Item 1.01
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Entry into a Material Definitive Agreement.
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License, Development and Commercialization Agreement
On October 31, 2018, MEI Pharma, Inc. (the Company) entered into a License, Development and Commercialization Agreement (the
Agreement) with Kyowa Hakko Kirin Co., Ltd (KHK). Pursuant to the terms of the Agreement, the Company and KHK have agreed to collaborate on the development, manufacturing and commercialization of
ME-401
in Japan (the Collaboration).
The Agreement has a term (the Term)
commencing on the effective date and continuing until the later of the date (i) of expiration of the applicable patents in Japan, (ii) of expiration of regulatory exclusivity in Japan or (iii) that is 10 years after the first
commercial sale in Japan.
During the Term, the Company grants to KHK an exclusive (subject to certain retained rights to perform
obligations under the Agreement), sublicenseable, payment-bearing, license under and to certain patents and
know-how
controlled by the Company to develop and commercialize
ME-401
and any pharmaceutical product containing
ME-401
for all human indications in Japan. KHK will be primarily responsible for the development of
ME-401
in Japan and, subject to certain exceptions, will be solely responsible for all costs related thereto. The Company will be primarily responsible for the development of
ME-401
outside Japan and will be solely responsible for all costs related thereto. The Company will also provide to KHK certain drug supplies necessary for the development of
ME-401
and, upon commercialization, for the manufacturing of
ME-401
pursuant to supply agreements to be entered into on customary terms, subject to KHKs option to
assume responsibility for manufacturing in certain circumstances.
Under the terms of the Agreement, KHK will pay the Company an initial
payment of $10 million within 30 days after the date of the Agreement, or within 30 days after the receipt of relevant tax forms from the Company. The Company may earn up to approximately $87.5 million in potential development and sales
milestone payments, plus royalties on net sales of
ME-401
in Japan, which are tiered and in the
mid-teens.
The Collaboration will be managed by a joint steering committee in which both parties are represented equally, which will serve as a forum for
the sharing of information and facilitating communications between the parties regarding development activities and commercialization.
Under the Agreement, each party will maintain ownership of its own technology and intellectual property existing prior to, or outside of, the
Collaboration, each party will be the exclusive owner of any and all inventions it solely develops with regard to
ME-401,
and the parties shall jointly own any and all inventions developed by the parties
jointly with regard to
ME-401.
KHK will grant to the Company a
non-exclusive,
sublicenseable, royalty-free, fully paid, perpetual license under KHKs applicable
technology as necessary for the Company to develop and commercialize
ME-401.
KHK has the right to
terminate the Agreement for convenience upon 180 days prior written notice. If either party materially breaches the Agreement, the
non-breaching
party may terminate the Agreement, if the breach is not
cured within 90 days (30 days in the event of payment-related breach) of receiving written notice of the breach. If either party files or institutes bankruptcy, reorganization, liquidation or receivership proceedings, or assigns a substantial
portion of the assets for the benefit of creditors, the other party may terminate the Agreement, provided, that, if such proceeding is involuntary, the other party may terminate the Agreement only if such proceeding is not dismissed within 90 days
of the filing. The Company may also terminate the Agreement in the event that KHK challenges any of the licensed patents. The Agreement shall also automatically terminate if KHK fails to make the upfront payment and is terminable by the Company if
KHK fails to comply with certain data privacy and security obligations. Each party may terminate the Agreement in connection with an event of force majeure under certain circumstances.