Subsequent Study definition

Subsequent Study has the meaning set forth in Section 3.14.1.
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Subsequent Study means a registrational study for the Combination in the same indication(s) and line(s) of therapy as that included in the Combination Arm(s).
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Subsequent Study means any subsequent clinical study conducted by Stanford under the ISRA pursuant to a protocol approved in writing by Amgen prior to November 20, 2019 or by Jasper thereafter. As of the Effective Date, there are not Subsequent Studies and the Parties do not have any intention of conducting additional clinical studies pursuant to the ISRA.
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Examples of Subsequent Study in a sentence

  • Without prejudice to Section 2.9 (Subsequent Study), this Agreement does not create any obligation for either Party to provide any compound other than its Compound or to provide its Compound for any activities other than the MSD Compound Study.

  • Except as expressly set forth in Section 2.9 (Subsequent Study), nothing in this Agreement obligates [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10).

  • Except as expressly set forth in Section 2.9 (Subsequent Study), nothing in this Agreement shall: [***].

  • During the Term and for a period of [***] thereafter, either Party shall have the option to propose amending this Agreement (and the Related Agreements as necessary) or negotiating a new agreement, as appropriate, for the purpose of conducting a Subsequent Study.

  • Neither Party will have any obligation to agree upon the details of or execute any such amendment or agreement; provided, however, in the event this Agreement is amended or a new agreement is executed for the purpose of conducting a Subsequent Study, the Parties shall grant to each other a non-exclusive, worldwide, royalty-free, fully paid-up, transferable, and sublicensable license [***].

Related to Subsequent Study

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • 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. [***]

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • 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 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.

  • 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.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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 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.

  • Milestone Event has the meaning set forth in Section 8.4.

  • 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.