Item 1.01    Entry Into a Material Definitive Agreement.

On July 28, 2019, Omeros Corporation (“Omeros”) entered into a Master Services Agreement (the “Agreement”) with Lonza Biologics Tuas Pte. Ltd. (“Lonza”) for the commercial production of narsoplimab, also referred to as OMS721, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). The Agreement also provides for certain regulatory support and related services to be provided by Lonza from time to time. 

Omeros and Lonza Sales AG previously entered into a Master Services Agreement, dated October 1, 2015, as amended, pursuant to which Lonza Sales AG provided certain development services and manufactured clinical supplies of narsoplimab for Omeros. The new Agreement provides for the production by Lonza of commercial quantities of narsoplimab in accordance with agreed specifications for use following regulatory marketing approvals. 

Omeros is preparing a biologics license application and a marketing authorization application for submission to the U.S. Food and Drug Administration and to the European Medicines Agency, respectively, for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros also has ongoing Phase 3 clinical programs for narsoplimab in immunoglobulin A (IgA) nephropathy and in atypical hemolytic uremic syndrome (aHUS).

Under the Agreement Lonza will manufacture narsoplimab pursuant to purchase orders issued in accordance with forecasts provided by Omeros. Omeros will purchase narsoplimab that meets agreed specifications in batches, with the price per batch varying according to the total number of batches ordered for serial production in a single manufacturing campaign. Omeros is obligated to purchase a minimum number of batches annually beginning on a specified anniversary of the first commercial sale of narsoplimab in either the United States or European Union. Omeros may be obligated to pay certain fees to Lonza upon cancellation of purchase orders.

The initial term of the Agreement expires five years after the first commercial sale of narsoplimab in either the United States or European Union, subject to automatic renewal for an additional four-year term unless Omeros provides notice of non-renewal at least three years prior to the end of the initial term. Either party may terminate the Agreement, subject to applicable notice and cure periods, (i) if regulatory marketing approval for narsoplimab cannot be obtained in either the United States or European Union, (ii) if narsoplimab is withdrawn from both the United States and European Union markets following regulatory marketing approval, (iii) for material breach of the Agreement by the other party or (iv) due to the other party’s bankruptcy, insolvency, or dissolution.

The Agreement also includes customary provisions relating to, among others, insurance and indemnification, delivery and acceptance procedures, intellectual property, warranties, and confidentiality.

The foregoing description of the Agreement is only a summary of its material terms and does not purport to be complete. A copy of the Agreement will be filed as an exhibit to Omeros’ Quarterly Report on Form 10-Q for the quarter ending September 30, 2019. Pursuant to Item 601(b)(10)(iv) of Regulation S-K, Omeros intends to redact from the filed copy of the Agreement certain information that is both (i) not material and (ii) would be competitively harmful if publicly disclosed .