“Affected Territory” means the geographic area of any country (i) where there is an Outbreak or (ii) for which there is an Increased Outbreak Preparation Need or (iii) the Parties otherwise agree in writing and in each case, including healthcare workers providing healthcare in such a country regardless of their home country.
“Field” means the disease area relevant for the project.
“Increased Outbreak Preparation Need” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates in the Field, Funder determines, in its sole discretion, that there is a heightened need for the Product;
“Outbreak” means a Public Health Emergency of International Concern declared by WHO or a public health emergency on a national or regional scale declared by one or more national governments and in each case for a material increase in the number of cases of people infected in the Field including any regional outbreak, an epidemic or a pandemic;
“Outbreak Response Activities” include:
i. the collection and sharing of trial subject information in accordance with Funder Policies, including information about pathogens such as sequence data;
ii. engagement with affected communities to establish mutual trust;
iii. integration of Partner research efforts into Public Sector Agencies’ epidemic response;
iv. manufacture of additional investigational doses of Product (if necessary) or manufacture to replenish Investigational Stockpile;
v. negotiation of clinical trial contracts;
vi. performance of independent ethics reviews; and
vii. implementation of prepared clinical trial designs.
“Investigational Stockpile” means a quantity of doses of the Product adequate for the planned Clinical Trials in the Development Plan or as described in a Work Phase Statement which is manufactured and stored according to GMP, where the Product has been approved for use in clinical trials in humans, which has not received Marketing Approval;
3. Contributions and Work Phases
3.1. FUNDER Obligations. FUNDER shall: […]
3.1.2. Use Reasonable Efforts to do the following:
i. work with WHO and other stakeholders to address the issues of product liability for unlicensed products used in an Outbreak in the Field;
ii. work with Public Sector Agencies to develop and adopt ethical structures for the conduct of clinical trials of investigational vaccines in an Outbreak situation and establish and implement policy on access to trial sites in Affected Territories by FUNDER funded programs (“FUNDER Policy on Site Access”);
iii. facilitate stakeholder coordination for preparation for and response to potential future Outbreaks;
iv. collaborate with Public Sector Agencies to prioritize vaccines in the Field for Investigational Stockpile and Outbreak preparedness stockpile;
v. promote a smooth and well-understood regulatory process for investigational vaccines; and
vi. raise funding in advance for the funding of clinical trials in an Affected Territory if needed;
(together the “Outbreak System Activities”).
3.2 Partner Obligations
3.2.1 Before an Outbreak:
(i) develop the Product in accordance with the Development Plan and as more particularly detailed in the Work Phase Statements;
(ii) provide free of charge or at a discounted rate the services and facilities outlined in Schedule 3 in accordance with the timeframe (if any) set out at Schedule 3, the Application, and in more detail in specific Work Phase Statements; and
(iii) use its Reasonable Efforts either to establish directly or to enter into an agreement with Funder, a Public Sector Agency or another third party, for supply of Product into an Investigational Stockpile before the first subject receives the first dose in a Phase II Clinical Trial and perform the related obligations detailed at Clause 8.4;
(together the “Outbreak Preparation Activities”) in a timely manner and use Reasonable Efforts to achieve each Milestone by the relevant Milestone Date.
3.2.2 In the event of an Outbreak or Increased Outbreak Preparation Need, perform the Outbreak Response Activities detailed in any and all Work Phase Statements.
6. Development and Regulatory Activities
6.1 Development. The Partner shall use Reasonable Efforts to Develop the Product before any Outbreak or an Increased Outbreak Preparation Need and all reasonable endeavours to Develop the Product for use in the Affected Territory when an Outbreak or an Increased Outbreak Preparation Need has been declared and in each case in accordance with the terms and conditions of this Agreement and the Development Plan.