Exhibit 10.1

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

THE USE OF THE FOLLOWING NOTATION IN THIS EXHIBIT INDICATES THAT
A CONFIDENTIAL PORTION HAS BEEN OMITTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT AND THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE COMMISSION: [***]

 

 

LABORATORY MARKETING SERVICES AGREEMENT

 

THIS LABORATORY MARKETING SERVICES AGREEMENT (“Agreement”) is entered into
August 26, 2014, by and between BioVentive, Inc., a California corporation
(“Contractor”), and The National Reference Laboratory .for Breast Health, Inc. a
Delaware corporation (“NRLBH”). Contractor and NRLBH are referred to as a
“Party” or the “Parties.”

 

RECITALS

 

WHEREAS, NRLBH is a CLIA-certified laboratory that performs various tests,
including nipple aspirate fluid cytology tests (the “NAF Tests”) and that is in
the process of becoming qualified to perform pharmacogenomics tests (the
“Pharmacogenomic Tests”);

 

WHEREAS, Contractor markets laboratory tests to licensed physicians practicing
medicine (the “Contractor Customers”) throughout the United States (the
Territory”); and

 

WHEREAS, NRLBH wishes to engage Contractor to market the NAF Tests and
Pharmacogenomic Tests and any other tests that the parties mutually agree in
writing to be marketed by Contractor (collectively, the “Marketed Tests”),
performing such service as more fully described in Section 1 and Exhibit A
hereto (the “Services”), and Contractor is willing to provide those Services in
accordance with the terms set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing premises, the mutual covenants
and agreements contained herein, and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the Parties hereto,
intending to be legally bound, agree as follows:

 

I.ENGAGEMENT OF THE SERVICES.

 

A. Engagement of Contractor. NRLBH hereby appoints Contractor as an authorized
representative to use its reasonable commercial efforts to market and promote
the Marketed Tests to Contractor Customers in the Territory and the Contractor
hereby accepts such appointment.

 

B. Exclusivity. Contractor shall be a non-exclusive marketing contractor for the
NAF Tests and NRLBH shall be free to contract others to market and promote the
NAF Tests. Contractor shall be the exclusive marketing contractor for the
Pharmacogenomic Tests so long as the Contractor meets or exceeds the
Pharmacogenomic Test Minimums identified in Section ill.0 and during such
exclusive period NRLBH shall not contract with another party, directly or
indirectly to market and promote the Pharmacogenomic Test; however, if such
minimums are not met NRLBH shall provide written notice to the Contractor and
the Contractor shall automatically become non-exclusive with respect to the
Pharmacogenomic Tests and NRLBH shall then be free to contract with others to
market and promote the Pharmacogenomic Tests. However, nothing in this Agreement
shall limit or restrict NRLBH from utilizing its employees to market and promote
the Marketed Tests.

 

 

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

C. Scope of Services. Contractor shall render the Services identified in the
attached Exhibit A on behalf of NRLBH to the current and future Contractor
Customers. Contractor shall use reasonable commercial efforts to market and
promote the Marketed Tests to Contractor Customers in the Territory and (a)
exercise the highest degree of professionalism in the furnishing of the
Services, (b) be responsible to provide the infrastructure and personnel through
which it shall furnish the Services at its sole expense, and (c) perform the
Services in a timely and professional manner consistent with similarly situated
contractors and marketing consultants. Except as provided in Section III.E,
Contractor shall not sub-contract or otherwise delegate its obligations under
this Agreement, without NRLBH’s prior written consent. Contractor shall not,
directly or through others, distribute, market or promote products and services,
including the Marketed Tests, that are competitive, directly or indirectly, with
services and products provided by NRLBH or its parent company, Atossa Genetics,
Inc. (“Atossa”) and all Marketed Tests shall be marketed and promoted only for,
and provided only to, the NRLBH.

 

D. Legal Compliance. The manner and means by which Contractor performs its
Services for NRLBH shall be in Contractor’s sole discretion and control, subject
to this Agreement, applicable law and in compliance with all related Federal and
state regulations, ethical business practices and NRLBH’s regulatory compliance
policies, including those set forth in the attached Exhibit R.

 

II.COMPENSATION FOR SERVICES.

 

A. Fixed Monthly Service Fee. In consideration for the provision by Contractor
of the Services hereunder, NRLBH shall pay Contractor a fixed fee as set forth
in the attached Exhibit D (each, a “Monthly Service Fee”), which shall be paid
by NRLBH within 15 days of the end of the month for which the Monthly Service
Fee applies. NRLBH shall not be obligated to pay the Monthly Service Fee if
Contractor is in breach of this Agreement. If this Agreement is terminated for
any reason, NRLBH shall pay Contractor the Monthly Service Fee owing for all
Services performed by Contractor prior to and including the effective date of
termination.

 

B. Termination Fee. Contractor shall be entitled to, and the NRLBH shall pay, if
and when due, the Termination Fee set out in Section VI.C.

 

C. Compliance with Law. It is the intention of the Parties that the Monthly
Service Fee shall at all times be in compliance with all applicable laws, rules,
regulations, policies and interpretations and shall not exceed the Fair market
value for the Services provided by Contractor hereunder, and shall not be
determined in a manner that violates the federal Anti-Kickback Statute, 42
U.S.C. § 1320a-7b(b), or other applicable Federal Health Care Program laws,
rules, regulations, policies or interpretations. The term “Federal Health Care
Program” is used herein as it is defined in 42 U.S.C. 1320a-7b(f), and includes
any plan or program that provides health benefits, whether directly, through
insurance, or otherwise, which is funded directly, in whole or in part, by the
United States Government (e.g., Medicare, Medicaid, TRICARE). If either Party
determines at any time or is reliably informed by governmental authorities that
the compensation arrangements or other terms set forth herein violate or are
likely to be determined by a governmental authority to violate such laws, rules,
regulations, policies or interpretations, the Parties agree to meet immediately
and in good faith to amend this Agreement so as to eliminate such concern or
violation and to bring this Agreement into compliance with the foregoing. Any
such amendment shall, to the extent permitted by law, have the same aggregate
economic effect upon the Parties. Such determination, information or amendment
shall not allow either Party to claim that this Agreement is void or voidable.

 

2

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

III.ORDERING.

 

A. Purchase Terms. Marketed Tests shall be ordered directly by the Contractor
Customers and/or their healthcare providers. Contractor shall provide Contractor
Customers with test requisition forms which shall be supplied by NRLBH. The test
requisition forms shall have a unique identifier indicating that the test was
ordered by a physician who is -a Contractor Customer.

