MASTER LICENSE AGREEMENT
THIS MASTER LICENSE AGREEMENT (“Agreement”) is
entered into this 27 th day of July, 2007 (the
"Effective Date") by and between: (1) BIOFIELD CORP. ,
("LICENSOR"), a Delaware corporation, with offices at King of
Prussia Business Center, Suite C, 1019 West Ninth Avenue, King of
Prussia, PA 19406; and (2) THE MACKAY GROUP LIMITED , a Hong
Kong corporation with a registered address at Room 1005, Allied
Kajima Building, 138 Gloucester Road, Wanchai, Hong Kong, and/or
its nominees, delegees, and/or assigns (collectively,
“LICENSEE”).
LICENSOR and LICENSEE are hereinafter collectively referred to as
the “Parties” and individually referred to as a
“Party.”
W I T N E S S E T H:
WHEREAS , LICENSOR is the sole owner and holder of all
intellectual property, proprietary rights and know-how, and all
other rights and interests related to and associated with the
Biofield Breast Cancer Technology and the Patented and Unpatented
Licensed Technology (as those terms are defined below in Section 1
of this Agreement);
WHEREAS , LICENSOR is the sole owner and holder of the
Exclusive Distribution, Development, Manufacturing, Clinical,
Regulatory, and R&D Rights (as those terms are defined below in
Section 1 of this Agreement) related to and associated with the
Biofield Breast Cancer Technology and the Patented and Unpatented
Licensed Technology;
WHEREAS , to the best of its information, knowledge and
belief, LICENSOR has the power, right, and authority to grant to
LICENSEE an exclusive (even to LICENSOR), sublicensable,
royalty-bearing license to make, have made, use, import, offer for
sale, and sell devices, sensors, and other products or services
incorporating the Patented and Unpatented Licensed Technology and
to grant to LICENSEE the Exclusive Distribution, Development,
Manufacturing, Clinical, Regulatory, and R&D Rights; and
WHEREAS , LICENSEE wishes to make all commercially
reasonable efforts to: (a) make, have made, use, import, offer for
sale, and sell devices, sensors, and other products or services
incorporating the Patented and Unpatented Licensed Technology in
the Territory (as defined in Section 1 below of this Agreement);
and (b) exercise the Exclusive Distribution, Development,
Manufacturing, Clinical, Regulatory, and R&D Rights in the
Territory;
WHEREAS , LICENSEE has strategic government, industry,
technology, distribution, marketing, research & development,
design/engineering, manufacturing and other relationships and
contacts throughout the world which could assist in the marketing,
distribution, design, engineering, manufacturing, regulatory
approval, clinical development, research and development, and other
commercialization or utilization of the Patented and Unpatented
Licensed Technology, including, but not limited to, the
People’s Republic of China, Hong Kong,
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Macau, India, the Philippines, Malaysia, Singapore, Japan, Korea
and other parts of Asia; Europe; Africa; the Middle East; and Latin
America;
WHEREAS , LICENSEE wishes to make all commercially
reasonable efforts and to directly and indirectly bring resources
(time, technology, personnel, contacts/networks, financial, and
other resources) to bear: (a) to help LICENSOR enter certain global
markets (including, but not limited to, the People’s Republic
of China, Hong Kong, Macau, India, the Philippines, Malaysia,
Singapore, Japan, and other parts of Asia; and Europe, Africa, the
Middle East, and Latin America; (b) to help further update, design,
redesign, engineer, reengineer. and otherwise develop the current
and next generation versions of the Biofield Diagnostic Device and
sensors to optimize issues relating to size, cost, portability, and
sensitivity; (c) to help further develop the Patented and
Unpatented Licensed Technology, including, but not limited to,
further developing the Patented and Unpatented Licensed Technology
as an adjunct diagnostic modality; (c) to help further develop the
Patented and Unpatented Licensed Technology for screening, as
opposed to purely diagnostic, purposes; (d) to help extend the use
of the Patented and Unpatented Licensed Technology to detect
cancers other than breast cancer; (e) to help arrange additional
clinical trials and research and development; (f) to help arrange
regulatory approval in certain markets/ countries, including, but
not limited to, China and the Philippines; (g) to help
LICENSOR’s efforts to secure US FDA approval; and (h) to set
up manufacturing facilities (sensors and device) with comparative
cost advantages in China and/or other parts of the world;
WHEREAS, LICENSOR has had limited success at best in
commercializing the Patented and Unpatented Licensed Technology and
entering into critical global markets;
WHEREAS, under this Agreement, LICENSOR would not have to
incur, and would save itself from incurring, substantial resources
to market, distribute, manufacture, design redesign, engineer,
reengineer, further develop, and/or otherwise commercialize the
Patented and Unpatented Licensed Technology. LICENSOR would
not have to incur, and would save itself from incurring,
substantial resources associated with securing regulatory approval
and conducting clinical trials in certain parts of the world.
