Validation Work definition

Validation Work the development, process and analytical validation, and qualification work contemplated hereunder as set out in Clause 2 and Schedule 2 in order to produce Batches of Drug Substance Manufactured by Aesica for Myriad which satisfy Drug Substance and Drug Product Validation Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. requirements in connection with Product Licence applications; “Year” the period from the Commencement Date to 31 December 2005 and each consecutive period of 12 months thereafter commencing on 1 January and ending on 31 December during the period of this Agreement, or any shorter period commencing on 1 January and ending on the termination of this Agreement
Validation Work means such commercially reasonable and necessary primary testing associated with the validation of a Product, including without limitation, gene expression test training and test set(s) and additional technical and clinical support for final CLIA (Clinical Laboratory Improvement Amendments) validation, but expressly excluding any filing or approval process with the U.S. Food & Drug Administration.

Examples of Validation Work in a sentence

  • In addition, GE PSLF modeling information and various modeling guidelines documents have been prepared by the WECC Modeling and Validation Work Group.

  • WSCC Performance Validation Task Force (PVTF) of the Modeling and Validation Work Group, October 26, 2000.

  • Offutt, “Static analysis of mutant subsumption,” in Software Testing, Verification and Validation Work- shops (ICSTW), 2015 IEEE Eighth International Conference on, pp.

  • The Commission has also issued individual notices to the objectors and the Department of Energy, Government of Odisha, informing them about the date and time of hearing through hybrid mode (physical & virtual).

  • The JSC may, from time to time, update the Target Validation Work Plan to include additional activities with respect to one or more Additional Complement Pathway Target(s), provided that any such additional Target Validation Activities beyond those set forth in the Target Validation Work Plan shall require DICERNA’s prior written approval.

  • For analytical chemistry, the item being measured is usually the concentration, with a statement of its uncertainty, and sometimes the identity of an analyte.2.0 Single-Laboratory Validation Work 2.1 Preparation of the Laboratory Sample Product and laboratory sampling are frequently overlooked aspects of analytical work because very often product sampling is not under the control of the laboratory but the sample is supplied by the customer.

  • All transmission-connected generators must perform testing on initial startup consistent with the requirements of the WECC Synchronous Unit Dynamic Testing and Model Validation prepared by the WECC Control Work Group and Modeling and Validation Work Group in February 1997.

  • In Software Testing, Verification and Validation Work- shops (ICSTW), 2013 IEEE Sixth International Conference on, pages 461–468.

  • For these situations, Data Submitters are requested to provide the SDWG and Modeling and Validation Work Group (MVWG) with the rationale for exceptions.

  • Examples include digital asset exchange, or execution of an automated business process.• Validation: Work performed by all nodes in parallel, that verifies transactions using a consensus algorithm.

Related to Validation Work

  • demolition work means a method to dismantle, wreck, break, pull down or knock down of a structure or part thereof by way of manual labour, machinery, or the use of explosives;

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Installation Work means the construction and installation of the System and the Start-up, testing and acceptance (but not the operation and maintenance) thereof; all performed by or for the Power Producer at the Premises.

  • Construction Work means any work in connection with

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • Excavation work means the making of any man-made cavity, trench, pit or depression formed by cutting, digging or scooping;

  • Demolition works means any physical activity to tear down or break up a structure (or part thereof) or surface, or the like, and includes the loading of demolition waste and the unloading of plant or machinery.

  • construction work permit means a document issued in terms of regulation 3; "contractor" means an employer who performs construction work;

  • Contract Work means everything required to be furnished and done by the Contractor by any one or more of the parts of the Contract referred to in Article 1, except Extra Work as hereinafter defined.

  • Construction Works means all works and things necessary to complete the Project Facilities in accordance with this Agreement;

  • Tenant Improvement Work means the construction of the Tenant Improvements, together with any related work (including demolition) that is necessary to construct the Tenant Improvements.

  • Acceptance Tests means those tests performed during the Performance Period which are intended to determine compliance of Equipment and Software with the specifications and all other Attachments incorporated herein by reference and to determine the reliability of the Equipment.

  • Project Work means the work required to complete the Project.

  • Project Improvements means site improvements and facilities that are:

  • Installation Works means, as the context so requires,

  • Project Completion means completion of the Redevelopment in accordance with this Agreement to the state where the whole of the Morley Shopping Centre, as so redeveloped, is capable of occupation for its intended purpose;

  • The Work means each and every activity required for the successful performance of the services described in Section II, the Terms of Reference.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Tenant Improvements Defined in Exhibit B, if any.

  • Commissioning means the process for determining the need for and for obtaining the supply of healthcare and related services by the Trust within available resources.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Completion of work means completion of the entire contracted work. Exhaustion of quantity of any particular item mentioned in the bid document shall not imply completion of work or any component thereof.

  • New Work means any Services/Deliverables outside the scope of the Contract and not specifically provided under any Statement of Work, that once added will result in the need to provide the Contractor with additional consideration.

  • Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:

  • Acceptance Test is a test of the Features executed by the Customer to prepare the acceptance.

  • Hot Work means work involving electric or gas welding, cutting, brazing, or similar flame or spark-producing operations.