EXHIBIT 10.35

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 24b-2 under the Securities Exchange Act of 1934.
Such omissions are designated as ***.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) effective as of November 17, 2009 (the
“Effective Date”), is entered into by and among INVERNESS MEDICAL INNOVATIONS,
INC., a Delaware corporation (“IMI”), with a place of business at 51 Sawyer
Road, Suite 200, Waltham, Massachusetts 02453, USA, INVERNESS MEDICAL
SWITZERLAND GmbH, a Swiss private company (“IMS”, and together with IMI,
“Inverness”), with a place of business at Bahnhofstrasse 28, CH-6300 Zug,
Switzerland, and ORASURE TECHNOLOGIES, INC., a Delaware corporation (“OraSure”),
with a place of business at 220 East First Street, Bethlehem, Pennsylvania
18015, USA.

WHEREAS, Inverness and Church & Dwight Co., Inc., a Delaware corporation
(“C&D”), brought suit against OraSure in the United States District Court for
the District of New Jersey, Civil Action No. 08-cv-1856-GEB-DEA (the “Action”),
alleging that OraSure infringes U.S. Patent No. 6,485,982 (the “‘982 Patent”) by
selling, inter alia its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test; and

WHEREAS, OraSure denied infringement and counterclaimed that the ‘982 Patent is
invalid and unenforceable; and

WHEREAS, Inverness and OraSure have entered into a Settlement Agreement
effective as of the Effective Date (as amended or restated from time to time,
the “Settlement Agreement”), pursuant to which the parties have fully and
finally settled, resolved and released each other from all claims and disputes
as of the Effective Date, on the terms and conditions thereof; and

WHEREAS, due execution and delivery of this Agreement is a condition precedent
to the effectiveness of the Settlement Agreement.

NOW THEREFORE, in consideration of the promises and mutual covenants, terms and
conditions hereinafter set forth, the parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

In this Agreement, the following terms shall have the meanings set forth in this
Article 1. Any other capitalized terms used but not otherwise defined herein and
which are defined in the Settlement Agreement shall have the meanings ascribed
to such terms in the Settlement Agreement.

1.1 “‘982 Patent Rights” shall mean, collectively, (a) United States Patent
No. 6,485,982B1, entitled “Test Device and Method for Colored Particle
Immunoassay,” which was issued on November 26, 2002, and for which a
reexamination certificate was issued as United States Patent No. 6,485,982C1 on
January 29, 2008, (b) all patents that have issued or in

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

the future issue and claim priority to, or common priority with, the foregoing
(including utility model and design patents and certificates of invention),
(c) all reissues, reexamination certificates, renewals, extensions, corrections,
or additions thereof and thereto, and (d) all foreign counterparts thereof.

1.2 “Affiliate” shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under common control
with, such Person. For purposes of this definition, (a) “control” shall mean
(i) ownership by any Person of fifty percent (50%) or more of the Voting Stock
of any other Person, or (ii) otherwise possessing the power and authority to
direct or cause the direction of the management and policies of such other
Person whether by contract or otherwise; and (b) “Voting Stock” shall mean, with
respect to any Person, securities having the right (apart from rights arising
under special circumstances) to vote for the election of directors or persons
performing similar functions with respect to such Person. Notwithstanding the
foregoing to the contrary, neither SPD Swiss Precision Diagnostics GmbH nor
PBM-Selfcare LLC shall be deemed an “Affiliate” of Inverness.

1.3 “Ancillary Agreements” shall mean, collectively, the Distribution Agreement,
the Settlement Agreement and the Supply Agreement.

1.4 “Change in Control” shall mean (a) a merger, consolidation, business
combination, recapitalization, liquidation, dissolution or similar transaction
involving OraSure pursuant to which the stockholders of OraSure immediately
preceding such transaction hold less than a majority of the equity interests in
the surviving or resulting entity of such transaction; (b) the acquisition by
any Person (including by way of a tender or exchange offer or issuance by
OraSure), directly or indirectly, of beneficial ownership or a right to acquire
beneficial ownership of shares representing a majority of the number or voting
power of the outstanding shares of OraSure’s capital stock; or (c) the transfer
or sale of all or substantially all of OraSure’s business to which this
Agreement relates.

1.5 “Confidential Information” shall mean any and all information and data,
whether in tangible or intangible form, that (a) is disclosed by one party (the
“Disclosing Party”) to the other party (the “Recipient”) under this Agreement
and if disclosed in writing or other tangible medium is marked or otherwise
identified as confidential when disclosed by the Disclosing Party or, in the
case of information disclosed orally or in other intangible form, is
acknowledged at the time of disclosure to be confidential and is summarized and
confirmed as confidential in writing to the Recipient within thirty (30) days
after such disclosure, or (b) obtained by the Recipient through observation or
examination of the foregoing. Notwithstanding the foregoing, Confidential
Information of a party shall not include that portion of such information and
data which, and only to the extent, the Recipient can reasonably establish by
written documentation: (i) is known to the Recipient as evidenced by its written
records before receipt thereof from the disclosing party, (ii) is disclosed to
the Recipient free of confidentiality obligations by a third person who has the
right to make such disclosure, (iii) is or becomes part of the public domain
through no fault of the Recipient, or (iv) is or was independently developed by
persons on behalf of Recipient without access to or use of the information
disclosed by the Disclosing Party.

1.6 “Control”, “Controls” or “Controlled by” means, with respect to any item of
or right under the Lateral Flow Patent Rights, the possession of (whether by
ownership or license),

 

2

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

or the ability of Inverness to grant access to, or a license or sublicense of
such item or right as provided for herein without violating the terms of any
agreement or other arrangement with any third party existing at the time
Inverness would be required hereunder to grant OraSure such access, right or
(sub)license.

1.7 “Diabetes Tests” means any product or test which may be used for the
testing, monitoring, diagnosing, prognostication, treatment, management or cure
of diabetes or diabetes symptoms, in each case, including, without limitation,
by the measurement and/or management of the following in humans: (i) glucose or
glucose derivatives, (ii) glycated hemoglobin, (iii) insulin,
(iv) responsiveness to drugs which are labeled for the treatment of diabetes,
(v) fructosamine, and (vi) scientifically recognized diabetes genetic markers.

1.8 “Distribution Agreement” shall mean the Supply and Distribution Agreement
effective as of the Effective Date, between IMI and OraSure (as amended or
restated from time to time), pursuant to which OraSure has agreed to supply to
IMI, and IMI has agreed to purchase from OraSure and distribute, the OraQuick®
rapid HCV antibody test, on the terms and conditions thereof.

1.9 “Immunoassay” shall mean a lateral flow immunoassay.

