Source checked

KALA BIO signs U.S. ophthalmology testing distribution deal with Virotek

The five-year commercial agreement gives Kala exclusive U.S. distribution rights, subject to a September 2027 milestone, and half of net profit after Virotek recovers its cost of goods sold.

Sources

Verified facts from KALA BIO Form 8-K AccNo 0001829126-26-009999, Items 1.01 / 9.01 (Entry into a Material Definitive Agreement; Exhibits). Earliest event September 3, 2026; filed September 10, 2026. Exclusive Distribution and Reseller Agreement with Virotek, Inc. for U.S. ophthalmology genetic testing/screening Program; exclusivity contingent on Exhibit B milestone by September 3, 2027 (30-day cure then non-exclusive); equal net-profit split after Virotek recovers COGS in full; initial five-year term; ROFR on Ophthalmological Products. Commercial distribution agreement — not an acquisition or close.

Facts are as of the September 3, 2026 Exclusive Distribution and Reseller Agreement (earliest event), as summarized in the KALA BIO Form 8-K filed September 10, 2026 (AccNo 0001829126-26-009999). Framed as a commercial distribution/reseller agreement — not an acquisition or close. Exclusivity remains contingent on the September 3, 2027 Exhibit B milestone.

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Verified figures

Sources & evidence
  1. net profit share

    50/50 net-profit split after Virotek COGS recovery

    Economics of Exclusive Distribution and Reseller Agreement

    During term; may be varied by mutual written agreement

    KALA BIO, Inc. via SEC EDGARKALA BIO Form 8-K — Items 1.01 and 9.01 (AccNo 0001829126-26-009999)SEC Form 8-K · 09-10-2026

KALA BIO (Nasdaq: KALA) entered an Exclusive Distribution and Reseller Agreement with Virotek, Inc. dated September 3, 2026, appointing Kala sole and exclusive U.S. distributor and reseller of Virotek’s ophthalmology genetic testing and screening program. Exclusivity depends on Kala achieving an Exhibit B milestone by September 3, 2027; failure, subject to a 30-day cure period, makes the appointment non-exclusive. The commercial agreement provides for an equal net-profit split after Virotek recovers its cost of goods sold in full, an initial five-year term and a right of first refusal on proposed dispositions of Ophthalmological Products. Kala disclosed the agreement in a Form 8-K filed around September 10 under Items 1.01 and 9.01, AccNo 0001829126-26-009999.

Kala takes the commercial role

The agreement divides the work between the two companies: Kala handles commercial development, while Virotek, a Wyoming corporation, delivers and administers the program. The initial scope is ophthalmology genetic testing and clinical screening in the United States. The companies may add other verticals by mutual written agreement. This is a binding distribution and reseller arrangement; it does not transfer ownership of Virotek to Kala.

Exclusive rights carry a deadline

Kala’s exclusive appointment depends on meeting the milestone in Exhibit B by September 3, 2027. If Kala misses that requirement and does not cure the failure within the applicable 30-day period, its appointment converts to non-exclusive. That condition matters to the commercial opportunity: the agreement grants exclusive access to the U.S. distribution role, but keeping that position depends on performance.

Profit sharing follows cost recovery

Virotek first recovers its cost of goods sold in full. The companies then split net profit equally and review the economics monthly. The arrangement therefore gives Kala a share of net profit rather than half of gross sales. White-label economics are to be agreed in good faith. Those terms alone do not establish how much revenue or profit the program will generate for Kala.

Five-year term and a first-refusal right

The initial term runs for five years from September 3, 2026. Renewal requires mutual written agreement at least 180 days before expiration. Virotek also grants Kala a right of first refusal on a proposed sale, exclusive license or other disposition of any Ophthalmological Product, with at least 30 days to exercise that right. The provision gives Kala an opportunity to respond to a future proposed transaction; it is not itself a purchase of a product or business.

What determines the agreement’s durability

The September 2027 milestone is the key disclosed checkpoint for exclusivity. The agreement also allows termination for material breach left uncured for 30 days, insolvency, or loss of a required license, accreditation or Nasdaq listing that is not restored within 60 days. For investors, the distinction is between the contractual opportunity now established and the commercial results that still have to follow from development and delivery of the testing program.

Exhibit B milestone details, Program volume trajectory, and any white-label economics remain outside the 8-K summary

The Form 8-K summarizes exclusivity conditioning, equal net-profit split after COGS recovery, term, and ROFR; it does not publish the Exhibit B milestone metrics or forward Program revenue.

Document trail

Sources & evidence

Primary documents used for this piece.

  1. KALA BIO, Inc. via SEC EDGAR

    KALA BIO Form 8-K — Items 1.01 and 9.01 (AccNo 0001829126-26-009999)

    SEC Form 8-K · 2026-09-10

  2. KALA BIO, Inc. via SEC EDGAR

    Exclusive Distribution and Reseller Agreement dated September 3, 2026 — KALA BIO and Virotek

    SEC Exhibit 10.1 material contract · 2026-09-10

  3. U.S. Securities and Exchange Commission (EDGAR)

    KALA BIO Form 8-K filing index — AccNo 0001829126-26-009999

    SEC Form 8-K index · 2026-09-10

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