Master Alliance Provisions Guide (MAPGuide)

DNDi Template Research Collaboration and License Agreement

  • Equitable Access | Access plans & principles

<p>&#8220;<strong>Affordable Basisstrong>&#8221; shall mean pricing a Product at the lowest sustainable level which may include only: a) full production costs, as optimised without compromising the quality of the Product; and b) direct distribution costs, and c) a reasonable margin to ensure manufacturing and distribution of the Product on a sustainable basis.p>
<p>&#8220;<strong>Development Programstrong>&#8221; shall mean the activities to be conducted in connection with the development of a Clinical Candidate with the objective of generating a Product in the Field, covering Phase 1, Phase 2 and Phase 3 clinical studies on the Clinical Candidate, as well as certain preclinical regulatory studies and all activities needed to manufacture the Product on an industrial scale, to obtain all regulatory approvals for the Product in the Field and to distribute the Product, with a priority on distribution in the Territory on an Affordable Basis, including postregistration activities such as pharmacovigilance studies.p>
<p><span style=”textdecoration: underline;”><strong>Recitalsstrong>span>p>
<p><strong>A.strong> WHEREAS, DNDi is a notforprofit entity whose mission is to develop safe, effective, fieldadapted and affordable new treatments for people suffering from neglected diseases and to ensure equitable access to such treatments (the “<em><strong>Missionstrong>em>”);p>
<p><strong>B.strong> WHEREAS, acting in the public interest, DNDi bridges existing research and development (“<em><strong>R&amp;Dstrong>em>) gaps for these diseases by initiating and coordinating drug R&amp;D projects in collaboration with the international research community, the public sector, the pharmaceutical industry and other relevant partners;p>
<p><strong>C.strong> WHEREAS, Partner is &lt; add description &gt;;p>
<p><strong>D.strong> WHEREAS, Partner desires to provide Molecule(s) with potential activity in the Field and information relating thereto to DNDi for its Mission;p>
<p><strong>E.strong> WHEREAS, Partner and DNDi desire to collaborate in the Research Program with respect to such Molecule(s); andp>
<p><strong>F.strong> WHEREAS, when and if a Clinical Candidate is identified, Partner desires to have an option to collaborate with DNDi in the Development Program (which includes clinical development, manufacture and distribution of a Product on an Affordable Basis in the Territory), and DNDi desires to grant such an option to Partner.p>