Whereas the Public Readiness and Emergency Preparedness Act (“PREP Act“) authorizes the Secretary of Health and Human Services (the “Secretary”) to issue a Declaration to provide liability immunity to certain individuals and entities (“Covered Persons“) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (“Covered Countermeasures“).
Whereas the Secretary has issued a PREP Act Declaration on 10 March 2020, as amended, (herein referred to as “Secretary’s COVID-19 PREP Act Declaration“) and declared that the spread of novel Coronavirus (“SARS-CoV-2”) or a virus mutating therefrom and the resulting disease, Coronavirus Disease (“COVID-19”), constitutes a public health emergency.
IV. “PREP ACT” Coverage
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 Health and Human Service’s (“HHS”) 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, and on June 8, 2020, 85 Fed. Reg. 34740 (together, the “Prep Act Declaration“):
(i) This Project 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) Janssen’s performance of this Project Agreement falls within the scope of the “Recommended Activities” for responding to the COVID-19 public health emergency in accordance with Section III of the PREP Act Declaration; and
(iii) Janssen is a “Covered Person” per 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 Project Agreement, as long as Janssen’s activities fall within the terms and conditions of the PREP Act and the PREP Act Declaration.
The Government may not use, or authorize the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States (or a U.S. territory where U.S. law applies such as embassies, military installations and NATO installations) and is protected from liability under a declaration issued under the PREP Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope. Any use where the application of the PREP Act is in question will be discussed with Janssen prior to use and, if the parties disagree on such use, the dispute will be resolved according to Article VI, “Disputes.”
If the Government agrees to provide any additional clarity about the applicability of PREP Act immunity to any maker of a vaccine or pharmaceutical product to prevent or treat SARS-CoV-2, COVID-19, or mutations therefrom, the Government will provide the same clarity to Janssen under this Project Agreement.
V. Obligation and Payment
V.1 Limitation of Liability. In no case shall the Parties’ financial liability for performance exceed the amount obligated under this Project Agreement/Statement of Work.
XIX. General Provisions
XIX.5 Excusable Delay. Neither Party will be liable to the other Party for failure or delay in performing its obligations hereunder if such failure or delay arises from circumstances beyond the control and without the fault or negligence of the Party (an “Excusable Delay Event“). Examples of such circumstances are: authorized acts of the Government in its sovereign capacity (or failure to take reasonably expected acts), war, insurrection, freight embargos, fire, flood, or strikes. The Party asserting Excusable Delay as an excuse must take reasonable steps to minimize delay or damages caused by unforeseeable events. The Government may not identify any aspect of the COVID-19 pandemic as an Excusable Delay Event relieving it of its responsibilities under this Project Agreement.