Same deal (no Congressional oversight, etc.) with Advanced Technologies International contracts, cited by Brook Jackson and defendant Pfizer in Jackson’s False Claims Act case and Pfizer’s April 22, 2022 motion to dismiss,
Same deal (no Congressional oversight, etc.) with Advanced Technologies International contracts, cited by Brook Jackson and defendant Pfizer in Jackson’s False Claims Act case and Pfizer’s April 22, 2022 motion to dismiss,
in support of Pfizer argument that there has been no fraud by Pfizer against US government, because DOD through ATI did a military procurement contract for a “large scale vaccine manufacturing demonstration project,” not a contract for R&D, clinical trials, or good manufacturing practices.
Base Agreement between Pfizer and DOD, through ATI - July 2020
The Statement of Work at p. 10 is where the prototype language, and the exemption from “Good Clinical Practices” show up:
“The scope of this prototype project is the demonstration by Pfizer of the supply and logistics capability to manufacture and distribute to the Government of 100M doses of a novel mRNA- based vaccine that has received FDA-approval or authorization based on demonstration of efficacy (hereafter FDA-approved or authorized).
The criteria for successful Emergency Use Authorization (EUA) are described in Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders, January 2017; and Development and Licensure of Vaccine to Prevent COVID-19: Guidance for Industry June 2020.
The successful provision of these doses shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections.
While pre-clinical, clinical, and chemistry/manufacturing/controls (CMC) activities are described in the Background section of this Statement of Work, the Parties acknowledge and agree that such activities not related to the large-scale manufacturing demonstration are out-of-scope for this prototype project as Pfizer and BioNTech have and will continue to fund these activities, without the use of Government funding.”
Same deal (no Congressional oversight, etc.) with Advanced Technologies International contracts, cited by Brook Jackson and defendant Pfizer in Jackson’s False Claims Act case and Pfizer’s April 22, 2022 motion to dismiss,
https://www.dropbox.com/s/7iq61dzllyj7hpu/20220422%20Doc.%2037%20-%20Pfizer%20Motion%20to%20Dismiss.pdf?dl=0
in support of Pfizer argument that there has been no fraud by Pfizer against US government, because DOD through ATI did a military procurement contract for a “large scale vaccine manufacturing demonstration project,” not a contract for R&D, clinical trials, or good manufacturing practices.
Base Agreement between Pfizer and DOD, through ATI - July 2020
https://www.documentcloud.org/documents/22028603-pfizer-base-agreement
Statement of Work contract, also through ATI - July 2020
https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf
Whitney Webb reporting, Oct. 2020, on CIA-linked ATI used for Operation Warp Speed:
https://www.thelastamericanvagabond.com/operation-warp-speed-is-using-a-cia-linked-contractor-to-keep-covid-19-vaccine-contracts-secret/
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The Statement of Work at p. 10 is where the prototype language, and the exemption from “Good Clinical Practices” show up:
“The scope of this prototype project is the demonstration by Pfizer of the supply and logistics capability to manufacture and distribute to the Government of 100M doses of a novel mRNA- based vaccine that has received FDA-approval or authorization based on demonstration of efficacy (hereafter FDA-approved or authorized).
The criteria for successful Emergency Use Authorization (EUA) are described in Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders, January 2017; and Development and Licensure of Vaccine to Prevent COVID-19: Guidance for Industry June 2020.
The successful provision of these doses shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections.
While pre-clinical, clinical, and chemistry/manufacturing/controls (CMC) activities are described in the Background section of this Statement of Work, the Parties acknowledge and agree that such activities not related to the large-scale manufacturing demonstration are out-of-scope for this prototype project as Pfizer and BioNTech have and will continue to fund these activities, without the use of Government funding.”