Item 1.01
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Entry into a Material Definitive Agreement.
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License Agreement
On September 5, 2017, MEI Pharma, Inc. (the Company) entered into a License Agreement (the Agreement) with Presage Biosciences,
Inc. (Presage). Under the terms of the Agreement, Presage grants to the Company exclusive worldwide rights to develop, manufacture and commercialize Voruciclib, a clinical-stage, oral and selective cyclin-dependent kinase (CDK)
inhibitor, and related compounds. In exchange, the Company will pay Presage near-term payments of up to $2.9 million and additional potential payments of up to $181 million upon the achievement of certain development, regulatory and
commercial milestones. With respect to the first indication, an incremental $2.0 million payment, due upon dosing the first subject in the first registration trial will be owed to Presage, for total payments of $4.9 million up to receipt
of marketing approval of the first indication by the U.S., E.U. or Japan. The Company will also pay
mid-single-digit
tiered royalties on the net sales of any product successfully developed. As an alternative
to milestone and royalty payments related to countries in which the Company sublicenses product rights, the Company will pay to Presage a tiered percent (which decreases as product development progresses) of amounts received from such sublicensees.
The Agreement has a term commencing on the effective date and continuing, on a
country-by-country
basis, until the later of the date (i) of expiration of patents licensed by Presage to the Company in such country, or (ii) of expiration of
regulatory exclusivity in such country.
The Company will be solely responsible for the global commercialization of products and shall be solely
responsible for the costs related thereto.
The Company has the right to terminate the Agreement upon 90 days prior written notice. If at any time
following the second anniversary of the effective date, the Company has not taken certain actions towards the development of Voruciclib (other than for regulatory reasons or a need to manufacture clinical trial material) and there are no other
related products or compounds for which material development activities are being undertaken, or with respect to which material commercialization activities are being undertaken, by the Company for a period of at least 18 months, Presage may
terminate this Agreement upon written notice to the Company.
If either party materially breaches the Agreement, the
non-breaching
party may terminate the Agreement, if the breach is not cured within 60 days of receiving written notice of the breach.
If either party files or institutes bankruptcy, reorganization, liquidation or receivership proceedings, is the subject of involuntary bankruptcy proceedings,
or assigns a substantial portion of the assets for the benefit of creditors, the other party may terminate the Agreement, if such proceeding is not dismissed within 60 days of the filing. Presage may also terminate the Agreement in the event that
the Company challenges any of the licensed patents.
If the Agreement is terminated by the Company (other than as a result of an uncured material breach
of the Agreement by Presage), the parties have an obligation, at Presages election, to negotiate in good faith an agreement by which the Company would grant an exclusive worldwide license to the patents and know how developed by the Company in
connection with the development and commercialization of products and the Company shall transition the development of products to Presage and wind down any commercialization of products over a 12 month period. The Agreement also provides the Company
with certain rights in connection with a termination of the Agreement resulting from the bankruptcy, reorganization, liquidation or receivership of Presage, including a right of first refusal in connection with the proposed sale of Presages
rights and interest in products to a third party.
The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the
complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Companys Quarterly Report on Form
10-Q
for the quarter ended September 30, 2017.