This commentary discusses how product development funding agreements can facilitate sustainability through provisions that require: (i) a price that is sustainable for the manufacturer as well as affordable for lower-income populations; (ii) a commitment on the part of a developer or manufacturer for continuous long-term supply of the product; (iii) an ‘access license’ that a funder can exercise to ensure the continuity of product development and manufacturing in the event that their partner cannot do so, or if the partnership is terminated; and (iv) the transfer of equitable access obligations to successor organizations in the event that the partner is acquired or transfers project-related IP to another organization. Read more.

Ensuring that a product is affordable for the populations that need it is critical to achieving equitable access, and there are multiple approaches available for the inclusion of affordable pricing provisions in product development funding agreements. This commentary discusses options for fixed, soft and indirect obligations that can have an impact on the price of a final product, as well as providing insight into how and when they are most likely to be effective. Read more.

Ensuring that a product is ‘available’ to the populations that need it requires the consideration of multiple factors. This commentary examines how agreement provisions can support the achievement of product availability by addressing three key issues: (i) developing products that are appropriate and adoptable for all relevant populations; (ii) timely regulatory approval for use in all relevant markets; and (iii) sufficient and timely supplies of the product when and where it is needed. Read more.

Intellectual property (IP) management provisions in development funding agreements need to address: (i) which party owns the pre-existing and newly developed IP needed to support the project; (ii) if and how project-related IP will be protected; and (iii) if and how IP will be shared through licensing and technology transfer agreements. This commentary discusses the different approaches that can be taken to address each of these questions depending on the goals of the agreement. Read more.

Before entering into detailed negotiations for provisions addressing matters such as affordable pricing and product supply, it can be helpful for the parties to a funding agreement to agree upon some fundamental principles for the conduct of the project, including the parties’ intention to ensure equitable access to the product developed under the agreement and/or other results of the project. Read more.

There are many ‘access provisions’ that need to be considered to achieve the objective of making a funded product sustainably affordable and available to all those who need it. Access plans often include considerations related to a number of the building blocks of equitable access and can be a key tool in establishing and coordinating the concrete actions that a product developer will take to achieve equitable access to a safe and efficacious final product. Read more.

The definition of the territory, or markets in which a product must be sustainably affordable and available, should be considered based on: (i) the location(s) in which the disease(s) that the product is designed to prevent, treat or diagnose is prevalent; and (ii) the populations that are likely to be under-served in the absence of any equitable access obligations. This commentary provides examples of the definitions used across a range of agreements. Read more.

Sharing information and data related to the activities under a funding agreement can help to inform related research and development in the field, therefore broadening the impact of a funder’s investment. This commentary discusses the following approaches to information sharing: (i) providing non-public information to a funder under confidentiality restrictions; (ii) sharing underlying scientific data (e.g. clinical trial data) with the research community; and (iii) formal publication of the results of a project in a peer-reviewed journal. Read more.

The particular context of some product development funding agreements means that they need to include provisions designed to address issues that are specific to the product. This commentary examines two examples of such provisions: (i) stewardship obligations for antibacterial products; and (ii) preparedness and response provisions for products intended for use during a disease outbreak. Read more.

Governance provisions are a mechanism that enables funders to monitor a developer’s progress and use of funds on a project. This commentary provides insight into agreement provisions that establish the structure, responsibilities, decision-making authority and meeting format for project governance bodies. Read more.

Frequent project reports are an important tool for funders and PDPs in evaluating the progress of a project in achieving its objectives. Failures by a developer to produce timely reporting, meet deliverable and milestone deadlines, and/or manage the project budget can be indicators of risk to a funder’s investment. This commentary discusses different approaches for the type, structure, and frequency of reporting requirements and related audit rights that can be included in product development funding agreements. Read more.

While the partnerships formed through funding agreements start with the best of intentions, the parties may need to address disagreements, breaches of obligations, or product failures at some point during the project. This commentary discusses how dispute resolution and termination provisions can provide options for the agreement parties to pursue if such challenges arise. Read more.