“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.
“Rights of Reference” shall mean, with regard to a Party, a grant of rights (including through a Third Party) that allows the applicable Regulatory Authority in a country to have access to relevant information (by cross‐reference, incorporation by reference or otherwise) contained in a Regulatory Dossier (and any data contained therein) filed with another Regulatory Authority by or on behalf of the other Party (its Affiliate or sublicensee).
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.
7.5 If, for purposes of a Marketing Authorisation in the United States, the FDA requests changes to the Development Plan, the Parties shall discuss such changes in good faith to ensure that the FDA’s proposals do not interfere with the Regulatory Strategy and will not materially delay the clinical development of the Product that was discussed under the Regulatory Strategy.
7.6 The Parties shall act in good faith to develop the Regulatory Dossier of the Product according to the agreed Regulatory Strategy. Partner shall permit DNDi to review and make suggestions in relation to the Regulatory Dossier prior to submission to the Regulatory Authority and reasonably consider such suggestions.
7.7 Partner shall update DNDi as to the status of each Regulatory Dossier and will provide DNDi through the JDC with a report on its exchanges with the applicable Regulatory Authority.
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.
10. SAFETY REPORTING AND RECALLS
10.1 The Party that is the sponsor of any clinical trial performed under this Agreement shall remain fully responsible for ensuring safety reporting through individual and aggregate reports to Regulatory Authorities and other entities in countries for which it is responsible as required by Applicable Laws.
10.2 As long as DNDi is conducting clinical trials with a Product anywhere in the world, the Parties will promptly exchange all relevant information that relates to the safety of such Product and, especially, all adverse drug reactions. Within a period of six (6) months from the Effective Date, and/or before enrolment of the first patient in a Product.related clinical trial, the Parties will conclude a Pharmacovigilance Agreement to govern the investigation of and action to be taken with regard to Product related adverse experience reports, such that each Party can comply with its legal obligations worldwide.
10.3 Each Party shall be responsible for conducting, in accordance with all Applicable Laws, all withdrawals or recalls of the Product used in its respective clinical trials and shall comply at all times with all legal requirements on recalls. Each Party shall inform the other of any withdrawals or recalls and will provide the other with reasonable notice of the circumstances of any intended withdrawal or recall in an appropriate time.
10.4 During the post–registration phase, Partner (as the Marketing Authorisation holder) shall be fully responsible for ensuring safety reporting of individual and aggregate reports to the relevant Regulatory Authority and other entities as required by Applicable Laws and regulations.
13. INFORMATION EXCHANGE
13.2 Each Party has been provided and will keep providing to the other, with technical information and data necessary for the purpose of the Development and Distribution Program in its possession, including without limitation letters of reference granting the other Party the Rights of Reference to the Regulatory Dossier filed with a Regulatory Authority.