1.10 “Lateral Flow Field” shall mean the detection of the presence, absence or
amount of any antibody, antigen or other analyte (including without limitation
for the purpose of determination, prediction, prognosis, diagnosis or
monitoring) of any of the following diseases, predispositions, states or
conditions in humans: (a) infectious diseases (including, without limitation,
those listed on Exhibit A, but excluding respiratory specific infectious
diseases, but including HIV-associated pneumonia); (b) metabolic disorders
(including, without limitation, (i) disorders that involve an alteration in the
normal metabolism of carbohydrates, lipids, proteins, water, and nucleic acids,
as evidenced by various syndromes and diseases, and (ii) inflammation and
insulin resistance, but excluding diabetes); (c) oncology (excluding by means of
fecal occult blood testing (“FOBT”)); and (d) autoimmune disorders (including,
without limitation, disorders that result from an overactive immune response of
the body against substances and tissues normally present in the body, but
excluding diabetes).

1.11 “Lateral Flow Existing Patent Rights” shall mean, collectively, (a) all
patents and patent applications listed on Exhibit B; (b) all patents that have
issued or in the future issue and claim priority to, or common priority with,
the patents and patent applications described in the foregoing clause (a)
(including utility model and design patents and certificates of invention);
(c) all reissues, reexamination certificates, renewals, extensions, corrections,
or additions thereof and thereto; and (d) all foreign counterparts thereof.
Without limiting the generality of the foregoing, the Lateral Flow Existing
Patent Rights shall include the ‘982 Patent Rights.

1.12 “Lateral Flow New Patent Rights” shall mean, collectively, (a) to the
extent Controlled by Inverness, all patents and patent applications, other than
the Lateral Flow Existing Patent Rights, that include a Valid Claim to an
Immunoassay that is Visually Read, a product containing an Immunoassay that is
Visually Read, or the manufacture or use of any of the foregoing; provided,
however, that the Valid Claims described in this clause (a) shall not include
any claim to the extent it claims (i) a specifically identified reagent
(including without limitation

 

3

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

an antibody, antigen or other analyte) or the manufacture or use thereof, or
(ii) a separate apparatus, system or device for detecting and/or displaying the
result of an Immunoassay (including without limitation by electronic, optical,
digital or other non-Visually Read means) or the manufacture or use of such
separate apparatus, system or device; (b) all patents that have issued or in the
future issue and claim priority to, or common priority with, the patents and
patent applications described in the foregoing clause (a) (including utility
model and design patents and certificates of invention); (c) all reissues,
reexamination certificates, renewals, extensions, corrections, or additions
thereof and thereto; and (d) all foreign counterparts thereof.

1.13 “Lateral Flow Patent Rights” shall mean, collectively, the Lateral Flow
Existing Patent Rights and the Lateral Flow New Patent Rights.

1.14 “Lateral Flow Products” shall mean any Visually Read product (other than
the OraQuick® HCV Products, the OraQuick® HIV Products and Diabetes Tests), in
any format whatsoever, that is (a) developed by OraSure or its Affiliates and
exclusively owned by OraSure or its Affiliates, (b) acquired and exclusively
owned by OraSure or its Affiliates, or (c) developed or manufactured by a third
party, purchased by OraSure or its Affiliates and sold under one or more brand
names owned by OraSure or its Affiliates, in each such case that uses an
Immunoassay to detect the presence, absence or amount of any antibody, antigen
or other analyte from any oral fluid, blood, serum or plasma sample, the
manufacture, use, sale, offering for sale, or importation of which product would
infringe, but for the license granted by this Agreement, a Valid Claim of the
Lateral Flow Patent Rights in the country in which made, used, sold, offered for
sale or imported.

1.15 “Net Sales” shall mean, with respect to any Quarterly Period (or portion
thereof), the gross sales price invoiced by OraSure or its Affiliates for
Products sold by OraSure or its Affiliates to unaffiliated third parties, or to
Affiliates that are the end users of Products, during such Quarterly Period,
less (a) trade, cash and quantity discounts and rebates allowed and taken by the
unaffiliated third party, (b) amounts repaid, credited or allowed and taken by
the unaffiliated third party on account of returned or rejected Products,
recalls, billing errors, or retroactive price reductions or price reductions
imposed by governmental authorities, (c) tariffs, duties, excises and taxes
included in the amount charged to the unaffiliated third party, (d) freight,
insurance and other transportation and shipping costs included in the amount
charged to the unaffiliated third party, (f) sales commissions incurred on the
sale of Products; and (g) an allowance up to 1% of the amounts invoiced for
uncollectible or bad debts determined in accordance with generally accepted
accounting principles. In the event a Product is sold with any other products or
services of OraSure or its Affiliates, OraSure shall separately itemize and
individually price such Product on the invoice to the customer and such itemized
price shall be used to calculate OraSure’s Net Sales that includes the sale of
such Product. In no event shall the same Product be included in OraSure’s Net
Sales more than once.

1.16 “OraQuick® HCV Products” shall mean, collectively, (a) the products that
are described on Exhibit C as specifically developed and made by OraSure as of
the Effective Date, and (b) except for the rapid HCV antibody tests distributed
by IMI under the Distribution Agreement, any other Visually Read product that is
(i) developed by OraSure or its Affiliates and exclusively owned by OraSure or
its Affiliates, (ii) acquired and exclusively owned by OraSure or its
Affiliates, or (iii) developed or manufactured by a third party, purchased by
OraSure or its

 

4

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

Affiliates and sold under one or more brand names owned by OraSure or its
Affiliates, in each such case that uses an Immunoassay to detect the presence,
absence or amount of Hepatitis C Virus (“HCV”) or related antibodies, antigens
or other analytes, the manufacture, use, sale, offering for sale, or importation
of which product would infringe, but for the license granted by this Agreement,
a Valid Claim of the Lateral Flow Patent Rights in the country in which made,
used, sold, offered for sale or imported. The parties acknowledge and agree that
an OraQuick® HCV Product described in clause (a) above is a Visually Read
product that uses an Immunoassay.

1.17 “OraQuick® HIV Products” shall mean, collectively, (a) the products that
are described on Exhibit D as specifically developed and made by OraSure as of
the Effective Date, and (b) any other Visually Read product that is
(i) developed by OraSure or its Affiliates and exclusively owned by OraSure or
its Affiliates, (ii) acquired and exclusively owned by OraSure or its
Affiliates, or (iii) developed or manufactured by a third party, purchased by
OraSure or its Affiliates and sold under one or more brand names owned by
OraSure or its Affiliates, in each such case that uses an Immunoassay to detect
the presence, absence or amount of Human Immunodeficiency Virus (“HIV”) or
related antibodies, antigens or other analytes, the manufacture, use, sale,
offering for sale, or importation of which product would infringe, but for the
license granted by this Agreement, a Valid Claim of the Lateral Flow Patent
Rights in the country in which made, used, sold, offered for sale or imported.
The parties acknowledge and agree that an OraQuick® HIV Product described in
clause (a) above is a Visually Read product that uses an Immunoassay.

