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

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.

  • 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.

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

  • Upon termination of this Agreement, Hologic shall have the right to sell NTx Meter Strips then remaining in its possession or to be manufactured using Critical Reagents then held in inventory, and Ostex may sell NTx Meter Strips then remaining in its possession, within a reasonable time after termination hereof; provided, however, that all such Sales shall be subject to the royalty provisions of this Agreement, notwithstanding termination.

  • Ostex shall assist Hologic and Serex, at either's reasonable request, in the technical training of a mutually determined number of Hologic and/or Serex's employees, such training to include provision of information as to the nature, use and proper care of Critical Reagents.

  • In the event that Ostex licenses a third party to manufacture Critical Reagents to be supplied under this Agreement, Ostex shall ensure and provide evidence to Hologic demonstrating that such third-party manufacturer complies with good manufacturing practices (GMP) and all applicable governmental regulations relating thereto and is either in compliance with or working toward compliance with the quality standards established by the International Standards Organization, Rules 9000 et seq.

  • 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 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.

  • 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.

  • This indemnification provision shall be null and void and Ostex shall have no liability to the extent that NTx Assay Technology, Critical Reagents or Ostex Intellectual Property have been modified or tampered with in any way without the express written consent of Ostex, or if Hologic or Serex have any interest in the claim, suit or other legal proceeding, or any license to any right so asserted.


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 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

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

  • 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 the following river reaches and their 100 year floodplains: the Gunnison River downstream of the Uncompahgre River confluence, the Colorado River downstream of the exit 90 north bridge from I-70, the White River downstream of Rio Blanco Dam, the Green River downstream of the Yampa River confluence, and the Yampa River downstream of the Colo 394 bridge.

  • 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 or “CI” means Diagnosis of any of the following Covered Conditions which occur directly as a result of illness, and first occur after the Effective Date of Insurance:

  • 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.

  • Critical Component means, in respect of a weapons system referred to in the definition of Prohibited Defense Contract, a component used specifically in the production of the weapon system or plays a direct role in the lethality of the weapon system.

  • 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. 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.

  • 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.

  • critical functions means activities, services or operations the discontinuance of which is likely in one or more Member States, to lead to the disruption of services that are essential to the real economy or to disrupt financial stability due to the size, market share, external and internal interconnectedness, complexity or cross-border activities of an institution or group, with particular regard to the substitutability of those activities, services or operations;