Exhibit 10.1

 

CORGENIX MEDICAL CORPORATION HAS REQUESTED THAT THE PORTIONS OF THIS DOCUMENT
DENOTED BY BRACKETS AND ASTERISKS BE ACCORDED CONFIDENTIAL TREATMENT PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

COLLABORATIVE DEVELOPMENT AND MANUFACTURING AGREEMENT

 

Between

 

HEALTH DIAGNOSTIC LABORATORY, INC.

 

- and -

 

CORGENIX INC.

 

as of

 

October 22, 2013

 

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

 

COLLABORATIVE DEVELOPMENT AND MANUFACTURING AGREEMENT

 

This Collaborative Development and Manufacturing Agreement (this “Agreement”) is
made effective as of October 22, 2013 (the “Effective Date”) by and between
Health Diagnostic Laboratory, Inc., 737 N 5th Street, Suite 200, Richmond VA
23219 (“HDL”) and Corgenix, Inc., 11575 Main Street, Suite 400, Broomfield CO
80020 (“Corgenix”).  HDL and Corgenix are each referred to individually as a
“Party” and together as the “Parties”.

 

WHEREAS, HDL is an accredited leader in health management, and offers a
comprehensive test menu of risk factors and biomarkers for cardiovascular and
related diseases, including unique, proprietary diagnostic laboratory services
which HDL develops;

 

WHEREAS, Corgenix is a world-recognized leader in the design, manufacture and
marketing of medical diagnostic products, and has rights to certain technology
which may be used, after development, to detect a proprietary atherosclerosis
biomarker; and

 

WHEREAS, it is the objective of the Parties to collaborate on research and
development activities to culminate in HDL’s development and offering of a
laboratory developed test associated with detection of a proprietary
atherosclerosis biomarker, and for which Corgenix will manufacture certain
reagents for HDL, according to HDL’s specifications.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties hereby agree as follows:

 

ARTICLE 1
DEFINITIONS

 

Section 1.1                                   Definitions.  The following
initially capitalized terms, as used herein, have the following meaning:

 

“Acceptance” has the meaning ascribed to it in Section 3.1(b).

 

“Acceptance Testing” has the meaning ascribed to it in Section 3.1(a).

 

“Assay” means a laboratory developed test relevant to the detection, diagnosis,
prognosis, therapy or monitoring of atherosclerosis that is being developed,
tested, modified, validated, studied and offered by HDL.

 

“Breaching Party” has the meaning ascribed to it in Section 9.3.

 

“Confidential Information” means (i) any information, intellectual property,
expertise, data, trade secret, work, copyright, invention, process, art, method,
technique, program, design, composition, discovery or formula of the Discloser;
(ii) any marketing, advertising, financial, commercial, sales, information
technology or operations information of the Discloser; (iii) any budget, plan,
model or analysis of the Discloser; (iv) any written materials, compositions,
drawings, diagrams, computer programs or flowcharts, studies, work in progress,
visual demonstrations, ideas or concepts of the Discloser; (v) any information
of the Discloser relating to its business and research on disease biomarkers, or
any portion thereof, for any commercial, medical diagnostic, bio-informatic or
analytical purpose; and (vi) any other data of the Discloser including any of
the foregoing derived in whole or in part from the

 

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

 

Confidential Information including the fact that there is an agreement between
the Parties and the identity of Persons and Parties involved in this Agreement,
whether in oral, written, graphic, electronic or any other form or medium
whatsoever, which may be disclosed to the Recipient by the Discloser during the
course of this Agreement and which is marked as confidential.  The subject
matter of any oral, audio and/or visual disclosures must be identified and
confirmed in writing as Confidential Information by the Discloser within thirty
(30) days of the date of disclosure thereof.  “Confidential Information” shall
not include:  (a) information which is now or which hereafter becomes publicly
known or available through no act or failure on the part of Recipient, whether
through breach of this Agreement or otherwise; (b) information which is actually
known to Recipient prior to the time of receipt of such Confidential
Information, provided such actual knowledge can be established by evidence that
would be acceptable to a court of competent jurisdiction; (c) information which
is furnished to Recipient by a third party who has rightfully obtained the
information without restriction on disclosure; (d) information which is
independently developed by Recipient without use of or reference to Confidential
Information, provided such independent development can be established by
evidence that would be acceptable to a court of competent jurisdiction; or
(e) information which Recipient is by law, order of a court of competent
jurisdiction, or other legal compulsion required to disclose, provided that
Recipient provides written notice to Discloser reasonably in advance of any such
disclosure to allow sufficient opportunity for Discloser to object to and/or
prevent such disclosure.

 

“Corgenix Background Intellectual Property” has the meaning ascribed to it in
Section 4.4.

 

“Corgenix Manufactured Reagents” means means all reagents manufactured by
Corgenix pursuant to the terms of this Agreement.

 

“Customizations” means all improvements, innovations, customizations,
amendments, changes, enhancements, revisions, modifications, derivative works or
other changes.

 

“Deliverable” has the meaning ascribed to it in Section 4.6(i).

 

“Discloser” means the Party hereto which rightfully possesses the relevant
Confidential Information or the Intellectual Property Rights in and to an item
of Confidential Information, as the context requires, and discloses the
Confidential Information to the Recipient, and includes but is not limited to an
owner, possessor, developer or licensee of such Confidential Information.

 

“Dispute” has the meaning ascribed to it in Section 10.1(a).

 

“FDA” means the U.S. Food and Drug Administration.

 

“Governmental Authority” means any federal, state, provincial, territorial,
regional, municipal or local government or governmental authority,
quasi-governmental authority, regulatory organization, commission, board,
tribunal, or any administrative or other agency, or any political or other
subdivision, department, or branch of any of the foregoing, having competent
jurisdiction in any way over this Agreement, any of the subject Parties, or over
any other aspect of the Obligations.

 

“HDL Background Intellectual Property” has the meaning ascribed to it in
Section 4.5.

 

“HDL Supplied Reagents” has the meaning ascribed to it in Section 2.1.

 

“Initial Term” has the meaning ascribed to it in Section 9.1.

 

2

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

 

“Intellectual Property Rights” means any proprietary title, interest or right or
other protection (whether by statute, common law, or otherwise), existing from
time to time in a specific jurisdiction, whether registered or not, under any
patent law or other invention or discovery law, copyright law, industrial design
law, moral rights law, confidential information law, trade-mark law, or other
similar intellectual property or proprietary laws

 

“Losses” has the meaning ascribed to it in Section 8.1.

 

“Obligations” has the meaning ascribed to it in Section 2.1(a).

 

“Person” means any Governmental Authority, individual, sole proprietorship,
trust, corporation, entity, partnership, association or unincorporated
organization.

 

“Recipient” means the Party hereto who receives or is otherwise privy to, or
comes into possession of, an item of Confidential Information of which it is not
the Discloser.

