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
Xxxxxxxxx’x 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.
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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,
Xxxxxxxxx’x, Xxx Xxxxxx’x 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.
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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.
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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.
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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.
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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:
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R2 = R1 x
(Royalty Cap/T)
Where:
R1 is the
Royalty Rate
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, Xxxxxxxxx’x, and Xxx Xxxxxx’x disease
blood tests.
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Shares
of Transgenomic Common Stock with an aggregate Fair Market Value of
$100,000 upon the First Commercial
Sale
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Shares
of Transgenomic Common Stock with an aggregate Fair Market Value of
$500,000 upon reaching a cumulative total of $15,000,000 of Net
Sales
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For
purposes of this Section 5.4, the “Fair Market Value” of each share of
Transgenomic Common Stock means the average of its market prices on each of the
20 trading days prior to the date for which the determination is being made,
with each market price being the average of the high and low sale prices of the
Transgenomic Common Stock as quoted on the Nasdaq National Market System on such
trading day, or, in the event that no such sale takes place on such day, the
average of the reported closing bid and asked prices on such day, or, if the
Transgenomic Common Stock is listed on a national securities exchange, the
average of the high and low sale prices reported on the principal national
securities exchange on which the Transgenomic Common Stock is listed or admitted
to trading on such trading day, or, if no such reported sale takes place on such
day, the average of the closing bid and asked prices on such day on the
principal national securities exchange on which the Transgenomic Common Stock is
listed or admitted to trading, or, if the Transgenomic Common Stock is not
quoted on such National Market System nor listed or admitted to trading on a
national securities exchange, the average of the closing bid and asked prices in
the over-the-counter market on such day as reported through Nasdaq, or, if bid
and asked prices for the Transgenomic Common Stock on such day are not reported
through Nasdaq, the average of the bid and asked prices for such day as
furnished by any New York Stock Exchange member firm regularly making a market
in the Transgenomic Common Stock selected in good faith for such purpose by
Transgenomic, or, if none of the foregoing is applicable, then the fair market
value of the Transgenomic Common Stock as mutually determined in good faith by
Transgenomic and Power3.
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5.5 Sample Use and
Reimbursement. Power3 shall provide to Transgenomic samples
for use in its concordance and validation studies, such sample amounts and
properties to be further specified by Transgenomic and to be agreed by Power3.
Transgenomic shall reimburse Power3 for its full cost incurred as a result of
such sample use; provided, however, the payment referred to in Section 5.3.1 of
this Agreement represents payment in full for all samples delivered to
Transgenomic prior to the execution of this Agreement.
ARTICLE
6
ROYALTY REPORTS AND
ACCOUNTING
6.1 Reports. During
the term of this Agreement following the First Commercial Sale of a Licensed
Product, Transgenomic shall furnish to Power3 a report for each calendar quarter
showing in reasonably specific detail (a) the gross sales of Licensed Product
sold by Transgenomic or its Affiliates during the reporting period and the
calculation of Net Sales from such gross sales; (b) the royalties payable in
United States dollars, if any, which shall have accrued hereunder based upon Net
Sales; (c) the withholding taxes, if any, required by law to be deducted in
respect of such sales; and (d) the date of the First Commercial Sale of the
Licensed Product during the reporting period. Reports shall be due on the
forty-fifth (45th) day following the close of each calendar quarter.
Transgenomic shall keep, and shall cause its Affiliates to keep, complete and
accurate records in sufficient detail to properly reflect all gross sales and
Net Sales and to enable the royalties payable hereunder to be
determined. Such records shall be maintained for a minimum of five
(5) years from the end of the subject calendar year.
6.2 Audits.
Upon the written request of Power3, and not more than once in each calendar
year, Transgenomic shall permit an independent certified public accounting firm
of nationally recognized standing, selected by Power3 and reasonably acceptable
to Transgenomic, to have access during normal business hours to such of the
records of Transgenomic and its Affiliates as may be reasonably necessary to
verify the accuracy of the reports delivered by Transgenomic hereunder for any
year ending not more than thirty-six (36) months prior to the date of such
request. The accounting firm shall disclose to Power3 only whether
the records and calculation of royalties are correct and the details concerning
any specific discrepancies other than the amount of such
discrepancy. No other information shall be shared. In the
event that any audit report reveals an underpayment to Power3, Transgenomic will
immediately pay to Power3 the amount of such underpayment. Any such audit will
be performed at Power3’s expense, provided that the
reasonable fees and expenses of such audit will be paid by Transgenomic if such
audit reveals an underpayment by Transgenomic of more than ten percent (10%) or
$10,000 (whichever is greater) of the amounts payable by Transgenomic to Power3
in any twelve (12) month period.
