Common use of Records and Audits Clause in Contracts

Records and Audits. During the Research Term, Trubion shall keep books and accounts of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the calendar year in which they were generated in order to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyeth, Trubion shall permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth and reasonably acceptable to Trubion, to examine, at Wyeth's sole expense, the relevant books and records of Trubion as may be reasonably necessary to verify the amount of reimbursable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit. All information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreement.

Appears in 4 contracts

Samples: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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Records and Audits. During the Research Term(a) Erasca will keep, Trubion shall keep books and accounts of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP will require its Sublicensees to keep, complete and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the underlying revenue, expense and other data relating to the calculations of Net Sales generated in the then current calendar year in which they were generated in order and payments required under this Agreement, and during the preceding six (6) calendar years. Erasca will require its Sublicensees to enable audit provide to Erasca all information necessary to calculate the royalties payable to Katmai with respect to Net Sales of such Sublicensees, so that Katmai may exercise its rights under this Section 3.6 with respect to such information in Erasca’s possession. Each of Katmai and the UC will have the right, once annually at its own expense, to have a nationally recognized, independent, certified public accounting firm, selected by it and subject to Erasca’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed), review any such records as set forth below. Upon in the possession of Erasca and its Affiliates and Sublicensees (the “Audited Party”) in the location(s) where such records are maintained by the Audited Party upon reasonable written notice (which shall be no less than thirty (30) days days’ prior written notice from Wyethnotice) and during regular business hours and under obligations of confidentiality, Trubion shall permit an independent certified public accounting firm for the sole purpose of nationally recognized standing selected by Wyeth verifying the basis and reasonably acceptable to Trubionaccuracy of payments made under Article 3 (Fees, to examine, at Wyeth's sole expense, Royalties and Payments) within the relevant books and records of Trubion as may be reasonably necessary to verify the amount of reimbursable outseventy-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six two (3672) months before month period preceding the date of the requestrequest for review. The accounting firm shall be provided access Erasca will receive a copy of each such report concurrently with receipt by Katmai. Should such inspection lead to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm discovery of a discrepancy to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the auditKatmai’s detriment, Trubion shall refund the excess payments to Wyeth Erasca will, within thirty (30) days of its after receipt of such report from the auditor's report so concluding accounting firm, pay the amount of the discrepancy together with interest at the rate set forth in Section 3.5 (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such reportLate Payments). If Katmai will pay the amount full cost of the review unless the underpayment of amounts due to be refunded exceeds more Katmai is greater than ten [***]percent (10[***]%) of the amount that was properly payabledue for any calendar year in the period being examined, Trubion shall reimburse Wyeth for in which case Erasca will pay the cost charged by such accounting firm for such review. Should the audit lead to the discovery of a discrepancy to Erasca’s detriment, Erasca may credit the amount of the audit. All information of Trubion which is subject discrepancy, without interest, against future payments payable to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights Katmai under this Agreement, as may be necessary for Wyeth and if there are no such payments payable, then Katmai shall pay to exercise its rights under this AgreementErasca the amount of the discrepancy, or as otherwise expressly permitted under this Agreementwithout interest, within forty-five (45) days of Katmai’s receipt of the report.

Appears in 4 contracts

Samples: Exclusive License Agreement (Erasca, Inc.), Exclusive License Agreement (Erasca, Inc.), Exclusive License Agreement (Erasca, Inc.)

Records and Audits. During AKERO will keep complete and accurate records of the Research Termunderlying revenue and expense data relating to the calculations of Net Sales generated in the then current calendar year and payments required under this Agreement, Trubion shall keep books and accounts of record in connection with during the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least preceding three (3) years after calendar years. AMGEN will have the end of the calendar year in right, once annually at its own expense, to have a nationally recognized, independent, certified public accounting firm, selected by it and subject to AKERO’s prior written consent (which they were generated in order to enable audit of shall not be unreasonably withheld, conditioned or delayed), review any such records as set forth below. Upon of AKERO and its Affiliates and Sublicensees (the “Audited Party”) in the location(s) where such records are maintained by the Audited Party upon reasonable written notice (which shall be no less than thirty (30) days days’ prior written notice from Wyethnotice) and during regular business hours and under obligations of strict confidence, Trubion shall permit an independent certified public accounting firm for the sole purpose of nationally recognized standing selected by Wyeth verifying the basis and reasonably acceptable to Trubionaccuracy of payments made under Article 3 (Fees, to examine, at Wyeth's sole expense, Royalties and Payments) within the relevant books and records of Trubion as may be reasonably necessary to verify the amount of reimbursable outthirty-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before month period preceding the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepanciesrequest for review. No other information shall calendar year will be provided subject to Wyethaudit under this Section 3.5 more than once. If AKERO will receive a copy of each such report concurrently with receipt by AMGEN. Should such inspection lead to the accounting firm determines that the aggregate amount discovery of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audita discrepancy to AMGEN’s detriment, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if laterAKERO will, within fifteen forty-five (1545) days after resolution receipt of a bona fide objection by Trubion to such report from the findings accounting firm, pay any undisputed amount of the discrepancy together with interest at the rate set forth in such reportSection 3.4 (Late Payments). If AMGEN will pay the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the full cost of the auditreview unless the underpayment of amounts due to AMGEN is [***] for the entire period being examined, in which case AKERO will pay the cost charged by such accounting firm for such review. All information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject Should the audit lead to the provisions discovery of Article 7a discrepancy to AKERO’s detriment, and such Confidential Information shall not be disclosed AKERO may credit the amount of the discrepancy, without interest, against future payments payable to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights AMGEN under this Agreement, as may be necessary for Wyeth and if there are no such payments payable, then AMGEN shall pay to exercise its rights under this AgreementAKERO the amount of the discrepancy, or as otherwise expressly permitted under this Agreementwithout CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. interest, within [***] days of AMGEN’s receipt of the report.

