(E) Confidentiality, publication of data and intellectual property rights
Access to and publication of data
22. The MRC will provide Indevus with a copy of any proposed Protocol amendments and shall not implement any Protocol amendments until such amendments are submitted by Indevus to the FDA. Indevus, as the holder of the IND, shall be responsible for submitting any Protocol amendments to the FDA. The MRC will consult Indevus concerning any provisions of the Protocol or Protocol amendments which may deviate from or fail to meet the standards of the ICH Harmonised Tripartite Guideline for Good Clinical Practice or which affect the Product. Such provisions will only be included with Indevus’s agreement.
23. MRC will be responsible for provision of SAE and adverse event data as required to any regulatory authority, other than the FDA, with copies provided to Indevus. Indevus, as holder of the IND, will be responsible for providing SAE and adverse event data as required to the FDA, with copies provided to the MRC. CTU shall collect SAE reports from the centres in accordance with the Protocol and shall forward all such reports to Indevus immediately upon receipt. CTU, in consultation with Indevus and the Investigator, shall decide by the following calendar day whether the SAE meets the criteria for expedited reporting to the FDA. If either the CTU or Indevus believes the SAE meets the criteria for expedited reporting, CTU shall prepare a safety report and forward such report to Indevus within ten calendar days of notification of the SAE. Each Centre will be responsible for reporting to its national ethics committees.
24. The MRC will ensure that the Analysis Databases and the Centres Databases are created and validated and database entries checked in accordance with theICH Harmonised Tripartite Guideline for Good Clinical Practice.
30. Indevus may request the MRC’s assistance from time to time in providing the regulatory authorities with blinded data from the Analysis Databases and/or additional analyses in advance of publication of the First Full Report. The MRC and Indevus shall agree in writing in advance the scope of the work (and timetable) of any such requested assistance and to reimbursement of the MRC’s costs and expenses in doing so (including remuneration in respect of time spent by staff and/or agents both of the MRC and of the Centres). MRC shall provide Indevus with blinded summaries of all adverse events and other data needed to allow Indevus to comply with FDA regulations regarding the IND Annual Report (21 CFR 312.33).
31. Should the analyses included in the Main Master File be insufficient to meet European or USA regulatory requirements, Indevus may request the MRC’s assistance to carry out appropriate additional analyses. The MRC and Indevus shall agree in writing in advance the scope of the work (and timetable) of any such requested assistance and to reimbursement of the MRC’s costs and expenses in doing so (including remuneration in respect of time spent by staffand/or agents both of the MRC and of the Centres).
(F) OBLIGATIONS OF THE MRC UNDER THIS AGREEMENT
42. […] The MRC will require all Investigators to sign agreements requiring them to comply with the ICH Guidelines for Good Clinical Practice as required by the Protocol. In the event of any conflict between the Protocol and the ICH Guidelines for Good Clinical Practice, the Protocol is to take precedence (any deviations from ICH Good Clinical Practice required by the Protocol are to be agreed in advance with Indevus, as per clause 22 above of this Agreement). The MRC will require Centres to document any instances of non-compliance in an appropriate manner. The MRC shall use its reasonable endeavours to ensure that all Centres comply with the ICH Guidelines for Good Clinical Practice. The MRC will promptly inform Indevus of any significant non-compliance with the ICH Guidelines for Good Clinical Practice as soon as reasonably possible after the MRC becomes aware of such an event of significant non-compliance, and shall consult Indevus as to remedial action to be taken. The MRC shall require each of the Centres to ensure that the investigator responsible for conduct of the Programme has signed the Investigator’s Statement (a sample copy of which is appended at Schedule 3 to this Agreement) and Form FDA 1572 (Statement of Investigator).and shall provide copies thereof to Indevus. With respect to the Protocol, Indevus agrees to transfer, and MRC agrees to accept, some but not all of the obligations specified in CFR Title 21, Part 312 Subpart D “Responsibilities of Sponsors and Investigators”. Obligations to be transferred are specified in Schedule 7 appended to this Agreement.
43. The MRC shall be responsible for informing all investigators of any significant new information on the safety of the Product and/or matching placebo obtained in the course of the Programme.
44. The MRC shall be responsible for monitoring each Centre participating in the Phase III Clinical Trial involving the Product and matching placebo for the quality assurance of all data. Monitoring shall be done in compliance with ICH GCP Guidelines, and a copy of each monitoring report shall be provided to Indevus within 3 months of completing the monitoring visi