OMEROS CORPORATION (NASDAQ:OMER) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On October 4, 2017, Omeros Corporation (the “Company”) entered into a Settlement Agreement (the “Settlement Agreement”) and consent judgment with Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC (collectively, “Par”), resolving the Company’s patent litigation against Par, which arose from Par’s filing of an Abbreviated New Drug Application seeking approval from the U.S. Food and Drug Administration to market a generic version of the Company’s drug OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3%. to the Settlement Agreement, Par, which had previously stipulated to infringement, acknowledged and confirmed the validity of each of the patents listed in the Orange Book for OMIDRIA, which are U.S. Patent No. 8,173,707, U.S. Patent No. 8,586,633, U.S. Patent No. 9,066,856, U.S. Patent No. 9,278,101, U.S. Patent No. 9,399,040, and U.S. Patent No. 9,486,406.
Under the terms of the Settlement Agreement, the parties executed a consent judgment that was filed with the U.S. District Court for the District of Delaware on October 5, 2017. to the Settlement Agreement and consent judgment, Par and its affiliates will be prohibited by court order from launching a generic version of OMIDRIA until the earlier of April 1, 2032 or a date on which the Company or a third party, through licensing or any future final legal judgment, should one ever exist, with respect to the Company’s Orange Book listed patents, is able to launch a generic version of OMIDRIA, as further detailed in the Settlement Agreement (such date, the “Entry Date”). Under the Settlement Agreement, the Company granted Par a non-exclusive, non-sublicensable license to make, sell and distribute a generic version of OMIDRIA between the Entry Date and the latest expiration of the Company’s U.S. patents related to OMIDRIA (i.e., October 23, 2033). During this period, Par will pay to the Company a royalty equal to 15% of Par’s net sales of its generic version of OMIDRIA.
The foregoing is a brief description of the material terms of the Settlement Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the Settlement Agreement which is filed as Exhibit 10.1 to this Current Report on Form 8-K. The Settlement Agreement contains representations, warranties and covenants that were made only for purposes of such agreement and, as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed on by the contracting parties. The Settlement Agreement is not intended to provide any other factual information about the Company.
On October 5, 2017, Omeros Corporation issued a press release announcing its entry into the Settlement Agreement. A copy of the press release is attached hereto as Exhibit99.1 and is incorporated herein by reference.
| Item 1.01 | Financial Statements and Exhibits |
(d) Exhibit Index.
OMEROS CORP ExhibitEX-10.1 2 d417717dex101.htm EX-10.1 EX-10.1 Exhibit 10.1 SETTLEMENT AGREEMENT This Settlement Agreement (this “Settlement Agreement”),…To view the full exhibit click here
About OMEROS CORPORATION (NASDAQ:OMER)
Omeros Corporation is a biopharmaceutical company engaged in discovering, developing and commercializing small-molecule and protein therapeutics for market, as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. The Company’s marketed drug product, Omidria (phenylephrine and ketorolac injection), is used during cataract surgery or intraocular lens replacement. Its clinical programs include Mannan-binding lectin-associated serine protease-2 (MASP-2) (OMS721)-Lectin Pathway Disorders; PDE10 (OMS824)-CNS Disorders; peroxisome proliferator-activated receptor gamma (PPARy) (OMS405)-Addiction, and OMS201-Urology. Its preclinical programs include phosphodiesterase 7 (PDE7) (OMS527), Plasmin (OMS616), MASP-3 (OMS906)-Alternative Pathway Disorders, GPR17-CNS Disorders, GPR101-Metabolic Disorders, GPR151-CNS Disorders, GPR161-Cancer, GPR174-Immune Disorders, GPR183-Skeletal and Infectious Diseases, GPCR Platform and Antibody Platform.
