Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 131

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 131
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 applications as older patents near expiration. We believe that the anticipated        
 expiration of three U.S. patents related to our Gelrin technology—each scheduled to expire in the near term—does not               
 create a material gap in our intellectual property coverage or competitive position, due to newer, complementary patents and our   
 ongoing innovation. Accordingly, we do not rely on these expiring patents with respect to our current product candidates.          |

Data Agreement with TiGenix

We entered into a data agreement with TiGenix dated July 20, 2015, or the TiGenix Data Agreement, pursuant to which we licensed microfracture historical data that TiGenix compiled in a study that TiGenix conducted in 2011. The FDA has allowed us to use the licensed data as control data for our pivotal clinical trial for PMA.

The TiGenix Data Agreement grants the Company the right to use the control data on a non-royalty-bearing, paid-up, worldwide and non-exclusive basis for any purpose, including for use in connection with regulatory filings for the Company’s products, for a term for 30 years unless earlier terminated by the Company upon 30 days’ written notice, with or without cause. TiGenix is only permitted to early terminate the TiGenix Data Agreement if the Company fails to cure a material breach of the TiGenix Data Agreement within 60 days after receiving written 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
manufact