Common use of Audit and Inspection Rights Clause in Contracts

Audit and Inspection Rights. During the Term of this Agreement, Prometheus shall have the right to audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus shall have the right to audit and inspect all inventories of Products and Materials contained at the Facility. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours and shall be scheduled by Prometheus at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Parties; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus shall have the right at any time upon oral or written notice to GSK of five (5) Business Days to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any portions of the Facility, documents, records or other information which do not relate to Products or Materials. GSK may redact information relating to Third Parties or their respective products or materials from any documents deliverable to Prometheus in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the Products.

Audit and Inspection Rights. During the Term of this AgreementAgreement and thereafter during any applicable records retention period(s) under Section 9.3, Prometheus Approved Representatives shall have the right right, upon a prior written consent of Chemport, not to be unreasonably withheld or delayed, to audit and inspect those portions of the Facility (or the facility of a Material Third Party Supplier or Subcontractor, as the case may be) used in in, and those documents and records related to, the manufacture, packaginggeneration, storage, testing, treatment, holding, transportation, distribution or other handling, handling or receiving or invoicing of the Products API and Materials Third Party Materials. Such audits may be conducted [***] each [***]; provided, however, that Amarin may conduct additional “for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related cause” audits during a [***] to the Products and Materialsextent Chemport supplies Nonconforming API or in the event of Product complaints or Adverse Events caused by Nonconforming API. Chemport may redact from such deliveries to Amarin any Third Party confidential information or Chemport Confidential Information. During such inspections, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus Approved Representatives shall have the right to audit and inspect all inventories inventory of Products API and Third Party Materials contained at the FacilityFacility (or the facility of a Material Third Party Supplier or Subcontractor, as the case may be). Such Chemport agrees to reasonably cooperate and assist Amarin (and to require any Material Third Party Supplier or Subcontractor to cooperate and assist Amarin) in connection with any audits or inspections shall be limited pursuant to not more than [***] Business Days and this Section 9.2. Audits or inspections under this Section 9.2 shall occur during normal business hours and shall be scheduled by Prometheus Approved Representatives at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Partiesadvance; provided, however, that that, in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental AuthorityBody (whether of Chemport or a Material Third Party Supplier or Subcontractor) or other similar event or emergency involving any API or Third Party Materials, Prometheus Approved Representatives shall have the right at any time time, upon oral or written notice to GSK Chemport (or any Material Third Party Supplier or Subcontractor) of five (5) Business Days [***], to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any those affected portions of the FacilityFacility (or the facility of such Material Third Party Supplier or Subcontractor, documentsas the case may be) used in the manufacture, records generation, storage, testing, treatment, holding, transportation, distribution or other information which do not relate to Products handling or receiving of API and Third Party Materials. GSK may redact information relating Chemport shall ensure that Approved Representatives have access to Material Third Parties or their respective products or materials from Party Supplier’s and Subcontractor’s facilities in the manner set forth in this Section 9.2. Chemport shall as soon as practicable take any documents deliverable to Prometheus corrective action reasonably requested by Amarin in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the Products9.2.

