Common use of Financial Records; Audits Clause in Contracts

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 5 contracts

Samples: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)

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Financial Records; Audits. Each Party Clinigen shall keep, and shall cause its ------------------------- Affiliates Affiliates, sublicensees and sublicensees subcontractors to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party Clinigen or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) during the Term. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however however, that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the details of its their 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a ** five percent (**5%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, audit plus interest thereon calculated in accordance with Section 6.126.07, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 VI shall ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. be retained by the relevant Party during the United States Term Term. If the Recording Party is not Clinigen, Clinigen shall cause its Affiliate or sublicensee to perform the ROW Term, as applicableobligations under this Section 6.09.

Appears in 4 contracts

Samples: Commercialization Agreement, Commercialization Agreement (Theravance Biopharma, Inc.), Commercialization Agreement (Theravance Biopharma, Inc.)

Financial Records; Audits. Each Party GSK shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")) for at least the three subsequent Calendar Years to which the Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a [** percent (**%) ] shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 3 contracts

Samples: Strategic Alliance Agreement (Theravance Inc), Strategic Alliance Agreement (Theravance Inc), Strategic Alliance Agreement (Theravance Inc)

Financial Records; Audits. Each Party 6.5.1. During the Term, the Parties shall keep, maintain complete and shall cause its ------------------------- Affiliates accurate books and sublicensees to keep, such accurate and complete records for the purpose of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine determining the amounts due paid or payable pursuant to GSK and Adolor under this Agreement. Such books and records shall be kept for such period of time required by Applicable Laws, but no less than at least [*]. Such records shall be retained by each subject to inspection in accordance with Section 6.5.2. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted information. 6.5.2. Upon [*] written notice, a Party (“Audited Party”) will permit its books and records for the prior calendar year to be examined for any cost, expense, Net Sales or any of its Affiliates or sublicensees (in such capacityNet Profit for which it may owe a payment to the other Party [*], the "Recording Party"). During during normal business hours and with --------------- reasonable advance notice to the Recording Partyhours, such records shall be made available for inspection, review and audit, at the request and expense of by an independent auditor appointed by the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party ”) and reasonably acceptable to the Recording Audited Party, and at the Auditing Party’s expense (and the Auditing Party for shall not compensate such auditor on a contingent fee basis), to the sole purpose of verifying extent necessary to verify the accuracy of the Recording Party's accounting reports and payments made or amounts paid by the Audited Party to be made the Auditing Party pursuant to this Agreement; . Any information received as a result of such inspection will be maintained as the Audited Party’s Confidential Information. In the event that an examining auditor concludes any underpayment or overcharging by any Party, the auditor will specify such underpayment or overcharging in a written report, along with the information on which such conclusion is based. This report will be shared promptly with the Audited Party. The underpaying or overcharging Party shall remit such underpayment or reimburse such overpayment to the underpaid or overcharged Party within [*], provided, however that such audits may not be performed if a Party disputes the conclusion of the auditor, the Parties will attempt to resolve the dispute according to Section 12.2. Further, if the audit for an audited period shows an underpayment or an overcharge by any Party for that period in excess of [*] of the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit amounts properly determined, the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing underpaying or overcharging Party, as the case may be, shall reimburse the applicable underpaid or overcharged Party conducting the audit, for its respective audit fees and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All reasonable out-of-pocket costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 reimbursement shall be retained by the relevant Party during the United States Term or the ROW Term, as applicablemade within [*] after receiving appropriate invoices and other support for such audit-related costs.

Appears in 2 contracts

Samples: Distribution and Commercialization Agreement, Distribution and Commercialization Agreement (Adamis Pharmaceuticals Corp)

Financial Records; Audits. Each Party GSK shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")) for at least the three preceding Calendar Years to which the Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a [** percent (**%) ] shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 2 contracts

Samples: Collaboration Agreement (Theravance Inc), Collaboration Agreement (Theravance Inc)

Financial Records; Audits. Each Party shall keepwill maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount of (a) Development Costs under the EDP and Development Costs as to which Principia has an obligation to reimburse Sanofi as a result of the Co-Funding Election, (b) Net Sales, and shall cause its ------------------------- Affiliates (c) if applicable, with respect to the period in which the Profit (Loss) Share is in effect, Net Profit and sublicensees Net Loss (including methodologies used to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses arrive at “standard cost” to the extent established by Sanofi as are necessary to determine the amounts due to GSK and Adolor under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (set forth in such capacity, the "Recording Party"Exhibit K-1). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall will be made available open during regular business hours for inspection, review and audit, a period of [*] years from the date of rendering of the report to which the audit relates for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each Calendar Year and no more than once for a given period, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party pursuant to this Agreement; provided, however that . The audited Party may require such audits may accountant to enter into a reasonably acceptable confidentiality agreement and any such auditor will not be performed by disclose the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its review, except for (i) such information as is required auditing Party. Any amounts shown to be disclosed under this Agreement owed but unpaid, or overpaid and (ii) such information presented in a summary fashion as is necessary to report the accountants' conclusions to the Auditing Partyneed of reimbursement, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall will be paid by or refunded (as the Auditing Party unless case may be) within [*] days after the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such auditaccountant’s report, plus interest thereon calculated in accordance with Section 6.125.9 from [*] = Certain confidential information contained in this document, or alternatively shall have marked by brackets, is filed with the right Securities and Exchange Commission pursuant to offset and deduct any such shortfall in payments due to it against payments Rule 406 of the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW TermSecurities Act of 1933, as applicableamended.

Appears in 2 contracts

Samples: License Agreement (Principia Biopharma Inc.), License Agreement (Principia Biopharma Inc.)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amounts to be reimbursed, pursuant to this ARTICLE IX, with respect to Research and Development Expenses Costs, Shared Commercialization Costs, Shared Patents Costs or other amounts to be reimbursed, credited, offset or shared hereunder incurred or generated (as are necessary to determine the amounts due to GSK applicable) by such Party’s or its Affiliates’ achievement of milestones, royalty payments and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, at a period of […***…] years from the request and expense creation of the other Party (the "Auditing Party")individual records for examination not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party or its applicable Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party or such Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or such Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or its Affiliates’ confidential information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within […***…] days after the auditor’s report, plus interest (as set forth in Section 9.14) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with ARTICLE XV, any remaining disputed portion shall be paid within […***…] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost and expense of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or its Affiliates that resulted from a discrepancy in a report that the audited Party or its Affiliates provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information […***…] percent […***…] of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or its applicable Affiliate shall bear the full cost and expense of such audit. Each Party, at the request of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such auditother Party, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during on such non-requesting Party’s Sublicensees hereunder. During the United States Term or the ROW Term, as applicableeach Party shall consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit the other Party to close its books periodically in a timely manner.

