TENAX THERAPEUTICS, INC. 8-K

What Happened

• Tenax Therapeutics announced that on June 29, 2026 it and Orion Corporation entered a Supply Agreement under Orion’s option in the existing License Agreement. The Supply Agreement governs Orion’s manufacture and supply of the orally administered levosimendan product for development and, if approved, commercial use.
• Concurrently, Tenax and Orion executed a Sixth Amendment to the License Agreement that extends the U.S. regulatory approval milestone deadline to December 31, 2035 and adds certain information and cybersecurity requirements for Tenax.

Key Details

• Supply Agreement signed June 29, 2026; covers forecasting, ordering, delivery, quality, pricing, and handling of non‑conforming product.
• Initial Supply Agreement term: 5 years from first delivery; automatic 3‑year renewals unless either party gives 24 months’ prior written notice.
• Termination: either party may terminate for material breach (with a 60‑day cure period), insolvency, or in connection with termination of the License Agreement.
• Agreement includes cost‑sharing provisions to scale up Orion’s manufacturing capabilities.
• Sixth Amendment extends the date to obtain U.S. regulatory approval to Dec 31, 2035 and requires compliance with specified information/cybersecurity obligations.
• The Sixth Amendment is filed as Exhibit 10.1 to the 8‑K; the full Supply Agreement is intended to be filed with Tenax’s next Form 10‑Q.

Why It Matters

• This deal secures a named manufacturer and supplier for Tenax’s oral levosimendan candidate, a key step toward potential commercialization and managing supply‑chain risk.
• Extending the U.S. approval milestone to December 31, 2035 gives Tenax more time to pursue regulatory approval before either party can trigger termination for missed milestones.
• Cost‑sharing for scale‑up can lower Tenax’s near‑term capital burden but creates contractual commitments tied to manufacturing readiness.
• Investors should watch for the forthcoming Form 10‑Q exhibit with the full Supply Agreement and monitor progress toward regulatory and manufacturing milestones.