1.18 “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, governmental authority or any other form of entity or organization
not specifically listed herein.

1.19 “Product” shall mean, collectively, the OraQuick® HCV Products, the
OraQuick® HIV Products and the Lateral Flow Products.

1.20 “Professional Market” shall mean all distribution (including sales)
channels resulting in distribution to (a) licensed professional health-care
providers (including hospitals, physicians acting as such, and licensed
professional health-care centers), (b) other third parties permitted and trained
to administer and/or analyze diagnostic tests, and (c) professional diagnostic
laboratories, in each case of the foregoing clauses (a) through (c), only for
use in humans. Notwithstanding anything to the contrary in this Agreement,
“Professional Market” does not include any distribution (including sales)
channels where products are marketed, and intended for sale, to the
over-the-counter channel or to any end user consumer for self use.

1.21 “Quarterly Period” means each successive period of three (3) consecutive
months beginning on January 1, April 1, July 1 or October 1.

1.22 “Royalty Term” shall mean, (a) with respect to each OraQuick® HCV Product
and each OraQuick® HIV Product in a country, the term for which a Valid Claim of
the ‘982 Patent Rights or the Lateral Flow New Patent Rights remains in effect
and would be infringed, but for the license granted by this Agreement, by the
manufacture, use, sale, offer for sale or

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

importation of such Product in such country, and (b) with respect to each other
Product in a country, the term for which a Valid Claim of the Lateral Flow
Patent Rights remains in effect and would be infringed, but for the license
granted by this Agreement, by the manufacture, use, sale, offer for sale or
importation of such Product in such country.

1.23 “Supply Agreement” shall mean the US Distribution and Private Label Supply
Agreement effective as of the Effective Date, between Inverness Medical
Innovations North America, Inc., a Delaware corporation (“IMNA”), and OraSure
(as amended or restated from time to time), pursuant to which IMNA has agreed to
supply to OraSure, and OraSure is authorized to purchase and distribute, certain
point-of-care tests manufactured by or on behalf of IMNA, on the terms and
conditions thereof.

1.24 “Valid Claim” shall mean a claim of an issued and unexpired patent which
has not been held permanently revoked, unenforceable or invalid by a decision of
a court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been admitted
to be invalid or unenforceable through reissue or disclaimer or otherwise.

1.25 “Visually Read” shall mean visually read by a human without the aid or use
of any separate product, device or apparatus. For the avoidance of doubt,
Visually Read does not include the indication of results through a digital
display.

ARTICLE 2

REPRESENTATIONS AND WARRANTIES

2.1 By Each Party. Each party represents and warrants to the other party as
follows:

2.1.1 Organization. Such party is duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is organized.

2.1.2 Authorization and Enforcement of Obligations. Such party (a) has the
requisite corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder; and (b) has taken all
requisite action on its part to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such party, and constitutes a
legal, valid, binding obligation, enforceable against such party in accordance
with its terms.

2.1.3 Consents. All necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained
by such party in connection with this Agreement have been obtained.

2.1.4 No Conflict. The execution and delivery of this Agreement and the
performance of such party’s obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws, regulations or orders of
governmental bodies; and (b) do not conflict with, or constitute a default
under, any contractual obligation of such party.

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

2.2 By Inverness. Inverness represents and warrants to OraSure as follows:

2.2.1 Lateral Flow Patent Rights. Inverness (a) is the owner or licensee of the
Lateral Flow Patent Rights and (b) has the right to make the license grants
herein. Notwithstanding anything to the contrary in this Agreement, Inverness
makes no representation or warranty regarding the sufficiency of the Lateral
Flow Patent Rights to support the operation of OraSure’s or its Affiliate’s
business, or the making, using, selling, offering for sale or importation of any
product by OraSure or its Affiliates.

2.2.2 No Affiliate Lateral Flow Patent Rights. As of the Effective Date, no
Affiliate of Inverness Controls any patents or patent applications that would
otherwise be deemed a Lateral Plow Patent Right but for the fact that such
Affiliate Controls the applicable patents or patent application. OraSure’s sole
remedy, and Inverness’s sole obligation, for a breach of the representation in
this Section 2.2.2 shall be the licensing or sublicensing of the applicable
patent or patent application pursuant to Section 3.1 below.

2.3 By OraSure. OraSure represents and warrants to Inverness that OraSure has no
Affiliates as of the Effective Date.

2.4 No Other Representations or Warranties. IT IS FURTHER UNDERSTOOD BY THE
PARTIES THAT THE LATERAL FLOW PATENT RIGHTS AND ANY LICENSES GRANTED BY
INVERNESS TO ORASURE AND ITS AFFILIATES ARE PROVIDED UNDER THIS AGREEMENT “AS
IS” AND MAY CONTAIN DEFICIENCIES AND THAT, EXCEPT FOR THE REPRESENTATIONS AND
WARRANTIES EXPRESSLY SET FORTH IN SECTIONS 2.1 AND 2.2, INVERNESS MAKES NO
REPRESENTATIONS OR WARRANTIES UNDER THIS AGREEMENT REGARDING THE USE OR
PERFORMANCE OF SUCH LATERAL FLOW PATENT RIGHTS. EXCEPT AS OTHERWISE SET FORTH IN
SECTIONS 2.1, 2.2 AND 2.3, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED
REPRESENTATION OR WARRANTY WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NONINFRINGEMENT.

ARTICLE 3

LICENSE GRANTS, RIGHT TO FIRST NEGOTIATION,

AND RESTRICTIONS

3.1 Licenses.

3.1.1 OraQuick® HIV Products. Subject to the terms and conditions of this
Agreement, Inverness hereby grants to OraSure and its Affiliates a nonexclusive,
worldwide, royalty-bearing, non-transferable (except as expressly set forth in
Section 8.4) and non-sublicensable (sub)license under the ‘982 Patent Rights and
the Lateral Flow New Patent Rights, to develop, make, have made on its own
behalf, use, offer for sale, sell and import the OraQuick® HIV Products only in
the Lateral Flow Field in the Professional Market.

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

3.1.2 OraQuick® HCV Products. Subject to the terms and conditions of this
Agreement, Inverness hereby grants to OraSure and its Affiliates a nonexclusive,
worldwide, royalty-bearing, non-transferable (except as expressly set forth in
Section 8.4) and non-sublicensable (sub)license under the ‘982 Patent Rights and
the Lateral Flow New Patent Rights, to develop, make, have made on its own
behalf, use, offer for sale, sell and import the OraQuick® HCV Products only in
the Lateral Flow Field in the Professional Market.

