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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 5 contracts

Samples: Collaboration and License Agreement, Collaboration and License Agreement (Moderna, Inc.), Collaboration and License Agreement (Moderna, Inc.)

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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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: Vaccine Collaboration and License Agreement, Vaccine Collaboration and License Agreement, Vaccine Collaboration and License Agreement (Moderna, 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 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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

Samples: 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 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDAudited Party’s reports of Direct Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses as provided herein. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. 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 in confidence pursuant information subject to such the confidentiality agreementrestrictions of Article 8 hereof.

Appears in 3 contracts

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

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 the payments 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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 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

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

Records; Audits. Merck will keepDuring the Term and for two (2) years thereafter, the non-paying/receiving Party shall have a right to request an audit of each Selling Party in order to confirm the accuracy of royalty payments or any other applicable amount audited hereunder (an “Audit”); provided, however, that each non-paying/receiving Party shall only have the right to request such Audit one time during any given Calendar Year. Upon the written request by the non-paying/receiving Party to Audit a Selling Party, the non-paying/receiving Party shall have the right to engage an independent certified public accountant approved by the paying Party, such approval not to be unreasonably withheld, to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the royalty payments or any other applicable amount audited hereunder for the Calendar Year(s) requested by the non-paying/receiving Party; provided that (i) such accountants shall submit an audit plan, including audit scope, to the Selling Party for the Selling Party’s approval, which shall not be unreasonably withheld, prior to audit implementation, (ii) such accountants shall be given access to, and will cause each of the other Selling Parties, as applicable, shall be permitted to keep, examine 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, copy such books and records of accounting the Selling Party upon five (including those of its Affiliates, as applicable5) will be kept at each of their principal place of business. At days’ prior written notice to the request of either Selling Party, and at reasonable times on Business Days, (iii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Selling 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 Selling Party in order to have access keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the non-paying/receiving Party, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iv) such accountants shall use reasonable efforts to minimize any disruption to the Selling Party’s business. The Selling Party shall make personnel reasonably available during normal regular business hours to answer queries on all such books and records required for the purpose of the records as may be reasonably necessary Audit. The accountants shall deliver a copy of their findings to verify the accuracy each of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Parties upon completion of the review, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following and, in the end absence of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year fraud or be repeated for any Calendar Year. The accounting firm shall disclose to manifest error, the auditing Party only whether the reports are correct or incorrect and the amount findings of any discrepancy. No other Confidential Information such accountant 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 final and binding on each 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 Any underpayments by such accounting firm the Selling Party shall be paid to the non-paying/receiving Party within thirty (30) Business Days of notification of the results of such inspection. Any overpayments made by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Selling Party shall pay be refunded by the feesnon-paying/receiving Party within thirty (30) Business Days of notification of the results of such inspection. Upon The cost 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 accountants shall be binding the responsibility of the non-paying/receiving Party unless the accountants’ calculation shows that the actual royalties payable, Net Sales and/or any other applicable amount Audited hereunder to be underpaid by more than five percent (5%), than the amounts as paid and conclusive upon reported by the Parties, and Selling Party 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 period 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

Samples: Share Issuance Agreement (Ignyta, Inc.), Share Issuance Agreement (Ignyta, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: Collaboration and Licence Agreement (Amgen Inc), Licence Agreement (Amgen Inc)

Records; Audits. Merck will keep, 11.01 Sunesis shall keep accurate and will cause each adequate records with respect to the Net Sales of the other Products by Sunesis, its Affiliate(s) and the Sublicensee(s), including the Net Selling PartiesPrice thereof, as applicableduring the term of this Agreement and upon Dainippon’ written request, but not more frequently than once per calendar year, shall permit a certified independent public accountant selected by Dainippon and reasonably acceptable to keep, and Moderna will keep, adequate Sunesis to examine the books and records of accounting for Sunesis, its Affiliate(s) and the purpose Sublicensee(s) during regular business hours of calculating all royalties and other amounts payable by either Party Sunesis, its Affiliate(s) and, to the other Party hereunder and ensuring each Party’s compliance hereunder. For extent provided below, the [***] following Sublicensee(s), to verify the end accuracy thereof but only with respect to any calendar year ending not more than two (2) years prior to the date of the Calendar Year examination. To the extent that Sunesis does not have the right to which each will pertain, such grant Dainippon the right to audit the Sublicensees’ books and records of accounting (including those of hereunder, Sunesis shall, upon Dainippon’s request, exercise its Affiliates, as applicable) will be kept at each of their principal place of businessown audit right with respect to the Sublicensees by having such audit carried [*] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. At Confidential treatment has been requested with respect to the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an omitted portions out by a certified independent certified public accounting firm of internationally recognized standing account selected by the auditing Party Sunesis and reasonably acceptable to Dainippon and provide the other Party results of such audit for inspection by Dainippon pursuant to have access during normal business hours this Section 11.01. Sunesis shall provide any information reasonably required to such explain its records to the extent necessary. If the certified independent public accountant’s report establishes that the figures previously provided to Dainippon by Sunesis were incorrect and as the result, amount of the records as may be reasonably necessary to verify royalties already paid by Sunesis is different from the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933amount that should have been paid, AS AMENDED 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 difference shall be providedcompensated by Sunesis or Dainippon, as the case may be, within sixty (60) days after receipt of such report by Dainippon. If The fee and expense of the certified independent public accountant shall be borne by Dainippon, except that such accounting firm correctly identifies a discrepancy made fee and expense shall be borne by Sunesis if the certified independent public accountant’s report indicates Sunesis has underpaid amounts owed hereunder by [*] percent ([*]%) during such audited 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 2 contracts

Samples: License Agreement (Sunesis Pharmaceuticals Inc), License Agreement (Sunesis Pharmaceuticals Inc)

Records; Audits. Merck will keepPfizer and its Affiliates and its sublicensees and subcontractors shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, 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 [***] INDICATES MATERIAL THAT * CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933A CONFIDENTIAL TREATMENT REQUEST. Commercialization Payments and other amounts payable to Auxilium hereunder (including records of Net Sales), AS AMENDED due hereunder for and any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not other records reasonably required to be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose maintained with respect to the auditing Party only whether the reports are correct or incorrect Pfizer’s obligations under this Agreement, 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 each Party shall pay maintain complete and accurate records in sufficient detail to permit the other Party to confirm the amount accuracy of all Development Costs, Regulatory Costs and any other amounts payable or otherwise reimbursable hereunder, in each case for a minimum period of two (2) years or such longer period as required by applicable Law. Each Party shall have a right to request an audit of the discrepancy within [***] other Party in order to confirm the accuracy of any of the date of delivery of such accounting firm’s written report so correctly concludingforegoing (an “Audit”); provided, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Partyhowever, provided that if the underpayment or overcharge exceeds [***], the audited each Party shall pay only have the feesright to request such Audit of the other Party one time during any given calendar year. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud written request by a Party (its Affiliatesthe “Auditing Party”) to Audit the other Party (the “Audited Party”), the Auditing Party shall have the right to engage an independent, internationally recognized accounting firm to perform a review as applicableis reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the calendar year(s) requested by the calculation of amounts payable with respect to Auditing Party; provided that (i) such Calendar Year accountants 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 Agreementgiven access to, and shall cause its accounting firm be permitted to examine and copy such books and records of the Audited Party upon five (5) days’ prior written notice to the Audited Party, and at all reasonable times on such business days, (ii) prior to any such examination taking place, such accountants shall enter into an acceptable a confidentiality agreement with the audited Audited Party obligating it reasonably acceptable to retain the Audited Party in order to keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the Auditing Party, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to the Audited Party’s business. The Audited Party shall make personnel reasonably available during regular business hours to answer queries on all such Confidential Information books and records required for the purpose of the Audit. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) business days of the completion of the review, and, in confidence pursuant the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by a Party shall be paid to the other Party within ten (10) business days of notification of the results of such confidentiality agreementinspection. Any overpayments made by a Party shall be refunded by the other Party within ten (10) business days of notification of the results of such inspection. The cost of the accountants shall be the responsibility of the Auditing Party unless the accountants’ calculation shows that the actual royalties payable, Net Sales, Development Costs, Regulatory Costs, number of details, and/or any such other amount Audited hereunder to be different, by more than ten percent (10%), than the amounts as previously calculated by the Audited Party.

Appears in 2 contracts

Samples: Development and License Agreement (Auxilium Pharmaceuticals Inc), Development and License Agreement (Auxilium Pharmaceuticals Inc)

Records; Audits. Merck MPI will keep, maintain complete and will cause each accurate records in sufficient detail to permit SGI to confirm the accuracy of the calculation of royalty payments under this Agreement. Each Party will maintain complete and accurate records in sufficient detail to permit the other Selling PartiesParty to confirm the accuracy of all Joint Development Costs and, except as applicableprovided in Section 7.8, to keep, and Moderna will keep, adequate books and records of accounting for any other costs shared by the purpose of calculating all royalties and Parties or other amounts payable payments made by either one Party to the other Party hereunder and ensuring each Party’s compliance hereunderunder 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 [***] the Calendar Year to which each will pertainParty requesting the audit (the “Auditing Party”), such books and records of accounting (including those of its Affiliatesnot more often than [***], 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 Auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such being audited (the “Audited 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 the Audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by that Party or the amount of payments due by MPI or SGI under this Agreement. Any amounts shown to be [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDwithin thirty (30) days from the accountant’s report, plus interest (as set forth in Section 8.9) from the original due date. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any amounts shown to have been [***] within sixty (60) days from the accountant’s report. The Auditing Party shall bear the full cost of such audit [ *** ] = Certain confidential information contained in this document, AS AMENDED due hereunder for any Calendar Year ending marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. unless such audit discloses an underpayment of the amount actually owed during the applicable [***] of more than [***] following ], in which case 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 Audited 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 2 contracts

Samples: Collaboration Agreement (Takeda Pharmaceutical Co LTD), Collaboration Agreement (Seattle Genetics Inc /Wa)

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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: United States License and Collaboration Agreement, United States License and Collaboration Agreement (Transcept Pharmaceuticals Inc)

Records; Audits. Merck will keepLicensee shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, as applicable, all royalty payments and other amounts due to keepLicensor hereunder (including records of Net Sales), during the Term and Moderna for two (2) years thereafter or such longer period as required by Applicable Laws. Licensor shall have a right to request one audit of Licensee in each Calendar Year throughout the Term in order to confirm the accuracy of the foregoing (an “Audit”); provided, that, such one audit per Calendar Year limitation shall not apply in the event of any subsequent “for cause” audit. Upon the written A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC. request by Licensor to Audit Licensee, Licensor shall have the right to engage an independent, internationally recognized accounting firm reasonably acceptable to Licensee and which will keepbe subject to appropriate written obligations of confidentiality, adequate to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the Calendar Year(s) requested by Licensor. Licensee, shall make personnel reasonably available during regular business hours to answer queries on all such books and records of accounting required for the purpose of calculating all the Audit. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) Business Days of the completion of the review, and, in the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by Licensee shall be paid to Licensor within five (5) Business Days of notification of the results of such Audit. Any overpayments made by Licensee shall be refunded by Licensor within five (5) Business Days of notification of the results of such Audit. The cost of the accountants shall be the responsibility of Licensor unless the accountants’ calculation shows that the actual royalties and payable, Net Sales and/or any other amounts payable by either Party applicable amount Audited hereunder (in the aggregate with respect to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year entire period audited) to which each will pertainbe different, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 [**CONFIDENTIAL*], than the audited Party amounts as paid and reported by Licensee for the period subject to the Audit, in which case Licensee shall pay bear the feescosts of the accountants. Upon Any information obtained during such audit shall be treated as Confidential Information. In the expiration event that Licensor has a good faith basis, which shall be shared with Licensee, for believing that a Sublicensee of [***] following the end of any Calendar YearLicensee is not accurately reporting Net Sales (and thus that Licensee is not making appropriate royalty payments hereunder), absent willful misconduct or fraud by a Party (then at Licensor’s request, Licensee shall enforce its Affiliates, as applicable) the calculation of amounts payable audit rights with respect to any such Calendar Year Sublicensee and Licensee shall be binding and conclusive upon report back to Licensor regarding the Parties, and the Parties shall be released from outcome of 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

Samples: Asset Purchase Agreement (MEI Pharma, Inc.), Asset Purchase Agreement (MEI Pharma, Inc.)

