Common use of Records; Audits Clause in Contracts

Records; Audits. Merck will keep, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 6 contracts

Sources: Master Collaboration and License Agreement, Master Collaboration and License Agreement (Moderna, Inc.), Master Collaboration and License Agreement (Moderna, Inc.)

Records; Audits. Merck will 6.7.1. Each Party shall keep, and will shall cause each of the other Selling Partiesits Affiliates, as applicable, agents and sublicensees to keep, full and Moderna will keep, adequate accurate records and books and records of accounting account containing all particulars that may be necessary for the purpose of calculating Direct Development Costs (including Development Payments), Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses for Products to be received or borne by the Parties pursuant to this Agreement, including, but not limited to, inventory, purchase and invoice records, manufacturing records, sales analysis, general ledgers, financial statements, and tax returns relating to Products. Such books of account, with all royalties and other amounts payable necessary supporting data, shall be kept by either each Party to at its place of business for the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] three (3) years next following the end of the Calendar Year calendar year to which each will shall pertain, such books and records of . Each Party (the “Audited Party”) shall permit an independent accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, firm selected by the other Party will permit (and procure its Affiliates, to permitthe “Auditing Party”) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party Audited Party, which acceptance shall not be unreasonably withheld or delayed, to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end Audited Party’s reports of any Calendar YearDirect Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses as provided herein. Such examinations may not All such verifications shall be conducted at the expense of the Auditing Party and not more than once in each calendar year. In the event such audit concludes that adjustments should be made in the Auditing Party’s favor, then any Calendar Year or be repeated appropriate payments (plus accrued interest at a rate announced by the Bank of America as its prime rate in effect on the date that such payment was first due plus three percent (3%) for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether period starting from the reports are correct or incorrect and date the amount of any discrepancy. No other Confidential Information payment was first due ending on the date the payment was made) shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, paid by the appropriate Audited Party shall pay the other Party the amount of the discrepancy within [***] thirty (30) days of the date of delivery of such the Audited Party receives the Auditing Party’s accounting firm’s written report so correctly concluding, or unless the Audited Party shall have a good faith dispute as otherwise agreed upon by to the Partiesconclusions set forth in such written report, in which case the audited Party shall provide written notice to the Auditing Party within such thirty (30) day period of the nature of its disagreement with such written report. The Parties shall thereafter, for a period of sixty (60) days, attempt in good faith to resolve such dispute and if they are unable to do so then the matter will be submitted to dispute resolution in accordance with Section 12.7 hereof. The fees charged by such accounting firm shall be paid by the auditing PartyAuditing Party unless the audit discloses that adjustments in favor of the Auditing Party for the period are five percent (5%) or more of the aggregate amount paid or payable by the Audited Party to the Auditing Party during the period, provided that if in which case the underpayment or overcharge exceeds [***], the audited Audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud reasonable fees and expenses charged by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearaccounting firm. The auditing Party shall treat Parties agree that all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality 6.7 is confidential and non-use provisions of this Agreement, and that it shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information information subject to the confidentiality restrictions of Article 8 hereof. 6.7.2. In addition to the foregoing, Alimera shall permit an independent certified public accountant retained by UKRF to inspect the records and books of account described in confidence pursuant Section 6.7.1 during normal business hours and upon reasonable notice to the extent required by the UKRF Licenses. Such right of inspection shall last for two (2) years following the end of the calendar quarter to which such confidentiality agreementrecords and books of account pertain, shall be limited solely to those matters directly related to CDS royalty obligations under the UKRF Licenses, and shall be allowed no more than once a year.

Appears in 4 contracts

Sources: Collaboration Agreement (pSivida Corp.), Collaboration Agreement (Alimera Sciences Inc), Collaboration Agreement (pSivida LTD)

Records; Audits. Merck Each Party will keep, and will cause each of the their other Selling Parties, as applicable, to keep, and Moderna will keep, keep adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once [***] in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] days of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c9.5(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 4 contracts

Sources: Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.), Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.), Mrna Cancer Vaccine Collaboration and License Agreement

Records; Audits. Merck will keepVertex and its Affiliates will, and will cause each of the other Selling Parties, as applicable, their respective Sublicensees to keep, keep and Moderna will keep, adequate books maintain accurate and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]. Upon [***] following the end of the Calendar Year to which each will pertainprior written notice from Company, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party Vertex will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Party Company and reasonably acceptable to Vertex, to examine the other Party to have access during normal business hours to such relevant books and records of the records Vertex and its Affiliates and Sublicensees, as may be reasonably necessary to verify the accuracy of royalty reports submitted by Vertex in accordance with Section 6.3.7. An examination by Company under this Section 6.7 will occur not more than [***] and will be limited to the payments due hereunder pertinent books and records for any Calendar Year [***] ending not more than [***] following before the end date of any Calendar Year. Such examinations the request; provided that Company may not be conducted more than once exercise its audit right pursuant to this Section 6.7 in any Calendar Year or be repeated for any Calendar Year[***] in which an audit has been conducted pursuant to Section 5.10 of the Collaboration Agreement. The accounting firm shall disclose will be provided access to such books and records at Vertex’s facility or facilities where such books and records are normally kept and such examination will be conducted during Vertex’s normal business hours. Vertex may require the auditing Party only accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by Vertex are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other Confidential Information shall information will be providedprovided to Company. If such accounting firm correctly identifies a discrepancy made during such periodthe report or information submitted by Vertex resulted in an underpayment or overpayment, the appropriate Party shall owing the underpaid or overpaid amount will promptly pay such amount to the other Party the amount Party. The costs and fees of the discrepancy within any audit conducted by Company under this Section 6.7 will be borne by Company, unless such audit reveals an underpayment of amounts owed to or an overpayment of amounts owed by Company of more than [***] percent of the date of delivery of such accounting firm’s written report so correctly concluding, amount that was owed by Vertex or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliatesowed to Vertex, as applicable) the calculation of amounts payable , with respect to such Calendar Year shall be binding and conclusive upon the Partiesrelevant period, and in which case, Vertex will reimburse Company for the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) reasonable expense incurred by Company in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 3 contracts

Sources: Sublicense Agreement (Entrada Therapeutics, Inc.), Sublicense Agreement (Entrada Therapeutics, Inc.), Sublicense Agreement (Entrada Therapeutics, Inc.)

Records; Audits. Merck will keepVertex and its Affiliates will, and will cause each of the other Selling Partiestheir respective Sublicensees to, as applicable, to keep, keep and Moderna will keep, adequate books maintain accurate and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]. Company and its Affiliates will, and will require their respective Subcontractors to, keep accurate and complete records regarding all FTE Costs and Out-of-Pocket Costs incurred in connection with the performance of Research Activities and Additional Research Activities in sufficient detail to confirm the accuracy of any payments required under this Agreement, covering the [***]. Upon [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, prior written notice from the other Party (the “Auditing Party”), the Party required to maintain such records (as applicable, the “Audited Party”) will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Auditing Party and reasonably acceptable to the other Party Audited Party, to have access during normal business hours to such examine the relevant books and records of the records Audited Party and its Affiliates and Sublicensees as may be reasonably necessary to verify the accuracy of royalty reports submitted by Vertex in accordance with Section 5.4.6 or the payments due hereunder FTE Costs and Out-of-Pocket Costs reported by Company in accordance with Section 5.8.1 and Section 5.8.2, as applicable. An examination by the Auditing Party under this Section 5.11 will occur not more than [***] and will be limited to the pertinent books and records for any Calendar Year [***] ending not more than [***] following before the end date of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Yearthe request. The accounting firm shall disclose will be provided access to such books and records at the auditing Audited Party’s facility or facilities where such books and records are normally kept and such examination will be conducted during the Audited Party’s normal business hours. The Audited Party only may require the accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by Vertex or the FTE Costs and Out-of-Pocket Costs submitted by Company, as applicable, are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other Confidential Information shall information will be providedprovided to the Auditing Party. If such accounting firm correctly identifies a discrepancy made during such periodthe report or information submitted by the Audited Party resulted in an underpayment or overpayment, the appropriate Party shall owing the underpaid or overpaid amount will promptly pay such amount to the other Party. The costs and fees of any audit conducted by the Auditing Party under this Section 5.11 will be borne by the amount Auditing Party, unless such audit reveals an underpayment of amounts owed to or an overpayment of amounts owed by the discrepancy within Auditing Party of more than [***] percent of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon amount that was owed by the Parties. The fees charged by such accounting firm shall be paid by Audited Party or owed to the auditing Audited Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable , with respect to such Calendar Year shall be binding and conclusive upon the Partiesrelevant period, and in which case, the Parties shall be released from any liability or accountability with respect to amounts payable Audited Party will reimburse the Auditing Party for such Calendar Year. The auditing the reasonable expense incurred by the Auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 3 contracts

Sources: Strategic Collaboration and License Agreement (Entrada Therapeutics, Inc.), Strategic Collaboration and License Agreement (Entrada Therapeutics, Inc.), Strategic Collaboration and License Agreement (Entrada Therapeutics, Inc.)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and sold, and sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following the end of the Calendar Year to which each will pertain, such books and a given reporting period. (b) All records of accounting (including those of its Affiliates, as applicable) will shall be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY’S Internal Audit Department or by a public accountant selected by UNIVERSITY, reasonably acceptable to such LICENSEE, and in compliance with the other terms of this Agreement for the records as may be reasonably necessary sole purpose of verifying reports and payments. Such inspector shall not disclose to verify UNIVERSITY any information other than information relating to the accuracy of reports and payments made under this Agreement or other compliance issues. In the payments due hereunder for event that any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once such inspection shows an underpayment in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration excess of [***] following for any twelve (12) month period, then LICENSEE shall pay the end cost of the audit as well as any Calendar Yearadditional sum which would have been payable to UNIVERSITY had LICENSEE reported correctly, absent willful misconduct or fraud by plus an interest charge at a Party (its Affiliates, as applicable) the calculation rate of amounts payable with respect to [***] per year on such Calendar Year additional sum. Such interest shall be binding calculated from the date on which the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [***] for any twelve (12) month period, LICENSEE shall pay the difference within [***]. (c) LICENSEE agrees to have an audit of sales and conclusive upon the Partiesroyalties conducted by an independent auditor at least [***] if annual Net Sales by LICENSEE, and the Parties shall be released from any liability its Affiliates or accountability with respect to amounts payable for such Calendar YearSublicensees are totaling [***]. The auditing Party audit shall treat all financial information subject address, at a minimum, the amount of gross sales and Net Sales by or on behalf of LICENSEE during the audit period, the amount of royalties owed to review UNIVERSITY under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and whether the royalties owed have been paid to UNIVERSITY. A report certified by the auditor shall cause its accounting firm be submitted promptly by the auditor directly to enter into an acceptable confidentiality agreement UNIVERSITY on completion. [***]. [***] Certain information in this document has been omitted and filed separately with the audited Party obligating it Securities and Exchange Commission. Confidential treatment has been requested with respect to retain all such Confidential Information in confidence pursuant to such confidentiality agreementthe omitted portions.

Appears in 3 contracts

Sources: License Agreement (Mirna Therapeutics, Inc.), License Agreement (Mirna Therapeutics, Inc.), License Agreement (Mirna Therapeutics, Inc.)

Records; Audits. Merck will keep(a) Licensee shall, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of shall ensure that its Affiliates, maintain complete and accurate records in sufficient detail as applicablemay be necessary to permit Licensor to verify the accuracy of the reports provided under Section 9.2 and the calculation of royalty payments and any payments with respect thereto for a period of three (3) will be kept at each of their principal place of business. At years after the calendar quarter to which such report pertains. (b) Upon the written request of either PartyLicensor and not more than once in each calendar year, the other Party will Licensee shall permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party Licensor and reasonably acceptable to the other Party Licensee, at Licensor’s expense, to have access during normal business hours to such of the financial records of Licensee as may be reasonably necessary to verify the accuracy of the Net Revenue Payment reports and any payments due with respect thereto hereunder (other than records for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be which Licensor has already conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be providedan audit under this Section). If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such the audited period, the appropriate Party Licensee shall pay the other Party the amount of the discrepancy such additional amounts within [***] of forty-five (45) days after the date of delivery of Licensor delivers to Licensee such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by plus interest from the Partiesoriginal due date. The fees charged by such accounting firm shall be paid by the auditing PartyLicensor; provided, provided that however, if the audit discloses an underpayment or overcharge exceeds [***]by Licensee of more than seven and a half percent (7.5%) of the Net Revenue Payment payable by Licensee, the audited Party then Licensee shall pay the feesreasonable fees and expenses charged by such accounting firm. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (Licensor shall cause its Affiliates, as applicable) the calculation of amounts payable with respect accounting firm to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat retain all financial information subject to review under this Section 8.6(c9.4(b) in accordance with strict confidence; provided, however, that Licensee shall have the confidentiality and right to require that such accounting firm, prior to conducting such audit, enter into an appropriate non-use provisions of this Agreementdisclosure agreement with Licensee regarding such financial information. No other information shall be shared. Licensor shall treat all such financial information as Licensee’s confidential information, and shall cause its accounting firm not disclose such financial information to enter into an acceptable confidentiality agreement with any Third Party, except to Romeg as required in the audited Party obligating Gloperba License Agreement, or use it to retain all such Confidential Information for any purpose other than as specified in confidence pursuant to such confidentiality agreementthis Section 9.4(b).

Appears in 2 contracts

Sources: License Agreement (Scilex Holding Co), License Agreement (Oramed Pharmaceuticals Inc.)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and/or sold, and sublicense fees or other sublicense consideration received for the purpose of calculating all royalties and other amounts payable any Patent Rights or Licensed Methods under this Agreement. Such records shall be retained by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the LICENSEE for at least [***] following the end of the Calendar Year to which each will pertain, such books and a given reporting period. (b) All records of accounting (including those of its Affiliates, as applicable) will shall be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY’S Internal Audit Department or by a public accountant selected by UNIVERSITY and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments. Such inspector shall not disclose to such of the records as may be reasonably necessary UNIVERSITY any information other than information relating to verify the accuracy of reports and payments made under this Agreement or other compliance issues. In the payments due hereunder for event that any Calendar Year ending not more than such inspection shows an underpayment in excess of [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party then LICENSEE shall pay the other Party the amount cost of the discrepancy audit as well as any additional sum which would have been payable to UNIVERSITY had LICENSEE reported correctly, plus an interest charge at a rate of [***] per year on such additional sum. Such interest shall be calculated from the gate on which the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [***] for any [***] LICENSEE shall pay the difference within [***] without interest charge or inspection costs. (c) LICENSEE agrees to have an audit of the date of delivery of such accounting firm’s written report so correctly concludingsales and royalties conducted by an independent auditor at least every [***] if annual Net Sales by LICENSEE, its Affiliates or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds Sublicensees are totaling over [***]. The audit shall address, at a minimum, the audited Party shall pay amount of gross sales and Net Sales by or on behalf of LICENSEE during the fees. Upon audit period, the expiration amount of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect royalties owed to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review UNIVERSITY under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and whether the royalties owed have been paid to UNIVERSITY. A report certified by the auditor shall cause its accounting firm be submitted promptly by the auditor directly to enter into an acceptable confidentiality agreement with UNIVERSITY on completion. LICENSEE shall pay the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreemententire cost of the audit.

Appears in 2 contracts

Sources: License Agreement (HOOKIPA Pharma Inc.), License Agreement (HOOKIPA Pharma Inc.)

