Master Alliance Provisions Guide (MAPGuide)

Shionogi – GARDP, Cefiderocol License Agreement

  • Equitable Access | Access plans & principles

Preliminary Statements 

The common objectives of the Parties are to enable Sublicensees (as defined below) to provide, with a sense of urgency, affordable and sustainable access to quality Licensed Product (as defined below) for patients in need in countries in the Territory (as defined below) while preserving the efficacy and appropriate use of the Licensed Product and encouraging good antimicrobial stewardship (the Access and Stewardship Objectives).


2.1 Licensed Rights and Licensed Manufacturing Know-How 

(a) The Parties have agreed on a Market Access Plan (the “Market Access Plan, the initial version of which is set forth in a schedule to the Collaboration Agreement), which plans and tracks the various activities to be conducted by GARDP and Shionogi (and CHAI, where applicable) pursuant to the Collaboration Agreement in pursuit of the Access and Stewardship Objectives, including notably the activities of GARDP and Shionogi (and CHAI, where applicable) to enable and facilitate the Sublicensees to supply, develop, register, and distribute the Licensed Product in countries in the Territory. Each of Shionogi and GARDP shall use reasonable best efforts to conduct the activities and achieve the objectives for which it is responsible in the Market Access Plan. The Market Access Plan shall be managed and updated from time to time in accordance with the Collaboration Agreement, which provides that either Party (or CHAI) may propose changes to the Market Access Plan, and that all such changes shall require the approval of both Parties and, if applicable, of CHAI except as otherwise specifically set forth in the Collaboration Agreement.



(e) In recognition of the humanitarian objectives of this License Agreement, GARDP also will use reasonable best efforts to promote the affordable access to the Licensed Product through its Sublicensees in the Territory.

Schedule F: Provisions for Sublicense Agreement

1. Sublicensee Commitment. Sublicensee hereby agrees to use commercially reasonable efforts to implement an agreed registration and commercialization plan (the “Sublicense Access Plan), that includes specific target dates for various registration and commercialization objectives, and that furthers the Access and Stewardship Objectives. The Sublicense Access Plan shall be agreed to by Licensor, Sublicensor and Sublicensee.