Rather, LICENSEE would undertake and incur such
responsibilities and expenses;
WHEREAS , LICENSEE desires to obtain from LICENSOR an
exclusive (even as to LICENSOR), sublicensable, royalty-bearing
license with regard to the Patented and Unpatented Licensed
Technology in the Territory;
WHEREAS , LICENSEE and LICENSOR are in agreement with
respect to the terms and conditions upon which LICENSOR shall grant
LICENSEE an exclusive license for the Territory with regard to the
Patented and Unpatented Licensed Technology and shall grant
LICENSEE the Exclusive Distribution, Manufacturing, Development,
Clinical, Regulatory and R&D Rights for the Territory;
WHEREAS , pursuant to certain agreements dated March 30,
2006, as reported in LICENSOR’s Form 8-K, publicly available
at the website of the United States Securities and Exchange
Commission (http://www.sec.gov/Archives/edgar/data/1007018/
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000112178106000066/0001121781-06-000066-index.htm and attached
exhibit agreements), certain transactions were agreed to and
entered into between the MacKay Group and Dr. David M. Long, Jr.,
Donna R. Long, Dr. Raymond A. Long, the Long Family Trust, the Long
Family Partners II LP, and David and Donna Long Family Foundation
(the “Long Control Group”) on or about March 30, 2006
involving, inter alia , the transfer of shares, the
assignment of debt, and the conversion of debt, which upon
consummation of said transactions would effectively result in the
ownership and possession by the MacKay Group of fifty-one (51%)
percent of all the shares of common stock issued and outstanding
(on a fully-diluted basis) of Biofield. Dr. Long was
previously the Chief Executive Officer and Chairman of the Board of
Biofield. As reported in Biofield’s filings with the United
States Securities and Exchange Commission, the Long Control Group
previously held a substantial amount of shares of Biofield.
As set forth in Biofield’s US SEC filings, Dr. Long
and/or his affiliates further held a debt owed by Biofield in the
amount of approximately US$4.3 million (with interest continuing to
accrue) (the “Long Debt”). US$2 million of the Long
Debt was assigned to the MacKay Group on or about March 30, 2006
pursuant to one of aforementioned agreements. The Longs and the
MacKay Group were each represented by independent counsel with
respect to the transactions, who reviewed and approved the
transactions. The transactions were further reviewed and
approved by the then Board of Directors of Biofield. As set
forth in prior filings with the US SEC, James MacKay is a principal
and director in the MacKay Group as well as the Chairman of the
Board of Directors of Biofield Corp. This Agreement is being
executed only after undertaking and securing legal review with
regard to this Agreement;
WHEREAS , the royalty rate and other terms of this Agreement
exceed or are, at a minimum, comparable to the royalty rates and
other terms contained in: (a) various licensing and/or distribution
agreements which LICENSOR under prior management had previously
entered into, and which have all been terminated (the “Prior
Licensing Agreements”), including, but not limited to: (i)
LICENSOR’s licensing agreement in 1992 with Abel
Laboratories, an affiliate of LICENSOR’s former chairman and
chief executive officer, Dr. David Long, and holder of certain
patent rights relating to the Patented and Unpatented Licensed
Technology, whereby Abel Laboratories was entitled to a royalty of
5% of the net sales up to US$2.5 million and a payment of
US$100,000; and (ii) a royalty granted by LICENSEE in the amount of
2% and 1% of the gross sales up to US$8 million on devices and
sensors to its former vice president, research & development,
Mark Faupel; (b) the standard royalty rate set forth in industry
publications regarding royalties on patents for health care
inventions; and (c) the royalty rates and other terms of licensing
agreements associated with imaging, diagnostic, and screening
technology for breast cancer or other cancers as available on the
US SEC databases on WESTLAW and LEXIS and on the internet.