Records; Audits. Merck Xxxxxxxx will keep, and will cause each of the other Selling Partiesrequire its Affiliates, as applicable, sublicensees 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 to Heat pursuant to this Agreement. Such books and records will be kept for such period of time required by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the applicable laws, but no less than at least [***] following the end of the Calendar Year Quarter to which each will they pertain, such books and . Such records of accounting (including those of its Affiliates, as applicable) will be kept subject to inspection in accordance with this Section 4.8. Upon 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 least [***] INDICATES MATERIAL THAT written notice to Xxxxxxxx, Xxxxxxxx will permit an independent, reputable, certified public accountant mutually agreeable to the Parties (the “Auditor”), at reasonable times and upon reasonable notice to audit or inspect the books or records the Auditor deems reasonably necessary or appropriate for the purpose of verifying the calculation and reporting of Net Sales under this Agreement. Such Auditor will sign a nondisclosure agreement reasonably acceptable to Xxxxxxxx in form and substance, and will not disclose to Heat, its Affiliates or any Third Party any information that is Xxxxxxxx’x or its Affiliate’s or sublicensee’s confidential customer information regarding pricing or other competitively sensitive proprietary information. Any and all records examined by such Auditor will be deemed Xxxxxxxx’x Confidential Information. The Auditor will disclose to Heat only the amount and accuracy of calculations and payments reported and actually paid or otherwise [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not payable under this Agreement. The Auditor will send a copy of the report to Xxxxxxxx at the same time it is sent to Heat. Such inspections may be made no 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 agreementnormal business hours.

Appears in 1 contract

Samples: Exclusive License Agreement (Shattuck Labs, Inc.)

Records; Audits. Merck will keep, AMAG shall maintain complete and will cause each accurate records in sufficient detail to permit Takeda to confirm the accuracy of the other Selling PartiesFully Burdened Manufacturing Costs, as applicable, to keep, Baseline Materials Cost 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 Materials Cost under this Agreement and to verify AMAG’s compliance with Sections 2.1, 3.12 and 7.1(d), and Takeda shall maintain complete and accurate records in sufficient detail to permit AMAG to confirm the end accuracy of any amounts paid to Takeda under Section 6.3(b) and to confirm Takeda’s compliance with its obligations under Section 2.2 to provide a Commercial Supply Forecast that is reasonably consistent with its projected commercial sales of the Calendar Year to which each will pertainProduct on a quarterly basis. Upon reasonable prior notice, such books and records shall be available during regular business hours for a period of accounting three (including those 3) years from the creation of its Affiliatesindividual records for examination, as applicable) will be kept at not more often than once each of their principal place of business. At the request of either PartyFiscal Year, 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 other Party and reasonably acceptable to the other Party audited Party, for the sole purpose of verifying the accuracy of such amounts invoiced, AMAG’s compliance with Sections 2.1, 3.12 and 7.1(d), and Takeda’s compliance with Section 2.2. Any such auditor shall not disclose the audited Party’s Confidential Information, except to have access during normal business hours to the extent such of the records as may be reasonably disclosure is necessary to verify the accuracy of the invoices issued by such Party or the amount of payments due by a Party under this Agreement, confirm AMAG’s compliance with Sections 2.1, 3.12 and 7.1(d) or confirm Takeda’s compliance with Section 2.2. Any amounts shown to be owed but unpaid (and not otherwise the subject of a good faith dispute by a Party) shall be paid within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDfrom the accountant’s report, plus interest (as set forth in Section 7.2) from the original due date. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due Any amounts showed to have been overpaid (and not otherwise the subject of a good faith dispute by a Party) will be refunded within [***] from the accountant’s report. The auditing Party shall bear the full cost of such audit involving payments of amounts owed hereunder for any Calendar unless such audit discloses an overpayment by the auditing Party or underpayment by the audited Party during the applicable Fiscal 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 perioddue, 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

Samples: Supply Agreement (Amag Pharmaceuticals Inc.)

Records; Audits. Merck will keepLICENSEE shall keep accurate books of account and records covering all transactions relating to the license granted in this Agreement (including, but not limited to, sales of Licensed Products, purchases and will cause each uses of NBA hologram stickers and compliance with shipment tracking, identification and anti-counterfeiting systems and labels that NBAP may establish from time to time). NBAP and its authorized representatives shall have the right no more than once per year without good cause, at all reasonable hours of the other Selling Parties, as applicablebusiness day and upon ten (10) days' notice, to keep, examine and Moderna will keep, adequate audit such books of account and records and all other documents and materials in LICENSEE's possession or under its control (including records of accounting LICENSEE's parents, subsidiaries, affiliates and third parties if they are directly involved in activities which relate to this Agreement) relating to this Agreement. NBAP shall have free and full access for such purposes and for the purpose of calculating all royalties making extracts and other amounts payable copies. All such information shall be kept confidential in accordance with Paragraph 22(f) hereof. Should an audit by either Party NBAP establish a deficiency between the amount found to be due NBAP and the other Party hereunder amount LICENSEE actually paid or reported, the LICENSEE shall pay the amount of such deficiency, plus interest at the then current prime rate (as announced by Chase Bank, New York branch) from the date such amount should have been paid until the date of payment. Should such audit establish a deficiency of more than five percent (5%) and ensuring each Party’s compliance hereundergreater than five thousand dollars ($5,000) LICENSEE shall also pay for the reasonable cost of the audit. For LICENSEE shall pay such amount within thirty (30) days. All such books of account and records shall be kept available for at least two (2) years after the [***] following expiration or termination of this Agreement, or three (3) years after the end of the Calendar Contract Year to which each will pertainthey relate, such whichever is earlier. In order to facilitate inspection of its books and records of accounting (including those of its Affiliatesrecords, as applicable) LICENSEE shall designate a symbol or number which will be kept at each used exclusively in connection with the Licensed Products on which royalty payments are payable and shall maintain for inspection as provided in this Agreement duplicates of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, all xxxxxxxx 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 customers with respect to such Calendar Year Licensed Products. LICENSEE shall, within ten (10) business days of NBAP's request (which shall not be made more than four (4) times per Contract Year), furnish NBAP with a list of LICENSEE's top twenty-five (25) retail accounts for Licensed Products (on a country by country basis) and their monthly purchases of Licensed Products (broken down by unit sales and in dollar volume by retailer). LICENSEE shall, promptly upon execution thereof, supply NBAP with true and complete copies of any agreement it enters into with any Member Team or any NBA player. In addition, LICENSEE shall, on a quarterly basis during the Term, provide NBAP with copies of either (i) financial information furnished to the United States Securities and Exchange Commission or (ii) with all financial statements and other financial information prepared by LICENSEE for distribution to its banks or other financial lending institutions to whom it reports regularly. Such information, to the extent not publicly available, 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) kept confidential in accordance with the confidentiality and non-use provisions Paragraph 22(f) hereof. At NBAP's request, LICENSEE shall reasonably cooperate with NBAP in developing an electronic data interchange, or developing such other system, that will facilitate NBAP's review 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's graphic designs for Licensed Products.

Appears in 1 contract

Samples: Retail Product License Agreement (Marvel Entertainment Group Inc)

Records; Audits. Merck will keep, Auxilium 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 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 Auxilium Territory determined by Auxilium not more than once each calendar year covering the two immediately preceding calendar years (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) by an independent Third Party auditor selected by VIVUS and approved by Auxilium (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 Auxilium pursuant to this Agreement or of any payments made by Auxilium to VIVUS pursuant to this Agreement. Any such auditor shall not disclose Auxilium’s Confidential Information to VIVUS, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Auxilium or the amount of payments [due by Auxilium under this Agreement. Any undisputed amounts finally determined to be owed but unpaid shall be paid within *** from the accountant’s report, plus interest (as set forth in Section 7.7) from the original due date. Any amounts finally determined to have been overpaid may be credited by Auxilium against future payments to VIVUS hereunder. Auxilium may carry forward any unused credits to future calendar quarters; provided, that in the event there are *] ** INDICATES MATERIAL THAT HAS BEEN WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN WAS REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED due hereunder for any Calendar Year ending not more than [AMENDED. unused credit amounts upon the termination of this Agreement or expiration of the Royalty Term, VIVUS shall promptly pay to Auxilium such amounts. VIVUS shall bear the full cost of such audit unless such audit reveals an underpayment or under-reporting error of *** percent (***] following %) or more during 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 applicable audit period, in which case Auxilium shall bear the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery 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

Samples: License and Commercialization Agreement (Vivus Inc)

Records; Audits. Merck will keep, Each Party shall maintain complete and will cause each accurate records in sufficient detail to permit the other Party to confirm the accuracy of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records calculation of accounting for the purpose of calculating all royalties and other amounts payable by either Party payments to the other Party hereunder and ensuring each Party’s compliance hereunderunder this Agreement. For the Upon reasonable prior notice, such records shall be available during regular business hours of audited Party for a period of [***] following from the end creation of the Calendar Year to which individual records for examination at auditing Party's expense, and not more often than once each will pertainFiscal 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 audited Party, 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 pursuant to this Agreement. Any such auditor shall not disclose audited Party's Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by audited Party or the amount of payments due by audited Party 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 8.6) from the original due date. Any amounts determined to be overpaid shall be refunded within [*] INDICATES MATERIAL THAT 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 Fiscal Year of more than [*], in which case audited Party shall bear the full cost of such audit. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER OF THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar YearAMENDED. 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.55

Appears in 1 contract

Samples: Collaboration and License Agreement (Affymax Inc)

Records; Audits. Merck will GTC shall keep, and will cause each of the other Selling Partiesshall require its Affiliates, as applicable, collaborative partners and sublicensees to keep, complete and Moderna will keep, adequate accurate records and books and records of accounting account containing data reasonably required for the purpose computation and verification of calculating all royalties payments of the ------------------------ Confidential materials omitted and other amounts filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. Purchase Price due and payable as provided by either Party this Article 1. Subject 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 pertainsentence, GTC shall open such books and records of accounting upon reasonable notice during business hours for inspection by either (including those of its Affiliates, as applicablea) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit Genzyme auditor(s) or (and procure its Affiliates, to permitb) an independent certified public accounting firm of internationally recognized standing accountant selected by the auditing Party Genzyme and reasonably acceptable to GTC ("INDEPENDENT AUDITORS"), for the other Party to have access during normal business hours to such sole purpose of verifying the amount of payments of the records as may Purchase Price due and payable to Genzyme hereunder. Genzyme shall not be reasonably necessary entitled to verify conduct any such inspection more than once in each calendar year during the accuracy term of this Agreement and once during the payments [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDthree (3) year period following the expiration or termination of this Agreement. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder Genzyme shall be responsible for all expenses of each such inspection; PROVIDED that if (x) any Calendar Year ending not more inspection reveals an underpayment greater 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 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 that if the underpayment or overcharge exceeds [***]%) of the amounts due to Genzyme under this Article 1 and (y) an Independent Auditor conducted such inspection or verified the conclusions of such inspection made by Genzyme, the audited Party then GTC shall pay all reasonable and documented expenses of such inspection, including without limitation the feesreasonable and documented expenses incurred in connection with the verification by an Independent Auditor of the conclusions of the inspection by Genzyme auditors, if applicable. Upon the expiration of [***] following the end The amount of any Calendar Yearsuch underpayment, absent willful misconduct or fraud by a Party (its Affiliatestogether with the expenses of such inspection, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding due and conclusive upon payable within thirty (30) days of GTC's receipt of 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 agreementwritten report thereof.

Appears in 1 contract

Samples: Purchase Agreement (Genzyme Transgenics Corp)

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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: And License Agreement (NGM Biopharmaceuticals 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDAudited Party’s reports of Direct Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses as provided herein. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. 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 CONFIDENTIAL TREATMENT REQUESTED 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 in confidence pursuant information subject to such the confidentiality agreementrestrictions of Article 8 hereof.

Appears in 1 contract

Samples: Confidential Treatment Requested (Alimera Sciences Inc)

Records; Audits. Merck will keepLICENSEE shall keep accurate books of account and records covering all transactions relating to the license granted in this Agreement (including, but not limited to, sales of Licensed Products, purchases and will cause each uses of NBA hologram hang tags and compliance with shipment tracking, identification and anti-counterfeiting systems and labels that NBAP may establish from time to time). NBAP and its authorized representatives shall have the right, at all reasonable hours of the other Selling Parties, as applicableday and upon reasonable prior notice, to keep, examine and Moderna will keep, adequate audit such books of account and records and all other documents and materials in LICENSEE's possession or under its control (including records of accounting LICENSEE's parents, subsidiaries, affiliates and third parties, if they are involved in activities which relate to this Agreement) relating to this Agreement. NBAP shall have free and full access for such purposes and for the purpose of calculating all royalties making extracts and other amounts payable copies. Should an audit by either Party NBAP establish a deficiency between the amount found to be due NBAP and the other Party hereunder amount LICENSEE actually paid or reported, the LICENSEE shall pay the amount of such deficiency, plus interest at the then current prime rate (as announced by Chase Manhattan Bank, New York branch) from the date such amount should have been paid until the date of payment. Should such audit establish a deficiency of more than three percent (3%), LICENSEE shall also pay for the cost of the audit. LICENSEE shall pay such amount within thirty (30) days. All such books of account and ensuring each Party’s compliance hereunder. For records shall be kept available for at least two (2) years after the [***] following expiration or termination of this Agreement, or three (3) years after the end of the Calendar Contract Year to which each will pertainthey relate, such whichever is earlier. In order to facilitate inspection of its books and records of accounting (including those of its Affiliatesrecords, as applicable) LICENSEE shall designate a symbol or number which will be kept at each used exclusively in connection with the Licensed Products on which royalty payments are payable and shall maintain for inspection as provided in this Agreement duplicates of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, all xxxxxxxx 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 customers with respect to such Calendar Year Licensed Products. LICENSEE shall be binding on a quarterly basis furnish NBAP with a list of LICENSEE's top twenty-five (25) retail accounts for Licensed Products (on a country-by-country basis) and conclusive upon their quarterly purchases of Licensed Products (broken down by unit sales and in dollar volume by retailer). LICENSEE shall supply NBAP with true and complete copies of any agreement it has entered into, or in the Partiesfuture enters into, with any Member Team or any NBA player. In addition, LICENSEE shall, on a quarterly basis during the Term, provide NBAP with copies of either (i) financial information furnished to the United States Securities and the Parties shall be released from any liability Exchange Commission or accountability (ii) with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial statements and other financial information subject prepared by LICENSEE for distribution to its banks or other financial lending institutions to whom it reports regularly. LICENSEE shall cooperate with NBAP in developing an electronic data interchange through which NBAP may access LICENSEE'S electronic database relating to the manufacture, distribution and sale of Licensed Products (such as work-in-process, finished goods on hand, orders received, deliveries made and any other on-line information relating to the Licensed Products, but not including information as to LICENSEE'S profits) or developing such other system as will enable NBAP to obtain such information or facilitate NBAP's 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'S graphic designs for Licensed Products.

