Common use of Records and Audit Rights Clause in Contracts

Records and Audit Rights. (i) Each Party shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, in relation to Net Sales and Sales Related Payments. Each Party will keep such books and records for at least [***] following the [***] to which they pertain. (ii) Novartis may, upon written notice to Buyer, appoint an internationally-recognized independent accounting firm (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis its conclusions regarding any payments owed under this Agreement. (iii) Buyer and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely to verify the calculation of any Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any [***]. Novartis 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 if disclosure is required by Applicable Law, regulation or judicial order. (iv) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 9 contracts

Samples: Asset Purchase Agreement (Mereo Biopharma Group PLC), Asset Purchase Agreement (Mereo Biopharma Group PLC), Asset Purchase Agreement (Mereo Biopharma Group PLC)

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Records and Audit Rights. (ia) Each Party shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this Agreement, including, with respect to BuyerNovartis 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 Related Paymentsand 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. (iib) Novartis may, Enanta may upon written notice to Buyerrequest, appoint 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 or and books of accounts (accounts, as applicable) . Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Buyer or Enanta and its Affiliates in connection with as reasonably required to verify the calculation of any Sales Related Paymentsamounts 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 Buyer and Novartis pursuant to Party being audited by which the Auditor agrees to keep confidential all information reviewed during such the audit. The Auditor shall have the right to disclose to Novartis the auditing Party only its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Each Party and its Affiliates shall make their records available for inspection by such the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartisthe other Party. The records shall be reviewed solely to verify the calculation accuracy of any Sales Related Paymentspayments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than [***] (other than once in any calendar year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] once with respect to records covering any [***]specific period of time. Novartis 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 if disclosure is to the extent required by Applicable Lawto comply with any law, regulation or judicial order. (ivd) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer the audited Party at the same time the Audit Report such report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which auditing Party before it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.considered final. (ve) In the event that the Audit Report (as finally agreed upon by the Parties) final result of any such inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderoverpayment, the underpaid or overpaid amount shall be settled promptly. (vif) 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 be solely responsible 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 all costs 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 relating to any charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee. Confidential materials omitted and all filed separately with the Securities and Exchange Commission. Asterisks denote such audits as described in this Section 5.4(d).omission. 31

Appears in 2 contracts

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

Records and Audit Rights. (ia) Each Party shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this Agreement, including, with respect to BuyerNovartis, in relation to Net Sales and Sales Related Paymentsroyalties. Each Party will keep such books and records for at least [***] following the [***] Calendar Year to which they pertain. (iib) Novartis Licensor may, upon written notice request to BuyerNovartis, appoint cause an internationally-recognized independent accounting firm (which is reasonably acceptable to Novartis) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer Novartis or its Affiliates in connection with to verify the calculation royalties payable by Novartis and the related reports, statements and books of any Sales Related Paymentsaccounts, as applicable. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to by which the Auditor agrees shall agree to keep confidential all information Confidential Information reviewed during such audit. The Auditor shall have the right to disclose to Novartis Licensor only its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Novartis and its Affiliates shall make their records relating to each Sales & Royalty Report available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from NovartisLicensor. The records shall be reviewed solely to verify the calculation accuracy of any Sales Related PaymentsNovartis’ royalties and compliance with this Agreement. Such inspection right shall not be exercised more than [***] (other than once in any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Calendar Year and not more frequently than [***] once with respect to records covering any specific period of time. In addition, Licensor shall only be entitled to audit the relevant books and records of Novartis from the [***]] prior to the Calendar Year in which the audit request is made. Novartis Licensor agrees to hold in strict confidence all information Confidential 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 if disclosure is required by Applicable Law, regulation or judicial order. (iv) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).264814036 v4 EXECUTION COPY

Appears in 2 contracts

Samples: License and Collaboration Agreement (Molecular Partners Ag), License and Collaboration Agreement (Molecular Partners Ag)

Records and Audit Rights. (ia) Each Party shall, and Novartis shall ensure that its sublicensees hereunder, keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this Agreement, including, with respect to BuyerNovartis and its sublicensees, in relation to Net Sales and Sales Related Paymentsroyalties. Each Party will keep such books and records for at least [***] following the [***] Calendar Quarter to which they pertain, provided that if [*] in accordance with Section 9.5(b) below, such [*] retention period for books and records by Novartis shall be [*]. (iib) Novartis may, upon written notice Quark shall have the right for a period of [*] after receiving any Sales & Royalty Report to Buyer, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Novartis) (the “Auditor”) to inspect the relevant records of Novartis or its Affiliates to verify such reports, statements, records or books of accounts (accounts, as applicable) . In the sole event [*] exercises its rights under the [*] to conduct an audit of Buyer Quark, Quark shall have the right, for a period of [*] after receiving any Sales & Royalty Report to appoint an Auditor to inspect the relevant records of Novartis or its Affiliates in connection with to the calculation of any Sales Related Paymentsextent required or necessary under the [*]. In the event Novartis exercises the Option, [*]. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to shall keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis Quark only its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Novartis and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed Quark, solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any [***]. Novartis Quark 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 if disclosure is required by Applicable Lawlaw, regulation or judicial order. (ivd) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to by an Auditor shall be made available for review and comment by Novartis following Novartis. Buyer ’ request, and Novartis shall have the right right, at its expense, to request a further determination by the such Auditor as to matters which Buyer Novartis disputes by providing within [*] following receipt of such report. Novartis will provide Quark and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is providedprovided by Novartis, which determination shall be limited to the disputed matters. Any matter that remains unresolved If the Parties disagree as to results of such further determination, the dispute shall be resolved in accordance with subject to the dispute resolution procedures contained procedure specified in Article V.Section 17.5. (ve) In Unless disputed, if an audit discloses any underpayment by Novartis, Novartis shall promptly pay to Quark the amount of any such underpayment, together with interest calculated pursuant to Section 9.4, within [*] of receiving the final audit report establishing such obligation. Quark shall pay for such audits, as well as its own expenses associated with such audit, except that in the event there is any upward adjustment in aggregate amounts payable for any year shown by such audit of more than [*] of the amount paid, Novartis shall pay for such audit. (f) If Novartis discovers, whether by audit or otherwise that it has made an overpayment, it will deduct such overpayment in the Audit Sales and Royalty Report for the next Calendar Quarter. To the extent that any overpayment cannot be fully deducted from the royalty payment for such Calendar Quarter, Novartis may deduct such amount from subsequent amounts due to Quark until the full amount that Novartis was entitled to receive is deducted. If the full amount cannot be deducted from subsequent amounts, Quark shall promptly pay to Novartis the amount of any such overpayment within [*] of receiving an invoice from Novartis. (g) Quark shall keep all books and records relating to any Development Costs required to be reimbursed by Novartis pursuant to the Option Agreement and/or this Agreement. Novartis shall have the right for the period of [*] following the Calendar Quarter to which they pertain to appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Quark) to inspect the relevant records of Quark or its Affiliates to verify such reports and statements, or books of account, as finally agreed applicable. Before beginning the audit, the Auditor shall execute an undertaking acceptable to Quark pursuant to which the Auditor will keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis only its conclusions regarding any payment owed under this Agreement. Quark and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon by the Partiesreceipt of reasonable advance notice form Novartis. The provisions of Section 9.5(d) reveals an undisputed underpayment or overpayment and Novartis rights and obligations contained therein shall apply mutatis mutandis to Quark in respect of Sales Related Payments or other payments hereunderany such audit report. Unless disputed, if an audit discloses any overpayment by Novartis, Quark shall promptly pay to Novartis the underpaid or overpaid amount shall be settled promptlyof any such overpayment, together with interest calculated pursuant to Section 9.4, within [*] of receiving the final audit report establishing such obligation. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 2 contracts

