Pre-Clinical Activities definition

Pre-Clinical Activities means those activities required by the FDA to be undertaken in order to file an IND.
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Pre-Clinical Activities means all activities (including, but not limited to, development/scale-up, assay development, toxicology, pharmacokinetics, metabolism and safety pharmacology), undertaken to develop a Product Configuration (or a corresponding Development Candidate) which are determined by the Research Management Committee to be necessary or desirable to file an IND on such Product Configuration (or a corresponding Development Candidate), including the preparation and filing of an IND.
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Pre-Clinical Activities means in vitro and in vivo studies of a Licensed Product, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Collaboration Compound and whether the Collaboration Compound has a desired effect.
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Examples of Pre-Clinical Activities in a sentence

  • In accordance with Exhibit A-1, Moderna will Manufacture and supply AstraZeneca with non-cGMP Moderna mRNA API for use in support of the Services Program, Development Pool Services or Pre-Clinical Activities, as applicable, with respect to each applicable Collaboration mRNA Construct.

  • The Project Team Leader will be responsible for overseeing the operational aspects of the Pre-Clinical Activities and the Development of the applicable Development Candidate (or corresponding Collaboration Product), as directed by the Drug Development Committee, and will prepare and submit to the Drug Development Committee issues and problems to be decided by the Drug Development Committee.

  • In addition, the Parties agree to conduct such Pre-Clinical Activities and Development in compliance with applicable good laboratory, clinical or manufacturing practices of countries outside the Territory and the Co-Promotion Countries, provided, and only to the extent that, GenVec notifies Warner of such cGLP, cGCP and/or cGMP practices in any such countries, and such practices are not in conflict with the cGLP, cGCP or cGMP requirements in the Territory and the Co-Promotion Countries.

  • From time to time the Research Management Committee will propose, or either Party may propose, to the Executive Committee that further Pre-Clinical Activities be undertaken for one or more Product Configurations.

  • Warner may elect upon six (6) months prior written notice to (i) terminate its participation in or not to participate in the Pre-Clinical Activities or Development of any Development Candidate (or corresponding Collaboration Product), or (ii) terminate such activities with respect to all Development Candidates (and corresponding Collaboration Products) for a particular clinical indication.

  • LGBTIQ is an acronym for lesbian, gay, bisexual, transgender, intersex and queer.

  • If the Executive Committee determines that any Product Configuration meets the Pre-Clinical Development Criteria, and agrees to commence Pre-Clinical Activities with respect to such Product Configuration, then such Product Configuration shall be deemed to be a "Development Candidate".

  • This hilarious story concerns the efforts of a woman to put on the annual Christmas pageant despite having the cast of the meanest, nastiest, most inventively awful kids in the history of the world - the Herdmans! Come see if there will be a Christmas this year, or if the Herdmans will put a stop to everything.

  • However, it should be noted that these two sub-104 PRESENCE: VOLUME 7 , NUM BER 2 categories are strongly interwoven.

  • It is understood and agreed that any Development Costs incurred by GenVec and/or the Asian Partner specifically for Pre-Clinical Activities and Development of Collaboration Products for sale outside the Territory and the Co-Promotion Countries shall be borne by such Asian Partner and/or by GenVec.


More Definitions of Pre-Clinical Activities

Pre-Clinical Activities has the meaning set forth in Exhibit A-1, Paragraph 2(a).
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Pre-Clinical Activities has the meaning set forth in Exhibit X-0, Xxxxxxxxx 2(a).
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Pre-Clinical Activities will mean those activities required to be undertaken in order to file an IND with the FDA or an equivalent application to a similar foreign regulatory agency in another jurisdiction in the Primary EU Markets or EMA, which may include, inter alia, drug discovery and development, managing animal studies, as well as toxicology studies.
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Pre-Clinical Activities means those activities required to be undertaken in order to file an IND application with the United States Food and Drug Administration (“FDA”) or an equivalent application to a similar foreign regulatory agency in another jurisdiction, which may include, inter alia, managing animal studies, as well as toxicology studies. Pre-Clinical Activities shall not include testing, experimentation or other use in human patients. *** Confidential Treatment Requested ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
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Pre-Clinical Activities means, with respect to a Collaboration Compound or Product, those pre-clinical and other research and development activities that are non-clinical in nature.
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Pre-Clinical Activities means, with respect to a Product or MDX-1379, those pre-clinical and other research and development activities that are non-clinical.
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Related to Pre-Clinical Activities

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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).

  • 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.

  • Commercial Activities means activities conducted on a commercial basis.

  • 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.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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 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;

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • licensed activities means things authorised to be done by the licence

  • 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.

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

  • 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.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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.

  • Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.

  • School activities means any activity sponsored by the school including, but not limited to, classroom work, library activities, physical education classes, official assemblies and other similar gatherings, school athletic contests, band concerts, school plays and other theatrical productions, and in-school lunch periods.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.