Exhibit 10.32

 

EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT

 

This Exclusive License And Distribution Agreement (“Agreement”) is made and
entered into as of December 31, 2014 (“Effective Date”), between Nuo
therapeutics, Inc., (formerly Cytomedix Inc.) a Delaware corporation, with
principal office at 207 Perry Parkway, Suite 1, Gaithersburg, MD 20877 (“Nuo”),
and ROHTO Pharmaceutical Co., Ltd., a Japanese company, with its principal
office at 1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan (“Rohto”). Each
of Nuo and Rohto is hereinafter referred to as a “Party” and collectively the
“Parties.”

 

RECITALS

 

A.            Nuo is the owner of certain intellectual property rights pursuant
to which it has commercialized a point of care cell separation device which
produces a platelet based therapeutic formulation for use on chronic, hard to
heal wounds and ulcers offered as the Aurix System.

 

B.            Rohto has capability of conducting clinical studies of medical
devices and has facilities and experience in the distribution, sale and service
of medical devices in the Territory (defined below), and desires to become the
exclusive licensee of certain intellectual property rights of Nuo under which it
will distribute the Products (defined below) in the Field of Use (defined
below), pursuant to the terms of this Agreement.

 

Now, Therefore, in consideration of the foregoing, and for other good and
valuable consideration, the receipt and sufficiency of which are acknowledged,
the Parties intending to be legally bound agree as follows:

 

AGREEMENT

 

1.            DEFINITIONS. When used herein, capitalized terms shall have the
following meanings:

 

“Affiliate” means, in respect of any Party, any other Person which, but only for
so long as such other Person, directly or indirectly, controls, is controlled
by, or is under common control with, such Party. The term “control” means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management or policies of a Person, through the ownership of
voting securities or other equity interests, and the terms “controlled” and
“common control” have correlative meanings.

 

“Change of Control” means: (i) the direct or indirect sale or other disposition
(in one or more related transactions to one or more Persons) of all or
substantially all of the assets of a Person, or (ii) the direct or indirect
transfer of 50% or more of the outstanding voting interest of a Person, whether
in a single transaction or series of related transactions.

 

“FDA” means the United States Food and Drug Administration and any successor
entity.

 

   

 

 

“Field of Use” means the use of the Product in the Territory for all wound care
and topical dermatology applications in human and veterinary medicine.

 

“Gross Sales” means the total sales amount including sales tax invoiced by Rohto
from the commercialization and sale of the Products to wholesalers, hospitals or
doctors.

 

“Intellectual Property” means, collectively, Patents, Trade Secrets, Copyrights,
Trademarks, Know How, moral rights, trade names, rights in trade dress and all
other intellectual property rights and proprietary rights, whether arising under
the laws of the United States or any other state, country or jurisdiction in the
world, including all rights or causes of action for infringement or
misappropriation of any of the foregoing. For purposes of this Agreement: (a)
“Patents”, “Know How” and “Trademark” shall have the meaning set forth below;
(b) “Trade Secrets” shall mean all right, title and interest in all trade
secrets and trade secret rights arising under common law, state law, federal law
or laws of foreign countries; and (c) “Copyrights” shall mean all copyrights,
and all other literary property and authorship rights, and all right, title, and
interest in all copyrights, copyright registrations, certificates of copyright
and copyrighted interests throughout the world.

 

“Know How” means any and all current and future know-how, technical information,
technical knowledge, unpatentable inventions, manufacturing procedures, methods,
trade secrets, processes, formulas, documentation and other tangible or
intangible property or rights relating to the Wound Dressing or Products,
whether or not capable of precise separate description but which alone, or when
accumulated, gives to the Person acquiring it an ability to study, test,
formulate, manufacture, produce or market something which it otherwise would not
have known to study, test, formulate, manufacture, produce or market in the same
or similar way.

 

“Marketing Authorization” or “MA” means the authorization by MHLW to manufacture
/ import, promote and sell the Product in Japan.

 

“MHLW” means the Ministry of Health, Labour and Welfare in Japan.

 

“Net Sales” means the Gross Sales less (i) sales tax (ii) trade, cash and
quantity discounts or rebates allowed or taken, and (iii) charges of insurance,
freight, and other transportation costs directly related to the delivery of the
Product. Notwithstanding the sum of items (ii) and (iii) will not exceed 10% of
Gross Sales.

 

“New Devices” means the new device covered by Nuo Patent-2 and the new
centrifuge for the new device which Nuo is developing as of the Effective Date.

 

“NHI” means national health insurance system in Japan, granted by the MHLW upon
submission after Marketing Authorization of the Product is granted.

 

“NHI Pricing Event” means the event when the NHI reimbursement price for the
Product in the Territory is achieved

 

“Nuo Clinical Data” mean any and all clinical and other data Nuo used for the
FDA 510(k) clearance of Aurix System or former AutoloGel System, or for license
or approval by other governmental authorities.

 

“Nuo Know How” means the Know How Nuo owns and obtains during the term of this
Agreement relating to Wound Dressing, Product and improvement thereto,
including, but not limited to, Nuo Clinical Data, treatment method of patient
using Wound Dressing, and PRP separation technology (from patient’s blood)
embodied in the Centrifuge.

 

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“Nuo Patent” means the Nuo Patent-1 and Nuo Patent-2 described in Exhibit 1
attached hereto and any Patent relating to the improvement of the Wound Dressing
or the Product in the Territory which Nuo files or obtains rights from a third
party during the term of this Agreement.

 

“Nuo Technology” means Nuo Patent and Nuo Know-How.

 

“Nuo Trademarks” means any and all Trademarks, trade names, service marks,
service names, logos and similar proprietary rights whether now or in the future
owned, controlled or licensed by Nuo and currently used or to be used in
connection with the Product. As of the Effective Date Nuo Trademarks are
described in Exhibit 2 attached hereto.

 

“Patent” means any patent application or patent, including all of the following
kinds and their equivalents outside the United States (as applicable):
provisional, converted provisional (or regular), divisional, continuation,
continuation-in-part, and substitution applications; and regular utility,
re-issue, re-examination, renewal and extended patents (including Supplementary
Protection Certificates), as well as all right, title and interest in all
letters patent or equivalent rights and applications for letters patent or
rights, industrial and utility models, industrial designs, petty patents,
patents of importation, patents of addition, certificates of invention and other
government issued or granted indicia of invention ownership, including any
reissue, extension, division, continuation or continuation-in-part applications
throughout the world.

 

“Person” means any natural person or any corporation, partnership, limited
liability company, business association, joint venture or other entity.

 

“PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan, which is
an agency of MHLW to review application of Marketing Authorization of
pharmaceuticals and medical devices in Japan.

 

“Point of Shipment” shall have the meaning given in the INCOTERMS 2010.

