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 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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Examples of IND Candidate in a sentence

  • 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.

  • The parties anticipate that these preclinical development activities will continue with respect to a GLP Toxicology Candidate until the parties (i) develop an acceptable IND Candidate, (ii) determine that they are unlikely to develop an acceptable IND Candidate, or (iii) decide to seek commercialization of the GLP Toxicology Candidate and the corresponding Committed Target as described below.

  • 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”).

  • 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.

  • Note however that velocity data provided by ADCP moving vessel deployments are slightly degraded by various factors such as Doppler noise, large sampling volume and beam divergence over rapidly changing bathymetry.

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

  • 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.


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 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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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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Related to IND Candidate

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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 a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • Exempt compound means the same as defined in Rule 2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

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

  • Valid write-in candidate means a candidate who has qualified as a write-in

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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;

  • continuing candidate means any candidate not deemed to be elected, and not excluded,

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.