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”):

 

Art. Nr.

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   Description

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1001-0063

   Compound W Freeze OFF

 

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, acknowledged standards and
specific (but reasonable) instructions of the Purchaser in the relevant order
for any OTC Product(s). The OTC Product Specifications shall be deemed to be the
“Specifications” for the OTC Product for all purposes of the Original Agreement.

 

4.    Other Specifications.    The Specifications for all other Products are
hereby amended to include the Quality System Regulation (including then current
Good Manufacturing Practices) as promulgated by the United States Food and Drug
Administration.

 

5.    Supply of Packaging Components.    Purchaser shall be responsible for
supplying or arranging for the supply of the packaging and labeling materials
noted in Exhibit 4 to this Amendment (collectively, the “OTC Packaging
Components”). Seller shall not be responsible for providing or paying for the
OTC Packaging Components, but shall use such OTC Packaging Components in
packaging and assembling the OTC Product purchased hereunder.

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6.    Purchase Price.

 

(a) The price for the purchase of OTC Product shall be as set forth in Exhibit 6
to this Amendment.

 

(b) The parties acknowledge a typographical error in Section 4.2 of Amendment
No. 1. The change from “30%” to “10%” in such Section should have been, and is
hereby deemed to have been, made to Section 4.3 of the Original Agreement.

 

7.    No Other Changes.    Except as set forth in this Amendment, the Original
Agreement remains in full force and effect without any other changes. The
Original Agreement, together with this Amendment, constitute the entire
agreement between the Seller and the Purchaser with respect to the subject
matter hereof and thereof and supersede and cancel all previous negotiations,
agreements, and commitments, whether oral or in writing, with respect to such
subject matter. All references to the Original Agreement shall be deemed to mean
the Original Agreement as amended by this Amendment.

 

8.    Counterparts.    This Amendment may be executed in two or more
counterparts, each of which shall be deemed to be an original, but all of which
together shall constitute one and the same instrument. A facsimile transmission
of a signed original shall be deemed to be the same as delivery of a signed
original.

 

9.    Governing Law.    This Amendment and any controversy, claim or dispute
arising under this Amendment shall be governed by, and construed in accordance
with, the laws of the Netherlands.

 

IN WITNESS WHEREOF, the undersigned duly authorized officers of the Seller and
the Purchaser have executed this Amendment as of the date first above written.

 

ORASURE TECHNOLOGIES, INC.

     

KONINKLIJKE UTERMÖHLEN N.V.

By:   /s/ Mike Gausling       By:   /s/ D. T. van der Vat    

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Name: Mike Gausling

Title:   President and CEO

         

Name: D.T. van der Vat

Title:   President

 

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EXHIBIT 3

 

OTC Product Specifications

 

* * * * * * * * * * * *

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EXHIBIT 4

 

OTC Package Components

 

1. Boxes for each unit of OTC Product, with labeling approved by Purchaser;

2. Package inserts or instructions in form approved by Purchaser;

3. Shipping cases (standard corrugated);

4. Shipping case label in form approved by Purchaser; and

5. Transparent tamper resistant labels for the box (if required).

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EXHIBIT 6

 

OTC Product Price

(Per Unit)

 

          Price

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1.   

Materials

         

    - 110 ml. canister filled with 80 ml. of refrigerant

   * * * *     

    - Foam Bud Applicators (12 in a bag)

   * * * * 2.   

Labor

   * * * * 3.   

Overhead

   * * * * 4.   

Profit

   * * * *          

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        Total Price Per Unit

   * * * *

 

A unit of OTC Product shall consist of an 110 ml canister filled with 80 ml. of
refrigerant and a 12-count set of 5 mm. foam tip applicators, manufactured,
assembled and packaged in accordance with the OTC Product Specifications.