Provision Language
Definitions
“Access and Implementation Plan” shall mean a written plan setting forth the mutually agreed strategy based on needs while ensuring access to the Product on an Affordable Basis in the Field in the Territory.
Recitals
A. WHEREAS, DNDi is a not‐for‐profit entity whose mission is to develop safe, effective, field adapted and affordable new treatments for people suffering from neglected diseases, and ensure equitable access to such treatments (the “Mission”);
B. WHEREAS, acting in the public interest, DNDi bridges existing research and development (“R&D”) gaps for these diseases by initiating and coordinating drug R&D projects in collaboration with the international research community, the public sector, the pharmaceutical industry and other relevant partners;
C. WHEREAS, Partner is < add Partner’ introduction, mission here >;
D. WHEREAS, Partner has advanced a Molecule with potential activity in the Field; and
E. WHEREAS, Partner and DNDi desire to collaborate to undertake a development and distribution program with respect to such Molecule, which includes clinical development, manufacture and distribution of a Product on an Affordable Basis in the Territory.
3. DEVELOPMENT AND DISTRIBUTION PROGRAM
[…]
3.3 The Access and Implementation Plan will be drawn up in good faith at a high–level at the beginning of the Development and Distribution Program and will be developed by the Parties in more detail at a later stage.
7. REGULATORY STRATEGY AND REGISTRATION
Regulatory Strategy for Obtaining a Marketing Authorisation.
7.1 The Regulatory Strategy (including timelines and milestones) for the registration of the Product shall be defined by the Parties, following the high‐level Access and Implementation Plan. Upon agreement on the Regulatory Strategy for a country, the Parties shall jointly establish a detailed Access and Implementation Plan for such country to ensure availability of the Product through public and private distribution channels in the Territory on an Affordable Basis.