Records; Audits. Merck will keepCompany, and will cause each of the other Selling Partiesits Affiliates, as applicable, to keep, shall keep complete and Moderna will keep, adequate books and accurate records of accounting for the purpose Net Sales of calculating all royalties Products and other amounts payable consideration received by either Party Company or its Affiliate that is subject to the other Party hereunder and ensuring each Party’s compliance payment due to Licensor under Sections 3.1(a), (b) or (c), as applicable or the determination of such payments under Sections 3.1(d) or (e), in sufficient detail to permit Licensor to confirm the accuracy of payments due hereunder. For the Such records shall be open to inspection at any reasonable time during normal business hours not more often than [***] following each calendar quarter during the term of this Agreement and for [***] years after the end of the Calendar Year Royalty Term to which each will pertainsuch records relate. Licensor shall have the right to cause an independent, certified public accountant selected by Licensor to audit such books records to confirm Net Sales, royalty payments and other payments due under this Agreement for a period covering not more than the preceding [***] years. Licensor agrees to treat, and to use commercially reasonable efforts to cause such accountant to treat, all such information as confidential and not to use or disclose (except to Licensor and as needed to enforce the terms of this Agreement) any such information for any purpose except to determine compliance with this Agreement. For the avoidance of doubt, Company shall not be obligated to provide Licensor or such accountant with access to any records or information other than that which is necessary to confirm Net Sales, royalty payments and other payments hereunder. Such audits may be exercised upon reasonable prior written notice to Company. Prompt adjustments shall be made by the parties to reflect the results of accounting (including those such audit. The cost of its Affiliates, as applicable) the audits will be kept at each of their principal place of business. At the request of either Partyborne by Licensor; however, the if it is determined by any audit that Licensor has been underpaid in royalties and other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected payments by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds percent ([***]%) of what was owed to Licensor in any quarter that is the subject of the audit, the audited Party shall pay cost of the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud audit will be borne by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementCompany.

Appears in 2 contracts

Sources: Exclusive License Agreement (Connect Biopharma Holdings LTD), Exclusive License Agreement (Connect Biopharma Holdings LTD)

Records; Audits. Merck will keepCempra shall maintain, and will shall cause each its Affiliates, Sublicensees, and Product Partners to maintain, complete and accurate records of Royalty Products that are made, used, sold, leased or transferred under this Agreement, which records shall contain sufficient information to permit MP to confirm the accuracy of any reports or notifications delivered to it under Section 3.12 of this Agreement. Cempra shall retain, and cause its Affiliates, Sublicensees to retain, such records relating to a given Calendar Quarter for at least five (5) years after the conclusion of that Calendar Quarter, during which time MP and Harvard will, subject to the terms of this Section 3.19, have the right, at their expense, to cause an independent, certified public accountant (or, in the event of a non-financial audit, other Selling Partiesappropriate independent, neutral auditor) to inspect such records during normal business hours for the purposes of verifying the accuracy of any reports and payments delivered under this Agreement and Cempra’s compliance with the terms hereof. Such accountant or other auditor, as applicable, shall be bound by obligations of confidentiality and non-use with respect to keep, information disclosed by Cempra and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and shall not disclose to MP or Harvard any information other amounts payable by either Party than information relating to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of reports and payments delivered under this Agreement. MP shall promptly provide Cempra a copy of the payments due hereunder for any Calendar Year ending not more than [***] following the end results of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year audit or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Partiesinspection under this Section 3.19, and the Parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of the audit, provided that any overpayment by Cempra of royalties or any other amount paid to MP revealed by an inspection or audit shall, in Cempra’s sole discretion, (i) be released from fully-creditable against future payments under this Agreement or (ii) refunded to Cempra within thirty (30) Calendar Days of its request. If any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review audit performed under this Section 8.6(c3.19 reveals an underpayment in excess of five percent (5%) in accordance any Calendar Year, Cempra shall reimburse MP for all reasonable, documented amounts incurred in connection with the confidentiality such audit. MP and non-use provisions of Harvard may collectively exercise their rights under this Agreement, Section 3.19 only once every Calendar Year per audited entity and shall cause its accounting firm only with reasonable prior notice to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementCempra.

Appears in 2 contracts

Sources: Option and License Agreement (Cempra, Inc.), Option and License Agreement (Cempra, Inc.)

Records; Audits. Merck ▇▇▇ and its Affiliates and sublicensees will keep, maintain complete and will cause each accurate records in sufficient detail to permit Virobay to confirm the accuracy of the other Selling Partiescalculation of royalty payments and the achievement of sales milestone events. Virobay and its Affiliates will maintain complete and accurate records in sufficient detail to permit ▇▇▇ to confirm the accuracy of the calculation of FTEs and Third Party payments for Development or Manufacturing reimbursed by ▇▇▇ under Section 8.2. Upon reasonable prior notice, as applicable, to keep, and Moderna will keep, adequate books and such records shall be available during regular business hours for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [*** * *] following years from the end of the Calendar Year calendar year to which they pertain for examination, not more often than once each will pertaincalendar year, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party and reasonably acceptable to the audited Party, for the sole purpose of verifying the accuracy of the financial reports furnished by the other Party pursuant to have access during normal business hours this Agreement. Any such auditor shall not disclose the audited Party’s Confidential Information, except to the extent such of the records as may be reasonably disclosure is necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following financial reports furnished by the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year audited Party or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate payments due by one Party shall pay to the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Partiesunder this Agreement. The fees charged by such accounting firm Any amounts shown to be owed but unpaid shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds within [***], the audited Party shall pay the fees. Upon the expiration of [*** * *] following days from the end of any Calendar Yearaccountant’s report, absent willful misconduct or fraud by a Party plus interest (its Affiliates, as applicableset forth in Section 8.9) from the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearoriginal due date. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with bear the confidentiality and non-use provisions full cost of this Agreement, and shall cause its accounting firm to enter into such audit unless such audit discloses an acceptable confidentiality agreement with underpayment by the audited Party obligating it to retain all of more than [* * *] of the amount due, in which case the audited Party shall bear the full cost of such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 2 contracts

Sources: Development and License Agreement (Virobay Inc), Development and License Agreement (Virobay Inc)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and sold, and sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] at least five (5) years following the end of the Calendar Year to which each will pertain, such books and records of accounting a given reporting period. (including those of its Affiliates, as applicableb) will be kept at each of their principal place of business. At the Upon written request of either PartyUNIVERSITY, the other Party will permit (and procure its Affiliates, LICENSEE shall make such records available to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records UNIVERSITY as may be reasonably necessary to verify the accuracy of the reports and payments due hereunder hereunder. The specific requests shall be for records from any Calendar Year year ending not more than five (5) years prior to the date of such request. All records shall be available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY’s Internal Audit Department or by a Certified Public Accountant selected by UNIVERSITY and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such inspector shall not disclose to UNIVERSITY any information other than information relating to the accuracy of reports and payments made under this Agreement or other compliance issues. In the event that any such inspection shows an under reporting and underpayment in excess of [...***...] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such twelve (12) month period, the appropriate Party then LICENSEE shall pay the other Party the amount cost of the discrepancy within audit as well as any additional sum that would have been payable to UNIVERSITY had the LICENSEE reported correctly, plus an interest charge at a rate of [...***...] of per year. Such interest shall be calculated from the date the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [...***]...] for any twelve (12) month period, the audited Party LICENSEE shall pay the fees. Upon difference within thirty (30) days without interest charge or inspection cost. (c) UNIVERSITY may provide the expiration of [***] following VA with all financial information obtained from LICENSEE under Paragraph 4.1 hereof to the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Partiesextent required under VA/UC Agreement, and if such information is provided to the Parties shall be released from any liability or accountability with respect VA, UNIVERSITY will require that the VA not disclose it to amounts payable for such Calendar Year. The auditing Party third parties. (d) Notwithstanding Paragraph 4.2(c) hereof, UNIVERSITY shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, obtained from LICENSEE as confidential and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information financial information in confidence pursuant to such confidentiality agreementconfidence.

Appears in 2 contracts

Sources: License Agreement (Chimerix Inc), License Agreement (Chimerix Inc)

Records; Audits. Merck will keepEach of Celltech and Amgen and their respective Affiliates shall keep and maintain complete and accurate records and books of account documenting in detail sufficient to track and determine, in a manner consistent with GAAP, all revenues, expenses and will cause each all other data necessary for the Product Contributions and other sums payable pursuant to this Agreement and in compliance with the terms of the other Selling Parties, Agreement. Such records shall be retained for a period of the later of (a) a [*] period following the year in which any payments were made hereunder; (b) the expiration of the applicable tax statute of limitations (or any extensions thereof); or (c) such longer period as applicable, to keep, may be required by law. Each Party and Moderna will keep, adequate books and records their respective Affiliates shall permit independent accountants of accounting for the purpose of calculating all royalties and other amounts payable internationally recognised standing retained by either Party to the other Party hereunder and ensuring each (the “Auditing Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party Party, upon reasonable prior written notice, to have access during normal business hours to such its and its Affiliates’ records and books and premises for the sole purpose of determining the records as may be reasonably necessary appropriateness of costs charged by or accrued to verify the accuracy Party being audited and the correctness of the payments amounts due hereunder and payable under this Agreement for any Calendar Year year ending not no more than [*] prior to the date of such request; provided however, that the books and records for any particular Contract Year shall only be subject to one audit. Such examination shall be conducted during regular business hours and no more than once in each calendar year. The report of such accountant shall be limited to a certificate verifying, or not verifying, as the case may be, any report made or payment submitted by the audited Party during such period. In the event the accountant shall be unable to verify the correctness of any such payment, the accountant’s report shall specify why such payment is unverifiable and the amount of any discrepancy. The audited Party shall receive a copy of each such report concurrently with receipt by the Auditing Party and the Parties shall use good faith efforts to resolve any discrepancies. All information contained in any such report shall be deemed Confidential Information hereunder. If such examination reveals that such costs or payments have been misstated, any adjustment shall be promptly refunded or paid, as appropriate. The Auditing Party shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals a net discrepancy of [*] ([*]%) or more for the period examined which is to the disadvantage of the Auditing Party, in which case the Party who misreported shall pay all reasonable costs and expenses incurred by the Auditing Party in the course of making such determination. Upon the expiration of [*] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Contract Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of any such amounts payable with respect to such Calendar Year year shall be binding and conclusive upon the Parties, a Party entitled to such audit and the Parties other Party or its Affiliates shall be released from any liability or accountability with respect to such amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementyear.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Amgen Inc), Collaboration and License Agreement (Amgen Inc)

Records; Audits. Merck will Buyer shall keep, and will shall cause each of the other Selling Parties, as applicable, its Affiliates and third party licensees and sublicensees to keep, full and Moderna will keep, adequate accurate records and books and records of accounting account containing all particulars that may be necessary for the purpose of calculating Net Sales and any deductions to payments due to Seller pursuant to Section 3.1(e). Such records and books of account, with all royalties and other amounts payable necessary supporting data, shall be kept by either Party to the other Party hereunder and ensuring each PartyBuyer (or its Affiliates, licensees or sublicensees) at its place of business or at another location under Buyer’s compliance hereunder. For (or its Affiliates’, licensees’ or sublicensees’) control for the [***] years following the end of the Calendar Year calendar year to which each will shall pertain. Upon written request from Seller, such books and records of accounting not more than [**] per calendar year, Buyer (including those of or its Affiliates, as applicablelicensees or sublicensees) will be kept at each of their principal place of business. At the request of either Party, the other Party will shall permit (and procure its Affiliates, to permit) an independent certified public nationally recognized accounting firm of internationally recognized standing selected by the auditing Party Seller and reasonably acceptable to the other Party Buyer (it being agreed to and acknowledged by Buyer that Seller’s current accounting firm, ▇▇▇▇▇▇ Lupin, is acceptable to Buyer for such purposes), which acceptance shall not be unreasonably withheld, delayed or conditioned, to have access after reasonable advance notice and during normal business hours to such records and books of the records account as may be reasonably necessary to verify the accuracy of the payments Buyer’s reports of Net Sales as provided herein. In the event any such audit concludes that adjustments should be made in Seller’s favor, Seller shall provide to Buyer a complete copy of the accountant’s written report reflecting such adjustments. Buyer shall have the right to dispute such adjustments in good faith by providing written notice of such dispute to Seller within thirty (30) days of the date on which the applicable written report is received by Buyer. Any dispute shall be resolved in accordance with the provisions of Section 14.4. Buyer shall pay the amounts, if any, finally determined to be due hereunder for (plus accrued interest thereon, from the date originally due, at the annual rate announced by Bank of America (or any Calendar Year ending not more than successor) as its prime rate in effect on the date that such payment was first due plus [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within percent ([***] of ]%), and in no event later than thirty (30) days after the date of delivery of such Buyer receives Seller’s accounting firm’s written report so correctly concludingor the dispute is resolved in accordance with Section 14.4, or as otherwise agreed upon by the Partiescase may be. If any such audit determines that Buyer has overpaid any amount to the Seller, Seller shall promptly refund such amount. The fees charged by such the accounting firm shall be paid by Seller unless the auditing Partyaudit (or final resolution, provided if applicable) reflects that if adjustments in favor of Seller exceed the underpayment aggregate amount paid or overcharge exceeds [***]payable by Buyer for any relevant calendar year by five percent (5%) or more, the audited Party in which case Buyer shall pay the fees. Upon reasonable fees and expenses charged by such accounting firm, promptly after receipt of the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable invoice for such Calendar Yearaudit. The auditing Party shall treat Seller agrees that all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality 3.4 is Confidential Information of Buyer and non-use provisions of this Agreement, and that it shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information information subject to the confidentiality restrictions set forth in confidence pursuant to such confidentiality agreementthis Agreement.

Appears in 2 contracts

Sources: Asset Purchase Agreement (Ikaria, Inc.), Asset Purchase Agreement (Ikaria, Inc.)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and sold, and Sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] years following the end of the Calendar Year to which each will pertain, such books and a given reporting period. (b) All records of accounting (including those of its Affiliates, as applicable) will shall be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY’s Internal Audit Department or by a Certified Public Accountant selected by UNIVERSITY and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such inspector shall not disclose to such of the records as may be reasonably necessary UNIVERSITY any information other than information relating to verify the accuracy of reports and payments made under this Agreement or other compliance issues. In the payments due hereunder for event that any Calendar Year ending not more than such inspection shows an under reporting and underpayment in excess of [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm twelve-month (12-month) period, UNIVERSITY shall disclose to the auditing Party only whether the reports are correct or incorrect provide LICENSEE with a report of such inspector’s findings and the amount of any discrepancy. No other Confidential Information shall be providedconclusions. If such accounting firm correctly identifies a discrepancy made during such periodLICENSEE does not dispute the report, the appropriate Party then LICENSEE shall pay the other Party the amount cost of the discrepancy audit as well as any additional sum that would have been payable to UNIVERSITY had the LICENSEE reported correctly, plus an interest charge at a rate of [***] per year. Such interest shall be calculated from the date the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [***] for any twelve-month (12-month) period, LICENSEE shall pay the difference within [***] days without interest charge or inspection cost. Any unresolved dispute between the parties regarding the report shall first be referred to the Chief Financial Officer of LICENSEE and UNIVERSITY’s Assistant Vice Chancellor, Technology Transfer. If the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of dispute has not been resolved within [***] following days after such referral, then the end of parties may pursue any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall and all remedies that may be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review available under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, at law and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementequity.

