Regulatory Authority. Client will have the sole responsibility for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture of the Products. [[Organization A:Organization]] will assist Client, to the extent consistent with [[Organization A:Organization]]'s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture of all Products as quickly as reasonably possible.

Regulatory Authority Documentation. Client will provide copies of all relevant documents relating to Regulatory Authority approval for the commercial manufacture, distribution, and sale of the Product (“Regulatory Approval”) to Patheon on request and as required under the Quality Agreement. Patheon will review and verify the accuracy of these documents in accordance with the Quality Agreement. Client is not entitled to submit Regulatory Approvals referring to Patheon or its Affiliates or the Services until approved by Patheon.

Regulatory Authority. Client will have the sole responsibility at Client’s expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products (“Regulatory Approval”) and will provide copies thereof to Patheon on request. Patheon will assist Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products as quickly as reasonably possible.

Regulatory Authority. Client will have the sole responsibility at Client’s expense for filing all documents with all relevant Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products (“Regulatory Approval”) and will provide copies of relevant documents to [[Organization A:Organization]] on request. [[Organization A:Organization]] will use commercially reasonable efforts to support Client in obtaining Regulatory Authority approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.

“Regulatory Authority”. Regulatory Authority means any Governmental Authority, including but not limited to the SDA or the equivalent regulatory body in a Region other than Mainland [[Address A:Address]], with responsibility for granting licenses or approvals necessary for the marketing and sale of pharmaceutical products in a country or region.

Regulatory Authority. Client will have the sole responsibility at Client’s expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products (“Regulatory Approval”). Patheon will assist Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.

“Regulatory Authority”. Regulatory Authority means any Governmental Authority, including the FDA, EMEA or MHW, with responsibility for granting licenses or approvals (with the exception of price approvals) necessary for the marketing and sale of pharmaceutical preparations or products in any country.

“Regulatory Authority”. Regulatory Authority means any Governmental Authority, including but not limited to the CFDA or the equivalent regulatory body in a Region other than [[Address A:Address]] Mainland, with responsibility for granting licenses or approvals necessary for the marketing and sale of pharmaceutical products in a country or region.

Supplier shall advise [[OUTSET:Organization]] immediately of any proposed or unannounced visit or inspection by any Government Authority, including any Regulatory Authority or any environmental regulatory authority, and shall permit one or more qualified representatives of [[OUTSET:Organization]] to be present if requested by [[OUTSET:Organization]]. If [[OUTSET:Organization]] is not present during such a visit or inspection, Supplier shall promptly provide a summary report of the results of the inspection to [[OUTSET:Organization]] in English. Supplier shall promptly (and in no event later ​ days) furnish [[OUTSET:Organization]] English summaries of all reports, documents or correspondence with respect to any Regulatory Authority requests or inspections of any Facility, as well as a copy of each such report, document or correspondence in English.

The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of regulatory approval (including pricing and reimbursement approvals) for the Product.