Appears in 2 contracts

Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)

Financial Records; Audits. Each Party shall keepwill maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 11, with respect to Research Costs, Development Costs, Joint Commercialization Costs or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, royalty payments and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall will be made available open during regular business hours for inspection, review and audit, a period of [***] from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided, however that such audits . A Party may not be performed by the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed Any such auditor will not to reveal disclose the audited Party’s confidential information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; providedfinancial 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, howeveror overpaid and in need of reimbursement, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall will be paid or refunded (as the case may be) within [***] days after the accountant’s report, plus interest (as set forth in Section 11.16) from the original due date (unless challenged in good faith by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallaudited Party, in which case any undisputed portion will be paid in accordance with the Recording foregoing timetable, any dispute with respect to such challenge will be resolved in accordance with Article 17, any remaining disputed portion will be paid within [***] days after resolution of the dispute, and interest will not accrue with respect to the disputed portion during the period of time the dispute is being resolved). The auditing Party will bear the full cost of the such audit for unless such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12audit reveals an overpayment to, or alternatively shall have an underpayment by, the right to offset and deduct any such shortfall audited Party that resulted from a discrepancy in payments due to it against payments a report that the Auditing audited Party is otherwise required to make provided to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant other Party during the United States Term applicable audit period, which underpayment or overpayment was more than [***] of the ROW Termamount set forth in such report, as applicablein which case the audited Party will bear the full cost of such audit.

Appears in 2 contracts

Samples: Collaboration Agreement (Unum Therapeutics, Inc.), Collaboration Agreement (Unum Therapeutics, Inc.)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Third Party royalty payments, Patent Costs, Development Costs and Development Expenses Commercialization Costs as are necessary to determine the amounts due to GSK Yakult and Adolor Celsion under this Agreement. Such records shall be retained by each Party or any and all of its Affiliates or and sublicensees (in such capacity, the "Recording Party")”) for a period of no less than five (5) Calendar Years after the Calendar Year to which such records relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however however, that such audits may not be performed by the Auditing Party more than once [ * ] after the payment or report to be audited has been issued or more than [ * ] per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for for: (ia) such information as is required to be disclosed under this Agreement Agreement, and (iib) such information presented in a summary fashion as is necessary to report the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a *[ * ] percent (**%[ * ]) shortfall, in which case the Recording Party will bear the full cost [ * ] of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.125.11, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Recording Party under * Material has been omitted and filed separately with the Commission. this Agreement. The Recording Party will be entitled to receive any overpayment made by it as determined by such audit by offsetting and deducting any such overpayment against payments the Recording Party is otherwise required to make to the Auditing Party under this Agreement. The documents from which were calculated the sums due under this Article 6 ARTICLE 5 were calculated shall be retained by the relevant Party during the United States Term or the ROW Term, as applicableParty.

Appears in 1 contract

Samples: Development, Product Supply and Commercialization Agreement (Celsion CORP)

Financial Records; Audits. Each Party shall keepmaintain, and shall cause require its ------------------------- Affiliates to maintain, complete and sublicensees accurate records in sufficient detail to keeppermit the other Party to confirm the accuracy of any calculations by the other Party or any payments due by the other Party under this Agreement, such accurate 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, (c) royalty payments for purposes of determining any under- or over-payment of royalties, (d) Manufacturing Costs, Commercial Packaging and complete records of Net Sales Labeling Costs, Commercialization Costs, and its Marketing Expenses Medical Affairs Costs, (e) amounts payable under any supply agreement with respect to the Product to which the Parties or their Affiliates are party, and Development Expenses as are necessary to determine the amounts due to GSK and Adolor (f) other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records for any Year(s) ending not more than [*] prior to the date of such request shall be made available open during regular business hours for inspection, review and audit, examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each [*] period, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and payments made or to be made furnished by the audited Party pursuant to this Agreement; providedAgreement or of any payments made, however that such audits may not be performed by the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for (i) such information as is or required to be disclosed under made, by or to the audited Party to the other Party pursuant to this Agreement and (ii) such information presented in a summary fashion as is necessary to report the accountants' conclusions or any supply agreement with respect to the Auditing 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 determination of the number of FTEs (if applicable), and all calculation of such other information shall be deemed Confidential Information of included in the Recording Party; providedcalculation for Manufacturing Costs, howeverCommercial Packaging and Labeling Costs, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs Commercialization Costs, and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.Medical Affairs

Appears in 1 contract

Samples: Joint Commercialization Agreement (Seagen Inc.)

Financial Records; Audits. Each Party GSK shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) for at least the three preceding Calendar Years to which the Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a ** five percent (**5%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Theravance Inc)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and Development Expenses as are necessary accurate records in sufficient detail to determine permit the other Party to confirm the accuracy of the amounts due to GSK be reimbursed by such Party, pursuant to this ARTICLE XII, with respect to Allowable Expenses or other amounts to be reimbursed, credited, offset or shared hereunder incurred or generated (as applicable) by such Party’s or its Affiliates’ achievement of milestones, royalty payments and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, at a period of [***] years from the request and expense creation of the other Party (the "Auditing Party")individual records for examination not more often than once each Calendar Year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party or its applicable Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party or such Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or such Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or its Affiliates’ confidential information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within [***] days after the auditor’s report, plus interest (as set forth in Section 12.16) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with ARTICLE XIX, any remaining disputed portion shall be paid within [***] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost and expense of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or its Affiliates that resulted from a discrepancy in a report that the audited Party or its Affiliates provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for [***] percent (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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or its applicable Affiliate shall bear the full cost and expense of such audit. Each Party, at the request of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such auditother Party, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during on such non-requesting Party’s Sublicensees hereunder to the United States Term extent relating to Allowable Expenses or other amounts to be reimbursed, credited, offset, paid or shared hereunder. During the ROW Term, as applicableeach Party shall consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit the other Party to close its books periodically in a timely manner.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Assembly Biosciences, Inc.)

