Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Janssen, COVID-19 Vaccine Large Scale Manufacturing Agreement

  • Consortium structure & management | Roles & Responsibilities

III. Project Management, Modifications, and Administration
III.1 Management and Modifications
Technical and project management of the manufacture and delivery of up to 100 million Regimens of Ad26.COV2.S (“Project”) and the anticipated follow-on activities described in Article I, Section 6 above, established under this Project Agreement, shall be managed as detailed in this Article.

a. Project Governance. Janssen is responsible for the overall management of the Prototype Project and related decisions. The Government and Janssen are bound to each other by a duty of good faith in achieving the Prototype Project objectives as defined in Article I. As such, the Government will have continuous involvement with Janssen. Janssen shall provide project results in accordance with the Deliverables schedule identified in Article I.

b. Project Management. Janssen and the Government will each designate an individual responsible for facilitating the communications, reporting, and meetings between the Parties. For Janssen the individual will serve as PM, and for the Government the individual will be the AOR.

c. Project Reviews. Janssen and the Government will hold periodic project review meetings as determined by the Janssen Project Manager and AOR, however, these meetings shall not occur more frequently than every fourteen (14) calendar days.

d. Reviews Resulting in Modifications. During the performance of this Project Agreement, as described above, it may be necessary to modify the Statement of Work or delivery timeframes. No communications, whether oral or in writing, that purport to change this Project Agreement are valid unless a modification is issued by the AO. The Parties hereby agree that any mutually agreed upon written request for modification shall be executed in an expedited timeframe.

e. Bilateral Modifications. Janssen or the Government may propose modifications to this Project Agreement. A modification that materially changes the obligations of either the Government or Janssen must be in writing and signed by the AO and Janssen’s authorized official. Janssen’s requests for modifications shall detail the technical and chronological impact of the proposed change on the Statement of Work or delivery timeframes.

f. Unilateral Modifications. The AO may ONLY issue minor or administrative modifications, which do not change the obligations of Janssen in any adverse manner, such as changes to the paying office or appropriations data, or changes to Government personnel identified in the Project Agreement. Unilateral modifications will only be signed by the AO.