Item 1.01
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Entry Into a Material Definitive Agreement.
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On May 10, 2019 (the Effective Date), Aimmune Therapeutics, Inc. (the Company) entered into a Commercial Supply Agreement (the
Commercial Supply Agreement), pursuant to which CoreRx, Inc. (CoreRx) agreed to manufacture commercial supply of AR101, if approved.
Under the Commercial Supply Agreement, CoreRx will manufacture the commercial supply of AR101 in bulk capsule and sachet dosage forms according to agreed-upon
specifications in sufficient quantities to meet the Companys projected supply requirements in the United States and Canada. In particular, Aimmune is required to purchase a minimum percentage of its AR101 commercial supply requirements in each
of the first six years of the Commercial Supply Agreement, subject to certain conditions and restrictions, ranging from 100% in 2019 and decreasing to a majority in 2024. Aimmune is also required to purchase a minimum percentage of its AR101 supply
requirements for release testing in each of the first six years of the Commercial Supply Agreement, ranging from 100% in 2019 and decreasing to a significant majority in 2024. CoreRx will manufacture commercial supplies of AR101 at unit prices that
decrease with an increase in the quantity ordered. Aimmune is responsible for providing, at its expense, supplies of food-grade peanut flour to be used in manufacturing AR101.
The initial term of the Commercial Supply Agreement began on the Effective Date and will continue until December 31, 2024. The Commercial Supply
Agreement then automatically renews for successive
two-year
terms, unless earlier terminated pursuant to its terms, or upon either partys notice of termination to the other. The Supply Agreement may be
terminated by either party upon an uncured material breach of its terms by the other party, or due to the other partys bankruptcy, insolvency, or dissolution. The Company may terminate the Commercial Supply Agreement upon the occurrence of
certain events.
The Commercial Supply Agreement also includes customary provisions relating to, among others, delivery, inspection procedures,
warranties, quality management, regulatory and other approvals, intellectual property rights, indemnification, and confidentiality.
The foregoing
description of the material terms of the Commercial Supply Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Agreement, which will be filed as an exhibit to the Companys
Quarterly Report on Form
10-Q
for the quarter ending June 30, 2019 and is incorporated by reference herein. Portions of the Commercial Supply Agreement may be subject to a FOIA Confidential Treatment
Request to the SEC pursuant to Rule
24b-2
under the Exchange Act.