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6.3
Confidential Financial
Information. Power3 shall treat all financial information
subject to review under this Article 6 as Confidential Information pursuant to
Article 9 below, and shall cause its accounting firm to retain all such
financial information in confidence.
ARTICLE
7
PAYMENTS
7.1 Payment
Terms. Royalties shown to have accrued by each royalty report
provided for under Article 6 of this Agreement shall be due and payable on the
date such royalty report is due.
7.2 Payment
Method. All payments by Transgenomic to Power3 under this
Agreement shall be paid in United States Dollars, and all such payments shall be
made by bank wire transfer in immediately available funds to such account as
Power3 shall designate before such payment is due.
7.3 Taxes. All
payments under this Agreement will be made without any deduction or withholding
for or on account of any tax unless such deduction or withholding is required by
applicable laws or regulations. If Transgenomic is so required to deduct
or withhold, Transgenomic will (a) promptly notify Power3 of such requirement,
(b) pay to the relevant authorities the full amount required to be deducted or
withheld promptly upon the earlier of determining that such deduction or
withholding is required or receiving notice that such amount has been assessed
against Power3, and (c) promptly forward to Power3 an official receipt (or
certified copy) or other documentation reasonably acceptable to Power3
evidencing such payment to such authorities, and provide any further assistance
reasonably requested by Power3 to enable Power3 to obtain the benefit of any
such deduction.
7.4 Late
Fees. Any payments required to be made by Transgenomic
pursuant to this Agreement shall, if overdue, bear interest at the “prime rate”
of interest as published by the Wall Street Journal for the first business day
following the due date, plus one percent (1%), or the maximum rate permitted by
applicable law, whichever is less. The payment of such interest shall
not preclude Power3 from exercising any other rights it may have because any
payment is overdue.
ARTICLE
8
DEVELOPMENT AND
COMMERCIALIZATION OBLIGATIONS
8.1.
Continued
Development. Within thirty (30) days following the execution of this
Agreement, Transgenomic shall create a bank account funded with the amount of
One Hundred Fifty Thousand Dollars ($150,000), said account to be owned by
Transgenomic, and which funds will be used by Power3, with prior agreement by
Transgenomic, to fund Power3’s clinical validation activities of the
Neurodegenerative Diagnostic Tests; provided that the availability of such funds
to Power3 shall be governed by the terms and conditions set forth in the
Disbursement Control Agreement attached hereto as Exhibit D. Clinical
validation of the Neurodegenerative Diagnostic Tests shall be the responsibility
of Power3 until such time, if any, as Transgenomic shall assume some or all of
the future responsibility for clinical validation of the Neurodegenerative
Diagnostic Tests pursuant to Section 8.2. Power3 shall use commercially
reasonable efforts for said development and shall keep Transgenomic informed
about its progress in regular reports. Power3 shall disclose to Transgenomic the
available technical and clinical performance data of the then-current version of
its tests on regular basis, but in no event less often than
monthly.
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8.1.1 During
the period of continued development of the Neurodegenerative Diagnostic Tests by
Power3, Power 3 shall:
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(a)
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prepare
an Operating Plan and Budget for the clinical validation
activities;
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(b)
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provide
suitable laboratory facilities, equipment and personnel for the work to be
done in carrying out the clinical validation
activities;
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(c)
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coordinate
and obtain the approval of Transgenomic prior to the publication of
research results obtained from such continued development
activities;
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(d)
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discuss
with Transgenomic whether a license(s) need be obtained from any Third
Person(s) in order to make, use or sell the Licensed
Product;
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(e)
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determine,
subject to the approval of Transgenomic, the priority of assays to be
commercialized;
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(f)
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discuss
the patent/intellectual property strategy and implementation plan for
development and commercialization;
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(g)
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furnish
Transgenomic with summary reports within fifteen (15) days after the end
of each calendar quarter, describing its progress under the Operating Plan
and Budget; and
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(h)
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prepare
and furnish to Transgenomic comprehensive written reports within thirty
(30) days after the end of each calendar quarter describing in detail the
work accomplished by Power3 during such quarter and evaluating the results
of such work.
