Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party or other selling entity will keep such books and records for at least three (3) years following the Calendar Year to which they pertain. (b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement. (c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order. (d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final. (e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly. (f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party. (g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31
Appears in 2 contracts
Sources: Collaboration and License Agreement (Enanta Pharmaceuticals Inc), Collaboration and License Agreement (Enanta Pharmaceuticals Inc)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of research and to enable the royalties payable hereunder Development Plan Costs to be determinedreimbursed or shared, achievement of sales milestones, royalty payments and other amounts payable under this Agreement. Each Party or other selling entity will keep Upon reasonable prior notice, such books and records shall be open during regular business hours for a period of [*] years from the creation of individual records for examination at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written requestauditing Party’s expense, cause and not more often than once each calendar year, by an internationally-recognized independent accounting firm (certified public accountant selected by the “Auditor”) which is auditing Party and reasonably acceptable to Novartis the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to inspect this Agreement or of any payments made, or required to be made, by or to the relevant records of Novartis and its Affiliates audited Party pursuant to this Agreement. Any such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the royalties payable accuracy of the financial reports furnished by Novartis the audited Party or the amount of payments to or by the audited Party under this Agreement. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the related reportscase may be) within [*] days after the accountant’s report, statementsplus interest (as set forth in Section 9.7) from the original due date (unless challenged in good faith by the audited Party in which case any dispute with respect thereto shall be resolved in accordance with Section 15.7). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, records and books of accounts, as applicable. Novartis may upon written request, cause or an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditunderpayment by, the Auditor audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than [*] of the amount set forth in such report, in which case the audited Party shall execute an undertaking Confidential materials omitted and reimburse the auditing Party for the costs for such audit. [*] = Certain confidential information contained in this document, marked by brackets, is filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable Commission pursuant to Party being audited by which Rule 406 of the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt Securities Act of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits1933, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Partyamended.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31
Appears in 2 contracts
Sources: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its AffiliatesNovartis, in relation to Net Sales and royalties, and with respect to EnantaConatus, in relation to the Out-of-Pocket Costs and Development FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedCosts. Each Party or other selling entity will keep such books and records for at least three (3) [***] years following the Calendar Year calendar year to which they pertain.
(b) Enanta may The auditing Party may, upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) ), which is reasonably acceptable to Novartis the audited Party, to inspect the relevant records of Novartis the audited Party and its Affiliates to verify the, with respect to Novartis, the royalties payable by Novartis and the related reports, statements, records reports statements and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable and with respect to Enanta to inspect Conatus, the relevant records Out-of-Pocket Costs and FTE Costs, statements and books of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expensesaccounts, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to the audited Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each The audited Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other auditing Party. The records shall be reviewed solely to verify the accuracy of payments hereunder Novartis’ royalties or Conatus’ Out-of-Pocket Costs and FTE Costs, as the case may be, and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, auditing Party shall only be entitled to audit the books and records of the audited Party from the [***] calendar years prior to the calendar year in which the audit request is made. The auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such the inspection reveals an undisputed underpayment or overpaymentoverpayment by the audited Party, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such auditsinspections, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten [***] percent (10[***]%) of the total payments due hereunder for the applicable calendar year audit period is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta The audited Party shall have the right to request audits of sublicensees a further determination by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect such Auditor as to Product sales. Novartis will provide Enanta with a summary of matters which the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than audited Party disputes within [***] days following receipt of such report. The audited Party will provide the auditing Party and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the audit report and the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is discoveredprovided, the fees and expenses charged by the Auditor which determination shall be paid limited to the disputed matters. The Parties agree that they shall use reasonable efforts, through the participation of finance representatives of both companies, to resolve any dispute arising in relation to the Audit by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31good faith discussion.
Appears in 1 contract
Sources: Option, Collaboration and License Agreement (Conatus Pharmaceuticals Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of Development Expenses, achievement of milestones, royalty payments and to enable other amounts payable under this Agreement. Upon reasonable prior notice, such records shall be open during regular business hours for a period of *** from the royalties payable hereunder to be determined. Each Party or other selling entity will keep such books and creation of individual records for at least three (3) years following examination by an Confidential EXECUTION VERSION independent certified public accountant selected by the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is auditing Party and reasonably acceptable to Novartis the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to inspect the relevant records this Agreement or of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reportsany payments made, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably or required to verify be made, by or to the amounts payable by Novartis hereunder or Enantaaudited Party pursuant to this Agreement. Such audits not occur more often than *** each ***. Such auditor shall not disclose the audited Party’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose Information to the auditing Party only its conclusions regarding or to any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by Third Party, except to the Auditor during regular business hours at extent such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments hereunder and compliance with to or by the audited Party under this Agreement. Such inspection right Any amounts shown to be owed but unpaid shall not be exercised paid within *** after the accountant’s report, plus interest (as set forth in Section 7.5) from the original due date. The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than once *** of the amount set forth in any calendar year and not more frequently than once with respect to records covering any specific period of time. In additionsuch report, in which case the audited Party shall reimburse the auditing Party agrees to hold in strict confidence all information received and all information learned in for the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) costs for such audit. The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided will refund to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid received by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [Party within *****] is discovered, * after the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31accountant’s report.
Appears in 1 contract
Sources: License and Collaboration Agreement (Five Prime Therapeutics Inc)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation sufficient detail for the other Party to determine the payments due and costs incurred under this Agreement, includingincluding the Royalties, with respect to Novartis reimbursement for FTEs and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedother reimbursable costs hereunder. Each Party or other selling entity will keep such books and records for at least three (3) years following the Calendar Year end of the fiscal year to which they pertain.
(b) Enanta may upon written request, cause Each of SGX and Novartis (the “auditing Party”) shall have the right for a period of three (3) years after receiving any report or statement with respect to payments due and payable to appoint an internationally-recognized independent accounting firm (the “Auditorauditor”) which is reasonably acceptable to Novartis the other Party (the “audited Party”) to inspect the relevant records of Novartis and the audited Party or its Affiliates Affiliates, licensees or sublicensees to verify the royalties payable by Novartis and the related such reports, statements, records and or books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to the audited Party being audited by which the Auditor agrees to auditor shall keep confidential all information reviewed during the such audit. The Auditor auditor shall have the right to disclose to the auditing Party its only its conclusions regarding any payments owed under this Agreementto the auditing Party or the audited Party, as the case may be.
