Exhibit 10.1

CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

SUCH OMISSIONS DENOTED WITH [***].

Execution Version

[Redacted]

MASTER PROGRAM SERVICES AND PRODUCT CO-PROMOTION AGREEMENT

This Master Program Services and Product Co-Promotion Agreement (this
“Agreement”) is made and entered into effective as of June 10, 2014 (the
“Effective Date”) by and between ORASURE TECHNOLOGIES, INC., a Delaware
corporation having a principal place of business at 220 East First Street,
Bethlehem, Pennsylvania 18015 (“OraSure”), and ABBVIE BAHAMAS LTD. a Bahamian
limited corporation having a principal place of business at Sassoon House,
Shirley Street & Victoria Avenue, PO Box SS-5383, Nassau, New Providence,
Bahamas (“AbbVie”). OraSure and AbbVie are sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, OraSure has developed, and manufactures, markets, distributes and
sells, the OraQuick® HCV Rapid Antibody Test (U.S. Food and Drug Administration
(“FDA”) Premarket Approval No. P080027, as amended), an FDA-approved,
CLIA-waived point of care diagnostic test utilized for detecting HCV antibodies
in humans (the “Product”);

WHEREAS, AbbVie has a sales force of a size and nature suitable for effective
promotion of the Product in the Field in the Territory;

WHEREAS, AbbVie has developed a continuity of care model that involves a variety
of community outreach initiatives developed consistent with AbbVie internal
policies and procedures and intended to address HCV patient education, testing,
diagnosis, and treatment needs (the “Care Model”);

WHEREAS, the Care Model is intended to help improve clinical outcomes by
providing individuals the information and understanding necessary to participate
in the detection and management of HCV through the use of FDA-approved therapies
for the treatment of such condition;

WHEREAS, OraSure and AbbVie desire to co-promote the Product in order to promote
education and the early diagnosis, testing, and detection to appropriate
individuals in the Field in the Territory with respect to HCV;

WHEREAS, in furtherance of the foregoing: (A) AbbVie desires to engage OraSure
to provide certain services, and OraSure desires to provide such services, on
the terms and conditions set forth in this Agreement and in each individual
statement of work for engagements set forth in a statement of work (each such
statement of work a “Statement of Work”) executed

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

by both Parties (individually and collectively referred to herein as the
“OraSure Services”); and (B) OraSure desires to engage AbbVie to provide certain
services, and AbbVie desires to provide such services, on the terms and
conditions set forth in this Agreement and any Statement of Work (individually
and collectively referred to herein as the “AbbVie Services”); and

WHEREAS, a primary component of the OraSure Services, which is essential to the
implementation and success of the Care Model, is OraSure’s development and
ongoing maintenance of a proprietary database into which data relating to
individuals who are tested with the Product in the Field in the Territory and
who choose to opt-in to the Care Model, indicating interest and consent to
receive materials from AbbVie regarding HCV generally and regarding FDA-approved
therapies (“Patient Care Database”).

NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, do hereby agree as follows:

ARTICLE 1

DEFINITIONS

Unless otherwise specifically provided herein, the following terms shall have
the following meanings:

1.1 “AbbVie” has the meaning set forth in the preamble, and shall include its
successors and permitted assigns.

1.2 “AbbVie Competitors” has the meaning set forth in Exhibit A.

1.3 “AbbVie Indemnitees” has the meaning set forth in Section 7.1.

1.4 “AbbVie Services” has the meaning set forth in the Recitals.

1.5 “AbbVie Trademarks” has the meaning set forth in Section 2.11.

1.6 “Accounting Standards” means United States Generally Accepted Accounting
Principles (“G.A.A.P.”) or International Financial Reporting Standards (“IFRS”),
in each case consistently applied.

1.7 “Accrued Exclusivity Amount” has the meaning set forth in Section 4.2(a).

1.8 “Acquiror Product” has the meaning set forth in Section 2.2(c).

1.9 “ADR” has the meaning set forth in Section 9.4(c).

1.10 “Affiliate” means, with respect to a Party, any Person that, directly or
indirectly, through one (1) or more intermediaries, controls, is controlled by
or is under common control with such Party. For purposes of this definition,
“control” and, with correlative meanings, the terms “controlled by” and “under
common control with” means: (a) the possession, directly or

 

2

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

indirectly, of the power to direct the management or policies of a Person,
whether through the ownership of voting securities, by contract relating to
voting rights or corporate governance, or otherwise; or (b) the ownership,
directly or indirectly, of more than fifty percent (50%) of the voting
securities or other comparable ownership interest of a Person (or, with respect
to a limited partnership or other similar entity, its general partner or
controlling entity).

1.11 “Agreement” has the meaning set forth in the preamble, and shall include
this Agreement as amended or modified.

1.12 “Aggregate Exclusivity Amount” has the meaning set forth in Section 4.2(a).

1.13 “Annual Minimum Patient Care Database Threshold” has the meaning set forth
in Section 8.1(b).

1.14 “Applicable Law(s)” means federal, state, local, national and
supra-national laws, statutes, rules, and regulations, including any rules,
regulations, guidelines, or other requirements of the Regulatory Authorities,
major national securities exchanges or major securities listing organizations,
that may be in effect from time to time during the Term and applicable to a
particular activity hereunder.

1.15 “Audit Arbitrator” has the meaning set forth in Section 4.5.

1.16 “Breaching Party” has the meaning set forth in Section 8.2.

1.17 “Business Day” means a day other than a Saturday or Sunday on which banking
institutions in New York, New York are open for business.

1.18 “Calendar Quarter” means each successive period of three (3) calendar
months commencing on January 1, April 1, July 1 and October 1, except that the
first Calendar Quarter of the Term shall commence on the Effective Date and end
on the day immediately prior to the first to occur of January 1, April 1, July 1
or October 1 after the Effective Date, and the last Calendar Quarter shall end
on the last day of the Term.

1.19 “Calendar Year” means each successive period of twelve (12) calendar months
commencing on January 1 and ending on December 31, except the first Calendar
Year of the Term shall commence on the Effective Date and end on December 31,
2015 and the last Calendar Year of the Term shall commence on January 1 of the
year in which the Term ends and end on the last day of the Term.

1.20 “Care Model” has the meaning set forth in the Recitals and shall include
the Care Model as amended or modified.

1.21 “Change of Control” means: (a) the acquisition, directly or indirectly, by
any Person or group of related Persons (other than any Person that controls, is
controlled by or is under common control with a party) of beneficial ownership
(as such term is defined in Rule 13d-3 promulgated under the Securities Exchange
Act of 1934, as amended) of securities possessing more than fifty percent
(50%) of the total combined voting power of a Party’s outstanding securities;
(b) a merger or consolidation in which securities possessing more than

 

3

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

fifty percent (50%) of the total combined voting power of such Party’s
outstanding securities are transferred to a Person or Persons different from the
Persons holding those securities immediately prior to such transaction; or
(c) the sale, transfer, exclusive license or other disposition of all or
substantially all of such Party’s assets (determined on a consolidated basis).
For purposes of this definition, the term “control” including the term
“controlling” means the possession of, directly or indirectly, the capability to
control the direction of the management and policies of a Party, whether through
the ownership of shares, by contract or otherwise. For purposes of this
definition of “Change of Control” a Person shall not be deemed to have either
“voting power” in clause (b) above or “beneficial ownership” in clause (a) above
if such “voting power” or “beneficial ownership” (as applicable) is the result
of an agreement, arrangement or understanding to vote such applicable securities
where such agreement, arrangement or understanding arises solely from a
revocable proxy given in response to a proxy or consent solicitation made
pursuant to, and in accordance with, the applicable provisions of the Securities
Exchange Act of 1934 and the regulations thereunder, as amended from time to
time.

1.22 “Change of Laws” has the meaning set forth in Section 8.6.

1.23 “Commercially Reasonable Efforts” means, where applied to carrying out
specific tasks and obligations of a Party under this Agreement, expending (on
its own and/or acting through any of its Affiliates, agents or subcontractors)
reasonable, diligent, good faith efforts and resources to accomplish such task
or obligation as a similarly situated company would normally use to accomplish a
similar task or obligation under similar circumstances.

1.24 “Complaint” means a written, electronic or oral communication or expression
of dissatisfaction that alleges deficiencies related to the Product, including
the identity, quality, labeling, safety, accuracy or performance of the Product.

1.25 “Confidential Information” means any and all non-public information
provided orally, visually, in writing or other form by or on behalf of one
(1) Party (or an Affiliate or Representative of such Party) to the other Party
(or to an Affiliate or Representative of such Party) in connection with this
Agreement, including information relating to the terms of this Agreement, the
disclosing Party’s (or its Affiliate’s or Representative’s) business, financial
information and data, research and development plans, methods, concepts,
know-how and data, scientific and technical data, technology, manufacturing and
production data, product information, customer and supplier information,
business development, marketing and sales plans and data and any other materials
that have not been made to the general public by the disclosing Party (or an
Affiliate or Representative of such Party). Confidential Information does not
include patient information or other personal medical information or data
obtained pursuant to this Agreement.

1.26 “Control”, “Controls” or “Controlled” means, with respect to any
Intellectual Property Rights, material or item of a Person, the ability of such
Person (whether through ownership or license (other than a license granted in
this Agreement) to grant to the other Party and/or its Affiliates, as
applicable, the licenses, sublicenses or rights as provided herein without
violating the terms of any then-existing agreement with any Third Party and
without creating or increasing any payment obligation to a Third Party,
including any royalty or milestone payment.

 

4

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

1.27 “Convicted Entity” has the meaning set forth in Section 5.2(i).

1.28 “Convicted Individual” has the meaning set forth in Section 5.2(i).

1.29 “Co-Payment Assistance” has the meaning set forth in Section 2.4(b).

1.30 “Co-Payment Assistance Program” has the meaning set forth in
Section 2.4(b).

1.31 “Co-Promotion” means the activities associated with the promotion,
marketing and Detailing of the Product in the Field in the Territory as
contemplated by this Agreement.

1.32 “Co-Promotion Committee” has the meaning set forth in Section 2.6(a).

1.33 “Co-Promotion Fees” has the meaning set forth in Section 4.1.

1.34 “Co-Promotion Plan” means, for any period during the Term, a written plan
mutually agreed upon by the Parties pursuant to Section 2.5 that sets forth the
key elements of the sales and marketing strategy for the Product in the Field in
the Territory, including, but not limited to, plans for promotional materials,
advertising and number of Details.

1.35 “Current Good Manufacturing Practices” or “CGMP” means the current
standards for manufacture, as set forth in the FFDCA and applicable regulation
and guidelines promulgated thereunder or successors thereto and any Applicable
Law, as shall be in effect from time to time during the Term.

1.36 “Database Establishment, Ownership and Exclusivity Fees” has the meaning
set forth in Section 4.2(a).

1.37 “Database Exclusivity” has the meaning set forth in Section 2.2(a)(i).

1.38 “Debarred Entity” has the meaning set forth in Section 5.2(i).

1.39 “Debarred Individual” has the meaning set forth in Section 5.2(i).

1.40 “Default Notice” has the meaning set forth in Section 8.2.

1.41 “Detail” or “Detailing Activities” means a face-to-face contact between a
sales representative and a physician or other medical or health care
professional licensed or authorized under Applicable Law to administer the
Product, during which a secondary position detail is made to such Person in
order to market and promote the Product, during which contact (i) approved
Product Promotional Materials and (ii) scientific or medical information about
the Product are discussed in an effort to educate HCPs regarding the
administering of the Product for its Labeled Use; it being understood and agreed
that (a) a Detail does not include a reminder or sample drop (or other
comparable activity), and (b) Details shall be measured by each Party’s internal
recording of such activity (provided that such measurement shall be on the same
basis as the recording Party’s measurement for its sales representatives
detailing of such recording Party’s other products, consistently applied through
the Term); provided, that such meeting is consistent with and in accordance with
the requirements of Applicable Law and this Agreement. A

 

5

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

“secondary position detail” is one in which the promotional message involving
the Product is presented in the second position and is a principal topic of
discussion. When used as a verb, “Detail” means to engage in a Detail.

1.42 “Dispute” has the meaning set forth in Section 9.4(c).

1.43 “Dollars” or “$” means United States Dollars.

1.44 “Effective Date” has the meaning set forth in the preamble.

1.45 “Excluded Entity” has the meaning set forth in Section 5.2(i).

1.46 “Excluded Individual” has the meaning set forth in Section 5.2(i).

1.47 “Exclusivity” has the meaning set forth in Section 2.2(b).

1.48 “Exclusivity Period” has the meaning set forth in Section 4.2(a).

1.49 “Exclusivity Refund” has the meaning set forth in Section 4.2(a).

1.50 “Exclusivity Shortfall” has the meaning set forth in Section 4.2(a).

1.51 “FDA” means the United States Food and Drug Administration and any
successor agency(ies) or authority having substantially the same function.

1.52 “FDA’s Disqualified/Restricted Lists” has the meaning set forth in Section
5.2(i).

1.53 “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21
U.S.C. § 301 et seq., as amended from time to time, together with any rules,
regulations and requirements promulgated thereunder (including all additions,
supplements, extensions, and modifications thereto).

1.54 “Field” means the following: (a) physician- or nurse-administered clinics
at retail pharmacies; (b) primary care physician offices; (c) specialist care
offices consisting of gastroenterologists, hepatologists and infectious disease
specialists; (d) employers or employer groups mutually agreed by the Parties in
writing; and (e) physician- or nurse-administered clinics organized by the
Healthy Truckers Association of America and/or, if mutually agreed in writing by
the Parties, other Third Parties.

1.55 “Future Product” means any product, other than the Product, and all
improvements to such product, that OraSure Controls at any time during the Term,
that is used for the point-of-care detection of HCV antibodies in humans.

1.56 “Good Manufacturing Practice” or “GMP” means the current good manufacturing
practices applicable from time to time to the manufacturing of the Product, any
Product intermediate or components or accessories of the Product pursuant to
Applicable Law.

 

6

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

1.57 “Guiding Principles” means the principles for determining the Parties’
respective responsibilities for the co-promotion of the Product and the terms of
each Statement of Work, as set forth in Exhibit F.

1.58 “HCP” means: (a) health care providers qualified to prescribe, recommend,
or administer the Product, in each case who are authorized by Applicable Law to
authorize, utilize, or prescribe the Product; and (b) any associated staff who
need to be educated about the Product (including logistics related to the
Product), including nurses, laboratory technicians, physician assistants, and
administrative staff.

1.59 “HCV” means the hepatitis C virus.

1.60 “HIPAA” has the meaning set forth in Section 5.2(a).

1.61 “HIPAA Authorization Form” has the meaning set forth in Section 2.4(b)(i).

1.62 “HTAA Statement of Work” has the meaning set forth in Section 2.4(a).

1.63 “Indemnified Claim Notice” has the meaning set forth in Section 7.3.

1.64 “Indemnified Party” has the meaning set forth in Section 7.3.

1.65 “Intellectual Property Rights” means all rights, privileges and priorities
provided under federal, state, foreign and multinational law relating to
intellectual property, including all: (a) (i) U.S. and foreign patents and
patent applications, inventions, discoveries, machines, manufactures,
compositions of matter, processes, formulae, designs, methods, techniques,
procedures, concepts, developments, technology, new and useful improvements
thereof and know-how relating thereto, whether or not patented or patentable;
(ii) copyrights and works of authorship, including computer applications,
programs, software, hardware, files, mask works, compilations, databases,
documentation and related items; (iii) Trademarks; and (iv) trade secrets,
drawings, lists and all other proprietary, nonpublic or confidential
information, documents or materials in any media; and (b) all registrations,
applications, recordings and other legal protections or rights related to the
foregoing.

1.66 “Labeled Uses” means the diagnostic indications covered by the Marketing
Authorization for the Product.

1.67 “Litigation Conditions” has the meaning set forth in Section 7.4(a).

1.68 “Losses” has the meaning set forth in Section 7.1.

1.69 “Maintenance Services Payment” has the meaning set forth in Section 4.2(b).

1.70 “Marketing Authorization means the regulatory authorization required to
market, promote and sell the Product in the Field in the Territory.

1.71 “Marketing Consent Form” has the meaning set forth in Section 2.4(b)(i).

 

7

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

1.72 “Non-Breaching Party” has the meaning set forth in Section 8.2.

1.73 “Non-Governmental Payor Patients” has the meaning set forth in
Section 2.4(b).

1.74 “OraSure” has the meaning set forth in the preamble and shall include its
successors and permitted assigns.

1.75 “OraSure Indemnitees” has the meaning set forth in Section 7.2.

1.76 “OraSure Exclusivity” has the meaning set forth in Section 2.2(b)(i).

1.77 “OraSure Intellectual Property” means any and all Intellectual Property
Rights exclusively or non-exclusively Controlled by OraSure or its Affiliates
during the Term that are required for AbbVie to carry out its obligations to
promote, market and Detail the Product under this Agreement.

1.78 “OraSure Services” has the meaning set forth in the Recitals.

1.79 “OraSure Trademarks” has the meaning set forth in Section 2.11(a).

1.80 “Paid Exclusivity Fees” has the meaning set forth in Section 4.2(a).

1.81 “Party” or “Parties” has the meaning set forth in the preamble.

1.82 “Patient(s)” means those individuals who are tested for HCV through the
administration of the Product by an HCP in the Field in the Territory.

1.83 “Patient Care Database” has the meaning set forth in the Recitals.

1.84 “Patient Forms” has the meaning set forth in Section 2.4(b)(i).

1.85 “Patient Information” has the meaning set forth in Section 2.4(b)(i).

1.86 “Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated association,
joint venture or other similar entity or organization, including a government or
political subdivision, department or agency of a government.

1.87 “Personal Data” has the meaning set forth in Section 3.3.

1.88 “Process” or “Processing” has the meaning set forth in Section 3.3.

1.89 “Product” has the meaning set forth in the recitals and includes any future
modifications, variations, revisions or improvements thereto, to the extent such
modified, varied, revised or improved product is covered by the same FDA
premarket approval identified in the recitals, as such approval may be
supplemented from time to time, and, subject to Section 2.2(c), Future Products.

 

8

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

1.90 “Product Promotional Materials” has the meaning set forth in
Section 2.7(b).

1.91 “Regulatory Authority” means any applicable supra-national, federal,
national, regional, state, provincial, or local governmental or regulatory
authority, agency, department, bureau, commission, council, or other entities
regulating or otherwise exercising authority with respect to activities
contemplated in this Agreement.

1.92 “Representatives” of a Party or any of its Affiliates means the officers,
directors, employees and agents of such Party or Affiliate.

1.93 “Right of First Refusal” has the meaning set forth in Section 2.2(c).

1.94 “Sales Force” means the field-based sales representatives employed by or on
behalf of AbbVie or OraSure, as the case may be, for Co-Promoting the Product in
the Field in the Territory to the HCPs. Either Party’s Sales Force may include
sales representatives engaged through an arrangement with a contract sales
organization or other Third Party.

1.95 “Samples” mean free samples of the Product distributed by OraSure to a HCP.

1.96 “Security Breach” has the meaning set forth in Section 3.3(d).

1.97 “Senior Officer” means, with respect to OraSure, its Chief Executive
Officer or his/her designee, and with respect to AbbVie, its VP of Specialty
Brands or his/her designee.

1.98 “Statement of Work” has the meaning set forth in the Recitals and shall
include any modifications or amendments thereto.

1.99 “Term” has the meaning set forth in Section 8.1.

1.100 “Territory” means the United States of America (including the District of
Columbia) and its territories and possessions, including but not limited to
Puerto Rico.

1.101 “Third Party” means any Person other than OraSure, AbbVie and their
respective Affiliates.

1.102 “Third Party Claim” has the meaning set forth in Section 7.1.

1.103 “Third Party Provider” has the meaning set forth in Section 3.2.

1.104 “Trademark” means any word, name, symbol, color, designation or device or
any combination thereof that functions as a source identifier, including any
trademark, trade dress, brand mark, service mark, trade name, brand name, logo,
business symbol or domain names, whether or not registered.

