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 (a) The Purchaser shall have the Term right, and the Supplier shall permit the Purchaser (or, at the Supplier’s request, an independent auditor (who shall be a member of an internationally recognized accounting firm) selected by the Purchaser and acceptable to the Supplier, which acceptance may not be unreasonably withheld, conditioned or delayed, during normal business hours, to audit the calculation of the Contract Price, including each of the various components included in its formula (other than published components, such as the LME Aluminium Price, which may be validated by the Purchaser by reference to the publication source), including the New Tooling Upcharge charged by the Supplier pursuant to Section 2.4(c) and the alloy adjustment calculations contemplated in Schedule 2. (b) If any such audit reveals that the Purchaser paid a Contract Price greater than the amounts required to be paid under this Agreement, Prometheus the Supplier shall promptly remit to the Purchaser (in cash or by credit to a then outstanding invoice) an amount equal to the overpayment amount. In the event the audit reveals an underpayment by the Purchaser, the Purchaser shall promptly remit an amount equal to such underpayment to the Supplier. (c) The Purchaser shall have the right to audit and inspect those portions of visit the Facility used in the manufactureSupplier Facilities, packagingwith a view to reviewing, 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 on a quarterly basis during normal business hours and shall be scheduled by Prometheus at least [***] Business Days in advance by written notice outlining hours, 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 quality *** 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 control systems and production processes at the Supplier Facilities, including with a view to verifying compliance by the Supplier with the Specifications. (d) The Supplier shall make available to the manufacture Purchaser (and/or any auditor appointed pursuant to Section 2.15(a)), during normal business hours and following reasonable advance notice by the Purchaser, such books and records, and access to such personnel (either on or off the premises) and facilities, of Product is Supplier as Purchaser or the auditor may reasonably request in order to conduct the audit in an effective manner (other than any documents or information which the Supplier may not, pursuant to any legal or confidentiality obligations owed by it to a Third Party, disclose to the Purchaser, provided that the Supplier uses reasonable endeavours to seek a waiver or other release of such legal or confidentiality obligations and may withhold information only to the extent necessary to comply with such obligations). (e) The Supplier may (or, at the Purchaser’s request, an independent auditor (who shall be a member of an internationally recognized accounting firm) selected by the Supplier and acceptable to the Purchaser, which acceptance may not be unreasonably withheld, conditioned or delayed, may), during normal business hours, audit the Purchaser’s compliance with Sections 5.1 (subject to consent Section 2.15(f)), 5.2, 5.3 and 5.8. If such audit reveals that: (i) the conditions required to be met by the Purchaser under Sections 5.2 and 5.3, as applicable, have not been met for the Relevant Contract Year or Relevant Hardship Period (as applicable); (ii) the quantity of such GSK supplier Metal purchased by the Purchaser pursuant to the terms of this Agreement during the Relevant Contract Year or subcontractor. GSK may participate Relevant Hardship Period, as applicable, represents less than the amount required to be purchased in Prometheus' audit order to invoke the rights under Section 5 as set out in Section 5.8; (iii) the Total Pre-Hardship Consumption Amount notified to the Supplier under Section 5.1 is greater than the total quantity of slabs actually used or consumed by the Relevant Purchaser Entities during the Relevant 12-Month Period from all sources in the hot rolling process of the Relevant Purchaser Entities (including sources and casthouses within the Purchaser Group and including for the purpose of transformation or processing (tolling) of slabs by Third Parties), and consequently the conditions required to be met by the Purchaser under Section 5.3 or Section 5.8 have not been met; or (iv) the Total Hardship Consumption Amount notified to the Supplier under Section 5.8 for the