Item 1.01.
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Entry into a Material Definitive Agreement.
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On October 24, 2018, Keryx Biopharmaceuticals, Inc., a Delaware corporation (Keryx), entered into a letter agreement with Panion & BF
Biotech, Inc. (Panion) and Akebia Therapeutics, Inc. (Akebia) (the Letter Agreement) in connection with the Amended and Restated License Agreement between Keryx and Panion, dated March 17, 2008 as amended
(the License Agreement), under which Keryx licenses certain intellectual property rights covering Auryxia
®
from Panion. Pursuant to the Letter Agreement, Panion agreed to rescind
any and all prior termination threats or notices relating to the License Agreement and waived its rights to terminate the License Agreement based on any breach by Keryx of its obligation to use commercially reasonable efforts to commercialize
Auryxia
®
outside the United States until the parties execute an amendment to the License Agreement, in accordance with the terms of the Letter Agreement, following consummation of the proposed
business combination of Keryx and Akebia. These terms include establishing a joint steering committee consisting of Panion and Akebia representatives to oversee the development and commercialization of Fexeric
®
in Europe and providing Panion with an exclusive license under Keryx-owned patents covering the rights to make, use, sell, offer for sale and import ferric citrate in certain countries in the
Asia-Pacific region. The parties will agree on a regulatory plan for Fexeric
®
in Europe within four months after execution of the Letter Agreement. The parties will also agree on a
commercialization plan for Fexeric
®
in Europe following execution of the amendment. The amendment to the License Agreement will include alternatives in the event a commercialization plan is
not agreed upon, such as payment of an annual license maintenance fee to Panion or the return of European intellectual property rights to Panion. In addition, Panion has agreed that Keryx will have the right, but not the obligation, to conduct any
litigation against any infringer of patent rights under the License Agreement on the terms agreed upon in the Letter Agreement. In the event the proposed business combination of Keryx and Akebia is not consummated, Keryx and Panion are obligated to
fulfill the terms of the Letter Agreement, including negotiating in good faith an amendment to the License Agreement. Keryx also agreed to make a $500,000 payment to Panion promptly after execution of the Letter Agreement.
The foregoing description of the Letter Agreement does not purport to be complete and is qualified in its entirety by the full text of the Letter Agreement, a
copy of which is expected to be filed as an exhibit to a subsequent filing with the U.S. Securities and Exchange Commission (the SEC).
Merger Update
In addition to entering into the Letter
Agreement discussed above in Item 1.01, Keryx and Akebia are filing an amendment with the SEC to their joint proxy statement/prospectus regarding their previously disclosed business combination through the merger of Alpha Therapeutics Merger
Sub Inc., a Delaware corporation and wholly-owned subsidiary of Akebia (Merger Sub), with and into Keryx, with Keryx continuing after such merger as a wholly-owned subsidiary of Akebia (the Merger) pursuant to the Agreement
and Plan of Merger, dated June 28, 2018, by and between Keryx, Akebia and Merger Sub, as amended, which contains important information about the proposed Merger and the two companies.
Additional Information and Where to Find It
In
connection with the proposed Merger, Akebia and Keryx plan to file with the SEC and mail or otherwise provide to their respective stockholders a joint proxy statement/prospectus regarding the proposed transaction. BEFORE MAKING ANY VOTING DECISION,
AKEBIAS AND KERYXS RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF AKEBIA AND KERYX WITH THE SEC IN CONNECTION WITH THE
PROPOSED MERGER OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and stockholders will be able to obtain a free copy of the
joint proxy statement/prospectus and other documents containing important information about Akebia and Keryx, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Akebia and Keryx make available free
of charge at www.akebia.com and www.keryx.com, respectively (in the Investors section), copies of materials they file with, or furnish to, the SEC.
Participants in the Merger Solicitation
This document
does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. Akebia, Keryx and their respective directors, executive officers and certain employees and other persons may be deemed to be
participants in the solicitation of proxies from the stockholders of Akebia and Keryx in connection with the proposed merger. Security holders may obtain information regarding the names, affiliations and interests of Akebias directors and
officers in Akebias Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the SEC on March 12, 2018, and its definitive proxy statement for the 2018 annual meeting of stockholders, which was
filed with the SEC on April 30, 2018. Security holders may obtain information regarding the names, affiliations and interests of Keryxs directors and officers in Keryxs Annual Report on Form 10-K for the fiscal year ended
December 31, 2017, which was filed with the SEC on February 21, 2018, and the Amendment No. 1 on Form 10-K/A, which was filed with the SEC on April 30, 2018, and its definitive proxy statement for the 2018 annual meeting of
stockholders, which was filed with the SEC on May 31, 2018. To the extent the holdings of Akebia securities by Akebias directors and executive officers or the holdings of Keryx securities by Keryxs directors and executive officers
have changed since the amounts set forth in Akebias or Keryxs