Research findings
Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.Ĭollaboration Program means the program of research and Development in the Field that is engaged in by or on behalf of the Parties under this Agreement during the Collaboration Program Term.Ĭommercialization Plan has the meaning set forth in Section 6.2.ĭevelopment Data means, with respect to clinical trials and other development work conducted on a Product, all data, results, information and other Know-How generated from or related to such clinical trials and development work, including preclinical, non-clinical and clinical data, reports and information, protocols, statistical analysis plans, methods, and Batch Records for all Products used in such work.īioassay means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture.
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Research Plan shall have the meaning set forth in Section 2.1.Ĭlinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient Ĭollaboration means a process involving 2 or more health Researcher means a person appointed by us to carry out research into theoperation of this Contract Ĭlinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials. Research Program has the meaning set forth in Section 3.1.Ĭollaboration Know-How means Know-How that is within the Collaboration Intellectual Property. For purposes of this part, the following activities are deemed not to be research:Ĭollaboration Technology means the Collaboration Know-How and the Collaboration Patents. For example, some demonstration and service programs may include research activities. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
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When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results Ĭommercialization means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, and interacting with Regulatory Authorities regarding any of the foregoing.
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Scientific research means any activities in the fields of natural or applied science for the extension of knowledge. Research Field means any use in the field of scientific or commercial research, excepting any use that Involves treating humans in any way whatsoever for any condition or any use that involves diagnosis of, testing for, or detection of, a disease condition, or the predisposition or susceptibility thereto, or the clinical progress thereof.