Common use of Maintenance of Records; Audit Clause in Contracts

Maintenance of Records; Audit. Xxxxxx shall maintain, and shall cause its Affiliates to maintain, at a location in the United States, complete and accurate books and records in such detail as is necessary to accurately calculate the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end of the Calendar Year in which they were generated, or for such longer period as may be required by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix shall have the right to have an independent accounting firm reasonably acceptable to Xxxxxx audit and examine the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending not more than twenty-four (24) months prior to the date of the audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were correct or incorrect, and the amounts of any discrepancies. Prior to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment to the other of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 3 contracts

Samples: Supply and Distribution Agreement, Supply and Distribution Agreement (Salix Pharmaceuticals LTD), Supply and Distribution Agreement (Salix Pharmaceuticals LTD)

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Maintenance of Records; Audit. Xxxxxx shall maintain, Buyer and shall cause its Affiliates and Seller and its Affiliates will keep and maintain (and will require Sublicensees (or for Seller, sublicensees of the license granted in Section 2.7) to keep and maintain) books, at a location records and accounts in the United Statesconnection with royalty and other payments due pursuant to Sections 2.7 (License Grant by Buyer), complete 2.9 (Royalties) and 2.10 (Sublicense Fees and Milestones) in sufficient detail to permit accurate books and records in determination of all figures necessary for verification of such detail as is necessary to accurately calculate the amounts payable to Salix under Section 3.1payments. Such books books, records and records accounts shall be maintained for a period of at least five (5) 3 years after the end of the Calendar Year calendar year in which they were generated. No more frequently than once during any calendar year, or for each party will have the right, upon at least 10 days’ advance notice, to have a nationally recognized auditor conduct an audit of such longer period as may be required by Applicable Law. Once per each Calendar Year books, records and accounts, during the period commencing on other party’s (or its Affiliates) normal business hours and in a manner as not to unreasonably interfere with the Effective Date other party’s normal business activities. The auditing party’s auditor will execute and ending twenty-four (24) months after deliver to the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix shall have the right to have an independent accounting firm other party a confidentiality agreement reasonably acceptable to Xxxxxx audit and examine the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunderother party. Such audit and examination shall be conducted and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending not more than twenty-four (24) months prior to the date of the audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were correct or incorrect, and the amounts of any discrepancies. Prior to disclosing the results of During any such audit, the other party (and its Affiliates) will (a) supply the auditing party’s auditor shall present Xxxxxx with a preliminary report all the relevant books, records and accounts in the other party’s (or its Affiliate’s) possession or under its control that the auditing party’s auditor may reasonably request and (b) instruct its employees to cooperate with the review and answer fully all relevant inquiries from the auditor. The auditing party will bear the fees and expenses of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In such audit, provided that if the event that there was an audit reveals aggregate underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the other party of at least [*] Confidential treatment requested; certain information omitted and filed separately with during the SECaudited period, such costs will be borne by the other party. case may be, shall Any payment discrepancy correctly identified as a result of an audit under this Section 5.5 will promptly (but in no event later than thirty (30) days after its receipt of be corrected by a payment from the independent accountant’s report so concluding) make payment other party to the other auditing party of an underpaid amount, plus interest as provided for in Section 2.18 (Payment Provisions Generally), or a credit against future payments for an overpaid amount. Buyer and its Affiliates shall obtain the amount of right to audit its Sublicensees so that it can provide such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx information as is required to confirm the payments owed to Seller hereunder with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of such Sublicensees to any auditor conducting an audit in accordance with the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxxforegoing.

Appears in 2 contracts

Samples: Asset Purchase Agreement (Targeted Genetics Corp /Wa/), Asset Purchase Agreement (Targeted Genetics Corp /Wa/)

Maintenance of Records; Audit. Xxxxxx Thermal Cycler Supplier shall maintain, keep and maintain (and shall cause require its Affiliates to keep and maintain, at a location in the United States, ) complete and accurate books records and records in such sufficient detail as is necessary to accurately calculate the enable an independent certified public accountant or auditor retained by ABI to validate Thermal Cyclers Supplier’s compliance with this Agreement and verify amounts payable by Thermal Cycler Supplier. To the extent such records are financial in nature or relate to Salix under Section 3.1. Such books and royalty obligations, such records shall be compiled and maintained in accordance with Generally Accepted Accounting Principles (“GAAP”). Thermal Cycler Supplier shall keep and maintain such records and supporting data during the term of this Agreement hereof and for a period of at least five [***] thereafter. Such records and the supporting data shall be available for inspection and copying, for a period of [***] (5) years after the end of the Calendar Year in which they were generatedand access shall not be denied thereafter, or for such longer period as may be required if reasonably available), during regular business hours by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix shall have the right to have an independent accounting firm reasonably acceptable certified public accountant or auditor retained by ABI. ABI shall enter into a confidentiality agreement with such accountant or auditor that will require such accountant or auditor to Xxxxxx audit and examine the relevant books use such data and records as may be reasonably necessary to determine and/or verify solely for the amount purposes of payments due hereunder and Xxxxxx’x verifying Thermal Cycler Supplier’s compliance with its obligations hereunderroyalty obligations. Such audit and examination confidentiality agreement shall require that such accountant or auditor agrees not to disclose such records or data to any party other than ABI or Thermal Cycler Supplier. If in dispute, such records shall be conducted kept at least until the dispute is settled. Inspection and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination auditing shall be limited to pertinent books and records at ABI’s expense, unless the audit demonstrates that the amount payable that is stated in a report is understated by [***], in which case Thermal Cycler Supplier shall reimburse ABI for any Calendar Year ending not more than twenty-four (24) months prior to the date expense of the such audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under Portions of this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 Exhibit were correct or incorrect, and the amounts of any discrepancies. Prior to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and have been filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt Secretary of the independent accountant’s report so concluding) make payment Commission pursuant to the other Company’s application requesting confidential treatment under Rule 406 of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by XxxxxxSecurities Act.

