Common use of Financial Records; Audits Clause in Contracts

Financial Records; Audits. Procaps shall maintain complete and accurate records in sufficient detail to permit Galectin Therapeutics to confirm the accuracy of the Net Sales generated by Procaps and the calculation of royalty payments and the Net Sales Price. Upon reasonable prior notice of at least five (5) Business Days, such records shall be open during regular business hours for a period of three (3) years from the creation of individual records for examination at Galectin Therapeutics’ expense, and not more often than twice each calendar year, by an independent certified public accountant selected by Galectin Therapeutics for the sole purpose of verifying for Galectin Therapeutics the accuracy of the financial reports, royalty payment or Net Sales and Net Sales Price calculations or of any payments made by Procaps to Galectin Therapeutics pursuant to this Agreement. Any such auditor shall not disclose Procaps’ Confidential Information to Galectin Therapeutics, except to the extent such disclosure is necessary to verify the accuracy of the financial reports, royalty payment or Net Sales and Net Sales Price calculation furnished by Procaps or the amount of payments due by Procaps under this Agreement. Any amounts shown to be owed but unpaid or overpaid and in need of reimbursement shall be paid or refunded (as the case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 11.5) from the original due date. Galectin Therapeutics shall bear the full cost of such audit unless such audit discloses that Procaps paid too little because of a discrepancy in a report that Procaps provided to the JSC or Galectin Therapeutics during the applicable audit period, which underpayment was equal to more than five percent (5%) of the amount set forth in such report, in which case Procaps shall bear the full cost of such audit. Portions of this Exhibit were omitted, as indicated by [****], and have been provided separately to the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rules 24b-2 of the Securities Exchange Act of 1934, as amended.

Appears in 2 contracts

Samples: Supply, Marketing and Distribution Agreement (Galectin Therapeutics Inc), Supply, Marketing and Distribution Agreement (Galectin Therapeutics Inc)

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Financial Records; Audits. Procaps Adolor shall maintain keep, and shall cause its Affiliates and sublicensees to keep, such accurate and complete records as are necessary to determine the Cost of Goods and accurate amounts owing to Adolor under this Agreement. Such records in sufficient detail shall be retained by Adolor or any of its Affiliates or sublicensees. During normal business hours and with reasonable advance notice to permit Galectin Therapeutics to confirm the accuracy of the Net Sales generated by Procaps and the calculation of royalty payments and the Net Sales Price. Upon reasonable prior notice of at least five (5) Business DaysAdolor, such records shall be open during regular business hours made available for a period inspection, review and audit, at the request and expense of three (3) years from the creation of individual records for examination at Galectin Therapeutics’ expense, and not more often than twice each calendar yearGSK, by an independent certified public accountant selected accountant, or the local equivalent, appointed by Galectin Therapeutics GSK and reasonably acceptable to Adolor for the sole purpose of verifying for Galectin Therapeutics the accuracy of the financial reports, royalty payment or Net Sales Adolor’s accounting reports and Net Sales Price calculations or of any payments made by Procaps or to Galectin Therapeutics be made pursuant to this Agreement. Any ; provided, however that such auditor audits may not be performed by GSK more than once per Calendar Year and that GSK shall not disclose Procaps’ Confidential Information be permitted to Galectin Therapeuticsaudit the same period of time more than once. Such accountants shall be instructed not to reveal to GSK the details of its review, except for (i) such information as is required to the extent be disclosed under this Agreement and (ii) such disclosure information presented in a summary fashion as is necessary to verify report the accuracy accountants’ conclusions to GSK, and all such information shall be deemed Confidential Information of Adolor; provided, however, that in any event such information may be presented to GSK in a summary fashion as is necessary to report the financial reports, royalty payment or Net Sales accountants’ conclusions. All costs and Net Sales Price calculation furnished by Procaps or the amount of payments due by Procaps under this Agreement. Any amounts shown to be owed but unpaid or overpaid and expenses incurred in need of reimbursement connection with performing any such audit shall be paid or refunded by GSK unless the audit discloses at least a five percent (as the 5%) overpayment by GSK, in which case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 11.5) from the original due date. Galectin Therapeutics Adolor shall bear the full cost of the audit for such audit unless such audit discloses that Procaps paid too little because of a discrepancy Calendar Year. GSK shall be entitled to recover any shortfall in a report that Procaps provided payments due to the JSC or Galectin Therapeutics during the applicable audit period, which underpayment was equal to more than five percent (5%) of the amount set forth in such report, in which case Procaps shall bear the full cost of it as determined by such audit. Portions of , plus interest thereon calculated in accordance with Section 3.8, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments GSK is otherwise required to make to Adolor under this Exhibit were omitted, as indicated by [****], and have been provided separately to the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rules 24b-2 of the Securities Exchange Act of 1934, as amendedAgreement.