Appears in 1 contract

Samples: Retail Product License Agreement (Evenflo & Spalding Holdings Corp)

Records; Audits. Merck will keepHorizon and its Affiliates will, and Horizon will cause each of its Sublicensees, if any, to, maintain complete and accurate records in sufficient detail to confirm the other Selling Partiesaccuracy of the calculation of royalty payments and the achievement of milestone events, as applicable, to keep, and Moderna will keep, adequate books and records 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 after the Calendar Year in which such sales or events occurred. Upon reasonable prior notice and without disruption to Horizon’s business, such records of Horizon and its Affiliates shall be made available during regular business hours for a period of [***] from the end of the Calendar 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 not more often than [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDeach Calendar Year, by an independent certified public accountant selected by Arrowhead and reasonably acceptable to Horizon, for the sole purpose of and only to the extent necessary for verifying the accuracy of the financial reports furnished by Horizon pursuant to this Article 8. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Such independent accountant shall disclose to Arrowhead only the amounts that such independent accountant believes to be due and payable hereunder to Arrowhead, AS AMENDED due hereunder details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. The records for any particular Calendar Year ending shall only be subject to [***] audit hereunder. Any and all records examined by such independent accountant shall be deemed Horizon’s Confidential Information which may not be disclosed by such independent accountant to any Third Party, and Horizon may require such independent accountant to enter into an appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less protective than those set forth in Article 12. If, as a result of any inspection of the books and records of Horizon, it is shown that payments under this Agreement were less than the amount which should have been paid, then Horizon shall make all payments required to be made from the original due date to eliminate any discrepancy revealed by such inspection within [***] days. If, as a result of any inspection of the books and records of Horizon, it is shown that payments under this Agreement were more than the amount which should have been paid, then Arrowhead shall, at Horizon’s election, either make all payments required to be made to eliminate any discrepancy revealed by such inspection within [***] days or credit such amounts to Horizon against future payments. Arrowhead shall pay for such audits, except that in the event that the audited amounts were underpaid by Horizon by 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 undisputed amounts that should have been paid during the period in question as per the audit, the audited Party Horizon shall pay the fees. Upon costs 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 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

Samples: Collaboration and License Agreement (Arrowhead Pharmaceuticals, Inc.)

Records; Audits. Merck will keepAmgen and its Affiliates will, and Amgen will cause each of its Sublicensees, if any, to, maintain complete and accurate records in sufficient detail to confirm the other Selling Partiesaccuracy of the calculation of royalty payments and the achievement of milestone events, as applicable, to keep, and Moderna will keep, adequate books and records 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 after the Calendar Year in which such sales or events occurred. Upon reasonable prior notice and without disruption to Amgen’s business, such records of Amgen and its Affiliates shall be made available during regular business hours for a period of [***] from the end of the Calendar Year to which they pertain for examination, and not more often than once each will pertainCalendar Year, by an independent certified public accountant selected by Arrowhead and reasonably acceptable to Amgen, for the sole purpose of and only to the extent necessary for verifying the accuracy of the financial reports furnished by Amgen pursuant to this Article 9. Such independent accountant shall disclose to Arrowhead only the amounts that such independent accountant believes to be due and payable hereunder to Arrowhead, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. The records for any particular Calendar Year shall only be subject to one (1) audit hereunder. Any and all records examined by such independent accountant shall be deemed Amgen’s Confidential Information which may not be disclosed by such independent accountant to any Third Party, and Amgen may require such independent accountant to enter into an appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less protective than those set forth in Article 13. If, as a result of any inspection of the books and records of accounting (including those of its AffiliatesAmgen, it is shown that payments under this Agreement were less than the amount which should have been paid, then Amgen shall make all payments required to be made from the original due date to eliminate any discrepancy revealed by such inspection within [***]. If, as applicable) will be kept at each a result 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 any inspection of the books and records as may of Amgen, it is shown that payments under this Agreement were more than the amount which should have been paid, then Arrowhead shall, at Amgen’s election, either make all payments required to be reasonably necessary made to verify the accuracy of the payments eliminate any discrepancy revealed by such inspection within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDor credit such amounts to Amgen against future payments. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Arrowhead shall pay for such audits, AS AMENDED due hereunder for any Calendar Year ending not except that in the event that the audited amounts were underpaid by Amgen by 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.the

Appears in 1 contract

Samples: First Collaboration and License Agreement (Arrowhead Pharmaceuticals, Inc.)

Records; Audits. Merck will 5.7.1. Alimera 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 information that may be necessary for the purpose of calculating Royalties, as detailed in the Royalty Reports, including reports and supporting data detailing Net Revenues, Gross Revenues, Royalties, the number of units of Products sold or otherwise transferred and Third Party Consideration under this Agreement, including but not limited to sales ledgers and records, general ledgers, and sublicensee reporting to Alimera,. Such books of account, records and reports, with all royalties and other amounts payable necessary supporting data, shall be kept by either Party to Alimera at its place of business for the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] three (3) years following the end of the Calendar Year calendar year to which each will shall 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 Alimera shall permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party pSivida and reasonably acceptable to Alimera (the other Party “Audit Firm”), 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 Alimera’s reports of Net Revenues, Gross Revenues, Royalties and Third Party Consideration as provided herein. Such Audit Firm may be required by Alimera to enter into a commercially reasonable confidentiality agreement with it, and in no event shall such Audit Firm disclose to pSivida any information from the books and records of Alimera or its Affiliates to which such Audit Firm has access during the course of such audit other than such information as it relates to the accuracy of the reports and the calculation of payments made or due hereunder. All such verifications shall be conducted at the expense of pSivida and not more than once in each calendar year. The Audit Firm shall submit its final written report to both Parties. If pSivida agrees with the Audit Firm’s final written report, it shall provide notice of that agreement, pursuant to Section 11.5 of this Agreement, to Alimera. Once the notice of agreement has been provided by pSivida, Alimera shall have thirty (30) days in which to provide written notice of a good faith dispute to pSivida as to the conclusions set forth in the Audit Firm’s report, setting forth the nature of any disagreement with the written report. If such notice of dispute is provided, 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, the matter will be submitted to dispute resolution in accordance with Section 11.8. If no notice of dispute is provided but an adjustment is deemed [***] INDICATES MATERIAL THAT HAS BEEN WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN WAS REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED AMENDED. due, then Alimera shall, within forty-five (45) days of receiving the written report, pay any adjustment due hereunder to pSivida 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 the period starting from the date the payment was first due and ending on the date the payment was made. pSivida shall be responsible for the fees, and expenses associated with the audit, provided however, that if the audit concludes that an adjustment of five percent (5%) or more of the aggregate amount paid or payable by Alimera to pSivida during the relevant period is due in pSivida’s favor, then Alimera shall be responsible for the reasonable fees, costs, and expenses charged by the Audit Firm. An audit under this Section 5.7.1 shall be limited to the records and books of account for any Calendar Year 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 thirty-six (36) months before the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Partiesrequest. The fees charged by such accounting firm shall be paid by the auditing Party, provided Parties agree 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 5.7 is confidential and non-use provisions of this Agreement, and that pSivida 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 information subject to such the confidentiality agreementrestrictions of Article 7.

Appears in 1 contract

Samples: Collaboration Agreement (pSivida Corp.)

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 the payments royalty reports submitted by Sanofi in accordance with Section 11.3.8 or [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDreported by Kymera in accordance with Section 11.6, as applicable. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder An examination by the 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

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

Records; Audits. Merck will keepAmgen and its Affiliates will, and Amgen will cause each of its Sublicensees, if any, to, maintain complete and accurate records in sufficient detail to confirm the other Selling Partiesaccuracy of the calculation of royalty payments and the achievement of milestone events, as applicable, to keep, and Moderna will keep, adequate books and records 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 after the Calendar Year in which such sales or events occurred. Upon reasonable prior notice and without disruption to Amgen’s business, such records of Amgen and its Affiliates shall be made available during regular business hours for a period of [***] from the end of the Calendar Year to which they pertain for examination, and not more often than once each will pertainCalendar Year, by an independent certified public accountant selected by Arrowhead and reasonably acceptable to Amgen, for the sole purpose of and only to the extent necessary for verifying the accuracy of the financial reports furnished by Amgen pursuant to this Article 9. Such independent accountant shall disclose to Arrowhead only the amounts that such independent accountant believes to be due and payable hereunder to Arrowhead, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. The records for any particular Calendar Year shall only be subject to one (1) audit hereunder. Any and all records examined by such independent accountant shall be deemed Amgen’s Confidential Information which may not be disclosed by such independent accountant to any Third Party, and Amgen may require such independent accountant to enter into an appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less protective than those set forth in Article 12. If, as a result of any inspection of the books and records of accounting (including those of its AffiliatesAmgen, it is shown that payments under this Agreement were less than the amount which should have been paid, then Amgen shall make all payments required to be made from the original due date to eliminate any discrepancy revealed by such inspection within [***]. If, as applicable) will be kept at each a result 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 any inspection of the books and records as may of Amgen, it is shown that payments under this Agreement were more than the amount which should have been paid, then Arrowhead shall, at Amgen’s election, either make all payments required to be reasonably necessary made to verify the accuracy of the payments eliminate any discrepancy revealed by such inspection within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDor credit such amounts to Amgen against future payments. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Arrowhead shall pay for such audits, AS AMENDED due hereunder for any Calendar Year ending not except that in the event that the audited amounts were underpaid by Amgen by more than [***] following of the end of any Calendar Year. Such examinations may not be conducted more than once undisputed amounts that should have been paid during the period in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to question as per 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 periodaudit, the appropriate Party Amgen shall pay the other Party the amount costs 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 agreementaudit.

Appears in 1 contract

Samples: Second Collaboration and License Agreement (Arrowhead Pharmaceuticals, Inc.)

Records; Audits. Merck will Each Party shall keep, and will cause each shall require its Affiliates and, in the case of the other Selling PartiesSalubris, as applicable, Sublicensees to keep, complete and Moderna accurate records pertaining to this Agreement in sufficient detail to permit the other Party to confirm the accuracy of the amount of Development Costs to be reimbursed or shared, achievement of Net Sales milestones, and the amount of royalties and other payments payable under this Agreement. Each Party will keep, adequate 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 [***] years following the end of the Calendar Year to which each will they pertain, or such books longer period of time as may be required by Applicable Laws. Upon reasonable prior notice and during regular business hours at such place or places where such records of accounting (including those of its Affiliatesare customarily kept, as applicable) will a Party’s records may be kept at each of their principal place of business. At the request of either Party, inspected on the other Party will permit (and procure its Affiliates, to permit) Party’s behalf by an independent certified public accounting firm of internationally recognized standing accountant (the “Auditor”) 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, to the audited Party pursuant to this Agreement. 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. Such audits shall be limited to once each Calendar Year and once with respect to records as may be reasonably covering any Calendar Quarter. Such auditor shall not disclose the audited Party’s Confidential Information to the other Party, except to the extent such disclosure is necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 In the event that the final result of the inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount 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 settled within [***] of days after the date of delivery Auditor’s report. The auditing Party shall bear the full cost of such accounting firm’s written report so correctly concludingaudit unless such audit reveals an overpayment to, 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 an underpayment or overcharge exceeds [***]by, the audited Party of more than ten percent (10%), in which case the audited Party shall pay reimburse the fees. Upon auditing Party for the expiration costs of such audit within [***] following days after receipt of 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 agreementAuditor’s report.

