Exhibit 10.29

Execution Copy

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 ***.

SUPPLY AND DISTRIBUTION AGREEMENT

THIS SUPPLY AND DISTRIBUTION AGREEMENT (this “Agreement”) is made and entered
into as of this 11th day of February 2005 (“Effective Date”), by and between
Abbott Laboratories, an Illinois corporation with principal offices at 100
Abbott Park Road, Abbott Park, IL, 60064-3500 (“Abbott”), and OraSure
Technologies, Inc., a Delaware corporation with principal offices at 220 East
First Street, Bethlehem, Pennsylvania 18015 (“OraSure”).

BACKGROUND

WHEREAS, OraSure manufactures a rapid, point-of-care in vitro diagnostic product
for the detection of HIV-1 and HIV-2 antibodies, which test is sold under the
trade name, OraQuick® ADVANCE™ Rapid HIV-1/2 Antibody Test;

WHEREAS, Abbott is in the business of manufacturing and selling in vitro
diagnostic products as well as other healthcare products; and

WHEREAS, the parties desire to appoint Abbott as distributor for OraSure’s new
OraQuick® ADVANCE™ Rapid HIV-1/2 Antibody Test in certain segments in the United
States.

NOW, THEREFORE, in consideration of the foregoing, and of the mutual promises
and covenants contained in this Agreement, OraSure and Abbott, intending to be
legally bound, hereby set forth their agreement in its entirety, as follows:

ARTICLE 1 - DEFINITIONS

For the purposes of this Agreement, the following terms will have the respective
meanings set forth below:

1.1 “Abbott Complaint” shall have the meaning set forth in Section 6.6.

1.2 “Abbott Net Sales” shall mean, with respect to any month or Quarterly
Period, the gross amount invoiced by Abbott or its Affiliates for OraQuick®
ADVANCE™ Devices sold by Abbott or its Affiliates to unaffiliated third parties
(a distributor, sub-distributor or agent of Abbott or any of its Affiliates who
is not an Affiliate of Abbott or any of its Affiliates, shall be considered such
an unaffiliated third party) during such month or Quarterly Period, less
(i) trade, cash and quantity discounts and rebates allowed and taken by the
unaffiliated third party, (ii) amounts repaid, credited or allowed and taken by
the unaffiliated third party on account of returned or rejected OraQuick®
ADVANCE™ Devices, recalls, billing errors, or retroactive price

--------------------------------------------------------------------------------

reductions or price reductions imposed by governmental authorities,
(iii) tariffs, duties, excises and taxes included in the amount charged to the
unaffiliated third party, and (iv) freight, insurance and other transportation
and shipping costs included in the amount charged to the unaffiliated third
party. In the event an OraQuick® ADVANCE™ Device is sold with any other products
or services of Abbott, Abbott shall separately itemize and individually price
such OraQuick® ADVANCE™ Device on the invoice to the customer and such itemized
price shall be used to calculate Abbott Net Sales that includes the sale of such
OraQuick® ADVANCE™ Device. In no event shall the same OraQuick® ADVANCE™ Device
be included in Abbott’s Net Sales more than once.

1.3 “Abbott Trademarks” shall have the meaning set forth in Section 9.1.

1.4 “Affiliate” shall mean, when used with reference to a party, any individual
or entity directly or indirectly controlling, controlled by or under common
control with such party. For purposes of this Agreement, “control” (including
correlative meanings “controlling,” “controlled by,” or “under common control
with”) means: (a) the direct or indirect ownership, in the aggregate, of more
than fifty percent (50%) of the outstanding voting securities of an entity; or
(b) the right or power, directly or indirectly, to direct or cause the direction
of the policy decisions of an entity, whether by ownership of voting securities,
contract or otherwise.

1.5 “Approved Facility” shall mean an FDA-approved site for the Manufacture of
the Products. Such term includes all of the equipment, machinery and facilities
of OraSure at such location that are used in Manufacturing the Products.

1.6 “Competing Product” shall have the meaning set forth in Section 3.2.

1.7 “Confidential Information” shall mean all information disclosed hereunder in
writing, orally, visually or through some other media, which is identified as
confidential at the time of disclosure, except any portion thereof which (i) is
known to the recipient at the time of the disclosure free of any restriction as
to its use or disclosure, as evidenced by its written records; (ii) is disclosed
to the recipient by a third person lawfully in possession of such information
and not under an obligation of nondisclosure to the disclosing party; (iii) is
or becomes patented, published or otherwise part of the public domain through no
fault of the recipient; or (iv) is developed by or for the recipient
independently of Confidential Information disclosed hereunder, as evidenced by
the recipient's written records.

1.8 “Contract Year” shall mean, for the first Contract Year, the twelve
(12) month period beginning on the Effective Date and ending on December 31,
2005, and for all subsequent Contract Years, the twelve (12) month period
beginning on each January 1 thereafter.

1.9 “Contractual Minimum” shall have the meaning set forth in Section 2.1.5.

1.10 “FDA” shall mean the United States Food and Drug Administration, or any
successor entity thereto.

1.11 “GSA” shall mean the U.S. General Services Administration, or any successor
entity thereto.

 

2

--------------------------------------------------------------------------------

1.12 “HIV-1” shall mean the Human Immunodeficiency Virus, Type 1.

1.13 “HIV-2” shall mean the Human Immunodeficiency Virus, Type 2.

1.14 “HIV-1/2” shall mean both HIV-1 and HIV-2.

1.15 “Hospital” shall mean any of the approximate 5,000 acute care institutions
in the Territory that (i) are licensed and operated as hospitals, (ii) are
accredited as a hospital by the Joint Commission on Accreditation of Health Care
Organizations or the Bureau of Hospitals of the American Osteopathic Association
and, in each case, are certified as a hospital provider under Medicare,
(iii) provide for the care and treatment of resident in-patients for a variety
of medical conditions, both surgical and non-surgical, and (iv) provide
treatment under the supervision of a staff of physicians with twenty four
(24)-hour a day nursing care and internal laboratory services. The term
“Hospital” shall not include any affiliated clinic or treatment center or
physician office or physician practice unless that clinic, treatment center,
physician office or physician practice is wholly-owned by an institution
described in the first sentence of this definition.

1.16 “Hospital Adjustment Number” shall have the meaning set forth in
Section 8.2.2.

1.17 “Hospital Baseline” shall mean, with respect to a particular month or
Quarterly Period, an amount equal to the difference between (a) the product of
the aggregate number of OraQuick® ADVANCE™ Devices sold by Abbott or its
Affiliates in the Hospital Segment and U.S. Government Hospital Segment during
such month or Quarterly Period multiplied by the Transfer Price for such
OraQuick® ADVANCE™ Devices, minus (b) the product of the aggregate number of
OraQuick® ADVANCE™ Devices sold by Abbott or its Affiliates in the U.S.
Government Hospital Segment during such month or Quarterly Period multiplied by
the OraSure FSS Baseline for such month or Quarterly Period.

1.18 “Hospital Segment” shall mean the segment for rapid, point-of-care testing
of Whole Blood or Oral Fluid samples for HIV-1 and HIV-2 solely in the Territory
by Hospitals located in the Territory; provided that the Hospital Segment shall
not include any Hospitals included in the U.S. Government Hospital Segment.

1.19 “Improved Product” shall mean any and all modifications, improvements,
additions, alterations, or refinements to a Product, whether patented or
unpatented, (i) that relate solely to the detection of antibodies to HIV-1 or
HIV-2, (ii) are subject to a Regulatory Approval that permits the Product, as so
modified or improved, to be marketed and sold in the Segments in the Territory
and (iii) that OraSure has the right to market in the Territory; provided that a
New Product shall not constitute an Improved Product.

1.20 “Manufacture”, “Manufactured” or “Manufacturing” shall mean the
manufacture, assembly, labeling, packaging, handling, quality control, and
storing of the Products in accordance with applicable law.

1.21 “Negotiation Period” shall have the meaning set forth in Section 2.4.

 

3

--------------------------------------------------------------------------------

1.22 “New Product” shall mean any device, which OraSure has the right to market
in the Territory, that is subject to an approval of the FDA that permits the
device to be marketed and sold in the Territory for the rapid, point-of-care
detection of (a) any one or more diseases or conditions, other than HIV-1 and
HIV-2, in any specimen type or (b) HIV-1 and/or HIV-2 plus any one or more
diseases or conditions in any specimen type. An OraQuick® Combo Product shall be
deemed to be a New Product.

1.23 “New Product Notice” shall have the meaning set forth in Section 2.4.

1.24 “Oral Fluid” shall mean mucosal transudate, saliva, or other fluids
extracted from the human oral cavity.

1.25 “OraQuick® ADVANCE™ Controls” shall mean the positive and negative controls
that are developed, manufactured, marketed and sold by OraSure or any of its
Affiliates solely for use with the OraQuick® ADVANCE™ Devices to confirm the
ability of a person to properly use an OraQuick® ADVANCE™ Device and interpret
any resulting test results.

1.26 “OraQuick® ADVANCE™ Control Specifications” shall mean all product
specifications on the package inserts and product labeling for the OraQuick®
ADVANCE™ Controls.

1.27 “OraQuick® ADVANCE™ Device” shall mean the collection and testing device
that (i) is developed, manufactured, marketed, sold or otherwise distributed
under the trademark OraQuick® ADVANCE™ by OraSure or any of its Affiliates or
designees for the purpose of detecting both HIV-1 and HIV-2 in Whole Blood and
Oral Fluid, and (ii) meets the OraQuick® ADVANCE™ Device Specifications;
provided that an OraQuick® ADVANCE™ Device shall not include any device that is
a New Product or has claimed indications that permit marketing and sale under a
Regulatory Approval only with respect to the detection of HIV-1 in any specimen
type.

1.28 “OraQuick® ADVANCE™ Device Specifications” shall mean all product
specifications on the package inserts and package labeling for the OraQuick®
ADVANCE™ Device.

1.29 “OraQuick® ADVANCE™ Control Warranty Period” shall have the meaning set
forth in Section 10.1.2.

1.30 “OraQuick® ADVANCE™ Device Warranty Period” shall have the meaning set
forth in Section 10.1.1.

1.31 “OraQuick® Combo Product” shall have the meaning set forth in Section 2.4.

1.32 “OraSure FSS” shall mean the Federal Supply Schedule Contract effective
October 1, 2004 and numbered V797P-5755X that OraSure has filed with the GSA and
which lists the Products as available for sale pursuant to the GSA Federal
Supply Service, as such Federal Supply Schedule Contract may be amended or
modified from time to time by OraSure. In the event that the OraSure FSS is
amended or modified, OraSure shall provide written notice to Abbott of such
amendment or modification as soon as practicable thereafter.

 

4

--------------------------------------------------------------------------------

1.33 “OraSure FSS Baseline” shall mean, with respect to a particular month or
Quarterly Period, an amount equal to (i) the Transfer Price minus (ii) *** of
the unit price for OraQuick® ADVANCE™ Devices set forth on the OraSure FSS in
effect for such month or Quarterly Period; provided that the OraSure FSS
Baseline shall not be less than zero.

1.34 “OraSure Trademarks” shall have the meaning set forth in Section 9.1.

1.35 “Person” shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, government, governmental agency, authority or instrumentality, or
any other form of entity not specifically listed in this Agreement.

1.36 “Physicians’ Office Segment” shall mean the market for rapid, point-of-care
testing of Whole Blood and/or Oral Fluid for HIV-1 and HIV-2 solely in the
Territory by general practitioners, internists, obstetricians, gynecologists,
pediatricians and other licensed physicians located within the Territory;
provided that the Physicians’ Office Segment shall not include any such
physicians in offices or practices that are wholly-owned by any Hospital or that
practice in the Public Health Segment.

1.37 “PO/RL Adjustment Number” shall have the meaning set forth in
Section 8.2.3.

1.38 “PO/RL Baseline” shall mean, with respect to a particular month or
Quarterly Period, an amount equal to the product of (a) the aggregate number of
OraQuick® ADVANCE™ Devices sold by Abbott or its Affiliates in the Physicians’
Office Segment and Reference Lab Segment during such month or Quarterly Period,
multiplied by (b) the Transfer Price for such OraQuick® ADVANCE™ Devices.

1.39 “Products” shall mean the OraQuick® ADVANCE™ Controls and the OraQuick®
ADVANCE™ Devices.

1.40 “Promote,” “Promotion” or “Promotional” shall mean those activities
undertaken by a party to encourage sales of Products, including but not limited
to, journal advertising, broadcast advertising, direct mail programs, detailing,
customer meetings, convention and trade show exhibits, Product presentations,
symposia and other forms of advertising, promotion and sales support.

1.41 “Public Health Segment” shall mean the market for rapid, point-of-care
testing of any specimen type for HIV-1 and HIV-2 by community-based
organizations, AIDS service organizations, county public health departments,
correctional and criminal justice departments (including county, state, and
federal drug courts, probation centers, departments of correction, detention
centers, jails and prisons), substance abuse clinics, sexually transmitted
disease clinics, substance abuse centers, student health centers and clinics,
abortion clinics, family planning clinics, planned parenthood clinics, and any
other similar organization or entity, in each case located within the Territory;
provided that the Public Health Segment shall not include any clinic or
treatment center that is within the definition of Hospital.

1.42 “Purchase Order” shall have the meaning set forth in Section 7.1.

 

5

--------------------------------------------------------------------------------

1.43 “QSRs” shall mean current Quality Systems Regulations for the methods to be
used in, and the facilities and controls to be used for, the Manufacture,
processing, packing, labeling and storage of diagnostic products, all as set
forth in 21 CFR 820, including all amendments and supplements thereto throughout
the Term of this Agreement.

1.44 “Quarterly Period” means each successive period of three (3) months
beginning on the Effective Date.

1.45 “Reference Lab Segment” shall mean the market for rapid, point-of-care
testing of any specimen type for HIV-1 and HIV-2 by commercial reference
laboratories where such tests are performed solely by and within such
laboratories for outside customers and such tests are not resold or otherwise
distributed by such laboratories. Examples of such laboratories include Quest
Diagnostics and Labcorp.

1.46 “Regulatory Approvals” shall mean the technical, medical and scientific
licenses, registrations, authorizations and/or approvals of the Products
(including the prerequisite manufacturing approvals or authorizations, marketing
authorization based upon such approvals and labeling approvals related thereto)
that are required by the FDA for the Manufacture at the Approved Facility and
the distribution, marketing, storage, transportation, use, and sale of the
Products in the Segments in the Territory, as such Regulatory Approvals are
amended or supplemented from time to time.

1.47 “Revenue-Based Amount” shall have the meaning set forth in Section 8.2 of
this Agreement.

1.48 “Segments” shall mean the Hospital Segment, the Physicians’ Office Segment,
the U.S. Government Hospital Segment and the Reference Lab Segment.

1.49 “Senior Executive” means, with respect to OraSure, the Chief Executive
Officer of OraSure, and with respect to Abbott, the Vice President, U.S. Sales
Organization for the Diagnostics Division of Abbott.

1.50 “Senior Manager” means, with respect to OraSure, the Executive Vice
President, Marketing and Sales and Vice President, Sales of OraSure, and with
respect to Abbott, the Director of U.S. Sales for the Diagnostics Division of
Abbott.

1.51 “Sublicense” shall have the meaning set forth in Section 13.2.6.

1.52 “Territory” shall mean the United States and its geographic territories or
possessions.

1.53 “Transfer Price” shall mean the price payable by Abbott for the Products,
as determined in accordance with Exhibit 1.53.