Appears in 2 contracts

Samples: Thermal Cycler Supplier Agreement (BioTrove, Inc.), Thermal Cycler Supplier Agreement (BioTrove, Inc.)

Maintenance of Records; Audit. Xxxxxx (a) For a period of two (2) years, Endo shall maintain, and shall cause require its respective Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with GAAP of the Calendar Year in which they were generated, or for such longer period as Royalties due to EpiCept and any one-time bonus that may be due to EpiCept pursuant to Section 4.2(b)(3) above, including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix EpiCept shall have the right right, at its sole expense, to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Endo, which shall have the right to examine in confidence the relevant books and Endo records as may be reasonably necessary to determine and/or verify the amount of Royalty payments and/or one-time bonuses due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Endo shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) days prior written notice to Endo, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four twelve (2412) months prior to the date of request; provided that EpiCept shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Endo may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Endo) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.35.5. The EpiCept independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty and Net Sales reports submitted and the amounts paid pursuant by Endo to Section 3.2 were EpiCept are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing EpiCept any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. EpiCept agrees to hold in strict confidence all information disclosed to it, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment except to the other of the amount of such underpayment extent necessary for EpiCept to enforce its rights under this Agreement or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment disclosure is required by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxxlaw.

Appears in 2 contracts

Samples: License Agreement (Epicept Corp), License Agreement (Epicept Corp)

Maintenance of Records; Audit. Xxxxxx For a period of two (2) years from the end of the calendar quarter in which the particular sale occurred, Inspire shall maintain, and shall cause require its Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Inspire Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with GAAP of the Calendar Year in which they were generatedInspire Royalties due to InSite, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix InSite shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Inspire, which shall have the right to examine in confidence the relevant books and records of Inspire as may be reasonably necessary to determine and/or or verify the amount of royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Inspire shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) Business Days prior written notice to Inspire, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) months prior to the date of request; provided, however, that InSite shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Inspire may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Inspire) as to any Confidential Information confidential information which is to be provided to such accounting firm firm, or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the royalty reports submitted and amounts royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing InSite any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. InSite agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for InSite to enforce its findings and provide Xxxxxx with an opportunity rights under this Agreement or to respond to any questions raised or issues identifiedthe extent disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx hereunderInspire of amounts owed under this Agreement, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Inspire shall promptly (but in no event later than thirty (30) days after its Inspire’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to InSite of any shortfall. In the other event that there was an overpayment by Inspire hereunder, InSite shall promptly (but in no event later than thirty (30) days after InSite’s receipt of the amount independent auditor’s report so correctly concluding) refund to Inspire or credit to future royalties, at Inspire’s election, the excess amount. InSite shall bear the full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Inspire of the lesser of (i) [*] more than ten percent ([*]10%) of the aggregate amount of royalties in any twelve (12) month period, in which case, Inspire shall bear the full cost of such audit. Upon the expiration of twenty four (24) months following the end of any Inspire fiscal year, the calculation of royalties payable with respect to such year will be binding and conclusive upon InSite except with respect to any audit then underway, and except for fraud or misrepresentation, Inspire and its Affiliates will be released from any liability or accountability with respect to royalties for such fiscal year. In addition, Inspire shall maintain and permit Pfizer to audit books and records in connection with sales of Inspire Licensed Products in the same manner and to the same extent that InSite is required to be paid maintain and permit audits of InSite’s books and records with respect to such sales under Section 3.1 and (ii4(c) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by XxxxxxPfizer Agreement.

Appears in 2 contracts

Samples: License Agreement (Insite Vision Inc), License Agreement (Inspire Pharmaceuticals Inc)

Maintenance of Records; Audit. Xxxxxx For a period of [ * ] from the end of the calendar quarter in which the particular sale occurred, Licensee shall maintain, and shall cause require its Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail all material respects in connection with the sale of Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with GAAP of the Calendar Year in which they were generatedLicensee Royalties due to Teikoku, or for such longer period as may be including any records required by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and to calculate any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix shall have the right to have an independent accounting firm reasonably acceptable to Xxxxxx audit and examine the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations royalty adjustments hereunder. [ * ] Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Licensee shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. [ * ] Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending [ * ] provided, however, that Teikoku shall not be permitted to audit the same period of time more than twenty-four (24) months prior to the date of the auditonce. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Licensee may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information confidential information which is to be provided to such accounting firm firm, or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the royalty reports submitted and amounts royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing Teikoku any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. Teikoku agrees to hold in strict confidence all information disclosed to it, except to the auditor extent necessary for Teikoku to enforce its rights under this Agreement or to the extent disclosure is required by law. In the event there was an underpayment by Licensee of amounts owed under this Agreement, Licensee shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. promptly [ * ] In the event that there was an underpayment or overpayment by Xxxxxx Licensee hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Teikoku shall promptly (but in no event later than thirty (30) days after its receipt of [ * ] Teikoku shall bear the independent accountant’s report so concluding) make payment to the other of the amount full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year Licensee and the underreporting amount is in excess [ * ] in which case, Licensee shall bear the full cost of the lesser of (i) [*] percent ([*such audit. [ * ]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 2 contracts

Samples: License Agreement (Eagle Pharmaceuticals, Inc.), License Agreement (Eagle Pharmaceuticals, Inc.)

