Exhibit 10.12.2
AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
This amendment ("AMENDMENT"), dated December , 1995, is by and
between U.S. Bioscience, Inc. ("USB"), a corporation organized and existing
under the laws of the State of Delaware and Ben Venue Laboratories, Inc., a
corporation organized and existing under the laws of Pennsylvania, with
principal manufacturing facilities at 000 Xxxxxxxxxx Xxxx, Xxxxxxx, Xxxx 00000
("BVL").
WHEREAS, USB and BVL entered into a Manufacturing and Supply Agreement
dated September 23, 1993, and amended April 11, 1995, relating to the
manufacture and supply of Neutrexin(R) (trimetrexate glucuronate) and Ethyol(R)
(amifostine) (the "Agreement");
WHEREAS, USB and BVL desire to amend certain provisions of the
Agreement as hereinafter provided; and
NOW, THEREFORE, in consideration of the mutual promises contained
herein and intending to be legally bound hereby, the parties hereby agree as
follows:
1. Definitions: Except as otherwise specifically provided herein, all
capitalized terms used herein and not defined herein shall have the meaning
assigned to such terms in the Agreement.
2. Section 1.1 is hereby amended to delete from the last sentence of
that section:
"but if RA approval is not obtained within eighteen (18)
months after the date of this Agreement, BVL and USB agree to
meet and renegotiate in good faith all or any part of this
Agreement which may be affected by the delay of such RA
approval."
It is the intention of the parties that this Agreement shall be effective under
its current terms notwithstanding that RA in the United States was not received
within such eighteen (18) months.
3. The parties acknowledge that it will be extremely difficult to
predict required quantities of Product in the first two years of commercial sale
and they will work closely together to attempt to assure that required
quantities of Product are made available as quickly and efficiently as possible.
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4. Section 4.2 is hereby amended to delete from that section the
following sentences:
"USB shall provide its best estimate for the first commercial
order six (6) months in advance of the expected approval date.
USB's first commercial order shall be placed with BVL four (4)
months in advance of the expected approval date."
and in its place, the following shall be inserted:
"USB shall provide its best estimate for the first commercial
order for Ethyol ninety (90) days in advance of the expected
commercial launch of Ethyol in the United States. USB's first
commercial order for Ethyol shall be placed with BVL not less
than sixty (60) days in advance of the expected commercial
launch of Ethyol in the United States."
5. Section 4.3 is hereby deleted and in its place the following shall
be inserted:
"USB shall submit to BVL in advance of USB's first commercial
order, its estimate for both volumes and delivery dates for
Ethyol from expected commercial launch in the United States
through the end of the calendar year in which such launch is
expected to occur."
6. Section 4.4 is hereby amended to delete the first sentence of that
section:
"For the years subsequent to the period of Section 4.3, USB
shall submit to BVL not less than three (3) months prior to
each anniversary of the date of this Agreement, revised
estimates for both volumes and delivery dates of its annual
requirements,"
and in its place the following shall be inserted:
"For the years subsequent to the period of Section 4.3, USB
shall submit to BVL in each calendar year by October 1 for the
subsequent calendar year, revised estimates for both volumes
and delivery dates of its annual requirements."
7. Section 5.1 is hereby amended by deleting the second sentence of
that section and its place the following shall be inserted:
"BVL shall notify USB of price adjustments, if any, at least
120 days in
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advance of each calendar year during which this Agreement is
in place with such price becoming effective at the beginning
of the calendar year subsequent to the notification of any
such price increase."
8. Effect of the Amendment: Other than the specific amendments set
forth above, all other terms and conditions of the Agreement shall remain in
full force and effect. This Amendment embodies the full and complete
understanding of the parties hereto with respect to the matters addressed herein
and supersedes all prior understandings and agreements whether oral or written.
IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized officers to execute this Agreement.
U.S. BIOSCIENCE, INC.
By:______________________________
Title:_____________________________
Date:_____________________________
BEN VENUE LABORATORIES, INC.
By:______________________________
Title:____________________________
Date:____________________________
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