Common use of Records; Audit Rights Clause in Contracts

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determined. Such audit right shall not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in any event no later than [***] days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such audit.

Appears in 2 contracts

Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)

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Records; Audit Rights. MERCK and its Affiliates and Sublicensees With respect to each Research Program, Nimble shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales all Research Costs incurred by MERCK and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right it under such Research Program for a period of [***] years after receiving any the termination of the Research Term for such royalty payment Research Program. Rayze shall have the right during such [***] period to appoint at its expense an independent nationally recognized certified public accountant firm reasonably acceptable to MERCK Nimble and subject to obligations of confidentiality to Nimble to audit the relevant records of MERCK and its Affiliates and Sublicensees Nimble to verify that the amount of such payment was Research Costs incurred have been correctly determined. MERCK and its Affiliates and Sublicensees Nimble shall each make its records available for audit by such the independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedRayze. Such audit right shall not be exercised by ARCHEMIX Rayze more than [***] once in any [***] or more than period during each Research Term and [***] with respect to sales of a particular Product in a [***]. All records made available for audit shall be deemed to be Confidential Information of MERCKthereafter. The independent certified public accountant will only disclose the results (any sums either over/under paid) of each audit, if any, shall be binding on both Partiessuch audit to Rayze and no other details. In the event there was an error in the amount of such Research Costs reported by Xxxxxx hereunder, (a) if the effect of the error resulted in an underpayment by MERCK hereunderXxxxx to Nimble, MERCK then Rayze shall promptly (but in any event no later than [***] days after MERCK’s promptly, on receipt of the report so concluding) an invoice, make payment to ARCHEMIX Nimble of any shortfallthe underpayment amount and (b) if the effect of the error resulted in an overpayment by Xxxxx to Nimble, then Nimble shall promptly on receipt of an invoice make payment to Xxxxx of the overpayment amount. ARCHEMIX Rayze shall bear the full cost of such audit unless such audit discloses an underreporting overpayment by MERCK Xxxxx to Nimble of more than at least [***] percent ([***]%) of the aggregate amount of royalties payable the Research Costs in any Calendar YearYear subject to such audit, in which case MERCK Xxxxxx shall reimburse ARCHEMIX Rayze for all the costs incurred by ARCHEMIX in connection with of such audit.

Appears in 2 contracts

Samples: Research Collaboration and License Agreement (RayzeBio, Inc.), Research Collaboration and License Agreement (RayzeBio, Inc.)

Records; Audit Rights. MERCK AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall shall) keep and maintain for [********] years from the date of each payment of royalties hereunder complete and accurate (or such longer period as may be required by Applicable Law) records of gross sales and AZ Net Sales by MERCK and AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product, Product in sufficient detail to allow royalties to be determined accurately. ARCHEMIX Targacept shall have the right for a period of [********] years after receiving any such royalty payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK AstraZeneca to audit inspect or audit, the relevant records of MERCK AstraZeneca and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK AstraZeneca and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXTargacept, solely to verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by ARCHEMIX Targacept more than [********] in any Calendar Year more than [***] or more than [*****] with respect to sales of a particular Product in a particular period or more than [***]*****] years after the end of such period. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKAstraZeneca and prior to any such inspection or audit the accountant shall enter into a non-disclosure agreement in a form reasonably acceptable to AstraZeneca. The accounting firm shall disclose to the Parties whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment by MERCK AstraZeneca hereunder, MERCK AstraZeneca shall promptly (but in any event no later than [********] days after MERCKAstraZeneca’s receipt of the report so concluding) make payment to ARCHEMIX Targacept of any shortfall. ARCHEMIX In the event that there was an overpayment by AstraZeneca hereunder, Targacept shall promptly (but in any event no later than [********] after Targacept’s receipt of the independent accountant’s report so concluding) refund to AstraZeneca the excess amount. Targacept shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK AstraZeneca of more than [***] percent ([***]%) **] of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK AstraZeneca shall reimburse ARCHEMIX Targacept for all costs incurred by ARCHEMIX Targacept in connection with such inspection or audit.

Appears in 2 contracts

Samples: Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc)

Records; Audit Rights. MERCK ELAN and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK ELAN and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ELAN to audit the relevant records of MERCK ELAN and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK ELAN and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determined. Such audit right shall not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKELAN. The results of each audit, if any, shall be promptly (but in any event no later than [***] days) after the audit reported to both Parties in writing and shall be binding on both Parties. In the event there was an underpayment by MERCK ELAN hereunder, MERCK ELAN shall promptly (but in any event no later than [***] days after MERCKELAN’s receipt of the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK ELAN of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK ELAN shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such audit.

Appears in 2 contracts

Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Each Party shall keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross sales Development Costs and Commercialization Costs incurred with respect to the Product, and, in ELAN's case, Operating Income (Loss), Sublicense Income, and Net Sales by MERCK and its Affiliates and Sublicensees or Opt Out Net Sales of each Product, the Product in sufficient detail to enable tracking of such Development Costs, Commercialization Costs, Operating Income (Loss), Net Sales or Opt Out Net Sales and Sublicense Income and to allow royalties to be determined accuratelyconfirmation of same by the other Party. ARCHEMIX Each Party shall have the right for a period of [***] years ("deleted text") after receiving any such royalty payment Development Costs and Commercialization Costs, Sublicense Income, Net Sales, Opt Out Net Sales or Operating Income (Loss) are incurred to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party to audit the relevant records of MERCK the other Party and its Affiliates and Sublicensees to verify that the amount amounts of such payment was Development Costs and Commercialization Costs, Operating Income (Loss), Sublicense Income, Opt Out Net Sales or Net Sales were correctly determined. MERCK The audited Party and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days ("deleted text") written notice from ARCHEMIXthe auditing Party, solely to verify that royalty payments hereunder such Development Costs and Commercialization Costs, Operating Income (Loss), Sublicense Income, Net Sales, or Opt Out Net Sales were correctly determined. Such audit right shall not be exercised by ARCHEMIX the auditing Party more than [***] once in any [***] or Calendar Year and no period may be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKthe audited Party. The results of each audit, if any, shall be reported in writing to both Parties promptly (but in no event later than ("deleted text") after the audit and shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs, Commercialization Costs, or Operating Income (Loss) reported by MERCK the audited Party hereunder, MERCK (a) if the amount of such costs or payments was over reported, the audited Party shall promptly (but in any event no later than [***] days ("deleted text") after MERCK’s the audited Party's receipt of the report so concluding) make payment to ARCHEMIX the auditing Party of the amount required to achieve the appropriate sharing of such costs and (b) if the amount of such costs, or income or loss was under reported, the auditing Party shall promptly (but in any shortfallevent no later than ("deleted text") after the auditing Party's receipt of the report so concluding) make payment to the audited Party of the amount required to achieve the appropriate sharing of such costs or income or loss. ARCHEMIX The auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting under-payment by MERCK the audited Party of more than [***] percent ([***]%than("deleted text") of the aggregate relevant amount of Development Costs and Commercialization Costs, Operating Income (Loss), or royalties payable in any Calendar Year, in which case MERCK the audited Party shall reimburse ARCHEMIX the auditing Party for all costs incurred by ARCHEMIX the auditing Party in connection with such audit. If the discrepancy is an under-payment of royalties to WARATAH, the amount of such underpayment shall be paid to WARATAH within ("deleted text") of receiving a copy of the audit report. If the discrepancy is an over-payment of royalties to WARATAH, the amount of such over-payment of royalties shall be paid to ELAN within ("deleted text") of receiving a copy of the audit report.

Appears in 1 contract

Samples: Collaboration Agreement (Transition Therapeutics Inc.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] two years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, and the Cost of Goods Sold applicable to all Net Sales of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX CARDIOME shall have the right for a period of [***] two (2) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days thirty (30) days' written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedCARDIOME. Such audit right shall not be exercised by ARCHEMIX CARDIOME more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in any event no later than [***] thirty (30) days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX CARDIOME of any shortfall. ARCHEMIX CARDIOME shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***Redacted - amount] percent ([***]%) of the aggregate amount of total royalties payable in any Calendar Yearthe audited period, as determined by the accountant to be correct, in which case MERCK shall reimburse ARCHEMIX CARDIOME for all costs incurred by ARCHEMIX CARDIOME in connection with such audit.

