Common use of Quality Control and Assurance Clause in Contracts

Quality Control and Assurance. The Parties shall enter into an appropriate Quality Agreement contemporaneously with this Agreement and shall comply with their respective obligations therein. PATHEON will perform the quality control and quality assurance testing and other activities specified in the Quality Agreement. Release to RELYPSA will be the responsibility of PATHEON. PATHEON will perform its Release responsibilities in accordance with PATHEON’s standard operating procedures and the Quality Agreement. For each Batch, a certificate of analysis and certificate of compliance will be delivered to RELPSA that includes a statement that the Batch of Bulk or Finished Product, as applicable, has been manufactured and tested in accordance with Specifications, the Master Batch Record, PATHEON’s standard operating procedures and cGMP and meets the applicable Specifications. PATHEON will give RELYPSA copies of the Batch records for [***] Batches and complete Batch records for Batches [***] Batch will be provided to RELYPSA upon request. The form and style of Batch documents, including [***] are the exclusive property of PATHEON. The information about API, Bulk and Finished Product contained in those Batch documents and other records is RELYPSA’s exclusive property and RELYPSA Confidential Information.