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

  • Each Joint Global Study Budget, actuals must be reviewed and approved by the CC.

  • Ownership of Inventions and confidentiality and non-use obligations in connection with each Joint Global Study shall be subject to the terms and conditions of the License Agreement.

  • For each Joint Global Study, the Parties shall jointly agree on the selection of the CROs and other key vendors therefor, will jointly contract with such CROs and vendors unless they are specific to operations in a particular Sponsored Territory.

  • The Joint Global Development Plan and each Joint Global Study shall be approved by the CC.

  • AxxxXxxx and Allist now desire to conduct each Joint Global Study, under the terms and conditions set forth in this Collaboration Agreement.

  • The Parties acknowledge that this Collaboration Agreement shall govern all activities of the Parties with respect to each Joint Global Study from the Effective Date forward.

  • This Collaboration Agreement does not apply to any IIS/IST, Global Study and the Development Program that is not a Joint Global Study.

  • 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.

  • In the event that changes to each Joint Global Study affect the Joint Global Study Budget, the Parties may mutually agree through written consent of the Parties to amend the Collaborative Cost Model.

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


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 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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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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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 Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • 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 2.2.

  • 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.

  • JCC has the meaning set forth in Section 3.1.

  • JPC means Joint Planning Committee.

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

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

  • 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 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).

  • 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.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.