Moderna, Inc.

Item 1. Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described in our 2024 Form 10-K under the heading “Legal Proceedings.” Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2024 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

Proceedings Related to Patents Owned by Alnylam

As more fully described in our 2024 Form 10-K, Alnylam Pharmaceuticals, Inc. (Alnylam) brought two proceedings against Moderna in the U.S. District Court for the District of Delaware asserting that the manufacture and sale of our COVID vaccine infringes certain U.S. patents concerning cationic lipids. The Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit Court of Appeals decided the appeal in our favor on June 4, 2025. Following the Federal Circuit decision, Moderna and Alnylam entered into an agreement on September 15, 2025, to settle all disputes between the parties, including filing a stipulated dismissal of Alnylam’s claims with prejudice. The settlement did not include payments of any kind by Moderna.