Current Report · Items 1.01, 9.01 · 8-K
KALA BIO, Inc.
KALANASDAQEQUITYCurrent
Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement. On September 3, 2026, KALA BIO, Inc. (“Kala” or the “Company”) entered into an Exclusive Distribution and Reseller Agreement (the “Agreement”) with Virotek, Inc. (“Virotek”), a Wyoming corporation.…
Filed Sep 10, 2026Accepted Sep 10, 2026, 5:24 PM EDTCIK 1479419Accession 0001829126-26-009999
Company context
KALA is a clinical-stage biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins, and neurotrophic factors. KPI-012 received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing.
Current securities
Disclosure sections
Items 1.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 1.01Item 1.01 - Entry into Material Agreement
Item 1.01. Entry into a Material Definitive Agreement.
On September 3, 2026, KALA BIO, Inc. (“Kala”
or the “Company”) entered into an Exclusive Distribution and Reseller Agreement (the “Agreement”) with Virotek,
Inc. (“Virotek”), a Wyoming corporation. The following is a summary of the material terms of the Agreement and is qualified
in its entirety by the full text of the Agreement, a copy of which is filed as Exhibit 10.1 hereto. Capitalized terms used but not otherwise
defined herein have the meanings ascribed to such terms in the Agreement.
Pursuant to the Agreement, Virotek has appointed
Kala as the sole and exclusive distributor and reseller of a genetic testing and screening program for opththamology in the United States
for the term of the Agreement. This exclusive appointment is conditioned on Kala achieving the specific milestone set out in Exhibit B
of the Agreement on September 3, 2027. If Kala fails to meet this milestone, subject to a 30-day cure period, the appointment converts
from exclusive to non-exclusive.
The Program initially covers genetic testing and
clinical screening for ophthalmology, but the parties may expand into additional verticals by mutual written agreement. Kala is responsible
for all commercial development of the Program, while Virotek is responsible for delivery and administration of the Program. Before any
reseller may market or order the Program, Kala must cause the reseller to be bound by a written agreement on terms approved by Virotek.
Net profit is split equally between Virotek and
Kala after the cost of goods sold is recovered in full by Virotek. The split may be prospectively varied by mutual written agreement and
shall be reviewed monthly. When a white label opportunity arises, the applicable economics are to be agreed by the parties in good faith
prior to launch.
Virotek has granted Kala a right of first refusal
on any proposed sale, exclusive license, or other disposition by Virotek to a third party of any Opthalmological Product. Kala has at
least 30 days to exercise the right.
The Agreement has an initial term of five years
commencing September 3, 2026, and is renewable on agreed upon terms for successive periods by written mutual agreement at least 180 days
before expiration. Either party may terminate the Agreement immediately upon written notice if: (a) the other party commits a material
breach that remains uncured for 30 days after notice; (b) the other party becomes insolvent or enters bankruptcy proceedings; or (c) the
other party loses a required license, accreditation, or Nasdaq listing required to perform its obligation that is not restored within
60 days.