 

9

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

ARTICLE 2

SERVICES AND CO-PROMOTION OF THE PRODUCT

2.1 Grant of Co-Promotion Rights. During the Term, OraSure hereby grants to
AbbVie and its Affiliates (to the extent such Affiliates are Co-Promoting the
Product), the co-exclusive right (solely with OraSure and its Affiliates) to
Co-Promote the Product in the Field in the Territory and to conduct its
obligations under this Agreement, as permitted under and subject to the terms
and conditions set forth in this Agreement.

2.2 Exclusivity.

(a) Patient Care Database Exclusivity.

(i) During the Term, and subject to Section 2.2(a)(iii), OraSure will develop
and establish the Patient Care Database for, and on behalf of, and for the sole
and exclusive benefit of, AbbVie, and hereby grants AbbVie exclusivity with
respect to the Patient Care Database and the Intellectual Property Rights
therein (such exclusivity, the “Database Exclusivity”). OraSure shall not, and
shall cause its Affiliates and Representatives to not, directly or indirectly,
enter into any arrangement with any Third Party (other than with Third Party
Provider(s) engaged by OraSure or its Affiliates to develop, operate and
maintain the Patient Care Database) to provide access to, allow the reverse
engineering of, or otherwise permit or facilitate the ability of any Third Party
(except as permitted above) to use or access the Patient Care Database or,
except as may be required by Applicable Law or the order of a court or
Regulatory Authority, provide any list, data or other information from the
Patient Care Database to any such Third Party or otherwise commercialize the
Patient Care Database.

(ii) Additionally, upon the termination or nonrenewal of this Agreement at any
time, for any reason, subject to the terms of Section 8.7(d) and AbbVie
fulfilling its payment obligations pursuant to Section 4.2 below, OraSure and
its Affiliates shall no longer access or use the Patient Care Database or,
subject to Section 2.2(a)(iii), any data or information therefrom, and AbbVie
shall have such rights with respect thereto, including Intellectual Property
Rights, as set forth in Section 8.7(d).

(iii) Notwithstanding Sections 2.2(a)(i) and (ii), OraSure shall have the right
to use any data or information from the Patient Care Database as follows: (A) to
verify the amount of Maintenance Services Payments required to be paid by AbbVie
hereunder, (B) to administer and maintain the Patient Care Database, and (C) in
anonymized form not containing Personal Data for OraSure’s marketing purposes.

(b) Product Exclusivity.

(i) For the duration of the Term, OraSure and its Affiliates shall not, directly
or indirectly, enter into any arrangement in the Territory to co-promote,
market, Detail or sell the Product in the Field in the Territory (“OraSure
Exclusivity” and, collectively, with the Database Exclusivity, sometimes
referred to herein as the “Exclusivity”). Notwithstanding the foregoing, the
OraSure Exclusivity does not prohibit or restrict OraSure from (A) promoting,
marketing, Detailing or selling the Product directly or through or with any
distributor, subcontractor, agent, sales representative or other Third Party
that is not an AbbVie Competitor, (B) engaging in or undergoing a Change of
Control, or (C) entering into any arrangement to sell Product to Persons that
are provided grants or other funding, directly or indirectly, by an AbbVie
Competitor.

 

10

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

(ii) For the duration of the Term, AbbVie and its Affiliates shall not, directly
or indirectly, on their own or through any arrangement with any Person, promote,
co-promote, market, Detail or sell any diagnostic test in the Territory that is
utilized for detecting HCV antibodies in humans (other than the Product with
OraSure).

(c) Future Products. If during the Term OraSure Controls a Future Product and
OraSure decides to commercialize such Future Product in the Field in the
Territory, AbbVie shall have the right of first refusal to co-promote such
Future Product in the Field in the Territory (the “Right of First Refusal”). In
such case, OraSure shall promptly notify AbbVie in writing setting forth
information about such Future Product as is reasonably requested by AbbVie. For
clarity, this Section 2.2(c) shall not apply in the event a Third Party acquires
OraSure and the Third Party (or any of such Third Party’s then-existing
Affiliates) already has a product that would constitute a Future Product and
would otherwise fall within the scope of this Section 2.2(c) (an “Acquiror
Product”), and such Acquiror Product shall not be subject to this Section 2.2(c)
or otherwise be included in the definition of “Product” hereunder.

(i) If AbbVie wishes to co-promote such Future Product in the Territory, AbbVie
shall, within thirty (30) days following receipt of OraSure’s written
notification, deliver to OraSure written notice of AbbVie’s intent to co-promote
such Future Product.

(ii) If AbbVie does not deliver to OraSure written notice of its intent to
co-promote a Future Product within such thirty (30) day period, then OraSure
shall be free to negotiate and enter into a co-promotion agreement or similar
agreement for the relevant Future Product in the Field in the Territory with any
Third Party.

2.3 AbbVie Obligations.

(a) AbbVie shall utilize Commercially Reasonable Efforts to (in all cases in
accordance with the terms and conditions of this Agreement, Applicable Law, and
AbbVie policies and procedures regarding interactions with HCPs and use of
promotional materials) (i) Co-Promote the Product in the Field in the Territory
through the AbbVie Sales Force pursuant to its respective responsibilities set
forth in the Co-Promotion Plan; (ii) develop, deploy, make available to Patients
and maintain the Care Model during the Term in the Field in the Territory in
accordance with the terms and conditions of this Agreement and Applicable Law;
and (iii) introduce physicians and other HCPs in the Field to, and obtain the
participation of physicians and other HCPs in the Field in, the Care Model; in
each case subject to and in accordance with the Guiding Principles. In addition,
as part of its Co-Promotion efforts, AbbVie agrees to Detail the Product to
primary care physicians, gastroenterologists, hepatologists and infectious
disease specialists in the Territory and provide the minimum number of Details
set forth in Section 4.1(b), in the approximate proportions set forth in the
Guiding Principles. Notwithstanding the foregoing, AbbVie shall have the sole
discretion with respect to determining the deployment of the AbbVie Sales Force,
subject to the terms and conditions of this Agreement, including the
Co-Promotion Plan.

 

11

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

2.4 OraSure Obligations.

(a) AbbVie and OraSure are entering into this Agreement with the understanding
that OraSure will provide OraSure Services as further set forth in Article 3 and
for each engagement set forth in each Statement of Work, in substantially the
form attached hereto as Exhibit C. In furtherance thereof, the Parties have
entered into the Statement of Work attached hereto as Exhibit C-1 (the “HTAA
Statement of Work”). Specifically, during the Term, OraSure shall utilize
Commercially Reasonable Efforts (in all cases in accordance with the terms and
conditions of this Agreement, Applicable Law and OraSure policies and procedures
regarding interactions with HCPs and use of sales and marketing materials) to:
(i) Co-Promote the Product in the Field in the Territory through the OraSure
Sales Force pursuant to its respective responsibilities set forth in the
Co-Promotion Plan; (ii) obtain or cause to be obtained and maintain or cause to
be maintained from each Patient enrolling and participating in the Patient Care
Database the relevant Marketing Consent Form and HIPAA Authorization Form;
(iii) obtain or cause to be obtained and maintain or cause to be maintained the
relevant Marketing Authorization and any other applicable regulatory approvals
reasonably necessary to market and sell the Product in the Field in the
Territory to the HCPs; (iv) distribute Patient Forms to HCPs; (v) manufacture
and supply the Product to meet market demand all in accordance with CGMP and all
Applicable Law; (vi) sell the Product to HCPs desiring to purchase Product in
the Field in the Territory; and (vii) distribute the Product in the Field in the
Territory; in each case subject to and in accordance with the Guiding
Principles. OraSure shall also build and maintain the Patient Care Database
pursuant to Section 3.1 and provide Care Model-related data reasonably requested
by AbbVie to AbbVie.

(b) Co-Payment Assistance Program. OraSure has developed or is developing a
co-payment assistance program for the Product exclusively for Non-Governmental
Payor Patients (the “Co-Payment Assistance Program”) as described herein. For
the duration of the Term, to the extent permitted by Applicable Law, OraSure
shall exercise Commercially Reasonable Efforts to implement and administer,
through a Third Party Provider or otherwise, the Co-Payment Assistance Program
in the Field in the Territory. The amount of such co-payment assistance will be
up to [***] per eligible Patient per unit of Product (the “Co-Payment
Assistance”) paid to the party administering the HCV test using the Product.
Administration details of the Co-Payment Assistance Program shall be determined
by OraSure consistent with the Guiding Principles. The Co-Pay Assistance Program
shall only be made available to Patients who have commercial medical insurance
or who are uninsured (collectively, the “Non-Governmental Payor Patients”) and
Co-Payment Assistance shall not be payable to any Patient, but rather shall be
paid on behalf of such Patient to reduce the cost that a Patient would otherwise
have incurred in connection with the use of the Product to perform the HCV test
on the Patient. No Patient that receives benefits under a Federal health care
program as defined at 42 U.S.C. §1320a-7b(f), a State health care program as
defined at 42 U.S.C. §1320a-7(h), or any other federal, state, or local
government funded health care program, shall be eligible to participate in the
Co-Payment Assistance Program. Subject to Applicable Law, OraSure shall exercise
Commercially Reasonable Efforts to encourage HCPs in the Field in the Territory
who administer or intend to administer the Product to offer the Co-Payment
Assistance Program to eligible Patients (excluding those Patients specified
above) prior to the administration of the Product. OraSure shall be solely
responsible for all costs and expenses associated with the Co-Payment Assistance
Program.

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

12

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

(i) OraSure will provide Co-Payment Assistance only to Patients who agree to
participate in the Patient Care Database and who complete the following forms
and securely submit the Patient Forms into the Patient Care Database:
(A) authorization to disclose Patient’s HCV diagnosis, other health or medical
information, demographic information, including name and address, financial
information and any other information provided in connection with the Co-Payment
Assistance Program (“Patient Information”) subsequent to the administration of
the Product, as set forth in Exhibit D (“HIPAA Authorization Form”); and
(B) consent to receipt of AbbVie marketing communications as set forth in
Exhibit E (“Marketing Consent Form,” collectively with the HIPAA Authorization
Form, the “Patient Forms”, as such Patient Forms may be reasonably modified by
the Parties to comply with Applicable Law).

For clarity, a Patient shall not be required to participate in the Co-Payment
Assistance Program in order to participate in the Patient Care Database.
Additionally, nothing in this Agreement shall prevent any individual from having
access to the Product or otherwise be interpreted as conditioning an
individual’s access to the Product on such individual electing to receive
Co-Payment Assistance or otherwise consenting to participate in the Patient Care
Database or the Care Model or to receive AbbVie marketing communications.

(ii) Except as otherwise provided in the Co-Promotion Plan or otherwise agreed
to in writing, OraSure shall be prohibited from Detailing, promoting,
discussing, selling, advertising for sale and communicating in any way
(including verbally, using written materials or online communication) about,
AbbVie’s pharmaceutical products with any Person, including healthcare
professionals, patients or any other actual or potential customer for AbbVie’s
pharmaceutical products, including any AbbVie products currently in development,
that would result in a violation by OraSure of Applicable Law.

2.5 Product Co-Promotion Plan. Within sixty (60) days following the Effective
Date, the Parties shall make their best effort to agree upon a Co-Promotion Plan
which shall be attached hereto as Exhibit B, and which Co-Promotion Plan will
specify in reasonable detail all Co-Promotion activities the Parties shall
undertake in the Field in the Territory during the Term. The Co-Promotion Plan
shall include, among other things, subject to and in accordance with the Guiding
Principles, the following: (a) the targeted number of annual Details by customer
group to be provided by AbbVie in the Field in the Territory; (b) Product
positioning, strategy and tactics with supporting marketing and promotional
activity to be undertaken; (c) a determination of the HCP accounts that are
appropriate for Details; (d) any training programs to be conducted;
(e) appropriate awareness, medical and education programs to be conducted;
(f) professional and trade relations activities; (g) specifications for the
development of Product Promotional Materials and training materials (including
the specific types of such materials to be developed); (h) subsequent to the
Co-Promotion Committee’s formation, such other information relating to the
marketing and sales of the Product as deemed advisable by the Co-Promotion
Committee; (i) the projected budget for all of the activities and materials
anticipated under such plan and the Parties’ respective financial obligations;
(j) a process for OraSure to communicate to AbbVie aggregate data recorded by
OraSure in accordance with its standard record keeping procedures and which is
related to the Co-Promotion of the Product, including Product sales and any
other information reasonably requested by AbbVie on a periodic schedule (which
may vary by type of information required and shall be subject to distributor or
other Third Party limitations where OraSure relies

 

13

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

on such Third Parties for such data); (k) a process for AbbVie to report on
Details conducted by it in the Field in the Territory and recorded by AbbVie in
accordance with its standard record keeping procedures based on data recorded by
the Sales Force, including the number of Details and the names, addresses and
other contact information for the Detail recipients; and (l) a process for
AbbVie to provide information to OraSure regarding its Co-Promotion efforts and
installation of its Care Model in the Field in the Territory, and any other
information reasonably requested by OraSure on a periodic schedule (which may
vary by type of information required). For clarity, OraSure shall have sole
responsibility for establishing and setting the sales price of the Product in
the Field in the Territory and booking, billing, invoicing, and submitting
claims of receivables and amounts due resulting from the sale of the Product in
the Field in the Territory, and consummating the sale of, and distributing and
selling, the Product in the Field in the Territory.

2.6 Product Co-Promotion Committee.

(a) Establishment; Composition. Within thirty (30) days following the Effective
Date, the Parties shall make their best effort to establish a joint Product
co-promotion committee (the “Co-Promotion Committee”). The Co-Promotion
Committee shall consist of an equal number of representatives from each of the
Parties, each with the requisite experience and seniority to enable such person
to make decisions on behalf of the Parties with respect to issues falling within
the jurisdiction of the Co-Promotion Committee, with at least one
(1) representative of each Party required at all times to be the senior
executive responsible within such Party for this Agreement. From time to time,
subject to the foregoing sentence, each Party may substitute one (1) or more of
its representatives to the Co-Promotion Committee with written notice to the
other Party.

(b) Meetings; Responsibilities. The Co-Promotion Committee shall meet at least
quarterly to: (i) review and discuss the strategies related to the Co-Promotion
of the Product in the Field in the Territory, including a review of Product
Promotional Materials and any and all OraSure development and commercialization
plans relating directly or indirectly to the Product in the Field in the
Territory, AbbVie, the Patient Care Database or the Care Program;
(ii) periodically (no less often than quarterly) review and serve as a forum for
discussing the Co-Promotion Plan and review and approve amendments thereto, as
well as the Parties’ performance of the Co-Promotion Plan; (iii) oversee at a
high level all Detailing in the Field in the Territory with respect to the
Product, including the number, frequency and location of Details; (iv) review
updates regarding any Product development, clinical, regulatory,
manufacturing/supply and quality matters; and (v) perform such other functions
as are set forth herein or as the Parties may mutually agree in writing, except
where in conflict with any provision of this Agreement. For purposes of clarity,
the Co-Promotion Committee shall not have any oversight of management
responsibility or authority with respect to: (x) the manufacturing/supply or
pricing of the Product; (y) the Marketing Authorization related to the Product;
or (z) the distribution and sales of the Product by OraSure. The first meeting
of the Co-Promotion Committee shall be held as soon as practicable after the
Effective Date. Notwithstanding the creation of the Co-Promotion Committee, each
Party shall retain the rights, powers and discretions granted to it pursuant to
this Agreement. The Co-Promotion Committee shall not be delegated or vested with
any rights, power or discretions unless expressly provided for in this
Agreement. Without limiting the generality of the foregoing, the Co-Promotion
Committee may not amend or modify this Agreement, which may only be amended or
modified as set forth in Section 9.6.

 

14

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

(c) Procedural Rules. The Co-Promotion Committee shall have the right to adopt
such standing rules as shall be necessary for its work, to the extent that such
rules are not inconsistent with this Agreement. A quorum of the Co-Promotion
Committee shall exist whenever there is present at a meeting at least the senior
executive directly responsible within each Party for this Agreement.
Representatives of the Parties on the Co-Promotion Committee may attend a
meeting either in person or by telephone, video conference or similar means in
which each participant can hear what is said by, and be heard by, the other
participants. Representation by proxy shall be permitted (other than for the
senior executive directly responsible within each Party for this Agreement). The
Co-Promotion Committee shall take action by agreement of the representatives
present at a meeting at which a quorum exists, with each Party having a single
vote irrespective of the number of representatives of such Party in attendance,
or by a written resolution signed by at least one (1) representative appointed
by each Party. Employees or consultants of either Party that are not
representatives of the Parties on the Co-Promotion Committee may attend
meetings; provided, that such attendees: (i) shall not vote or otherwise
participate in the decision-making process of the Co-Promotion Committee; and
(ii) are bound by obligations of confidentiality and non-disclosure set forth in
this Agreement.

(d) Minutes. A representative of each Party, alternating between the Parties for
each meeting of the Co-Promotion Committee (with OraSure having responsibility
for the initial Co-Promotion Committee meeting), shall be responsible for
preparing and circulating minutes of each meeting of the Co-Promotion Committee,
setting forth, inter alia, an overview of the discussions at the meeting and a
list of any actions, decisions or determinations approved by the Co-Promotion
Committee. Such minutes shall be effective only after such minutes have been
approved by both Parties in writing. Definitive minutes of all Co-Promotion
Committee meetings shall be finalized no later than ten (10) Business Days after
the meeting to which the minutes pertain.

(e) Expenses. Each Party shall bear its own costs associated with its
participation in the Co-Promotion Committee, including the costs of travel and
lodging and expenses directly associated with participation on the Co-Promotion
Committee.

(f) Dispute Resolution. If the Co-Promotion Committee cannot, or does not, reach
agreement on an issue at a meeting or within such other period as the Parties
may agree, then the dispute shall be referred to the Senior Officers of the
Parties, who shall confer in good faith on the resolution of the issue. Any
final decision mutually agreed to by the Senior Officers shall be conclusive and
binding on the Parties. If the Senior Officers are not able to agree on the
resolution of any such issue within thirty (30) days after such issue was first
referred to them, then such dispute shall be resolved as follows: (i) the Senior
Officer of OraSure shall have final decision making authority with respect to
all matters pertaining to the Product, including, subject to Section 2.7(b)(ii),
Product Promotional Materials, Product training materials and content, and
scripts to be used by the Parties’ Sales Forces with respect to the Product (but
excluding matters pertaining to the deployment of the AbbVie Sales Force), and
(ii) the Senior Officer of AbbVie shall have final decision making authority
with respect to all matters pertaining to the development, implementation and
maintenance of the Care Model.

 

15

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

(g) Limits on Decision Making Authority. Notwithstanding Section 2.6(f), the
Senior Officer of a Party shall not have the right to exercise its final
decision-making authority to unilaterally: (1) determine that any obligations
have been fulfilled under this Agreement or that a Party has breached any
obligation under this Agreement; (2) determine that a milestone event required
for the payment of a milestone payment has or has not occurred including,
without limitation, the payments set forth in Article 4 herein; (3) make a
decision that is expressly stated to require the mutual agreement of the
Parties; (4) amend the Co-Promotion Plan to require the other Party to conduct
any activities; or (5) otherwise expand a Party’s rights or reduce a Party’s
obligations under this Agreement, including, without limitation, the payments
set forth in Article 4 herein.

2.7 Product Promotion Matters.

(a) Detailing Costs. Except as set forth in Section 2.8 (with respect to the
initial training of AbbVie personnel), AbbVie shall be responsible for all costs
and expenses related to (i) establishing, maintaining and training the AbbVie
Sales Force and conducting AbbVie’s Detailing Activities pursuant to the
Co-Promotion Plan, (ii) the Care Model, and (iii) awareness raising and
educational activities regarding HCV and available treatments in connection with
the Care Model. OraSure shall be responsible for all costs and expenses related
to (i) establishing, maintaining or training the OraSure Sales Force,
(ii) conducting OraSure’s promotional activities pursuant to the Co-Promotion
Plan, and (iii) the Co-Payment Assistance Program. Each Party also shall bear
such costs and expenses for activities as may be specified in the Guiding
Principles, the Co-Promotion Plan or any Statement of Work.

(b) Product Promotional Materials.

(i) Promptly following the Effective Date, OraSure shall provide to AbbVie
physical or electronic copies of existing artwork or training, sales and
promotional materials relating to the Product (“Product Promotional Materials”).
Subject to Section 2.7(b)(ii), AbbVie may create new Product Promotional
Materials, based on the existing OraSure materials or otherwise.

