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COLLABORATION
AND STRATEGIC
ALLIANCE AGREEMENT
This Collaboration and Strategic Alliance Agreement
(this “Agreement”) is entered into as of March 23,
2007, by and between Guardian Technologies International, Inc., a
Delaware corporation (“Guardian”), and Confirma Inc., a
Washington state corporation (“Confirma”).
RECITALS
WHEREAS, Guardian owns rights to certain
know-how, trade secrets, proprietary intellectual property, and
patent applications relating to image clarification,
visualization, and computer-aided-detection (“CAD”)
in image processing, based on its 3i Signature Mapping
TM algorithmic technology for clarification,
visualization and detection of a variety of uses including, but
not limited to, medical imaging modalities.
WHEREAS, Confirma owns rights to certain
know-how, trade secrets, proprietary intellectual property,
patents and patent applications relating to medical image
processing, visualization, and CAD. Confirma is also a leader in
the development, and marketing of CAD systems and accessories
for magnetic resonance imaging (“MRI”) in medical
imagery and wishes to expand its markets and products clinical
applications.
WHEREAS, Confirma and Guardian wish to
enter into this Agreement in order to conduct collaborative
research towards development of advanced, industry leading
product/products for the analysis and detection of medical
conditions across a variety of clinical applications by taking
advantage of the respective technologies and other resources and
assets of Confirma and Guardian, on the terms and subject to the
conditions of this Agreement.
NOW, THEREFORE, in consideration of the
terms and conditions contained herein, and for other valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties agree as follows.
AGREEMENT
I
.
Definitions
A.
“Affiliate” means any person, directly or indirectly,
controlling, controlled by or under common control with any other
person. “Control” shall mean the direct or indirect
ownership of 50% or more of the voting interest in, or 50% or more
of the interest in the income of, such other person, or the ability
to appoint, elect or direct at least 50% of the governing body of
any such person.
B.
“Alliance Coordinator” means the person designated by a
Party pursuant to Section III(
e) of this Agreement, to be the primary contact person for such
Party for purposes of this Agreement.
C.
“FDA” means the United States Food and Drug
Administration, and any successor entity that may be established
hereafter which has substantially the same authority or
responsibility currently vested in the United States Food and Drug
Administration.
D. “Governing Rules” means the general guidelines
established by the Managing Committee pursuant to Section
III (d) of this Agreement,
which will be used to guide generally the activities of the
Managing Committee and the Parties which are undertaken pursuant to
this Agreement.
E. “Implementation Strategy” means the comprehensive
approach and strategy, which is developed by the Managing Committee
with respect to the development and implementation of business
activities under this Agreement. The Implementation Strategy shall
generally relate to the delivery of medical imaging products and
technologies by Confirma and Guardian, which imaging products and
technologies incorporate into Confirma Products and Guardian
3i image processing technologies,
F.
“ 3i technology” means an interconnected set of
digital image and data processing methodologies, including but not
limited to methodologies that encompass three domains common to
imaging informatics: image processing, data mining, and rules
generation through machine learning that enables automatic
detection and decision-making. In the image processing domain, a
component called Signature Mapping is used, which is a dynamic and
iterative process, in which specifically designed algorithms impact
image pixels that represent the target material in a way that
causes these groups of related pixels to react in a unique
collective way. This response-based reaction generates new groups
of self classifying pixel features that result in a unique set of
signatures for each material. The resulting “signature
mapped” data, enables the implementation of a rich set of
imaging tools that provide new clinical approaches to imaging (that
can be used in medicine). These include image clarification and
visualization, feature extraction, tissue characterization and
quantification, disease detection, monitoring and staging.
G.
“Project Intellectual Property” means any intellectual
property rights which arise from the joint activities conducted
pursuant to this Agreement, and which shall be jointly owned as set
forth in Section VI of this
Agreement.
H.
“Law” means any local, state or federal rule,
regulation, statute or law relevant to the activities undertaken
pursuant to this Agreement or applicable to either of the Parties
with respect to any matters set forth herein.
I.
“Losses” means any liabilities, damages, costs or
expenses, including without limitation, reasonable attorneys’
fees (including the allocable cost of in-house counsel), which
arise from any claim, lawsuit, demand or other action by any third
party other than one of the Parties or an Affiliate of one of the
Parties.