Samples: Option Agreement (Quark Pharmaceuticals Inc), Option Agreement (Quark Pharmaceuticals Inc)

Records and Audit Rights. (ia) Each Party Novartis shall (and shall cause any of its Affiliates, licensees or sublicensees to) keep complete, true and accurate books and records in accordance with internationally recognized accounting standards IFRS in relation to this Agreement, including, with respect to Buyer, including in relation to Net Sales and Sales Related Paymentsroyalties. Each Party Novartis will keep (or cause to be kept) such books and records for at least [***] three (3) years following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice The Company shall have the right for a period of [*] after receiving any Sales Report to Buyer, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Novartis) (the “Auditor”) to inspect the relevant records of Novartis or its Affiliates to verify such reports, statements, records or books of accounts (accounts, as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to by which the Auditor agrees to shall keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis the Company its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Novartis and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed the Company, solely to verify the calculation accuracy of any the Sales Related PaymentsReports. Such inspection right shall not be exercised more frequently than [***] (other than once in any calendar year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] once with respect to records covering any [***]specific period of time. Novartis The Company 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 if disclosure is required by Applicable Lawlaw, regulation or judicial order. (ivd) The Auditor Company shall provide pay for such audits, as well as its audit report (the “Audit Report”) and basis for own expenses associated with enforcing its rights with respect to any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, except that in the underpaid or overpaid event there is any upward adjustment in aggregate amounts payable for any year shown by such audit of more than [*] percent ([*]%) of the amount shall be settled promptly. (vi) paid, Novartis shall be solely responsible pay for all costs and expenses relating such audit (as well as promptly paying to the Company the amount of any and all such audits as described in this Section 5.4(dadjustment).

Appears in 2 contracts

Samples: Asset Purchase and Licensing Agreement, Asset Purchase Agreement (Opexa Therapeutics, Inc.)

Records and Audit Rights. (i) Each Party Supplier shall keep complete, true and accurate books and records maintain in accordance with internationally recognized generally accepted accounting principles, quality standards in relation and industry practices, accurate and complete books and records, findings, metrics and other documentation (both physical and electronic) as well as an inspection and process control system covering any Services provided hereunder that is necessary to enable Supplier to demonstrate Supplier’s full compliance with this Agreement and each Order (the “Audit Materials”). Supplier acknowledges that Audit Materials encompass materials pertaining both to Supplier’s accounting/billing practices and its performance of its obligations under this Agreement, including, its compliance with respect Buyer’s policies and applicable laws. Supplier shall retain the Audit Materials for the later of: (i) the term of the Agreement and applicable Order and for a period of three (3) years after termination of the Agreement or the last outstanding Order (whichever is longer); (ii) resolution of any dispute in which the Audit Materials are relevant; and (ii) any additional time required by any governmental, judicial or regulatory authority (the “Retention Period”). At Buyer’s written request during the Retention Period, Supplier shall allow Buyer (directly and/or through third-parties) to audit and inspect Supplier’s facilities and Audit Materials, as well as copy any documents that Supplier has relating to the performance of Supplier’s obligations under the Agreement or any Order or other applicable legal requirements. Each of the parties will bear their own respective costs and expenses associated with the foregoing. Adjustments in favor of Buyer arising from any such audit shall be recognized as an adjustment of any future payment due Supplier, or, if no future payment is due Supplier, Supplier shall promptly pay the amount of any such adjustment to Buyer. If a financial audit or inspection uncovers any overcharge, Supplier shall refund the overcharge as a credit on the next invoice provided to Buyer, in relation or if no future payment is due, Supplier shall promptly pay the amount of the overcharge to Net Sales and Sales Related PaymentsBuyer. Each Party will keep such books and records for at least [***] following the [***] to which they pertain. (ii) Novartis may, upon written notice to Buyer, appoint an internationally-recognized independent accounting firm (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer or party shall bear its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis its conclusions regarding any payments owed under this Agreement. (iii) Buyer and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely to verify the calculation of any Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any [***]. Novartis 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 if disclosure is required by Applicable Law, regulation or judicial order. (iv) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all own costs and expenses relating associated with its own actions under this Section; provided however, if an audit reveals an overbilling or over-reporting of three percent (3%) or more, then Supplier shall reimburse Buyer for the cost of the audit. Access, inspections and audits shall be conducted in a manner not to any and all such audits as described in this Section 5.4(d)unduly interfere with Supplier’s operations.