Appears in 1 contract

Samples: Collaboration and License Agreement (Cardiome Pharma Corp)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales sale and Net Sales by MERCK and its Affiliates and Sublicensees of each Royalty-Bearing Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX ARIAD shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit audit, the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedARIAD. Such audit right shall not be exercised by ARCHEMIX ARIAD more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in any event no later than [***] thirty (30) days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX the ARIAD of any shortfall. ARCHEMIX ARIAD shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than the greater of [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar YearYear or $[***], in which case MERCK shall reimburse ARCHEMIX ARIAD for all costs incurred by ARCHEMIX ARIAD in connection with such audit.

Appears in 1 contract

Samples: Collaboration Agreement (Ariad Pharmaceuticals Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Xxxxxx shall keep and maintain for [*****] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Development Costs incurred with respect to Co-Developed Products in sufficient detail to allow royalties to be determined accuratelyconfirmation of same by Enanta. ARCHEMIX Enanta shall have the right for a period of [*****] years after receiving any such royalty payment Development Cost is reconciled in accordance with Section 5.2 to appoint inspect or audit, or to appoint, at its expense expense, an independent certified public accountant reasonably acceptable to MERCK Xxxxxx to audit inspect or audit, the relevant records of MERCK Xxxxxx and its Affiliates and Sublicensees to verify that the amount of such payment Development Costs was correctly determined. MERCK Xxxxxx and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXEnanta, solely to verify that royalty payments Development Costs hereunder were correctly determined. Such audit right ; provided that Enanta shall not be exercised by ARCHEMIX more than have the right to inspect or audit any Calendar Year [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKXxxxxx. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs reported by MERCK Xxxxxx hereunder, MERCK (a) if the amount of Development Costs was over-reported, Xxxxxx shall promptly (but in any event no later than [*****] days after MERCK’s Xxxxxx’x receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX Enanta of the over-reported amount and (b) if the amount of Development Costs was underreported, Enanta shall promptly (but in any shortfallevent no later than [*****] after Enanta’s receipt of the independent accountant’s report so concluding) make payment to Xxxxxx of the underreported amount. ARCHEMIX Enanta shall bear the full cost of such audit unless such audit discloses an underreporting over-reporting by MERCK Xxxxxx of more than [***] percent ([***]%) ] of the aggregate amount of royalties payable Development Costs reportable in any Calendar Year, in which case MERCK Xxxxxx shall reimburse ARCHEMIX Enanta for all costs incurred by ARCHEMIX Enanta in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)

Records; Audit Rights. MERCK and GSK, its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and GSK, its Affiliates and Sublicensees of each Royalty-Bearing Product, in sufficient detail to allow royalties to be determined accuratelyaccurately by an independent certified public accountant. ARCHEMIX SYNTA shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK GSK to audit the relevant records of MERCK GSK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and GSK, its Affiliates and Sublicensees shall each make its records available for audit by such the independent certified public accountant during regular business hours at such place or places where such records are customarily keptkept (for clarity these records may be kept at local business sites and not centrally in one location), upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedSYNTA. Such audit right shall not be exercised by ARCHEMIX SYNTA more than [***] once in any [***] Calendar Year or more than [***] with respect to sales of a particular Royalty-Bearing Product in a [***]twelve (12) month period. The independent certified public accountant will only disclose the results (any sums either over/under paid) of such audit to SYNTA and no other details. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both PartiesGSK. In the event there was an underpayment by MERCK GSK or overpayment to SYNTA hereunder, MERCK then the relevant Party shall promptly (but in any event no later than [***] days after MERCKGSK’s receipt of the report so concluding) make payment to ARCHEMIX the other Party of any shortfallamount due. ARCHEMIX SYNTA shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK GSK of more than at least [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK GSK shall reimburse ARCHEMIX SYNTA for all costs incurred by ARCHEMIX SYNTA in connection with such audit.

Appears in 1 contract

Samples: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees (a) Genentech shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete full, true and accurate records books of gross sales account containing all particulars which may be necessary for the purpose of showing Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and Net Sales by MERCK Third Party Manufacturing Royalties. Said books of account shall be kept at the principal place of business of Genentech. Said books and its Affiliates the supporting data shall be open at all reasonable times, for three (3) years following the end of the calendar year to which they pertain (and Sublicensees access shall not be denied thereafter, if reasonably available), to the inspection of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant retained by Connetics and reasonably acceptable to MERCK Genentech for the purpose of verifying Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and Third Party Manufacturing Royalties under this Agreement; provided, however, that Connetics shall give Genentech reasonable prior notice of such review by Connetics' independent public accountant and that such review shall not take place more often than once a year. If such review reveals that Connetics has overpaid Genentech for Bulk Product or Finished Product supplied hereunder, Genentech shall refund to audit the relevant records of MERCK and its Affiliates and Sublicensees to verify that Connetics the amount of such payment was correctly determinedoverpayment, plus interest thereon at the prime rate of interest as reported by Bank of America in San Francisco, California at the time of such review. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by If such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determined. Such audit right shall not be exercised by ARCHEMIX more overpayment is greater than [**] of the actual amount that should have been charged to Connetics, then Genentech shall pay Connetics' actual costs of such review. (b) Connetics shall pay to Genentech [*] in any [***of Genentech's fully burdened costs related to requests by Connetics to audit or inspect Genentech's, or Genentech's third party [ * ] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, if anyMARKED BY BRACKETS, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunderHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, MERCK shall promptly (but in any event no later than [***] days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such audit.AS AMENDED

Appears in 1 contract

Samples: Supply Agreement (Intermune Pharmaceuticals Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees (a) Genentech shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete full, true and accurate records books of gross sales account containing all particulars which may be necessary for the purpose of showing Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and Net Sales Third Party Manufacturing Royalties. Said books of account shall be kept at the principal place of business of Genentech. Said books and the supporting data shall be open at all reasonable times, for three (3) years following the end of the calendar year to which they pertain (and access shall not be denied thereafter, if reasonably available), to the inspection of an independent public accountant retained by MERCK Connetics and its Affiliates reasonably acceptable to Genentech for the purpose of verifying Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and Sublicensees Third Party Manufacturing Royalties under this Agreement; provided, however, that Connetics shall give Genentech reasonable prior notice of each Productsuch review by Connetics' independent public accountant and that such review shall not take place more often than once a year. If such review reveals that Connetics has overpaid Genentech for Bulk Product or Finished Product supplied hereunder, Genentech shall refund to Connetics the amount of such overpayment, plus interest thereon at the prime rate of interest as reported by Bank of America in sufficient detail San Francisco, California at the time of such review. If such overpayment is greater than [1] of the actual amount that should have been charged to allow royalties Connetics, then Genentech shall pay Connetics' actual costs of such review. (b) Connetics shall pay to be determined accuratelyGenentech [1] of Genentech's fully burdened costs related to requests by Connetics to audit or inspect Genentech's, or Genentech's third party contract manufacturer's, manufacturing facility, and such audits or inspections may occur only for the purpose of compliance with regulatory obligations. ARCHEMIX Connetics shall have the right to conduct such an audit, or such an inspection, of Genentech's, or Genentech's third party contract manufacturer's, manufacturing facility once every twenty-four (24) months from the Effective Date hereof and no more frequently than in twenty-four (24) month intervals, with at least ten [1] Confidential treatment has been requested for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determined. Such audit right shall not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]language which has been omitted. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both Parties. In such omitted material has been filed separately with the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in any event no later than [***] days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such auditSEC.