(ii) All Product Promotional Materials created or to be used by AbbVie shall be
reviewed and approved promptly by the Parties in accordance with the mutually
agreed upon review protocols prior to their use by AbbVie. AbbVie shall not be
required to use any Product Promotional Materials that are not reviewed by and
reasonably acceptable to AbbVie. AbbVie may not use any Product Promotional
Materials that are not reviewed by and acceptable to OraSure, other than the
Product Promotional Materials provided by OraSure to AbbVie for its use. If,
after its review of any Product Promotional Materials (including any new
materials introduced after the Effective Date), a Party believes that changes to
any such Product Promotional Materials are required to comply with Applicable
Law or other regulatory requirements, such proposed changes shall be reviewed by
the Co-Promotion Committee. OraSure shall be responsible for ensuring that all
Product Promotional Materials prepared or approved by OraSure comply with the
Labeled Use, Applicable Law or other regulatory requirements applicable to the
Product.

(iii) OraSure, at its sole cost and expense, shall provide to AbbVie physical or
electronic copies of current OraSure Product Promotional Materials as reasonably
requested by AbbVie in order for AbbVie to fulfill its Co-Promotion activities
set forth in the Co-Promotion Plan; provided, that, AbbVie may produce
additional approved Product Promotional Materials at its own cost and expense.

 

16

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

(iv) OraSure shall own, and AbbVie hereby assigns (on behalf of itself and its
Affiliates) to OraSure, all rights, including all copyrights, in and to all
Product Promotional Materials created by either Party or any of their respective
Affiliates (other than those items which are subject to Third Party copyrights).
OraSure shall, and does hereby, grant to AbbVie a royalty-free, non-exclusive
license in the Field in the Territory during the Term to use, reproduce and
distribute Product Promotional Materials or any other Product-related materials
made available to AbbVie by OraSure hereunder, in each case, solely for the
performance of AbbVie’s Co-Promotion obligations pursuant to this Agreement.

2.8 Training. (a) OraSure shall cooperate with AbbVie to educate and train
AbbVie’s and, to the extent AbbVie’s Affiliates employ sales and marketing
personnel used to Co-Promote the Product, such Affiliates’ sales and marketing
representatives regarding the Product; provided, that such training shall be
completed by no later than ninety (90) days after the Effective Date, it being
understood that: (i) OraSure shall provide AbbVie, free of charge, with
reasonable quantities of training materials which have been created and
developed by OraSure relating to the Product; and (ii) AbbVie and its Affiliates
shall not permit any of their respective sales personnel to Co-Promote the
Product unless such sales personnel have been trained by OraSure (or AbbVie as
provided below in this Section 2.8). AbbVie and its Affiliates referenced above
shall make their respective sales representatives available for such training
and participate in conducting such training. Training shall be carried out at
times and locations that are mutually acceptable to the Parties. As additional
members are added to AbbVie’s or its Affiliates’ Sales Forces responsible for
Co-Promoting the Product, training will be provided to such newly added members
by either OraSure or AbbVie using solely the training materials initially
developed by OraSure, as mutually agreed upon by the Parties. The Parties shall
mutually decide where the training of such sales representatives will occur and,
unless the Parties agree otherwise in writing, AbbVie and OraSure will be
responsible for the costs of transporting, housing and maintaining their
respective personnel conducting or receiving such training. Any and all training
materials and training assistance shall, at a minimum, address: (w) the HCV
disease state; (x) Product knowledge; (y) obligations under this Agreement; and
(z) any other information the Parties reasonably believe is necessary to
Co-Promote the Product in the Field in the Territory. OraSure shall be
responsible for providing additional training in the event Product circumstances
change (including, but not limited, to labeling revisions or issuance of new
instructions for use) on substantially the same terms as this Section 2.8(a).

(a) On such date as shall be agreed to by the Parties, AbbVie shall provide
OraSure with reasonable training regarding the Care Model, including the
information regarding the Care Model that the OraSure Sales Force may convey to
customers in the Field. AbbVie shall provide OraSure, free of charge, with
reasonable quantities of training and other materials which have been created
and developed by AbbVie relating to the Care Model. The Parties shall mutually
decide where the training of such sales representatives will occur and, unless
the Parties agree otherwise in writing, AbbVie and OraSure will be responsible
for the costs of transporting, housing and maintaining their respective
personnel conducting or receiving such training.

 

17

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

2.9 Compliance with Laws. Each of the Party’s Co-Promotion activities with
respect to the Product shall be conducted: (a) in a manner which is consistent
with the FFDCA, the Marketing Authorization and/or other regulatory requirements
which are then in effect with respect to the Product; and (b) in compliance with
Applicable Law, including all restrictions and regulations promulgated by the
FDA or any other applicable Regulatory Authority. In addition, in performing its
Co-Promotion duties hereunder, AbbVie shall, and shall cause its employees and
Sales Force to, comply with all regulatory, professional and legal requirements,
including, without limitation, the American Medical Association’s Guidelines on
Gifts to Physicians, the PhRMA Guidelines for Marketing Practices, the AdvaMed
Code, and the ACCME Standards for Commercial Support of Continuing Medical
Education, which may be applicable to the services to be provided by
Co-Promotion Partner hereunder. No employee or Sales Force member of either
Party shall make any representation, statement, warranty or guaranty with
respect to the Product that is not consistent with current labeling of the
Product or Product Promotional Materials approved by the Co-Promotion Committee,
that is deceptive or misleading or that disparages the Product or the good name,
goodwill and reputation of either Party. Both Parties shall use Commercially
Reasonable Efforts to ensure that its services hereunder will be provided in a
professional, ethical and competent manner.

2.10 Sampling. OraSure shall be permitted to provide co-branded samples of the
Product to HCPs in the Field in the Territory; provided, that the number of
Product samples each HCP is entitled to receive shall be limited to the number
of Product samples reasonably necessary for the HCP to learn how to properly
administer and interpret the test results of the Product, in accordance with all
Applicable Laws and the AdvaMed Code, but in no event more than [***] Product
units, provided further that OraSure may provide additional co-branded samples
of the Product (not to exceed [***]) to any HCP that previously has received
such samples as may be reasonably necessary for such HCP to refresh the HCP’s
learning of the proper administration and interpretation of test results of the
Product. In addition, OraSure agrees: (a) not to provide any Samples or other
free product of any type to AbbVie for distribution in any way; and (b) except
for the Co-Payment Assistance Program and Product samples as set forth above,
not to provide any remuneration or any financial incentive or free or discounted
products of any type, including Products, to healthcare practitioners to get
Patients to enroll in the Patient Care Database. OraSure shall be responsible
for all recordkeeping, registration and listing, and all other requirements
related to Product sampling under all Applicable Laws.

AbbVie and OraSure agree that all samples will be distributed by OraSure. To the
extent that the Parties desire to use a coupon or voucher to enable HCPs to
obtain Samples, AbbVie shall be permitted to distribute such coupons or
vouchers, provided that (i) OraSure has provided its prior written consent to
the use of such coupons or vouchers, and (ii) all such coupons and vouchers
shall not exceed an amount which enables OraSure to comply with its obligations
under this Section 2.10 above which limits the number of free Samples that can
be distributed.

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

18

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

2.11 Trademarks.

(a) During the Term, OraSure hereby grants to AbbVie and its Affiliates a
non-exclusive, royalty-free right and license to use the OraSure Trademarks
specified in Schedule 2.11 (the “OraSure Trademarks”) solely in connection with
performing its obligations under this Agreement. AbbVie and its Affiliates may
use the OraSure Trademarks on leaflets, brochures, advertising and Product
Promotional Materials. Notwithstanding the foregoing, any usage of OraSure
Trademarks by AbbVie or its Affiliates must be approved in advance by OraSure,
which approval shall not be unreasonably withheld, delayed or conditioned.
AbbVie shall ensure that each use of the OraSure Trademarks by it and its
Affiliates is accompanied by an acknowledgement that the OraSure Trademarks are
owned by OraSure.

(b) During the Term, AbbVie hereby grants to OraSure and its Affiliates a
non-exclusive, royalty-free right and license to use the AbbVie Trademarks
specified in Schedule 2.11 (the “AbbVie Trademarks”) solely in connection with
performing its obligations under this Agreement. OraSure and its Affiliates may
use the AbbVie Trademarks on leaflets, brochures, advertising and Product
Promotional Materials and Product samples. Notwithstanding the foregoing, any
usage of AbbVie Trademarks by OraSure or its Affiliates must be approved in
advance by AbbVie, which approval shall not be unreasonably withheld, delayed or
conditioned. OraSure shall ensure that each use of the AbbVie Trademarks by it
and its Affiliates is accompanied by an acknowledgement that the AbbVie
Trademarks are owned by AbbVie.

(c) Neither Party shall (i) use the Trademarks of the other Party in a way that
might prejudice their distinctiveness or validity or the goodwill of the owning
Party therein, or (ii) use any Trademarks so resembling any of the other Party’s
Trademarks as to be likely to cause confusion or deception.

(d) Each Party acknowledges the validity of the other Party’s right, title and
interest in and to the other Party’s Trademarks. The Parties shall not have,
assert or acquire any right, title or interest in or to any of the other Party’s
Trademarks.

(e) Each Party shall determine in its sole discretion what action, if any, to
take in response to the infringement or misappropriation or threatened
infringement or misappropriation of its Trademarks.

2.12 Regulatory Affairs.

(a) Complaints. If AbbVie or any of its Affiliates becomes aware of any
Complaint or concern regarding the Product (including related to the accuracy,
quality or performance of the Product or any complaints or concerns regarding
the sales, promotion, or marketing of the Product) in the Field in the
Territory, then AbbVie shall submit a written report of such Complaint or
concern, along with any documentation involved with the Complaint, if available,
to OraSure within two (2) Business Days after receipt of such Complaint or
concern by AbbVie. As between the Parties, OraSure shall have the sole authority
and responsibility to respond to any Regulatory Authority, including the FDA,
with respect to Complaints and concerns, and to handle all returns field alerts,
recalls or market withdrawals of the Product in accordance with Applicable Law;
provided, however, that the foregoing shall not be construed to

 

19

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

prevent AbbVie or its Affiliates in any way from complying with any Regulatory
Authority or Applicable Laws, rules or regulations or from responding to
Regulatory Authorities, including the FDA, with respect to Complaints regarding
the conduct of AbbVie. AbbVie shall forward all Complaints and inquiries to
OraSure in a timely manner as set forth in this Section 2.12 and shall follow
any reasonable and timely directions OraSure may provide in that respect. If an
investigation by OraSure is needed in response to a Complaint or inquiry, AbbVie
shall assist OraSure as reasonably requested by OraSure, at OraSure’s sole cost
and expense for reasonable direct costs and expenses incurred by AbbVie in
providing such assistance, and OraSure shall forward the results of the
investigation to AbbVie within two (2) Business Days to allow AbbVie to comply
with Applicable Law. OraSure shall have sole responsibility for direct,
front-line customer support including, without limitation, medical information
support for the Product. Such activities shall be at OraSure’s sole cost and
expense. OraSure shall be responsible for evaluating and reporting any
Complaints to Regulatory Authorities as required by Applicable Law. In addition,
OraSure shall provide AbbVie with any and all material Complaints relating to
the accuracy of the Product to the extent permitted by Applicable Law. OraSure
shall promptly provide AbbVie with: (i) reports to Regulatory Authorities in the
Territory regarding patient result errors; and (ii) all corrective actions,
preventative actions and similar communications to Regulatory Authorities that
relate to matters that would reasonably be deemed material to the
commercialization of the Product.

(b) Medical Inquiries. For all medical inquiries related to the Product, other
than inquiries for information within the scope of the Labeled Use or Product
Promotional Materials, AbbVie shall direct all such inquiries to OraSure and
OraSure shall handle such requests in accordance with all Applicable Laws and
FDA guidance. As between the Parties, any responses to such inquiries from a
Third Party shall be provided solely by OraSure and OraSure is solely
responsible for the content of such communications.

(c) Recalls. Each Party shall promptly (but in any case, not later than
forty-eight (48) hours) notify the other Party in writing of any order, request
or directive of a court or other Regulatory Authority to recall or withdraw the
Product. OraSure shall be responsible and have sole authority for handling all
inquiries, Complaints, or recalls of the Product at its sole cost and expense,
keeping AbbVie fully informed as to its plans and actions related to any such
recall. If requested by OraSure, AbbVie shall fully cooperate with a Product
recall in the Field in the Territory and follow all reasonable instructions
given by OraSure in that regard. If a Party (a) is contacted by any other
Regulatory Authority for any purpose pertaining specifically to this Agreement
or to the Product; or (b) becomes aware of an impending inspection or audit of
the facilities or operations involved with the Product, such Party shall
immediately notify the other Party in writing. AbbVie agrees that it shall not
respond to any such Regulatory Authority making an inquiry of it until and only
as reasonably directed by OraSure; provided, however, that the foregoing shall
not be construed to prevent AbbVie in any way from complying with any Regulatory
Authority or Applicable Laws. In the event that OraSure considers initiating a
voluntary recall of the Product, OraSure shall promptly inform AbbVie of such
deliberations (including the contributing facts and circumstances leading up to
such deliberations) and of its final determination, and keep AbbVie fully
informed as to its plans and actions related to any such voluntary recall.

 

20

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

2.13 Supply and Distribution. OraSure shall, at its sole cost and expense, use
Commercially Reasonable Efforts to: (a) have the Product manufactured either
directly or through a Third Party manufacturer for the Field in the Territory;
and (b) handle Product inventory, returns and receivables for the Field in the
Territory. OraSure shall utilize Commercially Reasonable Efforts to maintain, or
cause its Third Party Providers to maintain, sufficient stock of the Product
available in its inventory for prompt delivery to the HCPs in the Field and the
Territory following receipt of Product purchase orders. OraSure shall
manufacture or cause to be manufactured the Product for the Field and Territory
in accordance with all Applicable Law, including the FFDCA and Current Good
Manufacturing Practices, as applicable.

2.14 Completion of Exhibits. The Parties acknowledge that Exhibit B
(Co-Promotion Plan) and Exhibit G (Patient Care Database Requirements) are not
complete and final as of the Effective Date. The Parties shall use their best
efforts to agree upon final forms of these Exhibits, consistent with this
Agreement, no later than sixty (60) days after the Effective Date. Upon mutual
agreement by the Parties, these Exhibits will be attached hereto and
incorporated into this Agreement and become binding on the Parties.

2.15 Reservation of Rights. Except as expressly granted by OraSure in this
Agreement, OraSure does not grant to AbbVie any license, right or immunity,
whether by implication, estoppel or otherwise, with respect to any Intellectual
Property Rights of OraSure or any of its Affiliates. For clarity, OraSure
reserves the sole and exclusive right to pursue, obtain, maintain, defend and
enforce the OraSure Intellectual Property and its other Intellectual Property
Rights.

ARTICLE 3

SERVICES

3.1 OraSure Services. AbbVie desires to retain OraSure to perform the OraSure
Services, including such services relating to the Patient Care Database, in
furtherance of the Care Model as follows:

(a) Patient Care Database. For the duration of the Term, OraSure shall exercise
Commercially Reasonable Efforts to design, develop, implement and administer the
Patient Care Database and, subject to AbbVie’s compliance with Section 3.3,
maintain the security of the Patient Care Database and the Patient Information
contained therein, in accordance with the mutually agreed requirements therefor.
Any specifications with respect to the Patient Care Database that are set forth
in an agreement to be entered into between OraSure and a Third Party vendor
shall be subject to the prior written approval of AbbVie which approval shall
not be unreasonably withheld, conditioned or delayed and which specifications
shall be attached hereto as Exhibit G. OraSure shall provide training to AbbVie
and its Representatives on access and use of the Patient Care Database in a
manner consistent with Section 2.8. OraSure shall be solely responsible for all
costs and expenses associated with carrying out the activities described in the
first sentence of this Section 3.1(a) with respect to the Patient Care Database.
No modifications to the Patient Care Database or requirements therefore shall be
permitted without the Parties’ prior written consent.

 

21

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

(b) Additional Services. OraSure shall perform any additional services as
reasonably agreed to by the Parties and set forth in a Statement of Work to
effectuate the OraSure Services and purpose of this Agreement. Each Statement of
Work describing additional OraSure Services shall set forth, consistent with and
subject to the Guiding Principles and the terms of this Agreement: (i) the scope
of the relevant program, including a detailed explanation of such OraSure
Services to be provided; (ii) a list of applicable documents or materials which
are incorporated into the Statement of Work; (iii) performance requirements;
(iv) OraSure’s and AbbVie’s responsibilities, including payment of costs; (v) a
schedule for the program; (vi) both Parties’ project contacts; (vii) change
management; (viii) a listing of any Patient groups (grouped by state of
residence, payer or otherwise) who shall be excluded from the Program; and
(ix) a reference to this Agreement. With respect to any additional proposed
OraSure Services not previously approved by the Parties in accordance with the
terms of this Agreement, OraSure shall provide such OraSure Services only after
the scope of such OraSure Services has been approved by AbbVie and agreed to by
OraSure in writing in the form of a fully executed Statement of Work. In the
event the terms of any Statement of Work are inconsistent with or are in
conflict with the terms of this Agreement, the terms of this Agreement shall
control, unless a term of this Agreement is expressly intended to be replaced or
amended, as set forth in a fully executed Statement of Work.

3.2 Subcontracting of Services. Subject to Section 2.2(b), each Party shall have
the right to subcontract any of the services it is to provide or its other
obligations under this Agreement to a Third Party (a “Third Party Provider”)
without the prior written consent of the other Party. In the event a Party
subcontracts certain services or other obligations, the subcontracting Party
shall furnish the other Party with written notice identifying the Third Party
Provider and specifying the work subcontracted. The subcontracting Party shall
ensure that it obtains a written undertaking from the Third Party Provider that
it shall be subject to the applicable terms and conditions of this Agreement,
including compliance with Applicable Law, the data provisions of this Article 3
and the confidentiality provisions of Article 6. Notwithstanding the foregoing,
the subcontracting Party shall remain responsible and liable to the other Party
for any and all services and items furnished by such Third Party Provider and
such Third Party Provider’s breach of this Agreement.

3.3 Data Protection. A Party may be required to use, access, collect, retain,
disclose or otherwise process individually identifiable health information or
information, in combination with other information, identifiable to a living
individual, including Patient Information obtained in connection with this
Agreement (collectively, “Personal Data”). For purposes of this Agreement,
“Processing” (and its conjugates, including without limitation “Process”) shall
mean any operation or set of operations that is performed upon Personal Data,
including any collection, recording, retention, organization, storage,
adaptation, alteration, retrieval, consultation, blocking erasure use,
disclosure, access, transfer, or destruction, whether or not by electronic
means.

(a) Each Party shall use Commercially Reasonable Efforts to keep secure any
Personal Data in the possession or under the control of such Party or its
Affiliates, Representatives or Third Party Providers.

 

22

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

(b) In that event, each Party agrees to use, access, collect, retain, transmit,
disclose or otherwise process Personal Data solely as described in this
Agreement and the applicable Patient Forms, which means OraSure shall only use,
access, collect, retain, transmit, disclose or otherwise process Personal Data
solely for the purpose of creating and maintaining the Patient Care Database,
complying with its other obligations under this Agreement with respect thereto
and as provided in Section 2.2(a)(iii), and AbbVie shall only use, access,
collect, retain, disclose or otherwise process Personal Data solely for the
purposes set forth in this Agreement and the Patient Forms. Neither Party shall
use, access, collect, retain, transmit, disclose or otherwise process such
Personal Data for any other purpose or in any other manner except where such
further use is required by Applicable Law or Regulatory Authority.

(c) Each Party agrees to abide by all applicable data protection, privacy, and
security laws and regulations in connection with its activities under this
Agreement.

(d) Each Party will maintain appropriate safeguards to ensure the privacy,
confidentiality and security of the Personal Data.

