Development Candidate Selection Criteria definition

Development Candidate Selection Criteria means the criteria set forth on Schedule 1.33, as such criteria may be amended from time to time upon mutual agreement of the Parties.
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Development Candidate Selection Criteria or “DCSC” means (i) with respect to the DCSC for Development Candidates that arise from the MERCK Funded Research Projects or MERCK Internal Research Projects, the guideline criteria for selecting Optimized Lead Compounds that are sufficiently promising to warrant further Development as Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. Development Candidates as set forth in Schedule 5A attached hereto, as such Schedule 5A shall be amended from time to time by the JSC in order to account for Target specificities, which amendment shall occur before any activities with respect to such Development Candidate are initiated, in any material respect, in the Development Program and (ii) with respect to the DCSC for Development Candidates that arise from ARCHEMIX Internal Research Projects, the guideline criteria for selecting Optimized Lead Compounds that are sufficiently promising to warrant further Development as Development Candidates as set forth in Schedule 5B attached hereto, as such Schedule 5B shall be amended from time to time by ARCHEMIX in order to account for Target specificities.
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Development Candidate Selection Criteria or “DCSC” means the guideline criteria for selecting Optimized Lead Compounds that are sufficiently promising to warrant further Development as Development Candidates as set forth in Schedule 6 attached hereto, as such Schedule 6 shall be amended from time to time by the JSC, which amendment shall occur before any activities with respect to such Development Candidate are initiated, in any material respect, in the Development Program.
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Examples of Development Candidate Selection Criteria in a sentence

  • REVIEW OF MONITORING WORKS IN THE PAST YEAR 2.1 SCOPE OF PLANNED MONITORING EFFORTS Indicating which component will be covered by the monitoring efforts, including those to be completed for baseline survey and those to be conducted follow up surveys.

  • 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.

  • The JSC shall determine whether any Compound satisfies the applicable Development Candidate Selection Criteria.

  • For purposes of clarity, except as otherwise set forth in a Joint Development and Commercialization Agreement with respect to a Shared Product, EPIZYME shall not be obligated to conduct Development activities beyond those contemplated under the Research and Development Plan, regardless of whether any Compound identified or Developed under the Collaboration fails to meet the applicable Lead Candidate Criteria or Development Candidate Selection Criteria and regardless of whether Proof of Concept is achieved.

  • 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.

  • Within [**] days after the Effective Date, the Parties will establish a Subcommittee under the JDC for Manufacturing (including CMC) related matters, which shall initially be with respect to DOT1L (and thereafter, with respect to each Selected Target at the time a Compound Directed to such Selected Target meets the Development Candidate Selection Criteria pursuant to Section 2.2.5) (the “Manufacturing Subcommittee”).

  • Following the Effective Date and during the Research Term, the Parties shall mutually agree on any additional Development activities to be performed by the Parties beyond those necessary for the Current Lead Series to attain the Development Candidate Selection Criteria, which Development activities shall be included in the Research and Development Plan.

  • Upon the JSC’s determination that any Compound satisfies the applicable Development Candidate Selection Criteria, such Compound shall be deemed a Development Candidate for all purposes hereunder, with the expectation that a GLP Toxicology Study shall be commenced using such Development Candidate.

  • Suffice it to say, the court is intimately acquainted with the underlying facts of this case, many of which are highly disputed.

  • For purposes of clarity, notwithstanding anything in this Agreement to the contrary, EPIZYME shall not be obligated to conduct activities with respect to Selected Targets in addition to those contemplated under the applicable Research Plan, regardless of whether a Compound identified or synthesized under the Collaboration fails to meet the applicable Lead Candidate Criteria or Development Candidate Selection Criteria.


More Definitions of Development Candidate Selection Criteria

Development Candidate Selection Criteria means the criteria to be achieved by Compounds directed to a Selected Target as set forth in the Lead-2-Candidate row of Exhibit B.
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Development Candidate Selection Criteria means, with respect to a Compound, the criteria set forth on Exhibit A, as such criteria may be amended by the JSC hereunder.
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Development Candidate Selection Criteria means the criteria set forth on S chedule 1.35, as such criteria may be amended from time to time upon mutual agreement of the Parties.
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Related to Development Candidate Selection Criteria

  • 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.

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

  • 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.

  • 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.

  • 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)).

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • 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;

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • ASAM criteria means admission, continued service, transfer, and discharge criteria for the treatment of substance use disorders as published by the American Society of Addiction Medicine (ASAM).

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

  • 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 review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Eligibility and selection criteria means criteria for determining:

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

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

  • 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);

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

  • 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.

  • Examination Criteria means the loan classification criteria employed by, or any applicable regulations of, the Assuming Institution’s Chartering Authority at the time such action is taken, as such criteria may be amended from time to time.

  • 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).

  • 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.

  • Dose profile means the dose as a function of position along a line.

  • Over-Riding Nomination Criteria means the criteria set out in clause 4.2.

  • 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.