Appears in 1 contract

Samples: Supply Agreement (Connetics Corp)

Records; Audit Rights. MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors of each Product, in sufficient detail to allow royalties to be determined accuratelyaccurately determined. ARCHEMIX SUBLICENSOR shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ILDONG to audit the relevant records of MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors to verify that the amount of each such payment was correctly determined; provided, that, (a) if requested by ILDONG, SUBLICENSOR shall cause the independent certified public accountant to enter into a confidentiality agreement reasonably acceptable to ILDONG and (b) such independent certified public accountant may only disclose to SUBLICENSOR whether the royalties paid are correct and the details with respect to any discrepancies. MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedSUBLICENSOR. Such audit right shall not be exercised by ARCHEMIX SUBLICENSOR more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKILDONG. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment of royalties by MERCK ILDONG hereunder, MERCK ILDONG shall promptly (but in any event no later than [***] thirty (30) days after MERCKILDONG’s receipt of the report so concluding) make payment to ARCHEMIX SUBLICENSOR of any shortfall. ARCHEMIX SUBLICENSOR shall bear the full cost of such audit unless such audit discloses an underreporting underpayment by MERCK ILDONG of more than [***] * percent ([***]%) or more of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK ILDONG shall reimburse ARCHEMIX SUBLICENSOR for all costs incurred by ARCHEMIX SUBLICENSOR in connection with such audit. * Confidential material redacted and filed separately with the Commission.

Appears in 1 contract

Samples: Sublicense Agreement (Tg Therapeutics, Inc.)

Records; Audit Rights. MERCK DS and its Affiliates and Sublicensees shall keep and maintain for [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK DS and its Affiliates and Sublicensees of each Licensed Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX ARQULE shall have the right for a period of [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK DS to audit the relevant records of MERCK DS and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK DS and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [* (***] ) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedARQULE. Such audit right shall not be exercised by ARCHEMIX ARQULE more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Licensed Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKDS. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment by MERCK DS hereunder, MERCK DS shall promptly (but in any event no later than [* (***] ) days after MERCKDS’s receipt of the report so concluding) make payment to ARCHEMIX ARQULE of any shortfall. ARCHEMIX Should the audit lead to the discovery of a discrepancy to DS’s detriment, then DS may credit the amount of the discrepancy without interest against any future payments due to ARQULE under Section 4.3.1. ARQULE shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK DS of more than [***] * percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK DS shall reimburse ARCHEMIX ARQULE for all costs incurred by ARCHEMIX ARQULE in connection with such audit.

Appears in 1 contract

Samples: License and Co Commercialization Agreement (Arqule Inc)

Records; Audit Rights. MERCK (a) Lilly shall, and shall cause its Affiliates and its and their Sublicensees to, keep materially complete and accurate financial books and records pertaining to the commercialization of Products hereunder, including books and records of Net Sales of Products, in sufficient detail to calculate and verify all amounts payable hereunder. Lilly shall, and shall keep cause its Affiliates and maintain its and their Sublicensees to, retain such books and records until the latest of (a) [***] ([***]) years after the end of the period to which such books and records pertain, (b) the expiration of the applicable tax statute of limitations (or any extensions thereof) and (c) for such period as may be required by Applicable Law. (b) During the Term, Aduro shall not more than [***], have the right to have Lilly’s independent certified public accountants, or an independent auditor designated by Aduro from among one of the internationally recognized accounting firms known as KPMG, Deloitte, PricewaterhouseCoopers or Ernst & Young (i.e., the “Big 4” global accounting firms) (the “Auditor”), inspect Lilly’s records for [***] years from prior to the date Calendar Year in which the audit request is made, for the purpose of each payment determining the accuracy of royalties hereunder complete royalty payments. No period will be audited more than once. Aduro shall submit an audit plan, including audit scope, to Lilly [***], prior to audit implementation. The Auditor shall keep confidential any information obtained during such inspection and accurate records shall report to Aduro and Lilly only the amounts of gross net sales and Net Sales by MERCK royalties due and its Affiliates and Sublicensees of each Productpayable. If determined that additional royalties are owed, in sufficient detail to allow or that royalties to be determined accurately. ARCHEMIX shall have were overpaid, during such period, Lilly will pay Aduro the right for a period of additional royalties, or Aduro will pay Lilly the overpaid royalties, within [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determined. Such audit right shall not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a ([***]. All records made available for audit shall be deemed to be Confidential Information ) days of MERCKthe date the Auditor’s written report is received by the paying party. The results of each auditfees charged by the Auditor will be paid by Aduro, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in unless any event no later than [***] days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than additional royalties owed exceed [***] percent ([***]%) and [***] U.S. dollars ($[***]) of the aggregate amount of royalties payable in any Calendar Yearpaid for the royalty period subject to audit, in which case MERCK shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such auditLilly will pay the fees of the Auditor.

Appears in 1 contract

Samples: Research Collaboration and Exclusive License Agreement (Aduro Biotech, Inc.)

Records; Audit Rights. MERCK Purchaser and its Affiliates and Sublicensees licensees shall keep and maintain for [***] years from the date of each payment of royalties Net Sales payments hereunder complete and accurate records of gross sales Gross Sales and Net Sales by MERCK Purchaser and its Affiliates and Sublicensees of each Product, licensees in sufficient detail to allow royalties Net Sales payments to be determined accurately. ARCHEMIX Seller shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK Purchaser to audit the relevant records of MERCK Purchaser and its Affiliates and Sublicensees licensees to verify that the amount of such payment was correctly determined. MERCK Purchaser and its Affiliates and Sublicensees licensees shall each make its their records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedSeller. Such audit right shall not be exercised by ARCHEMIX Seller more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both PartiesPurchaser. In the event there was an underpayment by MERCK Purchaser hereunder, MERCK Purchaser shall promptly (but in any event no later than [***] days after MERCKPurchaser’s receipt of the report so concluding) make payment to ARCHEMIX Seller of any undisputed shortfall. ARCHEMIX In the event there was an overpayment by Purchaser hereunder, Purchaser may credit such overpayment to any future payments due under this Agreement. Seller shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK Purchaser of more than [***] percent ([***]%) or more of the aggregate amount of royalties royalty payments payable in any Calendar Year, in which case MERCK Purchaser shall reimburse ARCHEMIX Seller for all reasonable costs incurred by ARCHEMIX Seller in connection with such audit.

Appears in 1 contract

Samples: Asset Purchase Agreement (Alto Neuroscience, Inc.)

Records; Audit Rights. MERCK Affini-T and its Affiliates and Sublicensees involved in booking sales of the Licensed Product shall keep and maintain for [***] years from the date end of each payment of royalties hereunder the Calendar Year in which Net Sales occurred (the “Retention Period”) complete and accurate records of gross sales and Net Sales by MERCK by, as applicable, Affini-T and its Affiliates and Sublicensees of each Licensed Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX Metagenomi shall have the right for a period of [***] years after receiving any such royalty payment during the applicable Retention Period to appoint at its expense an a nationally recognized independent certified public accountant reasonably acceptable to MERCK Affini-T to audit the relevant records of MERCK Affini-T and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK Affini-T and its Affiliates and Sublicensees shall each make its records available for audit by such nationally recognized independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days ]written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedMetagenomi. Such audit right shall not be exercised by ARCHEMIX Metagenomi more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Licensed Product in a [***]particular period and such audit shall not unreasonably interfere with or impede Affini-T’s or its Affiliate’s or sublicensee’s business operations. All records made available for audit shall be deemed to be Confidential Information of MERCK. Affini-T. The results of each audit, if any, shall be provided to and are binding on both PartiesParties absent manifest error; provided, that, Affini-T shall be provided an opportunity to discuss the findings of any such audit with the auditor prior to disclosure of the results thereof to Metagenomi. In the event there was an underpayment by MERCK Xxxxxx-T hereunder, MERCK Affini-T shall promptly (but in any event no later than [***] days after MERCKAffini-T’s receipt of the report so concluding) make payment to ARCHEMIX Metagenomi of any shortfall. ARCHEMIX Metagenomi shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK Affini-T of more than [***] percent (or at least [***]%) ] of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK Affini-T shall reimburse ARCHEMIX Metagenomi for all costs incurred [***]. In the event there was an overpayment by ARCHEMIX Affini-T hereunder, Affini-T may, at its discretion, credit such overpayment in connection with the next royalty payment or request Metagenomi to and Metagenomi shall promptly (but in any event no later than [***] after Metagenomi’s receipt of the report so concluding) make repayment to Affini-T of any such auditoverage.

