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Laboratory Data Sample Clauses

Laboratory Data. Tabulate laboratory test results for inclusion in the geotechnical report, the report of tests sheet (Roadway Soil Survey Sheet), and for any necessary calculations and analyses.
Laboratory Data. Laboratory data will be transferred electronically as described in Section 2.9.4. Once received, the data will be uploaded into the Consultant’s database, which uses Microsoft SQL 2000 software or equivalent. The data are tracked in the database using both laboratories identifiers and the sampling point labels.
Laboratory Data. The Laboratory QA Reviewers will be responsible for validation of laboratory project implementation measures of success. The QA Reviewer will be responsible for the submittal of data packages to the Project Manager to support the quality management plans in Appendix B and Appendix C.
Laboratory DataClinical laboratory values will be expressed using SI units. For each arm, the actual value and change from baseline (Day 1, prior to the first administration of study drug) to each on study evaluation will be summarized for each clinical laboratory parameter, including hematology, and clinical chemistry. In the event of repeat values, the last non-missing value per study day/time will be used. In the event that Day 1 data are unavailable for a given patient/parameter, the screening value will substitute as the baseline value. Severity of select clinical lab measures will be determined using CTCAE criteria (e.g., those measures that have a corresponding CTCAE grade classification). Labs with CTCAE Grades ≥3 will be presented in a data listing. Shift tables that present changes from baseline to worst on- study and baseline to last on-study values relative to CTCAE classification ranges will be produced.
Laboratory Data. Blood and urine samples for determination of clinical chemistry, haematology, and urinalysis will be taken at the times indicated in the Study Plan at the time points described in section 6.4.5 of the Clinical Study Protocol. The baseline value of each laboratory variable will be derived, as described in the Clinical Study Protocol, values captured 3 days before baseline visit will be considered as baseline value. If multiple records are present between -3 days and baseline visit then last value obtained prior to the first dose of medication will be considered as baseline. Alternatively, if two visits are equally eligible to assess patient status at baseline (e.g., two assessment at screening or baseline both prior to first dose with no w ashout or other intervention in the screening period), the average can be taken as a baseline value. The other post-baseline assessment non missing value lab parameter closest to the scheduled visit date, will be considered as visit value. The visit will be missing if no assessment was reported within the specified visit window around the scheduled date. If two assessments are equidistant from a scheduled visit, then the earlier of the two will be used. Designation of visits for Lab data assessment are given in table below intermittent dosing schedule (2/5) (Table 3a) Cycle No. Visit day Target day Day Range Screening -1 -28 – -1 1 Day 1 (Baseline) 1 1 1 Day 2 2 2 1 Day 3 3 3 - 6 1 Day 9 9 7 – 12 1 Day 16 16 13 – 19 1 Day 23 23 20 – 26 2 Day 2 30 27 – 33 2 Day 8 36 34 – 39 2 Day 15 43 40 – 46 2 Day 22 50 47 – 54 3 Day 2 58 55 – 72 4 Day 2 86 73 – 100 Y Day 2 X X-13 – X+14 Where Y = 5,6, …. And X=(Y-1)*28+2 Designation of visits for Lab data assessment are given in table below for intermittent dosing schedule (4/3) (Table 3b) Cycle No. Visit day Target day Day Range Screening -1 -28 – -1 1 Day 1 (Baseline) 1 -3 – 1 1 Day 2 2 2 – 3 1 Day 5 5 4 – 7 1 Day 9 9 8 – 12 1 Day 16 16 13 – 19 1 Day 23 23 20 – 26 2 Day 2 30 27 – 33 2 Day 8 36 34 – 39 2 Day 15 43 40 – 46 2 Day 22 50 47 – 54 3 Day 2 58 55 – 72 4 Day 2 86 73 – 100 Y Day 2 X X-13 – X+14 Where y = 5,6, …. And X=(Y-1)*28+2 For Serum/Plasma Glucose, Insulin and Insulin c-peptide measurement a visit window rules are defined in table 3c and 3d for respective dosing cohorts.
Laboratory Data 