 

“Product” means the combination of devices to produce a Wound Dressing from the
patient’s blood. As of the Effective Date, the Product means Aurix System
(formerly AutoloGel System) which consists of Centrifuge, Wound Dressing Kit,
and Reagent Kit described in Exhibit 3 attached hereto.

 

“Territory” means Japan.

 

“Trademarks” shall mean all right, title and interest in all trademark, service
mark, trade name and trade dress rights arising under the common law, state law,
federal laws and laws of foreign countries, and all right, title, and interest
in all trademark, service mark, trade name and trade dress applications and
registrations interests throughout the world.

 

“Transfer Price” means the supply price of the Product from Nuo to Rohto, which
is Nuo’s manufacturing or procurement cost of Centrifuge and each Kit plus 10%
of such cost for Nuo’s direct overhead cost as described in exhibit 4 attached
hereto.

 

“Transition Event” means the earlier of (i) the occurrence of the NHI Pricing
Event or (ii) when NHI reimburse price submission is declined by MHLW.

 

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“Wound Dressing” means the mixture of platelet rich plasma (PRP) derived from
patient’s own blood and reagents which is covered by Nuo Patent-1.

 

2.            GRANT OF LICENSE

 

(a)          Exclusive License of Nuo Technology. Nuo grants to Rohto a royalty
bearing, nontransferable, exclusive license, with limited right to sublicense,
to use Nuo Technology for the development, import, use, marketing, sale, and
distribution of the Product in the Field of Use in the Territory.

 

(b)          Distribution Right. Rohto shall have an exclusive right, in the
Field of Use in the Territory, to import, use for development, promote, market,
sell and distribute the Product which Nuo manufactures or has contractor
manufacture for Nuo and supply to Rohto. Nuo shall not export, promote, or
supply the Product to any third party in the Territory.

 

(c)          Procurement of devices. Rohto reserves the right to manufacture or
purchase certain non-proprietary devices from a third party with Nuo’s approval,
such approval shall not be unreasonably withheld or delayed. In such case, Rohto
shall assemble such devices with other devices supplied by Nuo to make a Product
in the Territory. For avoidance of doubt, in such case the sales amount of
Rohto’s assembled Product as a whole shall be the base of Net Sales for royalty
payment set forth in Section 4 (c) of this Agreement.

 

(d)          Manufacturing Right. At any time after the Transition Event, upon
written notice to Nuo, Nuo shall grant to Rohto an exclusive license, with
limited right to sublicense, to use Nuo Technology for manufacturing, or having
third-party manufacture devices which are covered by Nuo Patent or embodied by
Nuo Know How, such as the New Devices and Centrifuge of current and future
version, for the Territory. Upon request of Rohto, Nuo shall provide Rohto with
reasonably sufficient information for Rohto to manufacture or have manufactured
such devices. For avoidance of doubt, in such case Rohto shall assemble Product
for the Territory, and sales amount of such Rohto’s assembled Product as a whole
shall be the base of Net Sale for royalty payment set forth in Section 4 (c) of
this Agreement.

 

(e)          Procurement by Rohto. With approval from Nuo, Rohto may procure all
components of the Product from Nuo’s suppliers and contract manufacturers
directly at the established Nuo contract prices. For avoidance of doubt, in such
case the sales amount of Rohto’s assembled Product as a whole shall be the base
of Net Sales for royalty payment set forth in Section 4 (c) of this Agreement.

 

(f)          Nuo Trademark. Nuo grants to Rohto a royalty free, nontransferable,
exclusive license, with the right to sublicense, to use Nuo Trademark for the
Product which Rohto import, develop, use, market, sell and distribute in the
Field of Use in the Territory. Nuo shall register the Nuo Trademark in the
Territory.

 

(g)          Trademark Option. Rohto reserves the right to use a trademark other
than Nuo Trademarks for the Product in the Territory.

 

(h)          Eastern and South Eastern Asian Countries. In the event Nuo intends
to appoint a licensee or a distributor of its Product in China, Hong Kong,
Macau, Mongolia, North Korea, South Korea, Taiwan, Brunei, Myanmar (Burma),
Cambodia, East Timor, Indonesia, Laos, Malaysia, Philippines, Singapore,
Thailand, Vietnam, India, Pakistan, or Bangladesh Nuo shall notify Rohto of such
intent and the expected timeframe for negotiations regarding such appointment. 
During the timeframe stipulated by Nuo, the Parties shall discuss in good faith
whether such country would be included in the Territory.

 

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(i)          Improvement by Nuo. In the event Nuo has filed a new patent
application in any country relating to Wound Dressing or Product, Nuo shall
promptly inform Rohto of the reasonable details of such patent application. For
avoidance of doubt, such patent application shall be included in the Nuo Patent.

 

(j)          Improvement by Rohto. In the event Rohto has filed a new patent
application for a new invention relating to Wound Dressing, Product or Nuo
Technology, Rohto shall inform Nuo of the reasonable details of such invention
promptly after Rohto has filed the patent application for such invention in the
Territory or in the U.S. In such event Rohto shall grant to Nuo a royalty free,
nonexclusive license to use such patent application outside the Territory during
the term of this Agreement. Upon request of Nuo at Nuo’s expense for filing,
prosecution and maintenance, Rohto shall file such patent application in
countries (other than Territory) designated by Nuo.

 

(k)          Modification of Component by Nuo. In the event Nuo intends to
modify or change any component (device) of the Product within the Field of Use,
Nuo shall inform Rohto of such intent reasonably prior to the implementation of
such modification or change. In the event Nuo decides to commercialize the New
Devices within the Field of Use in any country outside of Territory, Nuo shall
inform Rohto of such decision. For avoidance of doubt, the modified/changed
device or the New Devices shall be included in the Product and Rohto has the
exclusive right to import, use for development, promote, market, sell and
distribute such Product in the Territory and within the Field of Use.

 

(l)          Modification of Component by Rohto. Rohto reserves the right to
modify or change any component (device) of the Product in order to meet the
market needs in the Territory. In the event Rohto intends to implement such
modification or change within the Field of Use, Rohto shall inform Nuo of such
intent reasonably prior to the implementation of such modification or change.
For avoidance of doubt, the modified/changed device shall be included in the
Product and sales amount of such Rohto’s assembled Product as a whole shall be
the base of Net Sale for royalty payment set forth in Section 4 (c) of this
Agreement.

 

3.            DEVELOPMENT.

 

(a)          PMDA Consultation. Upon execution of this Agreement Rohto shall
consult with PMDA for a Marketing Authorization of the Product in the Territory.
Rohto shall conduct clinical studies in accordance with guidance of PMDA.

 

(b)          Nuo Information and Data. Upon Rohto’s reasonable request, Nuo
shall provide Rohto with Nuo Clinical Data, Product information, or other
information or data Nuo has or would be reasonably expected to have which are
required for MA application by Rohto in the Territory.