Maintenance of Records; Audit. Xxxxxx For a period of [**] years, Censa shall maintain, maintain and shall cause its Affiliates and sublicensees to maintain, at a location in the United States, maintain complete and accurate books and records in such detail connection with the sale of the Product, as is necessary to accurately allow the accurate calculation of royalties due hereunder including any records required to calculate the amounts payable to Salix under Section 3.1any royalty adjustments hereunder. Such books and records shall be maintained for a period of at least five (5) years after the end of the Calendar Year in which they were generated[**] per calendar year, or for such longer period as may be required by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix Shiratori shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Censa, at Shiratori’s expense, which shall have the right to examine in confidence the relevant books and Censa records as may be reasonably necessary to determine and/or verify the amount of royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted during Censa’s normal business hours, after at least [**] days' prior written notice to Censa and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours place at the Censa’s facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) [**] months prior to the date of the auditrequest. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Censa may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Censa) as to any Confidential Information of the confidential information of Censa, its Affiliates or sublicensees which is to be provided to such accounting firm or to which such accounting firm will shall have access access, while conducting the audit under this Section 3.3Section. The Shiratori’s independent accounting firm will shall prepare and provide to Salix both Shiratori and Xxxxxx Censa a written report stating disclosing only whether the royalty reports submitted and amounts royalties paid pursuant to Section 3.2 were by Censa are correct or incorrect, incorrect and the amounts of specific details concerning any discrepancies. Prior No other information shall be provided to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identifiedShiratori. In the event that there was an underpayment or overpayment by Xxxxxx Censa hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Censa shall promptly (but in no event later than thirty (30) [**] days after its Censa’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to Shiratori of any shortfall. In the other event that there was an overpayment by Censa hereunder, Shiratori shall promptly (but in no event later than [**] days after Shiratori’s receipt of the amount of such underpayment or overpaymentindependent auditor’s report so correctly concluding) refund to Censa the excess amount. Salix In the event any payment by Censa shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment prove to have been incorrect by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) more than [**] percent ([**]%) to Shiratori’s detriment, Censa shall pay the reasonable fees and costs of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the Shiratori’s independent auditor for conducting such audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: License Agreement (PTC Therapeutics, Inc.)

Maintenance of Records; Audit. Xxxxxx For a period of ***** (*****) *****, Aventis shall keep and maintain, and shall cause require its respective Affiliates and sublicensees to keep and maintain, at a location in the United States, such accurate and complete and accurate books and records in such detail connection with the sale of Products hereunder, as is are necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with generally accepted accounting principles of the Calendar Year in which they were generatedRoyalties due to ImmunoGen, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once ***** per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38*****, Salix ImmunoGen shall have the right to have engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to Xxxxxx audit and Aventis, which shall have the right to examine in confidence the relevant books and records of Aventis and its respective Affiliates and sublicensees as may be reasonably necessary to determine and/or verify the amount of Royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Aventis shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least ***** (*****) ***** prior written notice to Aventis, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four ***** (24*****) months ***** prior to the date of request; provided, that, ImmunoGen shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Aventis may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx each of the Parties) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The ImmunoGen independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of specific details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing ImmunoGen any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for ImmunoGen to enforce its findings and provide Xxxxxx with an opportunity to respond to any questions raised rights under this Agreement or issues identifiedif disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx Aventis hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Aventis shall promptly (but in no event later than thirty ***** (30*****) days ***** after its such Party’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the other event that there was an overpayment by Aventis hereunder, ImmunoGen shall promptly (but in no event later than ***** (*****) ***** after ImmunoGen’s receipt of the amount independent auditor’s report so correctly concluding) refund to Aventis the excess amount. ***** shall bear the ***** of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Aventis of the lesser of more than ***** (i) [*] percent ([*]%***) of the aggregate amount required to be paid under Section 3.1 and of Royalties in any ***** (ii*****) [*] dollars ($[*])*** period, in which case, Aventis shall reimburse ImmunoGen for all costs incurred by ImmunoGen in connection with such examination and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: Collaboration and License Agreement (Immunogen Inc)

Maintenance of Records; Audit. Xxxxxx (a) For a period of three (3) years, ALCiS shall maintain, and shall cause require its respective Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with GAAP of the Calendar Year in which they were generatedRoyalties due to BioZone, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix BioZone shall have the right right, at its sole expense, to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and ALCiS, which shall have the right to examine in confidence the relevant books and ALCiS records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunderRoyalty payments. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and ALCiS shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) days prior written notice to ALCiS, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four three (243) months years prior to the date of request; provided that BioZone shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx ALCiS may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx ALCiS) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3Section. The BioZone’s independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty and Net Sales reports submitted and the amounts paid pursuant by ALCiS to Section 3.2 were BioZone are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing BioZone any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. BioZone agrees to hold in strict confidence all information disclosed to it, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment except to the other of the amount of such underpayment extent necessary for BioZone to enforce its rights under this Agreement or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment disclosure is required by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxxlaw.

Appears in 1 contract

Samples: License and Manufacturing Agreement (Emerging Delta Corp)

Maintenance of Records; Audit. Xxxxxx Distributor shall maintain, and shall cause require its Affiliates to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the handling, sale, and distribution of all Products hereunder, as is necessary to accurately calculate allow the accurate calculation consistent with generally accepted accounting principles of the amounts payable due to Salix under Section 3.1. Such Manufacturer, the reporting obligations contemplated herein, and compliance with the terms of this Agreement, and Distributor shall maintain such books and records shall be maintained for a period of at least five (5) years [***] after the end of the Calendar Year calendar year in which they were generated, or for such longer period as may be required by Applicable Lawlaw. Once per each Calendar Year calendar year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38Term, Salix Manufacturer shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Distributor, at Manufacturer’s expense, which shall have the right to examine in confidence the relevant books and records as may be reasonably necessary to determine and/or or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunderhereof. Such audit and examination accounting firm shall be conducted and shall take placeconduct such examination, and Xxxxxx shall, and Distributor shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) months [***] prior to the date of request; provided that Manufacturer shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Distributor may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Distributor) as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3Section. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of any discrepancies. Prior to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that If there was an underpayment or overpayment by Xxxxxx Distributor hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Distributor shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountantauditor’s report so concluding) make payment to the other Manufacturer of any shortfall by wire transfer in U.S. dollars, including interest calculated in accordance with Section 3.9. If there was an overpayment by Distributor hereunder, Manufacturer shall promptly (but in no event later than thirty (30) days after Manufacturer’s receipt of the independent auditor’s report so concluding) refund to Distributor the excess amount of such underpayment or overpaymentby wire transfer in U.S. dollars. Salix shall bear all costs and expenses In the event of any such audit, except that if underpayment by Distributor resulting in a cumulative discrepancy during any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year calendar year in excess of the lesser greater of (i) [***] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and or (ii) [*] dollars ($[**]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by XxxxxxDistributor. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Appears in 1 contract