1.54 “U.S. Government Hospital Segment” shall mean the market for rapid,
point-of-care testing of Whole Blood and/or Oral Fluid for HIV-1 and HIV-2
solely in the continental United States by Hospitals (including Veterans
Administration and United States Military Hospitals) that (i) are owned and
operated by the United States government, (ii) purchase

 

6

--------------------------------------------------------------------------------

product (including the Products) and services under the U.S. General Services
Administration Federal Supply Service and (iii) are permanently located in the
continental United States.

1.55 “Whole Blood” shall mean blood specimen collected from humans by venous or
capillary puncture, plasma or serum.

ARTICLE 2 - APPOINTMENT

2.1 Appointments; Subdistributors.

2.1.1 Exclusive Appointment - Hospital Segment and Reference Lab Segment. In
accordance with the terms and subject to the conditions and limitations of this
Agreement, OraSure appoints Abbott, and Abbott accepts appointment, as the
exclusive marketer and distributor of the Products during the Term in the
Hospital Segment and Reference Lab Segment, with the right to commercially
distribute the Products on an exclusive basis to customers solely in the
Hospital Segment and Reference Lab Segment, including all activities ancillary
thereto (including, without limitation, warehousing, order entry, shipping,
billing and collection, promotional, advertising, marketing and sales
activities). Subject to Section 2.1.5, the grant of exclusive rights to Abbott
under this Section 2.1.1 means that, for so long as Abbott’s rights under this
Section 2.1.1 with respect to the Hospital Segment and Reference Lab Segment
remain exclusive, OraSure may not promote, market and sell the Products,
directly or indirectly, to customers in the Hospital Segment or Reference Lab
Segment, except that OraSure shall be permitted to engage in promotional,
advertising, marketing and sales support activities pursuant to or as permitted
by Article 5.

2.1.2 Non-Exclusive Appointment – Physicians’ Office Segment. In accordance with
the terms and subject to the conditions and limitations of this Agreement,
OraSure appoints Abbott, and Abbott accepts appointment, as the non-exclusive
marketer and distributor of Products during the Term in the Physicians’ Office
Segment, with the right to commercially distribute the Products on a
non-exclusive basis to customers solely in the Physicians’ Office Segment,
including all activities ancillary thereto (including, without limitation,
warehousing, order entry, shipping, billing and collection, promotional,
advertising, marketing and sales activities). The grant of non-exclusive rights
to Abbott under this Section 2.1.2 means that OraSure shall be permitted to
promote, market and sell Products, directly or indirectly, to customers in the
Physicians’ Office Segment, including engaging in all activities ancillary
thereto (including, without limitation, warehousing, order entry, shipping,
billing and collection, promotional, advertising, marketing and sales
activities). The parties agree to meet after the end of each Contract Year to
review the level of Abbott’s sales of Product into the Physicians’ Office
Segment and penetration of that Segment by Abbott to determine if such sales and
penetration are sufficient to warrant converting Abbott’s non-exclusive
appointment for the Physicians’ Office Segment to an exclusive appointment. Each
party shall determine whether to agree to such conversion in its sole
discretion.

2.1.3 Exclusive Appointment – U.S. Government Hospital Segment.

 

7

--------------------------------------------------------------------------------

(a) In accordance with the terms and subject to the conditions and limitations
of this Agreement, OraSure appoints Abbott, and Abbott accepts appointment, as
the exclusive marketer and distributor of the Products during the Term in the
U.S. Government Hospital Segment, with the right to commercially distribute the
Products on an exclusive basis to customers solely in the U.S. Government
Hospital Segment, including all activities ancillary thereto (including, without
limitation, warehousing, order entry, shipping, billing and collection,
promotional, advertising, marketing and sales activities). Subject to
Section 2.1.5, the grant of exclusive rights to Abbott under this Section 2.1.3
means that, for so long as Abbott’s rights under this Section 2.1.3 with respect
to the U.S. Government Hospital Segment remain exclusive, OraSure may not
promote, market and sell the Products, directly or indirectly, to customers in
the U.S. Government Hospital Segment, except that OraSure shall be permitted to
engage in promotional, advertising, marketing and sales support activities
pursuant to or as permitted by this Section 2.1.3 and Article 5.

(b) All sales of Product by Abbott to the U.S. Government Hospital Segment shall
be made by Abbott pursuant to and in compliance with the terms and conditions of
the then current OraSure FSS and in compliance with all applicable laws and
regulations relating to the OraSure FSS. OraSure agrees to cooperate with Abbott
in Abbott’s provision of services, compliance with the OraSure FSS, compliance
with applicable laws and regulations relating to the OraSure FSS and Abbott’s
provision of services thereunder. Abbott shall not list or otherwise offer the
Products on a Federal Supply Schedule filed by Abbott or any of its Affiliates.
In the event the OraSure FSS is modified, expires or is terminated and such
action materially and adversely affects Abbott’s ability to meet the Contractual
Minimums, then the parties shall negotiate in good faith reasonable reductions
to the Contractual Minimums to reflect such action and the quantity of OraQuick®
ADVANCE™ Devices sold by Abbott in the U.S. Government Hospital Segment during
the most recent twelve (12) month period.

(c) It is expected that customers in the U.S. Government Hospital Segment will
remit payment for the Products directly to Abbott. If, however, OraSure receives
payment from a customer in the U.S. Government Hospital Segment with respect to
the sale of Products to such customer, OraSure will receive such payment in
trust for Abbott and either (i) pay Abbott the entire amount of the payment
received, or (ii) credit Abbott the entire amount of the payment received
against another Abbott payment.

(d) OraSure shall be responsible for, at OraSure’s cost, adding Abbott as a
distributor under the OraSure FSS in the U.S. Government Hospital Segment. In
addition, OraSure acknowledges and agrees that it is responsible for the IFF
payment related to the OraSure FSS. Abbott agrees that it shall comply with the
obligations of a distributor under the then current OraSure FSS, including
without limitation the clause entitled, “G-FSS-913 Contractor’s Billing
Responsibilities,” as such clause may be amended from time to time.

2.1.4 Sub-distributors. Abbott may appoint sub-distributors or agents solely in
the Physicians’ Office Segment and in no other Segment; provided, however, that
(i) each such sub-distributor or agent agrees in writing to comply with Abbott’s
obligations under this Agreement that are applicable to the distribution of the
Products and (ii) Abbott’s use of sub-distributors or agents does not relieve
Abbott of any of its obligations under this Agreement.

 

8

--------------------------------------------------------------------------------

2.1.5 Conditions to Exclusivity. In order to maintain its exclusive appointment
under Sections 2.1.1 and 2.1.3, Abbott must purchase the following number of
OraQuick® ADVANCE™ Devices in respect of each of the following Contract Years,
such that OraSure may invoice Abbott and delivery to Abbott must occur for the
specified number of OraQuick® ADVANCE™ Devices during the applicable Contract
Year: (a) at least *** OraQuick® ADVANCE™ Devices during the first Contract Year
(so long as Abbott is not prevented from launching the Products in one or more
of the Segments by May 1, 2005 solely as a result of a failure by OraSure to
supply Product ordered by Abbott in accordance with this Agreement); (b) at
least *** OraQuick® ADVANCE™ Devices during the second Contract Year, and (c) at
least *** OraQuick® ADVANCE™ Devices during the third Contract Year (each a
“Contractual Minimum”). The Contractual Minimums shall be equitably adjusted in
the event OraSure fails to supply Product as provided in Section 7.7 or is
unable to supply Product with a shelf life of at least seven (7) months as
provided in Section 10.5. The Contractual Minimums for any Contract Year
following the Initial Term shall be determined pursuant to Section 13.1. In the
event that Abbott does not meet its Contractual Minimum for any Contract Year,
then OraSure’s sole and exclusive remedy shall be to convert Abbott’s
appointment under Section 2.1.1 to non-exclusive and to terminate Abbott’s
exclusive appointment under Section 2.1.3. OraSure shall exercise its right to
convert or terminate under this Section 2.1.5 by giving Abbott written notice
thereof. If OraSure exercises any of its rights under this Section 2.1.5 to
convert or terminate an appointment under this Agreement, OraSure shall have the
right to promote, market, sell and distribute the Products, directly or
indirectly through one or more distributors, sub-distributors or agents, in the
Segment in which Abbott’s appointment has been converted or terminated,
including engaging in all activities ancillary thereto (including, without
limitation, warehousing, order entry, shipping, billing and collection,
promotional, advertising, marketing and sales activities). Once an appointment
is converted to non-exclusive or terminated under this Agreement it may not be
restored to an exclusive appointment by any means including, without limitation,
Abbott taking delivery of an additional quantity of OraQuick® ADVANCE™ Devices
in a subsequent Contract Year that would satisfy the Contractual Minimum for
such Contract Year. Without limiting the generality of the foregoing, a failure
to meet any required Contractual Minimum may not be cured by issuance of a
Purchase Order during a Contract Year calling for delivery in a subsequent
Contract Year or taking delivery of OraQuick® ADVANCE™ Devices in a subsequent
Contract Year equal to or greater than the aggregate of the number of units of
OraQuick® ADVANCE™ Devices that Abbott failed to order and take delivery during
a prior Contract Year in order to satisfy the applicable Contractual Minimum
plus the Contractual Minimum for such subsequent Contract Year. The number of
units of OraQuick® ADVANCE™ Devices in excess of the Contractual Minimum for a
given Contract Year that Abbott orders and takes delivery during the Contract
Year shall not be credited to the Contractual Minimum for any subsequent
Contract Year.

2.1.6 Favored Nation Pricing. If, during the Term, OraSure exercises its right
under Section 2.1.5 to convert Abbott’s appointment under this Agreement with
respect to the Hospital Segment to non-exclusive as a result of Abbott failing
to meet the Contractual Minimum for any Contract Year, OraSure agrees that, for
Purchase Orders delivered by Abbott after such conversion, the Transfer Price
for Products purchased under such Purchase Orders shall not be higher than ***
of the lowest price charged by OraSure or its Affiliates to any third party
(other than Affiliates of OraSure) purchasing substantially similar volumes of
the same Products for sale or distribution in the Hospital Segment in the
Territory. In addition, with

 

9

--------------------------------------------------------------------------------

respect to the Physicians’ Office Segment, OraSure shall not provide Products to
any other distributor to the Physicians’ Office Segment at a transfer price
which is less than *** of the Transfer Price.

2.2 Restrictions. Abbott shall not, directly or indirectly, promote, market,
sell or otherwise distribute or provide (or arrange any sale, distribution or
provision of) the Products outside of the Hospital Segment, Physicians’ Office
Segment, U.S. Government Hospital Segment, Reference Lab Segment or the
Territory. Abbott further agrees not to sell the Products to customers whom
Abbott knows has resold or distributed or facilitated the resale or distribution
of the Products outside the Hospital Segment, Physicians’ Office Segment, U.S.
Government Hospital Segment, Reference Lab Segment or the Territory in violation
of this Agreement or to customers that Abbott knows intend to take such action.
For so long as Abbott’s appointment in any Segment under this Agreement is
exclusive, if Products sold by OraSure to a distributor are being resold inside
such Segment, then, upon written notice by Abbott of such occurrence, OraSure
shall pursue any contractual remedies it may have against such distributor, such
remedy to be determined by OraSure’s election in OraSure’s sole discretion, to
prevent such resale or distribution, including discontinuation of sales of
Products to such distributor, until such time as such distributor discontinues
selling Products in the applicable Segment. If Products sold by Abbott to a
distributor are being resold outside the Physicians’ Office Segment or outside
the Territory, then upon written notice by OraSure of such occurrence, Abbott
shall pursue any contractual remedies it may have against such distributor, such
remedy to be determined by Abbott’s election in Abbott’s sole discretion, to
prevent such resale or distribution including discontinuing of sales of Products
to such distributor or person until such time as such distributor or person
discontinues selling Products outside the Physicians’ Office or Territory, as
the case may be. The parties shall each designate a representative who will have
quarterly meetings with the other party’s representative to try to resolve any
issues that may arise related to Product being sold outside of either party’s
designated Segments.

2.3 Non-Assertion. During the Term and any additional period contemplated by
Section 13.3.3, OraSure covenants that it will not enforce any patent rights
owned or licensed by OraSure against Abbott, its Affiliates or its customers in
respect of the marketing, distribution, sale, and use of the Products in the
Segments in the Territory purchased by Abbott in accordance with this Agreement.

2.4 New Product. Except as provided in this Section 2.4, if OraSure develops a
New Product and desires to distribute the New Product in the Territory, OraSure
shall have no obligation to offer Abbott the right to distribute, market,
promote, sell and/or represent the New Product and Abbott shall have no
distribution rights with respect to such New Product. Notwithstanding the
foregoing sentence, if OraSure develops and desires to distribute a New Product
which consists solely of a device using OraSure’s OraQuick® platform for the
rapid, point of care detection of both HIV-1 and HIV-2 as well as one or more
other infectious diseases or conditions on the same device (an “OraQuick® Combo
Product”), OraSure shall provide Abbott with written notice thereof (“New
Product Notice”). Abbott shall have a right of first negotiation with respect to
the distribution of such OraQuick® Combo Product in the Segments in the
Territory for a ninety (90) day period commencing on the date it receives the
New Product Notice (the “Negotiation Period”), subject to the terms and
conditions set forth in this Section 2.4. During the Negotiation Period, the
parties shall negotiate in good faith regarding the terms

 

10

--------------------------------------------------------------------------------

and conditions of a distribution agreement with respect to such OraQuick® Combo
Product. If following the end of the Negotiation Period, the parties have not
executed and delivered a mutually agreeable form of distribution agreement
providing for the distribution by Abbott of such OraQuick® Combo Product in the
Segments in the Territory, (i) Abbott’s right of first negotiation with respect
to such OraQuick® Combo Product shall terminate (provided that Abbott shall have
a continuing first right of negotiation with respect to any different OraQuick®
Combo Products developed in the future, in accordance with the procedures set
forth in this Section 2.4) and (ii) OraSure shall be free to distribute the
OraQuick® Combo Product, directly or indirectly through one or more agents or
subdistributors, in any market or territory including the Segments in the
Territory, provided that any such distribution arrangement with a third party
entered into by OraSure or its Affiliates within twelve (12) months of the
expiration of the Negotiation Period shall be on terms which, when taken as a
whole, using reasonable judgment, are not materially more favorable to such
third party than those terms offered by OraSure to Abbott during the Negotiation
Period.

2.5 Improved Product. If OraSure develops an Improved Product and desires to
distribute, have distributed, market, have marketed, promote, have promoted or
sell or have sold such Improved Product in the Territory, Abbott shall have the
same rights to the Improved Product as it has to the Products under this
Agreement, and such Improved Product shall be deemed to be a “Product” hereunder
and may be supplied by OraSure in lieu of the original Product supplied
hereunder. Nothing in this Agreement shall obligate OraSure to develop or seek
FDA approval of an Improved Product, including without limitation an Improved
Product that has indications or claims that are different than those approved by
the FDA for the Products or reflected in the Regulatory Approvals as of the
Effective Date.

2.6 OTC Approval. It is possible that OraSure may seek to obtain FDA approval
for the marketing and sale of a device for the rapid, point-of-care detection of
HIV-1 and/or HIV-2 in the retail or over-the-counter market segment in the
Territory. Abbott shall have no rights with respect to the marketing, promotion,
distribution, representation and/or sale of such a device in the retail or
over-the-counter market segment in the Territory, and no adjustments shall be
made to this Agreement in connection with OraSure seeking or obtaining any such
FDA approval or OraSure directly or indirectly marketing, promoting,
distributing and/or selling such a device in the retail or over-the-counter
market segment in the Territory.