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(i)
|
Discuss
the plan and timing of development by Transgenomic of next-generation
high-throughput immunoassays and platforms, and the plan, timing and
budget for the supporting role to be taken by Power3 in these
efforts.
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11
8.1.2 Power3
shall keep complete and accurate records of its expenditures under the Operating
Plan and Budget. Transgenomic shall have the right, at its own expense, to
appoint an independent certified public accountant to examine such records,
during regular business hours at the place or places where such records are
customarily kept, upon reasonable notice from Transgenomic, to the extent
reasonably necessary to verify the accuracy of the expenditures and required
reports. Transgenomic agrees to hold in confidence all information concerning
such expenditures, other than their total amounts, and all information learned
in the course of any audit or inspection, except to the extent that it is
necessary for Transgenomic to reveal the information in order to enforce any
rights it may have pursuant to this Agreement or if disclosure is required by
law. Failure by Transgenomic to request verification of any expenditures within
two years after such expenditure has been made shall be considered acceptance of
the accuracy of such expenditure, and Power3 shall have no obligation to
maintain any records pertaining to such report or statement beyond the two-year
period.
8.2 Assumption of Development by
Transgenomic. If, at any time during the term of this
Agreement, Power3 breaches its obligations under this Agreement or the
Disbursement Control Agreement attached hereto as Exhibit D or
Transgenomic is dissatisfied with Power3’s clinical validation activities of the
Neurodegenerative Diagnostic Tests pursuant to this Agreement or such
Disbursement Control Agreement, Transgenomic may assume some or all of the
responsibility for future development of the Neurodegenerative Diagnostic Tests
if Power3 has not cured such breaches or the reasons for Transgenomic’s
dissatisfaction within forty-five (45) days after notice thereof by
Transgenomic, which notice will specifically state the nature of such breaches
or the reasons for such dissatisfaction in reasonable detail. In addition,
Transgenomic may, in its discretion, assume some or all of the responsibility
for future development of the Neurodegenerative Diagnostic Tests at any time
after the entire $150,000 referred to in Section 8.1 of this Agreement has been
disbursed to Power3. At such time as Transgenomic assumes responsibility for
development of the Neurodegenerative Diagnostic Tests, Power3 shall transfer to
Transgenomic the physical embodiment of all Licensed Technology useful or
necessary for use in such future development activities, including but not
limited to (i) pre-clinical and clinical research data and results, (ii)
laboratory and compound samples, (iii) all other embodiments of the Licensed
Technology, whether any of the foregoing are in Power3’s possession or control
or in the possession and control of Third Parties.
ARTICLE
9
CONFIDENTIALITY
9.1 Confidential
Information. During the term of this Agreement, and for a
period of five (5) years following the expiration or earlier termination hereof,
each party shall maintain in confidence all written information and data
provided by one party to the other hereunder and marked “Confidential” or, if
information disclosed orally, visually or in some other form, which is
summarized in writing, is confirmed in writing as “Confidential” to the other
party within thirty (30) days of such disclosure (the “Confidential
Information”), and shall not use, disclose or grant the use of the Confidential
Information of the other except on a need-to-know basis to those directors,
officers, employees, agents, attorneys, accountants, advisors, counterparties
and permitted assignees of it and its Affiliates, to the extent such disclosure
is reasonably necessary in connection with such party’s activities as expressly
authorized by this Agreement. To the extent that disclosure is
authorized by this Agreement, prior to disclosure, each party hereto shall
obtain agreement of any such Person to hold in confidence and not make use of
the Confidential Information for any purpose other than those permitted by this
Agreement. Notwithstanding the foregoing, all orally disclosed
Licensed Know-How shall be deemed the Confidential Information of Power3 without
marking or other designation.