Audit and Inspection Rights. During Upon *** prior written notice from either Party (the Term “Requesting Party”), the Party receiving such notice (the “Audited Party”) shall permit an independent certified public accountant selected by the Requesting Party (or any designee thereof, including with respect to BDSI, Meda) and reasonably acceptable to the Audited Party (with respect to inspections or audits directly concerning financial matters) or any designee selected by the Requesting Party and reasonably acceptable to the Audited Party (with respect to inspections or audits not directly concerning financial matters) to audit and/or inspect only those Books and Records (including but not limited to financial records) as may be necessary pursuant to the terms of the applicable Section of this Agreement, Prometheus shall have Agreement granting the right to applicable audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related and/or inspection rights to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus shall have the right Requesting Party pursuant to audit and inspect all inventories of Products and Materials contained at the Facility. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours and shall be scheduled by Prometheus at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Partiesthis Section 14.11; provided, however, that in the no event may any audit and/or inspection right granted under any Section of an Adverse Event or this Agreement be conducted more than once in any proposed or actual inspection Calendar Year, unless otherwise agreed by the FDA Audited Party. Any such independent accounting firm or other Governmental Authority, Prometheus designee shall have be subject to the right at any time upon oral or written notice to GSK confidentiality provisions of five (5) Business Days to conduct an audit or inspection hereunderthis Agreement. Except in In the case of any audit and/or inspection directly concerning financial matters, a copy of any report provided to a Party by the accountant shall be given concurrently to the other Party and shall be considered the Audited Party’s Confidential Information. Subject to the terms of this paragraph, any such inspection or audit shall be conducted (a) at the sole cost of the Requesting Party and (b) during the Audited Party’s normal business hours. If the applicable audit involves payments made and/or to be made by one Party to the other Party and such accounting firm concludes that there was an Adverse Eventoverpayment or underpayment by one Party to the other Party with respect thereto, Prometheus within *** of the date of delivery of such accounting firm’s report concluding that an overpayment or underpayment occurred, the amount overpaid shall limit be promptly repaid by the overpaid Party or the amount underpaid shall be promptly augmented by the underpaying Party as necessary to correct the underpayment, and if there was an underpayment, the underpaying Party shall pay interest on the unpaid amount at the rate set forth in Section 4.03(c). If the amount of such audits underpayment for any particular Calendar Quarter was equal to no more or greater than once every twelve (12) months*** of the proper amount payable with respect to such Calendar Quarter, the Audited Party shall promptly reimburse the Requesting Party for the reasonable, documented costs associated with the audit. Prometheus' audit and inspection The Parties agree that the rights granted to BDSI under this Section 9.1 shall not extend to any portions of the Facility, documents, records or other information which do not relate to Products or Materials. GSK 14.11 may redact information relating to Third Parties or their respective products or materials from any documents deliverable to Prometheus be exercised by CDC in connection a manner consistent with Prometheus' exercise of its audit and inspection similar rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested established with respect to CDC in the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the ProductsCDC Agreement.

Audit and Inspection Rights. During the Term of this AgreementAgreement and thereafter during any applicable records retention period(s) under Section 9.3, Prometheus Amarin representatives (collectively, “Audit Representatives”) shall have the right right, in Amarin’s discretion but not more than on [***] in any [***], to audit and inspect those portions of the Facility (or the facility of a Third Party Supplier or Subcontractor, as the case may be) used in in, and documents and records related to, the manufacture, packaginggeneration, storage, testing, treatment, holding, transportation, distribution or other handling, handling or receiving or invoicing of the Products API and Materials Third Party Materials. Notwithstanding the foregoing, Amarin may perform additional “for cause” audits during a [***] to the sole purposes extent Equateq supplies Nonconforming API or in the event of ensuring Product complaints or Adverse Events cause by Nonconforming API. Equateq may redact from such documents and Third Party or Equateq Confidential Information that is not relevant to the supply of API to Amarin and specifically Equateq may redact Equateq Confidential Information from batch records and provide view-only access to such redacted records provided that the Audit Representatives can nevertheless reasonably complete such audits to its reasonable satisfaction, and such redaction does not prevent Amarin from compliance with the Specifications and the Quality Agreement, and, as related to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Actsits Legal Requirements. Prometheus Audit Representatives shall have the right to audit and inspect all inventories inventory of Products API and Third Party Materials contained at the FacilityFacility (or the facility of a Third Party Supplier or Subcontractor, as the case may be). Such Equateq agrees to cooperate and assist Amarin (and to require any Third Party Supplier or Subcontractor to cooperate and assist Amarin) in connection with any audits or inspections pursuant to this Section 9.2 provided that Equateq shall not be limited obliged to interrupt its business operations and Amarin shall procure that its Audit Representative shall not more than [***] Business Days and disrupt Equateq’s business operations in the conduct of such audits or