Appears in 2 contracts

Samples: Purchase Agreement, Terms of Purchase

Records and Audit Rights. (ia) Each Party shall keep resTORbio will keep, and will cause its Affiliates and sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, its Accounting Standards in relation to Net Sales and Sales Related Paymentsroyalties payable to Novartis hereunder. Each Party resTORbio will keep keep, and will cause its Affiliates and sublicensees to keep, such books and records for at least [***] three (3) years following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerresTORbio, appoint an internationally-internationally- recognized independent accounting firm (which is reasonably acceptable to resTORbio) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer resTORbio or its Affiliates in connection with or sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to resTORbio by which the Auditor agrees to will keep confidential all information Information reviewed during such audit. The Auditor shall will have the right to disclose to Novartis its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer resTORbio and its Affiliates shall and sublicensees will make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than once in any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Calendar Year and not more frequently than [***] once with respect to records covering any [***]specific period of time. In addition, Novartis will only be entitled to audit the relevant books and records of resTORbio relating to a Sales & Royalty Report for a period of three (3) Calendar Years after receipt of the applicable Sales & Royalty Report. Novartis agrees to will hold in strict confidence all information Information received and all information Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Lawlaw, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer resTORbio at the same time the Audit Report such report is provided to Novartis, before it is considered final. Buyer shall resTORbio will have the right to request a further determination by the such Auditor as to matters which Buyer resTORbio disputes by providing within thirty (30) days following receipt of such report. resTORbio will provide Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall will undertake to complete such further determination within [***] thirty (30) days after the dispute notice is provided, which determination shall will be limited to the disputed matters. Any matter that remains unresolved shall will be resolved in accordance with the dispute resolution procedures contained in Article V.Section 16.5. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby resTORbio, the underpaid or overpaid amount shall will be settled promptly. (vif) Novartis shall be solely responsible will pay for all costs and such audits, as well as its own expenses relating associated with enforcing its rights with respect to any and all payments hereunder, except that in the event there is any upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audits as described in this Section 5.4(d)audit of more than four percent (4%) of the amount paid, resTORbio will pay for such audit.

Appears in 2 contracts

Samples: License Agreement (resTORbio, Inc.), License Agreement (resTORbio, Inc.)

Records and Audit Rights. (ia) Each Party shall keep Company will keep, and will cause its Affiliates and sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, its Accounting Standards in relation to Net Sales and Sales Related Paymentsroyalties payable to Novartis hereunder. Each Party Company will keep keep, and will cause its Affiliates and sublicensees to keep, such books and records for at least [***] following the [***] delivery of the Sales & Royalty Report for the Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerCompany, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Company) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer Company or its Affiliates in connection with or sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to Company by which the Auditor agrees to will keep confidential all information Confidential Information reviewed during such audit. The Auditor shall will have the right to disclose to Novartis its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer Company will, and will cause its Affiliates shall and sublicensees to, make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect ]. In addition, Novartis will only be entitled to audit the relevant books and records covering any of Company relating to a Sales & Royalty Report for a period of [***]] after receipt of the applicable Sales & Royalty Report. Novartis agrees to will hold in strict confidence in accordance with Section 10 all information Confidential Information received and all information Confidential Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer Company at the same time the Audit Report such report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which , before it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.considered final. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby Company, the underpaid or overpaid amount shall will be settled promptly. (vif) Novartis shall be solely responsible will pay for all costs and any such audits, as well as its own expenses relating associated with enforcing its rights with respect to any and all payments hereunder, except that in the event there is any upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audits as described in this Section 5.4(d)audit of more than [***] of the amount paid, Company will pay for such audit.

Appears in 2 contracts

Samples: License Agreement (Vera Therapeutics, Inc.), License Agreement (Vera Therapeutics, Inc.)

Records and Audit Rights. (ia) Each Party shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this Agreement, including, with respect to BuyerNovartis 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 Related Paymentsand 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. (iib) Novartis may, Enanta may upon written notice to Buyerrequest, appoint 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 or and books of accounts (accounts, as applicable) . Novartis may upon written request, cause an Auditor that is reasonably acceptable to Enanta to inspect the relevant records of Buyer or Enanta and its Affiliates in connection with as reasonably required to verify the calculation of any Sales Related Paymentsamounts 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 acceptable to Buyer and Novartis pursuant to Party being audited by which the Auditor agrees to keep confidential all information reviewed during such the audit. The Auditor shall have the right to disclose to Novartis the auditing Party only its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Each Party and its Affiliates shall make their records available for inspection by such the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartisthe other Party. The records shall be reviewed solely to verify the calculation accuracy of any Sales Related Paymentspayments hereunder and compliance with this Agreement. Such inspection right shall not be exercised more than [***] (other than once in any calendar year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] once with respect to records covering any [***]specific period of time. Novartis 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 if disclosure is to the extent required by Applicable Lawto comply with any law, regulation or judicial order. (ivd) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer the audited Party at the same time the Audit Report such report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which auditing Party before it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.considered final. (ve) In the event that the Audit Report (as finally agreed upon by the Parties) final result of any such inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderoverpayment, the underpaid or overpaid amount shall be settled promptly. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. 30 (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. (vig) 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 be solely responsible 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 all costs 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 relating to any and all such audits as described in this Section 5.4(d)charged by the Auditor shall be paid by Novartis, unless otherwise borne by the sublicensee.

Appears in 1 contract

Samples: Collaboration and License Agreement (Enanta Pharmaceuticals Inc)

