Common use of Audits and Interim Reviews Clause in Contracts

Audits and Interim Reviews. Each Party will maintain accurate books and records regarding Program Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses, Net Revenues and Net Sales, as applicable, sufficient to enable the calculation of amounts payable hereunder to be verified, and will retain such books and records for each quarterly period for three (3) years after submission of the corresponding report pursuant to this Agreement. Either Party will have the right to request that an independent certified public accountant selected by it (but excluding its own accountant) and reasonably acceptable to the other Party perform an audit, not more than once in any four (4) consecutive Calendar Quarters during the Term, but including one post-termination audit and, if any such audit results in a material restatement of records (i.e., a discrepancy of 5% or more for any calendar year), such Party will be permitted an additional examination within such four (4) quarter period, of the other Party’s books of accounts covering the preceding three (3) year period for the sole purpose of verifying compliance with the payment provisions of this Agreement. Such audits will be conducted at the expense of the requesting Party at reasonable times during regular business hours and upon at least twenty (20) business days’ prior notice. Audit results will be shared with both Parties, subject to Article 12 (Confidentiality); provided, however, that the accounting firm may not disclose copies of the audited Party’s books of accounts (or excerpts thereof) to the other Party. Any accounting firm conducting such an audit will enter into a confidentiality agreement with both Parties containing restrictions substantially similar to the confidentiality provisions of Article 12 (Confidentiality) limiting the disclosure and use of information contained in such books and records for the purposes expressly permitted by this Section 8.8. Any inspection or audit pursuant to this Section 8.8 will be at the expense of the Party initiating the audit; provided, however, that if the Party’s accountants reasonably determine that Net Profits or Net Revenues have been understated or Program Costs (including associated labor costs, reimbursable costs and expenses) or Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses have been overstated by an amount equal to or greater than five percent (5%), for any calendar year, the audited Party will pay the reasonable fees of such accountants for such audit, in addition to remitting the Net Profits [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. or refund of Net Losses, Program Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, or Internal Development Expenses with interest thereon computed in accordance with Section 8.10 (Interest on Late Payments).

Appears in 2 contracts

Samples: License and Co Development Agreement (Genzyme Corp), License and Co Development Agreement (Isis Pharmaceuticals Inc)

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Audits and Interim Reviews. Each Party will maintain accurate books and records regarding Program Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses, Net Revenues and Net Sales, as applicable, sufficient to enable the calculation of amounts payable hereunder to be verified, and will retain such books and records for each quarterly period for three (3) years after submission of the corresponding report pursuant to this Agreement. Either Party will have the right to request that an independent certified public accountant selected by it (but excluding its own accountant) and reasonably acceptable to the other Party perform an audit, not more than once in any four (4) consecutive Calendar Quarters during the Agreement Term, but including one post-termination audit and, if any such audit results in a material restatement of records (i.e., a discrepancy of 5% or more for any calendar yearCalendar Year), such Party will be permitted an additional examination within such four (4) four-quarter period, of the other Party’s books of accounts covering the preceding three (3) three-year period for the sole purpose of verifying compliance with the payment provisions of this Agreement. Such audits will be conducted at the expense of the requesting Party at reasonable times during regular business hours and upon at least twenty (20) business days20 Business Days’ prior notice. Audit results will be shared with both Parties, subject to Article 12 ARTICLE 8 (Confidentiality); provided, however, that the accounting firm may not disclose copies of the audited Party’s books of accounts (or excerpts thereof) to the other Party. Any accounting firm conducting such an audit will enter into a confidentiality agreement with both Parties containing restrictions substantially similar to the confidentiality provisions of Article 12 ARTICLE 8 (Confidentiality) limiting the disclosure and use of information contained in such books and records for the purposes expressly permitted by this Section 8.86.8. Any inspection or audit pursuant to this Section 8.8 6.8 will be at the expense of the Party initiating the audit; provided, however, that if the Party’s accountants reasonably determine that Net Profits or Net Revenues Losses have been understated or Program Costs (including associated labor costs, reimbursable costs and expenses) or Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses have been overstated by an amount equal to or greater than five percent (5%), for any calendar yearCalendar Year, then the audited Party will pay the reasonable fees of such accountants for such audit, in addition to remitting the Net Profits [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. or refund of Net Losses, Program Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, or Internal Development Expenses with interest thereon computed in accordance with Section 8.10 (Interest on Late Payments)6.11.

Appears in 2 contracts

Samples: License Agreement (Ionis Pharmaceuticals Inc), License Agreement (Akcea Therapeutics, Inc.)

