Candidate Selection Stage definition

Candidate Selection Stage means, as applicable, that stage of progression of a Research Program, or a Collaboration Compound within a Research Program, which is defined by the demonstration by Regulus (as confirmed by the JSC) that a Collaboration Compound within such Research Program has met the Candidate Selection Criteria and is ready for advancement into a [...***...]. For purposes of clarity, notwithstanding the foregoing, the Candidate ***Confidential Treatment Requested Selection Stage shall be deemed to have been achieved if, at any time during the Research Collaboration Term for a Research Program, GSK or the JSC requests that Regulus begin a [...***...] of a Collaboration Compound under such Research Program prior to Regulus’ demonstration (and the JSC’s confirmation) that a Collaboration Compound meets the Candidate Selection Criteria.
Sample 1Sample 2
Candidate Selection Stage means, with respect to any compound, the stage of pharmaceutical product development whereby the activities included in the Development Candidate Activities are first completed and (i) the Development Candidate Criteria are achieved or (ii) the JSC determines such compound to be a Development Candidate or, if such compound had previously been determined to be a Follow-On Compound, confirms that such compound remains a Follow-On Compound.
Sample 1Sample 2
Candidate Selection Stage means the earlier of (a) the Parties’ selection of a development candidate pursuant to Section 4.4, or (b) the completion of all activities pursuant to the Joint Research Plan.
Sample 1Sample 2

Examples of Candidate Selection Stage in a sentence

  • From and after the Effective Date and before Candidate Selection Stage, each Party will be responsible for supplying its own demands for API Bulk Drug Substance, Delivery Compound, and Formulated Bulk (as applicable) in quantities that are sufficient for the conduct of Discovery activities as defined in the Joint Research Plan.

  • Notwithstanding Section 6.4 of the Agreement, there shall be no Discovery Milestone payment with respect to the Regulus Mir-122 Program, and instead the payment due upon the Regulus Mir-122 Program reaching Candidate Selection Stage shall be [***], payable within [***] days of receipt by GSK of an invoice sent from Regulus on or after the date of achievement of such Milestone Event.

  • For clarity, it is contemplated that, if any Program contains more than one Progressed Compound that (i) reaches the Candidate Selection Stage (by way of example, but without limitation, a Development Candidate and a Follow-On Compound) and (ii) is developed further by Targacept, each such Progressed Compound would have its own Early Development Plan.

  • Each Research Program will be carried out by Regulus pursuant to a Research Plan, which will outline (subject to JSC [***] and/or amendment as set forth in Section 2.1.6), for each Collaboration Target, as appropriate: discovery, research and optimization activities in connection with the identification and progression of Collaboration Compound to Candidate Selection Stage; and estimated timelines for completion of the studies and activities to be undertaken by Regulus thereunder.

  • Notwithstanding Section 6.4 of the Agreement, there shall be no Discovery Milestone payment with respect to the Regulus Mir-122 Program, and instead the payment due upon the Regulus Mir-122 Program reaching Candidate Selection Stage shall be […***…], payable within […***…] days of ***Confidential Treatment Requested receipt by GSK of an invoice sent from Regulus on or after the date of achievement of such Milestone Event.

  • In addition, if prior to the exercise by GSK of the applicable Program Option, Targacept elects in its sole discretion to conduct any further Development activities of any Follow-On Compound that reaches the Candidate Selection Stage and is then confirmed by the JSC as a Follow-On Compound, such activities shall also constitute part of the Early Development Program.


More Definitions of Candidate Selection Stage

Candidate Selection Stage means, as applicable, that stage of progression of a Research Program, or a Collaboration Compound within a Research Program, which is defined by the demonstration by Regulus (as confirmed by the JSC) that a Collaboration Compound within such Research Program has met the Candidate Selection Criteria and is ready for advancement into a [...***...]. For purposes of clarity, notwithstanding the foregoing, the Candidate
Sample 1

Related to Candidate Selection Stage

  • 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.

  • 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;

  • 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 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.

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

  • 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)).

  • 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.

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

  • 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.

  • 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.

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

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • JCC has the meaning set forth in Section 2.1.

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

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.

  • JDC has the meaning set forth in Section 3.2.

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

  • 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:

  • 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”.

  • 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.

  • 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.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.