NOW, THEREFORE , in consideration of the promises and
agreements set forth herein, the sufficiency of which is mutually
and explicitly acknowledged by the Parties, the Parties, each
intending to be legally bound hereby, do promise and agree as
follows.
1.
DEFINITIONS . As used in this Agreement, the
following terms shall have the following respective meanings:
Page 3 of 33
1.1.
“Affiliate” means any corporation, company,
partnership, joint venture and/or firm which controls, is
controlled by, or is under common control of either Party. For
purposes of this definition, control shall mean direct or indirect
ownership of more than fifty percent (50%) of the stock or
participating shares entitled to vote for the election of directors
(but only as long as such ownership exists).
1.2.
“Biofield Breast Cancer Technology” means any and all
technology which, as of the time immediately prior to execution of
this Agreement, was licensed to and/or was developed, possessed,
used, and/or owned by and for Biofield Corp. to diagnose, screen
for, and/or otherwise detect breast or other epithelial cancer
and/or to assist in diagnosing, screening for, and/or otherwise
detecting breast or other epithelial cancer, including, but not
limited to, devices, sensors, other components, algorithms,
software, systems, procedures, protocols, processes, and other
technologies, as described in, inter alia , (a) Biofield
Corp.’s prior Form 10-KSBs and other filings and submissions
with the U.S. SEC as of the Effective Date; (b) Biofield
Corp.’s prior filings and submissions with the US FDA,
European regulatory authorities associated with Biofield
Corp’s CE Mark, and any other regulatory authority; and (c)
Biofield Corp.’s prior patent, trademark, copyright, and/or
other intellectual property filings and submissions, including
those listed in Exhibit A attached hereto. Included, without
limitation, within the scope of the term “Biofield Breast
Cancer Technology” are the technologies and all aspects
related thereto known or referred to as the Biofield Diagnostic
System, the Biofield Breast Cancer Proliferation Detection System,
the Breast Cancer Diagnostic Device, and the Biofield Breast
Examination or BBE SM .
1.3.
“Confidential Information” shall mean any confidential
or proprietary information of a Party including, without
limitation, all specifications, know-how, inventions, trade
secrets, technical information, drawings, software, prototypes,
models, inventions, discoveries, assays, methods, procedures,
formulae, protocols, techniques, data, and unpublished patent
applications, customer lists, business plans, operational methods,
pricing policies, marketing plans, sales plans, identity of
suppliers or customers, sales, profits or other financial and
business information, whether disclosed in oral, written, graphic,
or other electronic form. All information exchanged between the
Parties in connection with this Agreement as well as this Agreement
itself shall be deemed Confidential Information under this
Agreement.
1.4.
“Effective Date” shall have the meaning ascribed to
such term in the opening paragraph of this Agreement.
1.5.
“Exclusive Clinical Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
arrange or conduct clinical trials or other aspects of clinical
development for devices, sensors and other products or services
incorporating the Patented and Unpatented Licensed Technology and
Improvements in the Territory.
1.6.
“Exclusive Development Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
design, redesign, engineer, reengineer, and/or otherwise develop
(technically, clinically, and otherwise) devices, sensors and other
products or services
Page 4 of 33
incorporating the Patented and Unpatented Licensed Technology and
Improvements in the Territory.
1.7.
“Exclusive Distribution Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
market, distribute, advertise, sell, have sold, import,
commercialize, and/or otherwise utilize devices, sensors and other
products or services incorporating the Patented and Unpatented
Licensed Technology and Improvements in the Territory.
1.8.
