IND Candidate definition

IND Candidate means a Committed Compound that meets or exceeds the criteria established by the Research Committee for a compound that is ready for human clinical trials, including data sufficient to support the filing of an IND, as documented in the Research Plan.
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IND Candidate means any Collaboration Compound that has been determined by GBT to be a candidate for commencement of IND-Enabling Studies pursuant to Section 2.4(a).
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IND Candidate means, on a Target-specific basis, (a) a Lead Compound which the JMC has designated for IND-enabling pre-clinical studies and clinical development in accordance with Section 3.7 and which satisfies the criteria for IND Candidates set forth in the Research Plan, or (b) a Research Compound or Lead Compound that CVT uses for IND-enabling pre-clinical studies and clinical development pursuant to a license obtained by CVT pursuant to Section 4.6.
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Examples of IND Candidate in a sentence

  • Promptly after any such nomination, each Party shall present to the JSC the data and results of analyses generated by or on behalf of either Party with respect to such Collaboration Compound that are reasonably useful to evaluate such Collaboration Compound as a potential IND Candidate.

  • GBT may exercise the Option at any time during the period (A) commencing on the earlier of (i) the date of GBT’s designation of the first IND Candidate pursuant to Section 2.4, and (ii) if no IND Candidate is so designated as of the end of the Research Term, the date of the expiration or earlier termination of the Research Term, and (B) ending at 11:59 pm Pacific Time on the 180th day after the date of the expiration or earlier termination of the Research Term (the “Option Exercise Period”).

  • Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote.

  • GBT solely, acting through its representatives on the JSC or otherwise, shall determine whether any such Collaboration Compound shall be designated as an IND Candidate or whether to propose that additional research activities be conducted with respect to such Collaboration Compound, after which such Collaboration Compound may be reconsidered for nomination as an IND Candidate.

  • SB may designate a Royalty-Bearing Product as an IND Candidate Compound using the criteria set forth in Schedule C or other criteria subsequently agreed upon by the parties.

  • Upon completion of the testing set forth above, the parties will select, pursuant to Section 2.1 of the Agreement, a lead candidate compound to designate as the IND Candidate.

  • Each Party shall conduct the activities allocated to it under the Research Plan and Research Budget, and use Commercially Reasonable Efforts to identify at least one IND Candidate.

  • SB will make its selections of IND Candidate Compounds in its sole discretion under the criteria in Schedule C or other criteria subsequently agreed upon by the parties, however SB will not treat Licensed Compounds or ArQule Analog Compounds differently from other compounds that SB considers as IND Candidates.

  • Within [***] following the Option Effective Date (or such other time upon mutual agreement by the Parties), GBT may, upon written notice, request that Syros manufacture and supply to GBT its reasonable requirements for Collaboration Compounds or Products for any IND Candidate for the conduct of IND-Enabling Studies or First-in-Human Clinical Trials.

  • SB shall promptly furnish ArQule with written notice upon the selection of a Royalty-Bearing Product as an IND Candidate Compound.


More Definitions of IND Candidate

IND Candidate means the FGF Lead Product Candidate for which INDs (or IND Equivalents) have already been filed by Schering in the U.S. and Europe (which INDs are referred to herein as the “AGT IND(s)”). The U.S. AGT IND has sometimes been referred to by the Parties as IND Number BB-IND-7471 (along with associated amendments and protocols). The European IND Equivalents have been referred to by various different designations. The IND Candidate has sometimes been referred to by the Parties as Ad5FGF-4, Xx0-XXX0, Xx0.0-XXX0, or Generx™.
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IND Candidate means a particular compound in a [*] that has met [*] typically used to support a decision to move into initial human testing and, in the case of a compound having [*] against a [*], is designated by the JRC pursuant to Section 4.9 as a candidate for the filing of an IND.
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IND Candidate means a Collaboration Compound that meets or exceeds the criteria established by the Research Committee for a compound that is ready for human clinical trials, including data sufficient to support the filing of an IND, as documented in the Research Plan.
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Related to IND Candidate

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compound means [***].

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • POC (Proof of Concept) means testing the Software for evaluation purposes.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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.

  • Candidate means the person Introduced by the Agency to the Client for an Engagement including any officer, employee or other representative of the Candidate if the Candidate is a corporate body, and members of the Agency’s own staff;

  • 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.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.