On April 22, 2024, Delcath Systems, Inc. ("Delcath") entered into a Fifth Amendment, effective May 1, 2024 (the "Amendment"), to the License, Supply and Contract Manufacturing Agreement with Synerx Pharma, LLC and Mylan Teoranta, dated October 13, 2010 (as subsequently amended, the "Agreement"), for Delcath's supply of melphalan hydrochloride (the "Product"). The Amendment (i) extends the term of the Agreement to December 31, 2028; (ii) requires Delcath to place purchase orders for the Product at least 210 days before the delivery date; (iii) modifies the price per vial for the Product; and (iv) provides for certain annual price increases for the Product equivalent to the percent increase of the published producer price index for pharmaceutical preparation and manufacturing measured per calendar year.
The foregoing description of the Amendment is not complete and is qualified in its entirety by the full text of the Amendment, a copy of which will be filed as an exhibit to the Company's Quarterly Report on Form 10-Qfor the quarter ending June 30, 2024.
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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATO KIT is a drug/device combination product designed to administer high-dose chemotherapy directly into the liver while limiting systemic exposure and associated side effects. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO KIT, but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).
DELCATH SYSTEMS, INC. 