inspections. Audits or inspections under this Section 9.2 shall occur during normal business hours and shall be scheduled by Prometheus Audit Representatives at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Partiesadvance; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental AuthorityBody (whether of Equateq or a Third Party Supplier or Subcontractor) or other similar event or emergency involving any API or Third Party Materials, Prometheus Audit Representatives shall have the right at any time time, upon oral or written notice to GSK Equateq (or any Third Party Supplier or Subcontractor) of five (5) Business Days [***], to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any those affected portions of the FacilityFacility (or the facility of such Third Party Supplier or Subcontractor, documentsas the case may be) used in the manufacture, records generation, storage, testing, treatment, holding, transportation, distribution or other information which do not relate to Products handling or receiving of API and Third Party Materials. GSK may redact information relating Equateq shall have the benefit of equivalent arrangements in any contract with Third Party Suppliers so as to ensure that Audit Representatives have access to Third Party Supplier’s and Subcontractor’s facilities in the manner set forth in this Section 9.2. Without limiting the generality of the foregoing, Amarin or a third party consultant acceptable to both Parties or their respective products or materials from shall have the right to conduct a mock inspection of the Facility and to request potential corrective actions in advance of any documents deliverable regulatory authority’s pre-approval inspection(s) for cGMP compliance. Amarin shall be entitled to Prometheus review the results of such pre-approval inspection if performed by a third party consultant. Equateq shall promptly take any corrective action reasonably requested by Amarin in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such auditSection 9.2, with a including corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture requested as a result of the Productsmock pre-approval inspection.

Audit and Inspection Rights. During the Term of this Agreement, Prometheus shall have the right to audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus shall have the right to audit and inspect all inventories of Products and Materials contained at the Facility. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours and shall be scheduled by Prometheus at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Parties; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus shall have the right at any time upon oral or written notice to GSK of five (5) Business Days to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any portions of the Facility, documents, records or other information which do not relate to Products or Materials. GSK may redact information relating to Third Parties or their respective products or materials from any documents deliverable to Prometheus in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or Upon *** Certain information on this page has been omitted prior written notice from either Party (the “Requesting Party”), the Party receiving such notice (the “Audited Party”) shall permit an independent certified public accountant selected by the Requesting Party (or any designee thereof) and filed separately reasonably acceptable to the Audited Party (with respect to inspections or audits directly concerning financial matters) or any designee selected by the Securities Requesting Party and Exchange Commission. reasonably acceptable to the Audited Party (with respect to inspections or audits not directly concerning financial matters) to audit and/or inspect only those Books and Records (including Confidential Treatment Requested by BioDelivery Sciences International, Inc. Confidential treatment has been requested with respect to certain portions hereof denoted with “***” but not limited to financial records) as may be necessary pursuant to the omitted portionsterms of the applicable Section of this Agreement granting the applicable audit and/or inspection rights to the Requesting Party pursuant to this Section 14.11. subcontractors For greater certainty, the Audited Party shall not disclose, nor be required to disclose, to the independent accounting firm, and the independent accounting firm shall not audit, inspect or disclose to the Requesting Party, any competitively sensitive or strategic information of the Audited Party to the extent directly and solely related to any product other than the manufacture of Licensed Product is and/or any jurisdiction other than the Territory. Any such independent accounting firm or designee shall be subject to consent the confidentiality provisions of this Agreement. In the case of any audit and/or inspection directly concerning financial matters, a copy of any report provided to a Party by the accountant shall be given concurrently to the other Party and shall be considered the Audited Party’s Confidential Information. Subject to the terms of this paragraph, any such inspection or audit shall be conducted (a) at the sole cost of the Requesting Party and (b) during the Audited Party’s normal business hours. If the applicable audit involves payments made and/or to be made by one Party to the other Party and such accounting firm concludes that there was an overpayment or underpayment by one Party to the other Party with respect thereto, within *** of the date of delivery of such GSK supplier accounting firm’s report concluding that an overpayment or subcontractorunderpayment occurred, the amount overpaid shall be promptly repaid by the overpaid Party or the amount underpaid shall be promptly augmented by the underpaying Party as necessary to correct the underpayment, and if there was an underpayment, the underpaying Party shall pay interest on the unpaid amount at the rate set forth in Section 4.03(c). GSK may participate in Prometheus' audit and shall respond If the amount of such underpayment for any particular Calendar Quarter was equal to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture or greater than *** of the Productsproper amount payable with respect to such Calendar Quarter, the Audited Party shall promptly reimburse the Requesting Party for the reasonable, documented costs associated with the audit.

