Critical Reagents definition

Critical Reagents shall also include any improvement to or successor antibody(ies) with immunoaffinity to the NTx Epitope or similar epitopes resulting from bone resorption which may be developed or marketed by Ostex in any form during the term of this Agreement.
Critical Reagents means the set of reagents supplied by Ostex for use in the development of the NTx Meter Strips, currently consisting of: monoclonal antibodies or fragments thereof, for example the monoclonal antibody produced by hybridoma 1H11, that shows specific immunoaffinity for the NTx Epitope (at concentrations to be agreed on, appropriate for use in the NTx Meter Test) antibody diluent; analyte (NTx Epitope)-containing controls; and other reagents. Reagents will be supplied by Ostex "in bulk," provided that Ostex shall also supply a reasonable number of Osteomark(R) Laboratory Test Kits in a microtiter plate format for Serex use for comparison and control purposes. As of the effective date of this Agreement, Critical Reagents include the 1H11 monoclonal antibody, diluent, calibrators and controls. These reagents may be changed upon mutual agreement of the parties and upon reasonable notice to scale up to commercial quantities. The term "Critical Reagents" shall also include any improvement to or successor antibody(ies) with immunoaffinity to the NTx Epitope or similar epitopes resulting from bone resorption which may be developed or marketed by Ostex in any form during the term of this Agreement.
Critical Reagents means the set of reagents necessary or useful for the measurement of the antibody for the NTx Epitope by the NTx/Digital Response Device, currently consisting of: monoclonal antibodies or fragments thereof, for example the monoclonal antibody produced by hybridoma 1H11, that shows specific immunoaffinity for the NTx Epitope (at concentrations to be agreed on, appropriate for use in the NTx/Digital Response Device); antibody diluent; analyte (NTx Epitope)-containing controls; and other reagents. Reagents will be supplied by Ostex "in bulk," provided that Ostex shall also supply a reasonable number of Osteomark(R) Laboratory Test Kits in a microtiter plate format for Metrika's use for comparison and control purposes. As of the Effective Date of this Agreement, Critical Reagents include the 1H11 and/or alternative antibodies, monoclonal antibody, diluent, calibrators and controls. These reagents may be changed upon mutual agreement of the parties and reasonable notice to scale up to commercial quantities. The term "Critical Reagents" shall also include any improvement to or successor antibody(ies) with immunoaffinity to the NTx Epitope or similar NTx epitopes resulting from bone resorption which may be developed or marketed by Ostex in any form during the term of this Agreement.

Examples of Critical Reagents in a sentence

  • Each Rolling Forecast shall be considered a purchase order with respect to the forecasted demand for Critical Reagents over the first three months thereof.

  • All Critical Reagents purchased under this Agreement shall be shipped F.O.B. Origin.

  • During the term hereof, Ostex shall use its commercially reasonable efforts to respond to technical questions or problems which may arise from time to time in connection with the Critical Reagents, WRF Bone Resorption Technology and Ostex Intellectual Property.

  • It is almost impossible to acquire commercial real estate today without working with a real estate broker.

  • Ostex shall use its best commercial efforts to supply the need of Hologic and its designated manufacturer(s) for Critical Reagents as necessary to meet the demand for NTx Meter Systems, in accordance with purchase orders received by Ostex from Hologic and its designated manufacturer(s), and in SECTIONS 6.3.1 AND 6.3.2 below.

  • Alternatively, Hologic may return Critical Reagents remaining in inventory and in good condition to Ostex for a refund of the original transfer price (or for credit toward any amounts due).

  • All out of pocket costs of a required or agreed recall insofar as such recall relates to Critical Reagents (except printing and mailing costs incurred to notify customers of such recall), shall be borne by Ostex.

  • Each party to this Agreement shall maintain accurate books and records with respect to all Critical Reagents and NTx Meters and NTx Meter Strips.

  • When using an alternative approach, it is necessary to take account of demographic growth and market signals, but this cannot include using more recent versions of published SNHP.

  • Within sixty days of the start of each calendar quarter, Hologic or its designated manufacturer(s) shall deliver to Ostex a "rolling" forecast of quantities of Critical Reagents to be purchased by Hologic and its designated manufacturer(s) and supplied by Ostex during each month of the following quarter, and each of the subsequent three quarters (the "Rolling Forecast").


More Definitions of Critical Reagents

Critical Reagents means the set of reagents required by Metrika to be supplied by Ostex during Phase I, for use in the manufacture, quality control, and/or clinical trials of the NTx/DRx Device. As of the Effective Date of this Agreement, such Critical Reagents are limited to: ***** These Critical Reagents may be changed upon mutual agreement of the parties and reasonable notice to scale up to commercial quantities. *****
Critical Reagents has the meaning set forth in Exhibit A.

