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.
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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.
Sample 1Sample 2
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. *****
Sample 1

Examples of Critical Reagents in a sentence

  • 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.

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

  • With respect to international shipments of any goods purchased, sold, distributed, or otherwise transferred hereunder, including the Critical Reagents, the purchasing party shall be responsible for clearing all such goods through customs and shall pay any and all taxes and/or duties imposed by any governmental authority in connection therewith.

  • At all times during the distribution term of this Agreement, Ostex shall supply and Hologic or its designated manufacturer(s) shall keep sufficient inventory of Critical Reagents to carry out reasonable demand or orders for NTx Meter Strip(s) without undue delay.

  • 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").

  • 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.

  • Shipping Validation Reports 1 electronic copy to COR For shipment of cGMP, Clinical materials and Critical Reagents.

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

  • 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.


More Definitions of Critical Reagents

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.
Sample 1
Critical Reagents has the meaning set forth in Exhibit A.
Sample 1

Related to Critical Reagents

  • 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

  • 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.

  • 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 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.

  • 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.

  • 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.

  • 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.

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