Common use of Inspection by Regulatory Agencies Clause in Contracts

Inspection by Regulatory Agencies. Each party shall promptly notify the other party upon being contacted by the FDA for any purpose or reason directly relating to the manufacture of the Product, including without limitation, any announced or unannounced FDA inspection. At BLP's request, ISTA will provide BLP with copies of all correspondence and documentation provided to the FDA which relate to BLP's scale-up manufacturing activities. At ISTA's request, BLP will provide ISTA with copies of all correspondence and documentation provided to the FDA which relate to the Product or the manufacture of the Product. BLP shall permit an ISTA representative to be present at BLP's facilities during any such inspection directly relating to manufacture of the Product. Duly authorized representative(s) from the FDA or other applicable regulatory agencies shall be permitted access, at reasonable times during BLP's normal business hours, to visit, in the company of a BLP representative, the manufacturing and/or packaging facility or facilities where the Product will be or is being manufactured and/or packaged for the purposes of auditing BLP's processes to ensure that the Product is being manufactured, packaged, stored and handled in accordance with the Specifications, Applicable Laws, and BLP policies and procedures to the extent that such policies and procedures do not conflict with any terms or conditions of this Agreement or with Applicable Laws.. BLP shall, at its own expense, promptly respond to all inquiries and questions resulting from such visits and inspections and, at its own expense, promptly correct any deficiencies reported as a result of such inspections. BLP shall immediately notify ISTA if an authorized agent of the FDA or other governmental agency visits BLP's manufacturing facility for the purposes of inspecting the manufacturing and testing of the Products.