COLLABORATION AND EXCLUSIVE
LICENSE AGREEMENT
This Collaboration and Exclusive License
Agreement, dated as of January 23, 2009 (this
“Agreement”), is entered into between Transgenomic,
Inc., a Delaware corporation (“Transgenomic”), and
Power3 Medical Products, Inc., a New York corporation
(“Power3”).
WITNESSETH:
WHEREAS, Power3 has rights in and is developing
the Licensed Technology as a diagnostic tool for the early
detection of neurodegenerative diseases, including
Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS), and
Parkinson’s disease;
WHEREAS Power3 is currently conducting clinical
validation studies of the Licensed Technology in order to
commercialize the Licensed Technology;
WHEREAS, Transgenomic is willing to provide
certain funds to Power3 for use in the reimbursement of costs
incurred by Power3 in the clinical validation studies of the
Licensed Technology necessary to commercialize the Licensed
Technology;
WHEREAS, Transgenomic may also desire to
collaborate in the performance of clinical validation
studies of the Licensed Technology; and
WHEREAS, Transgenomic desires to obtain, and
Power3 is willing to grant, an exclusive license in the Licensed
Technology on the terms and conditions of this
Agreement.
NOW, THEREFORE, in consideration of the
foregoing premises and the mutual covenants herein contained, the
parties, intending to be legally bound, agree as
follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms
defined in this Article 1 shall have the respective meanings set
forth below:
1.1
“ Affiliate ” means with respect to any Person,
any other Person that directly or indirectly controls, is
controlled by, or is under common control with, such Person.
A Person shall be regarded as in control of another Person if it
owns, or directly or indirectly controls, at least fifty
percent (50%) of the voting stock or other ownership interest
of the other Person, or if it directly or indirectly possesses the
power to direct or cause the direction of the management and
policies of the other Person by any means whatsoever.
1.2
“ First Commercial Sale ” means, with respect to
a Licensed Product, the first bona fide transaction in a country in
the Territory for which consideration is received for the sale,
use, lease, transfer or similar disposition of such Licensed
Product by Transgenomic, its Affiliate or (sub)licensee to
customers who are not Affiliates in such country after all
applicable marketing and pricing approvals (if any) have been
granted by the applicable governing health authority of such
country or, prior to any pricing approval by any applicable
governing health authority, the first bona fide transaction in a
country in the Territory for which consideration (revenue) is
received for performing an assay of the Licensed Product by
Transgenomic.
1.3
“ Improvements ” means Power3
Improvements and Transgenomic Improvements.
1.4
“ Licensed Know-How ” means
proprietary information or other know-how, whether or not
patentable, and whether stored or transmitted in oral, documentary,
electronic, or other form, including without limitation, ideas,
concepts, formulas, methods, procedures, designs, compositions,
plans, documents, data, inventions, discoveries, developments,
works of authorship, biological and chemical materials, and any
information relating to research and development plans,
experiments, results, compounds, products, preclinical and clinical
data, trade secrets, chemical synthesis, scale-up and
manufacturing, toxicology, regulatory, stability, and any other
information relevant to Neurodegenerative Diagnostic
Tests.
1.5
“ Licensed Patent Rights ” means
(a) all patents and patent applications listed on
Exhibit A hereto which are owned by or licensed to
Power3, and have application in connection with Neurodegenerative
Diagnostic Tests; (b) all patents that have issued or in the
future shall issue therefrom, including utility, model and design
patents and certificates of invention; and (c) all
divisionals, continuations, continuations-in-part, reissues,
renewals, reexaminations, extensions or additions to any such
patent applications and patents.
1.6
“ Licensed Product ” means test kits or systems
for performing Neurodegenerative Diagnostic Tests using the
Licensed Technology.
1.7
“ Licensed Technology ” means,
collectively, the Licensed Patent Rights, the Licensed Know-How,
the Improvements and as related to the foregoing items, all
laboratory notebooks, research plans, inventions, proteins and
protein fragments, biomarkers, assay methodology, processes,
materials and methods for production, recovery and purification of
natural products, formulae, plans, specifications, characteristics,
marketing surveys and plans and business plans.