Appears in 2 contracts

Sources: License Agreement (Prothena Corp PLC), License Agreement (Prothena Corp PLC)

Records; Audits. Merck will keep, Purdue shall maintain complete and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate accurate books and records in accordance with GAAP (to the extent appropriate) in sufficient detail to permit Transcept to confirm the accuracy of accounting for the purpose of calculating all royalties milestones, super royalty payments, royalty payments and other amounts compensation payable under this Agreement for a period of five (5) years from the creation of individual records or any longer period required by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of businessApplicable Law. At the request of either PartyTranscept’s request, the other Party will permit records going back no more than three (and procure its Affiliates, to permit3) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access years shall be available for review not more than once each calendar year (during normal business hours on a mutually agreed date with reasonable advance notice) by an independent Third Party auditor selected by Transcept and approved by Purdue (such approval not to such be unreasonably withheld, conditioned, or delayed) and subject to confidentiality and non-use obligations no less stringent than those set forth in Article 11 for the sole purpose of verifying for Transcept the accuracy of the records as may be reasonably financial reports furnished by Purdue pursuant to this Agreement or of any payments made by Purdue to Transcept pursuant to this Agreement. Any such auditor shall not disclose Purdue’s Confidential Information to Transcept, except to the extent such disclosure is necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year financial reports furnished by Purdue or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancypayments due by Purdue under this Agreement. No other Confidential Information Any amounts shown to be owed but unpaid or overpaid and in need of reimbursement shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, paid or refunded (as the appropriate Party shall pay the other Party the amount of the discrepancy case may be) within [***] of after the date of delivery accountant’s report, plus interest (as set forth in Section 7.9) from the original due date. Transcept shall bear the full cost of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon audit unless such audit reveals an underpayment by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration Purdue of [***] following percent ([***]%) or more during the end applicable audit period, in which case Purdue shall bear the full cost of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 2 contracts

Sources: License and Collaboration Agreement, License and Collaboration Agreement (Transcept Pharmaceuticals Inc)

Records; Audits. Merck will keep(a) Licensee shall, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of shall ensure that its Affiliates, maintain complete and accurate records in sufficient detail as applicablemay be necessary to permit Licensor to verify the accuracy of the reports provided under Section 9.2 and the calculation of royalty payments and any payments with respect thereto for a period of three (3) will be kept at each of their principal place of business. At years after the calendar quarter to which such report pertains. (b) Upon the written request of either PartyLicensor and not more than once in each calendar year, the other Party will Licensee shall permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party Licensor and reasonably acceptable to the other Party Licensee, at Licensor’s expense, to have access during normal business hours to such of the financial records of Licensee as may be reasonably necessary to verify the accuracy of the Net Revenue Payment reports and any payments due with respect thereto hereunder (other than records for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be which Licensor has already conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be providedan audit under this Section). If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such the audited period, the appropriate Party Licensee shall pay the other Party the amount of the discrepancy such additional amounts within [***] of forty-five (45) days after the date of delivery of Licensor delivers to Licensee such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by plus interest from the Partiesoriginal due date. The fees charged by such accounting firm shall be paid by the auditing PartyLicensor; provided, provided that however, if the audit discloses an underpayment or overcharge exceeds [***]by Licensee of more than seven and a half percent (7.5%) of the Net Revenue Payment payable by Licensee, the audited Party then Licensee shall pay the feesreasonable fees and expenses charged by such accounting firm. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (Licensor shall cause its Affiliates, as applicable) the calculation of amounts payable with respect accounting firm to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat retain all financial information subject to review under this Section 8.6(c9.4(b) in accordance with strict confidence; provided, however, that Licensee shall have the confidentiality and right to require that such accounting firm, prior to conducting such audit, enter into an appropriate non-use provisions of this Agreementdisclosure agreement with Licensee regarding such financial information. No other information shall be shared. Licensor shall treat all such financial information as Licensee’s confidential information, and shall cause its accounting firm not disclose such financial information to enter into an acceptable confidentiality agreement with any Third Party, except to Oishi and Itochu as required in the audited Party obligating Development Agreement and the Supply Agreement, or use it to retain all such Confidential Information for any purpose other than as specified in confidence pursuant to such confidentiality agreementthis Section 9.4(b).

Appears in 2 contracts

Sources: Licensing Agreement (Scilex Holding Co), Lidocaine License Agreement (Oramed Pharmaceuticals Inc.)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and sold, and Sublicense Fees paid and received under this Agreement. Such records shall be retained by LICENSEE for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following a given reporting period. (b) Subject to entry of commercially reasonable confidentiality agreements between the end of the Calendar Year to which each will pertainParties and any audit firm, such books and all records of accounting (including those of its Affiliates, as applicable) will shall be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access available during normal business hours for inspection at the expense of Cornell by Cornell’s Internal Audit Department or by a Certified Public Accountant selected by Cornell and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such access need not be given to any such set of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more often than once each calendar year or more than [***] following after the end date of any Calendar Yearreport to be audited. Such examinations may inspector shall not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to Cornell any information other than information relating to the auditing Party only whether accuracy of reports and payments made under this Agreement or other compliance issues. In the reports are correct or incorrect event that any such inspection shows an under reporting and the amount underpayment in excess of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such [***] period, the appropriate Party then LICENSEE shall pay the other Party the amount cost of the discrepancy audit as well as any additional sum that would have been payable to Cornell had the LICENSEE reported correctly, plus an interest charge at a rate of [***]. Such interest shall be calculated from the date the correct payment was due to Cornell up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [***] period, LICENSEE shall pay the difference within [***] without inspection cost but with interest charge per the provisions of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the PartiesParagraph 4.3 (c). The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [[ ***]* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar YearMARKED BY BRACKETS, absent willful misconduct or fraud by a Party HAS BEEN OMITTED BECAUSE IT IS BOTH (its Affiliates, as applicableI) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(cNOT MATERIAL AND (II) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementIS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

Appears in 1 contract

Sources: License Agreement (Lexeo Therapeutics, Inc.)

Records; Audits. Merck will (a) Each Party shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees or licensees to keep, complete, true and Moderna will keep, adequate accurate books of accounts and records of accounting for the purpose of calculating all royalties and other determining the amounts payable pursuant to Article VII or confirming pursuant to Sections 4.4 and 4.6(a) any reimbursement of FTE Costs and Out-of-Pocket Costs. Such records shall be kept for the longer of (i) the period of time required by either Party to applicable Law in the other Party hereunder Licensed Territory and ensuring each Party’s compliance hereunder. For the (ii) [***] following the end expiration or termination of this Agreement. (b) Each Party shall have the Calendar Year right to which each will pertain, such examine and audit the other Party’s and its Affiliates’ and licensees’ or Sublicensees’ relevant books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of any reports and payments prepared or delivered by the payments due hereunder other Party pursuant to this Agreement. Any such audit shall be on at least [***] prior written notice, shall be limited to not more than [***], and shall be limited to the pertinent books and records for any Calendar Year ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not The audit shall be conducted more than once in any Calendar Year or be repeated for any Calendar Yearperformed at the requesting Party’s sole expense by an independent certified public accounting firm of internationally recognized standing that is selected by such requesting Party and reasonably acceptable to the other Party. The accounting firm shall disclose be required to enter into a reasonable and customary confidentiality agreement with the audited Party to protect the confidentiality of its books and records. The audited Party, its Affiliates and licensees or Sublicensees shall make the relevant books and records reasonably available during normal business hours for examination by the accounting firm. Except as may otherwise be agreed, the accounting firm shall be provided access to such books and records at the audited Party’s and/or its Affiliates’ or licensees’ or Sublicensees’ facilities where such books and records are normally kept. Upon completion of the audit, the accounting firm shall provide both Parties a written report disclosing whether or not the relevant reports or payments are correct, and the specific details concerning any discrepancies. The decision of the accounting firm shall be final and binding on the Parties absent manifest error. The accounting firm shall not provide to the auditing requesting Party only whether any additional information or access to the reports are correct audited Party’s or incorrect its Affiliates’ or licensees’ or Sublicensees’ Confidential Information. If the accounting firm conducting an audit pursuant to this Section 8.4(b) concludes as a result of such audit that any additional amounts were due and payable to the amount of any discrepancy. No other Confidential Information requesting Party, such additional amounts shall be provided. If paid to such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within thirty [***] of the date of delivery of that the Parties receive such accounting firmaccountant’s written report so correctly concluding, or as otherwise agreed upon report. In the event that the total amount of any underpayments by the Parties. The fees charged by such accounting firm shall be paid by audited Party to the auditing Party, provided that if requesting Party for the underpayment or overcharge audited period exceeds [***]] of the aggregate total amount that was properly due and payable to the requesting Party for the audited period, then the audited Party shall pay also reimburse the fees. Upon requesting Party for the expiration documented, reasonable out of [***] following pocket Third Party expenses incurred in conducting the end of audit, except to the extent that such underpayment was due to any Calendar Year, absent willful misconduct inaccurate or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect incomplete information provided to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementby the requesting Party.

Appears in 1 contract

Sources: License Agreement (Seres Therapeutics, Inc.)

Records; Audits. Merck will keep(a) GSK shall, and will cause each of the other Selling Parties, shall ensure that its Affiliates and Sublicensees (as applicable), keep complete and accurate records in accordance with its record retention policies applicable to keep, and Moderna will keep, adequate such books and records records, but in any event for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following after the end of the Calendar Year in which any such payment becomes payable, in sufficient detail to which each will pertain, confirm the accuracy of the calculations hereunder and in accordance with the applicable Accounting Standard that is normally applied by such books and records of accounting (including those Party with respect to the filing of its Affiliatesreporting. (b) During the Term and for [***] thereafter, as applicable) will be kept at each of their principal place of business. At the request of either PartyGSK shall permit, the other Party will permit (and procure shall cause its Affiliates, Affiliates or Sublicensees to permit) , an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party Arrowhead, and reasonably acceptable to the other Party GSK or such Affiliate or Sublicensee, to have access to and to review, during normal business hours to such and under obligations of confidentiality at least as protective of GSK Confidential Information as the records as may be reasonably necessary confidentiality provisions of ‎Article 7 and upon [***] prior written notice, no more frequently than once in any [***] period (except in the case of fraud), to verify the accuracy of the Royalty Reports and payments due hereunder for under this ‎Article 5 with respect to any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Yearthree (3) years prior to such audit request. The accounting firm shall disclose to the auditing Party GSK and Arrowhead only whether the reports Royalty Reports are correct or incorrect and the amount of specific details concerning any discrepancy. No other Confidential Information shall be provideddiscrepancies. If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such period, the appropriate Party and GSK agrees with such calculation, GSK shall pay the other Party the amount of the discrepancy additional undisputed amount, plus interest as set forth in Section ‎5.5(c), within [***] of the date of delivery days following GSK’s receipt of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Partiesand a Valid Invoice in accordance with Section ‎5.5(b). The fees charged by If such accounting firm concludes that an overpayment was made, such overpayment shall be paid fully creditable against amounts payable in subsequent payment periods. If GSK disagrees with such calculation, GSK and Arrowhead shall, acting reasonably and in good faith, work to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within twenty (20) Business Days, the dispute shall be submitted for resolution to an accounting firm jointly selected by the auditing PartyParties to conduct a review, provided and if such firm concurs that if any additional amounts were owed by GSK during such period, GSK shall make the underpayment or overcharge exceeds [***]required payment, the audited Party shall pay the fees. Upon the expiration of plus interest as set forth in Section ‎5.5(c), within [***] days following GSK’s receipt of the end report of its accounting firm and a Valid Invoice in accordance with Section ‎5.5(b). Arrowhead shall pay for the cost of any Calendar Yearaudit, absent willful misconduct unless GSK has underpaid Arrowhead by [***] or fraud by a Party (its Affiliates, as applicable) more for the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearaudited period. The auditing Each Party shall treat all financial information subject to review that it receives under this Section 8.6(c‎5.6(b) in accordance with the confidentiality and non-use provisions of ‎Article 7 of this Agreement, and shall cause its accounting firm to enter into an acceptable acceptable, reasonable confidentiality agreement with the audited other Party obligating it such firm to retain all such Confidential Information financial information in confidence pursuant to such confidentiality agreement, except to the extent necessary for such Party to enforce its rights under this Agreement.

Appears in 1 contract

Sources: Exclusive License Agreement (Arrowhead Pharmaceuticals, Inc.)

Records; Audits. Merck will keepEach of Celltech and Amgen and their respective Affiliates shall keep and maintain complete and accurate records and books of account documenting in detail sufficient to track and determine, in a manner consistent with GAAP, all revenues, expenses and will cause each all other data necessary for the Product Contributions and other sums payable pursuant to this Agreement and in compliance with the terms of the other Selling Parties, Agreement. Such records shall be retained for a period of the later of (a) a [*] period following the year in which any payments were made hereunder; (b) the expiration of the applicable tax statute of limitations (or any extensions thereof); or (c) such longer period as applicable, to keep, may be required by law. Each Party and Moderna will keep, adequate books and records their respective Affiliates shall permit independent accountants of accounting for the purpose of calculating all royalties and other amounts payable internationally recognised standing retained by either Party to the other Party hereunder and ensuring each (the “Auditing Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party Party, upon reasonable prior written notice, to have access during normal business hours to such its and its Affiliates' records and books and premises for the sole purpose of determining the records as may be reasonably necessary appropriateness of costs charged by or accrued to verify the accuracy Party being audited and the correctness of the payments amounts due hereunder and payable under this Agreement for any Calendar Year year ending not no more than [*] prior to the date of such request; provided however, that the books and records for any particular Contract Year shall only be subject to one audit. Such examination shall be conducted during regular business hours and no more than once in each calendar year. The report of such accountant shall be limited to a certificate verifying, or not verifying, as the case may be, any report made or payment submitted by the audited Party during such period. In the event the accountant shall be unable to verify the correctness of any such payment, the accountant's report shall specify why such payment is unverifiable and the amount of any discrepancy. The audited Party shall receive a copy of each such report concurrently with receipt by the Auditing Party and the Parties shall use good faith efforts to resolve any discrepancies. All information contained in any such report shall be deemed Confidential Information hereunder. If such examination reveals that such costs or payments have been misstated, any adjustment shall be promptly refunded or paid, as appropriate. The Auditing Party shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals a net discrepancy of [*] ([*]%) or more for the period examined which is to the disadvantage of the Auditing Party, in which case the Party who misreported shall pay all reasonable costs and expenses incurred by the Auditing Party in the course of making such determination. Upon the expiration of [*] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Contract Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of any such amounts payable with respect to such Calendar Year year shall be binding and conclusive upon the Parties, a Party entitled to such audit and the Parties other Party or its Affiliates shall be released from any liability or accountability with respect to such amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementyear.

Appears in 1 contract

Sources: Collaboration and License Agreement (Amgen Inc)

Records; Audits. Merck Vertex will keep, and will cause each of the other Selling Parties, as applicable, its Affiliates and will use Commercially Reasonable Efforts to keep, cause its Sublicensees to keep and Moderna will keep, adequate books maintain accurate and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]. Company will keep accurate and complete records regarding all [***] following the end incurred in connection with its performance of the Calendar Year Follow-On Research, in sufficient detail to which each will pertainconfirm the accuracy of any payments required under this Agreement, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of businesscovering the [***]. At the request of either Party, Upon [***] prior written notice from the other Party (the “Auditing Party”), the Party required to maintain such records will permit (and procure Vertex will cause its Affiliates, Affiliates and use Commercially Reasonable Efforts to cause its Sublicensees to permit) (as applicable, the “Audited Party”) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Auditing Party and reasonably acceptable to the other Party Audited Party, to have access during normal business hours to such examine the relevant books and records of the records Audited Party and its Affiliates, as may be reasonably necessary to verify the accuracy of sales milestone report under Section 7.5.3 and the payments due hereunder royalty reports submitted by Vertex in accordance with Section 7.6.6 or the [***] reported by Company in accordance with Section 7.8, as applicable. An examination by the Auditing Party under this Section 7.11 will occur not more than [***] in any Calendar Year and will be limited to the pertinent books and records for any Calendar Year ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not No records will be conducted audited more than once in any Calendar Year or be repeated for any Calendar Yearunless a discrepancy with respect to such records is discovered during a prior audit. The accounting firm shall disclose will be provided access to such books and records at the auditing Audited Party’s facility or facilities where such books and records are normally kept and such examination will be conducted during the Audited Party’s normal business hours. The Audited Party only may require the accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by Vertex or the[***] submitted by Company, as applicable, are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other Confidential Information information will be provided to the Auditing Party. If the report or information submitted by the Audited Party results in an underpayment or overpayment, (a) the Party owing an underpaid amount will promptly pay the amount of such underpayment to the other Party, and (b) any such overpayment shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay creditable against future payments to the other Party hereunder. The costs and fees of any audit conducted by the amount Auditing Party under this Section 7.11 will be borne by the Auditing Party, unless such audit reveals an underpayment of amounts owed to the discrepancy within Auditing Party or overpayment of amounts owed to the Audited Party of more than [***] percent of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided amount that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable was owed with respect to such Calendar Year shall be binding and conclusive upon the Partiesrelevant period, and in which case, the Parties shall be released from any liability or accountability with respect to amounts payable Audited Party will reimburse the Auditing Party for such Calendar Year. The auditing the reasonable expense incurred by the Auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Master Collaboration Agreement (Molecular Templates, Inc.)