Appears in 1 contract

Samples: Row Supply Agreement (Adolor Corp)

Financial Records; Audits. Procaps ASTELLAS shall maintain keep, and shall cause its Affiliates and sublicensees to keep, such accurate and complete records of Net Sales as are necessary to determine the amounts due to THERAVANCE under this Agreement and accurate such records shall be retained by ASTELLAS or any of its Affiliates or sublicensees (in sufficient detail such capacity, the “Recording Party”) for at least the three Calendar Years after the period to permit Galectin Therapeutics to confirm the accuracy of which the Net Sales generated by Procaps relate. During normal business hours and with reasonable advance notice to the calculation of royalty payments and the Net Sales Price. Upon reasonable prior notice of at least five (5) Business DaysRecording Party, such records shall be open during regular business hours made available at a single location for a period inspection, review and audit, at the request of three (3) years from the creation of individual records for examination at Galectin Therapeutics’ expense, and not more often than twice each calendar yearTHERAVANCE, by an independent certified public accountant selected accountant, or the local equivalent, appointed and paid by Galectin Therapeutics THERAVANCE and reasonably acceptable to the Recording Party for the sole purpose of verifying for Galectin Therapeutics the accuracy of the financial reports, royalty payment or Net Sales Recording Party’s accounting reports and Net Sales Price calculations or of any payments made by Procaps or to Galectin Therapeutics be made pursuant to this Agreement; provided, however that such audits may not be performed by THERAVANCE more than once per Calendar Year. Any such auditor Such accountants shall be instructed not disclose Procaps’ Confidential Information to Galectin Therapeuticsreveal to THERAVANCE the details of its review, except for (i) such information as is required to the extent be disclosed under this Agreement and (ii) such disclosure information presented in a summary fashion as is necessary to verify report the accuracy accountants’ conclusions to THERAVANCE, and all such information shall be deemed Confidential Information of the financial reportsRecording Party; provided, royalty payment or Net Sales and Net Sales Price calculation furnished however, that in any event such [*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information may be presented to THERAVANCE in a summary fashion as is necessary to report the accountants’ conclusions. All external expenses incurred in connection with performing any such audit shall be paid by Procaps or THERAVANCE unless the amount audit discloses at least a [*] shortfall, in which case the Recording Party will bear the full expense of the audit for such Calendar Year. THERAVANCE will be entitled to recover any shortfall in payments due to it as determined by Procaps such audit, plus interest thereon calculated in accordance with Section 6.08, or alternatively shall have the right to offset and deduct any such shortfall in payments due to it against payments THERAVANCE is otherwise required to make to the Reporting Party under this Agreement. Any amounts shown ASTELLAS may offset any overpayment against any other payment(s) due THERAVANCE hereunder or require THERAVANCE to be owed but unpaid or overpaid and in need of reimbursement refund the overpayment within 30 days. The documents from which were calculated the sums due under this ARTICLE 6 shall be paid or refunded (as retained by the case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 11.5) from the original due date. Galectin Therapeutics shall bear the full cost of such audit unless such audit discloses that Procaps paid too little because of a discrepancy in a report that Procaps provided to the JSC or Galectin Therapeutics relevant Party during the applicable audit period, which underpayment was equal to more than five percent (5%) of the amount set forth in such report, in which case Procaps shall bear the full cost of such audit. Portions of this Exhibit were omitted, as indicated by Term-Total plus [****]. The foregoing in this Section 6.10 shall apply mutatis mutandis regarding THERAVANCE’s and its Affiliates’ recordkeeping and ASTELLAS’ right to review and audit records of expenses for which THERAVANCE may seek reimbursement under this Agreement, and have been provided separately to the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rules 24b-2 of the Securities Exchange Act of 1934, as amendedincluding without limitation Registration Expenses.

