Batch Release. 3.1 The Contractor will manufacture and test the Product according to established, approved procedures and current Good Manufacturing Practices. 3.2 Batch review and release of the Product and all of its components will be the sole responsibility of the Contractor. 3.3 The Contractor will have a formal retest policy and procedure in place that is in accordance with applicable regulations. 3.4 The Contractor will notify NA, within 48 hours, in the event that any test reveals contamination, lack of sterility, or degradation beyond specifications in any batch of Product. The Contractor will file any reports required by the applicable regulations.
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Sources: Distribution Agreement (Lantheus MI Intermediate, Inc.), Distribution Agreement (Lantheus MI Intermediate, Inc.)