 

(c)          Clinical Studies. Rohto shall conduct required clinical and other
studies for the Marketing Authorization at its own expenses and responsibility.
Upon request of Rohto, Nuo shall supply Rohto with the Product or specific
devices in the Product at the Transfer Price.

 

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(d)           Safety Reporting. Prior to clinical studies, the parties shall
enter into a quality agreement that includes safety reporting for clinical
studies.

 

(e)          Marketing Authorization. Upon completion of the required studies,
and without unreasonable delay in the Territory, Rohto shall submit the MA
application for the Product with MHLW, and upon approval, Rohto shall be the
holder of the Marketing Authorization of the Product.

 

(f)          Inspection. In the event PMDA or other agency of MHLW requires
inspections of Nuo’s and/or its suppliers’ facilities (of the devices and
Product), Nuo will reasonably cooperate with such inspections and use
commercially reasonable efforts to cause its suppliers of the devices/Product to
cooperate with such inspections.

 

(g)          NHI Pricing. Promptly after the Marketing Authorization for the
Product is granted, Rohto shall submit, at its own expense, NHI reimbursement
for the Product with MHLW.

 

(h)          No Warranty. Rohto shall make commercially reasonable effort to
conduct required studies and seek the Marketing Authorization and NHI
reimbursement for the Product, provided that Rohto shall not ensure the
achievement of such approval or grant. Nuo acknowledges that such approval or
grant is at the discretion of MHLW.

 

(i)          Restriction. The Parties acknowledge that Rohto is strictly
prohibited by the relevant laws and regulations in the Territory to promote,
advertise, or sell the Product in the Territory until after the Transition
Event. Rohto shall start marketing and sale of the Product in the Territory only
after the Transition Event.

 

(j)          Quality Agreement. Prior to the Transition Event, the Parties shall
enter into a separate quality agreement that (a) defines Rohto’s rights to audit
manufacturing sites of each component (device) of the Product in compliance with
the requirements of relevant (QMS) regulations in Japan, (b) defines
specifications, shelf life of each component (device) of the Product, and
remedies for non-conforming Product, (c) defines labeling and package insert of
the Product, and (d) conforms to the quality plan and systems of Nuo.

 

(k)          Safety Agreement. Prior to the Transition Event, the Parties shall
enter into a separate safety agreement that defines the safety report, safety
database, product recall, post marketing survey, and so on in compliance with
the requirement of relevant laws and regulations in Japan and the United States.

 

(l)          Supply And Distribution Agreement. Prior to the Transition Event,
the Parties shall enter into a supply and distribution agreement with respect to
then current Product available at Nuo , which shall include the provisions of
Section 5. (DISTRIBUTION) and Section 6. (SUPPLY OF PRODUCT) of this Agreement
and minimum performance requirements.

 

4.            CONSIDERATION.

 

In consideration of the right and license granted to Rohto under this Agreement,
Rhoto shall pay to Nuo the following amount.

 

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(a)          Upfront Payment. Rohto shall pay to Nuo an upfront non-refundable
payment of Three Million United States dollars ($3,000,000) by wire transfer of
immediately available funds to the following account within thirty (30) days
after the Effective Date of this Agreement.

 

Company Name: NUO Therapeutics, Inc. Company Address: 207A Perry Parkway, Suite
1 Gaithersburg, MD 20877 USA     Bank Name: Capital One Bank (USA), N.A. Bank
Address: 1680 Capital One Drive McLean, VA 22102     Swift Code: HIBKUS44    
Routing Number: 255071981     Account Number: 2554300542

 

(b)          Milestone Payment. Upon occurrence of the NHI Pricing Event, Rohto
shall pay to Nuo a non-refundable payment of One Million United States dollars
($1,000,000) by wire transfer of immediately available funds to the account
specified above or to such other account as may be specified by Nuo in writing
within thirty (30) days after the NHI Pricing Event.

 

(c)          Royalty. Rohto shall pay to Nuo a royalty at the rate of nine (9)
percent based on the Net Sales (“Royalty”).

 

(i)          Report. No later than thirty (30) days after the end of each
calendar quarter, Rohto shall deliver to Nuo a written report detailing: (i) the
number of Product sold, (ii) Gross Sales and Net Sales generated from the sales,
and (iii) the resulting Royalty owed to Nuo.

 

(ii)         Payment. The Royalty owed to Nuo shall be paid by Rohto to Nuo by
wire transfer of immediately available funds in U.S. dollars to the account
specified above or to such other account as may be specified by Nuo or its
designee in writing. The Royalty shall be paid to such account within forty–five
(45) days after the end of each calendar quarter.

 

(iii)        Audit. Nuo shall have the right to audit the records of Rohto
relating to Net Sales at any time during the normal business hours upon
reasonable advance written notice. The audit will be performed no more than once
a fiscal year of Rohto by an independent reputable accounting firm at Nuo’s sole
expense. If the accounting firm determines that Nuo was not paid the full
Royalty owed, Nuo shall have the accounting firm submit the audit findings to
Rohto, and Rohto shall pay the amount of any shortfall within thirty (30)
business days after receipt of the audit findings. If Rohto fails to pay such
shortfall within such five (5) business day cure period, then interest shall
accrue on such shortfall (from the date it was due) at fifteen percent (15%) per
annum.

 

(d)          Withhold Tax. If applicable laws and regulations require
withholding of income or other taxes imposed upon any payments made by Rohto to
Nuo under this Agreement, Rohto shall make such withholding payments as may be
required and shall subtract such withholding payments from such payments. Rohto
shall submit appropriate proof of payment of the withholding taxes to Nuo within
a reasonable period of time. Rohto shall render Nuo reasonable assistance in
order to allow Nuo to obtain the benefit of any present or future treaty against
double taxation which may apply to such payments.

 

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5.            DISTRIBUTION.

 

(a)          Distribution. On and after the Transition Event, Rohto shall use
best efforts to market, distribute and sell the Product, consistent with the
terms and conditions of this Agreement. Additionally, Rohto shall provide
post-sale customer service for the Products in the Territory under the terms set
forth in this Agreement.

 

(b)          Appointment of Sub-Distributors. The Parties agree that Rohto’s
rights and obligations under this Agreement will, subject to terms and
limitations contained in this Agreement, be discharged and administered directly
by Rohto and may include the use of contractors, subcontractors, and agents, in
a manner substantially similar to the method that Rohto currently utilizes to
operate its existing businesses. Rohto shall remain responsible to Nuo for any
and all acts and omissions of such sub-distributors and agents.

 

(c)          Promotion of Product; Advertising.