“Exclusive Manufacturing Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
make, have made, and manufacture devices, sensors and other
products or services incorporating the Patented and Unpatented
Licensed Technology and Improvements in the Territory.
1.9.
“Exclusive Regulatory Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
seek, handle, coordinate, manage, administer and secure regulatory
approval (technically, clinically, and otherwise) with respect to
devices, sensors and other products or services incorporating the
Patented and Unpatented Licensed Technology and Improvements in the
Territory.
1.10.
“Exclusive R&D Rights” shall mean any and all
rights, on an exclusive basis and with the right to sublicense, to
conduct research and development (technically, clinically, and
otherwise) with respect to devices, sensors and other products or
services incorporating the Patented and Unpatented Licensed
Technology and Improvements in the Territory.
1.11.
“First Commercial Sale” means the first sale of the new
version of the Biofield Diagnostic Device in the Territory, after
Regulatory Approval in the People’s Republic of China, by
LICENSEE or its Affiliates (or their sublicensee(s)) to any
unaffiliated third party as evidenced by the selling party's
invoice or other relevant document to such third party. A sale to
an unaffiliated third party shall not include quantities delivered
solely for research, demonstration, and/or investigatory purposes,
for clinical trials or quantities distributed as samples or
promotions. A sale to an unaffiliated third party shall not
include: (1) any sale in the Territory of the Biofield Diagnostic
Device or any other device related to the Biofield Breast Cancer
Technology, and associated sensors prior to the Effective Date; (2)
any sale of sensors for any Biofield Diagnostic Device or any other
device related to the Biofield Breast Cancer Technology, which were
sold or shipped prior to the Effective Date; and/or (3) any sales
of the current version (as opposed to the new version being
developed) of the Biofield Diagnostic Device, including those
devices which are, as of the Effective Date, being maintained at
Biofield Corp’s U.S. offices, Hong Kong, mainland China,
and/or the Philippines.
1.12.
“Gross Receipts” shall mean the total amount of funds
actually received and collected by LICENSEE and its Affiliates from
sales of devices, sensors, and/or other product or service
utilizing the Patented and Unpatented Licensed Technology,
including, but not limited to, (x) cash, money orders and cleared
checks less charges imposed by banks for clearing, deposits,
redeposits or returns and (y) cleared credit card charges less the
bank discount rate; less the
Page 5 of 33
following amounts actually paid by LICENSEE, its affiliates,
licensees, distributors and manufacturers: i.) discounts allowed;
ii.) returns; iii.) transportation charges or allowances; iv.)
packing and transportation packing material costs; v.)
customs and duties charges; and vi.) sales, transfer and
other excise taxes or other governmental charges (including any tax
or government charge, duty or assessment or any tax such as a value
added or similar tax or government charge) levied on or measured by
the sales but no franchise or income tax of any kind whatsoever.
The term “Gross Receipts” shall also include funds
actually received and collected by LICENSEE from any sublicensee of
LICENSEE in connection with the Patented and Unpatented Licensed
Technology, including, but not limited to, any licensing fees
received by LICENSEE from sublicensees of LICENSEE regarding the
Patented and Unpatented Licensed Technology. The term
“Gross Receipts” shall also include funds actually
received and collected by LICENSEE from or as a result of any
settlement, judicial, mediation or arbitration proceedings, or
litigation arising from an alleged infringement by a third party of
the Patented or Unpatented Licensed Technology. To the extent
possible, the term “Gross Receipts” shall be
interpreted in according with U.S. GAAP principles. Revenue
received from foreign sources shall be at its value in U.S. dollars
when received.
1.13.
“Improvements” means all additions, developments,
modifications, enhancements and adaptations (i) which directly
relate to or are used in connection with the Patented and
Unpatented Licensed Technology, and (ii) which are conceived or
reduced to practice prior to or during the Term.
1.14.
“Minimum Royalty Payments” shall mean the minimum
royalty payments referenced in subsection 11.3 of this Agreement
and set forth in Exhibit B to this Agreement.
1.15.