 

B. Pricing; Billing. NRLBH shall provide Contractor from time to time with price
sheets for the Marketed Tests and Contractor shall use the prices indicated on
such price sheets, and no others, in marketing the Marketed Tests. NRLBH shall
be responsible for all billing to Contractor Customers.

 

C. Minimums. Exhibit C sets forth the minimum quantity of Pharmacogenomic Tests
that must be ordered by the Contractor Customers on or before the dates and at
the minimum prices set forth in Exhibit C (the “Pharmacogenomic Test Minimums”).

 

D. Sales Materials. NRLBH shall make available to the Contractor a copy of
brochures, literature, training materials and labeling which may be copied, but
not altered in anyway, by Contractor at its sole expense and utilized to
distribute, market and promote the Marketed Tests. The Contractor shall use only
such sales materials as are provided by NRLBH or those materials that are
otherwise approved in writing in advance by NRLBH. All use by the Contractor of
the name “NRLBH,” “National Reference Laboratory for Breast Health” or any other
name or mark that is copyrighted, trademarked or service-marked by NRLBH shall
be subject to The prior written approval of NRLBH. Upon any termination of this
Agreement, the Contractor shall immediately cease the use of all such names and
marks and shall return to NRLBH any supplies, samples, brochures, product
literature, training materials and other materials bearing such names or marks.

 

E. Authorized Sub-contractors and Sub-Contractors. Contractor may delegate or
assign some or all of its duties envisioned by this Agreement hereunder to its
qualified employees and independent representatives and other personnel engaged
and/or employed by Contractor (“Contractor Representatives”), provided that:

 

1. Such representatives shall not be health care professionals or persons in a
similar position who might be capable of exerting undue influence on a
Contractor Customer or its patients.

 

3

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

2. NRLBH retains the right, at its sole discretion, to revoke permission for
Contractor to allow any of Contractor’s independent contractors or employees to
take actions in furtherance of the Contractor’s duties under this Agreement.

 

3. Contractor must require its contractors, sub-Contractors and/or employees to
be bound by the terms and conditions of this Agreement or substantially similar
terms relating to Contractor, all in a document reasonably satisfactory to
NRLBH. NRLBH retains the right to inspect and/or require modifications to
Contractor’s agreements with its independent, contractors and sub-Contractors
and/or employees at any time.

 

4. Contractor shall remain liable as a principal and not as surety for all of
its obligations hereunder.

 

5. Contractor shall indemnify, defend and hold harmless NRLBH and its employees,
shareholders, officers, directors, agents and other affiliates, to the fullest
extent permitted by law, against any and all claims, actions, demands, losses,
costs, expenses, damages and claims of any kind whatsoever which NRLBH may
sustain or incur, including reasonable legal fees and costs, as a result of or
arising from Contractor’s failure to fulfill its obligations or perform its
duties with respect to its employees, contactors, shareholders, officers,
directors, agents, sub-contractors, and other affiliates of Contractor. Said
indemnification by Contractor shall include its negligent, willful or
intentional action, and/or omission.

 

F. NRLBH Discretion in Acceptance. NRLBH shall have ultimate discretion
regarding the acceptance by NRLBH of requests for the Marketed Tests. In
exercising such discretion, NRLBH shall take into consideration such factors as
it deems relevant, including but not limited to whether it has the necessary
licenses to deliver the Marketed Tests in the location of the Contractor
Customer, and the necessary billing or provider numbers to bill and be paid for
such services by third party payors, and other relevant factors such as the
number and mix of Marketed Tests requested by or at a given location. NRLBH may
require Contractor Customers to execute such typical and customary forms of
agreement as applicable to NRLBH’s customers generally, including forms and
formats for ordering testing and for submitting billing information.

 

G. Training. During the first 30 days of the term of this Agreement and from
time to time thereafter as determined by NRLBH, NRLBH will provide Contractor’s
sales personnel with training geared toward reasonably preparing such personnel
to market and sell the Marketed Tests in a manner generally accepted for similar
products in the industry.

 

H. Specimen Collection.

 

1. Atossa Devices. Contractor shall not market, promote or distribute the
medical devices offered by Atossa. If a Contractor Customer inquires about an
Atossa medical device, Contractor shall refer the Contractor Customer to Atossa
or one of Atossa’s medical device distributors. Contractor shall not receive any
compensation for such referral.

 

2. Other Specimen Collection Materials. Subject to Section III.H.1., the parties
may mutually agree that Contractor shall provide other specimen collection
materials to Contractor Customers, such as shipping containers, and other
materials reasonably necessary for the collection and transport of specimens to
NRLBH. However, Contractor shall be responsible for procuring and providing, at
its sole cost, the patient specimen collection kits for the Pharmacogenomic
Tests and such collection kits shall comply with all regulatory requirements and
be reasonably acceptable to NRLBH.

 

4

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

IV.INDEPENDENT CONTRACTOR RELATIONSHIP.

 

Contractor’s relationship with NRLBH will be that of an independent contractor
and nothing in this Agreement should be construed to create a partnership, joint
venture, franchise, or employer-employee relationship. Contractor is not
authorized to make any representation, contract, or commitment on behalf of
NRLBH not expressly authorized by NRLBH. Contractor will not be entitled to any
of the benefits that NRLBH may make available to its employees, such as group
insurance, profit sharing or retirement benefits. Contractor will be solely
responsible for all lax returns and payments required to be filed with or made
to any federal, state or local tax authority with respect to Contractor’s
performance of services and receipt of fees under this Agreement. NRLBH will
regularly report amounts paid to Contractor by filing Form 1099-M1SC with the
Internal Revenue Service as required by law. NRLBH will not withhold or make
payments for social security; make unemployment insurance or disability
insurance contributions; or obtain worker’s compensation insurance on
Contractor’s behalf. Contractor agrees to accept exclusive liability for
complying with all applicable state and federal laws governing self-employed
individuals, including obligations such as payment of taxes, social security,
disability and other contributions based on fees paid to Contractor, its agents
or employees under this Agreement. Contractor hereby agrees to indemnify and
defend NRLBH against any and all such taxes or contributions, including
penalties and interest.

 

V.CONFIDENTIALITY.

