Master Alliance Provisions Guide (MAPGuide)

MPP – Gates Medical Research Institute, TB therapeutic (Sutezolid) Sublicense Agreement

  • Intellectual Property | License Grants

Definitions

Know-How” shall mean the Confidential Information described in Exhibit B.

Licensed IP” shall mean the Know-How and the Patent Rights.

Patent Rights” shall mean those patents and patent applications as set forth in Exhibit A, which may be updated in good faith by the Parties to include additional patents or patent applications or remove patents that have expired or not issued.

Territory” shall mean all countries of the world.

2. Scope of the Grant

2.1 Upon the terms and subject to the conditions set out in this Agreement, MPP hereby grants to the Licensee, and the Licensee hereby accepts, a non-exclusive, non- sublicensable, non-transferable royalty-free, fully-paid license under the Licensed IP to develop, make, have made, use, file for regulatory approval, sell, have sold, offer to sell, import, export and otherwise exploit Licensed Products in the Field in the Territory.

2.2 For avoidance of doubt, nothing in this Agreement shall be construed to prevent Licensee from engaging in any activities inside or outside the Territory where such activities would not infringe a valid claim of a Patent Right granted and in force or use the Know-How.

2.3 At the request of Licensee, MPP shall negotiate in good faith to promptly enter into license or other agreements under which it would grant royalty-free, fully paid sublicenses under the Licensed IP to collaborators, contractors, or others involved in the development, manufacture, or commercialization of the Licensed Product with the Licensee, on terms substantially similar to this Agreement.

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.

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3.4 Most favored licensee. MPP agrees that it will not grant any other sublicense pursuant to the Pfizer License on terms that are more favorable to such sublicensee than that granted to Licensee under this Agreement, taking into account all relevant factors, such as the date on which a sublicense is granted and the purpose for which the sublicense is granted.

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3.6 Product Labeling. Licensee will cause that the labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool where local law permits.

Exhibit C. Development Milestones

MPP acknowledges that, as a medical research organization focused on translational development, that Licensee does not currently intend to itself conduct Ph3 studies nor commercialize drug products. Accordingly, the activities noted above beyond the completion of the Ph2b/c study would require identifying later-stage partners willing to undertake development and commercialization efforts beyond Phase 2b/c, including availability of funding and access to other drugs included in the applicable regimen, including the cooperation of those asset owners.