Relevant Contract Year or Relevant Hardship Period is greater than the actual quantity of slabs used or consumed by it from all sources in the hot rolling process of the Relevant Purchaser Entities (including sources and casthouses within the Purchaser Group and including for the purpose of transformation or processing (tolling) of slabs by Third Parties) during the Relevant Contract Year or Relevant 12-Month Period (as applicable), and consequently the conditions required to be met by the Purchaser under Section 5.8 have not been met, then the Purchaser shall be deemed to be in breach of its obligations to purchase Metal under this Agreement and shall respond not be entitled to any issues raised reduction in the quantity of Metal which is required to be purchased by Prometheus it under this Agreement, and any such reduction which it has sought to claim pursuant to Section 5 and has failed to purchase or take delivery of shall be deemed to be Metal which it has failed to pay for or take delivery of for the purposes of Section 3. (f) The Supplier may audit the Purchaser’s compliance with the Hardship Conditions in Section 5.1(i) for any Hardship Period claimed by the Purchaser. If the Supplier elects to so audit compliance with Section 5.1(i), the parties shall mutually agree, acting reasonably and without undue delay, on an independent industry expert (who shall not be an Affiliate of either the Purchaser Group or the Supplier Group) to make such determination. If the independent industry expert determines that the Hardship Conditions were not satisfied for such Hardship Period, then the Purchaser shall not be entitled to reduce the quantity of Metal which is required to be purchased by it under this Agreement based on such auditclaimed Hardship Period, with a corrective action plan mutually and any such reduction which it has sought to claim pursuant to Section 5, and any Metal it has accordingly failed to purchase or take delivery of, shall be deemed to be Metal which it has failed to pay for or take delivery of for the purposes of Section 3. (g) The Supplier may (or, at the Purchaser’s request, an independent auditor selected by the Supplier and acceptable to the Parties. For Purchaser, which acceptance may not be unreasonably withheld, conditioned or delayed (who shall be a member of an internationally recognized accounting firm) may), audit the avoidance Purchaser’s determination of doubtthe PPM Level pursuant to Schedule 6, nothing in this Section 9.1 and the Purchaser shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related the Supplier such reasonable supporting documentation relating to manufacture the determination of the ProductsPPM Level as the Supplier may request (other than any documents or information which the Purchaser may not, pursuant to any legal or confidentiality obligations owed by it to its or the Purchaser Group’s customers, disclose to the Supplier). If such audit reveals that the PPM Level is greater than that determined by the Purchaser pursuant to Schedule 6 and that the Purchaser has paid a Quality Upcharge in excess of that which it should have been in respect of the audited PPM Level, the Supplier shall promptly remit to the Purchaser (in cash or by credit to a then outstanding invoice) an amount equal to the overpayment amount. If such audit reveals that the PPM Level is lower than that determined by the Purchaser pursuant to Schedule 6 and that the Purchaser has paid a smaller Quality Upcharge than that which it should have paid in respect of the audited PPM Level, the Purchaser shall promptly remit to the Supplier (in cash or by credit to a then outstanding invoice) an amount equal to the underpayment amount. (h) Each Party shall bear the costs they incur in connection with any audit, expert determination or inspection undertaken pursuant to this Section 2.15, except that if: (i) an independent auditor is appointed to undertake such audit and such auditor’s audit reveals any discrepancies equal to at least 3% of the audited amounts which are adverse to the Party conducting the audit, the fees and expenses of such auditor shall be borne by the Party that is being audited; and (ii) if the independent industry expert appointed by the Supplier under Section 2.15(f) reveals that the conditions in Section 5.1(a) have not been satisfied in respect of the relevant Hardship Period, the fees and expenses of such expert shall be borne by the Purchaser. (i) No amounts may be audited twice under this Section 2.15.