(c) Each The audited Party and or its Affiliates Affiliates, licensees or sublicensees, as applicable, shall make their its records available for inspection by the Auditor such auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other auditing Party. The records shall be reviewed , solely to verify the accuracy of the audited Party or its Affiliate’s, licensee’s or sublicensee’s sales reports, payments hereunder records or books of accounts and compliance in other respects with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not Calendar Year nor more frequently than once with respect to records covering any specific period of time. In addition, the The auditing Party agrees to shall hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary for the auditing Party to reveal such information in order to enforce its rights under this Agreement or to the extent if disclosure is required to comply with any by law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for its own costs of such auditsinspections, as well as its own legal expenses associated with enforcing its rights right with respect to any payments payment hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of except that in the total payments due hereunder for the applicable calendar year event there is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include any upward adjustment in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay aggregate amounts payable for any year shown by such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment inspection of more than [*****] is discoveredof the amount paid, the fees audited Party shall pay for such inspection. Novartis shall promptly pay SGX the amount of any underpayment of Royalties, amounts reimbursed for FTEs or other reimbursable costs. SGX shall promptly pay Novartis the amount of any overpayment of amounts reimbursed for FTEs or other reimbursable costs, and expenses charged by Novartis may credit against any subsequent Royalties due to SGX the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31amount of any overpayment of Royalties.
Appears in 1 contract
Sources: License and Collaboration Agreement (SGX Pharmaceuticals, Inc.)
Records and Audit Rights. (a) Each During the Term of this Agreement, and for a period of [*] after their creation, each Party shall will keep complete, true complete and accurate books and records in accordance sufficient to verify compliance or non-compliance with its Accounting Standards in relation to the provisions of this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party will, upon at least thirty (30) days' prior written request by the other Party, allow such Party, or other selling entity will keep a representative of such Party who is reasonably acceptable to the audited Party, to audit such books and records for at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except 's premises to the extent necessary to enforce verify the performance of the other Party's obligations hereunder; provided that (a) any such audit is conducted during normal business hours and in a manner designed to not unreasonably interfere with the audited Party's ordinary business operations; (b) audits may not occur more frequently than once every twelve (12) months; and (c) each such audit may only cover periods that were not previously audited. The audited Party will cooperate with the auditing Party and its rights under this Agreement or to representatives in the extent required to comply with conduct of such audit. If any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to reveals that the audited Party at the time such report is provided to has failed properly account for, charge and/or pay any amount hereunder which results in an overpayment by the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To , then the extent applicableaudited Party will promptly pay the auditing Party any such amount, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring together with interest on the sublicensee to maintain records monies owed at an annual rate of sales [*] from on the date on which such overpayment was made pursuant to or such license and to grant access to such records by Novartis’ designated independent accountant overdue amount should have been paid to the same extent and under auditing Party. If any audit reveals that the same obligations as required of Novartis under this Agreementaudited Party has failed properly account for, charge and/or pay any amount hereunder which results in an overpayment by the audited Party or an underpayment by the audited Party, by [*] or more, then in addition to paying any such amount due, the audited Party will reimburse the other Party for its reasonable out-of-pocket expenses incurred in conducting such audit. Enanta shall have the right Each Party agrees that any information learned by or disclosed to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta it or its auditor in advance of each connection with such audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary is Confidential Information of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31audited Party.
Appears in 1 contract
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of Clinical Development Costs, Operating Profit (and to enable the Loss), royalties payable hereunder to be determined. Each Party or and other selling entity will keep such books and records for at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates . Upon reasonable prior notice, such records shall make their records available for inspection by the Auditor be open during regular business hours at such place or places where such records are customarily kept, upon receipt for a period of reasonable advance notice […***…] years from the other creation of individual records for examination by an independent certified public accountant selected by the CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT between CUREVAC and ARCTURUS Confidential auditing Party and reasonably acceptable to the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or of any payments made, or required to be made, by or to the audited Party pursuant to this Agreement. Such audits not occur more often than [*…***…] each calendar year. Such auditor shall not disclose the audited Party. The records shall be reviewed solely ’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments hereunder and compliance with to or by the audited Party under this Agreement. Such inspection right Any amounts shown to be owed but unpaid shall not be exercised paid within […***…] days after the accountant’s report, plus interest (as set forth in Section 8.7) from the original due date (unless challenged in good faith by the audited Party in which case any dispute with respect thereto shall be resolved in accordance with Section 14.6). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than once […***…] percent ([…***…]%) of the amount set forth in any calendar year and not more frequently than once with respect to records covering any specific period of time. In additionsuch report, in which case the audited Party shall reimburse the auditing Party agrees to hold in strict confidence all information received and all information learned in for the course of costs for such audit. If any audit or inspectionsuch overpayment exceeds such five percent amount, except to then the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited auditing Party at the time will refund such report is provided amount to the auditing Party before it is considered final.
within […***…] days after the accountant’s report (e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid unless challenged in good faith by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include Party in each sublicense granted by it to which case any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee dispute with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor thereto shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately resolved in accordance with the Securities and Exchange Commission. Asterisks denote such omission. 31Section 14.7).
Appears in 1 contract
Sources: Co Development and Co Commercialization Agreement (Arcturus Therapeutics Ltd.)
Records and Audit Rights. (a) Each Party shall keep complete, true true, and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, including with respect to Novartis and its AffiliatesDevelopment Costs, in relation to Net Sales and royaltiesSales, collaboration payments, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedProduct Price. Each Party or other selling entity will keep such books and records for at least three (3) years following the Calendar Year to which they pertain.
. Each Party (bthe “Auditing Party”) Enanta may may, upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) ), which is reasonably acceptable to Novartis the other Party (the “Audited Party”), to inspect the relevant records of Novartis such Audited Party and its Affiliates to verify the royalties payable payments made and amounts reported by Novartis the Audited Party and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to the Audited Party being audited by which the Auditor agrees shall agree to keep confidential all information reviewed made available to the Auditor during the audit. The Auditor shall have the right to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) . Each Party and its Affiliates and sublicensees shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Auditing Party. The records shall be reviewed solely to verify the accuracy of the Audited Party’s collaboration payments hereunder and other payment obligations and compliance with the financial terms of this Agreement. Such inspection right shall not be exercised more than once without cause in any calendar year Calendar Year and not more frequently than once without cause with respect to records covering any specific period of time. In addition, the auditing Auditing Party shall only be entitled to audit the books and records of the Audited Party from the three (3) Calendar Years prior to the Calendar Year in which an audit request is made. The Auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspectionaudit, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation Applicable Law or judicial order.