Appears in 1 contract

Samples: Development, Option and License Agreement (Metagenomi Technologies, LLC)

Records; Audit Rights. MERCK Biotest and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of royalties hereunder complete and accurate records of their respective Commercialization Expenses, as well as all gross sales and Net Sales by MERCK Biotest and its Affiliates and Sublicensees of each Licensed Product, in sufficient detail to allow royalties to be determined accurately and ImmunoGen and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of Net Income Payments complete and accurate records of its Commercialization Expenses, as well as all gross sales and Net Sales of each Co-Developed Product in sufficient detail to allow Net Income Payments to be determined accurately. ARCHEMIX Each Party shall have the right for a period of [***] ([***]) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party to inspect or audit the relevant records of MERCK and such Party, its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and The Audited Party, its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXthe Auditing Party, solely to verify that Commercialization Expenses, royalty and Net Income payments hereunder were correctly accounted for or determined. Such inspection or audit right shall not be exercised by ARCHEMIX the Auditing Party more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Licensed Product in a [***]particular period. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKthe Audited Party. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK the Audited Party hereunder, MERCK the Audited Party shall promptly (but in any event no later than [***] ([***]) days after MERCKthe Audited Party’s receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX the Auditing Party of any shortfall. ARCHEMIX In the event that there was an overpayment by the Audited Party hereunder, the Auditing Party shall promptly (but in any event no later than [***] ([***]) days after the Auditing Party’s receipt of the independent accountant’s report so concluding) refund to the Audited Party the excess amount. The Auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK the Audited Party of more than [***] percent ([***]%) of the aggregate amount of royalties payable or Net Income Payments payable, or Commercialization Expenses allocable, in any Calendar Year, in which case MERCK the Audited Party shall reimburse ARCHEMIX the Auditing Party for all costs incurred by ARCHEMIX the Auditing Party in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Immunogen Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right for For a period of [***] ([***]) years after receiving following receipt by Biotest of any accounting described in this Section 5.1.5, ImmunoGen shall keep complete and accurate records pertaining to the Pivotal MAY Compound Process Development Costs and the Pivotal MAY Compound Process Development Percentage in sufficient detail to allow the accuracy of the payments hereunder to be confirmed. At each meeting of the JDC the Parties shall update the JDC as to such royalty payment Pivotal MAY Compound Process Development Costs incurred through the date of such JDC meeting. ImmunoGen shall keep complete and accurate records of associated Pivotal MAY Compound Process Development Costs in sufficient detail to allow the accuracy of the payments hereunder to be confirmed. Biotest shall have the right to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ImmunoGen to inspect or audit the relevant records of MERCK ImmunoGen and its Affiliates and Sublicensees to verify that the amount of such payment Pivotal MAY Compound Process Development Costs was correctly determined. MERCK ImmunoGen and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXBiotest, solely to verify that royalty payments Pivotal MAY Compound Process Development Costs hereunder were correctly determined. Such inspection or audit right shall not be exercised by ARCHEMIX Biotest more than [***] once in any [***] or more than [***] with respect to sales of a particular Product in a [***]Calendar Year. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKImmunoGen. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Pivotal MAY Compound Process Development Costs reported by MERCK ImmunoGen hereunder, MERCK (a) if the amount of Pivotal MAY Compound Process Development Costs was over-reported, ImmunoGen shall promptly (but in any event no later than [***] ([***]) days after MERCK’s the ImmunoGen's receipt of the independent accountant's report so concluding) make payment to ARCHEMIX Biotest of the amount owed to Biotest, and (b) if the amount of Pivotal MAY Compound Process Development Costs was underreported, Biotest shall promptly (but in any shortfallevent no later than [***] ([***]) days after Biotest's receipt of the independent accountant's report so concluding) make payment to ImmunoGen of the amount owed to ImmunoGen. ARCHEMIX Biotest shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK ImmunoGen of more than [***] percent [***] ([***]%) of the aggregate amount of royalties payable Pivotal MAY Compound Process Development Costs reportable in any Calendar Year, in which case MERCK ImmunoGen shall reimburse ARCHEMIX Biotest for all costs incurred by ARCHEMIX Biotest in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Immunogen Inc)

Records; Audit Rights. MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors of each Product, in sufficient detail to allow royalties to be determined accuratelyaccurately determined. ARCHEMIX SUBLICENSOR shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ILDONG to audit the relevant records of MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors to verify that the amount of each such payment was correctly determined; provided, that, (a) if requested by ILDONG, SUBLICENSOR shall cause the independent certified public accountant to enter into a confidentiality agreement reasonably acceptable to ILDONG and (b) such independent certified public accountant may only disclose to SUBLICENSOR whether the royalties paid are correct and the details with respect to any discrepancies. MERCK ILDONG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedSUBLICENSOR. Such audit right shall not be exercised by ARCHEMIX SUBLICENSOR more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKILDONG. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment of royalties by MERCK ILDONG hereunder, MERCK ILDONG shall promptly (but in any event no later than [***] thirty (30) days after MERCKILDONG’s receipt of the report so concluding) make payment to ARCHEMIX SUBLICENSOR of any shortfall. ARCHEMIX SUBLICENSOR shall bear the full cost of such audit unless such audit discloses an underreporting underpayment by MERCK ILDONG of more than [***] * percent ([***]%) or more of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK ILDONG shall reimburse ARCHEMIX SUBLICENSOR for all costs incurred by ARCHEMIX SUBLICENSOR in connection with such audit.

Appears in 1 contract

Samples: Sublicense Agreement (Tg Therapeutics, Inc.)

Records; Audit Rights. MERCK AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall shall) keep and maintain for [********] years from the date of each payment of royalties hereunder complete and accurate (or such longer period as may be required by Applicable Law) records of gross sales and AZ Net Sales by MERCK and AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product, Product in sufficient detail to allow royalties to be determined accurately. ARCHEMIX Targacept shall have the right for a period of [********] years after receiving any such royalty payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK AstraZeneca to audit inspect or audit, the relevant records of MERCK AstraZeneca and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK AstraZeneca and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXTargacept, solely to verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by ARCHEMIX Targacept more than [********] in any Calendar Year more than [***] or more than [*****] with respect to sales of a particular Product in a particular period or more than [***]*****] years after the end of such period. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKAstraZeneca and prior to any such inspection or audit the accountant shall enter into a non-disclosure agreement in a form reasonably acceptable to AstraZeneca. The accounting firm shall disclose to the Parties whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment by MERCK AstraZeneca hereunder, MERCK AstraZeneca shall promptly (but in any event no later than [********] days after MERCKAstraZeneca’s receipt of the report so concluding) make payment to ARCHEMIX Targacept of any shortfall. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such audit.any

Appears in 1 contract

Samples: Collaborative Research and License Agreement (Targacept Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Each Party shall keep and maintain for [***] ([***]) years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Co-Development Costs incurred with respect to Licensed Products in sufficient detail to allow royalties confirmation of same by the JFC. Each Party Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to be determined accuratelythe Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. ARCHEMIX shall have the right for a period of [***] ([***]) years after receiving any such royalty payment Development Cost is reconciled in accordance with Section 5.2.1 to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party to inspect or audit the relevant records of MERCK the other Party and its Affiliates and Sublicensees to verify that the amount of such payment Co-Development Costs was correctly determined. MERCK The Audited Party and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXthe Auditing Party, solely to verify that royalty payments Co-Development Costs hereunder were correctly determined. Such inspection or audit right shall not be exercised by ARCHEMIX the Auditing Party more than [***] once in any [***] or more than [***] with respect to sales of a particular Product in a [***]Calendar Year. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKthe Audited Party. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Co-Development Costs reported by MERCK the Audited Party hereunder, MERCK (a) if the amount of Co-Development Costs was over-reported, the Audited Party shall promptly (but in any event no later than [***] ([***]) days after MERCK’s the Audited Party's receipt of the independent accountant's report so concluding) make payment to ARCHEMIX the Auditing Party of a percentage of the over-reported amount consistent with the equal sharing of Development Costs and (b) if the amount of Co-Development Costs was underreported, the Auditing Party shall promptly (but in any shortfallevent no later than [***] ([***]) days after the Auditing Party's receipt of the independent accountant's report so concluding) make payment to the Audited Party of a percentage of the underreported amount consistent with the equal sharing of Development Costs. ARCHEMIX The Auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK the Audited Party of more than [***] percent [***] ([***]%) of the aggregate amount of royalties payable Co-Development Costs reportable in any Calendar Year, in which case MERCK the Audited Party shall reimburse ARCHEMIX the Auditing Party for all costs incurred by ARCHEMIX the Auditing Party in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Immunogen Inc)

