CYTOB's Duties if Manufacturing Clause Samples
CYTOB's Duties if Manufacturing. CYTOB agrees to furnish to AMAR with every Shipment a written certificate of analysis and Certificate of Compliance that confirms conformity of the Product to the Specifications and this Agreement. AMAR shall analyze each Shipment promptly upon receipt in accordance with Section 8.02. In addition, CYTOB shall:
(a) provide AMAR with written sampling and testing procedures used by CYTOB or its manufacturer to assure that the Product conforms to the Specifications;
(b) retain a sample of each batch of Product for a period equal to the greater of (i) one year after the date of Manufacture of such batch of Product or (ii) such period as required by Applicable Laws. Upon the request of AMAR, CYTOB shall make such samples available to AMAR for inspection. The retained sample shall be sufficient in size to allow AMAR to perform tests to determine whether the Product meets the Specifications. CYTOB shall store the retained sample in accordance with the Specifications and Applicable Law,
(c) maintain records to ensure AMAR’s ability to perform a complete lot history via lot tracing of the Product,
(d) keep on file all manufacturing records and analytical results pertaining to the Manufacture of each batch of Product for a period expiring not earlier than one year after the expiration date of the last lot of the last batch of Product Manufactured by CYTOB. CYTOB shall make, and shall cause any Third Party manufacturer to make, such records available to AMAR upon request.