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 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) 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 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 inspectionunderpayment by one Party to the other Party with respect thereto, 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 within *** Certain information of the date of delivery of such accounting firm’s report concluding that an overpayment or underpayment 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 this page has been omitted and filed separately with the Securities and Exchange Commissionunpaid amount at the rate set forth in Section 4.03(c). Confidential treatment has been requested If the amount of such underpayment for any particular Calendar Quarter was equal to or greater than *** of the proper amount payable with respect to such Calendar Quarter, the omitted portions. subcontractors related to Audited Party shall promptly reimburse 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 Requesting Party for the reasonable, documented costs associated with the 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 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. 12.1 During the Term term of this Agreement and any extension thereof, NCH shall have the right, at its sole cost and expense and upon prior written notice to Supplier, to send NCH representatives to audit, inspect and observe the manufacture, storage, disposal and transportation of the Licensed Products, and all other materials related thereto or used in connection therewith, with reasonable notice during normal business hours. Such NCH representatives shall have no responsibility for supervision of Supplier employees performing the manufacture, storage, disposal or transportation operations themselves. The audit and inspection rights set forth in this Section 12.1 are for the purpose of determining Supplier's compliance with the terms of this Agreement. 12.2 Supplier shall make available to NCH all records and reports relating to the manufacture, Prometheus storage, disposal and transportation of the Licensed Products, and all other materials related thereto or used in connection therewith, including without limitation those documents relating to analytical data, for NCH's review during normal business hours and upon reasonable prior written notice, and NCH shall have the right to audit copy these documents as required. Such records 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 reports shall be subject to the Products and Materials, each confidentiality provisions of cGMPs, Applicable Laws, and Regulatory ActsArticle 8 of this Agreement. Prometheus NCH shall have the right to audit conduct inventory reconciliation audits and inspect all inventories other audits as reasonably required for its internal control, at NCH's sole cost and expense. 12.3 If, as a result of Products and Materials contained at the Facilityany such inspection, NCH concludes that Supplier is not in compliance with any of its obligations hereunder, it shall so notify Supplier in writing, specifying such areas of noncompliance in reasonable detail. Such audits or inspections Supplier shall be limited provide 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 NCH within thirty (30) days of NCH's request a written notice outlining the purpose and focus action plan satisfactory to NCH, with a time line for resolution of the audit or inspectionproblems identified within a reasonable, whereby such audit or inspection date shall be mutually agreed by the Parties; provided, however, that in the event upon time frame. 12.4 Supplier shall inform NCH within twenty-four (24) hours of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus shall have the right at notification to Supplier of 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 site visits to any of GSKSupplier's suppliers facilities by the FDA, state 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 federal regulatory agencies or any other governmental or regulatory agency, relating, directly or indirectly, to the manufacture of Product is subject the Licensed Products, and shall provide to consent NCH all other materials related thereto or used in connection therewith. NCH shall have the option of such GSK supplier participating in any site visit by any governmental or subcontractorregulatory agency, if the site visit relates, directly or indirectly, to the manufacturing, storage, disposal and transportation of the Licensed Products. GSK may Should NCH not participate in Prometheus' audit and the site visit, Supplier shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to report in writing 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 results of the Productsvisit to NCH within seven (7) days of the occurrence thereof. In the event that any such governmental or regulatory agency finds that the site is deficient or unsatisfactory in any respect, Supplier shall cure all deficiencies within the cure period as ordered by the government or regulatory agency. If all deficiencies are not cured within the required time frame, NCH shall have the option to immediately terminate this Agreement, without liability.

