Candidate Selection Compound definition

Candidate Selection Compound means a Collaboration Compound that has met the Candidate Selection Criteria, or that is designated as a Candidate Selection Compound by the JSC, in either case as determined by the JSC as described in Section 3.4.
Candidate Selection Compound means a compound resulting from a Program that the JSC determines meets all of the Candidate Selection Criteria as established by the JSC.
Candidate Selection Compound means a compound resulting from a Program that the JSC determines meets all of the Candidate Selection Criteria as established by the JSC.

Examples of Candidate Selection Compound in a sentence

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  • Upon exercise of a GSK Program Option, subject to Section 16.1, the relevant Candidate Selection Compound shall be designated as a GSK Development Compound, unless and until GSK terminates its Development and/or Commercialization activities with respect to such GSK Development Compound pursuant to Section 4.2.7 or this Agreement is terminated, whether in its entirety or with respect to such GSK Development Compound and such Program (alone or with other Programs).

  • OncoMed will notify the JSC when OncoMed believes a proposed Candidate Selection Compound has met the Candidate Selection Criteria and will provide the JSC with all material data and information supporting OncoMed’s determination that the Collaboration Compound has met the Candidate Selection Criteria.

  • The JSC shall establish the PoC Criteria for a Candidate Selection Compound directed to a particular Collaboration Target not later than the earlier of either (a) [***] prior to the expected [***] or (b) [***] have been made available to the JSC for review.

  • GSK shall exercise its GSK Program Option, if at all, by written notice to OncoMed, which notice shall make reference to this Agreement and the relevant Candidate Selection Compound and Program.

  • If the JSC does not agree with OncoMed’s designation of a Collaboration Compound as a Candidate Selection Compound, then the JSC shall advise OncoMed in writing of the basis for its position within such [***] period.

  • If, prior to GSK’s exercise of a GSK Program Option, OncoMed enters into discussions with contract manufacturer(s) with respect to the negotiation of agreements for the process, analytical, or formulation development, and/or manufacture and supply of clinical supplies, of a Candidate Selection Compound to be used in Clinical Trials after Completion of the PoC Trials, OncoMed will notify GSK and collaborate with and include GSK in such discussions.

  • The Parties shall establish a joint program committee (the “Joint Program Committee” or “JPC”) for each Program when a Candidate Selection Compound has been identified for such Program.

  • GSK shall conduct such activities in compliance with all applicable legal and regulatory requirements, including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials after exercise of the GSK Program Option and the Commercialization of Products containing such Candidate Selection Compound.


More Definitions of Candidate Selection Compound

Candidate Selection Compound means a Compound that meets its Candidate Selection Criteria, or is deemed by the JRC, or by GSK as set forth in Sections 2(c)v.A and 2(c)v.B, as having met its Candidate Selection Criteria.

Related to Candidate Selection Compound

  • 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.

  • 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)).

  • 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.

  • 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.

  • 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.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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;

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

  • Selection Criteria means and includes all of the requirements, considerations,

  • 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.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • hit means the existence of a match or matches established by the Central System by comparison between biometric […] data recorded in the computerised central database and those transmitted by a Member State with regard to a person, without prejudice to the requirement that Member States shall immediately check the results of the comparison pursuant to Article 26(4);

  • 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.

  • 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.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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.

  • Compounds means a small molecule HMT inhibitor.

  • 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 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).

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

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

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

  • 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.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).