Records; Audit Rights. MERCK “[***]” shall, and shall cause its Affiliates and permitted Sublicensees shall to, keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder under Section 4.5.1(a) (Royalty Rate) complete and accurate records of gross sales and Net Sales of each Collaboration Product by MERCK and “[***]”, its Affiliates and Sublicensees of each Productits permitted Sublicensees, in sufficient detail to allow royalties the payments owing under Section 4.5.1(a) (Royalty Rate) to be determined accurately. ARCHEMIX Intec Pharma shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint appoint, at its expense expense, an independent certified public accountant reasonably acceptable to MERCK “[***]”, to audit the relevant records of MERCK and “[***]”, its Affiliates and its permitted Sublicensees in order to verify that the amount of such payment was correctly determined. MERCK and “[***]”, its Affiliates and its permitted Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedIntec Pharma. Such audit right shall not be exercised by ARCHEMIX Intec Pharma more than [***] once in any [***] or more than [***] with respect to sales of a particular Product in a [***]Calendar Year. All records made available for audit shall be deemed to be Confidential Information of MERCK“[***]”. The results of each audit, if any, shall be binding on both Parties. In the event If such independent certified public accountant correctly concludes that there was an underpayment by MERCK “[***]” hereunder, MERCK “[***]” shall promptly (but in any event no later than [***] forty-five (45) days after MERCKIntec Pharma’s receipt of the report so concluding) make payment to ARCHEMIX Intec Pharma of any shortfall. ARCHEMIX Intec Pharma shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than [***] percent ([***]” or its Affiliates or permitted Sublicensees of five percent (5%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK “[***]” shall reimburse ARCHEMIX Intec Pharma for all costs incurred by ARCHEMIX Intec Pharma in connection with such audit. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE.

Appears in 1 contract

Samples: Research, Option and License Agreement (Intec Pharma Ltd.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of royalties hereunder complete and accurate records of gross sales sale and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX ARIAD shall have the right for a period of [***] ([***]) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit audit, the relevant records of MERCK and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedARIAD. Such audit right shall not be exercised by ARCHEMIX ARIAD more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunder, MERCK shall promptly (but in any event no later than [***] thirty (30) days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX ARIAD of any shortfall. ARCHEMIX ARIAD shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK of more than the greater of [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar YearYear or $[***], in which case MERCK shall reimburse ARCHEMIX ARIAD for all costs incurred by ARCHEMIX ARIAD in connection with such audit.

Appears in 1 contract

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

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Records; Audit Rights. MERCK Biogen shall, and shall cause its Affiliates and permitted Sublicensees shall to, keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder under Section 4.5.1(a) (Royalty Rate) complete and accurate records of gross sales and Net Sales of each Collaboration Product by MERCK and Biogen, its Affiliates and Sublicensees of each Productits permitted Sublicensees, in sufficient detail to allow royalties the payments owing under Section 4.5.1(a) (Royalty Rate) to be determined accurately. ARCHEMIX Intec Pharma shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint appoint, at its expense expense, an independent certified public accountant reasonably acceptable to MERCK Biogen, to audit the relevant records of MERCK and Biogen, its Affiliates and its permitted Sublicensees in order to verify that the amount of such payment was correctly determined. MERCK and Biogen, its Affiliates and its permitted Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedIntec Pharma. Such audit right shall not be exercised by ARCHEMIX Intec Pharma more than [***] once in any [***] or more than [***] with respect to sales of a particular Product in a [***]Calendar Year. All records made available for audit shall be deemed to be Confidential Information of MERCKBiogen. The results of each audit, if any, shall be binding on both Parties. In the event If such independent certified public accountant correctly concludes that there was an underpayment by MERCK Biogen hereunder, MERCK Biogen shall promptly (but in any event no later than [***] forty-five (45) days after MERCKIntec Pharma’s receipt of the report so concluding) make payment to ARCHEMIX Intec Pharma of any shortfall. ARCHEMIX Intec Pharma shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK Biogen or its Affiliates or permitted Sublicensees of more than [***] five percent ([***]5%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK Biogen shall reimburse ARCHEMIX Intec Pharma for all costs incurred by ARCHEMIX Intec Pharma in connection with such audit. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE.

Appears in 1 contract

Samples: Research and License Agreement (Intec Pharma Ltd.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees ARIAD shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales Development Costs and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Commercialization Costs incurred with respect to Products in sufficient detail to allow royalties confirmation of same by MERCK, including without limitation confirmation of the proper allocation of FTEs to be determined accuratelyDevelopment of Products. ARCHEMIX MERCK shall have the right for a period of [***] years after receiving any such royalty payment Development Cost or Commercialization Cost is reported in accordance with Section 3.11.2(a) to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ARIAD to audit the relevant records of MERCK ARIAD and its Affiliates and Sublicensees to verify that the amount of such payment was Development Costs and Commercialization Costs were correctly determined. MERCK ARIAD and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedMERCK. Such audit right shall not be exercised by ARCHEMIX MERCK more than [***] once in any [***] or Calendar Year and the records of Development Costs and Commercialization Costs for a given period may not be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKARIAD. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs and Commercialization Costs reported by ARIAD hereunder, (a) if the amount of Development Costs and Commercialization Costs was over reported, ARIAD shall promptly (but in any event no later than thirty (30) days after ARIAD’s receipt of the report so concluding) make payment to MERCK hereunderof the over reported amount and (b) if the amount of Development Costs and Commercialization Costs was underreported, MERCK shall promptly (but in any event no later than [***] thirty (30) days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX ARIAD of any shortfallthe underreported amount. ARCHEMIX MERCK shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK ARIAD of more than [***] percent (the greater of [***]%) % of the aggregate amount of royalties payable Development Costs and Commercialization Costs reportable in any Calendar YearYear or $[***], in which case MERCK ARIAD shall reimburse ARCHEMIX MERCK for all costs incurred by ARCHEMIX MERCK in connection with such audit.

Appears in 1 contract

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

Records; Audit Rights. MERCK and its Affiliates and Sublicensees CARDIOME shall keep and maintain for [***] two years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales Development Costs incurred by MERCK and its Affiliates and Sublicensees of each Product, it in accordance with a Global Development Plan in sufficient detail to allow royalties confirmation of same by the JSC and MERCK, including confirmation of the proper allocation of FTEs to be determined accuratelyDevelopment of Products. ARCHEMIX MERCK shall have the right for a period of [***] two (2) years after receiving any such royalty payment receipt of the report referred to in Section 2.8.1 to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK CARDIOME to audit the relevant records of MERCK CARDIOME and its Affiliates and Sublicensees to verify that the amount of such payment Development Costs was correctly determined. MERCK CARDIOME and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days thirty (30) days' written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedMERCK. Such audit right shall not be exercised by ARCHEMIX MERCK more than [***] once in any [***] or Calendar Year and the records of Development Costs for a given period may not be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKCARDIOME. The results of each audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs reported by CARDIOME hereunder, (a) if the amount of Development Costs was overpaid, CARDIOME shall promptly (but in any event no later than thirty (30) days after CARDIOME’s receipt of the report so concluding) make payment to MERCK hereunderof the overpaid amount and (b) if the amount of Development Costs was underpaid, MERCK shall promptly (but in any event no later than [***] thirty (30) days after MERCK’s receipt of the report so concluding) make payment to ARCHEMIX CARDIOME of any shortfallthe underpaid amount. ARCHEMIX MERCK shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK CARDIOME of more than [***Redacted - amount] percent ([***]%) of the aggregate amount of royalties payable Development Costs reportable in any Calendar Year, in which case MERCK CARDIOME shall reimburse ARCHEMIX MERCK for all costs incurred by ARCHEMIX MERCK in connection with such audit.

