Supplier Records Sample Clauses

Supplier Records. Fresenius Kabi Austria-GmbH will provide a Certificate of Analysis and a Certificate of Conformity with statement of conformance with each batch. The current version of the Purchased Component Specification to which the product was manufactured will be documented in the Quality Agreement. The Certificate of Conformity will note conformance to the Quality Agreement. • Labeling Requirements The following labels will appear on the product and product packaging: • The primary container will be labeled per Label, Product, Lung Solution, REF [***] ([***]). • The shipping package will be labeled per Label, Packaging, Lung Solution, REF [***] ([***]). Upon receipt at TransMedics each lot of Solution will be inspected according to Quality Procedure, OCS Lung Solution ([***]). The inspection will include verification of the expiration date based on the procedure found below in “Product Expiration Date.” • Packaging Requirements • Bags shall be shipped in a cardboard box containing [***] units per box. • Bags shall be oriented in the box perpendicular to the long edge • Note that the unit of measure for [***] is [***]. • Storage Requirements • Storage of the OCS Lung Solution is recommended as follows. ◾ Do not store above [***]. ◾ Do not [***]. ◾ Upon receipt, the bags will be inspected according to Quality Procedure, OCS Lung Solution ([***]). ◾ Inspect carefully for indication of damage prior to distribution to end-users. • Safety and Handling Requirements Not applicable • Handling Requirements Not applicable Document: [***] Purchased Component Specification, OCS Lung Solution, REF [***] [***] Purchased Component Specification, OCSTM Lung Solution, REF 2300 The manufacture and testing of the OCS Lung Solution includes participation of (4) vendors. Their contact information and participation are as follows: Fresenius Kabi Austria-GmbH Xxxxxxxxxxxxx 00 0000 Xxxx-Xxxxxxx (X) +00 (0) 000 000 0 (F) +00 (0) 000 000 0000 ◾ Project Management ◾ Raw Material Testing ◾ Formulation/Fill ◾ Sterilization ◾ Labeling ◾ Lot Release including Testing Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES) Institut für medizinische Mikrobiologie und Hygiene Xxxxxxxxxxxxxxxx 0, X-0000 Xxxx, Xxxxxxx ◾ Sterility Testing SGS Life Science Services SGS INSTITUT FRESENIUS Berlin GmbH & Co. XX Xxxxxxx Xxx 33 D-10589 Berlin Germany ◾ Raw Material Testing-[***] 40 Pharmacosmos A/S Roervangsvej 30 DK—0000 Xxxxxxx Xxxxxxx ◾ Raw Material Provider -[***] Each batch will be in...
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Supplier Records. Supplier shall maintain books, records, documents, and other information sufficient to determine the status of Supplier’s performance, testing, and compliance with the requirements of the Agreement.
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Supplier Records. Supplier shall maintain records, documents and other information reasonably required to meet Client’s audit rights under this Agreement, including, without limitation, all information reasonably necessary to verify the accuracy of Charges to Client included on any invoice provided to Client (“Supplier Records”). Supplier shall retain Supplier Records in accordance with Supplier’s records retention policy as it may be reasonably adjusted from time to time and provided to Client in writing upon request; provided, however, that Supplier shall at all times comply fully with the Policy and Procedures Manuals regarding records retention.
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Supplier Records. The Seller will ensure that there are adequate records of their supplier management program. These records will be made available to the Buyer in English when requested. The records will be retained for a period of 12 months past the end of life of the product being produced by the supplier. If the Seller discontinues business with the sub-supplier, the Seller is responsible to obtain all the records and production tools from the supplier prior to discontinuing the business and retaining those records for 12 months from the date of discontinuance of business.
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Supplier Records. Supplier shall maintain true and accurate books and records of account concerning the manufacture, delivery and sale of Enzyme/Protein pursuant to this Agreement.
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Supplier Records. Supplier shall maintain, at all times during the Term and at no additional charge to Customer, complete and accurate records and supporting documentation pertaining to: (i) all Charges and financial matters under this Agreement; (ii) all other transactions, reports, filings, returns, analyses, Work Product, data and/or information created, generated, collected, processed or stored by Supplier and/or Supplier’s subcontractors in the performance of the Services; and (iii) Supplier’s internal controls and Customer’s control over the activities of Supplier (collectively, “Supplier Records”), all in a manner sufficient and to the extent necessary to permit the audits in accordance with this Section 9.9. Supplier records do not include information, records and documentation of Supplier, its Affiliates or subcontractors relating solely to (A) their internal processes and operations that Supplier is not otherwise required to provide to Customer or otherwise maintain or operate under this Agreement, (B) other customers, (C) internal or Third Party costs or cost structure, (D) employee personal data, including salary, performance or other private data, and (E) internal audit reports prepared by their corporate internal audit groups (collectively, “Supplier Internal Records”).
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Supplier Records. 1. Review the following documents/records as applicable; a. FAI approval by customer, if applicable (AS9102 Forms) b. Material Certificates c. Special Process Certificates d. Manufacturing records (Routers, Inspection reports, Test reports, etc.) e. Nonconformance Records/Documents
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Supplier Records. Where contractual agreements have been for a supplier to maintain records, details are indicated in the Purchase Order or contract. Access by Nordion to these records is part of the terms and conditions.
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Related to Supplier Records

  • Computer Records World Omni and the Depositor will cause their accounting and computer records to be marked to indicate the sale and assignment of the Receivables from World Omni to the Depositor and from the Depositor to the Trust.

