OcuMedic’s Technology

OcuMedic’s technology was developed by Dr. Mark Byrne, Distinguished Professor of Chemical and Biomedical Engineering & Founding Head of the Biomedical Engineering Department at Rowen University and his research team. Dr. Byrne serves as Co-founder of OcuMedic and Chief Technical Officer. The technology rests on 9 issued patents, efficacy has been proven in an animal model. The intellectual property teaches a novel therapeutic contact lens with memory capable of controlled release of first line ophthalmic agents, both inflammatory and antibiotic. The technology has been developed for the most common and widely used contact lens material silicon hydrogel, (SiHy). The technology is also a platform technology and has been tested for a wide range of other drugs as well as molecules to enhance lens comfort and treat dry eye.

Controlled release from contact lenses has been the subject of discussions and investigation for fifty, (50) years. Previous methods suffer from either poor control of the release profile or inadequate drug loading with the overwhelming majority of researchers demonstrating both problems. Thus there are no products on the market today. With the OcuMedic’s method memory for the drug is produced during polymer synthesis where monomers are complexed non-covalently to the drug and crosslinked into a hydrogel matrix. Upon removal of the drug, macromolecular memory sites remain within the hydrogel with affinity for the drug. The drug’s heightened interaction with these memory pockets enhances its loading and SLOWS its transport within the hydrogel despite comparable free volume of drug transport. It has been shown that the extension of release has a strong dependence on mimicking biological recognition in the design exploiting the chemical diversity and amounts of monomers in relation to the drug. Thus OcuMedic’s can literally…. DIAL IN THE RELEASE OF DRUG FROM THE LENS OVER TIME delivering a therapeutic concentration of drug payload for the duration of wear.

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Overview OcuMedic’s intellectual property (“IP”) was developed at Auburn University (Auburn, Alabama) by Dr. Byrne and is owned by Auburn University. The IP is exclusively licensed worldwide in all fields of use to OcuMedic, Inc. with full rights to sublicense pursuant to the License Agreement, and all amendments, (collectively, the “License Agreement”). Available under NDA in due-diligence.

OcuMedic exclusively licenses 9 issued patents (5 US, 2 Canada, 1 Mexico, 1 India) and 1 pending patent (European Union). The License Agreement lists each patent in the appendices. Dr. Byrne was previously employed by Auburn as a tenured, endowed, distinguished professor and is the lead inventor on all intellectual property licensed to OcuMedic. All other listed inventors were/are members of the academic research team directed by Dr. Byrne.

The patents claim methods for making a lens which leads to controlled continuous release of an agent that covers all classes of therapeutics within topical eye drops as well as the two major types of contact lenses materials – hydrogel and silicone hydrogel lenses.

The License Agreement was originally executed on June 1, 2008 and has had three executed amendments (February 17, 2009, August 17, 2011, March 12, 2012) to add additional patents to the licensing agreement reflect additions to the patent portfolio. The license was updated (as of November 9, 2016) due to the reaching of various milestones, the addition of patents to the portfolio, and patent costs. The term of the License Agreement is perpetual until all technology rights to products based on the last issued patent expire in all countries worldwide, or unless otherwise terminated pursuant to the terms of the License Agreement.

The milestones that OcuMedic has reached as of the date of this report are as follows: proof of in vivo extended release from a contact lens platform in an animal model accompanied with a comparative in vivo release profile of at least one topical alternative and the first demonstration of clinical efficacy of contact lens mediated drug delivery in a platform subject to patent rights in an animal model.

A license issue fee was waived in lieu of equity interest. License maintenance fees and milestone payments are scheduled. Development milestones are included and involve an initial round of financing within 2 years of the restructuring effective date, phases of human clinical studies completed within 6 years, first commercial sale for human use within 8 years, and minimum sales of $250K per year starting in year 9 and every year afterward. Except as otherwise noted, failure to meet any of the above milestones will be grounds for Auburn to terminate the agreement, subject to a mutually agreeable period to allowing OcuMedic to rectify any such breach.

OcuMedic will pay Auburn a royalty of 1.75% of net sales of licensed products sold by OcuMedic and any sublicensees. License maintenance fees and milestone payments are due after commencement of clinical trials ($45K), upon FDA approval ($25K), Year 8 ($30K), Year 9 ($40K), Year 10 ($50K), Year 11 ($70K), Year 12 and every year afterward ($100K). Such payments are creditable towards royalties due for the given year (but not towards royalties in future years).

OcuMedic will pay Auburn a set percentage on all qualifying sublicense revenue received by OcuMedic from any sublicensee, based on OcuMedic’s achievement of milestones at the time of sublicense. These are on a sliding scale, before phase II human clinical trials (40%), before completing phase III (20%), before FDA approval (10%), after FDA approval (5%).

Issued Patents

• U.S. Patent 8,349,351. S. Venkatesh, M.E. Byrne. Contact Drug Delivery
System, Issued January 8, 2013.
• U.S. Patent 8,404,271. S. Venkatesh, M.E. Byrne. Contact Drug Delivery
System, Issued March 26, 2013.
• India Patent 252,966. S. Venkatesh, M.E. Byrne. A Method for Making a Contact Drug Delivery System,
Issued December 6, 2012.
• Mexico Patent MX 296025B. S. Venkatesh, M.E. Byrne. Contact Drug Delivery System,
Issued February 13, 2012. • Canada Patent 2,597,219. S. Venkatesh, M.E. Byrne. Contact Drug Delivery System,
Issued April 15, 2014. • Canada Patent 2,829,533. S. Venkatesh, M.E. Byrne. Contact Drug Delivery System,
Notice of Allowance January 4, 2016 (allowance fees are being paid). • U.S. Patent 8,349,352. A.L. Collins, A.D. Vaughan, S. Venkatesh, M.E. Byrne. Therapeutic Contact Lenses with Anti-Fungal Delivery,
Issued January 8, 2013.
• U.S. Patent 8,388,995. M. Ali, M.E. Byrne. Controlled and Extended Delivery of Hyaluronic Acid and Comfort Molecules Via A Contact Lens,
Issued March 5, 2013.
• U.S. Patent 9,238,003. C. White, S. Venkatesh, M. Ali, M.E. Byrne. Extended or Continuous Wear Silicone Hydrogel Contact Lenses for the Extended Release of Comfort Molecules,
Issued January 19, 2016.

Pending Patents

• European Union Patent Application 06734512.4 (PCT/US2006/004306) S. Venkatesh, M.E. Byrne. Contact Drug Delivery System. Auburn University’s (OcuMedic’s) contracted patent attorneys attend oral proceedings on July 20, 2016 at the European Patent Office (EPO) in Munich with amended claims in the above-referenced patent application.