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 [***] [***] 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. Purchased Component Specification, OCSTM Lung Solution, REF 2300 • Approved Manufacturers The manufacture and testing of the OCS Lung Solution includes participation of (4) vendors. Their contact information and participation are as follows: Vendor Vendor Participation 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 Tes...
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”).
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.
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.
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.
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.
Supplier Records. 1. Review the following documents/records as applicable;
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.