Records; Audits. Merck will keep, 9.13.1 Each Party shall maintain complete and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate accurate books and records in sufficient detail in relation to this Agreement to permit the other Party to confirm the accuracy of accounting for the purpose achievement of calculating all milestones, the amount of royalties and other amounts payable by either payments under this Agreement. Each Party to the other Party hereunder will keep such books and ensuring each Party’s compliance hereunder. For the records for at least [***] following the end of redacted]following the Calendar Year to which they pertain. 9.13.2 Upon reasonable prior notice, each will pertain, Party (the “Auditing Party”) shall have the right to inspect and audit such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permitthe “Audited Party”) an during regular business hours at such place or places where such records are customarily kept by a recognized international independent certified public accounting firm of internationally recognized standing (the “Auditor”) selected by the auditing Auditing Party and reasonably acceptable to the other Audited Party to have access during normal business hours to such for the sole purpose of verifying for the Auditing Party the accuracy of the financial reports, statements or invoices furnished by the Audited Party pursuant to this Agreement or of any payments made, or required to be made, by or to the Audited Party pursuant to this Agreement. As of the Effective Date, Deloitte & Touche, Ernst & Young, KPMG and ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ are acceptable to the Parties as Auditors. Before beginning its audit, the Auditor shall execute an undertaking acceptable to each Party by which the Auditor agrees to keep confidential all information reviewed during the audit. Such audits may occur no more often than [redacted]and not more frequently than [redacted]with respect to records as may covering any specific period of time. Each Party shall only be reasonably entitled to audit the books and records for the [redacted]periods prior to the Calendar Year in which the audit request is made. Such Auditor shall not disclose the Audited Party’s Confidential Information to the Auditing Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports, statements or invoices furnished by the Audited Party or the amount of payments due hereunder to or by the Audited Party under this Agreement. In the event that the final result of the audit reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled within [redacted]after the Auditor’s report. The Auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the Audited Party that resulted from a discrepancy in the financial report, statement or invoice provided by the Audited Party for any Calendar Year ending not the audited period, which underpayment or overpayment was more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***redacted] of the date of delivery of amount set forth in such accounting firm’s written report so correctly concludingreport, or as otherwise agreed upon by in which case the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Audited Party shall pay reimburse the fees. Upon Auditing Party for the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable costs for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Collaboration & License Agreement (Aurinia Pharmaceuticals Inc.)

Records; Audits. Merck will keepOno and its Affiliates and Sublicensees on one hand, and will cause each of Forty Seven and its Affiliates on the other Selling Partieshand, as applicable, will maintain complete and accurate records in sufficient detail to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to permit the other Party hereunder to confirm the accuracy of the calculation of royalty and ensuring each Party’s compliance hereunderother payments under this Agreement. For the Upon reasonable prior notice, such records shall be available during regular business hours for a period of [***] following from the end creation of individual records for examination at the auditing Party’s expense, and not more often than once each Calendar Year to which each will pertainYear, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing one Party and reasonably acceptable to the other Party to have access during normal business hours to such Party, for the sole purpose of verifying the accuracy of the records as may be reasonably financial reports furnished by the audited Party pursuant to this Agreement. Any such auditor shall not disclose Confidential Information of the audited Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments due hereunder for any under this Agreement. For clarity, the auditor shall disclose the Confidential Information of the audited Party to the auditing Party only to the extent necessary to confirm calculation of royalty payments and supply price under this Agreement, as applicable. The auditing Party shall provide the audited Party with a copy of audit report within [***] from its receipt of the accountant’s report. Any amounts shown to be owed but unpaid shall be paid within [***] from the accountant’s report, plus interest (as set forth in Section 9.7) from the original due date. Any amounts shown to have been overpaid shall be creditable and refunded within [***] from the accountant’s report. The auditing Party shall bear the full cost of such audit unless such audit discloses an underpayment of the amount actually owed during the applicable Calendar Year ending not of more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], in which case the audited Party shall pay bear the fees. Upon the expiration full cost of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Exclusive License and Collaboration Agreement (Forty Seven, Inc.)

Records; Audits. Merck will keepBMS shall, and will shall cause each of the other Selling Partiesits Affiliates and Sublicensees to, as applicable, to keep, keep complete and Moderna will keep, adequate accurate books and records pertaining to Net Sales of accounting for the purpose of calculating Licensed Products in sufficient detail to calculate all royalties and other amounts payable hereunder with respect thereto and to verify compliance with its obligations under this Agreement. MTEM shall keep complete and accurate books and records pertaining to [***] (and, if applicable, [***] incurred under [***]). Such books and records shall be retained by either BMS (and its Affiliates and Sublicensees) and by MTEM until [***] after the end of [***] to which such books and records pertain. Upon reasonable [***] prior written notice by a Party (the “Auditing Party”) to the other Party hereunder required to maintain such books and ensuring each records (the “Audited Party’s compliance hereunder. For ”), for the [***] following the end of the Calendar Year [***] to which each will shall pertain, such books and records shall be made available for audit at reasonable times during normal business hours, in the case of accounting (including those of its Affiliates, BMS as applicable) will be kept at each of their principal place of business. At the request of either Audited Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing selected by the auditing Party MTEM, and reasonably acceptable to BMS, for inspecting and confirming the other Party payments to have access during normal business hours be made by BMS pursuant to such this ARTICLE 7 or, in the case of MTEM as the Audited Party, by an independent public accounting firm selected by BMS, and reasonably acceptable to MTEM, for inspecting and confirming the amounts due to MTEM for the conduct of the records as may Research Plans. Such right to audit shall not be reasonably necessary exercised more than once per [***] period. The accounting firm shall report to verify the accuracy Parties whether the applicable payments are correct, and if they are not correct, the amount of the payments applicable over- or underpayment, and no other information shall be shared with Audited Party. Any underpayments shall be paid by BMS within [***] of notification of the results of such audit. Any overpayments shall be credited against amounts payable by BMS in subsequent payment periods, or reimbursed to BMS within [***] of notification of the results of such audit should there be no subsequent payment period. The Auditing Party shall pay for the costs of such audit, except in the event such audit shows there has been an overpayment of Research Costs by BMS (in the case of BMS as the Auditing Party) or an underpayment of any amounts due hereunder by BMS (in the case of MTEM as the Auditing Party) for any Calendar Year ending not [***] of more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such periodpaid, in which case the appropriate Audited Party shall pay reimburse the other Auditing Party for the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon reasonable costs incurred by the Parties. The fees charged by Auditing Party in connection with such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Collaboration Agreement (Molecular Templates, Inc.)

Records; Audits. Merck Vertex will keep, keep and will cause each of the other Selling Parties, as applicable, to keep, maintain accurate and Moderna will keep, adequate books and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]preceding Calendar Years. Company will keep accurate and complete records regarding all FTE Costs and Out-of-Pocket Costs incurred in connection with Follow-On Research, in sufficient detail to confirm the accuracy of any payments required under this Agreement, covering the three preceding Calendar Years. Upon [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, prior written notice from the other Party (the “Auditing Party”), the Party required to maintain such records (as applicable, the “Audited Party”) will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Auditing Party and reasonably acceptable to the other Party Audited Party, to have access during normal business hours to such examine the relevant books and records of the records Audited Party and its Affiliates, as may be reasonably necessary to verify the accuracy of royalty reports submitted by Vertex in accordance with Section 7.6.7 or the payments due hereunder FTE Costs and Out-of-Pocket Costs reported by Company in accordance with Section 7.9, as applicable. An examination by the Auditing Party under this Section 7.12 will occur not more than once in any Calendar Year and will be limited to the pertinent books and records for any Calendar Year ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not No records will be conducted audited more than once in any Calendar Year or be repeated for any Calendar Yearonce. The accounting firm shall disclose will be provided access to such books and records at the auditing Audited Party’s facility or facilities where such books and records are normally kept and such examination will be conducted during the Audited Party’s normal business hours. The Audited Party only may require the accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by Vertex or the FTE Costs and Out-of-Pocket Costs submitted by Company, as applicable, are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other Confidential Information information will be provided to the Auditing Party. If the report or information submitted by the Audited Party results in an underpayment or overpayment, (a) the Party owing the underpaid or overpaid amount will promptly pay the amount of such underpayment to the other Party, and (b) any such overpayment shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay creditable against future payments to the other Party hereunder. The costs and fees of any audit conducted by the amount Auditing Party under this Section 7.12 will be borne by the Auditing Party, unless such audit reveals an underpayment of amounts owed to the discrepancy within Auditing Party of more than [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon amount that was owed by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Partiesrelevant period, and in which case, the Parties shall be released from any liability or accountability with respect to amounts payable Audited Party will reimburse the Auditing Party for such Calendar Year. The auditing the reasonable expense incurred by the Auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Master Collaboration Agreement (Kymera Therapeutics, Inc.)

Records; Audits. Merck Each Party will keepmaintain complete and accurate records in sufficient detail to permit (a) AMAG to confirm the accuracy of the calculation of royalty payments, and will cause each (b) with respect to any Increase in Scope, Takeda Opt-In Studies and AMAG Opt-In Studies, Takeda and AMAG to confirm the accuracy of the other Selling Partiescalculation of Out-of-Pocket Costs under this Agreement. Upon reasonable prior notice, as applicable, to keep, and Moderna will keep, adequate books and such records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the shall be available during [***] following INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. regular business hours for a period of three (3) years from the end of the Calendar Fiscal Year to which each will pertain, such books and records they pertain for examination at the expense of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either auditing Party, the other Party will permit (and procure its Affiliatesnot more often than once each calendar year, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such audited Party, for the sole purpose of verifying the accuracy of the records as may be reasonably financial reports and/or invoices furnished by the audited Party pursuant to this Agreement. Any such auditor shall not disclose the audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year financial reports furnished by such Party or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancypayments due by or to such Party under this Agreement. No other Confidential Information shall Any amounts shown to be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm owed but unpaid shall be paid by within thirty (30) days from the auditing Partyaccountant’s report, provided that if plus interest (as set forth in Section 8.8) from the underpayment or overcharge exceeds [***], the audited Party shall pay the feesoriginal due date. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of Any amounts payable with respect shown to such Calendar Year have been overpaid shall be binding and conclusive upon refunded within thirty (30) days from the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearaccountant’s report. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with bear the confidentiality and non-use provisions full cost of this Agreement, and shall cause its accounting firm to enter into such audit unless such audit discloses an acceptable confidentiality agreement with underpayment by the audited Party obligating it to retain all of more than five percent (5%) of the amount due, in which case the audited Party shall bear the full cost of such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Amag Pharmaceuticals Inc.)

Records; Audits. Merck Amgen will keep, keep and will cause each of the other Selling Parties, as applicable, to keep, maintain accurate and Moderna will keep, adequate books and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]. Generate will keep accurate and complete records regarding all [***] following incurred in connection with Follow-On Research, in sufficient detail to confirm the end accuracy of any payments required under this Agreement, covering the Calendar Year to which each will pertain[***]. Upon [***] prior written notice from Generate, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party Amgen will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Party Generate and reasonably acceptable to Amgen, to examine the other Party to have access during normal business hours to such relevant books and records of the records Amgen and its Affiliates, as may be reasonably necessary to verify the accuracy of royalty reports submitted by Amgen in accordance with Section 6.5.7. An examination by Generate under this Section 6.10 will occur not more than once in any [***] and will be limited to the payments due hereunder pertinent books and records for any Calendar Year [***] ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not No records will be conducted audited more than once in any Calendar Year or be repeated for any Calendar Yearonce. The accounting firm shall disclose will be provided access to such books and records at Amgen’s facility or facilities where such books and records are normally kept and such examination will be conducted during Amgen’s normal business hours. Amgen may require the auditing Party only accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by ▇▇▇▇▇ are correct or incorrect and the specific details concerning any discrepancies. No other information will be provided to Generate. If the report or information submitted by Amgen results in an underpayment or overpayment, (a) Amgen will promptly pay the amount of any discrepancy. No other Confidential Information such underpayment to Generate, and (b) any such overpayment shall be providedcreditable against future payments to Generate hereunder. If The costs and fees of any audit conducted by Generate under this Section 6.10 will be borne by [***], unless such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount audit reveals an underpayment of the discrepancy within amounts owed to Generate of more than [***] of the date of delivery of such accounting firm’s written report so correctly concludingamount that was owed by ▇▇▇▇▇ with respect to the relevant period, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Partyin which case, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Generate Biomedicines, Inc.)

Records; Audits. Merck will keepMTPC and its Affiliates and Sublicensees on one hand, and will cause each of ADCT and its Affiliates on the other Selling Partieshand, as applicable, will maintain complete and accurate records in sufficient detail to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to permit the other Party hereunder to, or have an independent certified public accountant selected by the other Party to, confirm the accuracy of the calculation of royalty, Direct Development Cost, Manufacturing Cost and ensuring each Party’s compliance hereunderother payments under this Agreement. For the Upon reasonable prior notice, such records shall be available during regular business hours for a period of [***] following years from the end of the Fiscal Year concerned for examination at the auditing Party’s expense, and not more often than once each Calendar Year to which each will pertainYear, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing one Party and reasonably acceptable to the other Party to have access during normal business hours to such (which acceptance shall not be unreasonably withheld), for the sole purpose of verifying the accuracy of the records as may be reasonably financial reports furnished by the audited Party pursuant to this Agreement. Any such auditor shall not disclose Confidential Information of the audited Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments due hereunder for any Calendar Year ending not more than [***] following under this Agreement. For clarity, the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm auditor shall disclose the Confidential Information of the audited Party to the auditing Party only whether to the reports are correct or incorrect extent necessary to confirm calculation of royalty payments and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliatessupply price under this Agreement, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with provide the audited Party obligating it with a copy of audit report within [**] days from its receipt of such audit report from the accountant. Any amounts shown to retain all be owed but unpaid shall be paid within [**] days from the receipt of the copy of audit report by the audited party, plus interest (as set forth in Section 3.5) from the original due date. Any amounts shown to have been overpaid shall be creditable and refunded within [**] days from the accountant’s report. The auditing Party shall bear the full cost of such Confidential Information audit unless such audit discloses an underpayment of the amount actually owed during the applicable Calendar Year of more [**] percent ([**]%) of the amounts actually owed, in confidence pursuant to which case the audited Party shall bear the full cost of such confidentiality agreementaudit.

Appears in 1 contract

Sources: License Agreement (ADC Therapeutics SA)

Records; Audits. Merck The Parties will keep, (and will cause each their respective Affiliates and sublicensees to) at all times keep and maintain accurate and complete records regarding, in the case of the other Selling PartiesMyoKardia, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the Net Sales during [**], and in the case of Fulcrum, any costs for Fulcrum FTEs or Out-of-Pocket Expenses covered by the initial prepaid research funding or reimbursed by MyoKardia pursuant to Section 3.8 (Research Funding). Upon [**] following prior written notice from the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either auditing Party, the other non-auditing Party will permit (and procure will cause its Affiliates, to permitAffiliates and sublicensees to) permit an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Party and reasonably acceptable to the other Party non-auditing Party, to have access during normal business hours to such examine the relevant books and records of the records non-auditing Party, its Affiliates, and sublicensees, as may be reasonably necessary to verify verify, in the accuracy case of MyoKardia, the payments due hereunder royalty reports submitted by MyoKardia in accordance with Section 6.4.6 (Royalty Reports), and in the case of Fulcrum, the invoices submitted by Fulcrum in accordance with Section 3.8 (Research Funding). An examination by either Party under this Section 6.7 (Records; Audits) will occur not more than once in any Calendar Year and will be limited to the pertinent books and records for any Calendar Year ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not be conducted more than once in Further, a Party’s (or its Affiliates’ or sublicensees’) books of records for any Calendar Year or may be repeated for any Calendar Yearexamined [**]. The accounting firm shall disclose will be provided access to such books and records at the facility or facilities where such books and records are normally kept and such examination will be conducted during normal business hours. The non-auditing Party only whether (or any Affiliate or sublicensee) may require the accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Fulcrum and MyoKardia a written report disclosing whether, in the case of MyoKardia, the reports submitted by MyoKardia, or in the case of Fulcrum, the invoices submitted by Fulcrum, are correct or incorrect and the amount of specific details concerning any discrepancy. No other Confidential Information shall be provideddiscrepancies. If such accounting firm correctly identifies a discrepancy made during such periodany report submitted by MyoKardia or invoice submitted by Fulcrum results in an underpayment or overpayment, the appropriate Party shall owing the underpaid or overpaid amount will promptly pay such amount to the other Party with interest calculated in accordance with Section 6.8 (Late Payment). The costs and fees of any audit conducted by a Party under this Section 6.7 (Records; Audits) will be borne by the amount auditing Party, unless, in the case of the discrepancy within an audit conducted by Fulcrum, such audit reveals an underpayment of amounts owed to Fulcrum of more than [***] of the date of delivery of such accounting firm’s written report so correctly concludingamount that was owed by MyoKardia, or as otherwise agreed upon in the case of an audit conducted by MyoKardia, such audit reveals an overpayment of amounts owed to Fulcrum of more than [**] of the Parties. The fees charged amount that was properly payable by such accounting firm shall be paid MyoKardia in accordance with Section 3.8 (Research Funding), in either case, with respect to the relevant Calendar Year, in which case, the non-auditing Party will reimburse the auditing Party for the reasonable expense incurred by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Collaboration and License Agreement (Fulcrum Therapeutics, Inc.)

