Clinical Development Data definition

Clinical Development Data means all data, charts, summaries, analyses, reports, know how and other information resulting or derived from any animal or human clinical trials or studies of the Compound or the Licensed Products or the Licensed Combination Products conducted under or in connection with any Development Plan relating to United Therapeutics Intellectual Property but excluding (i) any Non-Clinical Development Data, or (ii) any information, data and materials that refer to, relate to, incorporate or claim Supernus Intellectual Property;
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Clinical Development Data means all data and results (including pre-clinical and clinical trial results) generated by or on behalf of either Party, or their respective Subsidiaries, from the conduct of Clinical Development whether prior to or after the Effective Time.
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Clinical Development Data means all information and data resulting from Clinical Development activities, and specifically the results of related clinical studies.
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Examples of Clinical Development Data in a sentence

  • Notwithstanding the provisions of this clause 12.2, Supernus may use the Clinical Development Data only for purposes of preparing, prosecuting or maintaining Patents.

  • We train a machine learning system to recognize the patterns of extended interaction that typify the beginning or end of a dialysis session in our HCW location data.

  • IBM will provide facilitated training on how to use the IBM Clinical Development Data Migrator functionality using Client's study design and collaborate with Client to create the initial study import.

  • For clarity, Nycomed, its Affiliates and its Third Party licensees and sub-distributors shall have access rights to Clinical Development Data pertaining to Additional Products generated by or for Sepracor in accordance with Section 6.3.5.

  • Id. Based on her conversations with Larson, Rahn, and Iselo, Plaintiff did not believe she needed to file a complaint with EEO and did not do so until several months later.

  • In addition to the Mandatory One-Time Fees set forth in Section 1.3.1 below, Client will be charged for usage for the following:IBM Clinical Development Up TimeUp Time is calculated daily, while the Clinical Trial is set to Live status, using the following tiered structure:● Tier 1: 1 to 182 Days● Tier 2: 183 to 365 Days● Tier 3: 366 to 730 Days● Tier 4: more than 730 DaysIBM Clinical Development Data PointsA data point is any value that is saved to the system database (Data Point).

  • With respect to Clinical Development Data, each Party shall provide in a timely manner to the other Party all Clinical Development Data it holds regarding Regulatory Approvals in its territory for Special Products.

  • Statistical analyses will be performed by an external Contract Research Organisation (CRO) managed by the Sponsor’s Clinical Development Data Sciences Department.A reporting and analysis plan (RAP) describing the planned statistical analysis in detail with tables, figures and listings (TFLs) templates will be developed as a separate document.Statistical evaluation will be performed using Statistical Analysis System (SAS)® (Version 8 or higher).

  • Upon request, the other Party shall provide in a timely manner data (other than Clinical Development Data) it holds regarding Regulatory Approvals in its territory that may be required by the Interacting Party to prepare and submit Regulatory Submissions in the Interacting Party’s territory.

  • The depreciated replacement cost approach (‘‘DRC’’) is based on an estimate of the market value for the existing use of the land, plus the current cost of replacement of the existing structures less deductions for physical deterioration and all relevant forms of obsolescence and optimization.


More Definitions of Clinical Development Data

Clinical Development Data means all data and results (including pre-clinical and clinical trial results) generated by or on behalf of either
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Related to Clinical Development Data

  • Clinical 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.

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Clinical 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;

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Phase means the period before a vehicle type is type approved.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.