Appears in 3 contracts

Samples: Quality Agreement (Akero Therapeutics, Inc.), Quality Agreement (Akero Therapeutics, Inc.), Quality Agreement (Akero Therapeutics, Inc.)

Records and Audits. During Trevi will keep complete and accurate records relating to the Research Term, Trubion shall keep books and accounts calculations of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the calendar year in which they were Net Sales generated in order the then current calendar year, and during the preceding [**]. Penwest will have the right, [**] at its own expense, to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyethhave a nationally recognized, Trubion shall permit an independent independent, certified public accounting firm of nationally recognized standing firm, selected by Wyeth it and reasonably acceptable to TrubionTrevi, to examine, at Wyeth's sole expense, the relevant books and review any such records of Trubion as may be reasonably necessary to verify Trevi and its Affiliates and Sublicensees (the amount of reimbursable out-of-pocket expenses incurred. An examination “Audited Party”) in the location(s) where such records are maintained by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and the Audited Party upon reasonable written notice (which shall be limited to no less than [**] prior written notice) and during regular business hours and under obligations of strict confidence, for the pertinent books sole purpose of verifying the basis and records for any calendar year ending not more than thirty six (36) months before accuracy of payments made under Section 4.3 and 4.5 within the [**] period preceding the date of the requestrequest for review. The accounting firm shall No calendar year will be provided access subject to audit under this Section more than [**] except for cause. Trevi will receive a copy of each such books and records at Trubion's facility(ies) where report concurrently with receipt by Penwest. Should such books and records are normally kept and inspection lead to the discovery of a discrepancy to Penwest’s detriment, Trevi will, within [**] after receipt of such examination shall be conducted during Trubion's normal business hours. Trubion may require report from the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning firm, pay any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate undisputed amount of out-of-pocket expenses actually incurred the discrepancy, plus interest on the underpayment at a rate per annum equal to the lesser of [**] percent ([**]%) per month or the highest rate permitted by Trubion applicable law, calculated from the date the underpayment was less than made until the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments date of payment to Wyeth within thirty (30) days of its receipt Penwest of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution underpayment. Penwest will pay the full cost of a bona fide objection by Trubion the review unless the underpayment of amounts due to the findings in such report). If the amount to be refunded exceeds more Penwest is greater than ten [**] percent (10[**]%) of the amount that was properly payabledue for the entire period being examined, Trubion shall reimburse Wyeth for in which case Trevi will pay the cost of such review. Any undisputed overpayment of royalties by Trevi revealed by an examination will be paid by Penwest within [**] of Penwest’s receipt of the auditapplicable report. All information Any disagreement regarding the results of Trubion which is subject to review any audit conducted under this Section 3.6.3 shall will be deemed to be Confidential Information of Trubion subject to the dispute resolution provisions of set forth in Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreement.X.

Appears in 3 contracts

Samples: Exclusive License Agreement (Trevi Therapeutics, Inc.), Exclusive License Agreement (Trevi Therapeutics, Inc.), Exclusive License Agreement (Trevi Therapeutics, Inc.)

