Clinical Trial Data definition

Clinical Trial Data means data, results, information, discoveries, inventions, processes and methods (whether patentable or not) resulting from or developed by Investigator or Study Personnel in the performance of the Clinical Trial, but excludes all Personal Information and medical records;

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Clinical Trial Data means, with respect to a Product that is a Licensed Product or Collaboration Product, (a) all pharmacokinetic, clinical, safety and other similar data that relate to the Development of such Product, including all data and information related to any Clinical Trials of such Product (including all final reports and case report forms) and (b) all clinical test designs and operating records related to any Clinical Trial for such Product.

Clinical Trial Data means all Patient Data generated from the one or more of the clinical trial sites (including UHN, Calgary and Halifax), but excludes Sample Processing Data. For greater certainty, investigator suspected adverse events are not separately identified within the Clinical Trial Data, but are reviewed in accordance with the Clinical Trial Protocol and reported to Avro in accordance with obligations as outlined in Sections 2.4.4 to 2.4.6.

Examples of Clinical Trial Data in a sentence

• On and after the date of exercise by Enanta of its Co-Development and Profit Share Option for a Co-Developed Product and continuing for the Term of this Agreement [*****], whichever date is earlier, each Party shall provide written notice to the other Party to the extent it Materially Used any Shared Clinical Trial Data (the “Shared Clinical Trial Notice”).

• In the event that a Party Materially Used the other Party’s Shared Clinical Trial Data in such submission, the submitting Party shall immediately pay its applicable Shared Clinical Trial Cost Sharing Percentage to the other Party upon written request by the other Party.

• Promptly following the submission of each Regulatory Filing, and any amendments or supplements thereto, the Party making such submission shall provide a full and complete copy of such filing to the other Party for purposes of determining whether the submitting Party has Materially Used the other Party’s Shared Clinical Trial Data without having paid its applicable Shared Clinical Trial Cost Sharing Percentage associated with such Shared Clinical Trial Data.

• Institution shall use reasonable efforts to give [choose Sponsor or CRO to match contracting party] notice before destroying the Clinical Trial Documentation and Clinical Trial Data.

• Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.

More Definitions of Clinical Trial Data

Clinical Trial Data means all data, results and information produced in the conduct by or on behalf of WCCI of any Clinical Trials.

Clinical Trial Data means all data (including raw data) and results collected, generated or otherwise resulting from the Phase I/II Clinical Trial, including any and all data collected and maintained in the Trial Databases and Trial Master Files in accordance with Section 2.8.

Clinical Trial Data means clinical source data and clinical trial documentation generated through sponsored and/or otherwise supported, either internally or externally, studies as required by, or prepared in support of, the United States Food and Drug Administration (“FDA”) and/or International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) guidelines, in whatever form, written or electronic, embodying, reflecting, containing, reporting, and/or otherwise relating to any and al data observed, compiled, and/or collected in the course of any human clinical trial conducted by, or on behalf, of Company in connection with the Intellectual Property Rights or Technological Information granted hereunder.

Clinical Trial Data means any data, documentation and technical or scientific information (whether or not of clinical relevance) resulting from a Clinical Trial undertaken and supported by or on behalf of MTIA, including, but not limited to, patient demographics, the patient outcome, screening procedures, and the relations between the screening procedures and the relations between the screening results and the patient outcomes. Clinical Trial Data shall be Echo Confidential Information.

Clinical Trial Data means all data and results generated by UTMDACC in a UTMDACC-INVOLVED CLINICAL TRIAL.

Clinical Trial Data means data provided to HCRI by the Clinical Sites during the Trial and may include, but shall not be limited to, information contained in case report forms, core laboratory data, if any, and clinical laboratory data, if any.

Clinical Trial Data has the meaning set forth in Section 5.3(c).