QIAGEN IVD definition

QIAGEN IVD means an IVD developed by QIAGEN in the course of a Project including its respective development stages.
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QIAGEN IVD means an IVD being developed by QIAGEN pursuant to the Initiation Agreement and/or the Statement of Work No. 2 or by HTG pursuant to the Statement of Work No.
Sample 1

Examples of QIAGEN IVD in a sentence

  • Without limiting the foregoing, QIAGEN shall use commercially reasonable and diligent efforts to: [**], (e) at Tokai’s request, permit Tokai to participate in scheduled meetings with Governmental Authorities in each Major Market regarding development of the Tokai Product for use with the QIAGEN IVD, (f) obtain Regulatory Approval of the QIAGEN IVD in each Major Market and (g) support any efforts of Tokai to obtain Regulatory Approval for the Tokai Product for use with the QIAGEN IVD in each Major Market.

  • To the extent Tokai Commercializes a Tokai Product in certain countries or territories, QIAGEN shall Commercialize the corresponding QIAGEN IVD in each Major Market, and may Commercialize such QIAGEN IVD in such other markets included in the Project Schedule.

  • QIAGEN shall be solely responsible for the manufacture and supply of a QIAGEN IVD to the Contract Laboratories for clinical utility testing and for sufficient educating and training of the Contract Laboratories personnel as necessary for conducting the clinical utility testing.

  • QIAGEN shall be responsible for obtaining and maintaining, [**], Regulatory Approvals for the QIAGEN IVD in any Major Markets identified by Tokai in a Project Schedule, as well as any other Markets that are mutually agreed by the Parties in a Project Schedule.

  • The Parties agree that the ultimate goal of each Project conducted under this Agreement is the Commercialization of a QIAGEN IVD used in connection with the Tokai Product.

  • In the absence of an agreement under a Schedule to the contrary, however, Tokai shall be responsible and authorized to select and contract the Contract Laboratories engaged to assess the clinical utility of a QIAGEN IVD, subject to QIAGEN’s prior consent which may only be withheld in case QIAGEN has reasonable quality concerns with respect to the performance of such sample testing by such Contract Laboratory.

  • Commerce stated that it “determined that the value added consideration was of less significance than the essential qualities imparted by the weaving and priming of the canvas in India because the enduring qualities of a particular artist canvas are defined by the unprimed canvas itself and are finally set once the unprimed canvas is coated with priming material.”72 A similar situation exists in this case.

  • Without limiting the foregoing, QIAGEN shall use commercially reasonable and diligent efforts to: (a) ensure the availability of the QIAGEN IVD for purchase in the Markets for use in connection with the initiation and ongoing treatment of patients with the Tokai Product and (b) collaborate with Tokai to seek any necessary reimbursement approvals for the QIAGEN IVD from Governmental Authorities and other third party payors in each of the Major Markets.

  • Notwithstanding the foregoing, QIAGEN shall have the unilateral right to make final decisions on matters relating to the safety or performance of the QIAGEN IVD.

  • QIAGEN will develop the Clinical Trial Assay or QIAGEN IVD for use as a companion diagnostic for the SYROS Product and shall be responsible for (a) providing oversight over any testing of patient samples from the corresponding Clinical Trial with the Clinical Trial Assay or QIAGEN IVD and (b) any other Activities related to the corresponding Clinical Trial with the Clinical Trial Assay or QIAGEN IVD, in each case, as described in the applicable Schedule.

Related to QIAGEN IVD

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

  • 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 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.

  • 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.

  • 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.

  • 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.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such 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.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed System means, collectively:

  • Manufacturing Process means any process for—

  • 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”).

  • GSK has the meaning set forth in the preamble.

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

  • 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;

  • 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.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Compound means [***].

  • Novartis shall have the meaning set forth in the Preamble.

  • 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 III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

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

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Commercialization Plan has the meaning set forth in Section 6.2.