Master Alliance Provisions Guide (MAPGuide)

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

  • Term & termination | Effect of termination
  • Term & termination | Term of agreement
  • Term & termination | Termination & withdrawal

<p>II. Term and Terminationp>
<p><strong>II.1 Term. strong>The Period of Performance for this Project Agreement/Statement of Work is from the date of contract award through January 31, 2022.p>
<p><strong>II.2 Termination. strong>Termination for Vaccine Discontinuation. In the event thatp>
<p>(a) Janssen notifies the Government that, as a result of significant emerging safety or efficacy data, Janssen is ceasing efforts to develop the Ad26.COV2.S, or (b) such a vaccine receives U.S. regulatory approval or authorization on or prior to expiration of the period of performance of this Project Agreement, but such approval or authorization is subsequently withdrawn and, after a reasonable amount of time, the Government determines that the authorization will not be restored or approval will not be granted, the Government will notify Janssen of its intent to terminate this Agreement. Under (a), if Janssen notifies the Government in good faith of a significant safety or efficacy issue, and the Government does not respond within a reasonable amount of time, then Janssen has the right to terminate the Project Agreement.p>
<p>Janssen shall have no liability to repay the Government for Regimens delivered prior to the notification of termination. Janssen shall be entitled to full payment for Regimens for which manufacturing has been completed, but which have not yet been delivered to the Government. With respect to Regimens for which manufacturing has been initiated but not completed, Janssen shall be entitled to payment of a proportion of the $10/Regimen price based on a percentage of the work performed toward release and delivery of such Regimens, plus reasonable charges that Janssen can demonstrate to the satisfaction of the Government using its standard record keeping system to have resulted from the termination, but not to exceed $10/Regimen. By way of example, these costs may include, but are not necessarily limited to, costs associated with noncancellable agreements with vendors to obtain manufacturing capacity or supplies in the performance of this Project Agreement. Janssen shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit Janssen&#8217;s records. Janssen shall not be paid for any work performed or costs incurred which reasonably could have been avoided. From and after the effective date of any such termination, Janssen shall have no further obligation to deliver any vaccine Regimens, and the Government shall have no further obligation to accept any such Regimens for delivery. After termination of this Project Agreement, Janssen may sell or transfer to a third party any Regimens that have not been delivered to the Government.p>
<p><span style=”textdecoration: underline;”>Stop Work Orders.span> Except as required by applicable law or regulation, or judicial or administrative order, the Government shall not have the authority to issue a stop work order to halt the work contemplated under this Statement of Work.p>
<p><strong>II.3 Extension of Term.strong> The Parties may extend by mutual written agreement the term of this Project Agreement if funding availability and research opportunities reasonably warrant. Any extension shall be formalized through modification of the Project Agreement by the Agreements Officer (&#8220;AO&#8221😉 and the Janssen Project Manager (&#8220;PM&#8221;). If the Recipient desires an extension to the period of performance of this Project Agreement, the Recipient shall submit a request in writing to the AO. Any request for an extension should include a revised milestone/project schedule (if applicable).p>