12
9.2 Permitted
Disclosures. The confidentiality obligations contained in
Section 9.1 of this Agreement shall not apply to the extent that
(a) any receiving party (the “Recipient”) is required (i) to disclose
information by law, order or regulation of a governmental agency or a court of
competent jurisdiction, or (ii) to disclose information to any governmental
agency for purposes of obtaining approval to test or market a product, provided
in either case that the Recipient shall provide written notice thereof to the
other party and sufficient opportunity to object to any such disclosure or to
request confidential treatment thereof; or (b) the Recipient can demonstrate
that (i) the disclosed information was public knowledge at the time of such
disclosure to the Recipient, or thereafter became public knowledge, other than
as a result of actions of the Recipient in violation hereof; (ii) the disclosed
information was rightfully known by the Recipient (as shown by its written
records) prior to the date of disclosure to the Recipient by the other party
hereunder; or (iii) the disclosed information was disclosed to the Recipient on
an unrestricted basis from a source unrelated to any party to this Agreement and
not under a duty of confidentiality to the other party.
9.3 Equitable
Relief. Each party hereby acknowledges and agrees that, in the
event of any breach or threatened breach of this Article 9 by the Recipient, the
disclosing party may suffer irreparable injury for which damages at law may not
be an adequate remedy. Accordingly, without prejudice to any other
rights and remedies otherwise available to the disclosing party, the disclosing
party shall be entitled to seek equitable relief, including injunctive relief
and specific performance, for any breach or threatened breach of this Article 9
by the Recipient, its Affiliates, or any of its or their employees, directors,
officers, members, agents, or representatives.
9.4 Non-Use of Names;
Confidentiality of Agreement. Subject to Section 9.5, neither
party shall make any public announcement, issue any press release or publish any
study (collectively, all such communications, “Publication”) concerning the
transactions contemplated herein, or make any Publication which includes the
name of the other party or any of its Affiliates, or otherwise use the name or
names of the other party or any of their employees or any adaptation,
abbreviation or derivative of any of them, whether oral or written, related to
the terms, conditions or subject matter of this Agreement, without the prior
written permission of such other party, except as may be required by applicable
law, regulation or judicial order (and then only following consultation with the
other party). Such permission may not unreasonably be
withheld.
9.5 Press
Release. The parties shall issue a press release substantially
in the form attached hereto as Exhibit E promptly after the
execution of this Agreement.
13
ARTICLE
10
INTELLECTUAL
PROPERTY
10.1 Ownership.
10.1.1
Assignment of
Transgenomic Improvements. Subject to a perpetual, exclusive,
royalty-free (other than Transgenomic’s continuing obligations to pay royalties
as provided in Article 5 of this Agreement), world-wide license, with the right
to sub-license, hereby retained by Transgenomic, Transgenomic hereby irrevocably
assigns and agrees to assign to Power3 all worldwide right, title and interest
in and to Transgenomic Improvements. Transgenomic agrees that Transgenomic shall
sign, execute and acknowledge or cause to be signed, executed and acknowledged
(any out-of-pocket costs for which shall be at Power3’s sole cost) any and all
documents and to perform such acts as may be necessary, useful or convenient for
the purposes of perfecting the foregoing assignment and obtaining, enforcing and
defending intellectual property rights with respect to Transgenomic
Improvements.
10.1.2 Retention of
Rights. Except for the rights and licenses expressly provided
herein, Power3 and Transgenomic retain all of their respective worldwide right,
title and interest in and to any intellectual property made, conceived or
reduced to practice by or on behalf of Power3 and Transgenomic, respectively. No
licenses are granted by implication, estoppel or otherwise.
10.2 Actual or Threatened
Disclosure or Infringement. If information comes to the attention of
Transgenomic to the effect that any patent rights relating to a Licensed Product
or Reference Laboratory Service, have been or are threatened to be infringed,
Transgenomic shall have the right, at its expense, to take such action as it may
deem necessary to prosecute or prevent such infringement, including the right to
bring or defend any suit, action or proceeding involving any such infringement.
Transgenomic shall notify Power3 promptly of the receipt of any such information
and of the commencement of any such suit, action or proceeding. If Transgenomic
determines that it is necessary or desirable for Power3 to join any such suit,
action or proceeding, Power3 shall execute all papers and perform such other
acts as may be reasonably required to permit Transgenomic to act in Power3’s
name. In the event that Transgenomic brings a suit, it shall be entitled to all
sums recovered in such suit or in its settlement without any further obligation
to Power3. If Transgenomic does not, within 120 days after giving notice to
Power3 of the above-described information, notify Power3 of Transgenomic’s
intent to bring suit against any infringer, Power3 shall have the right to bring
suit for such alleged infringement, but it shall not be obligated to do so.
