Moderna Inc.
03/05/2026 | Press release | Distributed by Public on 03/05/2026 05:03
Material Agreement (Form 8-K)
Item 1.01. Entry into a Material Definitive Agreement.
On March 3, 2026 (the "Effective Date"), Moderna, Inc. (the "Company") and ModernaTX, Inc. (together with the Company, "Moderna") and Arbutus Biopharma Corporation ("Arbutus"), Genevant Sciences GmbH ("Genevant" and, together with Arbutus, "Arbutus/Genevant"), and, solely for certain purposes, Genevant Sciences Ltd., entered into a settlement agreement (the "Settlement Agreement") to resolve all patent infringement litigation between Moderna and Arbutus/Genevant pending in the U.S. and internationally (the "Litigation"). The Settlement Agreement resolves all worldwide Arbutus/Genevant litigation related to Spikevax®and mRESVIA®and provides certainty going forward for Moderna's full infectious disease portfolio, including mNEXSPIKE®, mCOMBRIAX®and its future vaccine pipeline, with no future royalties owed. Under the terms of the Settlement Agreement, Moderna will make a $950 million noncontingent lump sum payment to Arbutus/Genevant on or before July 8, 2026.
The Settlement Agreement requires each of Moderna and Arbutus/Genevant to file stipulated judgments and stipulations of dismissal for the respective courts or tribunals to enter judgment or dismiss with prejudice or withdraw (as the case may be) all claims in the Litigation. Under the agreement, Moderna may appeal to the Court of Appeals for the Federal Circuit (the "Federal Circuit") with respect to whether 28 U.S.C. § 1498 ("§ 1498") bars Arbutus/Genevant's claims for direct infringement and indirect infringement against Moderna for vaccine doses that were sold to the U.S. Government under a particular contract. If Moderna ultimately prevails on that issue, no further payments will be due.
Pursuant to the Settlement agreement, (i) if the Federal Circuit (whether by the initial panel, upon panel rehearing or en banc) affirms, or if there is a final non-appealable judgment that affirms, the rejection of Moderna's affirmative defense pursuant to § 1498 by the District Court in its entirety or otherwise holds that § 1498 does not bar Arbutus/Genevant's claim against Moderna as to either or both of direct infringement and indirect infringement with respect to all of the doses subject to Moderna's appeal, or (ii) upon a failure to timely file, or voluntary dismissal of, Moderna's appeal, then Moderna will make an additional $1.3 billion contingent lump sum payment to Arbutus/Genevant within 90 days of that decision. If the Federal Circuit instead determines that § 1498 bars Arbutus/Genevant's infringement claims as to some, but not all, of the doses subject to Moderna's appeal, the Settlement Agreement provides that Moderna will pay Arbutus/Genevant a prorated amount of $1.3 billion, calculated based on the number of doses for which § 1498 bars Arbutus/Genevant's infringement claims as clearly articulated by the Federal Circuit, or if not clearly articulated by the Federal Circuit, as mutually agreed by the parties or determined in an accelerated binding arbitration process. Any payment from Moderna to Arbutus/Genevant as described in this paragraph is referred to herein as the "Contingent Payment."
If Arbutus/Genevant receives a Contingent Payment based on a decision that is subsequently overturned in Moderna's favor in a final nonappealable decision, Arbutus/Genevant is required to return the Contingent Payment to Moderna, plus interest. The Settlement Agreement includes mutual financial covenants to ensure payment or repayment of the Contingent Payment.
The Settlement Agreement also contains customary mutual releases in favor of each of Moderna and Arbutus/Genevant in respect of the Litigation. In addition, the Settlement Agreement includes a fully paid-up, royalty free, irrevocable, non-exclusive, worldwide license and covenant not to sue granted by Arbutus/Genevant to Moderna under any patents and patent applications owned or licensable by Arbutus/Genevant or their respective direct and indirect wholly owned subsidiaries to make, sell and generally otherwise exploit Moderna's infectious disease vaccines that include a lipid SM-102-based lipid nanoparticle ("LNP") formulation, including Spikevax, mNEXSPIKE and mRESVIA, as well as a covenant not to sue with respect to certain other Arbutus/Genevant patents and Moderna products.
The foregoing description of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which will be filed as an exhibit to the Company's Quarterly Report on Form 10-Q for the quarterly period ending on March 31, 2026.
Moderna Inc. published this content on March 05, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on March 05, 2026 at 11:03 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]