Common use of Regulatory Matters Records Clause in Contracts

Regulatory Matters Records. 8.1 Access to Company’s Facilities by Client Representatives. During regular business hours and mutually agreed upon times, Client may review the records of Company relating to the Services performed and expenses incurred to assure compliance with all provisions of this Agreement. Such review [*], unless otherwise agreed, and shall be offered to Client by Company not more than [*]. Subsequent reviews during the same calendar year or such reviews that cannot be completed in [*] will be at Client’s sole cost and expense, at Company’s then current rates [*]. Client shall also be provided an invoice for any incidental expenses Company incurs resulting from such review. While Services are being performed for Client, [*], or more if agreed upon by the Parties in writing, shall be permitted to be on-site at Company’s Facility as reasonably required to monitor such Services. Client’s rights in this Section 8.1 shall be subject to compliance with Company’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Company’s premises rules that are generally applicable to all persons at Company’s Facilities. Company reserves the right to require an independent third party to audit on behalf of any client deemed by Company in its reasonable discretion to be a direct competitor of Company. Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of Client hereunder and such third party(ies) shall be subject to any and all conditions upon Client’s rights that are set forth in this Section. At all times, Company shall be solely responsible for obtaining, maintaining and paying for all necessary approvals, licenses and permits to perform the Services provided in this Agreement at each of its Facilities. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Any ‘for cause’ audits shall be conducted in accordance with the Quality Agreement (defined below).

Regulatory Matters Records. 8.1 Access to Company’s Facilities by Client Representatives6.3.1 Contractor shall keep documentation and records in accordance with the requirements of cGMP. During regular business hours Copies of all documentation and mutually agreed upon times, Client may review the records of Company information relating to the Services performed Manufacture, processing, packaging and expenses incurred shipping of Drug Products and/or required to assure compliance with support PCYC's NDA (or IND, if appropriate) or other regulatory submission, including but not limited to information relating to Batch records, methods, equipment and the Facility, will be provided by Contractor to PCYC for review and inclusion as necessary in its regulatory submissions. Contractor shall maintain all provisions records and documentation under this Section 6.3 and any inspection samples and data for at least one (1) year past the expiration dates of this Agreementeach Batch or for such longer period as may be required by cGMP or other regulations promulgated by the Regulatory Authorities applicable to the relevant Drug Product. Such review [*], unless otherwise agreedContractor shall invoice PCYC, and PCYC shall be offered to Client by Company not more than [*]. Subsequent reviews during the same calendar year or pay Contractor, for such reviews that cannot be completed in [*] will be at Client’s sole cost and expense, at Company’s then current rates [*]. Client shall also be provided an invoice for any incidental expenses Company incurs resulting from such review. While Services are being performed for Client, [*], or more if agreed upon by the Parties in writing, shall be permitted to be on-site at Company’s Facility regulatory work as reasonably required to monitor such Services. Client’s rights in this Section 8.1 shall be subject to compliance with Company’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Company’s premises rules that are generally applicable to all persons at Company’s Facilities. Company reserves the right to require an independent third party to audit on behalf of any client deemed by Company in its reasonable discretion to be a direct competitor of Company. Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of Client hereunder and such third party(ies) shall be subject to any and all conditions upon Client’s rights that are set forth in this Sectionthe applicable Regulatory Plan. At all times, Company shall be solely responsible for obtaining, maintaining and paying for all necessary approvals, licenses and permits to perform the Services provided in this Agreement at each of its Facilities. [*] = Certain confidential information contained in this document, marked by brackets, Indicates that material has been omitted and confidential treatment has been requested therefor. All such omitted material has been filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 24b-2. 