UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01. | Entry into a Material Definitive Agreement. |
On March 30, 2023, United-Guardian, Inc. (the “Company”) entered into a manufacturing and supply agreement with Amsino Healthcare (USA), Inc. (“Amsino”), the successor in interest to Smiths Medical, effective as of January 1, 2023 (the “Agreement”). This Agreement, modeled after a previously executed manufacturing and supply agreement with Smiths Medical, provides the framework in which Amsino would manufacture and supply the Company with its pharmaceutical product, Renacidin® Irrigation.
The Agreement provides for an initial term of six years from the effective date, with the option to automatically renew for two successive two-year periods following the conclusion of the initial term, unless earlier terminated pursuant to the Agreement. The Agreement also contains customary representations, warranties, and covenants on behalf of the Company and Amsino, including those relating to regulatory and licensure requirements, quality control, product and facility inspections, recall and adverse reaction procedures, indemnification, and confidentiality.
The forgoing summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is being filed as Exhibit 10.2 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number | Description | |
| 10.2*† | Manufacturing and Supply Agreement between the Company and Amsino Healthcare (USA), effective as of January 1, 2023 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |
* Filed herewith.
† Certain exhibits and schedules to the Agreement have been omitted pursuant to Item 601 of Regulation S-K. The registrant will furnish copies of any of the exhibits and schedules to the Securities and Exchange Commission upon request.
SIGNATURES
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.
| UNITED-GUARDIAN, INC. | ||
| By: | /s/ Donna Vigilante | |
| Name: | Donna Vigilante | |
| Title: | President | |
Date: March 1, 2024