“Patented Licensed Technology” means any and all
technologies, including, but not limited to, devices, sensors,
other components, algorithms, software, systems, procedures,
protocols, processes, information, data, methods of use,
techniques, ideas, inventions and other technologies, which is
governed by the Patents. To the extent that the Patent for
certain Patented Licensed Technology expires, lapses, and/or is
otherwise terminated or rendered invalid, such Patented Licensed
Technology shall be automatically and immediately deemed Unpatented
Licensed Technology for the balance of the Term for the Unpatented
Licensed Technology, provided that this Agreement is still in
effect and has not been properly terminated.
1.16.
“Patents” means the patent applications and
patents listed in Exhibit A hereto and any and all other patent
applications and patents and amendments thereto, including foreign
equivalents, and any and all substitutions, extensions, additions,
reissues, re-examinations,
renewals,
divisions, continuations, continuations-in-part or supplementary
protection certificates owned by or licensed to Biofield Corp.
prior to and during the Term relating to the Biofield Breast Cancer
Technology or any Improvements.
1.17.
“Regulatory Approval” means all governmental approvals
and authorizations necessary for the manufacture and commercial
sale of devices, sensors, and/or other components or services
incorporating the Biofield Breast Cancer Technology in a country of
the Territory,
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including, but not limited to, marketing authorization, pricing
approval and pricing reimbursement, as applicable.
1.18.
“Term” means the term set forth in Exhibit B to this
Agreement.
1.19.
“Term for the Patented Licensed Technology” means the
life or duration of each applicable Patent, as renewed,
reinstituted, and/or otherwise extended.
1.20.
“Term for the Unpatented Licensed Technology” means the
Term as defined in subsection 1.18 above and Exhibit B to this
Agreement.
1.21.
“Territory” means the territories and countries set
forth in Exhibit B to this Agreement.
1.22.
“Unpatented Licensed Technology” means any and all
components of the Biofield Breast Cancer Technology other than the
Patented Licensed Technology, including, but not limited to,
devices, sensors, other components, algorithms, software, systems,
procedures, protocols, processes, information, data, methods of
use, techniques, ideas, inventions, trade secrets and any other
technical information or proprietary technologies relating to the
development, use or sale of any device, sensor or other product,
service, or manifestation of the Biofield Breast Cancer Technology,
provided that Biofield Corp. has the right to license and/or
sublicense to The MacKay Group Limited. To the best of Biofield
Corp.'s knowledge and belief, Biofield Corp. has the right to
license and/or sublicense substantially all of the Unpatented
Licensed Technology. To the extent that the Patent for
certain Patented Licensed Technology expires, lapses, and/or is
otherwise terminated or rendered invalid, such Patented Licensed
Technology shall be automatically and immediately deemed Unpatented
Licensed Technology for the balance of the Term for the Unpatented
Licensed Technology, provided that this Agreement is still in
effect and has not been properly terminated.
1.23.
“US FDA” means the United States Food and Drug
Administration.
1.24.
“U.S. SEC” means the U.S. Securities and Exchange
Commission.
2.
EXCLUSIVE SUBLICENSABLE, ROYALTY-BEARING
LICENSE GRANT.
2.1.
Exclusive Sublicensable, Royalty-Bearing License Grant for
Patented Licensed Technology . Subject to the provisions
of this Agreement, LICENSOR hereby grants to LICENSEE for the Term
for the Patented Licensed Technology the exclusive (even as to
LICENSOR), sublicensable, royalty-bearing right and license to
make, have made, use, import, offer for sale, and sell devices,
sensors and other products or services incorporating the Patented
Licensed Technology and Improvements in the Territory.
2.2.
Exclusive Sublicensable, Royalty-Bearing License Grant for
Unpatented Licensed Technology . Subject to the
provisions of this Agreement, LICENSOR hereby grants to LICENSEE
for the Term for the Unpatented Licensed Technology the exclusive
(even as to
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LICENSOR), sublicensable, royalty-bearing right and license to
make, have made, use, import, offer for sale, and sell devices,
sensors and other products or services incorporating the Unpatented
Licensed Technology in the Territory.
2.3.