Records; Audits. Merck NGM will keep, and will cause each of the other Selling Partiesits Affiliates and subcontractors, as applicable, to keep, and Moderna will keep, adequate books and records of accounting of all FTEs, FTE spend and out-of-pocket expenses for the Collaboration for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s its compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) relate will be kept at each of their its principal place of business. At the request of either PartyMerck, the other Party NGM will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party Merck and reasonably acceptable to the other Party NGM to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder from Merck in connection with FTEs and out-of-pocket expenses for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party Merck only whether the reports are correct or incorrect and the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] thirty (30) days of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing PartyMerck; provided, provided however, that if the underpayment or overcharge by NGM exceeds [***], the audited Party then NGM shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party NGM (or its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the PartiesMerck, and the Parties NGM shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party Merck shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party NGM obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 1 contract

Sources: Research Collaboration, Product Development and License Agreement (NGM Biopharmaceuticals Inc)

Records; Audits. Merck will keep, Each Party shall maintain complete and will cause each of the other Selling Parties, as applicable, accurate records in sufficient detail in relation to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party this Agreement to permit the other Party hereunder and ensuring each Party’s compliance hereunder. For to confirm the [***] following the end accuracy of the Calendar Year amount of Joint Work Costs, Independent Work Costs, and the Manufacturing Costs to which each be reimbursed or shared, achievement of sales milestones, and the amount of Transfer Price (including calculation of the ENS and the ANS, actual Net Sales and sales volumes for a given Fiscal Year) and other payments under this Agreement. Each Party will pertain, keep such books and records of accounting (including those of its Affiliatesfor at least [ * ] years following the Fiscal Year to which they pertain. Upon reasonable prior notice, as applicable) will such records may be inspected during regular business hours at such place or places where such records are customarily kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party and reasonably acceptable to the other audited Party to have access during normal business hours to such for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or of any payments made, or required to be made, by or to the audited Party pursuant to this Agreement. Such audits may occur no more often than once each Fiscal Year and not more frequently than once with respect to records as may covering any specific period of time. Each Party shall only be reasonably entitled to audit the books and records from the [ * ] Fiscal Years prior to the Fiscal Year in which the audit request is made. Such auditor shall not disclose the audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following financial reports furnished by the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year audited Party or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancypayments to or by the audited Party under this Agreement. No other Confidential Information shall Any amounts shown to be provided. If such accounting firm correctly identifies owed but unpaid as a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery result of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm audit shall be paid by within [ * ] days from the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the feesauditor’s report (plus interest on such amounts pursuant to Section 8.2). Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of Any amounts payable with respect shown to such Calendar Year have been overpaid shall be binding and conclusive upon refunded to the Parties, and overpaying party within [ * ] days from the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearauditor’s report. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) bear the full cost of such audit unless such audit discloses an underpayment of the amount actually owed of more than [ * ] percent ([ * ]%), in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with which case the audited Party obligating it to retain all shall bear the full out-of-pocket, external cost of such Confidential Information audit. [ * ] = Certain confidential information contained in confidence this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to such confidentiality agreementRule 24b-2 of the Securities Exchange Act of 1934, as amended.

Appears in 1 contract

Sources: Exclusive License and Supply Agreement (Versartis, Inc.)

Records; Audits. Merck will (a) LICENSEE shall keep, and will cause each of the other Selling Parties, as applicable, shall require its Affiliates and Sublicensees to keep, accurate and Moderna will keep, adequate books and correct records of accounting all Licensed Products manufactured, used, and sold, and Sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] at least five (5) years following the end of the Calendar Year to which each will pertain, such books and a given reporting period. (b) All records of accounting (including those of its Affiliates, as applicable) will shall be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access available during normal business hours for inspection at the expense of Cornell by Cornell’s Internal Audit Department or by a Certified Public Accountant selected by Cornell and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such inspector shall not disclose to such of the records as may be reasonably necessary Cornell any information other than information relating to verify the accuracy of reports and payments made under this Agreement or other compliance issues. In the payments due hereunder event that any such inspection shows an under reporting and underpayment in excess of five percent (5%) for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such twelve-month (12-month) period, the appropriate Party then LICENSEE shall pay the other Party the amount cost of the discrepancy audit as well as any additional sum that would have been payable to Cornell had the LICENSEE reported correctly, plus an interest charge at a rate of ########*. Such interest shall be calculated from the date the correct payment was due to Cornell up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of five percent (5%) for any twelve-month (12-month) period, LICENSEE shall pay the difference within [***] thirty (30) days without inspection cost. Cornell shall be permitted to exercise its right to review LICENSEE’s records one (1) time in each calendar year, and Cornell shall provide reasonable advance notice to LICENSEE of its intent to exercise such right. _____________________________ * ######## = Material omitted pursuant to a request for Confidential Treatment and filed separately with the Commission on the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions filing of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.Form 8-K.

Appears in 1 contract

Sources: License Agreement (Neurologix Inc/De)

Records; Audits. Merck will keepSobi and its Affiliates and Sublicensees on one hand, and will cause each of ADCT and its Affiliates on the other Selling Partieshand, as applicable, will maintain complete and accurate records in sufficient detail to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to permit the other Party hereunder and ensuring each Party’s compliance hereunderto, or have an independent certified public accountant selected by the other Party to, confirm the accuracy of the calculation of any royalty, Direct Development Cost, Manufacturing Cost or other payments under this Agreement. For the Upon reasonable prior notice, such records shall be available during regular business hours for a period of [***] following years from the end of the Calendar Year to which concerned for examination at the auditing Party’s expense, and not more often than once each will pertainCalendar Year, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing one Party and reasonably acceptable to the other Party to have access during normal business hours to such (which acceptance shall not be unreasonably withheld, conditioned or delayed), for the sole purpose of the records as may be reasonably necessary to verify verifying the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement. Any such auditor shall not disclose Confidential Information of the audited Party, except to the extent such disclosure is necessary to demonstrate a discrepancy discovered by the auditor. For clarity, the auditor shall disclose the Confidential Information of the audited Party to the auditing Party only to the extent necessary to confirm calculation of royalty payments and supply price under this Agreement, as applicable. The auditing Party shall provide the audited Party with a copy of audit report within [**] days from its receipt of such audit report from the accountant. Any amounts shown to be owed but unpaid shall be paid within [**] days from the receipt of the copy of audit report by the audited party, plus interest (as set forth in Section 10.6 (Late Payments)) from the original due hereunder for any date. Any amounts shown to have been overpaid shall be creditable and refunded within [**] days from the accountant’s report. The auditing Party shall bear the full cost of such audit unless such audit discloses an underpayment of the amount actually owed during the applicable Calendar Year ending not of more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concludingamounts actually owed, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], in which case the audited Party shall pay bear the fees. Upon the expiration full cost of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: License Agreement (ADC Therapeutics SA)

Records; Audits. Merck will keep(a) Advaccine shall, and will shall cause each its Affiliates and their respective Sublicensees to, maintain in accordance with Accounting Standards, reasonably complete and accurate records in sufficient detail to permit Inovio to confirm the accuracy of the other Selling Parties, as applicable, to keep, calculation of royalty payments and Moderna will keep, adequate books and records the achievement of accounting for the purpose of calculating all royalties milestone events. All payments and other relevant amounts payable by either Party to the other Party hereunder under this Agreement shall be accounted for in accordance with Accounting Standards. Upon reasonable prior written notice, in any event no less than thirty (30) days prior written notice, such records shall be available for examination during regular business hours and ensuring each Partyin a manner that does not interfere with Advaccine’s compliance hereunder. For the [***] following business activities for a period of three (3) years from the end of the Calendar Fiscal Year to which each will they pertain, such books and records of accounting (including those of its Affiliatesnot more often than once each Fiscal Year, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party Inovio and reasonably acceptable to Advaccine, for the other Party to have access during normal business hours to such sole purpose of verifying the accuracy of the records as may be reasonably financial reports furnished by Advaccine pursuant to this Agreement and any payments with respect thereto. Any such auditor shall not disclose Advaccine’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Advaccine or the amount of payments due hereunder for any Calendar Year ending not under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 8.7) from the original due date. Inovio shall bear the full cost of such audit unless such audit discloses an underpayment by Advaccine of more than [***] following of the amount due for the audited period, in which case Advaccine shall bear the full cost of such audit (b) Inovio shall, and shall ensure that its Affiliates and its and their respective employees, agents and contractors, maintain complete and accurate records with respect to Inovio’s pharmacovigilance-related obligations set forth in Section 5.8. Upon reasonable prior written notice, such records shall be available for examination during regular business hours for a period of three (3) years from the end of any Calendar Year. Such examinations may the Fiscal Year to which they pertain, and not be conducted more often than once in any Calendar each Fiscal Year by Advaccine or its designee that is reasonably acceptable to Inovio, for the sole purpose of ensuring compliance with NMPA and other Regulatory Authority regulations. Any such records shall be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other deemed Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementInovio.

Appears in 1 contract

Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)

Records; Audits. Merck Ziopharm and its Affiliates will keepmaintain complete and accurate records in reasonably sufficient detail to permit Precigen to confirm the accuracy of (a) the calculation of Operating Profits (or Loss) under Section 6.2 (including any Development Credits accrued with respect thereto), (b) the Sublicensing Income payments under Section 6.4, (c) the calculation of royalty payments under Section 6.5 and (d) the calculation of any Makeup Payments under Section 6.7. Precigen and its Affiliates will cause each maintain complete and accurate records in reasonably sufficient detail to permit Ziopharm to confirm the accuracy of (i) the other Selling Partiescalculation of Development Costs or Operating Profits (or Loss) under Section 6.2, as applicable(ii) the Licensing Income payments under Section 6.6(a), to keep(iii) the calculation of royalty payments under Section 6.6(b) and (iv) the calculation of any Makeup Payments under Section 6.7. Upon reasonable prior notice, and Moderna will keep, adequate books and such records shall be available during regular business hours for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following three (3) years from the end of the Calendar Year calendar year to which they pertain for examination, not more often than once each will pertaincalendar year, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party and reasonably acceptable to the audited Party, for the sole purpose of verifying the accuracy of the financial reports furnished by the other Party pursuant to have access during normal business hours this Agreement. Any such auditor shall enter into a confidentiality agreement with the audited Party and shall not disclose the audited Party’s Confidential Information, except to the extent such of the records as may be reasonably disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments due hereunder for by one Party to the other Party under this Agreement. Any amounts shown to be owed but unpaid shall be paid, and any Calendar Year ending not amounts showed to be overpaid will be refunded, within forty-five (45) days from the accountant’s report. The auditing Party shall bear the full cost of such audit unless such audit discloses an underpayment or overcharge by the audited Party of more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds percent ([***]%) of the amount due, in which case the audited Party shall pay bear the fees. Upon the expiration full cost of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Exclusive License Agreement (Ziopharm Oncology Inc)

Records; Audits. Merck will During the Term and for [***] ([***]) years thereafter, Aimmune shall keep, and will shall cause each its Affiliates and Sublicensees to keep and provide to Xencor, complete and accurate records pertaining to the sale or other disposition of Product in sufficient detail to permit Xencor to confirm the other Selling Partiesaccuracy of payments due hereunder. Xencor shall have the right, upon [***] ([***]) days’ prior written notice to Aimmune, to cause an independent, certified international public accounting firm reasonably acceptable to Aimmune or reasonably acceptable to its Affiliates or Sublicensees, as applicable, to keepaudit such records during Aimmune’s, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Partyor its Affiliate’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliatesor Sublicensees’, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such confirm the number of Product units sold, the gross sales and Net Sales of Product, the royalties payable, the method used to calculate the royalties payable, and the exchange rates used in accordance with Section 8.2. The audit shall be limited to pertinent records as may be reasonably necessary to verify the accuracy of the payments due hereunder kept by Aimmune and its Affiliates and Sublicensees for any Calendar Year year ending not more than [***] following ([***]) months prior to the end date of the written notice. An audit under this Section 8.4 shall not occur more than [***] in any Calendar Year. Such examinations may not be conducted more than once , except in the case of any Calendar Year or be repeated subsequent “for any Calendar Yearcause” audit. The accounting firm shall disclose to the auditing Party Xencor only whether the reports are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other information shall be provided to Xencor. The accounting firm shall provide Aimmune with a copy of any disclosures or reports made to Xencor and Aimmune shall have an opportunity to discuss such disclosures or reports with Xencor and the accounting firm. Information, disclosures, or reports arising from any such examination shall be Confidential Information of Aimmune subject to the confidentiality and other obligations of ARTICLE 12. Prompt adjustments shall be providedmade by the Parties to reflect the results of such audit. If Xencor shall bear the full cost of such accounting firm correctly identifies a discrepancy made during audit unless such period, the appropriate Party shall pay the other Party the amount audit discloses an underpayment of the discrepancy within more than [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds percent ([***]%) of the payments due under this Agreement, the audited Party shall pay the fees. Upon the expiration of in which case, [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement].

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Aimmune Therapeutics, Inc.)

Records; Audits. Merck will Each Party shall keep, and will shall cause each of the other Selling Parties, as applicable, its Affiliates and Third Party sublicensees to keep, full and Moderna will keep, adequate accurate records and books and records of accounting account containing all particulars that may be necessary for the purpose of calculating Development Costs and Net Sales of a Product for an Indication to be received or borne by the Parties pursuant to this Agreement, including without limitation, inventory, purchase and invoice records, manufacturing records, sales analysis, general ledgers, financial statements, and tax returns. Such books of account, with all royalties and other amounts payable necessary supporting data, shall be kept by either such Party to at its place of business for the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] six (6) years next following the end of the Calendar Year calendar year to which each will shall pertain, such books and records of . Each Party (the “Audited Party”) shall permit an independent accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, firm selected by the other Party will permit (and procure its Affiliates, to permitthe “Verifying Party”) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party Audited Party, which acceptance shall not be unreasonably withheld or delayed, to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder Audited Party’s reports of Development Costs and Net Sales of a Product for any Calendar Year ending not more than [***] following the end of any Calendar Yearan Indication as provided herein. Such examinations may not All such verifications shall be conducted at the expense of the Verifying Party and not more than once in each calendar year. In the event such audit concludes that adjustments should be made in the Verifying Party’s favor, then any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [payments ***] of * shall be paid by the date of delivery of such Audited Party within twenty (20) Business Days after the Audited Party receives the Verifying Party’s accounting firm’s written report so correctly concluding, or unless the Audited Party shall have a good faith **** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission dispute as otherwise agreed upon by to the Partiesconclusions set forth in such written report, in which case the audited Party shall provide written notice to the Verifying Party within such twenty (20) Business Day period of the nature of its disagreement with such written report. The Parties shall thereafter, for a period of forty (40) Business Days, attempt in good faith to resolve such dispute and if they are unable to do so then the matter will be submitted to dispute resolution in accordance with Section 2.2.2 hereof. The fees charged by such accounting firm shall be paid by the auditing Party, provided Verifying Party unless the audit discloses that if adjustments in favor of the underpayment or overcharge exceeds [Verifying Party for the period ***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Osiris Therapeutics, Inc.)