Appears in 1 contract

Samples: Exclusive Collaboration and License Agreement (Sunesis Pharmaceuticals Inc)

Records; Audits. Merck will keepHanX, its Affiliates, sublicensees and assignees shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, 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 to Onconova hereunder (including records of Net Sales) and any other records reasonably required to be maintained with respect to HanX’s obligations under this Agreement, in each case for a minimum period of four (4) years or such longer period as required by either applicable Law. Onconova shall have a right to request an audit of HanX, its Affiliates or sublicensees or assignees (the “Audited Party”) in order to confirm the accuracy of any of the foregoing (an “Audit”); provided, however, that Onconova shall only have the right to request such Audit one time during any given calendar year. Upon the written request by Onconova to Audit the Audited Party, Onconova shall have the right to engage an independent, internationally recognized accounting firm that is reasonably acceptable to the Audited Party to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end accuracy of any of the Calendar Year foregoing for the calendar year(s) requested by Onconova; provided that (i) such accountants shall be given access to, and shall be permitted to which each will pertain, examine and copy such books and records of accounting the Audited Party upon five (including those of its Affiliates, as applicable5) will be kept at each of their principal place of business. At business days’ prior written notice to the request of either Audited Party, and at all reasonable times on such business days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access during normal business hours to keep all information and data contained in such of the books and records as may be reasonably necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending strictly confidential and shall not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year disclose such information 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 copies 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 books and records to any third person including the auditing Party, provided that if but shall only use the underpayment same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to Audited Party’s business. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) business days of the completion of the review, and, in the absence of fraud or overcharge exceeds [***]manifest error, the audited Party shall pay the fees. Upon the expiration findings 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 accountant shall be final and binding and conclusive upon on each of the Parties, and the Parties . Any underpayments by HanX shall be released from any liability or accountability with respect paid to amounts payable for Onconova within ten (10) business days of notification of the results of such Calendar Yearinspection. Any overpayments made by HanX shall be refunded by Onconova within ten (10) business days of notification of the results of such inspection. The auditing Party cost of the accountants shall treat all financial information subject be the responsibility of Onconova unless the accountants’ calculation shows that the actual royalties payable, and/or any such other amount audited hereunder to review under this Section 8.6(c) be different, by more than five percent (5%), than the amounts as previously calculated by the Audited Party, in accordance with which event the confidentiality cost shall be the responsibility of HanX and non-use provisions of this Agreement, and HanX shall cause its accounting firm to enter into an acceptable confidentiality agreement with reimburse Onconova for any Onconova costs incurred for the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementAudit.

Appears in 1 contract

Samples: License and Collaboration Agreement (Onconova Therapeutics, Inc.)

Records; Audits. Merck Norgine will keep, maintain complete and will cause each accurate records in sufficient detail to permit Tranzyme to confirm the accuracy of the other Selling Partiescalculation of royalty payments under this Agreement. 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 three (3) years from the end of the Calendar Year calendar year to which they pertain for examination at the expense of Tranzyme, 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 accountant selected by Tranzyme and associated with an independent accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to Norgine, for the other Party to have access during normal business hours to such sole purpose of the records as may be reasonably necessary to verify verifying the accuracy of the payments [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDfinancial reports furnished by Norgine pursuant to this Agreement. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 The accounting firm shall enter into appropriate obligations with Norgine to treat all information it receives during its examination in any Calendar Year or be repeated for any Calendar Yearconfidence. The accounting firm shall disclose to the auditing Party Tranzyme only whether the reports Norgine’s calculations of royalty payments under this Agreement are correct or incorrect and the amount of details concerning any discrepancy. No discrepancies, but no other Confidential Information information shall be provideddisclosed to Tranzyme. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party Any amounts shown to be owed but unpaid shall pay the other Party the amount of the discrepancy be paid within thirty (30) days from PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. the accountant’s report, plus interest (as set forth in Section 8.9) from the original due date. Any amounts shown to have been overpaid shall be, at Tranzyme’s election, refunded as soon as practicable after the accountant’s report or credited towards future payments owed by Norgine to Tranzyme over time. Tranzyme shall bear the full cost of such audit unless such audit discloses an underpayment by Norgine of more than five percent (5%) of the date of delivery amount due, in which case Norgine 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

Samples: License Agreement (Tranzyme Inc)

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 PartiesAcceleron, 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 Net Sales during the [**], and in the case of Fulcrum, any costs for Fulcrum FTEs or out-of-pocket expenses reimbursed by Acceleron pursuant to Section 3.5 (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 Acceleron, the payments royalty reports submitted by Acceleron in accordance with Section 6.3.4 (Royalty Reports), and in the case of Fulcrum, the invoices submitted by Fulcurm in accordance with Section 3.5 (Research Funding). An examination by either Party under this Section 6.6 (Records; Audits) will occur not more than [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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 Acceleron a written report disclosing whether, in the case of Acceleron, the reports submitted by Acceleron, 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 Acceleron 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 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 Partieswith interest calculated in accordance with Section 6.7 (Late Payment). The costs and fees charged of any audit conducted by such accounting firm shall a Party under this Section 6.6 (Records; Audits) will be paid borne by the auditing Party, provided that if unless, in the case of an audit conducted by Fulcrum, such audit reveals an underpayment or overcharge exceeds of amounts owed to Fulcrum of more than [***], the audited Party shall pay the fees. Upon the expiration of ] percent ([**]%) of the amount that was owed by Acceleron, or in the case of an audit conducted by Acceleron, such audit reveals an overpayment of amounts owed to Fulcrum of more than [**] following percent ([**]%) of the end of any amount that was properly payable by Acceleron in accordance with Section 3.5 (Research Funding), in either case, with respect to the relevant Calendar Year, absent willful misconduct or fraud by a Party (its Affiliatesin which case, 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 non-auditing Party shall treat all financial information subject to review under this Section 8.6(c) will reimburse the auditing Party for the reasonable expense incurred by the auditing Party 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

Samples: Collaboration and License Agreement (Fulcrum Therapeutics, 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 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDfrom its receipt of the accountant’s report. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any amounts shown to be owed but unpaid shall be paid within [***] from the accountant’s report, AS AMENDED plus interest (as set forth in Section 9.7) from the original due hereunder for any 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

Samples: Exclusive License and Collaboration Agreement (Forty Seven, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

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

Records; Audits. Merck will keepHorizon and its Affiliates will, and Horizon will cause each of its Sublicensees, if any, to, maintain complete and accurate records in sufficient detail to confirm the other Selling Partiesaccuracy of the calculation of royalty payments and the achievement of milestone events, as applicable, to keep, and Moderna will keep, adequate books and records 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 after the Calendar Year in which such sales or events occurred. Upon reasonable prior notice, such records of Horizon and its Affiliates shall be made available during regular business hours for a period of [***] from the end of the Calendar Year to which they pertain for examination, and not more often than once each will pertainCalendar Year (unless there is a just cause for an additional examination based upon results of the earlier audit during such Calendar 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 Alpine and reasonably acceptable to Horizon, for the other Party sole purpose of and only to have access during normal business hours to such of the records as may be reasonably extent necessary to verify for verifying the accuracy of the payments financial reports furnished by Horizon pursuant to this Article 6. Such independent accountant shall disclose to Alpine only the amounts that such independent accountant believes to be due and payable hereunder to Alpine, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. The records for any particular Calendar Year shall only be subject to [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDaudit hereunder. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any and all records examined by such independent accountant shall be deemed Horizon’s Confidential Information which may not be disclosed by such independent accountant to any Third Party, AS AMENDED and Horizon may require such independent accountant to enter into an appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less protective than those set forth in Article 10. If, as a result of any inspection of the books and records of Horizon, it is shown that payments under this Agreement were less than the amount which should have been paid, then Horizon shall make all payments required to be made from the original due hereunder date to eliminate any discrepancy revealed by such inspection within [***] of such finding. If, as a result of any inspection of the books and records of Horizon, it is shown that payments under this Agreement were more than the amount which should have been paid, then Alpine shall, at Horizon’s election, either make all payments required to be made to eliminate any discrepancy revealed by such inspection within [***] of such finding or credit such amounts to Horizon against future payments. Alpine shall pay for any Calendar Year ending not such audits, except that in the event that the audited amounts were underpaid by Horizon by more than [***] following of the end of any Calendar Year. Such examinations may not be conducted more than once undisputed amounts that should have been paid during the period in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to question as per 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 periodaudit, the appropriate Party Horizon shall pay the other Party the amount costs 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 agreementaudit.

Appears in 1 contract

Samples: License and Collaboration Agreement (Alpine Immune Sciences, Inc.)

Records; Audits. Merck will keepKaken and its Affiliates, sublicensees and subcontractors shall keep true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, as applicable, all amounts payable to keepBrickell hereunder (including records of Net Sales), and Moderna will keepany other records reasonably required to be maintained with respect to Kaken’s obligations under this Agreement, adequate books and each Party shall maintain complete and accurate records of accounting for the purpose of calculating all royalties and other amounts payable by either Party in sufficient detail to permit the other Party hereunder and ensuring to confirm the accuracy of all amounts payable or otherwise reimbursable hereunder, in each Party’s compliance hereundercase for a minimum period of five (5) years or such longer period as required by applicable Law. For the [***] following the end Each Party shall have a right to request an audit of the Calendar Year other Party in order to which confirm the accuracy of any of the foregoing (an “Audit”); provided, however, that each will pertainParty shall only have the right to request such Audit of the other Party one time during any given calendar year. Upon the written request by a Party (the “Auditing Party”) to Audit the other Party (the “Audited Party”), the Auditing Party shall have the right to engage an independent, internationally recognized accounting firm to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the calendar year(s) requested by the Auditing Party; provided that (i) such accountants shall be given access to, and shall be permitted to examine and copy such books and records of accounting the Audited Party upon five (including those of its Affiliates, as applicable5) will be kept at each of their principal place of business. At days’ prior written notice to the request of either Audited Party, and at all reasonable times on such Business Days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the Auditing Party, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to the Audited Party’s business. The Audited Party shall make personnel reasonably available during normal regular business hours to answer queries on all such books and records required for the purpose of the records as may be reasonably necessary Audit. The accountants shall deliver a copy of their findings to verify the accuracy each of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Parties within twenty (20) days of the completion of the review, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following and, in the end absence of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year fraud or be repeated for any Calendar Year. The accounting firm shall disclose to manifest error, the auditing Party only whether the reports are correct or incorrect and the amount findings of any discrepancy. No other Confidential Information such accountant shall be providedfinal and binding on each of the Parties. If such accounting firm correctly identifies Any underpayments by a discrepancy made during such period, the appropriate Party shall pay be paid to the other Party the amount within twenty (20) days of notification of the discrepancy results of such inspection. Any overpayments made by a Party shall be refunded by the other Party within [***] twenty (20) days of notification of the date of delivery results of such accounting firm’s written report so correctly concludinginspection. The cost of the accountants shall be the responsibility of the Auditing Party unless the accountants’ calculation shows that the actual amount Audited hereunder is different, or by more than five percent (5%), from the amounts as otherwise agreed upon previously calculated by the PartiesAudited Party. 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 1 contract

Samples: License, Development and Commercialization Agreement (Brickell Biotech, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: 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 sublicensees to keep, such accurate and Moderna will keep, adequate books and complete records of accounting (i) for Xxxxxxx, Development Costs and Net Sales, for Products sold in the purpose of calculating all royalties United States: Profits (Losses), Development Costs and other Allowable Expenses, and for Products sold outside the United States: Net Sales, royalties, and the calculations thereof; and (ii) for Theravance, Development Costs and, for Products sold in the United States, Allowable Expenses, and the calculations thereof, in each case as are necessary to determine the amounts payable by either Party due to the other Party hereunder under this Agreement and ensuring such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party’s compliance hereunder") for at least the three (3) calendar years subsequent to the calendar year to which such costs, expenses or Net Sales, and Profits (Losses) relate. For During normal business hours and with reasonable advance notice to the [***] following Recording Party, such records shall be made available for inspection, review and audit, at the end request and expense 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 other Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing selected accountant, or the local equivalent, appointed by the auditing other Party and reasonably acceptable to the other Recording Party to have access during normal business hours to such for the sole purpose of the records as may be reasonably necessary to verify verifying the accuracy of the Recording Party's accounting reports and payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933made or to be made pursuant to this Agreement; provided, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations however that such audits may not be conducted performed by the other Party more than once in any Calendar Year or per calendar year. Such accountants shall be repeated for any Calendar Year. The accounting firm shall disclose instructed not to reveal to the auditing Party only whether the reports are correct or incorrect details of its review, except for (i) such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as is necessary to report the amount of any discrepancy. No other accountants' conclusions to the auditing Party, and all such information shall be deemed Confidential Information shall be providedof the Recording Party. Following completion of an audit, the independent public accounting firm shall, prior to distribution to the auditing Party, share its report with the audited Party. If such the audited Party provides the independent public accounting firm correctly identifies a discrepancy made during such periodwith justifying remarks for inclusion in the report, the appropriate Party independent public accounting firm shall pay incorporate such remarks into its report prior to sharing the other Party the amount of the discrepancy within [***] of the date of delivery conclusions of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such independent public accounting firm with the auditing Party. All costs and expenses incurred in connection with performing any such audit shall be paid by the auditing Party, provided that if Party unless the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of audit discloses at least a [***] following shortfall with respect to Net Sales or excess with respect to costs or expenses, as applicable, in which case the end Recording Party will bear the full cost of the audit for such calendar year. The auditing Party will be entitled to recover any Calendar Year, absent willful misconduct shortfall in payments due to it (or fraud overpayment made by a Party (its Affiliatesit, as applicable) the calculation of amounts payable with respect to as determined by such Calendar Year shall be binding and conclusive upon the Partiesaudit, 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) plus interest thereon calculated in accordance with Section 6.14. The documents from which were calculated the confidentiality and non-use provisions of sums due under this Agreement, and Article 6 shall cause its accounting firm to enter into an acceptable confidentiality agreement with be retained by each Recording Party during the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementTerm.

