Human In Vitro Diagnostic Field definition

Human In Vitro Diagnostic Field means the in vitro measurement, observation, and/or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of a human being. [**]
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Human In Vitro Diagnostic Field or “HIVD Field” means the in vitro measurement, observation, and/or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of a human being, including without limitation: (a) genetic testing, including determinations of genetic predisposition, for such medical management; (b) oncology and cancer predisposition testing for such medical management; (c) testing for tissue typing for such medical management; (d) infectious disease detection, screening, confirmation and monitoring for such medical management; (e) therapeutic drug monitoring; and (f) blood screening for blood intended to be introduced into a live human for therapeutic or diagnostic purposes. The HIVD Field excludes all other fields, including but not limited to, research (except for research solely for uses reasonably related to the development of a diagnostic product under a United States Food and Drug Administration regulation), epidemiology (i.e., the screening or testing of groups of people or populations for control of disease in groups of people or for the study of patterns or causes of disease or medical conditions), biosecurity, identity testing, forensic testing, testing and monitoring of environmental and food samples, and, with respect to products other than products licensed hereunder, quality assurance and quality control.
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Human In Vitro Diagnostic Field means the in vitro measurement, observation, and/or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of such human being. The Human In Vitro Diagnostic Field includes, but is not limited to, the use, sale or promotion of a real-time thermal cycler, such as a Licensed Real-Time Thermal Cycler, or a through-hole array such as an Array, in connection with analyte specific reagents in the United States or with any registered in vitro diagnostic product worldwide. Without limiting the foregoing, any real-time thermal cycler, such as a Licensed Real-Time Thermal Cycler, that is registered with any regulatory authority for use as a diagnostic instrument or that bears a diagnostic use label (e.g. CE-IVD mxxx) shall be deemed within the Human In Vitro Diagnostic Field.
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Examples of Human In Vitro Diagnostic Field in a sentence

  • Notwithstanding anything herein to the contrary, all other terms and conditions of the license granted herein under the ABC Patent Rights, including without limitation the royalties to be paid pursuant to Section 3.1 (b) and other restrictions placed on Licensee with respect to activities in the Field, shall continue to apply to the such activities in the Field (whether or subject to this Section 2.10 such activities are in the Human In Vitro Diagnostic Field).

Related to Human In Vitro Diagnostic Field

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Therapeutic school means a residential group living facility:

  • 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.

  • Diagnostic mammography means a method of screening that

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Licensed Field means all fields of use.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • 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.

  • 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.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

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

  • Licensed Field of Use means all fields.

  • 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;

  • 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.