“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.
“Regulatory Strategy” shall mean the strategy for obtaining a Marketing Authorisation with the aim of ensuring equitable and affordable access to such Product in the Territory at the earliest possible date, consistent with the Access and Implementation Plan.
“Territory” shall mean all countries in which one or more of the diseases of the Field is endemic, as listed and revised by the WHO from time to time; and any additional countries that might be added subject to the written agreement of the Parties.
3. DEVELOPMENT AND DISTRIBUTION PROGRAM
3.5 During the Term, each Party shall use Reasonable Efforts to conduct, advance and complete the activities assigned to it in a timely way and as soon as reasonably practical, including devoting such employees/consultants/CSPs with sufficient skills and experience, and facilities and equipment as are reasonably necessary to complete its obligations under the Collaboration Plans. In particular, the Parties shall use Reasonable Efforts to develop, obtain Regulatory Approval(s) for and, following Marketing Authorisation, use all Reasonable Efforts to provide an adequate supply of Product on an Affordable Basis in the Field in the Territory and provide a strong supply network to support such distribution.
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. The Regulatory Strategy will for the time being be based on the process under Article 58 of Regulation (EC) No. 776/2004 and on the local registration requirements in the Territory. Any other regulatory mechanism that could facilitate registration of a Product in the Field in the Territory shall be considered by the Parties and could possibly lead to a change in the Regulatory Strategy upon written agreement between the Parties.
7.2 The Party responsible for a relevant clinical trial shall lead and be responsible for the Regulatory Strategy of such clinical trial in consultation with the other Party.
7.3 Partner shall be responsible for obtaining and maintaining Marketing Authorizations for the Product covering the Territory.
7.4 The roles and responsibilities of the Parties are defined by the Parties in the Regulatory Responsibilities Plan. In case of contradictions between the Regulatory Responsibilities Plan and the terms of the main body of this Agreement, the terms of the main body of this Agreement shall prevail. The Parties shall also undertake their roles and activities at all times with the goal of making a Product available on an Affordable Basis in the Field in the Territory as early as possible.
7.8 Support for Registration. DNDi shall use its Reasonable Efforts to assist Partner in obtaining the Marketing Authorisation of the Product for use in the Field in the Territory, and in answering questions from any Regulatory Authority with respect to the Product.
7.9 As soon as feasible, the Parties shall prepare a Product needs’ forecast for the Territory and attach the same to this Agreement as Annex 5. Such forecast shall not be binding but shall serve as a reference to support decisions on the Regulatory Strategy and the Access and Implementation Plan.
9. MANUFACTURE AND SUPPLY
Manufacture of the Product
9.2 Partner shall manufacture, scale up, package, label and supply the Product(s) pursuant to all Applicable Laws, to make it accessible as outlined in the Access and Implementation Plan.
9.3 Partner represents that it has known sources of supply and sufficient production capacities to ensure a continuity of supply of the Product(s) to the Territory in reasonable quantities as may be requested under normal conditions.
9.4 Partner shall inform DNDi, as soon as possible, of all proposed changes in the manufacturing of any of the Product required by the Regulatory Authorities or any other events, which may result in a disruption in the supply of such materials. Partner will use Reasonable Efforts to carry out this change as quickly as possible to satisfy as much as possible the orders of the Product from the Territory.
Product Distribution and Pricing
9.6 Partner shall be responsible for the distribution, either directly or through any Third Party it may appoint, of the Product in accordance with this Agreement. Following receipt of the applicable Marketing Authorisation, Partner shall make the Product available in the Territory on an Affordable Basis.
9.8 Partner shall transfer manufacturing technology in full to one or more Third Party manufacturers if such transfer reduces the cost of the Product in accordance with a technology transfer plan mutually agreed upon by the Parties which shall include, at a minimum the terms attached hereto as Annex 6, provided that (i) such Third Party manufacturers’ quality standards meets Good Manufacturing Practice; and (ii) the transfer will not delay access to the Product in the Territory.