Stage 1 Research definition

Stage 1 Research means the Research so described conducted under the Research Agreement.
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Stage 1 Research means discovery of Novel Gene Products, characterisation and studies of such Novel Gene Products in animal models and human gene expression studies as resulting from such Stage 1 Research performed according to this agreement as described in Schedule 5.
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Examples of Stage 1 Research in a sentence

  • Please refer to the Question Specific Advice for the Stage 1 Research Ethics Application Form at the above weblink.

  • N.B. If you are conducting research that involves ‘animals (dead or alive) and significant habitats’, please use the Stage 1 Research Ethics Application Form involving Animals and Habitats (www.aru.ac.uk/researchethics).Applicants carrying out research with children or vulnerable adults may also need to carry out an online Safeguarding course and submit the pass certificate with their ethics application.

  • The scientific priorities and direction of the parties' respective staff under the Stage 1 Research Plan, the Revised Stage 1 Research Plan and under the Stage 2 Research Plan will be determined by the Management Committee.

  • Whilst Lipha is continuing Stage 1 Research, Stage 2 Research, Further Development or paying royalties to Autogen under any Commercialisation Licence, Lipha has a non-exclusive royalty free right to use the Pre-Stage 2 Results for the purposes of its own internal research for human therapeutic purposes.

  • Each party agrees to use its best efforts to assure the complete and prompt exchange of Background Technology, Collaboration Technology and the results of all activities conducted pursuant to the Stage 1 Research Plan, the Revised Stage 1 Research Plan and/or the Stage 2 Research Plan.

  • Any such patent application in respect of Stage 1 Research will be in the name of Autogen.

  • Preliminary applications will be submitted in response to the Stage 1 Research Opportunity Announcement (ROA), OTA-19-008.

  • The preliminary application requests summary/overview information on the proposed asset and associated clinical trial.Preliminary applications are submitted in response to this Stage 1 Research OpportunityAnnouncement (ROA).

  • Ethical elements include:• Oath of allegiance and oath of office• Conflict of interest• Political activity rights and restrictions• Disclosure of wrongdoingWe are required to meet our performance commitments, in context with the ethical framework, according to our job description and related roles and responsibilities.

  • The Parties agree to establish a scientific board comprised of both Parties’ representatives to discuss between the parties the carrying out of Stage 1 Research.

Related to Stage 1 Research

  • Basic research means any original investigation for the advancement of scientific or technological knowledge that will enhance the research capacity of this state in a way that increases the ability to attract to or develop companies, jobs, researchers, or students in this state.

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

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • Development Program means the implementation of the development plan.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Public research university means Rutgers, The State University

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Stage 1 means the area at Port Xxxxxxx which is the subject of this Agreement and of the ERMP and which is shown bordered in purple as “stage 1” on Department of Land Administration 4 Miscellaneous Plan No. 1743;

  • 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;

  • 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.

  • Development Work means any work carried out in relation to the physical construction of a mine;

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

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Research Program has the meaning set forth in Section 3.1.

  • 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;

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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 II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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).