3.1.3 Lateral Flow Products. Subject to the terms and conditions of this
Agreement, Inverness hereby grants to OraSure and its Affiliates a nonexclusive,
worldwide, royalty-bearing, non-transferable (except as expressly set forth in
Section 8.4) and non-sublicensable (sub)license under the Lateral Flow Patent
Rights, to develop, make, have made on its own behalf, use, offer for sale, sell
and import Lateral Flow Products only in the Lateral Flow Field in the
Professional Market.

3.2 No Sublicensing. OraSure and its Affiliates shall not have the right to
sublicense, directly or indirectly, any of the rights granted to it under
Section 3.1.

3.3 Nonassertion Covenants.

3.3.1 Neither Inverness nor their respective successors, assigns, licensees or
other transferees shall enforce (or attempt or purport to enforce) against
OraSure, its Affiliates, licensees, manufacturers, distributors or other
purchasers any Lateral Flow Existing Patent Rights (other than the ‘982 Patent
Rights, which are the subject of the licenses set forth in Sections 3.1.1 and
3.1.2), to prevent or restrict them from developing, making, using, offering for
sale, selling or importing the OraQuick® HCV Products or the OraQuick® HIV
Products in the Professional Market. Inverness shall cause each Affiliate of
Inverness, and their respective successors, assigns, licensees or other
transferees not to enforce (or attempt or purport to enforce) against OraSure,
its Affiliates, licensees, manufacturers, distributors or other purchasers any
Lateral Flow Existing Patent Rights (other than the ‘982 Patent Rights, which
are the subject of the licenses set forth in Sections 3.1.1 and 3.1.2), to
prevent or restrict them from developing, making, using, offering for sale,
selling or importing the OraQuick® HCV Products or the OraQuick® HIV Products in
the Professional Market. These nonassertion covenants shall be a covenant that
transfers with any sale, license or other disposition or grant of rights under
the applicable patent rights.

3.3.2 Neither Inverness nor their respective successors, assigns, licensees or
other transferees shall enforce (or attempt or purport to enforce) against any
supplier to OraSure or any of its Affiliates (or to any manufacturer for OraSure
or any of its Affiliates), acting in such capacity, any Lateral Flow Patent
Rights to prevent or restrict such supplier from supplying to OraSure or the
applicable Affiliate any material used in or component of any Product to be made
and sold pursuant to any of the licenses set forth in Section 3.1. Inverness
shall cause each Affiliate of Inverness, and their respective successors,
assigns, licensees or other transferees not to enforce (or attempt or purport to
enforce) against any supplier to OraSure or any of its Affiliates (or to any
manufacturer for OraSure or any of its Affiliates), acting in such capacity, any
Lateral Flow Patent Rights to prevent or restrict such supplier from supplying
to OraSure or the applicable Affiliate any material used in or component of any
Product to be made and sold pursuant to any of the licenses set forth in
Section 3.1 These nonassertion covenants shall be a

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

covenant that transfers with any sale, license or other disposition or grant of
rights under the applicable patent rights. Nothing in this Section 3.3.2 shall
prevent or restrict Inverness, any Affiliate of Inverness or its or their
respective successors, assigns, licensees or other transferees from asserting
any Lateral Flow Patent Right against any supplier to OraSure or any of its
Affiliates (or to any manufacturer for OraSure or any of its Affiliates) to
prevent or restrict such supplier from supplying a party other than OraSure or
an Affiliate of OraSure (or any manufacturer for OraSure or any of its
Affiliates) with any material used in or component of any product.

3.4 Right of First Negotiation.

3.4.1 OraSure hereby grants the Inverness/P&G Joint Venture, SPD Swiss Precision
Diagnostics GmbH (the “JV”), a right of first negotiation with respect to the
marketing and distribution of OraSure’s OraQuick ADVANCE® HIV-1/2 Antibody Test
on an exclusive basis into the over-the-counter (“OTC”) markets worldwide (the
“Transaction”), on the following terms and conditions. For a period of one
hundred twenty (120) days following the Effective Date, the JV and OraSure shall
negotiate in good faith and attempt to reach mutual agreement regarding the
terms and conditions of the Transaction, including, without limitation, the
market definition, term, transfer price, types and amounts of marketing and
promotional support to be provided by the JV, minimum purchase obligations and
other provisions typically included in similar transactions. Notwithstanding the
foregoing, neither the JV nor OraSure shall have any obligations to the other
with respect to the Transaction unless and until a mutually agreeable definitive
agreement setting forth the terms of the Transaction is duly executed and
delivered by OraSure and the JV (the “Definitive Agreement”). Each of the JV and
OraSure shall also have the right (exercisable in its sole discretion) not to
enter into a Definitive Agreement. If, following such one hundred twenty (120)
day period, or any mutually agreed upon extension, the JV and OraSure have not
executed and delivered a mutually agreeable Definitive Agreement, (a) the JV’s
right of first negotiation with respect thereto shall terminate, and (b) OraSure
shall be free to negotiate with, and offer and grant rights related to the
OraQuick ADVANCE® HIV-1/2 Antibody Test in any of the OTC markets worldwide to
any third party or to market and distribute such product directly, in each case
free and clear of any rights of the JV under this Section 3.4.

3.4.2 The parties hereby acknowledge and agree that the rights under 3.4.1 above
are intended to benefit the JV, and that the JV shall be deemed an intended
third party beneficiary under this Agreement solely and exclusively for purposes
of enforcing its rights under Section 3.4.1 above.

3.5 Restrictions.

3.5.1 Except as expressly set forth herein, Inverness hereby reserves and
retains all right, title and interest in and to the Lateral Flow Patent Rights
and all other rights not expressly granted hereunder and any and all remedies
herein expressly conferred upon a party will be deemed cumulative with, and not
exclusive of, any other remedy conferred hereby, or by law or equity upon such
party, and the exercise by a party of any one remedy will not preclude the
exercise of any other remedy available under this Agreement or otherwise. For
example, and

 

9

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

not by way of limitation, Inverness is not granting to OraSure a license outside
of the Lateral Flow Field or outside of the Professional Market.

3.5.2 Notwithstanding anything to the contrary in this Agreement, any Product
described in clause (c) of Section 1.14, clause (b)(iii) of Section 1.16, or
clause (b)(iii) of Section 1.17 may not be (a) sold by OraSure to the third
party that sold such Product to OraSure (or any Affiliate of such third party),
or (b) sold or otherwise distributed by OraSure under the direct control of such
third party (or any Affiliate of such third party).

3.6 Patent Marking. With respect to Products manufactured after the Effective
Date, to the extent commercially practicable and consistent with industry
practices for similar products, OraSure and its Affiliates shall mark and/or
cause to be marked all Products in a manner to provide sufficient notice under
35 U.S.C. § 287(a) and other applicable law.