(e) Each Party shall provide written notice to the other Party of any
unauthorized or improper use, access to, or disclosure of Personal Data obtained
in connection with this Agreement (“Security Breach”), including any use, access
or disclosure not expressly permitted under this Agreement, within three
(3) Business Days of becoming aware of such Security Breach. Such notice shall
include the timing and nature of the Security Breach, as well as a description
of the Breach. Each Party acknowledges that it shall be responsible and liable
for any Security Breach by it or its Affiliates. A Party shall not have any
liability to the other Party or any other Person for any liability to the extent
attributable to a Security Breach or other failure by its agents or other Third
Parties under its control, provided that such Party shall use Commercially
Reasonable Efforts to pass through to the other Party the benefit of any
representations, warranties, and indemnities made by the agent or Third Party
under its agreements with such Party and any other remedies such Party may have
against such agents and Third Parties. Each Party shall take reasonable measures
to remedy the Security Breach, provided that it shall also reasonably consider
all reasonable measures recommended by the other Party.

(f) Where applicable data protection, privacy or security laws or regulations
require additional agreements, breach remedies or mitigation, data safeguards or
privacy protections as a result of Personal Data that is collected and
maintained and transferred to the Patient Care Database, each Party will use
Commercially Reasonable Efforts to ensure that all necessary agreements are
implemented and in place, and that all breach remedies or mitigation, data
safeguards or privacy protections are implemented and in place.

(g) These provisions will survive termination or expiration of this Agreement.

 

23

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

ARTICLE 4

COMPENSATION

4.1 Co-Promotion Fees. During the Term of this Agreement, OraSure shall pay, as
compensation for AbbVie’s Co-Promotion activities and obligations under this
Agreement, a co-promotion fee (the “Co-Promotion Fees”) as follows:

(a) The number of Details per year provided by the AbbVie Sales Force is
expected to range from [***] as indicated below. Each Detail will be a secondary
position detail (as defined in Section 1.38) at a cost of [***] per Detail,
subject to Section 4.1(b). AbbVie will provide OraSure a report on the Details
performed within ten (10) days of the end of each Calendar Quarter, and together
with such report shall provide a written invoice to OraSure for the Co-Promotion
Fee.

(b) The table below sets forth, on an annual basis, the minimum number of
Details required from AbbVie’s Sales Force and the maximum cost that OraSure
shall be obligated to pay for such Details, regardless if the number of such
Details performed exceeds the amounts set forth below during the applicable
annual period.

 

     2014   2015   2016   2017   2018   2019

# Physicians

   [***]

Calls per MD

   [***]   [***]   [***]   [***]   [***]   [***]

$ Per Call

   [***]

Maximum $

   [***]   [***]   [***]   [***]   [***]   [***]

(c) If the target primary care physician, gastroenterologist, hepatologist
and/or infectious disease specialist market for the Product materially changes
at any time during the Term, at OraSure’s request, the Parties agree to discuss
in good faith potential adjustment to the level of Details to be performed per
year and/or the Co-Promotion Fees.

4.2 Fees for Database Establishment, Ownership, Exclusivity and Other OraSure
Services.

(a) Database Establishment, Ownership and Exclusivity Fees. Subject to the
termination rights set forth herein, AbbVie shall pay OraSure the fees set forth
in this Section 4.2(a) for the design and development of, and AbbVie’s exclusive
rights to, the Patient Care Database, as well as the Right of First Refusal and,
subject to rights retained by OraSure under Section 2.2(a) during the Term, the
Exclusivity granted to AbbVie hereunder (collectively referred to herein as the
“Database Establishment, Ownership and Exclusivity Fee”):

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

24

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

Patient Care Database Ownership and Exclusivity

Fee Payment Date

 

US$ Amount

Within thirty (30) days following the Effective Date

  Fifteen Million Dollars ($15,000,000)

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Within [***] days following [***]

 

[***]

Except as specifically provided below, the Database Establishment, Ownership and
Exclusivity Fees shall be non-refundable, non-creditable and not subject to
setoff. The maximum aggregate amount of the Database Establishment, Ownership
and Exclusivity Fees payable by AbbVie to OraSure pursuant to this Agreement
shall be Seventy Five Million Dollars ($75,000,000) (the “Aggregate Exclusivity
Amount”), unless otherwise agreed to by the Parties in connection with a renewal
of this Agreement or material expansion of the Field. Notwithstanding the
schedule of fee payments set forth above, the Aggregate Exclusivity Amount shall
accrue and be earned ratably on a daily basis by OraSure during the period from
the Effective Date through the end of the Term on December 31, 2019 (the
“Exclusivity Period”). In the event this Agreement is terminated prior to
December 31, 2019, either by OraSure for convenience pursuant to Section 8.5 or
by AbbVie as a result of a material breach by OraSure pursuant to Section 8.2,
then OraSure shall refund to AbbVie an amount (the “Exclusivity Refund”) equal
to the excess, if any, of (i) the aggregate Database Establishment, Ownership
and Exclusivity Fees received by OraSure hereunder on or prior to the effective
date of termination (the “Paid Exclusivity Fees”), over (ii) the portion of the
Accrued Exclusivity Amount accrued and earned through the effective date of
termination (the “Accrued Exclusivity Amount”). For clarity, the Accrued
Exclusivity Amount shall equal (A) the Aggregate Exclusivity Amount multiplied
by (B) a fraction having (x) a numerator equal to the number of calendar days
occurring from the Effective Date through the date of termination, and (y) a
denominator equal to the total number of calendar days in the Exclusivity
Period. To the extent that the Paid Exclusivity Fees are less than the Accrued
Exclusivity Amount (the “Exclusivity Shortfall”), AbbVie shall be obligated to
pay such Exclusivity Shortfall to OraSure. Payment of

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

25

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

any Exclusivity Refund or Exclusivity Shortfall hereunder, as applicable, shall
occur no later than thirty (30) days after the effective date of termination.
For avoidance of doubt, no Exclusivity Refund or Exclusivity Shortfall shall be
payable in respect of termination of this Agreement other than termination
either by OraSure for convenience pursuant to Section 8.5 or by AbbVie as a
result of a material breach by OraSure pursuant to Section 8.2. In the event
this Agreement is terminated by AbbVie for convenience pursuant to Section 8.5,
AbbVie will not be obligated to pay OraSure any Database Establishment,
Ownership and Exclusivity Fees payable after the effective date of such
termination and, subject to its compliance with Section 8.7(b) and fulfillment
of its obligations under this Agreement, AbbVie shall obtain rights to the
Patient Care Database and Intellectual Property Rights therein as specified in
Section 8.7(d).

(b) Fee for Maintenance Services. AbbVie shall pay OraSure for each Calendar
Year, within thirty (30) days of receipt of OraSure’s invoice therefor, the
following fees for services relating to data collection, input, aggregation,
analytics and the ongoing operations and maintenance of the Patient Care
Database based upon the aggregate number of new Patients testing HCV positive
using the Product that are entered into the Patient Care Database during the
applicable Calendar Year as verified by the information from the Patient Care
Database (each a “Maintenance Services Payment”), and which aggregate diagnosis
thresholds shall be reported by AbbVie to OraSure within twenty (20) days of the
end of each Calendar Year. For the sake of clarity, any Patient testing HCV
positive using the Product who has been included in the calculation of the
Maintenance Services Payment during a prior Calendar Year shall be excluded from
the calculation of the Maintenance Services Payment in any subsequent Calendar
Year.

 

26

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

Tier

  

Patients Tested Positive with Product and Entered

in Patient Care Database

  

US$ Amount

1    [***]    Three Million Five Hundred Thousand Dollars ($3,500,000) 2   
[***]    [***] 3    [***]    [***] 4    [***]    [***] 5    [***]    [***] 6   
[***]    [***] 7    [***]    [***] 8    [***]    [***] 9    [***]    [***] 10   
[***]    [***] 11    [***]    [***] 12    [***]    [***] 13    [***]    [***] 14
   [***]    [***] 15    [***]    [***] 16    [***]    [***] 17    [***]    [***]

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

27

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

18    [***]    [***] 19    [***]    [***] 20    [***]    Fifty Five Million Five
Hundred Thousand Dollars ($55,500,000)

The Maintenance Services Payment shall be non-refundable, non-creditable and not
subject to setoff, provided, however, in the event of an accounting error the
Parties will true up any discrepancies related to the number of diagnoses
subject to the chart above on or before the date that the next Maintenance
Services Payment is due and owing. Moreover, the Parties acknowledge and agree
that (i) aggregate services contracted for do not exceed those that are
reasonable and necessary for the legitimate business purposes of the
arrangement, and (ii) the compensation to be paid over the term of each
arrangement is set in advance, does not exceed fair market value for this arm’s
length transaction, and, is not determined in a manner that takes into account
the volume or value of any referrals between the Parties. The Parties
acknowledge and agree that the services to be furnished under this Agreement do
not involve the counseling or promotion of a business arrangement or other
activity that violates any applicable Federal or State law.

4.3 Invoicing and Payment. All payments required to be made under this Agreement
shall be paid on or before the date specified for such payment in this
Agreement, and if not so specified, within thirty (30) days of receipt of an
invoice therefor.

4.4 Interest on Late Payments. If any payment due to either Party under this
Agreement is not paid when due, then the receiving Party shall have the right to
require that such paying Party pay interest thereon (before and after any
judgment) at a rate equal to the lesser of: (a) one and one half percentage
points (1.5%) above the prime rate as published by Citibank, N.A., New York, New
York, or any successor thereto, at 12:01 a.m. on the first day of each Calendar
Quarter in which such payments are overdue or (b) the maximum rate permitted by
Applicable Law, such interest to run from the date on which payment of such sum
became due until payment thereof in full together with such interest.

4.5 Audit.

(a) Maintenance of Books and Records. Each Party shall maintain complete and
accurate books and records in sufficient detail, in accordance with the
Accounting Standards and Applicable Law, to enable verification of the
performance of such Party’s obligations and the amounts required to be paid by
such Party under this Agreement. Such records shall be maintained for a period
of seven (7) years after the end of the Term or longer if required by Applicable
Law.

(b) Audit Procedure. At the request of the other Party, each Party shall, and
shall cause its Affiliates to, as applicable, permit an independent public
accounting firm of

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

28

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

nationally recognized standing designated by the other Party and reasonably
acceptable to the audited Party, at reasonable times during normal business
hours and upon reasonable notice, to audit the books and records of the audited
Party to ensure the accuracy of all reports and payments made hereunder. Such
examinations may not: (i) be conducted for any Calendar Quarter more than three
(3) years after the end of such quarter; (ii) be conducted more than once in any
twelve (12) month period (unless a previous audit during such twelve (12)-month
period revealed an underpayment or other material issues with respect to such
period); or (iii) be repeated for any Calendar Quarter. The accounting firm
shall disclose only whether the reports and payments are correct or not, and the
specific details concerning any discrepancies or noncompliance with this
Agreement. No other information shall be shared. Except as provided below, the
cost of this audit shall be borne by the auditing Party, unless the audit
reveals a variance of more than five percent (5%) from the reported amounts, in
which case the audited Party shall bear the cost of the audit. Unless disputed
pursuant to Section 4.5(c) below, if such audit concludes: (y) additional
amounts were owed by the audited Party, the audited Party shall pay the
additional amounts, with interest from the date originally due as provided in
Section 4.4; or (z) excess payments were made by the audited Party, the auditing
Party shall reimburse such excess payments, in either case ((y) or (z)), within
sixty (60) days after the date on which such audit is completed by the auditing
Party.

(c) Audit Dispute. In the event of a dispute with respect to any audit under
Section 4.5, the Parties shall work in good faith to resolve the disagreement.
If the Parties are unable to reach a mutually acceptable resolution of any such
dispute within thirty (30) days, the dispute shall be submitted for resolution
to a certified public accounting firm jointly selected by each Party’s certified
public accountants or to such other Person as the Parties shall mutually agree
(the “Audit Arbitrator”). The decision of the Audit Arbitrator shall be final
and the costs of such arbitration as well as the initial audit shall be borne
between the Parties in such manner as the Audit Arbitrator shall reasonably
determine. Not later than thirty (30) days after such decision and in accordance
with such decision, the audited Party shall pay the additional amounts, with
interest from the date originally due as provided in Section 4.4 or the auditing
Party shall reimburse the excess payments, as applicable. The Parties shall
cause the Audit Arbitrator to enter into a reasonably acceptable confidentiality
agreement with the audited Party obligating such firm to retain all such
financial information in confidence pursuant to such confidentiality agreement.

4.6 Tax Withholding. If Applicable Law requires that taxes be withheld with
respect to any payments by a Party to the other Party under this Agreement, the
paying Party shall: (a) deduct those taxes from the remittable payment, (b) pay
the taxes to the proper taxing authority, and (c) send evidence of the
obligation together with proof of tax payment to the payee Party on a timely
basis following that tax payment. Each Party agrees to cooperate with the other
Party in claiming refunds or exemptions from such deductions or withholdings
under any relevant agreement or treaty which is in effect. The Parties shall
discuss applicable mechanisms for minimizing such taxes to the extent possible
in compliance with Applicable Laws. In addition, the Parties shall cooperate in
accordance with Applicable Laws to minimize indirect taxes (such as sales tax,
consumption tax and other similar taxes) in connection with this Agreement.

 

29

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

4.7 Fair Market Value; Independent Appraisal. The Database Ownership and
Exclusivity Fees, Database Maintenance Fees and other fees for OraSure Services
paid toOraSure by AbbVie and the Co-Promotion Fees paid to AbbVie by OraSure
have each been determined by the Parties to be consistent with the fair market
value of the applicable items and services provided hereunder, without taking
into account any source of referrals, or the volume or value of any business
generated by OraSure or its Affiliates for AbbVie or its Affiliates, or by
AbbVie or its Affiliates for OraSure or its Affiliates that is reimbursed under
any governmental or commercial health care payment or insurance program. All of
the fees set forth herein have been established as of the Effective Date through
good-faith and arm’s length bargaining between the Parties.

ARTICLE 5

REPRESENTATIONS AND WARRANTIES

5.1 Mutual Representations and Warranties. Each Party represents and warrants to
the other, as of the Effective Date, as follows:

(a) Organization. It is a corporation duly organized, validly existing, and in
good standing under the laws of the jurisdiction of its organization, and has
all requisite power and authority, corporate or otherwise, to execute, deliver,
and perform their respective obligations under this Agreement.

(b) Authorization. The execution and delivery of this Agreement and the
performance by it of the transactions contemplated hereby have been duly
authorized by all necessary corporate action, and do not violate: (a) such
Party’s charter documents, bylaws, or other organizational documents; (b) in any
material respect, any agreement, instrument, or contractual obligation to which
such Party is bound; (c) any requirement of any Applicable Law applicable to
such Party; or (d) any order, writ, judgment, injunction, decree, determination,
or award of any court or Regulatory Authority presently in effect applicable to
such Party.

(c) Binding Agreement. This Agreement is a legal, valid, and binding obligation
of such Party enforceable against it in accordance with its terms and
conditions, subject to the effects of bankruptcy, insolvency, or other laws of
general application affecting the enforcement of creditor rights, judicial
principles affecting the availability of specific performance, and general
principles of equity (whether enforceability is considered a proceeding at law
or equity).

(d) No Inconsistent Obligation. It is not under any obligation, contractual or
otherwise, to any Person that conflicts with or is inconsistent in any material
respect with the terms of this Agreement, or that would impede the diligent and
complete fulfillment of its obligations hereunder.

5.2 Additional Representations and Warranties of OraSure. OraSure further
represents and warrants to AbbVie, as of the Effective Date, as follows:

(a) Compliance with Applicable Law. OraSure is in compliance with, and
undertakes that in performance of its obligations and exercise of its rights
under this Agreement, it shall continue to comply with all Applicable Laws,
including anti-bribery and anti-corruption laws, the Patient Protection and
Affordable Care Act of 2010, the Health Insurance Portability and Accountability
Act of 1996 (as amended) (“HIPAA”), laws applicable to the use and

 

30

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

disclosure of personally identifiable information, rules governing healthcare
programs and applicable FDA regulatory requirements, and Applicable Laws
relating to OraSure’s Co-Payment Assistance Program.

(b) OraSure Intellectual Property. OraSure and its Affiliates: (i) Control the
OraSure Intellectual Property licensed or needed to grant the rights granted to
AbbVie hereunder, that such rights to such OraSure Intellectual Property have
been, to OraSure’s knowledge, validly granted to OraSure and its Affiliates, and
the granting of such rights to AbbVie and its Affiliates under this Agreement
does not, to OraSure’s knowledge, require the consent of a Third Party in
accordance with the terms of this Agreement; and (ii) have not granted any right
or license to any Third Party relating to the OraSure Intellectual Property
and/or the Product that would conflict with the rights granted to AbbVie and its
Affiliates under this Agreement.

(c) Absence of Litigation. (i) There are no claims, judgments or settlements
against or owed by OraSure or its Affiliates or any pending or, to OraSure’s
knowledge, threatened claims or litigation relating to the Product or the
Product Promotional Materials used by OraSure prior to the Effective Date; and
(ii) there are no claims, judgments or settlements against or owed by OraSure or
its Affiliates relating to the OraSure Intellectual Property.

(d) Intellectual Property Infringement. To OraSure’s knowledge, there are no
Third Party patents, patent applications or other Third Party Intellectual
Property Rights that would be infringed by making, using, or selling the Product
or any related Product Promotional Materials in the Field in the Territory.

(e) Misappropriation. To OraSure’s knowledge, there is no infringement or
misappropriation by a Third Party of the OraSure Intellectual Property that
would have a material adverse effect on the Product, OraSure, or the ability of
the Parties to perform under this Agreement.

(f) Licenses and Permits. OraSure (and any Third Party subcontractors used by
OraSure) has obtained all necessary licenses, permits and certifications under
Applicable Law to use, make, Co-Promote and otherwise commercialize the Product
or provide Samples in the Field in Territory.

(g) Product Promotional Materials and Training Materials. All Product
Promotional Materials and training materials used by OraSure in connection with
the Product in the Field in the Territory comply, and all Product Promotional
Materials and training materials to be created and developed by OraSure pursuant
to this Agreement shall comply, with all Applicable Laws.

(h) Performance Standards. All activities and obligations performed under this
Agreement by OraSure shall be performed: (i) in a professional and workmanlike
manner; and (ii) by appropriately qualified individuals.

(i) Debarment and Exclusion. None of OraSure or its employees performing
activities or services hereunder, nor to OraSure’s knowledge, any agents or
Third Party Providers of OraSure performing activities or services hereunder,
are currently, or currently are the subject of a proceeding that could lead to
OraSure or such employees, agents, or subcontractors

 

31

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

becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded
Entity or Excluded Individual or a Convicted Entity or Convicted Individual, nor
are they listed on the FDA’s Disqualified and Restricted Lists. OraSure further
covenants, represents and warrants that if, during the Term, OraSure, or any of
its employees, agents or Third Party Providers performing activities or services
hereunder, becomes or is the subject of a proceeding that could lead to that
party becoming, as applicable, a Debarred Entity or Debarred Individual, an
Excluded Entity or Excluded Individual or a Convicted Entity or Convicted
Individual, or added to FDA’s Disqualified and Restricted Lists, OraSure shall
immediately notify AbbVie. The provision of this paragraph regarding notice of
acts occurring during the Term shall survive termination or expiration of this
Agreement. For purposes of this provision, the following definitions shall
apply: (i) a “Debarred Individual” is an individual who has been debarred by the
FDA pursuant to Title 21 of the United States Code (“USC”) Section 335a(a) or
(b) from providing services in any capacity to a person that has an approved or
pending drug product application; (ii) a “Debarred Entity” is (A) a corporation,
partnership or association that has been debarred by the FDA pursuant to Title
21 of USC Section 335a(a) or (b) from submitting or assisting in the submission
of any drug application, or (B) an agent, subsidiary or affiliate of a Debarred
Entity; (iii) an “Excluded Individual” or “Excluded Entity” is (A) 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 (B) 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 U.S. General Services Administration (GSA);
(iv) a “Convicted Individual” or “Convicted Entity” is an individual or entity,
as applicable, who has been convicted of a criminal offense or has been subject
to a civil penalty that falls within the ambit of Title 21 of USC
Section 335a(a) or (b), Title 42 of USC Section 1320a – 7(a), or Title 42 of
U.S.C. Section 1320a – 7(b)(1) –(3) but has not yet been excluded, debarred,
suspended or otherwise declared ineligible; and (v) “FDA’s
Disqualified/Restricted Lists” are (A) the list of clinical investigators FDA
has determined repeatedly or deliberately failed to comply with regulatory
requirements for studies, or submitted false information to the study sponsor or
the FDA, and as a result have been disqualified or “totally restricted” from
receiving investigational drugs, biologics, or devices and is ineligible to
conduct any clinical investigation that supports and application for research or
marketing permit for products regulated by the FDA, and (B) the list of clinical
investigators whom FDA has placed certain restrictions with respect to their
conduct of clinical investigations.