6.3.2 PCYC shall have sole responsibility, at its expense, for obtaining all permits and licenses necessary or required for the sale, marketing and commercialization of Drug Products. Contractor shall be responsible, at its expense, for obtaining and maintaining all permits and licenses required for it to carry out its development, regulatory and Manufacturing obligations hereunder. Contractor agrees to use commercially reasonable efforts to assist PCYC in obtaining any Regulatory Approval which may be required for the marketing of Drug Products in any country agreed to in the applicable Regulatory Plan. Such efforts shall include, without limitation, (a) providing information in Contractor's possession that is useful or required by PCYC to submit regulatory filings or obtain permits or licenses with respect to Drug Products, including all information necessary for PCYC to complete the CMC portions of its regulatory filings; (b) allowing the use of Contractor's name in any such filings; and (c) taking any and all other actions reasonably required to assist in the licensing of Drug Products. 6.3.3 Upon the request of any Regulatory Authority, such entity shall have access to observe and inspect the Facility and Contractor's procedures used for the Manufacture, testing or storage of any API or Drug Product, including process development and Manufacturing operations, and to audit such Facility for compliance with cGMP and/or other applicable regulatory standards. Contractor shall give PCYC immediate notice of any upcoming inspections or audits by a Regulatory Authority of the Securities Exchange Act Facility relating to any Drug Product Manufactured hereunder, and shall provide PCYC the opportunity to be present at such inspection or audit. Access to the Facility may be subject to reasonable restrictions customarily placed upon visitors to the site. 6.3.4 Contractor also agrees to notify PCYC within two (2) business days of 1934any written or oral inquiries, as amendednotifications, or inspection activity by any Regulatory Authority (or any third party authorized by a Regulatory Authority) in regard to any Drug Product. Any ‘for cause’ audits Contractor shall provide a reasonable description to PCYC of any such inquiries, notifications or inspections promptly (but in no event later than five (5) business days) after such visit or inquiry. Contractor shall furnish to PCYC (a) within two (2) business days after receipt, any report or correspondence issued by the Regulatory Authority (or a third party authorized by a Regulatory Authority) in connection with such visit or inquiry, including but not limited to, any FDA Form 483 (List of Inspectional Observations) or warning letter, and (b) not later than five (5) business days prior to the time it provides to a Regulatory Authority, copies of any and all proposed written responses or explanations relating to items set forth above (each, a "Proposed Response"), in each case purged only of trade secrets or other confidential or proprietary information of Contractor that are unrelated to its obligations under this Agreement or are unrelated to Drug Products. Contractor shall discuss with PCYC any comments provided by PCYC on the Proposed Response and the Parties shall mutually agree on those portions of the final written response or explanation to be conducted provided to the Regulatory Authority that have a material effect on any Drug Product Manufactured hereunder. Notwithstanding the preceding sentence, in accordance the event that either PCYC fails to promptly respond to the comments of Contractor in connection with preparation of the Proposed Response or a portion of such response is likely to have a material effect on Contractor's customers other than PCYC, then Contractor shall have the sole right to prepare such portion of such response, provided that Contractor shall in good faith consider PCYC's comments relating thereto and shall use reasonable efforts to incorporate such comments. After the filing of a response with the Quality Agreement (defined below).appropriate Regulatory Authority, Contractor will notify PCYC of any further contacts with a Regulatory Authority relating to

Regulatory Matters Records. 8.1 Access to Company’s Facilities by Client Representatives. During regular business hours DOTTIKON shall keep documentation and mutually agreed upon times, Client may review the records of Company relating to the Services performed and expenses incurred to assure compliance with all provisions of this Agreement. Such review [*], unless otherwise agreed, and shall be offered to Client by Company not more than [*]. Subsequent reviews during the same calendar year or such reviews that cannot be completed in [*] will be at Client’s sole cost and expense, at Company’s then current rates [*]. Client shall also be provided an invoice for any incidental expenses Company incurs resulting from such review. While Services are being performed for Client, [*], or more if agreed upon by the Parties in writing, shall be permitted to be on-site at Company’s Facility as reasonably required to monitor such Services. Client’s rights in this Section 8.1 shall be subject to compliance with Company’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Company’s premises rules that are generally applicable to all persons at Company’s Facilities. Company reserves the right to require an independent third party to audit on behalf of any client deemed by Company in its reasonable discretion to be a direct competitor of Company. Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of Client hereunder and such third party(ies) shall be subject to any and all conditions upon Client’s rights that are set forth in this Section. At all times, Company shall be solely responsible for obtaining, maintaining and paying for all necessary approvals, licenses and permits to perform the Services provided in this Agreement at each of its Facilities. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Any ‘for cause’ audits shall be conducted in accordance with the Quality requirements of cGMP. DOTTIKON shall provide fully-executed copies of all documents approved by PCYC promptly following signature of such documents by each Party's authorized representative. DOTTIKON will provide to PCYC copies of all documentation and information relating to the Manufacture, processing, packaging and shipping of Product and/or required to support PCYC's NDAs (or INDs, if appropriate) or other regulatory submissions, including but not limited to information relating to Batch records, specifications, methods, method validations, equipment and the Facility, for review and inclusion as necessary in PCYC's regulatory submissions. DOTTIKON shall maintain all records and documentation under this Section 6.3 and any inspection samples and data for at least [ *** ] past the expiration dates of each Batch or for such longer period as may be required by cGMP or other regulations promulgated by the Regulatory Authorities applicable to the relevant Product Prior to DOTTIKON's destruction of any of the records or documentation described in Section 6.3.1, DOTTIKON shall notify PCYC in writing specifically identifying the records or documentation that it wishes to destroy. PCYC shall have [ *** ] from its receipt of such notice to notify DOTTIKON that it desires to receive such records or documentation. In such event, such records or documentation shall be delivered to PCYC or its designee at PCYC's expense. If PCYC does not notify DOTTIKON that it desires to receive such records or documentation within such [ *** ] period, then DOTTIKON shall be free to destroy such records or documentation. DOTTIKON shall be solely responsible, at its expense, for obtaining and maintaining all Regulatory Approvals required for it to carry out its development, regulatory and Manufacturing obligations hereunder. DOTTIKON agrees to cooperate fully with PCYC in PCYC's efforts to obtain and maintain any Regulatory Approval which may be required for the use of the Products, or the Manufacture and/or marketing of Drug Products, in any country. Such efforts shall include, without limitation, (a) providing information in DOTTIKON's possession that is useful or required by PCYC to submit regulatory filings or obtain or maintain Regulatory Approvals with respect to Products and/or Drug Products, including all information necessary for PCYC to complete the CMC portions of its regulatory filings; (b) allowing the use of DOTTIKON's name in any such filings; and (c) taking any and all other actions reasonably required to assist PCYC or its designee in obtaining Regulatory Approval of Drug Products. Upon the request of any Regulatory Authority, such entity shall have access to observe and inspect the Facility and DOTTIKON's quality and manufacturing documents and procedures used for the Manufacture of any Product, including process development and Manufacturing operations, and to audit such Facility, documents and procedures for compliance with cGMP and/or other applicable regulatory standards. DOTTIKON shall give PCYC immediate notice of any upcoming inspections or audits by a Regulatory Authority of the Facility, documents and/or procedures relating to any Product Manufactured hereunder, and shall provide PCYC the opportunity to conduct a pre-inspection of the Facility and such documents and procedures, and to observe and participate in such inspection or audit. DOTTIKON also agrees to notify PCYC within [ *** ] of any written or oral inquiries, notifications, or inspection activity by any Regulatory Authority in connection with any Product. DOTTIKON shall provide a reasonable written description to PCYC of any such inquiries, notifications or inspections promptly (but in no event later than [ *** ] after such visit or inquiry. DOTTIKON shall furnish to PCYC (a) within [ *** ] after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to any FDA Form 483 (List of Inspectional Observations) or warning letter, and (b) not later than [ *** ] prior to the time it provides to a Regulatory Authority, copies of any and all proposed written responses or explanations relating to items set forth above (each, a "Proposed Response"), in each case purged only of trade secrets or other confidential or proprietary information of DOTTIKON that are unrelated to the obligations under this Agreement (defined below)or are unrelated to Products. DOTTIKON shall discuss with PCYC any comments provided by PCYC on the Proposed Response and the Parties shall mutually agree on the final written response or explanation to be provided to the Regulatory Authority. After the filing of a response with the appropriate Regulatory Authority, DOTTIKON will notify PCYC of any further contacts with a Regulatory