Records and Audits. During XXXXX will keep complete and accurate records of the Research Termunderlying revenue and expense data relating to the calculations of Net Sales generated in the then current calendar year and payments required under this Agreement, Trubion shall keep books and accounts of record in connection with during the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least preceding three (3) years after calendar years. AMGEN will have the end of the calendar year in right, once annually at its own expense, to have a nationally recognized, independent, certified public accounting firm, selected by it and subject to XXXXX’x prior written consent (which they were generated in order to enable audit of shall not be unreasonably withheld), review any such records as set forth below. Upon of XXXXX and its Affiliates and Sublicensees (the “Audited Party”) in the location(s) where such records are maintained by the Audited Party upon reasonable written notice (which shall be no less than thirty (30) days days’ prior written notice from Wyethnotice) and during regular business hours and under obligations of strict confidence, Trubion shall permit an independent certified public accounting firm for the sole purpose of nationally recognized standing selected by Wyeth verifying the basis and reasonably acceptable to Trubion, to examine, at Wyeth's sole expense, accuracy of payments made under Section 3.3 Section 3.1 (Royalties) within the relevant books and records of Trubion as may be reasonably necessary to verify the amount of reimbursable outthirty-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before month period preceding the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepanciesrequest for review. No other information shall calendar year or portion thereof will be provided subject to Wyethaudit under this Section more than once. If XXXXX will receive a copy of each such report concurrently with receipt by AMGEN. Should such inspection lead to the accounting firm determines that the aggregate amount discovery of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audita discrepancy to AMGEN’s detriment, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if laterXXXXX will, within fifteen forty-five (1545) days after resolution receipt of a bona fide objection by Trubion to such report from the findings accounting firm, pay any undisputed amount of the discrepancy together with interest at the rate set forth in such reportSection 3.7 (Late Payments). If AMGEN will pay the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the full cost of the auditreview unless the underpayment of amounts due to AMGEN is [***] for the entire period being examined, in which case XXXXX will pay the cost charged by such accounting firm for such review. All information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject Should the audit lead to the provisions discovery of Article 7a discrepancy to XXXXX’x detriment, and such Confidential Information shall not be disclosed XXXXX may credit the amount of the discrepancy, without interest, against future payments payable to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights AMGEN under this Agreement, as may be necessary for Wyeth and if there are no such payments payable, then AMGEN shall pay to exercise its rights under this AgreementXXXXX the amount of the discrepancy, or as otherwise expressly permitted under this Agreementwithout interest, within [***] days of AMGEN’s receipt of the report.

Appears in 2 contracts

Samples: Exclusive License Agreement (Vigil Neuroscience, Inc.), Exclusive License Agreement (Vigil Neuroscience, Inc.)

Records and Audits. AstraZeneca 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 Exercise Price payable by Moderna to AstraZeneca under this Schedule A and ensuring Moderna’s compliance under this Schedule A. Such books and records will be maintained by AstraZeneca for at least [***] from the date of creation. During the Research Option Agreement Term, Trubion shall keep such books and accounts records of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three accounting (3) years after the end including those of the calendar year in which they were generated in order to enable audit other Selling Parties, as applicable) will be kept at each of such records as set forth belowtheir principal places of business. Upon thirty (30) days prior written notice from WyethAt the request of Moderna, Trubion shall AstraZeneca will, and AstraZeneca will cause each of the other Selling Parties to, permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth Moderna and reasonably acceptable to TrubionAstraZeneca, during normal business hours and upon reasonable notice, to examine, at Wyeth's sole expense, examine the relevant books and records maintained pursuant to this Paragraph 2.4(c) (Schedule A). Such examinations may not (i) be conducted for any calendar year after the end of Trubion as the Option Agreement Term (except that the books and records relating to the last year of the Option Agreement Term may be reasonably necessary to verify examined for [***] after the amount end of reimbursable the Option Agreement Term), (ii) be conducted more than [***] in any [***] period and going back no more than [***] after receipt of the respective invoice and report or (iii) be repeated for any calendar year. Moderna will provide AstraZeneca with a copy of the accounting firm’s written report within [***] of completion of such report. Except as provided below, the cost of this examination will be borne by Moderna, unless the audit reveals a variance of more than [***] from the reported amounts for a calendar year, in which case AstraZeneca will bear the reasonable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit, [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. All 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 A&R OPTION AGREEMENT provided such variance exceeds [***]. Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, AstraZeneca will pay the additional amounts or Moderna will reimburse such excess payments, with interest from the date originally due as provided in Paragraph 2.4(f) (Schedule A), within [***] days after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amount owed to Moderna under this Paragraph 2.4(c) (Schedule A), Moderna and AstraZeneca will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] days, such dispute will be resolved in accordance with the dispute resolution procedures set forth in Section 11.1 of the A&R Services and Collaboration Agreement. The receiving Party will treat all information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to Paragraph 2.4(c) (Schedule A) in accordance with the confidentiality provisions of Article 7Section 11 of the Option Agreement, and AstraZeneca will cause any accounting firm, auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with AstraZeneca obligating such Confidential Information shall not be disclosed firm to any retain all such financial information in confidence pursuant to such confidentiality agreement. Moderna may provide Third Parties to which Moderna owes payments on Products information in such audit report that are relevant and required to comply with such Third Party’s audit rights under the applicable license agreement between Moderna and such Third Party, provided that such Third Party or used for any purpose other than verifying the is obligated to keep such information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreementconfidential.

