Validation Services. Xxxx Atlantic will launch queries for the validation of all calling card calls, collect calls, and billed-to-third number calls to a Line Information Data Base (LIDB). The validation costs for queries of LIDB may be separate from the individual call rates. Xxxx Atlantic will also launch queries for validations to another company’s LIDB if that company has a card honoring agreement with Xxxx Atlantic. APPENDIX C
Validation Services. Catalent shall perform the Product qualification, validation and stability services described in Attachment A (the “Validation Services”).
Validation Services. During the Term, Cardinal Health shall perform the qualification and validation services described in Exhibit D of this Agreement for the prices specified therein.
Validation Services. Catalent shall process validation batches and perform validation services at prices to be agreed in writing between the parties.
Validation Services. Xxxx Atlantic will launch a query for the validation of all calling card calls, collect calls, billed-to-third number calls and public telephone checks to a Line Information Data Base (LIDB). The query costs for query of the Xxxx Atlantic LIDB are included in Xxxx Atlantic Carrier Call Representative (CCR) Work Second or Automated call rate specified in Appendix X. Xxxx Atlantic will also launch queries as stated for validations to other companies' LIDBs. This information is Xxxx Atlantic Proprietary and Confidential APPENDIX C EXCHANGE OF INFORMATION ----------------------- Technical information will be furnished via the use of a Technical Questionnaire to be provided by Xxxx Atlantic. Such information will include, but not be limited to, the following:
Validation Services. Prior to the execution of this Agreement by the parties, the parties entered into that certain Quotation entitled “Process Validation of Pirfenidone Manufacture Capsulation ([ * ]) dated July 28, 2009, a copy of which is attached hereto as Attachment A (the “Validation Services Quotation”), whereby Catalent shall perform for Client the qualification and Process validation services set forth therein (the “Validation Services”). The parties acknowledge and agree that pursuant to the terms of the Validation Services Quotation, upon execution of this Agreement, Catalent shall manufacture the fully compounded bulk pharmaceutical product containing API in accordance with the terms and conditions set forth in the Validation Services Quotation. The parties hereby agree that upon completion of the manufacture of the [ * ] batches of such product referred to as “Campaign I” in the Validation Services Quotation by Catalent, release of such batches by Catalent, final release of such batches by Client, and completion of all the other services all as set forth in the Validation Services Quotation, such batches shall be referred to herein as “Commercial Validation Batches” and the products within such batches shall be deemed “Products” for purposes of this Agreement and shall be available for Catalent’s fulfillment of Client’s Purchase Orders under Article 4 of this Agreement. For purposes of clarity, all the activities set forth in the Validation Services [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Quotation shall be governed by the existing terms and conditions thereunder and this Agreement shall have no legal effect thereon; provided, however that when the products within the Commercial Validation Batches become Products for purposes of this Agreement, this Agreement shall then govern.
Validation Services. For clients required to comply with FDA 21CFR Part 11, DocXellent provides services to establish proper requirements, installation and functionality qualification documentation and evidence inclusive of a User Requirements Specification, Traceability Matrix, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as well as Deviation and Validation Summary Reports. For Cloud clients, these services are included in Cloud pricing. For on- premises clients, these are optional services that can be provided if requested. Additional Client initiated validation services that not part of the standard DocXellent provided services can be considered on an as-needed basis and may be subject to further quotation.
Validation Services. Catalent will perform the Product qualification, validation and stability services as described in and in accordance with Process Performance Qualification Protocol No. KP2016-144, as separately agreed by the parties. Such services will be provided for an aggregate of [**] validation batches of Product in accordance with the terms and conditions of that certain Statement of Work No. 38 pursuant to the Master Services Agreement dated as of July 6, 2007, as amended. In consideration for the foregoing services, Client agrees to make the payments to Catalent as described in such Statement of Work. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.
Validation Services. Catalent shall Process validation Batches and perform validation services at prices to be agreed in writing between the parties. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.EXECUTION VERSION
Validation Services. Catalent shall perform Product technology transfer and Process validation (the “Validation Services”), if any, under one or more Quotations or QARs executed by the Parties, which Validation Services (including acceptance and rejection) shall be governed by the Development Agreement. However, any Batches from Validation Services that are (a) accepted by Client under the Development Agreement and (b) released to Client for commercial sale in accordance with the Quality Agreement, shall be governed by this Agreement. Any modified or additional Validation Services will be performed under a Quotation or QAR, as applicable, executed by the Parties and governed by the Development Agreement with any Batches meeting the criteria in the immediately preceding sentence also being governed by this Agreement following release for commercial sale.
