Common use of Regulatory Authority Inspections and Correspondence Clause in Contracts

Regulatory Authority Inspections and Correspondence. Sutro shall permit Regulatory Authorities to conduct such inspections of any Facility at which any of the Manufacturing activities relating to the Product(s) are performed, as such Regulatory Authorities may request, including pre-approval inspections,· and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case that is related to the Manufacture of Product(s). Sutro shall give SutroVax or its Affiliates prior written notice of any such inspections, and shall keep SutroVax informed about the results and conclusions of each such regulatory inspection, including actions taken by Sutro to remedy conditions cited in such inspections. Sutro shall provide SutroVax with copies of any written inspection reports issued by anyRegulatory Authority and all correspondence between Sutro and any Regulatory Authority with respect thereto, including any notices of observation and all related correspondence, in each case relating to the Product(s) or its Manufacture or to general manufacturing concerns (e.g., facility compliance or the like) that are reasonably likely to impact the Product(s) to the extent such general manufacturing matters would be reasonably expected to have a material effect on the manufacture of Vaccine Compositions; provided that Sutro may redact from any such report and correspondence any Sutro Core Know-How and any information subject to an obligation of confidentiality to a Third Party. In addition, Sutro agrees to promptly notify and provide SutroVax copies of any material request, directive, or other written communication to or from Regulatory Authorities related to the Product or its Manufacture that would reasonably be expected to have a material effect on the manufacture of Vaccine Compositions (it being understood that SutroVax, its Affiliates and Sublicensees shall not have access to Sutro Core Know How (which Sutro may redact from such reports or correspondence provided to SutroVax) or Sutro’s Drug Master Files or other confidential Regulatory Materials submitted for a similar purpose as a Drug Master File). Sutro shall provide SutroVax with a copy of the applicable portion of any correspondence made by Sutro to a Regulatory Authority for review and comment prior to submission to the applicable Regulatory Authority solely to the extent such correspondence made by Sutro is related to SutroVax or is in response to a request, directive or correspondence from the applicable Regulatory Authority regarding SutroVax or a Vaccine Composition (e.g., in response to a report regarding a pre-approval inspection for SutroVax). Sutro will consider in good faith any comments received from SutroVax within the time period indicated by Sutro (which shall not be less than [***], to the extent consistent with the require timeline for Sutro’s response) with respect to any matter that relates to SutroVax. In addition, Sutro shall notify SutroVax of any occurrences or information that arise out of Sutro’s Manufacturing activities that have, or could reasonably be expected to have, adverse regulatory compliance or reporting consequences concerning any Product(s) or which might otherwise be reasonably expected to adversely affect the supply by Sutro of Product(s) to SutroVax.

Regulatory Authority Inspections and Correspondence. Sutro Supplier shall permit Regulatory Authorities to conduct such inspections of any its Facility at which any of the Manufacturing activities relating to the Product(s) are performed, as such Regulatory Authorities may request, including pre-approval inspections,· , and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case that is related to the Manufacture of Product(s). Sutro Supplier shall give SutroVax or its Affiliates Buyer prior written notice of any such inspections, and shall keep SutroVax Buyer informed about the results and conclusions of each such regulatory inspection, including actions taken by Sutro Supplier to remedy conditions cited in such inspections. Sutro In addition, Supplier shall allow Buyer or its representative to assist in the preparation for and be present at, and participate in, such inspections, subject to the confidentiality obligations set forth in this Manufacturing Agreement. To the extent that Supplier requires any such representative to sign a separate confidentiality agreement in connection with such inspection, the Parties agree to use the form set forth in Exhibit 3.4. Supplier shall provide SutroVax Buyer with copies of any written inspection reports issued by anyRegulatory any Regulatory Authority and all correspondence between Sutro Supplier and any Regulatory Authority with respect thereto, including any notices of observation and all related correspondence, in each case relating to the Product(s) or its Manufacture or to general manufacturing concerns (e.g., facility compliance or the like) that are reasonably likely to may impact the Product(s) ). Supplier shall provide Buyer with a copy of its response to the extent such general manufacturing matters would be reasonably expected to have a material effect on the manufacture of Vaccine Compositions; provided that Sutro may redact from any such report and correspondence any Sutro Core Know-How and any information subject to an obligation of confidentiality to a Third Party. In addition, Sutro agrees to promptly notify and provide SutroVax copies of any material request, directive, or other written communication to or from Regulatory Authorities related to the Product or its Manufacture that would reasonably be expected to have a material effect on the manufacture of Vaccine Compositions (it being understood that SutroVax, its Affiliates and Sublicensees shall not have access to Sutro Core Know How (which Sutro may redact from such reports or correspondence provided to SutroVax) or Sutro’s Drug Master Files or other confidential Regulatory Materials submitted for a similar purpose as a Drug Master File). Sutro shall provide SutroVax with a copy of from the applicable portion of any correspondence made by Sutro to a Regulatory Authority FDA for review and comment prior to submission to the applicable Regulatory Authority solely to the extent such correspondence made by Sutro is related to SutroVax or is in response to a request, directive or correspondence from the applicable Regulatory Authority regarding SutroVax or a Vaccine Composition (e.g., in response to a report regarding a pre-approval inspection for SutroVax). Sutro will consider in good faith any comments received from SutroVax within the time period indicated by Sutro (which shall not be less than [***], to the extent consistent with the require timeline for Sutro’s response) with respect to any matter that relates to SutroVaxAuthority. In addition, Sutro Supplier shall notify SutroVax Buyer of any occurrences or information that arise out of SutroSupplier’s Manufacturing activities that have, or could reasonably be expected to have, adverse regulatory compliance or reporting consequences concerning any Product(s) or which might otherwise be reasonably expected to adversely affect the supply by Sutro Supplier of Product(s) to SutroVaxBuyer.