2.7 Sales to CDC, Etc. Nothing in this Agreement shall preclude OraSure from
marketing, promoting, selling or distributing Products to the Centers for
Disease Control and Prevention (“CDC”), the Substance Abuse and Mental Health
Services Administration (“SAMHSA”) or other government agencies, including
without limitation state or county public health departments. OraSure shall
exercise commercially reasonable efforts to prevent the CDC, SAMHSA and such
other governmental agencies from reselling any Product into the Hospital Segment
or U.S. Government Hospital Segment; provided that in the event the CDC, SAMHSA
or such other governmental agency donates or otherwise provides or uses any
Product in Hospitals for clinical studies or other purposes, such action shall
not constitute a breach of this Agreement by OraSure, or entitle Abbott to any
adjustments to this Agreement except as provided below. So long as Abbott’s
appointments under Sections 2.1.1 and 2.1.3 have not been converted to
non-exclusive or terminated within sixty (60) days following the end of each
Contract Year, or, if such appointments are converted or terminated, such
conversion or

 

11

--------------------------------------------------------------------------------

termination was reasonably caused by such reselling or donating by the CDC,
SAMHSA or other such governmental agencies, the parties shall meet to discuss
the quantity of OraQuick® ADVANCE™ Devices sold by OraSure to the CDC, SAMHSA or
other governmental agencies that are shown by reasonable documentation to have
been sold or distributed by the CDC, SAMHSA or such agency into the Hospital
Segment or U.S. Government Hospital Segment during such Contract Year other than
for purposes of a clinical or non-clinical study or research (the “Subject
Quantity”). If the Subject Quantity is greater than ten percent (10%) of the
Contractual Minimum for the preceding Contract Year, the parties shall negotiate
in good faith an appropriate adjustment to the Contractual Minimum for the next
Contract Year, taking into account whether the same or different Subject
Quantity is reasonably expected during such next Contract Year.

2.8 Records; Audit. Abbott and OraSure each shall keep records sufficient, in
accordance with generally accepted accounting principles in the United States,
to permit verification of the determination of the Subject Quantity made under
Section 2.7, above, and any other information required by Section 2.7, and as
may be required to confirm that each such party is marketing and selling Product
within the segments permitted under this Agreement. Such records shall be
maintained and made available for examination in accordance with this
Section 2.8 for at least two (2) years after the close of the applicable
Quarterly Period to which they relate. Abbott and OraSure each shall permit such
records to be examined during normal business hours by independent third party
public accountants designated by the other party and reasonably acceptable to
the party being audited. Such accountants shall report to the party requesting
the audit only the amount by which the Subject Quantity in respect of the
audited period was overstated or understated and the amount of Product being
sold by either party which is not in compliance with this Agreement, and the
basis for such determination, and shall make such report simultaneously
available to both OraSure and Abbott. Such accountants shall also agree to keep
any information they obtain during an audit and the results of their audit
confidential pursuant to the terms of a confidentiality agreement with the party
being audited, which agreement shall be in form and substance reasonably
satisfactory to the party being audited. Any dispute regarding the Subject
Quantity or regarding whether a party is marketing or selling Products in a
segment which is not in compliance with this Agreement, shall be brought to the
Oversight Committee for resolution and, if not resolved, shall be handled
pursuant to Section 5.13.

2.9 Transition. The parties acknowledge that, prior to the Effective Date,
OraSure entered into commitments to sell Products into the Hospital Segment.
OraSure shall, subject to the proviso set forth at the end of this sentence,
(a) cease selling Products directly into the Hospital Segment and (b) use
commercially reasonable efforts to terminate or transfer to Abbott its existing
contractual commitments to sell Products to that Segment; provided that in no
event shall OraSure be required to breach any contract that it made prior to the
Effective Date with respect to the sale or distribution of the Product into the
Hospital Segment (including the sale and supply of Products pursuant to purchase
orders issued and accepted after the Effective Date under such contracts).

 

12

--------------------------------------------------------------------------------

ARTICLE 3 - OBLIGATIONS OF ABBOTT.

3.1 Level of Effort. Abbott shall use commercially reasonable efforts to market
and promote the Products in the Hospital Segment, Physicians’ Office Segment and
U.S. Government Hospital Segment.

3.2 Competition. During the Term, Abbott shall not, directly or indirectly
(including without limitation through Affiliates or other third parties or
business arrangements), develop, import, manufacture, market, promote,
distribute or sell any rapid, point-of-care test for detecting HIV-1 or HIV-2
(including a test that can detect HIV-1 and/or HIV-2 as well as one or more
other diseases or conditions) that competes or would compete with the OraQuick®
ADVANCE™ Device in the Territory (a “Competing Product”), provided that such
prohibition shall not include any product sold or supplied by OraSure to Abbott.
If any provision of this Section 3.2 shall be held unenforceable because of
scope, duration or area of its applicability, it shall be deemed modified to the
extent necessary to make it enforceable, while preserving its intent, In the
event Abbott fails to comply with this Section 3.2, OraSure’s sole remedy shall
be to terminate this Agreement in accordance with Section 13.2.2.

3.3 Staffing. Abbott shall provide sufficient staffing in order to meet its
obligations under this Agreement to promote, market, sell and distribute the
Products for use in the Hospital Segment, Physicians’ Office Segment and U.S.
Government Hospital Segment.

3.4 Compliance with Laws. Abbott shall comply with all applicable treaties,
laws, rules, regulations and Regulatory Approvals within the Territory in
connection with its promotion, marketing and/or sale of the Products and
performance of its obligations under this Agreement.

3.5 Records. Abbott shall maintain accurate and complete records of its sales of
the Products including an auditable method of determining the particular Segment
(i.e., Hospital Segment, Physicians’ Office Segment, U.S. Government Hospital
Segment and Reference Lab Segment) into which a particular unit of the Products
is distributed or sold by Abbott. The records shall include but not be limited
to the quantity of Product sold in units by region and Segment (and by
individual customers in the Hospital Segment and U.S. Government Hospital
Segment) in a manner sufficient for OraSure to allocate sales to their sales
personnel. In addition, Abbott shall maintain accurate and complete records of
all customer complaints or inquiries it receives with respect to the Products
and any responses or investigations related to such complaints or inquiries.
Abbott shall maintain such records for at least three (3) years from the date of
sale or such longer period as may be required by applicable law or regulation.
Abbott shall comply with all applicable record-keeping requirements imposed by
the FDA in the Territory. At OraSure’s expense, Abbott shall cooperate with
OraSure in OraSure’s communication and correspondence with the FDA, including
providing information required by OraSure to respond to or prepare filings with
the FDA, provided that any Confidential Information provided by Abbott shall be
maintained by OraSure in accordance with Article 12. Other than as required
under this Section 3.5, for the purposes of complying with an FDA audit or
investigation, as contemplated under Article 5 (including providing reports
under Section 5.12), or complying with the audit requirements in Section 8.2,
Abbott shall not be obligated to disclose the records required by this
Section 3.5 to OraSure.

 

13

--------------------------------------------------------------------------------

ARTICLE 4 - OBLIGATIONS OF ORASURE.

4.1 Regulatory Approvals. OraSure shall use commercially reasonable efforts to
obtain and maintain all requisite Regulatory Approvals in the Territory. All
such Regulatory Approvals shall be owned by OraSure or its nominee. OraSure
shall bear all costs related to obtaining and maintaining all Regulatory
Approvals.

4.2 Compliance with Laws. OraSure shall comply with all applicable treaties,
laws, rules, regulations and Regulatory Approvals within the Territory in
connection with its Manufacture of the Products and performance of its
obligations under this Agreement.

4.3 Approved Vendor. Abbott shall only accept a Product that was manufactured at
a facility that has passed an Abbott supplier quality audit for qualification as
an “Approved Vendor”. Abbott may perform annual quality audits pursuant to this
Section 4.3 and Section 6.3. The scope of any quality audit permitted hereunder
shall be subject to approval by OraSure and Abbott, which shall not be
unreasonably withheld. The parties acknowledge that Abbott has recently
performed such an audit at OraSure’s Bethlehem, Pennsylvania facilities, but not
specifically for the Products, and that at the time of such audit, OraSure was
found to be an Approved Vendor. Abbott shall also be entitled to perform a
quality audit at OraSure’s Bethlehem, Pennsylvania facility (not to exceed one
(1) week in duration) within thirty (30) days after the execution of this
Agreement and at each relocated Approved Facility at which OraSure will
Manufacture the Products no later than thirty (30) days after receipt of
OraSure’s notice to Abbott of the relocation of the Approved Facility. Any
audits permitted under this Section 4.3 shall otherwise be performed in
accordance with Section 6.3. Within thirty (30) days after the completion of
each quality audit performed after the date of this Agreement, Abbott shall
inform OraSure in writing of the results of such audit. If OraSure does not pass
any audit and the reasons for such failure can be remedied within a reasonable
period of time (which shall not be less than sixty (60) days), then Abbott shall
provide OraSure with a list of proposed remedial action items and a proposed
commercially reasonable timeframe within which to accomplish such action items.
If (i) OraSure does not pass such audit and the reasons for such failure cannot
be remedied within a reasonable period of time, (ii) OraSure fails or elects not
to complete any remedial actions suggested by Abbott, or (iii) the parties are
unable to agree on the appropriate scope of the audit, then Abbott’s sole and
exclusive remedy shall be to terminate this Agreement in accordance with the
provisions of Section 13.2.3. Notwithstanding the foregoing, in no event shall
OraSure be required to meet quality requirements more stringent than those
required under any Regulatory Approvals applicable to the Manufacture of the
Products in the Territory, and OraSure shall not be required to disclose or make
available to Abbott any of OraSure’s proprietary technology, know-how, trade
secrets, processes, methods or raw materials relating to the Products or
otherwise.

4.4 Manufacturing Changes. OraSure shall notify Abbott in writing of any changes
in its manufacturing process which could potentially affect the safety or
efficiency or materially affect the fit, form or function of the Products,
including but not limited to any changes that affect written quality plans for
production or written quality procedures respecting same, as well as any changes
outside the validated level or procedure, in manufacturing procedures, component

 

14

--------------------------------------------------------------------------------

part or raw materials vendors, manufacturing sites or batch sizes. Upon the
request of Abbott, OraSure shall provide to Abbott representative samples of
such changed Products in reasonable quantities. In the event such manufacturing
change has an impact on any Regulatory Approvals, OraSure shall be responsible
for and bear the costs of any amendment, notification or resubmission required
with respect to such Regulatory Approvals as a result of such manufacturing
change.

ARTICLE 5 – PRODUCT COMMERCIALIZATION.

5.1 Joint Promotion. The parties hereby agree to jointly Promote the Products in
the Segments in the Territory, as provided in this Article 5.

5.2 Oversight Committee. In order to effect the objectives of this Article 5,
the parties agree to establish an oversight committee which shall operate as
provided below (“Oversight Committee”).

5.2.1 Composition. The Oversight Committee shall consist of the sales and
marketing managers and such other relevant personnel (as needed) from each party
as each party shall appoint from time to time. The Oversight Committee shall
have two (2) co-chairpersons, one designated by each of OraSure and Abbott. Each
party shall confirm to the other in writing its representatives to serve on the
Oversight Committee.

5.2.2 Meetings. The Oversight Committee shall, at a minimum, meet once each
calendar quarter, and as otherwise mutually agreed by the parties. Meetings may
be held in person, by telephone, or by video conference call, and the location
of each meeting shall alternate between sites selected by each of the parties’
respective co-chairperson, unless otherwise agreed. Additional participants may
be invited by any representative to attend meetings where appropriate.

5.2.3 Decision-Making. All decisions by the Oversight Committee shall be made by
vote of the co-chairpersons, with each co-chairperson having one vote, and all
decisions shall be by unanimous consent of the co-chairpersons. The parties
shall cause their respective representatives on the Oversight Committee to use
diligent efforts, acting in good faith, to resolve all matters presented to them
as expeditiously as possible. Each party shall be responsible for expenses
incurred by its employees and representatives in attending or otherwise
participating in Oversight Committee meetings and activities. To the extent the
Oversight Committee is unable to resolve any matter or dispute which should
arise, the procedures set forth in Section 5.13, shall be followed.

5.2.4 Duties and Responsibilities. The Oversight Committee will be responsible
for all Promotional activities as set forth herein, including but not limited
to, the following:

 

  (a) Determine the general Marketing Plan as provided in Section 5.3, including
general positioning, sales and marketing strategies for the Hospital Segment and
U.S. Government Hospital Segment;

 

15

--------------------------------------------------------------------------------

  (b) Develop advertising material and strategies and other sales and
Promotional materials for use by the Abbott sales representatives for the
Products, design packaging for the Products (subject to Article 9), and plan and
oversee educational and professional symposia, trade shows and other similar
activities and speaker and activity programs for the Products in the Territory;

 

  (c) Develop and implement a publication strategy for the Products, targeted at
the Segments;

 

  (d) Coordinate and develop Product presentations and Product exhibits and
booths for use at medical or trade show meetings and Promotional events;

 

  (e) Schedule periodic joint meetings for the Abbott and OraSure sales forces
and marketing representatives; and Provide updates to each party’s management
regarding the Oversight Committee’s activities and progress against the
Marketing Plan.

5.3 Marketing Plan. The Oversight Committee shall develop a marketing plan
(each, a “Marketing Plan”) for each Contract Year during the Term, consistent
with the terms of this Agreement, applicable law and the Regulatory Approvals.
The Oversight Committee shall review the Marketing Plan during each quarterly
period and make any modifications or updates deemed necessary by the Oversight
Committee based on such review. OraSure shall be permitted to engage in
Promotion, marketing and sales support activities, as provided in this Agreement
and the Marketing Plan or as otherwise approved by the Oversight Committee. The
Marketing Plan will describe the plan for promoting, marketing, advertising and
selling the Products in the Segments in the Territory, including: (a) general
strategies for the marketing of the Products (including positioning, sales and
marketing strategies for the Hospital Segment and U.S. Government Hospital
Segment) and allocation of responsibilities for marketing activities; (b) each
party’s training activities; (c) sales and marketing forecasts for the Products;
(d) advertising, public relations, and other Promotional programs, including
professional symposia, speaker and activity programs and trade shows to be used
in the Promotion of the Products in the Segments; and (e) such other matters
related to the Promotion of the Products as the Oversight Committee shall
determine. The parties may from time to time add to or modify the scope of the
Marketing Plan and responsibilities and duties of the Oversight Committee by
setting forth such additions or modifications in a written instrument agreed to
by both parties.

5.4 Training. OraSure shall provide initial Product training for Abbott’s sales
force in accordance with OraSure’s existing training programs at such time. Such
initial training shall occur on not more than three occasions, at such times and
locations as may be mutually agreed by the parties. OraSure shall be permitted
to attend and participate in Abbott’s annual sales meetings and other meetings
of Abbott’s sales force; provided that such participation shall be limited to
those portions of the meetings dealing with the Segments for which Abbott
maintains an exclusive appointment hereunder and for which no proprietary or
confidential information will be disclosed. OraSure shall provide additional
ongoing sales and Product training for Abbott sales representatives, or assist
Abbott in providing such training, as may be mutually agreed by the parties.
Abbott shall be responsible for the costs of the foregoing training and sales
meetings

 

16

--------------------------------------------------------------------------------

including production of training materials, except that OraSure shall be
responsible for its lodging and transportation costs of attending such training
meetings.

