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.

  • Never use matches or a flame.• If the valve leaks, tighten the nut, then try to open the valve again, and check for leaks once more.• If the valve continues to leak, change the cylinder.

  • The event in Stage 3 may benefit from the program of varietal seed certification.Considering the above, the following table summarizes the new subcategories that shall take effect on the SRD events where shown: Stage 1 (Research plasmid), Step 2 (Research and development event) and Stage 3 (With commercial approval in other countries) correspond to events without vicarious liability (SRD).

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

  • 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.

  • 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.

  • Thank you for completing the Stage 1 Research Ethics Application Form.

  • 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.

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

  • To submit the Ph.D. dissertation within five years from the date of enrollment as a Stage 1 Research Student.

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 methodical investigation into a subject.

  • Development Program means the implementation of the development plan.

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

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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;

  • 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 the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

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

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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 2.1.

  • 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.

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

  • 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 study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.