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 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.
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Examples of Clinical Development Data in a sentence

  • 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.

  • IBM will provide up to three (3) consecutive business days of facilitated training for up to six (6) designers on the core IBM Clinical Development Data Migrator functionality using actual Client study data or a sample study for Client's study design.

  • Together these illustrate the willingness and desire to further protect the youngest and the most innocent of victims.

  • Notwithstanding the foregoing, if a Third Party License Agreement regarding any Patents, Trademarks, Know-How or Clinical Development Data could be relevant, necessary or useful to Develop, Manufacture, use or Commercialize any Special Product both in the Abbott Territory and the AbbVie Territory, in each case, the Parties shall jointly agree which Party shall be primarily responsible for negotiating and entering into any such Third Party License Agreement.

  • 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.

  • 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.

  • Subject to Section 3.06(b)(iii), Abbott shall be responsible for negotiating and entering into any Third Party License Agreements regarding Patents, Trademarks, Know-How or Clinical Development Data that could be relevant, useful or necessary to Develop, Manufacture, use or Commercialize any Special Product in the Abbott Territory.

  • The Client will need to engage an IBM Seller to place a new order for additional Clinical Trials.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).

  • 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 9.3 or higher).


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

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • 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 Kouga 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;

  • Development Works means the external development works and internal development works on immovable property;

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.