 

A. Confidentiality. The Parties acknowledge that the terms of this Agreement are
confidential and will not be disclosed without the prior written consent of the
non-disclosing Party except as may otherwise be required by law. Further, during
the Term of this Agreement, and at all times following termination thereof, each
Party shall keep strictly confidential all information which they obtain from
the other Party during the Term, including, in particular, “Proprietary
Information” and “Third Party Information,” as each of such terms is defined
below. Neither Party shall use or disclose to any person, firm, or other entity
or permit any person to examine, copy or duplicate any such confidential
information furnished by one Party to the other, except as otherwise required by
law. Upon the termination of this Agreement (irrespective of the reason or
circumstances), unless otherwise agreed to in writing by the Parties, each Party
will return to the other Party all such confidential information in its
possession, as well as any copies or information derived therefrom. Without
limiting any other provision herein, the provisions of this Section shall
survive any termination or expiration of this Agreement. Furthermore, upon
termination of this Agreement, unless otherwise agreed to in writing by the
Parties, NRLBH and Contractor shall immediately discontinue their use (if any)
of the name or trademarks .of the other (or developed for NRLBH by Contractor)
and shall immediately discontinue all representations or statements from which
it might be inferred that any relationship exists between NRLBH and Contractor.

 

5

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

B. Defined Terms. For purposes of this Agreement:

 

“Proprietary Information” includes, without limitation: (a) trade secrets,
inventions, ideas, processes, formulas, source and object codes, data, programs,
other works of authorship, know-how, improvements, discoveries, developments,
designs and techniques; (b) information regarding plans for research,
development, new products, marketing and selling, business plans, budgets and
unpublished financial statements, licenses, prices and costs, suppliers,
customers and prospective customers; and (c) information regarding the skills
and compensation of employees and contractors. Notwithstanding the other
provisions of this Agreement, Proprietary Information does not include (x)
information that has been published or is otherwise readily available to the
public other than by a breach of this Agreement; (y) information independently
developed by personnel or agents of one Party having no access to the other
Party’s Proprietary Information; or (z) information known to the receiving Party
prior to its receipt from the disclosing Party.

 

“Third Party Information” means Proprietary Information received from a third
party (i.e. a person or entity other than a Party to this Agreement). The
Parties each understand that shall maintain the confidentiality of Third Party
Information in accordance with the foregoing terms of this Section V.

 

C. HIPAA Compliance. In connection with the provision of the Services provided
hereunder. Contractor may have access to certain protected health information as
defined by the Health Insurance Portability and Accountability Act of 1996
(“HIPAA”), as amended. Contractor agrees to execute and comply with the HIPAA
Business Associate Agreement attached Exhibit E, which is hereby incorporated by
reference. This Section V.C. shall survive the termination of this Agreement.

 

D. Ownership of Proprietary Information. Each Party acknowledges that all data,
documents (whether in draft or final form), databases, storage media, files,
electronic or otherwise, computers, equipment and accessories, pagers, personal
digital assistants, telephones and other property containing or referring to
Proprietary Information shall at all times be the exclusive property of the
disclosing Party.

 

E. Remedies. NRLBH and Contractor acknowledge and agree that the agreements,
covenants and undertakings contained in this Section V relate to matters which
are of a special unique and extraordinary character and that a violation of the
terms of this Article will cause irreparable injury to the other Party, the
amount of which may be extremely difficult, if not impossible, to estimate or
determine and may not be adequately compensated by monetary damages. Therefore,
NRLBH and Contractor agree that either Party shall be entitled to an injunction,
restraining order or other equitable relief from any court of competent
jurisdiction, restraining any violation or threatened violation of any such
terms by the other Party or such other persons, as the court will order. The
rights and remedies provided by this Section V are cumulative and will be in
addition to any other rights and remedies which either Party may have at law or
equity.

 

VI.TERMINATION.

 

A. Term. Unless terminated by either Party in accordance with the terms of this
Section VI, the initial term of this Agreement shall be three years (the
“Initial Term”). Further, this Agreement will automatically renew for an
additional two year terms (each, a “Renewal Term”), unless terminated by either
Party upon ninety (90) days’ prior written notice prior to the expiration of the
Initial Term or the then-applicable Renewal Term. The Initial Term and the
Renewal Term are sometimes referred to in this Agreement together as the “Term.”

 

6

 

 

CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

B. Termination. This Agreement may be terminated as follows:

 

1. Either Party may terminate this agreement after the Initial Term upon thirty
(30) days’ prior written notice to other Party.

 

2. Either Party may terminate this Agreement at any time upon a material breach
of this Agreement by the other Party if such breach is not cured within 60 days
after written notice of said breach by the non-breaching Party to the Party in
breach (the “Cure Period”) or if the Agreement is alleged by a federal or state
regulator, or based on advice of counsel to either Party, to violate a Health
Care Law.

 

3. NRLBH may terminate this Agreement if Contractor fails to meet or exceed the
Pharmacogenomic Test Minimums.

 

4. NRLBH may terminate this Agreement upon a change in control of NRLBH or
Atossa, through merger, share transfer, completed tender offer, or otherwise, or
upon the sale or license of all or substantially all the assets of NRLBH or
Atossa.

 

A termination pursuant to clause (2) or (3) shall be considered a “Termination
for Cause”.

 

C. Termination Fee. In the event the Agreement is terminated by NRLBH for any
reason other than a Termination for Cause, then NRLBH shall pay to Contractor
within 30 days of such termination a fee equal to (the “Termination Fee”): the
actual cash received by NRLBH for the sale of Pharmacogenomic Tests to
Contractor Customers during the three month period preceding the effective date
of termination multiplied by 30%.

 

D. Return of Property. Upon termination of this Agreement or earlier if
requested by the other Party, any and all notes, memoranda, specifications,
devices, formulas, and documents, together with all copies thereof in any form,
and any other material containing or disclosing any Third Party Information or
Proprietary Information shall be returned to the Party that provided such
information to the other Party under this Agreement.