Appears in 1 contract

Samples: Collaboration and License Agreement (Cardiome Pharma Corp)

Records; Audit Rights. MERCK Xxxxxx and its Affiliates and Sublicensees shall keep and maintain for [*****] years from the date of each payment of royalties hereunder Royalty Payment, Operating Income Payment and Sublicense Income Payment complete and accurate records of gross sales and Net Sales by MERCK Xxxxxx and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties Royalty Payments, Operating Income Payments and Sublicense Income Payments to be determined accurately. ARCHEMIX Enanta shall have the right for a period of [*****] years after receiving any such royalty payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK Xxxxxx to inspect or audit the relevant records of MERCK Xxxxxx and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK Xxxxxx and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXEnanta, solely to verify that royalty payments hereunder Royalty Payments and Sublicense Income Payments were correctly accounted for or determined. Such Enanta shall not exercise such inspection or audit right shall not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKXxxxxx. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK hereunderXxxxxx, MERCK Xxxxxx shall promptly (but in any event no later than [*****] days after MERCK’s Xxxxxx’x receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX Enanta of any shortfall, together with the interest payment as provided in Section 6.5.5. ARCHEMIX In the event that there was an overpayment by Xxxxxx, Enanta shall promptly (but in any event no later than [*****] after Enanta’s receipt of the independent accountant’s report so concluding) refund to Xxxxxx the excess amount. Enanta shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK Xxxxxx of more than [***] percent ([***]%) ] of the aggregate amount of royalties Royalty Payment or Sublicense Income Payments payable in any Calendar Year, in which case MERCK Xxxxxx shall reimburse ARCHEMIX Enanta for all costs incurred by ARCHEMIX Enanta in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Each Party shall keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross sales Development Costs and Commercialization Costs incurred with respect to the Product, and, in ELAN’s case, Operating Income (Loss), Sublicense Income, and Net Sales by MERCK and its Affiliates and Sublicensees or Opt Out Net Sales of each Product, the Product in sufficient detail to enable tracking of such Development Costs, Commercialization Costs, Operating Income (Loss), Net Sales or Opt Out Net Sales and Sublicense Income and to allow royalties to be determined accuratelyconfirmation of same by the other Party. ARCHEMIX Each Party shall have the right for a period of [***] years three (3) Calendar Years after receiving any such royalty payment Development Costs and Commercialization Costs, Sublicense Income, Net Sales, Opt Out Net Sales or Operating Income (Loss) are incurred to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party to audit the relevant records of MERCK the other Party and its Affiliates and Sublicensees to verify that the amount amounts of such payment was Development Costs and Commercialization Costs, Operating Income (Loss), Sublicense Income, Opt Out Net Sales or Net Sales were correctly determined. MERCK The audited Party and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIXthe auditing Party, solely to verify that royalty payments hereunder such Development Costs and Commercialization Costs, Operating Income (Loss), Sublicense Income, Net Sales, or Opt Out Net Sales were correctly determined. Such audit right shall not be exercised by ARCHEMIX the auditing Party more than [***] once in any [***] or Calendar Year and no period may be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKthe audited Party. The results of each audit, if any, shall be reported in writing to both Parties promptly (but in no event later than thirty (30) days) after the audit and shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs, Commercialization Costs, or Operating Income (Loss) reported by MERCK the audited Party hereunder, MERCK (a) if the amount of such costs or payments was over reported, the audited Party shall promptly (but in any event no later than [***] thirty (30) days after MERCKthe audited Party’s receipt of the report so concluding) make payment to ARCHEMIX the auditing Party of the amount required to achieve the appropriate sharing of such costs and (b) if the amount of such costs, or income or loss was under reported, the auditing Party shall promptly (but in any shortfallevent no later than thirty (30) days after the auditing Party’s receipt of the report so concluding) make payment to the audited Party of the amount required to achieve the appropriate sharing of such costs or income or loss. ARCHEMIX The auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting under-payment by MERCK the audited Party of more than [***] seven and one half percent ([***]7.5%) of the aggregate relevant amount of Development Costs and Commercialization Costs, Operating Income (Loss), or royalties payable in any Calendar Year, in which case MERCK the audited Party shall reimburse ARCHEMIX the auditing Party for all costs incurred by ARCHEMIX the auditing Party in connection with such audit. If the discrepancy is an under-payment of royalties to WARATAH, the amount of such underpayment shall be paid to WARATAH within ten (10) business days of receiving a copy of the audit report. If the discrepancy is an over-payment of royalties to WARATAH, the amount of such over-payment of royalties shall be paid to ELAN within ten (10) business days of receiving a copy of the audit report.

Appears in 1 contract

Samples: Collaboration Agreement (Transition Therapeutics Inc.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Xxxxxx shall keep and maintain for [*****] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Development Costs incurred with respect to Co-Developed Products in sufficient detail to allow royalties to be determined accuratelyconfirmation of same by Enanta. ARCHEMIX Enanta shall have the right for a period of [*****] years after receiving any such royalty payment Development Cost is reconciled in accordance with Section 5.2 to appoint inspect or audit, or to appoint, at its expense expense, an independent certified public accountant reasonably acceptable to MERCK Xxxxxx to audit inspect or audit, the relevant records of MERCK Xxxxxx and its Affiliates and Sublicensees to verify that the amount of such payment Development Costs was correctly determined. MERCK Xxxxxx and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXEnanta, solely to verify that royalty payments Development Costs hereunder were correctly determined. Such audit right ; provided that Enanta shall not be exercised by ARCHEMIX more than have the right to inspect or audit any Calendar Year [***] in any [***] or more than [***] with respect to sales of a particular Product in a [***]. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKXxxxxx. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Development Costs reported by MERCK Xxxxxx hereunder, MERCK (a) if the amount of Development Costs was over-reported, Xxxxxx shall promptly (but in any event no later than [*****] days after MERCK’s Xxxxxx’x receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX Enanta of the over-reported amount and (b) if the amount of Development Costs was underreported, Enanta shall promptly (but in any shortfallevent no later than [*****] after Enanta’s receipt of the independent accountant’s report so concluding) make payment to Xxxxxx of the underreported amount. ARCHEMIX Enanta shall bear the full cost of such audit unless such audit discloses - 30 - Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 3/21/2019 <![CDATA[Collaborative Development & License Agreement]]> xxxxx://xxx.xxx.xxx/Archives/xxxxx/data/1177648/000119312512454422/d401292dex101.htm 36/136 an underreporting over-reporting by MERCK Xxxxxx of more than [***] percent ([***]%) ] of the aggregate amount of royalties payable Development Costs reportable in any Calendar Year, in which case MERCK Xxxxxx shall reimburse ARCHEMIX Enanta for all costs incurred by ARCHEMIX Enanta in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development & License Agreement

Records; Audit Rights. MERCK TG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall keep and maintain for [***] three (3) years from the date of each payment of royalties and/or Sublicense Royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK TG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors of each Product, in sufficient detail to allow royalties and/or Sublicense Royalties to be determined accuratelyaccurately determined. ARCHEMIX LICENSOR shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK TG to audit the relevant records of MERCK TG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors to verify that the amount of each such payment was correctly determined; provided, that, (a) if requested by TG, LICENSOR shall cause the independent certified public accountant to enter into a confidentiality agreement reasonably acceptable to TG and (b) such independent certified public accountant may only disclose to LICENSOR whether the royalties and/or Sublicense Royalties paid are correct and the details with respect to any discrepancies. MERCK TG and its Affiliates Affiliates, Sublicensees and Sublicensees Distributors shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedLICENSOR. Such audit right shall not be exercised by ARCHEMIX LICENSOR more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKTG. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment of royalties by MERCK TG hereunder, MERCK TG shall promptly (but in any event no later than [***] thirty (30) days after MERCKTG’s receipt of the report so concluding) make payment to ARCHEMIX LICENSOR of any shortfall. ARCHEMIX LICENSOR shall bear the full cost of such audit unless such audit discloses an underreporting underpayment by MERCK TG of more than [***] five percent ([***]5%) or more of the aggregate amount of royalties and/or Sublicense Royalties payable in any Calendar Year, in which case MERCK TG shall reimburse ARCHEMIX LICENSOR for all costs incurred by ARCHEMIX LICENSOR in connection with such audit.