Records and Audit Rights. (ia) Each Party Vanda shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this License Agreement, including, with respect to Buyer, including in relation to Net Sales and Sales Related PaymentsRoyalties. Each Party Vanda will keep such books and records for at least [***] following *. (b) Novartis shall have the [right for a period of ***] * after receiving each Sales, Royalty & Commercialization Report to which they pertain. (ii) Novartis may, upon written notice to Buyer, appoint an internationally-recognized independent accounting firm (the “Auditor”) to inspect the relevant records of Vanda or its authorized sublicensees to verify such reports, statements, records or books of accounts (accounts, as applicable) of Buyer or . No records for any given year may be audited more than once and Vanda and its Affiliates in connection with will not be audited more than once per year. (c) In order to initiate an audit, Novartis must provide written notice to Vanda, which notice shall include one or more proposed dates for the calculation audit and which notice shall be given not less than sixty (60) days prior to the first proposed audit date. Vanda will reasonably accommodate the scheduling of any Sales Related Paymentssuch audit. Before beginning its auditPrior to commencing the work, the Auditor shall execute will enter into an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such auditappropriate confidentiality agreement with Xxxxx. The Auditor shall will have the right to disclose to Novartis its conclusions regarding any payments owed under this License Agreement. (iii) Buyer and its Affiliates shall make their records available for inspection by such . For the avoidance of doubt, notwithstanding the foregoing, the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely to verify the calculation of any Sales Related Payments. Such inspection right shall not be exercised disclose to Novartis any more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect detailed information that Novartis would have otherwise been entitled to records covering any [***]receive pursuant to this License Agreement. Novartis 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 that such information is not confidential and/or it is necessary to disclose it to enforce its rights under this License Agreement or if disclosure is required by Applicable Law, regulation or judicial order. **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (ivd) The Auditor Vanda and Xxxxx’s authorized sublicensees shall provide its audit report (the “Audit Report”) and basis make their records available for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination inspection by the Auditor as during regular business hours at such place or places where such records are customarily kept, to matters which Buyer disputes by providing Novartis and verify the Auditor with a reasonably detailed statement accuracy of the grounds upon which it disputes Sales & Royalty Reports and compliance with this License Agreement (e) Novartis shall pay for such audits, as well as its own expenses associated with enforcing its rights with respect to any findings in the Audit Report within [payments hereunder, except that, if an underpayment of ***] days following receipt of * is discovered, the Audit Report. The failure reasonable fees and expenses charged by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered or incurred by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.paid by Xxxxx. (vf) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby Xxxxx, the underpaid or overpaid amount shall be settled promptly****. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: License Agreement (Vanda Pharmaceuticals Inc.)

Records and Audit Rights. (ia) Each Party shall keep Pharming will keep, and will cause its Affiliates and Sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this AgreementMilestones, including, Net Sales and royalties payable to Novartis hereunder with respect to Buyerthe Licensed Compound and Licensed Products. Pharming will keep, in relation and will cause its Affiliates, licensees and Sublicensees to Net Sales and Sales Related Payments. Each Party will keep keep, such books and records for at least [***] following years after the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerPharming, appoint an internationally-recognized internationallyrecognized independent accounting firm (which is reasonably acceptable to Pharming) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer Pharming or its Affiliates in connection with Affiliates, licensees or Sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to Pharming by which the Auditor agrees to will keep confidential all information Confidential Information reviewed during such audit. The Auditor shall will only have the right to disclose to Novartis its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer Pharming will, and will cause its Affiliates shall and Sublicensees to, make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than in any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Calendar Year and not more frequently than [***] once with respect to records covering any specific period of time. In addition, Novartis will only be entitled to audit the relevant books and records of Pharming relating to a Sales & Royalty Report for a period of [***]] Calendar Years after receipt of the applicable Sales & Royalty Report. Novartis agrees to will hold in strict confidence all information Confidential Information received and all information Confidential Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer Pharming at the same time the Audit Report such report is provided to Novartis, before it is considered final. Buyer shall Pharming will have the right to request a further determination by the such Auditor as to matters which Buyer Pharming disputes by providing within [***] days after receipt of such report. Pharming will provide Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall will undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall will be limited to the disputed matters. Any matter that remains unresolved shall will be resolved in accordance with the dispute resolution procedures contained in Article V.Section 15.5. (ve) In If the event that final result of the Audit Report (as finally agreed upon by the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby Pharming, the underpaid or overpaid amount shall will be settled promptly. (vif) Novartis shall be solely responsible will pay for all costs and any such audits, as well as its own expenses relating associated with enforcing its rights with respect to any and all payments hereunder, except that if there is an upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audits as described in this Section 5.4(d)audit of more than [***] of the amount paid, Pharming will pay for such audit.

Appears in 1 contract

Samples: License Agreement

Records and Audit Rights. (ia) Each Party Novartis shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this Agreementthe Fully Burdened Manufacturing Cost, includingwhere used to reduce the Royalty Payments pursuant to Clause 7.8, with respect to Buyer, in relation to Net Sales and Sales Related PaymentsRoyalty Payments under this Agreement. Each Party Novartis will keep such books and records for at least [***] three (3) years following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice NexMed shall have the right for a period of three (3) years after receiving any Sales & Royalty Report to Buyer, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Novartis) (the “Auditor”) to inspect the relevant records of Novartis to verify such reports, statements, records or books of accounts (accounts, as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to by which the Auditor agrees to shall keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis NexMed its conclusions regarding any payments owed under this Agreement. (iiic) Buyer Novartis and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed NexMed, solely to verify the accuracy of the Sales & Royalty Reports and the calculation of any Sales Related PaymentsFully Burdened Manufacturing Costs, solely in the event such are used to reduce the Royalty Payments pursuant to Clause 7.8. Such inspection right shall not be exercised more than [***] (other than once in any calendar year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] once with respect to records covering any [***]specific period of time. Novartis NexMed 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 if disclosure is required by Applicable Lawlaw, regulation or judicial orderorder (which such disclosure shall be governed by the provision of Clause 10.3(b)). (ivd) The Auditor NexMed shall provide pay for such audits, as well as its audit report (the “Audit Report”) and basis for own expenses associated with enforcing its rights with respect to any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, except that in the underpaid or overpaid event there is any upward adjustment in aggregate amounts payable for any year shown by such audit of more than five percent (5%) of the amount shall be settled promptly. (vi) paid, Novartis shall be solely responsible pay for all costs and expenses relating to any and all such audits as described in this Section 5.4(d)audit.

Appears in 1 contract

Samples: License Agreement (Nexmed Inc)

