Common use of Specifications Changes Clause in Contracts

Specifications Changes. In the event that RELYPSA wishes to change the Specifications, or in the event that RELYPSA is required to change the Specification pursuant to Laws or in response to the order or request of an Authority: (i) RELYPSA shall promptly advise PATHEON in writing of any such change(s) to such Specifications, and PATHEON shall promptly advise RELYPSA as to any scheduling and/or Price adjustments which may result from any such change(s), if any. The notification and approval procedure shall be in accordance with Quality Agreement, as well as any additional standard operating procedures (i.e., change control procedures) agreed by RELYPSA and PATHEON in writing from time to time. (ii) Prior to implementing change(s) to the Specifications, RELYPSA and PATHEON shall negotiate in good faith in an attempt to reach agreement on (i) the new Price, if any, for Bulk or Finished Product which embodies such change(s) to the Specifications, giving due consideration to the effect of such change(s) on PATHEON’s costs for Bulk and Finished Product as well as any other relevant factors, (ii) the costs, if any, to PATHEON of implementing such changes, and (iii) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the lead time for Firm Orders). Implementation of such change(s) to the Specifications shall be as set forth in the Quality Agreement. (iii) RELYPSA will reimburse PATHEON for the reasonable and necessary expenses incurred by PATHEON as a result of any such change(s) to the Specifications, including, but not limited to, reimbursing PATHEON for [***]. (iv) Upon PATHEON’s receipt of a written notice from RELYPSA regarding any change in Specifications, PATHEON shall not commence or continue to manufacture and RELYPSA shall have no obligation to accept or pay for Bulk or Finished Product after receipt of such notice without RELYPSA’s prior written consent in its sole discretion, and RELYPSA shall only be required to accept Bulk and Finished Product that conforms to amended Specifications incorporating such change in Specifications. Any Bulk or Finished Product as to which manufacturing has commenced or is completed by PATHEON prior to receipt of such written request for a change in Specifications and which is Released by PATHEON and otherwise conforms to this Agreement under the prior Specifications shall be paid for by RELYPSA.