Appears in 1 contract

Samples: License and Collaboration Agreement (Theravance Biopharma, Inc.)

Records; Audits. Merck will keepLicensee and its Affiliates shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties royalty payments and other amounts payable by either Party to the other Party Licensor 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 (including records of accounting Net Sales), and any other records reasonably required to be maintained with respect to Licensee’s obligations under this Agreement, for a minimum period of two (including those of its Affiliates2) years or such longer period as required by Laws. Licensor shall have a right to cause an independent, 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 Licensor, which may be Licensee’s statutory auditor, and reasonably acceptable to Licensee, to audit such records of Licensee, and its Affiliates in order to confirm the other Party to have access accuracy of the foregoing (an “Audit”) for a period covering not more than the preceding thirty-six (36) months. Such Audits may be conducted during normal business hours upon reasonable prior written notice to Licensee, but no more than frequently than once per year. Licensee shall make personnel reasonably available during regular business hours to answer queries on all such books and records required for the purpose of the records Audit. Any underpayments by Licensee shall be paid to Licensor within fifteen (15) business days of notification of the results of such inspection. Licensor shall cause the accounting firm to execute a reasonable written confidentiality agreement with Licensee, which shall provide that such accounting firm will disclose to Licensor only such information as may be is reasonably necessary to verify the accuracy provide Licensor with information regarding any actual or potential discrepancies between amounts reported or paid and amounts payable under this Agreement and not disclose to Licensor any information, financial or otherwise, unrelated to sales of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Licensed Product, AS AMENDED due hereunder for including any Calendar Year ending not more financial information regarding any of Licensee’s products other 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 YearLicensed Product. The accounting firm will send a copy of the report it prepares for Licensor to Licensee at the same time such report is delivered to Licensor. The report sent to Licensee will include the methodology and calculations used to determine the results. Prompt adjustments shall disclose be made by the Parties to reflect the auditing Party only whether results of such Audit. Any overpayments made by Licensee shall be refunded by Licensor within thirty (30) business days of notification of the reports are correct or incorrect and results of such inspection. Licensor shall bear the amount cost of any discrepancy. No such Audit, unless the Audit reveals that the actual royalties payable, Net Sales, and/or any other Confidential Information applicable amount audited hereunder to be different, by more than five percent (5%) than the amounts as previously calculated by Licensee in which case Licensee shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, bear the appropriate Party shall pay the other Party the amount cost 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 PartiesAudit. 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 Licensor 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. Licensee shall be free, including in any instance wherein Licensee disputes the results, findings or methodologies of Licensor’s auditor, to engage a suitable auditor, at Licensee’s own cost to review the work of Licensor’s auditor and Licensor shall use Commercially Reasonable Efforts to cause its auditor to meet with Licensee and Licensee’s auditor and provide to Licensee and Licensee’s auditor all relevant documents and information reasonably related to any issues concerning royalty and Milestone Payments, and Licensor and Licensee shall cause its accounting firm meet in good faith to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain resolve any and all such Confidential Information in confidence pursuant to such confidentiality agreementissues.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement (Cadrenal Therapeutics, Inc.)

Records; Audits. Merck will keep, Each Party shall maintain complete and will cause each accurate records in sufficient detail to permit the other Party to confirm the accuracy of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records calculation of accounting for the purpose of calculating all royalties and other amounts payable by either Party payments to the other Party hereunder and ensuring each under this Agreement. Upon reasonable prior notice, such records shall be available during regular business hours of audited Party for a period of * ( * ) years from the creation of individual records for examination at auditing Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which expense, and not more often than once each will pertainFiscal 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 audited Party, 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 pursuant to this Agreement. Any such auditor shall not disclose audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 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 due by audited 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 * ( * ) days from the auditing Partyaccountant’s report, provided that if plus interest (as set forth in Section 8.6) 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 determined to such Calendar Year be overpaid shall be binding and conclusive upon refunded within * ( * ) 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) bear the full cost of such audit unless such audit discloses an underpayment of the amount actually owed during the applicable Fiscal Year of more than * %, in accordance which case audited Party shall bear the full cost of such audit. * Confidential material redacted and filed separately with the confidentiality Commission. * Confidential material redacted and non-use provisions filed separately with the Commission. * Confidential material redacted and filed separately with the Commission. CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this Agreement, document have been redacted and shall cause its accounting firm to enter into an acceptable confidentiality agreement have been separately filed with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.Commission. ARTICLE IX. ARTICLE 9

Appears in 1 contract

Samples: Confidential Treatment (Tg Therapeutics, Inc.)

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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDroyalty 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). ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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

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

Records; Audits. Merck will keepLICENSEE shall keep accurate books of account and records covering all transactions relating to the license granted in this Agreement (including, but not limited to, sales of Licensed Products, purchases and will cause each uses of NBA hologram stickers and compliance with shipment tracking, identification and anti- counterfeiting systems and labels that NBAP may establish from time to time). NBAP and its authorized representatives shall have the right no more than once per year without good cause, at all reasonable hours of the other Selling Parties, as applicablebusiness day and upon ten (10) days' notice, to keep, examine and Moderna will keep, adequate audit such books of account and records and all other documents and materials in LICENSEE's possession or under its control (including records of accounting LICENSEE's parents, subsidiaries, affiliates and third parties, if they are directly involved in activities which relate to this Agreement) relating to this Agreement. NBAP shall have free and full access for such purposes and for the purpose of calculating all royalties making extracts and other amounts payable copies. All such information shall be kept confidential in accordance with Paragraph 22(g) hereof. Should an audit by either Party NBAP establish a deficiency between the amount found to be due NBAP and the other Party hereunder amount LICENSEE actually paid or reported, the LICENSEE shall pay the amount of such deficiency, plus interest at the then current prime rate (as announced by Chemical Bank, New York branch) from the date such amount should have been paid until the date of payment. Should such audit establish a deficiency of more than five percent (5%) and ensuring each Party’s compliance hereundergreater than five thousand dollars ($5,000) LICENSEE shall also pay for the reasonable cost of the audit. For LICENSEE shall pay such amount within thirty (30) days. All such books of account and records shall be kept available for at least two (2) years after the [***] following expiration or termination of this Agreement, or three (3) years after the end of the Calendar Contract Year to which each will pertainthey relate, such whichever is earlier. In order to facilitate inspection of its books and records of accounting (including those of its Affiliatesrecords, as applicable) LICENSEE shall designate a symbol or number which will be kept at each used exclusively in connection with the Licensed Products on which royalty payments are payable and shall maintain for inspection as provided in this Agreement duplicates of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, all xxxxxxxx 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 customers with respect to such Calendar Year Licensed Products. LICENSEE shall, within ten (10) business days of NBAP's request (which shall not be made more than four (4) times per Contract Year), furnish NBAP with a list of LICENSEE's top twenty-five (25) retail accounts for Licensed Products (on a country by country basis) and their monthly purchases of Licensed Products (broken down by unit sales and in dollar volume by retailer). LICENSEE shall, promptly upon execution thereof, supply NBAP with true and complete copies of any agreement it enters into with any Member Team or any NBA player. In addition, LICENSEE shall, on a quarterly basis during the Term, provide NBAP with copies of either (i) financial information furnish to the United States Securities and Exchange Commission or (ii) with all financial statements and other financial information prepared by LICENSE E for distribution to its banks or other financial lending institutions to whom it reports regularly. Such information, to the extent not publicly available, 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) kept confidential in accordance with the confidentiality and non-use provisions Paragraph 22(g) hereof. At NBAP's request, LICENSEE shall reasonably cooperate with NBAP in developing an electronic data interchange or developing such other system, that will facilitate NBAP's review 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's graphic designs for Licensed Products.

Appears in 1 contract

Samples: Retail Product License Agreement (Marvel Entertainment Group Inc)

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 Each Party will maintain complete and accurate records in sufficient detail to permit (and procure its Affiliates, a) AMAG 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 confirm the accuracy of the payments calculation of royalty payments, and (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 calculation of Out-of-Pocket Costs under this Agreement. Upon reasonable prior notice, such records shall be available during [***] 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 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED due hereunder AMENDED. regular business hours for any Calendar Year ending not more than [***] following a period of three (3) years from the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar the Fiscal Year or be repeated to which they pertain for any Calendar Year. The accounting firm shall disclose to examination at the auditing Party only whether the reports are correct or incorrect and the amount expense 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 and not more often than once each calendar year, by an independent certified public accountant selected by the underpayment or overcharge exceeds [***]auditing Party and reasonably acceptable to the audited Party, for the sole purpose of verifying the accuracy of the financial reports and/or invoices furnished by the audited Party pursuant to this Agreement. Any such auditor shall pay not disclose the fees. Upon audited Party’s Confidential Information, except to the expiration extent such disclosure is necessary to verify the accuracy of [***] following the end financial reports furnished by such Party or the amount of any Calendar Year, absent willful misconduct payments due by or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year Party under this Agreement. Any amounts shown to be owed but unpaid shall be binding and conclusive upon paid within thirty (30) days from the Partiesaccountant’s report, and plus interest (as set forth in Section 8.8) from the Parties original due date. Any amounts shown to have been overpaid shall be released refunded within thirty (30) days from any liability or accountability with respect to amounts payable for such Calendar Yearthe accountant’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

Samples: License, Development and Commercialization Agreement (Amag 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 the end of the Calendar Year prior notice, Avanir shall, and shall require its Affiliates and use reasonable efforts to which each will pertainrequire its sublicensees to, make such books and records of accounting (including those of its Affiliates, as applicable) will be kept available during regular business hours at each of their such Party’s principal place of business. At the request business for a period 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933from the end of the Fiscal Year to which they pertain for examination, AS AMENDED due hereunder for any Calendar Year ending and 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 of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by amount actually owed during 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 applicable Fiscal Year, absent willful misconduct or fraud by a Party (in which case Avanir shall reimburse OptiNose for 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 out-of-pocket expenses incurred for such Calendar Yearaudit. The auditing Party OptiNose shall treat hold all financial information subject disclosed to review it under this Section 8.6(c8.6(a) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm all Royalty Reports delivered by Avanir pursuant to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Section 8.3(b) as Confidential Information in confidence pursuant to such confidentiality agreementof Avanir.

Appears in 1 contract

Samples: License Agreement (Avanir Pharmaceuticals, Inc.)

Records; Audits. Merck will keep, Licensee 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 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 a period of five (5) years from the purpose creation of calculating all royalties and other amounts payable individual records or any longer period required by either Party to the other Party hereunder and ensuring each Party’s compliance hereunderApplicable Law. For the [***] following the end of the Calendar Year to which each will pertainAt VIVUS’ request, such books and records of accounting shall be available for review at Licensee’s headquarters located at 10 Xxxxxxxx Xxxxx, 0xx Xxxxx, Xxxxxxxx, Xxx Xxxxxx 00000, or a mutually agreeable location determined by Parties not more than once each calendar year covering the two (including those of its Affiliates, as applicable2) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit immediately preceding calendar years (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) by an independent Third Party auditor selected by VIVUS and approved by Licensee (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 Licensee pursuant to this Agreement or of any payments made by Licensee to VIVUS pursuant to this Agreement. Any such auditor shall not disclose Licensee’s Confidential Information to VIVUS, except to the extent such disclosure is necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 Licensee 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 Licensee under this Agreement. No other Confidential Information shall Any undisputed amounts finally determined 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 within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 7.5) from the original due date. Any amounts finally determined to have been overpaid may be credited by Licensee against future payments to VIVUS hereunder. Licensee may carry forward any unused credits to future calendar quarters; provided, that in the auditing Partyevent there are unused credit amounts upon the termination of this Agreement or expiration of the MTPC Royalty Period, provided that if VIVUS shall promptly pay to Licensee such amounts. VIVUS shall bear the full cost of such audit unless such audit reveals an underpayment or overcharge exceeds [***]under-reporting error of ten percent (10%) or more during the applicable audit period, in which case Licensee shall bear the audited Party shall pay 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

Samples: License and Commercialization Agreement (Petros Pharmaceuticals, 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDAudited Party’s reports of Development Costs and Net Sales of a Product for an Indication as provided herein. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. 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

Samples: Collaboration Agreement (Osiris Therapeutics, Inc.)