Authority relating to DOTTIKON's Manufacture of Products. DOTTIKON shall promptly notify PCYC of any other production issues or other information of which DOTTIKON becomes aware that may affect the regulatory status of a Product or the ability of DOTTIKON to supply a Product in accordance with PCYC's forecasted requirements. DOTTIKON agrees to promptly rectify or resolve any deficiencies noted by a Regulatory Authority in a report or correspondence issued to DOTTIKON, and that are based on DOTTIKON's performance under this Agreement, at DOTTIKON's expense. Each Party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the Manufacture of a Product under this Agreement and which are required by the FDA, other applicable Regulatory Authority or other applicable laws or governmental regulations, and shall confer with each other with respect to the best means to comply with such requirements. Drug Master File. DOTTIKON shall file and maintain the appropriate DMF for its Manufacture of each Product hereunder, at DOTTIKON's expense, except as otherwise agreed in writing by the Parties. DOTTIKON shall provide PCYC and its affiliates, partners, licensees and designees with letters of authorization to reference such DMF in their respective filings with the FDA and other Regulatory Authorities. Upon PCYC's request, DOTTIKON shall provide PCYC with copies of such DMFs.

Regulatory Matters Records. 8.1 Access to Company’s Facilities LONZA shall keep documentation and records in accordance with the requirements of cGMP. LONZA shall provide fully-executed copies of all documents approved by Client RepresentativesPCYC promptly following signature of such documents by each Party's authorized representative. During regular business hours Copies of all documentation and mutually agreed upon times, Client may review the records of Company information relating to the Services performed Manufacture, processing, packaging and expenses incurred shipping of Product and/or required to assure support PCYC's NDAs (or INDs, if appropriate) or other regulatory submissions, including but not limited to information relating to Batch records, specifications, methods, method validations, equipment and the Facility, will be provided by LONZA to PCYC for review and inclusion as necessary in PCYC's regulatory submissions. LONZA shall maintain all records and documentation under this Section 6.3 and any inspection samples and data for at least [ *** ] past the expiration dates of each Batch or for such longer period as may be required by cGMP or other regulations promulgated by the Regulatory Authorities applicable to the relevant Product. Prior to LONZA's destruction of any of the records or documentation described in Section 6.3.1, LONZA shall notify PCYC in writing specifically identifying the records or documentation that it wishes to destroy. PCYC shall have [ *** ] from its receipt of such notice to notify LONZA that it desires to receive such records or documentation. In such event, such records or documentation shall be delivered to PCYC or its designee at PCYC's expense. If PCYC does not notify LONZA that it desires to receive such records or documentation within such thirty-day period, then LONZA shall be free to destroy such records or documentation. LONZA shall be solely responsible, at its expense, for obtaining and maintaining all Regulatory Approvals required for it to carry out its development, regulatory and Manufacturing obligations hereunder. LONZA agrees to cooperate fully with PCYC in PCYC's efforts to obtain and maintain any Regulatory Approval which may be required for the use of the Products, or the Manufacture and/or marketing of Drug Products, in any country. Such efforts shall include, without limitation, (a) providing information in LONZA's possession that is useful or required by PCYC to submit regulatory filings or obtain or maintain Regulatory Approvals with respect to Products and/or Drug Products, including all information necessary for PCYC to complete the CMC portions of its regulatory filings; (b) allowing the use of LONZA's name in any such filings; and (c) taking any and all other actions reasonably required to assist PCYC and/or its designee in obtaining Regulatory Approval of Drug Products. Upon the request of any Regulatory Authority, such entity shall have access to observe and inspect the Facility and LONZA's quality and manufacturing documents and procedures used for the Manufacture of any Product, including process development and Manufacturing operations, and to audit such Facility, documents and procedures for compliance with all provisions cGMP and/or other applicable regulatory standards. LONZA shall give PCYC immediate notice of this Agreement. Such review [*]any upcoming inspections or audits by a Regulatory Authority of the Facility, unless otherwise agreeddocuments and/or procedures relating to any Product Manufactured hereunder, and shall provide PCYC the opportunity to conduct a pre-inspection of the Facility and such documents and procedures, and to observe and participate in such inspection or audit. LONZA also agrees to notify PCYC within [ *** ] of any written or oral inquiries, notifications, or inspection activity by any Regulatory