Records and Audit Rights. (ia) Each Party shall keep Licensee will keep, and will cause its Affiliates and sublicensees to keep, complete, true true, and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, its Accounting Standards in relation to Net Sales and Sales Related Payments. Each Party will keep such books and records royalties payable to Novartis hereunder for at a period of least [***] following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerLicensee, appoint an internationally-recognized independent accounting firm firm, which must be reasonably acceptable to Licensee (the “Auditor”) ), to inspect the relevant reports, statements, records records, or books of accounts (as applicable) of Buyer or Licensee, its Affiliates in connection with Affiliates, and its Sublicensees to verify the calculation accuracy of any Sales Related Payments. & Royalty Report. (c) Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to Licensee by which the Auditor agrees to will keep confidential all information Information reviewed during such audit. The Auditor shall have the right to disclose to Novartis its conclusions regarding any payments owed under this Agreement. (iii) Buyer Licensee will, and will cause its Affiliates shall and sublicensees to make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any [***]. Novartis agrees to hold in strict confidence all information received and all information learned in the course specific period of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Law, regulation or judicial ordertime. (ivd) The Auditor shall will have the right to disclose to Novartis and Licensee its conclusions regarding any payment owed under this Agreement. The Auditor will provide its audit report (the “Audit Report”) and basis for any determination to Buyer Licensee at the same time the Audit Report such report is provided to NovartisNovartis and before it is considered final. Buyer shall Licensee will have the right to request a further determination by the such Auditor as to matters which Buyer Licensee disputes by providing within [**] following receipt of such report. Licensee will provide Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall will undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall will be limited to the disputed matters. Any matter Following such determination, the Auditor will issue a final report to the Parties. (e) In the event that remains unresolved shall the final report of the Auditor reveals an underpayment or overpayment by Licensee, any undisputed underpaid or overpaid amount will be resolved settled in accordance with Section 5.1(a). To the extent that either Party disputes the factual or legal findings of the of the Auditor, the Parties agree to submit any such disputes to binding arbitration in accordance with the dispute resolution procedures contained provisions of Section 11.5, with the right of the prevailing Party as to each issue in Article V.dispute to receive its costs and attorney fees. (vf) In the event that the Audit Report (Novartis will pay for any such audits, as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in well as its own expenses associated with enforcing its rights with respect of Sales Related Payments or other to any payments hereunder, except that in the underpaid or overpaid event there is any upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audit of more than [**]% of the amount shall be settled promptlypaid, Licensee will pay for such audit. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: License Agreement (Verve Therapeutics, Inc.)

Records and Audit Rights. (i) Each Party Day One shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to for the purpose of determining the amounts payable under this Agreement, including, with respect to Buyer, in relation to Net Sales and Sales Related Payments. Each Party will keep such Such books and records for at least shall be kept by Day One [***] following the ]. Day One shall make such accounting records available, on reasonable notice sent by XxxXxxx, for inspection [***] to which they pertain. (ii) Novartis may], upon written notice to Buyer, appoint by an internationally-recognized independent certified public accounting firm (nominated by MabCare and reasonably acceptable to Day One, for the “Auditor”) to inspect purpose of verifying the relevant reports, statements, records or books of accounts (as applicable) of Buyer or its Affiliates in connection with the calculation accuracy of any Sales Related Paymentsstatement or report given by Day One and to verify the accuracy of the payments due hereunder for any Calendar Year. Before beginning Such auditor shall advise the Parties simultaneously promptly upon its auditcompletion of its audit whether or not the payments due hereunder have been accurately recorded, calculated, and reported, and, if not, the Auditor amount of such discrepancy. Except in the case of willful misconduct or fraud, [*]. The auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees be required to keep confidential all information reviewed learned during any such audit. The Auditor shall have the right inspection, and to disclose to Novartis its conclusions regarding any payments owed under this Agreement. (iii) Buyer and its Affiliates shall make their records available for inspection by MabCare only such Auditor during regular business hours at such place details as may be necessary to report the accuracy of Day One’s statement or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartisreport. The records MabCare shall be reviewed solely responsible for the auditor’s costs, unless the auditor certifies an underpayment by Day One that resulted from a discrepancy in a report that Day One provided to verify MabCare during the calculation of any Sales Related Payments. Such inspection right shall not be exercised applicable audit period, which underpayment was more than [***] (other than any year of the amount set forth in which a Change of Control Transaction occurssuch report, in which year case Day One shall bear the full cost of such right may audit. If such accounting firm identifies a discrepancy made during such period, any unpaid amounts or overpaid amounts that are discovered shall be exercised [***]) and not more frequently than [***] with respect to records covering paid/refunded promptly but in any [***]. Novartis 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 if disclosure is required by Applicable Law, regulation or judicial order. (iv) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report event within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within date of delivery of such [***] day period shall constitute Buyeraccounting firm’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyerwritten report so correctly concluding, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (or as finally otherwise agreed upon by the Parties) reveals . MabCare shall treat all financial information subject to review under this Section 6.10 in accordance with the confidentiality and non-use provisions of Article 7, and shall cause its accounting firm to enter into an undisputed underpayment or overpayment acceptable confidentiality agreement with Day One obligating it to retain all such information in confidence pursuant to such confidentiality agreement. [*], royalty calculations with respect of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount to such Calendar Year shall be settled promptly. (vi) Novartis binding and conclusive upon both Parties. Execution Version Unless an audit is ongoing with respect to such period, Day One shall be solely responsible released from any liability or accountability with respect to said calculations for all costs and expenses relating to any and all such audits as described in this Section 5.4(d)Calendar Year.

Appears in 1 contract

Samples: Exclusive License Agreement (Day One Biopharmaceuticals, Inc.)

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Records and Audit Rights. (ia) Each Party shall keep Pharming will keep, and will cause its Affiliates and Sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this AgreementMilestones, including, Net Sales and royalties payable to Novartis hereunder with respect to Buyerthe Licensed Compound and Licensed Products. Pharming will keep, in relation and will cause its Affiliates, licensees and Sublicensees to Net Sales and Sales Related Payments. Each Party will keep keep, such books and records for at least [***] following years after the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerPharming, appoint an internationally-recognized internationallyrecognized independent accounting firm (which is reasonably acceptable to Pharming) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer Pharming or its Affiliates in connection with Affiliates, licensees or Sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to Pharming by which the Auditor agrees to will keep confidential all information Confidential Information reviewed during such audit. The Auditor shall will only have the right to disclose to Novartis its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer Pharming will, and will cause its Affiliates shall and Sublicensees to, make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than in any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Calendar Year and not more frequently than [***] once with respect to records covering any specific period of time. In addition, Novartis will only be entitled to audit the relevant books and records of Pharming relating to a Sales & Royalty Report for a period of [***]] Calendar Years after receipt of the applicable Sales & Royalty Report. Novartis agrees to will hold in strict confidence all information Confidential Information received and all information Confidential Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer Pharming at the same time the Audit Report such report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which , before it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).considered

Appears in 1 contract

Samples: License Agreement (Pharming Group N.V.)