 

(i)          Promotion. Rohto shall use its best efforts to develop a customer
base and market, sell and distribute the Product within the Territory. Rohto
shall advertise and otherwise promote the Product in a commercially reasonable
manner and furnish appropriate Product information and promotional materials to
its customers in a fashion similar to that used with Rohto’s other products.

 

(ii)         Translation of Materials. Rohto shall bear the cost and
responsibility to create and maintain all literature required, in all languages
required, in order to market, sell, distribute and service the Product in the
Territory, including all labeling, package inserts, instruction manuals,
registrations, sales literature and other promotional materials for the Product.
All translated materials shall be approved by Nuo prior to release and
distribution. Rohto shall attach a written statement with the translated
materials submitted to Nuo for approval certifying that the translation does not
misrepresent the claims of the original English-language material and is an
accurate translation.

 

(iii)        Recognition of Patents and Patents Pending. Subject to rules,
regulations and codes controlling the labeling and packaging of the Products,
Rohto may at its discretion include on each Product packaging a printed
statement identifying the patents under which the product is produced and
distributed. This notice may be modified by mutual consent of the Parties as
reasonably necessary to comply with applicable patent marking provisions of the
U.S. patent laws.

 

(d)          Forecasting of Products. Rohto shall annually provide to Nuo a
rolling forecast of Rohto’s requirements for the Product for the twelve (12)
month period commencing that quarter. The requirements for the first quarter
period of each forecast shall constitute a firm and binding Purchase Order for
Product, and shall be delivered to Rohto in full prior to the end of the same
quarter. The remaining rolling quarterly forecast shall constitute non-binding
estimates of Product and requirements for the period described; provided that,
the second (2nd) quarter in any forecast shall be varied by no more than 20%
when reported in the subsequent binding forecast, unless agreed to by Nuo. The
fourth (4th) quarter of each forecast are non-binding and may be modified by
Rohto at any time in its sole discretion. Nuo will not guarantee fulfillment of
orders constituting an aggregate increase in firm order quantities over
forecasted quantities for a given quarter in excess of 20%. In addition to the
forecast, Rohto is encouraged to provide Nuo at any time with advance
non-binding notice of expected significant changes to the existing quarterly
forecast for purposes of production planning.

 

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(e)          Regular Communication. The Parties will meet telephonically or
face-to-face no less than quarterly to review, among other things, sales
performance, progress on sales metrics, on hand inventory levels, customer usage
information, and make such adjustments and changes as are agreed to by the
Parties.

 

(f)          Reservation of Title. Except as expressly provided in this
Agreement, Nuo reserves to itself and retains all right, title and interest in
and to all Intellectual Property related to the Product and to any
modifications, enhancements, improvements and upgrades thereto implemented by
Nuo. Rohto may not duplicate, translate, decompile, reverse engineer or adapt
any Product or component parts thereof without Nuo’s prior written consent.

 

(g)          No Other Rights. Except as expressly provided in this Agreement, no
right, title, or interest is granted by Nuo to Rohto hereunder. Nuo may
distribute any products, other than the Product, which shall not compete with
the Product, within the Territory, either directly or indirectly through
distributors, and no right, title or interest is granted by Nuo to Rohto
relating to such products.

 

(h)          Other Information Reporting. Rohto shall provide to Nuo, at Rohto’s
expense and in English, each and every Product-related quality and/or
performance complaint reasonably after receipt of such complaint by customer.
Rohto shall use a complaint reporting form agreed upon by the Parties for
reporting the information to Nuo.

 

(i)          Post-Sale Service, Technical Assistance, and Support. Rohto shall
provide to its customers post-sale service, technical assistance and support for
Products sold by Rohto in the Territory, at Rohto’s sole cost and expense (other
than warranty claims in accordance with this Agreement).

 

6.            SUPPLY OF PRODUCT.

 

(a)          Transfer Price. On and after the Transition Event, Rohto shall
purchase, and Nuo shall supply all Products currently in production at the
Transfer Price.

 

(b)          Trade Term.

 

The Transfer Price for Product purchased by Rohto hereunder shall be Free
Carrier (“FCA”), Nuo’s Point of Shipment or other trade term the Parties agree.

 

(c)          Certain Taxes. The Parties acknowledge that the Transfer Prices of
Product do not include any sales, excise, use, value added or other government
taxes or duties that may be applicable to the export, import or purchase of the
Product, including all income and income-based taxes imposed on Nuo under
applicable laws in Territory, which taxes shall be the sole responsibility of
Rohto and Rohto agrees that it will bear all such taxes and duties.

 

(d)          Order and Acceptance. All orders for Product shall be by means of a
written purchase order which shall be submitted to Nuo at Nuo’s address for
notice purposes set forth in Section 12(e), and shall request a delivery date.
Orders may be placed by telephone, facsimile transmission or, upon the Parties’
agreement, by e-mail; provided, however, that a signed confirming purchase order
is received by Nuo no later than ten (10) business days after such order. Nuo
shall notify Rohto in writing within a reasonable period of time from submission
of the purchase order of any rejected order and the reason(s) for such
rejection.

 

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(e)          Invoicing; Payment. Nuo shall submit an invoice to Rohto with each
shipment of Product ordered by Rohto. Such invoice shall be due and payable
thirty (30) days following the date of such invoice. All invoices shall be sent
to Rohto’s address for notice purposes set forth in Section 12(e), without
regard to the actual shipping address for the Product. Each such invoice shall
state Rohto’s aggregate and unit purchase price for Product in the relevant
shipment, plus any freight, taxes or other costs incident to the purchase or
shipment initially paid by Nuo and to be borne by Rohto hereunder. Rohto shall
make all payments to Nuo under this Agreement in United States dollars in
immediately available funds to a bank account designated by Nuo in such invoice,
or otherwise designated by Nuo in writing. Rohto shall not take any credits or
offsets against amounts billed Rohto by Nuo without Nuo’s prior written consent.

 

(f)          Shipping; Risk of Loss.

 

(i)          All Product delivered by Nuo pursuant to this Agreement shall be
suitably packed for surface or air shipment, in Rohto’s sole discretion, in a
bulk shipping carton per the requirements set forth in the applicable purchase
order, marked for shipment to such location or locations as Rohto may designate,
and delivered to Rohto or its carrier, FCA, Nuo’s Point of Shipment. Risk of
loss of Product shall pass to Rohto upon delivery to the carrier at the FCA
Point of Shipment.

 

(ii)         Nuo shall ship all Product in accordance with Rohto’s delivery
instructions specified in Rohto’s purchase orders; provided, however, that if
Rohto does not provide delivery instructions with respect to the carrier to be
used, Nuo may use its customary carrier. Partial shipments are allowed. All
freight, insurance and other shipping expenses, as well as any special packing
expenses, shall be paid by Rohto. Rohto shall also bear all applicable taxes and
duties that may be assessed against the Product after delivery to the carrier at
the FCA Point of Shipment.

