Provision Language
DEFINITIONS
Sublicense Access Plan means the plan of Manufacturing and Manufacturing Approval objectives and specific target dates to be achieved by the Sublicensee. The initial Sublicense Access Plan is attached as Schedule F. Any modifications thereto shall require the agreement of GARDP and the Sublicensee.
Whereas
(E) The common objectives of Shionogi and GARDP under the Shionogi License Agreement are to enable sublicensees to provide, with a sense of urgency, affordable and sustainable access to quality Licensed Product for patients in need in countries in the Territory while preserving the efficacy and appropriate use of the Licensed Product and encouraging good antimicrobial stewardship (the “Access and Stewardship Objectives”).
2. SHIONOGI LICENSE AGREEMENT
2.2 Access and Stewardship Objectives. As a manufacturing sublicensee of GARDP under the Shionogi License Agreement, the Sublicensee will, in furtherance of the Access and Stewardship Objectives of the Shionogi License Agreement: (a) use its best efforts to achieve the objectives set out in the Sublicense Access Plan to diligently implement the Manufacturing of, and to obtain all required Manufacturing Approvals for, the Manufacture of quality Licensed Compound and Licensed Product at the Facility(ies), and (b) use its reasonable best efforts to Manufacture sufficient and affordable quantities of quality Licensed Compound and Licensed Product to supply in a timely manner the requirements of Customers for patients in need in the Territory.
3. LICENSE GRANT
3.3 Sublicensee Sublicense Access Plan Commitment. The Sublicensee shall use its best efforts to achieve the Manufacturing and Manufacturing Approval objectives and specific target dates set out in the Sublicense Access Plan in furtherance of the Access and Stewardship Objectives.
Should the Sublicensee not achieve any of the objectives set out in the Sublicense Access Plan by the corresponding target dates, the Parties shall consult in good faith to discuss the situation, the causes of any such delays, and possible actions to minimize the delay and/or prevent future delays. If requested by GARDP, the Parties shall discuss and agree an access action plan to remedy the situation (each an “Access Action Plan”), and the Sublicensee shall diligently and in good faith implement the Access Action Plan.
Schedule F – Sublicense Access Plan
The Sublicensee:
1. Will initiate the Manufacturing development for the Licensed Compound and Licensed Product (i.e., commence the manufacturing development process for API) at the latest six (6) months from the technology transfer a kick-off meeting with Shionogi and GARDP
2. Will commence the construction of the Fixed dose formulation facility within 15 months from the technology transfer kick-off meeting with Shionogi and GARDP
3. Will commence the manufacturing of stability batches “to support the WHO PQ dossier” for drug substance (API) within 20 months from the technology transfer (note a) kick-off meeting with Shionogi and GARDP
4. Will commence the manufacturing of R&D batches (non-sterile lab scale lyophilised product meant for lab feasibility and validation) for drug product (FDF) within 25 months from the technology transfer kick-off meeting with Shionogi and GARDP
5. Will complete the submission of active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) applications for WHO Prequalification at the latest 44 months from the Shionogi Technical Transfer kick-off meeting (note c)
6. Will ensure that it has the capacity to produce 3 validation batches (note b) of licensed product and if it receives an order or financial support or guarantees to do so, use such validation batches if they are still within shelf-life parameters of Licensed Product to supply at the latest 46 months from the Shionogi Technical Transfer kick-off meeting. Supply of Licensed Product assumes the appropriate regulatory approvals or other permissions from relevant authorities are in place to allow importation and use of Licensed Product (note c).
a. Note: Technology transfer is anticipated to be an on-going process where GARDP (and its partner CHAI) shall be extending support to the sub-licensee beyond the face-to-face kick-off meeting with relevant experts from Shionogi.
b. Note: If validation batches have expired before receiving the order, the sub-licensee may need to produce a batch of licensed product. This is also assuming appropriate regulatory approvals or other permissions from relevant authorities are in place.
c. Note (on milestones 5 & 6): These timelines are subject to the receipt of manufacturing license for Cefiderocol, from the central and state regulatory authorities in India, by the sub-licensee.