Clinical Diagnostic Field definition

Clinical Diagnostic Field means the nucleic acid probe based testing of samples taken from a human patient for the purpose of detecting, identifying or quantifying, or testing for drug susceptibility of, hepatitis virus, other viral organisms, or cancer (including markers of early disease stages), for the purpose of research, diagnosis or medical care; provided, however, that the Clinical Diagnostic Field shall exclude the Blood Screening Field. For purposes of clarity and to avoid uncertainty, the Clinical Diagnostic Field shall exclude testing for genetic predisposition to disease. For purposes of clarity and to avoid uncertainty, the Clinical Diagnostic Field shall include the use in connection with the testing described above of standards and controls which are not taken from a human patient.
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Clinical Diagnostic Field means the assaying, testing or determination outside of a living organism, of a substance in any biological test material, in connection with clinical practice, for the purpose of identifying, characterizing, defining or diagnosing a disease or other condition in humans or animals, including without limitation, a determination of the state of health, in order to treat or prevent disease.
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Examples of Clinical Diagnostic Field in a sentence

  • Chiron shall use its Commercially Reasonable Efforts to promote, market, sell and meet the reasonably foreseeable market demands for the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field.

  • If the breaching party is obligated as of the date of the breach in connection with the provisions of this Agreement pertaining to both the Blood Screening Field and the Clinical Diagnostic Field, then the non-breaching party may terminate this Agreement in its entirety for any material breach if the breaching party has not cured such breach within ninety (90) days after notice.

  • Novartis acknowledges and agrees that Gen-Probe will continue its pre-existing development program for the Panther Instrument in the Clinical Diagnostic Field.

  • Chiron will not make any agreement with sub-contract manufacturers that will restrict Gen-Probe’s ability to negotiate its own contract with the vendors for the manufacture and purchase of modified eSAS- 2 Instruments for the Clinical Diagnostic Field.

  • SomaLogic hereby grants to Archemix a non-exclusive, royalty-free, paid-up license under the SomaLogic Licensed Patents and the SomaLogic Patents, that claim or relate to the SELEX Process and Aptamers or Photoaptamers, to research, develop, make, have made, use, have used, sell, offer for sale, have sold, keep, import and export RiboReporters solely for uses outside of the Clinical Diagnostic Field, during the Term and throughout the Territory.

  • Notwithstanding anything in the Ultrio Addendum, the WNV Addendum or this Agreement to the contrary, Gen-Probe shall have the right to manufacture and sell the hepatitis B discriminatory probe assay portion of the Ultrio Assay Product (the “HBV Discriminatory Assay”) and the WNV Assay Product for use in the Clinical Diagnostic Field within the territory of Japan.

  • If Gen-Probe develops any new instrument for use with TMA Assays in the Clinical Diagnostic Field, it shall offer to grant to Chiron, during the Clinical Diagnostic Term and on reasonable terms to be negotiated, rights to such instrument comparable to the rights granted under this Agreement as to the Clinical Diagnostic Instruments existing on the Effective Date, to the extent that Gen-Probe reasonably concludes that it is not prohibited as of the Effective Date from granting such rights.

  • Chiron shall use its Commercially Reasonable Efforts to promote, market, sell and meet the reasonably foreseeable market demands for such Exclusive Future Clinical Diagnostic Assays in the Territory for use in the Clinical Diagnostic Field.

  • Notwithstanding Section 6.2.1 of this eSAS 2 Addendum or Sections 3.3.4 or 4.4.3 of the Agreement, Gen-Probe shall have the exclusive right to manufacture (and have manufactured) the eSAS 2 Instruments for use in the Clinical Diagnostic Field.

  • CDS shall have the right to co-promote the Combo Clinical Diagnostic Assay, if sold by Chiron, the Initial Clinical Diagnostic Assay for the qualitative detection of HCV, and the Future Clinical Diagnostic Assays in Japan, China, Taiwan and Korea for use in the Clinical Diagnostic Field, provided that such co-promotion conforms with the marketing, product, pricing, and promotional strategy as determined by Chiron or the Major Distributor (provided that no such strategy shall preclude co-promotion).

Related to Clinical Diagnostic Field

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • 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:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Field means [***].

  • 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.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Compound means [***].

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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.

  • 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.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Therapeutic school means a residential group living facility:

  • Licensed Field of Use means all fields.

  • Licensed Territory means worldwide.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Commercialized shall have corresponding meanings.

  • 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.

  • 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.

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

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Licensed Services means all functions performed by the Licensed System.

  • Field means all fields of use.