Power3 may join Transgenomic as party plaintiff, if appropriate, in which event
Power3 shall hold Transgenomic free, clear and harmless from any and all costs
and expenses of such litigation, including reasonable attorneys’ fees, and all
sums recovered in any such suit or in its settlement shall belong to Power3
without any further obligation to Transgenomic. Each party shall always have the
right to be represented by counsel of its own selection and at its own expense
in any suit instituted by the other for infringement, under the terms of this
Section. If Transgenomic lacks standing to bring any such suit, action or
proceeding, then Power3 shall do so at the request of Transgenomic and at
Transgenomic’s expense.
14
10.3 Infringement
Claims.
10.3.1
Defense of
Infringement Claims. Each party will cooperate with the other in the
defense of any suit, action or proceeding against either such party or any
sublicensee of such party alleging the infringement of the intellectual property
rights of a Third Person by reason of the use of the Licensed Technology in the
manufacture, use or sale of a Licensed Product or a Reference Laboratory
Service. Each party shall give the other party prompt written notice of the
commencement of any such suit, action or proceeding or claim of infringement and
will furnish the other party with a copy of each communication relating to the
alleged infringement. The party defending any such suit or action shall have
full authority (including the right to exclusive control of defense of any such
suit, action or proceeding and the exclusive right to compromise, litigate,
settle or otherwise dispose of any such suit, action or proceeding), to defend
or settle any such suit, action or proceeding. If the parties agree that the
other party should institute or join any suit, action or proceeding pursuant to
this Section 10.3.1, the non-moving party may join the other party as a
defendant if necessary or desirable, and each such party shall execute all
documents and take all other actions, including giving testimony, which may
reasonably be required in connection with the prosecution of such suit, action
or proceeding.
10.3.2
Costs of Infringement
Claims. With regard to a suit, action or proceeding brought against
Transgenomic for infringement arising out of the use of the Licensed Technology
by Transgenomic, Power3 will be responsible for the costs incurred by
Transgenomic under Section 10.3.1 above (“Infringement Litigation Costs”).
Transgenomic may recover Infringement Litigation Costs from Power3 to the extent
of all royalties and milestone previously paid under this and Agreement and may
recoup any excess amount of Infringement Litigation Costs from future royalties
and milestones due to Power3.
10.4 Additional
Patents.
10.4.1
Power3 shall decide whether (and where) to file any patent application relating
to Improvements. Power3 may select counsel, prepare and prosecute such
applications. Power3 shall be responsible for in all expenses incurred by such
counsel.
10.4.2
In the event Power3 elects not to file or elects not to continue prosecution of
an application on any Improvement, Transgenomic may file and prosecute any such
application(s) at its own expense.
10.4.3
In the event that Power3 determines that it is no longer interested in
prosecuting or maintaining a particular patent application or granted patent
included in Licensed Patents, Power3 shall so inform Transgenomic in sufficient
time to permit Transgenomic to assume the responsibility and expense for the
further prosecution and/or maintenance of such application or patent. If
Transgenomic assumes such responsibility and expense, any expenses incurred by
Transgenomic in prosecuting or maintaining such patent shall be deducted from
future royalties or milestone payments due to Power3.
15
ARTICLE
11
TERMINATION
11.1
Expiration. Subject
to the provisions of Sections 11.2, 11.3 and 11.4 of this Agreement, this
Agreement shall expire on the termination of Transgenomic’s obligation to pay
royalties to Power3 under Article 5 of this Agreement.
11.2 Termination by
Transgenomic. Transgenomic may terminate this Agreement, in
its sole discretion, upon ninety (90) days prior written notice to
Power3.
11.3
Termination by
Power3. Power3 may terminate this Agreement, in its sole
discretion, upon ninety (90) days prior written notice to Transgenomic if (i)
the First Commercial Sale has not occurred within 12 months after execution of
this Agreement, unless such failure is due to events of force majeure referred
to in Article 13 of this Agreement, or (ii) Power3 has not received at least
$10,000 in royalties under Section 5.1 prior to 18 months after execution of
this Agreement, unless such failure is due to events of force majeure referred
to in Article 13 of this Agreement; provided, however, Transgenomic may avoid
the occurrence of the event described in this clause by paying to Power3 prior
to the expiration of such 90-day period an amount which, when added to the
royalties paid to Power3 under Section 5.1, totals $10,000.
