BioNTech SE Files 6-K, Discusses NIH Talks

TL;DR

BioNTech in talks with NIH, details TBD.

AI Summary

BioNTech SE filed a Form 6-K on December 27, 2024, reporting its activities for the month of December 2024. The filing indicates that the company is in discussions with the National Institutes of Health (NIH) concerning unspecified matters.

Why It Matters

This filing signals ongoing engagement between BioNTech and a key US health agency, potentially impacting future research collaborations or funding.

Risk Assessment

Risk Level: low — The filing is a routine report and does not contain specific financial or operational risks.

Key Players & Entities

• BioNTech SE (company) — Registrant
• National Institutes of Health (NIH) (company) — Party in discussions

FAQ

Key Financial Figures

• $791.5 m — e Company will, among other things, pay $791.5 million, consisting of $750.0 million as
• $750.0 million — ings, pay $791.5 million, consisting of $750.0 million as a settlement for claimed royalties d
• $41.5 million — ies during calendar years 2020-2023 and $41.5 million in consideration for the NIH's entry in
• $364.5 million — has agreed to reimburse the Company for $364.5 million of the claimed royalties paid to the NI

Filing Documents

• form6-knih27dec2024.htm (6-K) — 15KB
• 0001776985-24-000103.txt ( ) — 16KB

From the Filing

Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF DECEMBER 2024 COMMISSION FILE NUMBER 001-39081 BioNTech SE (Translation of registrant's name into English) An der Goldgrube 12 D-55131 Mainz Germany +49 6131-9084-0 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) INFORMATION INCLUDED AS PART OF THIS FORM 6-K BioNTech SE (the "Company") previously disclosed that it was in discussions with the National Institutes of Health ("NIH") concerning royalties and other related amounts allegedly owed on sales of the Company's, and its collaboration partner, Pfizer Inc.'s ("Pfizer"), COVID-19 vaccine since commercialization. On December 20, 2024, the Company entered into a settlement agreement with the NIH (the "Settlement Agreement"). Under the terms of the Settlement Agreement, the Company will, among other things, pay $791.5 million, consisting of $750.0 million as a settlement for claimed royalties during calendar years 2020-2023 and $41.5 million in consideration for the NIH's entry into an Amended and Restated License Agreement, dated December 20, 2024 (the "Amended License Agreement," and such payment, the "Settlement Payment") to the NIH within 60 days of December 20, 2024. The Company's execution of the Settlement Agreement does not in any way constitute an admission of liability with respect to any allegation raised by the NIH, all of which the Company expressly denies, and nothing in the Settlement Agreement shall be taken as or construed to be an admission by the Company as evidence supporting any such allegation, any matter of fact or law, any violation of law or any other liability whatsoever. Upon the receipt of the Settlement Payment, the NIH has agreed to consider any alleged noncompliance under the Amended License Agreement to be resolved for the period up to and including January 1, 2024, including any claimed historical royalty payments allegedly owed by the Company prior to January 1, 2024, and agreed to withdraw the notice of default previously issued to the Company in connection with such alleged noncompliance. Concurrent with entry into the Settlement Agreement, the Company and the NIH entered into the Amended License Agreement, pursuant to which the Company and the NIH agreed that the Company's amended royalty obligation on Net Sales of Licensed Products will be an amount of up to a low single-digit percentage on Net Sales of Licensed Products (as defined in the Amended License Agreement, and which includes the Company's and Pfizer's COVID-19 vaccine), effective as of January 1, 2024, and which provides a framework for a license for use in combination products, which would include the COVID-19 vaccine used in combination with other active pharmaceutical ingredients. In connection with the Settlement Agreement, Pfizer has agreed to reimburse the Company for $364.5 million of the claimed royalties paid to the NIH for 2020-2023 sales under the Settlement Agreement. SIGNATURE Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BioNTech SE By s Jens Holstein By s Dr. Sierk Poetting Name Jens Holstein Name Dr. Sierk Poetting Title Chief Financial Officer Title Chief Operating Officer Date December 27, 2024

View Full Filing

View this 6-K filing on SEC EDGAR