 

VII.REPRESENTATIONS AND WARRANTIES; INSURANCE; INDEMNITY

 

A. No Debarment/Exclusion. Each Party certifies to the other that neither it nor
any of its employees, agents or contractors performing services under this
Agreement is excluded under 42 U.S.C. §1320(a)-7 from participation under any
Federal Health Care Program; and (ii) no action has occurred or is pending or
threatened against it or to its knowledge against any employee, Contractor or
agent engaged to provide items or services that could result in such exclusion
(collectively, “Exclusions/Adverse Actions”). During the term of this Agreement,
Each Party agrees to notify the other Party in writing of any Exclusions/Adverse
Actions within five (5) days of learning of any such Exclusions/Adverse Actions
and provide the basis of the Exclusions/Adverse Actions. Each Party acknowledges
that the exclusion of any of its personnel from participation in the Medicare or
Medicaid programs shall result in his or her immediate removal from work under
this Agreement, Each Party acknowledges and agrees that any unresolved
Exclusions/Adverse Actions of or against it or any employee, agent or contractor
utilized, directly or indirectly, in .the performance of this Agreement may
serve as the basis for the immediate termination of this Agreement by the other
Party.

 

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CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

B. Insurance; Expenses. Each Party shall carry general liability and
professional liability (if applicable) insurance covering liability for claims,
causes of actions, actions, losses, liabilities, damages, and expenses arising
out of, caused by or otherwise resulting from the negligence or otherwise
wrongful acts or omissions of its employees and/or agents occurring while each
is engaged in activities related to this Agreement. Said policies shall contain
minimum limits of liability of one million dollars ($1,000,000) per occurrence
and three million dollars ($3,000,000) in the aggregate, or as the Parties may
otherwise mutually agree. All expenses incurred by either Party, including for
marketing, training and promotional purposes, shall be the sole responsibility
of the Party incurring such expenses.

 

C. NRLBH Indemnity. NRLBH shall indemnify and hold Contractor harmless from any
claims arising out of the Marketed Tests from any third party, including
government entities (including any fees, costs, including, without limitation,
attorneys’ fees, expert witness fees and costs of court, and expenses associated
with the defense against Same), except to the extent such claims arise from the
negligence or willful misconduct of Contractor, including any breach of this
Agreement.

 

D. Authority. NRLBH represents that it is a corporation duly organized under the
laws of the State of Delaware and Contractor represents that it is corporation
duly organized under the laws of the State of California. Each party represents
that (i) it has all necessary corporate power to enter into this Agreement, (ii)
the execution and delivery of this Agreement has been duly authorized by all
necessary corporate action, and (iii) this Agreement, once executed and
delivered, shall be a legal, valid and binding obligation of the respective
Party enforceable in accordance with their respective terms.

 

E. Contractor Indemnity. Contractor shall indemnify and hold NRLBH harmless from
any claims arising out of the Services provided by Contractor from any third
party, including government entities (including any fees, costs, including,
without limitation, attorneys’ fees, expert witness fees and costs of court, and
expenses associated with the defense against same), except to the extent such
claims arise from the negligence or willful misconduct of NRLBH, including any
breach of this agreement.

 

F. Goodwill. Each Party agrees that the goodwill and reputation of the other
Party are essential and should not be impaired at any time. Neither Party nor
its agents shall communicate or cause or encourage others to communicate with
any person in a manner which: (i) disparages the other Party or its respective
affiliates, directors, officers, employees, representatives, agents, business
partners, sub-contractors, contractors, suppliers, or the products or services
of any of the foregoing; or (ii) adversely affects, disrupts or interferes with
the other Party’s reputation, goodwill, business relationships, business plans,
litigation, claims, business arrangements or agreements; or (iii) causes
economic harm to the other Party.

 

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CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

VIII.MISCELLANEOUS.

 

A. Severability. If one or more of the provisions contained in this Agreement
shall, for any reason, be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceable shall not affect the other
provisions of this Agreement, and this Agreement shall be construed as if such
invalid, illegal or unenforceable provision had never been contained herein.
Notwithstanding the foregoing, a court of competent jurisdiction may reform any
provision found invalid, illegal, or unenforceable in a manner consistent with
the intent of the Parties so as render such provision fully enforceable to the
extent permitted by law.

 

B. Counterparts; Electronic Transmission. This Agreement may be executed in
counterparts, with all counterparts constituting one and the same original.
Signatures may be transmitted or delivered by electronic means, including
facsimile and digital image (e.g., .PDF, .JPG) and such electronic version shall
constitute an original for all purposes.

 

C. No Assignment. This Agreement may not be assigned by either Party without the
other Party’s prior written consent, which consent shall not be unreasonably
withheld, conditioned or delayed. Subject to the foregoing, this Agreement shall
be binding upon the heirs, successors, and permitted assigns of the Parties
hereto.

 

D. Governing Law. This Agreement shall be governed by and construed under the
laws of the State of Washington without regard to the principles of conflicts of
laws thereof. Any judicial proceeding brought to enforce this Agreement, or any
matter related thereto, shall be brought in the appropriate court for King
County, State of Washington or the appropriate United States District Court for
the Western District of Washington. By execution of this Agreement, each Party
accepts and agrees to the exclusive jurisdiction and venue of the aforesaid
courts and irrevocably agrees to be bound by any judgment rendered thereby in
connection with this Agreement, subject to a Party’s appeal rights.

 

E. Injunctive Relief. A breach of certain promises or agreements contained in
this Agreement may result in irreparable and continuing damage to the
non-breaching Party for which there may be no adequate remedy at law, and the
non-breaching Party is therefore entitled to seek injunctive relief as well as
such other and further relief as may be appropriate. For purposes of this
Section WILE., if a non-breaching Party seeks injunctive relief, the breaching
Party shall waive any requirement of a bond or other security and shall be
liable for reasonable attorney fees and costs incurred in enforcing the terms of
this Agreement.

 

F. Survival. The following provisions shall survive termination of this
Agreement Sections V, Section V.C, VI.C, Section VII.D, Section VII.F, and
Section VIII.

 

G. Waiver. No waiver by a Party to this Agreement of any breach of this
Agreement shall be a waiver any preceding or succeeding breach. No waiver by a
Party to this Agreement of any right under this Agreement shall be construed as
a waiver of any other right. Neither Party shall be required to give notice to
enforce strict adherence to all terms of this Agreement.

 

H. Entire Agreement. This Agreement and the exhibits attached hereto, constitute
the final, complete and exclusive agreement of the Parties with respect to the
subject matter hereof and supersede and merge all prior discussions between the
Parties. No modification of or amendment to this Agreement, nor any waiver of
any rights under this Agreement, will be effective unless in writing and signed
by the Party to be charged.

