Master Alliance Provisions Guide (MAPGuide)

Funder Development Partnering Agreement

  • Access to medicines | Outbreak preparedness

3. Contributions and Work Phases

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.