Audit and Inspection Rights. During Upon *** prior written notice from either Party (the Term “Requesting Party”), the Party receiving such notice (the “Audited Party”) shall permit an independent certified public accountant selected by the Requesting Party (or any designee thereof) and reasonably acceptable to the Audited Party (with respect to inspections or audits directly concerning financial matters) or any designee selected by the Requesting Party and reasonably acceptable to the Audited Party (with respect to inspections or audits not directly concerning financial matters) to audit and/or inspect only those Books and Records (including but not limited to financial records) as may be necessary pursuant to the terms of the applicable Section of this Agreement granting the applicable audit and/or inspection rights to the Requesting Party pursuant to this Section 14.11. For greater certainty, the Audited Party shall not disclose, nor be required to disclose, to the independent accounting firm, and the independent accounting firm shall not audit, inspect or disclose to the Requesting Party, any competitively sensitive or strategic information of the Audited Party to the extent directly and solely related to any product other than the Licensed Product and/or any jurisdiction other than the Territory. Any such independent accounting firm or designee shall be subject to the confidentiality provisions of this Agreement. In the case of any audit and/or inspection directly concerning financial matters, Prometheus a copy of any report provided to a Party by the accountant shall have the right to audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related be given concurrently to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus shall have the right to audit and inspect all inventories of Products and Materials contained at the Facility. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours other Party and shall be scheduled by Prometheus considered the Audited Party’s Confidential Information. Subject to the terms of this paragraph, any such inspection or audit shall be conducted (a) at least [***] Business Days in advance by written notice outlining the purpose and focus sole cost of the Requesting Party and (b) during the Audited Party’s normal business hours. If the applicable audit or inspectioninvolves payments made and/or to be made by one Party Confidential Treatment Requested by BioDelivery Sciences International, whereby such audit or inspection date shall be mutually agreed by the Parties; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus shall have the right at any time upon oral or written notice to GSK of five (5) Business Days to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any portions of the Facility, documents, records or other information which do not relate to Products or Materials. GSK may redact information relating to Third Parties or their respective products or materials from any documents deliverable to Prometheus in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Inc. Confidential treatment has been requested with respect to the omitted portions. subcontractors related certain portions hereof denoted with “***” to the manufacture other Party and such accounting firm concludes that there was an overpayment or underpayment by one Party to the other Party with respect thereto, within *** of Product is subject to consent the date of delivery of such GSK supplier accounting firm’s report concluding that an overpayment or subcontractorunderpayment occurred, the amount overpaid shall be promptly repaid by the overpaid Party or the amount underpaid shall be promptly augmented by the underpaying Party as necessary to correct the underpayment, and if there was an underpayment, the underpaying Party shall pay interest on the unpaid amount at the rate set forth in Section 4.03(c). GSK may participate in Prometheus' audit and shall respond If the amount of such underpayment for any particular Calendar Quarter was equal to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture or greater than *** of the Productsproper amount payable with respect to such Calendar Quarter, the Audited Party shall promptly reimburse the Requesting Party for the reasonable, documented costs associated with the audit.