1.8
“ Net Sales ” means, with respect to any
Licensed Product or Reference Laboratory Service, the gross sales
price of such Licensed Product or Reference Laboratory Service
invoiced by Transgenomic, its Affiliate, or its (sub)licensee to
customers who are not Affiliates (or are Affiliates but are the end
users of such Licensed Product) less, to the extent actually paid
or accrued by Transgenomic or its Affiliate (as applicable),
(a) credits, allowances, discounts and rebates to, and
chargebacks from the account of, such customers for spoiled,
damaged, out-dated or returned Licensed Product or for Reference
Laboratory Services erroneously performed; (b) freight and
insurance costs incurred by Transgenomic or its Affiliate (as
applicable) in transporting such Licensed Product; (c) cash,
quantity and trade discounts, rebates and other price reductions
for such Licensed Product or Reference Laboratory
Service given to customers under price reduction programs that
are consistent with industry practices; (d) sales, use,
value-added and other direct taxes incurred on the sale of such
Licensed Product and Reference Laboratory Service; (e) customs
duties, surcharges and other governmental charges incurred in
exporting or importing such Licensed Product and (f) reimbursement
decreases from list price due to insurance company, hospital or
government reimbursement price reductions. Notwithstanding
anything to the contrary in this Agreement, if any reusable
instrument (that is itself a Licensed Product) is used in
combination with a separate diagnostic device (that is itself a
Licensed Product) to detect or measure one or more analytes from a
patient sample on or in such device, then for purposes of
calculating Net Sales, such diagnostic device shall constitute a
Licensed Product, but such instrument shall not constitute a
Licensed Product.
1.9
“ Neurodegenerative Diagnostic Tests ” means
proteomic neurodegenerative diagnostic screening tests performed as
a series of blood serum tests designed to diagnose motor neuron,
cognitive, and other neurodegenerative disorders including, but not
limited to, Alzheimer’s, Parkinson’s, Lou
Gehrig’s disease (ALS), psychiatric diseases or movement
disorders in individuals. The test monitors the concentration of
selected biomarkers residing in a panel of blood serum protein
biomarkers to distinguish normal patients from those with
neurodegenerative diseases, by applying a statistical model
that evaluates the quantitative information of the protein
biomarkers and automatically assigning a probability score for the
individual.
1.10 “
Person ” means an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
1.11 “
Power3 ” means Power3 Medical, Inc., a New York
corporation, and its Affiliates.
1.12 “
Power3 Improvement ” means any and all intellectual
property developed, created, reduced to practice, conceived, or
otherwise made by Power3, its employees, agents or independent
contractors that are derived from or based upon the Licensed
Technology.
1.13 “
Publications ” means the publicly available
information describing Power3´s work with respect to
Neurodegenerative Diagnostic Tests, including but not limited to
published patents and patent applications listed in Exhibit
A , conference presentations and peer-reviewed
publications.
1.14 “
Reference Laboratory Services ” shall mean use of a
laboratory developed and laboratory validated test service that
(a) is offered or sold by reference laboratories and/or
service laboratories and (b) is developed and validated in
accordance with regulations promulgated under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) (or under an
equivalent subsequent legislation) for the evaluation of a
Neurodegenerative Diagnostic Test performed using a Licensed
Product.
1.15 “
Territory ” means the entire world except for those
territories listed on Exhibit B hereto.
1.16 “
Third Party ” means any Person other than
Power3 and Transgenomic and their respective Affiliates.
1.17 “
Transgenomic ” means Transgenomic, Inc., a Delaware
corporation.
1.18 “
Transgenomic Common Stock ” means the
Common Stock, par value $0.01, of Transgenomic.
1.19 “
Transgenomic Improvements ” means any and all
intellectual property developed, created, reduced to practice,
conceived, or otherwise made by employees or independent
contractors of Transgenomic, in the course of performing any
activities pursuant to this Agreement or under the license granted
thereunder, and that are specific to the Licensed
Technology.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES OF
POWER3
Power3 hereby represents and warrants to
Transgenomic as follows:
2.1
Corporate Existence and Power . Power3
(a) is a corporation duly organized, validly existing and in
good standing under the laws of New York (b) has
the corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted and (c) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties,
business, financial or other condition of Power3 and would not
materially adversely affect its ability to perform its obligations
under this Agreement.
2.2
Authorization and Enforcement of Obligations
. Power3 (a) has the corporate power and authority
to enter into this Agreement and to perform its obligations
hereunder and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of Power3,
and constitutes a legal, valid, binding obligation, enforceable
against Power3 in accordance with its terms.
2.3
No Consents . All necessary consents, approvals
and authorizations of all governmental authorities and other
Persons required to be obtained by Power3 in connection with this
Agreement have been obtained.
2.4
Rights in Licensed Technology . Power3 is the
legal and beneficial owner of all right, title and interest in and
to the Licensed Technology or has sufficient rights thereto
(including, without limitation, the rights under that certain
license agreement referred to in the next succeeding sentence),
having good title or a valid license thereto, free and clear of any
and all mortgages, liens, and security interests created by Power3.
Power3 previously has delivered to Transgenomic a full and complete
copy, together with all amendments thereto, of the BCM License
(defined in Section 4.7 of this Agreement). The BCM License is in
full force and effect and neither party thereto is in default under
the BCM License. Power3 shall comply with all applicable laws,
rules, and regulations of any governmental authority in the
performance of its obligations under this Agreement.
