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Item 1.01
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Entry into a Material Definitive Agreement.
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On February 4, 2025, the Company entered into a Binding Memorandum of Understanding (the "Binding MOU") with BioXtek, LLC, a Florida limited liability company ("BioXtek") setting forth the terms of a joint development, manufacturing, marketing and funding arrangement to be entered into by the Company and BioXtek in various phases (the "Joint Venture").
BioXtek is a privately-held Florida-based company engaged in the development, manufacturing and marketing of biologic regenerative therapeutics, with a focus on human placental tissue-derived ("HAF") products. BioXtek manufactures products both for itself and third parties. BioXtek's primary revenues are derived from the sale of membrane patches that are used primarily in the wound care and surgical markets ("Membrane Products").
BioXtek operates a cGMP, cGTP and AATB compliant 11,000 square foot manufacturing facility in Pompano Beach, Florida (the "BioXtek Facility").
The Joint Venture contemplates, among other matters:
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ZEO relocating its current operations located at Nova Southeastern University in Davie, Florida, to sublet space at the BioXtek Facility in Pompano Beach, Florida expected to be completed by May 31. 2025, which will include administrative, laboratory (research and development) and clean room (tissue processing) space, as well as shared common area space;
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BioXtek providing ZEO with the services of BioXtek technical, quality control and shipping personnel, as well as additional use of clean rooms, as ZEO may reasonably request, at agreed upon rates;
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If requested by ZEO and subject to BioXtek meeting ZEO's quality control and regulatory compliance, BioXtek becoming the exclusive contract manufacturer for ZEO's HAF and peripheral blood derived products;
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ZEO and BioXtek establishing a jointly-owned (50/50) special purpose entity (the "SPE"), to pursue the development and commercialization of agreed upon products including the Membrane Products, and conduct and complete of all required clinical trials with the goal of the SPE obtaining United States Food and Drug Administration (the "FDA") approval in the form of a "BLA" license or other designated license required by the FDA to permit the SPE to commercialize product(s) for mutually agreed upon indication(s) (the "SPE Business");
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ZEO and BioXtek contributing or licensing all necessary intellectual property to the SPE needed for it to conduct the SPE Business;
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ZEO and BioXtek using their respective commercially reasonable efforts to secure funding for the SPE Business;
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ZEO and BioXtek agreeing to certain confidentiality and non-competition covenants with respect to the SPE Business;
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The SPE becoming the exclusive distributor (subject to certain agreed upon exceptions for current customers of BioXtek) of the Membrane Products;
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Each of ZEO and BioXtek having certain rights with respect to the intellectual property, contributed or licensed to or developed by the SPE in the event the SPE is dissolved;
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