SECURITIES AND EXCHANGE COMMISSION
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|Item 1.01.|| |
Entry into a Material Definitive Agreement.
On December 30, 2020, Apellis Pharmaceuticals, Inc. (“Company”) entered into a commercial supply agreement (the “Supply Agreement”) with Bachem Americas, Inc. (“Bachem”) to supply Company with the drug substance for the finished dosage form of APL-2 (pegcetacoplan). The Supply Agreement is effective as of January 1, 2021.
Under the Supply Agreement, Company has agreed to purchase from Bachem a significant portion of its requirements for the drug substance during the term of the agreement, and to purchase all of its requirements for drug substance for commercial sale, subject to certain exceptions, for a period after the effective date of the agreement.
Unless earlier terminated, the initial term of the Supply Agreement continues for five (5) years (the “Initial Term”). Thereafter, the Supply Agreement will automatically renew for an additional two (2) year term. At least twenty-four (24) months prior to the end of the Initial Term, Bachem will notify Company in writing if it is willing to continue to manufacture and supply the drug substance following the end of the Initial Term. For a period of twelve (12) months after receipt of such notice, Company has the right to negotiate pricing terms that would apply during the renewal term, which upon agreement will be finalized in an amendment to the Supply Agreement. Company may terminate the Supply Agreement in the event any required license, permit or certificate of Bachem related to the manufacturing facility or the drug substance is not approved or issued (or is withdrawn) by the relevant governmental authority. Additionally, each party may terminate the Supply Agreement upon an uncured material breach of the Supply Agreement by the other party or upon the other party’s insolvency or bankruptcy.
The Supply Agreement also includes customary provisions relating to, among others, delivery, inspection procedures, warranties, quality, 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, which the Company intends to file with the Securities and Exchange Commission as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2020.
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.
|Apellis Pharmaceuticals, Inc.|
|Date: January 4, 2021||By:|
Chief Financial Officer