Combination Therapy Trial definition

Combination Therapy Trial means each Clinical Trial designed to evaluate the Combination Therapy as agreed by the Parties under this Agreement. For clarity, Combination Therapy Trial includes any Confirmatory Combination Therapy Trial, unless otherwise specified in this Agreement.
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Combination Therapy Trial means a Phase 1 Clinical Trial designed to evaluate the safety and early evidence of effectiveness of the Combination Therapy and conducted pursuant to the Research Plan.
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Examples of Combination Therapy Trial in a sentence

  • The Parties shall jointly agree to the content and timing of all external communications with respect to this Agreement, including an initial press release to be jointly issued by the Parties in the form attached hereto as Exhibit 12.1, subsequent press releases, media Q&As, and the content and wording of any listing of a Combination Therapy Trial on a public database or public registry (such as xxxxxxxxxxxxxx.xxx).

  • Affimed shall prepare the patient informed consent form (“ICF”) for the Combination Therapy Trials conducted under the Development Plan (which shall include any required consent for the sharing and use of Combination Therapy Clinical Data under this Agreement) and provide a draft copy to Artiva for review, comment and any necessary input according to Xxxxxx’s responsibilities in the Combination Therapy Trial under this Agreement and the Development Plan.

  • At each regularly scheduled JSC meeting, each Party shall provide the JSC with regular reports detailing its Development activities for the Combination Therapy, the results of such activities, and if applicable, an update on its spend for the performance of any Confirmatory Combination Therapy Trial Activities.

  • Samples collected in the course of Combination Therapy Trial activities shall be solely owned by Affimed (to the extent not owned by the patient and/or the clinical trial site), except that Samples collected in the course of the Confirmatory Combination Therapy Trial shall be jointly owned by the Parties in equal and undivided shares (to the extent not owned by the patient and/or the clinical trial site).

  • Such policy will be placed for the entire duration of any Combination Therapy Trial until its termination.

  • Each Combination Therapy Trial shall be conducted in accordance with a protocol (each, as may be amended, a “Protocol”) to be drafted by Affimed with contributions and input provided by Artiva according to Xxxxxx’s responsibilities in the Combination Therapy Trial under this Agreement and the Development Plan, and approved by the JSC, subject to Section 3.5. Any amendments to a Protocol shall be subject to approval of the JSC (subject to Section 3.5) or by written agreement of the Parties.

  • If the Parties perform Confirmatory Combination Therapy Trial Activities in accordance with Section 5.4, within [***] after the end of each Calendar Quarter, each Party shall provide to the other Party a written report of its actual FTE Costs and Out-of-Pocket Expenses incurred with respect to the performance of such Confirmatory Combination Therapy Trial Activities to be shared by the Parties in accordance with Section 5.4 for such Calendar Quarter.

Related to Combination Therapy Trial

  • Pivotal Clinical Trial means a human clinical trial of a Licensed Product that (a) would satisfy the requirements of 21 C.F.R. 312.21(c) or corresponding foreign regulations; or (b) that is intended to provide sufficient efficacy data to support the Filing of a BLA for such Licensed Product in such country. A Pivotal Clinical Trial includes a Phase 2 Clinical Trial or Phase 3 Clinical Trial that satisfies the foregoing definition.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • 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.

  • 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 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 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.