 

(iii)        Nuo shall use its good faith efforts to ship the Product within a
reasonable amount of time after receipt and acceptance of Rohto’s purchase order
for the Product, consistent with Nuo’s shipping procedures in place from time to
time. All shipments of Product shall be deemed to conform to the relevant
purchase order unless Nuo receives from Rohto, no later than fifteen (15) days
after the receiving date of a given shipment, written notice specifying the
shipment, the purchase order number and the exact nature of the discrepancy
between the shipment and the order.

 

7.            ADDITIONAL OBLIGATIONS OF ROHTO.

 

(a)          Compliance with Laws. Rohto shall comply in all respects with the
laws and regulations (including health and safety regulations) applicable to the
marketing, distribution, sale and service of Product within the Territory. Rohto
shall monitor the appropriate information sources in the Territory for material
changes in such laws and regulations relating to the distribution of Product
within the Territory and notify Nuo in writing of all such material changes.

 

(b)          U.S. Export Controls. Rohto understands and acknowledges that Nuo
is subject to regulation by agencies of the United States Government, including
the United States Department of Commerce, the United States Department of the
Treasury, and the United States Food and Drug Administration, which prohibit
export or diversion of certain products and technology to certain countries. Any
and all obligations of Nuo to provide the Product, documentation, or any media
in which any of the foregoing is contained, as well as any other technical
assistance shall be subject in all respects to such United States laws and
regulations as shall from time to time govern the license and delivery of
technology and products abroad by Persons subject to the jurisdiction of the
United States, including the Export Administration Act of 1979, as amended, any
successor legislation, and the Export Administration Regulations issued by the
Department of Commerce, Bureau of Export Administration. Rohto agrees to
cooperate with Nuo, including providing required documentation, in order to
obtain export licenses or exemptions therefrom.

 

 10 

 

 

(c)          Regulatory Relationships. Rohto shall communicate with regulatory
agencies within the Territory where the Product is registered, sold or serviced
by Rohto for purposes of monitoring and maintaining any necessary documents or
filings required for Rohto to conduct sales of the Product.

 

(d)          No Conflicting Commitments. Rohto shall not enter into any third
party commitments or contracts for Product sales or service and repair that
supersedes or conflicts with the terms and conditions of this Agreement.

 

(e)          Distribution of Competitive Products. Rohto agrees not to, directly
or indirectly, distribute or otherwise offer for sale platelet based products in
wound care.

 

(f)          Commercialization Resources and Diligence. Rohto shall apply best
efforts to the marketing, sales and customer support of the Product similar to
the effort and resources Rohto applies to its other products.

 

8.            ADDITIONAL OBLIGATIONS OF NUO.

 

(a)          Compliance with Laws. Notwithstanding Section 7 of this Agreement,
Nuo will obtain and maintain at its expense the necessary regulatory clearances
in the United States supporting the approval and clearance of the Product. Nuo
will assist Rohto, at Rohto’s expense, in obtaining regulatory clearances in
Rohto’s name for the Product. Nuo shall comply in all material respects with all
laws and regulations within the United States applicable to the manufacture,
labeling, packaging and sale of the Product. Nuo shall supply to Rohto only
Product which has 510(k) clearance or for which an application for such
clearance has been filed.

 

(b)          Support. Nuo shall provide consultation to Rohto concerning
technical aspects, regulatory approvals, and use of the Product from time to
time as reasonably requested by Rohto. Nuo shall also provide consultation to
Rohto regarding regulatory approvals within the Territory.

 

(c)          Scientific and Technical Information. Nuo shall provide to Rohto
scientific and technical information available to Nuo and required for
distribution to obtain any registrations, licenses and permits required for the
sale and distribution of the Product within the Territory, or to respond to
inquiries from customers or governmental or regulatory authorities.

 

(d)          Product Training. Nuo shall provide Product training for Rohto’s
product managers and field application specialists on an as-needed basis to
enable Rohto to promote the sale of Product and to perform post-sale customer
training, technical assistance and support for its customers. Such Product
training shall be conducted, at times and locations requested by Rohto and
agreed upon by Nuo, and will be free of charge, provided, however, that Rohto
shall be responsible for all out-of-pocket expenses incurred in connection with
such Product training, including travel, airfare and lodging expenses incurred
by Rohto’s personnel while attending such training. In addition, Nuo will
provide Product updates and service bulletins as they become available.

 

 11 

 

 

(e)          Information Reporting. Nuo shall provide to Rohto, at Nuo’s
expense, (i) information regarding any discovered defects in the Product, or any
malfunction or deterioration in the performance of the Products, and (ii) any
inadequacy in the labeling or the instructions for use. Rohto is responsible for
disseminating the information to customers and sales representatives as
appropriate.

 

(f)          Registrations, Licenses and Patents. Nuo shall, as necessary to
support approval, registration and licensing of the Products by Rohto in the
Territory: (a) maintain all current regulatory files, registrations and licenses
for Products outside of the Territory, (b) maintain and pay fees associated with
any third party intellectual property licenses, if any, necessary to practice
the rights granted under this Agreement, and (c) maintain and pay the associated
filing and maintenance fees for all patents owned by Nuo.

 

(g)          Responsible Person. Rohto shall notify the competent authorities in
Territory that it has been designated as the person responsible for the
marketing and distribution of the Product within the Territory, and Rohto’s
address for notice purposes in Section 12(e) shall be the principal place of
business for such purposes.

 

(h)          Inventory Requirement. Nuo or its contracted manufacturers will
maintain no less than forty five (45) days’ finished goods inventories of
Products based upon Rohto’s annual unit forecast, updated on a rolling quarterly
basis, pursuant to Section 5(d) above, and forty five (45) days’ inventory of
service and support parts, based on historical usage, to assure supply of
Product for customers.

 

(i)          Indemnity Obligations. Nuo will indemnify, hold harmless and upon
Rohto’s request, defend at its own expense Rohto and its officers, directors,
employees, agents, representatives, successors and assigns (collectively, the
“Rohto Indemnified Persons”) from and against any loss, claim, cost, suit,
action, liability, judgment, decree, damage or expense including reasonable
attorney’s fees, imposed upon, incurred by or asserted against the Rohto
Indemnified Persons, arising from any third party claim, demand or action
arising from (i) the infringement or misappropriation of the intellectual
property rights of a third party by a Product or use thereof, or Rohto’s use of
the Nuo Trademarks, pursuant to this Agreement and (ii) any defect in the
manufacturing or design of a Product.

