Common use of Audits and Interim Reviews Clause in Contracts

Audits and Interim Reviews. (a) Subject to the provisions of Section 5.7.3, either Party may request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which is not either Party’s independent accounting firm, perform an audit or interim review of the other Party’s books as they relate to this Agreement in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, under this Agreement. Such audits or review shall be conducted at the expense of the requesting Party. (b) Upon [* * *] Business Days’ prior written notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) shall permit such accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation Statement. An examination by a Party under this Section 5.7.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * *] and shall be limited to the pertinent books and records for any Contract Year ending not more than [* * *] months before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene and Acceleron a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Auditing Party. If the accountant determines that, based on errors in the reports so submitted, any report prepared in accordance with this Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * *] days after receipt of the accountant’s report, along with interest as provided in Section 5.7.5; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment, the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. In the event of any sublicense or transfer of rights with respect to Licensed Compounds or Licensed Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4.

Appears in 5 contracts

Sources: Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc)

Audits and Interim Reviews. (a) Subject to the provisions of Section 5.7.36.10.3, either Party may request (such requesting party, the “Auditing Party”) that a nationally recognized, independent accounting firm to be certified public accountant mutually agreed upon by the Parties, which is not either Party’s independent accounting firm, perform an audit or interim review of the other Party’s books (such other Party, the “Audited Party”) as they relate to this Agreement in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, under this Agreement. Such audits or review shall be conducted at the expense of the requesting Auditing Party. However, and without prejudice to any other remedy or action available due to breach of this Agreement, if the audit should determine a discrepancy between royalty or other payments reported and the royalty or payments actually due resulting in the underpayment of royalties or payments of more than five percent (5%) then the cost and expense of the audit shall be borne by the Audited Party. (b) Upon [* * *] ten (10) Business Days’ prior written notice from a Party (the Auditing Party”), the other Audited Party (the “Audited Party”) shall permit such accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation StatementReport. An examination by a Party under this Section 5.7.4 6.10.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * *] once in any Contract Year and shall be limited to the pertinent books and records for any Contract Year ending not more than [* * *] thirty-six (36) months before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene Genocea and Acceleron Isconova a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Auditing Party. If the accountant determines that, based on errors in the reports so submitted, any report prepared in accordance with this Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * *] thirty (30) days after receipt of the accountant’s report, along with interest as provided in Section 5.7.56.10.5; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment, the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. In the event of any sublicense or transfer of rights with respect to the Licensed Compounds Adjuvant or Licensed Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.46.10.4.

Appears in 4 contracts

Sources: License and Collaboration Agreement (Genocea Biosciences, Inc.), License and Collaboration Agreement (Genocea Biosciences, Inc.), License and Collaboration Agreement (Genocea Biosciences, Inc.)

Audits and Interim Reviews. (a) Subject Either Party shall have the right to the provisions of Section 5.7.3, either Party may request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which is not either Party’s independent accounting firm, perform an audit or interim review of the other Party’s books and records as they relate to activities under this Agreement in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, expenses under this Agreement. Such audits or review shall will be conducted at the expense of the requesting Party. (b) . Upon [* * *] Business Days’ prior written notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) shall permit such the mutually agreed upon independent accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, Party and its Affiliates as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation Statement. An examination by a Party under this Section 5.7.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * *] and shall be limited to the pertinent books and records for any Contract Year calendar year ending not more than [* * *] months before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) and/or the facilities of its Affiliates or sublicensees where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this the Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene Biogen Idec and Acceleron Portola a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning and supporting analysis for any discrepancies. No other information shall be provided to the Auditing Party. If the accountant accounting firm determines that, based on errors in the reports so submitted, any report prepared in accordance with this the Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * *] days after receipt of the accountant’s report, along with interest as provided in Section 5.7.5at the lesser of (i) the annualized interest rate at [*] or (ii) the highest rate permitted by applicable law from the date that such additional amount should have first been paid; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement being incorrect were in the reports provided by the Party to receive such additional amount[*]. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate overstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment], the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. Notwithstanding anything to the contrary herein, the Parties shall coordinate with their Affiliates such that [*] with respect to the development, manufacturing, commercialization or other use of [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. the Product under any written agreement between the Parties and/or their Affiliates relating to the Product. In the event of any sublicense or transfer of rights with respect to Licensed Compounds or Licensed Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4Agreement.