Samples: Distribution and Supply Agreement (Santarus Inc)

Maintenance of Records; Audit. Xxxxxx Distributor shall maintain, and shall cause require its Affiliates to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the handling, sale, and distribution of all Products hereunder, as is necessary to accurately calculate allow the accurate calculation consistent with generally accepted accounting principles of the amounts payable due to Salix under Section 3.1. Such Manufacturer, the reporting obligations contemplated herein, and compliance with the terms of this Agreement, and Distributor shall maintain such books and records shall be maintained for a period of at least five (5) years [***] after the end of the Calendar Year calendar year in which they were generated, or for such longer period as may be required by Applicable Lawlaw. Once per each Calendar Year calendar year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38Term, Salix Manufacturer shall have the right to have engage an *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. independent accounting firm reasonably acceptable to Xxxxxx audit and Distributor, at Manufacturer’s expense, which shall have the right to examine in confidence the relevant books and records as may be reasonably necessary to determine and/or or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunderhereof. Such audit and examination accounting firm shall be conducted and shall take placeconduct such examination, and Xxxxxx shall, and Distributor shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) months [***] prior to the date of request; provided that Manufacturer shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Distributor may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Distributor) as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3Section. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of any discrepancies. Prior to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that If there was an underpayment or overpayment by Xxxxxx Distributor hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Distributor shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountantauditor’s report so concluding) make payment to the other Manufacturer of any shortfall by wire transfer in U.S. dollars, including interest calculated in accordance with Section 3.9. If there was an overpayment by Distributor hereunder, Manufacturer shall promptly (but in no event later than thirty (30) days after Manufacturer’s receipt of the independent auditor’s report so concluding) refund to Distributor the excess amount of such underpayment or overpaymentby wire transfer in U.S. dollars. Salix shall bear all costs and expenses In the event of any such audit, except that if underpayment by Distributor resulting in a cumulative discrepancy during any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year calendar year in excess of the lesser greater of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and 5% or (ii) [*] one hundred thousand dollars ($[*]100,000.00), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by XxxxxxDistributor.

Appears in 1 contract

Samples: Distribution and Supply Agreement (Santarus Inc)

Maintenance of Records; Audit. Xxxxxx Thermal Cycler Supplier shall maintain, keep and maintain (and shall cause require its Affiliates to keep and maintain, at a location in the United States, ) complete and accurate books records and records in such sufficient detail as is necessary to accurately calculate enable an independent certified public accountant or auditor retained by ABI to validate Thermal Cycler Supplier’s compliance with this Agreement, and for the time period preceding the Effective Date to validate Thermal Cycler Supplier's compliance with its earlier Thermal Cycler Supplier Agreement having an effective date of April 1, 1998, and verify amounts payable by Thermal Cycler Supplier. To the extent such records are financial in nature or relate to Salix under Section 3.1. Such books and royalty obligations, such records shall be compiled and maintained in accordance with Generally Accepted Accounting Principles (“GAAP”). Thermal Cycler Supplier shall keep and maintain such records and supporting data during the term of this Agreement and for a period of at least five (5) years after [**] . Such records and the supporting data shall be available for inspection and copying, for a period of [**] the end of the Calendar Year calendar year to which they pertain, during regular business hours by an independent certified public accountant or auditor retained by ABI. If in dispute, such records shall be kept at least until the dispute is settled. Inspection and auditing shall be at ABI's expense, unless the audit demonstrates that the amount payable that is stated in a report is understated by [**] , in which they were generatedcase Thermal Cycler Supplier shall reimburse ABI for the expense of such audit. The Parties agree that any certified public accountant or auditor inspecting Thermal Cycler Supplier's records pursuant to this Section 3.5 shall retain as confidential all information about Thermal Cycler Supplier's finances and customers gained as a result of that inspection, with the exception that the accountant shall be free to communicate with ABI (i) whether or not Thermal Cycler Supplier complied with the terms of its Thermal Cycler Supplier Agreement having an effective date of April 1, 1998, or for such longer period as may be required by Applicable Law. Once per each Calendar Year during is in compliance with the period commencing on terms of this Agreement, (ii) the Effective Date and ending twenty-four (24) months after the end results of the Calendar Quarter audit, including financial information but not customer information, and (iii) if, in which all rebate the auditor's professional opinion, Thermal Cycler Supplier is not complying or has not complied with the terms of its Thermal Cycler Supplier Agreement having an effective date of April 1, 1998 or this Agreement, the underlying facts and chargeback amounts on Generic Product sold during information relevant to said non-compliance. Without limiting the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38foregoing audit rights Applera, Salix through its independent auditors, shall have the right to have an independent accounting firm reasonably acceptable to Xxxxxx audit and examine the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placesoftware (including, and Xxxxxx shallwithout limitation, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending not more than twenty-four (24) months prior to the date of the audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were correct or incorrectsource code, and the amounts of any discrepancies. Prior to disclosing the results of any same shall be made available by Thermal Cycler Supplier for such audit, ) distributed or provided directly or otherwise by Thermal Cycler Supplier to determine the auditor shall present Xxxxxx with a preliminary report accuracy and completeness of its findings BioRad’s reporting and provide Xxxxxx with an opportunity paying of royalties under this Agreement in view of the licenses granted pursuant to respond to any questions raised or issues identifiedArticle 2 of this Agreement under the Algorithm Patent Rights. In the event that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment to the other of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: Thermal Cycler Supplier Agreement (Bio Rad Laboratories Inc)

