Change Notifications. Seller represents that it has an established Change Control and Notification Procedure to ensure that Buyer is notified in the event of any changes. Major Changes: Seller shall provide no less than twelve (12) months advance written notice to Buyer of any temporary suspension or permanent implementation of major changes in the production of Products; such notice shall be countersigned by Buyer prior to becoming effective. Major changes shall include changes: (i) in the composition, source or grade of any raw material (including fluid contact raw materials); (ii) in the method of production, processing, sterilization or testing that may affect the form, fit or function of the Products; (iii) in any specification of the Products; (iv) in any other field impacting the fit, form or function of the final Products; (v) in any change in production location to a non-qualified manufacturing site. Minor Changes: Seller shall provide no less than six (6) months advance written notice to Buyer before any minor changes to Products are made. Minor changes shall include: (i) methods or equipment used for testing the Products; (ii) any other quality assurance activities relating to the Products; (iii) change of production location to a qualified manufacturing site. Seller shall produce enough unchanged material to supply Buyer for a minimum period of forty-eight (48) months after the implementation of the announced change.
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Sources: Terms and Conditions of Purchase, Terms and Conditions of Purchase