 

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CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

I. Notices. All notices, requests and other communications under this Agreement
must be in writing, and must be mailed by registered or certified mail, postage
prepaid and return receipt requested, or delivered by hand to the Party to whom
such notice is required or permitted to be given. If mailed, any such notice
will be considered to have been given five (5) business days after it was mailed
postage prepaid to the address provided below or updated by delivery of written
notice in accordance with the provisions of this Section VIII.I. If delivered by
hand, any such notice will be considered to have been given when received by the
Party to whom notice is given.

 

NRLBH CONTRACTOR     National Reference Laboratory for BIOVENTIVE, INC. Breast
Health, Inc. 26895 Aliso Creek Road, B-793 1616 Eastlake Ave., East, No. 300
Aliso Viejo, CA 92656 Seattle, Washington 98102 Attention: President Attention:
President Tel.: (858) 856-2870 Tel.: (800) 351-3902 Fax: (949) 618-8850 Fax:
(206) 430-1288  

  

10

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representative as of the date first set forth above.

 

 

NATIONAL REFERENCE LABORATORY   BIOVENTIVE, INC.   FOR BREAST HEALTH, INC.      
                      By:   /s/ Kyle Guse   By: /s/ Brett R. Nauta     Kyle Guse
    Brett R. Nauta     Chief of Financial Officer and General Counsel     Chief
Executive Officer  

 

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CONFIDENTIAL TREATMENT REQUESTED BY ATOSSA GENETICS INC.

 

 

EXHIBIT A

 

CONTRACTOR SERVICES

 

Contractor shall promote and market the Marketed Tests, by providing promotional
and marketing services, including without limitation, the services more fully
described below (the “Services”) through qualified employees and independent
representatives and other personnel engaged and/or employed by Contractor
(“Contractor Representatives”) in accordance with the Agreement to which this
Exhibit A forms a part

 

1.Customer Liaison Services. Contractor shall provide customer service liaison
support to Contractor Customers, in person and by phone, regarding issues such
as specimen collection, complaints, missed tests, logistical questions with
Marketed Tests, specimen requirements and labeling, specimen transport and
tracking. Contractor shall ensure the ongoing in-person and phone customer
service required to maintain Contractor Customers; however, NRLBH shall also
maintain customer service support during West coast and East coast business
hours. Contractor shall report to NRLBH any customer service problems upon
occurrence. Contractor shall maximize sales of Marketed Tests.

 

2.Insurance Coordination. Contractor will assist NRLBH in obtaining information
necessary to yen insurance eligibility of patients.

 

3.Training. Contractor will provide ongoing training to its Contractor
Representatives and all necessary sales support, and will compensate its
employees and representatives as may be appropriate and in compliance with
applicable Federal, State and local laws and regulations.

 

4.Authorized Materials. Contractor shall use only materials supplied by or
approved by the NRLBH, including without limitation test requisitions and order
forms and sales and marketing materials. Contractor is not authorized to extend
any representation, warranty, guaranty, obligation or responsibility (express or
implied) with respect to the Marketed Tests without express written
authorization from NRLBH.

 

5.No Impermissible Services. In no case shall Contractor or its Contractor
Representatives perform any tasks that are normally the responsibility of the
Contractor Customer or its office staff, including without limitation,
performing nursing functions, or performing clerical services for the Contractor
Customer. Upon request by NRLBH, Contractor shall provide to NRLBH a signed
certification from each Contractor Representative assigned to perform Services
hereunder that the Contractor Representative shall comply fully with the
Agreement and this Exhibit.

 

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EXHIBIT B

 

ADDITIONAL COMPLIANCE OBLIGATIONS OF CONTRACTOR

 

1.Chief Compliance Officer. Contractor shall designate a Chief Compliance
Officer who shall make it a key point of his or her efforts to assure that all
Contractor Representatives continue to gain additional knowledge on
compliance-related issues. Contractor’s Chief Compliance Officer shall timely
inform NRLBH’s Compliance Officer of any compliance-related issues (within not
later than 5 business days following the initial discovery of issues that may
raise a compliance concern, with periodic updates as required by NRLBH until the
issue is resolved).

 

2.HIPAA Privacy Standards. In accordance with HIPAA, Contractor will adopt and
maintain HIPAA compliance plan, as well as HIPAA-compliant privacy standards.
Contractor will appoint a privacy officer.

 

3.Background Checks on Employees and Contractors. Contractor will ensure that
none of its employees, owners or contractors have been excluded or debarred from
Medicare or Medicaid or any other Federal Health Care Program.

 

4.No Kickbacks. Contractor will maintain policies and procedures reasonably
calculated to assure that all individuals providing services to NRLBH and the
Contractor Customers:

 

a.Are prohibited from engaging in any act or omission that promotes, encourages
or results in the overutilization of the Marketed Tests.

 

b.Are required to comply with the Anti-Kickback Statute and other applicable
state and federal statutes, policies and regulations.

 

c.May not engage in any illegal activities related to the furnishing of the
Marketed Tests (such illegal activities include – but are not limited to –
paying kickbacks, incentives and/or gratuities to Contractor Customers or to
individuals who might influence a customer’s decision to order lab testing from
NRLBH, or to provide such person with gifts, bribes, services, or any other form
of remuneration in exchange for – or to induce – referrals):

 

d.Act in accord with applicable guidance issued by the Inspector General of the
Department of Health and Human Services (as updated from time to time).

 

e.They may not be a health care professional or person in a similar position who
might be capable of exerting undue influence on a Contractor Customer or their
patients.

 

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EXHIBIT C

 

MINIMUM PHARMACOGENOMIC TESTS

 

  Minimum Annual Test Quantity Processed by NRLBH Minimum Average Cash Receipts
Per Test Measured Monthly       First year of Agreement [***] $[***] Second year
of Agreement [***] $[***] Third year of Agreement [***] $[***]

Annually after Initial

Three Year Term

[***] $[***]      

 

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EXHIBIT D

 

FIXED MONTHLY FEE FOR CONTRACTOR SERVICES

 

Fixed Monthly Service Fee payable to Contractor shall be an amount equal to
actual cash received by the NRLBH during the month from Marketed Tests performed
for patients of Contractor Customers multiplied by [***].

 

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EXHIBIT E

 

BUSINESS ASSOCIATE AGREEMENT

 

This Business Associate Agreement (“BA Agreement”) dated August 26, 2014 (the
“Effective Date”) is entered into by and between The National Reference
Laboratory for Breast Health, Inc. (“NRLBH”), and BioVentive, Inc.
(“Contractor”), each a “Party” and collectively, the “Parties.”