Appears in 2 contracts

Samples: Option Agreement (Moderna, Inc.), Option Agreement (Moderna, Inc.)

Records and Audits. During TESARO will keep complete and accurate records relating to the Research Term, Trubion shall keep books and accounts calculations of record Net Sales generated in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the then current calendar year in which they were generated in order and payments required under this Agreement, and during the preceding * years. AMGEN will have the right, * at *, to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyethhave a nationally recognized, Trubion shall permit an independent independent, certified public accounting firm of nationally recognized standing firm, selected by Wyeth and reasonably acceptable to Trubionit, to examine, at Wyeth's sole expense, the relevant books and review any such records of Trubion as may be reasonably necessary to verify TESARO and its Affiliates and Sublicensees (the amount of reimbursable out-of-pocket expenses incurred. An examination “Audited Party”) in the location(s) where such records are maintained by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and the Audited Party upon reasonable written notice (which shall be limited to no less than * days’ prior written notice) and during regular business hours and under obligations of strict confidence, for the pertinent books sole purpose of verifying the basis and records for any calendar year ending not more than thirty six accuracy of payments made under Section 3.3 (36Royalties) months before within the * month period preceding the date of the requestrequest for review. The accounting firm shall No * will be provided access subject to audit under this Section more than once. TESARO will receive a copy of each such books and records at Trubion's facility(ies) where report concurrently with receipt by AMGEN. Should such books and records are normally kept and inspection lead to the discovery of a discrepancy to AMGEN’s detriment, TESARO will, * days after receipt of such examination shall be conducted during Trubion's normal business hours. Trubion may require report from the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning firm, pay any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate undisputed amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during discrepancy together with interest at the period covered by rate set forth in Section 3.6 (Late Payments). * will pay the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt full cost of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution review unless the underpayment of a bona fide objection by Trubion amounts due to the findings in such report). If the amount to be refunded exceeds more * is greater than ten * percent (10%) * of the amount that was properly payable, Trubion shall reimburse Wyeth due for the entire period being examined, in which case * will pay the cost charged by such accounting firm for such review. Should the audit lead to the discovery of a discrepancy to * detriment, * may credit the amount of the audit. All information of Trubion which is subject discrepancy, without interest, against future payments payable to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights * under this Agreement, as may be necessary for Wyeth and if there are no such payments payable, then * shall pay to exercise its rights under this Agreement* the amount of the discrepancy, or as otherwise expressly permitted under this Agreementwithout interest, within * days of * receipt of the report.

Appears in 2 contracts

Samples: Exclusive License Agreement (TESARO, Inc.), Exclusive License Agreement (TESARO, Inc.)

Records and Audits. During the Research Term, Trubion EVL and its Affiliates shall keep and maintain or cause to be maintained books and accounts records pertaining to the calculation of record in connection with Cost of Goods Sold, Net Sales and Net Profits during the expenses reimbursable under Section 3.6.1 hereof Term and for two (2) years thereafter. Such books and records shall be maintained in accordance with GAAP and with all records and details necessary to enable Catalyst to verify the foregoing. All factors included in sufficient detail to permit accurate the determination of all figures necessary the Cost of Goods Sold, Net Sales and Net Profits shall be specific to the Product, reasonably documented, and available for verification independent audit purposes. Catalyst shall have the right once per calendar year, at its own expense, during the Term and for two (2) years thereafter, to have an independent public accountant, reasonably acceptable to EVL, audit the relevant financial books and records of costs account of EVL for up to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least the preceding three (3) years after the end of the calendar year in which they were generated in order to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyeth, Trubion shall permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth and reasonably acceptable to Trubion, to examine, at Wyeth's sole expense, the relevant books and records of Trubion as may be reasonably necessary to verify the amount of reimbursable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours, upon reasonable advance notice, to determine or verify the applicable Cost of Goods Sold, Net Sales and Net Profits. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 If errors are correct or incorrect and the specific details concerning found, any discrepancies. No other information undisputed deficiency shall be provided to Wyethpaid within sixty (60) days following delivery of written documentation reasonably substantiating such deficiency. If errors are discovered as a result of such audit in Catalyst’s favor exceeding ten percent (10%) of Net Profits for the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was period audited (which shall be no less than one (1) year), EVL shall reimburse Catalyst for the amount reimbursed reasonable expense of such audit. In the event that there is any overpayment by Wyeth during EVL revealed (a) by an examination and review conducted on behalf of Catalyst, or (b) by an examination and review of a Net Profit Report by EVL’s accountants within one (1) year of delivery of such Net Profit Report, then EVL shall be permitted to carry over such overpayment and apply it against its payment obligations pursuant to Section 6.1.1 for future Calendar Quarters; provided, however, that if such overpayment is not fully recovered within the period covered by following two Calendar Quarters or EVL does not have continuing payment obligations pursuant to Section 6.1.1, then EVL may invoice Catalyst for the audit, Trubion unrecovered overpayment and Catalyst shall refund the excess payments pay such unrecovered overpayment to Wyeth EVL within thirty (30) days of its receipt such invoice, by wire transfer of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of immediately available funds to a bona fide objection bank account designated in writing by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit. All information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this AgreementEVL.