3.7 Prosecution, Enforcement and Defense. As between the parties, Inverness
shall have the sole right, but not the obligation, in its sole discretion to
file, prosecute, maintain, enforce and defend the Lateral Flow Patent Rights,
and OraSure and its Affiliates shall have no rights with respect to any such
activities, or to file, prosecute, maintain, enforce or defend the Lateral Flow
Patent Rights.

ARTICLE 4

FINANCIAL TERMS

4.1 Initial Payment. Within one (1) business day after the satisfaction or
waiver of the conditions set forth in Section 3.3.1 of the Settlement Agreement,
OraSure shall pay to Inverness the sum of $3,000,000. The payment required by
this Section 4.1 shall be made by wire transfer, without deduction for any taxes
or other charges.

4.2 Future Royalties. Subject to the terms and conditions of this Agreement,
during the applicable Royalty Term for a Product, OraSure shall pay to Inverness
the following royalties:

4.2.1 *** of Net Sales of OraQuick® HIV Products in the Professional Market,
occurring on or after January 1, 2013 (excluding sales to Inverness and/or its
Affiliates);

4.2.2 *** of Net Sales of an OraQuick® HCV Product in the Professional Market in
a country, occurring on or after the second anniversary of the commercial launch
thereof in the Professional Market in such country (excluding sales to Inverness
and/or its Affiliates); and

4.2.3 (i) *** of Net Sales of Lateral Flow Products in the Professional Market
occurring through June 30, 2011 (excluding sales to Inverness and/or its
Affiliates), and (ii) *** of Net Sales of Lateral Flow Products in the
Professional Market occurring on or after July 1, 2011 (excluding sales to
Inverness and/or its Affiliates).

Only one royalty under Section 4.2.1, 4.2.2 or 4.2.3, but not under more than
one such Section, shall be owing for a Product regardless of how many Valid
Claims of the applicable Lateral Flow

 

10

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

Patent Rights would be infringed, but for the license granted by this Agreement,
by the manufacture, use, sale, offering for sale, or importation of such
Product.

4.2.4 Royalty Rate Increase Upon a Change in Control. In the event of a Change
in Control of OraSure where the acquiring entity is participating in the
diagnostics market in one or more countries where there is a Valid Claim of the
applicable Lateral Flow Patent Rights, the royalty rates under Sections 4.2.1,
4.2.2 and 4.2.3 shall automatically be increased by twenty-five percent (25%)
(i.e., from *** to ***, *** to ***, and from *** to ***, as applicable) for
sales occurring after the occurrence of such Change in Control.

4.3 Royalty Reports. Within forty five (45) days after the end of each Quarterly
Period during the term of this Agreement, OraSure shall furnish to Inverness a
written report showing in reasonably specific detail (a) the calculation of the
royalties for each Product by country, if any, that shall have accrued
hereunder, including its calculation of the aggregate Net Sales for such
Quarterly Period; (b) the withholding taxes, if any, required by law to be
deducted with respect to such sales; and (d) the exchange rates, if any, used in
determining the amount of United States dollars. With respect to amounts
invoiced in United States dollars, all amounts shall be expressed in United
States dollars. With respect to amounts invoiced in a currency other than United
States dollars, all such amounts shall be expressed both in the currency in
which the distribution is invoiced and in the United States dollar equivalent.
The United States dollar equivalent shall be calculated using the average of the
exchange rate (local currency per US$1) published in The Wall Street Journal,
Western Edition, under the heading “Currency Trading” on the last business day
of each month during the applicable Quarterly Period.

4.4 Records; Audits.

4.4.1 OraSure and its Affiliates shall keep complete and accurate records in
accordance with past practices, for seven (7) years after the sale of a Product,
regarding Net Sales of Products and all amounts invoiced or received by OraSure
and its Affiliates for the sale of Products (together with deductions of the
kinds described in Section 1.15 applicable to such sales of Products).

4.4.2 Upon the written request of Inverness and not more than once in each
calendar year, OraSure shall permit an independent certified public accounting
firm of nationally recognized standing selected by Inverness and reasonably
acceptable to OraSure, to have access during normal business hours to such of
the financial records of OraSure as may be reasonably necessary to verify the
accuracy of the royalty payment and reports hereunder for the eight (8)
Quarterly Periods immediately prior to the date of such request (other than
records for which Inverness has already conducted an audit under this
Section 4.4).

4.4.3 If such accounting firm concludes that additional amounts were owed during
the audited period, OraSure shall pay such additional amounts within thirty (30)
days after the date Inverness delivers to OraSure such accounting firm’s written
report so concluding. The fees charged by such accounting firm shall be paid by
Inverness; provided, however, if the audit discloses that the royalties payable
by OraSure for such period are more than one hundred seven percent (107%) of the
royalties actually paid for such period, then OraSure shall pay the reasonable
fees and expenses charged by such accounting firm.

 

11

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

4.4.4 Inverness shall cause its accounting firm to retain all financial
information subject to review under this Section 4.4 in strict confidence;
provided, however, that OraSure shall have the right to require that such
accounting firm, prior to conducting such audit, enter into an appropriate
non-disclosure agreement with OraSure regarding such financial information. The
accounting firm shall disclose to Inverness only whether the reports are correct
or not and the amount of any discrepancy. No other information shall be shared.
Inverness shall treat all such financial information as OraSure’s Confidential
Information.

4.5 Payments.

4.5.1 Payment Terms. Royalties accrued by the end of each Quarterly Period shall
be due and payable on the date such royalty report is due. Payment of royalties
in whole or in part may be made in advance of such due date. All payments under
this Agreement shall be made when due hereunder in U.S. dollars by transfer to
an Inverness bank account as designated by Inverness. Any payments that are not
paid on or before the date such payments are due under this Agreement shall bear
interest at a rate equal to the lesser of one percent (1%) per month or the
highest rate permitted by applicable law, including, notwithstanding the
foregoing, interest on the payment for past sales owed pursuant to Section 4.1.
Interest payable shall be calculated on a compound basis with a monthly
compounding period from the date the payment was due until the date payment is
received by Inverness.

4.5.2 Exchange Control. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country where the
Product is sold, OraSure shall have the right, in its sole discretion, to make
such payments by depositing the amount thereof in local currency to Inverness’s
account in a bank or other depository institution in such country. If the
royalty rate specified in this Agreement should exceed the permissible rate
established in any country, the royalty rate for sales in such country shall be
adjusted to the highest legally permissible or government-approved rate.

4.5.3 Withholding Taxes. OraSure shall be entitled to deduct the amount of any
withholding taxes, value-added taxes or other taxes, levies or charges with
respect to such amounts, other than United States taxes, paid by OraSure or its
Affiliates, or any taxes required to be withheld by OraSure or its Affiliates,
to the extent OraSure or its Affiliates, pays to the appropriate governmental
authority on behalf of Inverness such taxes, levies or charges. OraSure shall
use reasonable efforts to minimize any such taxes, levies or charges required to
be withheld on behalf of Inverness by OraSure or its Affiliates. OraSure
promptly shall deliver to Inverness proof of payment of all such taxes, levies
and other charges, together with copies of all communications from or with such
governmental authority with respect thereto.