 

WHEREAS, NRLBH and Contractor have entered into, or are entering into, or may
subsequently enter into, agreements or other documented arrangements
(collectively, the “Business Arrangements”) pursuant to which Contractor may
provide products and/or services for NRLBH that require Contractor to access,
create and use health information that is protected by state and/or federal law;
and

 

WHEREAS, pursuant to the Administrative Simplification provisions of the Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”), the U.S.
Department of Health & Human Services (“HHS”) promulgated the Standards for
Privacy of Individually Identifiable Health Information (the “Privacy
Standards”), at 45 C.F.R. Parts 160 and 164, requiring certain individuals and
entities subject to the Privacy Standards (each a “Covered Entity”, or
collectively, “Covered Entities”) to protect the privacy of certain individually
identifiable health information (“Protected Health Information”, or “PHI”); and

 

WHEREAS, pursuant to HIPAA, FIRS has issued the Security Standards (the
“Security Standards”), at 45 C.F.R. Parts 160, 162 and 164, for the protection
of electronic protected health information (“EPHI”); and

 

WHEREAS, in order to protect the privacy and security of PHI, including EPHI,
created or maintained by or on behalf of NRLBH, the Privacy Standards and
Security Standards require NRLBH to enter into a “Business Associate Agreement”
with certain individuals and entities providing, services for or on behalf of
NRLBH if such services require the use or disclosure of PHI or EPH1; and

 

WHEREAS, on February 17, 2009, the federal Health Information Technology for
Economic and Clinical Health Act (the “HITECH Act”), was signed into law and the
HITECH Act imposes certain privacy and security obligations on NRLBH in addition
to the obligations created by the Privacy Standards and Security Standards; and

 

WHEREAS, the HITECH Act revises many of the requirements of the Privacy
Standards and Security Standards concerning the confidentiality of PHI and EPHI,
including extending certain HIPAA and HITECH Act requirements directly to
business associates; and

 

WHEREAS, the HITECH Act requires that certain of its provisions be included in
business associate agreements, and that certain requirements of the Privacy
Standards be imposed contractually upon NRLBH as well as business associates;
and

 

WHEREAS, Contractor and NRLBH desire to enter into this Business Associate
Agreement;

 

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NOW THEREFORE, in consideration of the mutual promises set forth in this
Agreement and the Business Arrangements, and other good and valuable
consideration, the sufficiency and receipt of which are hereby severally
acknowledged, the Parties agree as follows:

 

1. Contractor Obligations. Contractor may receive from NRLBH, or create or
receive on behalf of NRLBH, health information that is protected under
applicable state and/or federal law, including without limitation, PHI and EPHI.
All capitalized terms not otherwise defined in this Agreement shall have the
meanings set forth in the Privacy Standards, Security Standards or the HITECH
Act, as applicable (collectively referred to hereinafter as the “Confidentiality
Requirements”). All references to PHI herein shall be construed to include EPHI.
Contractor agrees not to use or disclose (or permit the use or disclosure of)
PHI in a manner that would violate the Confidentiality Requirements if the PHI
were used or disclosed by NRLBH in the same manner.

 

2. Use of PHI. Except as otherwise required by law, Contractor shall use PHI in
compliance with 45 C.F.R. § 164.504(e). Furthermore, Contractor shall use PHI
(i) solely for NRLBH’s benefit arid only for the purpose of performing services
for NRLBH as such services are defined in Business Arrangements, and (ii) as
necessary for the proper management and administration of the Contractor or to
carry out its legal responsibilities, provided that such uses are permitted
under federal and state law. NRLBH shall retain all rights in the PHI not
granted herein. Use, creation and disclosure of de-identified health information
by Contractor are not permitted unless expressly authorized in writing by NRLBH.

 

3. Disclosure of PHI. Subject to any limitations in this BA Agreement,
Contractor may disclose PHI to any third party persons or entities as necessary
to perform its obligations under the Business Arrangement and as permitted or
required by applicable federal or state law. Further, Contractor may disclose
PHI for the proper management and administration of the Contractor, provided
that (i) such disclosures are required by law, or (ii) Contractor: (a) obtains
reasonable assurances from any third party to whom the information is disclosed
that it will be held confidential and further used and disclosed only as
required by law or for the purpose for which it was disclosed to the third
party; (b) requires the third party to agree to immediately notify Contractor of
any instances of which it is aware that PHI is being used or disclosed for a
purpose that is not otherwise provided for in this Agreement or for a purpose
not expressly permitted by the Confidentiality Requirements. Additionally,
Contractor shall ensure that all disclosures of PHI by Contractor and the third
party comply with the principle of “minimum necessary use and disclosure,” i.e.,
only the minimum PHI that is necessary to accomplish the intended purpose may be
disclosed; provided further, Contractor shall comply with Section 13405(b) of
the HITECH Act, and any regulations or guidance issued by HHS concerning such
provision, regarding the minimum necessary standard and the use and disclosure
(if applicable) of Limited Data Sets. If Contractor discloses PHI received from
NRLBH, or created or received by Contractor on behalf of NRLBH, to agents,
including a sub-Contractor (collectively, “Recipients”), Contractor shall
require Recipients to agree in writing to the same restrictions and conditions
that apply to the Contractor under this Agreement. Contractor shall report to
NRLBH any use or disclosure of PHI not permitted by this Agreement, of which it
becomes aware, such report to be made within two (2) business days of the
Contractor becoming aware of such use or disclosure. In addition to Contractor’s
obligations under Section 9, Contractor agrees to mitigate, to the extent
practical and unless otherwise requested by NRLBH in writing, any harmful effect
that is known to Contractor and is the result of a use or disclosure of PHI by
Contractor or Recipients in violation of this Agreement.

 

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4. Accounting of Disclosures. Contractor shall make available to NRLBH in
response to a request from an individual, information required for an accounting
of disclosures of PHI with respect to the individual in accordance with 45 CFR §
164.528, as amended by Section 13405(c) of the HITECH Act and any related
regulations or guidance issued by HHS in accordance with such provision.
Contractor shall provide to NRLBH such information necessary to provide an
accounting within thirty (30) days of NRLBH’s request or such shorter time as
may be required by state or federal law. Such accounting must be provided
without cost to the individual or to NRLBH if it is the first accounting
requested by an individual within any twelve (12) month period. For subsequent
accountings within a twelve (12) month period, Contractor may charge a
reasonable fee based upon the Business’s labor costs in responding to a request
for electronic information (or a cost-based fee for the production of
non-electronic media copies) so long as Contractor informs NRLBH and NRLBH
informs the individual in advance of the fee, and the individual is afforded an
opportunity to withdraw or modify the request. Such accounting obligations shall
survive termination of this Agreement and shall continue as long as Contractor
maintains PHI.

