8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________

FORM 8-K

______________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 6, 2015

Nuo Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

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Delaware	01-32518	23-3011702
(State or Other Jurisdiction	(Commission	(I.R.S. Employer
of Incorporation)	File Number)	Identification No.)

207A Perry Parkway, Suite 1, Gaithersburg, MD 20877

(Address of Principal Executive Office) (Zip Code)

240-499-2680

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry into a Material Definitive Agreement.

On January 6, 2015, Nuo Therapeutics, Inc., a Delaware corporation (the “Company”), entered into Distributor Agreement and License with Rohto Pharmaceutical Co., Ltd., a Japanese company, with its principal offices in Osaka, Japan (“Rohto”) (the “Rohto Agreement”). Under the terms of the Rhoto Agreement, the Company granted to Rohto a royalty bearing, nontransferable, exclusive license, with limited right to sublicense, to use certain of the Company’s intellectual property for the development, import, use, manufacturing, marketing, sale and distribution for all wound care and topical dermatology applications of the Aurix system and related intellectual property and know-how in human and veterinary medicine in Japan, in exchange for an upfront payment to the Company of USD$3 million (which is reduced by the USD$1.5 million payment to Millennia Holdings, as set forth below). The Rohto Agreement also contemplates a milestone payment of USD$1 million in the event the reimbursement price for the product in Japan is achieved in the future, and future royalty payments based upon net sales of such systems in Japan. Rohto agreed to conduct required clinical and other studies for the marketing authorization with Japan’s Ministry of Health, Labour and Welfare at its own expense, including submission of the marketing authorization application with such regulatory agency. In the event the Company determines to seek distribution in other Eastern and South Eastern Asian countries, the parties agreed to negotiate in good faith such potential distribution arrangement. The initial term of the Rohto Agreement is fifteen years, which term is automatically renewable for an additional one-year period unless terminated by either party to the agreement. The Rohto Agreement contains other terms and provisions that are customary to agreements of this nature.

In connection with and effective as of the entering into the Rohto Agreement, the Company executed Amendment No. 5 to its Licensing and Distribution Agreement for the Company’s Aurix system in Japan with Millennia Holdings, Inc. (“Millennia”) dated September 10, 2009, as subsequently amended to date (the “Millennia Agreement”) to terminate the Millennia Agreement and to allow for the Company to transfer the exclusivity rights from Millennia to Rohto (the “Millennia Agreement Amendment”). The Millennia Agreement Amendment contemplates, among other things, termination of the Millennia Agreement effective upon the effective date of the Rohto Agreement, payment of one-time, non-refundable fee in the amount of USD$1.5 million to Millennia upon the Company’s receipt of the USD$3 million upfront payment from Rohto pursuant to the Rohto Agreement, and payment of certain future royalty payments to Millennia based upon net sales in Japan. The Millennia Agreement Amendment contains other terms and provisions that are customary to agreements of this nature.

The Rohto Agreement and the Millennia Agreement Amendment contain representations and warranties by each of the parties thereto. These representations and warranties have been made solely for the benefit of the other parties to such agreements and (i) should not be treated as statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate; (ii) may have been qualified in the agreements by disclosures that were made to the other party in connection with the negotiation of the agreements; (iii) may apply contract standards of “materiality” that are different from “materiality” under the applicable securities laws; and (iv) were made only as of the date of such agreements or such other date or dates as may be specified in the agreements.

Item 8.01 Other Events

On January 8, 2015, the Company issued a press release with respect to the above-referenced agreements. A copy of the press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01	Exhibits
99.1	Press Release dated January 8, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

Nuo Therapeutics, Inc.
By:	/s/ Martin Rosendale
	Martin Rosendale, ChiefExecutive Officer

Date: January 8, 2015

EX-99.1

Exhibit 99.1

 

