Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 129

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 129
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 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 automatically renewable for consecutive 1-year
terms (with the exception of pricing, which will be re-negotiated 90 days prior to the expiration of the term), unless either party gives
notice of termination at least 90 days prior to the then current term. The Supply Agreement may be terminated without cause by Baxter
upon