Records; Audits. Merck NGM will keep, and will cause each of the other Selling Partiesits Affiliates and subcontractors, as applicable, to keep, and Moderna will keep, adequate books and records of accounting of all FTEs, FTE spend and out-of-pocket expenses for the Collaboration for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s its compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) relate will be kept at each of their its principal place of business. At the request of either PartyMerck, the other Party NGM will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party Merck and reasonably acceptable to the other Party NGM to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder from Merck in connection with FTEs and out-of-pocket expenses for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party Merck only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] thirty (30) days of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing PartyMerck; provided, provided however, that if the underpayment or overcharge by NGM exceeds [***], the audited Party then NGM shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party NGM (or its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the PartiesMerck, and the Parties NGM shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party Merck shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party NGM obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 1 contract

Sources: Research Collaboration, Product Development and License Agreement (NGM Biopharmaceuticals Inc)

Records; Audits. Merck will keep, Menarini shall maintain complete and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate accurate books and records in accordance with Accounting Standards in sufficient detail to permit VIVUS to confirm the accuracy of accounting milestone payments, royalty payments, and any other compensation payable under this Agreement for the purpose a period of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following * from the end creation of the Calendar Year to which each will pertainindividual records or any longer period required by Applicable Law. At VIVUS’s request, such books and records of accounting shall be available for review at a location in the Menarini Territory not more than once each calendar year (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours on a mutually agreed date with reasonable advance notice) at a location in the Menarini Territory by an independent Third Party auditor selected by VIVUS and approved by Menarini (such approval not to such be unreasonably withheld, conditioned, or delayed) and subject to confidentiality and non-use obligations no less stringent than those set forth in Article 11 for the sole purpose of verifying for VIVUS the accuracy of the records as may be reasonably financial reports furnished by Menarini pursuant to this Agreement or of any payments made by Menarini to VIVUS pursuant to this Agreement. Any such auditor shall not disclose Menarini’s Confidential Information to VIVUS, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Menarini or the amount of payments due hereunder for any Calendar Year ending not by Menarini under this Agreement. Any amounts shown to be owed but unpaid shall be paid within *** from the accountant’s report, plus interest (as set forth in Section 7.9) from the original due date. Any amounts shown to have been overpaid may be credited by Menarini against future payments to VIVUS hereunder. No payment to VIVUS shall be reduced by more than [*** percent (***] following %) as a result of such credit, and Menarini may carry forward any unused credits to future calendar quarters. VIVUS shall bear the end full cost of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year such audit unless such audit reveals a payment or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount reporting error of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [*** percent (***] of %) or more during the date of delivery applicable audit period, in which case Menarini shall bear the full cost of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: License and Commercialization Agreement (Vivus Inc)

Records; Audits. Merck Sanofi will keep, keep and will cause each of the other Selling Parties, as applicable, to keep, maintain accurate and Moderna will keep, adequate books and complete records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For regarding Net Sales during the [***]. Kymera will keep accurate and complete records regarding all [***] following incurred in connection with the end Research activities relating to [***], in sufficient detail to confirm the accuracy of any payments required under this Agreement, covering the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business[***]. At the request of either Party, Upon [***] prior written notice from the other Party (the “Auditing Party”), the Party required to maintain such records (as applicable, the “Audited Party”) will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing standing, selected by the auditing Auditing Party and reasonably acceptable to the other Party Audited Party, to have access during normal business hours to such examine the relevant books and records of the records Audited Party and its Affiliates, as may be reasonably necessary to verify the accuracy of royalty reports submitted by Sanofi in accordance with Section 11.3.8 or [***] reported by Kymera in accordance with Section 11.6, as applicable. An examination by the payments due hereunder Auditing Party under this Section 11.9 will occur not more than once in any Calendar Year and will be limited to the pertinent books and records for any Calendar Year ending not more than [***] following before the end date of any Calendar Yearthe request. Such examinations may not No records will be conducted audited more than once in any Calendar Year or be repeated for any Calendar Yearonce. The accounting firm shall disclose will be provided access to such books and records at the auditing Audited Party’s facility or facilities where such books and records are normally kept and such examination will be conducted during the Audited Party’s normal business hours. The Audited Party only may require the accounting firm to sign a customary non-disclosure agreement before providing the accounting firm access to its facilities or records. Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing whether the reports submitted by Sanofi or [***] submitted by Kymera, as applicable, are correct or incorrect and the amount of specific details concerning any discrepancydiscrepancies. No other Confidential Information shall information will be providedprovided to the Auditing Party. If the report or information submitted by the Audited Party results in an underpayment or overpayment, (a) the Party owing the underpaid or overpaid amount will promptly pay the amount of such accounting firm correctly identifies a discrepancy made during underpayment to the other Party, and (b) any such period, the appropriate Party shall pay overpayment will be creditable against future payments to the other Party hereunder. The costs and fees of any audit conducted by the amount Auditing Party under this Section 11.9 will be borne by the Auditing Party, unless such audit reveals an underpayment of amounts owed to the discrepancy within Auditing Party of more than [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon amount that was owed by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Partiesrelevant period, and in which case, the Parties shall be released from any liability or accountability with respect to amounts payable Audited Party will reimburse the Auditing Party for such Calendar Year. The auditing the reasonable expense incurred by the Auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance connection with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementaudit.

Appears in 1 contract

Sources: Collaboration and License Agreement (Kymera Therapeutics, Inc.)

Records; Audits. Merck Amgen will keep, and will or cause each or procure to be kept, and, for at least [***] from the date of the other Selling Partiesapplicable written report delivered in accordance with Section 8.7.2, as applicableretain, to keepcomplete and accurate data, accounts and Moderna will keep, adequate books supporting documentation in respect of all Amgen Contract No. [***] xxxii Products sold by or on behalf of Amgen and/or its Affiliates and records of accounting the Net Sales thereof solely for the purposes of and to the extent such Records are reasonably required for the computation and verification of royalties and all other sums payable under this Agreement (collectively, “Records”). Amgen will give to, or procure for, ▇▇▇▇▇’s nominated representative, which shall be an independent public accounting firm reasonably acceptable to Amgen (the “Accounting Firm”), upon reasonable request in writing (provided that such request will provide Amgen with not less than [***] notice) and no more than once in any [***] period (subject to any access reasonably necessary to clarify the issues and unless good reason otherwise exists), access to Amgen’s Records during ▇▇▇▇▇’s regular business hours for the sole purpose of calculating all verifying computation and verification of royalties and other amounts sums payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For under this Agreement within the [***] following period preceding the end date of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) request for review. No calendar year will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, subject to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not audit under this Section 8.8 more than once. The Accounting Firm will be required to sign ▇▇▇▇▇’s confidential disclosure agreement prior to performing any audit procedures or receiving any information from Amgen. The report and communication of such Accounting Firm shall be limited to a certificate stating whether any report made or payment submitted by Amgen during such period is accurate or inaccurate and the amount of any payment discrepancy, regardless if the discrepancy is favorable or unfavorable to TScan. TScan shall provide Amgen with a copy of each such report within [***] following of its receipt. Should the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose inspection lead to the auditing Party only whether the reports are correct or incorrect and the amount discovery of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such periodto ▇▇▇▇▇’s detriment, the appropriate Party Amgen shall pay the other Party the amount of the discrepancy within [***] of Amgen’s agreement with the date findings of delivery the inspection. Should the inspection lead to the discovery of a discrepancy to ▇▇▇▇▇’s detriment, Amgen will have the right to deduct such accounting firm’s written report so correctly concludingamount from any future royalty payment obligations; to the extent that no or insufficient future royalty obligations are reasonably expected to be due within six (6) months to TScan, or as otherwise agreed upon by the Parties. The fees charged by ▇▇▇▇▇ agrees to pay such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of amount to Amgen within [***] following of receiving an invoice from Amgen. TScan shall pay the end full cost of any Calendar Yearthe inspection unless the discrepancy is to TScan’s detriment and is greater than [***] due in such calendar year, absent willful misconduct or fraud in which case Amgen shall pay the reasonable cost charged by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable Accounting Firm for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementinspection.

Appears in 1 contract

Sources: Research Collaboration and License Agreement (TScan Therapeutics, Inc.)

Records; Audits. Merck NGM will keep, and will cause each of the other Selling Partiesits Affiliates and subcontractors, as applicable, to keep, and Moderna will keep, adequate books and records of accounting of all FTEs, FTE spend and out-of-pocket expenses for the Collaboration for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s its compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) relate will be kept at each of their its principal place of business. At the request of either PartyMerck, the other Party NGM will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party Merck and reasonably acceptable to the other Party NGM to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder from Merck in connection with FTEs and out-of-pocket expenses for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once [***] in any Calendar Year or be repeated for any Calendar Year[***]. The accounting firm shall disclose to the auditing Party Merck only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, concluding or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing PartyMerck; provided, provided however, that if the underpayment or overcharge exceeds by NGM [***], the audited Party then NGM shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party NGM (or its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the PartiesMerck, and the Parties NGM shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party Merck shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party NGM obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

Appears in 1 contract

Sources: Research Collaboration, Product Development and License Agreement (NGM Biopharmaceuticals Inc)

Records; Audits. Merck will Licensee shall keep, and will cause each of the other Selling Parties, as applicable, require its Affiliates and Sublicensees directly engaged by Licensee to keep, complete, fair and Moderna will keep, adequate true books of accounts and records of accounting for the purpose of calculating all royalties and other determining the amounts payable by either Party to the other Party hereunder Inventiva pursuant to this Agreement. Such books and ensuring each Party’s compliance hereunder. For the records shall be kept for at least [***] following the end of the Calendar Year to which each will they pertain. Inventiva shall have the right to cause an independent, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and accountant reasonably acceptable to Licensee to audit such records to confirm Net Sales, royalties and other payments for a period covering not more than the other Party preceding [***] Calendar Years; provided that such accountant shall be bound by non-use and non-disclosure obligations no less stringent than those set forth in this Agreement with respect to have access the content of the audit. Such audits (i) may be exercised during normal business hours upon reasonable prior written notice to such Licensee, (ii) shall be initiated on a date specified by Inventiva in its written notice to Licensee, provided that in any event the date of sending the records as may written notice shall be reasonably necessary at least [***] prior to verify the accuracy initiating date of audit, (iii) shall be limited to the payments due hereunder for any Calendar Year ending not aspect of financial performance of Licensee, (iv) shall be limited to no more than [***] following the end of any each Calendar Year. Such examinations may not Prompt adjustments shall be conducted made by the Parties to reflect the results of such audit. Inventiva shall bear the full cost of such audit unless such audit discloses an underpayment by Licensee of more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date amount of delivery royalties or other payments due under this Agreement for any applicable Calendar Semi-Annual Period, in which case, Licensee shall bear the cost of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm audit and shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of promptly (but in any event no later than [***] following after its receipt of the end accounting firm’s report so concluding) remit to Inventiva the amount of any Calendar Year, absent willful misconduct or fraud underpayment. Any overpayment by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year Licensee revealed by an audit shall be binding fully-creditable against future payment owed by Licensee to Inventiva (and conclusive upon the Partiesif no further payments are due, and the Parties shall be released from any liability or accountability with respect promptly refunded by Inventiva to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementLicensee).

Appears in 1 contract

Sources: Exclusive License and Collaboration Agreement (Inventiva S.A.)

Records; Audits. Merck will keep(a) Advaccine shall, and will shall cause each its Affiliates and their respective Sublicensees to, maintain in accordance with Accounting Standards, reasonably complete and accurate records in sufficient detail to permit Inovio to confirm the accuracy of the other Selling Parties, as applicable, to keep, calculation of royalty payments and Moderna will keep, adequate books and records the achievement of accounting for the purpose of calculating all royalties milestone events. All payments and other relevant amounts payable by either Party to the other Party hereunder under this Agreement shall be accounted for in accordance with Accounting Standards. Upon reasonable prior written notice, in any event no less than thirty (30) days prior written notice, such records shall be available for examination during regular business hours and ensuring each Partyin a manner that does not interfere with Advaccine’s compliance hereunder. For the [***] following business activities for a period of three (3) years from the end of the Calendar Fiscal Year to which each will they pertain, such books and records of accounting (including those of its Affiliatesnot more often than once each Fiscal Year, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party Inovio and reasonably acceptable to Advaccine, for the other Party to have access during normal business hours to such sole purpose of verifying the accuracy of the records as may be reasonably financial reports furnished by Advaccine pursuant to this Agreement and any payments with respect thereto. Any such auditor shall not disclose Advaccine’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Advaccine or the amount of payments due hereunder for any Calendar Year ending not under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 8.7) from the original due date. Inovio shall bear the full cost of such audit unless such audit discloses an underpayment by Advaccine of more than [***] following of the amount due for the audited period, in which case Advaccine shall bear the full cost of such audit. (b) Inovio shall, and shall ensure that its Affiliates and its and their respective employees, agents and contractors, maintain complete and accurate records with respect to Inovio’s pharmacovigilance-related obligations set forth in Section 5.8. Upon reasonable prior notice, such records shall be available for examination during regular business hours for a period of three (3) years from the end of any Calendar Year. Such examinations may the Fiscal Year to which they pertain, and not be conducted more often than once in any Calendar Year each Fiscal Year, by Advaccine or its designee that is reasonably acceptable to Inovio, for the sole purpose of ensuring compliance with NMPA and other Regulatory Authority regulations. Any such records shall be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other deemed Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementInovio.

Appears in 1 contract

Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)

Records; Audits. Merck will keep, CFFT shall keep and will shall cause each its Affiliates and Sublicensees to keep accurate books and accounts of record in accordance with all applicable accounting standards and law and regulations and consistent with the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for CFFT generally, that accurately reflect all costs, expenses, and revenues relevant to the purpose determination of calculating all any payment obligations pursuant to this Agreement, including, without limitation, the calculation of any royalties and or other amounts payable due CFFT by either Party any Sublicensee. CFFT shall maintain and shall cause its Affiliates and Sublicensees to the other Party hereunder maintain such books and ensuring each Party’s compliance hereunder. For the [***] following records for a period of at least three (3) full Calendar Years after the end of the Calendar Year Quarter in which they were generated. Altus, together with its independent representatives and accountants reasonably acceptable to which each will pertainCFFT (and subject to the execution of an appropriate written agreement of confidentiality), such shall be entitled to audit the books and records of accounting (including those CFFT and its Affiliates at reasonable times and upon reasonable notice, solely for purpose of its Affiliatesverifying the correctness or completeness of any such report, as applicable) will be kept at each of their principal place of business. At the request of either Partydetermination, the other Party will permit (and procure its Affiliates, or payment with respect to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than three (3) years before Altus’ request. The foregoing right of review may be exercised only once per Calendar Year and only once with respect to any such periodic report and payment. The results of any such examination shall be (a) limited to information relating to the sum being audited, and (b) treated as Confidential Information. Altus shall bear the full cost of the performance of any such audit, unless such audit discloses a variance to the detriment of Altus of more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party from the amount of the discrepancy original report, royalty, or payment calculation. In such case, CFFT shall bear the full cost of the performance of such audit. CFFT shall, within ten days of receipt of the report of the auditor, make a correcting payment to Altus in an amount sufficient to correct any underpayment determined by the audit and to pay interest on the amount of the underpayment equal to [***] of over the prime rate as published from time to time by the Wall Street Journal, compounded annually, from the date the underlying payments were originally due to the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Partiescorrecting payment. The fees charged by such accounting firm Any overpayment shall be paid promptly refunded by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect Altus to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementCFFT without interest.

Appears in 1 contract

Sources: License Agreement (Altus Pharmaceuticals Inc.)