 

5. Withdrawal of Authorization. If the use or disclosure of PHI in this
Agreement is based upon an individual’s specific authorization for the use of
his or her PHI, and (i) the individual revokes such authorization in writing,
(ii) the effective date of such authorization has expired, or (iii) the consent
or authorization is found to be defective in any manner that renders it invalid,
Contractor agrees, if it has notice of such revocation or invalidity, to cease
the use and disclosure of any such individual’s PHI except to the extent it has
relied on such use or disclosure, or where an exception under the
Confidentiality Requirements expressly applies.

 

6. Records and Audit. Contractor shall make available to the United States
Department of Health and Human Services or its agents, its internal practices,
books, and records relating to the use and disclosure of PHI received from,
created, or received by Contractor on behalf of NRLBH for the purpose of
determining NRLBH’s compliance with the Confidentiality Requirements or any
other health oversight agency, in a time and manner designated by the Secretary.
Except to the extent prohibited by law, Contractor agrees to notify NRLBH
immediately upon receipt by Contractor of any and all requests by or on behalf
of any and all federal, state and local government authorities served upon
Contractor for PHI.

 

7. Implementation of Security Standards; Notice of Security Incidents.
Contractor will use appropriate safeguards to prevent the use or disclosure of
PHI other than as expressly permitted under this Agreement. Contractor will
implement administrative, physical and technical safeguards that reasonably and
appropriately protect the confidentiality, integrity and availability of the PHI
that it creates, receives, maintains or transmits on behalf of NRLBH. Contractor
acknowledges that the HITECH Act requires Contractor to comply with 45 C.F.R.
§§ 164.308, 164.310, 164.312 and 164.316 as if Contractor were a Covered Entity,
and Contractor agrees to comply with these provisions of the Security Standards
and all additional security provisions of the HITECH Act. Furthermore, to the
extent feasible, Contractor will use commercially reasonable efforts to ensure
that the technology safeguards used by Contractor to secure PHI will render such
Pill unusable, unreadable and indecipherable to individuals unauthorized to
acquire or otherwise have access to such PHI in accordance with HHS Guidance
published at 74 Federal Register 19006 (April 17, 2009), or such later
regulations or guidance promulgated by HHS including the National Institute for
Standards and Technology (“NIST”) standards adopted by HHS concerning the
protection of identifiable data such as PHI. Lastly, Contractor will promptly
report to NRLBH any successful Security Incident of which it becomes aware. At
the request of NRLBH, Contractor shall identify: the date of the Security
Incident, the scope of the Security Incident, the Contractor’s response to the
Security Incident and the identification of the party responsible for causing
the Security Incident, if known.

 

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8. Data Breach Notification and Mitigation.

 

8.1 HIPAA Data Breach Notification and Mitigation. Contractor agrees to
implement reasonable systems for the discovery and prompt reporting of any
“breach” of “unsecured PHI” as those terms are defined by 45 C.F.R. § 164.402
(hereinafter a “HIPAA Breach”). The Parties acknowledge and agree that 45 C.F.R.
§ 164.404, as described below in this Section, governs the determination of the
date of a HIPAA Breach. In the event of any conflict between this Section and
the Confidentiality Requirements, the more stringent requirements shall govern.
Contractor will, following the discovery of a HIPAA Breach, notify NRLBH
immediately within fifteen (15) Contractor discovers such HIPAA Breach, unless
Contractor is prevented from doing so by 45 C.F.R. § 164.412 concerning law
enforcement investigations. For purposes of reporting a HIPAA Breach to NRLBH,
the discovery of a HIPAA Breach shall occur as of the first day on which such
HIPAA Breach is known to the Contractor or, by exercising reasonable diligence,
would have been known to the Contractor. Contractor will be considered to have
had knowledge of a HIPAA Breach if the HIPAA Breach is known, or by exercising
reasonable diligence would have been known, to any person (other than the person
committing the HIPAA Breach) who is an employee, officer or other agent of the
Contractor. No later than three (3) business days following a HIPAA Breach,
Contractor shall provide NRLBH with sufficient information to permit NRLBH to
comply with the HIPAA Breach notification requirements set forth at 45 C.F.R. §
164.400 et seq. Specifically, if following information is known to (or can be
reasonably obtained by) the Contractor, Contractor will provide NRLBH with: (i)
contact information for individuals who were or who may have been impacted by
the HIPAA Breach (e.g., first and last name, mailing address, street address,
phone number, email address); (ii) a brief description of the circumstances of
the HIPAA Breach, including the date of the HIPAA Breach and date of discovery;
(iii) a description of the types of unsecured PHI involved in the HIPAA Breach
(e.g., names, social security number, date of birth, address(es), account
numbers of any type, disability codes, diagnostic and/or billing codes and
similar information); (iv) a brief description of what the Contractor has done
or is doing to investigate the HIPAA Breach, mitigate harm to the individual
impacted by the HIPAA Breach, and protect against future HIPAA Breaches; and (v)
appoint a liaison and provide contact information for same so that NRLBH may ask
questions or learn additional information concerning the HIPAA Breach. Following
a HIPAA Breach, Contractor will have a continuing duty to inform NRLBH of new
information learned by Contractor regarding the HIPAA Breach, including but not
limited to the information described in items (i) through (v), above.

 

8.2 Data Breach Notification and Mitigation under Other Laws. In addition to the
requirements of the foregoing Section, Contractor agrees that in the event any
Individually Identifiable Information is lost, stolen, used or disclosed in
violation of one or more State data breach notification laws, Contractor shall
promptly: (1) cooperate and assist NRLBH with any investigation into any State
Breach or alleged State Breach; (ii) cooperate and assist NRLBH with any
investigation into any State Breach or alleged State Breach conducted by any
State Attorney General or State Consumer Affairs Department (or their respective
agents); (iii) comply with NRLBH’s determinations regarding NRI.BH’s and
Contractor’s obligations to mitigate to the extent practicable any potential
harm to the individuals impacted by the State Breach; and (iv) assist with the
implementation of any decision by NRLBH or any State agency, including any State
Attorney General or State Consumer Affairs Department (or their respective
agents), to notify individuals impacted or potentially impacted by a State
Breach.