 

“Reported Test” means each test run by HDL using the Assay (a “Test”) and
reported to a third party.  For purposes of clarity, Reported Test shall not
include any failed use of the Assay, any use of the Assay for instrument
calibration purposes, or any otherwise unreportable result from use of the
Assay.

 

“Research Manual” has the meaning ascribed to it in Section 4.2(a).

 

“Research Records” has the meaning ascribed to it in Section 4.1.

 

“Restricted Period” means, as applicable, during the Initial Term, (i) twelve
(12) months after the Effective Date to enable the validation and
commercialization of the Test by HDL (the “Phase I Exclusivity Period”),
(ii) twelve (12) months from and after the Phase I Exclusivity Period, so long
as HDL performs at least an average of [*] Reported Tests per month during such
twelve (12) months (the “Phase II Exclusivity Period”), or (iii) twelve (12)
months following the Phase II Exclusivity Period, either so long as HDL performs
at least an average of [*] Reported Tests per month during such twelve (12)
month period.

 

“Sample” means a human tissue and/or a biological fluid and/or venous blood
sample as more particularly described in Schedule A.

 

“Standard Operating Procedure” has the meaning ascribed to it in Section 4.2(a).

 

“Territory” means the United States of America.

 

“Term” has the meaning ascribed to it in Section 9.1.

 

“Third Party Claim” has the meaning ascribed to it in Section 8.1.

 

CORGENIX MEDICAL CORPORATION HAS REQUESTED THAT THE PORTIONS OF THIS DOCUMENT
DENOTED BY BRACKETS AND ASTERISKS BE ACCORDED CONFIDENTIAL TREATMENT PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

3

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

 

ARTICLE 2
OBLIGATIONS

 

Section 2.1                                   Obligations.

 

(a)                                 HDL intends to work with Corgenix to develop
appropriate specifications for reagents required for the Assay, which Corgenix
will then provide, in accordance with the HDL-developed specifications.  Each
Party’s respective obligations, responsibilities and milestone events detailed
in this Agreement and in Schedule A hereto shall be referred to herein
collectively as the “Obligations”.

 

(b)                                 HDL and Corgenix will provide each other
with reasonable cooperation, information, materials, data and support service,
as specified in Schedule A and Schedule B, which may reasonably be required for
the performance of the Obligations.

 

(c)                                  Except as otherwise provided herein, each
Party shall exercise its respective rights, and perform and provide its
respective Obligations under this Agreement, at its own respective cost, expense
and risk without recourse to other Party, except as otherwise expressly provided
in this Agreement.

 

(d)                                 Corgenix shall provide to HDL all Corgenix
Manufactured Reagents listed on Exhibit A (“Corgenix Manufactured Reagents”), on
time frames that the Parties mutually agree to.  If at any time Corgenix expects
that it will not be able to meet HDL’s demand for the foregoing, Corgenix will
use commercially reasonable efforts to establish a secondary production source. 
The Parties understand that HDL is independently developing and/or sourcing
other required reagents as defined in Exhibit A (“HDL Supplied Reagents”).

 

(e)                                  Promptly upon a Party becoming aware of any
delays in performance of any of its respective Obligations, or upon the
reasonable expectation of such delays, such Party shall provide the other Party,
as applicable:  (i) complete and accurate written notice of such actual or
expected delays, and any reasons, influences and circumstances that may
reasonably be expected to cause, or that have caused, such delays ; and (ii) a
written report proposing a strategy and undertakings to avoid, mitigate or
remedy such circumstance and any detrimental impact of such circumstance on the
other Parties’ ability to fully perform this Agreement.

 

Section 2.2                                   Obligations Standards.

 

(a)                                 Without limiting any other provisions of
this Agreement, the Obligations shall be performed by each Party diligently and
professionally, and in a manner and to an extent that is reasonably consistent
with the quality of care, diligence, standards and practices in the industry for
the performance of such services.  All personnel who perform any part of the
Obligations shall have the training, experience, professional qualifications and
technical expertise that are reasonably necessary to perform the Obligations and
shall not be barred or otherwise prohibited by a Governmental Authority from
engaging in clinical testing or product development activities.

 

(b)                                 As a part of the Obligations, each Party, as
applicable, shall provide and implement commercially reasonable quality
assurance processes and procedures consistent with industry standards, to manage
and facilitate the performance of this Agreement

 

(c)                                  Neither Party shall, without the prior
written consent of the other Party, subcontract or otherwise engage any
consultant or other third party to perform any of the activities or Obligations
under this Agreement.  If a Party consents to the other Party’s subcontracting
or engaging any consultant or third party to perform any of the activities or
obligations under this Agreement, the subcontracting Party shall require that
all terms and conditions of this Agreement are carried through into any
subcontracts, and the subcontracting Party shall remain wholly responsible for
any subcontracts it enters into.

 

4

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

 

(d)                                 In connection with this Agreement, the
Parties shall not make an untrue statement of material fact to or file a false
claim or report with any Governmental Authority, or fail to disclose a material
fact required to be disclosed to any Governmental Authority.

 

ARTICLE 3
VERIFICATION AND AUDIT

 

Section 3.1                                   Acceptance of Obligations.

 

(a)                                 Upon the completion of each of its
Obligation in Schedule B, hereof, including all Sample analysis and delivery
dates, Corgenix shall provide HDL with written notice of such completion and
readiness for review, inspection, testing, verification and acceptance of same
by HDL.  HDL may, at its sole and absolute discretion, for the purpose of
validating such completion and readiness, conduct reasonably diligent and
thorough empirical verification, assessment and testing thereof that HDL
reasonably determines is necessary and appropriate in relation to such
Obligation (“Acceptance Testing”).

 

(b)                                 HDL shall, upon the conclusion of the
Acceptance Testing period, provide Corgenix with written notice that indicates
either the acceptance by HDL (“Acceptance”) or rejection (with written reasons)
of the subject Obligations.  In the event of rejection, Corgenix shall use
reasonable efforts available to it consistent with industry standards to remedy
deficiencies and resubmit to HDL pursuant to Section 3.1(a).

 

(c)                                  An Obligation stipulated in Schedule B
hereof shall not be deemed or considered to have been provided or performed by
Corgenix pursuant to this Agreement until HDL has completed such Acceptance
Testing and provided a notice of Acceptance pursuant to Section 3.1(b).  HDL
shall use reasonable efforts to complete Acceptance Testing in a timely fashion,
not to exceed three (3) months from date of shipment.

 

Section 3.2                                   Audit.  During the Term of this
Agreement and (i) upon written notice of not less than fifteen (15)  business
days and subject to determining a mutually acceptable date with Corgenix, HDL
may, during regular business hours audit and inspect, or have audited or
inspected, at the expense of HDL:  (i) any facility or part of a facility and
related records at which Corgenix is providing and performing the Obligations
and which is not otherwise unaccessable for proprietary business reasons, no
more often than once every twelve (12) months unless HDL needs to do so as a
result of an order or requirement of a Governmental Authority in order to
verify:

 

(a)                                 performance by Corgenix of its Obligations
under this Agreement; and

 

(b)                                 the internal controls, practices and
procedures used by Corgenix relating to the Obligations.