Authority in connection with any Product. LONZA shall provide a reasonable written description to PCYC of any such inquiries, notifications or inspections promptly (but in no event later than [ *** ]) after such visit or inquiry. LONZA shall furnish to PCYC (a) within [ *** ]after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to any FDA Form 483 (List of Inspectional Observations) or warning letter, and (b) not later than [ *** ] prior to the time it provides to a Regulatory Authority, copies of any and all proposed written responses or explanations relating to items set forth above (each, a "Proposed Response"), in each case purged only of trade secrets or other confidential or proprietary information of LONZA that are unrelated to the obligations under this Agreement or are unrelated to Products. LONZA shall discuss with PCYC any comments provided by PCYC on the Proposed Response and the Parties shall mutually agree on the final written response or explanation to be offered provided to Client the Regulatory Authority but only to the extent that such reply is specific to a Product. After the filing of a response with the appropriate Regulatory Authority, LONZA will notify PCYC of any further contacts with a Regulatory Authority relating to LONZA's Manufacture of Products. LONZA shall promptly notify PCYC of any other production issues or other information of which LONZA becomes aware that may affect the regulatory status of a Product or the ability of LONZA to supply a Product in accordance with PCYC's forecasted requirements. LONZA agrees to promptly rectify or resolve any deficiencies noted by Company not more than [*]. Subsequent reviews during the same calendar year a Regulatory Authority in a report or such reviews correspondence issued to LONZA, and that cannot be completed in [*] will be at Client’s sole cost and expenseare based on LONZA's performance under this Agreement, at Company’s then current rates [*]LONZA's expense. Client Each Party shall also be provided an invoice promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the Manufacture of a Product under this Agreement and which are required by the FDA, other applicable Regulatory Authority or other applicable laws or governmental regulations, and shall confer with each other with respect to the best means to comply with such requirements. Drug Master File. LONZA shall file and maintain the appropriate DMF for any incidental expenses Company incurs resulting from such review. While Services are being performed for Clientits Manufacture of each Product hereunder, [*], or more if at LONZA's expense except as otherwise agreed upon by the Parties in writing, . LONZA shall provide PCYC and/or its designee with letters of authorization to reference such DMF in its filings with the FDA and other Regulatory Authorities Stability Testing. LONZA shall be permitted to be on-site at Company’s Facility as reasonably required to monitor such Services. Client’s rights responsible for performing stability testing of each commercial Product, in this Section 8.1 shall be subject to compliance with Company’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Company’s premises rules that are generally applicable to all persons at Company’s Facilities. Company reserves the right to require an independent third party to audit on behalf of any client deemed by Company in its reasonable discretion to be a direct competitor of Company. Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent accordance with the obligations requirements of confidentiality required all applicable Regulatory Authorities. Changes in Manufacture. LONZA shall not alter any processing steps with respect to the Manufacture of Client hereunder and each Product, as such third party(ies) shall be subject to any and all conditions upon Client’s rights that steps are set forth in this Sectionthe NDA, DMF (or IND, if appropriate), applicable Manufacturing protocols, Master Batch Records or any other document governing such steps. At all timesLONZA may, Company from time to time, suggest to PCYC changes LONZA may wish to make in the Manufacture of a Product, the location of Manufacture within the Facility, the equipment used to Manufacture such Intermediate or Product or the process used to Manufacture such Intermediate or Product. LONZA shall notify PCYC of any such suggested changes via LONZA's change notice procedure, but shall not implement any such changes until signature approval has been received from PCYC's authorized Quality Assurance and Chemical Operations representatives designated in the applicable Product Appendix. PCYC shall have no obligation to accept any such suggestions. Any such changes shall be solely responsible for obtaining, maintaining and paying for all necessary approvals, licenses and permits to perform the Services provided in this Agreement at each of its Facilities. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Any ‘for cause’ audits shall be conducted made in accordance with both LONZA's and PCYC's change control policies and procedures. In the Quality Agreement (defined below)event that [ *** ], unless otherwise agreed by the Parties in writing: For clarity, neither [ *** ] [ *** ].