Exclusive Sublicensable, Grant of Exclusive Clinical,
Development, Distribution, Manufacturing, and R&D Rights
Associated with the Patented and Unpatented Licensed Technology
. To the extent not already granted by LICENSOR to LICENSEE
in subsections 2.1 and 2.2 above of this Agreement, subject to the
terms and conditions of this Agreement, LICENSOR grants to
LICENSEE, on an exclusive basis in the Territory, the Exclusive
Clinical, Development, Distribution, Manufacturing and R&D
Rights associated with the Patented and Unpatented Licensed
Technology for the applicable Term for Patented Technology and Term
for Unpatented Technology.
2.4.
LICENSEE may grant sublicenses to any third party in its sole
discretion with respect to any of the licenses and rights granted
by LICENSOR to LICENSEE, including, but not limited to, the
licenses and rights granted in subsections 2.1-2.3 above of this
Agreement, provided that LICENSEE shall make all commercially
reasonably efforts (a) to ensure that the sublicensee meets the
applicable obligations of LICENSEE under this Agreement (other than
the obligations by the LICENSEE to pay Royalties and Licensing Fees
under this Agreement) and (b) to ensure that price charged by any
sublicensee for devices, sensors and other products or services
incorporating the Patented and Unpatented Licensed Technology
reasonably comports with market conditions for the applicable
countr(ies) in the Territory.
3.
COMPENSATION.
3.1.
Subject to the terms and conditions of this Agreement, in
consideration for the licenses and rights granted hereunder
relating to Patented Licensed Technology, LICENSEE agrees to pay to
LICENSOR during the Term for Patented Licensed Technology a royalty
in the amount set forth in Schedule B attached hereto (the
“Royalty”) based on LICENSEE’S Gross Receipts
with respect to the Patented Licensed Technology.
3.2.
Subject to the terms and conditions of this Agreement, in
consideration for the licenses and rights granted hereunder
relating to Unpatented Licensed Technology, LICENSEE agrees to pay
to LICENSOR during the Term for Unpatented Licensed Technology a
royalty in the amount set forth in Schedule B attached hereto (the
“Royalty”) based on LICENSEE’S Gross Receipts
with respect to the Unpatented Licensed Technology.
3.3.
Over and above the royalties set forth in subsections 3.1 and 3.2
above of this Agreement, subject to the terms and conditions of
this Agreement, during the applicable Term for Patented Licensed
Technology or Term for Unpatented Licensed Technology, LICENSEE
agrees to pay to LICENSOR a royalty in the amount set forth in
Schedule B attached hereto based on LICENSEE’S Gross Receipts
with respect to Improvements developed solely by LICENSEE, provided
that LICENSOR fulfills all of its obligations to LICENSEE under
this Agreement and this Agreement is still in effect and/or has not
been properly terminated. Further, during the applicable Term
for Patented Licensed Technology or Term for Unpatented
Licensed
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Technology, LICENSEE licenses back to LICENSOR the rights to any
and all Improvements developed solely by LICENSEE. Additional
details relating to this license-back will be worked out in good
faith by the Parties upon the development by LICENSEE of any and
all Improvements.
3.4.
Unless otherwise agreed by the Parties, the Royalty owed LICENSOR
shall be calculated on a quarterly calendar basis (the "Royalty
Period") and shall be payable no later than thirty (30) days after
the end of the preceding full calendar quarter, i.e., commencing on
the first (1st) day of January, April, July, and October with the
exception of the first and last calendar quarters which may be
"short" depending upon the Effective Date of this Agreement.
3.5.
With each Royalty payment, LICENSEE shall provide LICENSOR
with a written royalty statement in a form acceptable to LICENSOR
and consistent with industry standards, which shall, at a minimum,
itemize the Gross Receipts received by LICENSEE during the Royalty
Period, and which shall delineate the nature, source, and amount of
such Gross Receipts. LICENSEE shall make commercially
reasonable efforts to make available to LICENSOR information it
receives from any of LICENSEE’s sublicensees pertaining to
gross receipts received by LICENSEE from such sublicensee.
3.6.
