Joint Global Study definition

Joint Global Study shall have the meaning set forth in Section 5.4(b).
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Joint Global Study means any Global Study that has been agreed by the Parties to be included into the Joint Global Development Plan and jointly conducted by the Parties. Each Joint Global Study objectives, designs, study execution plan shall be agreed to by the Parties and studies may be conducted in both the Retained and Licensed Territory.
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Joint Global Study means a global Clinical Trial or a set of global Clinical Trials of a Licensed Product which include Clinical Trial sites in and outside of the Territory.
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Examples of Joint Global Study in a sentence

  • As between the Parties in connection with any Joint Global Study, the Sponsor Party will be responsible for developing strategies for and preparing and submitting all Regulatory Filings and application for Regulatory Approval for the Licensed Product in its Sponsored Territory.

  • Table 2: Sources of Housing Supply by planning status Source of Local Plan Land Supply 2022-37UnitsAllocations (including permitted sites within Allocations)7,554Permissions (Detailed)1,652Permissions (Outline only)918Sites without Permission or Allocation1,361Windfalls (Extant + Modelled: sites of 1 to 4 dwellings)405Total11,890 8.

  • The Parties may amend the Joint Global Development Plan by adding, removing, or modifying each Joint Global Study only by approval of the CC.

  • For each Joint Global Study, as between the Parties, the Sponsor Party shall be responsible for the set up and maintenance of the Trial Master File and collection of documents for Regulatory Filings from its Sponsored Territory.

  • Before making any submission to any Regulatory Authority, the Sponsor Party shall consult with and provide the other Party the opportunity to review draft Regulatory Filings with respect to a Joint Global Study (e.g., Type B meeting packages, key documents in INDs, NDAs, fast track, breakthrough designation and orphan drug application) to be submitted to the Regulatory Agency in its Sponsored Territory in advance of submission.

  • Through this intervention, the number of eligible female candidates entering the teaching profession will be increased.

  • The Parties agree that each Joint Global Study shall have one clinical database, one Statistical Analysis Plan (“SAP”) and one Clinical Study Report (“CSR”).

  • The Shared Costs for each Joint Global Study will be based on the final Protocol for such Joint Global Study.

  • Any key meetings with a Regulatory Agency regarding a Regulatory Filing with respect to a Joint Global Study shall be conducted by the Sponsor Party for its Sponsored Territory, with prior written notification to the other Party when practicable such that the other Party will have the opportunity to be present with one (1) representative as an observer.

  • The TMF shall contain all documentations related to the Joint Global Study.


More Definitions of Joint Global Study

Joint Global Study means a Global Study where a Licensee Entity is the Local Registration Agent in the Territory and for which Licensee is responsible for paying a portion of costs as set forth in Section 8.03(b).
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Joint Global Study. BioInvent shall, and shall cause its Third Party licensees or sublicensees (as applicable) to, allow CASI to participate in a Joint Global Study by allowing CASI to (i) include and coordinate Clinical Trial sites in the Territory, and (ii) enroll study subjects in the Territory in such Joint Global Study prior to the completion of such Joint Global Study, at an amount to be agreed by Parties, but in any event no less than the minimum amount required by the applicable Regulatory Authorities in the Territory for CASI to qualify the Clinical Trials to be conducted in the Territory as part of the Joint Global Study (along with any data generated by the Joint Global Study outside the Territory) as a Pivotal Trial in the Territory. The Parties shall negotiate in good faith and agree on the details and logistics of any such Joint Global Study. CASI shall be responsible for [***] Development in the Territory by CASI under a Joint Global Study.
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Joint Global Study means a Global Study which includes clinical sites in the Territory and is designed to be sufficient to support Regulatory Approval in Greater China, for which Licensee elects to participate pursuant to Section 4.01(c) and is responsible for paying a portion of costs as set forth in Section 4.02(b).
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Related to Joint Global Study

  • Joint Research Committee or “JRC” has the meaning set forth in Section 3.1.1.

  • JDC has the meaning set forth in Section 3.2.

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

  • 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.

  • JSC has the meaning set forth in Section 3.1.

  • Joint Patent Committee or “JPC” has the meaning set forth in Section 7.1.3(a).

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • 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.

  • 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.

  • JRC has the meaning set forth in Section 2.1.1.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • 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.

  • JCC has the meaning set forth in Section 2.1.

  • JPC means Joint Planning Committee.

  • Development Committee shall have the meaning set forth in Section 3.4.1.

  • 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 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).

  • Joint Steering Committee or “JSC” has the meaning set forth in Section 3.1.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

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

  • 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.

  • 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.

  • 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.

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

  • 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.