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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
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) [***].
Sample 1Sample 2

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.

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

  • 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.

  • 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.

  • For the avoidance of doubt, from and after the Amendment Effective Date and prior to Development Candidate Selection (or the end of the Research Term if prior to Development Candidate Selection), GSK and its Affiliates and Sublicensees shall not conduct any chemistry activities based on the chemical structures of the Licensed Compounds.

  • 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).

  • Disclosure of the chemical structures of all Licensed Compounds determined from and after the Amendment Effective Date and prior to Development Candidate Selection (or the end of the Research Term if prior to Development Candidate Selection) will occur on a regular schedule every [**] after the Amendment Effective Date.

  • Confidential treatment has been requested with respect to the omitted portion Development Candidate is not actively being tested and progressed toward Development Candidate Selection according to the Preliminary Research Plan as described in Exhibit 2; and (iii) after Vitae’s notification, BI shall have a period of six (6) weeks to test such Collaboration Compound or Potential Development Candidate for eligibility as Development Candidate.

  • 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.

  • In no event shall a GLP Toxicology Study for a Compound be commenced prior to the determination by the JSC that such Compound satisfies the applicable Development Candidate Selection Criteria without the prior written consent of EISAI.


More Definitions of Development Candidate Selection

Development Candidate Selection shall have the meaning set forth in Section 3.5.
Sample 1

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 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.

  • 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 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.

  • 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 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).

  • 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: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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 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 3.4 (Joint Commercialization Committee).

  • 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.

  • Development Program means the implementation of the development plan.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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 3.1.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.