Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 128

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 128
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 notice of such material breach from TiGenix. Under the TiGenix Data Agreement, the Company paid TiGenix $400,000 upon execution of the TiGenix Data Agreement and has agreed to pay TiGenix an additional $400,000 upon the Company’s first submission to the FDA for a pre-market approval submission incorporating the control data for approval of a Company product. The TiGenix Data Agreement also provides that the Company may not use the control data for the approval of a product that competes or is likely to compete, directly or indirectly, with the TiGenix product ChondroCelect®, indicated for the repair of knee cartilage lesions, in certain countries listed in the TiGenix Data Agreement, and such list does not include the United States.

Manufacturing and Supply

We do not own or operate manufacturing
facilities for the production of clinical or commercial quantities of GelrinC. We rely on one from an expanding group of contract manufacturing
organizations, or CMOs, who are cGMP compliant and relevant technology qualified. The batches we used for the pivotal trial to-date were
manufactured and filled at an Israeli CMO. We intend to add North American and European CMOs when we progress to additional scale-up and
commercial launch needs. We currently have commercial supply agreements with our more strategic suppliers in the United States. and Europe
and continue to seek additional suppliers for strategically essential materials as well.

Some of the critical materials
and components used in manufacturing GelrinC are “off the shelf” components while others are custom-made components for us.
We currently have two suppliers, and to our knowledge, both are GMP compliant.

The following are summary
descriptions of our two supplier agreements to which we are a party.

Baxter Supply Agreement

On July 24, 2008, we entered
into a supply agreement, or the Supply Agreement, with Baxter Healthcare Corporation, or Baxter, and Teva Medical (Marketing) Ltd., or
Teva, which was amended and restated on January 6, 2009, pursuant to which we agreed to purchase Tisseel VHSD fibrin sealant Kit, or Tisseel,
from Teva, with Teva being Baxter’s exclusive distribution agent in Israel for Tisseel, for manufacturing of GelrinC.

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The Supply Agreement had an
initial term of 3 years which ended on April 1, 2011 but has an ever-green clause and is