11.4 Termination for
Cause. Except as otherwise provided in Article 13 of this
Agreement, a party may terminate this Agreement upon or after the breach of any
material provision of this Agreement by the other party if the other party has
not cured such breach within forty five (45) days after notice thereof by the
non-breaching party.
11.5 Effect of Expiration or
Termination. Expiration or termination of this Agreement shall
not relieve the parties of any obligation accruing prior to such expiration or
termination, and the provisions of Articles 9, 10, 12, 14 and 15 shall survive
the expiration or termination of this Agreement.
ARTICLE
12
INDEMNIFICATION
Transgenomic
shall defend, indemnify and hold Power3 harmless from all losses, liabilities,
damages, fines, penalties and expenses (including reasonable attorneys’ fees and
costs) incurred by Power3 as a result of any Third Party claim, demand, action
or other proceeding arising out of the manufacture, use, sale, performance or
other exploitation of the Licensed Technology by Transgenomic, or their
respective customers or a breach of the warranty set forth in Section
3.4. Power3 shall defend, indemnify and hold Transgenomic harmless
from all losses, liabilities, damages, fines, penalties and expenses (including
reasonable attorneys’ fees and costs) incurred by Transgenomic as a result of
any Third Party claim, demand, action or other proceeding arising from a breach
by Power3 of the warranties set forth in Sections 2.4 or 2.5. If
either party proposes to seek indemnification from the other party under the
provisions of this Section 12.1, it shall notify the indemnifying party
within thirty (30) days of receipt of notice of any such claim or suit;
provided, that the failure to notify shall not preclude a party's obligations
under this Section unless the failure to timely notify the other party
materially prejudices the other party. The indemnified party shall
have the right but not the obligation to participate in the defense of such
claim, and the parties shall mutually agree upon counsel and settlement terms
with respect to any such claim.
16
ARTICLE
13
FORCE
MAJEURE
Neither
party shall be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement to the extent, and for so
long as, such failure or delay is caused by or results from causes beyond the
reasonable control of the affected party including but not limited to fire,
floods, embargoes, war, acts of terror, acts of war (whether war be declared or
not), insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority (including the FDA) or other party. The
foregoing shall not apply to monetary obligations.
ARTICLE
14
LIMITATION OF LIABILITY;
WARRANTY DISCLAIMER
14.1 Limitation of
Liability. EXCEPT
FOR CLAIMS ARISING FROM BREACH OF ARTICLE 9 OR INFRINGEMENT OR MISAPPROPRIATION
OF A PARTY'S INTELLECTUAL PROPERTY RIGHTS OR CLAIMS INDEMNIFIED HEREUNDER, IN NO
EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA OR USE,
INCURRED BY EITHER PARTY OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR
TORT, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES.
14.2 Disclaimer of
Warranties. EXCEPT AS EXPRESSLY WARRANTED IN THIS
AGREEMENT, POWER3 DISCLAIMS AND TRANSGENOMIC HEREBY WAIVES ANY AND
ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION REGARDING THE SCOPE, COVERAGE, VALIDITY OR
ENFORCEABILITY OF ANY OF THE LICENSED TECHNOLOGY AND REGARDING THE INTENDED USE
BY TRANSGENOMIC OF THE LICENSED TECHNOLOGY OR LICENSED PRODUCTS (INCLUDING, BUT
NOT LIMITED TO, ANY INFRINGEMENT, MISAPPROPRIATION OR VIOLATION OF ANY
INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY AND ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE). FURTHER,
POWER3 MAKES NO REPRESENTATION OR WARRANTY THAT TRANSGENOMIC CAN SUCCESSFULLY
MAKE, SELL OR USE ANY LICENSED PRODUCTS.
17
ARTICLE
15
MISCELLANEOUS
15.1 Notices. Any
consent, notice or report required or permitted to be given or made under this
Agreement by one of the parties hereto to the other party shall be in writing,
delivered by any lawful means, and addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and (except as otherwise provided in this
Agreement) shall be effective upon receipt by the addressee as evidenced by the
delivery receipt.
