Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the Company, if publicly disclosed. Double asterisks denote omissions.
AMENDED AND RESTATED
PRODUCT MANUFACTURE AND SUPPLY AND FACILITY CONSTRUCTION AGREEMENT
KERYX BIOPHARMACEUTICALS, INC.
This amended and restated Product Manufacture and Supply and Facility Construction Agreement (this Amended Agreement) is made and entered into on September 4, 2020 (Amendment Effective Date) by and between BioVectra Inc., with its registered offices at 11 Aviation Avenue, Charlottetown, PEI, C1E 0A1, Canada (BioVectra) and Keryx Biopharmaceuticals, Inc., a wholly owned subsidiary of Akebia Therapeutics, Inc., with its offices at 245 First Street, Cambridge, Massachusetts 02142, USA (Keryx) (each hereafter a Party, and together, Parties).
WHEREAS, BioVectra has the capability to Manufacture, and in the past has Manufactured GMP-grade quantities of Keryxs proprietary active pharmaceutical ingredient, ferric citrate, at BioVectras API Facility, pursuant to the Manufacture and Supply Agreement (as defined herein below);
WHEREAS, Keryx desires to purchase certain quantities of Product (as defined herein below) from BioVectra over a defined period of time and BioVectra is willing to construct a facility for the Manufacture of Product and to supply Product to Keryx on the terms and conditions provided herein;
WHEREAS, effective December 11, 2017 (the Effective Date), BioVectra and Keryx entered into a Product Manufacture and Supply and Facility Construction Agreement, as amended by Amendment No. 1 to Product Manufacture and Supply and Facility Construction Agreement, dated April 20, 2018 (Original Agreement); and
WHEREAS, the Parties now desire to amend and restate the Original Agreement by entering into this Amended Agreement (the Original Agreement, as amended and restated by this Amended Agreement, the Agreement).
NOW THEREFORE, in consideration of the mutual covenants hereafter set forth, the Parties hereto mutually agree as follows:
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Definitions. Unless this Agreement expressly provides to the contrary, the following terms, whether used in the singular or plural, have the respective meanings set forth below