Clinical Diagnostic Product definition

Clinical Diagnostic Product means any Product used for the clinical diagnosis, evaluation or monitoring of any disease states and/or morphologies or biological processes in humans.
Sample 1Sample 2
Clinical Diagnostic Product means the Analytically Validated Product and/or Prototype Product, as applicable, ordered by ARNO for use in Clinical Trials.
Sample 1
Clinical Diagnostic Product means any version, successor or application of FRI's Lumipulse system now in existence or hereafter devised, which is sold to medical centers, reference laboratories, cancer centers, clinicians, pathologists, oncologists and others that typically utilize diagnostic kits and automated systems to provide clinical information to assist in the diagnosis, prognosis, monitoring or screening of cancer or potential cancer patients.
Sample 1

Examples of Clinical Diagnostic Product in a sentence

  • If information comes to the attention of Bayer or OSI to the effect that any Patent Rights relating to a Clinical Diagnostic Product, have been or are threatened to be infringed, Bayer shall have the right, at its expense, to take such action as it may deem necessary to prosecute or prevent such infringement, including the right to bring or defend any suit, action or proceeding involving any such infringement.

  • Each Party grants the Target Antigen Provider an option to license exclusively such rights as are set forth in subparagraph (b) of this Section 10.2. Notwithstanding anything herein to the contrary, at any time from the Effective Date to the date [***] following the end of the term of the Product Collaboration, a Target Antigen Provider may exercise such option by (I) written notice to the other Party and (II) acceptance of the obligations set forth under this Agreement with respect to Licensed Product(s).

  • LBS will manufacture and supply to ARNO’s Designated Laboratory(s) the Clinical Diagnostic Product in the quantity specified in the Project Agreement for use in Clinical Trials for the Drug (in accordance with Section 8.2.1 and the clinical product request agreement, attached to this Agreement as and hereinafter referred to as: “Clinical Product Request Agreement”) .

  • FDA has implemented this provision in regulations establishing mandatory reporting requirements for manufacturers, importers, and distributors (21 CFR part 803).

  • During the Term, LBS will supply to ARNO Clinical Diagnostic Product for use in Clinical Trials in accordance with and subject to LBS’s standard supply terms and Clinical Product Request Agreement.

  • Alternatively, upon request by ARNO, LBS will ship such Clinical Diagnostic Product to one or more Designated Laboratory(s) or investigator(s) designated by ARNO.


More Definitions of Clinical Diagnostic Product

Clinical Diagnostic Product means test kits or systems, other than manual or semi-automated microtiter plate-based test kits and systems, which are developed pursuant hereto for use in the Field, it being understood that such product format is typically targeted for the Clinical Diagnostic Market; provided, however, that such products shall exclude any products that are subject to any exclusive rights held by any of the Other Companies pursuant to agreements with OSI in effect prior to the Effective Date. 1.12 "Clinical Research Market" means those medical centers, laboratories, cancer centers, clinical researchers, pathologists, oncologists and others that typically utilize test kits and systems which do not require approval by the United States Food and Drug Administration (the "FDA") to establish clinical utility and correlation and that often publish the results in academic or research journals, but shall specifically exclude any utilization of research products in life science research typically performed with non-human specimens that is the subject of the sublicense granted by OSI to Calbiochem-Novabiochem Corporation under the Sublicense Agreement dated as of August 2, 1995.
Sample 1

Related to Clinical Diagnostic Product

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Licensed Compound means [***].

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

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

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

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

  • 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.

  • 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;

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • 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.

  • Commercialized shall have corresponding meanings.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • 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.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.