ARTICLE 5

CONFIDENTIALITY

5.1 Confidentiality. During the term of this Agreement and for a period of
five (5) years following the expiration or earlier termination thereof, each
party shall maintain in confidence the Confidential Information of the other
party, shall not use or grant the use of the Confidential Information of the
other party except as expressly permitted hereby, and shall not disclose the
Confidential Information of the other party except on a need-to-know basis to
such

 

12

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

party’s and its Affiliates’ directors, officers, employees and consultants, to
the extent such disclosure is reasonably necessary in connection with such
party’s activities as expressly authorized by this Agreement. To the extent that
disclosure to any person is authorized by this Agreement, prior to disclosure, a
party shall obtain written agreement of such person to hold in confidence and
not disclose, use or grant the use of the Confidential Information of the other
party except as expressly permitted under this Agreement. Each party shall
notify the other party promptly upon discovery of any unauthorized use or
disclosure of the other party’s Confidential Information.

5.2 Terms of Agreement. Neither party shall disclose any terms or conditions of
this Agreement to any third party without the prior consent of the other party;
provided, however, that a party may disclose the terms or conditions of this
Agreement on a need-to-know basis, (a) to its legal and financial advisors to
the extent such disclosure is reasonably necessary, and (b) to a third party in
connection with (i) an equity investment in such party, (ii) a merger,
consolidation or similar transaction by such party, or (iii) the sale of all or
substantially all of the assets of such party to which this Agreement relates,
provided in each case that such persons are bound by written confidentiality
obligations or, in the case of professional advisers, ethical duties, respecting
such disclosures in accordance with the terms of this Agreement. Notwithstanding
the foregoing, prior to execution of this Agreement, the parties have agreed
upon the substance of information that can be used to describe the terms and
conditions of this transaction, and each party may disclose such information, as
modified by mutual written agreement of the parties, without the consent of the
other party.

5.3 Permitted Disclosures. The confidentiality obligations under this Article 5
shall not apply to the extent that a party is required to disclose information
by applicable law, regulation or order of a governmental agency or a court of
competent jurisdiction; provided, however, that such party shall (i) provide
written notice thereof to the other party, consult with the other party with
respect to such disclosure and provide the other party sufficient opportunity to
object to any such disclosure or to request confidential treatment thereof and
(ii) shall furnish only that portion of the information which is legally
required.

ARTICLE 6

INDEMNIFICATION

6.1 By OraSure. OraSure shall indemnify and hold harmless Inverness from all
losses, liabilities, damages and expenses (including reasonable attorneys’ fees
and costs) resulting from any claims, demands, actions or other proceedings by
any third party to the extent resulting from (a) any breach by OraSure of any
representation, warranty or covenant under this Agreement, or (b) the gross
negligence or willful misconduct of OraSure in the performance of its
obligations or exercise of its rights under this Agreement, except in each case
to the extent arising from the gross negligence or willful misconduct of
Inverness or the breach by Inverness of any representation, warranty or covenant
under this Agreement.

6.2 By Inverness. Inverness shall indemnify and hold harmless OraSure from all
losses, liabilities, damages and expenses (including reasonable attorneys’ fees
and costs) resulting from any claims, demands, actions or other proceedings by
any third party to the extent resulting from (a) any breach by Inverness of any
representation, warranty or covenant under this

 

13

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

Agreement, or (b) the gross negligence or willful misconduct of Inverness in the
performance of its obligations or exercise of its rights under this Agreement,
except in each case to the extent arising from the gross negligence or willful
misconduct of OraSure or the breach by OraSure of any representation, warranty
or covenant under this Agreement.

6.3 Procedure. A party (the “Indemnitee”) that intends to claim indemnification
under this Article 6 shall promptly notify the other party (the “Indemnitor”),
of any claim, demand, action or other proceeding for which the Indemnitee
intends to claim such indemnification. The Indemnitor shall have the right to
participate in, and to the extent the Indemnitor so desires to assume, the
defense thereof with counsel selected by the Indemnitor; provided, however, that
the Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor, if representation of the Indemnitee by
the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between the Indemnitee and any other party
represented by such counsel in such proceeding. The indemnity obligations under
this Article 6 shall not apply to amounts paid in settlement of any claim,
demand, action or other proceeding if such settlement is effected without the
prior express written consent of the Indemnitor, which consent shall not be
unreasonably withheld or delayed. The failure to deliver notice to the
Indemnitor within a reasonable time after notice of any such claim or demand, or
the commencement of any such action or other proceeding, if prejudicial to its
ability to defend such claim, demand, action or other proceeding, shall relieve
such Indemnitor of any liability to the Indemnitee under this Article 6 with
respect thereto, but the omission so to deliver notice to the Indemnitor shall
not relieve it of any liability that it may have to the Indemnitee otherwise
than under this Article 6. The Indemnitor may not settle or otherwise consent to
an adverse judgment in any such claim, demand, action or other proceeding, that
diminishes the rights or interests of the Indemnitee without the prior express
written consent of the Indemnitee, which consent shall not be unreasonably
withheld or delayed. The Indemnitee, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the investigation
and defense of any claim, demand, action or other proceeding covered by this
Article 6.

ARTICLE 7

TERM AND TERMINATION

7.1 Term. The term of this Agreement shall commence on the Effective Date, and
unless terminated in accordance with the provisions set forth below in
Section 7.2, shall remain in effect until there are no more Valid Claims
contained within the Lateral Flow Patent Rights. Notwithstanding the foregoing,
the effectiveness of this Agreement and the Ancillary Agreements is subject to
the (a) Court having approved the Dismissal Order (as defined in the Settlement
Agreement), and (b) the parties having duly executed and delivered the Ancillary
Agreements. The parties shall use commercially reasonable efforts to cause such
conditions to be fulfilled as promptly as possible following the execution of
this Agreement. If such conditions have not been fulfilled, or waived by the
parties, within ten (10) days following the execution of this Agreement (or such
longer period of time on which the parties mutually agree in writing), then upon
the expiration of such period, this Agreement and the Ancillary Agreements
automatically shall terminate in full ab initio.

 

14

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

7.2 Termination.

7.2.1 Termination for Breach. Inverness shall have the right to terminate this
Agreement upon written notice to OraSure in the event that OraSure materially
breaches this Agreement and such breach remains uncured for more than (i) thirty
(30) days in the case of nonpayment, or (ii) sixty (60) days in the event of any
other breach, in each case after receipt by OraSure of written notice specifying
the breach and requiring its remedy.