J. “Managing Committee” means the committee established
pursuant to Section III which
is responsible for the development and oversight of all activities
pursuant to this Agreement, in accordance with the terms of this
Agreement.
K.
“Confirma Products” means any products, supplies or
other goods which are designed, developed, manufactured or marketed
by Confirma independent of Guardian and this Collaboration
Agreement, whether existing on the date of this Agreement or
subsequently developed, acquired or otherwise obtained by Confirma,
including all Confirma Background IP.
L.
“Party” or “Parties” means Confirma or
Guardian, or Confirma and Guardian, collectively, as
appropriate.
M.
“Senior Management Representative” means an executive
officer of each Party designated to facilitate the resolution of
disputes hereunder, as described in Section III of this Agreement.
N.
“Target Product(s)” means a product(s) developed for an
application that utilize Guardian’s technologies including,
but not limited to, Guardian’s 3i imaging technologies
and Confirma Products which are to be delivered through the
cooperative efforts of the Parties as contemplated by this
Agreement.
II .
General Agreement
Confirma and Guardian shall collaborate to design,
develop and clinically evaluate imaging technologies for
commercialization for the detection and characterization of
specifically targeted medical conditions, utilizing Confirma
Products and Guardian’s 3i technology, as set forth
herein. The identification of product and or clinical applications
technical candidates, and the specific terms regarding the scope
and type of the collaborative efforts (including, without
limitation, the economic terms with respect to the parties), shall
be determined from time-to-time in accordance with Sections
III and IV of this Agreement.
III.
Managing Committee
A.
Confirma and Guardian shall establish a Managing Committee
hereunder, which shall consist of two (2) representatives from each
of Confirma and Guardian. The initial designees are set forth in
Schedule A hereto. Confirma and Guardian may each from time-to-time
replace its respective representatives on the Managing Committee,
in its sole and absolute discretion, by notice to the other Party
the goal of the group is to provide focus and direction order to
leverage both companies capabilities and technologies.
B.
It is among the objectives of the Parties to work together to
conduct collaborative research towards development of an advanced,
industry leading product/products for the analysis and detection of
medical conditions across a variety of clinical applications by
taking advantage of the respective technologies and other resources
and assets of Confirma and Guardian, on the terms and subject to
the conditions of this Agreement, and to design, develop and
implement the Target Products in a reasonably practicable fashion,
subject however, to the respective corporate regulatory, financial
and other obligations and considerations of each of the Parties
from time-to-time determined. To achieve this objective, the
Managing Committee shall be responsible for identifying
Guardian’s imaging technologies which are appropriate
candidates for consideration under this Agreement, and establishing
an Implementation Strategy for those Guardian imaging technologies
from time-to-time designated and determined by the Managing
Committee.
C.
The Managing Committee shall meet at such times and places as it
shall determine appropriate to carry out its responsibilities
hereunder. Such meetings may be in person or by means of telephonic
communication. Either Party may designate an alternate member of
the Managing Committee to act on behalf of a member on a
temporary or interim basis, in the reasonable discretion of such
Party. Either Party through its Managing Committee members, may
call a meeting of the Managing Committee by giving written notice
thereof to the members of the other Party.
D.
The Managing Committee shall establish guidelines to govern the
strategic activities, co-development and related activities of the
Parties; the Managing Committee shall also establish such
guidelines with respect to operational matters at such time as a
Target Product is commercialized or in a pre-commercialized phase,
as contemplated by this Agreement. All such guidelines shall be
subject to the qualification of Section III (G) hereof. The Managing Committee
shall be responsible for taking such other actions as may be
provided for or contemplated by this Agreement, subject at all
times to the requirements of Section III (G), including the establishment and
implementation of the “Governing Rules.”
F.
The Parties shall each name one (1) of its Managing Committee
members as its Alliance Coordinator, who shall be the primary
contact for purposes of this Agreement, except to the extent the
Parties may otherwise agree. Either Party may change its
designation of Alliance Coordinator, in its sole and absolute
discretion, upon written notice to the other Party.
F.
