Pre-Clinical Data definition

Pre-Clinical Data means data derived from a study to test the Compound for use in the Field, including, but not limited to, laboratory studies, toxicology, safety pharmacology, disease models and animal models.
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Pre-Clinical Data means all data stemming from research and development activities related to a Licensed Product conducted prior to the commencement of a Clinical Trial relating to such Licensed Product.
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Pre-Clinical Data means the results arising from the conduct of those pre-clinical and non-clinical studies which are carried out under the Development Plan whether by GW Pharma or Otsuka or CROs or other researchers appointed by either of them.
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Examples of Pre-Clinical Data in a sentence

  • If XXXXXXXX terminates this Agreement for non-payment or material breach by XXXX in accordance with Article 20.2(a) or 20.2(b), the licenses granted to CORONADO by XXXX with respect to XXXX Pre-Clinical Know-How, XXXX Patent Rights, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions, shall remain in effect.

  • Without further request, CORONADO shall promptly send or return all documents, copies of documents and electronically memorised data referencing the XXXX Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions licensed to it by XXXX, and XXXX’x Confidential Information.

  • Domain knowledge guided deep learning with electronic health records.

  • However, the licenses granted to CORONADO by XXXX with respect to XXXX Pre-Clinical Know-How, XXXX Patent Rights, Pre-Clinical Data, Clinical Data, and Inventions, including XXXX’x right to the Royalty and XXXX’x rights connected to such Royalty, shall remain in effect.

  • The Canadian experiment, by providing a peacefulmicrocosm of the full range of modern diversity, is meant to show the world that polyethnic liberalism could eventually be realized by all states.

  • Without further request, XXXX and OVAMED shall promptly send or return all documents, copies of documents and electronically memorised data referencing the Pre-Clinical Data, Clinical Data, or Inventions licensed to it by CORONADO, and CORONADO’s Confidential Information.

  • In any case CORONADO is not allowed to retain any of the XXXX Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, or Inventions licensed to it by XXXX, and any of XXXX’x Confidential Information in any form.

  • The idea would be to incorporate several themes including health, medicine, place and culture.

  • NM-136 Pre-Clinical Data Showed Key Improvements• In this study done in mice, NM-136 (30 mg/kg) attenuated the insulin response to oral glucose by 2/3 and eliminated the insulin response to co-administered glucose.• The effect at 60 mg/kg weekly on weight gain decreased by 46.5% and was equivalent to the low-fat diet control mice.• There were NO differences in the amount of food consumed among the treatment groups.

  • Notwithstanding the foregoing, the licenses granted to CORONADO by XXXX with respect to XXXX Pre-Clinical Know-How, XXXX Patent Rights, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions, including XXXX’x right to the Royalty and XXXX’x rights connected to such Royalty, shall remain in effect.


More Definitions of Pre-Clinical Data

Pre-Clinical Data means technical, analytical, stability, quality control data, and CMC data relating to the Product and/or results of physico-chemical, pharmaceutical, biological including microbiological, toxicological and pharmacological tests of the Product.
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Pre-Clinical Data means data resulting from any pre-clinical study of the Compound or any Product conducted by or on behalf of any Equillium Person, together with the applicable protocol for each such study; but, in each case, excluding Biocon Data.
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Pre-Clinical Data means pre-clinical data for the Licensed Material that is Controlled by Sorrento as of the Effective Date.
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Pre-Clinical Data means data resulting from any and all pre-clinical animal studies and other non-clinical studies of the Product generated by or for Seller, together with the applicable protocol, if any, for each such study.
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Pre-Clinical Data means data and information generated in the performance of Pre-Clinical Development.
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Related to Pre-Clinical Data

  • 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:

  • 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:

  • 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.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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.

  • 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;

  • 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.

  • 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.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • 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.

  • 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 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.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • 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 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 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 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.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

  • 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 III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.