 

Section 3.3                                   Audits by Governmental
Authorities.

 

(a)                                 Each Party will notify the other Party
within twenty-four (24) hours in the event that the FDA or any other
Governmental Authority notifies a Party of a pending inspection/audit relating
to the Assay, or makes written or oral inquiries regarding any aspect of a
Party’s activities pursuant to this Agreement.

 

(b)                                 During the term of this Agreement, each
Party agrees to permit Governmental Authorities to examine the facilities where
the Party is performing the Obligations.  During any such

 

5

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

 

inspection or inquiry, the Party being inspected agrees to make reasonable
efforts to disclose only the information required to be disclosed. If not
prohibited by Applicable Law, that Party shall notify the other Party in advance
of the audit, inspection or investigation by Governmental Authorities, and that
Party will have the right to be present during and participate in any such
inspection, audit, investigation or regulatory action related to activities
undertaken pursuant to this Agreement. Each Party will forward to the other
Party any written communication received, initiating, generated by or as a
result of the inspection/audit within twenty-four (24) hours of receipt of such
communication and agrees to allow the other Party to assist in responding to any
citations.  Such responses shall be made within two (2) weeks of issuance of any
citations or within any other deadline set by the issuing Governmental
Authority.

 

(c)                                  The inspected Party shall also provide to
the other Party copies of any documents provided to any inspector or auditor. 
In the event the FDA or other Governmental Authority requests or requires any
action to be taken to address any citations, the inspected Party agrees, after
consultation with the other Party, to take such action as necessary to address,
object to or appeal such citations.

 

(d)                                 The inspected Party shall promptly provide
to the other Party a copy of all inspection related correspondence between it
and a Governmental Authority pertaining to activities undertaken pursuant to
this Agreement, purged only of Confidential Information that is unrelated to the
activities under this Agreement.  The inspected Party shall provide to the other
Party a copy of any proposed response to FDA or another Governmental Authority
for the review of the other Party prior to submission that relates to activities
under this Agreement.  Each Party shall immediately notify the other Party of
any violation or deficiency noted by FDA or any other Governmental Authority
related to the Assay.

 

ARTICLE 4
RECORDS, REPORTS AND INTELLECTUAL PROPERTY

 

Section 4.1                                   Research Records.  Corgenix shall
create and maintain reasonably accurate, complete and current records concerning
its provision and performance of its Obligations (“Research Records”).  For
greater certainty, Research Records shall include all analyses, results and
documents required, or otherwise created, in any connection with this Agreement,
including reports and financial records, which shall be maintained in accordance
with Applicable Laws.

 

Section 4.2                                   Research Manuals.

 

(a)                                 Subject to the provisions of Article 6 of
this Agreement, the Parties shall separately and/or jointly as appropriate,
develop and create research manuals that shall combine, aggregate, consolidate
and set out all separate and shared Obligations, including a reasonably detailed
description of the standard operating procedures, experimental methodology,
research processes and the standard operating procedure for Sample processing
that are established among the Parties relating to HDL’s use of the Assay
(“Standard Operating Procedure”).  Such research manual shall include all
documentation, manuals, data, business information, business process or
operational descriptions or flow charts, reports and other materials that are
required to be produced, created or maintained pursuant to this Agreement
(“Research Manual”).  HDL will collaborate with, and direct Corgenix on, the
Research Manual and the Standard Operating Procedures, which shall be written in
English.  The Research Manual is being created for the benefit of HDL and at the
direction of HDL and shall be the sole property of HDL.  Except as otherwise
provided herein, Corgenix hereby agrees and acknowledges that it will have no
intellectual property or ownership rights in and to the Research Manual and upon
termination of this Agreement, it shall return all copies of the Research Manual
to HDL.  Without limiting the foregoing, the Research Manual shall include a
description of:

 

6

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

 

(i)                                    the Obligations provided and performed
under this Agreement including, how the Parties shall perform and deliver their
respective Obligations under this Agreement;

 

(ii)                                all experimental processes, procedures,
methodologies, practices and operations of HDL to which the Obligations relate;

 

(iii)                            an inventory of equipment, hardware, software
and other assets being used to provide and support the Obligations; and

 

(iv)                             the activities the Parties propose to undertake
to provide and perform the Obligations, including those direction, supervision,
monitoring, staffing, reporting, planning and oversight activities normally
undertaken to provide services of the type.

 

(b)                                 The Parties will periodically, but not less
than quarterly unless otherwise agreed to by the Parties, keep current and
update the Research Manual to reflect changes in the Standard Operating
Procedure described therein.  Updates thereof will be provided to HDL for the
review of HDL, comment and written approval.

 

Section 4.3                                   Data.  HDL shall be the owner of
all records, accounts, notes, reports and data (including new data) generated or
prepared by Corgenix in the course of performing the Obligations (“Data”) and
all rights, title and interest in and to such Data shall vest solely with HDL. 
Corgenix agrees to assign, and hereby does assign, all of its rights, title and
interests in and to the Data and further agrees to execute or ensure the
execution of any documents or undertake any further actions if requested by HDL
to evidence transfer to title to such Data.  Corgenix and HDL further agree to
maintain records and Data during and after the term or early termination of this
Agreement in compliance with all Applicable Laws but in no event for less than
five (5) years following expiration or termination of this Agreement.

 

Section 4.4                                   Corgenix Background Intellectual
Property.  Corgenix shall exclusively own and retain all right, title and
interest, including all Intellectual Property Rights, in and to all technology,
information, materials, know-how, trade secrets, documents, designs, systems,
processes, methods and inventions that are:  (i) owned by Corgenix or licensed
to it by a third party prior to the Effective Date; or (ii) developed by or on
behalf of Corgenix (alone or jointly with another person) independent from, and
that is not created either directly or indirectly in connection with, this
Agreement (collectively, the “Corgenix Background Intellectual Property”).

 

Section 4.5                                   HDL Background Intellectual
Property. HDL shall exclusively own and retain all right, title and interest,
including all Intellectual Property Rights, in and to all technology,
information, materials, know-how, trade secrets, documents, designs, systems,
processes, methods and inventions that are:  (A) owned by HDL or licensed to HDL
by a third party prior to the Effective Date; or (B) developed by or on behalf
of HDL (alone or jointly with another person) independent from, and that is not
created directly or indirectly in connection with, this Agreement (collectively,
the “HDL Background Intellectual Property”).