5.3 Additional Representations and Warranties of AbbVie. AbbVie further
represents and warrants to OraSure, as of the Effective Date as follows:

(a) Compliance with Applicable Law. AbbVie is in compliance with, and undertakes
that in performance of its obligations and exercise of its rights under this
Agreement, it shall continue to comply with, all Applicable Laws, including
anti-bribery and anti-corruption laws, Patient Protection and Affordable Care
Act of 2010, HIPAA, laws applicable to the use and disclosure of personally
identifiable information, rules governing healthcare programs and applicable FDA
regulatory requirements.

 

32

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

(b) AbbVie Intellectual Property. AbbVie and its Affiliates: (i) Control the
Intellectual Property Rights licensed or otherwise granted by AbbVie to OraSure
hereunder, that such rights to such Intellectual Property Rights have been, to
AbbVie’s knowledge, validly granted to AbbVie and its Affiliates, and the
granting of such rights to OraSure and its Affiliates under this Agreement does
not, to AbbVie’s knowledge, require the consent of a Third Party in accordance
with the terms of this Agreement; and (ii) have not granted any right or license
to any Third Party relating to the Intellectual Property Rights licensed or
otherwise granted by AbbVie to OraSure hereunder that would conflict with the
rights granted to OraSure and its Affiliates under this Agreement.

(c) Absence of Litigation. (i) There are no claims, judgments or settlements
against or owed by AbbVie or its Affiliates or any pending or, to AbbVie’s
knowledge, threatened claims or litigation relating to the Care Model or HCV
therapeutics of AbbVie or its Affiliates; and (ii) there are no claims,
judgments or settlements against or owed by AbbVie or its Affiliates relating to
the AbbVie Intellectual Property.

(d) Intellectual Property Infringement. To AbbVie’s knowledge, there are no
Third Party patents, patent applications or other Third Party Intellectual
Property Rights that would be infringed by establishing, deploying, offering or
administering the Care Model.

(e) Misappropriation. To AbbVie’s knowledge there is no infringement or
misappropriation by a Third Party of any Intellectual Property Rights Controlled
by AbbVie that would have a material adverse effect on the Care Model, AbbVie,
or the ability of the Parties to perform under of this Agreement.

(f) Licenses and Permits. AbbVie (and any Third Party subcontractors used by
AbbVie) has obtained all necessary licenses, permits and certifications under
Applicable Law to Co-Promote the Product and to establish, deploy, administer
and offer the Care Program to Patients.

(g) Performance Standards. All activities and obligations performed under this
Agreement by AbbVie shall be performed: (i) in a professional and workmanlike
manner; and (ii) by appropriately qualified individuals.

(h) Care Model. All materials relating to the Care Model and any HCV awareness
programs conducted by or on behalf of AbbVie or its Affiliates comply and shall
comply with all Applicable Laws.

(i) Debarment and Exclusion. None of AbbVie or its employees performing
activities hereunder, nor to AbbVie’s knowledge, any agents or Third Party
Providers of AbbVie performing activities hereunder are currently, or currently
are the subject of a proceeding that could lead to AbbVie or such employees,
agents, or subcontractors becoming, as applicable, a Debarred Entity or Debarred
Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or
Convicted Individual, nor are they listed on the FDA’s Disqualified and
Restricted Lists. AbbVie further covenants, represents and warrants that if,
during the Term, AbbVie, or any of its employees, agents or Third Party
Providers performing activities hereunder, becomes or is the subject of a
proceeding that could lead to that party becoming, as

 

33

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

applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or
Excluded Individual or a Convicted Entity or Convicted Individual, or added to
FDA’s Disqualified and Restricted Lists, AbbVie shall immediately notify
OraSure. The provision of this paragraph regarding notice of acts occurring
during the Term shall survive termination or expiration of this Agreement.

5.4 Disclaimer of Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 5, ALL
OTHER WARRANTIES, CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, STATUTORY
OR OTHERWISE, INCLUDING A WARRANTY AS TO THE QUALITY OR FITNESS FOR ANY
PARTICULAR PURPOSE OF THE PRODUCT ARE HEREBY EXCLUDED.

ARTICLE 6

CONFIDENTIALITY

6.1 Confidentiality Obligations. At all times during the Term and for a period
of ten (10) years following termination or expiration hereof in its entirety,
each Party shall, and shall cause its Affiliates and its and their respective
Representatives to, keep confidential and not publish or otherwise disclose to a
Third Party and not use, directly or indirectly, for any purpose, any
Confidential Information furnished or otherwise made known to it, directly or
indirectly, by the other Party or its Affiliates, except to the extent such
disclosure or use is expressly permitted by the terms of this Agreement.
Notwithstanding the foregoing, to the extent the receiving Party can be
demonstrate by documentation or other competent proof, the confidentiality and
non-use obligations under this Section 6.1 with respect to any Confidential
Information shall not include any information that:

(a) has been published by a Third Party or otherwise is or hereafter becomes
part of the public domain by public use, publication, general knowledge or the
like through no wrongful act, fault or negligence on the part of the receiving
Party;

(b) has been in the receiving Party’s possession prior to disclosure by the
disclosing Party without any obligation of confidentiality with respect to such
information;

(c) is subsequently received by the receiving Party from a Third Party without
restriction and without breach of any agreement between such Third Party and the
disclosing Party;

(d) is generally made available to Third Parties by the disclosing Party without
restriction on disclosure; or

(e) has been independently developed by or for the receiving Party without
reference to, or use or disclosure of, the disclosing Party’s Confidential
Information.

Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of the receiving Party merely
because the Confidential Information is embraced by more general information in
the public domain or in the possession of the receiving Party. Further, any
combination of Confidential Information shall not be considered in the public
domain or in the possession of the receiving Party merely because

 

34

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

individual elements of such Confidential Information are in the public domain or
in the possession of the receiving Party unless the combination and its
principles are in the public domain or in the possession of the receiving Party.

6.2 Permitted Disclosures. Each Party may disclose Confidential Information to
the extent that such disclosure is:

(a) in the reasonable opinion of the receiving Party’s legal counsel, required
to be disclosed pursuant to Applicable Law, regulation or a valid order of a
court of competent jurisdiction or other supra-national, federal, national,
regional, state, provincial and local governmental body of competent
jurisdiction (including by reason of filing with securities regulators or rules
of a securities exchange, but subject to Section 6.4); provided, that the
receiving Party shall first have given prompt written notice (and to the extent
reasonably possible, at least five (5) Business Days’ notice) to the disclosing
Party and given the disclosing Party a reasonable opportunity, if reasonably
possible, to take whatever action it deems necessary to protect its Confidential
Information (for example, quash such order or to obtain a protective order or
seek confidential treatment requiring that the Confidential Information and
documents that are the subject of such order be held in confidence by such court
or governmental body or, if disclosed, be used only for the purposes for which
the order was issued). In the event that no protective order or other remedy is
obtained, or the disclosing Party waives compliance with the terms of this
Agreement, the receiving Party shall furnish only that portion of Confidential
Information which the receiving Party is advised by legal counsel is legally
required to be disclosed;

(b) made by or on behalf of the receiving Party to the Regulatory Authorities as
required in connection with any filing, application or request for Marketing
Authorization, all in accordance with the terms of this Agreement; provided,
that reasonable measures shall be taken to assure confidential treatment of such
Confidential Information to the extent practicable and consistent with
Applicable Law;

(c) made to its or its Affiliates’ financial and legal advisors who have a need
to know such disclosing Party’s Confidential Information and are either under
professional codes of conduct giving rise to expectations of confidentiality and
non-use or under written agreements of confidentiality and non-use, in each
case, at least as restrictive as those set forth in this Agreement; provided,
that the receiving Party shall be responsible for any failure by such financial
and legal advisors, to treat such Confidential Information as required under
this Article 6;

(d) made by the receiving Party or its Affiliates to potential or actual
investors or acquirers as may be necessary in connection with their evaluation
of such potential or actual investment or acquisition; provided, that such
Persons shall be subject to obligations of confidentiality and non-use with
respect to such Confidential Information substantially similar to the
obligations of confidentiality and non-use of the receiving Party pursuant to
this Article 6; and

 

35

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

(e) made by the receiving Party to its advisors, consultants, vendors, Third
Party Providers or other Third Parties as may be necessary in connection with
the performance of its obligations or exercise of its rights as contemplated by
this Agreement; provided, that such Persons shall be subject to obligations of
confidentiality and non-use with respect to such Confidential Information
substantially similar to the obligations of confidentiality and non-use of the
receiving Party pursuant to this Article 6.

6.3 Use of Name. Except as expressly provided herein related to the co-branding
of Product Promotional Materials and Product samples and as provided in
Section 2.11, neither Party shall mention or otherwise use the name, logo, or
Trademark of the other Party or any of its Affiliates (or any abbreviation or
adaptation thereof) in any publication, press release, marketing and promotional
material, or other form of publicity without the prior written approval of such
other Party in each instance. The restrictions imposed by this Section 6.3 shall
not prohibit either Party from making any disclosure identifying the other Party
that, in the opinion of the disclosing Party’s legal counsel, is required by
Applicable Law; provided, that, subject to Section 6.4, such Party shall submit
the proposed disclosure identifying the other Party in writing to the other
Party as far in advance as reasonably practicable (and in no event less than
five (5) Business Days prior to the anticipated date of disclosure) so as to
provide a reasonable opportunity to comment thereon.

6.4 Public Announcements. The Parties have agreed upon the content of a press
release which shall be issued substantially in the agreed upon form, the release
of which the Parties shall coordinate in order to accomplish such release
promptly upon execution of this Agreement. Neither Party shall issue any other
public announcement, press release, or other public disclosure regarding this
Agreement or its subject matter without the other Party’s prior written consent,
except for any such disclosure that is, in the opinion of the disclosing Party’s
counsel, required by Applicable Law or the rules of a stock exchange on which
the securities of the disclosing Party are listed. Notwithstanding the
foregoing, the Parties contemplate that additional press releases may be issued
in connection with the continued promotion and commercialization of the Product
within the Field, subject to the consent rights in this Section 6.4. In the
event a Party is, in the opinion of its legal counsel, required by Applicable
Law or the rules of a stock exchange on which its securities are listed to make
such a public disclosure, such Party shall submit the proposed disclosure in
writing to the other Party as far in advance as is reasonably practicable under
the circumstances so as to provide a reasonable opportunity to comment thereon.
Each Party acknowledges and agrees that the other Party may file a redacted copy
of this Agreement to the U.S. Securities and Exchange Commission and if a Party
does submit this Agreement to the U.S. Securities and Exchange Commission, such
Party agrees to consult with the other Party with respect to the preparation and
submission of, a confidential treatment request for this Agreement.

6.5 Return of Confidential Information. Upon the effective date of the
termination of this Agreement for any reason, each Party shall, with respect to
Confidential Information to which such Party does not retain rights under the
surviving provisions of this Agreement: (a) as soon as reasonably practicable,
destroy all copies of such Confidential Information in the possession of the
other Party and confirm such destruction in writing to the requesting Party; or
(b) as soon as reasonably practicable, deliver to the requesting Party, at the
other Party’s expense, all copies of such Confidential Information in the
possession of the other Party; provided, that the other Party shall be permitted
to retain one (1) copy of such Confidential Information for the sole purpose of
performing any continuing obligations hereunder, as required

 

36

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

by Applicable Law, or for archival purposes. Notwithstanding the foregoing, such
other Party also shall be permitted to retain such additional copies of or any
computer records or files containing such Confidential Information that have
been created solely by such Party’s automatic archiving and back-up procedures,
to the extent created and retained in a manner consistent with such other
Party’s standard archiving and back-up procedures, but not for any other use or
purpose.

6.6 Survival. All Confidential Information shall continue to be subject to the
terms of this Agreement for the period set forth in Section 6.1.

ARTICLE 7

INDEMNIFICATION; INSURANCE

7.1 Indemnification by OraSure. OraSure shall defend, indemnify and hold AbbVie,
its Affiliates and their respective Representatives (“AbbVie Indemnitees”)
harmless from and against any liabilities, losses, damages, penalties, charges,
costs, or expenses, including reasonable attorneys’ fees and settlement payments
(collectively, “Losses”) that arise from any claim, lawsuit or other action by a
Third Party (“Third Party Claim”) against an AbbVie Indemnitee to the extent
resulting from:

(a) the Co-Promotion or the research, development, manufacture,
commercialization, distribution, importation or use of the Product by OraSure or
its Affiliates, or the Co-Payment Assistance Program;

(b) the accuracy of the Product;

(c) performance of the Product, including the reporting of Product results to
physicians or Patients;

(d) a breach by OraSure of its covenants or the material terms and conditions of
this Agreement;

(e) an actual or alleged infringement by the Product or any Product Promotional
Materials of any Intellectual Property Right of a Third Party;

(f) the infringement or other violation of any Third Party Trademarks with
respect to the use by AbbVie of the OraSure Trademarks in accordance with the
terms and conditions of this Agreement;

(g) subject to Section 3.3(d), the performance of the OraSure Services by
OraSure or its employees, agents or subcontractors;

(h) an inaccuracy of any of OraSure’s representations and warranties under this
Agreement; or

(i) the negligence, gross negligence or intentional misconduct of OraSure, its
Affiliates or their respective employees, agents or Third Party Providers.

 

37

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

The foregoing obligations shall not apply in the case of Losses for which
AbbVie, in whole or in part, has an obligation to indemnify OraSure pursuant to
Section 7.2, as to which Losses each Party shall indemnify the other Party to
the extent of their respective liability for the Losses.

7.2 Indemnification by AbbVie. AbbVie shall defend, indemnify and hold OraSure,
its Affiliates and their respective Representatives (“OraSure Indemnitees”)
harmless from and against any Losses that arise from any Third Party Claim
against an OraSure Indemnitee resulting from:

(a) the Co-Promotion of the Product (including all Detailing Activities) by
AbbVie or its Affiliates, or the Care Model;

(b) a breach by AbbVie of its covenants or the material terms and conditions of
this Agreement;

(c) an actual or alleged infringement by the Care Model or any materials
relating to the Care Model or any HCV awareness program conducted by or on
behalf of AbbVie or its Affiliates of any Intellectual Property Right of a Third
Party;

(d) the infringement or other violation of any Third Party Trademarks with
respect to the use by OraSure of the AbbVie Trademarks in accordance with the
terms and conditions of this Agreement;

(e) an inaccuracy of any of AbbVie’s representations and warranties under this
Agreement;

(f) training by AbbVie or its Affiliates of AbbVie’s Sales Force in a manner
inconsistent with the training or training materials provided to AbbVie by
OraSure; or

(g) the negligence, gross negligence or intentional misconduct of AbbVie, its
Affiliates or their respective employees, agents, subcontractors or Third Party
Providers.

(h) The foregoing obligations shall not apply in the case of Losses for which
OraSure, in whole or in part, has an obligation to indemnify AbbVie pursuant to
Section 7.1, as to which Losses each Party shall indemnify the other Party to
the extent of their respective liability for the Losses.

7.3 Notice of Claim. All indemnification claims in respect of a Party, its
Affiliates, or their respective Representatives shall be made solely by such
Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall
give the indemnifying Party prompt written notice (an “Indemnification Claim
Notice”) of any Losses or discovery of fact upon which such Indemnified Party
intends to base a request for indemnification under this Section 7.3, but in no
event shall the indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss is known at such time). The Indemnified
Party shall furnish promptly to the indemnifying Party copies of all papers and
official documents received in respect of any Losses or any Third Party Claim.

 

38

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

7.4 Control of Defense.

(a) In General. The indemnifying Party (or its insurer) may assume the defense
of any Third Party Claim by giving written notice to the Indemnified Party
within thirty (30) days after the indemnifying Party’s receipt of an
Indemnification Claim Notice, provided that, (i) such Third Party Claim solely
seeks monetary damages and (ii) the indemnifying Party expressly agrees in
writing that as between the indemnifying Party and the Indemnified Party, the
indemnifying Party shall be solely obligated to satisfy and discharge such Third
Party Claim in full (the matters described in (i) and (ii), the “Litigation
Conditions”); provided further that the Indemnified Party may, at any time,
assume the defense of a Third Party Claim if at any time the Litigation
Conditions are not satisfied with respect to such Third Party Claim. The
assumption of the defense of a Third Party Claim by the indemnifying Party shall
not be construed as an acknowledgment that the indemnifying Party is liable to
indemnify the Indemnified Party in respect of the Third Party Claim, nor shall
it constitute a waiver by the indemnifying Party of any defenses it may assert
against the Indemnified Party’s claim for indemnification. Upon assuming the
defense of a Third Party Claim, the indemnifying Party may appoint as lead
counsel in the defense of the Third Party Claim any legal counsel selected by
the indemnifying Party which shall be reasonably acceptable to the Indemnified
Party. In the event the indemnifying Party assumes the defense of a Third Party
Claim, the Indemnified Party shall immediately deliver to the indemnifying Party
all original notices and documents (including court papers) received by the
Indemnified Party in connection with the Third Party Claim. Should the
indemnifying Party assume the defense of a Third Party Claim, except as provided
in Section 7.4(b), the indemnifying Party shall not be liable to the Indemnified
Party for any legal expenses subsequently incurred by such Indemnified Party in
connection with the analysis, defense or settlement of the Third Party Claim
unless specifically requested in writing by the indemnifying Party. In the event
that it is ultimately determined that the indemnifying Party is not obligated to
indemnify, defend or hold harmless the Indemnified Party from and against the
Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party
for any Losses incurred by the indemnifying Party in its defense of the Third
Party Claim.

(b) Right to Participate in Defense. Without limiting Section 7.4(a), any
Indemnified Party shall be entitled to participate in, but not control, the
defense of such Third Party Claim and to employ counsel of its choice for such
purpose; provided, that such employment shall be at the Indemnified Party’s own
expense unless: (i) the employment thereof, and the assumption by the
indemnifying Party of such expense, has been specifically authorized by the
indemnifying Party in writing; (ii) the indemnifying Party has failed to assume
the defense and employ counsel in accordance with Section 7.4(a) or the
Litigation Conditions are not satisfied (in which case the Indemnified Party
shall control the defense); or (iii) the interests of the Indemnified Party and
the indemnifying Party with respect to such Third Party Claim are sufficiently
adverse to prohibit the representation by the same counsel of both Parties under
Applicable Law, ethical rules or equitable principles.

(c) Settlement. With respect to any Losses relating solely to the payment of
money damages in connection with a Third Party Claim that shall not result in
the Indemnified Party’s becoming subject to injunctive or other relief, and as
to which the indemnifying Party shall have acknowledged in writing the
obligation to indemnify the Indemnified Party hereunder, the indemnifying Party
shall have the sole right to consent to the entry of any judgment, enter

 

39

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

into any settlement or otherwise dispose of such Loss, on such terms as the
indemnifying Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Third Party Claims, where the
indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 7.4(a), the indemnifying Party shall have authority to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss; provided, that it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld, conditioned
or delayed). If the indemnifying Party does not assume and conduct the defense
of a Third Party Claim as provided above, the Indemnified Party may defend
against such Third Party Claim. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, no Indemnified Party shall
admit any liability with respect to, or settle, compromise or dispose of, any
Third Party Claim without the prior written consent of the indemnifying Party,
which consent shall not to be unreasonably withheld, conditioned or delayed. The
indemnifying Party shall not be liable for any settlement, compromise or other
disposition of a Loss by an Indemnified Party that is reached without the
written consent of the indemnifying Party, which consent shall not be
unreasonably withheld, conditioned or delayed.

