BioNTech SE Files 6-K, Discusses NIH Talks

Ticker: BNTX · Form: 6-K · Filed: 2024-12-27T00:00:00.000Z

Sentiment: neutral

Topics: regulatory-filing, collaboration

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

FAQ

What is the subject of the discussions between BioNTech SE and the NIH?

The filing does not specify the subject of the discussions between BioNTech SE and the NIH.

When were these discussions initiated or disclosed?

The filing states that BioNTech SE previously disclosed it was in discussions with the NIH, but the exact date of this prior disclosure is not provided within this document.

What is the purpose of this Form 6-K filing?

This Form 6-K is a report of a foreign private issuer pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934, for the month of December 2024.

Where is BioNTech SE's principal executive office located?

BioNTech SE's principal executive office is located at An der Goldgrube 12, D-55131 Mainz, Germany.

Does BioNTech SE file annual reports under Form 20-F or Form 40-F?

BioNTech SE indicates it files annual reports under Form 20-F.

From the Filing

0001776985-24-000103.txt : 20241227 0001776985-24-000103.hdr.sgml : 20241227 20241227072153 ACCESSION NUMBER: 0001776985-24-000103 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20241227 FILED AS OF DATE: 20241227 DATE AS OF CHANGE: 20241227 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BioNTech SE CENTRAL INDEX KEY: 0001776985 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: 2M FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39081 FILM NUMBER: 241582404 BUSINESS ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 BUSINESS PHONE: 0049613190840 MAIL ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 6-K 1 form6-knih27dec2024.htm 6-K Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16 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 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T 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 percentag

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