Benzinga | Jun 21, 2021 05:22PM EDT

Moleculin Biotech 8-K Shows Co. Entered Amendment To Patent, Technology License Deal With University Of Texas

On June 15, 2021, Moleculin Biotech, Inc. (the "Company") entered into an amendment no. 4 (the "Amendment 4") to the Patent and Technology License Agreement dated April 2, 2012 entered into by and between the Company and The Board of Regents (the "Board") of The University of Texas System on behalf of The University of Texas M. D. Anderson Cancer Center ("UTMDACC"), as previously amended on October 19, 2015 ("Amendment 1"); November 1, 2018 ("Amendment 2"); and May 20, 2020 ("Amendment 3" and collectively with the prior amendments, the "WP122 Agreement"). Pursuant to the WP1122 Agreement, the Company obtained a royalty-bearing, worldwide, exclusive license to intellectual property, including patent rights, related to its WP1122 portfolio and to the drug product candidate, WP1122. In consideration, the Company must make payments to UTMDACC including an up-front payment, license documentation fee, annual maintenance fee, milestone payments and minimum annual royalty payments for sales of products developed under the WP1122 Agreement.



Pursuant to the WP1122 Agreement, the Board and UTMDACC have the right to terminate the WP1122 Agreement if the Company does not, within certain time periods: (i) file an Investigational New Drug Application with the FDA for a Phase I Study for a licensed product ("IND filing requirement"); (ii) commence a Phase I Study for a licensed product ("Phase I study requirement"); and (iii) commence a Phase II Study for a licensed product ("Phase II study requirement"). Pursuant to the WP1122 Agreement, the Company is required to meet the IND filing requirement within nine months of the date of the Amendment 3, the Phase I study requirement within 2.5 years of the date of the Amendment 3, and the Phase II study requirement within 4.5 years of the date of the Amendment 3; provided the Company has the right to extend such time periods for up to an additional 18 months by the payment of three six-month extension payments to UTMDACC. As disclosed in the Company's Form 10-K for the year ended December 31, 2020, in February 2021, the Company extended the periods by six months by payment of the first extension fee.



The Amendment modifies the IND filing requirement by providing that the Company can satisfy the requirement by filing the equivalent of an Investigational New Drug Application for a Phase I Study for a licensed product in the United Kingdom, India, Australia or Brazil prior to August 20, 2021. If the Company fails to meet this requirement prior to August 20. 2021, it will required to pay the second extension fee in order to maintain the agreement.