Human POP Study definition

Human POP Study means, on a Collaboration Program-by-Collaboration Program basis, a Clinical Study that tests [***]; and specifically, (a) with respect to the HD Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(a), (b) with respect to the PD Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program Product that meets the requirements set forth in Schedule 1.140(b); [***], (c) with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. respect to the FA Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(c), (d) with respect to the SMA Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(d), and (e) with respect to the Future Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements for the Human POP Study included in the Collaboration R&D Plan for the Future Collaboration Program in accordance with Section 4.3.1 (Collaboration R&D Plans) and appended hereto as Schedule 1.140(e).
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Human POP Study has the meaning set forth in the Master Agreement.
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Human POP Study means, on a Collaboration Program-by-Collaboration Program basis, a Clinical Study that tests [***]; and specifically, (a) with respect to the HD Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(a), (b) with respect to the PD Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program Product that meets the requirements set forth in Schedule 1.140(b); [***], (c) with respect to the FA Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(c), (d) with respect to the SMA Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements set forth in Schedule 1.140(d), and (e) with respect to the Future Collaboration Program, the first such Clinical Study for a Gene Therapy Product under such program that meets the requirements for the Human POP Study included in the Collaboration R&D Plan for the Future Collaboration Program in accordance with Section 4.3.1 (Collaboration R&D Plans) and appended hereto as Schedule 1.140(e).
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Examples of Human POP Study in a sentence

  • During the Option Period for each Collaboration Program, Voyager shall reasonably consult with, and obtain the approval of, the DAC regarding the design of and the written protocol for each Human POP Study proposed to be conducted for any Collaboration Product.

  • Subject to Section 9.1.6 (Decision-Making), Voyager shall not Initiate any Human POP Study until the protocol of such study has been approved by the DAC.

  • Notwithstanding the foregoing, Voyager shall not deliver an Option Notice to Genzyme prior to Human POP Study Completion for the Collaboration Product and unless and until all of the activities necessary to generate the information set forth on Schedule 1.173 (Option Data Package) have been completed.

  • If Genzyme’s representatives of the DAC vote to approve such protocol, then if the study is performed in accordance with such protocol, the study will be deemed to meet the definition of Human POP Study in Section 1.140 (Human POP Study).

  • For each Collaboration Program other than the Future Collaboration Program, the Development activities that are necessary or useful to be undertaken to achieve Human POP Study Completion for one or more Collaboration Products in such Collaboration Program (including the design of such Human POP Study(ies)) shall be set forth in reasonable detail in a written work plan and time table (a “Collaboration R&D Plan”).

  • Notwithstanding the foregoing, in no event may either Party amend or update any Collaboration R&D Plan such that the Collaboration R&D Plan fails to meet the requirements of Collaboration R&D Plans set forth in this Section 4.3 (Collaboration R&D Plans), the Human POP Study or the Program IND.

  • During the Option Period for each Collaboration Program, Voyager shall use Commercially Reasonable Efforts to Develop Collaboration Products under each Collaboration Program in accordance with the Collaboration R&D Plan for such Collaboration Products through achievement of Human POP Study Completion.

  • Further, if Voyager does not Initiate a Human POP Study by [***] for such Agreement Program or within such [***] period for the Future Collaboration Program as a result of a regulatory delay or a force majeure event, such time period shall be extended for so long as such regulatory delay or force majeure event continues and Voyager shall not be deemed to have failed to Initiate a Human POP Study pursuant to this Section 4.10 (Failure to Initiate Human POP Studies).

  • Further, if Voyager does not Initiate a Human POP Study by December 31, 2026 for such Agreement Program or within such 10 year period for the Future Collaboration Program as a result of a regulatory delay or a force majeure event, such time period shall be extended for so long as such regulatory delay or force majeure event continues and Voyager shall not be deemed to have failed to Initiate a Human POP Study pursuant to this Section 4.10 (Failure to Initiate Human POP Studies).


More Definitions of Human POP Study

Human POP Study means [***].
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Related to Human POP Study

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

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

  • 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.

  • 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.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • 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.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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 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 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 BMS and that otherwise fit the foregoing definition.

  • 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 I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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.

  • 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.

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • 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:

  • 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 II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.