5.5 Promotional Materials. The Abbott sales forces will only use promotional,
advertising, marketing, communication and educational materials, including all
written, graphic, electronic, audio and video pieces, general advertisements,
direct mail, internet postings, broadcast advertisements and sales aids relating
to the Products that have been approved by the Oversight Committee for Promotion
in the Segments in the Territory (“Promotional Materials”), and shall only
conduct Promotional activities for the Products, which in each case have been
approved in the Marketing Plan or otherwise by the Oversight Committee and
comply with the Regulatory Approvals. At substantially the same time that any
Promotional Materials and any Product-related communication is sent in hard
copy, electronically, by voice mail or otherwise by Abbott to its sales force,
Abbott will provide OraSure with copies of all such materials. All Promotional
activities conducted by the Abbott sales force shall be consistent with the
Promotional Materials so approved, the then-current Marketing Plan, applicable
law and the Regulatory Approvals. Unless and until Promotional Materials are
approved by the Oversight Committee for publication or other general
dissemination, each party shall maintain them in confidence pursuant to the
terms of Article 12; provided that nothing herein shall preclude OraSure from
using Promotional Materials that it develops for promotional activities and
sales in the Physicians’ Office Segment or any other segment in which OraSure is
permitted to Promote, distribute or sell Products.

5.6 Samples and Free Product. The parties, through the Oversight Committee,
shall determine whether it is necessary and appropriate to undertake a sampling
program for the Products or to otherwise make available “free Product” to
customers within the Segments. If a sampling or “free Product” program is
adopted within the Segments, Abbott shall be solely responsible for accounting
for the Product used in such program and shall make such records available to
OraSure.

5.7 Medical Inquiries. The Oversight Committee will provide Abbott with
information and materials appropriate to allow its medical and sales
professionals, as appropriate, to respond to those medical questions or
inquiries from medical and paramedical professions relating to any Promotional
Materials. Any medical questions or inquiries that do not relate to Promotional
Materials will be forwarded to OraSure for the appropriate response to those
questions or inquiries. Abbott will only use the materials provided by the
Oversight Committee, which shall be consistent with the relevant FDA-approved
Product labeling and applicable Regulatory Approvals, when answering questions
and inquiries under this Section 5.7.

5.8. Trade Shows, Meetings, Symposia and Marketing Activities. It is generally
agreed that Product presentations, exhibits and booths at meetings and symposia,
including trade shows related to or including the Segments, will be a joint
Abbott and OraSure activity under the Marketing Plan and that the costs thereof
shall be borne by Abbott, except for OraSure’s out-of-pocket expenses of
attending such meetings and symposia. To the extent that Abbott sponsors an
exhibit or booth and intends to Promote the Products at such event, space for
promoting the Products will be provided in accordance with the Marketing Plan
and OraSure shall be permitted to send a representative to such exhibit or
booth. To the extent not included within the

 

17

--------------------------------------------------------------------------------

Marketing Plan, OraSure, at its sole expense, shall have the right to make
Product presentations and have its own exhibits and booths that feature the
Products, provided that any such presentations, exhibits and booths are
consistent with the Marketing Plan to the extent directed at any of the
Segments.

5.9 Abbott Sales Force. Abbott shall maintain a sales force in the Territory
comprised of sales representatives who are adequately trained to Promote the
Products in the Segments in the Territory. Nothing in this Agreement shall be
construed to provide that any employees or agents of Abbott are employees or
agents of OraSure or subject to OraSure’s direction and control. Abbott shall
have sole authority over the terms and conditions of its employees’ and agents’
employment, and shall select, engage and discharge its employees and agents in
its sole discretion. Abbott agrees that the sales of the Products in the
Hospital Segment and U.S. Government Hospital Segment may constitute an element
in the variable compensation of Abbott’s sales representatives for such
Segments, as determined by Abbott.

5.10 OraSure Sales Force. OraSure may, at its option, maintain a sales force in
order to provide Promotional and sales support for the Abbott sales force, for
the purpose of Promoting and selling the Products into the Segments in the
Territory. The OraSure sales force may perform those functions specifically set
forth in the Marketing Plan and may include customer meetings and co-traveling
with Abbott sales representatives, training and other support. OraSure may
directly solicit sales in the Hospital Segment, U.S. Government Hospital Segment
and Reference Lab Segment so long as such activity is coordinated with Abbott
and all such sales are referred to Abbott for handling in accordance with this
Agreement.

5.11 Responsibility for Expenses. Except as otherwise specifically provided
herein, Abbott shall be solely responsible for all sales and Promotional
expenses related to the Segments, including without limitation, expenses
incurred for sales aids, training programs and materials, collateral materials,
exhibits, trade shows and conventions, direct mail programs, broadcast
advertisements, journal advertisements, peer influence/symposia, public
relations, and sampling and “free Product”, and screening programs.

5.12 Sales Reports. Notwithstanding anything to the contrary contained in this
Agreement, Abbott shall deliver to OraSure by the tenth (10th) day of each month
a general summary of Abbott Net Sales by Segment for the preceding month and by
the fifteenth (15th) day of each Quarterly Period during the Term a report in
form mutually agreed by the parties, setting forth the Abbott Net Sales, broken
down by Segments and geographic territory within the Territory (including solely
with respect to the Hospital Segment and U.S. Government Hospital Segment the
quantity of Product sold in units by region and individual customers in a manner
sufficient for OraSure to allocate sales to their sales personnel.) for the
preceding Quarterly Period and on a Contract Year-to-date basis.

5.13 Deadlocks. If for any reason the Oversight Committee cannot resolve any
matter properly referred or presented to it, either party may refer the matter
to the Senior Managers for resolution. If after discussing the matter in good
faith and attempting to find a mutually satisfactory resolution to the issue,
the Senior Managers fail to come to consensus within thirty (30) days of the
date on which the matter is referred to the Senior Managers, either party may

 

18

--------------------------------------------------------------------------------

refer the matter to the Senior Executives for resolution. If after discussing
the matter in good faith and attempting to find a mutually satisfactory
resolution to the issue, the Senior Executives fail to come to consensus within
thirty (30) days of the date on which the matter is referred to the Senior
Executives, the provisions of Section 14.13 shall apply for resolution of the
matter. It is the parties’ intention to exercise diligent efforts to resolve all
matters without resorting to Section 14.13, if possible.

ARTICLE 6 - QUALITY ASSURANCE.

6.1 Facility Compliance. OraSure shall maintain the Approved Facility and shall
conduct all Manufacturing in compliance with all applicable laws, rules,
regulations and Regulatory Approvals, including QSRs, at all times during the
Term of this Agreement. OraSure shall be responsible for all costs and expenses
related to the compliance of the Approved Facility with such laws, rules and
regulations. OraSure shall notify Abbott at least thirty (30) days prior to any
relocation of the Approved Facility. In the event a relocation of the Approved
Facility has an impact on any Regulatory Approvals, OraSure shall be responsible
for and bear the costs of any amendment, notification or resubmission required
with respect to such Regulatory Approvals as a result of such relocation of the
Approved Facility.

6.2 Quality Control. OraSure shall maintain a quality control program consistent
with QSRs and other applicable laws or regulations. In addition, OraSure will
test and release Products in accordance with its quality control program. Each
shipment of Products from OraSure to Abbott shall be accompanied by a
certificate of compliance from OraSure’s quality assurance department indicating
that the Products, as sampled pursuant to OraSure’s quality control program,
have passed the quality control parameters developed by OraSure. OraSure shall
notify Abbott as soon as practicable after OraSure becomes aware of any material
design or manufacturing problems with respect to the Products and subsequently
OraSure and Abbott shall meet to discuss solutions to any such problems.

6.3 Audit Rights. Abbott shall have the right, upon thirty (30) days’ prior
written notice to OraSure, to conduct during normal business hours a quality
assurance audit (subject to Section 4.3) and inspection of OraSure’s records and
production facilities relating to OraSure’s compliance with the terms of this
Agreement, including with respect to the Manufacture of Products, and to perform
follow-up audits as reasonably necessary. The duration of such audits shall not
exceed three (3) days and such audits shall be performed by no more than three
(3) auditors. Notwithstanding the foregoing, in no event shall Abbott be
entitled to conduct more than one (1) audit in any Calendar Year, whether such
audit occurs under Section 4.3 or this Section 6.3, unless significant
compliance issues are discovered during such audit in which case Abbott shall be
entitled to conduct reasonable follow up audits in accordance with this
Section 6.3. At OraSure’s request, Abbott shall provide OraSure with a written
summary of the results of any audit conducted under this Section 6.3.
Notwithstanding the foregoing, Abbott shall have the right at any time during
the Term of this Agreement, upon reasonable prior written notice to OraSure, to
conduct any audits specifically mandated by the FDA or to respond to specific
questions from the FDA, to the extent such audits relate to the Products or
Manufacture thereof.

 

19

--------------------------------------------------------------------------------

Visits by Abbott to OraSure’s production facilities may involve the transfer of
Confidential Information, and any such Confidential Information shall be subject
to the terms of Article 12 hereof. The results of such audits and any
information obtained during such audits shall be considered Confidential
Information of the party disclosing such Confidential Information and shall not
be disclosed by the receiving party to third persons, including but not limited
to the FDA, except in accordance with Article 12.

If Abbott utilizes auditors that are not employees of Abbott, each of such
auditors shall execute a non-disclosure agreement, with confidentiality terms at
least as stringent as those set forth herein which protect the Confidential
Information of OraSure, and Abbott shall provide OraSure with written
representation that such auditors have executed such non-disclosure agreement.

6.4 Recalls. In the event OraSure shall be required (or shall voluntarily
decide) to initiate a recall, withdrawal or field correction of, or field alert
report with respect to, the Products, whether or not such recall, withdrawal,
field correction or field report has been requested or ordered by the FDA,
OraSure shall notify Abbott, and Abbott shall fully cooperate with OraSure, at
OraSure’s expense, to implement the same. OraSure shall make all contacts with
the FDA and shall be responsible for coordinating all of the necessary
activities in connection with any such recall, withdrawal, field correction or
field alert report, and subject to Section 12.1 and 12.4, OraSure shall make all
statements to the media, including press releases and interviews for publication
or broadcast. Abbott agrees to make no statement to the media, except to refer
the media to OraSure for comment, unless otherwise required by law, and in any
such event, Abbott shall cooperate with OraSure and obtain OraSure’s prior
approval on the content of any such statement. OraSure shall indemnify Abbott
against all reasonable and necessary costs and expenses that Abbott may incur as
a result of any recall, withdrawal, field correction or field alert, except to
the extent it is the direct result of any fault or omission attributable to
Abbott, its Affiliates or permitted subdistributors or agents. Abbott shall
indemnify OraSure against all reasonable and necessary costs and expenses that
OraSure may incur as a result of any recall, withdrawal, field correction or
field alert to the extent that it is the direct result of any fault or omission
attributable to Abbott, its Affiliates or permitted subdistributors or agents.
In no event shall either party have liability to the other for lost profits.

6.5 Adverse Experience. Any adverse experience information obtained by Abbott
shall be reported to OraSure, by telephone or by facsimile within three
(3) business days after Abbott’s initial receipt of any such information:
provided, however, any report of a serious adverse event or any report of a
death shall be reported to OraSure by telephone within twenty-four (24) hours
after Abbott’s receipt of the information and by facsimile within forty-eight
(48) hours after Abbott’s receipt of the information. Reports under this
Section 6.5 shall be sent to OraSure’s Vice President, Regulatory Affairs and
Quality.

6.6 Customer Support and Complaints. OraSure shall also provide and maintain, at
its own expense, adequate support services and a staff properly trained in all
aspects of the Products to provide Abbott with such levels of customer service
and technical support throughout the Term that are commercially reasonable in
light of the then current and reasonably

 

20

--------------------------------------------------------------------------------

anticipated sales volumes of the Products under this Agreement. Such customer
service and technical support will be available Monday through Friday during the
hours of 8 a.m. to 5 p.m. Eastern Time by dialing a toll-free telephone number
established by OraSure. In the event that Abbott receives any customer complaint
regarding Products covered by this Agreement, Abbott shall give OraSure written
notice of the complaint as soon as practicable and in no event later than ten
(10) days after Abbott’s receipt of the complaint, which notice shall include a
copy of any written correspondence of the customer and Abbott and a written
summary of any oral communications in respect of such complaint. OraSure shall
commence the investigation and evaluation of customer complaints received on
Products sold to customers by Abbott as soon as practicable but in no event
later than ten (10) days after OraSure’s receipt of Abbott’s written notice of
any such complaint. OraSure shall use commercially reasonable efforts to close
any customer complaint evaluation and investigation as soon a practicable and,
if practicable, in no event later than thirty (30) days after OraSure’s receipt
of the complaint or notice of the complaint. OraSure shall handle all follow-up
of and correction regarding Product complaints directly with the customer unless
otherwise stated herein or otherwise agreed between the parties. At Abbott’s
reasonable request, OraSure shall provide Abbott reasonable access to customer
complaint evaluations and closed records relating thereto with respect to any
Product sold to Abbott hereunder. Notwithstanding the foregoing, Abbott will be
responsible for investigating and evaluating, and will bear all costs of
evaluation, investigation and closure of, any customer complaint to the extent
such complaint results from any cause or event arising from factors that are
attributable solely to Abbott or its Affiliates, sub-distributors or agents
(such complaint, an “Abbott Complaint”). Abbott promptly shall provide notice to
OraSure of each Abbott Complaint and, at OraSure’s reasonable request, Abbott
shall provide OraSure reasonable access to Abbott Complaint evaluations and
closed records relating thereto. Unless otherwise agreed by the parties, Abbott
shall handle all follow-up of and correction regarding Abbott Complaints
directly with the applicable customers. As necessary, Abbott shall handle all
follow-up and correction regarding Abbott Complaints directly with the FDA.
Notwithstanding the foregoing, the parties shall cooperate in communicating with
any customer concerning a complaint (including an Abbott Complaint), and both
Abbott and OraSure shall be permitted to communicate with such customer (so long
as it advises the other party in writing of such communication and any response
from the customer) to the extent required to meet applicable legal or regulatory
requirements or the requirements of this Agreement.

6.7 Retention of Samples. OraSure shall retain a sufficient quantity of each
batch of the Products to allow investigation of complaints and confirmation of
product shelf life. OraSure shall maintain samples of each batch of the Products
in a suitable storage facility until at least six (6) months after the end of
the assigned shelf life of such batch, or such longer period as may be required
under applicable law, regulation or rule. All such samples shall be available
for inspection by Abbott or a third party chosen by Abbott at its sole
discretion, including but not limited to any Affiliate of Abbott, upon
reasonable notice.

6.8 Batch Failures. OraSure shall notify Abbott as soon as practicable and in no
event later than five (5) business days after discovery of any batch failure
that could result in OraSure’s inability to meet Abbott’s requested delivery
dates. OraSure shall notify Abbott as soon as practicable and in no event later
than three (3) business days after any failure of a released batch of Products
distributed to Abbott.

 

21

--------------------------------------------------------------------------------

6.9 Notification of Inspections. OraSure agrees to notify Abbott of any action
by the FDA in regard to the Products or OraSure’s Manufacturing activities that
could materially affect OraSure’s ability to perform its obligations hereunder.