 

9.            REPRESENTATIONS AND WARRANTIES OF THE PARTIES.

 

(a)          Nuo. Nuo hereby represents and warrants to Distributor that:

 

(i)          Nuo is a corporation duly incorporated, validly existing and in
good standing under the laws of the State of Delaware, and has all corporate
power and authority to own, lease and operate its properties and to carry on its
businesses as it is currently being conducted. Nuo has all necessary corporate
power and authority to enter into this Agreement and to perform its obligations
hereunder. This Agreement has been duly authorized, executed and delivered by
Nuo.

 

(ii)         The execution, delivery and performance by Nuo of this Agreement
and the consummation of the transactions contemplated hereby do not violate or
conflict with the Certificate of Incorporation or Bylaws of Nuo, any material
contract, agreement or instrument to which Nuo is a party or by which it or its
properties are bound, or any judgment, decree, order or award of any court,
governmental body or arbitrator by which Nuo is bound, or any law, rule or
regulation applicable to Nuo.

 

 12 

 

 

(iii)        As of the Effective Date Nuo has terminated the License And
Distribution Agreement executed as of September 10, 2009 between Cytomedix (now
Nuo) and Millennia Holdings, Inc.

 

(iv)        Nuo holds valid licenses to third party intellectual property, if
any, necessary to practice the rights granted in this Agreement. Further, Nuo is
the sole, exclusive and lawful owner of all right, title and interest in and to
the applicable Nuo Technology incorporated in the Product and to the Nuo
Trademarks. Nuo has not granted to any other Person any license, franchise or
other rights to acquire, use or exploit the Nuo Technology within the Territory
(or any portion thereof). Nuo has the right to grant the license, distribution
and other rights to Rohto hereunder.

 

(v)         Nuo has in place, and shall have in place during the time that the
manufacturing of the Products remains under its regulatory control: (1) a
quality management system that meets the requirements of current ISO 13485:2003
and 21CFR820; (2) required U.S. FDA registrations; (3) good manufacturing
practice (GMP) controls at all manufacturing facilities associated with Product;
(4) a change management system to control internal and supplier processes, so
that changes to processes, contact materials and devices/components are approved
by Nuo prior to implementation; (5) special process validations, specifically
for cleaning, sterile barrier packaging and sterilization; and (6) sterilizers
which maintain proper ISO certifications.

 

(b)          Rohto. Rohto hereby represents and warrants to Nuo that:

 

(i)          Rohto is a company duly organized and existing under the laws of
Territory, and has all power and authority to own, lease and operate its
properties and to carry on its businesses as currently conducted. Rohto has all
necessary power and authority to enter into this Agreement and to perform its
obligations hereunder. This Agreement has been duly authorized, executed and
delivered by Rohto.

 

(ii)         The execution, delivery and performance by Rohto of this Agreement
and the consummation of the transactions contemplated hereby do not violate or
conflict with the Certificate of Incorporation or Bylaws of Rohto, any material
contract, agreement or instrument to which Rohto is a party or by which it or
its properties are bound, or any judgment, decree, order or award of any court,
governmental body or arbitrator by which Rohto is bound, or any law, rule or
regulation applicable to Rohto.

 

(iii)        Rohto has (directly and/or with its Affiliates) the distribution
facilities and personnel reasonably necessary to perform its functions and
otherwise carry out its obligations under the terms of this Agreement.

 

10.          TERM AND TERMINATION.

 

(a)          Term. The term of this Agreement shall commence on the Effective
Date and shall continue for fifteen (15) years (the “Initial Term”), unless
earlier terminated pursuant to Section 10(b). If prior to the expiration of the
Initial Term either Party has not provided the other Party with written notice
of termination at least six (6) months prior to the expiration of the Initial
Term, this Agreement shall be automatically renewed for additional one (1) year
periods (the “Renewal Term” and together with Initial Term, the “Term”), subject
to termination during such Renewal Terms as set forth in this Agreement.

 

 13 

 

 

(b)          Termination of Agreement. This Agreement may be terminated as
follows:

 

(i)          The Parties may terminate this Agreement upon their mutual written
agreement.

 

(ii)         Nuo may terminate this Agreement if Rohto breaches any of its
material representations, warranties, covenants or obligations under this
Agreement and such breach continues for a period of thirty (30) days following
Rohto’s receipt of written notice from Nuo setting forth the nature of such
breach.

 

(iii)        Rohto may terminate this Agreement if Nuo breaches any of its
material representations, warranties, covenants or obligations under this
Agreement and such breach continues for a period of thirty (30) days following
Nuo’s receipt of written notice from Rohto setting forth the nature of such
breach.

 

(iv)        One Party may terminate immediately this Agreement by written notice
to the other Party upon the occurrence of any of the following events: (i) the
other Party is or becomes insolvent or unable to pay its debts as they become
due within the meaning of the United States Bankruptcy Code (or any successor
statute) or any analogous foreign statute; or (ii) the other Party appoints or
has appointed a receiver for all or substantially all of its assets, or makes an
assignment for the benefit of its creditors; or (iii) the other Party files a
voluntary petition under the United States Bankruptcy Code (or any successor
statute) or any analogous foreign statute; or (iv) the other Party has filed
against it an involuntary petition under the United States Bankruptcy Code (or
any successor statute) or any analogous foreign statute, and such petition is
not dismissed within ninety (90) days.

 

(v)         After the Initial Term or each Renewal Term, either Party may
terminate this Agreement at the end of the current Renewal Term by giving the
other Party written notice of termination at least six (6) months prior to the
end of the current Renewal Term.

 

(c)          Effect of Termination.

 

(i)          The expiration or earlier termination of this Agreement shall not
relieve any Party of any of its rights or liabilities arising prior to or upon
such expiration or earlier termination.

 

(ii)         Within ten (10) business days following the effective date of the
expiration or earlier termination of this Agreement, Rohto shall provide to Nuo
a complete inventory of Product in Rohto’s possession, in transit between
Rohto’s authorized locations or in transit to Rohto from Nuo or otherwise in
Rohto’s control. Nuo may inspect Rohto’s Product inventory and audit Rohto’s
records in the manner provided herein.

 

(iii)        If Rohto gives written notice of its intention not to renew for the
Renewal Term in accordance with this Agreement, then Rohto and Nuo shall meet to
establish a transition plan. In addition to establishing a transition plan,
Rohto shall:

 

(1)         make available any existing inventory of Product to Nuo, including
any Product that has been customized by Rohto;

 

 14 

 

 

(2)         transfer and assign all regulatory certifications or licenses
related to the Product;

 

(3)         provide customer information needed to facilitate the orderly
transition of the sale and marketing of the Product;

 

(4)         transition all manufacturing and vendor agreements;

 

(5)         negotiate in good faith to provide a license to use any Rohto
Intellectual Property related to or used in the sale of the Products by Rohto
pursuant to this Agreement; and

 

(6)         take any other action reasonably requested by Nuo to facilitate the
orderly transition of the sale and marketing of the Product in the Territory
following expiration of the Term.