Financial Records; Audits. (a) Each Party shall keep, and shall cause its ------------------------- Affiliates Related Parties (and sublicensees subcontractors that form a Party’s sales field force or a portion thereof), to keepkeep complete and accurate records in accordance with Accounting Standards in sufficient detail to enable the calculation of Development Costs (and each Party’s share thereof), such accurate Net Profits and complete records of Net Losses (and each Party’s share thereof), Net Sales, Sales Milestone Payments, Royalty Payments, Patent Costs and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees Trademark Costs (in such capacitycollectively, the "Recording Party")“Calculated Amounts”) and other amounts payable hereunder to be determined. During normal business hours and with --------------- reasonable advance notice to Upon the Recording written request of a Party, such records shall be made available for inspectionand not more than once in each Calendar Year, review and auditupon [****] written notice, at the request and expense of the other Party (the "Auditing Party")shall, by and shall cause its Related Parties to, permit an independent certified public -------------- accountant, or the local equivalent, appointed accounting firm of internationally recognized standing selected by such Auditing requesting Party and reasonably acceptable to the Recording other Party (“Auditor”), at the requesting Party’s expense except as set forth below, to have access during normal business hours to such records of the other Party and its Related Parties as may be reasonably necessary to verify the accuracy of the calculations of the Calculated Amounts payable hereunder for any Calendar Year ending not more than [****] Calendar Years prior to the date of such request for the sole purpose of verifying the basis and accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to under this Agreement; provided, however that such audits may not be performed by the Auditing Party more than once per . The records for any Calendar Year and that such Auditing Party shall not may be permitted to audit the same period of time audited no more than once. Such accountants The auditors shall be instructed only state factual findings in the audit reports and shall not to reveal interpret the Agreement. The auditors shall share all draft audit findings with the audited Party before sharing such findings with the other Party and before the final audit report is issued. The Auditor shall provide its final audit report and basis for any determination to the Auditing requesting Party and the other Party at the same time and before it is considered final. Either Party shall have the right to request a further determination by the Auditor as to matters which such Party disputes in respect of the audit report or the basis for any determination within [****] days following receipt of such report. The disputing Party shall provide the non-disputing Party and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the audit report and the Auditor shall undertake to complete such further determination within [****] days after the dispute notice is provided. Following such further determination, the Auditor shall promptly provide its final audit report to Roche and Alnylam. (b) If the Auditor identifies a discrepancy made during the period subject to the applicable audit, the applicable Party shall pay the other Party the details amount of its reviewthe over-billed or underpaid discrepancy for any underpaid amount, 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 within [****] days after the accountants' conclusions date the requesting Party delivers to the Auditing Partyother Party the Auditor’s written report setting forth such conclusion, and all or as otherwise agreed by the Parties in writing. The fees charged by such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit accounting firm shall be paid by the Auditing requesting Party, unless such discrepancy results from a reporting error by the other Party unless the audit discloses and represents an underpayment by such other Party of at least a ** percent ([**%) shortfall**] of the total amounts due from such other Party hereunder or [****], whichever is greater, or represents an overpayment to such other Party of at [****] of the total amounts due to such other Party hereunder or [****], whichever is greater, in a Calendar Year, in which case such fees, to the Recording Party will bear extent reasonable, shall be paid by the full cost other Party. (c) Unless an audit for a Calendar Year has been commenced prior [****], the calculation of the audit Calculated Amounts with respect to such Calendar Year shall be binding and conclusive upon both Parties, and each Party and its Related Parties shall be released from any further liability or accountability with respect to such calculation of the Calculated Amount for such Calendar YearYear upon such [****]. The Auditing If an audit for a Calendar Year has been commenced prior to the [****], the calculation of Calculated Amounts and other payments payable hereunder with respect to such Calendar Year shall be binding and conclusive upon both Parties, and each Party will and its Related Parties shall be entitled released from any further liability or accountability with respect to recover any shortfall in payments due to it as determined by such Calculated Amounts, following the conclusion of such audit, plus interest thereon calculated . (d) Each Party shall treat all financial information subject to review under this Section 8.12 as the audited Party’s Confidential Information in accordance with Section 6.12, the confidentiality and non-use provisions of this Agreement and shall cause its Auditor to enter into an acceptable written confidentiality agreement with the audited Party or alternatively shall have the right its Related Parties obligating it to offset retain all such information in confidence pursuant to such confidentiality agreement that includes obligations of confidentiality and deduct any such shortfall non-use at least as protective as those set forth in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable12.

Appears in 1 contract

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

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Third Party royalty payments, Patent Costs, Cost of Goods, Marketing Expenses and Development Expenses Costs as are necessary to determine the amounts due to GSK Pfizer and Adolor under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) for a period of no less than ** Calendar Years after the Calendar Year to which such records relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however however, that such audits may not be performed by more than ** years after the Auditing Party payment or report to be audited has been issued or more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for for: (ia) such information as is required to be disclosed under this Agreement Agreement, and (iib) such information presented in a summary fashion as is necessary to report the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** five percent (**5%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.127.13, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The Recording Party will be entitled to receive any overpayment made by it as determined by such audit by offsetting and deducting any such overpayment against payments the Recording Party is otherwise required to make to the Auditing Party under this Agreement. The documents from which were calculated the sums due under this Article 6 ARTICLE 7 were calculated shall be retained by the relevant Party during the United States Term or the ROW Term, as applicableParty.