Regulatory Matters Records. 8.1 Access to Company’s Facilities by Client Representatives. During regular business hours ▇▇▇▇▇ shall keep documentation and mutually agreed upon times, Client may review the records of Company relating to the Services performed and expenses incurred to assure compliance with all provisions of this Agreement. Such review [*], unless otherwise agreed, and shall be offered to Client by Company not more than [*]. Subsequent reviews during the same calendar year or such reviews that cannot be completed in [*] will be at Client’s sole cost and expense, at Company’s then current rates [*]. Client shall also be provided an invoice for any incidental expenses Company incurs resulting from such review. While Services are being performed for Client, [*], or more if agreed upon by the Parties in writing, shall be permitted to be on-site at Company’s Facility as reasonably required to monitor such Services. Client’s rights in this Section 8.1 shall be subject to compliance with Company’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Company’s premises rules that are generally applicable to all persons at Company’s Facilities. Company reserves the right to require an independent third party to audit on behalf of any client deemed by Company in its reasonable discretion to be a direct competitor of Company. Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of Client hereunder and such third party(ies) shall be subject to any and all conditions upon Client’s rights that are set forth in this Section. At all times, Company shall be solely responsible for obtaining, maintaining and paying for all necessary approvals, licenses and permits to perform the Services provided in this Agreement at each of its Facilities. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Any ‘for cause’ audits shall be conducted in accordance with the Quality requirements of cGMP. ▇▇▇▇▇ will provide to PCYC copies of all documentation and information relating to the Manufacture, processing, packaging and shipping of Product and/or required to support PCYC's NDAs (or INDs, if appropriate) or other regulatory submissions, including but not limited to information relating to Batch records, specifications, methods, method validations, equipment and the Facility, for review and inclusion as necessary in PCYC's regulatory submissions. ▇▇▇▇▇ shall maintain all records and documentation under this Section 6.3 and any inspection samples and data for at least [ *** ] past the expiration dates of each Batch or for such longer period as may be required by cGMP or other regulations promulgated by the Regulatory Authorities applicable to the relevant Product. Prior to DIXIE's destruction of any of the records or documentation described in Section 6.3.1, ▇▇▇▇▇ shall notify PCYC in writing specifically identifying the records or documentation that it wishes to destroy. PCYC shall have [ *** ] from its receipt of such notice to notify ▇▇▇▇▇ that it desires to receive such records or documentation. In such event, such records or documentation shall be delivered to PCYC or its designee at PCYC's expense. If PCYC does not notify ▇▇▇▇▇ that it desires to receive such records or documentation within such thirty-day period, then ▇▇▇▇▇ shall be free to destroy such records or documentation. ▇▇▇▇▇ shall be solely responsible, at its expense, for obtaining and maintaining all Regulatory Approvals required for it to carry out its development, regulatory and Manufacturing obligations hereunder. ▇▇▇▇▇ agrees to cooperate fully with PCYC in PCYC's efforts to obtain and maintain any Regulatory Approval which may be required for the use of the Products, or the Manufacture and/or marketing of Drug Products, in any country. Such efforts shall include, without limitation, (a) providing information in DIXIE's possession that is useful or required by PCYC to submit regulatory filings or obtain or maintain Regulatory