Subject to the terms and conditions of this Agreement, in
consideration for the licenses granted by LICENSOR to LICENSOR
herein pertaining to the Patented and Unpatented Licensed
Technology, LICENSEE agrees to pay to LICENSOR the collective
Licensing Fee (the "Licensing Fee") set forth in Schedule B to this
Agreement.
4.
AUDIT .
4.1.
LICENSOR shall have the right, upon thirty (30) days written
notice, to inspect LICENSEE'S books and records and all other
documents and material in the possession of or under the control of
LICENSEE with respect to the subject matter of this Agreement at
the place or places where such records are normally retained by
LICENSEE.
4.2.
All books and records relative to LICENSEE'S obligations hereunder
shall be maintained and kept accessible and available to LICENSOR
for inspection for at least five (5) years after the date to which
they pertain.
4.3.
In the event that an investigation of LICENSEE’S books and
records is made, certain confidential and proprietary business
information of LICENSEE may necessarily be made available to the
person or persons conducting such investigation. It is agreed
that such confidential and proprietary business information shall
be retained in confidence by LICENSOR and shall not be used by
LICENSOR or disclosed to any third party for a period of five (5)
years from the date of disclosure, or without the prior express
written permission of LICENSEE unless required by law. It is
understood and agreed, however, that such information may be used
in any proceeding based on LICENSEE’S failure to pay its
actual Royalty obligation.
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4.4.
In accordance with applicable law, LICENSEE will make commercially
reasonable efforts to make available to LICENSOR all material
information it receives from any of LICENSEE’s sublicensees
pertaining to gross receipts received by such sublicensee with
respect to the Patented and Unpatented Licensed Technology.
5.
WARRANTIES & OBLIGATIONS .
5.1.
Licensor’s Warranties &
Obligations.
5.1.1.
LICENSOR represents and warrants that to the best of its
information, knowledge and belief: (a) it is the sole owner of and
controls -- free and clear of all material claims, liabilities,
licenses, liens, pledges, charges and encumbrances materially
affecting LICENSEE’s obligations under this Agreement -- all
rights, title and interests associated with the Patented and
Unpatented Licensed Technology; (b) it has the right, power, and
authority to fully and unconditionally enter into this Agreement
and to grant the rights and licenses granted herein; (c) all
necessary consents, approvals and authorizations, if any, of all
government authorities and other persons required to be obtained by
LICENSOR in connection with the execution, delivery and performance
of this Agreement have been obtained or will be obtained, provided
that no representation or warranty is given with respect to
governmental approvals necessary for the manufacture, use, sale,
offer for sale or importation of the Patented and Unpatented
Licensed Technology; (d) there are no other agreements with any
other party in material conflict herewith; and (e) this Agreement
is a legal and valid obligation binding upon LICENSOR and
enforceable in accordance with its terms.
5.1.2.
LICENSOR further represents and warrants to the best of its
knowledge, information, and belief that notwithstanding anything to
the contrary in this Agreement, the execution and delivery of this
Agreement and the performance of the Parties’ obligations
hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations and (b) do not and will not conflict
with, violate or breach or constitute a default of, or require any
consent under, any contractual obligations of LICENSOR, except such
consents as shall have been obtained prior to the Effective
Date.
.
5.1.3.
LICENSOR further represents and warrants to the best of its
information, knowledge, and belief, that all material Patents,
trademarks, copyrights, and/or other intellectual property
associated with the Patented Licensed Technology are current,
valid, and effective and/or that to the extent that any such
Patents, trademarks, copyrights, and/or other intellectual property
have become invalid due to non-payment of any maintenance and/or
other administrative fees, the fees will be promptly paid by
LICENSOR and LICENSOR shall promptly, at its sole expense, take all
necessary actions to reinstate the Patent, trademark, copyright
and/or other intellectual property.
5.1.4.
LICENSOR further represents and warrants to the best of its
information, knowledge, and belief that all material audits,
approvals, certificate of conformity, certifications, and other
aspects associated with the CE Mark for the Patented and Unpatented
Licensed Technology are current, valid, and effective, and/or that
to the extent they are not, LICENSOR
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will, at its sole expense, promptly take all necessary actions to
renew, reinstate, or reapply for such audits, approvals,
certificate of conformity, certifications, and other aspects
associated with the CE Mark.
