Novavax Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On April 29, 2025, Novavax, Inc. (the “Company”) entered into a collaboration and exclusive license agreement, as amended, (the “Amended Collaboration Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”) which amends and supersedes the collaboration and exclusive license agreement, dated February 24, 2021, (the “Original Agreement,” together with the Amended Collaboration Agreement, the “Agreement”).
The Original Agreement, which granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373, the Company’s vaccine candidate for the SARS-CoV-2 virus (the “Vaccine”) in Japan, has been amended so that Takeda may develop and commercialize a strain for the Vaccine that is different from the strain that the Company selects for the year, provided such Takeda selected strain must be procured from the Company. Under the Amended Collaboration Agreement, Takeda will continue to purchase the Company’s Matrix-M™ adjuvant to manufacture doses of finished Vaccine with updated adjuvant forecast and other supply terms.
Under the Amended Collaboration Agreement, the Company will receive a non-refundable upfront payment of $19.5 million of which $5 million is creditable against royalties owed by Takeda for its fiscal year 2024. In addition, on an annual basis, (i) the Company will receive $2 million to compensate the Company for services provided by the Company under the Agreement, and (ii) the Company will receive an additional $8 million annual milestone payment of which $5 million is creditable against royalties owed by Takeda in its fiscal year 2025 or thereafter, if Takeda receives marketing approval of the Vaccine in that year or such approval is not necessary for such year. The parties have also updated the financial terms to replace the share of operating profits and, instead, provide the Company with a tiered royalty as a percentage of Takeda’s, its affiliates’ and sublicensees’ total net sales in the mid to high-teen percentages (subject to certain capped royalty reductions), commencing on April 1, 2024 and will continue until the latest of (a) twenty years after April 29, 2025, (b) all the Company’s know-how licensed under the Amended Collaboration Agreement has become publicly available through no fault of Takeda, and (c) the expiration of the last valid claim in the intellectual property rights licensed by the Company to Takeda under the Amended Collaboration Agreement covering the Vaccine in Japan.
In connection with the Amended Collaboration Agreement, on April 29, 2025, the Company entered into a release agreement with Takeda under which the Company released Takeda and Takeda released the Company from all claims that were asserted or could have been asserted by either party against the other party that related to the Original Agreement and the activities thereunder.
A summary of the material terms of the Original Agreement was included in the Company’s Current Report on Form 8-K filed on March 2, 2021, which is qualified in its entirety by reference to the full text of the Original Agreement (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on May 10, 2021 and incorporated herein by reference).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Novavax, Inc. | ||
| Date: May 5, 2025 | By: | /s/ Mark Casey |
| Name: | Mark Casey | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |