MNLO Menlo Therapeutics Inc

Item 1.01 Entry into a Material Definitive Agreement.

On April 28, 2023, VYNE Therapeutics Inc. (the “Company”) and Tay Therapeutics Limited (formerly known as In4Derm Limited, “Tay”) entered into a License Agreement (the “License Agreement”) granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of Tay’s BD2-selective bromodomain and extra-terminal domain (“BET”) inhibitors in all fields. The parties entered into the License Agreement following the Company’s exercise of its exclusive option under the Evaluation and Option Agreement, dated as of April 30, 2021. The Company made a $3.75 million cash payment to Tay in connection with the exercise of its option.

Pursuant to the terms of the License Agreement, the Company has the sole responsibility for development, regulatory, marketing and commercialization activities to be conducted for the licensed products at the sole cost and discretion of the Company, and shall use commercially reasonable efforts to develop and, if approved, commercialize such products. VYNE may sublicense its rights to a third party without Tay’s consent. Pursuant to the License Agreement, a joint development committee consisting of one representative from each party reviews the progress of the development plan for the licensed products. The Company has agreed to make cash payments of up to an aggregate of $43.75 million upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed product in the U.S. for all indications. Tay is entitled to additional milestones upon the achievement of regulatory approvals in certain jurisdictions outside the U.S. up to an aggregate of $25.0 million for all indications. In addition, with respect to any products the Company commercializes under the License Agreement, the Company will pay tiered royalties to Tay on net sales of such licensed products by the Company, its affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales bands subject to specified reductions. The Company is obligated to pay royalties until the later of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis. The Company may terminate the License Agreement in its entirety, or on a product-by-product and country-by-country basis, for any reason or no reason upon 90 days’ notice. In addition, the License Agreement contains representations and warranties customary for this type of agreement.

The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the License Agreement, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2023.