(d) Cooperation. Regardless of whether the indemnifying Party chooses to defend
or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause
each indemnitee to, cooperate in the defense or prosecution thereof and shall
furnish such records, information and testimony, provide such witnesses and
attend such conferences, discovery proceedings, hearings, trials and appeals as
may be reasonably requested in connection therewith. Such cooperation shall
include access during normal business hours afforded to the indemnifying Party
to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making
Indemnified Parties and other employees and agents available on a mutually
convenient basis to provide additional information and explanation of any
material provided hereunder, and the indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in connection
therewith.

(e) Expenses. Except as provided above, the reasonable and verifiable costs and
expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any Third Party Claim shall be reimbursed
on a quarterly basis in arrears by the indemnifying Party, without prejudice to
the indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the indemnifying Party is
ultimately held not to be obligated to indemnify the Indemnified Party.

7.5 Special, Indirect, and Other Losses. EXCEPT (A) FOR WILLFUL MISCONDUCT,
(B) FOR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 6 OR SECTION 2.2(b),
AND (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY
AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE
7, NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR INDIRECT,
INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING
LOSS OF PROFITS OR BUSINESS INTERRUPTION, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR
OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS
AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE.

 

40

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

7.6 Insurance. Both Parties shall obtain and carry in full force and effect the
minimum insurance requirements set forth herein or be sufficiently self-insured.
Such insurance: (a) shall be primary insurance with respect to each party’s own
participation under this Agreement; (b) shall be issued by a recognized insurer
rated by A.M. Best “A-VII” (or its equivalent) or better, or an insurer
pre-approved in writing by the other party; (c) shall list the other party as an
additional named insured thereunder; and (d) shall require thirty (30) days’
written notice to be given to the other party prior to any cancellation thereof.

(a) Types and Minimum Limits. The types of insurance, and minimum limits shall
be: (i) Worker’s Compensation with statutory limits in compliance with the
Worker’s Compensation laws of the state or states in which the Party has
employees in the United States (excluding Puerto Rico); (ii) Employer’s
Liability coverage with a minimum limit of $500,000 per occurrence; provided,
that a Party has employees in the United States (excluding Puerto Rico); and
(iii) General Liability Insurance with a minimum limit of $10,000,000 per
occurrence and $10,000,000 in the aggregate. General Liability Insurance shall
include, at minimum product liability insurance. Insurance limits may be
provided in any combination of primary or excess liability insurance policies as
long as the limit of insurance required under this contract is met.

(b) Certificates of Insurance. Upon request by either Party, Certificates of
Insurance evidencing compliance with this Section 7.6 shall be provided. The
insurance policies may be written under an occurrence or claims made form. For
claims made policies both parties agree to either maintain coverage or purchase
a claims reporting tail of at least three (3) years after the natural end or
termination of this contract.

ARTICLE 8

TERM; TERMINATION

8.1 Term and Termination.

(a) Term and Termination. This Agreement shall commence on the Effective Date
and shall continue in full force and effect until December 31, 2019, unless
otherwise terminated pursuant to the terms and conditions set forth herein (the
foregoing period plus any renewals is referred to as the “Term”). The Parties
agree to commence good faith discussions regarding one or more two (2) year
extensions of the Term no later than six (6) months prior to the expiration of
the then current Term. Upon expiration of the Term, this Agreement shall
terminate without any notice of termination being required, unless the Parties
agree in writing to extend the Agreement for an additional period to be agreed
upon in writing by the Parties.

(b) Termination due to Insufficient Patient Care Database. AbbVie may, subject
to this Section 8.1(b), terminate this Agreement upon sixty (60) days written
notice to OraSure if OraSure fails to input and store into the Patient Care
Database in the second or any subsequent Calendar Year at least [***] additional
new Patients testing HCV

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

41

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

positive using the Product during each applicable Calendar Year (the “Annual
Minimum Patient Care Database Threshold”) of the Term, provided however, that if
the failure to meet the Annual Minimum Patient Care Database Threshold for any
Calendar Year results, in whole or in part, from AbbVie’s failure to meet its
obligations under this Agreement, including its obligations to fully design,
develop, implement and make available to Patients the Care Model in the Field in
the Territory or AbbVie’s failure to comply with its Co-Promotion or Detailing
obligations hereunder, then AbbVie shall have no right of termination in respect
of the applicable Calendar Year pursuant to this Section 8.1(b). Notwithstanding
the foregoing, if OraSure is using Commercially Reasonable Efforts to satisfy
the Annual Minimum Patient Care Database Threshold and fails to meet such
threshold and the proviso in the preceding sentence does not apply, then the
Parties shall work in good faith during such sixty (60) day period to develop a
mutually acceptable plan for OraSure to implement in connection with meeting the
Annual Minimum Patient Care Database Threshold. If the Parties are unable to
reach a mutually acceptable plan in writing upon the expiration of such sixty
(60) day period, then this Agreement shall terminate effective upon AbbVie’s
delivery of written notice to OraSure. This Section 8.1(b) sets forth AbbVie’s
sole and exclusive remedy in the event of a failure to meet the Annual Minimum
Patient Care Database Threshold for any Calendar Year.

8.2 Termination for Breach. If either Party (the “Non-Breaching Party”) believes
that the other Party (the “Breaching Party”) has breached one (1) or more of its
material obligations under this Agreement, then the Non-Breaching Party may
deliver notice of such material breach to the Breaching Party (a “Default
Notice”), which Default Notice shall describe such breach in reasonable detail
and shall state the non-breaching Party’s intention to terminate this Agreement
pursuant to this Section 8.2. The following shall be considered a non-exclusive
list of material obligations by the respective Party under this Agreement (the
failure of which shall be deemed a material breach by such Party): (i) solely
with respect to OraSure, OraSure’s material failure to exercise Commercially
Reasonable Efforts to design, develop, implement and administer the Patient Care
Database throughout the Term in the Field in the Territory in accordance with
Section 3.1(a); (ii) solely with respect to AbbVie, AbbVie’s material failure to
develop, deploy, make available to Patients and maintain the Care Model during
the Term in the Field in the Territory in accordance with Section 2.3(a) or
AbbVie’s material failure to Detail the Product in accordance with Sections
2.3(a) and 4.1(b); and (iii) with respect to each Party (A) such Party’s
material failure to exercise Commercially Reasonable Efforts to implement,
within one (1) year after the Effective Date, a retail pharmacy initiative to
co-promote the Product in accordance with terms that are mutually acceptable to
the Parties and consistent with the Co-Promotion Plan and the Guiding
Principles, provided, however, that such one (1) year period shall not apply to
either Party to the extent such one (1) year period is exceeded due to a factor
outside of such Party’s reasonable control, including any delay directly or
indirectly caused by a Third Party retail pharmacy or the other Party or the
other Party’s Affiliates or Third Party Providers; (B) such Party’s material
failure to reasonably respond to and negotiate in good faith with the other
Party in connection with executing and implementing a new Statement of Work
proposed by the other Party as long as such proposed Statement of Work is
contemplated by, and structured in a manner materially consistent with, this
Agreement, the Co-Promotion Plan and the Guiding Principles; and (C) such
Party’s failure to comply with its material obligations

 

42

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

contained in each Statement of Work, including, without limitation, the HTAA
Statement of Work, or such Party’s material failure to negotiate in good faith
agreements with any Third Parties that are reasonably necessary for and material
to such Party’s ability to carry out its responsibilities pursuant to each
Statement of Work. Nothing in this Section 8.2 shall be interpreted as limiting
either Party’s rights or claims with respect to asserting the other Party’s
breach of any other material obligation that it has pursuant to this Agreement.

(a) If the Breaching Party does not dispute that it has committed a breach of
one (1) or more of its material obligations under this Agreement, then if the
Breaching Party fails to cure such breach within thirty (30) days after receipt
of the Default Notice, or if such compliance cannot be fully achieved within
such thirty (30) day period and the Breaching Party has failed to commence
compliance or has failed to use diligent efforts to achieve full compliance as
soon thereafter as is reasonably possible (but in any event within sixty
(60) days after receipt of the Default Notice), the Non-Breaching Party may
terminate this Agreement upon written notice to the Breaching Party.

(b) If the Breaching Party disputes that it has committed a breach of one (1) or
more of its material obligations under this Agreement, the Breaching Party may
submit the dispute to dispute resolution pursuant to Section 9.4(c).

(c) During the pendency of any dispute under this Agreement initiated before the
end of any applicable cure period under this Section 8.2, (i) this Agreement
will remain in full force and effect, (ii) the provisions of this Agreement
relating to termination for material breach will not be effective, (iii) the
time periods for cure under Section 8.2 as to any termination notice given prior
to the initiation of the arbitration proceeding will be tolled, and (iv) neither
Party will issue a notice of termination pursuant to this Agreement based on the
subject matter of the ADR (and no effect will be given to previously issued
termination notices), until the ADR has confirmed the existence of the facts
claimed by a Party to be the basis for the asserted material breach.

8.3 Termination for Insolvency. In the event that either Party: (a) files for
protection under bankruptcy or insolvency laws; (b) makes a general assignment
of a substantial portion of its assets for the benefit of creditors;
(c) appoints or suffers appointment of a receiver or trustee over substantially
all of its property that is not discharged within ninety (90) days after such
filing; (d) proposes or is a party to any dissolution or liquidation related to
its business; or (e) files a petition under any bankruptcy or insolvency act or
has any such petition filed against that is not discharged within ninety
(90) days of the filing thereof; then the other Party may terminate this
Agreement in its entirety effective immediately upon written notice to such
Party.

8.4 Termination Upon Change of Control. AbbVie will have the right to
immediately terminate this Agreement by written notice to OraSure in the event
of a Change of Control of OraSure involving an AbbVie Competitor. OraSure shall
provide notice to AbbVie not less than sixty (60) days prior to its proposed
Change of Control; provided, however, that if OraSure is advised by its legal
counsel that it is precluded from providing AbbVie with this prior notice under
Applicable Law or contractual restriction, then OraSure shall deliver such
notice immediately following the earlier of: (i) such time as OraSure is able to
notify AbbVie in compliance with Applicable Law or contractual restriction, and
(ii) after consummation of the

 

43

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

Change of Control. The above notice shall contain the following information
regarding the Person that will assume control of OraSure: (a) the name and legal
composition of the Person; and (b) a general description of the Change of
Control.

8.5 Termination for Convenience. Either Party will have the right to terminate
this Agreement for convenience (i.e., without cause) with termination effective
any time on or after December 31, 2016 by giving the other Party not less than
six (6) months prior written notice. For the purposes of clarity, it is the
understanding of the Parties that during the notice period described above, the
rights and obligations of the Parties shall continue in full force and effect
until the applicable date of termination of the Agreement.

8.6 Termination for Change of Laws. In the event that any law or regulation
enacted, promulgated or amended after the date of this Agreement or any
interpretation of law or regulation by a court or regulatory authority of
competent jurisdiction after the date of this Agreement (collectively, “Change
of Laws”) materially and adversely affects the validity or enforceability of
this Agreement, or materially and adversely impacts upon the ability of either
Party to perform its obligations under this Agreement (excluding payment and
other financial considerations), then either Party may request renegotiation of
the applicable terms of this Agreement to address the Change of Law by written
notice to the other Party. If, in the reasonable, good faith opinion of either
Party, the Parties are unable to in good faith negotiate an amendment to this
Agreement that addresses issue caused by the Change of Law as described in the
immediately preceding sentence and which reasonably and materially preserves the
original reasonable expectations of the Parties to the extent possible in a
manner consistent with the Change of Law, then either Party may terminate this
Agreement upon thirty (30) days written notice to the other Party; provided
however, that if the other Party objects to such termination then the matter
shall be resolved in accordance with Section 9.4(c) herein.

8.7 Effects of Expiration or Termination.

(a) Survival. Termination or expiration of this Agreement for any reason shall
be without prejudice to any rights that shall have accrued to the benefit of a
Party prior to such termination or expiration. Such termination or expiration
shall not relieve a Party from obligations that are expressly indicated to
survive the termination or expiration of this Agreement. Without limiting the
foregoing, Sections 2.2(a)(iii), 2.7(b)(iv), 2.12, 2.14, 3.3, 4.2(a) (to the
extent related to an Exclusivity Refund or Exclusivity Shortfall), 4.4, 4.5,
7.1, 7.2, 7.3, 7.4, 7.5, and 8.7 and Articles 5, 6 and 9 of this Agreement shall
survive the termination or expiration of this Agreement for any reason. Except
for payments that have accrued prior to the termination or expiration of this
Agreement or otherwise as expressly set forth in Section 8.7(b) relating to a
termination for convenience by either Party or a termination by OraSure for
breach, in the event of the termination of this Agreement, AbbVie shall not be
obligated to pay OraSure for any amount of compensation set forth in Article 4
of this Agreement that relates to a time period after the effective date of
termination of this Agreement, including, without limitation, any Database
Establishment, Ownership and Exclusivity Fee that would otherwise have accrued
after the effective date of termination of this Agreement.

 

44

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

(b) Termination For Convenience or Termination by OraSure for Breach. In the
event either Party terminates this Agreement for convenience pursuant to
Section 8.5, the terminating Party shall pay an early termination penalty in the
amount of [***] (the “Termination Fee”) to the other Party, provided however,
that in the event that (i) AbbVie has paid Forty Million and 00/100 Dollars
comprised of the initial three installments of the Database Establishment,
Ownership and Exclusivity Fee due through the second anniversary of the
Effective Date pursuant to Section 4.2(a); and (ii) AbbVie has delivered its
written notice to OraSure exercising its right to terminate for convenience
pursuant to Section 8.5 at least six (6) months prior to December 31, 2016 with
a termination effective date of December 31, 2016, then no Termination Fee shall
be due from AbbVie. Moreover, as to the Maintenance Services Payments, in the
event AbbVie terminates this Agreement pursuant to Section 8.5, or OraSure
terminates this Agreement for breach pursuant to Section 8.2 , AbbVie shall pay
to OraSure the pro-rated Maintenance Services Payment set forth in
Section 4.2(b) for the Calendar Year of termination based upon the annualized
threshold that would have been achieved had the Calendar Year been completed.
Such annualized threshold will be calculated utilizing the number of new
Patients testing positive for HCV using the Product that have opted-in to the
Patient Care Database during such Calendar Year through the effective date of
termination and who are entered into the Patient Care Database consistent with
the terms of this Agreement or whose Patient Information has been collected or
authorized to be collected, but not previously entered into the Patient Care
Database. For example, if this Agreement is terminated effective on
September 30, 2017 and the actual number of Patients meeting the criteria set
forth in the previous sentence achieved during the first nine (9) months of 2017
is [***], then those [***] new Patients would be annualized to [***], which is
on pace for Tier 6 of the Maintenance Services Payment chart and a Service
Payment of [***] would be due to OraSure [***] x 75%) because Tier 6 requires
the payment of a [***] Maintenance Services Payment and the effective date of
termination occurred seventy five percent (75%) through the 2017 Calendar Year.

(c) Termination of Rights. Upon the termination or expiration this Agreement for
any reason, AbbVie shall immediately cease all of its promotional and marketing
activities for the Product and both Parties shall discontinue any use of the
other Party’s Trademarks and return to the other Party or destroy all sales
materials, training materials and AbbVie-developed Product Promotional Materials
for the Product. After any expiration or termination OraSure shall retain the
right to use any sales training and Product Promotional Materials developed
during the term of this Agreement, provided, however, that OraSure shall have no
further right to use AbbVie’s name or any AbbVie Trademarks or logos in
connection therewith.

(d) Transition. Additionally, notwithstanding the foregoing or anything in this
Agreement to the contrary, upon the termination or expiration of this Agreement,
but subject to AbbVie’s fulfillment of its obligations under this Agreement:

(i) OraSure shall, and shall cause its Affiliates, agents and Third Party
Providers to, use their Commercially Reasonable Efforts to engage in an orderly
transition of the data and information contained in the Patient Care Database to
AbbVie or its designee(s). Such transitional services shall include, without
limitation, continued input into the Patient Care Database, for a period of
thirty (30) days after such expiration or termination, of any Patient
Information collected or authorized to be collected, but not previously entered
into the Patient Care Database.

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

45

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

(ii) OraSure shall, and shall cause its Affiliates, agents and Third Party
Providers to, transfer and assign to AbbVie, all of their rights (including
Intellectual Property Rights) in and to the data and information regarding
Patients contained in the Patient Care Database.

(iii) To the extent that OraSure owns and has the right to transfer such items
to AbbVie, OraSure shall transfer and assign to AbbVie any records, forms,
files, materials, passwords, accounts, databases, software, source code, object
code, algorithms, analytic tools, documentation, procedures, manuals, policies
and other items, in each case solely relating to the Patient Care Database,
including any Intellectual Property Rights solely relating to the Patient Care
Database.

ARTICLE 9

MISCELLANEOUS

9.1 Force Majeure. Neither Party shall be held liable or responsible to the
other Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, earthquakes,
hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war
(whether war be declared or not), terrorist acts, insurrections, riots, civil
commotion, strikes, lockouts, or other labor disturbances (whether involving the
workforce of the non-performing Party or of any other Person), acts of God or
acts, omissions or delays in acting by any governmental authority (except to the
extent such delay results from the breach by the non-performing Party or any of
its Affiliates of any term or condition of this Agreement). The non-performing
Party shall immediately notify the other Party of such force majeure within five
(5) Business Days after such occurrence by giving written notice to the other
Party stating the nature of the event, its anticipated duration, and any action
being taken to avoid or minimize its effect. The suspension of performance shall
be of no greater scope and no longer duration than is necessary and the
non-performing Party shall use commercially reasonable efforts to remedy its
inability to perform.

9.2 Assignment. Without the prior written consent of the other Party, neither
Party shall sell, transfer, assign, delegate (except as permitted by
Section 3.2), or otherwise dispose of, whether voluntarily, involuntarily, by
operation of law or otherwise, this Agreement or any of its rights or duties
hereunder to any Third Party; provided, however, that, except as otherwise
specifically provided herein, either Party may make such an assignment without
the other Party’s consent to its Affiliate (for so long as it remains an
Affiliate of such Party) or to a successor, whether in a merger, sale of stock,
sale of assets or any other transaction, of the business to which this Agreement
relates. Any attempted assignment or delegation in violation of this Section 9.2
shall be void and of no effect. All validly assigned and delegated rights and
obligations of the Parties hereunder shall be binding upon and inure to the
benefit of and be enforceable by and against the successors and permitted
assigns of OraSure or AbbVie, as the case may be. The permitted assignee or
transferee shall assume all obligations of its assignor or transferor under this
Agreement, provided, however, that a Party assigning or transferring this
Agreement or its rights or duties hereunder to an Affiliate shall remain fully
liable for the performance of this Agreement by such Affiliate.

 

46

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

9.3 Severability. If any provision of this Agreement is held to be illegal,
invalid, or unenforceable under any present or future law, and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision shall be fully severable,
(b) this Agreement shall be construed and enforced as if such illegal, invalid,
or unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid, or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable
provision, the Parties shall negotiate in good faith a valid, legal and
enforceable substitute provision that most nearly reflects the original intent
of the Parties. To the fullest extent permitted by Applicable Law, each Party
hereby waives any provision of law that would render any provision hereof
illegal, invalid, or unenforceable in any respect.

9.4 Governing Law, Jurisdiction and Service.

(a) Governing Law. This Agreement or the performance, enforcement, breach or
termination hereof shall be interpreted, governed by and construed in accordance
with the laws of the State of Delaware, United States, excluding any conflicts
or choice of law rule or principle that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another jurisdiction.

(b) Service. Each Party further agrees that service of any process, summons,
notice or document by registered mail to its address set forth in Section 9.5
shall be effective service of process for any action, suit, or proceeding
brought against it under this Agreement in any such court.

