Validation and Testing Sample Clauses

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.
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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
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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.
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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.
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Validation and Testing o Provide a business processes validation and test plan o Provide business processes validation and test report
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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.
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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.
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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 [***].
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Validation and Testing 
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Related to Validation and Testing

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.

  • Testing Landlord shall have the right to conduct annual tests of the Premises to determine whether any contamination of the Premises or the Project has occurred as a result of Tenant’s use. Tenant shall be required to pay the cost of such annual test of the Premises; provided, however, that if Tenant conducts its own tests of the Premises using third party contractors and test procedures acceptable to Landlord which tests are certified to Landlord, Landlord shall accept such tests in lieu of the annual tests to be paid for by Tenant. In addition, at any time, and from time to time, prior to the expiration or earlier termination of the Term, Landlord shall have the right to conduct appropriate tests of the Premises and the Project to determine if contamination has occurred as a result of Tenant’s use of the Premises. In connection with such testing, upon the request of Landlord, Tenant shall deliver to Landlord or its consultant such non-proprietary information concerning the use of Hazardous Materials in or about the Premises by Tenant or any Tenant Party. If contamination has occurred for which Tenant is liable under this Section 30, Tenant shall pay all costs to conduct such tests. If no such contamination is found, Landlord shall pay the costs of such tests (which shall not constitute an Operating Expense). Landlord shall provide Tenant with a copy of all third party, non-confidential reports and tests of the Premises made by or on behalf of Landlord during the Term without representation or warranty and subject to a confidentiality agreement. Tenant shall, at its sole cost and expense, promptly and satisfactorily remediate any environmental conditions identified by such testing in accordance with all Environmental Requirements. Landlord’s receipt of or satisfaction with any environmental assessment in no way waives any rights which Landlord may have against Tenant.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • Inspection and Verification The Secured Parties and such persons as the Secured Parties may reasonably designate shall have the right to inspect the Collateral, all records related thereto (and to make extracts and copies from such records) and the premises upon which any of the Collateral is located, to discuss the Grantor’s affairs with the officers of the Grantor and its independent accountants and to verify under reasonable procedures the validity, amount, quality, quantity, value, condition and status of, or any other matter relating to, the Collateral, including, in the case of collateral in the possession of any third Person, by contacting any account debtor or third Person possessing such Collateral for the purpose of making such a verification. Out-of-pocket expenses in connection with any inspections by representatives of the Secured Parties shall be (a) the obligations of the Grantor with respect to any inspection after the Secured Parties’ demand payment of the Notes or (b) the obligation of the Secured Parties in any other case.

  • Investigation and Prevention Transfer Agent shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to:

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput across the Berths, nor will Operator be obligated to accept Product that fails to meet the quality specifications set forth in the arrival notice.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • EFFECT OF COMPLETION This agreement shall, as to any of its provisions remaining to be performed or capable of having or taking effect following Completion, remain in full force and effect notwithstanding Completion.

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