Audit and Inspection Rights. 6.1 During the Term term of this AgreementAgreement and any extension thereof, Prometheus twice per calendar year OmegaTech shall have the right right, at its sole cost and expense, to audit send OmegaTech representatives to audit, inspect and inspect those portions of the Facility used in observe the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing disposal and transportation of the Products Products, and Materials all other materials directly related thereto or used in connection therewith, with reasonable notice during normal business hours. Such OmegaTech representatives shall have no responsibility for supervision of XX Xxxxx employees performing the manufacture, storage, packaging, disposal or transportation operations themselves. The audit and inspection rights set forth in this Section 6.1 are for the sole purposes limited purpose of ensuring determining XX Xxxxx’x compliance with the Specifications and terms of this Agreement. The limit on OmegaTech site visits of twice per calendar year would specifically not apply to OmegaTech representatives being on site at XX Xxxxx for the Quality Agreement, and, as related purpose of witnessing the execution of Development Projects that are accepted by XX Xxxxx under the terms described in Section 7. *The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Products Securities and MaterialsExchange Commission. 6.2 XX Xxxxx shall make available to OmegaTech all records and reports relating to the manufacture, each storage, packaging, disposal and transportation of cGMPs, Applicable Lawsthe Products, and Regulatory Acts. Prometheus all other materials related thereto or used in connection therewith, including without limitation those documents relating to analytical data, for OmegaTech’s review during normal business hours and upon reasonable prior notice, and OmegaTech shall have the right to audit and inspect all inventories of Products and Materials contained at the Facilitycopy these documents as required. Such audits or inspections copies shall be limited subject 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 confidentiality provision of the audit Article 4 or this Agreement. 6.3 If, as a result of any such inspection, whereby OmegaTech concludes that XX Xxxxx is not in compliance with any of its obligations hereunder, it shall so notify XX Xxxxx in writing, specifying such audit or inspection date areas of noncompliance in reasonable detail. XX Xxxxx shall be provide to OmegaTech a problem resolution plan within thirty (30) days of OmegaTech’s request. XX Xxxxx shall use reasonable efforts to remedy and/or provide an action plan with an actual time line for the problems identified within a reasonable, mutually agreed upon time frame. 6.4 XX Xxxxx shall inform OmegaTech within twenty-four (24) hours of any notification to XX Xxxxx of any site visits to the plant by the Parties; providedFDA, however, that in the event of an Adverse Event state or federal regulatory agencies or any proposed other governmental or actual inspection by the FDA or other Governmental Authorityregulatory agency, 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 directly to the manufacture of Product is subject to consent of such GSK supplier the Products, and all other materials related thereto or subcontractorused in connection therewith. GSK may participate . XX Xxxxx shall report in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to writing 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 results of the Productsvisit to OmegaTech within seven (7) days of the occurrence thereof. In the event that any such governmental or regulatory agency finds that the site is deficient or unsatisfactory in any respect, XX Xxxxx shall cure all deficiencies within such cure period as ordered by the government or regulatory agency. If all deficiencies are not cured within the required time frame, OmegaTech shall have the option to immediately terminate this Agreement.

Audit and Inspection Rights. 8.1 During the Term term of this AgreementAgreement and the Extension Period, Prometheus Ciba and its authorized representatives shall have the right, at Ciba's expense, to audit, inspect and observe the manufacture, storage, disposal and transportation of the Laminate and System of Waste during normal business hours upon five (5) days prior notice. All employees and representative of Ciba (a) shall comply with and observe all applicable rules and regulations governing their conduct while performing their audit, inspection, or observation, and (b) shall have no authority to manage, supervise, or control any of Noven's employees. Noven agrees to respond to Ciba's audit findings within thirty (30) days of receipt of the audit report, and to the responsive to the recommendations contained therein. 8.2 Noven shall make available all records and reports relating to the manufacture, storage, disposal and transportation of System and/or Waste to Ciba, as well as those documents relating to analytical and stability data, for Ciba's review during normal business hours and upon reasonable prior notice to Noven, and Ciba shall have the right to audit and inspect those portions of copy these documents as required. In the Facility event that Ciba supplies materials to be used in the manufactureby Noven, 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 Ciba shall have the right to audit conduct inventory reconciliation audits and inspect all inventories other audits as reasonably required for its internal control. 8.3 Noven agrees to fully respond, within forty-five (45) days of Products receipt, to an annual questionnaire provided by Ciba concerning Noven's safety, health and Materials contained at environmental practices and any changes thereto. 8.4 Noven shall promptly give Ciba advance notice, to the Facility. Such audits extent that advance notice is given to Noven, of any site visit to the Plants regarding the manufacture, storage, disposal 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 transportation of the audit Laminate, System, or inspection, whereby such audit Waste by any governmental or inspection date shall be mutually agreed by the Partiesregulatory agency; provided, however, that in the event Noven shall notify Ciba within eight (8) hours of an Adverse Event or notification to Noven of any proposed or actual inspection site visits by the FDA or other Governmental Authority, Prometheus FDA. Ciba shall have the right at option of attending any time upon oral such site visit by any governmental or written notice regulatory agency, if the site visit relates, directly or indirectly to GSK the manufacturing, storage, disposal and transportation of five (5) Business Days to conduct an audit or inspection hereunderthe Laminate and System. Except Should Ciba not participate in the case of an Adverse Eventsite visit, Prometheus Noven shall limit such audits to no more than once every twelve (12) months. Prometheus' audit fully report in writing the substance and inspection rights under this Section 9.1 shall not extend to any portions results of the Facility, documents, records or other information which do not relate visit 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 Ciba within seven (7) days of the Productsoccurrence thereof. In the event that any such governmental or regulatory agency finds that the Plant(s) are deficient or unsatisfactory in any respect, Ciba shall have the option to (a) assist Noven, at Noven's expense, in correcting the deficiency, or (b) terminate this Agreement provided the violations materially impair Noven's capability to continue to produce Laminate and System in accordance with this Agreement.

