Provision Language
Definitions
“Clinical Candidate” shall mean any active pharmaceutical ingredient derived from a Molecule, which: a) has completed all the Investigational New Drug /Investigational Medicinal Product (or equivalent) enabling studies; b) meets DNDi’s published target candidate profile (TCP) and has the potential to meet the target product profile (TPP) for < a disease of > the Field; c) has the potential to be developed as a Product for < such disease/the Field >; and d) is a suitable candidate for the Development Program as a result of the Research Program.
“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.
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.
7.3 Notwithstanding the above, DNDi may continue the development of the Clinical Candidate at its own costs and expenses during the periods set forth under Sections 7.1 and 7.2 so as not to delay such activity.
7.4 If the Development Option is not exercised by Partner or if Partner and DNDi do not execute a definitive Development Agreement within the Negotiation Period, then DNDi shall be free, without any further obligation to Partner, to solicit and accept offers for, to engage in any negotiations with any Third Party regarding, and to enter into a definitive Development Agreement governing the Development Program.
7.5 Neither Party shall be obligated to enter into a Development Agreement or any such transaction.
7.6 In the event that DNDi does not wish to or is unable to pursue the development of a Clinical Candidate and has not executed a Development Agreement with a Third Party pursuant to Section 7.3 relating to the manufacture or distribution of a Product in the Field, for reasons other than related to benefit/risk aspects (potency, safety and toxicity), DNDi shall so notify Partner in writing. Partner shall have the right to pursue development of such Clinical Candidate and manufacture or distribution of such Product in the Field independently of DNDi without financial compensation or other further obligation to DNDi.
