§5.01 Access, Not Excess.
(a) The purpose of CARB-X is to protect humanity from the most serious threats from drug-resistant bacterial infections by accelerating antibacterial product development. Over the long term, the new products invented or developed with CARB-X funding (the “Products”) must be sustainably managed and used to promote “Access, Not Excess,” including:
(i) Thoughtful and effective stewardship of new Products whose utility is diminished by resistance, to prevent inappropriate use and therefore premature resistance, in line with the Global Action Plan on Antimicrobial Resistance developed by the World Health Organization;
(ii) Through planning for and ensuring appropriate access to new Products, especially in low and middle-income countries; and
(iii) Avoidance of misaligned commercial incentives, which go against the above-stated goals.
(b) Therefore, the Subrecipient agrees that Products will be manufactured, marketed, and sold under practices consistent with the applicable principles of the Davos Declaration on Antimicrobial Resistance – January 2016 or the Industry Roadmap for Progress on Combatting Antimicrobial Resistance – September 2016.
(c) The Stewardship and Access Plan. When its Product enters Phase III trials (or Phase IIb trials, if they are intended as the pivotal trials to support registration, or otherwise, when the Subrecipient is preparing a Product that is not a therapeutic or preventative for First Approval as defined in Section 5.01(d) below), the Subrecipient shall create and provide to the PTE within ninety (90) days, a plan reasonably describing how it intends to meet the above stewardship and access obligations for the Product, (the “Stewardship and Access Plan”). The Stewardship and Access Plan shall not include confidential business information and shall include:
(i) Strategy to support access and stewardship (e.g. proposed reliable production with sufficient capacity, supply systems, the broad approach to product labelling, and the broad approach to ensure economic barriers to access are as low as reasonably possible);
(ii) Identifying obstacles and constraints to access and stewardship;
(iv) Strategy to ensure marketing approvals are received for key territories in a timely manner; and
(v) Strategy for monitoring effectiveness of access and stewardship, including proposed metrics to measure success.
(d) The Subrecipient shall update the Stewardship and Access Plan and provide it to the PTE when the Product is first approved by any of the FDA, EMA (or national authorities), or Japan’s PMDA (the “First Approval”). After First Approval, the Stewardship and Access Plan shall be updated if there are significant market or product changes, or if events so require. The Subrecipient shall use best reasonable efforts to comply with its Plan at all times.
(e) The Stewardship and Access Plan will be a non-confidential document and will be publicly posted on the PTE website.
(f) Obligations Follow the Product:
(i) If control of the Subrecipient’s Project IP Rights resulting from the Project changes, whether through sale, transfer, license, assignment or otherwise, the Subrecipient will require the obligations of Sections 5.01, 5.03 and 6.04 to follow the Product and be incorporated into any such sale, transfer, license, assignment or otherwise to the new company (the “Acquirer”). Prompt notice will be provided by the Subrecipient to the PTE of any such event. If the Acquirer accepts obligations under Sections 5.01, 5.03 and 6.04, the Subrecipient is discharged from further obligations from Sections 5.01, 5.03 and 6.04.
(ii) If the Subrecipient fails to provide the Stewardship and Access Plan as provided in Section 5.01, within ninety (90) days, the PTE can demand the same in writing within sixty (60 days).
(iii) The obligations of this Section 5.01 survive the termination or expiry of this Subaward Agreement and shall continue in force until the expiration of the last patent or exclusivity periods in the United States, the European Union or Japan for any Project IP Rights (the “Project IP Expiration”).
(g) If the PTE informs the Subrecipient that it is no longer receiving CARB-X funding and no longer operates CARB-X, then Wellcome Trust will assume the rights reserved to the PTE in this Section 5.01, and, for purposes of this Section 5.01, the Wellcome Trust is an intended third-party beneficiary of this Subaward Agreement, and is entitled to enforce its rights as described in this Section 5.01 as if it were a party hereto.