Records; Audits. Merck will keep(a) Avanir shall maintain, and will cause each shall require its Affiliates and sublicensees to maintain, complete and accurate records in sufficient detail to permit OptiNose to confirm the accuracy of (i) the other Selling Partiescalculation of Net Sales, as applicable, to keepRoyalties and the achievement of Sales Milestones under this Agreement, and Moderna will keep, adequate books and records (ii) the calculation of accounting for Joint Development Costs incurred during the purpose of calculating all royalties and other amounts payable Term by either Party to the other Party hereunder and ensuring each Party’s compliance hereunderAvanir or its Affiliates. For the Upon at least [***] following prior notice, Avanir shall, and shall require its Affiliates and use reasonable efforts to require its sublicensees to, make such records available during regular business hours at such Party’s principal place of business for a period of [***] from the end of the Calendar Fiscal Year to which each will pertainthey pertain for examination, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following each Fiscal Year, by an independent certified public accountant from a nationally recognized firm in the end United States selected by OptiNose, for the sole purpose of any Calendar Yearverifying the accuracy of the financial reports furnished by Avanir pursuant to this Agreement; provided that Avanir may require such accountant(s) to enter into a customary confidentiality agreement for arrangements of such type. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm accountants shall disclose to the auditing Party OptiNose, with a copy to Avanir, only whether the reports (A) Net Sales, Royalties and other payments hereunder are correct or incorrect incorrect; (B) whether the calculation of Joint Development Costs incurred by Avanir is accurate, and the amount of discrepancy, if any, in either case; and/or (C) if it believes in good faith that Avanir is in breach of any discrepancyof its payment obligations hereunder. No other Confidential Information information shall be providedprovided to OptiNose. If With respect to Royalties and other payments owed to OptiNose hereunder, any amounts shown to be owed but unpaid shall be paid within [***] from the accountant’s report. Any amounts shown to have been overpaid shall be refunded within [***] from the accountant’s report. OptiNose shall bear the full cost of such accounting firm correctly identifies a discrepancy made during audit unless such period, the appropriate Party shall pay the other Party the amount audit discloses an underpayment of the discrepancy within more than [***] of the date amount actually owed during the applicable Fiscal Year, in which case Avanir shall reimburse OptiNose for its out-of-pocket expenses incurred for such audit. OptiNose shall hold all information disclosed to it under this Section 8.6(a) and all Royalty Reports delivered by Avanir pursuant to Section 8.3(b) as Confidential Information of delivery Avanir. (b) OptiNose shall, and shall require its Affiliates to, maintain complete and accurate records in sufficient detail to permit Avanir to confirm the accuracy of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon Joint Development Costs incurred by the PartiesOptiNose under this Agreement. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds Upon [***]] prior notice, the audited Party OptiNose shall, and shall pay the fees. Upon the expiration require its Affiliates to, make such records shall be available during regular business hours for a period of [***] following from the end of any Calendar the Fiscal Year to which they pertain for examination, and not more than [***] each Fiscal Year, absent willful misconduct or fraud by an independent certified public accountant selected by Avanir from a Party nationally recognized firm in the United States, for the sole purpose of verifying the accuracy of the Joint Development Costs reported by OptiNose pursuant to this Agreement; provided that OptiNose may require such accountant(s) to enter into a customary confidentiality agreement for arrangements of such type. Such accountants shall disclose to Avanir, with a copy to OptiNose, only whether: (its Affiliates, as applicableA) the calculation of amounts payable with respect to such Calendar Year Joint Development Costs incurred by Avanir, are correct or incorrect; (B) the amount of discrepancy, if any; and (C) if it believes in good faith that OptiNose is in breach of any of its payment obligations hereunder. No other information shall be binding and conclusive upon provided to Avanir. In the Partiesevent the audit reveals an error in the calculation of any Joint Development Costs previously reported by OptiNose, and the Parties such Joint Development Costs shall be released from any liability or accountability with respect to amounts payable adjusted for purposes of this Agreement. Avanir shall bear the full cost of such audit unless such audit discloses an overstatement of more than [***] of the Joint Development Costs actually incurred by OptiNose during the applicable Fiscal Year, in which case OptiNose shall reimburse Avanir for its out-of-pocket expenses incurred for such Calendar Yearaudit. The auditing Party Avanir shall treat hold all financial information subject disclosed to review it under this Section 8.6(c8.6(b) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such as Confidential Information in confidence pursuant to such confidentiality agreementof OptiNose.

Appears in 1 contract

Sources: License Agreement (Avanir Pharmaceuticals, Inc.)

Records; Audits. Merck will keep9.10.3.1 GSK will, and will cause each of the other Selling Parties, ensure that its Related Parties (as applicable), keep complete and accurate records in accordance with its record retention policies applicable to keep, and Moderna will keep, adequate such books and records records, but in any event for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following after the end of the Calendar Year in which any such payment becomes payable, in sufficient detail to which each will pertain, confirm the accuracy of the calculations hereunder and in accordance with the applicable Accounting Standard that is normally applied by such books and records of accounting (including those Party with respect to the filing of its Affiliatesreporting. 9.10.3.2 During the Term and for [***] thereafter, as applicable) GSK will be kept at each of their principal place of business. At the request of either Partypermit, the other Party and will permit (and procure cause its Affiliates, Related Parties to permit) , an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party Wave, and reasonably acceptable to the other GSK or such Related Party to have access to and to review, during normal business hours to such and under obligations of confidentiality at least as protective of GSK Confidential Information as the records as may be reasonably necessary confidentiality provisions of Section 10 (Confidentiality) and upon [***] prior written notice, no more frequently than [***] period (except in the case of fraud), to verify the accuracy of the Royalty Reports and payments due hereunder for under this Section 9 (Payments) with respect to any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Yearprior to such audit request. The accounting firm shall will disclose to the auditing Party GSK and Wave only whether the reports Royalty Reports are correct or incorrect and the amount of specific details concerning any discrepancy. No other Confidential Information shall be provideddiscrepancies. If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such period, the appropriate Party shall and GSK agrees with such calculation, GSK will promptly pay the other Party additional undisputed amount. If such accounting firm concludes that an overpayment was made, such overpayment will be fully creditable against amounts payable in subsequent payment periods. Wave will pay for the amount cost of the discrepancy within any audit, unless GSK has underpaid Wave by [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], more for the audited period. Each Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall will treat all financial information subject to review that it receives under this Section 8.6(c) 9.10.3.2 in accordance with the confidentiality and non-use provisions of this AgreementSection 10 (Confidentiality), and shall will cause its accounting firm to enter into an acceptable acceptable, reasonable confidentiality agreement with the audited other Party obligating it such firm to retain all such Confidential Information financial information in confidence pursuant to such confidentiality agreement., except to the extent necessary for such Party to enforce its rights under this Agreement. ‑87‑

Appears in 1 contract

Sources: Collaboration and License Agreement (Wave Life Sciences Ltd.)

Records; Audits. Merck will keep(a) GSK shall, and will cause each of the other Selling Parties, shall ensure that its Affiliates and Sublicensees (as applicable), keep complete and accurate records in accordance with its record retention policies applicable to keep, and Moderna will keep, adequate such books and records records, but in any event for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following ([***]) after the end of the Calendar Year in which any such payment becomes payable, in sufficient detail to which each will pertain, permit ▇▇▇▇▇▇▇▇ to confirm the accuracy of the calculations hereunder and in accordance with the applicable Accounting Standard that is normally applied by such books and records of accounting (including those Party with respect to the filing of its Affiliatesreporting. (b) During the Term and for [***] ([***]) thereafter, as applicable) will be kept at each of their principal place of business. At the request of either PartyGSK shall permit, the other Party will permit (and procure shall cause its Affiliates, Affiliates or Sublicensees to permit) , an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party ▇▇▇▇▇▇▇▇, and reasonably acceptable to the other Party GSK or such Affiliate or Sublicensee, to have access to and to review, during normal business hours to such and under obligations of confidentiality at least as protective of GSK Confidential Information as the confidentiality provisions of ‎Article 8 and upon [***] ([***]) prior written notice, no more frequently than once in any [***] ([***]) period (except in the case of fraud), any records as may be reasonably necessary contemplated by clause ‎(a) above to verify the accuracy of the Royalty Reports and payments due hereunder for under this ‎Article 6 with respect to any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year([***]) prior to such audit request. The accounting firm shall disclose to the auditing Party GSK and Scynexis only whether the reports Royalty Reports and GSK’s payments under this ‎Article 6 are correct or incorrect and the amount specific details concerning any discrepancies (it being understood that Scynexis shall not receive any other information from such accounting firm in respect of any discrepancy. No other Confidential Information shall be providedsuch audit). If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such period, the appropriate Party shall pay the other Party the amount of the discrepancy and GSK does not notify Scynexis within [***] ([***]) of the date of delivery receipt of such accounting firm’s written report so correctly concludingthat GSK disagrees in good faith with such calculation, or as otherwise agreed GSK shall pay the additional undisputed amount, plus interest at the rate set forth in Section ‎6.7(c) calculated from the date upon by which payment of such sum became due until the Parties. The fees charged by such date upon which the Parties receive the accounting firm shall be paid by the auditing Partyfirm’s written report, provided that if the underpayment or overcharge exceeds within [***] ([***]) from the date on which GSK receives a Valid Invoice in accordance with Section ‎6.7. If such accounting firm concludes that an overpayment was made, the audited Party such overpayment shall pay the feesbe fully creditable against amounts payable in subsequent payment periods. Upon the expiration If GSK provides notice of its good faith disagreement with such calculation within such [***] following ([***]) period, GSK and Scynexis shall, acting reasonably and in good faith, work to resolve the end disagreement. If the Parties are unable to reach a mutually acceptable resolution of any Calendar Yearsuch dispute within [***] ([***]), absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year dispute shall be binding submitted for resolution to an accounting firm jointly selected by the Parties to conduct a review and conclusive upon the Partiesprovide a final determination, and if such firm concurs that any additional amounts were owed by GSK during such period, GSK shall make the required payment, plus interest at the rate set forth in Section ‎6.7(c) calculated from the date upon which payment of such sum became due until the date upon which the Parties receive the accounting firm’s written report. In the event the Parties are unable to mutually select an accounting firm, each Party shall be released from select an accounting firm and the two selected accounting firms shall jointly select a third accounting firm to conduct a review and provide a final determination. Scynexis shall pay for the cost of any liability audit, unless GSK has underpaid Scynexis by [***] percent ([***]%) or accountability with respect to amounts payable more for the audited period, in which case GSK shall pay for the cost of such Calendar Yearaudit. The auditing Each Party shall treat all financial information subject to review that it receives under this Section 8.6(c‎6.8(b) in accordance with the confidentiality and non-use provisions of ‎Article 8 of this Agreement, and shall cause its accounting firm to enter into an acceptable acceptable, reasonable confidentiality agreement with the audited other Party obligating it such accounting firm to retain all such Confidential Information financial information in confidence pursuant to such confidentiality agreement, except to the extent necessary for such Party to enforce its rights under this Agreement. No record audited pursuant to this Section ‎6.8(b) may be audited more than once.

Appears in 1 contract

Sources: Exclusive License Agreement (Scynexis Inc)

Records; Audits. Merck will 6.7.1. Each Party shall keep, and will shall cause each of the other Selling Partiesits Affiliates, as applicable, agents and sublicensees to keep, full and Moderna will keep, adequate accurate records and books and records of accounting account containing all particulars that may be necessary for the purpose of calculating Direct Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses for Products to be received or borne by the Parties pursuant to this Agreement, including, but not limited to, inventory, purchase and invoice records, manufacturing records, sales analysis, general ledgers, financial statements, and tax returns relating to Products. Such books of account, with all royalties and other amounts payable necessary supporting data, shall be kept by either each Party to at its place of business for the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] three (3) years next following the end of the Calendar Year calendar year to which each will shall pertain, such books and records of . Each Party (the "Audited Party") shall permit an independent accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, firm selected by the other Party will permit (and procure its Affiliates, to permitthe "Auditing Party") an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party Audited Party, which acceptance shall not be unreasonably withheld or delayed, to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end Audited Party's reports of any Calendar YearDirect Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses as provided herein. Such examinations may not All such verifications shall be conducted at the expense of the Auditing Party and not more than once in each calendar year. In the event such audit concludes that adjustments should be made in the Auditing Party's favor, then any Calendar Year or be repeated appropriate payments (plus accrued interest at a rate announced by the Bank of America as its prime rate in effect on the date that such payment was first due plus three percent (3%) for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether period starting from the reports are correct or incorrect and date the amount of any discrepancy. No other Confidential Information payment was first due ending on the date the payment was made) shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, paid by the appropriate Audited Party shall pay the other Party the amount of the discrepancy within [***] thirty (30) days of the date of delivery of such the Audited Party receives the Auditing Party's accounting firm’s 's written report so correctly concluding, or unless the Audited Party shall have a good faith dispute as otherwise agreed upon by to the Partiesconclusions set forth in such written report, in which case the audited Party shall [*]-INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. provide written notice to the Auditing Party within such thirty (30) day period of the nature of its disagreement with such written report. The Parties shall thereafter, for a period of sixty (60) days, attempt in good faith to resolve such dispute and if they are unable to do so then the matter will be submitted to dispute resolution in accordance with Section 12.7 hereof. The fees charged by such accounting firm shall be paid by the auditing PartyAuditing Party unless the audit discloses that adjustments in favor of the Auditing Party for the period are five percent (5%) or more of the aggregate amount paid or payable by the Audited Party to the Auditing Party during the period, provided that if in which case the underpayment or overcharge exceeds [***], the audited Audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud reasonable fees and expenses charged by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearaccounting firm. The auditing Party shall treat Parties agree that all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality 6.7 is confidential and non-use provisions of this Agreement, and that it shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information information subject to the confidentiality restrictions of Article 8 hereof. 6.7.2. In addition to the foregoing, Alimera shall permit an independent certified public accountant retained by UKRF to inspect the records and books of account described in confidence pursuant Section 6. 7.1 during normal business hours and upon reasonable notice to the extent required by the UKRF Licenses. Such right of inspection shall last for two (2) years following the end of the calendar quarter to which such confidentiality agreementrecords and books of account pertain, shall be limited solely to those matters directly related to CDS royalty obligations under the UKRF Licenses, and shall be allowed no more than once a year.

Appears in 1 contract

Sources: Collaboration Agreement (pSivida LTD)

Records; Audits. Merck will keep(a) Potlatch shall maintain detailed operating and financial records of all harvest operations carried out pursuant to this Agreement, including (i) operating records setting forth the volumes of each Product cut and scaled and the date and location of each scaling, and will cause (ii) financial records setting forth the Total Administrative Cost and the Costs of Log and Haul and invoices or other evidence of all such costs. Potlatch shall maintain such records relating to each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting Harvest Year for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following not less than five (5) years after the end of the Calendar Year to which each will pertain, such books and Harvest Year. Such records of accounting (including those of shall be available for review by Partnership or its Affiliates, as applicable) will be kept representatives at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access Potlatch's offices at any time during normal business hours on not less than three (3) days prior written notice. (b) As promptly as practicable but in no event later than five (5) business days after the last day of each calendar quarter, Potlatch shall cause to be delivered to Partnership a report (a "Quarterly Logging Audit") setting forth for such calendar quarter the total volume of each Product cut and scaled pursuant to this Agreement, the records Total Administrative Costs and the Total Costs of Log and Haul for the relevant Harvest Year and such other information (other than prices) as may be reasonably necessary to verify establish the accuracy Total Purchase Price for such calendar quarter. The Quarterly Logging Audit shall be prepared and certified by Potlatch. Unless Potlatch or Partnership objects to a Quarterly Logging Audit within ten (10) days after delivery thereof, the payment of the payments due hereunder Adjustment Amount for such calendar quarter shall be based upon the Quarterly Logging Audit. In the event of an objection, any Calendar Year ending undisputed amount shall be paid and Potlatch and Partnership shall use diligent efforts in good faith to resolve such dispute promptly. Potlatch and Partnership shall have the right to audit and review the Quarterly Logging Audit and the related records and information respecting any calendar quarter provided that such audit shall be commenced not more later than [***] following the end date one (1) year after delivery of the Quarterly Logging Audit for such calendar quarter, and shall be completed not later than the date two (2) years after delivery of the Quarterly Logging Audit for such calendar quarter. Unless Potlatch or Partnership shall have timely commenced and completed such an audit, the Quarterly Logging Report as to such calendar quarter shall be final and binding as of the date two (2) years after delivery of such Quarterly Logging Audit. In the event any Calendar Year. Such examinations may not be conducted more than once such audit results (through negotiation or arbitration) in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose an adjustment to the auditing Party only whether Total Purchase Price for the reports are correct or incorrect and relevant calendar quarter, the party owing such adjustment shall pay the amount of any discrepancy. No other Confidential Information such adjustment within twenty (20) days after such amount shall be provided. If such accounting firm correctly identifies a discrepancy made during such periodhave been determined, together with interest thereon from the appropriate Party shall pay the other Party the amount last day of the discrepancy within [***] relevant calendar quarter until paid, at a variable rate equal to the sum of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicablei) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the PartiesPrime Rate then in effect, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(cplus (ii) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementtwo percent.

