UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company
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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 | |||||
Document and Entity Information |
Apr. 22, 2024 |
|---|---|
| Cover [Abstract] | |
| Security Exchange Name | NASDAQ |
| Amendment Flag | false |
| Entity Central Index Key | 0000872912 |
| Document Type | 8-K |
| Document Period End Date | Apr. 22, 2024 |
| Entity Registrant Name | DELCATH SYSTEMS, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-16133 |
| Entity Tax Identification Number | 06-1245881 |
| Entity Address, Address Line One | 566 Queensbury Avenue |
| Entity Address, City or Town | Queensbury |
| Entity Address, State or Province | NY |
| Entity Address, Postal Zip Code | 12804 |
| City Area Code | (212) |
| Local Phone Number | 489-2100 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, $0.01 par value |
| Trading Symbol | DCTH |
| Entity Emerging Growth Company | false |