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;
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 data, results and information produced in the conduct by or on behalf of WCCI of any Clinical Trials.
Examples of Clinical Trial Data in a sentence
Clinical Trial Data and Results and Raw Data developed under a Collaborative Agreement will be made available to Collaborator(s), the NCI, and the FDA, as appropriate and unless additional disclosure is required by law or court order as described in the IP Option to Collaborator ( http://ctep.cancer.gov/industryCollaborations2/intellectual_property.htm).
Samples will be ordered in CRIS and tracked through a Clinical Trial Data Management system.
Clinical Trial Data and Results and Raw Data developed under a Collaborative Agreement will be made available to Collaborator(s), the NCI, and the FDA, as appropriate and unless additional disclosure is required by law or court order as described in the IP Option to Collaborator (http://ctep.cancer.gov/industryCollaborations2/intellectual_property.htm).
Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.
Clinical Trial Data and Results and Raw Data developed under a Collaborative Agreement will be made available exclusively to Collaborator(s), the NCI, and the FDA, as appropriate and unless additional disclosure is required by law or court order.
More Definitions of Clinical Trial Data
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.
Clinical Trial Data means all data and results generated by UTMDACC in a UTMDACC-INVOLVED CLINICAL TRIAL.
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 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 all data, results and information produced in the conduct by or on behalf of WCCI of any Clinical Trials. 1.14 “Commercialization” or “Commercialize” means, with respect to a Product, any and all activities directed to the pre-marketing, marketing, detailing, promotion, distribution and sale of such Product after the date of filing of an NDA with respect to such Product. When used as a verb, “Commercializing” means to engage in Commercialization and “Commercialized” shall have a corresponding meaning. 1.15 “Commercially Reasonable Efforts” or “Commercially Reasonable” means the efforts and resources comparable to those undertaken by [***], as applicable, [***] of similar products that are not subject to this Agreement, taking into account the [***]. 1.16 Commercially Reasonable Justification” means, with respect to WCCI’s obligations to use Commercially Reasonable Efforts, the [***]or [***]of (a) [***] (such as a [***], or [***], by [***]) that could be [***] to [***] and [***] and/or [***]; (b) [***]; (c) [***]; (d) [***] with respect to the [***] (including, without limitation, a [***]) that is [***]; or (e) [***] with respect to [***]. 1.17 “Commercialization Regulatory Approval” means, with respect to any Product, the Regulatory Approval required by Applicable Laws in the Territory to sell such Product for use in the Field in such Territory. “Commercialization Regulatory Approval” shall include, without limitation, the approval of any NDA, sNDA or other Drug Approval Application. 1.18 “Confidential Information” means (a) with respect to Paratek, all tangible embodiments of Paratek Technology, (b) with respect to WCCI, all tangible embodiments of WCCI Technology and (c) with respect to each Party, (i) all tangible embodiments of Joint Technology and (ii) with respect to a Party (the “receiving Party”), all information and Technology which are disclosed by the other Party or any of its Affiliates (the “disclosing Party”) to the receiving Party hereunder or to any of its employees, consultants, Affiliates or sublicensees, whether orally, visually, in writing or by way of any other media, that if disclosed in tangible form is marked “confidential,” or if disclosure is not in tangible form, the disclosing Party has notified the receiving Party at the time of disclosure that such disclosure is confidential and summarized such disclosure in writing, marking the summary “confidential” and submitting it to the receiving Party (or, if applicable, to such o...
Clinical Trial Data means the data collected by or on behalf of Sellers in connection with clinical trials conducted by or on behalf of Sellers or Sellers’ Affiliates to support the safety and efficacy of the Product and all rights of reference thereto, including (a) assessment of enrolled patients’ disease characteristics, (b) correlation among endpoints without regard to treatment assignment, (c) evaluation of characteristics of screen failures, and (d) reference to data collection methods.
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.