  • Contractor Records The Contractor shall make, keep, maintain, and, upon request, provide to the UCRC or its agents or designees a complete file of all materials or records required in Exhibit A, Verification Plan. This provision survives termination of this SCIA until completion of the Pilot Program.

  • Your records You agree to keep adequate records in accordance with Applicable Regulations to demonstrate the nature of orders submitted and the time at which such orders are submitted.

  • Personnel Records Section 1. Each Agency shall maintain one (1) official personnel file for each employee, located at the primary Human Resources office for the Agency. For purposes of this Article, “Agency” shall include health-related licensing boards and institutions that maintain the official personnel files for their employees. Where the personnel records are maintained on microfiche/microfilm, the personnel file will include both microfiche/microfilm and any material not yet copied. Upon reasonable notice, an employee may inspect the records, excluding any confidential reports from previous employers, in his/her official Agency personnel file or supervisory working file; provided that, if the official personnel file or supervisory working file is kept at a separate facility, the employee shall, at the Agency’s discretion, either be allowed to go where the file is kept or the file will be brought to the employee for review within five (5) days of his/her request. With the employee’s written authorization, his/her Union Xxxxxxx may inspect the employee’s official personnel file, and supervisory working file, consistent with the time requirements provided herein. If the supervisory working file cannot be made available due to the absence of a supervisor, extensions of up to ten (10) days will be granted. No grievance material shall be kept in an employee’s official personnel file. Section 2. No information reflecting critically upon an employee except notices of discharge shall be placed in the employee’s official personnel file that does not bear the signature of the employee. The employee shall be required to sign material to be placed in his/her official personnel file provided the following disclaimer is attached: “Employee’s signature confirms only that the supervisor has discussed and given a copy of the material to the employee. The employee’s signature does not indicate agreement or disagreement with the contents of this material.” If an employee is not available within five (5) working days or refuses to sign the material, the Agency may place the material in the file, provided a statement has been signed by two (2) management representatives and a copy of the document was mailed certified to the employee at his/her address of record or hand delivered to the employee. Section 3. Employees shall be entitled to prepare and provide copies of any written explanation(s) or opinion(s) regarding any critical material placed in his/her official personnel file or supervisory working file. The employee’s explanation or opinion shall be attached to the critical material and shall be included as part of the employee’s official personnel record or supervisory working file so long as the critical materials remain in the file. Where the personnel records are maintained on microfiche/microfilm, the explanation or opinion will be placed next to or in closest possible proximity to the critical material. Section 4. An employee may include in his/her official personnel file a reasonable amount of relevant material such as letters of commendation, licenses, certificates, college course credits, and other material which relates creditably on the employee. This material shall be retained for a minimum of three (3) years except that licenses, certificates, or college credit information may be retained so long as they remain valid and relevant to the employee’s work. Section 5. Material reflecting caution, consultation, warning, admonishment, and reprimand shall be retained for a maximum of three (3) years. Such material will, at the employee’s request, be removed after twenty-four (24) months, provided there has been no recurrence of the problem or a related problem in that time. Earlier removal will be permitted when requested by an employee and if approved by the Appointing Authority. Material relating to disciplinary action recommended, but not taken, or disciplinary action which has been overturned and ordered removed from the official personnel file(s) on final appeal, shall be removed. Incorrect material will be removed, upon request, from an employee’s personnel file. (See Article 85--Position Descriptions and Performance Evaluation.) Section 6. Upon written request by the employee, the Agency will make a good faith effort to return material removed from the official personnel file to the employee. A copy of the request will be maintained in the official personnel file.

  • Training Records A. Employees may request a copy of their training record. The Employer will provide either a hard copy or electronic access to their training record. If an employee provides documentation to the Employer of work-related training it will be recorded in the training record or the employee personnel file. B. At the time of permanent layoff employees will be provided an opportunity to submit documentation of successfully completed training to be considered.

  • How to Update Your Records You agree to promptly update your registration records if your e-mail address or other information changes. You may update your records, such as your e-mail address, by using the Profile page.

  • Contractor’s Records The Contractor shall keep true and accurate accounts, records, books and data which shall correctly reflect the business transacted by the Contractor in accordance with generally accepted accounting principles. These records shall be stored in Orange County for a period of three (3) years after final payment is received from the County. Storage of records in another county will require written approval from the County of Orange assigned Deputy Purchasing Agent.

  • Client Records 25.2.1 CONTRACTOR shall prepare and maintain accurate and 26 complete records of clients served and dates and type of services provided 27 under the terms of this Agreement in a form acceptable to ADMINISTRATOR.

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with Xxxxxxxx’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • Records The Administrator shall maintain appropriate books of account and records relating to services performed hereunder, which books of account and records shall be accessible for inspection upon reasonable written request by the Issuer, the Seller and the Indenture Trustee at any time during normal business hours.

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