Appears in 1 contract

Samples: License and Collaboration Agreement (Adolor Corp)

Financial Records; Audits. Each Party GSK shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) for at least the three preceding Calendar Years to which the Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a ** five percent (**5%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Theravance Inc)

Financial Records; Audits. Each Party Cephalon shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses in the Territory as are necessary to determine the amounts due to GSK and Adolor XxXxxx under this Agreement. Such records shall be retained by each Party Agreement during the Term and the period during which Base Sunset Fees, Upside Sunset Fees or any other amounts may be payable by Cephalon to XxXxxx and for a period of its Affiliates or sublicensees one (in such capacity, the "Recording Party")1) year thereafter. During normal business hours and with --------------- reasonable not less than [**] advance written notice to the Recording PartyCephalon, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")XxXxxx, by an independent certified public -------------- accountant, or the local equivalent, accountant appointed by such Auditing Party XxXxxx and reasonably acceptable to the Recording Party Cephalon for the sole purpose of verifying the accuracy of the Recording Party's Cephalon’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party XxXxxx more than once per Calendar Year and that such Auditing Party XxXxxx shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party XxXxxx the details of its review, except for (ia) such information as is required to be disclosed under this Agreement and (iib) such information presented in a summary fashion as is necessary to report the accountants' conclusions to the Auditing PartyXxXxxx, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusionsCephalon. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party XxXxxx unless the audit discloses at least a [** *] percent ([**]%) shortfallshortfall in the amounts due to XxXxxx, in which case the Recording Party Cephalon will bear the full cost of the audit for such Calendar Year. The Auditing Party XxXxxx will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable5.5.

Appears in 1 contract

Samples: Co Promotion Agreement (Cephalon Inc)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount of achievement of milestones, royalties and shall cause its ------------------------- Affiliates and sublicensees other amounts to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreementbe shared or paid hereunder. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of three (3) years from the date of rendering of the report to which the audit relates for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided, however that . The audited Party may require such audits may not be performed by the Auditing Party more than once per Calendar Year accountant to enter into a reasonably acceptable confidentiality agreement and that any such Auditing Party auditor shall not be permitted to audit disclose the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; providedfinancial 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, howeveror overpaid and in need of reimbursement, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by or refunded (as the Auditing case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 8.5) from the original due date. The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit discloses at least a ** period, which underpayment or overpayment was more than five percent (**5%) shortfallof the amount set forth in such report, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit. If the audited Party challenges the auditing results in good faith, plus interest thereon calculated in accordance with Section 6.12, or alternatively the audited party shall have the right to offset and deduct any such shortfall in payments due select another independent certified public accountant to it against payments conduct another audit of its financial records. If the Auditing Party is otherwise required to make to results of the Reporting Party under this Agreement. The documents from which were calculated two accountants are inconsistent, then the sums due under this Article 6 dispute shall be retained by the relevant Party during the United States Term or the ROW Term, as applicableresolved in accordance with ARTICLE 15.

Appears in 1 contract

Samples: Development and License Agreement (Liquidia Technologies Inc)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and Development Expenses as are necessary accurate records in sufficient detail to determine permit the amounts due other Party to GSK and Adolor under confirm the accuracy of any amount to be paid, reimbursed, credited, offset or shared in accordance with the terms of this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of three (3) years from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party or Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements, reports and or notices furnished by the audited Party or Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or Affiliate’s Confidential Information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within […***…] after the accountant’s report, plus interest (as set forth in Section 12.9) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with Section 16.6, any remaining disputed portion shall be paid within […***…] after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or Affiliate that resulted from a discrepancy in a report that the audited Party or Affiliate provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information […***…] of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or Affiliate shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit. Each Party, plus interest thereon calculated in accordance with Section 6.12at the request of the other Party, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during the United States Term or the ROW Term, as applicableon such non-requesting Party’s Sublicensees hereunder.

Appears in 1 contract

Samples: Transition & Amendment Agreement (Galapagos Nv)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 8, with respect to Development Expenses Costs, Joint Commercialization Costs, or other amounts to be reimbursed, credited, offset or shared hereunder incurred or generated (as are necessary to determine the amounts due to GSK applicable) by such Party’s or Affiliate’s achievement of sales milestones, royalty payments and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of […***…] years from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountantaccountant selected by the * Confidential Information, or indicated by […***…], has been omitted from this filing and filed separately with the local equivalent, appointed by such Auditing Securities and Exchange Commission. auditing Party and reasonably acceptable to the Recording audited Party or Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party or Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or Affiliate’s confidential information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within […***…] days after the accountant’s report, plus interest (as set forth in Section 8.14) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with Article 14, any remaining disputed portion shall be paid within […***…] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or Affiliate that resulted from a discrepancy in a report that the audited Party or Affiliate provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for […***…] percent (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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or Affiliate shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit. Each Party, plus interest thereon calculated in accordance with Section 6.12at the request of the other Party, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during the United States Term or the ROW Term, as applicableon such non-requesting Party’s Sublicensees hereunder.

Appears in 1 contract

Samples: License and Collaboration Agreement (Galapagos Nv)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 9, with respect to Joint Development Costs, Joint Commercialization Costs, Joint Medical Affairs Costs or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, royalty payments and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspectiona period of [*] years from the creation of individual records for records pertaining to activities in [*], review and auditfor a period of [*] years from the creation of individual records for all other records, in each case, for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s confidential information to the auditing Party, however that except to the extent such audits may not be performed disclosure is necessary to verify the accuracy of the financial reports furnished by the Auditing audited Party more than once per Calendar Year or the amount of payments due by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid and that in need of reimbursement, shall be paid or refunded (as the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 9.11) from the original due date (unless (x) challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such Auditing Party challenge shall be resolved in accordance with Article 15, any remaining disputed portion shall be paid within [*] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved; or (y) such underpayment or overpayment resulted from a discrepancy in a report that the other party provided, in which case no interest shall be due with respect thereto). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information [*] of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Financial Records; Audits. Each Party Adolor shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreement. Such records shall be retained by each Party Adolor or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")sublicensees. During normal business hours and with --------------- reasonable advance notice to the Recording PartyAdolor, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")GSK, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party GSK and reasonably acceptable to the Recording Party Adolor for the sole purpose of verifying the accuracy of the Recording Party's Adolor’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party GSK more than once per Calendar Year and that such Auditing Party GSK shall not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party GSK the 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 accountants' conclusions to the Auditing PartyGSK, and all such information shall be deemed Confidential Information of the Recording PartyAdolor; provided, however, that in any event such information may be presented to the Auditing Party GSK in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party GSK unless the audit discloses at least a ** five percent (**5%) shortfall, in which case the Recording Party Adolor will bear the full cost of the audit for such Calendar Year. The Auditing Party GSK will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement5.8. The documents from which were calculated the sums due under this Article 6 5 shall be retained by the relevant Party during for five (5) years after the United States Term or end of the ROW Term, as applicableyear to which they pertain.