7.2.2 Termination of the Distribution Agreement. Inverness shall have the right
to terminate this Agreement upon written notice to OraSure upon the termination
of the Distribution Agreement by IMI pursuant to clause (b) of Section 13.2.1
thereof following the final determination by a court of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, or the mutual
agreement of the parties thereto, that OraSure has materially breached such
Distribution Agreement and that IMI has properly exercised its right to so
terminate the Distribution Agreement. In the event of a termination of the
Distribution Agreement other than by IMI pursuant to clause (b) of
Section 13.2.1thereof, Inverness shall not have the right to terminate this
Agreement pursuant to this Section 7.2.2.

7.2.3 Termination for Convenience by OraSure. OraSure shall have the right to
terminate this Agreement for convenience (i) upon at least three (3) months
prior written notice to Inverness, which notice shall set forth the date for
such termination, and (ii) upon payment in full of all amounts due to Inverness
hereunder through such termination date.

7.2.4 Challenge to Lateral Flow Patent Rights. If OraSure or any of its
Affiliates brings, pursues, maintains, or causes any claim or other assertion
directly or indirectly in any court or other governmental forum of competent
jurisdiction (including any patent office) seeking a judgment or other decision
that any Valid Claim of the Lateral Flow Patent Rights is invalid or
unenforceable (other than in defense of, in response to, or in connection with a
claim, demand, action, proceeding or assertion directly or indirectly by or on
behalf of any third party, its Affiliates or their respective successors,
assigns, licensees or other transferees under or in connection with the Lateral
Flow Patent Rights), and if such claim or assertion, and any resulting
proceeding, is not withdrawn or dismissed within thirty (30) days after receipt
of written notice from Inverness thereof, then Inverness shall have the right,
in its sole discretion effective upon written notice to OraSure, to exclude such
Valid Claim from the scope of the license granted to OraSure under this
Agreement.

7.2.5 Termination of Settlement Agreement. This Agreement shall automatically
terminate if the Settlement Agreement is terminated pursuant to Section 3.3.3
thereof.

7.3 Effect of Expiration or Termination. Upon any expiration or termination of
this Agreement other than pursuant to Section 7.2.5 above, all terms and
conditions of this Agreement, including without limitation all rights and
obligations of the parties under this Agreement, shall cease except that
(i) OraSure’s obligation to make any payment of any amounts accrued pursuant to
this Agreement on or prior to the date of expiration or termination shall
survive and (ii) ARTICLE 1, Section 3.4, Section 4.4, ARTICLE 5, ARTICLE 6, this
Section 7.3 and ARTICLE 8 shall survive in accordance with their respective
terms. Upon termination of

 

15

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

this Agreement pursuant to Section 7.2.5 above, all terms and conditions of this
Agreement, including without limitation all rights and obligations of the
parties under this Agreement, shall cease.

ARTICLE 8

MISCELLANEOUS

8.1 Governing Law. This Agreement shall be governed by, interpreted and
construed in accordance with the laws of the State of Delaware, without regard
to the conflicts of law principles thereof. Each of the parties hereby submits
to the exclusive general jurisdiction of the courts of the State of Delaware and
the courts of the United States of America for the District of Delaware in any
action or proceeding arising out of or relating to this Agreement and to the
jurisdiction of the appellate courts to which appeals are required to be taken
from any of the foregoing. Each of the parties irrevocably waives any defense of
inconvenient forum to the maintenance of any such action or proceeding.

8.2 Attorneys’ Fees. The prevailing party in any court action arising out of,
resulting from or relating in any way to this Agreement or the performance by a
party of its obligations under this Agreement shall be entitled to recover its
reasonable attorneys’ fees and expenses incurred in connection with such suit or
proceeding.

8.3 Waiver. No waiver by a party hereto of any condition, or of the breach or
default of any of the provisions, representations, warranties, covenants or
agreements herein set forth, whether by conduct or otherwise, in any one or more
instances, shall be deemed a waiver as to any subsequent and/or similar breach
or default and shall in no manner affect the right of such party to enforce the
same at a later time.

8.4 Assignment.

8.4.1 Neither this Agreement nor any right or obligation hereunder may be
assigned, granted, transferred or delegated, in whole or part, whether by
operation of law, merger, Change In Control, or otherwise, by OraSure without
the prior express written consent of Inverness; provided, however, that
(a) OraSure may, without the written consent of Inverness, assign this Agreement
in whole in connection with the transfer or sale of all or substantially all of
its business to which this Agreement and the Ancillary Agreements relate, or in
the event of its merger, consolidation, Change In Control or similar
transaction; (b) any such assignment shall not relieve OraSure of any of its
responsibilities for performance of its obligations under this Agreement; and
(c) in the event of any permitted assignment by OraSure of this Agreement, the
definitions of each of “the OraQuick® HCV Products”, “the OraQuick® HIV
Products” and “the Lateral Flow Products” under this Agreement shall only apply
to the extent that the applicable Product was commercially sold or in bona fide
development by (or on behalf of) OraSure or its Affiliates immediately prior to
giving effect to such permitted assignment and shall not extend to any other
product, including, without limitation, any new product of OraSure or any of the
assignee’s products. A Change in Control constitutes an assignment for purposes
of this Section 8.4. Any permitted assignee shall assume, in a writing delivered
to Inverness, all obligations of OraSure under this Agreement.

 

16

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

8.4.2 In connection with any assignment or transfer by Inverness of this
Agreement or the licenses contemplated by this Agreement, Inverness shall
assign, license or otherwise grant to the applicable assignee sufficient rights
to or under the applicable Lateral Flow Patent Rights as is necessary for
OraSure to continue to exercise its license rights hereunder. Any assignment,
transfer, license or grant of any right, title or interest by Inverness of the
Lateral Flow Patent Rights shall be subject this Agreement and the licenses
contemplated by this Agreement.

8.4.3 Any purported assignment, delegation or transfer in violation of this
Section 8.4 shall be void. Subject to the foregoing, this Agreement shall be
binding on the parties and their successors and assigns.

8.5 Independent Contractors. The relationship of the parties hereto is that of
independent contractors. The parties hereto are not deemed to be agents,
partners or joint venturers of the others for any purpose as a result of this
Agreement or the transactions contemplated thereby.

8.6 Further Actions. Each party shall execute, acknowledge and deliver such
further documents and instruments and to perform all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.

8.7 Notices. All requests and notices required or permitted to be given to the
parties hereto shall be given in writing, shall expressly reference the
section(s) of this Agreement to which they pertain, and shall be delivered to
the other party, effective on receipt, at the appropriate address as set forth
below or to such other addresses as may be designated in writing by the parties
from time to time during the term of this Agreement.