 

(iv)        Notwithstanding the expiration or earlier termination of this
Agreement, Rohto may continue to market, distribute and sell Products within the
Territory after the expiration or earlier termination of this Agreement until
the earlier of (i) the date that Rohto has sold all of its Product inventory
existing as of the effective date of expiration or earlier termination and (ii)
the six (6)-month anniversary of the effective date of expiration or earlier
termination.

 

(d)          Force Majeure. Neither Party shall be liable to the other Party for
non-performance of or delay in performing its obligations hereunder to the
extent that performance is rendered impossible by strike, riot, war, acts of
God, acts of terrorism, earthquake, fire, flood, governmental acts or orders or
restrictions, failure of suppliers, or any other reason to the extent that the
failure to perform is beyond the reasonable control of the non-performing Party.

 

11.         CONFIDENTIALITY.

 

(a)          Confidentiality. Each Party acknowledges that, in the course of
performing its duties and obligations under this Agreement, certain information
that is confidential or proprietary to such Party (“Confidential Information”)
will be furnished by the other Party or such other Party’s representatives. Each
Party agrees that any Confidential Information furnished by the other Party or
such other Party’s representatives will not be used by it or its representatives
except in connection with, and for the purposes of, the development, promotion,
marketing, distribution and sale of Products under this Agreement and, except as
provided herein, will not be disclosed by it or its representatives without the
prior written consent of the other Party. Notwithstanding the foregoing, the
Parties agree that other than trade secrets (as defined under the Uniform Trade
Secrets Act or its equivalent in the Territory) all Confidential Information
shall be clearly marked “CONFIDENTIAL” or, if furnished in oral form, shall be
stated to be confidential by the Party disclosing such information at the time
of such disclosure and reduced to a writing by the Party disclosing such
information which is furnished to the other Party or such other Party’s
representatives within forty-five (45) days after such disclosure.

 

(b)          Exceptions. The confidentiality obligations of each Party under
Section 11(a) do not extend to any Confidential Information furnished by the
other Party or such other Party’s representatives that (i) is or becomes
generally available to the public other than as a result of a disclosure by such
Party or its representatives, (ii) was available to such Party or its
representatives on a non-confidential basis prior to its disclosure thereto by
the other Party or such other Party’s representatives, (iii) was independently
developed without the use of the other Party’s Confidential Information by
representatives of such Party who did not have access to the other Party’s
Confidential Information, as established by contemporaneous written records, or
(iv) becomes available to such Party or its representatives on an
non-confidential basis from a source other than the other Party or such other
Party’s representatives; provided, however, that such source is not bound by a
confidentiality agreement with the other Party or such other Party’s
representatives.

 15 

 

 

 

(c)          Authorized Disclosure. Notwithstanding any other provision of this
Agreement, each Party may disclose Confidential Information of the other Party:
(i) to the extent required to comply with applicable legal requirements
including as part of regular securities law reporting requirements and/or in
accordance with securities regulatory authority or securities exchange rules,
demands and/or practice; (ii) to the extent and to the persons and entities
required by rules of the National Association of Securities Dealers; provided,
however, that the responding Party shall first have given prompt notice to the
other Party hereto to enable it to seek any available exemptions from or
limitations on such disclosure requirement and shall reasonably cooperate in
such efforts by the other Party; or (iii) as necessary to file or prosecute
patent applications, prosecute or defend litigation or otherwise establish
rights or enforce obligations under this Agreement, but only to the extent that
any such disclosure is necessary.

 

(d)          Compelled Disclosure. In the event that either Party or its
representatives are requested or become legally compelled (by oral questions,
interrogatories, requests for information or document subpoena, civil
investigative demand or similar process) to disclose any Confidential
Information furnished by the other Party or such other Party’s representatives
or the fact that such Confidential Information has been made available to it,
such Party agrees that it or its representatives, as the case may be, will
provide the other Party with prompt written notice of such request(s) so that
the other Party may seek a protective order or other appropriate remedy and/or
waive compliance with the provisions of this Agreement. In the event that such
protective order or other remedy is not obtained, or that the other Party waives
compliance with the provisions of this Agreement, such Party agrees that it will
furnish only that portion of such Confidential Information that is legally
required and will exercise its best efforts to obtain reliable assurance that
confidential treatment will be accorded to that portion of such Confidential
Information and other information being disclosed.

 

(e)          Ownership of Confidential Information. The Party disclosing or
otherwise furnishing Confidential Information to the other Party will retain the
exclusive ownership of all right, title and interest in and to such Confidential
Information.

 

(f)          Survival. The obligations of the Parties under this Section 11
shall survive the expiration or earlier termination of this Agreement for a
period of three (3) years; provided, however, that information that is a “trade
secret” shall be not be used and shall be kept confidential by the Party
receiving such Confidential Information from the disclosing Party until such
information is no longer deemed a “trade secret” under the Uniform Trade Secrets
Act or its equivalent in the Territory.

 

12.         GENERAL PROVISIONS.

 

(a)          Independent Contractors. The relationship of Nuo and Rohto
established by this Agreement is that of independent contractors, and nothing
shall be deemed to create or imply any employer/employee, principal/agent,
partner/partner or co-venturer relationship, or that the Parties are
participants in a common undertaking. Neither Party may direct or control the
activities of the other Party or incur or assume any obligation on behalf of the
other Party or bind such other Party to any obligation for any purpose
whatsoever.

 

 16 

 

 

(b)          Governing Law. This Agreement and all acts and transactions
pursuant hereto and the rights and obligations of the Parties shall be governed,
construed and interpreted in accordance with the laws of the State of New York,
without reference to rules of conflicts or choice of laws. 

 

(c)          Dispute Resolution. Any disputes or controversies which may arise
between parties in connection with this Agreement shall be finally settled by
arbitration. Such arbitration shall be held in English, in Wilmington, Delaware,
the United States, pursuant to the Commercial Arbitration Rules of the American
Arbitration Association if arbitration proceedings are initiated by Rohto, and
in Osaka, Japan, pursuant to the rules of Conciliation and Arbitration of the
International Chamber of Commerce if arbitration proceedings are initiated by
Nuo. The decision of the arbitrator(s) shall be final and binding, and judgment
on the award rendered by the arbitrator(s) may be entered in any court having
jurisdiction thereof. The arbitrator(s) shall be authorized to award any relief,
whether legal or equitable, to the Party so entitled to such relief.

 

(d)          Entire Agreement. This Agreement, including the exhibits and any
schedules, sets forth the entire agreement and understanding of the Parties
relating to the subject matter hereof and supersedes all prior oral and written,
and all contemporary oral, negotiations, agreements and understandings with
respect to the same.