Records and Audit Rights. (ia) Each Party NLS shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards the Accounting Standards in relation to its obligations under this Agreement, including, with respect to Buyer, in relation to including regarding Net Sales and the Sales Related PaymentsReport. Each Party NLS will keep such books and records for at least [***] three (3) years following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice shall have the right for a period of three (3) years after receiving each Sales Report to Buyer, appoint an internationally-recognized independent accounting firm (hereinafter referred to as the “Auditor”) to inspect the relevant records of NLS and its Affiliates or its sublicensees to verify such reports, statements, records or books of accounts (accounts, as applicable) of Buyer or . NLS’ agreements with its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor or sublicensees shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during permit such auditaudit by Novartis. The Auditor shall have the right to disclose to Novartis and/or other Affiliates of Novartis its conclusions regarding any payments owed under this Agreement. Novartis shall have the right to do one audit per calendar year, and can only audit the same period once. (iiic) Buyer NLS and its Affiliates and sublicensees shall make their records available for inspection by such the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely , its Affiliate or designated independent accounting firm, to verify the calculation accuracy of any the Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Reports and not more frequently than [***] compliance with respect to records covering any [***]this Agreement. Novartis agrees to, and to cause the Auditor to, hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent that such information is not confidential and/or it is necessary to disclose it to enforce its rights under this Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (ivd) The Auditor Novartis shall provide pay for such audits, as well as its audit report own expenses associated with enforcing its rights with respect to any payments hereunder, except that, if an underpayment exists such that the interest amount calculated under section 7.4(e) below is more than five percent (5%) of a particular milestone amount that was audited, the “Audit Report”) reasonable fees and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination expenses charged by or incurred by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.paid by NLS. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby NLS, the underpaid or overpaid amount shall be settled promptlypromptly to Novartis with interest at the rate per annum equal to the lesser of: (i) two (2) times the three (3)-month USD-LIBOR rate (or if the three (3)-month USD-LIBOR rate is no longer available, its official successor or such other comparable interbank three-month borrowing rate) as quoted on Bloomberg (or if it no longer exists, a similarly authoritative source); or (ii) the highest rate permitted by Law, calculated on the number of days such payment is paid after the date such payment is due, and compounded monthly from the date such underpayment was due until the date that NLS makes the underpayment. (vif) Novartis For the avoidance of doubt, the information provided by NLS pursuant to this Section 7.5 shall be solely responsible deemed to be Information of NLS for all costs and expenses relating to any and all such audits as described in purposes of this Section 5.4(d)Agreement.

Appears in 1 contract

Samples: License Agreement (NLS Pharmaceutics Ltd.)

Records and Audit Rights. (ia) Each Party During the Royalty Term ChemGenex shall keep completefull, true and accurate books of account and records in accordance with internationally recognized generally accepted United States accounting standards in relation to this Agreementprinciples, includingconsistently applied, with respect to Buyer, in relation to Net Sales containing all particulars and Sales Related Payments. Each Party will keep such books and records reasonable supporting documentation as may be necessary for at least [***] following the [***] to which they pertain. (ii) Novartis may, upon written notice to Buyer, appoint an internationally-recognized independent accounting firm (the “Auditor”) to inspect the relevant reports, statements, records or books purpose of accounts (as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis its conclusions regarding any determining royalty payments owed under this Agreement. (iiib) Buyer Annually during the Royalty Term, and within 90 days from the end of its Affiliates financial year, ChemGenex must provide, at its expense, a worldwide detailed ChemGenex Revenue report detailed by countries and products, and certified by their auditors, being a firm approved by SEC for public companies. (c) All such books of account, records and supporting documentation shall make their records available be open for inspection by such Auditor at a time mutually acceptable to the parties, during regular normal business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely to verify the calculation of any Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not no more frequently than [***] with respect once per year, for three (3) years following the end of each calendar year to records covering which they apply, by any [***]independent certified public accountant retained by Stragen (reasonably acceptable to ChemGenex) on behalf of Stragen for the purpose of verifying ChemGenex's reports and royalty payments. Novartis agrees If such audit discloses an underpayment, ChemGenex shall promptly pay to hold in strict confidence all information received Stragen the amount of such underpayment. The costs and all information learned in expenses of performing such audits shall be borne by Stragen; provided, however, that if the course amount of any an underpayment for the audited period is five percent (5%) or more of the amount actually due, then the costs and expenses of performing such audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required shall be promptly reimbursed by Applicable Law, regulation or judicial orderChemGenex. (ivd) The Auditor shall provide Stragen must ensure that the independent certified accountant enters into a confidentiality deed with ChemGenex which includes an obligation not to disclose to Stragen or its audit report (the “Audit Report”) and basis for Affiliates any determination to Buyer at the same time the Audit Report information other than that which is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited relevant to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.rights of Stragen under this Agreement. (ve) In the event of a dispute between the independent certified public accountants of ChemGenex and Stragen with respect to any matter called for by this Agreement, the parties shall select a third independent public accounting firm to arbitrate the dispute, provided, that such firm shall have the Audit Report (as finally agreed upon authority only to select from among the positions of the original two firms that position which it deems most accurate. The fees of such third firm shall be borne by the Parties) reveals an undisputed underpayment or overpayment in respect party whose position is not approved of Sales Related Payments or other payments hereunder, the underpaid or overpaid amount shall be settled promptlyby such arbitrator. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: HHT Development and Commercialisation Agreement (Chemgenex Pharmaceuticals LTD)

