3 unchanged sentences
Our threshold for disclosing material environmental legal proceedings involving a government authority where potential monetary sanctions are involved is $1.0 million.
−Removed: In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora Pharma Private Limited (Annora), requesting approval to market a generic version of TAVALISSE.
+Added: In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora, requesting approval to market a generic version of TAVALISSE.
The notice letter included a Paragraph IV certification with respect to our US Patent Nos.
7 unchanged sentences
We served an answer to Annora’s invalidity and non-infringement contentions in March 2023.
−Removed: Litigation continues, and no trial date is currently set.
−Removed: We intend to vigorously enforce and defend our intellectual property related to TAVALISSE.
+Added: In March 2025, we entered into a settlement agreement with Annora resolving patent litigation related to our product TAVALISSE.
+Added: Under the terms of the settlement agreement, Annora will have a license to sell its generic product in the second quarter of 2032 or earlier under certain circumstances.
+Added: In accordance with the settlement agreement, the parties terminated all ongoing litigation between us and Annora regarding TAVALISSE patents pending in New Jersey as of March 26, 2025.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.