Company: PCRX
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001396814-25-000061
Chunk: 85

Company: Pacira BioSciences, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 1
Chunk 85
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 with Fresenius Kabi USA, LLC, eVenus Pharmaceuticals Laboratories, Inc. and Jiangsu Hengrui Pharmaceuticals Co., Ltd., (together, the “Fresenius Parties”), related to patents for EXPAREL. As part of the settlement, the Fresenius Parties will be enjoined from marketing a generic bupivacaine liposome injectable suspension before the expiration of the patents-in-suit, except as provided for in the settlement, as we have agreed to provide the Fresenius Parties with a license to our patents required to manufacture and sell certain volume-limited amounts of a generic bupivacaine liposome injectable suspension in the U.S. beginning on a confidential date in early 2030. In addition, we have agreed to provide the Fresenius Parties with a license to our patents required to manufacture and sell an unlimited quantity of a generic bupivacaine liposome injectable suspension in the U.S. beginning on a confidential date in 2039. The license will permit entry of a generic bupivacaine liposome injectable suspension before the July 2, 2044 expiration date of the last-to-expire Orange Book-listed patents for EXPAREL.

For more information, see Note 16, Commitments and Contingencies, to our condensed consolidated financial statements included herein.

Pacira BioSciences, Inc.  |  Q1 2025 Form 10-Q  |  Page 35

•In April 2025, the U.S. District Court, District of Nevada issued judgment in our favor that royalties were not owed to the Research Development Foundation, or RDF, on EXPAREL manufactured under our enhanced, larger-scale manufacturing process. As a result, this judgment means that the low single-digit royalty that we had been paying RDF is eliminated, thus directly benefitting our cost of goods sold and gross margin. Additionally, we are seeking repayment of up to $23.1 million, plus interest, from RDF, representing the royalties that we paid to RDF under protest on the collection of revenues of EXPAREL that occurred after December 24, 2021, the expiration date of U.S. Patent No. 9,585,838.

•In April 2025, we announced that the first patient was dosed in our Phase 2 ASCEND study evaluating the safety and efficacy of PCRX-201 for the treatment of OA of the knee. The two-part, multicenter ASCEND study