2.5
Non-Infringement . To the best
knowledge of Power3, the Licensed Technology does not infringe upon
or unlawfully or wrongfully use any proprietary rights, including
but not limited to patent rights, owned or claimed by a Third
Party. Power3 has not received any notice of any claim of
infringement relating to the Licensed Technology.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF
TRANSGENOMIC
Transgenomic hereby represents and warrants to
Power3 as follows:
3.1
Corporate Existence and Power . Transgenomic
(a) is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware; (b) has the
corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted and (c) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties,
business, financial or other condition of Transgenomic and would
not materially adversely affect its ability to perform its
obligations under this Agreement.
3.2
Authorization
and Enforcement of Obligations . Transgenomic
(a) has the corporate power and authority and the legal right
to enter into this Agreement and to perform its obligations
hereunder and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of
Transgenomic, and constitutes a legal, valid, binding obligation,
enforceable against Transgenomic in accordance with its
terms.
3.3
No Consents . All necessary consents, approvals
and authorizations of all governmental authorities and other
Persons required to be obtained by Transgenomic in connection with
this Agreement have been obtained.
3.4
Compliance with Laws . Transgenomic shall comply
with all applicable laws, rules, and regulations of any
governmental authority in the performance of its obligations under
this Agreement.
ARTICLE 4
LICENSE GRANT
4.1
Exclusive License . On the terms and subject to the
conditions of this Agreement, Power3 hereby grants to Transgenomic
an exclusive, royalty-bearing license for the Territory (together
with the right to grant sublicenses) to research, develop, obtain
regulatory approval for, commercialize, make, have made, use, have
used, offer for sale and sell the Licensed Technology, the Licensed
Products, and the Reference Laboratory Services in connection with
performing or having performed Neurodegenerative Diagnostic Tests.
On the terms and subject to the conditions of this Agreement, the
exclusive license granted (i) with respect to Licensed Patent
Rights, continues until the earlier of the expiration of such
patents or the expiration or termination of this Agreement
(provided that upon the expiration of any such patent Transgenomic
shall have a perpetual license in the technology covered by such
patent in the Territory) and (ii) with respect to unpatented
Licensed Technology, continues until the expiration or termination
of this Agreement.
4.2
Trademark Licensed . Power3 hereby grants
to Transgenomic a license to use Power3’s NuroPro®
trademark registered with the United States Patent and Trademark
Office in connection with the license granted in Section 4.1 and
shall execute a license agreement for such trademark in the form of
Exhibit C to this Agreement.
4.3.
Licensed Know How . After the effective
date of this Agreement, Power3 will make available to Transgenomic
all relevant Licensed Know How relating to the Licensed Patent
Rights.
4.4
Reservation of Rights . Power3
retains all right, title and interest in and to the Licensed
Technology other than those expressly granted in this
Agreement.
4.5
365(n) of Bankruptcy Code . All
rights and licenses now or hereafter granted under or pursuant to
any Section of this Agreement, are rights to
“intellectual property” (as defined in
Section 101(35A) of Title 11 of the United States Code, as
amended (such Title 11, the “Bankruptcy Code”)).
Power3 grants to Transgenomic and its Affiliates a right of access
and to obtain possession of, and to benefit from copies of, (i)
pre-clinical and clinical research data and results, (ii)
laboratory and compound samples required to be delivered to
Transgenomic to the extent not previously delivered, all of which
((i) and (ii)) constitute “embodiments” of intellectual
property pursuant to Section 365(n) of the Bankruptcy Code),
and (iii) all other embodiments of such intellectual property,
whether any of the foregoing are in
Power3’s possession or control or in the
possession and control of Third Parties.
4.6
Sublicenses . The right of
Transgenomic to sublicense under this Agreement is subject to the
following conditions: (a) in each such sublicense, the
sublicensee shall be prohibited from granting further sublicenses
and shall be subject to the applicable terms and conditions of the
license granted to Transgenomic under this Agreement; (b) in
each such sublicense, Transgenomic shall use its best efforts to
obtain limitations of liability and indemnity protection for Power3
that are at least as comprehensive as that granted to Transgenomic;
(c) Transgenomic shall forward to Power3, within thirty
(30) days following execution, a complete and accurate copy
written in the English language of each sublicense granted
hereunder; and (d) notwithstanding any such
sublicense, Transgenomic shall remain primarily liable to Power3
for all of the duties and obligations of Transgenomic contained in
this Agreement.
