Combination Therapy Trial definition
Examples of Combination Therapy Trial in a sentence
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.
In addition, Affimed shall promptly notify Artiva of any Regulatory Authority meetings or inspections, or any other events potentially impacting regulatory status of the Combination Therapy Trial or the Artiva Product promptly after Affimed becomes aware of such.
Such policy will be placed for the entire duration of any Combination Therapy Trial until its termination.
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).
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 ▇▇▇▇▇▇’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.
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 ▇▇▇▇▇▇’s responsibilities in the Combination Therapy Trial under this Agreement and the Development Plan.
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.
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 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇).
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.
Samples collected in the course of the Combination Therapy Trial shall be owned by Immatics (to the extent not owned by the patient and/or the clinical trial site) and may be used as set forth in the Protocol and the Research Plan.