 

Section 4.6                                   Program Intellectual Property.
“Program Intellectual Property” shall be defined collectively as:

 

(i)                                    (a) all research, records, information,
reports, studies, research, notes, correspondence, analysis, ideas, formulae,
algorithms, concepts, innovations, inventions or know-how, specifications,
designs, plans, drawings, systems, processes, methodologies, techniques, flow
charts, documents, materials, technology, prototypes, business or strategic
plans, business rules, administrative and operational requirements, intellectual
property, works in any media, trade secrets, materials, trade-

 

7

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

 

marks, logos, names, brand indicia, goodwill, patents, copyright, property or
proprietary interests and other materials however embodied or the expression of
such ideas, formulae, algorithms, concepts or inventions, that are invented,
conceived, created, produced or otherwise authored by whether separately or
jointly, in any connection with this Agreement (“Deliverable”) and all
Customizations of any Deliverables made by either Party during the term of this
Agreement; and

 

(ii)                                (b) all Confidential Information, Research
Records, patent applications, intellectual property, applications to any
Government Authority, data, records, files, computer files, information,
studies, research, notes, correspondence, analysis, memoranda, drawings,
innovations, processes, methods, systems, written materials, diagrams, drawings,
trade-marks, logos, names, brand indicia, goodwill, business information,
customer information, marketing materials, customer files, business information,
proposals, employee information, accounting information, trade secrets and other
material that is related to, or that is provided by, HDL or otherwise made
available to, or collected by, Corgenix in connection with this Agreement,
including the provision and performance of any Obligations.

 

For purposes of clarity, Program Intellectual Property shall not include any
improvement to process or method developed, created or invented by HDL in
connection with HDL’s use of the Corgenix Manufactured Reagents so long as such
improvement is not imbedded in the underlying technology of the any of the
Corgenix Manufactured Reagents.

 

Section 4.7                                   Rights in Program Intellectual
Property. Subject to each party’s rights in its Background Intellectual Property
as defined in Sections 4.4 and 4.5 above and subject to the terms and conditions
of any third party license agreement to Corgenix or HDL for any intellectual
property which may be embodied in the Deliverable, the Program Intellectual
Property shall be equally co-owned by Corgenix and HDL.

 

Section 4.8                                   Grants of Licenses by HDL to
Corgenix.  Subject to the terms and conditions of this Agreement, HDL grants to
Corgenix during the Term, a fully paid-up, royalty-free, non-exclusive,
revocable license to use, copy and create Customizations from HDL Background
Intellectual Property, solely and strictly as necessary for the purpose of
fulfilling the Obligations under this Agreement.

 

Section 4.9                                   Grants of Rights by Corgenix to
HDL.  Corgenix, hereby grants to HDL fully paid-up, royalty-free, non-exclusive
(except to the extent provided in Section 7.3), non-transferrable rights in the
Territory to use and copy any Corgenix Background Intellectual Property, as the
case may be, that is:  (i) used in providing the Obligations; (ii) is
necessarily required for the proper functioning of any Program Intellectual
Property; or (iii) is embedded into any Deliverable.  Corgenix hereby represents
and covenants that it has or will obtain all rights to such Corgenix
Intellectual Property, as the case may be, so as to give effect to this
Section 4.9 Corgenix shall notify HDL immediately in the event (a) of any change
to or loss of Corgenix’s rights to Corgenix Background Intellectual Property or
(b) Corgenix receives any notice or has knowledge of any third party challenge
to the Corgenix Background Intellectual Property or that the Corgenix Background
Intellectual Property infringes on the rights of any third party.

 

ARTICLE 5
COMPENSATION

 

Section 5.1                                   Royalties and Compensation.

 

(a)                                 Subject to terms of this Agreement, in
exchange for the Corgenix Manufactured Reagents, HDL shall pay to Corgenix in
accordance with the terms set forth on Exhibit B:

 

8

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

 

(b)                                 The amount as described in Exhibit B is the
full and complete consideration for all Obligations performed.

 

Section 5.2                                   Payment Method.  All amounts due
to Corgenix hereunder (including royalty payments) will be paid in United States
Dollars by wire transfer in immediately available funds to an account designated
by Corgenix.  Any amount owed under this Agreement that is not paid within the
applicable time period set forth herein shall accrue interest at an annual rate
equal to two percent (2%).

 

Section 5.3                                   Payment Schedules; Reports. 
During the Phase I Exclusive Period, HDL shall be invoiced with each shipment of
Corgenix Manufactured Reagents with payment due Net 30 days. Beginning with the
Phase II Exclusive Period, HDL shall provide to Corgenix an accounting of the
aggregate Reported Tests on a calendar monthly basis within thirty (30) days
after the end of such month.  Except to the extent the payment hereunder is
under review pursuant to Section 5.5, the payments due pursuant to this
ARTICLE 5 are due and payable within thirty (30) days after the end of each
calendar month.

 

Section 5.4                                   Taxes.  Corgenix will be
responsible for any and all income or other taxes owed by Corgenix and required
by Applicable Law to be withheld or deducted from any of the royalty and other
payments made by or on behalf of HDL to Corgenix hereunder.

 

Section 5.5                                   Records Retention; Audit and
Certification.

 

(a)                                 Record Retention.  HDL will maintain
complete and accurate books, records and accounts relevant for the calculation
of aggregate Reported Tests for each quarter, and any other amounts payable to
Corgenix hereunder, in sufficient detail to confirm the accuracy of any payments
required under this Agreement, which books, records and accounts will be
retained by HDL for two (2) years after the end of the period to which such
books, records and accounts pertain, or longer as is required by Applicable Law.

 

(b)                                 Audit.  In the event Corgenix disputes the
aggregate Reported Test calculation for any calendar quarter, Corgenix shall
provide HDL with written notice of objection within sixty (60) days after the
end of the applicable quarter.  If the Parties cannot resolve the dispute within
fifteen (15) days of HDL’s receipt of such objection notice, Corgenix will have
the right to have an independent certified public accountant have access during
normal business hours, upon reasonable prior written notice to verify the
accuracy of the calculation of amounts payable hereunder.  Results of such
inspections shall be made available to HDL and, unless contested by HDL within
forty-five (45) days of its receipt of such results, shall be final and binding
on the Parties.

 

(c)                                  Payment of Additional Amounts.  If, based
on the results of any audit, additional payments are owed to Corgenix under this
Agreement, then HDL will make such additional payments within ten (10) business
days after HDL receives the accounting firm’s written report unless HDL contests
such report, in which case the Parties shall follow the dispute resolution
procedures described in ARTICLE 10.  In the latter event, HDL shall pay any
amount ultimately found due within ten (10) business days after resolution of
the dispute.

 

(d)                                 Confidentiality.  All information that is
shared in connection with any audit under this Section 5.5 shall be treated by
the Parties in accordance with the provisions of ARTICLE 6.