Audits and Interim Reviews. Each Party will shall maintain accurate books and records regarding Program Research and Development Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development ExpensesCommercialization Costs, Net Revenues Revenues, and Net Sales, as applicable, sufficient to enable the calculation of amounts payable hereunder to be verified, and will shall retain such books and records for each quarterly period for three (3) years after submission of the corresponding report pursuant to this Agreement. Either Party will shall have the right to request that an independent certified public accountant selected by it (but excluding its own accountant) and reasonably acceptable to the other Party perform an audit, not more than once in any four (4) consecutive Calendar Quarters calendar quarters during the Term, but including one post-termination audit and, if any such audit results in a material restatement of records (i.e., a discrepancy of 5% or more for any calendar year), such Party will shall be permitted an additional examination within such four (4) quarter period, of the other Party’s books of accounts covering the preceding three (3) year period for the sole purpose of verifying compliance with the payment provisions of this Agreement. Such audits will be conducted at the expense of the requesting Party at reasonable times during regular business hours and upon at least twenty (20) business daysBusiness Days’ prior notice. Audit results will be shared with both Parties, subject to Article 12 (Confidentiality); providedXI, however, provided that the accounting firm may not disclose copies of the audited Party’s books of accounts (or excerpts thereof) to the requesting Party or any other Partyparty. Any accounting firm conducting such an audit will shall enter into a confidentiality agreement with both Parties containing restrictions substantially similar to the confidentiality provisions of Article 12 (Confidentiality) XI limiting the disclosure and use of information contained in such books and records for the purposes expressly permitted by this Section 8.85.7. Any inspection or audit pursuant to this Section 8.8 will 5.7 shall be at the expense of the Party initiating the audit; provided, however, that if the Party’s accountants reasonably determine that Net Profits or Net Revenues royalties have been understated or Program Net Losses, Research and Development Costs, or Commercialization Costs (including associated labor costsFTEs, reimbursable costs and expenses) or Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses have been overstated by an amount equal to or greater than five percent (5%), for any calendar year, the audited Paying Party will shall pay the reasonable fees of such accountants for such audit, in addition to remitting the Net Profits [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. or royalty payment or refund of Net Losses, Program Research and Development Costs, Fully-Absorbed Cost of Goodsor Commercialization Costs (including associated FTEs, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, or Internal Development Expenses reimbursable costs and expenses) with interest thereon computed in accordance with Section 8.10 (Interest on Late Payments)17.4.

Appears in 1 contract

Samples: Collaboration Agreement (Mirati Therapeutics, Inc.)

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Audits and Interim Reviews. Each Party will maintain accurate books and records regarding Program POC Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses, Net Revenues Shared Costs and Net Sales, as applicable, sufficient to enable the calculation of amounts payable hereunder to be verified, verified and will retain such books and records for each quarterly period for three (3) years after submission of the corresponding report pursuant to this Agreement. Either Party will have the right to request that an independent certified public accountant selected by it (but excluding its own accountant) and reasonably acceptable to the other Party (such reasonable acceptance shall not be unreasonably withheld, conditioned, or delayed) perform an audit, not more than once in any four (4) consecutive Calendar Quarters during the Term, but including one post-termination audit and, if any such audit results in a material restatement of records (i.e., a discrepancy of 5[***]% or more for any calendar year), such Party will be permitted an additional examination within such four (4) quarter period, of the other Party’s books of accounts covering the preceding three (3) year period for the sole purpose of verifying compliance with the payment provisions of this Agreement. Such audits will be conducted at the expense of the requesting Party at reasonable times during regular business hours and upon at least twenty (20) business days’ prior notice. Audit results results, but not the underlying books and records, will be shared with both Parties, subject to Article 12 (Confidentiality); provided, however, that the accounting firm may not disclose copies of the audited Party’s books of accounts (or excerpts thereof) to the other Party. Any accounting firm conducting such an audit will enter into a confidentiality agreement with both Parties containing restrictions substantially similar to the confidentiality provisions of Article 12 (Confidentiality) limiting the disclosure and use of information contained in such books and records for the purposes expressly permitted by this Section 8.87. Any inspection or audit pursuant to this Section 8.8 6.4 will be at the expense of the Party initiating the audit; provided, however, that if the Party’s accountants reasonably determine that Net Profits Sale or Net Revenues Profits have been understated or Program Shared Costs (including associated labor costs, reimbursable costs and expenses) or Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, and Internal Development Expenses have been overstated by an amount equal to or greater than five percent (5%), [***] for any calendar year, the audited Party will pay the reasonable fees of such accountants for such audit, in addition to remitting the Net Profits [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. or refund of Net Losses, Program Costs, Fully-Absorbed Cost of Goods, External Sales & Marketing Expenses, Internal Sales & Marketing Expenses, External Development Expenses, or Internal Development Expenses with interest thereon computed in accordance with Section 8.10 (Interest on Late Payments).

Appears in 1 contract

Samples: Feasibility Study and License Agreement (Selecta Biosciences Inc)

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