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UG > SEC Filings for UG > Form 8-K on 18-Nov-2013All Recent SEC Filings

Show all filings for UNITED GUARDIAN INC

Form 8-K for UNITED GUARDIAN INC


18-Nov-2013

Entry into a Material Definitive Agreement, Financial Statements and Exhibits


Item 1.01 Entry into a Material Definitive Agreement.

On November 12, 2013 the Registrant entered into a written manufacturing and supply agreement with Smiths Medical ASD, Inc. ("Smiths"), retroactive to November 1, 2013, pursuant to which Smiths would supply Registrant with a new single-dose form of one of the Registrant's pharmaceutical products, Renacidin® Irrigation. The agreement provides for the Registrant and Smiths to work together to develop the new product and provide sufficient data for the Registrant to file a supplement to its currently approved New Drug Application for Renacidin with the U.S. Food and Drug Administration. The approval would allow the Registrant to market Renacidin in a new single dose sterile 30mL vial that would be manufactured using blow-fill-seal packaging technology. Smith's obligations under the agreement are contingent upon the Registrant obtaining FDA approval to market the new product by March 31, 2015. The Registrant expects to file the application in the first half of 2014.



Item 9.01 - Financial Statements and Exhibits

(d) Exhibits. The following exhibits are filed with this report:

Exhibit Description

Number
10.1    Manufacturing and Supply Agreement between the Registrant and Smiths
        Medical ASD, Inc. signed November 12, 2013 and effective as of November
        1, 2013.


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