Retained Samples. GSK shall retain samples from each batch of Products for a period of one (1) year after the shipment of such batch to Prometheus or such longer period required by Applicable Laws for record keeping, testing and regulatory purposes. In the event that Prometheus want samples from any batch of Products retained longer than one (1) year, Prometheus shall provide a written request to GSK not less than thirty days prior to the first anniversary of the shipment of such batch requesting that such Product be shipped to Prometheus or a specified designee. Promptly after receiving such request, GSK shall ship such Product to Prometheus at Prometheus' sole cost and expense. In the absence of any such request, GSK shall have the right to dispose of Product samples in accordance with Applicable Law at GSK's sole cost and expense.
Retained Samples. Bachem Shall retain sufficient samples of Product for [***] years after batch release A quantity sufficient to perform at least [***] shall be retained. Xeris Shall retain Product samples as described in Section 6.1 above.
Retained Samples. Cempra shall retain samples, as required to comply with cGMP or Applicable Law in the Territory, from each batch of Supplied Compound or Clinical Supply to the extent prescribed in the Quality Agreement.
Retained Samples. Helsinn will maintain a sample of API from each lot as required by applicable regulatory standards or as otherwise mutually agreed by Indevus and Helsinn. Helsinn will be responsible for maintaining and storing retention samples of the API as may be required by applicable regulatory standards and the Quality Technical Agreement. Helsinn shall provide Indevus with reasonable access to and portions of the retained samples upon Indevus’ request. Preservation samples/retained samples, as referred to herein, do not include samples retained for purposes of stability testing.
Retained Samples. FRESENIUS will take and retain, for such period and in such quantities as required by GMP and the applicable Quality Agreement, samples of Product Manufactured under this Agreement (“Retained Samples”).
Retained Samples. Matricel will retain sufficient samples of the product to carry out [***] full specification test of the ACI-Maix-Membrane Product.
Retained Samples. Supplier shall retain and store in accordance with cGMP Requirements and Supplier’s internal quality standard operating procedures, retained samples of each batch of Product manufactured under this Agreement.
Retained Samples. 6.4.1 Active Ingredients - C*P will retain samples of the active ingredients as agreed between C*P and ORPHAN. 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.
Retained Samples. 5.4.1 Sample Types ELITE shall retain adequate representative samples of each batch or lot of the Product(s), of raw material, and of components used in the Manufacture of the Product(s). (21 CFR Part 211.170a)
Retained Samples. 11.1 For the purpose of verification of product quality, the Seller will retain lot samples of Products sold for the period of the shelf life of the product. Should a dispute concerning quality arise, further sample testing will be undertaken by the Seller and it reserves the right to instruct a laboratory of its choosing. The Buyer will be bound by results of the sample testing.
