Common use of Regulatory Communications and Inspections Clause in Contracts

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s request, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents provided directly by BVL to any Agency shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to comment, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents are provided to any Agency. BVL shall notify Customer Immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection received from any Agency shall be provided by BVL to Customer no later than two (2) business days after such communications are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact Product; provided, however, BVL may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately of any notices, observations or other written communications from an Agency regarding any deficiencies that have or are likely to have a material adverse effect on the Product or BVL’s ability to perform its obligations under this Agreement, and BVL shall discuss with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised of its progress in remedying such deficiencies. 3.5.2. Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical studies and commercial use. In addition, Customer shall provide BVL on an annual basis with its anticipated schedule of material Agency regulatory filings for the next two calendar years. BVL acknowledges that such schedule may change at any time. 3.5.3. BVL will provide, at Customer’s request, a copy of the BVL Drug Master File (DMF) and authorization for FDA or Customer to access the DMF. This may be used by the Customer only to prepare any required regulatory filing. In the event Customer plans to file for regulatory approval of Product in a country that is not at such time included as part of the Regulatory Territory, the Parties shall meet to discuss any regulatory requirements in such country that are different than the regulatory requirements BVL is otherwise obligated to meet under this Agreement, and BVL shall provide to Customer an assessment of any additional costs that will be incurred by BVL if it is required to meet such additional regulatory requirements. Upon mutual agreement by the Parties on reasonable additional fees to be paid by Customer, if any, with respect to Manufacturing of Product in compliance with such additional regulatory requirements, and, unless compliance with such additional regulatory requirements cannot reasonably be achieved by BVL without undue burden, the Parties will execute a written amendment to this Agreement to add the applicable country to the Regulatory Territory.

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product and/or the Facilities directly relevant to the manufacture of the Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s requestmanner, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents directly related to Product and a summary of all information provided directly by BVL to any Agency shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to commentif feasible, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents and information are provided to any Agency. The foregoing obligation of disclosure excludes any information which BVL is prohibited from disclosing and/or requested or directed by a regulatory authority not to disclose, including without limitation, drafts of any potential consent decrees. BVL shall notify Customer Immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly all scheduled inspections relating to the Manufacture of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection directly related to Product received from any Agency shall be provided by Customer and BVL to Customer the other Party no later than two five (25) business days after such communications or notices are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact ProductParty; provided, however, BVL that if such document is from BVL, it may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately of any notices, observations or other written written, formal communications from an such Agency provided to BVL after the Effective Date regarding any deficiencies that have or are likely to may have a material an adverse effect on the Product or BVL’s ability to perform its obligations under this Agreement. For the avoidance of doubt, the foregoing obligation of disclosure excludes any information which BVL is prohibited from disclosing, and/or directed or requested by a regulatory agency not to disclose, including without limitation, drafts of any potential consent decrees. Notwithstanding anything to the contrary hereunder, Customer shall have the right to postpone all pending and BVL shall discuss future Purchase Orders hereunder (and adjust all forecasts accordingly) in the event of (i) any such notices, observations or communications newly provided to Customer following the Effective Date; (ii) any regulatory or other concerns under Applicable Law newly discovered following the Effective Date; (iii) any material issues with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised the supply of its progress in remedying such deficienciesProducts hereunder (including atypical Manufacturing deviations of the sort requiring investigation hereunder); (iv) any consent decree; or (v) violations of any of the Product quality provisions of this Agreement. 3.5.2. To the extent BVL does not already have copies, Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical studies and commercial use. In addition, Customer shall provide BVL BVL, on an annual basis basis, with its anticipated schedule of material Agency regulatory filings for the next two (2) calendar years. BVL acknowledges that such schedule may change at any time. 3.5.3. BVL will provide, at Customer’s request, a copy of the BVL Drug Master File Files (DMFDMFs) and authorization for FDA or Customer to access the DMFDMFs. This may be used by the Customer only to prepare any required regulatory Regulatory filing. In the event Customer plans to file for regulatory approval of Product in a country that is not at such time included as part Any other use of the Regulatory Territory, the Parties DMF shall meet to discuss any regulatory requirements in such country that are different than the regulatory requirements BVL is otherwise obligated to meet under this Agreement, and BVL shall provide to Customer an assessment of any additional costs that will be incurred by BVL if it is required to meet such additional regulatory requirements. Upon mutual agreement by the Parties on reasonable additional fees to be paid by Customer, if any, with respect to Manufacturing of Product in compliance with such additional regulatory requirements, and, unless compliance with such additional regulatory requirements cannot reasonably be achieved by BVL without undue burden, the Parties will execute a require BVL’s prior written amendment to this Agreement to add the applicable country to the Regulatory Territoryapproval.