Appears in 1 contract

Samples: Agreement (Theravance Inc)

Financial Records; Audits. Procaps During the term of this Agreement and for one (1) year thereafter, BCGT shall maintain complete and accurate not more than once each year have the right to have an independent certified public accountant firm reasonably acceptable to Xxxxx inspect/audit records in sufficient detail to permit Galectin Therapeutics to confirm for solely the one year immediately preceding such audit for the purpose of determining the accuracy of the Net Sales generated by Procaps royalty payments. During normal business hours and the calculation of royalty payments and the Net Sales Price. Upon reasonable prior notice of with at least five sixty (560) Business Daysdays’ notice from BCGT to Lilly, such records shall will be open during regular business hours made available for a period of three (3) years from the creation of individual records for examination at Galectin Therapeutics’ expenseinspection, review and not more often than twice each calendar yearaudit, by an such independent certified public accountant selected by Galectin Therapeutics BCGT and approved by Xxxxx, such approval not to be unreasonably withheld for the sole purpose of verifying for Galectin Therapeutics the accuracy of the financial reports, royalty payment or Net Sales accounting reports and Net Sales Price calculations or of any payments made by Procaps to Galectin Therapeutics pursuant to this Agreement. Any such auditor BCGT shall submit an audit plan, including audit scope, to Lilly for Xxxxx’x approval, which shall not disclose Procaps’ Confidential Information be unreasonably withheld, prior to Galectin Therapeutics, except audit implementation. Such auditor will be required to enter into a confidentiality agreement with Lilly or the extent such disclosure is necessary relevant Lilly Company prior to verify performing the audit. The auditor will not be retained on a contingent fee basis or similar outcome incentive fee-based arrangement. Such audit shall be limited to verifying the accuracy of the financial reports, royalty payment or payment. Only the auditor’s determination of the amounts of Net Sales and Net Sales Price calculation furnished royalties due and payable will be transmitted to BCGT and Lilly. Such audits may not be performed by Procaps or the amount of payments due by Procaps under this AgreementBCGT more than once per Calendar Year and each period can only be audited once. Any amounts shown to be owed but unpaid or overpaid All costs and expenses incurred in need of reimbursement shall performing any such audit will be paid or refunded (as by BCGT unless the case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 11.5) from the original due date. Galectin Therapeutics shall bear the full cost of such audit unless such audit discloses that Procaps paid too little because of at least a discrepancy in a report that Procaps provided to the JSC or Galectin Therapeutics during the applicable audit period, which underpayment was equal to more than five percent (5%) of the amount set forth in such report, in which case Procaps shall bear the full cost of such audit. Portions of this Exhibit were omitted, as indicated by [***] that exceeds at least [***], in which case Xxxxx will bear all reasonable costs and have been provided separately to the Secretary expenses of the Commission pursuant audit. BCGT will be entitled to recover any shortfall in payments as determined by such audit. Similarly, if the Company’s application requesting confidential treatment audit reveals an overpayment, Xxxxx will be entitled to recover such overpayment as determined by such audit as actually received by BCGT. If the audit determined that additional royalties are owed, or that royalties were overpaid, during such audited period, Xxxxx will pay BCGT the additional royalties, or as to any overpaid royalties, Lilly shall deduct/offset such overpayment from future amounts owed to BCGT under Rules 24b-2 this Agreement commencing in the Calendar Quarter following such audit provided that if no further amounts are owed by Xxxxx under this Agreement in amounts sufficient to cover the overpayment, then BCGT shall pay Lilly any remaining balance of the Securities Exchange Act overpaid royalties within sixty (60) days of 1934, as amendedBCGT’s receipt of notice to such effect from Xxxxx.

