Provision Language
Definitions
“Affordable Basis” 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.
“Development Program” 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 post‐registration activities such as pharmaco‐vigilance studies.
“Territory” shall mean all countries in which one or more of the diseases of the Field is endemic as listed and revised by the World Health Organization (WHO) from time to time; and any additional countries that might be added subject to the written agreement of the Parties.
7. PARTNER’S DEVELOPMENT OPTION
7.1 Partner shall have the right of first negotiation to become the Development Partner and participate in the Development Program pursuant to the Development Agreement (such right, the “Development Option”). Partner (or its Affiliate) may exercise the Development Option within a period of < ninety (90) days > after the designation by the JRC of a Clinical Candidate by giving notice in writing to DNDi.
7.2 If Partner exercises the Development Option, the Parties shall negotiate a Development Agreement in good faith within a < six (6) month > period starting from the date of Partner’s notice to exercise the Development Option or such other period as the Parties may agree in writing (the “Negotiation Period”). The Development Agreement shall govern the terms under which the Development Partner:
a) contribute, along with DNDi, to financially support Phase 1, Phase 2 and Phase 3 clinical studies, and certain preclinical regulatory studies, of the Clinical Candidate;
b) be responsible for and bear all costs relating to activities concerning the clinical and industrial scale‐up of the Product and the preparation and submission of all filings and applications for regulatory approvals of the Product for the Field in the Territory;
c) conduct the manufacture of the Product in such a way as to ensure its widespread availability in the Field in the Territory;
d) distribute the Product for the Field on an Affordable Basis in the Territory; and
e) together with DNDi, monitor and manage the risk of the development of disease resistance should the same Product be used to treat humans and animals for diseases in the Field.