EXHIBIT 10.1

Portions of this Exhibit were omitted and filed separately with the Secretary of
the Commission pursuant to an application for confidential treatment filed with
the Commission pursuant to Rule 406 under the Securities Act of 1933. Such
omissions are designated as ***.

AMENDMENT NO. 1 TO DISTRIBUTION AGREEMENT

This Amendment No. 1 to Distribution Agreement (this “Amendment”), dated as of
January 1, 2007, is between OraSure Technologies, Inc., a corporation organized
under the laws of the State of Delaware, U.S.A., with principal offices at 220
East First Street, Bethlehem, Pennsylvania 18015-1360 (“OSUR”), and SSL
International plc, a limited liability company organized under the laws of
England, with principal offices Venus, 1 Old Park Lane, Manchester, England M41
7HA (“Distributor”).

BACKGROUND

OSUR and Distributor previously entered into that certain Distribution
Agreement, dated as of June 1, 2005 (the “Original Agreement”), pursuant to
which OSUR agreed to manufacture and supply the Product for distribution by
Distributor in the OTC Market in the Territory. Capitalized terms not otherwise
defined in this Amendment shall have the meanings set forth in the Original
Agreement. The parties desire to amend the Original Agreement to modify its
terms for the 2007 Contract Year, as more specifically set forth in this
Amendment.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing, and the other mutual promises
and covenants contained in this Amendment, OSUR and Distributor, intending to be
legally bound, hereby agree as follows:

1.    Product Price—2007 Contract Year.    Subject to OSUR’s reimbursement
obligation pursuant to Section 5, below, the Price for all Product purchased by
Distributor for shipment and delivery in the Contract Year beginning January 1,
2007 and ending December 31, 2007 (the “2007 Contract Year”), shall be *** per
Unit. Except as specifically provided in this Section 1, nothing in this
Amendment shall modify or otherwise affect the Price payable for Product
purchased by Distributor in any other Contract Year.

2.    Purchase Quantities—2007 Contract Year.    Distributor agrees to purchase
during the 2007 Contract Year at least *** Units of Product, which amount shall
be the Total Territory Minimum Quantity for the 2007 Contract Year.
Distributor’s obligation to meet such Total Territory Minimum Quantity for the
2007 Contract Year hereby supersedes and replaces Distributor’s obligation to
purchase the Territory A Minimum Quantity for any Territory A Country, the Total
Territory B Minimum Quantity and the Total Territory Minimum Quantity for the
2007 Contract Year originally set forth in the Original Agreement. To the extent
Distributor purchases more than the new Total Territory Minimum Quantity for the
2007 Contract Year, as set forth above, such excess shall not be counted toward
meeting the Total Territory Minimum Quantity for any subsequent or prior
Contract Year. Except as provided in this Section 2 with

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respect to the 2007 Contract Year, nothing in this Amendment shall modify or
otherwise affect Distributor’s minimum purchase commitments under the Agreement
for any other period or Contract Year.

3.    2007 Purchase Orders.

3.1    Initial Orders.    To the extent not previously delivered, concurrently
with the execution of this Amendment, Distributor shall deliver to OSUR one or
more firm, binding Purchase Orders for the purchase and delivery of at least the
*** Unit Total Territory Minimum Quantity for the 2007 Contract Year described
in Section 2, above. The foregoing Purchase Orders may omit the specific country
designation or SKU for the Units to be purchased, provided that Distributor
shall exercise commercially reasonable efforts to provide that information to
OSUR not less than ninety (90) days prior to the scheduled delivery date for the
affected Units of Product. To the extent OSUR supplies Product after being
provided with the country-specific designation or SKU less than sixty (60) days
in advance of the scheduled delivery date (the “Late Designation”), OSUR shall
be entitled to receive, and Distributor agrees to pay, to OSUR up to *** per
Unit of Product supplied by OSUR, as reimbursement for costs incurred by OSUR as
a result of the Late Designation. OSUR shall separately invoice Distributor and
provide supporting documentation reasonably satisfactory to Distributor, in
order to obtain reimbursement of the costs incurred as a result of a Late
Designation. The Purchase Orders required under this Section 3 shall constitute
firm financial commitments on the part of Distributor.

3.2    Prior Orders.    To the extent that Distributor has delivered one or more
Purchase Orders during 2007 prior to the execution of this Amendment and such
Purchase Orders do not reflect the Product Price and other terms of this
Amendment, the parties agree that such Purchase Orders shall be deemed to be
modified to the extent necessary to be consistent with the terms hereof.