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s requestmanner, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents provided directly by BVL related to any Agency Product shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to commentif feasible, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents and information are provided to any Agency. The foregoing obligation of disclosure excludes any information which BVL is prohibited from disclosing and/or directed or requested by a regulatory agency not to disclose, including without limitation, drafts of any potential consent decrees. BVL shall notify Customer Immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly all scheduled inspections relating to the Manufacture of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection directly related to Product received from any Agency shall be provided by Customer and BVL to Customer the other Party no later than two five (25) business days after such communications or notices are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact ProductParty; provided, however, BVL that if such document is from BVL, it may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately of any notices, observations or other formal written communications from an such Agency provided to BVL after the Effective Date regarding any deficiencies that have or are likely to may have a material an adverse effect on the Product or BVL’s ability to perform its obligations under this Agreement. For the avoidance of doubt, the foregoing obligation of disclosure excludes any information which BVL is prohibited from disclosing and/or directed or requested by a regulatory agency not to disclose, including without limitation, drafts of any potential consent decrees. Notwithstanding anything to the contrary hereunder, Customer shall have the right to postpone all pending and BVL shall discuss future Purchase Orders hereunder in the event of (i) any such notices, observations or communications newly provided to Customer following the Effective Date; (ii) any regulatory or other concerns under Applicable Law newly discovered following the Effective Date; (iii) any material issues with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised the supply of its progress in remedying such deficienciesProducts hereunder (including atypical Manufacturing deviations of the sort requiring investigation hereunder); (iv) any consent decree; or (v) violations of any of the Product quality provisions of this Agreement. 3.5.2. To the extent BVL does not already have copies, Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical studies and commercial use. In addition, Customer shall provide BVL BVL, on an annual basis basis, with its anticipated schedule of material Agency regulatory filings for the next two (2) calendar years. BVL acknowledges that such schedule may change at any time. 3.5.3. BVL will provide, at Customer’s request, a copy of the BVL Drug Master File Files (DMFDMFs) and authorization for FDA or Customer to access the DMFDMFs. This may be used by the Customer only to prepare any required regulatory Regulatory filing. In the event Customer plans to file for regulatory approval of Product in a country that is not at such time included as part Any other use of the Regulatory Territory, the Parties DMF shall meet to discuss any regulatory requirements in such country that are different than the regulatory requirements BVL is otherwise obligated to meet under this Agreement, and BVL shall provide to Customer an assessment of any additional costs that will be incurred by BVL if it is required to meet such additional regulatory requirements. Upon mutual agreement by the Parties on reasonable additional fees to be paid by Customer, if any, with respect to Manufacturing of Product in compliance with such additional regulatory requirements, and, unless compliance with such additional regulatory requirements cannot reasonably be achieved by BVL without undue burden, the Parties will execute a require BVL’s prior written amendment to this Agreement to add the applicable country to the Regulatory Territoryapproval.