Appears in 1 contract

Samples: Termination Agreement (Adolor Corp)

Financial Records; Audits. Each Party shall GSK will keep, and shall will cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete true books of accounts and other records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and or by Adolor under this Agreement. Such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) in accordance with GSK’s record retention policy. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Adolor, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Adolor and reasonably acceptable to the Recording Party (the “Auditor”) for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Adolor more than once per Calendar Year [**] and that such Auditing Party shall Adolor [**]. The Auditor will enter into a written confidentiality agreement with the Recording Party. The Auditor will not be permitted to audit the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party Adolor the 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 accountants' conclusions to the Auditing PartyAdolor, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Adolor in a summary fashion as is necessary to report the accountants' conclusions; provided, further, GSK may preserve the confidentiality of information related to its products and such information will not be provided to Adolor. The Auditor will provide a detailed account of its findings and methodology to the Recording Party. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Adolor unless the audit discloses at least a [** *] percent ([**]%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Adolor will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.12 of the Collaboration Agreement, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party that Adolor is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated [**] =Certain information on this page has been omitted and filed separately with the sums due under this Article 6 shall be retained by Commission. Confidential treatment has been requested with respect to the relevant Party during the United States Term or the ROW Term, as applicableomitted portions.

Appears in 1 contract

Samples: Distribution Services Agreement (Adolor Corp)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail in relation to this Agreement to permit the other Party to confirm the accuracy of the amount of Device Development Costs to be reimbursed, and shall cause its ------------------------- Affiliates the amount of royalty and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other payments payable under this Agreement. Such Each Party shall keep such books and records shall be retained by each Party or any of its Affiliates or sublicensees for at least five (in such capacity, 5) years following the "Recording Party")Calendar Year to which they pertain. During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior written notice, such records shall be made available for inspection, review and audit, inspected during regular business hours at the request and expense of the other Party (the "Auditing Party"), such place or places where such records are customarily kept by an internationally-recognized (i.e., “Big Four”) independent certified public -------------- accountant, or accountant (the local equivalent, appointed “Auditor”) selected by such Auditing the auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made made, by the audited Party pursuant to this Agreement; provided. Before beginning its audit, however that such the Auditor shall execute an undertaking reasonably acceptable to each Party by which the Auditor agrees to keep confidential all information reviewed during the audit. Such audits may not be performed by the Auditing Party occur no more often than once per each Calendar Year and that such Auditing not more frequently than once with respect to records covering any specific period of time. Each Party shall not only be permitted entitled to audit the same period of time more than once. Such accountants shall be instructed not to reveal books and records from the five (5) Calendar Years prior to the Auditing Party Calendar Year in which the details of its review, except for (i) such information as audit request is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as is necessary to report made. The Auditor shall not disclose the accountants' conclusions audited Party’s Confidential Information to the Auditing auditing Party, and all shall only verify the accuracy or inaccuracy of the financial reports furnished by the audited Party or the amount of payments by such information Party under this Agreement, and, in the case of any inaccuracy, the amount of such inaccuracy. In the event that the final result of the inspection reveals an underpayment or overpayment, the underpaid or overpaid amount shall be deemed Confidential Information settled within thirty (30) days after the Auditor’s report by payment thereof to, or credit against future amounts owed hereunder by (or reimbursement if no future amounts will be owed hereunder), the Party owed such payment, as promptly elected thereby in writing. The auditing Party shall bear the reasonable, documented cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party, which underpayment or overpayment was more than five percent (5%) of the Recording Party; provided, however, that in any event such information may be presented amount properly payable with respect to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any period covered by such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will bear shall reimburse the full cost of auditing Party for the audit reasonable, documented costs for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: License Agreement (Eyenovia, Inc.)

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Financial Records; Audits. Each Party 6.5.1. During the Term, the Parties shall keep, maintain complete and shall cause its ------------------------- Affiliates accurate Books and sublicensees to keep, such accurate and complete records Records for the purpose of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine determining the amounts due paid or payable pursuant to GSK and Adolor under this Agreement. Such Books and Records shall be kept for such period of time required by Applicable Laws, but no less than at least [***]. Such records shall be retained by subject to inspection in accordance with Section 6.5.2. 6.5.2. Upon [***] prior written notice and no more than [***] for each category of costs or revenues, a Party (“Audited Party”) will permit its Books and Records for the prior calendar year to be examined for any cost, expense, Supply Price, Net Sales or any of its Affiliates or sublicensees (in such capacityNet Profit for which it may owe a payment to the other Party [***], the "Recording Party"). During during normal business hours and with --------------- reasonable advance notice to the Recording Partyhours, such records shall be made available for inspection, review and audit, at the request and expense of by an independent auditor appointed by the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party ”) and reasonably acceptable to the Recording Audited Party, and at the Auditing Party’s expense (and the Auditing Party for shall not compensate such auditor on a contingent fee basis), to the sole purpose of verifying extent necessary to verify the accuracy of the Recording Party's accounting reports and payments made or amounts paid by the Audited Party to be made the Auditing Party pursuant to this Agreement; . Any information received as a result of such inspection will be maintained as the Audited Party’s Confidential Information. In the event that an examining auditor concludes any underpayment or overcharging by any Party, the auditor will specify such underpayment or overcharging in a written report, along with the information on which such conclusion is based. This report will be shared promptly with the Audited Party. The underpaying or overcharging Party shall remit such underpayment or reimburse such overpayment to the underpaid or overcharged Party within [***] of the date of such report, provided, however that such audits may not be performed if a Party disputes the conclusion of the auditor, the Parties will attempt to resolve the dispute according to Section 12.3. Further, if the audit for an audited period shows an underpayment or an overcharge by any Party for that period in excess of [***] of the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit amounts properly determined, the same period of time more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing underpaying or overcharging Party, as the case may be, shall reimburse the applicable underpaid or overcharged Party conducting the audit, for its respective audit fees and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All reasonable out-of-pocket costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 reimbursement shall be retained by the relevant Party during the United States Term or the ROW Term, as applicablemade within [***] after receiving appropriate invoices and other support for such audit-related costs.