ARTICLE 7 - ORDERING AND DELIVERY.

7.1 Generally. Abbott may order units of the Products by issuing binding
purchase orders (each, a “Purchase Order”) to OraSure pursuant to the terms of
this Agreement. Each Purchase Order or any acknowledgment thereof, whether
printed, stamped, typed, or written, shall be governed by the terms of this
Agreement and none of the provisions of such Purchase Order or acknowledgment
shall be applicable except those specifying quantity ordered, delivery dates,
special shipping instructions and invoice information.

7.2 Acceptance or Rejection of Purchase Orders. OraSure shall indicate its
acceptance or rejection of each Purchase Order within ten (10) business days
after receipt; provided that OraSure may reject a Purchase Order, in whole or in
part, only if: (a) the Purchase Order fails to comply with the terms and
conditions of this Agreement; (b) the delivery date is less than ninety
(90) days from the date of OraSure’s receipt of such Purchase Order; or (c) the
volume under the Purchase Order and all other accepted Purchase Orders covering
the applicable monthly period exceeds the volume set forth in Abbott’s
then-current forecast (delivered pursuant to Section 7.3) by more than fifty
percent (50%). If requested by Abbott, following Abbott’s receipt of OraSure’s
rejection notice under clause (c) above, OraSure will use commercially
reasonable efforts to deliver the excess volume of the Products specified in the
rejected Purchase Order, but OraSure’s failure to so deliver the excess volume
shall not be a breach of this Agreement. OraSure shall use commercially
reasonable efforts to fill Abbott’s orders for the Products. In no event shall
OraSure be liable to any third party for OraSure’s failure to deliver the
Products to Abbott by any delivery date set forth in any Purchase Order.

7.3 Forecasts. Within thirty (30) days after the Effective Date, Abbott shall
issue to OraSure Abbott’s written forecast of Abbott’s anticipated monthly
requirements for the Products during the next twelve (12) calendar month period.
Thereafter, Abbott shall provide to OraSure monthly a rolling twelve (12) month
forecast of requirements of Products to be supplied by OraSure. The first three
(3) months of such forecast shall be binding on Abbott and may not be cancelled
or rescheduled without prior written agreement of OraSure. The remaining nine
(9) months of such forecast shall be used by OraSure for planning purposes only
and shall not be considered firm orders.

7.4 Shipment. OraSure shall ship Products FCA (Incoterms 2000) the Approved
Facility. OraSure shall be deemed to have delivered the Products and title and
risk of loss shall pass to Abbott at the time such Products are loaded onto a
carrier designated by Abbott. Abbott shall be responsible for all shipping and
insurance costs. OraSure shall ensure that the Products are suitably packed in
bulk for shipment in OraSure standard containers. OraSure shall provide to
Abbott, in advance of each shipment, all necessary information relating to such
shipment, including without limitation, the identity of the carrier, flight
number or similar information, scheduled arrival time and package identification
number. All shipments under this Agreement shall be made to a single centralized
shipping destination identified by Abbott in writing after the date of this
Agreement, and each shipment hereunder shall contain not less than 5,000

 

22

--------------------------------------------------------------------------------

OraQuick® ADVANCE™ Devices. All Products purchased hereunder shall be purchased
in OraSure’s standard type and size boxes, which for purposes of the OraQuick®
ADVANCE™ Devices shall contain either 25 or 100 OraQuick® ADVANCE™ Devices.

7.5 Inspection by Abbott. Within thirty (30) days after receipt of the Products,
Abbott shall check whether there is any shortage and whether the Products are in
compliance with the warranties stated in Article 10. If Abbott finds any
shortage, Abbott shall notify OraSure within thirty (30) days of receipt of the
Products and Abbott’s sole remedy shall be prompt shipment by OraSure of
additional Products so that Abbott receives the proper quantity. If Abbott finds
any noncompliance with the warranties stated in Article 10, then Abbott shall
follow the procedures indicated in Article 10.

7.6 Safety Stock. Within thirty (30) days after the first delivery of Products
to Abbott, OraSure shall maintain at least a six (6) month safety stock of the
critical components (including, but not limited to, antigens and nitrocellulose)
for the Products, based on the most recent forecast provided by Abbott pursuant
to Section 7.3. OraSure shall rotate the safety stock with each new
manufacturing lot.

7.7 Failure to Supply.

7.7.1 Abbott Remedies. If, during any Contract Year, OraSure is unable for any
reason to supply at least ninety percent (90%) of the quantities of Products, in
accordance with the terms and conditions of this Agreement ordered by binding
Purchase Order that complies with the terms of Article 7 (which quantities shall
not include any excess quantities contemplated by Section 7.2 (c)), and such
failure continues for at least sixty (60) days after the delivery date set forth
in such Purchase Order, then Abbott may elect either of the following: (i) to
adjust the Contractual Minimums specified for such Contract Year under
Section 2.1.5 or (ii) to obtain a supply of a replacement rapid, point of care
diagnostic test for HIV-1 and HIV-2 (a “Replacement Product”) from a third party
(a “Third Party Supplier”) in an amount equal to the quantity of Product OraSure
is unable to supply. Abbott shall notify OraSure in writing of its election no
later than thirty (30) days after the end of the sixty (60) day period specified
above, after which Abbott shall no longer be entitled to exercise any remedy in
connection with such failure to supply.

7.7.2 Adjustment of Minimums. If Abbott elects to adjust the Contractual
Minimums as permitted in Section 7.7.1, the Contractual Minimum for the Contract
Year in which the failure to supply occurred shall equal (x) three hundred sixty
five (365) (or the actual number of days in such Contract Year) minus the number
of days after the applicable delivery date the failure to supply continued,
multiplied by (y) the quotient of the unadjusted Contractual Minimum for such
Contract Year divided by three hundred sixty five (365) (or the actual number of
days in such Contract Year).

7.7.3 Third Party Supplier. If Abbott exercises its right to have a Third Party
Supplier manufacture and supply a Replacement Product pursuant to Section 7.7.1
and thereafter during the Term OraSure desires to resume supplying Abbott with
the Product (whether by OraSure, through another source or otherwise), then
OraSure shall notify Abbott of such desire. Abbott shall then resume purchasing
Product exclusively from OraSure for the remainder of the

 

23

--------------------------------------------------------------------------------

Term of this Agreement as soon as OraSure demonstrates to Abbott’s reasonable
satisfaction that OraSure (whether by OraSure, another source or otherwise) is
capable of re-establishing a satisfactory supply of Product; provided that
Abbott shall not be required to cancel any contract with a Third Party Supplier
or a purchase orders for Replacement Product with a Third Party Supplier that
were issued in accordance with the forecasts required by Section 7.3 to the
Third Party Supplier prior to the date that OraSure gave Abbott notice of its
desire to resume supply. Abbott agrees that it will not enter into any contracts
with Third Party Suppliers in accordance with this Section under which Abbott
cannot terminate its purchase commitments for Product within six (6) months from
the date such contracts are executed. If OraSure is capable of re-establishing a
supply of Product and Abbott does not resume purchasing Product exclusively from
OraSure for any reason including a contractual commitment to a Third Party
Supplier, then OraSure shall be permitted to directly or indirectly market,
distribute and sell Products into the Hospital Segment and the U.S. Government
Hospital Segment, notwithstanding Abbott’s exclusive appointment to such
Segments, until Abbott resumes purchasing Product exclusively from OraSure;
provided that OraSure shall redirect any customers it obtains in the Hospital
Segment and U.S. Government Hospital Segment to Abbott once Abbott resumes
purchasing Product exclusively from OraSure, and any sales by OraSure to such
customers shall be credited against the Contractual Minimums for the Contract
Year in which such sales occur. Any action by OraSure pursuant to the preceding
sentence shall not constitute a waiver of OraSure’s available remedies in the
event Abbott fails to resume purchasing Product exclusively from OraSure in
accordance with this Section 7.7.3.

7.7.4 Nondiscrimination. In the event OraSure is unable to supply all Product
ordered by Abbott hereunder (other than excess quantities of Product
contemplated by Section 7.2 (c)), OraSure shall distribute available Product to
Abbott on a pro-rata basis with OraSure’s other customers based upon each
customer’s (including Abbott’s) aggregate purchases for the prior twelve
(12) months.

ARTICLE 8 - COMPENSATION.

8.1 Transfer Price.

8.1.1 Transfer Prices. Abbott shall pay OraSure the applicable per unit Transfer
Price as set forth in Exhibit _1.53 for Products ordered under this Agreement.
The Transfer Price payable by Abbott hereunder may be adjusted by OraSure in
accordance with Exhibit 1.50. The Transfer Prices are based on the assumption
that OraSure will package individual OraQuick® ADVANCE™ Devices and OraQuick®
ADVANCE™ Controls in its standard type and size boxes. If Abbott desires to
purchase Products packaged in non-standard type or size boxes, the parties shall
meet to discuss an appropriate allocation of costs and adjustments to the
applicable Transfer Prices.

8.1.2 Taxes. The Transfer Prices for the Products are exclusive of all sales,
use, excise, ad valorem, value added and other similar taxes (other than taxes
assessed on OraSure’s income), which shall be paid solely by Abbott. Abbott
shall provide OraSure with a valid resale

 

24

--------------------------------------------------------------------------------

certificate for all purchases that are exempt from sales tax. In addition,
Abbott shall be solely responsible for paying any import, customs and other fees
or governmental charges.

8.1.3 Other Charges. OraSure reserves the right to charge Abbott a commercially
reasonable fee for: (i) any change or cancellation by Abbott of an accepted
Purchase Order; and (ii) any order that requires any special shipping or
handling. Abbott shall be solely responsible for freight, shipping and insurance
charges relating to Products purchased hereunder.

8.1.4 Payment. Abbott shall pay all amounts due under Section 8.1 of this
Agreement no later than thirty (30) days after receipt of an invoice from
OraSure and delivery of the quantity of Products in covered by such invoice.

8.2 Revenue-Based Amount.

8.2.1 Revenue-Based Amounts. The parties shall be obligated to pay separate
revenue-based amounts in respect of each Quarterly Period based on Abbott Net
Sales during such Quarterly Period to the Hospital Segment and U.S. Government
Hospital Segment, on the one hand, and to the Physicians’ Office Segment and
Reference Lab Segment, on the other, in accordance with this Section 8.2 (each a
“Revenue-Based Amount”). At the end of each month, Abbott shall report to
OraSure the number of OraQuick® ADVANCE™ Devices sold and the Abbott Net Sales
generated from such sales in each Segment and at the end of each Quarterly
Period Abbott shall report to OraSure the number of OraQuick® ADVANCE™ Devices
sold in each of the Segments during such Quarterly Period, including a breakout
of the number of OraQuick® ADVANCE™ Devices sold by Segment (and with respect to
the Hospital Segment and U.S. Government Hospital Segment a breakout by specific
customer and region in a manner sufficient for OraSure to allocate sales to
their sales personnel) and the Abbott Net Sales generated from such sales.

8.2.2 Revenue-Based Amount for Hospitals. If an amount equal to *** of Abbott
Net Sales in the Hospital Segment and U.S. Government Hospital Segment for a
Quarterly Period (such amount being the “Hospital Adjustment Number”) exceeds
the Hospital Baseline for such Quarterly Period, then Abbott shall pay OraSure a
Revenue-Based Amount equal to the excess of the Hospital Adjustment Number over
the product of (a) the total number of OraQuick® ADVANCE™ Devices sold in the
Hospital Segment and U.S. Government Hospital Segment during such Quarterly
Period, multiplied by (b) the Transfer Price for such Products. If, however, the
Hospital Adjustment Number for the Quarterly Period is less than the Hospital
Baseline for the Quarterly Period, then OraSure shall pay Abbott, in the form of
a credit against amounts due to OraSure under this Agreement, an amount equal to
the difference of (x) the product of the Transfer Price for the OraQuick®
ADVANCE™ Device multiplied by the total number of OraQuick® ADVANCE™ Devices
sold in the Hospital Segment during the Quarterly Period minus (y) the Hospital
Baseline for the Quarterly Period.

8.2.3 Revenue-Based Amount for Physicians’ Offices and Reference Labs. In
addition to the amount payable to Abbott pursuant to Section 8.2.2, if an amount
equal to *** of Abbott Net Sales in the Physicians’ Office Segment and Reference
Lab Segment in a Quarterly Period (such amount being the “PO/RL Adjustment
Number”) exceeds the PO/RL Baseline for

 

25

--------------------------------------------------------------------------------

such Quarterly Period, then Abbott shall pay OraSure a Revenue-Based Amount
equal to the excess of the PO/RL Adjustment Number for such Quarterly Period
over the PO/RL Baseline.

8.2.4 Change in Transfer Price. Whenever a reference is made to the Transfer
Price in making a calculation required to apply this Section 8.2 and the
Transfer Price changed during the month or Quarterly Period or the units sold
into the Segment during the month or Quarterly Period had different Transfer
Prices, the Transfer Price applicable to the units sold during the Quarterly
Period shall be determined using a first in, first out methodology.

8.2.5 Reporting. Abbott shall deliver the report required under Section 8.2.1 to
OraSure no later than ten (10) days after the end of each month and fifteen
(15) days after the end of each Quarterly Period, which report shall include all
the information specified in Section 8.2.1 and a calculation of Abbott Net
Sales, the Hospital Adjustment Number, the PO/RL Adjustment Number, the Hospital
Baseline, the PO/RL Baseline and the Revenue-Based Amounts for the applicable
month and Quarterly Period. If a payment is due to Abbott under this
Section 8.2, the payment shall be included with the report for the Quarterly
Period. If an amount is due from OraSure to Abbott under Section 8.2.2, Abbott
shall submit an invoice with the report for the Quarterly Period in the amount
due under Section 8.2.2 to Abbott and OraSure shall issue the credit in the
amount shown on the invoice no later than thirty (30) days after receipt thereof
unless it disputes the invoice in good faith.

8.2.6 Records; Audit. Abbott shall keep records sufficient, in accordance with
generally accepted accounting principles in the United States, to permit
verification of the determinations made under this Section 8.2, the calculations
of Abbott Net Sales, the Hospital Adjustment Number, the PO/RL Adjustment
Number, the Hospital Baseline, the PO/RL Baseline, any Revenue-Based Amounts and
any other information required by Section 8.2.1. Such records shall be
maintained and made available for examination in accordance with this Section 8
for at least two (2) years after the close of the applicable Quarterly Period.
Abbott shall permit such records to be examined during normal business hours by
independent third party public accountants designated by OraSure and reasonably
acceptable to Abbott. Such accountants shall report to OraSure only the amount
by which a Revenue-Based Amount due under this Section 8.2. in respect of the
audited period was overpaid or underpaid and the basis for such determination,
and shall make such report simultaneously available to both OraSure and Abbott.
In the event an examination of Abbott’s records reveals that a Revenue-Based
Amount paid to OraSure was less than the amount required to be paid to OraSure
under Section 8.2.1 in respect of the audited period, Abbott shall promptly pay
the amount of such underpayment. In the event that such underpayment amounts to
five percent (5%) or more of the total correct amount of the Revenue-Based
Amount, Abbott shall also reimburse OraSure for all reasonable out-of-pocket
costs of the examination to a maximum amount of twenty thousand dollars
($20,000.00) and Abbott shall pay to OraSure interest at a rate per annum equal
to the lesser of one-half percent (0.5%) per month or such lower rate as may be
required by applicable law from the date on which the Revenue-Based Amount for
the audited period was due. In the event an examination of Abbott’s records
reveals that a Revenue-Based Amount paid to OraSure was more than the amount
required to be paid to OraSure under this Section 8.2. in respect of the audited
period, OraSure shall credit the amount of the overpayment against amounts
otherwise due to OraSure under this Agreement.

