Item 1.01.
|
Entry into a Material Definitive Agreement.
|
On October 12, 2016, Keryx Biopharmaceuticals, Inc.
(Keryx) and Patheon Manufacturing Services LLC and certain of its affiliates (collectively, Patheon) entered into a Master Manufacturing Services Agreement (the Master Agreement) and two related Product Agreements
(each a Product Agreement, and collectively with the Master Agreement, the Agreement) for Patheons manufacture of commercial supplies of Auryxia
®
(ferric citrate)
tablets at Patheons Greenville, North Carolina and Bourgoin-Jallieu Cedex, France manufacturing sites. Under the Agreement, Keryx is responsible for supplying the active pharmaceutical ingredient for Auryxia to Patheon. Patheon is responsible
for manufacturing the Auryxia tablets, conducting quality control, quality assurance, analytical testing and stability testing, packaging, and providing related services for the Auryxia tablets.
Pursuant to the Agreement, Keryx has agreed to order from Patheon at least a certain percentage of its annual commercial requirements for Auryxia tablets
in the United States and European Union each year for the term of the Agreement, which initial percentage is subject to reduction if Patheon fails to supply specified quantities of Auryxia tablets within specified timeframes.
The Agreement has an initial term ending December 31, 2021, and will automatically renew after the initial term for successive terms of two years each,
unless either party gives notice of its intention to terminate the Agreement within a specified time prior to the end of the then current term.
Keryx may
terminate a Product Agreement upon 30 days prior written notice if any governmental agency takes any action that prevents Keryx from researching, developing, importing, exporting, purchasing, selling or otherwise commercializing Auryxia. Further,
Keryx will give at least six months advance notice (or such shorter period if required pursuant to action taken by a governmental agency) if Keryx intends to no longer order manufacturing services for Auryxia due to discontinuance of Auryxia
in the market.
Either party may terminate the Master Agreement or a Product Agreement (a) upon written notice if the other party has failed to
remedy a material breach under the Master Agreement or a Product Agreement and in the case of curable breaches within 60 days following receipt of written notice of such breach, (b) immediately upon written notice to the other party in the
event that the other party is declared insolvent or bankrupt, a voluntary petition of bankruptcy is filed in any court by such other party or the Agreement is assigned by such other party for the benefit of creditors, and (c) upon six months
written notice if the other party assigns the Master Agreement or a Product Agreement to an assignee that, in the opinion of the non-assigning party acting reasonably, is: (i) not a credit worthy substitute for the other party; or (ii) a
competitor of the non-assigning party.
Patheon will have the option, at its sole discretion, to provide a 60 day notice to Keryx of Patheons
intention to terminate the Product Agreement if Keryx does not require Patheons manufacturing services for a specified time period.
The Agreement
contains certain representations, warranties, limitations of liabilities, confidentiality and indemnity obligations and other provisions customary for agreements of this type.
The foregoing description of the Master Agreement and each Product Agreement does not purport to be complete and is qualified in its entirety by the full text
of each agreement, copies of which Keryx expects to file as exhibits to Keryxs Annual Report on Form 10-K for the year ended December 31, 2016.