Appears in 2 contracts

Samples: Development, License and Commercialization Agreement, Development, License and Commercialization Agreement (Catalyst Pharmaceuticals, Inc.)

Records and Audits. During the Research Term, Trubion shall Everest will keep books complete and accounts of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the calendar year in which they were underlying revenue and expense data relating to the calculations of Net Sales generated in order the then current Calendar Year and payments required under this Agreement, and during the preceding [***] Calendar Years. Xxxxx will have the right, once annually at its own expense, to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyethhave a nationally recognized, Trubion shall permit an independent independent, certified public accounting firm of nationally recognized standing firm, selected by Wyeth it and reasonably acceptable subject to TrubionEverest’s prior written consent (which shall not be unreasonably withheld, to examineconditioned or delayed), at Wyeth's sole expense, the relevant books and review any such records of Trubion as may be reasonably necessary to verify Everest and its Affiliates and Sublicensees (the amount of reimbursable out-of-pocket expenses incurred. An examination “Everest Audited Party”) in the location(s) where such records are maintained by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and the Everest Audited Party upon reasonable written notice (which shall be limited to no less than [***] prior written notice) and during regular business hours and under obligations of strict confidence, for the pertinent books sole purpose of verifying the basis and records for any calendar year ending not more than thirty six accuracy of payments made under Section 3.3 (36Royalties) months before within the [***] period preceding the date of the requestrequest for review. The accounting firm shall No records will be provided access subject to audit under this Section 3.7 (Records and Audits) more than once. Xxxxxxx will receive a copy of each such books and records at Trubion's facility(ies) where report concurrently with receipt by Xxxxx. Should such books and records are normally kept and inspection lead to the discovery of a discrepancy to Xxxxx’x detriment, Everest will, within [***] after receipt of such examination shall be conducted during Trubion's normal business hours. Trubion may require report from the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning firm, pay any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate undisputed amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during discrepancy together with interest at the period covered by rate set forth in Section 3.6 (Late Payments). Xxxxx will pay the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt full cost of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution review unless the underpayment of a bona fide objection by Trubion amounts due to the findings in such report). If the amount to be refunded exceeds more Xxxxx is greater than ten percent (10%) [***] of the amount that was properly payable, Trubion shall reimburse Wyeth due for the entire period being examined, in which case Everest will pay the cost charged by such accounting firm for such review. Should the audit lead to the discovery of a discrepancy to Everest’s detriment, then notwithstanding any other provision of this Agreement, Everest may credit the amount of the audit. All information of Trubion which is subject discrepancy, without interest, against future payments payable to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights Xxxxx under this Agreement, as may be necessary for Wyeth and if there are no such payments payable, then Xxxxx shall pay to exercise its rights under this AgreementEverest the amount of the discrepancy, or as otherwise expressly permitted under this Agreementwithout interest, within [***] of Xxxxx’x receipt of the report.

Appears in 1 contract

Samples: Collaboration and License Agreement (Kezar Life Sciences, Inc.)

