The U.S. government is trying to force a COVID-19 vaccine manufacturer to hand over money, the manufacturer said in new filings.
BioNTech received a notice of default from the U.S. National Institutes of Health (NIH) on March 22, BioNTech said in one of the forms.
The notice relates to “alleged amounts owed” and breaches under a license between NIH and BioNTech, the German company said.
“As previously disclosed, the company disagrees with the positions being taken by the NIH, and intends to vigorously defend against all allegations of breach,” it stated.
BioNTech and Pfizer developed one of the world’s most-used COVID-19 vaccines. More than 366 million doses have been administered in the United States alone.
A notice of default is a precursor to legal action.
The NIH did not respond to requests for comment. BioNTech did not respond when asked for a copy of the notice of breach. The Epoch Times has filed Freedom of Information Act (FOIA) requests for the notice and license.
The NIH said in 2021 that it licensed a version of the COVID-19 spike protein to BioNTech in 2020.
In another recent filing, BioNTech said, “We may disagree from time to time with licensors or collaborators regarding, among other things, the interpretation of each party’s obligations or the amounts payable under our agreements.
“For example, we are in ongoing discussions with the University of Pennsylvania and the National Institute of Health, or NIH, concerning royalties and other related amounts allegedly owed on sales of our COVID-19 vaccine since commercialization,” the company continued. “We and the NIH have exchanged detailed characterizations of our positions and NIH has delivered a communication threatening to send a notice of default for breach of our agreement. While we disagree with the positions being taken by the University of Pennsylvania and NIH, the ultimate outcome of these matters is uncertain and we cannot guarantee that our interpretation of these license agreements will prevail, or that we will not ultimately need to pay some or all of the royalty and other related amounts in dispute.”
The University of Pennsylvania did not respond to a request for comment.
The filings were submitted to the U.S. Securities and Exchange Commission.
Pfizer has not disclosed any similar communications or notices. Pfizer did not return an inquiry.
BioNTech made $18.3 billion from its COVID-19 vaccines in 2022 alone, according to the company. Pfizer has also reported billions in profit from the shots, which were purchased by governments around the world and mandated by some of them.
Moderna Royalties
The Moderna COVID-19 vaccine, which was developed with the help of NIH scientists, has earned the government hundreds of millions of dollars in royalties.
The government received $400 million from Moderna, according to a contract obtained by The Epoch Times through a FOIA request.
Moderna for years declined to give the government any money for the work on the vaccine but ultimately relented and described the $400 million as a “catch-up payment.”
The NIH was also due to receive “low single digit royalties” on future sales of the company’s COVID-19 vaccines.
The NIH received up to $2 billion in royalties from 34 drug contracts between 1991 and 2019, according to a report from the U.S. Government Accountability Office. The office recommended that NIH be more transparent about the licensing. Individual officials, including the former head of the U.S. National Institute for Allergy and Infectious Diseases Dr. Anthony Fauci, also received royalties, according to documents obtained by an investigative nonprofit.
Moderna has made tens of billions of dollars from its COVID-19 vaccines, the first product the U.S.-based company brought to market.
The contract showed that along with the NIH, the spike protein utilized by Moderna has ownership shared by Scripps Research Institute and Dartmouth University’s Geisel School of Medicine. Dartmouth has said it was going to make money from the agreement. Scripps did not respond to a request for comment.
From The Epoch Times