(c) Dispute Resolution. If a dispute arises between the Parties in connection
with or relating to this Agreement or any document or instrument delivered in
connection herewith (a “Dispute”), it shall be resolved pursuant to this
Section 9.4(c). The Parties shall discuss in good faith for a period of thirty
(30) days any Dispute to obtain resolution of the issue. Any final decision
mutually agreed to by the Parties shall be conclusive and binding on the
Parties. If the Parties are not able to agree on the resolution of any such
issue within thirty (30) days, either Party may, by written notice to the other
Party, elect to initiate an alternative dispute resolution (“ADR”) proceeding
pursuant to the procedures set forth in Schedule 9.4 for purposes of having the
matter settled. Any ADR proceeding under this Agreement shall take place
pursuant to the procedures set forth in Schedule 9.4. Notwithstanding the
procedures set forth in Schedule 9.4, in the event of an actual or threatened
breach hereunder, the aggrieved Party may seek equitable relief (including
restraining orders, specific performance or other injunctive relief) in any
court or other forum, without first submitting to any dispute resolution
procedures hereunder.

9.5 Notices.

(a) Notice Requirements. Any notice, request, demand, waiver, consent, approval,
or other communication permitted or required under this Agreement shall be in
writing, shall refer specifically to this Agreement and shall be deemed given
only if (i) delivered by hand, (ii) sent by facsimile (with transmission
confirmed), electronic mail transmission (email), or (iii) by internationally
recognized overnight delivery service that maintains records of

 

47

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

delivery, addressed to the Parties at their respective addresses specified in
Section 9.5(b) or to such other address as the Party to whom notice is to be
given may have provided to the other Party in accordance with this
Section 9.5(a). Such notice shall be deemed to have been given as of the date
delivered by hand or transmitted by facsimile (with transmission confirmed) or
email or on the second Business Day (at the place of delivery) after deposit
with an internationally recognized overnight delivery service. Any notice
delivered by facsimile shall be confirmed by a hard copy delivered as soon as
practicable thereafter. This Section 9.5(a) is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their obligations under the terms of this Agreement.

 

(b)      Address for Notice.      If to AbbVie, to:      AbbVie Bahamas Ltd.
     c/o AbbVie Inc.      1 North Waukegan Road      North Chicago, IL 60064
     Attention:   VP Specialty Brands      Facsimile:   847-785-8534      with a
copy (which shall not constitute notice) to:      AbbVie Inc.      1 North
Waukegan Road      North Chicago, IL 60064      Attention:   VP Business Legal
     Facsimile:   847-935-9643      If to OraSure, to:      220 East First
Street      Bethlehem, PA 18014      Attention:   President & CEO     
Facsimile:   610-882-2275      with a copy (which shall not constitute notice)
to:      220 East First Street      Bethlehem, PA 18014      Attention:  
General Counsel      Facsimile:   610-882-2275

9.6 Entire Agreement; Amendments. This Agreement, together with the Exhibits and
Schedules attached hereto, and the Nondisclosure Agreement among the Parties
dated as of September 23, 2013, sets forth and constitutes the entire agreement
and understanding between the Parties with respect to the subject matter hereof
and all prior agreements, understandings, promises, and representations, whether
written or oral, with respect thereto are superseded hereby. Each Party confirms
that it is not relying on any representations or warranties of the

 

48

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

other Party except as specifically set forth in this Agreement. No amendment,
modification, release, or discharge shall be binding upon the Parties unless in
writing and duly executed by authorized Representatives of both Parties.

9.7 English Language. This Agreement shall be written and executed in, and all
other communications under or in connection with this Agreement shall be in, the
English language. Any translation into any other language shall not be an
official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.

9.8 Waiver and Non-Exclusion of Remedies. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party hereto of any right hereunder or of the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by such
other Party whether of a similar nature or otherwise. The rights and remedies
provided herein are cumulative and do not exclude any other right or remedy
provided by Applicable Law or otherwise available except as expressly set forth
herein.

9.9 No Benefit to Third Parties. Except as provided in Article 7, the covenants
and agreements set forth in this Agreement are for the sole benefit of the
Parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other Persons.

9.10 Further Assurance. Each Party shall duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.

9.11 Relationship of the Parties. It is expressly agreed that OraSure, on the
one hand, and AbbVie, on the other hand, shall be independent contractors and
that the relationship between the two (2) Parties shall not constitute a
partnership, joint venture, or agency. Neither OraSure, on the one hand, nor
AbbVie, on the other hand, shall have the authority to make any statements,
representations, or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior written consent of the other Party to
do so. All persons employed by a Party shall be employees of such Party and not
of the other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.

9.12 Performance by Affiliates. The Parties recognize that each may perform some
or all of its obligations under this Agreement through Affiliates or may
exercise some or all of its rights under this Agreement through Affiliates,
provided, however, that each Party shall remain responsible and be guarantor of
the performance by its Affiliates and shall cause its Affiliates to comply with
the provisions of this Agreement in connection with such performance. In
particular

 

49

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

and without limitation, all Affiliates of a Party that receive Confidential
Information of the other Party pursuant to this Agreement shall be governed and
bound by all obligations set forth in Article 6. Each Party will prohibit all of
its Affiliates from taking any action that such Party is prohibited from taking
under this Agreement as if such Affiliates were parties to this Agreement. The
use of an Affiliate by a Party shall have no effect on the rights and
obligations of such Party under this Agreement.

9.13 Counterparts; Facsimile or Electronic Execution. This Agreement may be
executed in two (2) or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one (1) and the same
instrument. This Agreement may be executed by facsimile, .pdf or other
electronically transmitted signatures and such signatures shall be deemed to
bind each Party hereto as if they were original signatures.

9.14 References. Unless otherwise specified: (a) references in this Agreement to
any Article, Section, Exhibit or Schedule shall mean references to such Article,
Section, Exhibit or Schedule of this Agreement; (b) references in any Section to
any clause are references to such clause of such Section; and (c) references to
any agreement, instrument, or other document in this Agreement refer to such
agreement, instrument, or other document as originally executed or, if
subsequently amended, replaced, or supplemented from time to time, as so
amended, replaced, or supplemented and in effect at the relevant time of
reference thereto.

9.15 Schedules and Exhibits. In the event of any inconsistencies between this
Agreement and any schedules, exhibits or other attachments hereto, the terms of
this Agreement shall control.

9.16 Construction. Except where the context otherwise requires, wherever used,
the singular shall include the plural, the plural the singular, the use of any
gender shall be applicable to all genders and the word “or” is used in the
inclusive sense (and/or). Whenever this Agreement refers to a number of days,
unless otherwise specified, such number refers to calendar days. The captions of
this Agreement are for convenience of reference only and in no way define,
describe, extend, or limit the scope or intent of this Agreement or the intent
of any provision contained in this Agreement. The term “including,” “include,”
or “includes” as used herein shall mean “including, but not limited to,” and
shall not limit the generality of any description preceding such term. The
language of this Agreement shall be deemed to be the language mutually chosen by
the Parties and no rule of strict construction shall be applied against either
Party hereto. Each Party represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has
participated in the drafting hereof. In interpreting and applying the terms and
provisions of this Agreement, the Parties agree that no presumption will apply
against the Party which drafted such terms and provisions.

[SIGNATURE PAGE FOLLOWS]

 

50

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

THIS MASTER PROGRAM SERVICES AND PRODUCT CO-PROMOTION AGREEMENT IS EXECUTED by
the duly authorized representatives of the Parties as of the Effective Date.

 

ORASURE TECHNOLOGIES, INC.     ABBVIE BAHAMAS LTD. By:  

 

    By:  

 

Name:  

 

    Name:   William J. Chase Title:  

 

    Title:   Director and President

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

EXHIBIT A

ABBVIE COMPETITORS

“AbbVie Competitors” means any Third Party that, at the relevant time, (a) is
marketing and selling in the Territory [***] and which product directly and, as
determined in AbbVie’s reasonable discretion, materially competes with [***] of
AbbVie or any of its Affiliates in the Territory; (b) is identified as among
[***] and is a material competitor of AbbVie and its Affiliates (on a
consolidated basis) in any of the following fields: [***]; or (c) [***]. For
purposes of this definition, (i) the “relevant time” means (A) with respect to
Section 2.2(b)(i), the time during which the activities described in such
Section occur, and (B) with respect to Section 8.4, the date on which a Change
of Control of OraSure is consummated, and (ii) this definition shall be limited
to clause (a) above with respect to Section 2.2(b)(i).

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

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

EXHIBIT B

CO-PROMOTION PLAN

[To be agreed and attached within 60 days of the Effective Date]

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

EXHIBIT C

STATEMENT OF WORK TEMPLATE

See Attached

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

Exhibit C

Statement of Work

(Template)

 

Program #                     

   Date:             , 2014

Products Covered: OraQuick Rapid HCV Test

This Statement of Work is issued under the Master Program Services and Product
Co-Promotion Agreement, dated as of June 10, 2014 (the “Agreement”), between
OraSure Technologies, Inc. (“OraSure”) and AbbVie Bahamas Ltd. (“AbbVie”). This
Statement of Work, as amended, modified, or supplemented, includes the terms and
conditions of such Agreement, which are incorporated by this reference. A
capitalized term not otherwise defined herein shall have the meaning ascribed to
such term in the Agreement. To the extent that there is a conflict between this
SOW and the Agreement, the Agreement shall supersede, control, and prevail.

Scope of Work

Per the Agreement, OraSure agrees to provide testing and AbbVie agrees to
generate awareness and patient activation among [Describe initiative or event].
The program by which this partnership exists shall be called
                    for any and all communications or programs related to [Name
other party(ies) to initiative/event].

Two agreements will be generated, one for OraSure and [Name other party(ies) to
initiative/event] address of                     and another for AbbVie address
of 1 North Waukegan Rd., North Chicago, IL 60064 and [Name other party(ies) to
initiative/event] address of                     .

 

1. Responsibilities

Per the Agreement, OraSure shall be responsible for any and all services related
to testing, including, but not limited to: [(i) public affairs activities,
(ii) administration of the Co-Payment Assistance Program (via vendor) with
                    (including copay payment, processing, transaction fees, and
related materials), (iii) distribution of Product sampling, (iv) providing tests
by direct sales, distribution through distributors and/or donations),
(v) collaborating with                     in generating promotion among
                    for the Product and generating Product testing/screening
participation, (vi) community outreach activities, (vii) advisory boards,
(viii) ongoing Product support, (ix) Product training, (x) CLIA training,
(xi) distribution costs related to Product; (xii) establishing and maintaining
the Patient Care Database; (xiii) obtaining or causing to be obtained and
maintaining from each Patient enrolling and participating in the Patient Care
Database the relevant Marketing Consent Form and HIPAA Authorization Form;
(xiv) obtaining and maintaining the Marketing Authorization and any other
applicable regulatory approvals reasonably necessary to market and sell the
Product in the Field in the Territory to the

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

HCPs; and (xvii) distributing Patient Forms to HCPs.] [Specific responsibilities
to be determined for each initiative/event as contemplated by the Agreement and
Guiding Principles]

AbbVie shall be responsible for: [(i) developing and making the Care Model
available to                     , (ii) introducing physicians and other HCPs to
the Care Model, and (iii) creating and providing materials to
                    that include: (a) promotional, disease state awareness and
educational materials regarding HCV and the availability of rapid HCV testing in
written or digital form for HCPs; (b) promotional, disease state awareness and
educational materials regarding HCV and the availability of rapid HCV testing in
written or digital form for consumers; (c) patient materials that allow patients
to register for the Care Model; (d) exhibition/health fairs materials and
booths; and (e) market research regarding                     .] [Specific
responsibilities to be determined for each initiative/event as contemplated by
the Agreement and Guiding Principles]

[Define other responsibilities].

In addition, all parties hereto agree to participate in the Coalition of Cure
initiative including using likeness and endorsements in print, digital, social
media, radio, television and any other medium deemed appropriate by all parties.

 

2. List of Applicable Documents

See Exhibit XX for the detailed budget broken out by related activities.

 

3. Program Contacts

AbbVie: Melissa Bassler, Senior Product Manager

OraSure: Deborah Katz, Marketing Director

 

4. Estimated Program Schedule/Term of the Program

The length of the Agreement will be 5 years (60 Months) from the date of
execution.

 

5. Sub-contractors

[To be determined]

 

6. Price and Payment

AbbVie agrees to pay                     for the tactics outlined in Exhibit XX
per the agreed payment schedule below. Budgets for years     will be established
annually per the agreed timelines by both parties.

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

OraSure agrees to pay                     as agreed to by OraSure and
                    or as outlined in Exhibit XX.

Invoices under this Program Agreement and shall be sent to:

AbbVie, Inc.

1 North Waukegan Road

North Chicago, IL 60064

Attention: Melissa Bassler

(Identify all expenses or third party vendor charges that may be approved for
reimbursement by AbbVie.)

 

7. Payment Schedule.

[To be determined]

 

8. Change Management

Program Modification. This Program may be modified only upon the written
approval of both parties.

The scope change request process will be the vehicle for communicating change.
Either party may initiate a change request in writing. Both parties must review
the proposed change and either approve or reject such change in writing prior to
proceeding with any change to this SOW. Only the following individuals are
authorized to make and/or approve changes.

 

OraSure:    AbbVie:    Tony Zezzo, EVP, Marketing and Sales    Lutz Schlicht,
Vice President US Hepatology   

 

9. Reviewed for content, deliverables and expenses:

 

  ABBVIE DIVISIONAL OWNER.   By:  

 

  Name:  

 

  Date:  

 

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

10. OUR AGREEMENT

While the signatures of the AbbVie Division Owner and AbbVie Corporate
Purchasing on this Statement of Work signify acceptance of the descriptions,
charges and expenses, the legal commitment of funds from AbbVie for this project
or program are only conveyed by the issuance of a Purchase Order. Signatures on
this Statement of Work do not authorize the commencement of chargeable work
towards this project or program. OraSure agrees to commence chargeable work only
after a Purchase Order is issued for the project or program.

This Statement of Work and our existing Agreement form the basis for our
agreement. Please indicate your acceptance by signing below.

[Other terms and/or modifications to this form shall be determined by agreement
of the parties]

AGREED AND ACCEPTED:

 

ABBVIE BAHAMAS LTD.       ORASURE TECHNOLOGIES, INC. By:   

 

      By:   

 

Printed Name: William J. Chase       Printed Name:   

 

Title: Director and President       Title:   

 

Date: June 10, 2014       Date: June 10, 2014

 

ABBVIE, INC.

CORPORATE PURCHASING

By:  

 

Printed Name:  

 

Title:  

 

Date: June 10, 2014

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

EXHIBIT C-1

HTAA STATEMENT OF WORK

See Attached

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

Exhibit C-1 to Master Program and Product Co-Promotion Agreement

HTAA Statement of Work

 

Program #                                    Effective Date: June 10, 2014

Products Covered: HCV

This Statement of Work (“SOW”), effective as of the Effective Date, is issued
pursuant to the Master Program and Product Co-Promotion Services Agreement,
dated of even date herewith (the “Agreement”), between OraSure Technologies,
Inc. (“OraSure”) and AbbVie Bahamas Ltd. (“AbbVie”). This Statement of Work, as
amended, modified, or supplemented, includes the terms and conditions of such
Agreement, which are incorporated by this reference. A capitalized term not
otherwise defined herein shall have the meaning ascribed to such term in the
Agreement. To the extent that there is a conflict between this SOW and the
Agreement, the Agreement shall supersede, control, and prevail.

Scope of Work

Pursuant to the Agreement, OraSure agrees to, among other matters, promote and
supply the Product, establish and maintain the Patient Care Database and
administer the Co-Payment Assistance Program for eligible Patients, and AbbVie
agrees to educate patients about HCV and provide patients with access to the
Care Model. To accomplish these objectives, OraSure and AbbVie will collaborate
with the Healthy Trucking Association of America (HTAA) and MedMatRx (MMR). The
collaboration between OraSure, AbbVie, HTAA and MMR shall be known as “Truckers
Rolling Against Hep-C” for any and all communications or programs related to
Truckers.

In order to enter into this multi-party collaboration, two separate services
agreements will be executed: one (1) between OraSure and MMR/HTAA (“OraSure
Services Agreement”), and one (1) between AbbVie and MMR/HTAA (“AbbVie Services
Agreement”) (collectively, the “Services Agreements”).

 

11. Responsibilities

Per the Agreement, OraSure shall be responsible for any and all services related
to testing, including, but not limited to: (i) public affairs activities,
(ii) administration of the Co-Payment Assistance Program (through its vendor)
for eligible Patients with MMR/HTAA (including copay payment, processing,
transaction fees, and related materials), (iii) distribution of Product
sampling, (iv) providing Product (including negotiating price for direct
purchases by MMR/HTAA, distributing Product to clinics and providers through
distributors and/or donations), (v) collaborating with MMR/HTAA in generating
promotion among the HTAA membership base and extended network for the Product
and generating Product testing/screening participation, (vi) community outreach
activities, (vii) funding event staffing for tests at non-clinic initiatives
(Healthwatch), health fairs and/or truck shows, (viii) advisory boards,
(ix) ongoing Product support, (x) Product training, (xi) CLIA training,
(xii) distribution costs related to Product; (xiii) establishing and maintaining
the Patient Care Database; (xiv) obtaining or causing to be obtained and
maintaining from each Patient enrolling and participating in the

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

Patient Care Database the relevant Marketing Consent Form and HIPAA
Authorization Form; (xv) obtaining and maintaining the Marketing Authorization
and any other applicable regulatory approvals reasonably necessary to market and
sell the Product in the Field in the Territory to the HCPs; and
(xvi) distributing Patient Forms to HCPs. In addition, OraSure agrees to
evaluate, and if deemed appropriate, participate in or support one or more
pharmacoeconomic studies related to Truckers and HCV.

AbbVie shall be responsible for: (i) developing and making the Care Model
available to HTAA’s membership base, clinics and extended network of providers,
(ii) introducing physicians and other HCPs to the Care Model, and (iii) creating
and providing materials to HTAA/MMR that include: (a) promotional, disease state
awareness and educational materials regarding HCV and the availability of rapid
testing in written or digital form for HCPs; (b) promotional, disease state
awareness and educational materials regarding HCV and the availability of rapid
testing in written or digital form for consumers; (c) patient materials that
allow patients to register for the Care Model; (d) exhibition/health fairs
materials and booths; and (e) market research regarding Truckers and HCV. In
addition, AbbVie agrees to evaluate, and if deemed appropriate by the Health
Economics and Outcomes Research department at AbbVie, conduct one or more
pharmacoeconomic studies related to Truckers and HCV.

OraSure and AbbVie acknowledge that HTAA/MMR will be responsible for
(i) creating awareness of HCV among Truckers, in particular HTAA’s membership
base, clinics and extended network; (ii) promoting and conducting non-clinical
testing events at truck stops, truck industry events, employer/terminal sites,
trucking schools, and/or CDL HUB sites; (iii) purchasing Product directly from
OraSure as needed and facilitating access by OraSure to affiliated clinics and
provider network for sale of Product by OraSure’s distributors; assisting AbbVie
in various community outreach activities among Truckers, in particular HTAA’s
membership base and extended network, with respect to the Care Model;
(iii) participating in the “Coalition of Cure” initiative; (iv) providing
guidance to AbbVie/OraSure on strategic approaches to the Transportation
Industry, as requested by AbbVie/OraSure; and (v) assisting AbbVie/OraSure in
facilitating the establishment of contacts with and an open channel of direct
communications and dialogue with clinics, Truckers, Trucker fleets, Trucker
training schools and work place sites where Truckers visit. This will be done
through consumer, professional, provider, media and management programming,
using materials provided by AbbVie/OraSure, and more fully set forth in the
Services Agreements. In addition, HTAA/MMR will agree to provide data,
information and/or consulting services required for AbbVie/OraSure to conduct a
pharmacoeconomic study or studies.

In addition, all parties agree to participate in the Coalition of Cure
initiative including using likeness and endorsements in print, digital, social
media, radio, television and any other medium deemed appropriate by all parties.

All responsibilities and activities will be performed in compliance with all
Applicable Laws, including anti-bribery and anti-corruption laws, the Patient
Protection and Affordable Care Act of 2010, the Health Insurance Portability and
Accountability Act of 1996 (as amended) (“HIPAA”), rules governing healthcare
programs and applicable FDA regulatory requirements.

 

2

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

12. List of Applicable Documents

See Exhibit A to the AbbVie Services Agreement for the detailed budget and
description of services to be performed by MMR/HTAA for AbbVie.

See Exhibit A to the OraSure Services Agreement for the detailed budget and
description of services to be performed by MMR/HTAA for OraSure.