Maintenance of Records; Audit. Xxxxxx For a period of three (3) years, Adolor shall maintain, and shall cause require its respective Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with generally accepted accounting principles of the Calendar Year in which they were generatedRoyalties due to EpiCept, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix EpiCept shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Adolor, which shall have the right to examine in confidence the relevant books and Adolor records as may be reasonably necessary to determine and/or verify the amount of Royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Adolor shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) days prior written notice to Adolor, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twentythirty-four six (2436) months prior to the date of request; provided that EpiCept shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Adolor may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Adolor) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The EpiCept independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing EpiCept any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. EpiCept agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for EpiCept to enforce its findings and provide Xxxxxx with an opportunity to respond to any questions raised rights under this Agreement or issues identifiedif disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx Adolor hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Adolor shall promptly (but in no event later than thirty (30) days after its such Party's receipt of the independent accountant’s auditor's report so correctly concluding) make payment to EpiCept of any shortfall. In the other event that there was an overpayment by Adolor hereunder, EpiCept shall promptly (but in no event later than thirty (30) days after EpiCept's receipt of the amount independent auditor's report so correctly concluding) refund to Adolor or credit to future royalties, at Adolor's election, the excess amount. EpiCept shall bear the full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Adolor of the lesser of (i) [more than *] percent ([*]%) * of the aggregate amount required to be paid under Section 3.1 and of Royalties in any twelve (ii12) [*] dollars ($[*])month period, all costs and expenses in which case, Adolor shall bear the full cost of the such audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: License Agreement (Epicept Corp)

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Maintenance of Records; Audit. Xxxxxx Distributor shall maintain, and shall cause require its Affiliates and permitted Third Parties to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the handling, sale, and distribution of all Products hereunder, as is necessary to accurately calculate allow the accurate calculation consistent with U.S. generally accepted accounting principles of the amounts payable due to Salix under Section 3.1. Such Manufacturer, the reporting obligations contemplated herein, and compliance with the terms of this Agreement, and Distributor shall maintain such books and records shall be maintained for a period of at least five (5) years [**] after the end of the Calendar Year calendar year in which they were generated, or for such longer period as may be required by Applicable Law. Once Subject to Section 10.4, no more than once per each Calendar Year calendar year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38Term, Salix Manufacturer shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Distributor, at Manufacturer’s expense, which shall have the right to examine the relevant in confidence such books and records as may be reasonably necessary to determine and/or or verify the amount of payments due hereunder under this Agreement and Xxxxxx’x compliance with its the obligations hereunderhereof. Such audit and examination accounting firm shall be conducted and shall take placeconduct such examination, and Xxxxxx shall, and Distributor shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are customarily maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) [**] months prior to the date of request, except that Manufacturer shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Distributor may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement (in reasonable form and substance reasonably acceptable to Xxxxxx substance) as to any Confidential Information of Distributor which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3Section. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of any discrepancies. Prior to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event that If there was an underpayment or overpayment by Xxxxxx Distributor hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Distributor shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountantauditor’s report so concluding) make payment to the other Manufacturer of any shortfall by wire transfer in U.S. dollars, plus interest on the amount of such underpayment or overpaymentshortfall calculated at the Applicable Rate from the date such payment should have been made to the date the shortfall is paid. Salix If there was an overpayment by Distributor hereunder, Manufacturer shall bear all costs and expenses promptly (but in no event later than thirty (30) days after Manufacturer’s receipt of the independent auditor’s report so concluding) refund to Distributor the excess ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. amount by wire transfer in U.S. dollars. In the event of any such audit, except that if underpayment by Distributor resulting in a cumulative discrepancy during any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year calendar year in excess of the lesser of (i) greater [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by XxxxxxDistributor.

Appears in 1 contract

Samples: Distribution and Supply Agreement (Auxilium Pharmaceuticals Inc)

Maintenance of Records; Audit. Xxxxxx Members of Licensee’s Group shall maintainkeep complete, accurate and shall cause its Affiliates up-to-date records relating to maintainthe use and distribution of Information and to the associated Operational Controls, at a location in sufficient to demonstrate compliance with the United States, complete Agreement and accurate books and records in such detail as is necessary to accurately calculate the amounts identify all sums payable to Salix BHB in accordance with the Agreement. Where applicable, Licensee shall require Subscribers to maintain similar records. All records required to be maintained under Section 3.1. Such books and records this Agreement shall be maintained for a minimum of three (3) years and made available to BHB upon request for audit inspection. BHB and its auditor(s) shall have the right during the term of the Agreement and for a period of at least five two (52) years after afterwards, to visit the end premises of members of Licensee’s Group and Subscribers during normal business hours and during or in preparation for any such audit visit to obtain access to and inspect systems, controls, books and records, insofar as they relate to the distribution of the Calendar Year in which they were generatedInformation, or for such longer period as may be required by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term related Operational Controls and any applicable selloff period under Section 11.9 are finally reconciled sums payable to BHB. BHB shall provide notice of audits and conduct all audits in accordance with Section 1.38XXX Appendix 3. BHB and its auditors shall treat all information obtained in the audit confidentially and use it only for the purpose of the audit. The purpose of the audit, Salix unless otherwise agreed in advance, shall be to verify compliance by the audited parties with the Agreement. BHB and its auditors shall comply with all health, safety and security requirements in effect at the premises visited during the course of the audit. Licensee shall ensure full co-operation by members of Licensee’s Group and Subscribers with the preparation and completion of any audit permitted under this Agreement. BHB agrees to conduct the audit in such a way as to conform to any reasonable requirements of any audited party that are necessary to protect the confidentiality of records to be inspected in the course of the audit. If an audit reveals unauthorized use, or a lack of records or failure of Operational Controls, but the amount of underreported Fees and Charges cannot be established with reasonable certainty or agreed between the parties in accordance with the procedures described in XXX Xxxxxxxx 0, XXX reserves the right to (i) xxxx an audit settlement amount based on BHB’s own reasonable estimate or (ii) appoint an independent professional auditor to assess or estimate the amount owed to BHB and in this event the parties agree to accept the assessment and/or reasonable estimate of the appointed auditor. Licensee shall have the right to have an independent accounting firm reasonably acceptable to Xxxxxx audit and examine terminate this Agreement within 30 days of payment in accordance with the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending not more than twenty-four (24) months prior to the date of the audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were correct or incorrect, and the amounts Agreement of any discrepanciesaudit settlement based on a BHB estimate or the assessment and/or estimate of an appointed independent professional auditor. Prior to disclosing If an audit reveals any underpayment in fees due under the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event Agreement by Licensee that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment to the other of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] exceeds ten percent ([*]10%) of the aggregate amount required to be total paid under Section 3.1 and (ii) [*] dollars ($[*])by Licensee for the period covered by the audit, all Licensee shall bear the reasonable costs and expenses of the audit, including the expenses cost of the any assessment or estimate provided by an independent accounting firm, shall be borne and promptly paid by Xxxxxxprofessional auditor in accordance with Clause 10.5.