 

9

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

 

ARTICLE 6
CONFIDENTIALITY

 

Section 6.1                                   Acknowledgement.  The Recipient
acknowledges that the Confidential Information is:  (i) secret, privileged,
proprietary, and confidential; (ii) the exclusive property of the Discloser; and
(iii) only being made available to the Recipient for the limited purposes of
this Agreement and for no other purpose.

 

Section 6.2                                   Confidentiality Obligations.  The
Recipient agrees:  (a) to hold the Confidential Information secret and in strict
confidence at all times; (b) use reasonable efforts to protect the Confidential
Information from any unauthorized access, harm, tampering, exploitation,
manipulation, modification, interference, misuse, misappropriation, copying or
disclosure whatsoever; (c) not to disclose such Confidential Information in its
original form, or by way of summary or analysis, to any Person; (d) not to make
paper, electronic or other copies of any materials other than as reasonably
necessary for the purposes of exercising its rights and obligations under this
Agreement; (e) to use the Confidential Information only for the purposes of
carrying out its rights and obligations under this Agreement; and (f) not to use
the Confidential Information for any purpose other than as permitted under the
terms of this Agreement.

 

Section 6.3                                   Irreparable Harm.  The Recipient
agrees that disclosure of the Confidential Information, whether in its original
form or by way of summary or analysis, by the Recipient, or by any
representative of the Recipient, to any Person could cause the Discloser
irreparable harm and damage.

 

Section 6.4                                   Permitted Disclosure.  The
Recipient may disclose such of the Confidential Information to such of the
Recipient’s affiliates and representatives as require access to such information
for purposes of this Agreement only, provided that the Recipient shall only
disclose such of the Confidential Information as needs to be disclosed to an
affiliate or representative for such purposes, and provided that each such
affiliate or representative agrees in writing to keep such information
confidential pursuant to the terms of this Agreement.  The Recipient agrees to
be responsible for the undertakings and obligations of confidentiality of its
affiliates and representatives to keep all information confidential under this
Agreement.

 

Section 6.5                                   Return of Confidential
Information.  Upon termination or expiration of this Agreement, or upon the
Discloser’s request at any time:  (a) the Recipient shall cease all use of the
Confidential Information; (b) the Recipient shall promptly return to the
Discloser all tangible Confidential Information of the Discloser, including all
copies, reproductions, summaries, memos, correspondence, compilations and all
other tangible materials, and shall promptly destroy all non-tangible
Confidential Information and electronic and other non-tangible copies of
materials bearing Confidential Information, so that it no longer has any
Confidential Information in its possession or under its control in any format
whatsoever, including electronic and paper formats; and (c) the Recipient shall
certify in writing to the Discloser by an authorized officer that it has
returned all tangible Confidential Information and copies of materials bearing
Confidential Information, it has promptly destroyed all electronic and other
non-tangible Confidential Information and copies of materials bearing
Confidential Information, and it no longer has any Confidential Information in
it possession or under its control in any format whatsoever.

 

Section 6.6                                   Equitable Relief.  Each of the
Parties acknowledges that in the event of a breach by a Party of the
confidentiality obligations of this ARTICLE 6, the harm suffered by the
Discloser may not be compensable by monetary damages alone and, accordingly,
that the Discloser may, in addition to other available legal or equitable
remedies, be entitled to the issuance of immediate injunctive relief, specific
performance and any other remedies in law or equity for such breach or
threatened breach of the Recipient’s obligations hereunder.

 

10

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

 

ARTICLE 7
WARRANTIES

 

Section 7.1                                   Mutual Representations and
Warranties.  Without limiting any other representations, warranties or covenants
set out herein, the Parties each represent, warrant and covenant to the other,
as of the Effective Date, as follows:

 

(a)                                 they are each duly organized and in good
standing in their respective jurisdiction of organization and have the full
power, authority and right to enter into and deliver this Agreement and to
perform their respective obligations hereunder;

 

(b)                                 they each satisfy all statutory conditions
and have obtained all required licenses, registrations, authorizations,
consents, approvals and permits that they each have to obtain from any Person in
connection with their performance of this Agreement, and, to their respective
knowledge, each is otherwise in full compliance with all Applicable Laws;

 

(c)                                  they each have duly and properly executed
and delivered this Agreement, and this Agreement constitutes a legal, valid and
binding obligation that is enforceable in accordance with its terms;

 

(d)                                 each Party has general knowledge of, and
familiarity with, the prohibitions, restrictions and requirements of laws
concerning this Agreement and the respective Party has not violated such laws in
any material respects; and

 

(e)                                  performance of their respective obligations
under this Agreement will not interfere with, limit, contravene, detrimentally
affect, infringe, breach or otherwise violate any rights, agreement and
covenants with any other Person, including any contractual restrictive covenants
or intellectual property licenses.

 

Section 7.2                                   Additional Representations and
Warranties of Corgenix.  To the best of its knowledge, Corgenix hereby
represents, warrants and covenants as follows:

 

(a)                                 its performance of this Agreement, including
the provision and performance of all Obligations, does not infringe the
Intellectual Property Rights of any Third Person;

 

(b)                                 it has and shall have the right and
authority to use Corgenix Intellectual Property, to provide Obligations during
the Term and to grant to HDL the licenses and rights in its Corgenix
Intellectual Property, as described herein.  No use by HDL of any Obligations,
Deliverables or Corgenix Intellectual Property, respectively in connection with
this Agreement, shall infringe the Intellectual Property Rights of a third
party;

 

(c)                                  no third party, affiliate, research
institution, academic institution, commercial enterprise or other party has or
shall have any right or interest to, as a result of the performance and
provision of Corgenix’s Obligations, the subject matter of this Agreement,
including HDL Background Intellectual Property;

 

(d)                                 there is no action, suit, claim,
investigation or legal proceeding currently pending or, to the best of
Corgenix’s knowledge, currently threatened, against it, which when decided
would, or would likely, interfere with, limit or to any extent adversely affect
HDL’s use of HDL Background Intellectual Property;

 

11

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

 

(e)                                  it satisfies all statutory conditions in
all material respects and has obtained all required licenses, consents,
approvals, permits, registrations and authorizations from any Person in
connection with its performance of this Agreement; and

 

(f)                                   it shall have available to it at all times
the equipment, technology and resources to enable it to properly and adequately
provide the Obligations to HDL.

 

Section 7.3                                   Restrictive Covenants.

 

(a)                                 Competitive Restrictions.  During the
Restricted Period, Corgenix agrees that it shall not anywhere in the Territory:

 

(i)                                    provide or perform services, research,
consultations or advice to any other third party related to the creation and/or
validation of a laboratory developed test or product which would directly
compete with the Assay; or

 

(ii)                                provide or perform services or research,
collaborate with any other third party or enter into any arrangement, whereby
such provision or performance of services or research, such collaboration or
such entering into any arrangement shall commercially compete with the Program
Intellectual Property directly related to the creation and/or validation of the
Assay; or

 

(iii)                            directly or indirectly sell, convey, or
otherwise transfer the Corgenix Manufactured Reagents to any competitor of HDL
or to any party that offers diagnostic laboratory testing relating to cardiac
disease.