(d) . The Auditor shall provide its audit report and basis for any determination to the audited Audited Party at the time such report is provided to the auditing Auditing Party before it is considered final.
(e) . In the event that the final result of any such the inspection reveals an undisputed underpayment or overpaymentan overpayment by either Party, the underpaid or overpaid amount shall be settled promptly.
(f) . The auditing Auditing Party shall pay for such auditsany audit, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition; provided, that, if an underpayment (with respect to royalties) of amounts due or overpayment (with respect to research-related payments to Enanta) of amounts payable by the Auditing Party of more than ten twenty percent (1020%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31
Appears in 1 contract
Sources: License and Collaboration Agreement (Cellular Biomedicine Group, Inc.)
Records and Audit Rights. (a) Each Party (the “Paying Party”) shall keep and cause its applicable Affiliates to keep (and, in the case of Infinity, Infinity shall cause the Infinity Related Parties to keep) complete, true and accurate books and records in accordance with its Accounting Standards in relation sufficient detail for the other Party (the “Paid Party”) to determine the payments due and costs incurred under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under including the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedRoyalties. Each Paying Party or other selling entity will keep such books and records for at least three (3) years following the Calendar Year date of the payment to which they pertain.
(b) Enanta may upon Upon the written requestrequest of the Paid Party and not more than once in each calendar year, cause the Paying Party shall permit an internationally-recognized independent certified public accounting firm (of nationally recognized standing selected by the “Auditor”) which is Paid Party and reasonably acceptable to Novartis the Paying Party to inspect have access during normal business hours to such of the relevant records of Novartis the Paying Party and its applicable Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts(and, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(cInfinity Related Parties) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall as may be reviewed solely reasonably necessary to verify the accuracy of the payments hereunder due and compliance with costs incurred under this Agreement. Such inspection right shall , including the royalty reports under this Agreement, for any period ending not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except three (3) years prior to the extent necessary to enforce its rights under this Agreement or date of such request. The accounting firm shall disclose to the extent Paid Party only whether the payments due and costs incurred, including any payment reports (as applicable), are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Paid Party without the prior consent of the Paying Party unless disclosure is required to comply with any by law, regulation or judicial order. If the Paid Party determines that disclosure is required by law, regulation or judicial order, it shall, if permitted, give the Paying Party prior notice thereof reasonably sufficient for the Paying Party to seek a protective order against or limiting such disclosure. The Paying Party is entitled to require the accounting firm to execute a reasonable confidentiality agreement prior to commencing any such audit.
(dc) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time fees charged by such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount accounting firm shall be settled promptly.
(f) The auditing Party shall pay for such auditspaid by the Paid Party; provided, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In additionhowever, that if the audit uncovers an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten by the Paying Party that exceeds five percent (105%) of the total payments due hereunder for the applicable calendar year is discoveredpayment owed, then the fees and expenses charged by the Auditor of such accounting firm shall be paid by the audited Paying Party unless the reason for such underpayment was a miscalculation on the part of the Paid Party.
. Any underpayments or unpaid amounts discovered by such audit or otherwise will be paid promptly by the Paying Party within thirty (g30) To days of the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring date the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant Paid Party delivers to the same extent and under Paying Party such accounting firm’s written report, or as otherwise agreed upon by the same obligations as required Parties, plus interest calculated in accordance with Section 9.7 unless the reason for such underpayment was a miscalculation on the part of Novartis the Paid Party. In the event of an overpayment by the Paying Party, the Paying Party shall be entitled to credit such overpayment against any subsequent payment due to the Paid Party under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31.
Appears in 1 contract
Sources: Development and License Agreement (MEI Pharma, Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees maintain, and Genentech shall cause its Sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied)maintain, complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of Next Gen Research Plan Costs and to enable the royalties payable hereunder to be determined. Each Party or Joint Development Costs, achievement of milestones, royalty payments and other selling entity will keep such books and records for at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates . Upon reasonable prior notice, such records shall make their records available for inspection by the Auditor be open during regular business hours at such place or places where such records are customarily kept, upon receipt for a period of reasonable advance notice [*] from the creation of individual records for examination by an independent certified public accountant selected by the auditing Party and reasonably acceptable to the audited entity for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the other Party pursuant to this Agreement or of any payments made, or required to be made, by or to the other Party pursuant to this Agreement. Such audits shall not occur more often than once each calendar year. Such auditor shall not disclose the audited entity’s Confidential Information to the auditing Party. The records shall be reviewed solely , except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the other Confidential Execution Version Party or the amount of payments hereunder and compliance with to or by the other Party under this Agreement. Such inspection right shall not Any amounts shown to be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount owed but unpaid shall be settled promptly.
paid within [*] after the accountant’s report, plus interest (fas set forth in Section 7.8) from the original due date. The auditing Party shall pay for bear the full cost of such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if audit unless such audit reveals an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of by, the total payments due hereunder other Party that resulted from a discrepancy in the financial report provided by the other Party for the applicable calendar year is discoveredaudited period, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an which underpayment of was more than [*] of the amount set forth in such report, in which case the other Party shall reimburse the auditing Party for the costs for such audit. If the auditing Party does not request verification of any achievement of milestones, royalty payments and other amounts payable under this Agreement within [*], then the auditing Party will [***] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31].
