Common use of Reserve Samples Clause in Contracts

Reserve Samples. 11.1 BIO HOSPITAL shall sample, store and maintain appropriate reserve samples (identified by Batch number) (the “Reserve Samples”) of (i) Product and (ii) all Raw Materials used to Process or package Product, in accordance with cGMP and other US federal requirements including 21 CFR 211.170 (b), and in each case with respect to quantities as set forth in the Specifications attached hereto and stored under conditions and in the same immediate container-closure system as defined in the Specifications. If additional reserve samples are required the parties will jointly determine and agree upon what additional cost is appropriate to store such samples in excess of the current Specifications. Reserve Samples of Product from each batch of Product to permit at least two (2) full re-examinations. Reserve Samples of each batch of Product shall be retained for at least two (2) years after the expiration date of the respective batch. BIO HOSPITAL shall notify OCEANA that Product is approaching expiration and if OCEANA requests the Reserve Samples, OCEANA shall inform BIO HOSPITAL where the Reserve Samples shall be sent. The Reserve Samples shall be visually inspected by BIO HOSPITAL at least once a year for evidence of deterioration. BIO HOSPITAL shall record the results of such inspection, as required by cGMP regulations, especially US federal regulation 21 CFR 211.170 (b). BIO HOSPITAL shall provide OCEANA and any Regulatory Authority with reasonable access to any portions of the Reserve Samples for testing and other purposes upon OCEANA’ request.