NurExone Biologic Inc.'s wholly-owned subsidiary, Exo-Top Inc., has entered into a binding Memorandum of Understanding (MOU) with ExoLyra LLC to distribute naïve mesenchymal stem cell (MSC)-derived exosome products in Mexico. The agreement establishes a structured commercial foothold for Exo-Top by outlining specific financial and operational terms intended for incorporation into a Definitive Agreement within 45 calendar days. This arrangement marks Exo-Top's first structured commercial entry into the naïve exosome sector.

Proposed Agreement Targets Mexico And Broader Expansion

Under the MOU, ExoLyra would receive exclusive rights to market, import, and sell Exo-Top's exosome products in Mexico. The agreement also provides ExoLyra with a preferential right to negotiate exclusive distribution rights for Brazil and Panama for two years. Outside Mexico, the proposed agreement would grant ExoLyra non-exclusive global sales rights, subject to customer pre-clearance and customer-specific exclusivity provisions tied to purchase thresholds. Per-customer exclusivity may be triggered for pre-cleared international customers that purchase at least 90 units within a 90-day period, subject to annual maintenance of at least 150 units per year.

Financial Commitments And Performance Requirements

The proposed Mexico exclusivity period would initially span three years, with extension options that could bring the total term to 10 years if performance requirements are met. ExoLyra has agreed to fund initial distribution and market penetration efforts with available capital of at least $800,000, including licensing fees. The agreement calls for a non-refundable territorial exclusivity fee totaling $180,000, consisting of a $40,000 payment upon signing the definitive agreement and an additional $140,000 payment once products are ready for commercial shipment. Beginning in the fourth year, Exo-Top would also be entitled to an annual sales maintenance fee of $100,000.

Minimum Purchase Thresholds And Regulatory Responsibilities

To retain exclusivity in Mexico, ExoLyra must satisfy minimum annual purchase commitments, beginning with 20,000 units during the first 18 months, increasing to 35,000 units in Year 2, 50,000 units in Year 3, and 60,000 units annually from Year 4 onward. These commitments are subject to a 5% annual growth escalator up to a minimum performance ceiling of 70,000 units per year. At least half of those annual minimum purchases must be distributed within Mexico. ExoLyra would assume responsibility for regulatory compliance, including marketing, importation, distribution, labeling, and product classification requirements across active territories. The MOU also contemplates a 120-day cure period for financial or volumetric deficiencies before Exo-Top may convert the Mexico license to non-exclusive status or void it.