 

26

--------------------------------------------------------------------------------

ARTICLE 9 –INTELLECTUAL PROPERTY

9.1 Branding. OraSure shall label the Products using the trademarks of both
OraSure and Abbott and the trade dress of OraSure, in accordance with this
Section 9.1. The individual OraQuick® ADVANCE™ Devices, the laminated packages
containing individual OraQuick® ADVANCE™ Devices, and the individual OraQuick®
ADVANCE™ Controls shall be labeled solely with OraSure’s trademarks, trade
names, logos and trade dress (the “OraSure Trademarks”) as determined by OraSure
in its sole discretion. The boxes in which packages containing individual
OraQuick® ADVANCE™ Devices and OraQuick® ADVANCE™ Controls are packaged (the
“OraQuick® Boxes”) shall be labeled with the OraSure Trademarks and with
Abbott’s trademarks and tradenames (the “Abbott Trademarks”) identified from
time to time by Abbott. Abbott shall provide OraSure with at least sixty
(60) days advance notice of the Abbott Trademarks or any changes in the Abbott
Trademarks proposed by Abbott for labeling on OraQuick® Boxes. Subject to
Article 5, the parties shall cooperate in the design of the labeling for
OraQuick® Boxes and the final labeling design shall be subject to approval by
both parties, which shall not be unreasonably withheld, conditioned or delayed.
Abbott shall reimburse OraSure for OraSure's actual out-of-pocket costs of
making any label changes on the OraQuick® Boxes resulting from Abbott’s
modifications to the Abbott Trademarks proposed for such labeling; provided,
however, that in no event shall Abbott be required to reimburse OraSure for more
than three (3) months production requirements, as set forth in Abbott’s most
recent forecast provided pursuant to Section 7.3, for such labels, unless
purchase of such excess items had previously been authorized in writing by
Abbott. Abbott hereby consents to OraSure’s use of the Abbott Trademarks on
labeling for the OraQuick® Boxes in accordance with this Section 9.1. The
pricing set forth in this Agreement for Products assumes that the same label and
packaging, including OraSure’s standard type and size boxes, will be used for
all Products supplied to Abbott under this Agreement and if this assumption is
proved incorrect, the parties shall meet to discuss a reasonable allocation of
costs.

9.2 Promotional Materials. OraSure hereby consents to the use by Abbott of the
OraSure Trademarks on promotional materials for the purpose of promoting,
marketing and selling the Products in the Segments in the Territory. No
promotional materials bearing the OraSure Trademarks may be used without
OraSure’s prior written approval, which shall not be unreasonably withheld,
conditioned or delayed by more than fourteen (14) days after receipt of Abbott’s
request for approval.

9.3 No Other Rights; Allocation of Goodwill. Except for the rights herein,
neither party shall acquire any right, title, or interest in any trademark,
trade name, logo or trade dress, copyright, patent, or any other intellectual
property rights of the other party by reason of this Agreement. Abbott
acknowledges and agrees that all use of any of the OraSure Trademarks and all of
the goodwill associated therewith shall inure solely to OraSure’s
benefit. OraSure acknowledges and agrees that all use of any of the Abbott
Trademarks and all of the goodwill associated therewith shall inure solely to
Abbott’s benefit.

 

27

--------------------------------------------------------------------------------

9.4 Effect of Termination. Upon termination of this Agreement both parties shall
immediately cease all use of the other party’s trademarks, trade names, logos
and trade dress, except such use as is necessary to complete Manufacturing and
sale of Products under open Purchase Orders at the time of termination or to
sell off inventory as permitted under Section 13.3.3.

ARTICLE 10 –PRODUCT WARRANTIES.

10.1 Limited Product Warranty.

10.1.1 Limited Warranty for OraQuick® ADVANCE™ Devices. OraSure warrants to
Abbott that: (a) each OraQuick® ADVANCE™ Device, when delivered, will conform to
the specifications set forth in the OraQuick® ADVANCE™ Device Specifications for
the OraQuick® ADVANCE™ Device; and (b) each OraQuick® ADVANCE™ Device shall be
free from defects in materials, workmanship, packaging or labeling for a period
equal to its stated shelf life (the “OraQuick® ADVANCE™ Device Warranty
Period”).

10.1.2 Limited Warranty for OraQuick® ADVANCE™ Controls. OraSure warrants to
Abbott that: (a) each OraQuick® ADVANCE™ Control, when delivered, will conform
to the specifications set forth in the OraQuick® ADVANCE™ Control Specifications
for the OraQuick® ADVANCE™ Control; and (b) each OraQuick® ADVANCE™ Control
shall be free from defects in materials, workmanship, packaging or labeling for
a period equal to its stated shelf life (the “OraQuick® ADVANCE™ Control
Warranty Period”).

10.2 OraSure Disclaimer. THE EXPRESS LIMITED WARRANTIES FOR ORAQUICK® ADVANCE™
DEVICES AND ORAQUICK® ADVANCE™ CONTROLS SET FORTH IN SECTION 10.1 AND THE
ADDITIONAL REPRESENTATIONS AND WARRANTIES SET FORTH IN SECTION 11.1 AND SECTION
14.16 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS
OR IMPLIED. ORASURE HEREBY DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND
WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED, WHETHER ARISING FROM A COURSE OF
DEALING OR USAGE OF TRADE, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

10.3 Warranty Claim Procedure. Unless otherwise agreed by OraSure, to make a
warranty claim, Abbott shall at Abbott’s expense return the allegedly defective
Products, or a representative sample thereof, together with a description of the
alleged defect. OraSure shall, promptly after receipt and as required, inspect
the alleged defective Products. If such inspection results reasonably confirm
that the Products do not conform with the applicable warranty set forth in
Section 10.1 and the non-conformance did not arise from misuse, mishandling,
storage in a manner inconsistent with labeling, neglect, modification or unusual
physical or chemical stress after delivery to the carrier, Abbott shall return
any remaining Products in Abbott’s inventory with the same defect at OraSure’s
expense, and the sole and exclusive warranty remedies set forth in Section 10.4
shall apply. If such test results fail to confirm the Products’ non-conformance
to the applicable warranty set forth in Section 10.1, or if the parties fail to

 

28

--------------------------------------------------------------------------------

otherwise resolve the dispute, the parties shall submit the affected Products,
or a representative sample thereof, along with a reference batch which has
previously been shown by Abbott to conform to the applicable warranty set forth
in Section 10.1, to a mutually acceptable independent laboratory along with the
inspection protocols described in the specifications and mutually agreeable
interrogatories to be answered by such laboratory. The determination of the
affected Products’ conformance or non-conformance to the applicable warranty set
forth in Section 10.1 shall be binding upon the parties. If the laboratory
determines that the Products conform to the applicable warranty set forth in
Section 10.1, Abbott shall pay all independent laboratory and shipping costs
incurred by OraSure, and if such laboratory confirms that the Products do not
conform with the applicable warranty set forth in Section 10.1, OraSure shall
pay all independent laboratory and shipping costs incurred by Abbott and the
sole and the exclusive warranty remedies set forth in Section 10.4 shall apply.

10.4 Abbott’s Warranty Remedies. During the OraQuick® ADVANCE™ Device Warranty
Period and OraQuick® ADVANCE™ Control Warranty Period, as the case may be,
OraSure shall replace, at OraSure’s expense, or at Abbott’s option, refund or
credit the purchase price of, any Product that does not comply with the
applicable limited warranty set forth in Section 10.1. OraSure’s obligation to
replace defective Products or to refund or credit the purchase price paid for
such Products pursuant to this Section 10.4 shall not apply to any Products that
have been subjected to misuse, mishandling, storage in a manner inconsistent
with labeling, neglect, modification or unusual physical or chemical stress
after delivery to the carrier. Other than as specifically provided in Sections
6.4 and 11.3.2, this Section 10.4 states Abbott’s sole and exclusive remedy for
failure of any Product to comply with the applicable limited warranty set forth
in Section 10.1.

10.5 Product Shelf Life. OraSure will use commercially reasonable efforts to
supply Abbott with Products that have a remaining shelf life of at least ***
from the time of delivery. If OraSure is unable to supply Products with at least
such remaining shelf life, OraSure shall notify Abbott of that fact and the
parties shall cooperate to facilitate the distribution of the affected Product
in accordance with this Agreement. If the parties are unable, after exercising
good faith efforts, to complete the distribution of the affected Products by
Abbott, Abbott’s sole remedy shall be to adjust the Contractual Minimums, in
which case the Contractual Minimum for the Contract Year in which OraSure’s
inability occurs shall equal (i) three hundred sixty-five (365) days (or the
actual number of days in such Contract Year) minus the number of days after the
applicable delivery date during which OraSure’s inability to supply continued,
multiplied by (ii) the quotient of the unadjusted Contract Minimum for such
Contract Year divided by three hundred sixty-five (365) days (or the actual
number of days in such Contract Year.)

ARTICLE 11 -REPRESENTATIONS AND ADDITIONAL WARRANTIES AND INDEMNIFICATION.

11.1 By OraSure. OraSure represents and warrants to Abbott that: (a) OraSure has
full corporate power and authority to enter into and carry out its obligations
under this Agreement; (b) this Agreement has been duly executed and delivered by
OraSure and constitutes the legal, valid and binding obligation of OraSure
enforceable against it in accordance with its

 

29

--------------------------------------------------------------------------------

terms; (c) the execution, delivery and performance of this Agreement will not
conflict with, are not inconsistent with and will not result in any breach of
any terms, conditions or provisions of, or constitute (with due notice or lapse
of time, or both) a default under any agreement, contract, document or
instrument to which OraSure is a party or by which it is otherwise bound; (d) no
authorization, consent, approval or similar action of or by any third party is
required for or in connection with OraSure’s authorization, execution, delivery
or performance of this Agreement; and (e) there are no suits, claims or
proceedings pending or (to OraSure’s knowledge) threatened against OraSure or
any of its Affiliates in any court or by or before any governmental body or
agency with respect to intellectual property incorporated in or used in the
development and/or Manufacture of the Products.

11.2 By Abbott. Abbott represents and warrants to OraSure that: (a) Abbott has
full corporate power and authority to enter into and carry out its obligations
under this Agreement; (b) this Agreement has been duly executed and delivered by
Abbott and constitutes the legal, valid and binding obligation of Abbott
enforceable against it in accordance with its terms; (c) the execution, delivery
and performance of this Agreement will not conflict with, are not inconsistent
with and will not result in any breach of any terms, conditions or provisions
of, or constitute (with due notice or lapse of time, or both) a default under
any agreement, contract, document or instrument to which Abbott is a party or by
which it is otherwise bound; and (d) no authorization, consent, approval or
similar action of or by any third party is required for or in connection with
Abbott’s authorization, execution, delivery or performance of this Agreement.

11.3 Indemnification.

11.3.1 By Abbott. Abbott shall indemnify, defend and hold harmless OraSure, its
Affiliates, and the respective directors, officers, employees, agents and
representatives of each of the foregoing from and against any and all claims,
suits and proceedings by a Person (other than a party to this Agreement or its
Affiliates) (individually and collectively, “Claims”), and any and all losses,
obligations, damages, deficiencies, costs, penalties, liabilities, assessments,
judgments, amounts paid in settlement, fines, and expenses (including court
costs and reasonable fees and expenses of attorneys) in respect of any Claims
(individually and collectively, “Losses”): (a) arising out of the negligence or
willful misconduct of Abbott or its Affiliates, employees, agents or any other
person for whose actions Abbott is legally liable; (b) arising out of or in
connection with a material breach by Abbott of any of its obligations under this
Agreement including any representations or warranties set forth in Sections 11.2
or 14.16; or (c) arising out of any claim that any of the Abbott Trademarks
constitutes an infringement or dilution of a third party’s trademark rights in
the Territory; provided, however, that Abbott shall have no liability to OraSure
for any Claims or Losses to the extent that such Claims or Losses resulted from
or arose out of: (i) the negligence or willful misconduct of OraSure or its
Affiliates, employees, agents or any person for whose actions OraSure is legally
liable; (ii) a material breach by OraSure of any of its obligations under this
Agreement including any representations or warranties set forth in Article 10,
Section 11.1, Section 12.2 or Section 14.16; or (iii) any occurrence for which
OraSure has liability to Abbott pursuant to Section 11.3.2.

11.3.2 By OraSure. OraSure shall indemnify, defend and hold harmless Abbott, its
Affiliates, and the respective directors, officers, employees, agents and
representatives of each of the foregoing from and against any and all Claims and
Losses: (a) related to bodily injury,

 

30

--------------------------------------------------------------------------------

death and property damage caused by the OraQuick® ADVANCE™ Device; (b) arising
out of the negligence or willful misconduct of OraSure or its Affiliates,
employees, agents or any other person for whose actions OraSure is legally
liable; (c) arising out of a material breach by OraSure of any of its
obligations under this Agreement including any representations or warranties set
forth in Sections 11.1, 12.2 or 14.16; (d) arising out of any claim that any of
the OraSure Trademarks constitutes an infringement or dilution of a third
party’s trademark rights in the Territory; or (e) arising out of a claim that
any of the Manufacture, marketing, import, sale or use of the Products infringes
upon any patent rights (except patents under which Abbott has a non-royalty
right to practice); provided, however, that OraSure shall have no liability to
Abbott for any Claims or Losses to the extent that such Claims or Losses
resulted from or arose out of: (i) the negligence or willful misconduct of
Abbott or its Affiliates, subdistributors, employees, agents or any person for
whose actions Abbott is legally liable; (ii) a material breach by Abbott of any
of its obligations under this Agreement including any representations or
warranties set forth in Section 11.2, Section 12.2 or Section 14.16; or
(iii) any occurrence for which Abbott has liability to OraSure pursuant to
Section 11.3.1.

11.3.3 Indemnification Procedures. When seeking indemnification under this
Agreement, the party seeking indemnification must, as a condition of
indemnification, provide the indemnifying party with: (i) prompt notice of the
reported or alleged Claim and Loss; (ii) the opportunity to investigate such
Claim, control the defense of such Claim, and settle such Claim at its
discretion; (iii) all information obtained by the party seeking indemnification
relating to the Claim and Loss; and (iv) such additional information and
assistance as the indemnifying party may reasonably require to defend or settle
such Claim. The indemnifying party shall have the option to assume the other
party’s defense in any such Claim with counsel reasonably satisfactory to the
other party. No settlement or compromise shall be binding on a party hereto
without its prior written consent, which consent shall not be unreasonably
withheld.

11.4 Additional Rights for Claims of Infringement. Without limitation of any of
the rights and obligations of OraSure and Abbott under Section 11.3 of this
Agreement, if a third party asserts or threatens any claim, suit or action
asserting that any of the Manufacture, marketing, import, sale or use of the
Products infringes upon any patent rights (except patents under which Abbott has
a non-royalty right to practice), then OraSure may, at its option (i) procure
for Abbott a license to continue selling and distributing the infringing
Product, (ii) modify such Product to make it non-infringing, (iii) make an
appropriate adjustment to the applicable Transfer Price, acceptable to Abbott,
for the infringing Product hereunder to reflect any additional royalties that
might become payable by Abbott to such third party, or (iv) if none of the
foregoing is commercially practicable, terminate this Agreement in accordance
with Section 13.2.4.