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Records and Audits. During the Research Term, Trubion shall Puma will keep books complete and accounts of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the calendar year in underlying revenue and expense data relating to its calculations of Net Sales and payments required under this Agreement for the longer of (i) the time period required by applicable Law, or (ii) [***] following the Calendar Year to which they were generated in order to enable audit of such records as set forth belowpertain. Upon thirty (30) days prior written notice from WyethTakeda will have the right, Trubion shall permit an independent [***] at its own expense, to have a nationally recognized, independent, certified public accounting firm of nationally recognized standing firm, selected by Wyeth Takeda and reasonably acceptable to TrubionPuma, to examine, at Wyeth's sole expense, the relevant books and review any such records of Trubion as may Puma or its Affiliates or subject to the last sentence of this Section 3.11, Sublicensees (the “Audited Party”) in the location(s) where such records are maintained by the Audited Party upon reasonable written notice (which shall be reasonably no less than [***] prior written notice) and during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the basis and accuracy of payments made under this Article 3 within the [***] preceding the date of the request for review. Puma will receive a copy of the portions of each such report necessary to verify the accuracy of any purported discrepancy. Should such inspection lead to the discovery of a discrepancy to Takeda’s detriment, Puma will, within [***] after receipt of such report from the accounting firm, pay any undisputed amount of reimbursable out-of-pocket expenses incurredthe discrepancy together with interest at the rate set forth in Section 3.10. An examination by Wyeth under this Section 3.6.3 shall occur not more Takeda will [***] unless the underpayment of amounts due to Takeda is greater than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) [***] of the amount that was properly payable, Trubion shall reimburse Wyeth due for the cost entire period being examined, in which case Puma will [***]. Should the audit lead to the discovery of a discrepancy to Puma’s detriment, Puma may credit the amount of the audit. All information of Trubion which is subject discrepancy, [***], against future payments payable to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights Takeda under this Agreement, and if there are no such payments payable, then Takeda shall pay to Puma the amount of the discrepancy, [***], within [***] of Takeda’s receipt of the report. Puma shall use commercially reasonable efforts to obtain consent from Sublicensees to allow Takeda to audit records of Sublicensees as may be necessary for Wyeth to exercise its rights under required by this AgreementSection 3.11, or provided that [***], as otherwise expressly permitted under required in this AgreementSection 3.11.

Appears in 1 contract

Samples: Exclusive License Agreement (Puma Biotechnology, Inc.)

Records and Audits. During the Research Term, Trubion shall Each party will keep books complete and accounts of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three (3) years after the end of the underlying revenue and expense data relating to the calculations of (a) WuXi Net Sales (in the case of WuXi), or (b) Net Sales (in the case of Vir, solely where Vir is required to pay a royalty to WuXi under the terms of the Cell Line License Agreement) generated in the then current calendar year and payments required under this Agreement, and during the preceding [***]. Each party will have the right, once annually, and solely during any period when royalties are payable by the other party under this Agreement (in which they were generated the case of WuXi) or the Cell Line License Agreement (in order the case of Vir) at its own expense, to enable audit of such records as set forth below. Upon thirty (30) days prior written notice from Wyethhave an internationally recognized, Trubion shall permit an independent independent, certified public accounting firm of nationally recognized standing firm, selected by Wyeth it and reasonably acceptable subject to Trubionthe other party’s prior written consent (which shall not be unreasonably withheld), to examine, at Wyeth's sole expense, the relevant books and review any such records of Trubion as may be reasonably necessary to verify the amount of reimbursable out-of-pocket expenses incurred. An examination other party and its Affiliates and Sublicensees in the location(s) where such records are maintained by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and the other party upon reasonable written notice (which shall be limited to [***] prior written notice) and during regular business hours and under obligations of strict confidence, for the pertinent books sole purpose of verifying the basis and records for any calendar year ending not more than thirty six accuracy of payments made (36i) months before by WuXi under Sections 7.1 and 7.3, or (ii) by Vir, under the Cell Line License Agreement, and within the [***] preceding the date of the requestrequest for review. No calendar year will be subject to audit under this Section 7.8 more than once. Should such inspection lead to the discovery of a discrepancy to one party’s detriment, the other party will, within [***] after receipt of such report from the accounting firm, pay any undisputed amount of the discrepancy together with interest at the rate set forth in Section 7.7. The auditing party will pay the full cost of the review unless the underpayment of amounts due to the auditing party is greater than [***] of the amount due for the entire period being examined, in which case the other party will pay the cost charged by such accounting firm shall be provided access for such review. Should the audit lead to the discovery of a discrepancy to the other party ‘s detriment, such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion other party may require credit the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the discrepancy, without interest, against future payments payable to the auditing party under this Agreement or the Cell Line License Agreement, as applicable, and if there are no such payments payable, then the auditing party shall pay to the other party the amount reimbursed by Wyeth during of the period covered by discrepancy, without interest, within [***] of the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its auditing party’s receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit. All information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to the provisions of Article 7, and such Confidential Information shall not be disclosed to any Third Party or used for any purpose other than verifying the information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreement.

Appears in 1 contract

Samples: Development and Manufacturing Collaboration Agreement (Vir Biotechnology, Inc.)