Records; Audits. Merck Ultragenyx 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 (i) Net Sales during the [**] preceding Calendar Years, including deductions (by deduction category) from gross amounts billed or invoiced taken in calculating Net Sales, (ii) Option Territory Development Costs incurred by Ultragenyx during the [**] following preceding Calendar Years in sufficient detail to confirm the end accuracy of the Calendar Year to which each will pertainany payments required under this Agreement, such books and records of accounting (iii) Net Income or Net Loss (including those Ultragenyx’s Allowable Expenses) during the [**] preceding Calendar Years. Solid will keep accurate and complete records regarding all FTE Costs and Out-of-Pocket Costs incurred in connection with the Development activities performed by or on behalf of its AffiliatesSolid and Solid’s Allowable Expenses in sufficient detail to confirm the accuracy of any payments required under this Agreement, as applicable) will be kept at each of their principal place of businesscovering the [**] preceding Calendar Years. 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 Ultragenyx in accordance with Section 9.3.7, the payments Option Territory Development Costs reported by Ultragenyx, the Net Income or Net Loss calculation for Income Share Products, or the FTE Costs and Out-of-Pocket Costs reported by Solid in accordance with Section 9.6, as applicable. An examination by the Auditing Party under this Section 9.10 will occur not more than [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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 Year[**]. 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 reports, Option Territory Development Costs or calculation of Net Income or Net Loss submitted by Ultragenyx or the FTE Costs, Out-of-Pocket Costs and Allowable Expenses submitted by Solid, 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 9.10 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 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 audited amount that was owed by 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 commercially 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

Samples: Collaboration and License Agreement (Solid Biosciences Inc.)

Records; Audits. Merck will Licensee and its Affiliates shall keep, and will cause each Licensee shall require its sublicensees and subcontractors to keep, full, true and accurate records and books of account containing all particulars that may be necessary for the other Selling Partiespurpose of confirming the accuracy of, and calculating, 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 to Immunomedics hereunder (including records of Net Sales), as well as the number and types of Details performed, the costs incurred by either Licensee in connection with its Commercialization activities hereunder (including Advertisement and Promotion Costs) and any other records reasonably required to be maintained with respect to Licensee’s obligations under this Agreement, and each Party shall maintain complete and accurate records in sufficient detail to permit the other Party hereunder and ensuring to confirm the accuracy of all amounts payable or otherwise reimbursable hereunder, in each Party’s compliance hereunder. For the [case for a minimum period of ***] following the end * or such longer period as required by applicable Law. Each Party shall have a right to request an audit of the Calendar Year other Party in order to which each will pertainconfirm the accuracy of any of the foregoing (an “Audit”). Upon the written request by a Party (the “Auditing Party”) to Audit the other Party (the “Audited Party”), the Auditing Party shall have the right to engage an independent, internationally recognized, accounting firm to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the calendar year(s) requested by the Auditing Party; provided that (i) such accountants shall be given access to, and shall be permitted to examine and copy 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 Audited Party upon *** prior written notice to the Audited Party, and at all reasonable times on such business days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the Auditing Party, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to determine *** Portion for which confidential treatment requested. any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to the Audited Party’s business. The Audited Party shall make personnel available during normal regular business hours to answer queries on all such books and records required for the purpose of the records as may be reasonably necessary Audit. The accountants shall deliver a copy of its findings to verify the accuracy each of the payments [Parties within *** *** of the completion of the review, and, in the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by a Party shall be paid to the other Party within *** of notification of the results of such inspection plus interest at the rate specified in Section 9.10. Any overpayments made by a Party shall be refunded by the other Party within *** of notification of the results of such inspection. The cost of the accountant shall be the responsibility of the Auditing Party unless the accountants calculation shows that the actual royalties payable, Net Sales, number of Details, and/or any such other amount Audited hereunder to be different, by more than *** percent (***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933%), AS AMENDED 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 amounts as otherwise agreed upon previously calculated by the Parties. The fees charged by such accounting firm shall be paid by 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 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

Samples: License and Collaboration Agreement (Immunomedics Inc)

Records; Audits. Merck will Astellas shall keep, and will cause each of the other Selling Parties, as applicable, require its Sublicensees 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 Vical pursuant to this Agreement, as well as the other Party hereunder and ensuring each Party’s compliance hereunder. For the expenses of any [***…]. Such books and records shall be kept for such period of time required by law, but no less than […***…] ([…***…]) years following the end of the Calendar Year Quarter to which each will they pertain, such books and records . Vical (or City of accounting (including those of its AffiliatesHope or CytRx, as applicable) will be kept at each of their principal place of business. At shall have the request of either Partyright to cause an independent, 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 Astellas, to audit such records to confirm Net Sales, royalties and other payments for a period covering not more than the other Party to have access preceding […***…] ([…***…]) years. Except for any audits of the expenses of any […***…], for-cause audits or as otherwise permitted under the City of Hope Agreement or CytRx Agreement, as applicable, audits may be exercised not more often than […***…] each year, […***…] for each relevant record, and during normal business hours upon reasonable prior written notice to Astellas. Any such of auditor shall not disclose Astellas’ Confidential Information to Vical, except to the records as may be reasonably extent such disclosure is necessary to verify the accuracy of such records. Prompt adjustments shall be made by the payments parties to reflect the results of such audit. Vical (or City of Hope or CytRx, as applicable) shall bear the full cost of such audit unless such audit discloses an underpayment by Astellas of more than [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED percent ([…***…]%) of the amount of royalties or other payment due hereunder for any Calendar Year ending not under this Agreement or an overstatement by more than [***] following percent ([…***…]%) of the end expenses 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 which case, Astellas shall disclose bear the full cost of such audit and shall promptly remit to the auditing Party only whether the reports are correct or incorrect and Vical the amount of any discrepancyunderpayment. 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.Treatment Requested

Appears in 1 contract

Samples: License Agreement (Vical Inc)

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Records; Audits. Merck will keepDuring the Term and for two (2) years thereafter, the non-paying/receiving Party shall have a right to request an audit of each Selling Party in order to confirm the accuracy of royalty payments or any other applicable amount audited hereunder (an “Audit”); provided, however, that each non-paying/receiving Party shall only have the right to request such Audit one time during any given Calendar Year. Upon the written request by the non-paying/receiving Party to Audit a Selling Party, the non-paying/receiving Party shall have the right to engage an independent certified public accountant approved by the paying Party, such approval not to be unreasonably withheld, conditioned or delayed, to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the royalty payments or any other applicable amount audited hereunder for the Calendar Year(s) requested by the non-paying/receiving Party; provided that (i) such accountants shall submit an audit plan, including audit scope, to the Selling Party for the Selling Party’s approval, which shall not be unreasonably withheld, conditioned or delayed, prior to audit implementation, (ii) such accountants shall be given access to, and will cause each of the other Selling Parties, as applicable, shall be permitted to keep, examine and Moderna will keep, adequate copy such books and records of accounting the Selling Party upon five (5) days’ prior written notice to the Selling Party, and at reasonable times on Business Days, (iii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the Selling Party reasonably acceptable to the Selling Party in order to keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the non-paying/receiving Party, but shall only use the same for the purpose of calculating all royalties the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and other amounts payable by either Party (iv) such accountants shall use reasonable efforts to minimize any disruption to the other Party hereunder and ensuring each Selling Party’s compliance hereunderbusiness. For The Selling Party shall make personnel reasonably available during regular business hours to answer queries on all such books and records required for the purpose of the Audit. The accountants shall deliver a copy of their findings to each of the Parties upon completion of the review, and, in the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by the Selling Party shall be paid to the non-paying/receiving Party within thirty (30) Business Days of notification of the results of such inspection. Any overpayments made by the Selling Party shall be refunded by the non-paying/receiving Party within thirty (30) Business Days of notification of the results of such inspection. The cost of the accountants shall be the responsibility of the non-paying/receiving Party unless the accountants’ calculation shows that the actual royalties payable, Net Sales and/or any other applicable amount Audited hereunder to be underpaid by more than five percent (5%), than the amounts as paid and reported by the Selling Party for the period subject to the Audit. This Section 7.10 shall apply mutatis mutandis with respect to Lilly’s right to audit records in connection with payments that Licensee receives and that Lilly is entitled to share in pursuant to Section 7.2; provided, however, that Lilly’s right to audit such records pursuant to the final sentence of this Section 7.10 in connection with payments that Licensee receives and that Lilly is entitled to share in pursuant to Section 7.2 shall terminate [***] 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 from 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 which Lilly has received $15,000,000 pursuant to such confidentiality agreementSection 7.2.

Appears in 1 contract

Samples: Share Issuance Agreement (Ignyta, Inc.)

Records; Audits. Merck will keep, NEKTAR AL shall keep full and will cause each accurate records and books of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting account containing all particulars that may be reasonably necessary for the purpose of calculating determining amounts that are charged to COMPANY pursuant to this AGREEMENT are consistent with NEKTAR AL's standard current practices for charging THIRD PARTIES for similar services for similar REAGENTS as those provided by NEKTAR AL to COMPANY pursuant to this AGREEMENT. Such books of account shall be kept by NEKTAR AL at its places of business and, with all royalties necessary supporting data shall, for the two (2) years following the end of the calendar year to which each shall pertain be open for inspection by an independent certified accountant selected by COMPANY and other reasonably acceptable ---------- *** Portions of this page have been omitted pursuant to a Request for Confidential Treatment filed separately with the SEC. to NEKTAR AL upon reasonable notice during normal business hours for the sole purpose of verifying that the amounts payable charged to COMPANY under this AGREEMENT are consistent with NEKTAR AL's standard practices for charging THIRD PARTIES for similar services for similar REAGENTS as those provided by either Party NEKTAR AL to COMPANY pursuant to this AGREEMENT. The foregoing inspection shall occur no more than once each calendar year. All information and data offered shall be redacted to protect any confidential information of the other Party hereunder THIRD PARTY and ensuring each Party’s compliance hereundershall be used only for the purpose of verifying the consistency of amounts charged to COMPANY. For In the event that such inspection shall indicate in any calendar year that the charges paid by COMPANY exceeded by [***] following percent or more the end charges (as adjusted to reflect any increase in PPI) paid by THIRD PARTIES for similar services for similar REAGENTS as those provided by NEKTAR AL to COMPANY pursuant to this AGREEMENT, then NEKTAR AL shall pay the cost of the Calendar Year to which each inspection. COMPANY 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder invoice NEKTAR AL for any Calendar Year ending not more overpayments, which shall become due and payable no later than [***] following the end days after receipt 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 an invoice 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 1 contract

Samples: Research and License Agreement (Healthcare Acquisition Corp)

Records; Audits. Merck will keepAllergan and its Affiliates will, and Allergan will cause each of its Sublicensees, if any, to, maintain complete and accurate records in sufficient detail to confirm the other Selling Partiesaccuracy of the calculation of royalty payments and the achievement of milestone events, as applicablefor a period of five (5) years after the Calendar Year in which such sales or events occurred. Upon reasonable prior notice, to keep, and Moderna will keep, adequate books and such records of accounting Allergan and its Affiliates shall be made available during regular business hours 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 five (5) years from the end of the Calendar Year to which they pertain for examination, and not more often than once each will pertainCalendar Year, by an independent certified public accountant selected by Molecular Partners and reasonably acceptable to Allergan, for the sole purpose of and only to the extent necessary for verifying the accuracy of the financial reports furnished by Allergan pursuant to this Agreement. Such independent accountant shall disclose to Molecular Partners only the amounts that such independent accountant believes to be due and payable hereunder to Molecular Partners, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. Any periods previously audited may be re-audited one (1) additional time if Molecular Partners discovers a discrepancy or other issue in a subsequent audit. Any and all records examined by such independent accountant shall be deemed Allergan’s Confidential Information which may not be disclosed by such independent accountant to any Third Party, and Allergan may require such independent accountant to enter into an appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less protective than those set forth in Article 12. If, as a result of any inspection of the books and records of accounting Allergan, it is shown that payments under this Agreement were less than the amount which should have been paid, then Allergan shall make all payments required to be made plus interest (including those of its Affiliatesas set forth in Section 8.8) from the original due date to eliminate any discrepancy revealed by such inspection within thirty (30) days. If, as applicable) will be kept at each a result 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 any inspection of the books and records as may of Allergan, it is shown that payments under this Agreement were more than the amount which should have been paid, then Molecular Partners shall, at Allergan’s election, either make all payments required to be reasonably necessary made to verify eliminate any discrepancy revealed by such inspection within ninety (90) days or credit such amounts to Allergan against future payments. Molecular Partners shall pay for such audits, except that in the accuracy event that the audited amounts were underpaid by Allergan by more than *** of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933undisputed amounts that should have been paid during the period in question as per the audit, AS AMENDED 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 Allergan shall pay the other Party the amount costs 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 agreementaudit.

