EXHIBIT
10.94
MASTER DEVELOPMENT
AGREEMENT
THIS MASTER DEVELOPMENT AGREEMENT (this “Agreement”) is
made on and effective from this 4 th day of February,
2009 (“Effective Date”), between Guardian Technologies
International Inc., (“Guardian”), a Delaware
corporation having its principal place of business at 516 Herndon
Parkway, Suite A, Herndon, VA, 20170, Aurum
Innova (Pty) Ltd (“Innova”), a South African company
having its principle place of business at The Ridge, 29 Queens
Road, Parktown, Johannesburg, 2001, South Africa. Capitalized
terms used in this Agreement have the meanings given in Section
11.5 or in the context in which the term is used.
1
BACKGROUND
1.1
Guardian owns rights to certain knowledge, trade secrets,
proprietary intellectual property, and patent applications for
image clarification, visualization, and computer-aided-detection
based on its 3i and algorithmic technologies for use in automated
medical applications for clarification, visualization, detection
and quantification and staging of diseases (collectively
“Signature Mapping™”).
1.2
Innova has experience in and own rights to certain know-how and
intellectual property relating to developing country medical needs,
influential contacts, access to funding sources, specialized
clinical knowledge, clinical research, management expertise,
product evaluation capabilities and access to grant development
applicable to the treatment of diseases including tuberculosis
(TB), silicosis and malaria.
1.3
The Parties believe there is a substantial worldwide market
opportunity for products and services aimed at the screening, early
detection and staging of diseases including TB, silicosis and
malaria, and desire to work together to pursue the development of
Signature Mapping™ enabled products for the detection of such
diseases (each, a “Product” and, collectively, the
“Products”).
1.4
The Parties desire to enter into a definitive agreement with
respect to the research, development, and commercialization of the
Products for sale to national, regional, provincial, and municipal
governments as well as private health institutions and
organizations in Africa, and for eventual worldwide market
distribution.
2
PROJECTS
Each Project to be Subject to a Project Specification
. The Parties will enter into separate project specifications
and project plans (each, a “Project Specification”) for
each Product they intend to develop under this Agreement. In
addition, from time to time Innova and Guardian may have
opportunities to collaborate on projects funded by grants that may
be available to either Party. If these opportunities are in
line with Innova’s and Guardian’s overall strategies,
the Parties may enter into a Project Specification under this
Agreement to pursue and exploit those opportunities. Except
as specified in this Agreement or as required to meet statutory or
regulatory requirements, no Project Specification may change the
terms of this Agreement. However, each Project Specification
will specify, to the extent reasonably possible, the details and
goals of the Product development, evaluation and distribution as
set forth in Sections 3 and 4 below. All Project
Specifications must be in the form of the Project Specification for
the TB Product that is attached to this Agreement as Exhibit 1.
No Project Specification will be binding on any Party until
it has been executed by authorized representatives of that Party.
The term “this Agreement” includes any duly
executed Project Specifications, except where the context of the
usage of the term does not permit it to include Project
Specifications.
3
PRODUCT DEVELOPMENT AND EVALUATION.
3.1
Provision of Testable Material
. At its own expense, Innova will establish and determine in
accordance with diagnostic and treatment exigencies, the
presentation criteria and protocols for the collection of, and will
collect “truthed” (positive and negative for the
disease applicable to the Project Specification) project specimens
and deliver digital image samples of those specimens to Guardian.
The digital images must be of sufficient quantity for
Guardian
to perform proof of concept testing showing the ability of the
Signature Mapping™ technology to detect and quantify
automatically the targeted areas of interest in actual samples.
3.2
Proof of Concept Testing
. At its own expense, Guardian will plan, develop and conduct
the proof of concept testing described in Section 3.1. Innova
will, in cooperation with Guardian, provide final approval for
specifications and requirements for each Product to be so tested
pursuant to this Agreement in accordance with the time period
specified in the Project Specification. Innova will cooperate
in such testing as reasonably requested by Guardian. The criteria for determining whether the proof
of concept is successful will be set forth in the Project
Specification.
3.3
Commercial Product Development
.
(a)
Once the concept has been proven as specified in Section 3.2,
Innova will raise the funds specified in the relevant Project
Specification to complete the development of the Product.
Innova will make every reasonable effort to obtain the
necessary funding (whether from grants or other funding sources,
and potentially both from in South Africa and in other countries),
but not be under an obligation to provide the funds themselves.
Guardian will cooperate in the fundraising efforts as reasonably
requested by the Innova, including by providing information in
Guardian’s possession as reasonably requested by Innova.