Records and Audit Rights. (ia) Each Party Ultragenyx shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, in relation to Net Sales . Upon the written request of BRI and Sales Related Payments. Each Party will keep such books and records for at least [***] following the [***] to which they pertain. (ii) Novartis may, upon written notice to Buyer, appoint an internationally-recognized independent accounting firm (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis its conclusions regarding any payments owed under this Agreement. (iii) Buyer and its Affiliates shall make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely to verify the calculation of any Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change each Calendar Year, Ultragenyx shall permit an independent certified public accounting firm selected by BRI, and reasonably acceptable to Ultragenyx, to have access during normal business hours to such of Control Transaction occurs, in which year such right the records of Ultragenyx as may be exercised [***]) and reasonably necessary to verify the accuracy of the royalty reports hereunder for any Calendar Year ending not more frequently than [***] prior to the date of such request. BRI shall treat all financial information subject to review under this Section 4.9 or under any sublicense agreement in accordance with respect the confidentiality and non-use provisions of this Agreement. (b) Ultragenyx may require an accounting firm conducting an audit hereunder to records covering sign a non-disclosure agreement to protect the confidentiality of Ultragenyx’s Confidential Information before providing such accounting firm access to Ultragenyx’s facilities, books or records. Upon completion of any audit hereunder, the accounting firm shall provide both Ultragenyx and BRI a written report disclosing whether the royalty reports submitted by Ultragenyx are correct or incorrect, whether the amounts paid are correct or incorrect, and in each case, the specific details concerning any discrepancies. (c) BRI shall bear its internal expenses and the out-of-pocket costs for engaging such accounting firm in connection with performing such audits; provided , however , that if any such audit uncovers an underpayment of milestones payments or royalties by Ultragenyx that exceeds [***] percent ([***]. Novartis agrees to hold in strict confidence all information received %) of the total owed for such payment or payment period, as applicable, then Ultragenyx shall reimburse BRI for the expenses 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 if disclosure is required by Applicable Law, regulation or judicial ordercosts for such audit. (ivd) The Auditor If such accounting firm identifies an underpayment by Ultragenyx during such period, Ultragenyx shall provide its audit report (pay BRI the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement amount of the grounds upon which it disputes any findings in the Audit Report discrepancy within [***] days following receipt of the Audit Report. The failure by Buyer date BRI delivers to dispute Ultragenyx such accounting firm’s written report with the Audit Report within amount of underpayment accruing interest at the rate such [***] day period shall constitute Buyer’s acceptance of all of the items reflected forth in the Audit ReportSection 4.7. If such accounting firm identifies an overpayment by Ultragenyx during such period, Ultragenyx shall, at its option, have the right to request a request for further determination is timely delivered by Buyerrefund of such overpaid amount, the Auditor or credit such overpaid amount against subsequent payment obligations to BRI, and BRI shall undertake make such refund to complete such further determination Ultragenyx within [***] days after the dispute notice is providedof Ultragenyx’s request if so requested. If Ultragenyx has no future payment obligations under this Agreement, which determination then Ultragenyx may require BRI to refund such overpayment and BRI shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (v) In the event that the Audit Report (as finally agreed upon by the Parties) reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunder, the underpaid or pay such overpaid amount shall be settled promptlyto Ultragenyx within [***] days of Ultragenyx’s request. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: License Agreement (Ultragenyx Pharmaceutical Inc.)

Records and Audit Rights. (ia) Each Party Retrophin shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this License Agreement, including, with respect to Buyer, including in relation to Net Sales and Sales Related PaymentsRoyalties. Each Party Retrophin will keep such books and records for at least [***] ########* following the [***] ########* to which they pertain. (iib) Novartis may, upon written notice shall have the right for a period of ########* to Buyer, audit whether by itself or through its Affiliate(s) and/or to appoint an internationally-recognized independent accounting firm (whether Novartis, its Affiliate or an accounting firm, hereinafter referred to as the “Auditor”) with experience in the pharmaceutical industry to inspect the relevant records of Retrophin or its Affiliates or applicable authorized sublicensees to verify such reports, statements, records or books of accounts (accounts, as applicable) . No more than one audit of Buyer Retrophin or its Affiliates authorized sublicenses may occur in connection with any ########* period and such audits may only take place during Retrophin’s or its applicable authorized sublicensee’s regular business hours and after reasonable advance written notice (not less than two (2) weeks). Where the calculation of any Sales Related Payments. Before beginning its auditAuditor is not Novartis, the Auditor shall execute an undertaking acceptable to Buyer and Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis and/or other Affiliates of Novartis its conclusions regarding any payments owed under this License Agreement. ________________________ * ######## = Material omitted pursuant to a request for Confidential Treatment and submitted separately to the Commission on the date of submission of this Registration Statement on Form S-1. (iiic) Buyer Retrophin and its Affiliates authorized sublicensees shall make their records available for inspection by such the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely Auditor to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports and compliance with this License Agreement. Such inspection right Any such party conducting an audit shall not be exercised more than [***] (other than any year in enter into a reasonable confidentiality agreement provided by Retrophin, which a Change will allow disclosure of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any [***]. Novartis 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 only if it is necessary to disclose it to enforce its Novartis’ rights under this License Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (iv) The Auditor shall provide its audit report (the “Audit Report”) and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby Retrophin, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: License Agreement (Retrophin, Inc.)

Records and Audit Rights. (ia) Each Party shall keep QED will keep, and will cause its Affiliates and sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, its Accounting Standards in relation to Net Sales and Sales Related Paymentsroyalties payable to Novartis hereunder. Each Party QED will keep keep, and will cause its Affiliates and sublicensees to keep, such books and records for at least [***] three years following the [***] Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice to BuyerQED, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to QED) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer QED or its Affiliates in connection with or sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to QED by which the Auditor agrees to will keep confidential all information Information reviewed during such audit. The Auditor shall will have the right to disclose to Novartis its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer QED will, and will cause its Affiliates shall and sublicensees to make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than once in any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) Calendar Year and not more frequently than [***] once with respect to records covering any [***]specific period of time. In addition, Novartis will only be entitled to audit the relevant books and records of QED relating to a Sales & Royalty Report for a period of three Calendar Years after receipt of the applicable Sales & Royalty Report. Novartis agrees to will hold in strict confidence all information Information received and all information Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Lawlaw, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer QED at the same time the Audit Report such report is provided to Novartis, before it is considered final. Buyer shall QED will have the right to request a further determination by the such Auditor as to matters which Buyer QED disputes by providing within [***] following receipt of such report. QED will provide Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall will undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall will be limited to the disputed matters. Any matter that remains unresolved shall will be resolved in accordance with the dispute resolution procedures contained in Article V.Section 15.5. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby QED, the underpaid or overpaid amount shall will be settled promptly. (vif) Novartis shall be solely responsible [***] will pay for all costs and any such audits, as well as its own expenses relating associated with enforcing its rights with respect to any and all payments hereunder, except that in the event there is any upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audits as described in this Section 5.4(d)audit of [***].