Appears in 1 contract

Samples: www.bahrainbourse.com

Maintenance of Records; Audit. Xxxxxx For a period of two (2) years after the date of the invoice, CollaGenex shall maintain, and shall cause require its respective Affiliates to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with generally accepted accounting principles of the Calendar Year in which they were generatedroyalties and Sublicense Income payments due to Skold, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix Skold shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and CollaGenex, which shall have the right to examine in confidence the relevant books and CollaGenex records as may be reasonably necessary to determine and/or verify the amount of royalties and Sublicense Income payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and CollaGenex shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) days prior written notice to CollaGenex, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) months prior to the date of request; provided that Skold shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx CollaGenex may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx CollaGenex) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The Skold independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the royalties and Sublicense Income payment reports submitted and amounts royalties and Sublicense Income payments paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing Skold any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. Skold agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for Skold to enforce its findings and provide Xxxxxx with an opportunity to respond to any questions raised rights under this Agreement or issues identifiedif disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx CollaGenex hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, CollaGenex shall promptly (but in no event later than thirty (30) days after its such Party’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to Skold of any shortfall. In the other event that there was an overpayment by CollaGenex hereunder, Skold shall promptly (but in no event later than thirty (30) days after Skold’s receipt of the amount independent auditor’s report so correctly concluding) refund to CollaGenex or credit to future royalties, at CollaGenex’s election, the excess amount. Skold shall bear the full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess CollaGenex of the lesser of (i) [*] more than ten percent ([*]10%) of the aggregate amount required to be paid under Section 3.1 of royalties and Sublicense Income payments in any twelve (ii12) [*] dollars ($[*])month period, all costs and expenses in which case, CollaGenex shall bear the full cost of the such audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: Asset Purchase and Product Development Agreement (Collagenex Pharmaceuticals Inc)

Maintenance of Records; Audit. Xxxxxx For a period of three (3) years, Wyeth-Ayerst shall maintain, maintain and shall cause its Affiliates and sublicensees to maintain, at a location in the United States, maintain complete and accurate books and records in such detail connection with the sale of Collaboration Products hereunder, as is necessary to accurately allow the accurate calculation of Royalties due hereunder including any records required to calculate the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end of the Calendar Year in which they were generated, or for such longer period as may be required by Applicable Lawany Royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38, Salix calendar year Neurocrine shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Wyeth-Ayerst, at Neurocrine's expense, which shall have the right to examine in confidence the relevant books and Wyeth-Ayerst records as may be reasonably necessary to determine and/or verify the amount of Royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted during Wyeth-Ayerst's normal business hours, after at least fifteen (15) days prior written notice to Wyeth-Ayerst and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours place at the Wyeth-Ayerst facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twentythirty-four six (2436) months prior to the date of the auditrequest. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Wyeth-Ayerst may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Wyeth-Ayerst) as to any Confidential Information of Wyeth-Ayerst's, its Affiliates or sublicensees' confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.39.5 (e). The Neurocrine independent accounting firm will prepare and provide to Salix both Neurocrine and Xxxxxx Wyeth-Ayerst a written report stating disclosing only whether the Royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were by Wyeth-Ayerst are correct or incorrect, incorrect and the amounts of specific details concerning any discrepancies. Prior No other information shall be provided to disclosing the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identifiedNeurocrine. In the event that there was an underpayment or overpayment under-payment by Xxxxxx Wyeth-Ayerst hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Wyeth-Ayerst shall promptly (but in no event later than thirty (30) days after its Wyeth-Ayerst's receipt of the independent accountant’s auditor's report so correctly concluding) make payment to the other of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses Neurocrine of any such auditshort-fall. In the event that there was an over-payment by Wyeth-Ayerst hereunder, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year Neurocrine shall promptly (but in excess of the lesser of no event later than thirty (i30) [*] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and (ii) [*] dollars ($[*]), all costs and expenses of the audit, including the expenses days after Neurocrine's receipt of the independent accounting firmauditor's report so correctly concluding) refund to Wyeth-Ayerst the excess amount. In the event any payment by Wyeth-Ayerst shall prove to have been incorrect by more than seven and one-half percent (7.5%) to Neurocrine's detriment, shall be borne Wyeth-Ayerst will pay the reasonable fees and promptly paid by Xxxxxxcosts of Neurocrine's independent auditor for conducting such audit.

