Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 128

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 128
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:----|:---------------|:----|:--------------|
| Dec. 14, 2016 |     | CA 3006695      |     | Organic solvent free compositions comprising protein-polymer 
 conjugates and uses thereof                                  |     | Canada  |     | GelrinC |     | Utility Patent |     | Dec. 14, 2036 |

| 1 | Nominal expiration date                                                                                           
 based on earliest effective filing date. Not including any possible future patent term extensions or adjustments. |

| 2 | As part                                                                                                                                     
 of our intellectual property strategy, we routinely file new patent applications aimed at protecting improvements and innovations           
 across our product candidates and platforms. We actively manage our patent portfolio to ensure continuity of coverage, including            
 filing newer, more targeted patent 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