4.    2007 Advertising Expenditures.    Subject to Section 5, below, Distributor
agrees that it will incur and pay for *** of Advertising and Promotional
Expenditures (as defined below) for the advertising and promotion of the
Products in the OTC Market in the Territory during the 2007 Contract Year. For
purposes hereof, the term “Advertising and Promotional Expenditures” shall mean
the external costs actually incurred by Distributor only for television, radio
and print media advertising, public relations and promotion (including trade
promotion) for the Product in the OTC Market in the Territory. Distributor shall
make available to OSUR as requested written evidence documenting Distributor’s
compliance with this Section 4.

5.    OSUR Reimbursement—2007 Contract Year.

5.1    Reimbursement of Eligible Expenditures. OSUR shall reimburse Distributor
for Advertising and Promotional Expenditures actually incurred by Distributor
during the 2007 Contract Year (“Eligible Expenditures”) in accordance with this
Section 5.1. OSUR shall reimburse Distributor for Eligible Expenditures at the
rate of *** per Unit of Product purchased by and shipped to Distributor during
the 2007 Contract Year up to a maximum of *** of Eligible

 

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Expenses. To the extent Distributor purchases more than *** Units of Product
during the 2007 Contract Year, OSUR shall provide Distributor with additional
reimbursement of Eligible Expenditures in excess of *** at the rate of *** per
Unit of Product for each Unit actually sold by Distributor and shipped to its
OTC Market customers in excess of *** Units during the 2007 Contract Year. For
example, if during the 2007 Contract Year Distributor purchases *** Units from
OSUR and sells and ships *** Units to its OTC Market customers, Distributor
would receive up to *** in reimbursed Eligible Expenditures actually incurred
during the 2007 Contract Year (i.e. ***). If during the 2007 Contract Year
Distributor purchases *** Units from OSUR and sells and ships *** Units to its
OTC Market customers, Distributor would receive up to *** in reimbursed Eligible
Expenditures actually incurred during the 2007 Contract Year (i.e. ***).
Distributor shall be entitled to receive reimbursement for incurred Eligible
Expenditures at the applicable per Unit rate only for the actual number of Units
of Product purchased or sold by Distributor during the 2007 Contract Year as
provided above.

5.2    Reimbursement Procedures.    In order to receive reimbursement for
Eligible Expenditures hereunder, Distributor shall provide to OSUR on a monthly
basis a summary spreadsheet detailing Eligible Expenditures/Advertising and
Promotional Expenditures incurred during the immediately preceding month during
the 2007 Contract Year as well as copies of invoices or other written evidence
reasonably satisfactory to OSUR documenting the incurrence of such Eligible
Expenditures for each month during the 2007 Contract Year and for which
Distributor is seeking reimbursement hereunder. Upon receipt of each such
monthly spreadsheet and invoices or other documentation from Distributor of
Eligible Expenditures, OSUR shall as soon as practicable, but no later than
thirty (30) days after invoice receipt, reimburse Distributor for such Eligible
Expenditures in an amount calculated in accordance with Section 5.1 above. To
the extent Distributor has not purchased or sold a sufficient number of Units or
Product to obtain full reimbursement of Eligible Expenditures incurred in any
month, any shortfall in reimbursement may be carried over to a future month
during the 2007 Contract Year and shall be paid to the extent Distributor
purchases or sells a sufficient number of Units in any such future month(s)
during the 2007 Contract Year, in accordance with Section 5.1.

6.     Product Modification.    As indicated in Section 4.4.4(a) of the Original
Agreement, OSUR has developed a modified form of the Product containing a ***.
It is agreed that OSUR shall begin to supply the modified form of Product as
soon as reasonably practicable for distribution by Distributor initially into
those markets utilizing the United Kingdom or Spanish/Portuguese language
packages. The modified form of Product shall be supplied for distribution by
Distributor into other Countries in the Territory, subject to completion of user
studies with mutually acceptable results, agreement by the parties on
appropriate Product labeling and the timing of such supply. The foregoing
modified form of Product shall be supplied by OSUR during the 2007 Contract
Year, without an increase in the applicable Price as provided in Section 1,
above. Nothing herein shall require any further modification to the modified
delivery system without agreement by both OSUR and Distributor.