 

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9. Term and Termination.

 

9.1 This BA Agreement shall commence on the Effective Date and shall remain in
effect until terminated in accordance with the terms of this Section, provided,
however, that termination shall not affect the respective obligations or rights
of the Parties arising under the Business Arrangements prior to the effective
date of termination, all of which shall continue in accordance with their terms.

 

9.2 NRLBH shall have the right to terminate this BA Agreement if the Contractor
fails to observe or perform any material covenant or obligation contained in
this BA Agreement for ten (10) days after written notice thereof has been given
to the Contractor.

 

9.3 Termination of this BA Agreement pursuant to Section 9.2 above shall be
cause for NRLBH to immediately terminate for cause any Business Arrangement
pursuant to which Contractor is entitled to receive PHI from NRLBH.

 

9.4 Upon termination of this BA Agreement for any reason, Contractor agrees
either to return to NRLBH or to destroy all PHI received from NRLBH or otherwise
through the performance of services for NRLBH, that is in the possession or
control of Contractor or its agents. In the case of PHI which is not feasible to
“return or destroy,” Contractor shall extend the protections of this BA
Agreement to such PHI and limit further uses and disclosures of such PHI to
those purposes that make the return or destruction infeasible, for so long as
Contractor maintains such PHI. Contractor further agrees to comply with other
applicable state or federal law, which may require a specific period of
retention, redaction, or other treatment of such PHI.

 

10. No Warranty. PHI IS PROVIDED TO Contractor SOLELY ON AN “AS IS” BASIS.
COMPANY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, AND FITNESS FOR A PARTICULAR
PURPOSE.

 

11. Miscellaneous.

 

11.1 Notice. All notices, requests, demands and other communications required or
permitted to be given or made under this BA Agreement shall be in writing, shall
be effective upon receipt or attempted delivery, and shall be sent by (1)
personal delivery; (ii) certified or registered United States mail, return
receipt requested; or (iii) overnight delivery service with proof of delivery.
Neither Party shall refuse delivery of any notice hereunder.

 

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To NRLBH:

 

National Reference Laboratory for Breast Health, Inc.
1616 Eastlake Ave., East, No. 300
Seattle, Washington 98102

Attention: President

Tel.: (800) 351-3902

Fax: (206) 430-1288

 

To Contractor:

 

BIOVENTIVE, INC.

26895 Aliso Creek Road, B-793

Aliso Viejo, CA 92656

Attention: President

Tel.: (858) 856-2870

Fax: (949) 618-8850

 

 

 

11.2 Waiver. No provision of this BA Agreement or any breach thereof shall be
deemed waived unless such waiver is in writing and signed by the Party claimed
to have waived such provision or breach. No waiver of a breach shall constitute
a waiver of or excuse any different or subsequent breach.

 

11.3 Severability. Any provision of this BA Agreement that is determined to be
invalid or unenforceable will be ineffective to the extent of such determination
without invalidating the remaining provisions of this BA Agreement or affecting
the validity or enforceability of such remaining provisions.

 

11.4 Entire Agreement. This BA Agreement constitutes the complete agreement
between Contractor and NRLBH relating to the matters specified in this
Agreement, and supersedes all prior representations or agreements, whether oral
or written, with respect to such matters. In the event of any conflict between
the terms of this BA Agreement and the terms of the Business Arrangements or any
such later agreement(s), the terms of this BA Agreement shall control unless the
terms of such Business Arrangements are more strict with respect to PHI and
comply with the Confidentiality Requirements, or the Parties specifically
otherwise agree in writing. No oral modification or waiver of any of the
provisions of this BA Agreement shall be binding on either Party; provided,
however, that upon the enactment of any law, regulation, court decision or
relevant government publication and/or interpretive guidance or policy that
NRLBH believes in good faith will adversely impact the use or disclosure of PHI
under this BA Agreement, NRLBH may amend the BA Agreement to comply with such
law, regulation, court decision or government publication, guidance or policy by
delivering a written amendment to Contractor which shall be effective thirty
(30) days after receipt. No obligation on either Party to enter into any
transaction is to be implied from the execution or delivery of this BA
Agreement. This BA Agreement is for the benefit of, and shall be binding upon
the Parties, their affiliates and respective successors and assigns. No third
party shall be considered a third-party beneficiary under this BA Agreement, nor
shall any third party have any rights as a result of this BA Agreement.

 

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11.5 Governing Law. This BA Agreement shall be governed by and interpreted in
accordance with the laws of the state of Washington, excluding its conflicts of
laws provisions. Jurisdiction and venue for any dispute relating to this BA
Agreement shall exclusively rest with the state and federal courts in the county
in which NRLBH is located.

 

11.6 Equitable Relief. Contractor understands and acknowledges that any
disclosure or misappropriation of any PHI in violation of this BA Agreement will
cause NRLBH irreparable harm, the amount of which may be difficult to ascertain,
and therefore agrees that NRLBH shall have the right to apply to a court of
competent jurisdiction for specific performance and/or an order restraining and
enjoining any such further disclosure or breach and for such other relief as
NRLBH shall deem appropriate. Such right of NRLBH is to be in addition to the
remedies otherwise available to NRLBH at law or in equity. Contractor expressly
waives the defense that a remedy in damages will be adequate and further waives
any requirement in an action for specific performance or injunction for the
posting of a bond by NRLBH.

 

11.7 Nature of Agreement; Independent Contractor. Nothing in this BA Agreement
shall be construed to create (i) a partnership, joint: venture or other joint
business relationship between the Parties or any of their affiliates, or (ii) a
relationship of employer and employee between the Parties. Contractor is an
independent Contractor, and not an agent of NRLBH. This BA Agreement does not
express or imply any commitment to purchase or sell goods or services.

 

11.8 Counterparts. This BA Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same document. In making proof of this BA
Agreement, it shall not be necessary to produce or account for more than one
such counterpart executed by the Party against whom enforcement of this
Agreement is sought.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.

  

National Reference Laboratory     For Breast Health,
Inc.                                                    BioVentive, Inc.      
By: /s/ Kyle Guse                                         By: /s/ Brett R.
Nauta                                              Printed Name: Kyle Guse  
Printed Name: Brett R. Nauta Title: Chief of Financial Officer and   Title:
Chief Executive Officer General Counsel    

 

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