ARTICLE 12 -CONFIDENTIALITY AND NON-USE OF INFORMATION.

12.1 Non-Disclosure. Each party will, for the Term of this Agreement and for a
period of five (5) years thereafter, (i) keep confidential and not disclose to
others, all Confidential Information of the other party, and (ii) not use any of
the other party’s Confidential Information for its own direct or indirect
benefit, or the direct or indirect benefit of any third party, except

 

31

--------------------------------------------------------------------------------

that each of Abbott and OraSure may use the other party’s Confidential
Information to the extent necessary to perform its duties and obligations, or to
enforce such party’s rights, under this Agreement. The foregoing shall not
prohibit disclosures: (x) made to the receiving party’s employees, agents or
permitted subdistributors who have a “need to know” the other party’s
Confidential Information to the extent such disclosure is necessary to perform
such party’s duties and obligations, or to enforce such party’s rights, under
this Agreement, provided that such sub-distributors, employees or agents agree
in writing or are otherwise compelled to comply with the obligations of this
Article 12; or (y) compelled to be made by any requirement of law or pursuant to
any legal, regulatory or investigative proceeding before any court, or
governmental or regulatory authority, agency or commission so long as the party
so compelled to make disclosure of Confidential Information of the other party
provides prior written notice to such other party so that the other party may
seek a protective order or other remedy to protect the confidentiality of the
Confidential Information and/or waive the compelled party’s compliance with this
Article 11. If such protective order, other remedy or waiver is not obtained by
the time the compelled party is required to comply, the compelled party may
furnish only that portion of the Confidential Information of the other party
that it is legally compelled to disclose and shall request, at the other party’s
expense, that such Confidential Information be accorded confidential treatment
(if such procedure is available). In the event that a party must disclose the
other party’s Confidential Information or the terms of this Agreement pursuant
to requirements of the Securities and Exchange Commission (“SEC”), in addition
to the other requirements under this Section 12.1, the disclosing party shall
pursue confidential treatment of such Confidential Information and, consistent
with the rules and practices of the SEC, any competitively sensitive information
contained in this Agreement, and the non-disclosing party shall cooperate with
the disclosing party in preparing the disclosure and any request for
confidential treatment.

12.2 Employees. Each party represents to the other that its employees,
sub-distributors, agents and contractors are or will be governed by company
regulations or agreements, which prohibit the disclosure of confidential and
proprietary information, which may belong to the other party, and that such
internal regulations and agreements will enable it to comply with all of the
items of this Article 12.

12.3 Remedies. Any breach of the restrictions contained in this Article 12 by
either Abbott or OraSure is a breach of this Agreement that may cause
irreparable harm to the other party entitling such other party to injunctive
relief in addition to all other legal remedies.

12.4 Publicity. Neither party shall use the name of the other party in any
publicity, advertising or in any written, verbal or any other form of public
disclosure (except as required by applicable law or regulation including any
requirements of the SEC) without the express written consent of the other party,
which consent shall not be unreasonably conditioned, withheld or delayed.
Notwithstanding the foregoing, OraSure and Abbott acknowledge that they are
reviewing a draft press release disclosing the fact that this Agreement has been
executed and the general nature of the matters covered hereby, and agree that
they will use their best efforts to complete the release so that OraSure may
issue the release within four (4) business days after the Effective Date.

 

32

--------------------------------------------------------------------------------

ARTICLE 13 -TERM AND TERMINATION.

13.1 Term.

13.1.1 Initial Term and Renewals. The term of this Agreement shall begin on the
Effective Date and, subject to earlier termination pursuant to Section 13.2 or
as otherwise set forth herein, terminate upon the last day of the third Contract
Year (the “Initial Term”). Thereafter, subject to Section 13.1.2 and the last
sentence of this Section 13.1.1, this Agreement shall automatically renew for
successive periods of one (1) Contract Year each (each, a “Renewal Term,” and
together with the Initial Term, the “Term”) unless this Agreement is otherwise
terminated earlier pursuant to the terms hereof. Notwithstanding anything to the
contrary in this Section 13.1.1 or 13.1.2, if Abbott has failed to meet the
Contractual Minimums in any Contract Year ending on or prior to the end of the
Initial Term or any Renewal Term, then this Agreement shall not automatically
renew at the end of the Initial Term or Renewal Term, as the case may be.

13.1.2. Conditions to Renewal. The provisions of this Section 13.1.2 shall only
apply if Abbott meets the Contractual Minimums for all Contract Years. At least
one-hundred eighty (180) days prior to the end of the Initial Term and each
Renewal Term (if any), Abbott and OraSure shall meet to discuss the new
Contractual Minimum for the next succeeding Renewal Term; provided that any
agreement on a new Contractual Minimum shall be at each party’s sole discretion.
If the parties reach agreement on the new Contractual Minimum at least
one-hundred twenty (120) days prior to the commencement of the next succeeding
Renewal Term, and provided Abbott has met the Contractual Minimums for all
Contract Years (including the Contract Year in which the parties met to discuss
the new Contractual Minimum), this Agreement shall automatically renew for such
Renewal Term and the Contractual Minimum agreed to by the parties shall be the
Contractual Minimum for such Renewal Term under Section 2.1.5. If the parties
fail to agree on a new Contractual Minimum within the time frame set forth
above, the Agreement shall not automatically renew without the further agreement
of both parties. In the event that the Agreement does not renew because the
parties fail to agree to a new Contractual Minimum, Abbott shall,
notwithstanding the foregoing and subject to the last sentence of this
Section 13.1.2, have the right to renew this Agreement for an additional Renewal
Term with a Contractual Minimum equal to *** of the greater of (i) the
Contractual Minimum for the last Contract Year prior to renewal and (ii) the
number of OraQuick® ADVANCE™ Devices actually sold to Abbott under this
Agreement during the last Contract Year prior to renewal. At the end of each
Renewal Term, this Agreement shall terminate or renew in accordance with
Sections 13.1.1 and 13.1.2. Notwithstanding the foregoing, if OraSure desires to
have Abbott discontinue distributing the Products after Abbott has exercised its
right to renew as provided above, Abbott shall not be permitted to renew and
this Agreement shall terminate, in which case, OraSure shall pay to Abbott a
royalty in quarterly installments over *** commencing immediately after
termination of this Agreement equal to *** of the Abbott Net Sales for the last
Contract Year prior to termination of this Agreement. In the event that this
Agreement is renewed for one or more Renewal Terms, OraSure shall also pay to
Abbott an additional royalty in quarterly installments over the *** after
termination of the Agreement equal to *** of the Abbott Net Sales for the last
Contract Year prior to termination of this Agreement.

 

33

--------------------------------------------------------------------------------

13.2 Termination.

13.2.1 Termination for Breach. Either party may terminate this Agreement by
giving written notice to the other party (a) upon the bankruptcy of or
commencement of a voluntary or involuntary insolvency involving the other party,
which notice shall be effective immediately; or (b) upon the breach of any
representation, warranty, or covenant or any other material provision of this
Agreement by the other party, in which case termination shall be effective
thirty (30) days after delivery of such notice unless the breach is cured within
such thirty (30) days.

13.2.2 Competing Product. If, during the Term, Abbott shall fail to comply with
Section 3.2, then OraSure shall have the right to terminate this Agreement
immediately by giving written notice thereof to Abbott.

13.2.3 Quality Audit. Subject to the last sentence of Section 4.4, Abbott and
OraSure shall each have the right to immediately terminate this Agreement upon
written notice to the other if (i) the Approved Facility fails to pass an Abbott
supplier quality audit conducted in accordance with the provisions of
Section 4.3 and OraSure either elects not to or fails to remedy the reasons for
such failure within sixty (60) days following written notice by Abbott of such
failure or (ii) the parties are unable to agree on the appropriate scope of a
quality audit of an Approved Facility and such failure continues for a period of
at least sixty (60) days.

13.2.4 Claims of Infringement. Without limitation of any of the rights and
obligations of OraSure and Abbott under Articles 10 and 11 and Section 14.13.2
of this Agreement, if a third party asserts or threatens any claim, suit or
action asserting that any of the Manufacture, marketing, import, sale or use of
any of the Products infringes upon any patent rights (except patents under which
Abbott has a non-royalty right to practice), then either party may, if a
commercially reasonable alternative is not feasible, immediately terminate this
Agreement upon written notice to the other party.

13.2.5 Force Majeure. In accordance with Section 14.3, a party shall have the
right to immediately terminate this Agreement upon written notice to the other
if an event of force majeure prohibits the other party’s performance under this
Agreement for a period of at least ninety (90) consecutive days.

13.2.6 Termination of Sublicense. OraSure shall have the right to terminate this
Agreement upon thirty (30) days prior written notice to Abbott in the event that
the Sublicense Agreement, dated as of June 14, 2002 and providing for the
license to OraSure by Abbott of certain intellectual property owned by or
licensed to Abbott with respect to the Products (the “Sublicense”), between the
parties is terminated as a result of a “Change in Control” (as defined in the
Sublicense) of OraSure.

13.2.7 Termination Because of Debarment, Etc. In the event that either party is
or becomes a Debarred Entity, Excluded Entity or Convicted Entity, then the
other party shall have the right to terminate this Agreement immediately upon
written notice to the affected party.

 

34

--------------------------------------------------------------------------------

13.3 Effect of Termination.

13.3.1 Subsisting Obligations. Termination or expiration of this Agreement shall
not relieve the parties of any obligation arising prior to the effective date of
such termination or expiration and shall not constitute a waiver of any right of
the parties under this Agreement as a result of breach or default.

13.3.2 Return of Confidential Information. Upon expiration of this Agreement or
its termination by either party, each party, as the other may direct, shall
destroy or return to the other promptly all tangible materials provided to it by
the other that embody the other’s Confidential Information and shall erase or
delete all such Confidential Information embodied in any magnetic, optical or
similar medium or stored or maintained on any information storage or retrieval
device. Notwithstanding the foregoing, and subject to the provisions set forth
in Article 12 of this Agreement, each party may retain one (1) copy of such
materials for archival purposes.

13.3.3 Inventory. Following expiration of this Agreement or its lawful
termination by either party, Abbott and its permitted subdistributors and agents
shall be entitled to continue to sell their existing inventory of the Products
in the Segments solely for a period equal to the remaining shelf life for each
such Product.

13.3.4 Purchase of Labeling. Following expiration or termination of this
Agreement, Abbott shall purchase from OraSure up to three (3) months inventory
of any unused labels or OraQuick® Boxes with labels containing any Abbott
Trademarks which are then held by OraSure or are in process at any vendor of
OraSure, to the extent that such inventory level is consistent with Abbott’s
most recent forecast provided under Section 7.3. Such labels shall be purchased
by Abbott at OraSure’s fully loaded cost, as evidenced by OraSure’s accounting
records prepared in accordance with generally accepted accounting principles as
applied in OraSure’s publicly filed financial statements. Payment shall be made
by Abbott no later than thirty (30) days after termination or expiration.

13.3.5 Survival. The rights and obligations of the respective parties pursuant
to Article 1 (Definitions), Section 6.4 (Recalls), Section 6.5 (Adverse
Experience), Section 6.7 (Retention of Samples), Section 8.1 (Transfer Price),
Section 8.2 (Payment), Article 9 (Intellectual Property), Article 10 (Product
Warranties), Article 11 (Representations and Additional Warranties and
Indemnification), Article 12 (Confidentiality and Non-Use of Information),
Article 13 (Term and Termination) and Article 14 (General Provisions) shall
survive the termination or expiration of this Agreement and shall bind the
parties and their legal representatives, successors and permitted assigns. Any
other provisions of this Agreement contemplated by their terms to pertain to a
period of time following termination or expiration of this Agreement shall
survive.

ARTICLE 14 - GENERAL PROVISIONS.

14.1 Currency. All amounts payable under this Agreement shall be paid in U.S.
dollars, unless otherwise agreed in writing.

 

35

--------------------------------------------------------------------------------

14.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware, excluding its conflict of
laws principles.

14.3 Force Majeure. Notwithstanding anything to the contrary set forth herein,
neither party shall be liable in damages, nor shall either party have the right
to terminate this Agreement for any delay or default in performing any
obligation hereunder, if such delay or default is caused by conditions beyond
the reasonable control of the relevant party, including but not limited to, acts
of God, new governmental restrictions or regulations, wars or insurrections,
terrorism, strikes, fire, floods, work-stoppages, lack of materials, unforeseen
occurrences or other occurrences beyond the reasonable control of the affected
party; provided, however, that the party so affected shall employ reasonable
actions to avoid or to remove such cause of non-performance, and shall continue
performance under this Agreement with the utmost dispatch whenever the relevant
cause is abated; and further provided that if a party is unable to fulfill any
relevant obligation under this Agreement due to any such cause, and this
situation continues for a period of ninety (90) consecutive days, then the other
party hereto shall have the right to terminate this Agreement immediately upon
written notice.

14.4 Assignment. Neither party shall assign this Agreement nor any part thereof
without the prior written consent of the other party; provided, however:
(i) either party may assign this Agreement, in whole or in part, to any of its
Affiliates without such consent; and (ii) either party, without such consent,
may assign this Agreement in connection with the transfer or sale of
substantially all of its business to which this Agreement pertains or in the
event of its merger or consolidation with another company. Any permitted
assignee shall assume all obligations of its assignor under this Agreement. No
assignment shall relieve any party of responsibility for the performance of any
accrued obligation that such party then has hereunder.

14.5 Limitation of Liability. EXCEPT IN RESPECT OF EITHER PARTY’S
INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS UNDER SECTION 6.4 AND ARTICLE
11, NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION
WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGE.

14.6 No Third Party Beneficiaries. Abbott and OraSure intend that only Abbott
and OraSure and their permitted assignees will benefit from, and are entitled to
enforce the provisions of, this Agreement. No third party beneficiary is
intended under this Agreement.

14.7 Modifications; Waiver. No modification to this Agreement shall be effective
unless such modification is in a writing signed by a duly authorized
representative of each of Abbott and OraSure. No waiver of any rights or breach
or default under this Agreement shall be effective unless assented to in writing
by the party to be charged with such waiver. The waiver of any breach or default
shall not constitute a waiver of any other right, breach or default hereunder or
any subsequent breach or default.

14.8 Notices. Any notices under this Agreement shall be given in writing at the
address of each party set forth below, or to such other address as either party
may substitute by written notice to the other in the manner contemplated in this
Section 14.8, and shall be deemed

 

36

--------------------------------------------------------------------------------

given (a) when personally delivered; (b) if sent by recognized overnight courier
service, on the next business day after deposit with such courier, properly
addressed and fee prepaid; (c) if sent by U.S. certified mail, return receipt
requested, on the fourth (4th) business day after deposit in the U.S. mail,
properly addressed and postage prepaid; or (d) if sent by facsimile, upon and
after the receipt of a machine-generated report corresponding to the notice
given evidencing the proper facsimile number of the receiving party and
successful transmission of all pages, provided a copy of such notice is also
sent by regular first-class U.S. mail. All notices shall be sent to the
attention of respective parties as follows:

 

To Abbott:    Copy to:

Director, Global Licensing

           Divisional Vice President

Abbott Diagnostics Division, D9RK AP6C

           Domestic Legal, D322 AP6D

Abbott Laboratories

           Abbott Laboratories

100 Abbott Park Road

           100 Abbott Park Road

Abbott Park, IL 60064-6094

           Abbott Park, IL 60064-6049

Fax: (847) 937-6951

           Fax: (847) 938-1206 To OraSure:    Copy to:

Chief Executive Officer

           Senior Vice President

OraSure Technologies, Inc.

           and General Counsel

220 East First Street

           OraSure Technologies, Inc.