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.

Audit and Inspection Rights. 12.1 During the Term term of this Agreement and any extension thereof, Novartis shall have the right, at its sole cost and expense, to send Novartis representatives to audit, inspect and observe the manufacture, storage, disposal and transportation of the Products, and all other materials related thereto or used in connection therewith, with reasonable notice during normal business hours. Such Novartis representatives shall have no responsibility for supervision of Supplier employees performing the manufacture, storage, disposal or transportation operations themselves. The audit and inspection rights set forth in this Section 12.1 are for the purpose of determining Supplier's compliance with the terms of this Agreement. 12.2 Supplier shall make available to Novartis all records and reports relating to the manufacture, Prometheus storage, disposal and transportation of the Products, and all other materials related thereto or used in connection therewith, including without limitation those documents relating to analytical data, for Novartis' review during normal business hours and upon reasonable prior notice, and Novartis shall have the right to audit copy these documents as required. Such records 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 reports shall be subject to the Products and Materials, each confidentiality provisions of cGMPs, Applicable Laws, and Regulatory ActsSection 8 of this Agreement. Prometheus Novartis shall have the right to audit conduct inventory reconciliation audits and inspect all inventories other audits as reasonably required for its internal control, at Novartis' sole cost and expense. 12.3 If, as a result of Products and Materials contained at the Facilityany such inspection, Novartis concludes that Supplier is not in compliance with any of its obligations hereunder, it shall so notify Supplier in writing, specifying such areas of noncompliance in reasonable detail. Such audits or inspections Supplier shall be limited provide to not more than Novartis within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] Business Days and of Novartis' request a written action plan satisfactory to Novartis, with a time line for resolution of the problems identified within a reasonable, mutually agreed upon time frame. 12.4 Supplier shall occur during normal business hours and shall be scheduled by Prometheus at least inform Novartis within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] 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 any notification to Supplier 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 site visits to any of GSKSupplier's suppliers facilities by the FDA, state 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 federal regulatory agencies or any other governmental or regulatory agency, directly relating to the manufacture of Product is the Products, and shall provide to Novartis all other materials related thereto or used in connection therewith. Novartis shall have the option of participating in any site visit by any governmental or regulatory agency, if the site visit directly relates to the manufacturing, storage, disposal and transportation of the Products , subject to consent of such GSK supplier or subcontractorreasonable restraints on such participation as Supplier may reasonably require. GSK may Should Novartis not participate in Prometheus' audit and the site visit, Supplier shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to report in writing 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 results of the Productsvisit to Novartis within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of the occurrence thereof. In the event that any such governmental or regulatory agency finds that the site is deficient or unsatisfactory in any respect, Supplier shall cure all deficiencies within the earlier of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] or such cure period as ordered by the government or regulatory agency. If all deficiencies are not cured within the required time frame, Novartis shall have the option to immediately terminate this Agreement, without liability. 12.5 In the event that any provision of Article 12 should conflict with any provision of the QA Agreement, then the applicable provision of the QA Agreement shall take precedence over the applicable provision of this Agreement.