I. Scope of the Project Agreement
I.3 Prototype Project, Milestones, and Pricing Assumptions and Conditions
Prototype Project. The scope of this Prototype Project is the demonstration by Janssen of the rapid, large scale supply and logistics capability to manufacture and deliver to the Government, 100M Regimens of the Ad26.COV2.S vaccine. Consistent with the Government’s objectives under Operation Warp Speed (“OWS“), Janssen intends to employ its proprietary manufacturing technology and processes, in a manner compliant with applicable laws and regulations, including 21 CFR 210 and 211 and the Drug Supply Chain Security Act (“DSCSA“) (to the extent required for COVID-19 medical countermeasures, as defined by relevant U.S. Food and Drug Administration (“FDA“) guidance), to manufacture and deliver the Ad26.COV2.S vaccine. The successful provision of these Regimens shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections. While preclinical and clinical activities are described in the Introduction section of this Statement of Work, the Parties acknowledge and agree that such activities are not related to the large-scale manufacturing demonstration and are out-of-scope for this Prototype Project. This effort constitutes a prototype project because it will be used to evaluate the technical feasibility of completion of the Prototype Project during the ongoing COVID-19 pandemic and unprecedented threats to several components of the Prototype Project. In addition, this is a prototype project because Janssen will demonstrate and prove-out the at-scale, multi-lot proprietary manufacturing activities in order to assess the feasibility to support the necessary quantity of safe and effective regimens required for vaccination of the U.S. population. Successful completion of the Prototype Project will demonstrate Janssen’s capability to rapidly manufacture product, which can be further scaled-up to meet mutually agreed to surge requirements with limited advance notification.