Approvals with respect to Products and/or Drug Products, including all information necessary for PCYC to complete the CMC portions of its regulatory filings; (b) allowing the use of DIXIE's name in any such filings; and (c) taking any and all other actions reasonably required to assist PCYC or its designee in obtaining Regulatory Approval of Drug Products. Upon the requirement of any Regulatory Authority, such entity shall have access to observe and inspect the Facility and DIXIE's quality and manufacturing documents and procedures used for the Manufacture of any Product, including process development and Manufacturing operations, and to audit such Facility, documents and procedures for compliance with cGMP and/or other applicable regulatory standards. ▇▇▇▇▇ shall give PCYC immediate notice of any upcoming inspections or audits by a Regulatory Authority of the Facility, documents and/or procedures relating to any Product Manufactured hereunder, and shall provide PCYC the opportunity to conduct a pre-inspection of the Facility and such documents and procedures, and to observe and participate in such inspection or audit. ▇▇▇▇▇ also agrees to notify PCYC within [ *** ] of any written or oral inquiries, notifications, or inspection activity by any Regulatory Authority in connection with any Product. ▇▇▇▇▇ shall provide a reasonable written description to PCYC of any such inquiries, notifications or inspections promptly (but in no event later than [ *** ]) after such visit or inquiry. ▇▇▇▇▇ shall furnish to PCYC (a) within [ *** ] after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to any FDA Form 483 (List of Inspectional Observations) or warning letter, and (b) not later than [ *** ] prior to the time it provides to a Regulatory Authority, copies of any and all proposed written responses or explanations relating to items set forth above (each, a "Proposed Response"), in each case purged only of trade secrets or other confidential or proprietary information of ▇▇▇▇▇ that are unrelated to the obligations under this Agreement (defined below)or are unrelated to Products. ▇▇▇▇▇ shall discuss with PCYC any comments provided by PCYC on the Proposed Response and the Parties shall mutually agree on the final written response or explanation to be provided to the Regulatory Authority. After the filing of a response with the appropriate Regulatory Authority, ▇▇▇▇▇ will notify PCYC of any further contacts with a Regulatory Authority relating to DIXIE's Manufacture of Products. ▇▇▇▇▇ shall promptly notify PCYC of any other production issues or other information of which ▇▇▇▇▇ becomes aware that may affect the regulatory status of a Product or the ability of ▇▇▇▇▇ to supply a Product in accordance with PCYC's forecasted requirements. ▇▇▇▇▇ agrees to promptly rectify or resolve any deficiencies noted by a Regulatory Authority in a report or correspondence issued to ▇▇▇▇▇, and that are based on DIXIE's performance under this Agreement, at DIXIE's expense except as otherwise set forth in Section 6.6.3. Each Party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the Manufacture of a Product under this Agreement and which are required by the FDA, other applicable Regulatory Authority or other applicable laws or governmental regulations, and shall confer with each other with respect to the best means to comply with such requirements. Drug Master File. ▇▇▇▇▇ shall file and maintain the appropriate DMF for its Manufacture of each Product hereunder, at DIXIE's expense. ▇▇▇▇▇ shall provide PCYC and its Affiliates, partners, licensees and designees with letters of authorization to reference such DMF in their respective filings with the FDA and other Regulatory Authorities. Stability Testing. ▇▇▇▇▇ shall be responsible for performing stability testing of each commercial Product, in accordance its own internal policies and procedures, except as otherwise set forth in the applicable Product Appendix.