Audit and Inspection Rights. During the Term of this AgreementAgreement and thereafter during any applicable records retention period(s) under Section 9.3, Prometheus Approved Representatives shall have the right right, upon a prior written consent of Chemport, not to be unreasonably withheld or delayed, to audit and inspect those portions of the Facility (or the facility of a Material Third Party Supplier or Subcontractor, as the case may be) used in in, and those documents and records related to, the manufacture, packaginggeneration, storage, testing, treatment, holding, transportation, distribution or other handling, handling or receiving or invoicing of the Products API and Materials Third Party Materials. Such audits may be conducted [***] each [***]; provided, however, that Amarin may conduct additional “for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related cause” audits during a [***] to the Products and Materialsextent Chemport supplies Nonconforming API or in the event of Product complaints or Adverse Events caused by Nonconforming API. Chemport may redact from such deliveries to Amarin any Third Party confidential information or Chemport Confidential Information. During such inspections, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus Approved Representatives shall have the right to audit and inspect all inventories inventory of Products API and Third Party Materials contained at the FacilityFacility (or the facility of a Material Third Party Supplier or Subcontractor, as the case may be). Such Chemport agrees to reasonably cooperate and assist Xxxxxx (and to require any Material Third Party Supplier or Subcontractor to cooperate and assist Amarin) in connection with any audits or inspections shall be limited pursuant to not more than [***] Business Days and this Section 9.2. Audits or inspections under this Section 9.2 shall occur during normal business hours and shall be scheduled by Prometheus Approved Representatives at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Partiesadvance; provided, however, that that, in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental AuthorityBody (whether of Chemport or a Material Third Party Supplier or Subcontractor) or other similar event or emergency involving any API or Third Party Materials, Prometheus Approved Representatives shall have the right at any time time, upon oral or written notice to GSK Chemport (or any Material Third Party Supplier or Subcontractor) of five (5) Business Days [***], to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any those affected portions of the FacilityFacility (or the facility of such Material Third Party Supplier or Subcontractor, documentsas the case may be) used in the manufacture, records generation, storage, testing, treatment, holding, transportation, distribution or other information which do not relate to Products handling or receiving of API and Third Party Materials. GSK may redact information relating Chemport shall ensure that Approved Representatives have access to Material Third Parties or their respective products or materials from Party Supplier’s and Subcontractor’s facilities in the manner set forth in this Section 9.2. Chemport shall as soon as practicable take any documents deliverable to Prometheus corrective action reasonably requested by Xxxxxx in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the Products9.2.

Audit and Inspection Rights. During the Term of this Agreement, Prometheus Purchaser shall have the right to audit and inspect those portions of the Facility Facilities used in the manufacture, packaging, generation, storage, testing, treatment, holding, distribution transportation, or other handling, handling or receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related to the Products APIs and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus Purchaser shall have the right to audit and inspect all inventories 22611.4-688182 v8 15 inventory of Products APIs and Materials contained at the FacilityFacilities. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours and shall be scheduled by Prometheus Purchaser at least […***…] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Partiesadvance; provided, however, that in the event of an Adverse Event with respect to any Finished Product manufactured using any API supplied hereunder or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus Purchaser shall have the right at any time upon oral or written notice to GSK FIS of five (5) Business Days […***…] to conduct an audit or inspection hereunder. Except in the case of an Adverse EventEvent with respect to any Finished Product manufactured using any API supplied hereunder, Prometheus Purchaser shall limit such audits to no more than once every twelve […***…] per calendar year for each Facility except for audit for cause, follow-up of corrective ation plans, or Pre-Approval Inspection (12PAI) monthspreparation. Prometheus' FIS and Purchaser may agree to reduce the audit frequency depending upon the results of the previous audit(s) and the quality performance of Purchaser. Purchaser’s audit and inspection rights under this Section 9.1 8.1 shall not extend to any portions of the any Facility, documents, records or other information which do not relate to Products APIs or Materials. GSK Materials or, to the extent they relate or pertain to Third Parties or their products or materials, FIS may redact information relating to Third Parties or and their respective products or materials from any documents deliverable to Prometheus Purchaser in connection with Prometheus' Purchaser’s exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may FIS shall participate in Prometheus' Purchaser’s audit and shall respond to any issues raised by Prometheus Purchaser based on such audit, audit with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the Productsplan.