UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT PURSUANT TO
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SECURITIES EXCHANGE ACT OF 1934
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Item 1.01 – Entry into a Material Definitive Agreement.
On April 18, 2023, Amicus Therapeutics, Inc. (“Amicus”) entered into a Supply and Manufacturing Services Agreement (the “WuXi Agreement”) with WuXi Biologics (Hong Kong) Limited, WuXi Biologics Ireland Limited and WuXi Biologics Germany GmbH (collectively, “WuXi”).
Pursuant to the terms of the WuXi Agreement, WuXi has agreed to manufacture and supply to Amicus, and Amicus has agreed to purchase from WuXi, both the active pharmaceutical ingredient (“API”) in ATB200 and the finished enzyme replacement drug product, consisting of the API formulated as a finished dosage form according to certain specifications (the “Drug Product”). The WuXi Agreement provides for pricing of the API and the Drug Product on a per batch and per vial basis, subject to a rolling 18-month forecast and 9-month forecast, respectively. Amicus has also agreed to reserve an additional manufacturing suite from WuXi to ensure appropriate capacity to meet ATB200 projections. Furthermore, the WuXi Agreement permits Amicus to obtain API and Drug Product at certain WuXi facilities outside of China.
The WuXi Agreement has an initial term of five years from the effective date of the agreement, followed by successive two-year automatic renewal periods. Amicus may terminate the WuXi Agreement upon twelve (12) months written notice prior to any renewal period or by written notice in the event of certain adverse regulatory developments, quality failures or supply failures (each being defined in the agreement). Either party may also terminate the WuXi Agreement for customary reasons, such as material breaches or bankruptcy.
The WuXi Agreement contains provisions relating to compliance by WuXi with current Good Manufacturing Practices (known as “cGMP”), cooperation with Amicus for regulatory purposes, indemnification, confidentiality, dispute resolution and other items customary for an agreement of this kind.
Amicus plans to file the WuXi agreement as an exhibit to its quarterly report on Form 10-Q for the quarter ending June 30, 2023, with confidential portions redacted. The foregoing description is qualified in its entirety by reference to the complete text of the WuXi Agreement when filed.
Signature Page
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AMICUS THERAPEUTICS, INC. | ||
Date: April 24, 2023 | By: | /s/ Ellen S. Rosenberg |
Name: Ellen S. Rosenberg | ||
Title: Chief Legal Officer and Corporate Secretary |