Records and Audits. AstraZeneca 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 Exercise Price payable by Moderna to AstraZeneca under this S chedule A and ensuring Moderna’s compliance under this Schedule A. Such books and records will be maintained by AstraZeneca for at least [***] from the date of creation. During the Research Option Agreement Term, Trubion shall keep such books and accounts records of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three accounting (3) years after the end including those of the calendar year in which they were generated in order to enable audit other Selling Parties, as applicable) will be kept at each of such records as set forth belowtheir principal places of business. Upon thirty (30) days prior written notice from WyethAt the request of Moderna, Trubion shall AstraZeneca will, and AstraZeneca will cause each of the other Selling Parties to, permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth Moderna and reasonably acceptable to TrubionAstraZeneca, during normal business hours and upon reasonable notice, to examine, at Wyeth's sole expense, examine the relevant books and records maintained pursuant to this Paragraph 2.4(c) (Schedule A). Such examinations may not (i) be conducted for any calendar year after the end of Trubion as the Option Agreement Term (except that the books and records relating to the last year of the Option Agreement Term may be reasonably necessary to verify examined for [***] after the amount end of reimbursable the Option Agreement Term), (ii) be conducted more than [***] in any [***] period and going back no more than [***] after receipt of the respective invoice and report or (iii) be repeated for any calendar year. Moderna will provide AstraZeneca with a copy of the accounting firm’s written report within [***] of completion of such report. Except as provided below, the cost of this examination will be borne by Moderna, unless the audit reveals a variance of more than [***] from the reported amounts for a calendar year, in which case AstraZeneca will bear the reasonable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit, provided such variance exceeds [***]. All Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, AstraZeneca will pay the additional amounts or Moderna will reimburse such excess payments, with interest from the date originally due as provided in Paragraph 2.4(f) (Schedule A), within [***] days after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amount owed to Moderna under this Paragraph 2.4(c) (Schedule A), Moderna and AstraZeneca will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] days, such dispute will be resolved in accordance with the dispute resolution procedures set forth in Section 11.1 of the A&R Services and Collaboration Agreement. The receiving Party will treat all information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to Paragraph 2.4(c) (Schedule A) in accordance with the confidentiality provisions of Article 7Section 11 of the Option Agreement, and AstraZeneca will cause any accounting firm, auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with AstraZeneca obligating such Confidential Information shall not be disclosed firm to any retain all such financial information in confidence pursuant to such confidentiality agreement. Moderna may provide Third Parties to which Moderna owes payments on Products information in such audit report that are relevant and required to comply with such Third Party’s audit rights under the applicable license agreement between Moderna and such Third Party, provided that such Third Party or used for any purpose other than verifying the is obligated to keep such information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreementconfidential.

Appears in 1 contract

Samples: Option Agreement

Records and Audits. AstraZeneca 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 Exercise Price payable by Moderna to AstraZeneca under this Schedule A and ensuring Moderna’s compliance under this Schedule A. Such books and records will be maintained by AstraZeneca for at least [***] from the date of creation. During the Research Option Agreement Term, Trubion shall keep such books and accounts records of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three accounting (3) years after the end including those of the calendar year in which they were generated in order to enable audit other Selling Parties, as applicable) will be kept at each of such records as set forth belowtheir principal places of business. Upon thirty (30) days prior written notice from WyethAt the request of Moderna, Trubion shall AstraZeneca will, and AstraZeneca will cause each of the other Selling Parties to, permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth Moderna and reasonably acceptable to TrubionAstraZeneca, during normal business hours and upon reasonable notice, to examine, at Wyeth's sole expense, examine the relevant books and records maintained pursuant to this Paragraph 2.4(c) (Schedule A). Such examinations may not (i) be conducted for any calendar year after the end of Trubion as the Option Agreement Term (except that the books and records relating to the last year of the Option Agreement Term may be reasonably necessary to verify examined for [***] after the amount end of reimbursable the Option Agreement Term), (ii) be conducted more than [***] in any [***] period and going back no more than [***] after receipt of the respective invoice and report or (iii) be repeated for any calendar year. Moderna will provide AstraZeneca with a copy of the accounting firm’s written report within [***] of completion of such report. Except as provided below, the cost of this examination will be borne by Moderna, unless the audit reveals a variance of more than [***] from the reported amounts for a calendar year, in which case AstraZeneca will bear the reasonable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit, A&R OPTION AGREEMENT provided such variance exceeds [***]. All Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, AstraZeneca will pay the additional amounts or Moderna will reimburse such excess payments, with interest from the date originally due as provided in Paragraph 2.4(f) (Schedule A), within [***] days after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amount owed to Moderna under this Paragraph 2.4(c) (Schedule A), Moderna and AstraZeneca will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] days, such dispute will be resolved in accordance with the dispute resolution procedures set forth in Section 11.1 of the A&R Services and Collaboration Agreement. The receiving Party will treat all information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to Paragraph 2.4(c) (Schedule A) in accordance with the confidentiality provisions of Article 7Section 11 of the Option Agreement, and AstraZeneca will cause any accounting firm, auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with AstraZeneca obligating such Confidential Information shall not be disclosed firm to any retain all such financial information in confidence pursuant to such confidentiality agreement. Moderna may provide Third Parties to which Moderna owes payments on Products information in such audit report that are relevant and required to comply with such Third Party’s audit rights under the applicable license agreement between Moderna and such Third Party, provided that such Third Party or used for any purpose other than verifying the is obligated to keep such information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreementconfidential.

