Master Alliance Provisions Guide (MAPGuide)

Sanofi – DoD Agreement for Adjuvanted Recombinant COVID-19 Vaccine Development

  • Liability | Limitation of liability/damage

5.5 PREP Act

In accordance with the Public Readiness and Emergency Preparedness Act (“PREP Act”), Pub. L. No. 109-148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well as the Secretary of HHS’s Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on April 15, 2020, 85 Fed. Reg. 21012 (together, the “Prep Act Declaration”):

  • (i) This Agreement is being entered into for purposes of facilitating the manufacture, testing, development, distribution, administration, and use of “Covered Countermeasures” for responding to the COVID-19 public health emergency, in accordance with Section VI of the PREP Act Declaration;
  • (ii) Contractor’s performance of this Agreement falls within the scope of the “Recommended Activities” for responding to the COVID-19 public health emergency, to the extent it is in accordance with Section III of the PREP Act Declaration; and
  • (iii) Contractor is a “Covered Person” to the extent it is a person defined in Section V of the PREP Act Declaration.

Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act (42 U.S.C. § 247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the HHS, expressly acknowledges and agrees that the HHS Declaration cited above, specifically its language providing immunity from suit and liability is applicable to this acquisition as long as Contractors activities fall within the terms and conditions of the PREP Act and the PREP Act Declaration.

Undefinitized Project Action 

  1. Limitations on Obligations: 

The Government will not obligate more than 50 percent of the Not-To-Exceed (NTE) Price before definitization. 

  1. Limitation of Government Liability: 
    • a) In performance of this Agreement, the Contractor is not authorized to make expenditures or incur obligations exceeding $1,769,013,470 dollars. 
    • b) The maximum amount for which the Government shall be liable if this Agreement is terminated is $1,769,013,470 dollars.