Common use of Inspections by Regulatory Agencies Clause in Contracts

Inspections by Regulatory Agencies. LONZA shall allow representatives of any Regulatory Authority to inspect the relevant parts of the Facility where the manufacture or supply of a Product is carried out and to inspect the Master Production Record and Batch Records to verify compliance with Applicable Laws and other practices or regulations and shall cooperate with such Regulatory Authority with respect to such inspections and any related matters. LONZA shall promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture and supply of Product and shall keep CLIENT informed about the results and conclusions of each such regulatory inspection relating to a Product, including actions taken by LONZA to remedy conditions cited in such inspections. In addition, LONZA shall allow CLIENT or its representative to assist in the preparation for and be present at such inspections relating to a Product. LONZA will promptly send to CLIENT a copy of any reports, citations, warning letters, or other correspondence received by LONZA from any Regulatory Authority, including, but not limited to, FDA Form 483, Notices of Observation, and all related correspondence, to the extent such documents relate to the Product, its manufacture or general manufacturing concerns applicable to Products (including facility compliance or the like). Prior to responding to any reports, requests, directive or other communications issued by any Regulatory Authority relating to a Product or its manufacture, to the extent practicable, LONZA shall provide CLIENT a copy of its proposed response for CLIENT’s review and comments and LONZA shall take under careful consideration and use good faith efforts to implement any comments or recommendations provided by CLIENT with respect thereto prior to submitting such response to the applicable Regulatory Authority.

Inspections by Regulatory Agencies. LONZA shall LHI will promptly notify CLIENT if any regulatory agency visits the Facility concerning the manufacture of the Product. LHI will allow representatives of any Regulatory Authority regulatory agency to inspect the relevant parts of the Facility where any activities conducted hereunder with respect to the manufacture or supply of a Product is are carried out and to inspect the Master Production Record SOW Documentation and Batch Records to verify compliance with Applicable Laws cGMP and other practices or regulations and shall cooperate with such Regulatory Authority with respect to such inspections and any related matters. LONZA shall will promptly notify CLIENT of the scheduling of any such inspection relating to the manufacture and supply of Product and shall keep CLIENT informed about the results and conclusions of each such regulatory inspection relating to a Product, including actions taken by LONZA to remedy conditions cited in such inspectionsinspection. In addition, LONZA shall allow CLIENT or its representative to assist in the preparation for and be present at such inspections relating to a Product. LONZA LHI will promptly send to CLIENT a copy of any reports, citations, or warning letters, or other correspondence letters received by LONZA from any Regulatory Authority, including, but not limited to, FDA Form 483, Notices LHI in connection with an inspection of Observation, and all related correspondence, a regulatory agency to the extent such documents relate to or affect the manufacture of the Product. CLIENT is permitted to be on site and available for questions regarding the Product during any such inspection. To the extent practicable, its manufacture or general manufacturing concerns applicable LHI shall furnish to Products (including facility compliance or the like). Prior to responding CLIENT copies of proposed responses to any reportsregulatory agency with respect to any such inspection to the extent such proposed responses are related to the Product or Process, requests, directive subject to redaction of LHI’s Confidential Information or other communications issued by any Regulatory Authority relating information of LHI that is unrelated to a the Product or its manufacture, as promptly as reasonably possible prior to the time it submits such responses. Prior to responding, to the extent practicable, LONZA shall provide CLIENT a copy of its LHI will discuss the proposed response for CLIENT’s review with CLIENT and comments and LONZA shall take under careful consideration and use will implement in good faith efforts to implement any comments or recommendations provided by CLIENT with respect thereto prior to submitting such response relating to the applicable Regulatory AuthorityProduct which LHI deems applicable. After the filing of a response with any regulatory agency, LHI will notify CLIENT of any further written contacts with such regulatory agency relating to the subject matter of the response.