Appears in 1 contract

Samples: Collaboration and License Agreement (Neurocrine Biosciences Inc)

Maintenance of Records; Audit. Xxxxxx For a period of [***]([***])[***], Aventis shall keep and maintain, and shall cause require its respective Affiliates and sublicensees to keep and maintain, at a location in the United States, such accurate and complete and accurate books and records in such detail connection with the sale of Products hereunder, as is are necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with generally accepted accounting principles of the Calendar Year in which they were generatedRoyalties due to ImmunoGen, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38[***]per[***], Salix ImmunoGen shall have the right to have engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to Xxxxxx audit and Aventis, which shall have the right to examine in confidence the relevant books and records of Aventis and its respective Affiliates and sublicensees as may be reasonably necessary to determine and/or verify the amount of Royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Aventis shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least [***]([***]) [***]prior written notice to Aventis, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four [***](24[***]) months [***]prior to the date of request; provided, that, ImmunoGen shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Aventis may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx each of the Parties) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The ImmunoGen independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of specific details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing ImmunoGen any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for ImmunoGen to enforce its findings and provide Xxxxxx with an opportunity to respond to any questions raised rights under this Agreement or issues identifiedif disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx Aventis hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Aventis shall promptly (but in no event later than thirty [***](30[***]) days [***]after its such Party’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the other event that there was an overpayment by Aventis hereunder, ImmunoGen shall promptly (but in no event later than [***]([***]) [***]after ImmunoGen’s receipt of the amount Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. independent auditor’s report so correctly concluding) refund to Aventis the excess amount. [***]shall bear the [***]of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Aventis of the lesser of (i) more than [*] percent **]([***]%) of the aggregate amount required to be paid under Section 3.1 and of Royalties in any [***](ii[***]) [*] dollars ($[**])period, in which case, Aventis shall reimburse ImmunoGen for all costs incurred by ImmunoGen in connection with such examination and expenses of the audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: Collaboration and License Agreement (Immunogen Inc)

Maintenance of Records; Audit. Xxxxxx Members of Licensee’s Group shall maintainkeep complete, accurate and shall cause its Affiliates up-to-date records relating to maintainthe use and distribution of Information and to the associated Operational Controls, at a location in sufficient to demonstrate compliance with the United States, complete Agreement and accurate books and records in such detail as is necessary to accurately calculate the amounts identify all sums payable to Salix BHB in accordance with the Agreement. Where applicable, Licensee shall require Subscribers to maintain similar records. All records required to be maintained under Section 3.1. Such books and records this Agreement shall be maintained for a minimum of three (3) years and made available to BHB upon request for audit inspection. BHB and its auditor(s) shall have the right during the term of the Agreement and for a period of at least five two (52) years after afterwards, to visit the end premises of members of Licensee’s Group and Subscribers during normal business hours and during or in preparation for any such audit visit to obtain access to and inspect systems, controls, books and records, insofar as they relate to the distribution of the Calendar Year in which they were generatedInformation, or for such longer period as may be required by Applicable Law. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term related Operational Controls and any applicable selloff period under Section 11.9 are finally reconciled sums payable to BHB. BHB shall provide notice of audits and conduct all audits in accordance with Section 1.38XXX Appendix 3. BHB and its auditors shall treat all information obtained in the audit confidentially and use it only for the purpose of the audit. The purpose of the audit, Salix unless otherwise agreed in advance, shall be to verify compliance by the audited parties with the Agreement. BHB and its auditors shall comply with all health, safety and security requirements in effect at the premises visited during the course of the audit. Licensee shall ensure full co-operation by members of Licensee’s Group and Subscribers with the preparation and completion of any audit permitted under this Agreement. XXX agrees to conduct the audit in such a way as to conform to any reasonable requirements of any audited party that are necessary to protect the confidentiality of records to be inspected in the course of the audit. If an audit reveals unauthorized use, or a lack of records or failure of Operational Controls, but the amount of underreported Fees and Charges cannot be established with reasonable certainty or agreed between the parties in accordance with the procedures described in XXX Appendix 3, BHB reserves the right to (i) bill an audit settlement amount based on BHB’s own reasonable estimate or (ii) appoint an independent professional auditor to assess or estimate the amount owed to BHB and in this event the parties agree to accept the assessment and/or reasonable estimate of the appointed auditor. Licensee shall have the right to have an independent accounting firm reasonably acceptable to Xxxxxx audit and examine terminate this Agreement within 30 days of payment in accordance with the relevant books and records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year ending not more than twenty-four (24) months prior to the date of the audit. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx may require such independent accounting firm and its personnel involved in such audit to sign a customary confidentiality agreement in form and substance reasonably acceptable to Xxxxxx as to any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this Section 3.3. The independent accounting firm will prepare and provide to Salix and Xxxxxx a written report stating only whether the reports submitted and amounts paid pursuant to Section 3.2 were correct or incorrect, and the amounts Agreement of any discrepanciesaudit settlement based on a BHB estimate or the assessment and/or estimate of an appointed independent professional auditor. Prior to disclosing If an audit reveals any underpayment in fees due under the results of any such audit, the auditor shall present Xxxxxx with a preliminary report of its findings and provide Xxxxxx with an opportunity to respond to any questions raised or issues identified. In the event Agreement by Licensee that there was an underpayment or overpayment by Xxxxxx hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, shall promptly (but in no event later than thirty (30) days after its receipt of the independent accountant’s report so concluding) make payment to the other of the amount of such underpayment or overpayment. Salix shall bear all costs and expenses of any such audit, except that if any audit discloses an underpayment or overpayment by Xxxxxx with respect to any Calendar Year in excess of the lesser of (i) [*] exceeds ten percent ([*]10%) of the aggregate amount required to be total paid under Section 3.1 and (ii) [*] dollars ($[*])by Licensee for the period covered by the audit, all Licensee shall bear the reasonable costs and expenses of the audit, including the expenses cost of the any assessment or estimate provided by an independent accounting firm, shall be borne and promptly paid by Xxxxxxprofessional auditor in accordance with Clause 10.5.