If Innova is not able to find full funding, Guardian may work
with other organizations to obtain funds; but in such event Innova
will continue to remain committed to the success of the Project and
will continue to provide the other support and meets its other
obligations under this Agreement with respect to the Project in
question . If Innova is not able to obtain full
funding or if the funding is exhausted prior to the completion of
development of the Product, Guardian may elect to terminate the
Project Specification or to proceed with development, in its
discretion.
(b)
The Parties will work together to establish an appropriate
development program for each Product such that the Product may be
made commercially available. Such efforts may include
establishing Product specifications and requirements and developing
and executing clinical Product investigation and validation
programs. Product specifications may include descriptions of
mutually agreed upon Joint Intellectual Property development. Once
the Parties have mutually agreed on the Product development
program, the Parties shall mutually agree upon the sole
responsibility for the Product development.
4
PRODUCT DISTRIBUTION.
4.1
Generally
. Unless otherwise specified in the relevant Project
Specification, the Parties shall be jointly responsible for
identifying and securing distribution for the Products by entering
into contracts with third parties (“Distribution/Value Added
Reseller Agreements”). Innova will cooperate in such
efforts as reasonably requested by Guardian but will not function
as a distributor of the Products unless otherwise specified in a
Project Specification. All Distribution/Value Added Reseller
Agreements will contain Intellectual Property and Confidentiality
provisions at least as protective of the rights of the Parties as
those included in this Agreement. No Distribution/Value Added
Reseller Agreement may preclude Innova from promoting the use and
encouraging the purchase of the Products, nor may any
Distribution/Value Added Reseller Agreement reduce or eliminate the
rights of Innova set forth in Section 4.2.
4.2
Rights of Innova
.
(a)
Guardian will disclose to Innova the value of each
Distribution/Value Added Reseller Agreement entered into for the
Products.
(b)
Innova will be entitled to receive a mutually agreed upon royalty,
on a product by product basis, based on a percentage of the Net
Revenue received by Guardian through the Distribution/Value Added
Reseller Agreements. Such
percentage shall be clearly delineated in the Product
specifications for each product developed.
(c)
If Innova is directly responsible for the sale of a Product to a
customer, Innova will be entitled to receive a mutually agreed upon
additional commission on a product by product basis, based on the
Net Revenue received by Guardian under the sales contract entered
into by such customer. Such percentage shall be clearly
delineated in the Product specifications for each product
developed. This commission percentage will be in addition to the
royalty payable to Innova as provided in Section 4.2(b).
5
WARRANTY AND DISCLAIMER
5.1
Compliance with Laws
. Each Party warrants that it will, at its cost and expense,
obtain all necessary regulatory approvals, licenses, and permits
applicable to its business and comply with all laws applicable to
its business and the performance of its obligations under this
Agreement.
5.2
THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, INTEGRATION,
PERFORMANCE AND ACCURACY AND ANY IMPLIED WARRANTIES ARISING FROM
STATUTE, COURSE OF DEALING, COURSE OF PERFORMANCE OR USAGE OF
TRADE.
6
LIMITATION OF LIABILITY
6.1
General
. If a Party (the “Claiming Party”) should become
entitled to claim damages from another Party (the “Liable
Party”) for any reason (including for breach of contract,
breach of warranty, negligence or other tort claim), the Liable
Party will be liable only for the amount of the Claiming
Party’s actual direct damages up to the amounts paid to
Innova by Guardian under Section 4.2 with respect to the Project
Specification that is the subject of the claim during the eighteen
(18) months prior to the month in which the most recent event
giving rise to liability occurred; or, (ii) in the case of a claim
relating to the Agreement generally, the total amounts paid to
Innova by Guardian under Section 4.2 with respect to all Project
Specification during the eighteen (18) months prior to the month in
which the most recent event giving rise to liability occurred.
In no event, however, will a Party be liable to all the other
Parties (in the aggregate for all claims made with respect to this
Agreement) for more than the total amounts paid to Innova by
Guardian under Section 4.2. These limits also apply to
Consultant’s subcontractors. They are the maximum
liability for which Consultant and its subcontractors are
collectively responsible.
6.2
Exclusions of Damages
. In no event will a Party be liable for: (i) any
damages arising out of or related to the failure of another Party
or its Affiliates to perform their responsibilities; (ii) any
claims or demands of third parties; or (iii) any lost profits,
loss of business, loss of data, loss of use, lost savings or other
consequential, special, incidental, indirect, exemplary or punitive
damages, even if the Party has been advised of the possibility of
such damages. No Party will not be held responsible, or to
have failed to meet its obligations under this Agreement, if it
either delays performance or fails to perform as a result of any
cause beyond its reasonable control.