Appears in 3 contracts

Sources: License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc)

Audits and Interim Reviews. (a) Subject Either Party shall have the right to the provisions of Section 5.7.3, either Party may request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which Parties and that is not either Party’s independent accounting firm, firm perform an audit or interim review of the other Party’s books and records as they relate to *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. activities under this Agreement in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, expenses under this Agreement. Such audits or review shall will be conducted at the expense of the requesting Party. (b) . Either Party shall have the right to request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties and that is not either Party’s independent accounting firm perform an audit of the other Party’s books of accounts for the sole purpose of verifying compliance with the Agreement and the Transaction Agreements. Upon [* * ****] Business Days’ prior written notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) shall permit such the mutually agreed upon independent accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, Party and its Affiliates as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation Statement. An examination by a Party under this Section 5.7.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * ****] and shall be limited to the pertinent books and records for any Contract Year calendar year ending not more than [* * ****] months before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) and/or the facilities of its Affiliates or sublicensees where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this the Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene Biogen Idec and Acceleron PDL a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning and supporting analysis for any discrepancies. No other information shall be provided to the Auditing Party. If the accountant accounting firm determines that, based on errors in the reports so submitted, any report prepared in accordance with this the Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * ****] days after receipt of the accountant’s report, along with interest as provided in Section 5.7.5at the lesser of (i) the [****] or (ii) the highest rate permitted by applicable law from the date that such additional amount should have first been paid; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate overstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment**], the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. Notwithstanding anything to the contrary herein, the Parties shall coordinate with their Affiliates such that not more than [****] audit of a Party and its Affiliates as a whole, shall be performed in any given calendar year with respect to the *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. development, manufacturing, commercialization or other use of the Collaboration Product under any written agreement between the Parties and/or their Affiliates relating to the Collaboration Product. In the event of any sublicense or transfer of rights with respect to Licensed Compounds or Licensed Collaboration Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4.A.4 of this Exhibit C.

Appears in 3 contracts

Sources: Collaboration Agreement (Biotech Spinco, Inc.), Collaboration Agreement (Facet Biotech Corp), Collaboration Agreement (Protein Design Labs Inc/De)

Audits and Interim Reviews. (a) Subject Either Party shall have the right to the provisions of Section 5.7.3, either Party may request that a nationally an internationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which Parties and that is not either Party’s independent accounting firm, firm perform an audit or interim review of the other Party’s books and records as they relate to activities under this Agreement (including without limitation reports received and payments made) in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, expenses under this Agreement. Such audits or review shall will be conducted at the expense of the requesting Party. . Either Party shall have the right to request that an internationally recognized, independent accounting firm to be mutually agreed upon by the Parties and that is not either Party’s independent accounting firm perform an audit of the other Party’s books of accounts for the sole purpose of verifying compliance with the Agreement. Upon thirty (b30) Upon [* * *] Business Daysdays’ prior written notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) shall permit such the mutually agreed upon independent accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, Party and its Affiliates as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation StatementParty. An examination by a Party under this Section 5.7.4 6.4 (whether of the Audited Party or its AffiliatesAudits and Interim Reviews) shall occur not more than [* * *] once in any calendar year and shall be limited to the pertinent books and records for any Contract Year calendar year ending not more than [* * ***] months [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) and/or the facilities of its Affiliates or sub-distributors where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this the Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene and Acceleron Parties with a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning and supporting analysis for any discrepancies. No other information shall be provided to the Auditing Party. If the accountant accounting firm determines that, based on errors in the reports so submitted, any report prepared in accordance with this the Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * *] thirty (30) days after receipt of the accountant’s report, along with interest as provided in Section 5.7.5at the lesser of (i) the annualized interest rate at the [***] or (ii) the highest rate permitted by applicable law from the date that such additional amount should have first been paid; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement calculation being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant accounting firm determines that the reports submitted by the Audited Party misstate overstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment*], the Audited Party shall reimburse [***]. Notwithstanding anything to the Auditing contrary herein, the Parties shall coordinate with their Affiliates such that not more than one (1) audit of a Party for the expenses incurred by the Auditing Party and its Affiliates as a whole, shall be performed in conducting the audit. In the event of any sublicense or transfer of rights given calendar year with respect to Licensed Compounds or Licensed Products by a Party the Commercialization under this Agreement or any Related Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4.

Appears in 2 contracts

Sources: Distribution Agreement (Coherus BioSciences, Inc.), Distribution Agreement (Coherus BioSciences, Inc.)

