UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 1.01. | Entry into a Material Definitive Agreement. |
As previously disclosed, on December 11, 2017, Keryx Biopharmaceuticals, Inc. (“Keryx”), which became a wholly owned subsidiary of Akebia Therapeutics, Inc. (the “Company”) on December 12, 2018, entered into a Product Manufacture and Supply and Facility Construction Agreement with BioVectra Inc. (“BioVectra”), which was amended on April 20, 2018 (the “Original Agreement”). Pursuant to the Original Agreement, BioVectra has constructed a new facility for the manufacture and supply of Auryxia® (ferric citrate) drug substance (the “New Facility”), and Keryx has reimbursed BioVectra for certain New Facility construction costs. On September 4, 2020, consistent with the Company’s previously disclosed plans to lower the cost of goods sold for Auryxia, BioVectra and Keryx entered into an Amended and Restated Product Manufacture and Supply and Facility Construction Agreement (the “Amended and Restated Agreement”).
Pursuant to the Amended and Restated Agreement, Keryx is obligated to reimburse BioVectra for certain New Facility construction costs and to purchase minimum quantities of Auryxia drug substance that are lower than the minimum quantities under the Original Agreement, for a total cost of approximately $81.4 million through the end of the Term (as defined below), which amount may decrease upon the occurrence of certain conditions. This dollar amount is substantially lower than the dollar amount of the contractual obligation under the Original Agreement.
The term of the Amended and Restated Agreement began September 4, 2020 and ends December 31, 2026 (the “Term”), after which it automatically renews for successive one-year terms unless either party gives notice of its intention to terminate within a specified time prior to the end of the then-current term. Each party has the ability to terminate earlier upon the occurrence of certain conditions.
The Amended and Restated Agreement includes customary indemnification, intellectual property, confidentiality, remedies, and warranty terms, as well as certain quality requirements and other provisions.
The foregoing description of the Amended and Restated Agreement does not purport to be complete and is qualified in its entirety by reference to the Amended and Restated Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit |
Description | |
| 10.1# | Amended and Restated Product Manufacture and Supply and Facility Construction Agreement between BioVectra, Inc. and Keryx Biopharmaceuticals, Inc., dated September 4, 2020. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
| # | Indicates portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K |
SIGNATURES
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.
| AKEBIA THERAPEUTICS, INC. | ||||||
| Date: September 11, 2020 | By: | /s/ John P. Butler | ||||
| Name: | John P. Butler | |||||
| Title: | President and Chief Executive Officer | |||||