Appears in 1 contract

Samples: Exclusive License Agreement (Manhattan Pharmaceuticals Inc)

Records; Audit Rights. MERCK Xxxxx shall, and shall procure that its Affiliates and Sublicensees shall will, keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross sales amounts invoiced and Net Sales by MERCK Xxxxx and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX Evotec shall have the right for a period of [***] three (3) years after receiving any such royalty payment under this Section 6.3 to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK Xxxxx to audit the relevant records of MERCK Xxxxx and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK Xxxxx shall make, and shall procure that its Affiliates and Sublicensees shall each make make, its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedEvotec. Such audit right shall not be exercised by ARCHEMIX Evotec more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCK. The results of each audit, if any, shall be binding on both PartiesXxxxx. In the event there was that an underpayment by MERCK hereunderXxxxx hereunder is identified as a result of the audit, MERCK Xxxxx shall promptly (but in any event no later than [***] thirty (30) days after MERCKKazia’s receipt of the any undisputed audit report so concluding) make payment to ARCHEMIX Evotec of any shortfall. ARCHEMIX In the event that an overpayment by Xxxxx hereunder is identified as a result of the audit, then Xxxxx may take credit for such overpayment against any future payments due to Evotec (if no future payment is due, then Evotec shall promptly refund such amount to Xxxxx). Evotec shall bear the full cost of such any audit unless such audit discloses an underreporting by MERCK Xxxxx of more than [***] five percent ([***]5%) or greater of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK Xxxxx shall reimburse ARCHEMIX Evotec for all reasonable costs incurred by ARCHEMIX Evotec in connection with such audit.

Appears in 1 contract

Samples: License Agreement (Kazia Therapeutics LTD)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees Each Party shall keep and maintain for [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years from the date of each payment of royalties hereunder ) years, complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Shared Development Costs incurred with respect to Licensed Products in sufficient detail to allow royalties to be determined accuratelyconfirmation of same by the JSC and the other Party. ARCHEMIX Each Party (the “Cost Auditing Party”) shall have the right for a period of [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, after receiving any such royalty payment Shared Development Cost is reconciled in accordance with Section 3.11.2(a) to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party (the “Cost Audited Party”) to audit the relevant records of MERCK the Cost Audited Party and its Affiliates and Sublicensees to verify that the amount of such payment Development Costs was correctly determined. MERCK The Cost Audited Party and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedthe Cost Auditing Party. Such audit right shall not be exercised by ARCHEMIX the Cost Auditing Party more than [***] once in any [***] or Calendar Year and the records of Shared Development Costs for a given period may not be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKthe Cost Audited Party. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment error in the amount of Shared Development Costs reported by MERCK the Cost Audited Party hereunder, MERCK (a) if the amount of Shared Development Costs was over reported, the Cost Audited Party shall promptly (but in any event no later than [* (***] ) days after MERCKthe Cost Audited Party’s receipt of the report so concluding) make payment to ARCHEMIX the Cost Auditing Party of the Cost Audited Party’s Cost-Sharing Percentage of over reported amount and (b) if the amount of Shared Development Costs was underreported, the Cost Auditing Party shall promptly (but in any shortfallevent no later than * (*) days after the Cost Auditing Party’s receipt of the report so concluding) make payment to the Cost Audited Party of the Cost Audited Party’s Cost-Sharing Percentage of underreported amount. ARCHEMIX The Cost Auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK the Cost Audited Party of more than [***] * percent ([***]%) of the aggregate amount of royalties payable Shared Development Costs reportable in any Calendar Year, in which case MERCK the Cost Audited Party shall reimburse ARCHEMIX the Cost Auditing Party for all costs incurred by ARCHEMIX the Cost Auditing Party in connection with such audit.

Appears in 1 contract

Samples: License, Co Development and Co Commercialization Agreement (Arqule Inc)

Records; Audit Rights. MERCK AMBION and its Affiliates and Sublicensees shall keep and maintain for [***] three (3) years from the date of each payment of royalties hereunder complete and accurate records of their respective gross sales and Net Sales by MERCK AMBION and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX ROSETTA shall have the right for a period of [***] three (3) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK AMBION to inspect or audit the he relevant records of MERCK AMBION and its Affiliates and Sublicensees solely to verify that the amount of such payment was correctly determined. MERCK and AMBION, its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXROSETTA, solely to verify that royalty payments hereunder were correctly announced for or determined. Such inspection or audit right shall not be exercised by ARCHEMIX ROSETTA more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product Collaboration product or Collaboration Service in a [***]particular period, whichever is less frequent. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKAMBION and, at AMBION’s request, the accountant shall enter into a confidentiality agreement with both Parties substantially similar to Section 4.1 limiting the disclosure and use of such information. The results result of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK AMBION hereunder, MERCK AMBION shall promptly (but in any event no later than [***] thirty (30) days after MERCKAMBION’s receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX ROSETTA of any shortfall. ARCHEMIX In the event that there was an overpayment by AMBION’s hereunder, ROSETTA shall promptly (but in any event no later than thirty (30) days after ROSETTA’s receipt of the independent accountant’s report so concluding) refund to AMBION the excess amount. ROSETTA shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK AMBION of more than [***] percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK AMBION shall reimburse ARCHEMIX ROSETTA for all costs incurred by ARCHEMIX ROSETTA in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaboration and License Agreement (Rosetta Genomics Ltd.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees ARQULE shall keep and maintain for [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years from the date of each payment of royalties hereunder ) years, complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, Development Costs incurred with respect to Licensed Products in sufficient detail to allow royalties to be determined accuratelyconfirmation of same by the JEC and DS. ARCHEMIX DS shall have the right for a period of [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, after receiving any such royalty payment Development Costs is reconciled in accordance with Section 3.11.2(a) to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ARQULE to audit the relevant records of MERCK ARQULE and its Affiliates and Sublicensees to verify that the amount of such payment Development Costs was correctly determined. MERCK ARQULE and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [* (***] ) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedthe DS. Such audit right shall not be exercised by ARCHEMIX DS more than [***] once in any [***] or Calendar Year and the records of Development Costs for a given period may not be audited more than [***] with respect to sales of a particular Product in a [***]once. All records made available for audit shall be deemed to be Confidential Information of MERCKARQULE. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment error in the amount of Development Costs reported by MERCK ARQULE hereunder, MERCK (a) if the amount of Development Costs was over reported, ARQULE shall promptly (but in any event no later than [* (***] ) days after MERCKARQULE’s receipt of the report so concluding) make payment to ARCHEMIX DS of the portion of the Development Costs that were reimbursed by DS to ARQULE that were in excess of the actual amount of Development Costs incurred by ARQULE and (b) if the amount of Development Costs was underreported, DS shall promptly (but in any shortfallevent no later than * (*) days after the DS’s receipt of the report so concluding) make payment to ARQULE of the additional portion of the Development Costs that were not previously paid by DS to ARQULE. ARCHEMIX DS shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK ARQULE of more than [***] * percent ([***]%) of the aggregate amount of royalties payable the Development Costs reportable in any Calendar Year, in which case MERCK ARQULE shall reimburse ARCHEMIX DS for all costs incurred by ARCHEMIX DS in connection with such audit.