Appears in 1 contract

Samples: License and Collaboration Agreement (Molecular Partners Ag)

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 [**] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDdays 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 date. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any amounts shown to have been overpaid shall be Certain confidential information contained in this document, AS AMENDED due hereunder for any marked by [**], has been omitted because ADC Therapeutics SA has determined that the information (i) is not material and (ii) is customarily and actually treated by ADC Therapeutics as private or confidential. 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

Samples: License Agreement (ADC Therapeutics SA)

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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDdue by one Party to the other Party under this Agreement. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any amounts shown to be owed but unpaid shall be paid, AS AMENDED due hereunder for 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

Samples: Exclusive License Agreement (Ziopharm Oncology Inc)

Records; Audits. Merck will keep, Licensee 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 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’ request, such books and records of accounting shall be available for review at Licensee’s headquarters located at 00 Xxxxxxxx Xxxxx, 0xx Xxxxx, Xxxxxxxx, Xxx Xxxxxx 00000, or a mutually agreeable location determined by Parties not more than once each calendar year covering the *** immediately preceding calendar *** (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) by an independent Third Party auditor selected by VIVUS and approved by Licensee (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 Licensee pursuant to this Agreement or of any payments made by Licensee to VIVUS pursuant to this Agreement. Any such auditor shall not disclose Licensee’s Confidential Information to VIVUS, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Licensee or the amount of payments [due by Licensee under this Agreement. Any undisputed amounts finally determined to be owed but unpaid shall be paid within *** from the accountant’s report, plus interest (as set forth in Section ‎7.5) from the original due date. Any amounts finally determined to have been overpaid may be credited by Licensee against future payments to VIVUS hereunder. Licensee may carry forward any unused credits to future calendar quarters; provided, that in the event there are unused credit amounts upon the termination of this Agreement or expiration of the MTPC Royalty Period, VIVUS shall promptly pay to Licensee such amounts. VIVUS shall bear the full cost of such audit unless such audit reveals an underpayment or under-reporting error of *** percent (***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not %) or more than [***] following during 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 applicable audit period, in which case Licensee shall bear the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery 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

Samples: License and Commercialization Agreement (Vivus Inc)

Records; Audits. Merck will keepIncyte and its Affiliates, sublicensees, permitted distributors and subcontractors shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties Incyte Royalty Payments and other amounts payable by either to Hengrui hereunder (including records of Net Sales), and any other records reasonably required to be maintained with respect to Incyte’s obligations under this Agreement, and each Party shall maintain complete and accurate records in sufficient detail to permit the other Party hereunder and ensuring to confirm the accuracy of any other amounts payable or otherwise reimbursable hereunder, in each Party’s compliance hereunder. For the case for a minimum period of [***] following the end or such longer period as required by applicable Laws. Each Party shall have a right to request an audit of the other Party in order to confirm the accuracy of any of the foregoing (an “Audit”); provided, however, that each Party shall only have the right to request such Audit of the other Party one time during any given Calendar Year Year. Upon the written request by a Party (the “Auditing Party”) to which each will pertainAudit the other Party (the “Audited Party”), the Auditing Party shall have the right to engage an independent, internationally recognized accounting firm acceptable to the Audited Party to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the Calendar Year(s) requested by the Auditing Party; provided that (i) such accountants shall be given access to, and shall be permitted to examine and copy 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 Audited Party upon [**] prior written notice to the Audited Party, and at all reasonable times on such calendar days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access keep all information and data contained in such books and records strictly confidential and shall not disclose such information or copies of such books and records to any third person including the Auditing Party, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to the Audited Party’s business. The Audited Party shall make personnel reasonably available during normal regular business hours to answer queries on all such books and records required for the purpose of the records as may be reasonably necessary Audit. The accountants shall deliver a copy of their findings to verify the accuracy each of the payments Parties within [**] of the completion of the review, and, in the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by a Party, as well as interest for the underpayment according to Section 7.9, shall be paid to the other Party within [**] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDof notification of the results of such inspection. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any overpayments made by a Party shall be refunded by the other Party, AS AMENDED due together with interests for the overpayment according to Section 7.9, within [**] of notification of the results of such inspection. The cost of the accountants shall be the responsibility of the Auditing Party unless the accountants’ calculation shows that the actual royalties payable, Net Sales, and/or any such other amount Audited hereunder for any Calendar Year ending not to be different, by more than [***] following ], than the end of any Calendar Yearamounts as previously calculated by the Audited Party. 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 [***] = Portions of the date this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version 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 exhibit has been filed separately 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 agreementCommission.

Appears in 1 contract

Samples: License and Collaboration Agreement (Incyte Corp)

Records; Audits. Merck Licensee will keep, maintain complete and will cause each accurate records in sufficient detail to permit Licensor to confirm the accuracy of the other Selling Partiescalculation of royalty payments under this Agreement. 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 at the expense of Licensor, whereas such examination shall not occur 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 Licensor and reasonably acceptable to Licensee, 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 Licensee pursuant to this Agreement. Any such auditor shall not disclose Licensee’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Licensee or the amount of payments due by Licensee under this Agreement, Any amounts shown to be owed but unpaid shall be paid within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDdays from the accountant’s report. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not Licensor shall bear the full cost of such audit unless such audit discloses an underpayment by Licensee 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 amount due, in which case Licensee shall bear the full cost of such accounting firmaudit. In the event such audit reveals an overpayment, Licensor shall promptly refund Licensee any overpayment discovered in the course of such audit. Alternatively, at Licensee’s written report so correctly concludingelection, or as otherwise agreed upon Licensee shall have the right to credit any such overpayment to its future payment obligations to Licensor. Licensee shall include in each sublicense agreement under which a sublicense is granted by it pursuant to this Agreement a provision requiring the Parties. The fees charged by such accounting firm shall be paid by Sublicensees to make reports to the auditing PartyLicensee, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration to keep and maintain records 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 sales made pursuant to such confidentiality agreementsublicense, to grant access to such records by Licensee’s representatives to the same extent required of Licensee under this Agreement and to impose such obligations on any of its future sublicensee(s). In addition, Licensee shall use commercially reasonable efforts to include in each sublicense agreement under which a sublicense is granted pursuant to this Agreement a provision granting access to such records to Licensor in the same manner as and in addition to the access granted to Licensee.

Appears in 1 contract

Samples: License and Collaboration Agreement (Signal Genetics, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: And License Agreement (NGM Biopharmaceuticals Inc)

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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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 1 contract

Samples: Collaboration and License Agreement

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 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 (***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED%) as a result of such credit, and Menarini may carry forward any unused credits to future calendar quarters. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [VIVUS shall bear the full cost of such audit unless such audit reveals a payment or reporting error of *** percent (***] following %) or more during 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 applicable audit period, in which case Menarini shall bear the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery 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

Samples: License and Commercialization Agreement (Vivus Inc)

Records; Audits. Merck Each Party and its Related Parties will keepkeep full, true, and will cause each accurate records and books of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting account containing all particulars that may be necessary for the purpose of calculating all royalties confirming the accuracy of, and calculating, as applicable: (a) in the case of Agenus as the Auditing Party, [**]; and (b) in the case of Licensee as the Auditing Party, [**], in each case ((a) and (b)), and any other amounts payable records reasonably required to be maintained with respect to the Audited Party’s obligations under this Agreement, during the Term and for [**] thereafter or such longer period as required by either Applicable Law. Each Party will have a right to request an audit of the other Party hereunder in order to confirm the accuracy of the foregoing as provided in this Section 8.16 (Records; Audits) (an “Audit”); provided, however, that each Party will only have the right to request such Audit [**] during any given Calendar Year and ensuring each Party’s compliance hereunder[**], and may only Audit the records [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. For An unredacted version of this exhibit has been filed separately with the Commission. Exhibit 10.1 or books during the [**] period immediately prior to the date of such Audit. Upon the written request by a Party to Audit the other Party, the Auditing Party will engage an independent, internationally recognized accounting firm reasonably acceptable to the Audited Party to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of: (i) in the case of Agenus as the Auditing Party, [*] following *]; and (ii) in the end case of Licensee as the Auditing Party, [**], in each case ((i) and (ii)), for the Calendar Year Year(s) requested by the Auditing Party; provided that (1) such accounting firm will be given access to, and will be permitted to which each will pertain, examine and copy 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 Audited Party upon [**] prior written notice to the Audited Party, the other Party will permit and at all reasonable times on Business Days, (and procure its Affiliates2) prior to any such examination taking place, to permit) an independent certified public such accounting firm of internationally recognized standing selected by will enter into a confidentiality agreement with the auditing Audited Party and reasonably acceptable to the other Audited Party in order to have access keep all information and data contained in such books and records strictly confidential and only use the same for the purpose of the reviews, preparation of any audit reports or findings, or calculations that they need to perform in order to determine any amounts being reviewed, and (3) such accounting firm will use reasonable efforts to minimize any disruption to the Audited Party’s business. The Audited Party will make personnel reasonably available during normal regular business hours to answer queries on all such books and records to the extent required for the purpose of the records as may be reasonably necessary Audit. The accounting firm will deliver a copy of their findings to verify the accuracy each of the payments Parties within [**] of the completion of the review, and, unless the Audited Party invokes the dispute resolution mechanism set forth in Section 15.1 (Disputes) within [**] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDof the Audited Party’s receipt of such finding, the findings of such accounting firm will be final and binding on each of the Parties. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Any undisputed underpayments by the Audited Party will be paid to the Auditing Party within [**] of notification of the results of such Audit. Any undisputed overpayments made by the Audited Party will be refunded by the Auditing Party within [**] of notification of the results of such Audit. The cost of the accounting firm will be the responsibility of the Auditing Party unless the accounting firm’s calculation shows that the actual Royalty Payments payable, AS AMENDED due Net Sales, Agenus Co-Funding Share, Agenus GDP Trial Costs or any other applicable amount audited hereunder for any Calendar Year ending not (as applicable) to be different, by more than [***] following ], than the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year amounts as paid or be repeated reported by Audited Party for any Calendar Year. The accounting firm shall disclose the period subject 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 periodAudit, in which case, the appropriate Audited Party shall pay will reimburse the other Auditing Party for the amount cost 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 agreementAudit.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Agenus 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, XXxxx’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 Xxxxx’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 subject to audit under this Section 8.8 more than once. The Accounting Firm will be required to sign Xxxxx’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 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 report within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDof its receipt. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following 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 XXxxx’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 Xxxxx’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 XXxxx 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

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

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 payments prior [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDmonth period. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Before beginning its audit, AS AMENDED due hereunder for 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 Calendar Year ending payments 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

Samples: Licensing and Commercialization Agreement (Ophthotech Corp.)

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 Audited Party's reports of Direct Development Costs, Direct Commercialization Costs, Gross Sales, Net Sales, and Net Profits or Net Losses as provided herein. 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 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 the period starting from the date the payment was first due ending on the date the payment was made) shall be paid by the Audited Party within thirty (30) days of the date the Audited Party receives the Auditing Party's accounting firm's written report so concluding, unless the Audited Party shall have a good faith dispute as to the conclusions set forth in such written report, in which case the audited Party shall [***] INDICATES ]-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 406 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 19331934, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following AMENDED. provide written notice to the end Auditing Party within such thirty (30) day period of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Yearthe nature of its disagreement with such written report. The accounting firm Parties shall disclose 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 auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall matter will 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 Partiessubmitted 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 in confidence pursuant information subject to such the confidentiality agreementrestrictions of Article 8 hereof.

Appears in 1 contract

Samples: Collaboration Agreement (pSivida LTD)

Records; Audits. Merck will keepKnight, its Affiliates, sublicensees and assignees shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, 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 to Licensor hereunder (including records of Net Sales) and any other records reasonably required to be maintained with respect to Knight’s obligations under this Agreement, in each case for a minimum period of four (4) years or such longer period as required by either Applicable Laws. Licensor shall have a right to request an audit of Knight, its Affiliates or sublicensees or assignees (the “Audited Party”) in order to confirm the accuracy of any of the foregoing (an “Audit”); provided, however, that Licensor shall only have the right to request such Audit one time during any given Calendar Year. Upon the written request by Licensor to Audit the Audited Party, Licensor shall have the right to engage an independent, internationally recognized accounting firm that is reasonably acceptable to the Audited Party to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end accuracy of any of the foregoing for the Calendar Year Year(s) requested by Licensor; provided that (i) such accountants shall be given access to, and shall be permitted to which each will pertain, examine and copy such books and records of accounting the Audited Party upon five (including those of its Affiliates, as applicable5) will be kept at each of their principal place of business. At business days’ prior written notice to the request of either Audited Party, and at all reasonable times on such business days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access during normal business hours to keep all information and data contained in such of the books and records as may be reasonably necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending strictly confidential and shall not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year disclose such information 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 copies 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 books and records to any third person including the auditing Party, provided that if but shall only use the underpayment same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to Audited Party’s business. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) business days of the completion of the review, and, in the absence of fraud or overcharge exceeds [***]manifest error, the audited Party shall pay the fees. Upon the expiration findings 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 accountant shall be final and binding and conclusive upon on each of the Parties, and the Parties . Any underpayments by Knight shall be released from any liability or accountability with respect paid to amounts payable for Licensor within ten (10) business days of notification of the results of such Calendar Yearinspection. Any overpayments made by Knight shall be refunded by Licensor within ten (10) business days of notification of the results of such inspection. The auditing Party cost of the accountants shall treat all financial information subject be the responsibility of Licensor unless the accountants’ calculation shows that the actual royalties payable, and/or any such other amount audited hereunder to review under this Section 8.6(c) be different, by more than five percent (5%), than the amounts as previously calculated by the Audited Party, in accordance with which event the confidentiality cost shall be the responsibility of Knight and non-use provisions of this Agreement, and Knight shall cause its accounting firm to enter into an acceptable confidentiality agreement with reimburse Licensor for any Licensor costs incurred for the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementAudit.

