Existing Clinical Data definition

Existing Clinical Data means pre-clinical and clinical data relating to *** the Effective Date.
Sample 1
Existing Clinical Data has the meaning set forth in Section 8.2.2. 1.72 “Existing Confidentiality Agreement” means (a) that certain Confidential Disclosure Agreement, dated as of June 21, 2023, by and between GlaxoSmithKline LLC and Arrowhead; and (b) that certain Joinder Agreement to Confidential Disclosure Agreement, by and among GlaxoSmithKline LLC, Xxxxxxx, and Arrowhead, dated as of July 19, 2023. 1.73 “Existing Invention” has the meaning set forth in Section 8.2.2. 1.74 “Existing Joint Agreement Patent Rights” means any Agreement Patent Rights that (a) have a priority date prior to the Amended Effective Date; and (b) claim or otherwise disclose any Existing Invention that was jointly invented by or on behalf of (i) on the one hand, Arrowhead (or any of its Affiliates) and (ii) on the other hand, GSK (as the permitted assigned of Xxxxxxx) (whether or not they solely relate to the Registered Starting Material ([***])), including those Patent Rights set forth on Schedule 1.74. 1.75 “Exploit” means to make, have made, import, use, sell or offer for sale, including to research, develop, commercialize, register, manufacture, have manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute or have distributed by others, promote, market or have sold or otherwise dispose of, or have offered for sale, and convey or grant end-users use rights. “Exploiting” and “Exploitation” shall each have a correlative meaning. 1.76 “FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78dd-1 et. seq.), as may be amended at the relevant time. 1.77 “FDA” means the United States Food and Drug Administration or any successor agency thereto for the United States. 1.78 “Field” means all therapeutic, prophylactic and diagnostic uses in humans or animals. 1.79 “First Commercial Sale” means, on a Licensed Product-by-Licensed Product and country-by-country basis, with respect to a given Licensed Product in a given country, the first commercial sale for monetary value in an arms-length transaction of such Licensed Product to a Third Party purchaser by or on behalf of a Selling Party in such country following receipt of applicable Regulatory Approval for such Licensed Product in such country; provided, however, that First Commercial Sale shall not include any transfer of a Licensed Product (a) between or among GSK or any other Selling Party or any of its or their respective Third Party subcontractors (such as contract manufacturers, suppliers, or distrib...
Sample 1

Examples of Existing Clinical Data in a sentence

  • In this Agreement, “Confidential Information” shall, subject to Section 9.4., mean any and all Existing Clinical Data and Existing CMC Data, and the Study Results, including but not limited to the Study Plan, Study Protocol, Study Efficacy Data and Study Safety Data, whether oral or in writing or in any other form, disclosed before, on or after the Effective Date by one Party to the other Party, including the terms of this Agreement.

  • For the avoidance of doubt, the Existing Clinical Data and Existing CMC Data shall be deemed to constitute Confidential Information proprietary to Palatin.

Related to Existing Clinical Data

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

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

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • 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.

  • Information Technology means computers, software, databases, firmware, middleware, servers, workstations, networks, systems, routers, hubs, switches, data communications lines, and all other information technology equipment and associated documentation.

  • 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.

  • 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.

  • 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 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.

  • Peer-reviewed medical literature means a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the international committee of medical journal editors to have met the uniform requirements for manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier.

  • Information Technology Systems means all information technology systems, Software, computers, workstations, databases, routers, hubs, switches, networks and other information technology equipment used or held for use in, or otherwise relating to, the Business.

  • 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 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.

  • 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;

  • Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).

  • Training Materials means any and all materials, documentation, notebooks, forms, diagrams, manuals and other written materials and tangible objects, describing how to maintain the Facilities, including any corrections, improvements and enhancements thereto to the Bloom Systems which are delivered by Operator to Owner, but excluding any data and reports delivered to Owner.

  • 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 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 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.