If to
Power3:
Power3 Medical Products,
Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxx
Xxxxx X0-0
Xxx Xxxxxxxxx, Xxxxx
00000
Facsimile:
000-000-0000
If to
Transgenomic:
Transgenomic,
Inc.
00000
Xxxxx Xxxxxx
Xxxxx,
Xxxxxxxx 00000
Attn:
Legal Department
Facsimile:
000-000-0000
15.2 Governing
Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Nebraska, without regard to the
conflicts of law principles thereof.
15.3 Assignment. Neither
party shall assign its rights or obligations under this Agreement, in whole or
in part, by operation of law or otherwise, without the prior written consent of
the other party, which consent shall not be unreasonably withheld; provided,
however, that either party may assign this Agreement to the successor to all or
substantially all of its assets or business to which this Agreement relates or
to a successor through a merger. Any purported assignment in
violation of this Section 15.3 shall be void.
15.4 Waivers and
Amendments. No change, modification, extension, termination or
waiver of this Agreement, or any of the provisions herein contained, shall be
valid unless made in writing and signed by duly authorized representatives of
the parties hereto.
15.5 Entire
Agreement. This Agreement embodies the entire understanding
between the parties and supersedes any prior understanding and agreements
between and among them respecting the subject matter hereof. There
are no representations, agreements, arrangements or understandings, oral or
written, between the parties hereto relating to the subject matter of this
Agreement which are not fully expressed herein.
18
15.6 Severability. Any
of the provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the extent of such
invalidity or unenforceability in such jurisdiction, without rendering invalid
or unenforceable the remaining provisions hereof and without affecting the
validity or enforceability of any of the terms of this Agreement in any other
jurisdiction.
15.7 Waiver. The
waiver by either party hereto of any right hereunder or the failure to perform
or of a breach by the other party shall not be deemed a waiver of any other
right hereunder or of any other breach or failure by said other party whether of
a similar nature or otherwise.
15.8 Counterparts. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
15.9 Relationship of
Parties. Nothing in this
Agreement or in the course of business between Power3 and Transgenomic shall
make or constitute either Party a partner, employee or agent of the other
and the relationship between the Parties is
not a partnership, joint venture or agency. Neither Party shall have
any right or authority to commit or legally bind the other in any way whatsoever
including, without limitation, the making of any agreement, representation or
warranty.
15.10 Resolution of
Disputes. In the event of any dispute or disagreement between the
parties either in interpreting any provision of this Agreement or about the
performance of either party and upon the written request of either party
(“Dispute Notice”), each of the parties will appoint a designated representative
to attempt to resolve such dispute or disagreement. The designated
representatives will discuss the problem and negotiate in good faith in an
effort to resolve the dispute without any formal proceedings. The specific
format of such discussion shall be left to the discretion of the designated
representatives. In the event a dispute is not resolved within thirty (30)
days following the date of the Dispute Notice, the parties agree to proceed to
mediation under the Mediation Rules of the American Arbitration Association and
to conclude such mediation within ninety (90) days following the date of the
Dispute Notice. If the parties are unable to agree upon a mutually convenient
place for the mediation, the mediation shall take place in Omaha, Nebraska. Each
party will pay its own costs, plus an equal share of the cost of the mediator
and mediation facilities. If any dispute is not resolved by mediation, then
either party in its sole discretion may invoke litigation, provided that failure
to invoke litigation shall not be a waiver of any such
dispute. During any mediation or litigation which arises out of a
dispute, all parties will continue to proceed pursuant to the provisions of this
Agreement without prejudice to the rights of such parties under this Agreement.
Notwithstanding the foregoing, either party shall have the right, without
waiving any right or remedy available to such party under this Agreement or
otherwise, to seek and obtain from any court of competent jurisdiction any
interim or provisional relief that is necessary or desirable to protect the
rights or property of such party, pending the discussions and negotiations set
forth above.
19
IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first
set forth above.
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POWER3
MEDICAL PRODUCTS, INC.
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By:
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/s/ Xxxxx X. Xxxx
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Title: Interim
CEO
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TRANSGENOMIC,
INC.
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By:
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/s/ Xxxxx Xxxxxx
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Title: President &
CEO
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20
