo toxicology study, safety pharmacology study or sub-chronic (greater than one week) toxicology study, in each case in species that satisfy applicable regulatory requirements, using applicable GLPs, and meet the standard necessary for submission as part of an IND filing with the applicable Regulatory Authority, […***…]. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
View Source
IND-Enabling Study means any non-clinical study of a compound (a) that is intended to comply with GLP or (b) the results of which are necessary to support the filing of an IND for such compound.
View Source
IND-Enabling Study means those studies required by a Regulatory Authority for submission of an investigational new drug application prior to initiating Clinical Trials.
View Source
IND-Enabling Study means a pre-clinical GLP toxicity study designed to generate data necessary to file an IND with the FDA or other similar filing with another applicable Regulatory Authority.
View Source
IND-Enabling Study means an acute or chronic in vivo GLP toxicology study in species that satisfy applicable regulatory requirements, using applicable GLPs, and that meets the standards necessary for submission as part of an IND filing with the applicable Regulatory Authority, as reasonably determined by Merck.
View Source
IND-Enabling Study means any non‑clinical study of a drug or biologic product (a) that is intended to comply with GLP or (b) the results of which are necessary to support the filing of an IND for such drug or biologic product.
View Source
IND-Enabling Study means a study conducted by or on behalf of Genentech, a Genentech Affiliate or sublicensee, in a non-rodent animal, of the toxicological effects (and, in some cases, pharmacokinetic properties) of a compound or other substance that the entity directing the study believes may be useful as a drug, where (i) such study is conducted to Good Laboratory Practices standards, and (ii) the data is intended to be used to file an IND with the FDA.
View Source