CONFIDENTIAL TREATMENT REQUESTED .  Confidential portions of this document have
been redacted and have been separately filed with the Commission.
EXHIBIT 10.16

*****Confidential material redacted and filed separately with the Commission.

 
FIRST AMENDMENT TO
AMENDED & RESTATED LICENSE AGREEMENT
 
THE AMENDED & RESTATED LICENSE AGREEMENT, dated March 17, 2008, by and between
Panion & BF Biotech, Inc. and Keryx Biopharmaceuticals, Inc. is amended with
effect from the 14th day of November, 2008 (the "Effective Date") by amending
Section 7.7 to read as follows:
 
7.7           Production of Clinical Supplies of the Compound.
 
(a)            Licensor grants Licensee and its Sublicensees the exclusive
right, without any restrictions, to manufacture (and have manufactured) the
active pharmaceutical ingredient for purposes of developing and supplying the
same solely in the Territory, provided that Licensee and its Sublicensees shall
bear all costs associated with such production. For the period commencing on the
Effective Date of this Amendment and continuing for ***** following Registration
in the United States (the "Supply Period"), Licensee and its Sublicensees shall
pay to Licensor, in accordance with Article 6 and other applicable provisions of
this agreement, if any, a fee (the "Manufacturing Fee") equal to ***** of the
manufacturing and procurement cost of all batches of active pharmaceutical
ingredient that are manufactured by Licensee and its Sublicensees. For the
avoidance of doubt, the Manufacturing Fee shall be payable to Licensor only once
in respect of each batch of active pharmaceutical ingredient manufactured during
the Supply Period. During the Supply Period, Licensee shall provide to Licensor
all invoices for manufacture of active pharmaceutical ingredient at the same
time that Licensee provides its quarterly Progress Reports and Licensor shall
have inspection rights for those records in accordance with Article 6 and other
applicable provisions of this agreement, if any. Licensee agrees that the patent
rights licensed by Licensor to Licensee related to the active pharmaceutical
ingredient manufacturing technology are the sole proprietary property of
Licensor.
 
(b)           It shall be the responsibility of Licensee and its Sublicensees to
ensure that the quality of Clinical Supplies of the Compound in the Territory is
in compliance with the standards of the applicable Regulatory Authority.
 

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*****Confidential material redacted and filed separately with the Commission.
 
 
(c)           In the event that either party elects to procure Clinical Supplies
from the other during the Supply Period, in consideration for such clinical
supplies, the supplies shall be transferred at ***** over manufacturing and
procurement cost and the Manufacturing Fee shall not apply to such supplies.
 
(d)            For the avoidance of doubt, restrictions on sublicensing rights
contained in the Amended & Restated License Agreement (e.g. under Section 3.2)
shall continue to apply. All restrictions (other than the Manufacturing Fee and
fees in respect of sublicensing rights) on the ability of Licensee to develop,
have developed, manufacture or have manufactured the Compound for itself and its
Sublicensees are hereby eliminated.
 
IN WITNESS HEREOF, the parties have executed this Amendment as of the Effective
Date.
 
 

            By:
  
  By:
 
   
Michael S. Weiss
   
Michael Chiang
   
Chairman and CEO
   
Executive President
 

 
 
 

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