OMEROS CORPORATION (NASDAQ:OMER) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 Entry Into a Material Definitive Agreement.
On May22, 2018, Omeros Corporation (the “Company”) entered into a Settlement Agreement (the “Settlement Agreement”) and consent judgment with Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc. (collectively, “Lupin”), resolving the Company’s patent litigation against Lupin. The litigation arose from Lupin’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval from the U.S. Food and Drug Administration to market a generic version of the Company’s commercial drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% in May 2017. to the Settlement Agreement, Lupin 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, U.S. Patent No.9,486,406 and U.S. Patent No.9,855,246.
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 May23, 2018. The Company previously entered into a settlement agreement with ANDA-filer Par Sterile Products, LLC and Par Pharmaceutical, Inc. (collectively “Par”) under which Par is precluded from launching a generic version of OMIDRIA until April1, 2032 unless subsequently authorized to terms in that settlement agreement. In accordance with the Settlement Agreement and consent judgment with Lupin, Lupin will be prohibited by the judgment from launching a generic version of OMIDRIA until the earlier of (i)April1, 2032 if Par has forfeited its six month first-ANDA filer exclusivity, (ii)October1, 2032 if Par has not forfeited its six month first-ANDA filer exclusivity, or (iii)a date on which the Company or a third party, through licensing of, any future final legal judgment regarding, or the delisting, abandonment or expiration of the Company’s U.S. OMIDRIA patents, is able to launch a generic version of OMIDRIA.
Under the Settlement Agreement, Lupin is granted a non-exclusive, non-sublicensable license to make, sell and distribute a generic version of OMIDRIA between the permitted launch date and the latest expiration of the Company’s U.S. patents related to OMIDRIA (i.e., at least October23, 2033) and a non-exclusive, non-sublicensable waiver of the Company’s pediatric exclusivity for OMIDRIA until at least April23, 2034. During these license and exclusivity waiver periods, unless Par has not forfeited its six month first-ANDA filer exclusivity and until the Company or a third party launches a generic version of OMIDRIA, Lupin will be required to pay the Company a royalty equal to 15% of Lupin’s net sales of its generic version of OMIDRIA until the Company’s U.S. patents related to OMIDRIA expire, and thereafter an exclusivity waiver fee of 15% of Lupin’s net sales of its generic version of OMIDRIA until the Company’s pediatric exclusivity for OMIDRIA expires.
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 hereto. 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.
Item 1.01 Other Events.
On May24, 2018, the Company issued a press release announcing its entry into the Settlement Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 1.01 Financial Statements and Exhibits.
(d) Exhibit Index.
OMEROS CORP ExhibitEX-10.1 2 d573625dex101.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.
