2. RESEARCH AND DEVELOPMENT PROGRAM
2.1 Overview; R&D Plan. The Parties’ objective is to jointly conduct the R&D Plan for the purpose of assessing the efficacy of CAMB in the Field and, if such efficacy is established, DNDi will be responsible for obtaining all Regulatory Approvals and for the Distribution Through the Public Sector of CAMB under the terms hereinafter set out. The Parties’ framework for their activities hereunder is set forth in the R&D Plan, which may be amended only by mutual written agreement of the Parties. If the R&D Plan or any Project Plan conflicts with, or creates ambiguities with, this Agreement, then this Agreement will prevail.
3. REGULATORY APPROVALS, MANUFACTURE AND DISTRIBUTION
3.1 Allocation of Responsibilities. Beginning with the completion of the R&D Plan, DNDi will have sole responsibility for seeking and obtaining Regulatory Approvals for CAMB, and for the Distribution Through the Public Sector of CAMB in the Territory for use in the Field. DNDi may use a third party for Regulatory Approval activities, provided that the terms of the agreements with such third party conform to the terms of the present Agreement. BDSI shall have sole responsibility for the manufacture and supply to DNDi of CAMB for DNDi’s Distribution.
3.2 Regulatory Approvals. DNDi will be responsible, either directly or through a third party, and shall bear all costs for developing Regulatory Documentation, preparing and submitting Regulatory Filings, and seeking and maintaining Regulatory Approvals in the Territory for CAMB’s use in the Field. BDSI agrees to provide DNDi with all information and data in its possession relating to CAMB and to cooperate with DNDi, as reasonably requested by DNDi, in preparing and filing all Regulatory Documentation. DNDi will have the right to use all parts of the Program Data for developing Regulatory Documentation and BDSI will have the right to access or reference any of DNDi’s Regulatory Approvals for BDSI’s private sector Distribution of CAMB in or outside the Territory. Prior to DNDi providing a Regulatory Authority any Regulatory Documents in conjunction with any Regulatory Filing, DNDi will engage BDSI for review and comment on the Regulatory Documents prior to submission.
3.4 Adverse Event Reporting. DNDi will maintain a record of all non-medical and medical complaints and reports of adverse events which it shall receive with respect to the use of CAMB. DNDi will be responsible for reporting to Regulatory Authorities any such adverse events in compliance with all applicable Laws in each country of the Territory, and will promptly thereafter provide copies of all adverse events reports to BDSI.
3.5 Regulatory Approvals and Distribution Diligence; Progress Reports. DNDi will use diligent efforts for seeking Regulatory Approvals and for initiating and developing Distribution Through the Public Sector in the Territory for use in the Field during the Term. Once all activities under the R&D Plan are completed, DNDi will provide annual written progress reports to BDSI summarizing the status of Development and Distribution of CAMB during the prior year. DNDi will provide such progress report to BDSI no later than each anniversary of the Effective Date following the completion of all activities under the R&D Plan. The Parties shall additionally regularly discuss Distribution progress through the Parties respective Alliance Managers.