Regulatory Support. To the extent practicable, Eagle shall notify MDCO within ten (10) business days prior to any inspection (of which Eagle is aware) by the FDA or other regulatory agency relating to Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder and, within twenty-four (24) hours after such inspection, shall furnish MDCO with a copy of all documentation, including any Form 483 and the Third Party Manufacturer’s response thereto, relating to such inspection. In addition, Eagle shall notify MDCO within five (5) business days after its receipt of any other written regulatory actions or communications (other than ministerial, non-substantive communications) relating to the Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder. The Parties shall confer with each other with respect to any response regarding such action or communication and the best means to comply with such action or communication, but the final response shall be within Eagle’s final decision-making authority.
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Sources: Supply Agreement (Eagle Pharmaceuticals, Inc.), Supply Agreement (Eagle Pharmaceuticals, Inc.)