Appears in 1 contract

Samples: bahrainbourse.com

Maintenance of Records; Audit. Xxxxxx For a period of two (2) years from the end of the calendar quarter in which the particular sale occurred, Cornerstone shall maintain, and shall cause require its respective Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Product by Cornerstone, its Affiliates and sublicensees, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with GAAP of the Calendar Year in which they were generatedRoyalties due to Neos, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix Neos shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Cornerstone, which shall have the right to examine in confidence the relevant books and records of Cornerstone as may be reasonably necessary to determine and/or or verify the amount of payments the Royalties due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted during normal business hours, after at least fifteen (15) Business Days prior written notice to Cornerstone and shall take place, and Xxxxxx shall, and shall cause its Affiliates to, make such books and records available, during normal business hours place at the Cornerstone’s facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twenty-four (24) months prior to the date of request; provided that Neos shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Cornerstone may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Cornerstone) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.38.4. The independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing Neos any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. Neos agrees to hold in strict confidence all information disclosed to it by such accounting firm, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for Neos to enforce its findings and provide Xxxxxx with an opportunity rights under this Agreement or to respond to any questions raised or issues identifiedthe extent disclosure is required by Law. In the event that there was an underpayment or overpayment by Xxxxxx hereunderCornerstone of amounts owed under this Agreement, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Cornerstone shall promptly (but in no event later than thirty (30) days after its Cornerstone’s receipt of the [***] Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission. independent auditor’s report) make payment to Neos of any shortfall. In the event that there was an overpayment by Cornerstone hereunder, Neos shall promptly (but in no event later than thirty (30) days after Neos’ receipt of the independent accountantauditor’s report so concludingreport) make payment refund to Cornerstone or credit to future royalties, at Cornerstone’s election, the other of excess amount. Neos shall bear the amount full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Cornerstone of the lesser of (i) more than [***] percent ([***]%) of the aggregate amount required to be paid under Section 3.1 and of Royalties in any twelve (ii12) [*] dollars ($[*])month period, all costs and expenses in which case, Cornerstone shall bear the full cost of the such audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: Development, License and Services Agreement (Cornerstone Therapeutics Inc)

Maintenance of Records; Audit. Xxxxxx For a period of three (3) years, Adolor shall maintain, and shall cause require its respective Affiliates and sublicensees to maintain, at a location in the United States, complete and accurate books and records in such detail connection with the sale of Licensed Products hereunder, as is necessary to accurately calculate allow the amounts payable to Salix under Section 3.1. Such books and records shall be maintained for a period of at least five (5) years after the end accurate calculation consistent with generally accepted accounting principles of the Calendar Year in which they were generatedRoyalties due to EpiCept, or for such longer period as may be including any records required by Applicable Lawto calculate any royalty adjustments hereunder. Once per each Calendar Year during the period commencing on the Effective Date and ending twenty-four (24) months after the end of the Calendar Quarter in which all rebate and chargeback amounts on Generic Product sold during the Term and any applicable selloff period under Section 11.9 are finally reconciled in accordance with Section 1.38calendar year, Salix EpiCept shall have the right to have engage an independent accounting firm reasonably acceptable to Xxxxxx audit and Adolor, which shall have the right to examine in confidence the relevant books and Adolor records as may be reasonably necessary to determine and/or verify the amount of Royalty payments due hereunder and Xxxxxx’x compliance with its obligations hereunder. Such audit and examination shall be conducted and shall take placeconducted, and Xxxxxx shall, and Adolor shall cause make its Affiliates to, make such books and records available, during normal business hours hours, after at least fifteen (15) days prior written notice to Adolor, as applicable, and shall take place at the facility(ies) where such books and records are maintained. Each such audit and examination shall be limited to pertinent books and records for any Calendar Year year ending not more than twentythirty-four six (2436) months prior to the date of request; provided that EpiCept shall not be permitted to audit the auditsame period of time more than once. Before permitting such independent accounting firm to have access to such books and records, Xxxxxx Adolor may require such independent accounting firm and its personnel involved in such audit audit, to sign a customary confidentiality agreement (in form and substance reasonably acceptable to Xxxxxx Adolor) as to any Confidential Information confidential information which is to be provided to such accounting firm or to which such accounting firm will have access access, while conducting the audit under this Section 3.3paragraph. The EpiCept independent accounting firm will prepare and provide to Salix and Xxxxxx each Party a written report stating only whether the Royalty reports submitted and amounts Royalties paid pursuant to Section 3.2 were are correct or incorrect, incorrect and the amounts of details concerning any discrepancies. Prior Such accounting firm may not reveal to disclosing EpiCept any information learned in the results course of such audit other than the amount of any such auditdiscrepancies. EpiCept agrees to hold in strict confidence all information disclosed to it, except to the auditor shall present Xxxxxx with a preliminary report of extent necessary for EpiCept to enforce its findings and provide Xxxxxx with an opportunity to respond to any questions raised rights under this Agreement or issues identifiedif [**] CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION disclosure is required by law. In the event that there was an underpayment or overpayment by Xxxxxx Adolor hereunder, Xxxxxx or Salix, as the [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. case may be, Adolor shall promptly (but in no event later than thirty (30) days after its such Party’s receipt of the independent accountantauditor’s report so correctly concluding) make payment to EpiCept of any shortfall. In the other event that there was an overpayment by Adolor hereunder, EpiCept shall promptly (but in no event later than thirty (30) days after EpiCept’s receipt of the amount independent auditor’s report so correctly concluding) refund to Adolor or credit to future royalties, at Adolor’s election, the excess amount. EpiCept shall bear the full cost of such underpayment or overpayment. Salix shall bear all costs and expenses of any audit unless such audit, except that if any audit discloses an underpayment or overpayment underreporting by Xxxxxx with respect to any Calendar Year in excess Adolor of the lesser of (i) more than [**] percent ([*]%) of the aggregate amount required to be paid under Section 3.1 and of Royalties in any twelve (ii12) [*] dollars ($[*])month period, all costs and expenses in which case, Adolor shall bear the full cost of the such audit, including the expenses of the independent accounting firm, shall be borne and promptly paid by Xxxxxx.

Appears in 1 contract

Samples: License Agreement (Adolor Corp)

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