Appears in 1 contract

Samples: License Agreement (BridgeBio Pharma LLC)

Records and Audit Rights. (ia) Each Party The Questcor Parties shall keep complete, true and accurate books and records in accordance with internationally recognized accounting standards its Accounting Standards in relation to this License Agreement, including, with respect to Buyer, including in relation to Net Sales and Sales Related PaymentsRoyalties. Each Party The Questcor Parties will keep such books and records for at least [***] following the ([***] ]) years following the Calendar Quarter to which they pertain. (iib) Novartis may, upon written notice shall have the right for a period of [***] ([***]) years after receiving each Sales & Royalty Report to Buyer, audit whether by itself or through its Affiliate(s) and/or to appoint an internationally-recognized independent accounting firm (whether Novartis, its Affiliate or an accounting firm, hereinafter referred to as the “Auditor”) to inspect the relevant records of Purchaser or its authorized sublicensees to verify such reports, statements, records or books of accounts (accounts, as applicable) of Buyer or its Affiliates in connection with the calculation of any Sales Related Payments. Before beginning its audit, Where the Auditor shall execute an undertaking acceptable to Buyer and is not Novartis pursuant to which the Auditor agrees to keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to Novartis and/or other Affiliates of Novartis its conclusions regarding any payments owed under this License Agreement. (iiic) Buyer The Questcor Parties and its Affiliates Purchaser’s authorized sublicensees shall make their records available for inspection by such the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from Novartis. The records shall be reviewed solely , its Affiliate or designated independent accounting firm, to verify the calculation accuracy of any the Sales Related Payments. Such inspection right shall not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) & Royalty Reports and not more frequently than [***] compliance with respect to records covering any [***]this License Agreement. Novartis 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 that such information is not confidential and/or it is necessary to disclose it to enforce its rights under this License Agreement or if disclosure is required by Applicable Law, regulation or judicial order. (ivd) The Auditor Novartis shall provide pay for such audits, as well as its audit report own expenses associated with enforcing its rights with respect to any payments hereunder, except that, if an underpayment of more than three percent (3%) of the “Audit Report”) total payments due hereunder for the applicable Calendar Year is discovered, the reasonable fees and basis for any determination to Buyer at the same time the Audit Report is provided to Novartis. Buyer shall have the right to request a further determination expenses charged by or incurred by the Auditor as to matters which Buyer disputes by providing Novartis and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, the Auditor shall undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall be limited to paid by the disputed matters. Any matter that remains unresolved shall be resolved in accordance with the dispute resolution procedures contained in Article V.Questcor Parties. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby the Questcor Parties, the underpaid or overpaid amount shall be settled promptly. (vi) Novartis shall be solely responsible for all costs and expenses relating to any and all such audits as described in this Section 5.4(d).

Appears in 1 contract

Samples: License Agreement (Questcor Pharmaceuticals Inc)

Records and Audit Rights. (ia) Each Party shall keep Novartis will keep, and will cause its Affiliates and sublicensees to keep, complete, true and accurate books and records in accordance with internationally recognized accounting standards in relation to this Agreement, including, with respect to Buyer, its Accounting Standards in relation to Net Sales and Sales Related Paymentsroyalties payable to AVEO hereunder. Each Party Novartis will keep keep, and will cause its Affiliates and sublicensees to keep, such books and records for at least [***] years following the [***] Calendar Quarter to which they pertain. (iib) Novartis AVEO may, upon written notice to BuyerNovartis, appoint an internationally-recognized independent accounting firm (which is reasonably acceptable to Novartis) (the “Auditor”) to inspect the relevant reports, statements, records or books of accounts (as applicable) of Buyer Novartis or its Affiliates in connection with or sublicensees to verify the calculation accuracy of any Sales Related Payments& Royalty Report. Before beginning its audit, the Auditor shall will execute an undertaking reasonably acceptable to Buyer and Novartis pursuant to by which the Auditor agrees to will keep confidential all information Information reviewed during such audit. The Auditor shall will have the right to disclose to Novartis AVEO its conclusions regarding any payments payment owed under this Agreement. (iiic) Buyer Novartis and its Affiliates shall and sublicensees will make their records available for inspection by such Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from NovartisAVEO. The records shall will be reviewed solely to verify the calculation accuracy of any the Sales Related Payments& Royalty Reports. Such inspection right shall will not be exercised more than [***] (other than any year in which a Change of Control Transaction occurs, in which year such right may be exercised [***]) and not more frequently than [***] with respect to records covering any specific period of time. In addition, AVEO will only be entitled to audit the relevant books and records of Novartis relating to a Sales & Royalty Report for a period of [***]] Calendar Years after receipt of the applicable Sales & Royalty Report. Novartis agrees to AVEO will hold in strict confidence all information Information received and all information Information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Lawlaw, regulation or judicial order. (ivd) The Auditor shall will provide its audit report (the “Audit Report”) and basis for any determination to Buyer Novartis at the same time the Audit Report such report is provided to NovartisAVEO, before it is considered final. Buyer shall Novartis will have the right to request a further determination by the such Auditor as to matters which Buyer Novartis disputes by providing within [**] days following receipt of such report. Novartis will provide the AVEO and the Auditor with a reasonably detailed statement of the grounds upon which it disputes any findings in the Audit Report within [***] days following receipt of the Audit Report. The failure by Buyer to dispute the Audit Report within such [***] day period shall constitute Buyer’s acceptance of all of the items reflected in the Audit Report. If a request for further determination is timely delivered by Buyer, audit report and the Auditor shall will undertake to complete such further determination within [***] days after the dispute notice is provided, which determination shall will be limited to the disputed matters. Any matter that remains unresolved shall will be resolved in accordance with the dispute resolution procedures contained in Article V.Section 16.5. (ve) In the event that the Audit Report (as finally agreed upon by final result of the Parties) inspection reveals an undisputed underpayment or overpayment in respect of Sales Related Payments or other payments hereunderby Novartis, the underpaid or overpaid amount shall will be settled promptly. (vif) Novartis shall be solely responsible AVEO will pay for all costs and such audits, as well as its own expenses relating associated with enforcing its rights with respect to any and all payments hereunder, except that in the event there is any upward adjustment in aggregate amounts payable for any Calendar Quarter shown by such audits as described in this Section 5.4(d)audit of more than [**] percent ([**]%) of the amount paid, Novartis will pay for such audit.

Appears in 1 contract

Samples: License Agreement (Aveo Pharmaceuticals Inc)

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