Clinical Candidate Selection Criteria definition

Clinical Candidate Selection Criteria means the criteria (a) set forth in Exhibit A, and (b) as modified by the JSC for Compounds in each PROSENSA Collaboration Program pursuant to Section 2.6(a), for achievement of the Clinical Candidate Selection Milestone.
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Clinical Candidate Selection Criteria or “CCSC” means the guideline criteria for selecting Lead Compounds that are sufficiently promising to warrant further Development as Clinical Candidates (a) as set forth in Schedule 7 attached hereto for IL-23, and (b) as such Schedule 7 shall be amended from time to time by the JMC with respect to the other Program Targets listed on Schedule 1 as of the Effective Date and/or to any other Program Target Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. to be included in the Research Program, which amendment shall occur before any activities with respect to such Program Target are initiated, in any material respect, in the Research Program.
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Examples of Clinical Candidate Selection Criteria in a sentence

  • Within [***] of a Lead Vector achieving the Clinical Candidate Selection Criteria the Parties will establish a joint development committee comprised of personnel with relevant expertise to oversee the Development of the Lead Vector.

  • The JSC will commence a review at the point at which the first Lead Vector(s) is within [***] of achieving the Clinical Candidate Selection Criteria (or as otherwise may be earlier agreed by the JSC) in the relevant Collaboration Program to determine the liabilities associated with such Lead Vector(s).

  • The JSC shall agree upon the Clinical Candidate Selection Criteria for programs within the DMD Program 3 and DMD Program 4, within (i) * * * * * of GSK making the payment as per Section 2.5 and 6.2c.

  • The automation of the IPSS system has enabled the Provincial Government to:• Improve the co-ordination in informationrequest from municipalities by creating a single portal that can be used to extract information and reduce the burden of reporting by municipalities;• Better understand the state of governance in municipalities; and• Enable the design of an inclusive, tailor- made support plan, which addresses the specific support requirements of each municipality.

  • TELETHON-HSR will use Commercially Reasonable Efforts to obtain a reasonable scope of patent protection for Vectors that satisfy the Clinical Candidate Selection Criteria, using counsel of its own choice but reasonably acceptable to GSK.

  • GSK will use Commercially Reasonable Efforts to obtain a reasonable scope of patent protection for Compounds that satisfy the Clinical Candidate Selection Criteria covered by claims of such Joint Patent Rights, using counsel of its own choice but reasonably acceptable to PROSENSA.

  • Such Clinical Candidate Selection Criteria shall be consistent with the generic criteria attached in Exhibit A, modified as necessary by mutual agreement of the JSC.

  • Within six (6) months of a Lead Compound achieving the Clinical Candidate Selection Criteria the Parties will establish a joint development committee comprised of personnel with relevant expertise to oversee the Development of the Lead Compound.

  • Clinical Candidate Selection Criteria shall be consistent with the generic criteria attached in Exhibit A, modified as necessary by the mutual written agreement of the JSC as evidenced by the final mutually approved minutes of the JSC meeting.

  • PROSENSA will identify * * * * * Compounds from each project within DMD Program 4 and progress each such Compound to a point where it meets the Clinical Candidate Selection Criteria.

Related to Clinical 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,

  • 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.

  • 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.

  • 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”.

  • 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.

  • 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.

  • 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).

  • 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).

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

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

  • Eligibility and selection criteria means criteria for determining:

  • 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.

  • 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;

  • 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 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • 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 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.

  • 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.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.