(D) Reporting, accounting and financial auditing
17. Indevus shall render any reasonable assistance requested by the MRC to enable the MRC to provide DFID with reports (both financial and scientific) concerning the Programme as required, subject to confidentiality restrictions.
18. Indevus shall maintain appropriate accounting procedures and practices in respect of supplies of the Product and placebo for the purposes of the Programme.
19. Indevus’s accounting records in respect of supplies of the Product and placebo shall be subject during regular business hours to inspection and audit by DFID or the MRC or an independent public accounting firm retained by DFID or MRC, at their expense, upon at least ten (10) business days prior written notice to Indevus, and not more than once each calendar year, for any year ending not more than thirty-six (36) months prior to the date of such request
(E) Confidentiality, publication of data and intellectual property rights
Access to and publication of data
25. The MRC will permit Indevus (or their designee) to audit the Phase III Clinical Trial data management at CTU. The MRC will use reasonable endeavours to ensure that the Centres permit Indevus (or their designee) to audit the Phase III Clinical Trial data management at the Centres, including such actions as required by Clause 42 and Schedule 7. Such audits are to be permitted on the basis that Indevus provides three months’ (or such other period as may be required by applicable regulatory requirements or by agreement between Indevus and MRC) written notice of any such audit and such an audit takes place no more frequently than once per year at any Centre throughout the duration of the Programme. In the event that any Indevus audit identifies a problem requiring rectification, Indevus (or their designee) shall be permitted to make a follow-up visit to CTU/the relevant Centre to assess whether the problem has been adequately resolved, such follow-up visit to be on at least one month’s written notice. Audit by any regulatory authority will be permitted as required and Indevus shall promptly receive a copy of any comments by and responses to any regulatory authority in connection with any such audit.