Contract
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.
*****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: |
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By: |
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Xxxxxxx
X. Xxxxx
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Xxxxxxx
Xxxxxx
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Chairman
and CEO
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Executive
President
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