Appears in 1 contract

Samples: Distribution and Commercialization Agreement (Adamis Pharmaceuticals Corp)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the Shared Development Costs, Net Sales, and shall cause its ------------------------- Affiliates Allowable Expenses incurred or generated (as applicable) by such Party and sublicensees to keepthe calculation of Product Profit, such accurate achievement of Commercialization milestones, royalty payments and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation payable under this Agreement. Such records shall be retained by each Party or any Upon reasonable prior notice of its Affiliates or sublicensees at least fifteen (in such capacity, the "Recording Party"). During normal 15) business hours and with --------------- reasonable advance notice to the Recording Partydays, such records shall be made available open during regular business hours for inspection, review and audit, a period of three (3) years from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and or Commercialization milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made or by the audited Party to be made the other pursuant to this Agreement; provided, however that . Any such audits may not be performed by the Auditing Party more than once per Calendar Year and that such Auditing Party auditor shall not be permitted to audit disclose the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; provided, however, that 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 and in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit need of reimbursement shall be paid by or refunded (as the Auditing case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 8.10) from the original due date. The auditing Party shall bear the full cost of such audit unless the such audit discloses at least that the audited Party either paid too little or received too much payment because of a ** discrepancy in a report that the audited Party provided to the JSC during the applicable audit period, which underpayment or overpayment was equal to more than five percent (**5%) shortfallof the amount set forth in such report, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Combinatorx, Inc)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 8, with respect to Joint Development Costs, Net Profits or Losses, or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of [**] from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than [**], by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, however that except to the extent such audits may not be performed disclosure is necessary to verify the accuracy of the financial reports furnished by the Auditing audited Party more than once per Calendar Year or the amount of payments due by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid and that in need of reimbursement, shall be paid or refunded (as the case may be) within [**] after the accountant’s report, plus interest (as set forth in Section 8.12) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such Auditing Party challenge shall be resolved in accordance with Article 14, any remaining disputed portion shall be paid within [**] after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information [**] of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Arvinas, Inc.)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales (i) for MYLAN, Operating Profits (Losses) and its Marketing Expenses Royalties, and (ii) for THERAVANCE, Operating Profits (Losses) in the U.S., and Development Expenses in the Territory, and the calculations thereof, as are necessary to determine the amounts due to GSK and Adolor the other Party under this Agreement. Such Agreement and such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) for at least the three (3) subsequent Calendar Years to which such expenses or Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing the other Party and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing other Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing auditing Party the 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 accountants' conclusions to the Auditing auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing auditing Party unless the audit discloses at least a ** percent ([**%) shortfall*] shortfall with respect to Net Sales or excess with ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. respect to expenses, as applicable, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing auditing Party will be entitled to recover any shortfall in payments due to it (or overpayment made by it, as applicable) as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.05, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it or overpayment made by it against payments the Auditing auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article ARTICLE 6 shall be retained by the relevant each Recording Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amounts to be reimbursed by such Party, pursuant to this ARTICLE IX, with respect to Research and Development Expenses Costs, Allowable Expenses, Shared Patents Costs or other amounts to be reimbursed, credited, offset or shared hereunder incurred or generated (as are necessary to determine the amounts due to GSK applicable) by such Party’s or its Affiliates’ achievement of milestones, royalty payments and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, at a period of [***] years from the request and expense creation of the other Party (the "Auditing Party")individual records for examination not more often than once each Calendar Year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party or its applicable Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party or such Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or such Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or its Affiliates’ confidential information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within [***] days after the auditor’s report, plus interest (as set forth in Section 9.17) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with ARTICLE XV, any remaining disputed portion shall be paid within [***] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost and expense of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or its Affiliates that resulted from a discrepancy in a report that the audited Party or its Affiliates provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for [***] percent (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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or its applicable Affiliate shall bear the full cost and expense of such audit. Each Party, at the request of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such auditother Party, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during on such non-requesting Party’s Sublicensees hereunder. During the United States Term or the ROW Term, as applicableeach Party shall consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit the other Party to close its books periodically in a timely manner.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to Section 8.2 with respect to Joint Development Costs, Joint Commercialization Costs or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, royalty payments and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation payable under this Agreement, as well as recording and tracking of Details to be provided in the Shared Territory. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of [*] years from the date of rendering of the report to which the audit relates for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each Calendar Year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided, however that . The audited Party may require such audits may not be performed by the Auditing Party more than once per Calendar Year accountant to enter into a reasonably acceptable confidentiality agreement and that any such Auditing Party auditor shall not be permitted to audit disclose the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid financial reports furnished by the Auditing audited Party unless or the audit discloses at least a ** percent (**%) shortfall, in which case the Recording Party will bear the full cost amount of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting audited Party under this Agreement. The documents from which were calculated the sums due under this Article 6 opinion of said independent accountant regarding such reports and related payments shall be retained binding on the Parties, other than in the case of manifest error. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 8.10) from the original due date (unless challenged in good faith by the relevant audited Party in which case any dispute with respect thereto shall be resolved in accordance with Article 14). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the United States Term applicable audit period, which underpayment or overpayment was more than [*] of the ROW Termamount set forth in such report, as applicablein which case the audited Party shall bear the full cost of such audit.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Financial Records; Audits. Each Party shall keep, Novavax will keep and shall cause its ------------------------- Affiliates and sublicensees to keep, such maintain accurate and complete records of regarding its COVID-19 Research and Development Plan Costs, Manufacturing Costs for Materials supplied to Sanofi, Technology Transfer Costs, and any other costs and expenses that are reimbursable by Sanofi under this Agreement, and Sanofi will keep and maintain accurate and complete records regarding Net Sales and its Marketing Expenses and Development Expenses as are necessary Cancellation Fees of Licensed Products required to determine prepare the amounts due to GSK and Adolor reports, including the Royalty Report, or calculate payments required by Section 0 (Milestone Payments) or owed under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees Upstream License Agreement (in such capacitycollectively, the "Recording Party"“Financial Records”). During normal business hours and with --------------- reasonable advance notice Each Party shall retain Financial Records for a period of at least [***]. Upon [***] prior written notice, a Party (the “Auditing Party”) will have the right to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense have an audit conducted of the other Party Party’s (the "Auditing “Audited Party"), ”) Financial Records; provided that such audit right may not be exercised more than [***] and shall be limited to the Financial Records of the Audited Party pertaining to any financial report or payment due in any Calendar Quarter ending not more than [***] prior to such Party’s request. The audit will be conducted by an independent certified public -------------- accountantaccounting firm of internationally recognized standing, or selected by the local equivalent, appointed by such Auditing Party and reasonably acceptable to the Recording Audited Party for (the sole purpose of verifying “Auditor”). The Auditor shall examine the applicable Financial Records to determine the basis and accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to due under this Agreement; provided, however that such audits may not be performed by Agreement during the Auditing Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than oncecovered by the audit. Such accountants shall The Auditor will be instructed not to reveal provided access to the Auditing Audited Party’s Financial Records at the Audited Party’s facility or facilities where such books and records are normally stored, and such examination will be conducted during the Audited Party’s normal business hours. The Audited Party has the right to require the Auditor to sign a customary non-disclosure agreement before providing the Auditor access to its Financial Records. Upon completion of the audit, the Auditor will provide both Parties a written report disclosing whether the Financial Records or the Royalty Reports, as applicable, covered by the audit, are correct or incorrect, and if incorrect, the specific details of its reviewconcerning any discrepancies. If the audit reveals an underpayment, except for (i) then the Party that owes such information as is required to be disclosed under this Agreement and (ii) payment will pay such information presented in a summary fashion as is necessary to report the accountants' conclusions underpayment to the Auditing Partyother Party forthwith plus interest in accordance with Section 10.17 (Late Payment). If the audit reveals 88 an overpayment, then the Party that paid such overpayment may credit such amount against any future payments due to the other Party hereunder, and all if none are expected within a Calendar Year, then such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing other Party unless the audit discloses at least a ** percent (within [**%) shortfall, in which case the Recording Party will bear the full cost *] after receipt of the audit an invoice for such Calendar Yearamount that was overpaid. The Auditing Party will be entitled to recover costs and fees of any shortfall in payments due to it as determined audit conducted by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make under this Section 10.16 (Financial Records; Audits) will be borne by the Auditing Party, unless such audit reveals an underpayment of amounts owed to the Reporting Auditing Party under this Agreement. The documents from which were calculated exceeding the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.lesser of