6.3
Exceptions
. The limitations and exclusions of liability set forth in
Sections 6.1 and 6.2 will not apply with respect to any of the
following: (i) damages attributable to the intentional torts,
unlawful conduct or gross negligence of a Party; (ii) claims
that are the subject of indemnification pursuant to Section 6;
(iii) damages attributable to a Party’s breach of its
obligations with respect to Confidential Information of another
Party; or (iv) damages attributable to a Party’s breach
of its obligations with respect to Intellectual Property of another
Party.
7
INDEMNITIES
7.1
Indemnity by Guardian
. Guardian will defend, indemnify and hold Innova (and their
Affiliates, officers, directors, employees, agents and
representatives) harmless from any and all third party claims,
demands, liabilities, actions, suits, proceedings, losses, damages,
judgments, expenses and/or costs (including actual attorneys’
fees and related costs) (collectively, “Claims”) based
on or arising out of: (i) a breach by Guardian of any of the terms
and conditions of this Agreement; or (ii) any Claim that any
Guardian Intellectual Property infringes upon or violates any
patent, copyright, trade secret, trade name or trademark, or any
other proprietary right of any person not a party to this
Agreement.
7.2
Indemnity by Innova
. Innova will defend, indemnify and hold Guardian (and its
Affiliates, officers, directors, employees, agents and
representatives) harmless from any and all Claims based on or
arising out of: (i) a breach by Innova of any of the terms and
conditions of this Agreement; or (ii) any Claim that any Innova
Intellectual Property infringes upon or violates any patent,
copyright, trade secret, trade name or trademark, or any other
proprietary right of any person not a party to this
Agreement.
7.3
Indemnification Procedures
. Each
Party’s indemnification obligation in this Article 7 is conditioned on the indemnitee(s) cooperating
fully in all respects in defense of the Claim, providing prompt
notification of the Claim, and mitigating any actual or potential
damages to the extent reasonably warranted after receiving notice
of the Claim. Each Party also represents and warrants to the
other that it is not aware of any Claim subject to this Article
7 as of the Effective Date.
8
CONFIDENTIALITY.
8.1
Confidential Information
. “Confidential Information” means any
information disclosed by any Party in writing, orally or by
inspection of tangible objects (including information exchanged in
contemplation of entering into this Agreement): (i) in
tangible form and marked or designated in writing in a manner to
indicate it is confidential or a trade secret; or (ii) in
intangible form and that either is of a nature that a reasonable
person would understand to be confidential or a trade secret or is
identified as confidential or a trade secret in a writing provided
to the receiving party within thirty (30) business days after
disclosure. Confidential Information will not, however,
include any information that (i) was publicly known and made
generally available in the public domain prior to the time of
disclosure by the disclosing Party; (ii) becomes publicly known
through no action or inaction of the receiving Party; (iii) is
already in the possession of the receiving Party without obligation
of confidentiality at the time of disclosure by the disclosing
Party; (iv) is obtained by the receiving Party from a third party
without obligation of confidentiality;or (v) is independently
developed by the receiving Party without use of or reference to the
disclosing Party's Confidential Information.
8.2
Nondisclosure
. Confidential Information will remain the property of the
furnishing Party, and the receiving Party will not be deemed by
virtue of this Agreement or any access to the furnishing
Party’s Confidential Information to have acquired any right,
title or interest in or to the Confidential Information. The
receiving Party agrees: (i) to hold the furnishing
Party’s Confidential Information in strict confidence
affording the furnishing Party’s Confidential Information at
least the same level of protection against unauthorized disclosure
or use as the receiving Party normally uses to protect its own
information of a similar character, but in no event less than
reasonable care; (ii) to limit disclosure of the furnishing
Party’s Confidential Information to personnel having a need
to know the information for the purposes of this Agreement; (iii)
not to disclose any such Confidential Information to any third
party; (iv) to use the furnishing Party’s Confidential
Information solely and exclusively in accordance with the terms of
this Agreement in order to carry out its obligations and exercise
its rights under this Agreement; and (v) to notify the
furnishing Party promptly of any unauthorized use or disclosure of
the furnishing Party’s Confidential Information and cooperate
with and assist the furnishing party in every reasonable way to
stop or minimize such unauthorized use or disclosure.
8.3
Compelled Disclosure
. If the receiving Party receives a subpoena or other valid
administrative or judicial notice requesting the disclosure of the
furnishing Party’s Confidential Information, the receiving
Party will promptly notify the furnishing Party. If
requested, the receiving Party will provide reasonable cooperation
to the furnishing Party in resisting or limiting the disclosure at
the furnishing Party’s expense. Subject to its
obligations stated in the preceding sentence, the receiving Party
may comply with any binding subpoena or other process to the extent
required by law, but will in doing so make every effort to secure
confidential treatment of any materials disclosed.
8.4
Return or Destruction
. Upon termination or expiration of this Agreement, the
receiving Party, at the furnishing Party’s option, will
return or destroy all Confidential In