Common use of Regulatory Obligations Clause in Contracts

Regulatory Obligations. All obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any Product-related adverse experience reports, quality reports, and complaint reports. HSL shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL shall remain solely responsible, at its expense, for compliance with (A) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce Product; (B) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (C) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMI, unless the Proposal includes such activities. All information, documents and updates with regard to the manufacture of Product which are required by any governmental agency shall be provided by HSL in a timely manner, and HSL shall submit to all inquiries and inspections by any such agencies. All documents directly related to the Product and a summary of all information provided by HSL to any such agency shall be provided to LMI in advance of submission to such agency. LMI shall not file any documents relating to HSL with regulatory authorities without HSL’s prior written consent, which shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days of receipt and in the absence of delivery of such comments LMI may proceed with its filing. Notwithstanding the foregoing, LMI and HSL acknowledge that the regulatory support described in Proposal No. 973-5-11 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any costs associated with additional applications will require a separate quotation as described in Proposal No. 973-5-11.

Regulatory Obligations. All obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any Product-related adverse experience reports, quality reports, and complaint reports. HSL shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL shall remain solely responsible, at its expense, for compliance with (A) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce Product; (B) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (C) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMI, unless the Proposal includes such activities. All information, documents and updates with regard to the manufacture of Product which are required by any governmental agency shall be provided by HSL in a timely manner, and HSL shall submit to all inquiries and inspections by any such agencies. All documents directly related to the Product and a summary of all information provided by HSL to any such agency shall be provided to LMI in advance of submission to such agency. LMI shall not file any documents relating to HSL with regulatory authorities without HSL’s prior written consent, which shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days of receipt and in the absence of delivery of such comments LMI may proceed with its filing. Notwithstanding the foregoing, LMI and HSL acknowledge that the regulatory support described in Proposal NoNos. 973-57-11 15 and 973-9-16 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any costs associated with additional applications will require a separate quotation as described in Proposal No. 973-57-1115 and 973-9-16. LMI recognizes that HSL does not currently produce Products for several countries in the Territory and there can be no assurance HSL will be qualified in those or other countries in the Territory.

Regulatory Obligations. All obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any Product-related adverse experience reports, quality reports, and complaint reports. HSL shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL shall remain solely responsible, at its expense, for compliance with (A) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce Product; (B) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (C) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMI, unless the Proposal includes such activities. All information, documents and updates with regard to the manufacture of Product which are required by any governmental agency shall be provided by HSL in a timely manner, and HSL shall submit to all inquiries and inspections by any such agencies. All documents directly related to the Product and a summary of all information provided by HSL to any such agency shall be provided to LMI in advance of submission to such agency. LMI shall not file any documents relating to HSL with regulatory authorities without HSL’s prior written consent, which shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days of receipt and in the absence of delivery of such comments LMI may proceed with its filing. Notwithstanding the foregoing, LMI and HSL acknowledge that the regulatory support described in Proposal No. 973-58-11 20 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any costs associated with additional applications will require a separate quotation as described in Proposal No. 973-58-1120. LMI recognizes that HSL does not currently produce Products for several countries in the Territory and there can be no assurance HSL will be qualified in those or other countries in the Territory.

Regulatory Obligations. All Unless otherwise noted in the Quality Agreement, all obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any ProductNDA-related adverse experience reports, quality reports, and complaint reports. HSL CMO shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL CMO shall remain solely responsible, at its expenseCMO’s expense (except as provided in the following sentence), for compliance with (Ai) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce ProductAgreement); (Bii) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (Ciii) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMIapplicable. The allocation of **** shall be mutually determined by the Parties reasonably and in good faith, unless the Proposal includes such activitiestaking into consideration ****. All information, documents and updates with regard to to, relating to, or otherwise affecting, the manufacture Product or the manufacture, testing or shipping of Product which are required or requested by any governmental agency shall be provided by HSL CMO to such agency in a timely mannermanner (in each case, after providing LMI with (x) such information, documents and updates, (y) a reasonable opportunity to confer and comment on such information, documents and updates and (z) good faith consideration of any such conference and comments, in each case, reasonably in advance of submitting such information, documents and updates to such agency), and HSL CMO shall submit to all inquiries and inspections by any such agencies. All documents directly related to agencies (and notify, confer with, and in good fath consider the Product and a summary of all information provided by HSL to any such agency shall be provided to comments of, LMI reasonably in advance of submission (or, if not possible, immediately following) any such inquiries and inspections). CMO agrees to such agency. notify LMI shall not file of (and provide LMI with copies of any documents documentation relating to, and summaries of any unwritten communications relating to) any regulatory, civil or criminal proceedings, investigations, warnings or other adverse actions relating to HSL with regulatory authorities without HSL’s prior written consentany actual or alleged violations of applicable laws or regulations relating to, which arising out of or, or otherwise in connection with, its manufacture of the Product. CMO shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days keep records of receipt the manufacture, testing and in shipping of the absence of delivery Product(s), and retain samples of such comments Product(s) that are necessary to comply with manufacturing regulatory requirements as well as to assist with resolving product complaints and other similar investigations. Copies of such records and samples shall be made available to LMI may proceed with upon its filing. Notwithstanding request and shall be retained by CMO and be available to LMI for a period of **** (****) years following the foregoingdate of manufacture, LMI and HSL acknowledge that the regulatory support described in Proposal No. 973-5-11 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any costs associated with additional applications will require a separate quotation as described in Proposal No. 973-5-11or longer if required by law.