Related to Laboratory Data

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  • Licensed Technology (a) LICENSOR is not aware of any interference, infringement, misappropriation, or other conflict with any intellectual property rights of third parties, and LICENSOR has never received any charge, complaint, claim, demand, or notice alleging any such interference, infringement, misappropriation, or violation (including any claim that LICENSOR must license or refrain from using any intellectual property rights of any third party). To the knowledge of LICENSOR, no third party has interfered with, infringed upon, misappropriated, or otherwise come into conflict with any of the LICENSED TECHNOLOGY. (b) Exhibit A identifies each patent or registration which has been issued to LICENSOR with respect to any of the LICENSED TECHNOLOGY and identifies each pending patent application or application for registration which LICENSOR has made with respect to any of the LICENSED TECHNOLOGY. LICENSEE acknowledges that LICENSOR has previously made available to LICENSEE correct and complete copies of all such patents, registrations and applications (as amended to-date) in LICENSOR’s possession and has made available to LICENSEE correct and complete copies of all other written documentation in LICENSOR’s possession evidencing ownership and prosecution (if applicable) of each such item. (c) Exhibit A identifies each item of LICENSED TECHNOLOGY that is assigned to LICENSOR or that LICENSOR uses pursuant to license, sublicense, agreement, or permission. LICENSOR has made available to LICENSEE correct and complete copies of all such licenses, sublicenses, agreements, patent prosecution files and permissions (as amended to-date) in LICENSOR’s possession. With respect to each item of LICENSED TECHNOLOGY required to be identified in Exhibit A and to the knowledge of LICENSOR: (i) the license, sublicense, agreement, or permission covering the item is legal, valid, binding, enforceable, and in full force and effect; (ii) the license, sublicense, agreement, or permission will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms following the consummation of the transactions contemplated hereby; (iii) no Party to the license, sublicense, agreement, or permission is in breach or default, and no event has occurred which with notice or lapse of time would constitute a breach or default or permit termination, modification, or acceleration thereunder; (iv) no party to the license, sublicense, agreement, or permission has repudiated any provision thereof; (v) the underlying item of LICENSED TECHNOLOGY is not subject to any outstanding lien or encumbrance, injunction, judgment, order, decree, ruling, or charge; (vi) no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand is pending or is threatened which challenges the legality, validity, or enforceability of the underlying item of LICENSED TECHNOLOGY; and (vii) except as provided in Exhibit A, LICENSOR has not granted any license or similar right to the LICENSED TECHNOLOGY within the GENERAL FIELD or PARTHENOGENESIS FIELD.

  • Licensee Data Licensee acknowledges and agrees that Licensee will be solely responsible for backing-up, and taking all appropriate measures to protect and secure, Licensee Data. Licensee acknowledges that Nuix may make, store and maintain back up copies of Licensee Data, but is not obliged to do so. Nuix will not be liable for any loss or corruption of Licensee Data.

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  • Laboratory a. Drug tests shall be conducted by laboratories licensed and approved by SAMSHA which comply with the American Occupational Medical Association (AOMA) ethical standards. Upon advance notice, the parties retain the right to inspect the laboratory to determine conformity with the standards described in this policy. The laboratory will only test for drugs identified in this policy. The City shall bear the cost of all required testing unless otherwise specified herein. b. Tests for all controlled substances, except alcohol, shall be by oral fluid testing and shall consist of two procedures, a screen test and, if that is positive, a confirmation test. c. To be considered positive for reporting by the laboratory to the City, both samples must be tested separately in separate batches and must also show positive results on the confirmatory test. d. In the event of a positive test, the testing laboratory will perform an automatic confirmation test on the original specimen at no cost to the Covered Employee. In addition, the testing laboratory shall preserve a sufficient specimen to permit an independent re-testing at the Covered Employee’s request and expense. The same, or any other, approved laboratory may conduct re-tests. The laboratory shall endeavor to notify the designated MRO of positive drug, alcohol, or adulterant tests results within five (5) working days after receipt of the specimen.

  • Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Technical Information The Employer agrees to provide to the Union such information that is available relating to employees in the bargaining unit, as may be required by the Union for collective bargaining purposes.

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

  • Licensed Materials The materials that are the subject of this Agreement are set forth in Appendix A ("Licensed Materials").

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