On January 16, 2024, UroGen Pharma Ltd. entered into a license and supply agreement with Medac Gesellschaft für klinische Spezialpräparate m.b.H. (medac), pursuant to which medac granted to the Company an exclusive, worldwide, royalty-free, sublicensable license under medac?s intellectual property rights to develop, commercialize, import, export, use, distribute and register the pharmaceutical lyophilized product?a specific 80 mg formulation of mitomycin and 640 mg urea, manufactured according to medac?s proprietary lyophilization process (the Product)?as an integrated part of a pharmaceutical product that includes the Product and a reverse thermal gel, including the Company?s RTGel® reverse thermal hydrogels (the Combined Product). The Product was developed pursuant to a Development Agreement between the Company and medac dated August 18, 2019, as amended. Pursuant to the Agreement, medac has agreed to manufacture and supply the Company?s requirements for Product for commercial use at an agreed upon price, which may be renegotiated on an annual basis upon request of one of the parties.

The Company is responsible for development, commercialization, and regulatory approval activities, and medac agreed to use commercially reasonable efforts to provide reasonable and timely assistance for information and documents regarding the Product for use in obtaining and maintaining regulatory approvals. Pursuant to the Agreement, the Company retains the unlimited right to source from a party other than medac any lyophilized mitomycin for use in any Company product, including Jelmyto® (mitomycin) for pyelocalyceal solution and UGN-102, that: a) includes mannitol as an excipient; and b) is not manufactured according to the medac patents listed in the Agreement. Unless earlier terminated in accordance with the terms of the Agreement, the Agreement (a) will remain in effect for the United States until the expiration of the last to expire licensed patent; and (b) will remain in effect for countries other than the United States, for 10 years after the date of the Agreement, automatically renewing for successive two year terms unless the Company or medac provides written notice to the other at least 180 days in advance of the end of the then existing term that it does not wish to renew the term of the Agreement for such country.

medac has the right to terminate the Agreement if the Company does not progress development or suspends commercialization of a Combined Product in accordance with the terms of the Agreement or if a Combined Product is not approved in the United States by June 30, 2029. If a marketing authorization of the Combined Product is not approved in a country in the territory or such approval is withdrawn or cancelled in such country, medac has the right to terminate the Agreement with respect to such country upon 60 days? advance notice to the Company.

If the Company suspends commercialization of a Combined Product in any country and fails to resume commercialization 18 months following delivery to medac of a written plan of action to resume commercialization, medac may terminate the Agreement with respect to such country upon 30 days? advance notice to the Company. Furthermore, either party may terminate the License Agreement in the event of an uncured material breach of the other party.