Appears in 1 contract

Samples: Commercialization Agreement (BioNTech SE)

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Financial Records; Audits. Procaps During the term of this Agreement and for one (1) year thereafter, Lilly shall maintain complete and accurate not more than once each year have the right to have an independent certified public accountant firm reasonably acceptable to BCGT inspect/audit records in sufficient detail to permit Galectin Therapeutics to confirm for solely the one year immediately preceding such audit for the purpose of determining the accuracy of the Net Sales generated by Procaps royalty payments. During normal business hours and the calculation of royalty payments and the Net Sales Price. Upon reasonable prior notice of with at least five sixty (560) Business Daysdays’ notice from Lilly to BCGT, such records shall will be open during regular business hours made available for a period of three (3) years from the creation of individual records for examination at Galectin Therapeutics’ expenseinspection, review and not more often than twice each calendar yearaudit, by an such independent certified public accountant selected by Galectin Therapeutics Lilly and approved by BCGT , such approval not to be unreasonably withheld for the sole purpose of verifying for Galectin Therapeutics the accuracy of the financial reports, royalty payment or Net Sales accounting reports and Net Sales Price calculations or of any payments made by Procaps to Galectin Therapeutics pursuant to this Agreement. Any such auditor Lilly shall submit an audit plan, including audit scope, to BCGT for BCGT’s approval, which shall not disclose Procaps’ Confidential Information be unreasonably withheld, prior to Galectin Therapeutics, except audit implementation. Such auditor will be required to enter into a confidentiality agreement with BCGT or the extent such disclosure is necessary relevant BioNTech Company prior to verify performing the audit. The auditor will not be retained on a contingent fee basis or similar outcome incentive fee-based arrangement. Such audit shall be limited to verifying the accuracy of the financial reportsTHE SYMBOL “[***]” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, royalty payment or AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED payments. Only the auditor’s determination of the amounts of Net Sales and Net Sales Price calculation furnished royalties due and payable will be transmitted to Lilly and BCGT. Such audits may not be performed by Procaps or the amount of payments due by Procaps under this AgreementLilly more than once per Calendar Year and each period can only be audited once. Any amounts shown to be owed but unpaid or overpaid All costs and expenses incurred in need of reimbursement shall performing any such audit will be paid or refunded (as by Lilly unless the case may be) within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 11.5) from the original due date. Galectin Therapeutics shall bear the full cost of such audit unless such audit discloses that Procaps paid too little because of a discrepancy in a report that Procaps provided to the JSC or Galectin Therapeutics during the applicable audit period, which underpayment was equal to more than five percent (5%) of the amount set forth in such report, in which case Procaps shall bear the full cost of such audit. Portions of this Exhibit were omitted, as indicated by at least [***] shortfall that exceeds at least [***], in which case BCGTwill bear all reasonable costs and have been provided separately to the Secretary expenses of the Commission pursuant audit. Lilly will be entitled to recover any shortfall in payments as determined by such audit. Similarly, if the Company’s application requesting confidential treatment audit reveals an overpayment, BCGT will be entitled to recover such overpayment as determined by such audit as actually received by Lilly. If the audit determined that additional royalties are owed, or that royalties were overpaid, during such audited period, BCGT will pay Lilly the additional royalties, or as to any overpaid royalties, BCGT shall deduct/offset such overpayment from future amounts owed to Lilly under Rules 24b-2 this Agreement commencing in the Calendar Quarter following such audit provided that if no further amounts are owed by BCGT under this Agreement in amounts sufficient to cover the overpayment, then Lilly shall pay BCGT any remaining balance of the Securities Exchange Act overpaid royalties within sixty (60) days of 1934, as amendedXxxxx’x receipt of notice to such effect from BCGT.

Appears in 1 contract

Samples: Commercialization Agreement (BioNTech SE)

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