PREP Act definition
Examples of PREP Act in a sentence
The Company Group has not taken advantage of any limited liability under the Public Readiness and Emergency Preparedness Act (the “PREP Act”) to address alleged claims for damages arising from its distribution or use of “covered countermeasures,” as defined in the PREP Act, during the outbreak of COVID-19.
It is the intent of the Parties that the drug product provided pursuant to this Agreement be covered by the March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d, 85 Fed Reg.
To the extent DoD or BARDA is authorized to do so as an Authority Having Jurisdiction, the Government designates Regeneron as a covered person eligible for immunity under the PREP Act Declaration issued by DHHS on March 10, 2020, pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), for activities related to medical countermeasures against COVID-19.
Based on an independent review by each of the Parties of the PREP Act Declaration issued by DHHS on March 10, 2020, pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), and a related advisory opinion issued by the DHHS Office of General Counsel on April 14, 2020, the Parties believe that Regeneron is a covered person eligible for immunity under the PREP Act for activities related to medical countermeasures against COVID-19.
The Government further warrants that, except as set forth in Section 7.6, the drug product provided pursuant to this Project Agreement will not be (a) sold to any entity nor will it be returned after acceptance under the terms of this contract or (b) distributed or used, or authorized for distribution or use, outside the United States or to the extent such activities are not protected from liability under an active PREP Act declaration.
The Government further warrants that the drug product provided pursuant to this Project Agreement will not be (a) sold to any entity nor will it be returned after acceptance under the terms of this contract or (b) distributed or used, or authorized for distribution or use, outside the United States or to the extent such activities are not protected from liability under an active PREP Act declaration.
Section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), as enacted by the Public Readiness and Emergency Preparedness Act (PREP Act) (Pub.
Additional information on the PREP Act, including the declarations issued by the Secretary of HHS invoking the Act’s protections, may be found at: ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/Preparedness/legal/prepact/Pages/default.aspx.
Based on an independent review by each of the Parties of the PREP Act Declaration issued by DHHS on March 10, 2020, pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), and a related advisory opinion issued by the DHHS Office of General Counsel on April 14, 2020, the Parties believe that ▇▇▇▇▇▇▇▇▇ is a covered person eligible for immunity under the PREP Act for activities related to medical countermeasures against COVID-19.
Additional information on the PREP Act, including the declarations issued by the Secretary of HHS invoking the Act's protections, may be found at: ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/Preparedness/legal/prepact/Pages/default.aspx.