Company: PCRX
Filing Date: 2025-04-07
Form Type: 8-K
Source: 0001396814-25-000051
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Company: Pacira BioSciences, Inc.
Filing Date: 2025-04-07
Form: 8-K
Item: Item 1.01
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Item 1.01. Entry into a Material Definitive Agreement.

On April 7, 2025, Pacira BioSciences, Inc. (the “ Company”) and its wholly-owned subsidiary Pacira Pharmaceuticals, Inc. entered into a Settlement Agreement (the “ Settlement Agreement”) with Fresenius Kabi USA, LLC (“ Fresenius Kabi”), eVenus Pharmaceutical Laboratories Inc., (“eVenus”), and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (f/k/a Jiangsu Hengrui Medicine Co., Ltd, “ Jiangsu” and, together with Fresenius Kabi USA, LLC and eVenus Pharmaceuticals Laboratories, the “ Fresenius Parties”) with respect to the various patent infringement suits and related actions related to patents for EXPAREL®(bupivacaine liposome injectable suspension) with the Fresenius Parties [(21-cv-19829), (22-cv-00718), (23-cv-2367), (24-cv-6294), (24-cv-7680), (24-cv-12416) and (24-cv-11014)] (collectively, the “ Litigations”).

Pursuant to the Settlement Agreement, the parties will file consent judgments with the United States Court of Appeals for the Federal Circuit and the United States District Courts for the District of New Jersey and the Northern District of Illinois that enjoin the Fresenius Parties from marketing a generic bupivacaine liposome injectable suspension before the expiration of the patents-in-suit, except as provided for in the Settlement Agreement, as described below.

In settlement of all outstanding claims in the Litigations, the Company has agreed to provide the Fresenius Parties with a license to the Company’s patents required to manufacture and sell certain volume-limited amounts of a generic bupivacaine liposome injectable suspension in the United States beginning on a confidential date that is sometime in early 2030. The license will permit entry of a generic bupivacaine liposome injectable suspension before the July 2, 2044 expiration date of the last-to-expire of the Company’s Orange Book-listed patents for EXPAREL.

While the agreed-upon volume-limited percentages are confidential, they begin at a high-single-digit percentage of the total volumes distributed in the U. S. market and increase gradually in each 12-month period following the volume-limited entry date until reaching a percentage in the