Appears in 1 contract
Sources: License and Collaboration Agreement (Newlink Genetics Corp)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales and permit the other Party to enable confirm the royalties payable hereunder accuracy of the amount of Research Plan Costs, Development Costs, [*] to be determinedreimbursed, achievement of sales milestones, royalty payments and other amounts payable under this Agreement. Each Party or other selling entity will keep Upon reasonable prior notice, such books and records shall be open during regular business hours for a period of [*] years from the creation of individual records for at least three (3) years following examination by an independent certified public accountant selected by the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is auditing Party and reasonably acceptable to Novartis the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to inspect this Agreement or of any payments made, or required to be made, by or to the relevant records of Novartis and its Affiliates audited Party pursuant to this Agreement. Such audits not occur more often than once each calendar year. Such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the royalties payable accuracy of the financial reports furnished by Novartis and the related reportsaudited Party or the amount of payments to or by the audited Party under this Agreement. Any amounts shown to be owed but unpaid shall be paid within [*] days after the accountant’s report, statementsplus interest (as set forth in Section 11.10) from the original due date. The auditing Party shall bear the full costs of such audit unless such audit reveals an overpayment to, records and books of accounts, as applicable. Novartis may upon written request, cause or an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditunderpayment by, the Auditor audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than [*] of the amount set forth in such report, in which case the audited Party shall execute an undertaking Confidential materials omitted and filed separately with reimburse the Securities and Exchange Commission. Asterisks denote auditing Party for the costs for such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor If any such overpayment exceeds such [*] amount, then the auditing Party will refund such amount to the audited Party within [*] days after the accountant’s report. On the other hand, if any such overpayment does not exceed such [*] amount, the auditing Party shall have the right to disclose to credit the auditing Party only amount of such overpayment against its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination future payment obligations to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that future payments are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31expected.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Records and Audit Rights. (a) Each Owed Party shall keep complete, true and maintain complete and accurate books and records in accordance with of its Accounting Standards in relation to this Agreement, including, costs incurred with respect to Novartis and its Affiliates, in relation any activities for which it is entitled to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended reimbursement or payment under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records this Agreement in sufficient detail to properly reflect relevant Net Sales and to enable allow confirmation of the royalties payable hereunder to be determined. Each Party or other selling entity will keep such books and records amounts owed under this Article V for at least three five (35) years following Calendar Years after issuance of an invoice with respect thereto. [**] Material omitted and separately filed with the Calendar Year to which they pertainCommission under a request for confidential treatment.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (At the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records request of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party, each Party shall permit an independent certified public accountant retained by the other Party, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 5.5(a). The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once Except as provided in any calendar year and not more frequently than once with respect to records covering any specific period of time. In additionSection 5.5(c), the auditing Party agrees to hold in strict confidence all information received and all information learned in the course cost of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to be borne by the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpaymentParty, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from unless the audit and, if Enanta so requests, reveals a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment variance of more than [**] percent ([***] is discovered]%) from the invoiced amounts in favor of the audited Party, in which case the audited Party shall bear the cost of the audit. Unless disputed pursuant to Section 5.5(c), if such audit concludes that additional payments were owed or that excess payments were made during such period, the fees Party owing such additional payments shall pay such additional amounts, or the Party that received such excess payment shall reimburse such excess payments, as applicable, in either case, within thirty (30) days after the date on which such audit is completed and expenses charged by the Auditor conclusions thereof are notified to the Parties.
(c) If either Party disputes the results of any audit conducted pursuant to Section 5.5(b), Edge and Oakwood shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be paid submitted for arbitration to a certified public accounting firm selected by Novartiseach Party’s certified public accountants or to such other Person as the Parties shall mutually agree (the “Accountant”) or failing such agreement, unless otherwise as the Chairman of the International Chamber of Commerce (or such other body as the Parties may mutually agree), may nominate. The decision of the Accountant shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in a manner proportional to the Accountant’s determination of the Parties’ respective liability. If the Accountant determines that additional payments were owed by a Party or that excess payments were made by a Party for the sublicenseeapplicable period, no later than thirty (30) days after such decision and in accordance with such decision, the Party owing such additional payments shall pay such additional amounts or the Party that received such excess payments shall reimburse such excess payments, as applicable. Confidential materials omitted Any arbitration award against a Party may be entered in and filed separately with the Securities and Exchange Commission. Asterisks denote enforced by any court having jurisdiction over such omission. 31Party’s assets.
Appears in 1 contract
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation sufficient detail for the other Party to determine the payments due and costs incurred under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and including the royalties, and with respect to EnantaDevelopment Costs and, in relation to during the Co-Detailing Period, FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedutilization. Each Party or other selling entity will keep such books and records for at least three (3) ******** years following the Calendar Year end of the fiscal year to which they pertain.
(b) Enanta may upon written requestDuring the term of this Agreement and for ******** years thereafter, cause each Party (“Auditing Party”) shall have the right to appoint an internationally-independent, internationally recognized independent accounting firm (the “Auditor”) to audit the relevant records of the other Party and its Affiliates (and, in the case of Novartis, its sublicensees) which are authorized to sell Product or perform obligations of the Party pursuant to this Agreement (“Audited Party”) to confirm Net Sales, royalties, Development Costs, FTE utilization (with respect to Licensor) and other payments for a period covering not more than the preceding ******** fiscal years; provided, however, that the Auditor is reasonably acceptable to Novartis to inspect the relevant records of Novartis Audited Party and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before before beginning its audit, the Auditor shall execute executes an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 reasonably acceptable to the Audited Party being audited by which the Auditor agrees to shall keep confidential all information reviewed during such audit and any other agreement customarily required by the auditAudited Party relating to access to its premises and books and records. The Auditor shall have the right to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreementthe audit, which will remain Confidential Information of the Audited Party, subject to Section 12.
(c) Each The Audited Party shall make its records (and those of its Affiliates shall make their records and sublicensees, as applicable) available for inspection by the Auditor during regular business hours at such place or places the facility(ies) of the Audited Party where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed Auditing Party solely to verify the accuracy of the reports given, payments hereunder due and compliance with costs shared under this Agreement. Such inspection audit right shall not may only be exercised more than once in any per calendar year by the Auditing Party and not more frequently than only once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial orderfiscal year.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Auditing Party shall pay for bear the full cost of such auditsaudit, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if unless it discloses an underpayment (with respect to royalties) of royalties or overpayment (with respect to research-related payments to Enanta) overbooking of costs by the Audited Party of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered*** of the amount of royalties, costs or FTE funding due or incurred over the audited period, in which case, the fees Audited Party shall bear the full cost of such audit. The Audited Party shall promptly remit to the Auditing Party the amount of any underpayment of royalties or the amount due because of any overbooking of costs or FTEs, and expenses charged by Novartis may credit against any subsequent royalties due to Licensor the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31amount of any overpayment of royalties.