Appears in 1 contract

Samples: Collaboration and License Agreement (Novavax Inc)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of any calculations by the other Party or any payments due by the other Party under this Agreement, including (a) amounts to be reimbursed, pursuant to this Article 4.7, with respect to Allowable Expenses or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, (b) Net Sales, (c) royalty payments for purposes of determining any under or over payment of the royalties, (d) [ * ], (e) amounts payable under any supply agreement, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor (f) other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records for any Year(s) ending not more than [ * ] prior to the date of such request shall be made available open during regular business hours for inspection, review and audit, examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each [ * ] period, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided. [ * ]. Any such auditor shall not disclose the audited Party’s information to the auditing Party, however that except to the extent such audits may not be performed disclosure is necessary to verify the accuracy of the financial reports furnished by the Auditing audited Party more than once per Calendar Year or the amount of payments due by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid and that in need of reimbursement, shall be paid or refunded (as the case may be) within [ * ] after the accountant’s report, unless such Auditing Party report is challenged in good faith by the audited Party, in which case any undisputed portion shall be paid within [ * ] days after the accountant’s report and any remaining disputed portion shall be paid within [ * ] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved. The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for [ * ] percent (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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Joint Commercialization Agreement (Seattle Genetics Inc /Wa)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount of Development Costs to be shared, achievement of sales milestones, royalties and shall cause its ------------------------- Affiliates and sublicensees other amounts to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreementbe shared or paid hereunder. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of [***] from the date of rendering of the report to which the audit relates for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than [***], by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided, however that . The audited Party may require such audits may not be performed by the Auditing Party more than once per Calendar Year accountant to enter into a reasonably acceptable confidentiality agreement and that any such Auditing Party auditor shall not be permitted to audit disclose the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; providedfinancial reports furnished by the audited Party or the amount of payments due by the audited Party under this Agreement. Any undisputed amounts shown to be owed but unpaid, howeveror overpaid and in need of reimbursement, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by or refunded (as the Auditing Party unless the audit discloses at least a ** percent (case may be) within [**%*] after the accountant’s report, plus interest (as set forth in Section 9.9) shortfallfrom the original due date. The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than [***] of the amount set forth in such report, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit. If the audited Party challenges the auditing results in good faith, plus interest thereon calculated the audited Party may select another independent certified public accountant to conduct another audit of its financial records. If the results of the [***] accountants are inconsistent, then the dispute shall be resolved in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable15.

Appears in 1 contract

Samples: Collaboration and License Agreement (Molecular Partners Ag)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses Affiliates shall use all reasonable efforts to maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 8, with respect to Development Expenses Costs, Joint Commercialization Costs, or other amounts to be reimbursed, credited, offset or shared hereunder incurred or generated (as are necessary to determine the amounts due to GSK applicable) by such Party’s or Affiliate’s achievement of sales milestones, royalty payments and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of […***…] years from the creation of individual records for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party or Affiliate for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party or Affiliate pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party or Affiliate to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s or Affiliate’s confidential information to the auditing Party, however but shall, instead, report that such audits may there was or was not be performed a discrepancy uncovered by the Auditing Party more than once per Calendar Year audit and that if such Auditing Party a discrepancy was uncovered, the amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within […***…] days after the accountant’s report, plus interest (as set forth in Section 8.13) from the original due date (unless challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such challenge shall be resolved in accordance with Article 14, any remaining disputed portion shall be paid within […***…] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party or Affiliate that resulted from a discrepancy in a report that the audited Party or Affiliate provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the details of its review, except for […***…] percent (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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will or Affiliate shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit. Each Party, plus interest thereon calculated in accordance with Section 6.12at the request of the other Party, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make available to the Reporting other Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained results of any audit performed by the relevant non-requesting Party during the United States Term or the ROW Term, as applicableon such non-requesting Party’s Sublicensees hereunder.