NUO THERAPEUTICS AND ROHTO PHARMACEUTICAL CO. SIGN EXCLUSIVE LICENSING AND DISTRIBUTION AGREEMENT FOR AURIX IN JAPAN

GAITHERSBURG, Maryland – January 8, 2015 – Nuo Therapeutics, Inc. (OTCQX: NUOT) a pioneer in biodynamic therapies, today announced that it has signed an exclusive licensing and distribution agreement for the Aurix System with Rohto Pharmaceutical Co., Ltd. (“Rohto”), one of Japan’s leading pharmaceutical, health and wellness companies. Under the terms of the agreement, Nuo will receive an upfront payment from Rohto in exchange for an exclusive license and the right to develop and commercialize Aurix in the Japanese market. The agreement also contemplates additional royalty payments based on the net sales of Aurix in Japan and an additional future cash payment in the event specific milestones are met. In turn, Nuo will pay a one-time fee to Millennia Holdings (Millennia) to terminate the September 2009 license and distribution agreement. Millennia has been instrumental in establishing the advanced wound care market in Japan, and will continue to work with Rohto to develop the market for Aurix. Further, Rohto has assumed all responsibility for securing the Marketing Authorization (“MA”) from Japan’s Ministry of Health, Labour and Welfare (“MHLW”), while Nuo will provide relevant product information, as well as clinical and other data to support Rohto’s MA application.

“This agreement is a significant validation of Aurix from a leader in the Japanese healthcare market, and an important milestone as we expand the product’s footprint outside of the United States,” said Martin Rosendale, Chief Executive Officer of Nuo Therapeutics. “We are excited to work with the team at Rohto to support its regulatory initiatives, and to share in the longer-term commercial success of Aurix as it enters Japan.”

Kunio Yamada, Chief Executive Officer of Rohto Pharmaceutical Co., added, “We are thrilled to partner with Nuo to bring The Aurix System to the Japanese market. The license is consistent with our strategy of evolving Rohto into an integrated health and beauty care company and expanding into more advanced areas of life sciences, including wound care and regenerative medicine. We believe that the potential for this product is substantial, and look forward to taking Aurix through the regulatory process with the MHLW.”

The foregoing agreements contain other terms and provisions that are customary to agreements of this nature. For additional detail relating to the terms and provisions of such agreements please refer to the Company’s Current Report on Form 8-K filed with the SEC in connection therewith.

About Nuo Therapeutics

Nuo Therapeutics, Inc. is a biomedical company that pioneers leading-edge biodynamic therapies for wound care. The Company’s flagship product, Aurix is a biodynamic hematogel that harnesses a patient's innate regenerative abilities for the management of a variety of wounds. For additional information please visit www.nuot.com.

About Aurix

Aurix is the first platelet and plasma therapy system to be cleared by the FDA for the management of ulcers and wounds of all types (diabetic foot ulcer, pressure ulcer, venous leg ulcer, etc.) and all severities (partial thickness, full thickness, and complex wounds). It can be used successfully on patients with tunneling, sinus tracts, bone and tendon exposure, and hardware exposure.

Unlike other cellular-based treatment options, Aurix is derived from a patient's own platelets and plasma (autologous). Once applied, the product goes to work, stimulating the natural healing process to form tissue to fill in wound defects and help reduce wound volume. Aurix produces visible results in days, not weeks and is effective at all stages of wound care for non-healing wounds.

Safe Harbor Statement -- Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Nuo Therapeutics actual results may differ materially due to a number of factors, many of which are beyond Nuo Therapeutics' ability to predict or control, including, without limitation, the Company’s ability to expand and commercialize its products in Japan, to secure (directly or indirectly) necessary regulatory approvals, the Company's ability to successfully launch and rebrand its wound care system in the timeframe and to the extent anticipated, the Company’s ability to estimate the potential of the wound care market and to commercialize any of its rebranded products / therapies, successfully execute its Aurix (formerly AutoloGel) sales and commercialization strategies, the Company’s ability to launch Aurix as expected and derive financial and commercial benefits of such launch, to achieve Aurix expected reimbursement rates in 2014 and thereafter, the Company's ability to comply with the debt covenants and restrictions under the existing loan facilities, the Company’s ability to realize expected benefits from the Arthrex licensing arrangement, the Company's ability to collect the data necessary for the grant of the unconditional coverage, the Company's ability to continue in its efforts to expand in the wound care market, its ability to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments, the likelihood of a favorable CMS determination relating to the reimbursement rates for Aurix, to successfully realize sales of the Angel Technology resulting in the royalty stream to the Company, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Nuo Therapeutics ability to execute on its strategy to market the Aurix System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Nuo Therapeutics, Inc. Nuo Therapeutics operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Nuo Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2013, the most recent Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, and other subsequent public filings. These filings are available at www.sec.gov.

Contact:
Nuo Therapeutics, Inc. Martin Rosendale, CEO Steven Shallcross, EVP/ CFO
240-499-2680 Investors: The Ruth Group Lee Roth
646-536-7012 lroth@theruthgroup.com