License Transactions	9 Months Ended
Sep. 30, 2024
License Transactions
License Transactions	11. License Transactions In the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS. On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”) for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”) of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade RBS for the treatment of bacterial, fungal, and viral infections of the eye. The Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company paid $5,000 for the option that expires on May 31, 2023; agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option and up to $25,000 of past UM patent expenses for this IP; and entered into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis. On March 21, 2024, the Company entered into an Exclusive License Agreement with the UM for the license and development of the University’s IP related to photodynamic antimicrobial therapy in ophthalmology. The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell Licensed Products and/or Licensed Processes based upon patent-related rights. As consideration for the rights granted in the License Agreement, the Company paid an upfront fee of $10,000, royalties equal to 10% of net sales of Licensed Products and/or Licensed Processes, and annual payments of $1,000 on the first through fourth anniversaries of the License Agreement and $10,000 on every anniversary thereafter. In the event of a sublicense to a third party, the Company is obligated to pay royalties to the University equal to a percentage of sublicense income ranging from 10% to 30% depending on the phase of clinical trials. The License Agreement provides that, within one year, the Company will create a corporation (“NewCo”) for the purpose of developing and commercializing Licensed Products and Licensed Processes, assign the License Agreement to NewCo, and enter into an equity agreement with respect to NewCo’s securities. Pursuant to the equity agreement, NewCo will be required to issue to the University 5% of the total number of issued and outstanding shares of NewCo. The University will have certain anti-dilution rights related to additional issuances of NewCo securities before NewCo receives a total of $2,000,000 in cash. The License Agreement sets forth certain diligence milestones that include forming NewCo, creating a Licensed Product suitable for submission to the Food and Drug Administration (“FDA”), generating Licensed Product data suitable for required submission to the FDA, submitting a drug-device combination application to the FDA, and receiving clearance, approval or other authorization from the FDA for the Licensed Product portion of the drug device combination. The License Agreement also provides for development milestone payments of $5,000 upon the first commercial sale of an approved Licensed Product and $50,000 upon net sales of Licensed Product of at least $500,000. The term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years from the first commercial sale of Licensed Product and/or Licensed Process. The License Agreement provides that the Company may terminate the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after receipt of written notice

License Transactions

9 Months Ended

Sep. 30, 2024

11. License Transactions

In the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS. On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”) for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”) of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade RBS for the treatment of bacterial, fungal, and viral infections of the eye. The Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company paid $5,000 for the option that expires on May 31, 2023; agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option and up to $25,000 of past UM patent expenses for this IP; and entered into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis.

On March 21, 2024, the Company entered into an Exclusive License Agreement with the UM for the license and development of the University’s IP related to photodynamic antimicrobial therapy in ophthalmology. The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell Licensed Products and/or Licensed Processes based upon patent-related rights.

As consideration for the rights granted in the License Agreement, the Company paid an upfront fee of $10,000, royalties equal to 10% of net sales of Licensed Products and/or Licensed Processes, and annual payments of $1,000 on the first through fourth anniversaries of the License Agreement and $10,000 on every anniversary thereafter. In the event of a sublicense to a third party, the Company is obligated to pay royalties to the University equal to a percentage of sublicense income ranging from 10% to 30% depending on the phase of clinical trials.

The License Agreement provides that, within one year, the Company will create a corporation (“NewCo”) for the purpose of developing and commercializing Licensed Products and Licensed Processes, assign the License Agreement to NewCo, and enter into an equity agreement with respect to NewCo’s securities. Pursuant to the equity agreement, NewCo will be required to issue to the University 5% of the total number of issued and outstanding shares of NewCo. The University will have certain anti-dilution rights related to additional issuances of NewCo securities before NewCo receives a total of $2,000,000 in cash.

The License Agreement sets forth certain diligence milestones that include forming NewCo, creating a Licensed Product suitable for submission to the Food and Drug Administration (“FDA”), generating Licensed Product data suitable for required submission to the FDA, submitting a drug-device combination application to the FDA, and receiving clearance, approval or other authorization from the FDA for the Licensed Product portion of the drug device combination. The License Agreement also provides for development milestone payments of $5,000 upon the first commercial sale of an approved Licensed Product and $50,000 upon net sales of Licensed Product of at least $500,000.

The term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years from the first commercial sale of Licensed Product and/or Licensed Process. The License Agreement provides that the Company may terminate the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after receipt of written notice