Audits and Interim Reviews. (a) Subject Either Party shall have the right to the provisions of Section 5.7.3, either Party may request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which Parties and that is not either Party’s 's independent accounting firm, firm perform an audit or interim review of the other Party’s 's books as they relate to this Agreement the collaboration in order to express an opinion regarding such Party’s 's compliance with generally accepted accounting for revenues, costs and expenses, as applicable, under this Agreementprinciples. Such audits or review shall will be conducted at the expense of the requesting Party. . Either Party shall have the right to request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties and that is not either Party's independent accounting firm perform an audit of the other Party's books of accounts for the sole purpose of verifying compliance with the Agreement. Upon thirty (b30) Upon [* * *] Business Days’ days prior written notice from a Party (the "Auditing Party"), the other Party (the "Audited Party") shall permit such an independent certified public accounting firm of nationally recognized standing to be mutually agreed upon by the Parties and that is not either Party's independent accounting firm, to examine the relevant books and records of the Audited Party, including any Affiliates, Party and its Affiliates as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation Statementreconciliation report. An examination by a Party under this Section 5.7.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * *] once in any calendar year and shall be limited to the pertinent books and records for any Contract Year calendar year ending not more than [*** * *] months before the date of the request. The accounting CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS. firm shall be provided access to such books and records at the Audited Party’s 's facility(ies) where such books and records are normally kept and such examination shall be conducted during the Audited Party’s 's normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this Agreement before providing the accounting firm access to the Audited Party’s 's facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene Biogen and Acceleron Elan a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Auditing Party. If the accountant determines that, based on errors in the reports so submitted, any report prepared in accordance with this the Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement reconciliation report and any additional amount owed by one Party to the other shall be paid within [* * *] thirty (30) days after receipt of the accountant’s 's report, along with interest as provided at the lesser of (i) the annualized interest rate of two percent (2%) over the prime rate then in Section 5.7.5; effect at Fleet Bank or (ii) the highest rate permitted by applicable law from the date that such additional amount should have first been paid, provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement reconciliation report being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate overstate the Audited Party’s 's share of costs by more than [*** * *] percent [* * *] to the Auditing Party’s detriment, the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. In the event of any sublicense or transfer of rights with respect to Licensed Compounds or Licensed Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4.

Appears in 2 contracts

Sources: Development and Marketing Collaboration Agreement (Elan Corp PLC), Development and Marketing Collaboration Agreement (Biogen Inc)

Audits and Interim Reviews. (a) Subject to the provisions of Section 5.7.3, either Party may request that a nationally recognized, independent accounting firm to be mutually agreed upon by the Parties, which is not either Party’s independent accounting firm, perform an audit or interim review of the other Party’s books as they relate to this Agreement in order to express an opinion regarding such Party’s accounting for revenues, costs and expenses, as applicable, under this Agreement. Such audits or review shall be conducted at the expense of the requesting Party. (b) Upon [* * *] Business Days’ prior written notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) shall permit such accounting firm to examine the relevant books and records of the Audited Party, including any Affiliates, as may be reasonably necessary to verify the reports and information submitted by the Audited Party and the accuracy of any Royalty Report or Reconciliation Statement. An examination by a Party under this Section 5.7.4 (whether of the Audited Party or its Affiliates) shall occur not more than [* * *] and shall be limited to the pertinent books and records for any Contract Year ending not more than [* * *] months before the date of the request. The accounting firm shall be provided access to such books and records at the Audited Party’s facility(ies) where such books and records are normally kept and such examination shall be conducted during the Audited Party’s normal business hours. The Audited Party may require the accounting firm to sign a standard non-disclosure agreement with terms that are not inconsistent with the terms of this Agreement before providing the accounting firm access to the Audited Party’s facilities or records. Upon completion of the audit, the accounting firm shall provide both Celgene and Acceleron a written report disclosing whether the reports submitted by the Audited Party are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to the Auditing Party. If the accountant determines that, based on errors in the reports so submitted, any report prepared in accordance with this Agreement is incorrect, the Parties shall promptly revise the report and the associated Royalty Report or Reconciliation Statement and any additional amount owed by one Party to the other shall be paid within [* * *] days after receipt of the accountant’s report, along with interest as provided in Section 5.7.5; provided, however, that no such interest shall be payable if the errors leading to the Royalty Report or Reconciliation Statement being incorrect were in the reports provided by the Party to receive such additional amount. Additionally, if the accountant determines that the reports submitted by the Audited Party misstate the Audited Party’s share of costs by more than [* * *] percent [* * *] to the Auditing Party’s detriment, the Audited Party shall reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting the audit. In the event of any sublicense or transfer of rights with respect to Licensed Compounds or Licensed Products by a Party under this Agreement, the sublicensor or transferor shall provide for audit rights by the other Party to this Agreement in accordance with this Section 5.7.4.

Appears in 1 contract

Sources: Collaboration, License and Option Agreement (Acceleron Pharma Inc)