 

If to Inverness:

   Inverness Medical Innovations, Inc.    51 Sawyer Road, Suite 200    Waltham,
Massachusetts 02453    Attn: General Counsel

With a copy to:

   Goodwin Procter LLP    Exchange Place    Boston, Massachusetts 02109    Attn:
Anthony J. Downs and Stephen G. Charkoudian

If to OraSure:

   OraSure Technologies, Inc.    220 East First Street    Bethlehem,
Pennsylvania 18015    Attn: General Counsel

With a copy to:

   Morrison & Foerster LLP    12531 High Bluff Drive, Suite 100    San Diego,
California    Attn: David Doyle and Mark Wicker

 

17

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

8.8 Force Majeure. Nonperformance of a party (other than for the payment of
money) shall be excused to the extent that performance is rendered impossible by
strike, fire, earthquake, flood, governmental acts or orders or restrictions, or
any other similar reason where failure to perform is beyond the reasonable
control and not caused by the negligence, intentional conduct or misconduct of
the nonperforming party; provided, however, that the nonperforming party shall
use commercially reasonable efforts to resume performance as soon as reasonably
practicable.

8.9 No Consequential Damages. EXCEPT FOR BREACH BY EITHER PARTY OF ITS
CONFIDENTIALITY OBLIGATION SET FORTH IN ARTICLE 5, IN NO EVENT SHALL A PARTY BE
LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION
LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.9 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY UNDER ARTICLE 6.

8.10 Complete Agreement. This Agreement (together with the Ancillary Agreements)
constitutes the entire agreement between the parties regarding the subject
matter hereof, and all prior representations, understandings and agreements
regarding the subject matter hereof, either written or oral, expressed or
implied, are superseded and shall be and of no effect.

8.11 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed to be an original and together shall be deemed to be one and the
same agreement. Facsimile execution and delivery of this Agreement by either
party shall constitute a legal, valid and binding execution and delivery of this
Agreement.

8.12 Headings and Interpretation. The captions to the several sections hereof
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation. The term
“including” means “including, without limitation,” and “herein”, “hereof”, and
“hereunder” refer to this Agreement as a whole.

 

18

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

IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be
executed by their duly-authorized representatives as of the Effective Date.

 

INVERNESS MEDICAL INNOVATIONS, INC. By:   /s/ David Teitel Name:   David Teitel
Title:  

CFO

 

ORASURE TECHNOLOGIES, INC. By:   /s/ Ronald H. Spair Name:   Ronald H. Spair
Title:  

CFO and COO

 

19

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

EXHIBIT A

CERTAIN INFECTIOUS DISEASES

Human Immunodeficiency Virus

Hepatitis A Virus

Hepatitis B Virus

Hepatitis C Virus

Herpes Simplex Virus

Syphilis

Gonorrhea

Chlamydia

Human Papillomavirus

Chagas disease

Dengue fever

Lymphatic filariasis

Leishmaniasis

Onchocerciasis

Schistosomiasis

Trypanosomiasis

Malaria

E.coli

Lyme disease

Rocky Mountain Spotted Fever

Yellow Fever

Measles

Mumps

Rubella

Histoplasmosis

Meningitis

Encephalitis

Diphtheria

Tetanus

Staphlococcus

Enterococcus

Rotavirus

Shigellosis

Typhoid fever

E. Coli

Campylobacter

Salmonella

Listeria

Trichinosis

Chickenpox

 

Exhibit A - 1

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

EXHIBIT B

LATERAL FLOW PATENT RIGHTS

***

 

Exhibit B - 1

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

EXHIBIT C

ORAQUICK® HCV PRODUCTS

The OraQuick® Rapid HCV Antibody Test is a lateral flow immunoassay device
contained within a device housing that utilizes an indirect immunoassay method
in a lateral flow device to detect antibodies to HCV in a blood sample
(including without limitation blood via fingerstick or venipuncture, plasma,
serum) or in an oral fluid sample.

Such oral fluid samples are collected directly on a swab protruding from the
device and placed into a developer solution. Such blood samples are collected
via a collection device (including without limitation a specimen collection
loop) and mixed in a container with a developer solution.

In the device, antigens derived from HCV are placed on a test area (including
without limitation a test line) on a porous membrane (including without
limitation a nitrocellulose strip), and antibodies reactive with these antigens
are visualized by a protein A, particle labeled conjugate.

The device comprises a series of components from upstream to downstream—the
blocker pad, the conjugate pad, the porous membrane, and finally the absorbent
pad. The performance of the assay occurs as a mixture of the specimen and
developer solution moves along the test device, carrying the specimen and the
substances on the test device from the blocker pad to the absorbent pad.

As the mixture of the specimen and developer solution flows along the device,
antibodies, if present in the specimen, are bound to the protein A, particle
labeled conjugate. Labeled complexes then migrate along the porous membrane
until they reach the test area. At the test area, labeled complexes containing
HCV antibodies bind to the HCV antigens at the test area.

Reactive results generate a visible signal at the test area of the device that
is viewed by the human eye.

The OraQuick® Rapid HCV Antibody Test will be described with more particularity
in a package insert approved from time to time by the U.S. Food and Drug
Administration, as such package insert may be updated from time to time after
approval by the U.S. Food and Drug Administration.

 

Exhibit C - 1

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

EXHIBIT D

ORAQUICK® HIV PRODUCTS

The OraQuick® Rapid HIV Antibody Test is a lateral flow immunoassay device
contained within a device housing that utilizes an indirect immunoassay method
in a lateral flow device to detect antibodies to HIV in a blood sample
(including without limitation blood via fingerstick or venipuncture, plasma,
serum) or in an oral fluid sample.

Such oral fluid samples are collected directly on a swab protruding from the
device and placed into a developer solution. Such blood samples are collected
via a collection device (including without limitation a specimen collection
loop) and mixed in a container with a developer solution.

In the device, antigens derived from HIV are placed on a test area (including
without limitation a test line) on a porous membrane (including without
limitation a nitrocellulose strip), and antibodies reactive with these antigens
are visualized by a protein A, particle labeled conjugate.

The device comprises a series of components from upstream to downstream—the
blocker pad, the conjugate pad, the porous membrane, and finally the absorbent
pad. The performance of the assay occurs as a mixture of the specimen and
developer solution moves along the test device, carrying the specimen and the
substances on the test device from the blocker pad to the absorbent pad.

As the mixture of the specimen and developer solution flows along the device,
antibodies, if present in the specimen, are bound to the protein A, particle
labeled conjugate. Labeled complexes then migrate along the porous membrane
until they reach the test area. At the test area, labeled complexes containing
HIV antibodies bind to the HIV antigens at the test area.

Reactive results generate a visible signal at the test area of the device that
is viewed by the human eye.

The OraQuick® Rapid HIV Antibody Test is described with more particularity in
the package insert attached below to this Exhibit D, as such package insert may
be updated from time to time after approval by the U.S. Food and Drug
Administration.

 

Exhibit D - 1