 

(e)          Notices. All notices, requests, claims, demands and other
communications hereunder shall be in writing and shall be given (and shall be
deemed to have been duly given upon receipt) by delivery in person, by cable,
facsimile or international courier, or by registered or certified mail (postage
prepaid, return receipt requested), to the other Party at the following address
(or at such other address for which such Party gives notice hereunder):

 

If to Rohto:

 

ROHTO Pharmaceutical Co., Ltd.
Grand Front Osaka Tower-B 29F 3-1,, Ofuka-cho, Kita-ku,
Osaka 530-0011　Japan
Attn: Division Manager, Medical Business Promotion Division
Telephone: +81 6 6758 1344
Facsimile:+81 6 6758 1244

 

If to Nuo:

 

Nuo Therapeutics, Inc.
207 Perry Parkway, Suite 1
Gaithersburg, MD 20877
Attention: Office of the Controller
Telephone: (240) 499-2680
Facsimile:

 

(f)          Assignment and Binding Effect. Except as otherwise provided in this
Agreement, neither Party may, directly or indirectly, assign its rights or
delegate its duties under this Agreement without the prior written consent of
the other Party; provided that Nuo may assign this Agreement (i) to an
Affiliate, (ii) to a successor to all or substantially all of the business or
assets of Nuo, (iii) to any secured party in connection with its rights under
the credit agreement and the other financing documents. No permitted assignment
of rights or delegation of duties under this Agreement shall relieve the
assigning or delegating Party of its liabilities hereunder. For purposes of this
Agreement, either Party shall be deemed to have assigned this Agreement in the
event of a Change of Control with respect to such Party. Subject to the
foregoing, this Agreement is binding upon, and inures to the benefit of, the
Parties and their respective successors and permitted assigns.

 

 17 

 

 

(g)          Partial Invalidity. If any provision of this Agreement is held to
be invalid by a court of competent jurisdiction, then the remaining provisions
shall remain, nevertheless, in full force and effect. The Parties agree to
renegotiate in good faith any term held invalid and to be bound by the mutually
agreed substitute provision in order to give the most approximate effect
intended by the Parties.

 

(h)          No Waiver; Amendment. No waiver of any term or condition of this
Agreement shall be valid or binding on any Party unless agreed to in writing by
the Party to be charged. The failure of either Party to enforce at any time any
of the provisions of the Agreement, or the failure to require at any time
performance by the other Party of any of the provisions of this Agreement, shall
in no way be construed to be a present or future waiver of such provisions, nor
in any way affect the validity of either Party to enforce each and every such
provision thereafter. This Agreement may not be amended or modified except by
the written agreement of the Parties.

 

(i)          Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which, taken
together, shall constitute one instrument.

 

(j)          Consent Not Unreasonably Withheld. No Party given the right to
approve or consent to any matter shall unreasonably withhold, condition or delay
its approval or consent. The failure to respond in writing within any specified
time period shall be deemed unconditioned approval of or consent to the relevant
matter; provided that the Party requesting such approval or consent gives
written notice requesting a response at least two (2) business days prior to the
expiration of the specified time period, if any.

 

(k)          Construction; Interpretation. The headings contained in this
Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement. Any section, recital, exhibit,
schedule and Party references are to this Agreement unless otherwise stated. No
Party, nor its counsel, shall be deemed the drafter of this Agreement for
purposes of construing the provisions of this Agreement, and all provisions of
this Agreement shall be construed in accordance with their fair meaning, and not
strictly for or against any Party. Each Party hereby acknowledges that they have
not relied on any promise, representation or warranty that is not set forth in
this Agreement. Whenever the words “include,” “includes,” “including” or similar
expressions are used in this Agreement, they will be understood be followed by
the words “without limitation.” All references to “$” or “dollars” are to U.S.
dollars, and all amounts to be calculated or paid under this Agreement will be
in U.S. dollars.

 

(l)          Further Assurances. Each Party agrees to cooperate fully with the
other and execute such instruments, documents and agreements and take such
further actions to carry out the intents and purposes of this Agreement.

 

(m)          Press Releases and Announcements. Except as may be contemplated
hereunder, neither Party may issue any press release, product any professional
publications or make any public announcement concerning the transactions
contemplated by this Agreement without the prior consent of the other Party,
except for any releases, publications or announcements which may be required by
or, in such Party’s discretion, reasonably necessary under applicable law, in
which case the Party proposing to make such release or announcement will allow
the other Party a reasonable opportunity to review and comment on such release,
publications or announcement in advance of such issuance or making.

 

[Remainder of This Page Intentionally Left Blank; Signature Page Follows]

 

 18 

 

 

In Witness Whereof, each of the undersigned has caused this Agreement to be duly
executed.

 

  Nuo therapeutics Inc.       Date: January 5, 2015  By: /s/ Martin Rosendale  
  Name: Martin Rosendale     Title: CEO         ROHTO Pharmaceutical Co., Ltd.  
      By: /s/ Kunio Yamada     Name: Kunio Yamada     Title: CEO

 

 19 

 

 

Exhibit 1

Nuo Patent

 

Nuo Patnet-1       Application No. JP2000-555609     Patent No. JP3993981    
Nuo Patent-2       Application No. JP2012-534244     Patent No. JP5502207

 

 

 

 

Exhibit 2

Nuo Trademark

 

AURIX

 

AURIX SYSTEM

 

AUTOLOGEL

 

CYTOMEDIX

 

NUO THERAPEUTICS

 

 

 

 

Exhibit 3

Product

 

Centrifuge II

 

Wound Dressing Kit Section I

S-Monovette Tubes ACD-A, 6.0ml Safety-MultiFly Set 21g x ¾” Tourniquet   Alcohol
Prep Pads 2-Ply Medium, Saturated with 70% Gauze Sponges   Adhesive Bandage
Strips   Foam Tub Holder  

 

Wound Dressing Kit Section II

Alcohol Prep Pads 2-Ply Medium, Saturated with 70% Gauze Sponges   3 mL Syringe
w/Needle 20 G x 1” 5 mL Syringe w/Needle 20 G x 1” 20 mL Syringe w/Needle   3
Way Stop Lock Discofix Blunt Needle Monoject 16” x 1 ½” Skin Protection Wipe
Cavilon—No Sting Barrier Film, 1.0 ml N-Terface Dressing 4” x 12” Strip

 

Reagent Kit   Ascor L 500, Ascorbic Acid Injection, USP,  500mg/mL McGuff
Pharmaceuticals, Inc. Calcium Chloride Injection, USP, 10% American Reagents,
Inc. Thrombin Topical (Bovine Origin) USP, Thrombin-JMI 5,000U Kings
Pharmaceuticals

 

 

 

 

 

Exhibit 4

 

Transfer Price

 

Procurement Cost 10% Mark-up

 

Centrifuge II TBD     Wound Dressing Kit TBD     Reagent Kit TBD