Exhibit 10.11.1
AMENDMENT TO MANUFACTURING AGREEMENT
This amendment ("AMENDMENT"), dated April 12, 1995, is by and between
U.S. Bioscience, Inc. ("USB"), a corporation organized and existing under the
laws of the state of Delaware and Applied Analytical Industries, Inc., a
corporation organized and existing under the laws of Delaware, having a place of
business at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000 ("AAI").
WHEREAS, USB and AAI entered into a Manufacturing Agreement dated
January 1995 (the "Agreement"), relating to the manufacture of Hexalen(R)
(Altretamine);
WHEREAS, USB and AAI 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. Inspection: Section 8.2 of the Agreement shall be amended by
deleting Section 8.2 in its entirety and in its place inserting the following
Section 8.2:
"8.2 INSPECTION. USB and those of its distributors, licensees
and sub-licensees and their respective affiliates with rights
to market or sell the PRODUCT identified to AAI by USB and
satisfactory to AAI (collectively, the "USB Affiliates"), upon
reasonable notice, shall have the right, at their sole cost
and expense, to conduct periodic inspections of AAI's
facilities to inspect and observe AAI's manufacturing, quality
control and quality assurance procedures. AAI shall make
available to USB and the USB Affiliates during on-site
inspection all records and documentation addressing the
PREPARATION and quality control of the PRODUCT. AAI shall also
provide USB and the USB Affiliates, at their request, copies
of such records during such inspection at the sole cost and
expense of the party initiating the inspection."
3. Effect of Amendment: Other than the specific amendment 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:
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TITLE: Senior Vice President, Pharmaceutical Operations
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DATE: April 11, 1995
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APPLIED ANALYTICAL INDUSTRIES, INC.
BY:
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TITLE:
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DATE:
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