Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify the Client within [***] of receipt of any notice of inspection from a regulatory authority and within [***] of any regulatory authority request for CTM samples, batch documentation, or other information related to the CTM. Patheon will notify the Client within [***] of receipt of any Form 483’s warning letter or the like from any regulatory agency that relates to the CTM; or if the supply of CTM will be affected, or if the facilities used to produce, test or package the CTM will be affected. Patheon will provide redacted copies on any FDA form 483’s, warning letters or the like from applicable Regulatory Authorities within [***] of receipt and subsequent response(s) relating to the Product. Responses from Patheon related to the CTM will be reviewed and approved by the Client prior to submission to the regulatory agency. Patheon will notify the Client of any requests for information, notices of violations or other communications from a Regulatory Authority relating to environmental, occupational health and safety compliance relating to the CTM. Notwithstanding, Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so.
Government Agency Inspections, Communication and Requisitions. Each party will permit all relevant inspections by Regulatory Authorities of premises, procedures, and documentation. The parties will notify each other within [**] Business Days of receipt of any notice of inspection from a Regulatory Authority and within [**] of any regulatory authority request for Product samples, batch documentation, or similar information related to the Product. Each party reserves the right to be present on site during a regulatory inspection that relates to the Product. The parties will notify within [**] of receipt of any Form 483's warning letter or similar communication from any Regulatory Authority that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. During a regulatory inspection relating to the Product, upon request, a party will provide the requesting party with the applicable Product data for which it is responsible under this Agreement. Patheon is responsible for responding to all regulatory audits conducted at any Patheon site. Patheon will provide Client with a draft of any responses directly related to the Product prior to submission to the Regulatory Authority. Client must provide approval or request changes in a timely manner to enable Patheon to respond to the Regulatory Authority by the applicable deadline. Notwithstanding, Patheon reserves the right to respond to the Regulatory Authority without Client’s prior approval, if, in the opinion of Patheon’s Legal counsel, it is required or reasonable to do so. Client is responsible for responding to all regulatory audits at any Client site. Client will provide Patheon with a draft of any response directly related to Patheon services prior to submission to the Regulatory Authority. Patheon must provide approval or request changes in a timely manner to enable Client to respond to the Regulatory Authority by the applicable deadline. Notwithstanding, Client reserves the right to respond to the Regulatory Authority without Patheon’s prior approval, if, in the reasonable opinion of Client’s Legal counsel, it is required or reasonable to do so.
Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify the Client within one Business Day of receipt of any notice of inspection from a regulatory authority and within one Business Day of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. The Client reserves the right to be present on site for PRODUCT pre-approval inspections. Patheon will notify the Client within one Business Day of receipt of a Form 483s, warning letter, or the like, from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. A redacted copy will be provided to the Client within five Business Days. The responses from Patheon related to the Product will be reviewed and approved by the Client before submission to the regulatory agency. But Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so.
Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by Regulatory Authorities of premises, procedures, and documentation. Patheon will notify Penwest within three (3) Business Days after receipt of any notice of inspection from a Regulatory Authority and within one (1) Business Day after any Regulatory Authority request for Product samples, Batch documentation, or other information related to the Product. Patheon will notify Penwest within one (1) Business Day after receipt of any Form 483’s warning letter or the like from any Regulatory Authority that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. The responses from Patheon related to the Product will be reviewed and approved by Penwest prior to submission to the Regulatory Authority.
Government Agency Inspections, Communication and Requisitions. Subject to the terms and conditions set forth in the MSA, Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify Synageva within [**] of receipt of any notice of inspection from a regulatory authority. Patheon will permit Synageva to be present at Patheon’s facility during the inspections involving the Product and to participate in such inspections in accordance with Section 7.6 of the MSA. Patheon will notify Synageva [**] of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. Patheon will not make any commitments affecting the Product to any regulatory authority without first obtaining Synageva’s written agreement. In such cases, Synageva will provide Patheon with some feedback on the requested information within [**] from the date of request. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Patheon will notify Synageva [**] of receipt of any Form 483’s, warning letter, or the like from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. The responses from Patheon related to the Product are subject to review and approval by Synageva prior to submission to the regulatory agency. Notwithstanding, Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, the communication is necessary to comply with the terms of this Quality Agreement, the MSA or the requirements of any law, governmental order or regulation, subject to the prior notice obligations in Section 7.2 of the MSA.