5.1.5.
LICENSOR further represents and warrants that it will make all
commercially reasonable efforts to provide all the technical,
technology and other assistance needed for LICENSEE to begin
utilizing, manufacturing, and commercializing the Patented and
Unpatented Licensed Technology, including, but not limited to, any
required technology transfer and exchange and the transfer of
material information about the Patented and Unpatented Licensed
Technology (design, manufacture, testing, regulatory approval,
etc.), its clinical development and trials, and any developments
before the European regulatory authorities and the US FDA.
5.1.6.
LICENSOR further represents and warrants to the
best of its information, knowledge, and belief that it is not
aware of any circumstances pertaining to LICENSOR that would
materially affect LICENSEE’s ability to utilize and
commercialize the Patented and Unpatented Licensed
Technology.
5.1.7.
After the Effective Date, LICENSOR shall meet
with and provide LICENSEE with such information associated with
the Patented and Unpatented Licensed Technology relating to the
installation and operation of hardware, software, machinery,
equipment, materials, object codes, specifications, designs,
manufacturing and processing procedures, methods, layout and the
like which LICENSOR believes LICENSEE may require in order to
manufacture, sell, design, engineer, validate, market,
distribute, develop, secure regulatory approval for,
commercialize and/or utilize the Patented and Unpatented
Licensed Technology in the Territory.
5.2.
Licensee’s Warranties &
Obligations.
5.2.1.
LICENSEE will make all commercially reasonable
efforts to require all manufacturers, distributors, or
sublicensees of the Patented and Unpatented Licensed Technology
or any component thereof, to assure that when manufactured and
distributed, they will be in compliance with all applicable laws
and regulations in the applicable countries in the Territory,
the required good manufacturing practices, and with other
necessary technical, engineering, safety or regulatory
requirements; and
5.2.2.
LICENSEE will make all commercially reasonable
efforts to utilize and commercialize the Patented and Unpatented
Licensed Technology to perform the duties and obligations it has
assumed hereunder, including, but not limited to, making all
commercially reasonable efforts and bringing resources
(financial, personnel, time, expertise, distribution contacts
and networks, government contacts, and other resources):
5.2.2.1.
To enter into, and secure purchase orders and/or
distribution arrangements for, the following markets: the
People’s Republic of China, Hong Kong, Macau, the
Philippines, Singapore, Thailand, Japan, Korea, Vietnam,
Page 11 of 33
Malaysia and other Asian countries; Europe; the
Middle East; Africa; and Latin America;
5.2.2.2.
To seek and secure regulatory approval to
commercialize the Patented and Unpatented Licensed Technology in
the following markets: the People’s Republic of China,
India, Hong Kong, Macau, the Philippines, Singapore, Thailand,
Japan, Korea, Vietnam, Malaysia and other Asian countries;
Europe; the Middle East; Africa; and Latin America;
5.2.2.3.
To secure government and industry support in the
following markets: the People’s Republic of China,
India, Hong Kong, Macau, the Philippines, Singapore, Thailand,
Japan, Korea, Vietnam, Malaysia and other Asian countries;
Europe; the Middle East; Africa; and Latin America;
5.2.2.4.
To secure regulatory approval to market,
distribute, manufacture, utilize, and commercialize the Patented
and Unpatented Licensed Technology in the following markets: the
People’s Republic of China, India, Hong Kong, Macau, the
Philippines, Singapore, Thailand, Japan, Korea, Vietnam,
Malaysia and other Asian countries; the Middle East; Africa; and
Latin America;
5.2.2.5.
To update, redesign, reengineer, and further
develop the current and next generation versions of the Biofield
Diagnostic Device and sensors to optimize maximize issues
relating to size, cost, portability, and sensitivity;
5.2.2.6.
To further develop the Patented and Unpatented
Licensed Technology as an adjunct diagnostic modality;
5.2.2.7.
To further develop the Patented and Unpatented
Licensed Technology for screening, as opposed to purely
diagnostic, purposes;
5.2.2.8.
To further develop the Patented and Unpatented
License
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