Common use of Batch Failures Clause in Contracts

Batch Failures. Bulk and Finished Product shall be produced by PATHEON in compliance with cGMP and shall conform to the Specifications as defined in the Quality Agreement and the warranties in Section 6.1. Internal process specifications will be defined and agreed upon in the Quality Agreement. If a Batch of Bulk or Finished Product is Non-Conforming and is not Released by PATHEON or is Released by PATHEON and rejected by RELYPSA in accordance with Section 8.1, and the joint investigation demonstrates or determines that PATHEON manufactured Bulk or Finished Product in compliance with cGMP, the Quality Agreement, this Agreement and PATHEON’s standard operating procedures for manufacturing and that, [***], the Non-Conformance in the Batch of Bulk or Finished Product, as applicable, is caused by defects in the API not discoverable through examination and testing required by the Quality Agreement and cGMP (a “Nonconformance Exception”), RELYPSA will pay PATHEON the applicable fee for the Batch of Non-Conforming Bulk or Finished Product, as applicable. If any Batch of Bulk or Finished Product is Non-Conforming and is not Released by PATHEON or is rejected by RELYPSA, and such Non-Conforming Batch is not a Nonconformance Exception, PATHEON shall, utilizing RELYPSA’s existing procurement and logistics process, replace the API [***], including [***], used in such Batch and either (i) promptly (subject to receipt of API) replace such Non-Conforming Bulk or Finished Product, as applicable, at PATHEON’s sole expense, including the cost of Components, or (ii), upon mutual agreement of the Parties, refund to RELYPSA or issue a credit note to RELYPSA for the Price. API in a Non-Conforming Batch shall be [***].