Appears in 1 contract
Sources: License and Co Development Agreement (Cell Therapeutics Inc)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales and permit the other Party to enable confirm the royalties payable hereunder accuracy of the amount of Research Plan Costs, Development Costs, [ * ] to be determinedreimbursed, achievement of sales milestones, royalty payments and other amounts payable under this Agreement. Each Party or other selling entity will keep Upon reasonable prior notice, such books and records shall be open during regular business hours for a period of [ * ] years from the creation of individual records for at least three (3) years following examination by an independent certified public accountant selected by the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is auditing Party and reasonably acceptable to Novartis the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to inspect this Agreement or of any payments made, or required to be made, by or to the relevant records of Novartis and its Affiliates audited Party pursuant to this Agreement. Such audits shall not occur more often than once each calendar year. Such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the royalties payable accuracy of the financial reports furnished by Novartis and the related reportsaudited Party or the amount of payments to or by the audited Party under this Agreement. Any amounts shown to be owed but unpaid shall be paid within [ * ] days after the accountant’s report, statementsplus interest (as set forth in Section 11.10) from the original due date. The auditing Party shall bear the full costs of such audit unless such audit reveals an overpayment to, records and books of accounts, as applicable. Novartis may upon written request, cause or an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditunderpayment by, the Auditor audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than [ * ] of the amount set forth in such report, in which case the audited Party shall execute an undertaking Confidential materials omitted and filed separately with reimburse the Securities and Exchange Commission. Asterisks denote auditing Party for the costs for such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor If any such overpayment exceeds such [ * ] amount, then the auditing Party will refund such amount to the audited Party within [ * ] days after the accountant’s report. On the other hand, if any such overpayment does not exceed such [ * ] amount, the auditing Party shall have the right to disclose to credit the auditing Party only amount of such overpayment against its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination future payment obligations to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that future payments are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31expected.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Records and Audit Rights. Licensee shall (aand shall cause its Affiliates and Sublicensees to) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to for the purpose of determining the amounts payable under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party or other selling entity will keep such Such books and records shall be kept for at least three (3) years [*] following the end of the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm . Licensee and its Affiliates (the “AuditorAudited Party”) which is shall make such accounting records available, on reasonable notice (the “Auditing Party”), for inspection [*], by an independent certified public accounting firm nominated by such Auditing Party and reasonably acceptable to Novartis to inspect the relevant records Audited Party, for the purpose of Novartis verifying the accuracy of any statement or report given by the Audited Party and its Affiliates to verify the royalties payable by Novartis accuracy of the payments due hereunder for any Calendar Year. Such auditor shall advise the Parties simultaneously promptly upon its completion of its audit whether or not the payments due hereunder have been accurately recorded, calculated, and the related reportsreported, statementsand, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditif not, the Auditor amount of such discrepancy. Except for cause, the Audited Party’s financial records with respect to a given period of time shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commissiononly be subject to [*]. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees The auditor shall be required to keep confidential all information reviewed learned during the audit. The Auditor shall have the right any such inspection in accordance with written confidentiality and non-use provision at least as restrictive as those provided in Article 7 below, and to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall details as may be reviewed solely necessary to verify report the accuracy of payments hereunder and compliance with this Agreementthe Audited Party’s statement or report. Such inspection right The Auditing Party shall not be exercised more than once responsible for the auditor’s costs, unless the auditor certifies an underpayment by the Audited Party that resulted [*] in which case the Audited Party shall bear the full cost of such audit. If such accounting firm identifies a discrepancy made during such period, any calendar year and not more frequently than once with respect unpaid amounts or overpaid amounts that are discovered shall be [*], or as otherwise agreed upon by the Parties. The Auditing Party shall treat all financial information subject to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights review under this Agreement or Section 6.11 in accordance with the confidentiality and non-use provisions of Article 7, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by obligating it to any sublicensee a provision requiring the sublicensee to maintain records of sales made retain all such information in confidence pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31confidentiality agreement.
Appears in 1 contract
Sources: Exclusive License Agreement (Day One Biopharmaceuticals, Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales and permit the other Party to enable confirm the royalties payable hereunder accuracy of the amount of Research Plan Costs, Development Costs, [*] to be determinedreimbursed, achievement of sales milestones, royalty payments and other amounts payable under this Agreement. Each Party or other selling entity will keep Upon reasonable prior notice, such books and records shall be open during regular business hours for a period of [*] years from the creation of individual records for at least three (3) years following examination by an independent certified public accountant selected by the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is auditing Party and reasonably acceptable to Novartis the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports furnished by the audited Party pursuant to inspect this Agreement or of any payments made, or required to be made, by or to the relevant records of Novartis and its Affiliates audited Party pursuant to this Agreement. Such audits not occur more often than once each calendar year. Such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the royalties payable accuracy of the financial reports furnished by Novartis and the related reportsaudited Party or the amount of payments to or by the audited Party under this Agreement. Any amounts shown to be owed but unpaid shall be paid within [*] days after the accountant’s report, statementsplus interest (as set forth in Section 10.9) from the original due date. The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, records and books of accounts, as applicable. Novartis may upon written request, cause or an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditunderpayment by, the Auditor audited Party that resulted from a discrepancy in the financial report provided by the audited Party for the audited period, which underpayment or overpayment was more than [*] of the amount set forth in such report, in which case the audited Party shall execute an undertaking Confidential materials omitted and filed separately with reimburse the Securities and Exchange Commission. Asterisks denote auditing Party for the costs for such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor If any such overpayment exceeds such [*] amount, then the auditing Party will refund such amount to the audited Party within [*] days after the accountant’s report. On the other hand, if any such overpayment does not exceed such [*] amount, the auditing Party shall have the right to disclose to credit the auditing Party only amount of such overpayment against its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination future payment obligations to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that future payments are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31expected.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Records and Audit Rights. (a) Each During the Term of this Agreement, and for a period of [*] after their creation, each Party shall will keep complete, true complete and accurate books and records in accordance sufficient to verify compliance or non-compliance with its Accounting Standards in relation to the provisions of this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party will, upon at least thirty (30) days' prior written request by the other Party, allow such Party, or other selling entity will keep a representative of such Party who is reasonably acceptable to the audited Party, to audit such books and records for at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except 's premises to the extent necessary to enforce verify the performance of the other Party's obligations hereunder; provided that (a) any such audit is conducted during normal business hours and in a manner designed to not unreasonably interfere with the audited Party's ordinary business operations; (b) audits may not occur more frequently than once every twelve (12) months; and (c) each such audit may only cover periods that were not previously audited. The audited Party will cooperate with the auditing Party and its rights under this Agreement or to representatives in the extent required to comply with conduct of such audit. If any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to reveals that the audited Party at the time such report is provided to has failed properly account for, charge and/or pay any amount hereunder which results in an overpayment by the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
, then the audited Party will promptly pay the auditing Party any such amount, together with interest on the monies owed at an annual rate of two percent (g2%) To over the extent applicable, Novartis and its Affiliates shall include prime rate of interest reported in each sublicense granted by it to any sublicensee a provision requiring The Wall Street Journal from on the sublicensee to maintain records of sales date on which such overpayment was made pursuant to or such license and to grant access to such records by Novartis’ designated independent accountant overdue amount should have been paid to the same extent and under auditing Party. If any audit reveals that the same obligations as required of Novartis under this Agreementaudited Party has failed properly account for, charge and/or pay any amount hereunder which results in an overpayment by the audited Party or an underpayment by the audited Party, by [*] or more, then in addition to paying any such amount due, the audited Party will reimburse the other Party for its reasonable out-of-pocket expenses incurred in conducting such audit. Enanta shall have the right Each Party agrees that any information learned by or disclosed to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta it or its auditor in advance of each connection with such audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary is Confidential Information of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31audited Party.