Appears in 1 contract

Samples: Option Agreement (Moderna, Inc.)

Records and Audits. AstraZeneca 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 Exercise Price payable by Moderna to AstraZeneca under this Schedule A and ensuring Moderna’s compliance under this Schedule A. Such books and records will be maintained by AstraZeneca for at least [***] from the date of creation. During the Research Option Agreement Term, Trubion shall keep such books and accounts records of record in connection with the expenses reimbursable under Section 3.6.1 hereof in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of costs to be reimbursed hereunder. Trubion shall maintain such cost records for a period of at least three accounting (3) years after the end including those of the calendar year in which they were generated in order to enable audit other Selling Parties, as applicable) will be kept at each of such records as set forth belowtheir principal places of business. Upon thirty (30) days prior written notice from WyethAt the request of Moderna, Trubion shall AstraZeneca will, and AstraZeneca will cause each of the other Selling Parties to, permit an independent certified public accounting firm of nationally recognized standing selected by Wyeth Moderna and reasonably acceptable to TrubionAstraZeneca, during normal business hours and upon reasonable notice, to examine, at Wyeth's sole expense, examine the relevant books and records maintained pursuant to this Paragraph 2.4(c) (Schedule A). Such examinations may not (i) be conducted for any calendar year after the end of Trubion as the Option Agreement Term (except that the books and records relating to the last year of the Option Agreement Term may be reasonably necessary to verify examined for [***] after the amount end of reimbursable the Option Agreement Term), (ii) be conducted more than [***] in any [***] period and going back no more than [***] after receipt of the respective invoice and report or (iii) be repeated for any calendar year. Moderna will provide AstraZeneca with a copy of the accounting firm’s written report within [***] of completion of such report. Except as provided below, the cost of this examination will be borne by Moderna, unless the audit reveals a variance of more than [***] from the reported amounts for a calendar year, in which case AstraZeneca will bear the reasonable out-of-pocket expenses incurred. An examination by Wyeth under this Section 3.6.3 shall occur not more than once in any calendar year and shall be limited to the pertinent books and records for any calendar year ending not more than thirty six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at Trubion's facility(ies) where such books and records are normally kept and such examination shall be conducted during Trubion's normal business hours. Trubion may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Trubion's facilities or records. The accounting firm shall provide both Trubion and Wyeth a written report disclosing whether the certificates and invoices submitted by Trubion under Section 3.6.2 are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Wyeth. If the accounting firm determines that the aggregate amount of out-of-pocket expenses actually incurred by Trubion was less than the amount reimbursed by Wyeth during the period covered by the audit, Trubion shall refund the excess payments to Wyeth within thirty (30) days of its receipt of the auditor's report so concluding (or, if later, within fifteen (15) days after resolution of a bona fide objection by Trubion to the findings in such report). If the amount to be refunded exceeds more than ten percent (10%) of the amount that was properly payable, Trubion shall reimburse Wyeth for the cost of the audit, provided such variance exceeds [***]. All Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, AstraZeneca will pay the additional amounts or Moderna will reimburse such excess payments, with interest from the date originally due as provided in Paragraph 2.4(f) (Schedule A), within [***] days after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amount owed to Moderna under this Paragraph 2.4(c) (Schedule A), Moderna and AstraZeneca will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] days, such dispute will be resolved in accordance with the dispute resolution procedures set forth in Section 11.1 of the A&R Services and Collaboration Agreement. The receiving Party will treat all information of Trubion which is subject to review under this Section 3.6.3 shall be deemed to be Confidential Information of Trubion subject to Paragraph 2.4(c) (Schedule A) in accordance with the confidentiality provisions of Article 7Section 11 of the Option Agreement, and AstraZeneca will cause any accounting firm, auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with AstraZeneca obligating such Confidential Information shall not be disclosed firm to any retain all such financial information in confidence pursuant to such confidentiality agreement. Moderna may provide Third Parties to which Moderna owes payments on Products information in such audit report that are relevant and required to comply with such Third Party’s audit rights under the applicable license agreement between Moderna and such Third Party, provided that such Third Party or used for any purpose other than verifying the is obligated to keep such information provided by Trubion to Wyeth; provided, however, that such Confidential Information may be disclosed to Third Parties only to the extent necessary to enforce Wyeth's rights under this Agreement, as may be necessary for Wyeth to exercise its rights under this Agreement, or as otherwise expressly permitted under this Agreementconfidential.

Appears in 1 contract

Samples: Option Agreement

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