4.7
Sublicense of Baylor College of Medicine License
. For the avoidance of doubt, as a part of the Licensed
Patent Rights included in the Licensed Technology, Power3
sublicenses to Transgenomic all technology licensed by Power3 as
licensee under that certain Exclusive License Agreement between
Baylor College of Medicine (“BCM”) and Power 3, dated
June 28, 2004, attached hereto as a part of Exhibit A (the
“BCM License”), subject to and in accordance with the
terms and provisions of the BCM License. Transgenomic agrees to
comply with the requirements of the BCM License as applicable to
sublicensees; provided that in the event that Power3 breaches any
provision of the BCM License or receives any notice of default from
BCM relating to a possible termination of the BCM License, Power3
shall immediately notify Transgenomic of such breach or notice and
Transgenomic shall have the right, but not the obligation, to cure
such default or to perform an act or duty of Power3 under the BCM
License necessary to cure such default, and the cost of such
performance by Transgenomic, including but not limited to
reasonable attorneys’ fees, shall be deducted from any
payments otherwise due to Power3 under this Agreement. In the event
of the termination of the BCM License as a result of any
insolvency, dissolution, bankruptcy or receivership proceedings of
Power3, Power3 acknowledges that Transgenomic shall have the right,
but not the obligation, to seek to enter into a new license
agreement for all patents and technology covered by the BCM
License, directly with BCM, but subject to BCM’s consent and
the payment by Transgenomic of any additional fees required by BMC;
provided that Transgenomic shall continue to comply with its
obligations to Power3 under this Agreement, subject to its right to
deduct the cost of any payments or performance required under the
new license with BCM from any payments otherwise due to Power3
under this Agreement. Power3 shall not take any action
to amend or terminate the BCM License without the express advance
written consent of Transgenomic. Power3 covenants to Transgenomic
to duly and faithfully observe all terms and restrictions and
perform all of the obligations imposed on Power3 under the BCM
License, including without limitation payment of all royalties,
license fees and other payments. Power3 shall neither do nor permit
anything to be done which would cause the BCM License to be
terminated or forfeited by reason of any right of termination or
forfeiture reserved or vested in BCM under the BCM
License.
ARTICLE 5
COMPENSATION
5.1
Royalties . In partial consideration for
the license granted hereunder, during the term of this Agreement,
Transgenomic shall pay to Power3 royalties as follows:
5.1.1 Transgenomic
shall pay to Power3 royalties for the license granted in Section
4.1 at a rate (the “Royalty Rate”) of 20% of Net Sales,
but not to exceed 25% of the gross profit (as calculated pursuant
to U.S. generally accepted accounting principles) derived by
Transgenomic from such Net Sales; provided, however, such royalties
shall in no case be less than 10% of Net Sales. Such
royalties shall be due and payable on a calendar quarterly basis
and shall be submitted by Transgenomic along with the report as
specified in Section 6.1 below.
5.2
Third Party Licenses . If
Transgenomic is reasonably required to take a license under any
Third Party patents to use the Licensed Technology as reasonably
determined by Transgenomic, and Transgenomic’s total royalty
burden for Net Sales exceeds the applicable Royalty Rate plus four
percent (4%) (in sum, the “Royalty Cap”),
the Royalty Rate payable hereunder shall be reduced proportionally
in accordance with the following formula:
R2 = R1 x (Royalty Cap/T)
R2 is the adjusted reduced Royalty Rate
hereunder
T is the total royalty rates (on a percentage
basis) due to all licensors
By way of
example, if the Royalty Rate owed under Section 5.1.1. is 20%
(R1) and two additional patent licenses are needed from two Third
Parties and these two other royalty rates are 3% and 3.25% (total
of 6.25%), the value of T is 26.25 %, the Royalty Cap is
24% and the Royalty Rate due under this Agreement, as
adjusted (R2), is 20 x (24 % /26.25%) or 18.29 %.
Notwithstanding the foregoing, in no event will
the Royalty Rate due under this Agreement be reduced to less than
ten percent (10%) of Net Sales.
5.3
License Execution Fee .
5.3.1 Within
three (3) days following execution of this Agreement Transgenomic
shall deliver to Power3 via wire transfer the amount of
$100,000.
5.3.2 Within
thirty (30) days following execution of this Agreement Transgenomic
shall create an account for funding Power3’s clinical
validation efforts. These funds, referred to in Section 8.1 of this
Agreement, shall be disbursed in the manner and subject to the
conditions set forth in Section 8.1 and the Disbursement Control
Agreement referred to therein.
5.4
Milestone Fees . Transgenomic shall pay to Power3
the following milestone fees within thirty (30) days of the
occurrence of the applicable milestone event:
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$15,000 upon
publication of peer reviewed scientific journal
article(s) on biomarkers, clinical validations, medical and
scientific findings and implications of the Alzheimer’s,
Parkinson’s, and Lou Gehrig’s disease blood
tests.
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Shares of
Transgenomic Common Stock with an aggregate Fair Market Value of
$100,000 upon the
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