Provision Language
3. Development and Registration
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3.2 Accessibility. If the Licensed Product meets the TRP [Target Regimen Profile] and Licensee elects in its sole discretion to directly seek marketing authorization and to itself commercialize the Licensed Product, Licensee will then launch the Licensed Product(s) in a manner that facilitates its widespread availability in Target Countries (which will be prioritized by Licensee based on cost-effectiveness, impact and other relevant factors), which reasonable efforts shall include seeking to obtain adequate manufacturing capacity, adequate supply of product meeting specifications, registration of Licensed Product(s) with applicable local and global health authorities, participation in local tenders and making available to local policy makers information regarding the Licensed Product(s). If Licensee elects to commercialize the Licensed Product, then Licensee will use reasonable efforts to ensure that the Licensed Product(s) will be made available at Affordable Pricing as quickly as reasonably possible in sufficient quantities to meet the needs of TB patients in Target Countries prioritized by Gates MRI based on cost-effectiveness, impact and other relevant factors). “Affordable Pricing” shall mean the lowest sustainable, competitive price for the Licensed Product(s) which covers the cost of raw materials, manufacturing, distribution and operational overheads, and includes a reasonable margin to help ensure the economic sustainability of the production and distribution of the Licensed Product(s). Notwithstanding the foregoing, nothing in this provision will prevent Licensee from implementing accessibility policies that will result in prices for a Licensed Product being lower than what would be required by this Section 3.2 or a Licensed Product being more widely available than what would be required by this Section 3.2. MPP acknowledges that, as a medical research organization focused on translational development, that Licensee does not currently intend to itself commercialize drug products. However, if Licensee elects to seek marketing authorization of a Licensed Product and receives a Priority Review Voucher for a Licensed Product, any proceeds from the monetization of such PRV would be expected to be used to further Licensee’s charitable objectives.