Clinical Development Candidate definition

Clinical Development Candidate means a Therapy meeting the Clinical Development Candidate Criteria or designated as a Clinical Development Candidate by the JSC in accordance with Section 4.2;
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Clinical Development Candidate means (a) a Cell(s) that meets certain criteria and has certain characteristics that are necessary and desirable for the submission of an IND for use of such Cell(s) in Cell Therapy for at least one Cardiovascular Indication (and, therefore, make such Cell(s) suitable for a Clinical Development Program), as determined by the JSC; or (b) a Cell(s) that is or has been the subject of an IND for use of such Cell(s) in Cell Therapy for at least one Cardiovascular Indication. The term “Clinical Development Candidate” shall expressly exclude Cell Therapy Products.
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Clinical Development Candidate means (a) a MultiStem Product or Combination Product that meets the criteria and has the characteristics that are necessary and desirable for the submission of an IND for use of such MultiStem Product(s) or Combination Product(s) for treatment, prevention or control of a Pilot or Major Indication, as advanced and recommended by the JSC or the Development & Regulatory Committee; or (b) a MultiStem Product or Combination Product that is or has been the subject of an IND for use of such MultiStem Product or Combination Product(s) in the treatment, prevention or control of a Pilot or Major Indication.
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Examples of Clinical Development Candidate in a sentence

  • Athersys shall have the primary responsibility for communicating with any regulatory authority regarding any IND application or other regulatory filing pertaining to a Clinical Development Candidate that has not yet completed a Phase I Study.

  • In the event the non-discontinuing Party does not exercise the Sole Development Option within the six (6) month time period set forth in Section 6.1 above, and if agreed upon in writing by the Parties, the JSC may seek, or designate one of the Parties to seek, qualified Third Party(ies) to develop the applicable Clinical Development Candidate or Cell Therapy Product.

  • In the event that Athersys is materially unable, at any time, to fulfill its obligation to supply Clinical Development Candidates or Cell Therapy Products in a timely manner, as required hereunder, for any reason (a “Supply Disruption”), Athersys shall promptly notify Angiotech of such Supply Disruption and the estimated extent of such Supply Disruption (including the anticipated delay time and the quantity of Clinical Development Candidate or Cell Therapy Product involved).

  • 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).

  • Angiotech and/or Athersys may prepare and submit a Proposed Clinical Plan to the JSC in accordance with Section 3.5(c) for any Clinical Development Candidate.

  • If the JSC does not select any proposed Clinical Development Candidate within twenty one (21) Business Days of submission by Adaptimmune, then the JSC may specify within a further twenty one (21) Business Days what additional research activities, if any, that were not included in the applicable Development Plan are required to enable at least one (1) Lead Candidate to achieve the Clinical Development Candidate Criteria (the “Development Additional Work”).

  • To the extent either Party or its Affiliate has or receives any information regarding any new adverse event or any serious adverse event that may be relevant to the use of any Clinical Development Candidate or Cell Therapy Product, such Party shall immediately contact the other Party and provide the other Party with all such information in accordance with the adverse event reporting procedures established by Angiotech from time to time.

  • The Parties, either separately or jointly, may submit written proposals for Clinical Development Plans for any Clinical Development Candidate (“Proposed Clinical Plans”) to the JSC for review (which review shall take place at the first JSC meeting following submission of a Proposed Clinical Plan to the JSC) and recommendation to the Parties; provided that each Party may submit no more than one Proposed Clinical Plan per calendar quarter during the Term.

  • Upon the JSC’s determination that at least one Lead Candidate satisfies the applicable Clinical Development Candidate Criteria, such Lead Candidate shall be deemed the Clinical Development Candidate.

  • The Parties shall share equally all (a) income received from such Third Party(ies) and (b) Clinical Development Costs, Commercialization Costs and Manufacturing Costs (as applicable) associated with the wind-down of activities related to the applicable Clinical Development Candidate or Cell Therapy Product.


More Definitions of Clinical Development Candidate

Clinical Development Candidate means (a) a Cell(s) that meets certain criteria and has certain characteristics that are necessary and desirable for the submission of an Investigational New Drug (“IND”) application for use of such Cell(s) in Cell Therapy for at least one Therapeutic Indication (and, therefore, make such Cell(s) suitable for a Clinical Development Program), as determined by the JSC; or (b) a Cell(s) that is or has been the subject of an IND for use of such Cell(s) in Cell Therapy for at least one Therapeutic Indication. The term “Clinical Development Candidate” shall expressly exclude Cell Therapy Products.
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Clinical Development Candidate means a Compound that meets the Clinical Development Candidate Criteria for the initiation of a Clinical Development Program in the Field, and which is the subject of a written notice from CombinatoRx to CFFT that CombinatoRx intends to commence development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
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Related to Clinical Development Candidate

  • 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.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV 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)).

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

  • 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.

  • 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).

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • 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.

  • 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).

  • 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.

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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 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 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.

  • 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.

  • 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.

  • Clinical Trial means any human clinical trial of a Product.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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 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.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.