7.    Distributor Components; Product Labeling.

7.1    Components.    Distributor shall not be required to supply Distributor
Components for any Product ordered after the Effective Date of this Amendment
for purchase and delivery

 

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during the 2007 Contract Year. OSUR shall supply such components at its cost
pursuant to the Product Specifications as amended herein (“Packaging
Components”). To the extent an inventory of Distributor Components exists at the
Assembly Contractor on or after January 1, 2007, OSUR shall incorporate such
Distributor Components into Product supplied to Distributor during the 2007
Contract Year and shall reimburse Distributor (or provide a credit against
future payments by Distributor) for Distributor’s actual out of pocket cost for
such Distributor Components. To the extent any Packaging Components supplied by
OSUR hereunder, including any inventory of Distributor Components purchased by
OSUR, are rendered unusable or must be scrapped as a result of a change in
Purchase Order or Product labeling or packaging required by Distributor as a
result of the reduction from twelve to ten applicators in a Unit of Product, as
specified in Section 8, below, Distributor shall reimburse OSUR for the actual
out of pocket cost for such Packaging Components.

7.2    Labeling.    Notwithstanding Section 7.1, Distributor shall be
responsible for preparing the artwork and text translations for all Product
packaging and labeling, all of which shall be at Distributor’s sole cost and
subject to review and approval by OSUR and shall be provided in accordance with
OSUR’s quality requirements (including third party certified or notarized forms
thereof). Distributor shall provide OSUR with at least a four (4) week period to
review and approve any new or modified material or labeling. Notwithstanding the
foregoing, OSUR and Distributor shall equally share the costs of preparing any
third party certified or notarized translations of Product packaging or labeling
to the extent the packaging or labeling change giving rise to the need for such
translations is required by a regulatory authority in the Territory, a Product
modification or improvement, or the development of an Improved Product by OSUR.

8.    Product Specifications.    For Product purchased during the 2007 Contract
Year, the Product Specifications are hereby amended and restated as set forth in
Exhibit A attached hereto in order to incorporate the modified form of Product
referred to in Section 6, above. As indicated in Exhibit A, OSUR shall be
permitted to ***, subject to the prior agreement of Distributor (not to be
unreasonably withheld) that such *** shall not create a significant competitive
disadvantage for the Product in the applicable Country, any supply or assembly
constraints by the Assembly Contractor, the finalization of new Product labeling
and packaging and the utilization of existing inventories of packaging and
labeling. The Product Specifications as amended herein shall apply to Product
ordered after the Effective Date for purchase and delivery during the 2007
Contract Year.

9.    Marketing Committee.    The parties hereby agree to cooperate in the
development of sales, marketing and promotional strategies and plans for the
Product in the OTC Market in the Territory. A joint marketing committee (the
“Marketing Committee”) is hereby established and shall consist of at least two
senior management representatives of each party. The Marketing Committee shall
hold its first meeting as soon as reasonably practicable after the execution of
this Amendment and in no event later than the end of the first Quarterly Period
during the 2007 Contract Year, at which meeting Distributor shall provide OSUR
with detailed plans and strategies for the continued sale and distribution of
the Product in Countries in which the Product is currently being sold and plans
and strategies for the commercial launch of the Product in the OTC Market in
other Countries throughout the Territory. The Marketing Committee shall meet

 

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thereafter at least one time during each Quarterly Period, at which meeting
Distributor shall provide OSUR with a description in reasonable detail of its
updated sales, marketing, promotional and commercialization strategies and
plans. Distributor agrees to consult with OSUR regarding its sales, marketing,
promotional and commercialization plans and shall consider in good faith any
comments or input provided by OSUR. Distributor shall also, to the extent
available in audit data to which SSL subscribes, provide OSUR with quarterly
reports setting forth the aggregated sector data by trade channel as to the
quantity of Product sold by Distributor to retail outlets broken down by trade
and Country, consumer out sales broken down by trade and Country, and the level
of advertising and promotion expenditures and the types of advertising or
promotional activities broken down by Country to the extent reasonably
practicable for SSL to do so and if not, SSL shall provide relevant top line
data to OSUR.

10.    Removal of Countries.    At the first meeting of the Marketing Committee
during the first Quarterly Period of the 2007 Contract Year, Distributor shall
provide OSUR with fully-developed, reasonably detailed strategies and plans for
commercializing the Product in all Countries within the Territory. OSUR shall
evaluate the strategies and planning and shall have good faith discussions with
Distributor about a possible reduction in the number of *** Countries. To the
extent (i) Distributor fails to provide specific commercialization plans for any
Countries within the first Quarterly Period of the 2007 Contract Year, or
(ii) within thirty (30) days of receiving commercialization plans for any
Country OSUR determines, in a commercially reasonable manner, that such plans
are unsatisfactory, OSUR shall have the right, exercisable upon delivery of
written notice to Distributor, to remove any such *** from the Original
Agreement, as amended hereby, or convert Distributor rights thereto to
non-exclusive distribution rights. If any *** Country is removed from the
Original Agreement as amended hereby, (i) Distributor’s rights shall terminate
with respect thereto, and (ii) Distributor shall be relieved of its obligations
under Sections 3.1.5(a) and 3.1.5(b) of the Original Agreement with respect
thereto, and if Distributor’s rights are converted to nonexclusive with respect
to any *** Country, OSUR shall be free to import, market, promote, sell and
distribute the Product into such *** Country, either directly or indirectly
through any other party. In no event shall Distributor be entitled to any
payment or other compensation as a result of the termination or conversion of
its rights with respect to any *** Country pursuant to this Section 10.

