nice buy here
Gaithersburg's Nuo Therapeutics signs agreement to market its wound care products in Japan
Jan 9, 2015, 2:21pm EST
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Martin Rosendale is the chief executive officer of Nuo Therapeutics, formerly known as Cytomedix Inc. The company announced Friday it signed an exclusive licensing and distribution agreement for its Aurix wound-care system that will allow it to expand in Japan, officials announced Friday.
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Gaithersburg's biomedical Nuo Therapeutics (OTCQX: NUOT) signed an exclusive licensing and distribution agreement for its Aurix wound care system that will allow it to expand in Japan, officials announced Friday.
Under the agreement with Rohto Pharmaceutical Co., Ltd., one of Japan's leading pharmaceutical and wellness companies, Nuo will receive an upfront payment in exchange for an exclusive license and the right to develop and commercialize Aurix in the Japanese market. Nuo will pay a one-time fee to Millennia Holdings to terminate an agreement from a September 2009 license and distribution agreement. Millennia will continue to work with Rohto to develop the market for Aurix.
It's a significant move for the regenerative medicine company, which made a significant rebranding move last year by changing its name from Cytomedix, saying it wanted to focus on marketing Aurix, a platelet and plasma therapy system used for the management of ulcers and wounds.
The Centers for Medicare & Medicaid Services approved Cytomedix-Re-Launches-Chronic-Wound-Care-System-Under-Aurix-Brand.html" target="_blank" reimbursement coverage of Aurix last year. The company raised $37 million in capital for its capitalization strategy and Cytomedix relaunched the chronic wound care system under the brand Aurix. The company also moved to a 9,000-square-foot office near its former Perry Parkway headquarters. Nuo Therapeutics has 45 employees, with 21 of them working from the Gaithersburg office.
It was a big shift for the company that was delisted from the New York Stock Exchange in 2011.
"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," Martin Rosendale, chief executive officer of Nuo, said in a statement.
Rohto officials said the license is part of a strategy to evolve into an integrated health and beauty care company, as well as more advanced areas of life sciences — including wound care and regenerative medicine. "We believe that the potential for this product is substantial," Kunio Yamada, chief executive officer of Rohto, said in a statement.
n 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.
GAITHERSBURG, Md., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Nuo Therapeutics, Inc. (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.
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