Appears in 1 contract

Samples: License and Supply Agreement (Onconova Therapeutics, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: Licence Agreement (Amgen Inc)

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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: Joint Commercialization Agreement (Genmab a/S)

Records; Audits. Merck will keep, Each Party shall maintain complete and will cause each accurate records in sufficient detail to permit the other Party to confirm the accuracy of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records calculation of accounting for the purpose of calculating all royalties and other amounts payable by either Party payments to the other Party hereunder and ensuring each Party’s compliance hereunderunder this Agreement. For the [***] following the end of the Calendar Year to which each will pertainUpon reasonable prior notice, such books records shall be available during regular business hours of audited Party for a period of three (3) years from the creation of individual records for examination at auditing Party's expense, 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 and reasonably acceptable to audited Party, 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 pursuant to this Agreement. Any such auditor shall not disclose audited Party's Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by audited Party or the amount of payments due by audited Party 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 8.6) from the original due date. Any amounts determined to be overpaid shall be refunded within thirty (30) 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 Fiscal Year of more than [**], in which case audited Party shall bear the full cost of such audit. [*] INDICATES MATERIAL THAT = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER OF THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar YearAMENDED. 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.55

Appears in 1 contract

Samples: Collaboration and License Agreement (Affymax Inc)

Records; Audits. Merck will Each Party shall keep, and will shall cause each of the other Selling Parties, as applicable, its Affiliates and sublicensees to keep, such accurate and Moderna will keep, adequate books and complete records of accounting (i) for Xxxxxxx, Development Costs and Net Sales, for Products sold in the purpose of calculating all royalties United States: Profits (Losses), Development Costs and other Allowable Expenses, and for Products sold outside the United States: Net Sales, royalties, and the calculations thereof; and (ii) for Theravance, Development Costs and, for Products sold in the United States, Allowable Expenses, and the calculations thereof, in each case as are necessary to determine the amounts payable by either Party due to the other Party hereunder under this Agreement and ensuring such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the “Recording Party’s compliance hereunder”) for at least the three (3) calendar years subsequent to the calendar year to which such costs, expenses or Net Sales, and Profits (Losses) relate. For During normal business hours and with reasonable advance notice to the [***] following Recording Party, such records shall be made available for inspection, review and audit, at the end request and expense 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 other Party, the other Party will permit (and procure its Affiliates, to permit) by an independent certified public accounting firm of internationally recognized standing selected accountant, or the local equivalent, appointed by the auditing other Party and reasonably acceptable to the other Recording Party to have access during normal business hours to such for the sole purpose of the records as may be reasonably necessary to verify verifying the accuracy of the Recording Party’s accounting reports and payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933made or to be made pursuant to this Agreement; provided, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations however that such audits may not be conducted performed by the other Party more than once in any Calendar Year or per calendar year. Such accountants shall be repeated for any Calendar Year. The accounting firm shall disclose instructed not to reveal to the auditing Party only whether the reports are correct or incorrect details of its review, except for (i) such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as is necessary to report the amount of any discrepancy. No other accountants’ conclusions to the auditing Party, and all such information shall be deemed Confidential Information shall be providedof the Recording Party. Following completion of an audit, the independent public accounting firm shall, prior to distribution to the auditing Party, share its report with the audited Party. If such the audited Party provides the independent public accounting firm correctly identifies a discrepancy made during such periodwith justifying remarks for inclusion in the report, the appropriate Party independent public accounting firm shall pay incorporate such remarks into its report prior to sharing the other Party the amount of the discrepancy within [***] of the date of delivery conclusions of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such independent public accounting firm with the auditing Party. All costs and expenses incurred in connection with performing any such audit shall be paid by the auditing Party, provided that if Party unless the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of audit discloses at least a [***] following shortfall with respect to Net Sales or excess with respect to costs or expenses, as applicable, in which case the end Recording Party will bear the full cost of the audit for such calendar year. The auditing Party will be entitled to recover any Calendar Year, absent willful misconduct shortfall in payments due to it (or fraud overpayment made by a Party (its Affiliatesit, as applicable) the calculation of amounts payable with respect to as determined by such Calendar Year shall be binding and conclusive upon the Partiesaudit, 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) plus interest thereon calculated in accordance with Section 6.14. The documents from which were calculated the confidentiality and non-use provisions of sums due under this Agreement, and Article 6 shall cause its accounting firm to enter into an acceptable confidentiality agreement with be retained by each Recording Party during the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementTerm.

Appears in 1 contract

Samples: License and Collaboration Agreement (Theravance Biopharma, 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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

Samples: Development and License Agreement (NGM Biopharmaceuticals Inc)

Records; Audits. Merck will keepLicensee, its Affiliates, sublicensees and assignees shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and will cause each of the other Selling Partiescalculating, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties sales-related payments and other amounts payable to Licensor hereunder (including records of Net Sales) and any other records reasonably required to be maintained with respect to Licensee’s obligations under this Agreement, in each case for a minimum period of four (4) years or such longer period as required by either Applicable Laws. Licensor shall have a right to request an audit of Licensee, its Affiliates or sublicensees or assignees (the “Audited Party”) in order to confirm the accuracy of any of the foregoing (an “Audit”); provided, however, that Licensor shall only have the right to request such Audit one time during any given Calendar Year. Upon the written request by Licensor to Audit the Audited Party, Licensor shall have the right to engage an independent, internationally recognized accounting firm that is reasonably acceptable to the Audited Party to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end accuracy of any of the foregoing for the Calendar Year Year(s) requested by Licensor; provided that (i) such accountants shall be given access to, and shall be permitted to which each will pertain, examine and copy such books and records of accounting the Audited Party upon five (including those of its Affiliates, as applicable5) will be kept at each of their principal place of business. At business days’ prior written notice to the request of either Audited Party, and at all reasonable times on such business days, (ii) prior to any such examination taking place, such accountants shall enter into a confidentiality agreement with the other Audited 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 Audited Party in order to have access during normal business hours to keep all information and data contained in such of the books and records as may be reasonably necessary to verify the accuracy of the payments [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending strictly confidential and shall not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year disclose such information 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 copies 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 books and records to any third person including the auditing Party, provided that if but shall only use the underpayment same for the purpose of the reviews and/or calculations which they need to perform in order to determine any amounts being reviewed, and (iii) such accountants shall use reasonable efforts to minimize any disruption to Audited Party’s business. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) business days of the completion of the review, and, in the absence of fraud or overcharge exceeds [***]manifest error, the audited Party shall pay the fees. Upon the expiration findings 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 accountant shall be final and binding and conclusive upon on each of the Parties, and the Parties . Any underpayments by Licensee shall be released from any liability or accountability with respect paid to amounts payable for Licensor within ten (10) business days of notification of the results of such Calendar Yearinspection. Any overpayments made by Licensee shall be refunded by Licensor within ten (10) business days of notification of the results of such inspection. The auditing Party cost of the accountants shall treat all financial information subject be the responsibility of Licensor unless the accountants’ calculation shows that the actual royalties payable, and/or any such other amount audited hereunder to review under this Section 8.6(c) be different, by more than five percent (5%), than the amounts as previously calculated by the Audited Party, in accordance with which event the confidentiality cost shall be the responsibility of Licensee and non-use provisions of this Agreement, and Licensee shall cause its accounting firm to enter into an acceptable confidentiality agreement with reimburse Licensor for any Licensor costs incurred for the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementAudit.

Appears in 1 contract

Samples: Distribution, License and Supply Agreement (Onconova Therapeutics, 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 to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments preceding [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDCalendar 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 the content of the audit. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Such audits (i) may be exercised during normal business hours upon reasonable prior written notice to Licensee, AS AMENDED due hereunder for (ii) shall be initiated on a date specified by Inventiva in its written notice to Licensee, provided that in any Calendar Year ending not event the date of sending the written notice shall be at least [***] prior to the initiating date of audit, (iii) shall be limited to the 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

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

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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDdue under this Agreement. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933For clarity, AS AMENDED 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 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

Samples: License Agreement (ADC Therapeutics SA)

Records; Audits. Merck will (a) SciClone shall keep, and will cause each of the other Selling Partiesshall require its Affiliates, as applicable, Sublicensees and Subcontractors to keep, accurate 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 Y-mAbs 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 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDto which they pertain. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Y-mAbs shall have the right to cause an independent auditor reasonably acceptable to SciClone to audit such records to confirm Net Sales, AS AMENDED due hereunder royalties and other payments for any Calendar Year ending a period covering not more than the preceding [***], provided that an audit of the records relating to a particular [***] may be conducted not more than [***] following and the end of any Calendar Year. Such examinations may audit rights shall not be conducted exercised 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 [***] in any [***]. Such audits may be exercised during normal business hours upon reasonable prior written notice to SciClone. Prompt adjustments shall be made by the Parties to reflect the results of such audit, and SciClone shall promptly remit to Y-mAbs the amount of any underpayment. Y-mAbs shall bear the cost of such audit unless such audit discloses an underpayment by SciClone of more than [***] percent ([***]%) of the date amount of delivery of such accounting firm’s written report so correctly concluding, royalties 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 other payments due under this Agreement for any applicable [***], in which case, SciClone shall bear the audited Party cost of such audit. Any overpayment by SciClone revealed by an audit shall pay be fully-creditable against future payment owed by SciClone to Y-mAbs (and if no further payments are due, shall be refunded by Y-mAbs immediately at the feesrequest of SciClone). Upon the expiration of [***] following the end of With respect to 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 SciClone by Y-mAbs pursuant 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, Y-mAbs shall have the similar obligations as SciClone under the foregoing of this Section ‎6.3 and SciClone shall cause its accounting firm to enter into an acceptable confidentiality agreement with have the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreementsimilar audit rights as Y-mAbs under the foregoing of this Section ‎6.3 and this Section ‎6.3 shall apply mutatis mutandis.

Appears in 1 contract

Samples: License Agreement (Y-mAbs 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933determine, AS AMENDED due hereunder for 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

Samples: Safety Data Exchange Agreement (Cempra, 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 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED 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 to verify the accuracy of the payments exercised more than once per [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDperiod. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933The accounting firm shall report to the Parties whether the applicable payments are correct, AS AMENDED and if they are not correct, the amount of the 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

Samples: Collaboration Agreement (Molecular Templates, 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 royalty reports submitted by Vertex in accordance with Section 7.6.6 or the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDreported by Company in accordance with Section 7.8, as applicable. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder 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

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

Records; Audits. Merck will keepTenant shall keep accurate records of all Membership Dues, in accordance with Tenant's usual accounting practices, at one of its regular business offices, and will cause each of Landlord shall have the other Selling Partiesright, as applicableupon forty-five (45) days' notice in writing to Tenant, to keep, and Moderna will keep, adequate books and audit 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 [***] 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 [***] 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Lease Year. Such examinations may not audit shall be conducted performed during Tenant's usual business hours and without unreasonable interference with the conduct of business at the place where the audit is made. If Landlord shall have such an audit performed for any Lease Year and the Membership Dues shown by Tenant's statement for such Lease Year should be found to be understated and as a result, Tenant owes additional Percentage Rent, then Landlord shall notify Tenant of such deficiency and Tenant shall pay to Landlord the deficiency in Percentage Rent no later than ten (10) days after Tenant's receipt of said notice of deficiency from Landlord. If Landlord shall have such an audit performed for any Lease Year and the Membership Dues shown by Tenant's statement for such Lease Year should be found to be understated by more than once three percent (3%), and as a result Tenant owes additional Percentage Rent, then Tenant shall pay to Landlord the cost of such audit in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose addition to the auditing Party only whether deficiency in Percentage Rent as stated above. Any statements or payments made by Tenant and not the reports are correct or incorrect and the amount subject of any discrepancy. No other Confidential Information Landlord's notice hereunder within the aforesaid period 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 deemed final and conclusive upon the Partiesconclusive, and the Parties Tenant shall be released from any liability have no further obligations to keep such records or accountability with respect make them available 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 agreementLandlord.

Appears in 1 contract

Samples: Lease Agreement (Equity Lifestyle Properties Inc)

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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED"Audited Information"). ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Each 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 discovered discrepancies); provided, AS AMENDED due hereunder for any Calendar Year ending not 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.Product Development Development Obligations

Appears in 1 contract

Samples: Confidential Treatment (Sangstat Medical Corp)

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