Appears in 1 contract
Records and Audit Rights. (a) Each Party Licensee shall, and shall cause its Affiliates and Sublicensees to, keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to for the purpose of determining the amounts payable under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party or other selling entity will keep such Such books and records shall be kept for at least three (3) years [***] following the end of the Calendar Year to which they pertain.
. Licensee and its Affiliates (beach an “Audited Party”) Enanta may upon written requestshall make their records available, cause an internationally-recognized independent accounting firm on reasonable notice sent by Anaptys (the “AuditorAuditing Party”), for inspection during normal business hours, with not less than thirty (30) which is days’ advance written notice, by an independent certified public accounting firm nominated by such Auditing Party and reasonably acceptable to Novartis to inspect the relevant records Audited Party, for the purpose of Novartis verifying the accuracy of any accounting statement or report given by the Audited Party and its Affiliates to verify the royalties payable accuracy of the payments due hereunder for any Calendar Year. Such audits may not be performed by Novartis Anaptys more than once per calendar year. Such auditor shall advise the Parties simultaneously promptly upon its completion of its audit whether or not the payments due hereunder have been accurately recorded, calculated, and the related reportsreported, statementsand, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditif not, the Auditor amount of such discrepancy. The auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees be required to keep confidential all information reviewed learned during the audit. The Auditor shall have the right any such inspection, and to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall details as may be reviewed solely necessary to verify report the accuracy of payments hereunder and compliance with this Agreementthe Audited Party’s statement or report. Such inspection right The Auditing Party shall not be exercised more than once responsible for the auditor’s costs, unless the auditor certifies an underpayment by the Audited Party that resulted from a discrepancy in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, a report that the auditing Audited Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for during the applicable calendar year is discoveredaudit period, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an which underpayment of was more than [*****] is discoveredof the amount set forth in such report, in which case the fees and expenses charged by Audited Party shall bear the Auditor full cost of such audit. If such accounting firm identifies a discrepancy made during such period, any unpaid amounts or overpaid amounts that are discovered shall be paid by Novartis, unless otherwise borne by paid/refunded promptly but in any event within thirty (30) days of the sublicenseedate of delivery of such accounting firm’s written report. Confidential materials omitted and filed separately The Auditing Party shall treat all financial information subject to review under this Section 4.8 in accordance with the Securities confidentiality and Exchange Commissionnon-use provisions of Article 5, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the Audited Party obligating it to retain all such information in confidence pursuant to such confidentiality agreement. Asterisks denote such omission. 314.
Appears in 1 contract
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of research and to enable the royalties payable hereunder other costs to be determinedreimbursed, achievement of milestones, royalties and other amounts payable under this Agreement for the then current Calendar Year, and during the preceding [*] Calendar Years. Each Party or other selling entity will keep Upon reasonable prior notice, which shall be no less than upon [*] days prior written notice, such books and records shall be open during regular business hours for a period of [*] years from the creation of individual records for at least three (3) years following examination by an independent certified public accountant selected by the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is auditing Party and reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify audited Party for the royalties payable [*] = Certain confidential information contained in this document, marked by Novartis and the related reportsbrackets, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials has been omitted and filed separately with the Securities and Exchange CommissionCommission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to sole purpose of verifying for the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party the basis and its Affiliates shall make their records available for inspection accuracy of the financial reports furnished by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall be reviewed solely audited Party pursuant to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent of any payments made, or required to comply with any lawbe made, regulation by or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at pursuant to this Agreement; provided however, that records for a particular period may only be audited once. Such audits may occur no more often than [*]. Such auditor shall enter into a confidentiality agreement between the time such report is provided auditor and the auditing Party and not disclose the audited Party’s Confidential Information to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an Party. Any undisputed underpayment or overpaymentamounts shown to be owed but unpaid, the underpaid or overpaid amount and in need of refund, shall be settled promptly.
paid or refunded (fas the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 9.9) from the original due date. The auditing Party shall pay for bear the full cost of such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if audit unless such audit reveals an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discoveredof the amount due for the entire period being audited, in which case the fees and expenses charged by audited Party shall reimburse the Auditor shall be paid by Novartis, unless otherwise borne by auditing Party for the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote reasonable costs for such omission. 31audit.
Appears in 1 contract
Sources: Collaboration and License Agreement (Sangamo Therapeutics, Inc)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), maintain complete and accurate records in sufficient detail to properly reflect relevant Net Sales permit the other Party to confirm the accuracy of the amount of research and to enable the royalties payable hereunder other costs to be determined. Each Party or reimbursed, achievement of milestones, royalties and other selling entity will keep such books and records for at least three (3) years following the Calendar Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expensesunder this Agreement for the then current Calendar Year, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the auditpreceding [*] Calendar Years. The Auditor Upon reasonable prior notice, which shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates be no less than upon [*] days prior written notice, such records shall make their records available for inspection by the Auditor be open during regular business hours at such place or places where such records are customarily kept, upon receipt for a period of reasonable advance notice [*] years from the other Party. The creation of individual records shall be reviewed solely to verify the accuracy of payments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, for examination by an independent certified public accountant selected by the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination reasonably acceptable to the audited Party at for the time such report is sole purpose of verifying for the auditing Party the basis and accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or of any payments made, or required to be made, by or to the audited Party pursuant to this Agreement; provided however, that records for a particular period may only be audited once. Such audits may occur no more often than [*]. Such auditor shall enter into a confidentiality agreement between the auditor and the auditing Party and not disclose the audited Party’s Confidential Information to the auditing Party before Party. Any undisputed amounts shown to be owed [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is considered final.
both (ei) In the event that the final result of any such inspection reveals an undisputed underpayment or overpaymentnot material and (ii) would be competitively harmful if publicly disclosed. but unpaid, the underpaid or overpaid amount and in need of refund, shall be settled promptly.
paid or refunded (fas the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 9.9) from the original due date. The auditing Party shall pay for bear the full cost of such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if audit unless such audit reveals an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discoveredof the amount due for the entire period being audited, in which case the fees and expenses charged by audited Party shall reimburse the Auditor shall be paid by Novartis, unless otherwise borne by auditing Party for the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote reasonable costs for such omission. 31audit.
