Validation and Testing. Vertical and Mikart acknowledge that Mikart must validate three (3) Batches of each strength of the Product prior to selling any of the Product to Vertical (the “Validation”). After Mikart successfully completes the Validation, Vertical shall be obligated to purchase the Batches so validated in accordance with the terms of this Agreement. Such Batches shall be part of, and shall be applied to, Vertical’s minimum purchase requirements within the first Contract Year. Mikart shall conduct stability testing on the Product as required by federal law (the “Stability Testing”). Mikart shall maintain Stability Testing and Validation data at its Atlanta, Georgia facilities or at such other location as agreed to by Vertical and Mikart in accordance with FDA regulations. All of Mikart’s costs incurred in connection with the Validation, the Stability Testing and the storage of data related thereto shall be periodically billed to and paid by Vertical. Mikart shall maintain the ANDA in full force and effect at all times during the Term of this Agreement.
Validation and Testing. All new equipment must be validated and tested. The result of this validation and testing will form the basis for the Customer’s approval of the delivery (accepted costumer acceptance test), upon which the production may be initiated. An overview of the validation and testing process and responsibilities is provided in table 5.1. Sykehusapotekene HF (SAHF) will, in collaboration with the Contractor, validate and test the solution in accordance with the following standards: o EU Guidelines to good manufacturing practice for medicinal products for human and veterinary use vol 4; annex 1 Manufacture of sterile medicinal products o PIC/s Guide to good practices for the preparation of medicinal products in Healthcare establishments o Good Automated Manufacturing Practice – (GAMP) – GAMP 5 – A risk-based approach to compliant GxP computerised systems o EU Guidelines to good manufacturing practice for medicinal products for human and veterinary use vol 4; chapter 4: Documentation
Validation and Testing. The Contractor shall perform service validation and testing in conjunction with the development and deployment of system changes and in accordance with the GCSS-MC engineering processes. Validation and testing includes test environment and tools, test planning, external partner requirements, test execution, and test reporting. The Contractor shall provide a test schedule within the Detailed Test Plan identifying test events and activities as required by the Government. When required by the Government, the Contractor shall participate in test meetings hosted by the Government, such as test planning, test team, CCB, and deficiency review board meetings. The Government retains the right to participate in or witness all contractor testing activities. The Contractor shall ensure Government access to all development, test, and PSS environments.
Validation and Testing. Vertical and Mikart acknowledge that Mikart must validate three (3) Batches of each strength of the Product prior to selling any of the Product to Vertical (the “Validation”). After Mikart successfully completes the Validation, Vertical shall be obligated to purchase the Batches so validated in accordance with the terms of this Agreement. Such Batches shall be part of, and shall be applied to, Vertical’s minimum purchase requirements within the first Contract Year. Mikart shall conduct stability testing on the Product as required by THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. federal law (the “Stability Testing”). Mikart shall maintain Stability Testing and Validation data at its Atlanta, Georgia facilities or at such other location as agreed to by Vertical and Mikart in accordance with FDA regulations. All of Mikart’s costs incurred in connection with the Validation, the Stability Testing and the storage of data related thereto shall be periodically billed to and paid by Vertical. Mikart shall maintain the ANDA in full force and effect at all times during the Term of this Agreement.
Validation and Testing. Prior to the Manufacturing Transfer Date, at Otsuka’s reasonable request and, if applicable, as required by any Regulatory Authority in the Otsuka Territory, Perception shall conduct validation, analytical, stability and any other specific testing of API and Clinical Samples Manufactured and supplied by or on behalf of Perception for the Otsuka Territory, and [***]. In addition, at Otsuka’s reasonable request prior to the Manufacturing Transfer Date, Perception will provide assistance and one or more technology transfer(s) to Otsuka or its designee of information (including test methods for Clinical Sample QA/QC) necessary or reasonably useful to support Otsuka’s acceptance activities and, if applicable, secondary packaging of Clinical Samples, and for Otsuka to fulfill quality management responsibilities relating to Clinical Samples and [***].
Validation and Testing. Telcordia shall design, develop and run an end-to-end validation and test of the overall NAP of the Americas solution, to include the full business process flow, from order receipt and entry through service provision and billing. This will cover the major business functions and flows developed for the project. If the end-to-end validation and testing requirements are not met, Telcordia shall work with the respective principals toward the corrective action of such validation and testing.
Validation and Testing o Provide a business processes validation and test plan o Provide business processes validation and test report
Validation and Testing. (a) Medicis shall review and approve in writing all validation protocols, results and reports of the validation activities relating to the Product.
(b) Supplier shall test the integrity of the packaging for the Product in accordance with protocols approved by Medicis. Such test will be at Medicis’s cost and expense for validation batches, and at Supplier’s cost and expense for batches for commercial production. In the event a failure in the packaging is identified, Supplier and Medicis shall jointly investigate the causes of such failure, including which Party shall bear the cost of such investigation. Upon request, Supplier shall provide to Medicis any and all data and results in its possession relating to such testing.
(c) In accordance with the applicable Product Exhibit or protocols as designated by Medicis, Supplier, Medicis or a designated Third Party shall conduct stability tests on the Product. In the event that any lot of Product fails stability testing, Supplier and Medicis shall jointly investigate the causes of such failure, including which Party shall bear the cost of such investigation. Upon request, Supplier shall provide to Medicis any and all data and results in its possession relating to the stability testing.
Validation and Testing. 3.1 Validation and Quota. Manufacturer shall use its commercially reasonable efforts to become authorized as of the Product Approval Date to Manufacture the Product under the Drug Application as contemplated herein. To accomplish the same, Manufacturer shall conduct validation on Batches of Product until it has manufactured three (3) sequential Batches of the Product that conform to the specifications and are otherwise in compliance with the terms of this Agreement (such three (3) Batches being referred to as "Commercial Validation Batches"). AAI shall be obligated to purchase the Commercial Validation Batches in accordance with the terms of this Supply Agreement. Such Commercial Validation Batches shall be part of, and shall be applied to, AAI's minimum purchase requirements as set forth in Section 7.3 hereof. Manufacturer will utilize its commercially reasonable efforts to become qualified to Manufacture the Product as soon as reasonably practicable after the Effective Date and AAI shall provide reasonable technical assistance to Manufacturer to enable Manufacturer to become so qualified.
Validation and Testing