Provision Language
3. Development and Registration
3.1 Development timelines. Licensee will use reasonable efforts to research and develop the Licensed Product through Phase 2 and, if the Licensed Product is determined to meet Licensee’s target regimen profile (“TRP”) and strategic objectives and receives marketing approval, help facilitate the distribution of the Licensed Products in the Field in the Target Countries (which Target Countries will be prioritized by Licensee based on cost-effectiveness, impact and other relevant factors) and in accordance with Licensee’s charitable mission, strategies, and priorities. In conducting its research, development, and other activities for the Licensed Product, Licensee will adhere with the then-current open access policy and Global Access objectives of the Bill & Melinda Gates Foundation (see https://www.gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy and https://www.gatesfoundation.org/How-We-Work/General-Information/Global-Access-Statement). In addition, subject to applicable laws and regulations, Licensee will broadly share data and results of its research and development of the Licensed Product, including with other collaborations and public-private partnerships working to develop new TB drugs and drug regimens. Licensee will be presumed to be in noncompliance of its diligence obligations hereunder if it fails to reach the milestones at the time points as defined in Exhibit C unless Licensee can demonstrate that its failure to achieve a particular milestone was caused by scientific or clinical findings, delays caused by ethics committees or regulatory authorities, third party claims, the inability to obtain access to other compositions or compounds on appropriate terms as needed for the intended drug regimen, the lack of late stage development partners or funding, or other similar unexpected events or delays, including events beyond its reasonable control. If it is determined that a failure of due diligence has occurred and is not reasonably cured or adequately rebutted within thirty (30) days of MPP’s written notice to Licensee of such failure, MPP will have the right to terminate the licenses granted to Licensee pursuant to Section 6.3 hereof. Such termination is MPP’s sole and exclusive remedy for failure to satisfy any of the requirements of this Section 3.1.