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. 2. For the avoidance of doubt, the PDP Assay referred to in the Statement of Work No. 2 is a QIAGEN IVD.
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Examples of QIAGEN IVD in a sentence

  • QIAGEN shall be solely responsible for the manufacture and supply of a Clinical Trial Assay or a QIAGEN IVD, at SYROS’ expense as set forth in the applicable Schedule, to the Contract Laboratories for clinical validity testing and for sufficient educating and training of the Contract Laboratories personnel as necessary for conducting the clinical validity testing.

  • In the event the Parties agree to conduct Activities relating to health insurance reimbursement for the QIAGEN IVD, such Activities shall be outlined in a 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 solely responsible, at its own discretion and expense, for obtaining and maintaining any licenses or other rights to access or use any third party Intellectual Property that is necessary for the development, manufacture, use or Commercialization of the QIAGEN IVD System or the use of the QIAGEN IVD for [**] pursuant to this Agreement.

  • In fact, neither finding is necessary to establish direct adversity, as explained above.The referee’s recommendation that Brown be found not guilty of violating rules 4-1.7(a) and (b), based on his finding that Spillman did not raise the issue of the firearm’s ownership until after Brown’s representation of Parks had ended, was incorrect as a matter of law.

  • During a Project, the Parties will promptly notify each other of any claim by a third party that the Development or Commercialization of the SYROS Product or QIAGEN IVD may or does infringe any Intellectual Property right Controlled by a third party.

  • QIAGEN shall not engage or make use of any subcontractor or consultant (other than (i) individual consultants, (ii) distributors Commercializing the QIAGEN IVD in the Markets, and (iii) Clinical Affairs or Regulatory advisors) for the performance of the Activities (except as expressly set forth in the applicable Schedule) without SYROS’ prior written consent, not to be unreasonably withheld, conditioned, or delayed.

  • QIAGEN shall be responsible for obtaining and maintaining Regulatory Approvals for the QIAGEN IVD in each Market agreed by the Parties in a Schedule.

  • 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.

  • SYROS shall have the right to [**] during the course of any inspections, audits and investigations specifically related to the SYROS Product [**] impact the Regulatory Approval of the SYROS Product and/or the QIAGEN IVD, unless prohibited by Applicable Law or Governmental Authority, provided that [**].

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 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.

  • 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 any EZH2 Compound(s) that is:

  • GSK will have the meaning set forth in the Preamble.

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

  • 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 (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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 large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Development Program means the implementation of the development plan.

  • 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:

  • 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.

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