Appears in 1 contract
Sources: Collaboration and License Agreement (Sangamo Therapeutics, Inc)
Records and Audit Rights. (a) Each Party (the “Paying Party”) shall keep and cause its applicable Affiliates to keep (and, in the case of Infinity, Infinity shall cause the Infinity Related Parties to keep) complete, true and accurate books and records in accordance with its Accounting Standards in relation sufficient detail for the other Party (the “Paid Party”) to determine the payments due and costs incurred under this Agreement, includingincluding the Royalties and, with respect to Novartis and its Affiliatesas applicable, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determinedProfit-or-Loss payments. Each Paying Party or other selling entity will keep such books and records for at least three (3) years following the Calendar Year date of the payment to which they pertain.
(b) Enanta may upon Upon the written requestrequest of the Paid Party and not more than once in each calendar year, cause the Paying Party shall permit an internationally-recognized independent certified public accounting firm (of nationally recognized standing selected by the “Auditor”) which is Paid Party and reasonably acceptable to Novartis the Paying Party to inspect have access during normal business hours to such of the relevant records of Novartis the Paying Party and its applicable Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts(and, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed during the audit. The Auditor shall have the right to disclose to the auditing Party only its conclusions regarding any payments owed under this Agreement.
(cInfinity Related Parties) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall as may be reviewed solely reasonably necessary to verify the accuracy of the payments hereunder due and compliance with costs incurred under this Agreement. Such inspection right shall , including the royalty or Profit-or-Loss reports under this Agreement, for any period ending not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except three (3) years prior to the extent necessary to enforce its rights under this Agreement or date of such request. The accounting firm shall disclose to the extent Paid Party only whether the payments due and costs incurred, including any payment reports (as applicable), are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Paid Party without the prior consent of the Paying Party unless disclosure is required to comply with any by law, regulation or judicial order. If the Paid Party determines that disclosure is required by law, regulation or judicial order, it shall, if permitted, give the Paying Party prior notice thereof reasonably sufficient for the Paying Party to seek a protective order against or limiting such disclosure. The Paying Party is entitled to require the accounting firm to execute a reasonable confidentiality agreement prior to commencing any such audit.
(dc) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time fees charged by such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount accounting firm shall be settled promptly.
(f) The auditing Party shall pay for such auditspaid by the Paid Party; provided, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In additionhowever, that if the audit uncovers an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten by the Paying Party that exceeds five percent (105%) of the total payments due hereunder for the applicable calendar year is discoveredpayment owed, then the fees and expenses charged by the Auditor of such accounting firm shall be paid by the audited Paying Party unless the reason for such underpayment was a miscalculation on the part of the Paid Party.
. Any underpayments or unpaid amounts discovered by such audit or otherwise will be paid promptly by the Paying Party within thirty (g30) To days of the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring date the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant Paid Party delivers to the same extent and under Paying Party such accounting firm’s written report, or as otherwise agreed upon by the same obligations as required Parties, plus interest calculated in accordance with Section 9.7 unless the reason for such underpayment was a miscalculation on the part of Novartis the Paid Party. In the event of an overpayment by the Paying Party, the Paying Party shall be entitled to credit such overpayment against any subsequent payment due to the Paid Party under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31.
Appears in 1 contract
Sources: Development and License Agreement (Infinity Pharmaceuticals, Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books of account and records in accordance with its Accounting Standards in relation to for the purpose of determining the amounts payable under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party or other selling entity will keep such Such books and records shall be kept at the principal place of business of each Party, as the case may be, for at least three [*](3or such longer period as required by applicable Law) years following the Calendar end of the Fiscal Year to which they pertain.
(b) Enanta may upon written request, cause an internationally-recognized independent accounting firm . Each Party (the “AuditorAudited Party”) which is shall make such account and records available, on reasonable notice sent by the other Party (the “Auditing Party”), for inspection during normal business hours, with not less than [*]’ advance written notice, by an independent certified public accounting firm nominated by such and reasonably acceptable to Novartis to inspect for the relevant records Audited Party, for the purpose of Novartis verifying the accuracy of any statement or report given by the Audited Party and its Affiliates to verify the royalties payable by Novartis accuracy of the payments due hereunder for any Fiscal Year. Such auditor shall advise the Parties simultaneously promptly upon its completion of its audit whether or not the payments due hereunder have been accurately recorded, calculated, and the related reportsreported, statementsand, records and books of accounts, as applicable. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its auditif not, the Auditor amount of such discrepancy. Except in the case of willful misconduct or fraud, a Party’s financial records with respect to a given period of time shall execute only be subject to one (1) audit per Fiscal Year. The Auditing Party’s right to perform an undertaking Confidential materials omitted audit pertaining to any Fiscal Year shall expire [*]after the end of such Fiscal Year and filed separately with the Securities and Exchange Commissionno given period may be audited more than one (1) time. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees The auditor shall be required to keep confidential all information reviewed learned during the audit. The Auditor shall have the right any such inspection, and to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall details as may be reviewed solely necessary to verify report the accuracy of payments hereunder and compliance with this Agreementthe Audited Party’s statement or report. Such inspection right The Auditing Party shall not be exercised responsible for the auditor’s costs, unless the auditor certifies that an overpayment to, or an underpayment by, the Audited Party that resulted from a discrepancy in a report that the Audited Party provided to the Auditing Party during the applicable audit period, which underpayment or overpayment was in favor of the Auditing Party by more than once the greater of (i) [*]of the amount set forth in such report or (ii) $[*], in which case the Audited Party shall bear the full cost of such audit. If such accounting firm correctly identifies a discrepancy made during such period, any unpaid amounts or overpaid amounts that are discovered shall be paid/refunded promptly but in any calendar year event within [*]of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The Auditing Party shall treat all financial information subject to review under this Section 8.8 in accordance with the confidentiality and not more frequently than once non-use provisions of Article 9, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the Audited Party obligating it to retain all such information in confidence pursuant to such confidentiality agreement. Upon the expiration of [*]following the end of any Fiscal Year, royalty calculations and joint Development Cost sharing calculations with respect to records covering any specific period of time. In addition, the auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Party at the time such report is provided to the auditing Party before it is considered final.