If a disagreement arises between the Parties as to any matters
within the scope of this Agreement, either Party may give written
notice to the other. If the Alliance Coordinators are unable to
resolve the dispute satisfactorily, despite their good faith
efforts, within thirty (30) days of receipt of such notice, either
Alliance Coordinator may request a meeting of the Managing
Committee, which will, in good faith, diligently seek to resolve
the dispute. If the Managing Committee is unable to resolve the
dispute, notwithstanding the exercise of good faith efforts, within
thirty (30) days after such meeting, then, unless otherwise agreed
by the Alliance Coordinators, the matter shall thereafter formally
be referred to a Senior Management Representative of each of the
Parties, the initial designations of which are set forth in
Schedule A. Either Party may, in its sole discretion, change its
designee of the Senior Management Representative by written notice
to the other. Except as expressly provided in the immediately
following sentence, neither Party shall initiate any formal action
against the other, including, without limitation, the formal
commencement of arbitration proceedings or the formal filing of
legal action, until at least thirty (30) days have elapsed since
the first communication between the Senior Management
Representatives hereunder. Notwithstanding the foregoing, either
Party may initiate proceedings to seek injunctive relief before the
time period otherwise required hereunder shall elapse, if such
Party in good faith believes that it will suffer irreparable harm
without the initiation of such proceedings.
G.
Notwithstanding anything to the contrary contained in this
Agreement, the authority of the Managing Committee shall at all
time be subject to the respective requirements and obligations of
the quality systems and regulatory policies and procedures, and
internal corporate governance requirements, of each of Guardian and
Confirma. The Managing Committee shall establish Governing Rules,
which shall serve as guidelines for the general activities under
this Agreement, and Implementation Strategies relative to the
activities for each Target Product, all of which shall supplement
the terms hereof, but which procedures and systems shall satisfy
and be consistent with the respective policies, procedures, and
systems of Confirma and Guardian. In that regard, the Parties shall
reasonably cooperate in an attempt to assure their respective
systems do not unduly impede the execution of the intent of this
Agreement. Without limiting the generality of the foregoing, the
operations and authority of the Managing Committee shall be
consistent with the underlying corporate policies of each party
with respect to the operation of clinical trials and studies,
regulatory affairs relating to development, promotion, worldwide
distribution and servicing of the delivery of Target Products,
quality assurance activities, medical device and adverse event
reporting requirements, patent strategies, and the like. The
Managing Committee shall establish a proposed approach for the
Governing Rules within ninety (90) days of the execution of this
Agreement that shall consider the relevant respective obligations
of the parties.
IV.
Target
Products
The Parties shall diligently pursue the design,
development and ultimate commercialization of Target Products
designated by the Managing Committee. For each Target Product
designated as such by the Parties, the Managing Committee shall
develop an Implementation Strategy, which shall consist of a
comprehensive plan with respect to such activities. It is the
intention of the Parties that they will cooperate jointly in such
activities, as from time-to-time mutually determined by the
Managing Committee and agreed to by the Parties. The Parties
currently contemplate that the Implementation Strategies with
respect to each Target Product may be developed in one or more
phases, and may include or address, without limitation, the
following:
A.
Formulation of Guardian 3i imaging technologies for delivery
via Confirma, including, without limitation, enhancement,
clarification, detection, and characterization technologies.
Confirma shall be responsible generally for developing appropriate
MRI product/technology alternatives.
B.
Clinical research, including the design, development,
implementation and analysis of joint clinical trials and protocols,
feasibility studies and similar activities from time-to-time agreed
to by the Parties.
C.
Strategies and physical requirements for the integration of the
Guardian 3i technologies relative to the Target
Products.
D.
Market research activities.
E.
Patent strategies with respect to Project Intellectual
Property.
F.
Strategies and activities relative to the requisite regulatory
approvals of and post-market regulatory compliance for the
components of the Target Products.
G.
Market development activities, which may include, without
limitation, educational and other programs for healthcare
professionals and third-party payors.
H.
Marketing activities, which may include, without limitation,
activities directed to patients, healthcare professionals and third
party payors.
I.
Clinical and technical services to provide support relative to the
delivery systems for the Target Products, which may be based upon
the current Confirma model of providing technical services for
Confirma Products and 24-hour clinical services.
J.
Sales and related worldwide distribution activities relating to the
Target Products,
including the composition and structure of the sales force or
distribution network, or oth
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