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s requestmanner, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents provided directly by BVL to any Agency shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to commentif feasible, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents are provided to any Agency. BVL shall notify Customer Immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection received from any Agency shall be provided by Customer and BVL to Customer the other Party no later than two five (25) business days after such communications are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact ProductParty; provided, however, BVL that if such document is from BVL, it may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately of any notices, observations or other written communications from an such Agency regarding any deficiencies that have or are likely to may have a material adverse effect on the Product or BVL’s ability to perform its obligations under this Agreement. Manufacturing and Service Agreement (BVL and Vion Pharmaceuticals, and BVL shall discuss with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised of its progress in remedying such deficiencies.Inc.) 3.5.2. Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical studies and commercial use. In addition, Customer shall provide BVL on an annual basis with its anticipated schedule of material Agency regulatory filings for the next two calendar years. BVL acknowledges that such schedule may change at any time. 3.5.3. BVL will provide, at CustomerCUSTOMER’s request, a copy of the BVL Drug Master File (DMF) and authorization for FDA or Customer to access the DMF. This may be used by the Customer CUSTOMER only to prepare any required regulatory Regulatory filing. In the event Customer plans to file for regulatory approval of Product in a country that is not at such time included as part of the Regulatory Territory, the Parties shall meet to discuss any regulatory requirements in such country that are different than the regulatory requirements BVL is otherwise obligated to meet under this Agreement, and BVL shall provide to Customer an assessment of any additional costs that will be incurred by BVL if it is required to meet such additional regulatory requirements. Upon mutual agreement by the Parties on reasonable additional fees to be paid by Customer, if any, with respect to Manufacturing of Product in compliance with such additional regulatory requirements, and, unless compliance with such additional regulatory requirements cannot reasonably be achieved by BVL without undue burden, the Parties will execute a written amendment to this Agreement to add the applicable country to the Regulatory Territory.

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s requestmanner, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents directly related to Product and a summary of all information provided directly by BVL to any Agency shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to commentif feasible, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents and information are provided to any Agency. BVL shall notify Customer Immediately immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, inspections and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly all scheduled inspections relating to the Manufacture of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection directly related to Product received from any Agency shall be provided by Customer and BVL to Customer the other party no later than two five (25) business days after such communications or notices are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact ProductParty; provided, however, BVL that if such document is from BVL, it may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately immediately of any notices, observations or other written communications from an such Agency regarding any deficiencies that have or are likely to may have a material an adverse effect on the Product or BVL’s ability to perform its obligations under the Agreement. Notwithstanding anything to the contrary hereunder, Customer shall have the right to postpone all pending and future Purchase Orders hereunder (and adjust all forecasts accordingly) in the event of (i) any such notices, observations or communications; (ii) any regulatory or other concerns under Applicable Law; (iii) any material issues with the supply of Products, hereunder (including atypical Manufacturing deviations of the sort requiring investigation hereunder); (iv) any consent decree; or (v) violations of any of the Product quality provisions of this Agreement, and BVL shall discuss with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised of its progress in remedying such deficiencies. 3.5.2. To the extent BVL does not already have copies, Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical studies and commercial use. In addition, Customer shall provide BVL BVL, on an annual basis basis, with its anticipated schedule of material Agency regulatory filings for the next two calendar years. BVL acknowledges that such schedule may change at any time. 3.5.3. BVL will provide, at Customer’s request, a copy of the BVL Drug Master File Files (DMFDMFs) and authorization for FDA or Customer to access the DMFDMFs. This may be used by the Customer only to prepare any required regulatory Regulatory filing. In the event Customer plans to file for regulatory approval of Product in a country that is not at such time included as part Any other use of the Regulatory Territory, the Parties DMF shall meet to discuss any regulatory requirements in such country that are different than the regulatory requirements BVL is otherwise obligated to meet under this Agreement, and BVL shall provide to Customer an assessment of any additional costs that will be incurred by BVL if it is required to meet such additional regulatory requirements. Upon mutual agreement by the Parties on reasonable additional fees to be paid by Customer, if any, with respect to Manufacturing of Product in compliance with such additional regulatory requirements, and, unless compliance with such additional regulatory requirements cannot reasonably be achieved by BVL without undue burden, the Parties will execute a require BVL’s prior written amendment to this Agreement to add the applicable country to the Regulatory Territoryapproval.