(e) In the event that the final result of any such inspection reveals an undisputed underpayment or overpayment, the underpaid or overpaid amount Fiscal Year shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights binding and conclusive upon both parties. Unless an audit is ongoing with respect to such period, the Parties shall be released from any payments hereunder. In addition, if an underpayment (liability or accountability with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder said calculations for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Partysuch Fiscal Year.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of more than [*****] is discovered, the fees and expenses charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 31
Appears in 1 contract
Sources: License and Collaboration Agreement (Sutro Biopharma, Inc.)
Records and Audit Rights. (a) Each Party shall keep complete, true and accurate books of account and records in accordance with its Accounting Standards in relation to for the purpose of determining the amounts payable under this Agreement, including, with respect to Novartis and its Affiliates, in relation to Net Sales and royalties, and with respect to Enanta, in relation to FTE efforts expended under the Research Program. Novartis and its Affiliates shall require any sublicensees to keep (all in accordance with generally accepted accounting principles, consistently applied), complete and accurate records in sufficient detail to properly reflect relevant Net Sales and to enable the royalties payable hereunder to be determined. Each Party or other selling entity will keep such Such books and records shall be kept at the principal place of business of each Party, as the case may be, for at least three [***] (3or such longer period as required by applicable Law) years following the end of the Calendar Year to which they pertain.
. Each Party (the “Audited Party”) shall make such account and records available, on reasonable notice sent by the other Party (the “Auditing Party”), for inspection during normal business hours, with not less than [***] advance written notice, by an independent certified public accounting firm nominated by such and reasonably acceptable for the Audited Party, for the purpose of verifying the accuracy of any statement or report given by the Audited Party and to verify the accuracy of the payments due hereunder for any Calendar Year. Such auditor shall advise the Parties simultaneously promptly upon its completion of its audit whether or not the payments due hereunder have been accurately recorded, calculated, and reported, and, if not, the amount of such discrepancy. Except in the case of willful misconduct or fraud, (a) a Party’s financial records with respect to a given period of time shall only be subject to one (1) audit per Calendar Year, and (b) Enanta may upon written request, cause the Auditing Party’s right to perform an internationally-recognized independent accounting firm (audit pertaining to any Calendar Year shall expire [***] after the “Auditor”) which is reasonably acceptable to Novartis to inspect the relevant records end of Novartis and its Affiliates to verify the royalties payable by Novartis and the related reports, statements, records and books of accounts, as applicablesuch Calendar Year. Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Enanta and its Affiliates as reasonably The auditor shall be required to verify the amounts payable by Novartis hereunder or Enanta’s required FTE support or reimbursable expenses, as applicable. Before beginning its audit, the Auditor shall execute an undertaking Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 acceptable to Party being audited by which the Auditor agrees to keep confidential all information reviewed learned during the audit. The Auditor shall have the right any such inspection, and to disclose to the auditing Auditing Party only its conclusions regarding any payments owed under this Agreement.
(c) Each Party and its Affiliates shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the other Party. The records shall details as may be reviewed solely necessary to verify report the accuracy of payments hereunder and compliance with this Agreementthe Audited Party’s statement or report. Such inspection right The Auditing Party shall not be exercised more than once in any calendar year and not more frequently than once with respect to records covering any specific period of time. In additionresponsible for the auditor’s costs, unless the auditor certifies that an overpayment to, or an underpayment by, the auditing Audited Party agrees to hold that resulted from a discrepancy in strict confidence all information received and all information learned in a report that the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order.
(d) The Auditor shall provide its audit report and basis for any determination to the audited Audited Party at the time such report is provided to the auditing Auditing Party before it is considered final.
(e) In during the event that the final result of any such inspection reveals an undisputed applicable audit period, which underpayment or overpayment, the underpaid or overpaid amount shall be settled promptly.
(f) The auditing Party shall pay for such audits, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment (with respect to royalties) or overpayment (with respect to research-related payments to Enanta) of more than ten percent (10%) of the total payments due hereunder for the applicable calendar year is discovered, the fees and expenses charged by the Auditor shall be paid by the audited Party.
(g) To the extent applicable, Novartis and its Affiliates shall include in each sublicense granted by it to any sublicensee a provision requiring the sublicensee to maintain records of sales made pursuant to such license and to grant access to such records by Novartis’ designated independent accountant to the same extent and under the same obligations as required of Novartis under this Agreement. Enanta shall have the right to request audits of sublicensees by Novartis for reasonable cause. Novartis shall advise Enanta in advance of each audit of any sublicensee with respect to Product sales. Novartis will provide Enanta with a summary of the results received from the audit and, if Enanta so requests, a copy of the audit report with respect to Product sales. Novartis shall pay for any such audits of sublicensees, provided that Enanta will pay for any such audits of sublicensees that are expressly requested by Enanta in writing. Notwithstanding the foregoing, if an underpayment of was more than [***] of the amount set forth in such report or [***], whichever is greater, in which case the Audited Party shall bear the full cost of such audit. If such accounting firm correctly identifies a discrepancy made during such period, any unpaid amounts or overpaid amounts that are discovered shall be paid/refunded promptly but in any event within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The Auditing Party shall treat all financial information subject to review under this Section 9.8 in accordance with the confidentiality and non-use provisions of Article 10, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the Audited Party obligating it to retain all such information in confidence pursuant to such confidentiality agreement. Upon the expiration of [***] following the end of any Calendar Year, royalty calculations and joint Development Cost sharing calculations with respect to such Calendar Year shall be binding and conclusive upon both parties. Unless an audit is discoveredongoing with respect to such period, the fees and expenses charged by the Auditor Parties shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and filed separately released from any liability or accountability with the Securities and Exchange Commission. Asterisks denote respect to said calculations for such omission. 31Calendar Year.
Appears in 1 contract
Sources: License and Collaboration Agreement (Stoke Therapeutics, Inc.)