Analytically Validated Product definition

Analytically Validated Product means an analytically validated version of the Product developed by LBS under this Agreement in accordance with the applicable Project Agreement that (a) contains all reagents, including positive and negative control materials (if required), needed to perform the Assay(s), (b) is manufactured under GMP/GCP/GLP or in compliance with QSR, (c) is labeled “Investigational Use Only, the performance characteristics of this product have not been established” or “For Performance Evaluation” and (d) for which all validation testing required under the Project Agreement has been completed, with the exception of clinical validation studies.
Sample 1

Examples of Analytically Validated Product in a sentence

  • To the extent required under the applicable Project Agreement, LBS will train the Designated Laboratory(s)in the use of the Prototype Product or Analytically Validated Product, including but not limited to the scoring methodology.

  • In particular, during the Project, the Prototype Product, and Analytically Validated Product, as applicable, will be supplied to one or more Third Party contract laboratory(ies) (the “Designated Laboratory(s)”) selected by ARNO, and which pass any applicable proficiency testing, for the purpose of the Designated Laboratory(s)testing clinical patient samples using the Prototype Product or Analytically Validated Product, as applicable.

Related to Analytically Validated Product

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

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

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

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

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Licensed Compound means [***].

  • API means the American Petroleum Institute.

  • 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.

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

  • Designated Products means products provided by Motorola to Licensee with which or for which the Software and Documentation is licensed for use.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • 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;

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.