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.
A. General. The Parties shall communicate with one another in good faith and in a timely, responsive, and cooperative manner when raising issues under this Article.
B. Dispute Resolution Procedures.
1. Any claim or dispute between the Government and Janssen concerning questions of fact or law arising from or in connection with this Project Agreement, and, whether or not involving an alleged breach of this Project Agreement, shall be raised and resolved under this Article.
2. Whenever legal disputes or claims arise, the Parties shall attempt to resolve the issue(s) by discussion and come to mutual agreement on a resolution as soon as practicable. In no event shall a dispute, disagreement or misunderstanding that arose more than three (3) months prior to the notification made under sub–section B.3 of this article constitute the basis for relief under this article unless one level above the AO, in the interests of justice, waives this requirement.
3. Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party (through the AO or Janssen’s POC, as the case may be) in writing of the relevant facts, identifying unresolved issues, and specifying the clarification or remedy sought. Within five (5) working days after providing notice to the other Party, the aggrieved Party may, in writing, request a joint decision by the ACC–NJ Division Chief for Emerging Technologies and senior executive appointed by Janssen. The other Party shall submit a written response on the matter(s) in dispute within thirty (30) calendar days after being notified that a decision has been requested. The Division Chief and the Recipient senior executive shall conduct a review of the matter(s) in dispute and attempt to render a mutually agreeable decision in writing within thirty (30) calendar days of receipt of such written position. Any such joint decision is final and binding.