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.
Item 7.01 Regulation FD Disclosure.
On May 1, 2023, the Company issued a press release entitled "VYNE Therapeutics
Announces Selection of Development Candidate VYN202, a Potential
Best-in-Class Oral Small Molecule BD2-Selective BET Inhibitor for the Treatment
of Immuno-Inflammatory Conditions." A copy of the press release is attached
hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of
this Current Report on Form 8-K.
The information in Item 7.01 of this Form 8-K and Exhibit 99.1 attached hereto
shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to
the liabilities of that Section, or incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act, except as
shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is being furnished herewith.
Exhibit No. Description
99.1 Press Release dated May 1, 2023.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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