The proposed commercial launch of the RELIEFTA™ OTC topical pain relief patch relies on an operational alignment between 11Three, LLC, Univec, Inc., and cGMP manufacturer Remy Biosciences. While the strategic architecture is in place, the plan remains in a pre-execution state pending two primary operational triggers: securing ~$5M in capital and executing formal binding contracts.
11Three, LLC: Provides the USA patent pending nano-delivery formulation (SENDS™), brand ownership, sales force, and medical provider marketing network.
Univec, Inc. / CentennialRx: Provides the established FDA administrative framework, national labeler code, and Private Label Distributor (PLD) eDRLS registration path.
To protect incoming production capital from legacy parent company liabilities (~$16.88M current liabilities and legacy state forfeiture flags), operations are structured through a multi-tier Delaware corporate design:
DE File #2670427 (1996 Parent) Master Public Parent (OTC: UNVC)
Holds Top-Level Equity & Ultimate Financial Consolidation
DE File #6437157 (2017 DE Co.) Intermediate Holding Vessel
Active Delaware Standing (Updated Oct 2025)
CentennialRx, LLC / Inc. Clean Operating Subsidiary
Signs cGMP Manufacturing Deals (Remy Biosciences)
Submits FDA eDRLS PLD Listing for RELIEFTA™
Isolates Incoming $5M Capital from Parent Liabilities
Execution Timeline
1. Secure ~$5M Capital
2. Execute Binding Contracts (CentennialRx + 11Three + Remy)
3. Deploy cGMP Production Run (Source APIs, Convert Matrix, Pouching at Remy)
4. Complete FDA eDRLS Listing (Finalize 11-Digit NDC Assignment)
5. Commercial Rollout (Point-of-Care / Workers' Comp / Medicaid /Physician Dispensing)
Remy Biosciences operates as a contract manufacturer specialized in OTC monographs, sublinguals, and transdermal patch technology. As an OTC cGMP manufacturer, Remy Biosciences produces patches compliant with FDA Good Manufacturing Practices (21 CFR Part 211).
They do not manufacture prescription (Rx) NDA pharmaceuticals.
Their role in the RELIEFTA™ model is strictly that of a cGMP converting and manufacturing plant—taking the formulation, coating/converting the adhesive patch matrix, pouching the product, and mapping their FDA Establishment Identifier (FEI) to the NDC listing.
RELIEFTA™ does not wait for an FDA approval letter. It requires an eDRLS SPL electronic listing to generate a active NDC for commercial distribution. While OTC monograph patches do not require a prescription to be bought, insurance programs (such as Workers' Compensation or specific Medicaid plans) can reimburse them only if they are ordered by a physician and carry an active NDC listed in national drug databases. Sourcing through Remy Biosciences limits the product strictly to the OTC monograph or topical matrix space, reinforcing that the commercial strategy must rely on point-of-care dispensing, OTC monograph compliance, and non-prescription billing codes.
Key Takeaway
The multi-tier Delaware architecture protects incoming production capital while providing a viable regulatory pathway to market via Workers' Comp and physician dispensing networks. However, commercialization remains paused in the pre-execution phase until the ~$5M in capital is deployed and binding contracts are formally executed.
Disclaimer; Not advice to buy or sell, do your own due diligence.
PL
11Three, LLC: Provides the USA patent pending nano-delivery formulation (SENDS™), brand ownership, sales force, and medical provider marketing network.
Univec, Inc. / CentennialRx: Provides the established FDA administrative framework, national labeler code, and Private Label Distributor (PLD) eDRLS registration path.
To protect incoming production capital from legacy parent company liabilities (~$16.88M current liabilities and legacy state forfeiture flags), operations are structured through a multi-tier Delaware corporate design:
DE File #2670427 (1996 Parent) Master Public Parent (OTC: UNVC)
Holds Top-Level Equity & Ultimate Financial Consolidation
DE File #6437157 (2017 DE Co.) Intermediate Holding Vessel
Active Delaware Standing (Updated Oct 2025)
CentennialRx, LLC / Inc. Clean Operating Subsidiary
Signs cGMP Manufacturing Deals (Remy Biosciences)
Submits FDA eDRLS PLD Listing for RELIEFTA™
Isolates Incoming $5M Capital from Parent Liabilities
Execution Timeline
1. Secure ~$5M Capital
2. Execute Binding Contracts (CentennialRx + 11Three + Remy)
3. Deploy cGMP Production Run (Source APIs, Convert Matrix, Pouching at Remy)
4. Complete FDA eDRLS Listing (Finalize 11-Digit NDC Assignment)
5. Commercial Rollout (Point-of-Care / Workers' Comp / Medicaid /Physician Dispensing)
Remy Biosciences operates as a contract manufacturer specialized in OTC monographs, sublinguals, and transdermal patch technology. As an OTC cGMP manufacturer, Remy Biosciences produces patches compliant with FDA Good Manufacturing Practices (21 CFR Part 211).
They do not manufacture prescription (Rx) NDA pharmaceuticals.
Their role in the RELIEFTA™ model is strictly that of a cGMP converting and manufacturing plant—taking the formulation, coating/converting the adhesive patch matrix, pouching the product, and mapping their FDA Establishment Identifier (FEI) to the NDC listing.
RELIEFTA™ does not wait for an FDA approval letter. It requires an eDRLS SPL electronic listing to generate a active NDC for commercial distribution. While OTC monograph patches do not require a prescription to be bought, insurance programs (such as Workers' Compensation or specific Medicaid plans) can reimburse them only if they are ordered by a physician and carry an active NDC listed in national drug databases. Sourcing through Remy Biosciences limits the product strictly to the OTC monograph or topical matrix space, reinforcing that the commercial strategy must rely on point-of-care dispensing, OTC monograph compliance, and non-prescription billing codes.
Key Takeaway
The multi-tier Delaware architecture protects incoming production capital while providing a viable regulatory pathway to market via Workers' Comp and physician dispensing networks. However, commercialization remains paused in the pre-execution phase until the ~$5M in capital is deployed and binding contracts are formally executed.
Disclaimer; Not advice to buy or sell, do your own due diligence.
PL
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