Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Moderna, COVID-19 Vaccine Supply Agreement

  • Liability | Indemnification & liability

<p><span style=”textdecoration: underline;”><b>H.8 Public Readiness and Emergency Preparedness (PREP) Actb>span>p>
<p><span style=”fontweight: 400;”>ln accordance with the Public Readiness and Emergency Preparedness Act (“span><b>PREP Actb><span style=”fontweight: 400;”>”), Pub. L. No. 109148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d6d and 42 U.S.C. § 247d6e), as well as the Secretary of HHSs Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVlD19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on April 15, 2020, 85 Fed. Reg. 21012 (together, thespan><b><i>Prep Act Declarationi>b><span style=”fontweight: 400;”>”):span>p>
<p><span style=”fontweight: 400;”>(i) This Agreement is being entered into for purposes of facilitating the manufacture, testing, development, distribution, administration, and use ofCovered Countermeasuresfor responding to the COVID19 public health emergency, in accordance with Section VI of the PREP Act Declaration;span>p>
<p><span style=”fontweight: 400;”>(ii) Contractor&#8217;s performance of this Agreement falls within the scope of theRecommended Activitiesfor responding to the COVID19 public health emergency, to the extent it is in accordance with Section III of the PREP Act Declaration; andspan>p>
<p><span style=”fontweight: 400;”>(iii) Contractor is aCovered Personto the extent it is a person defined in Section V of the PREP Act Declaration.span>p>
<p><span style=”fontweight: 400;”>Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act (42 U.S.C. § 247d6d), 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.span>p>
<p><span style=”fontweight: 400;”>The Government may not use, or authorize the use of, any products or materials provided under this contract, unless such use occurs in the United States (or a U.S. territory where U.S. law applies such as embassies, military and NATO installations) and is protected from liability under a declaration issued under the PREP Act, or a successor COVID19 PREP Act Declaration of equal or greater scope. Any use where the application of the PREP Act is in question will be discussed with Moderna prior to use and, if the parties disagree on such use, the dispute will be resolved according to theDisputes Clause” (52.2331).span>p>
<p><span style=”fontweight: 400;”>The items and technology covered by this Contract are being developed for both civil and military applications.span>p>
<p><span style=”fontweight: 400;”>[***]span>p>