Stage 2 Research definition

Stage 2 Research means generally antibody production, large scale protein production, structural analysis, screening of compounds affecting the relevant novel gene product, combinatorial chemistry, toxicological studies and first clinical studies in obese patients and completion of dose efficiency relationship studies in diabetic patients (clinical Phase 2).
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Stage 2 Research means generally antibody productions, large scale protein production, structural analysis, screening of compounds affecting such Novel Gene Product, combinatorial chemistry, toxicological studies and first clinical studies in obese patients and completion of dose efficiency relationship studies in obese patients (clinical Phase 2), performed on products or technologies generated by Stage 1 Research according to this agreement as described in Schedule 5.
Sample 1
Stage 2 Research means a program of research and development directed at developing relevant Novel Gene Products within the Licensed Field and discovering Target Compounds for use within the Licensed Field and includes antibody production, large scale protein production, structural analysis, screening of compounds affecting such Novel Gene Product, combinatorial chemistry, toxiological studies and first clinical studies in target patient groups and completion of dose efficiency relationship studies in those patients (clinical Phase 2), the undertaking of relevant human clinical trials on Target Compounds, but does not include the generation of relevant scientific and clinical data which is uniquely required by the regulatory authorities of Europe or the United States.
Sample 1

Examples of Stage 2 Research in a sentence

  • 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.

  • 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.

  • Lipha must ensure at all times that Stage 2 Research is conducted and Products are developed, manufactured, tested and used strictly in accordance with all relevant applicable requirements and standards of relevant jurisdictions and Lipha will be responsible for conducting its own independent examination and verification of the accuracy and suitability of Pre-Stage 2 Results and for ensuring the same are suitable for the purposes for which the same are used.

  • 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.

  • Lipha will use its best endeavours to progress each Stage 2 Research Program in a timely and diligent fashion and with a substantial dedication of resources.

  • If, and each time, Lipha exercises its option under clause 3.5 or 3.9 then the Parties agree, if it is necessary, to enter into a Complementary Agreement which will take effect no later than 6 months prior to completion by Lipha of relevant Stage 2 Research Program.

  • If such right is terminated by Warner in accordance with the preceding sentence, any compound which is or becomes the subject of the Stage 2 Research Plan (or similar plan of research) as an IL-8 Inhibitor (or as an inhibitor for a chemokine other than IL-8 pursuant to Option 3) shall become a Warner Product subject to the terms and conditions of this Agreement.

  • Subject to the terms and conditions of this Agreement each party hereby grants and agrees to grant to the other a non-exclusive, worldwide, royalty-free license to use such party's Background Technology and Collaboration Technology for research and development of an IL-8 Inhibitor under the Stage 1 Research Plan and under the Stage 2 Research Plan and as to LeukoSite for development of a LeukoSite Product and as to Warner for development of a Warner Product and/or Warner-LeukoSite Product.

  • After completion of the relevant Stage 2 Research program Merck must use reasonable endeavours to promptly complete Phase III clinical trials, and to apply for and gain Registration in its own name in respect of one or more Products.

  • In no event will LeukoSite be required to perform (nor shall Warner be required to fund) activities under the Stage 2 Research Plan which would require support for more than five (5) persons per year; provided, however, that in all events LeukoSite will be reimbursed only for work approved by the Management Committee.


More Definitions of Stage 2 Research

Stage 2 Research means certain research in respect of the Novel Gene Product which Lipha is undertaking or will undertake, and in respect of which Lipha has appointed Autogen Research to carry out specific studies, and of which the Contract Services are a component;
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Related to Stage 2 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.

  • Research means a methodical investigation into a subject.

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

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

  • Development Program means the implementation of the development plan.

  • 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.

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

  • 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.

  • Research Program has the meaning set forth in Section 2.1.

  • Collaboration has the meaning set forth in Section 2.1.

  • 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.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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 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.

  • 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 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.

  • 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.

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

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Stage 2 means the construction of the second hotel and other developments facilities and amenities referred to in the Development Proposals;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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.