Appears in 1 contract

Samples: License and Collaboration Agreement (Galapagos Nv)

Financial Records; Audits. Each Party GSK shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor Theravance under this Agreement. Such Agreement and such records shall be retained by each Party GSK or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")”) for at least the three subsequent Calendar Years to which the Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party")Theravance, by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing Party Theravance and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's ’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing Party Theravance more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing Party Theravance the 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 accountants' conclusions to the Auditing PartyTheravance, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party Theravance in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party Theravance unless the audit discloses at least a [** percent (**%) ] shortfall, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing Party Theravance will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party Theravance is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Strategic Alliance Agreement (Theravance Inc)

Financial Records; Audits. Each Party shall keep, and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales (i) for MYLAN, Operating Profits (Losses) and its Marketing Expenses Royalties, and (ii) for THERAVANCE, Operating Profits (Losses) in the U.S., and Development Expenses in the Territory, and the calculations thereof, as are necessary to determine the amounts due to GSK and Adolor the other Party under this Agreement. Such Agreement and such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party")) for at least the three (3) subsequent Calendar Years to which such expenses or Net Sales relate. During normal business hours and with --------------- reasonable advance notice to the Recording Party, such records shall be made available for inspection, review and audit, at the request and expense of the other Party (the "Auditing Party"), by an independent certified public -------------- accountant, or the local equivalent, appointed by such Auditing the other Party and reasonably acceptable to the Recording Party for the sole purpose of verifying the accuracy of the Recording Party's accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by the Auditing other Party more than once per Calendar Year and that such Auditing Party shall not be permitted to audit the same period of time more than onceYear. Such accountants shall be instructed not to reveal to the Auditing auditing Party the 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 accountants' conclusions to the Auditing auditing Party, and all such information shall be deemed Confidential Information of the Recording Party; provided, however, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing auditing Party unless the audit discloses at least a ** percent ([**%) shortfall*] shortfall with respect to Net Sales or excess with ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ​ respect to expenses, as applicable, in which case the Recording Party will bear the full cost of the audit for such Calendar Year. The Auditing auditing Party will be entitled to recover any shortfall in payments due to it (or overpayment made by it, as applicable) as determined by such audit, plus interest thereon calculated in accordance with Section 6.126.05, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it or overpayment made by it against payments the Auditing auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article ARTICLE 6 shall be retained by the relevant each Recording Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of (a) in the case of Anacor, [*****], and shall cause its ------------------------- Affiliates and sublicensees to keep(b) in the case of Sandoz, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor under this Agreement[*****]. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspection, review and audit, a period of [*****] from the date of rendering of the report to which the audit relates for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than [*****] each Calendar Year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting reports and furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided, however that . The audited Party may require such audits may not be performed by the Auditing Party more than once per Calendar Year accountant to enter into a reasonably acceptable confidentiality agreement and that any such Auditing Party auditor shall not be permitted to audit disclose the same period of time more than once. Such accountants shall be instructed not to reveal audited Party’s Confidential Information to the Auditing Party the details of its reviewauditing Party, except for (i) to the extent such information as is required to be disclosed under this Agreement and (ii) such information presented in a summary fashion as disclosure is necessary to report verify the accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information accuracy of the Recording Party; providedreports 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, howeveror overpaid and in need of reimbursement, that in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid or refunded (as the case may be) within [*****] after the accountant’s report, plus interest (as set forth in Section 8.8) from the original due date (unless challenged in good faith by the Auditing audited Party in which case any dispute with respect thereto shall be resolved in accordance with Article 14). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit discloses at least a ** percent (period, which underpayment or overpayment was more than [**%) shortfall***] of the applicable amount for the audited period, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Distribution and Commercialization Agreement (Anacor Pharmaceuticals, Inc.)

Financial Records; Audits. Each Party shall keepmaintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to this Article 9, with respect to Joint Development Costs, Joint Commercialization Costs, Joint Medical Affairs Costs or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, royalty payments and shall cause its ------------------------- Affiliates and sublicensees to keep, such accurate and complete records of Net Sales and its Marketing Expenses and Development Expenses as are necessary to determine the amounts due to GSK and Adolor other compensation or reimbursement payable under this Agreement. Such records shall be retained by each Party or any of its Affiliates or sublicensees (in such capacity, the "Recording Party"). During normal business hours and with --------------- Upon reasonable advance notice to the Recording Partyprior notice, such records shall be made available open during regular business hours for inspectiona period of [*] years from the creation of individual records for records pertaining to activities in [*], review and auditfor a period of [*] years from the creation of individual records for all other records, in each case, for examination at the request auditing Party’s expense, and expense of the other Party (the "Auditing Party")not more often than once each calendar year, by an independent certified public -------------- accountant, or accountant selected by the local equivalent, appointed by such Auditing auditing Party and reasonably acceptable to the Recording audited Party for the sole purpose of verifying for the auditing Party the accuracy of the Recording Party's accounting financial statements or reports and or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made made, or required to be made, by or to be made the audited Party to the other pursuant to this Agreement; provided. Any such auditor shall not disclose the audited Party’s confidential information to the auditing Party, however that except to the extent such audits may not be performed disclosure is necessary to verify the accuracy of the financial reports furnished by the Auditing audited Party more than once per Calendar Year or the amount of payments due by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid and that in need of reimbursement, shall be paid or refunded (as the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 9.11) from the original due date (unless (x) challenged in good faith by the audited Party, in which case any undisputed portion shall be paid in accordance with the foregoing timetable, any dispute with respect to such Auditing Party challenge shall be resolved in accordance with Article 15, any remaining disputed portion shall be paid within [*] days after resolution of the dispute, and interest shall not be permitted accrue with respect to audit the same disputed portion during the period of time the dispute is being resolved; or (y) such underpayment or overpayment resulted from a discrepancy in a report that the other party [*] = 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 24b-2 of the securities exchange act of 1934, as amended. provided, in which case no interest shall be due with respect thereto). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than once. Such accountants shall be instructed not to reveal to the Auditing Party the 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 accountants' conclusions to the Auditing Party, and all such information shall be deemed Confidential Information [*] of the Recording Party; provided, however, that amount set forth in any event such information may be presented to the Auditing Party in a summary fashion as is necessary to report the accountants' conclusions. All costs and expenses incurred in connection with performing any such audit shall be paid by the Auditing Party unless the audit discloses at least a ** percent (**%) shortfallreport, in which case the Recording audited Party will shall bear the full cost of the audit for such Calendar Year. The Auditing Party will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 6.12, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments the Auditing Party is otherwise required to make to the Reporting Party under this Agreement. The documents from which were calculated the sums due under this Article 6 shall be retained by the relevant Party during the United States Term or the ROW Term, as applicable.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

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