Appears in 1 contract

Samples: License and Co Commercialization Agreement (Arqule Inc)

Records; Audit Rights. MERCK Tyligand and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK Tyligand and its Affiliates and Sublicensees Related Parties of each Product, in sufficient detail to allow royalties to be determined accuratelyaccurately determined. ARCHEMIX Context shall have the right for a period of [***] years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK Tyligand to audit the relevant records of MERCK Tyligand and its Affiliates and Sublicensees to verify that the amount of each such payment was correctly determined; provided, that, (i) if requested by Tyligand, Context shall cause the independent certified public accountant to enter into a confidentiality agreement reasonably acceptable to Tyligand and (ii) such independent certified public accountant may only disclose to Context whether the royalties are correct and the details with respect to any discrepancies. MERCK Tyligand and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedContext. Such audit right shall not be exercised by ARCHEMIX Context more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Product in a [***]period previously audited by Context. All records made available for audit shall be deemed to be Confidential Information of MERCKTyligand. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment of royalties by MERCK Tyligand hereunder, MERCK Tyligand shall promptly (but in any event no later than [***] days after MERCKTyligand’s receipt of the report so concluding) make payment to ARCHEMIX Context of any shortfall. ARCHEMIX Context shall bear the full cost of such audit unless such audit discloses an underreporting underpayment by MERCK Tyligand of more than [***] percent ([***]%) or more of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK Tyligand shall reimburse ARCHEMIX Context for all the reasonable costs incurred by ARCHEMIX of the certified public accountant who conducted the audit in connection with such audit. In the event such accounting determines that Tyligand paid Context more than the amount properly due in respect of any Calendar Quarter, then any excess payments made by Tyligand will be credited against future amounts due to Context from Tyligand, or if no such future amounts are reasonably expected to be due to Context from Tyligand, then Context will reimburse Tyligand for any overpayment by Tyligand.

Appears in 1 contract

Samples: License, Development, Manufacturing & Marketing Agreement (Context Therapeutics Inc.)

Records; Audit Rights. MERCK and its Affiliates and Sublicensees shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right for For a period of [***] ([***]) years after receiving following receipt by Biotest of any accounting described in this Section 5.1.5, ImmunoGen shall keep complete and accurate records pertaining to the Pivotal MAY Compound Process Development Costs and the Pivotal MAY Compound Process Development Percentage in sufficient detail to allow the accuracy of the payments hereunder to be confirmed. At each meeting of the JDC the Parties shall update the JDC as to such royalty payment Pivotal MAY Compound Process Development Costs incurred through the date of such JDC meeting. ImmunoGen shall Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. keep complete and accurate records of associated Pivotal MAY Compound Process Development Costs in sufficient detail to allow the accuracy of the payments hereunder to be confirmed. Biotest shall have the right to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK ImmunoGen to inspect or audit the relevant records of MERCK ImmunoGen and its Affiliates and Sublicensees to verify that the amount of such payment Pivotal MAY Compound Process Development Costs was correctly determined. MERCK ImmunoGen and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXBiotest, solely to verify that royalty payments Pivotal MAY Compound Process Development Costs hereunder were correctly determined. Such inspection or audit right shall not be exercised by ARCHEMIX Biotest more than [***] once in any [***] or more than [***] with respect to sales of a particular Product in a [***]Calendar Year. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKImmunoGen. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment error in the amount of Pivotal MAY Compound Process Development Costs reported by MERCK ImmunoGen hereunder, MERCK (a) if the amount of Pivotal MAY Compound Process Development Costs was over-reported, ImmunoGen shall promptly (but in any event no later than [***] ([***]) days after MERCK’s the ImmunoGen's receipt of the independent accountant's report so concluding) make payment to ARCHEMIX Biotest of the amount owed to Biotest, and (b) if the amount of Pivotal MAY Compound Process Development Costs was underreported, Biotest shall promptly (but in any shortfallevent no later than [***] ([***]) days after Biotest's receipt of the independent accountant's report so concluding) make payment to ImmunoGen of the amount owed to ImmunoGen. ARCHEMIX Biotest shall bear the full cost of such audit unless such audit discloses an underreporting over reporting by MERCK ImmunoGen of more than [***] percent [***] ([***]%) of the aggregate amount of royalties payable Pivotal MAY Compound Process Development Costs reportable in any Calendar Year, in which case MERCK ImmunoGen shall reimburse ARCHEMIX Biotest for all costs incurred by ARCHEMIX Biotest in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Immunogen Inc)

Records; Audit Rights. MERCK DS and its Affiliates and Sublicensees shall keep and maintain for [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, from the date of each payment of royalties hereunder complete and accurate records of gross sales and Net Sales by MERCK DS and its Affiliates and Sublicensees of each Licensed Product, in sufficient detail to allow royalties to be determined accurately. ARCHEMIX ARQULE shall have the right for a period of [* (*) years, or such other period of time as required by Applicable Laws if longer than * (**] years ) years, after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK DS to audit the relevant records of MERCK DS and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK DS and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] thirty (30) days written notice from ARCHEMIX, solely to verify that royalty payments hereunder were correctly determinedARQULE. Such audit right shall not be exercised by ARCHEMIX ARQULE more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Licensed Product in a [***]particular period. All records made available for audit shall be deemed to be Confidential Information of MERCKDS. The results of each audit, if any, shall be binding on both PartiesParties absent manifest error. In the event there was an underpayment by MERCK DS hereunder, MERCK DS shall promptly (but in any event no later than [* (***] ) days after MERCKDS’s receipt of the report so concluding) make payment to ARCHEMIX ARQULE of any shortfall. ARCHEMIX Should the audit lead to the discovery of a discrepancy to DS’s detriment, then DS may credit the amount of the discrepancy without interest against any future payments due to ARQULE under Section 4.3.1. ARQULE shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK DS of more than [***] * percent ([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case MERCK DS shall reimburse ARCHEMIX ARQULE for all costs incurred by ARCHEMIX ARQULE in connection with such audit.

Appears in 1 contract

Samples: License, Co Development and Co Commercialization Agreement (Arqule Inc)

Records; Audit Rights. MERCK Biotest and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of royalties hereunder complete and accurate records of their respective Commercialization Expenses, as well as all gross sales and Net Sales by MERCK Biotest and its Affiliates and Sublicensees of each Licensed Product, in sufficient detail to allow royalties to be determined accurately and ImmunoGen and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of Net Income Payments complete and accurate records of its Commercialization Expenses, as well as all gross sales and Net Sales of each Co-Developed Product in sufficient detail to allow Net Income Payments to be determined accurately. ARCHEMIX Each Party shall have the right for a period of [***] ([***]) years after receiving any such royalty payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK the other Party to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. inspect or audit the relevant records of MERCK and such Party, its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. MERCK and The Audited Party, its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] days written reasonable notice from ARCHEMIXthe Auditing Party, solely to verify that Commercialization Expenses, royalty and Net Income payments hereunder were correctly accounted for or determined. Such inspection or audit right shall not be exercised by ARCHEMIX the Auditing Party more than [***] once in any [***] Calendar Year or more than [***] once with respect to sales of a particular Licensed Product in a [***]particular period. All records made available for inspection or audit shall be deemed to be Confidential Information of MERCKthe Audited Party. The results of each inspection or audit, if any, shall be binding on both Parties. In the event there was an underpayment by MERCK the Audited Party hereunder, MERCK the Audited Party shall promptly (but in any event no later than [***] ([***]) days after MERCKthe Audited Party’s receipt of the independent accountant’s report so concluding) make payment to ARCHEMIX the Auditing Party of any shortfall. ARCHEMIX In the event that there was an overpayment by the Audited Party hereunder, the Auditing Party shall promptly (but in any event no later than [***] ([***]) days after the Auditing Party’s receipt of the independent accountant’s report so concluding) refund to the Audited Party the excess amount. The Auditing Party shall bear the full cost of such audit unless such audit discloses an underreporting by MERCK the Audited Party of more than [***] percent ([***]%) of the aggregate amount of royalties payable or Net Income Payments payable, or Commercialization Expenses allocable, in any Calendar Year, in which case MERCK the Audited Party shall reimburse ARCHEMIX the Auditing Party for all costs incurred by ARCHEMIX the Auditing Party in connection with such inspection or audit.

Appears in 1 contract

Samples: Collaborative Development and License Agreement (Immunogen Inc)

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