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. 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. 8 6.5 Routine Stability Program............................. 9 6.6 Out-of-Specification (OOS) Investigations............. 9
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. 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. 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. Products JB Labs 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 it's Specifications.
Retain Samples. OCTOPLUS is responsible for keeping retain samples of each batch of raw materials purchased by him. These samples shall be kept for at least 2 years after the end of the trail and after this period they will destroyed after written authorization by ESPERION. The size of the samples must be such that it is possible to perform 2 full quality control analyses (without microbiological testing).
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.
Retain Samples. Adequate retain samples from each lot of Material sent to Celldex will be taken and maintained at BIOSYN based on established criteria. REQUESTED INFORMATION BIOSYN will provide to Celldex any information required for regulatory submissions. This may include letters of cross reference to regulatory filings made by BIOSYN, data to support regulatory filings, and changes. PRODUCT COMPLAINTS BIOSYN will provide written investigation reports, regarding complaints of a quality nature for Material provided to Celldex, within [*] weeks of receiving written notification of the complaint. If additional time is required to complete the investigation, an interim report and timeline will be provided.
