Exhibit
10.15
Execution
Copy
AMENDMENT NO. 2 TO PRODUCTION
AGREEMENT
This Amendment No. 2 to Production
Agreement (this “Amendment”) is made and entered into
this 28th day of April, 2003 by and between OraSure Technologies,
Inc., a Delaware corporation, with its registered offices at
Bethlehem, Pennsylvania 18015 U.S.A. (the “Purchaser”),
and Koninklijke Utermöhlen N.V., a limited liability company
organized under the laws of the Netherlands, with its registered
offices at Wolvega, the Netherlands (the “Seller”).
Seller and Purchaser are each referred to herein as a
“Party” and collectively as the
“Parties.”
BACKGROUND
Seller and Purchaser are parties to
a Production Agreement, dated June 8, 1998, as amended by Amendment
No. 1 to Production Agreement (“Amendment No. 1”),
dated as of December 11, 2001 (collectively, the “Original
Agreement”), pursuant to which Seller agreed to produce
certain products related to the Histofreezer Business for the
Purchaser. The Parties desire to amend further the Original
Agreement in order to provide for the production of a New Product
by Seller for Purchaser for ultimate sale into the over-the-counter
or consumer market in certain territories.
AGREEMENT
NOW, THEREFORE, in consideration of
the foregoing, and of the mutual promises and covenants contained
in this Amendment, Seller and Purchaser, intending to be legally
bound, hereby agree as follows:
1.
Definitions . Capitalized terms not
otherwise defined in this Amendment shall have the meanings set
forth in the Original Agreement.
2. New
Product . Exhibit 1 to the Original
Agreement is hereby amended to add the following New Product
(referred to herein as the “OTC Product”):
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Art. Nr.
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Description
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1001-0063
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Compound W Freeze OFF
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The OTC Product shall be deemed to be a
“Product” under the Original Agreement.
3. OTC
Product Specifications . The
Specifications for the OTC Product (the “OTC Product
Specifications”) shall mean the technical file set forth in
Exhibit 3 to this Amendment as the same shall be amended from time
to time pursuant to Section 3.1 of the Original Agreement, together
with current ISO 9002/46002 standards, CE standards, all relevant
laws, all relevant regulations, all relevant directives, the
Quality System Regulation (including then current Good
Manufacturing Practices) as promulgated by the United States Food
and Drug Administration, principles of good workmanship,
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