Sub-study definition

Sub-study means a study undertaken by a person licensed to access Research Asset Intellectual Property, which involves the collection of new data, information or material not already included in the Research Asset;
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Sub-study means the clinical trial investigating the Combination Therapy for relapsed and refractory multiple myeloma to be performed under this Agreement and pursuant to the Sub-Study Protocol.
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Sub-study means the sub-studies under the Platform Study investigating the Combination Regimens for relapsed and refractory multiple myeloma performed under this Agreement and referred to as Sub-Study 3, Sub-Study 6 and Sub-Study 7 in the Development Plan. 1.125 “Supply Remediation Plan” has the meaning set forth in Section 8.2. 1.126 “Tax” means any present or future taxes, levies, imposts, duties, charges, assessments or fees in the nature of a tax imposed, collected or assessed by, or payable to, a Tax Authority (including interest, penalties and additions thereto). 1.127 “Tax Action” has the meaning set forth in Section 13.10. 1.128 “Tax Authority” means any government, state or municipality or any local, state, federal or other fiscal, revenue, customs or excise authority, body or official in the United Kingdom or elsewhere. 1.129 “Term” has the meaning set forth in Section 24.1. 1.130 “Third Party” means any person or entity other than GSK, SpringWorks or their respective Affiliates. 1.131 “Third Party License Payment” means any payment (e.g. upfront payment, milestone, royalty) due to any Third Party under license agreements or other written agreements granting rights to Intellectual Property Rights owned or controlled by such Third Party to the extent that such Intellectual Property Rights are necessary for (a) the making, using or importing of a Party’s Compound for the conduct of the activities under the Development Plan, (b) the conduct of the activities under the Development Plan, or (c) the Commercialization of a Party’s Compound in accordance with this Agreement.
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Related to Sub-study

  • 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).

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

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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.