 

(b)                                 Notwithstanding the foregoing, Corgenix
shall during the Restricted Period retain the rights to (i) use the Program
Intellectual Property, including all Corgenix Manufactured Reagents for purposes
of internal research and FDA filings (including, without limitation, performing
clinical trials with third parties for purposes of submitting data to the FDA)
and (ii) market and sell the Program Intellectual Property, including all
Corgenix Manufactured Reagents to research institutions that do not market or
use the Program Intellectual Property, including the Corgenix Manufactured
Reagents for profit or clinical diagnostic purposes.

 

(c)                                  All Parties agree and acknowledge that
Section 7.3(a) is fair and reasonable in the commercial circumstances of this
Agreement and that each Party’s agreement in Section 7.3(a) has been a material
inducement and promise by each Party upon which the other Parties have relied,
and been induced, to enter into this Agreement.  Without limiting the foregoing,
the Parties hereto agree that the character, duration and geographical scope of
the non-compete restrictions outlined in Section 7.3(a) are reasonable and
necessary given the total consideration to be received by Corgenix in connection
with the commercialization of HDL Background Intellectual Property.  If any
restriction set forth in the non-competition section is found by a court of
competent jurisdiction to be invalid or unreasonable, then Corgenix agrees and
hereby submits to the restrictions of such character, duration and geographic
scope as shall be deemed reasonable and necessary to assure HDL of the intended
benefit of Section 7.3(a).

 

(d)                                 Publication Prohibition.  Corgenix shall not
publish articles, present papers or disclose publicly in any manner, the
Obligations, HDL Background Intellectual Property or any research, findings,
results or discoveries concerning the performance of this Agreement except: 
(i) in collaboration with HDL; and (ii) with the prior written approval of HDL,
which approval shall not be unreasonably withheld.

 

12

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

 

Section 7.4                                   Disclaimer of Warranties.  EXCEPT
FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, NO PARTY MAKES ANY
REPRESENTATIONS OR GRANTS ANY WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY
OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS
ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR
PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE
NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 8
RISK MANAGEMENT

 

Section 8.1                                   Indemnification by Corgenix. 
Corgenix shall defend, indemnify and hold harmless HDL and its affiliates and
its officers, directors, shareholders, employees, agents, representatives,
successors and assigns from and against all charges, complaints, actions, suits,
proceedings, hearings, investigations, claims, demands, judgments, orders,
decrees, stipulations or injunctions of third parties (each a “Third Party
Claim”), and all associated damages, deficiencies, defaults, awards, settlement
amounts, assessments, fines, dues, penalties, costs, liabilities, obligations,
taxes, liens, losses, fees and expenses (including, without limitation, court
costs, interest and reasonable fees of attorneys, accountants and other experts)
(“Losses”), to the extent incurred or suffered by any of them to the extent
resulting from or arising out of:  (i) any negligent act or omission or willful
misconduct by Corgenix or (ii) any breach of any covenant, obligation,
representation or warranty of Corgenix under this Agreement.

 

Section 8.2                                   Indemnification by HDL.  HDL shall
defend, indemnify, and hold harmless Corgenix and its affiliates and their
respective officers, directors, shareholders, employees, agents,
representatives, successors and assigns from and against all Third Party Claims
(as defined in Section 8.1 above), and all associated Losses (as defined in
Section 8.1 above), to the extent incurred or suffered by any of them to the
extent resulting from or arising out of (i) any negligent act or omission or
willful misconduct by HDL or (ii) any breach of any covenant, obligation,
representation or warranty of HDL under this Agreement.

 

Section 8.3                                   Limitation of Liability.  IN NO
EVENT WILL A PARTY BE LIABLE FOR LOST PROFITS OR FOR ANY
SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER
CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION
AND ARISING IN ANY WAY OUT OF THIS AGREEMENT.  THE FOREGOING LIMITATIONS WILL
NOT LIMIT A PARTY’S OBLIGATIONS UNDER SECTION 8.1 OR SECTION 8.2 OR FOR BREACHES
OF CONFIDENTIALITY.

 

ARTICLE 9
TERM AND TERMINATION

 

Section 9.1                                   Term.  This Agreement shall
commence on the Effective Date and shall continue until expiration of the
Restricted Period, unless terminated as provided herein (the “Initial Term”,
together with any extension of the Initial Term, collectively, the “Term”). 
This Agreement shall automatically renew for additional one year terms unless
either Party provides the other Party with written notice of termination at
least ninety (90) days prior to expiration of the then current Term.

 

Section 9.2                                   Termination for Insolvency.  A
Party shall have the right to terminate this Agreement immediately upon written
notice to the other Party if, and upon the occurrence, of:  (a) an

 

13

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

 

admission in writing of inability to pay debts generally as they become due, or
makes a general assignment for the benefit of creditors, or a receiver, manager,
administrator, administrative receiver, receiver and manager, trustee, custodian
or other similar official or any other like Person is appointed by or on behalf
of or at the instance of a creditor of the other Party; (b) if any execution,
sequestration, extent or other process of any court becomes enforceable or if a
distress or analogous process is levied against any property that materially
adversely affects such Party’s ability to perform this Agreement; or (c) such
Party shall suffer any event, or any event or set of circumstances occurs or
comes about, analogous to clause (a) or (b) events.

 

Section 9.3                                   Breach.  A Party may, without
prejudice to any other remedies available to it at law or in equity, terminate
this Agreement in the event that the other Party (the “Breaching Party”) shall
have materially breached or defaulted in the performance of any of its
obligations hereunder.  The Breaching Party shall have sixty (60) days after
written notice thereof was provided to the Breaching Party by the non-breaching
Party to remedy such breach or default, if it is capable of being cured.  If the
breach or default is incapable of cure, the Parties may, in good faith, enter
into discussions to implement a solution without terminating this Agreement. 
Any such termination shall become effective at the end of such sixty (60) day
period unless the Breaching Party has cured any such breach or default prior to
the expiration of such sixty (60) day period or unless the Breaching Party has
invoked the dispute resolution procedures of ARTICLE 10.  In the latter event,
termination may occur if the Breaching Party fails to cure a material breach
within sixty (60) days after a disposition of the dispute in which such material
breach was found.

 

Section 9.4                                   Termination for Viability
Reasons.  HDL may terminate this Agreement, if, in its sole and absolute
opinion, acting reasonably, HDL determines that there is a safety or efficacy
reason to cease the development and/or commercialization of the Assay or there
is no reasonable prospect of the Assay being commercialized.

 

Section 9.5                                   Termination for failure to agree
on Exhibit A.  In the event the Parties cannot agree on the terms of Exhibit A
within sixty (60) days after the Effective Date, either Party may terminate this
Agreement by providing written notice to the other Party.

