Development Candidate Selection definition

Development Candidate Selection means the earlier to occur of (i) the identification by the Joint Steering Committee of a BACE Collaboration Compound or BI BACE Compound for Development and the decision by BI to start GLP toxicity studies with respect to a BACE Collaboration Compound or a BI BACE Compound, provided that BI’s internal decision-making process with respect to such BACE Collaboration Compound or BI BACE Compound is consistent with BI’s normal decision-making processes used for internally developed compounds, or (ii) the start of GLP toxicity studies with respect to a BACE Collaboration Compound or a BI BACE Compound by BI.
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Development Candidate Selection means the earlier to occur of (i) the identification by the Joint Steering Committee of a Collaboration Compound or BI Compound for Development and the decision by BI to start GLP toxicity studies with respect to a Collaboration Compound or a BI Compound, provided that BI’s internal decision-making process with respect to such Collaboration Compound or BI Compound is consistent with BI’s normal decision-making processes used for internally developed compounds, or (ii) the start of GLP toxicity studies with respect to a Collaboration Compound or a BI Compound by BI.
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Development Candidate Selection means selection of a candidate Small Molecule Compound selective modulator of a Research Target for further Research and Development based on the achievement of the following, as reasonably determined by [***]: (a) [***]; (b) [***]; (c) [***]; (d) [***]; and (e) [***].
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Examples of Development Candidate Selection in a sentence

  • If BI decides to commence Development of a Potential Development Candidate even if such Potential Development Candidate does not fulfill all criteria set forth in the Research Plan, then such Potential Development Candidate shall be deemed a Development Candidate after BI’s decision, and such decision shall trigger the obligation to pay the Development Candidate Selection milestone payment pursuant to Section 9.3.1 or 9.3.3.

  • The determination of whether a Potential Development Candidate has failed to meet the characteristics and/or properties described in Exhibit 2, as well as BI’s decision on Development Candidate Selection shall not be unreasonably delayed or withheld by BI.

  • In addition, the Parties agree that they shall follow the Potential Development Candidate Selection process set forth in Section 4.7.1.

  • BI has decided to advance either BACE Inhibitor ****or BACE Inhibitor **** to Development Candidate Selection and agrees to pay the milestone payment according to Section 9.3.1 of the Agreement.

  • The requirements only apply where a Therapy has progressed to a point in development where an item listed in this Schedule 7 is expected to exist as agreed by the JPT, JMC and JSC (e.g. it is not expected that clinical inventory will be available for an asset transferred at Clinical Development Candidate Selection).

  • On an Available Target-by-Available Target or Selected Target-by-Selected Target basis, as applicable, the JRC shall determine whether or not a Compound satisfies the applicable Development Candidate Selection Criteria; [**].

  • Subject to the oversight of the JSC and JRC, as applicable, Pliant will Manufacture (i) Research Compounds for Research in accordance with the applicable Research Plan up to Development Candidate Selection; and (ii) Licensed Compound or Licensed Product required for Research in accordance with the applicable Development Plan, in each case ((i) and (ii)) in accordance with quality standards in the industry for research purposes.

  • If the Executive Officers are unable to resolve the matter within [**] days after the matter is referred to them, any dispute regarding whether or not a Compound has satisfied the applicable Lead Candidate Criteria or Development Candidate Selection Criteria, or whether Proof of Concept has been achieved, as applicable, shall be resolved by referring the matter to a mutually-acceptable Third Party Technical Expert for a binding determination on the matter.

  • Upon the earlier of: (a) determination that any Compound satisfies the applicable Development Candidate Selection Criteria pursuant to the preceding sentence, or (b) the effectiveness of an IND with respect to a Compound, such Compound shall be deemed a Development Candidate for all purposes hereunder.

  • SCHEDULE 5A DEVELOPMENT CANDIDATE SELECTION CRITERIA MERCK Funded Research Projects; MERCK Internal Research Projects DEVELOPMENT CANDIDATE SELECTION CRITERIA Development Candidate Selection Criteria • [***] from [***] and [***] of [***] and [***] in [***] (e.g., [***] (or [***]) by a [***]).


More Definitions of Development Candidate Selection

Development Candidate Selection shall have the meaning set forth in Section 3.5.
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Related to Development Candidate Selection

  • 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.

  • 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.

  • 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 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)).

  • 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;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • 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.

  • 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.

  • 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.

  • Licensed Compound means [***].

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

  • Development Plan has the meaning set forth in Section 3.2.

  • 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);

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

  • 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).

  • 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.

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

  • 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.

  • Development Program means the implementation of the development plan.

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Research Program has the meaning set forth in Section 2.1.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.