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

  • Orthofix shall have the right to withhold payment due in respect of a Notice of Achievement covering the third Matrix II Development Milestone solely in the event that the data contained in the Pre-Clinical Data Package fails reasonably to indicate that the Matrix II meets the Matrix II Specifications.

  • F.S. Macaluso, J.R.F.Cummings, R.Atreya, J.Choi, and A.Orlando, "A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence", Expert Opin Biol Ther, 22(2), 203-223(2022).

  • In any case XXXX and OVAMED are not allowed to retain any of the Pre-Clinical Data, Clinical Data, or Inventions licensed to it by CORONADO, and any of CORONADO’s Confidential Information in any form.

  • In addition to and without limiting the generality of the foregoing, Xxxxxx shall use best efforts to ensure that any Regulatory Authorities and other Third Parties to whom any Pre-Clinical Data, Clinical Data, CMC Data and any other data in connection with the Product in the Field in the Territory are disclosed under and subject to the express terms and conditions of this Agreement shall, in each case, keep all such data segregated and confidential.

  • Animal Models Reflecting Chronic Obstructive Pulmonary Disease and Related Respiratory Disorders: Translating Pre-Clinical Data into Clinical Relevance.

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

  • However, the licenses granted to XXXX by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall cease and XXXX shall cease to use the XXXX Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, or Inventions licensed to it by CORONADO, and shall cease to Develop, use, have made by OVAMED, Commercialize and sell Product, in each case except except as required by law or to the extent required for an orderly transition.

  • However, notwithstanding the foregoing, the licenses granted to XXXX and/or OVAMED by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall remain in effect.

  • 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.

  • 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.


More Definitions of Pre-Clinical Data

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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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 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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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 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 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.

  • 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 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.

  • 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 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 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. [***]

  • 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 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 human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country 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.

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.