Regulatory Authority Inspections and Correspondence. Sutro Sopharma shall permit Regulatory Authorities to conduct such inspections of any Facility at which any of the Manufacturing activities relating to the Product(s) Products are performed, as such Regulatory Authorities may request, including pre-approval inspections,· , and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case that is related to the Manufacture of Product(s). Sutro Sopharma shall give SutroVax or its Affiliates Achieve prior written notice of any such inspections, and shall keep SutroVax Achieve informed about the results and conclusions of each such regulatory inspection, including actions taken by Sutro Sopharma to remedy conditions cited in such inspections. Sutro In addition, Sopharma shall allow Achieve or its representative to assist in the preparation for and be present at, and participate in, such inspections, subject to the confidentiality obligations set forth herein. Sopharma shall provide SutroVax Achieve with copies of any written inspection reports issued by anyRegulatory any Regulatory Authority and all correspondence between Sutro Sopharma and any Regulatory Authority with respect thereto, including any notices of observation and all related correspondence, in each case relating to the Product(s) Products or its their Manufacture or to general manufacturing concerns (e.g., facility Facility compliance or the like) that are reasonably likely to may impact the Product(s) to the extent such general manufacturing matters would be reasonably expected to have a material effect on the manufacture of Vaccine Compositions; provided that Sutro may redact from any such report and correspondence any Sutro Core Know-How and any information subject to an obligation of confidentiality to a Third PartyProducts. In addition, Sutro Sopharma agrees to promptly notify and provide SutroVax Achieve copies of any material request, directive, or other written communication to or from any Regulatory Authorities Authority related to the Product Products or their Manufacture. Sopharma shall provide Achieve with a copy of any such correspondence made by Sopharma and its Manufacture that would reasonably be expected response to have a material effect on the manufacture of Vaccine Compositions (it being understood that SutroVax, its Affiliates and Sublicensees shall not have access to Sutro Core Know How (which Sutro may redact from any such reports or correspondence provided to SutroVax) or Sutro’s Drug Master Files or other confidential Regulatory Materials submitted for a similar purpose as a Drug Master File). Sutro shall provide SutroVax with a copy of from the applicable portion of any correspondence made by Sutro to a Regulatory Authority for review and comment prior to submission to the applicable Regulatory Authority solely to the extent such correspondence made by Sutro is related to SutroVax or is in response to a requestAuthority, directive or correspondence from the applicable Regulatory Authority regarding SutroVax or a Vaccine Composition (e.g., in response to a report regarding a pre-approval inspection for SutroVax). Sutro will consider and Sopharma shall incorporate in good faith any comments received from SutroVax within the time period indicated recommendations provided by Sutro (which shall not be less than [***], Achieve with respect thereto prior to submitting such correspondence or response to the extent consistent with the require timeline for Sutro’s response) with respect to any matter that relates to SutroVaxapplicable Regulatory Authority. In addition, Sutro Sopharma shall notify SutroVax Achieve of any occurrences or information that arise out of SutroSopharma’s Manufacturing activities that have, or could reasonably be expected to have, adverse regulatory compliance or reporting consequences concerning any Product(s) Product or which might otherwise be reasonably expected to adversely affect the supply by Sutro Sopharma of Product(s) Products to SutroVaxAchieve. Notwithstanding the foregoing, nothing in this Section 6.5 shall require Sopharma to disclose to Achieve any Sopharma Know-How.