Bethlehem, PA 18015

           220 East First Street

Fax: 610-882-2275

           Bethlehem, PA 18015            Fax: 610-882-2275

14.9 Descriptive Headings. The headings of the several sections of this
Agreement are intended for convenience of reference only and are not intended to
be a part of or to affect the meaning or interpretation of this Agreement.

14.10 Severability. If any term or provision of this Agreement shall for any
reason be held invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other term or
provision hereof, and this Agreement shall be interpreted and construed as if
such term or provision, to the extent the same shall have been held to be
invalid, illegal or unenforceable, had never been contained herein.

14.11 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument. A facsimile transmission of a signed original shall
have the same effect as delivery of the signed original.

14.12 Expenses. Except as otherwise expressly set forth in this Agreement,
Abbott and OraSure shall bear their own respective expenses incident to the
preparation, negotiation, and execution of this Agreement and to the performance
of their respective obligations under this Agreement.

 

37

--------------------------------------------------------------------------------

14.13 Dispute Resolution.

14.13.1 Alternative Dispute Resolution. Subject to Sections 5.2.3, 5.13, 10.3,
14.13.2 and 14.13.3, any dispute in connection with this Agreement shall be
settled by final and binding alternative dispute resolution conducted under the
auspices of, and in accordance with, the provisions set forth in Exhibit
14.13.1.

14.13.2 Indemnification for Patent Infringement Claims. Any dispute arising in
respect of or related to indemnification obligations under Article 11 for any
third party claim, suit or action asserting an infringement of such third
party’s patent rights shall be subject to litigation in any court of competent
jurisdiction.

14.13.3 Right to Seek Injunctive Relief Preserved. Nothing in the Agreement
shall be construed as limiting or precluding either party from bringing any
action in any court of competent jurisdiction for injunctive or other equitable
relief as such party deems necessary or appropriate to compel the other party to
comply with its obligations under Article 12.

14.14 Relationship of the Parties. The relationship of the parties under this
Agreement is that of independent contractors. Nothing contained herein is
intended or is to be construed so as to constitute the parties as partners or
joint venturers or either party as an agent or employee of the other. Neither
party has the express or implied right under this Agreement to assume or create
any obligation on behalf of or in the name of the other, or to bind the other
party to any contract, agreement or undertaking with any third party.

14.15 Entire Agreement. This Agreement constitutes the entire and exclusive
agreement and understanding between Abbott and OraSure with respect to the
subject matter of this Agreement, and supersedes and cancels all previous
negotiations, agreements, and commitments, whether oral or in writing, in
respect to the subject matter of this Agreement; provided, however, that the
Sublicense (as defined in Section 13.2.6) which provides for the license to
OraSure by Abbott of certain intellectual property owned by or licensed to
Abbott shall not be deemed to have been superseded or cancelled and shall
continue in accordance with its terms.

14.16 Debarment. Each party warrants and represents to the other that it has
never been, and is not currently, a Debarred Entity, Excluded Entity or
Convicted Entity. Each party further agrees to notify the other as soon as
possible if it becomes a Debarred Entity, Excluded Entity or Convicted Entity,
or if any Person, performing or rendering services or assistance on its behalf
related to this Agreement, is or becomes a Debarred Individual, Debarred Entity,
Excluded Individual, Excluded Entity, Convicted Individual or Convicted Entity

14.16.1 A “Debarred Individual” is an individual who has been debarred by the
FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any
capacity to a person that has an approved or pending drug product application,
or an employer, employee or partner of a Debarred Individual.

14.16.2 “Debarred Entity” is a corporation, partnership or association that has
been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting
or assisting in

 

38

--------------------------------------------------------------------------------

the submission of any abbreviated drug application, or an employee, partner,
shareholder, member, subsidiary or affiliate of a Debarred Entity.

14.16.3 An “Excluded Individual” or “Excluded Entity” is (i) an individual or
entity, as applicable, who has been excluded, debarred, suspended or is
otherwise ineligible to participate in federal health care programs such as
Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the
U.S. Department of Health and Human Services, or (ii) is an individual or
entity, as applicable, who has been excluded debarred, suspended or is otherwise
ineligible to participate in federal procurement and non-procurement programs,
including those produced by the GSA.

14.16.4 A “Convicted Individual” or “Convicted Entity” is an individual or
entity, as applicable, who has been convicted of a criminal offense that falls
within the ambit of 42 U.S.C. §1320a – 7(a), but has not yet been excluded,
debarred, suspended or otherwise declared ineligible.

14.16.5 In the event any Person performing or rendering services or assistance
related to this Agreement on behalf of a party is or becomes a Debarred
Individual, Debarred Entity, Excluded Individual, Excluded Entity, Convicted
Individual or Convicted Entity, then the affected party shall immediately cause
such Person to cease any services or assistance relating to the activities
undertaken by such party under this Agreement. In the event either party is or
becomes a Debarred Entity, Excluded Entity or Convicted Entity, then the other
party shall have the right to terminate this Agreement pursuant to
Section 13.2.7.

[THE REMAINDER OF THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK.]

 

39

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the undersigned duly authorized officers of OraSure and
Abbott, respectively, hereby execute this Agreement on the date first above
written on behalf of OraSure and Abbott, respectively.

 

ORASURE TECHNOLOGIES, INC. By:  

/s/ Douglas A. Michels

Print Name:   Douglas A. Michels Title:   President & CEO ABBOTT LABORATORIES
By:  

/s/ Joseph M. Nemmers, Jr.

Print Name:   Joseph M. Nemmers, Jr. Title:  

Sr. Vice President, Diagnostic Operations

President, Diagnostics Division

 

40

--------------------------------------------------------------------------------

Exhibits

 

No.   

Title

1.53    Transfer Prices 14.13.1    Alternative Dispute Resolution

 

41

--------------------------------------------------------------------------------

EXHIBIT 1.53

TRANSFER PRICE; PRICE ADJUSTMENTS

1. Transfer Price – OraQuick® ADVANCE™ Device. Subject to Section 3, below,
Abbott shall pay OraSure a Transfer Price of *** for each OraQuick® ADVANCE™
Device purchased or supplied to Distributor under the Agreement.

2. Transfer Price – OraQuick® ADVANCE™ Controls. Subject to Section 3, below,
Abbott shall pay OraSure a Transfer Price for the OraQuick® ADVANCE™ Controls of
*** per kit, which shall contain one (1) negative control, one (1) HIV-1
positive control and one HIV-2 vial.

3. Price Adjustments. (a) OraSure may increase the Transfer Prices for the first
Renewal Term (if any) and each subsequent Renewal Term (if any) by giving notice
of the new Transfer Price thirty (30) days prior to the beginning of the
applicable Renewal Term. The Transfer Price increase for the first Renewal Term
shall not exceed the aggregate percentage increase in the Producer Price Index
for Standard Industrial Code 2835, as reported by the Bureau of Labor Statistics
of the United States Department of Labor (“PPI”), during the most recently
completed thirty six (36) consecutive month period for which PPI data (final or
preliminary) is available. The Transfer Price increase for each subsequent
Renewal Term shall not exceed the aggregate percentage increase in the PPI
during the most recently completed twelve (12) consecutive month period for
which PPI data (final or preliminary) is available.

(b) If there has been a decrease in the PPI as provided below, Abbott may
decrease the Transfer Prices for the first Renewal Term (if any) and each
subsequent Renewal Term (if any) by giving notice of the new Transfer Price
thirty (30) days prior to the beginning of the applicable Renewal Term. The
Transfer Price decrease for the first Renewal Term shall not exceed the
aggregate percentage decrease in the PPI during the most recently completed
thirty six (36) consecutive month period for which PPI data (final or
preliminary) is available. The Transfer Price decrease for each subsequent
Renewal Term shall not exceed the aggregate percentage decrease in the PPI
during the most recently completed twelve (12) consecutive month period for
which PPI data (final or preliminary) is available.

 

42

--------------------------------------------------------------------------------

EXHIBIT 14.13.1

ALTERNATE DISPUTE RESOLUTION (ADR)

The parties recognize that bona fide disputes as to certain matters may arise
from time to time during the term of this Agreement which relate to either
party’s rights and/or obligations. To have such a dispute resolved by this
Alternative Dispute Resolution (“ADR”) provision, a party first must send
written notice of the dispute to the other party for attempted resolution by
good faith negotiations between their respective presidents (or their designees)
of the affected subsidiaries, divisions, or business units within twenty-eight
(28) days after such notice is received (all references to “days” in this ADR
provision are to calendar days).

If the matter has not been resolved within twenty-eight (28) days of the notice
of dispute, or if the parties fail to meet within such twenty-eight (28) days,
either party may initiate an ADR proceeding as provided herein. The parties
shall have the right to be represented by counsel in such a proceeding.

 

1. To begin an ADR proceeding, a party shall provide written notice to the other
party of the issues to be resolved by ADR. Within fourteen (14) days after its
receipt of such notice, the other party may, by written notice to the party
initiating the ADR, add additional issues to be resolved within the same ADR.

 

2. Within twenty-one (21) days following receipt of the original ADR notice, the
parties shall select a mutually acceptable neutral to preside in the resolution
of any disputes in this ADR proceeding. If the parties are unable to agree on a
mutually acceptable neutral within such period, either party may request the
President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison
Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to
the following procedures:

(a) The CPR shall submit to the parties a list of not less than five
(5) candidates within fourteen (14) days after receipt of the request, along
with a Curriculum Vitae for each candidate. No candidate shall be an employee,
director, or shareholder of either party or any of their subsidiaries or
affiliates.

(b) Such list shall include a statement of disclosure by each candidate of any
circumstances likely to affect his or her impartiality.

(c) Each party shall number the candidates in order of preference (with the
number one (1) signifying the greatest preference) and shall deliver the list to
the CPR within seven (7) days following receipt of the list of candidates. If a
party believes a conflict of interest exists regarding any of the candidates,
that party shall provide a written explanation of the conflict to the CPR along
with its list showing its order of preference for the candidates. Any party
failing to return a list of preferences on time shall be deemed to have no order
of preference.

(d) If the parties collectively have identified fewer than three (3) candidates
deemed to have conflicts, the CPR immediately shall designate as the neutral the

 

43

--------------------------------------------------------------------------------

candidate for whom the parties collectively have indicated the greatest
preference. If a tie should result between two candidates, the CPR may designate
either candidate. If the parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the explanations
regarding conflicts and, in its sole discretion, may either (i) immediately
designate as the neutral the candidate for whom the parties collectively have
indicated the greatest preference, or (ii) issue a new list of not less than
five (5) candidates, in which case the procedures set forth in subparagraphs
2(a) - 2(d) shall be repeated.

 

3. No earlier than twenty-eight (28) days or later than fifty-six (56) days
after selection, the neutral shall hold a hearing to resolve each of the issues
identified by the parties. The ADR proceeding shall take place at a location
agreed upon by the parties. If the parties cannot agree, the neutral shall
designate a location other than the principal place of business of either party
or any of their subsidiaries or affiliates.

 

4. At least seven (7) days prior to the hearing, each party shall submit the
following to the other party and the neutral:

(a) a copy of all exhibits on which such party intends to rely in any oral or
written presentation to the neutral;

(b) a list of any witnesses such party intends to call at the hearing, and a
short summary of the anticipated testimony of each witness;

(c) a proposed ruling on each issue to be resolved, together with a request for
a specific damage award or other remedy for each issue. The proposed rulings and
remedies shall not contain any recitation of the facts or any legal arguments
and shall not exceed one (1) page per issue.

(d) a brief in support of such party’s proposed rulings and remedies, provided
that the brief shall not exceed twenty (20) pages. This page limitation shall
apply regardless of the number of issues raised in the ADR proceeding.

Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall
be required or permitted by any means, including depositions, interrogatories,
requests for admissions, or production of documents.

 

5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:

(a) Each party shall be entitled to five (5) hours of hearing time to present
its case. The neutral shall determine whether each party has had the five
(5) hours to which it is entitled.

(b) Each party shall be entitled, but not required, to make an opening
statement, to present regular and rebuttal testimony, documents or other
evidence, to

 

44

--------------------------------------------------------------------------------

cross-examine witnesses, and to make a closing argument. Cross-examination of
witnesses shall occur immediately after their direct testimony, and
cross-examination time shall be charged against the party conducting the
cross-examination.

(c) The party initiating the ADR shall begin the hearing and, if it chooses to
make an opening statement, shall address not only issues it raised but also any
issues raised by the responding party. The responding party, if it chooses to
make an opening statement, also shall address all issues raised in the ADR.
Thereafter, the presentation of regular and rebuttal testimony and documents,
other evidence, and closing arguments shall proceed in the same sequence.

(d) Except when testifying, witnesses shall be excluded from the hearing until
closing arguments.

(e) Settlement negotiations, including any statements made therein, shall not be
admissible under any circumstances. Affidavits prepared for purposes of the ADR
hearing also shall not be admissible.

As to all other matters, the neutral shall have sole discretion regarding the
admissibility of any evidence.

 

6. Within seven (7) days following completion of the hearing, each party may
submit to the other party and the neutral a post-hearing brief in support of its
proposed rulings and remedies, provided that such brief shall not contain or
discuss any new evidence and shall not exceed ten (10) pages. This page
limitation shall apply regardless of the number of issues raised in the ADR
proceeding.

 

7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its entirety the
proposed ruling and remedy of one of the parties on each disputed issue but may
adopt one party’s proposed rulings and remedies on some issues and the other
party’s proposed rulings and remedies on other issues. The neutral shall not
issue any written opinion or otherwise explain the basis of the ruling.

 

8. The neutral shall be paid a reasonable fee plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the prevailing
party (including all expert witness fees and expenses), the fees and expenses of
a court reporter, and any expenses for a hearing room, shall be paid as follows:

(a) If the neutral rules in favor of one party on all disputed issues in the
ADR, the losing party shall pay one hundred percent (100%) of such fees and
expenses.

(b) If the neutral rules in favor of one party on some issues and the other
party on other issues, the neutral shall issue with the rulings a written
determination as to how such fees and expenses shall be allocated between the
parties. The neutral shall

 

45

--------------------------------------------------------------------------------

allocate fees and expenses in a way that bears a reasonable relationship to the
outcome of the ADR, with the party prevailing on more issues, or on issues of
greater value or gravity, recovering a relatively larger share of its legal fees
and expenses.

 

9. The rulings of the neutral and the allocation of fees and expenses shall be
binding, non-reviewable, and non-appealable, and may be entered as a final
judgment in any court having jurisdiction.

 

10. Except as provided in paragraph 9 or as required by law (including
applicable securities laws and regulations), the existence of the dispute, any
settlement negotiations, the ADR hearing, any submissions (including exhibits,
testimony, proposed rulings, and briefs), and the rulings shall be deemed
Confidential Information. The neutral shall have the authority to impose
sanctions for unauthorized disclosure of Confidential Information.

 

11. All disputes referred to ADR, the statute of limitations, and the remedies
for any wrong that may be found, shall be governed by the laws of the State of
Delaware.

 

12. The neutral may not award punitive damages or any other damages excluded by
Section 14.5 (Limitation of Liability) of the Agreement. The parties hereby
waive the right to punitive damages.

 

13. The hearings shall be conducted in the English language.

 

46