 

Section 9.6                                   Effects of Termination.

 

(a)                                 Remedies Not Exhaustive.  Except as
expressly provided in this Agreement, all duties, obligations, rights and
remedies described in this Agreement shall be in addition to and not in
limitation of any available remedy under Applicable Laws.  All remedies shall be
cumulative.

 

(b)                                 Equitable Relief.  The Parties agree and
acknowledge that any material breach by any Party of this Agreement, or any
Obligations and, in particular, any breach of Section 5.1 or any of the
obligations of confidentiality may result in immediate and irreparable harm and
damage to the non-breaching Party for which monetary damages alone will not
fairly or adequately compensate the non-breaching Party or otherwise remedy such
breach.  Accordingly, the non-breaching Party may be entitled to equitable
relief or remedy associated with any such breach of this Agreement.

 

(c)                                  Survival.  The following Articles and
Sections, together with any definitions used or exhibits referenced therein,
will survive any termination or expiration of this Agreement: Articles 4, 6, and
8.

 

14

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

 

ARTICLE 10
DISPUTE RESOLUTION

 

Section 10.1                            Dispute Resolution.

 

(a)                                 Confidentiality. All disputes or
disagreements between the Parties concerning any aspect of this Agreement,
including any obligation of the Parties (“Dispute”), shall be held in strict
confidence between the Parties.

 

(b)                                 Expert Assistance.  Each Party shall have
the right to retain and secure expert assistance and advice concerning its
interests and efforts to resolve any Dispute at such Party’s sole and absolute
cost and expense.

 

(c)                                  Internal Dispute Resolution.  If a Dispute
arises, the Parties shall meet on a without prejudice basis (as quickly as
reasonably practical having regard to the nature, complexity, and impact of the
Dispute) to attempt to resolve the Dispute or to negotiate for an adjustment to
any provision of this Agreement.  Each Party acknowledges that it is in its
interest to have all matters resolved by mutual agreement and each agrees to act
expeditiously, reasonably, and in good faith, to permit and encourage the
resolution of such Dispute. If the Parties are not able to resolve any Dispute
referred to them within thirty (30) business days after such referral to them,
then each Party may pursue other appropriate legal proceedings.

 

Section 10.2                            [Intentionally Omitted]

 

Section 10.3                            [Intentionally Omitted]

 

Section 10.4                            No Suspension of Obligations. 
Notwithstanding anything to the contrary contained herein, if any Dispute arises
between the Parties (whether or not related to Compensation), in no event shall
a Party alter, suspend or otherwise interrupt the provision and performance of
any Obligations, or undertake any act or omission that interferes with, delays,
changes, prevents, impedes or reduces in any way the provision and performance
of Obligations or the ability of either party to conduct its business and
operational activities, unless authority to do so is expressly granted or
ordered by a court of competent jurisdiction.

 

ARTICLE 11
GENERAL

 

Section 11.1                            Notification. All notices, requests and
other communications hereunder shall be in writing, shall be addressed to the
receiving Party’s address set forth below or to such other address as a Party
may designate by notice hereunder, and shall be either (i) delivered by hand,
(ii) delivered in portable document format via electronic mail, (iii) made by
facsimile transmission (to be followed with written confirmation by the
delivering Party), (iv) sent by private courier service providing evidence of
receipt, or (v) sent by registered or certified mail, return receipt requested,
postage prepaid.  The addresses and other contact information for the Parties
are as follows:

 

If to HDL:

Health Diagnostic Laboratory, Inc.
737 N 5th Street, Suite 103
Richmond, VA 23219
Attn: Tonya Mallory, President and CEO
Facsimile: 804-343-2704
Email: tmallory@hdlabinc.com

 

15

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

 

 

With a copy to :
Health Diagnostic Laboratory, Inc.
737 N 5th Street, Suite 103
Richmond, VA 23219
Attn: General Counsel
Email: Generalcounsel@hdlabinc.com

 

 

If to Corgenix:

Corgenix, Inc.
11575 Main Street, Suite 400
Broomfield CO 80020
Attn: Douglass Simpson, President and CEO
Facsimile: 303-453-8896
Email: dsimpson@corgenix.com

With a copy to:
HuschBlackwell, LLP
1700 Lincoln Street, Suite 4700
Denver, Colorado 80203
Attn: Glenn Lenzen
Facsimile: 303-749-7272
Email: glenn.lenzen@huschblackwell.com

 

All notices, requests and other communications hereunder shall be deemed to have
been given either (i) if by hand, at the time of the delivery thereof to the
receiving Party at the address of such Party set forth above, (ii) if made in
portable document format via electronic mail, at the time of receipt, (iii) if
made by facsimile transmission, at the time that receipt thereof has been
acknowledged by the recipient, (iv) if sent by private courier, on the day such
notice is delivered to the recipient, or (v) if sent by registered or certified
mail, on the fifth (5th) business day following the day such mailing is made.

 

Section 11.2                            Language.  This Agreement has been
prepared in the English language and the English language shall control its
interpretation.

 

Section 11.3                            Governing Law.  This Agreement shall be
construed under the laws of the Commonwealth of Virginia, excluding its body of
law controlling conflicts of law.

 

Section 11.4                            Entire Agreement.  This Agreement is the
entire agreement between the Parties with respect to the subject matter hereof
and supersedes all prior representations, understandings and agreements between
the Parties with respect to the subject matter hereof.

 

Section 11.5                            Amendment.  No modification to this
Agreement shall be effective unless in writing with specific reference to this
Agreement and signed by the Parties.

 

Section 11.6                            Waiver.  The terms or conditions of this
Agreement may be waived only by a written instrument executed by the Party
waiving compliance.  The failure of either Party at any time or times to require
performance of any provision hereof shall in no manner affect its rights at a
later time to enforce the same.  No waiver by either Party of any condition or
term shall be deemed as a continuing waiver of such condition or term or of
another condition or term.  Time shall be of the essence of this

 

16

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

 

Agreement and of every part hereof and no extension or variation of this
Agreement shall operate as a waiver of this provision.

 

Section 11.7                            Headings.  Section and subsection
headings are inserted for convenience of reference only and do not form part of
this Agreement.

 

Section 11.8                            Assignment.  No Party may transfer or
assign or otherwise encumber this Agreement to any Third Party without the
written consent of the other Party; provided, however, that either Party may
assign, transfer or otherwise encumber this Agreement, without the consent of
other Party, in connection with a sale of all or substantially all of the assets
to which this Agreement relates, whether by merger, sale, assignment, transfer,
operation of law or change of control.  The provisions of this Agreement shall
be binding upon and inure to the benefit of the Parties and their respective
successors and assigns.

