Records; Audit Rights. (a) NT Pharma shall, and shall cause each Subcontractor engaged pursuant to Clause 3.9 to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product (the completion of which is evidenced by the obtaining of Regulatory Approval) and maintenance of Regulatory Approval in each country within the Territory (the “Product Records”). (b) NT Pharma shall retain all Product Records that it possesses or obtains through any arrangement with Subcontractors for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Licensor, the Product Records possessed by NT Pharma or obtained by NT Pharma through arrangements with Subcontractors shall be subject to inspection and audit by and at the expense of the Licensor no more than once in any Annual Period (or more frequently upon demonstration of reasonable cause). (c) Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Licensor and confirmed by NT Pharma in advance, which confirmation shall not be unreasonably withheld or delayed. The Licensor shall treat all information received or subject to review under this Clause 3.10 as Confidential Information of NT Pharma in accordance with the provisions of Clause 8. (d) The Licensor shall cause its independent auditor to enter into, before the commencement of the audit, a confidentiality agreement, in form and substance reasonably acceptable to NT Pharma, to maintain such records and information of NT Pharma in confidence in accordance with Clause 8 and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof.
Appears in 1 contract
Sources: Development and License Agreement
Records; Audit Rights. (a) NT Pharma shall, and shall cause each Subcontractor engaged pursuant to Clause 3.9 its Affiliates and sublicensees (as applicable) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable) and for purposes to confirm the accuracy of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved payments with respect to development of Product (the completion of which is evidenced by the obtaining of Regulatory Approval) and maintenance of Regulatory Approval in each country within the Territory royalties under this Agreement (the “Product Financial Records”).
(b) . NT Pharma shall retain all Product Financial Records that it possesses or obtains through any arrangement with Subcontractors for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Licensor, the Product Financial Records possessed by by, or reasonably available to, NT Pharma or obtained by NT Pharma through arrangements with Subcontractors shall be subject to inspection and audit by and at the expense of the Licensor no more than once in any Annual Period (or more frequently upon demonstration of reasonable cause).
(c) . Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Licensor and confirmed in advance by NT Pharma in advancePharma, which confirmation shall not be unreasonably withheld or delayed. The the Licensor shall treat all information received or subject to review under this Clause 3.10 4.8 as Confidential Information of NT Pharma in accordance with the provisions of Clause 8.
(d) The . the Licensor shall cause its independent auditor to enter into, before the commencement of the such audit, a confidentiality agreement, in form and substance reasonably acceptable to NT Pharma, to maintain such records and information of NT Pharma in confidence in accordance with Clause 8 and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. If any such audit reveals that NT Pharma has failed to accurately make any payment required under this Agreement, then NT Pharma shall promptly pay to the Licensor any underpaid amounts due under this Agreement, together with interest calculated as set forth in Clause 4.7, or the Licensor shall promptly pay to NT Pharma any overpaid amounts paid under this Agreement, as the case may be. If any such audit reveals an underpayment of amounts due under this Agreement greater than five percent (5%) of the amounts actually due for any Annual Period, then NT Pharma shall pay the reasonable out-of-pocket costs incurred in conducting such audit.
Appears in 1 contract
Sources: Development and License Agreement
Records; Audit Rights. (a) NT Pharma shall, and shall cause each Subcontractor engaged pursuant to Clause 3.9 its Affiliates and sublicensees (as applicable) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable) and for purposes to confirm the accuracy of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved payments with respect to development of Product (the completion of which is evidenced by the obtaining of Regulatory Approval) and maintenance of Regulatory Approval in each country within the Territory royalties under this Agreement (the “Product Financial Records”).
(b) . NT Pharma shall retain all Product Financial Records that it possesses or obtains through any arrangement with Subcontractors for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the LicensorPfenex, the Product Financial Records possessed by by, or reasonably available to, NT Pharma or obtained by NT Pharma through arrangements with Subcontractors shall be subject to inspection and audit by and at the expense of the Licensor Pfenex no more than once in any Annual Period (or more frequently upon demonstration of reasonable cause).
(c) . Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Licensor Pfenex and confirmed in advance by NT Pharma in advancePharma, which confirmation shall not be unreasonably withheld or delayed. The Licensor Pfenex shall treat all information received or subject to review under this Clause 3.10 Section 4.7 as Confidential Information of NT Pharma in accordance with the provisions of Clause 8.
(d) The Licensor Article VIII. Pfenex shall cause its independent auditor to enter into, before the commencement of the such audit, a confidentiality agreement, in form and substance reasonably acceptable to NT Pharma, to maintain such records and information of NT Pharma in confidence in accordance with Clause 8 Article VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. If any such audit reveals that NT Pharma has failed to accurately make any payment required under this Agreement, then NT Pharma shall promptly pay to Pfenex any underpaid amounts due under this Agreement, together with interest calculated as set forth in Section 4.6, or Pfenex shall promptly pay to NT Pharma any overpaid amounts paid under this Agreement, as the case may be. If any such audit reveals an underpayment of amounts due under this Agreement greater than five percent (5%) of the amounts actually due for any Annual Period, then NT Pharma shall pay the reasonable out-of-pocket costs incurred in conducting such audit.
Appears in 1 contract
Records; Audit Rights. (a) NT Pharma shall, and shall cause each Subcontractor engaged pursuant to Clause 3.9 Section 3.2 to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product (the completion of which is evidenced by the obtaining of Regulatory Approval) and maintenance of Regulatory Approval in each country within the Territory (the “Product Records”).
(b) . NT Pharma shall retain all Product Records that it possesses or obtains through any arrangement with Subcontractors for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the LicensorPfenex, the Product Records possessed by NT Pharma or obtained by NT Pharma through arrangements with Subcontractors shall be subject to inspection and audit by and at the expense of the Licensor Pfenex no more than once in any Annual Period (or more frequently upon demonstration of reasonable cause).
(c) . Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Licensor Pfenex and confirmed by NT Pharma in advance, which confirmation shall not be unreasonably withheld or delayed. The Licensor Pfenex shall treat all information received or subject to review under this Clause 3.10 Section 3.3 as Confidential Information of NT Pharma in accordance with the provisions of Clause 8.
(d) The Licensor Article VIII. Pfenex shall cause its independent auditor to enter into, before the commencement of the audit, a confidentiality agreement, in form and substance reasonably acceptable to NT Pharma, to maintain such records and information of NT Pharma in confidence in accordance with Clause 8 Article VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof.
Appears in 1 contract