Government Agency Inspections, Communication and Requisitions. CPI will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation related to the manufacture of the Drug Resin Complex. CPI will notify NEOS immediately but not more than twenty-four (24) hours of CPI’s receipt of any: (i) notice of inspection from a regulatory authority; or (ii) any regulatory authority request for Drug Resin Complex samples, batch documentation, or other information related to the Drug Resin Complex. CPI shall use reasonable efforts to provide daily updates to NEOS for those items or regulatory authority observations that directly pertain to the Drug Resin Complex. CPI will notify NEOS immediately but not more than twenty-four (24) hours of CPI’s receipt of any Form 483s, warning letter, or the like from any regulatory agency that relates to the Drug Resin Complex. The regulatory responses from CPI related to the Drug Resin Complex will be provided only to the Regulatory Consultant for review and comment before submission to the regulatory agency. CPI shall consider in good faith all comments provided by the Regulatory Consultant; provided, however, CPI shall not be obligated to accept or implement any comments or revisions provided by the Regulatory Consultant. CPI reserves the right to respond to the regulatory agency prior to receiving the Regulatory Consultant’s comments if the Regulatory Consultant has not responded within a reasonable amount of time, as determined by CPI. CPI shall provide the Regulatory Consultant with all copies of information provided or received by CPI prior to, in the course of, or as a result of any regulatory agency audit or inspection directly pertaining to the Drug Resin Complex. After receiving such information from CPI, the Regulatory Consultant shall prepare an executive summary report related thereto for review and comment by CPI (the “Executive Inspection Summary”). Once the Executive Inspection Summary is final, as mutually agreed upon by the Regulatory Consultant and CPI in writing, the Regulatory Consultant shall deliver the Executive Inspection Summary to NEOS.
Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify the Client within [***] of receipt of any notice of inspection from a regulatory authority and within [***] of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. Patheon will notify the Client within [***] of receipt of any Form 483’s warning letter or the like from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. The responses from Patheon related to the Product will be reviewed and approved by the Client prior to submission to the regulatory agency. Notwithstanding, Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so.
Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify the Client by telephone within twenty-four (24) hours, and in writing within two (2) Business Days after learning of any proposed visit to, or inspection of, a Manufacturing Site by any regulatory authority and immediately by telephone after learning of any unannounced visit to, or inspection of, a Manufacturing Site by any regulatory authority if such visit or inspection primarily relates to the manufacture of the Product or facilities used in the manufacturing of the product. Patheon shall also notify Client by telephone within twenty-four (24) hours, and in writing within two (2) Business Days, if the visit to, or inspection of, the Manufacturing Site by such regulatory authority becomes directed towards the manufacture of the Product. Patheon shall notify the Client immediately by telephone, and within one (1) Business Day of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. Patheon will notify the Client within three (3) Business Days of receipt of any Form 483’s, warning letter or the like from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. The responses from Patheon related to the Product will be provided by Patheon to Client for review and approval at least five (5) Business Days before submission to the regulatory agency. Client approval must not be unreasonably withheld and must be received in time for Patheon to meet submission due dates.
Government Agency Inspections, Communication and Requisitions. SUPPLIER will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. SUPPLIER will notify the head of SUPERNUS Quality Assurance immediately of receipt of any notice of inspection from a regulatory authority pertaining directly to the PRODUCT and within one (1) Business Day (BD) of any regulatory authority request for PRODUCT samples, batch documentation, or other information related to the PRODUCT. SUPPLIER will notify the head of SUPERNUS Quality Assurance within one (1) BD of receipt of any major Form 483 observations, warning letter or the like from any regulatory agency that relates directly to the PRODUCT; or if the supply of PRODUCT will be affected, or if the facilities or personnel used to produce, test or package the PRODUCT will be affected. SUPERNUS’ Head of Quality Assurance will be notified within one (1) BD of any inspection by a Regulatory Authority regarding the PRODUCT. SUPPLIER will permit a representative from SUPERNUS Quality Assurance to be present at inspections directly relating to involving SUPERNUS PRODUCTS. SUPPLIER will secure SUPERNUS’ agreement prior to making any commitment to a Regulatory Authority regarding the PRODUCT. Should the Regulatory Authority issue a warning letter or any major client-specific observations to SUPPLIER, a copy of these documents will be forwarded to SUPERNUS Quality Assurance within five (5) BD of receipt. Major Client-specific observations would include observations that have potential SUPERNUS PRODUCT safety impact. If necessary, SUPPLIER may redact names of other customers or products to protect confidentiality. Copies of formal response letters from SUPPLIER, including 483 observations or similar, to the Regulatory Authority that may have major SUPERNUS PRODUCT impact will also be forwarded to SUPERNUS Quality Assurance within five (5) BD upon issuance to the Regulatory Authority. Inspection report responses from SUPPLIER related to the PRODUCT will be reviewed and approved by SUPERNUS Quality Assurance prior to submission to the regulatory agency.
Government Agency Inspections, Communication and Requisitions. Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation. Patheon will notify MDCO within one (1) Business Day of receipt of any notice of inspection from a regulatory authority and within one (1) Business Day of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. Patheon will notify MDCO within one (1) Business Day of receipt of any Form 483’s warning letter or the like from any regulatory agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. The responses from Patheon related to the Product will be reviewed and approved by MDCO prior to submission to the regulatory agency. Notwithstanding, Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so.