Related to Critical Reagents

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Technical Report means a report prepared and filed in accordance with this Instrument and Form 43-101F1 Technical Report that includes, in summary form, all material scientific and technical information in respect of the subject property as of the effective date of the technical report; and

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Critical areas means any of the following areas or ecosystems: wetlands, critical aquifer recharge areas, streams, fish and wildlife habitat conservation areas, frequently flooded areas, and geologically hazardous areas as defined by the Growth Management Act (RCW 36.070A.170).

  • Critical habitat means habitat areas with which endangered, threatened, sensitive or monitored plant, fish, or wildlife species have a primary association (e.g., feeding, breeding, rearing of young, migrating). Such areas are identified herein with reference to lists, categories, and definitions promulgated by the Washington Department of Fish and Wildlife as identified in WAC 232-12-011 or 232-12-014; in the Priority Habitat and Species (PHS) program of the Department of Fish and Wildlife; or by rules and regulations adopted by the U.S. Fish and Wildlife Service, National Marine Fisheries Service, or other agency with jurisdiction for such designations. See also “Habitat of special significance.”

  • Critical area means an ISO Class 5 environment.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Critical Illness means an illness, sickness or disease or corrective measure as specified in Section 6 of this policy document.

  • Critical Path means those Trade Contractor Work activities identified on the Construction Schedule which, if delayed, will cause a corresponding Delay in the Substantial Completion Date.

  • Geotechnical report or "geotechnical analysis" means a scientific study or evaluation conducted by a qualified expert that includes a description of the ground and surface hydrology and geology, the affected land form and its susceptibility to mass wasting, erosion, and other geologic hazards or processes, conclusions and recommendations regarding the effect of the proposed development on geologic conditions, the adequacy of the site to be developed, the impacts of the proposed development, alternative approaches to the proposed development, and measures to mitigate potential site-specific and cumulative geological and hydrological impacts of the proposed development, including the potential adverse impacts to adjacent and down-current properties. Geotechnical reports shall conform to accepted technical standards and must be prepared by qualified professional engineers or geologists who have professional expertise about the regional and local shoreline geology and processes.

  • Critical group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Statistical Release means the statistical release designated “H.15(519)” or any successor publication which is published weekly by the Federal Reserve and which reports yields on actively traded United States government securities adjusted to constant maturities or, if such statistical release is not published at the time of any determination under the Indenture, then such other reasonably comparable index which shall be designated by the Company.

  • Statistical record means a record in a system of records maintained for sta- tistical research or reporting purposes only and not used in whole or in part in making any determination about an identifiable individual, except as pro- vided by 13 U.S.C. 8.

  • Medical record means any document or combination of documents, except births, deaths, and the fact of admission to or discharge from a hospital, that pertains to the medical history, diagnosis, prognosis, or medical condition of a patient and that is generated and maintained in the process of medical treatment.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Environmentally critical area means an area or feature which is of significant environmental value, including but not limited to: stream corridors, natural heritage priority sites, habitats of endangered or threatened species, large areas of contiguous open space or upland forest, steep slopes, and well head protection and groundwater recharge areas. Habitats of endangered or threatened species are identified using the Department’s Landscape Project as approved by the Department’s Endangered and Nongame Species Program.

  • Medical Records the Study Subjects’ primary medical records kept by the Institution on behalf of the Study Subjects, including, without limitation, treatment entries, x-rays, biopsy reports, ultrasound photographs and other diagnostic images. Zdravotní záznamy: primární zdravotní záznamy Subjektů studie vedené Zdravotnickým zařízením ve vztahu k Subjektu studie, zejména záznamy o poskytnuté péči, zázanym o RTG vyšetřeních, protokoly o provedených biopsiích, snímky z ultrazvukových vyšetření a další snímky diagnostické povahy. Study Data: all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product. Studijní data a údaje: veškeré záznamy, zprávy a protokoly, jež jsou odlišné od Zdravotních záznamů, a které jsou získány, shromážděny či vytvořeny v návaznosti na či připraveny v souvislosti se Studií, zejména zprávy, záznamy a protokoly (např., CRFs, datové přehledy, mezitímní zprávy a protokoly, a závěrečná zpráva), které jsou požadovány, aby byly poskytnuty Zadavateli v souladu s Protokolem a veškerými záznamy ohledně inventurní evidence a nakládání s veškerým množstvím Hodnoceného léčiva.

  • Specified anatomical areas means and includes:

  • Critical access hospital or “CAH” means a hospital licensed as a critical access hospital by the department of inspections and appeals pursuant to rule 481—51.52(135B).

  • Critical facility means a facility for which even a slight chance of flooding might be too great. Critical facilities include, but are not limited to, schools, nursing homes, hospitals, police, fire and emergency response installations, and installations which produce, use or store hazardous materials or hazardous waste.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Critical control point means a point, step, or procedure in a food proc- ess at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

  • Critical Test Concentration or "(CTC)" means the specified effluent dilution at which the Permittee is to conduct a single-concentration Aquatic Toxicity Test.

  • Periodically regenerating system means an exhaust emissions control device (e.g. catalytic converter, particulate trap) that requires a periodical regeneration