Retain Samples. Fresenius will retain samples of the raw materials used in the manufacture of the PRODUCTS for a period of no less than three years following the labeled expiration date of that component. The amount of sample retained will be at least twice the amount necessary to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and endotoxin testing. Fresenius will retain samples of the PRODUCTS for at least one year beyond the expiry period. The amount of sample retained will be twice the quantity required to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and endotoxin testing. Fresenius will notify TransMedics prior to the destruction of any PRODUCT designated as Clinical Trial Material involved in clinical trials in which TransMedics was engaged. 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.
Retain Samples. 5.1 The Contractor shall retain, under proper storage conditions, samples of the Product as required by the regulations for a period of:
Retain Samples. 8 6.5 Routine Stability Program............................. 9 6.6 Out-of-Specification (OOS) Investigations............. 9
Retain Samples. 6.3.1 DSM will retain samples of the active ingredients for one (1) year beyond the expiration date of the last product manufactured with that lot of active ingredient. DSM will retain samples of excipients for a minimum of two (2) years beyond the Date of Manufacture. The amount of sample retained will be at least twice the quantity required to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and pyrogen testing (CFR 211.170a).
Retain Samples. 6.4.1.1 Active Ingredients - C*P will retain samples of the active ingredients for at least one year beyond the expiry period of the PRODUCTS in which used. The amount of sample retained will be twice the quantity required to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and pyrogen testing. (CFR 21 1.1 70a)
Retain Samples. Supplier shall maintain retain samples and manufacturing records related to any Product for at least three (3) years after such Product has been de-listed by Xxxxxxx.
Retain Samples. 9.1. ELAN will hold sufficient retains of the PRODUCT in bulk, to enable complete re-analysis to be performed twice. COMPANY will hold sufficient retains of the packaged PRODUCT to meet their own retest requirements. The results of any such analysis on retains of PRODUCT will be provided to COMPANY.
Retain Samples. The Supplier shall keep retained samples under adequate conditions for six (6) years from the year of manufacture. The retained samples shall be large enough to perform full retest of the lot on two occasions. The retest shall include all tests specified for release. GEHC is entitled to receive a sample of retained material on request.
Retain Samples. In the case of initial samples intended for retention the same periods as that of the Quality records designated under paragraph 1 shall apply. Release samples of the current produc- tion batch have to be stored at least until the release of the next production batch.
Retain Samples. Supplier must, at Supplier’s cost, retain samples of each batch of Products manufactured and packed by it in accordance with the Specifications and such samples must be retained in their original packaging with the appropriate labelling affixed for a period corresponding to the shelf life of the Product plus one month. The samples must be provided to (or made available for inspection by) Distributor on reasonable request.