 

13. Program Contacts:

AbbVie: Melissa Bassler, Senior Product Manager

OraSure: Deborah Katz, Marketing Director

 

14. Estimated Program Schedule/Term of the Program

The term of each of the Services Agreements will begin on the Effective date and
end on the earlier of December 31, 2019 or the termination of the Agreement. The
Services Agreements may not be terminated without cause prior to December 31,
2016.

 

15 Sub-contractors:

Each of the Services Agreements will permit performance of activities by
subcontractors, including, but not limited to, Healthwatch and Rolling Strong.

 

16. Price and Payment:

AbbVie agrees to pay MMR/HTAA [***] in exchange for the services set forth in
Section 2.1 and Exhibit A of the AbbVie Services Agreement, which corresponds to
services performed from the Effective Date of the AbbVie Services Agreement
through December 31, 2015. A budget for 2016-2019 will be mutually agreed upon
by AbbVie and HTAA/MMR based on timelines set forth in the AbbVie Services
Agreement.

OraSure agrees to pay MMR/HTAA [***] in exchange for the services set forth in
Section 2 and Exhibit A of the OraSure Services Agreement. At present, within
the first [***] months, if not earlier, MMR/HTAA is expected to reach or exceed
[***] Truckers screened for HCV through the various programs set forth in the
OraSure Services Agreement. The number of truckers that enter the Care Model
will be discussed and a goal will be set so that all parties are satisfied.

 

17. Change Management.

SOW Modification. This SOW may be modified only upon the written approval of
both OraSure and AbbVie.

The scope change request process will be the vehicle for communicating change.
Either party may initiate a change request in writing. Both parties must review
the proposed change and either approve or reject such change in writing prior to
proceeding with any change to this SOW. Only the following individuals are
authorized to make and/or approve changes.

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

3

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

OraSure:   AbbVie:

Tony Zezzo, EVP, Marketing and Sales

U.S. Hepatology

  Lutz Schlicht, Vice President

 

18. Reviewed for content, deliverables and expenses:

 

  ABBVIE DIVISIONAL OWNER.   By:  

 

  Name:  

 

  Date:  

 

 

19. OUR AGREEMENT:

While the signatures of the AbbVie Division Owner and AbbVie Corporate
Purchasing on this Statement of Work signify acceptance of the descriptions,
charges and expenses, the legal commitment of funds from AbbVie for this project
or program are only conveyed by the issuance of a Purchase Order. Signatures on
this Statement of Work do not authorize the commencement of chargeable work
towards this project or program. OraSure agrees to commence chargeable work only
after a Purchase Order is issued for the project or program.

[Signatures appear on next page]

 

4

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

This Statement of Work and our existing Agreement form the basis for our
agreement and has been executed and effective as of the Effective Date.

AGREED AND ACCEPTED:

 

ABBVIE BAHAMAS LTD.       ORASURE TECHNOLOGIES, INC., a

Delaware corporation

By:   

 

      By:   

 

Printed Name: William J. Chase       Printed Name:   

 

Title: Director and President       Title:   

 

Date: June 10, 2014       Date: June 10, 2014

 

ABBVIE, INC.

CORPORATE PURCHASING

By:  

 

Printed Name:  

 

Title:  

 

Date: June 10, 2014

 

5

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

EXHIBIT D

HIPAA AUTHORIZATION FORM

See attached

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

HIPAA AUTHORIZATION FOR

USE AND DISCLOSURE OF HEALTH INFORMATION 1

Signing this document authorizes your Provider (named below) to use and/or
disclosure certain information about you, including certain demographic
information, contact information, OraQuick HCV Rapid Antibody Test results and
insurance information (collectively, “Health Information”). Please provide all
information requested or this form cannot be used for its intended purpose.

 

PATIENT NAME:  

 

   PROVIDER NAME:  

 

  

(“Provider”)

PROVIDER’S ADDRESS:  

 

    

 

  

AUTHORIZATION FOR USE AND DISCLOSURE

A. Provider would like to make you aware of a patient support program provided
by AbbVie to help newly diagnosed Hepatitis C patients at no additional charge
(the “Care Program”). AbbVie has partnered with OraSure in connection with the
development of a Patient Care Database as part of the Care Program. OraSure also
offers a patient co-payment assistance program in connection with your purchase
and use of the OraQuick HCV Rapid Antibody Test (the “Co-Payment Assistance
Program”) and your participation in the Patient Care Database. Patients who have
commercial insurance or are uninsured are eligible for the Co-Payment Assistance
Program while patients insured under any federal, state or local government
funded health care program are not eligible to participate. Participation in the
Co-Payment Assistance Program may also be limited or prohibited by law in
certain States.

B. I hereby authorize Provider to release the information described in Section C
to:

OraSure Technologies, Inc.

220 East First Street

Bethlehem, PA 18015

and/or

AbbVie, Inc.

1 North Waukegan Road

North Chicago, IL 60064

C. I authorize Provider to disclose the following information about me in
connection with my participation in the Care Program and the Co-Payment
Assistance Program: my date of birth, gender, ethnicity and contact information,
my OraQuick HCV Rapid Antibody Test results and my insurance information.

PURPOSE OF USE OR DISCLOSURE

I am requesting this disclosure so that I can participate in the Care Program,
including the Patient Care Database and/or the Co-Payment Assistance Program if
I am eligible to participate.

My participation in one or both programs will involve using and/or disclosing my
Health Information for the purposes of such programs and may include further
disclosure of my Health Information to other third parties that administer the
programs on behalf of AbbVie and/or OraSure. I also understand that
participation in the programs will involve the use of my Health Information for
marketing purposes, for which a separate authorization form will be requested of
me.

 

 

1  This form is designed to comply with HIPAA and may not comply with applicable
state laws. A state law analysis should be conducted and revisions should be
made to comply with state law prior to use.

 

1

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

EXPIRATION

This authorization expires on the earlier of (i) my Provider’s receipt of my
written revocation of this Authorization sent to the Provider’s address set
forth above, with copies sent to AbbVie and OraSure at the addresses set forth
below; or (ii) [five (5) years]2 from the date of my signature below.

PATIENT RIGHTS

I understand that I may refuse to sign this authorization, and my refusal will
not affect my ability to obtain treatment, eligibility for benefits, or payment
for health care services, except that OraSure and/or AbbVie will not be able to
evaluate my eligibility for the Programs and I will therefore not have the right
to participate in the either the Care Program or the Co-Payment Assistance
Program.

I understand that I may revoke this authorization at any time, but my revocation
will not change any uses, disclosures, or other actions already taken with my
Health Information. In order to revoke this authorization I must do so in
writing and send it to my Provider at the address set forth above, with copies
sent to AbbVie and OraSure at the addresses set forth below.

I acknowledge that I have been provided with a signed copy of this
authorization.

I understand that Health Information disclosed pursuant to this authorization in
some instances could be legally re-disclosed by the recipient without my
knowledge and in such cases may no longer be protected by federal
confidentiality law (HIPAA).

I understand that OraSure may benefit from the authorized use or disclosure of
my Health Information.

I understand that my Provider may benefit from the authorized use or disclosure
of my Health Information.

PATIENT SIGNATURE

 

Date:  

 

Signature:  

 

Print Name:  

 

If not the patient, indicate relationship to patient:
                            

ABBVIE’S ADDRESS

Attention: Privacy Officer

AbbVie, Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

ORASURE’S ADDRESS

Attention: General Counsel

OraSure Technologies, Inc.

220 East First Street

Bethlehem, Pennsylvania 18015

 

 

2 To be determined in accordance with applicable state law prior to use.

 

2

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

EXHIBIT E

MARKETING CONSENT FORM

See attached

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

Authorization to Enroll in the AbbVie Care Program and Patient Care Database

AbbVie and OraSure would like to make you aware of a patient support program
provided by AbbVie to help newly diagnosed Hepatitis C patients understand and
better manage their disease (the “Care Program”). The Care Program includes
support services at no additional charge, such as access to HCV education and
live support from AbbVie’s HCV patient educators. Please carefully read all of
the information below. If, after reading this information, you would like to
enroll in the Care Program and the Patient Care Database, please sign the
authorization.

Patient Authorization

I authorize OraSure and AbbVie to use certain information about me: my date of
birth, gender, ethnicity and contact information, my OraQuick HCV Rapid Antibody
Test results and my insurance information (collectively “Private Information”).
My Private Information may be provided directly by me or through my health care
providers. My Private Information will be used only in connection with the Care
Program, including AbbVie’s Patient Care Database and will only be used to:

 

  •   Allow AbbVie’s Patient Educators to contact me about issues related to
Hepatitis C;

 

  •   Administer the Care Program, which may require AbbVie or OraSure to
disclose my Private Information to third parties that AbbVie or OraSure hire to
help administer the Care Program and the Patient Care Database;

 

  •   Contact me by mail, email, or phone with marketing information about
AbbVie products or services that relate to Hepatitis C; or

 

  •   Contact me by mail, email, or phone about my participation in the Care
Program.

OraSure and AbbVie will use appropriate safeguards to protect my Private
Information and will not use or disclose my Private Information other than as
described in this authorization without my permission. OraSure and AbbVie will
not sell or transfer my Private Information to any third party for such third
party’s use of any kind that does not relate to the Care Program or the Patient
Care Database.

To be removed from the Care Program or the Patient Care Database or to request a
copy of this form, please contact AbbVie Customer Service at 1-800-255-5162.

Patient Rights

I understand that this authorization is voluntary and any re-disclosure of my
Private Information may not be protected by federal or state law.

I understand that I may decide not to sign this authorization, which will not
affect my ability to obtain care from my Provider, including diagnosis or
treatment, eligibility for benefits, or payment for health care services from
health care providers, health plans, and health insurance. However, I understand
that if I decide not to sign this form I will not be able to participate in the
Care Program, Patient Care Database or the OraSure Patient Co-Payment Assistance
Program.

I understand that being a member of the Care Program and Patient Care Database
does NOT require me to purchase or use any AbbVie or OraSure product.

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

I understand that I have the right to revoke this authorization in writing at
any time but that my revocation will not change any actions already taken in
reliance on my authorization.

Expiration of This Authorization

This authorization will expire upon the earlier of (i) AbbVie’s receipt of my
written revocation mailed to the address below; or (ii) [five (5) years]1 from
the date of my signature below.

 

Date:  

 

Signature:  

 

Print Name:  

 

If not the patient, indicate relationship to patient:
                            

ABBVIE’S ADDRESS

AbbVie, Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

Attention: Privacy Officer

 

 

1 To be determined in accordance with applicable state law prior to use.

 

2

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

EXHIBIT F

GUIDING PRINCIPLES

See attached

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

Exhibit F to Master Program Services and Product Co-Promotion Agreement (the
“Agreement”)

Responsibilities Related to Each of the Four “Pillars”1

Pillar 1: Employer Group (HTAA is representative model)

OraSure Responsibilities:

 

  •   Sell and distribute OraQuick Rapid HCV Test to HTAA and its affiliate
corporate organizations, mini-clinics, etc. (Direct sales to HTAA and through
distributors to clinics and providers and/or donations as determined by the
parties)

 

  •   Provide training and promotional materials pertaining to use of OraQuick
Rapid HCV Test (including CLIA training)

 

  •   Provide program set up (via vendor) for patient enrollment in Patient Care
Database at mini-clinics, truck shows, etc.

 

  •   Provide promotional materials for testing initiative to mini-clinics and
Providers

 

  •   Provide patient Co-Payment Assistance Program for commercially insured
patients, including Product training/education to mini-clinics/Providers for
implementation and consideration of kiosk program

 

  •   Assist in the coordination and implementation of testing programs into the
approximately [***] mini-clinics

 

  •   Provide a limited number of Product samples for training purposes as
reasonably requested by HTAA and determined by OraSure

 

  •   HTAA management fees associated with program implementation per agreed
budget with HTAA

 

  •   Provide funding to support event staffing by HTAA at non-clinic settings
if requested by HTAA and negotiate and pay reasonable and fair market value
management fees per agreed budget with HTAA

 

  •   Publicity for program successes

 

  •   Collaborate with AbbVie in development of Patient Forms and utilize and
implement the Patient Forms

AbbVie Responsibilities:

 

  •   Provide promotional support and material pertaining to Program for HTAA
corporate outreach initiatives

 

  •   Provide consumer education at health fairs , truck shows, training
schools, terminals pertaining to disease state awareness, the Care Model and the
availability of rapid HCV testing

 

  •   Train mini-clinic Providers and appropriate network physicians on disease
state awareness, the Care Model and the availability of rapid HCV testing

 

  •   Co-promote the Product

 

  •   Purchase Providers list from HTAA

 

  •   Provide electronic education and leave behind promotional material as
needed to Providers

 

  •   Advisory Board (1) for developing insights

 

  •   Provide media promotional spots/interviews (radio, iTruck TV, twitter
messaging) – Consumer Campaigns

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

1 A capitalized term not otherwise defined herein shall have the meaning
ascribed to such term in the Agreement.

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

  •   Deliver the Care Model

 

  •   Exhibition fees, booth & collateral for Trade Shows/Health Fairs

 

  •   Collaborate with OraSure on the development of Patient Forms

Pillar 2: Retail Pharmacy Clinic Initiative

OraSure Responsibilities:

 

  •   Sell and distribute OraQuick Rapid HCV Test product, targeting at least
[***] retail clinics and pharmacies (e.g., CVS, Walgreens, Target) to facilitate
birth cohort HCV antibody screening programs

 

  •   Provide training and promotional materials pertaining to use of OraQuick
Rapid HCV Test (including CLIA training)

 

  •   Provide program set up (via vendor) for patient enrollment in the Patient
Care Database at pharmacies and mini-clinics where permitted by retailer

 

  •   Provide promotional materials to introduce testing initiative to
pharmacies and mini-clinics

 

  •   Provide patient co-payment assistance program for commercially insured
patients, including training/education to pharmacies and mini-clinics for
implementation where permitted by retailers

 

  •   Coordination and implementation of testing programs into the mini-clinics

 

  •   Provide management fees to retailers associated with patient enrollment
per agreed upon budgets

 

  •   Publicity for program successes

 

  •   Collaborate with AbbVie in development of Patient Forms and utilize and
implement the Patient Forms

AbbVie Responsibilities:

 

  •   Provide promotional support and material pertaining to Program

 

  •   Provide co-branded “get tested” campaigns aimed at rapid HCV testing for
consumers (including social media, radio, etc.)

 

  •   Training on disease state awareness and Care Model to Providers associated
with mini-clinics, including educational leave behinds

 

  •   Provide electronic education and leave behind promotional material
pertaining to Care Model as needed to Providers

 

  •   Co-Promote the Product

 

  •   Delivery of Care Model

 

  •   Collaborate with OraSure on the development of Patient Forms

 

  •   EMR prompt to screen Baby Boomers (pilot)

Pillar 3: Specialty Physician Initiative

OraSure Responsibilities:

 

  •   Provide limited amount of Product Sample Kits for training purposes

 

  •   Provide product training and promotional materials pertaining to OraQuick
Rapid HCV Test through OraSure’s distributors, MROs and other third party
vendors.

[***] Portions of this page have been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

2

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

  •   Sell and distribute OraQuick Rapid HCV Test to appropriate
gastroenterologist, hepatologist and infectious disease specialist offices to
facilitate birth cohort HCV antibody screening programs

 

  •   Provide program set up at physician offices (via vendor) for patient
enrollment in Patient Care Database

 

  •   Provide patient Co-Payment Assistance Program (via vendor) for
commercially insured patients, including training/education to physician offices
for implementation

 

  •   Provide publicity for program success stories

 

  •   Collaborate with AbbVie in development of Patient Forms and utilize and
implement the Patient Forms

AbbVie Responsibilities:

 

  •   Develop a co-branded Disease State Awareness Campaign

 

  •   Develop all Provider-directed leave-behind promotional materials
associated with Disease State Awareness and the Care Model

 

  •   Provide consumer promotional support and material pertaining to Program

 

  •   Develop Consumer Campaign (digital, social)

 

  •   Detail target physicians as described in Agreement (P1: DSA, P2: Testing)

 

  •   Enroll HCPs in sample program (reps incentivized on Product ordered and %
of call plan targets who place an order)

 

  •   Install the Care Model (all program communications)

 

  •   Deliver The Care Model

 

  •   Collaborate with OraSure on the development of Patient Forms

 

  •   EMR prompt to screen Baby Boomers (pilot)

Pillar 4: Primary Care Physician Initiative

OraSure Responsibilities:

 

  •   Provide limited amount of Product Sample Kits for training purposes

 

  •   Provide product training and promotional materials pertaining to OraQuick
Rapid HCV Test through OraSure’s distributors, MROs and other third party
vendors

 

  •   Sell and distribute OraQuick Rapid HCV Test product to primary care
physician offices to facilitate birth cohort HCV antibody screening programs

 

  •   Provide program set up (via vendor) for patient enrollment at physician
offices in Patient Care Database

 

  •   Provide patient Co-Payment Assistance Program (via vendor) for
commercially insured patients, including training/education to physician offices
for implementation

 

  •   Publicity for program success stories

 

  •   Collaborate with AbbVie in development of Patient Forms and utilize and
implement the Patient Forms

AbbVie Responsibilities:

 

  •   Develop a co-branded Disease State Awareness Campaign

 

  •   Develop all Provider-directed leave-behind promotional materials
associated with Disease State Awareness and The Care Model

 

3

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

  •   Consideration in AbbVie’s discretion of establishing KOL speaker programs
and Centers of Excellence speaker programs with referral networks

 

  •   Provide consumer promotional support and material pertaining to Program

 

  •   Enroll HCPs in sample program (reps incentivized on Product ordered and %
of call plan targets who place an order)

 

  •   Install the Care Model (all program communications)

 

  •   Deliver the Care Model

 

  •   Detail to appropriate physicians as described in the Agreement (P1: DSA,
P2: Testing)

 

  •   Collaborate with OraSure on the development of Patient Forms

 

4

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

EXHIBIT G

PATIENT CARE DATABASE REQUIREMENTS

To Be Attached After the Effective Date

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

SCHEDULE 2.11

TRADEMARKS

OraSure Trademarks

OraSure Technologies Inc.

OraSure

OraQuick

OraQuick HCV

TestHepC.com

844-TEST-HEP C

AbbVie Trademarks

AbbVie, Inc.

AbbVie

Nurse Connectors

ProCeed

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

SCHEDULE 9.4

DISPUTE RESOLUTION PROCEDURES

Any Dispute referred to ADR under this Agreement shall be resolved as follows:

1. To begin an ADR proceeding, a Party shall provide written notice to the other
Party of the Dispute 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 arbitration, add additional issues to be resolved within the same
ADR.

2. Within twenty-one (21) days following the initiation of the ADR proceeding,
the Parties shall select a mutually acceptable independent, impartial and
conflicts-free neutral to preside in the resolution of all issues in this ADR
proceeding. If the Parties are unable to agree on a mutually acceptable neutral
within such period, each Party will select one (1) independent, impartial and
conflicts-free neutral and those two (2) neutrals will select a third
independent, impartial and conflicts-free neutral within ten (10) days
thereafter (such neutral(s), the “Neutral”). None of the neutrals selected may
be current or former employees, officers or directors of either Party or its
Affiliates.

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 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 ruling
shall not contain any recitation of the facts or any legal arguments, and the
proposed remedy shall not include any punitive damages. The proposed ruling and
the proposed remedy collectively 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.

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

5. 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.

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 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 therein 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 (1) of the Parties on each disputed issue but
may adopt one (1) 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 (1) 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 (1) 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 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, the existence of
the Dispute, any settlement negotiations, the ADR proceeding, any submissions
(including exhibits, testimony, proposed rulings, and briefs), and the rulings
shall be deemed to be Confidential Information of both Parties. The Neutral
shall have the authority to impose sanctions for unauthorized disclosure of
Confidential Information.

11. All ADR proceedings shall be conducted in the English language.

12. Notwithstanding anything to the contrary in this Schedule 9.4, the Neutral
shall have discretion to modify the procedures set forth herein (including with
respect to discovery) upon good cause shown by a Party.

13. Each Party shall have the right to be represented by counsel in all aspects
of any ADR proceeding.