UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
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-Q for the quarter ending June 30, 2024.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Date: April 26, 2024 | By: | /s/ Gerard Michel | ||||
| Name: | Gerard Michel | |||||
| Title: | Chief Executive Officer | |||||