 

Section 11.9                            Construction.  The Parties hereto
acknowledge and agree that:  (i) each Party and its counsel reviewed and
negotiated the terms and provisions of this Agreement and have contributed to
its revision; (ii) the rule of construction to the effect that any ambiguities
are resolved against the drafting Party shall not be employed in the
interpretation of this Agreement; and (iii) the terms and provisions of this
Agreement shall be construed fairly as to all Parties hereto and not in favor of
or against any Party, regardless of which Party was generally responsible for
the preparation of this Agreement.

 

Section 11.10                     Severability.  If any provision(s) of this
Agreement are or become invalid, are ruled illegal by any court of competent
jurisdiction or are deemed unenforceable under Applicable Law from time to time
in effect, it is the intention of the Parties that the remainder of this
Agreement shall not be affected thereby provided that a Party’s rights under
this Agreement are not materially affected.  The Parties hereto covenant and
agree to renegotiate any such term, covenant or application thereof in good
faith in order to provide a reasonably acceptable alternative to the term,
covenant or condition of this Agreement or the application thereof that is
invalid, illegal or unenforceable, it being the intent of the Parties that the
basic purposes of this Agreement are to be effectuated.

 

Section 11.11                     Status.  Nothing in this Agreement is intended
or shall be deemed to constitute a partner, agency, employer-employee, or joint
venture relationship between the Parties.

 

Section 11.12                     Further Assurances.  Each Party agrees to
execute, acknowledge and deliver such further instructions, and to do all such
other acts, as may be necessary or appropriate in order to carry out the
purposes and intent of this Agreement.

 

Section 11.13                     Counterparts.  This Agreement may be executed
simultaneously in one or more counterparts (including by facsimile), each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.  This Agreement shall become effective when each
Party shall have received a counterpart hereof signed by the other Party.  Until
and unless each Party has received a counterpart hereof signed by the other
Party, this Agreement shall have no effect and no Party shall have any right or
obligation hereunder (whether by virtue of any other oral or written agreement
or other communication).  No provision of this Agreement is intended to confer
any rights, benefits, remedies, obligations or liabilities hereunder upon any
Person other than the Parties and their respective successors and assigns.

 

17

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

 

[Signature Page Follows]

 

18

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

 

IN WITNESS WHEREOF the Parties hereto have executed this Agreement on the
Effective Date.

 

HEALTH DIAGNOSTIC LABORATORY INC.

 

By:

s/ Tonya Mallory

 

 

 

 

Name:

Tonya Mallory

 

 

 

 

Title:

President and CEO

 

 

 

CORGENIX, INC.

 

 

 

 

By:

s/ Douglass T. Simpson

 

 

 

 

Name:

Douglass T. Simpson

 

 

 

 

Title:

President and CEO

 

 

19

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

 

SCHEDULE A
OBLIGATIONS

 

HDL:

 

1.              Develop specifications for Laboratory Developed Test (LDT).

 

2.              Perform all proficiency, precision, and other validation testing
for the LDT

 

3.              Review and potentially co-author publications

 

4.              Develop and perform the Assay in its laboratories using Corgenix
Manufactured Reagents and HDL Supplied Reagents that meet HDL established
specifications; provided that such Assay is validated by HDL in accordance with
this Agreement

 

Corgenix:

 

1.              Provide technical transfer of biomarker

 

2.              Manufacture Corgenix Manufactured Reagents in accordance with
specifications established by HDL and agreed to by Corgenix

 

3.              Review and potentially co-author publications

 

4.              Provide project administration and management

 

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

 

SCHEDULE B
SCHEDULES AND MILESTONES

 

The Parties agree that the Project Outline may be tweaked or revised after the
Effective Date by mutual agreement of the Parties evidenced by email
confirmation between dsimpson@corgenix.com with a copy to
glenn.lenzen@huschblackwell.com and tmallory@hdlabinc.com, with a copy to
generalcounsel@hdlabinc.com.

 

Project Outline

 

Phase I:  Proof of Concept (4-8 weeks)

 

The purpose of Phase I is to determine the feasibility of HDL building and
optimizing the Assay or verifying certain aspects of the Assay. To the extent
necessary, Corgenix will provide HDL with Corgenix Manufactured Reagents
sufficient to perform applicable testing. The Assay must undergo an initial
round of development by HDL, including optimization and validation.  Phase I is
generally completed and documented as follows:

 

1.              Phase I Meeting

2.              Reagent Acquisition ([*])

3.              Reagent Functionality and Compatibility Testing

a.              [*]

b.              [*]

c.               [*]

4.              Phase I Initial Optimization

a.              [*]

b.              [*]

c.               [*]

d.              [*]

e.               [*]

5.              Phase I Validation Feasibility Testing

a.              [*]

b.              [*]

c.               [*]

6.              Phase I Deliverable(s):

a.              [*]

 

Phase II:  Product Validation (4 weeks)

 

The purpose of Phase II is to finalize the assay protocol and fully validate the
Assay.  To do this, all processes and protocols involved with producing the
Assay go through a final round of optimization, and then reagents for all
validation tests are created (beta production). Phase II is generally completed
as follows:

 

1.              Phase I — II Meeting

2.              Beta test production

3.              Full Validation Testing using beta production assays

a.              [*]

b.              [*]

c.               [*]

d.              [*]

 

CORGENIX MEDICAL CORPORATION HAS REQUESTED THAT THE PORTIONS OF THIS DOCUMENT
DENOTED BY BRACKETS AND ASTERISKS BE ACCORDED CONFIDENTIAL TREATMENT PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

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

 

e.               [*]

f.                [*]

g.               [*]

h.              [*]

4.              Phase II deliverables

a.              [*]

b.              [*]

c.               [*]

d.              [*]

 

CORGENIX MEDICAL CORPORATION HAS REQUESTED THAT THE PORTIONS OF THIS DOCUMENT
DENOTED BY BRACKETS AND ASTERISKS BE ACCORDED CONFIDENTIAL TREATMENT PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

3

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

 

EXHIBIT A

 

CORGENIX MANUFACTURED REAGENTS

 

The Parties agree that the final Exhibit A shall be mutually agreed to by the
Parties evidenced by email confirmation between dsimpson@corgenix.com, with a
copy to glenn.lenzen@huschblackwell.com, and tmallory@hdlabinc.com, with a copy
to generalcounsel@hdlabinc.com

 

Reagent

 

Quantity

 

Packaging

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HDL SUPPLIED REAGENTS

 

Reagent

 

 

4

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

 

EXHIBIT B

 

COST PER TEST AND COST PER REPORTABLE TEST

 

Year 1: $[*]/Test (based on 96 tests per microplate)

Year 2: $[*]/Reported Test

Year 3 and thereafter during the Term: to be negotiated between the parties
based on testing volumes

 

CORGENIX MEDICAL CORPORATION HAS REQUESTED THAT THE PORTIONS OF THIS DOCUMENT
DENOTED BY BRACKETS AND ASTERISKS BE ACCORDED CONFIDENTIAL TREATMENT PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

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