11.    Records.    Distributor’s obligation to maintain records and to make such
records available to OSUR, as provided in Section 4.8.1 of the Original
Agreement, is hereby amended to include any records required to determine
Distributor’s compliance with Section 4 of this Amendment and the accuracy,
timing, purpose and incurrence of any Advertising and Promotional Expenditures
or Eligible Expenditures.

12.    Reservation of Rights.    Except as provided below, OSUR agrees that it
shall not exercise or attempt to exercise any rights which would otherwise be
available to OSUR relating to any alleged or actual failure of Distributor to
meet its Total Territory Minimum Quantity for the 2006 Contract Year. OSUR is
willing to refrain from exercising such rights solely with respect to the 2006
Contract Year; provided that, if Distributor fails to comply fully with Sections
2 or 3.1 of this Amendment, or Section 3.1.1 of the Original Agreement, OSUR
shall be entitled to exercise any or all of such rights as it determines in its
sole discretion, in addition to

 

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any other rights and remedies it may have under the Original Agreement as
amended hereby, at law or otherwise.

13.    Future Contract Years.    The parties acknowledge and agree that the
modifications to the Original Agreement as set forth herein shall only apply to
the 2007 Contract Year. The parties agree to commence bona fide good faith
discussions on or prior to *** regarding additional modifications mutually
acceptable to the parties to the Original Agreement which would apply to one or
more of the Contract Years after the 2007 Contract Year (“Additional
Modifications”). Nothing herein shall obligate either party to agree to any
Additional Modifications to the Original Agreement, including those set forth
herein, for any Contract Year after the 2007 Contract Year. To the extent the
parties are unable to reach agreement on the Additional Modifications by ***,
notwithstanding their bona fide good faith efforts to do so, the Original
Agreement shall terminate on ***. Except as set forth in this Section 13 or as
otherwise agreed by the parties in writing, during the period from *** until
termination of the Agreement on *** in accordance with this Section 13, the
terms of the Original Agreement (without giving effect the this Amendment) shall
apply, including Distributor’s obligations under Section 3.1.1 of the Original
Agreement. In the event the Original Agreement is terminated in accordance with
this Section 13, Distributor shall be relieved of its obligations under Sections
3.1.5(a) and 3.1.5(b) as of the effective termination date.

14.    Effect of Amendment.    Except as amended hereby, the Original Agreement
shall remain in full force and effect. All references to the Original Agreement
shall be deemed to mean the Original Agreement as amended by this Amendment.

15.    Governing Law.    This Amendment shall be governed by, and construed and
interpreted in accordance with, the laws of the Commonwealth of Pennsylvania,
U.S.A., without reference to conflict of laws principles of any jurisdiction.

16.    Counterparts.    This Amendment may be executed by the parties in more
than one counterpart, each of which, when executed and delivered, shall be
deemed to be an original, and all such counterparts shall constitute a single
instrument. A facsimile transmission of a signed original shall constitute
delivery of the signed original.

 

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IN WITNESS WHEREOF, this Amendment has been executed by OSUR and Distributor as
of the date first written above.

 

ORASURE TECHNOLOGIES, INC. By:   /s/Douglas A. Michels  

Name: Douglas A. Michels

Title: President & CEO

 

SSL INTERNATIONAL PLC By:   /s/Ian Adamson  

Name: Ian Adamson

Title: Managing Director, Europe

 

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Exhibit A

Product Specifications+

(As Amended and Restated by Amendment No. 1 to Distribution

Agreement, dated as of January 1, 2007, between OSUR and Distributor)

 

1 “Unit” of Product shall consist of:

***

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+

Subject to Section 6 of the attached Amendment, each customer shall be supplied
with the *** shown on the figures attached hereto (or as further modified by
agreement of the parties based on the results of user studies to be conducted by
Distributor).

 

++

***