Appears in 1 contract

Sources: Timberland Management and Timber Purchase Agreement (Timberland Growth Corp)

Records; Audits. Merck will keepEach Party shall maintain, and will cause each of the other Selling Partiesrequire its Affiliates to maintain, as applicable, complete and accurate records in sufficient detail to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to permit the other Party hereunder and ensuring each Party’s compliance hereunder. For to confirm the [***] following the end accuracy of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, any calculations by the other Party will permit or any payments due by the other Party under this Agreement, including (a) amounts to be included in the calculation of Allowable Expenses or other amounts to be reimbursed or shared pursuant to this Agreement, (b) Net Sales, (a) royalty payments for purposes of determining any under- or over-payment of royalties, (b) Manufacturing Costs, Commercial Packaging and procure its AffiliatesLabeling Costs, Commercialization Costs, and Medical Affairs Costs, (e) amounts payable under any supply agreement with respect to permitthe Product to which the Parties or their Affiliates are party, and (f) other compensation or reimbursement payable under this Agreement. Upon reasonable prior notice, such records for any Year(s) ending not more than [*] prior to the date of such request shall be open during regular business hours for examination at the auditing Party’s expense, and not more often than once each [*] period, by an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party and reasonably acceptable to the other audited Party to have access during normal business hours to such for the sole purpose of verifying for the records as may be reasonably necessary to verify auditing Party the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following financial statements or reports furnished by the end audited Party pursuant to this Agreement or of any Calendar Year. Such examinations may not payments made, or required to be conducted more than once in any Calendar Year made, by or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing audited Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay to the other Party pursuant to this Agreement or any supply agreement with respect to the amount Product to which the Parties or their Affiliates are party. Such accountant shall be provided access to the audited Party’s data for the purpose of verifying, without limitation, the audited Party’s ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ determination of the discrepancy within [***] number of the date of delivery FTEs (if applicable), and calculation of such accounting firm’s written report so correctly concludingother information included in the calculation for Manufacturing Costs, or as otherwise agreed upon Commercial Packaging and Labeling Costs, Commercialization Costs, and Medical Affairs Costs actually incurred by the Partiesaudited Party for the Product. The fees charged by Any such accounting firm auditor shall be paid by not disclose the audited Party’s information to the auditing Party, provided except to the extent that if such disclosure is necessary to report on the underpayment or overcharge exceeds [***], accuracy of the financial reports furnished by the audited Party or the amount of payments due by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid, shall pay be paid or refunded (as the fees. Upon the expiration of case may be) within [**] days after the accountant’s report, unless such report is challenged in good faith by the audited Party, in which case any undisputed portion shall be paid within [*] following days after the end accountant’s report and any remaining disputed portion shall be paid within [*] days after resolution of any Calendar Yearthe dispute, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable and interest shall not accrue with respect to such Calendar Year shall be binding and conclusive upon the Parties, and disputed portion during the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Yearperiod of time the dispute is being resolved. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with bear the confidentiality and non-use provisions full cost of this Agreementsuch audit unless such audit reveals an overpayment to, and shall cause its accounting firm to enter into or an acceptable confidentiality agreement with underpayment by, the audited Party obligating it that resulted from a discrepancy in a report that the audited Party provided to retain all the other Party during the applicable audit period, which underpayment or overpayment was more than [*], in which case the audited Party shall bear the Out of Pocket Costs of such Confidential Information in confidence pursuant to such confidentiality agreement.audit. ​

Appears in 1 contract

Sources: Joint Commercialization Agreement (Genmab a/S)

Records; Audits. Merck will keep, Each Party shall keep complete and will cause accurate records reflecting all information necessary or useful in verifying the accuracy of each of the other Selling PartiesPayment Report, as applicable, to keep, and Moderna will keep, adequate books and well as records of accounting for the purpose of calculating reflecting all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably information necessary or useful to verify the accuracy of each Party's Supplemental Fees, Commissions, Net Distribution Margins, Net Sales, Manufacturing Costs, Distribution Expenses, Development Costs, Promotional and Marketing Costs, Physician Details, and Service Level Commitment (collectively, the payments due hereunder for "Audited Information"). Each Party shall have the right to hire an independent certified public accountant to inspect the Audited Information (which accountant shall agree in writing to keep all Audited Information confidential except as needed to disclose any Calendar Year ending not discovered discrepancies); provided, such audit: (i) is conducted during normal business hours, (ii) is conducted no more often then once per year (unless a discrepancy greater than [***] following five percent (5%) is discovered in favor of the end of any Calendar Year. Such examinations may not be auditing party), and (iii) is conducted more than once in any Calendar Year or be repeated for any Calendar Yearonly after the auditing party has given thirty (30) days' prior written notice. The accounting firm auditing party shall disclose to bear the full cost and expense of such audit, unless a discrepancy in excess of five percent (5%) in favor of the auditing Party only whether party is discovered, in which event the reports are correct or incorrect audited party shall bear the full cost and expense of such audit. Regardless of the amount of any discrepancy. No other Confidential Information discrepancy discovered, all discrepancies (and interest thereon) shall be provideddue and payable within thirty (30) days after the Party receives notice thereof. If such accounting firm correctly identifies a discrepancy made during such periodProduct Supplied for Clinical Trials, Promotional and Humanitarian Uses. The Executive Steering Committee shall determine the appropriate Party shall pay the other Party the amount quantity of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or each Product to be used for clinical trials and investigational IND's (as otherwise agreed upon that term is defined by the PartiesFDA). The fees charged by Product supplied for such accounting firm purposes shall be paid by the auditing Party, without charge hereunder except as provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the feesin this Section 6.14. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year Such Product shall be binding and conclusive upon the Partiessupplied at its Manufacturing Cost, and the Parties cost shall be released from treated (and allocated between the Parties) as Development Costs; no Supplemental Fee, Commissions, or other payment shall be due under this Agreement in respect of such use and any liability or accountability with respect to amounts payable Product used for such Calendar Yearpurpose shall not be included in calculation of Net Distribution Margin. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.Development Obligations

Appears in 1 contract

Sources: Co Promotion Agreement (Sangstat Medical Corp)

Records; Audits. Merck will Each Party shall keep, and will shall cause each of the other Selling Parties, as applicable, its applicable Affiliates and Sublicensees to keep, complete, true and Moderna will keepaccurate records in accordance to its Accounting Standards of the items underlying Development Costs, adequate Net Sales, Manufacturing Costs and Third Party Patent Rights royalties, other license fees and other payments relating to the reports and payments required by this Agreement. Each Party and its applicable Affiliates and Sublicensees shall keep such books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] years following the end of the Calendar Year to which each will they pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Each Party will permit (and procure have the right [**], at its Affiliatesown expense, to permit) have an independent independent, internationally-recognized, certified public accounting firm of internationally recognized standing (the “Auditor”), selected by the auditing such Party and reasonably acceptable to the other Party to have access Party, review any such records of the other Party, its Affiliates and Sublicensees in the location(s) where such records are customarily maintained upon reasonable notice and during normal regular business hours to such and under obligations of confidence, for the records as may be reasonably necessary to verify sole purpose of verifying the basis and accuracy of payments made under this Agreement within the prior [**] month period. Before beginning its audit, the Auditor shall execute an undertaking reasonably acceptable to the audited Party by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the Parties only its conclusions regarding any payments due hereunder for any Calendar Year ending owed under this Agreement. Such inspection right shall not be exercised more than [**] and not more frequently than [**] following with respect to records covering any specific period of time. In addition, the end auditing Party shall only be entitled to audit the books and records of the audited Party from the [**] Calendar Years prior to the Calendar Year in which the audit request is made. The auditing Party agrees to hold in confidence all information received and all information learned in the course of any Calendar Yearaudit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any applicable Law. Such examinations may not be conducted more than once in any Calendar Year or be repeated The Auditor shall provide its audit report and basis for any Calendar Year. The accounting firm shall disclose determination to the audited Party at the time such report is provided to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be providedbefore it is considered final. If the review of such accounting firm correctly identifies a discrepancy made during such periodrecords reveals that the audited Party has failed to accurately report information pursuant to this Agreement, then the appropriate audited Party shall promptly pay to the other auditing Party any resulting amounts due under this Agreement together with interest calculated in the manner provided in Section 7.11. If the audited Party has underpaid by an amount of the discrepancy within greater than [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds percent ([***]%) of the amounts actually due for a Calendar Quarter under this Agreement, the audited Party shall pay the fees. Upon the expiration reasonable costs of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementreview.

Appears in 1 contract

Sources: Licensing and Commercialization Agreement (Ophthotech Corp.)

Records; Audits. Merck will keep(a) Company shall, and will shall cause each of the other Selling Partiesits Affiliates and require its Sublicensees to, as applicable, keep complete and accurate records in accordance with its record retention policies applicable to keep, and Moderna will keep, adequate such books and records records, but in any event for a period of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the at least [***] following years after the end of the Calendar Year in which any royalties becomes payable (or such longer period as required under the applicable Accounting Standard or Law), in sufficient detail to which each will pertain, confirm the accuracy of the calculations hereunder and in accordance with the applicable Accounting Standard that is normally applied by such books and records of accounting (including those Party with respect to the filing of its Affiliatesreporting. (b) During the Term and for [***] years thereafter, as applicable) will be kept at and not more than [***] in each of their principal place of business. At the request of either PartyCalendar Year, the other Party will permit (Company shall permit, and procure shall cause its Affiliates, Affiliates and require its Sublicensees to permit) , an independent certified public accounting firm of internationally nationally recognized standing selected by the auditing Party Biosion, and reasonably acceptable to the other Party Company or such Affiliate or Sublicensee, to have access to and to review, during normal business hours to such upon not less than [***] days’ prior notice, the applicable records of the records as may be reasonably necessary Company and its Affiliates and Sublicensees to verify the accuracy of the Royalty Reports, statements of Sales Milestone Events or Sublicense Income or any other payments due hereunder under this Article 4. Such review may cover the records for sales made in any Calendar Year ending not more than [***] following years prior to the end date of such notice (provided that any Calendar Year. Such examinations may not be conducted more than once in any such Calendar Year or may only be repeated subject to audit [***], unless for any Calendar Yearcause). The accounting firm shall disclose to the auditing Party Biosion and Company only whether the reports Royalty Reports or statements of Sales Milestone Events or Sublicense Income are correct or incorrect and the amount of any discrepancydiscrepancies. No other Confidential Information information shall be provided. provided to Biosion. (c) If such accounting firm correctly identifies a discrepancy made concludes that additional amounts were owed during such period, the appropriate Party and Company agrees with such calculation, Company shall pay the other Party the additional undisputed amount of the discrepancy within [***] of days after the date of delivery of Biosion delivers to Company such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Partiesreport. The fees charged by If such accounting firm concludes that an overpayment was made, such overpayment shall be paid by fully creditable against amounts payable in subsequent payment periods (or reimbursed to the auditing Partyextent there are no subsequent payment periods). If Company disagrees with such calculation, provided that if Biosion and Company shall work together reasonably and in good faith to resolve the underpayment or overcharge exceeds [***], disagreement. If the audited Party shall pay the fees. Upon the expiration Parties are unable to reach a mutually acceptable resolution of any such Dispute within [***] following days, ​ then, notwithstanding Article 10, the end Dispute shall be submitted for resolution to a certified public accounting firm jointly selected by the Parties to conduct a review, and if such firm concurs that any additional amounts were owed by Company during such period, Company shall make the required payment within [***] days after the date Company receives the report of its accounting firm. Biosion shall pay for the cost of any Calendar Yearsuch audit, absent willful misconduct unless Company has underpaid Biosion by the greater of: (i) [***] and (ii) [***] or fraud by a Party more for the applicable audited period. (its Affiliates, as applicabled) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Each Party shall treat all financial information subject to review that it receives under this Section 8.6(c) 4.13 in accordance with the confidentiality and non-use provisions of Article 6 of this Agreement, and shall cause its accounting firm to enter into an acceptable acceptable, reasonable confidentiality agreement with the audited other Party obligating it such firm to retain all such Confidential Information financial information in confidence pursuant to such confidentiality agreement, except to the extent necessary for such Party to enforce its rights under this Agreement.

Appears in 1 contract

Sources: Exclusive License Agreement (Aclaris Therapeutics, Inc.)

Records; Audits. Merck will Toyama shall keep, and will cause each of and require to be kept by Sublicensees and Toyama Sole Distributors, such records as are reasonably required to determine (i) in a manner consistent with IFRS or applicable financial standard in the other Selling PartiesTerritory, as applicablethe payments and amounts due under this Agreement and (ii) whether or not Toyama, to keepSublicensees, and Moderna will keepToyama Sole Distributors are complying with the terms of this Agreement to, adequate books and with respect to this clause (ii) only, the extent constituting a sublicense granted by Cempra under the Scripps License; such records must be kept for a minimum of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] years following the end of the Calendar Year to which each will such records pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either PartyCempra, the other Party will permit Toyama shall (and procure its Affiliates, to permitToyama shall cause Sublicensees and Toyama Sole Distributors to) permit an independent certified public accounting firm engaged on behalf of internationally recognized standing selected Cempra (which firm may also represent Scripps with respect to any audit requested by the auditing Party or conducted on behalf of Scripps), at reasonable times not more than once a Calendar Year (unless Scripps requests an audit of Toyama and/or any Sublicensees or Toyama Sole Distributors during a particular Calendar Year in which Cempra has previously requested an audit of Toyama and/or any Sublicensees or Toyama Sole Distributors, in which case, one such request initiated by Scripps shall be honored hereunder during such Calendar Year, in addition to any preceding audit request made by Cempra independently of any audit request made by Scripps) and reasonably acceptable upon prior written notice, to the other Party to have access during normal business hours to such of the audit, examine, and/or copy those records as may be reasonably necessary relevant to verify the accuracy of the payments due hereunder for determine, with respect to any Calendar Year ending not more than [***] following years prior to the end applicable request, (x) the correctness or completeness of any Calendar Yearroyalty report or payment made under this Agreement or, with respect to any audit, examination, or inspection requested by or on behalf of Scripps, (y) whether or not Toyama, Sublicensees, and Toyama Sole Distributors are in compliance with this Agreement to the extent constituting a sublicense granted by Cempra under the Scripps License. Such examinations may not be conducted more than once With respect to any audit, examination, or inspection requested by or on behalf of Scripps, Cempra shall, if and as requested by Toyama, and without limitation of Scripps’ rights under their agreements with Cempra and their corresponding rights hereunder, (I) use Commercially Reasonable Efforts to schedule such audit and accompany the applicable certified public accounting firm on any such audit, examination, or inspection occurring on Toyama’s premises and (II) ensure that Scripps maintains any information they obtain from Toyama in the course of any Calendar Year or be repeated for any Calendar Yearaudit hereunder as confidential under the applicable terms of the Scripps License. The independent certified public accounting firm shall disclose not be paid on a contingency basis depending upon the results of [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. such audit and shall only report on (a) the existence of any over or under payment and the amount, if any, of such over or under payment and, to the auditing Party only extent engaged with respect to an audit, examination, or inspection requested by or on behalf of Scripps, to determine whether or not Toyama, Sublicensees, and Toyama Sole Distributors are complying with the reports are correct terms of this Agreement to the extent constituting a sublicense granted by Cempra under the Scripps License, as permitted above, (b) such compliance or incorrect the nature and extent of any failure by Toyama, Sublicensees, or Toyama Sole Distributors to comply with such terms hereof. Cempra shall promptly provide a copy of the results of any such audit or examination to Toyama. Cempra shall bear the full cost of the performance of any such audit or examination, unless such audit or examination discloses an underpayment exceeding [*] of the amount actually due hereunder with respect to any particular four (4) consecutive Calendar Quarters. Toyama shall, within twenty (20) Business Days of Toyama’s receipt of the results of such audit or examination pay to Cempra the amount of any discrepancyunderpayment revealed thereby. No Any actual overpayment of royalties or any other Confidential Information amount made to Cempra by Toyama hereunder revealed by an examination and review shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review credited against future payments due Cempra under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this AgreementAgreement or promptly refunded to Toyama, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementat Toyama’s request.

Appears in 1 contract

Sources: Exclusive License and Development Agreement (Cempra, Inc.)