Item 1.01
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Entry into a Material Definitive Agreement
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Effective as of May 30, 2018, Myovant
Sciences GmbH (MSG), a wholly owned subsidiary of Myovant Sciences Ltd. (the Company), entered into a Commercial Manufacturing and Supply Agreement (the Supply Agreement) with Takeda Pharmaceutical Company
Limited (Takeda) regarding relugolix. Takeda Pharmaceuticals International AG (TPIZ) and the Company are parties to that certain License Agreement, dated April 29, 2016 (License Agreement), pursuant to which
TPIZ granted to the Company an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by TPIZ to develop and commercialize relugolix, and products containing relugolix, for all human diseases and
conditions. The territory for the Companys exclusive license for relugolix covers all countries worldwide, except that TPIZ retains exclusive rights to Japan, China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan,
Thailand, and Vietnam (including, in each case, the territories and possessions of each of the foregoing) (collectively, the Takeda Territory).
Pursuant to the Supply Agreement, Takeda has agreed to supply to MSG and MSG has agreed to obtain from Takeda certain quantities of relugolix
drug substance according to agreed-upon quality specifications and in order to commercialize relugolix in accordance with the License Agreement. MSG may use, sell or otherwise transfer to any third party the drug substance supplied under the Supply
Agreement, or any drug product that incorporates such drug substance, to manufacture, develop or commercialize relugolix as authorized under the License Agreement. Under the Supply Agreement, MSG will pay Takeda a fixed price per kilogram of
relugolix drug substance through December 31, 2019, and MSG has made and Takeda has accepted, an initial firm order to supply relugolix drug substance to MSG through December 31, 2019. For drug substance manufactured or delivered on
or after such date, MSG will pay Takeda a price per kilogram of relugolix drug substance to be agreed upon between the parties at the beginning of each fiscal year.
In addition, under the Supply Agreement, Takeda has agreed to assist with the transfer of technology and Takeda manufacturing
know-how
to MSGs second contract manufacturing organization (CMO) to enable the manufacture of drug substance up until the successful completion of the applicable process validation protocol for
such CMO to MSGs reasonable satisfaction, including without limitation all inventions and other improvements to the manufacture of drug substance discovered or developed in connection with the Supply Agreement. Myovant has agreed to reimburse
Takeda for all internal costs, and external costs, charges, and expenses, in each case, reasonably incurred by Takeda in connection with any technology transfer services.
The initial term of the Supply Agreement began on May 30, 2018 and will continue for five years. At the end of the initial term, the
Supply Agreement automatically renews for successive
one-year
terms, unless either party gives notice of termination to the other at least 12 months prior to the end of the then-current term. The Supply
Agreement may be terminated by either party upon 90 days notice of an uncured material breach of its terms by the other party, or immediately upon notice to the other party of a partys bankruptcy. Each party will also have the right to
terminate the Supply Agreement, in whole or in part, for any reason upon 180 days prior written notice to the other party, provided that any then-open purchase orders, including the initial firm order for relugolix drug substance through
December 31, 2019, will remain in effect and be binding on both parties. The Supply Agreement, including any then-open purchase order thereunder, will terminate immediately upon the termination of the License Agreement in accordance with its
terms.
The Supply Agreement also includes customary provisions relating to, among others, delivery, inspection procedures, warranties,
quality management, storage, handling and transport, intellectual property, confidentiality and indemnification. The foregoing description of the Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the
Supply Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on
Form 10-Q
for the quarter ending June 30, 2018.