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A N N U A L R E P O R T F I S C A L Y E A R 2 0 0 7 OFFICE OF TECHNOLOGY TRANSFER ® OFFICE OF TECHNOLOGY TRANSFER 201 East Jefferson St., Ste. 215 James R. Zanewicz, JD, LL.M. Melea East, BBA, JD MedCenter Three Director Deputy Director email@example.com firstname.lastname@example.org Louisville, KY 40202 Phone: 502-852-2965 Fax: 502-852-2410 http://louisville.edu/thinker E-mail: email@example.com STAFF AND CONTACT INFO Cassandra Carmichael, BS Holly Symonds Clark, Ph.D Sandra Foster Matthew J. Hawthorne, JD Technology Manager Technology Manager Database and Finance Specialist Contract and Compliance firstname.lastname@example.org email@example.com firstname.lastname@example.org Specialist email@example.com Libby Kinberger Jacob N. Sotsky, BS Charlene Williams Christopher A. Willson, Administrative Assistant Asst. Technology Manager Docket and Compliance Specialist Ph.D., MBA firstname.lastname@example.org email@example.com firstname.lastname@example.org Assistant Director email@example.com Marketing Associates Sudeep Basu, Andrew Williams and Katerina Smolenkova are also vital to OTT’s operation. Welcome to the University of ings where we networked with colleagues and Louisville Office of Technology Transfer’s made contact with numerous potential com- Annual Report for fiscal year 2007 (July 1, 2006 mercial partners. We gave back both inside – June 30, 2007). We dedicate this report to UofL, educating students (our future work- those University of Louisville innovators who force) on research and intellectual property, continue to demonstrate their ability to “Think and outside UofL with many public service Outside the Lab.” events and other nonprofit activities. When you walk into the Office of Technology We paid tribute at the 2007 Celebration of Transfer (OTT), you immediately see our credo: Faculty Excellence to those innovators whose Imagine, inspire, dream. UofL’s innovators creative works resulted in awarded patents imagine that the world can become a better (five patents involving nine innovators) and place through their research and scholarly license and option agreements (seven agree- activities, they inspire others with their discov- ments involving 12 innovators). We continued eries and then they continue to dream that the successful Proof of Concept Grant program there are many more things to invent or ways (POCG), awarding four internal grants that will to improve what already exists. fund additional specific development of inno- The OTT strives to help them create maximum vations (i.e., data-generating tests, animal impact as we partner in this process, pledging studies or prototype creation) to enhance a to remain at the forefront of university engage- new discovery’s commercial potential. ment and to establish solid practices for the We hosted the inaugural Business Bootcamp, evolving national model of technology transfer. an intensive one-day workshop to educate the OTT’s model focuses on technology transfer as university community on business issues, and a series of ongoing partnerships, alliances and began an analysis that will enable us to more relationships — and making the best business closely align our business plan with the vision decisions possible for the university to gener- that Dr. Manuel Martinez-Maldonado, execu- ate value from our innovations rather than tive vice president for research, has for the dollars alone. At the same time we commit to university’s research development and growth. FROM THE DIRECT OR maintaining a high level of service to our part- ners and to advancing the educational mission Reading on, you will see that FY07 was once of the university. Our model’s success is again a year of milestones, excitement and demonstrated by the fact that OTT staff answer change. In closing, we’d like to note that while many questions from other universities who UofL came late into the technology transfer want to emulate our processes and organiza- game, as OTT learns and grows we continue to tional structure. imagine things to do that inspire our researchers, community partners and the com- In FY07 we are pleased to report the OTT monwealth of Kentucky to dream of a better evaluated 75 research disclosures — the world for us all. largest number yet — and our OTT-related alliances sponsored a record $1,884,740.13 in We welcome any comments or questions you research and clinical trials at UofL, keeping may have about our recent activities and any our “all income” amount over $2 million for suggestions you may have for new or improved the second year in a row. processes as we move forward. We continued UofL’s involvement in the Sincerely, Biotechnology Industry Organization (BIO) and the Licensing Executive Society (LES), as well as our partnership in the Ohio Valley Affiliates James R. Zanewicz, JD, LL.M for Life Sciences (OVALS). We also attended Director the COGR, NCURA and AUTM national meet- —1— TABLE OF WE THINK OUTSIDE THE LAB CONTENT S 3: ROI: RETURN ON INVESTMENT Mariusz Ratacjzak 4: INNOVATIONS AND RESEARCH Medicine-Oncology DISCLOSURES 5: COMMERCIAL ACTIVITY 6: ALLIES IN INNOVATION 7: PATENTS 8: CONTRACTS AND COMPLIANCE Shin-je Ghim 9: LOOKING AHEAD: FY08 Brown Cancer Center A. Bennett Jenson OTT THANKS THE Medicine-Oncology FY07 INTELLECTUAL PROPERTY COMMITTEE MEMBERS FOR THEIR SERVICE: Chair: Board of Trustees Nancy C. Martin, Q1 & Q2 Representative: Manuel Martinez-Maldonado, Sandra Metts Snowden Q3 & Q4 ULRF Officer: Faculty Representatives: Jonathan Blue John T. Cross Gina E. Bertocci James E. Graham Mechanical Engineering Legal Counsel to the Committee: William I. Norton Angela D. Koshewa Michael J. Voor Staff Representative: Danny K. McClung Student Representative: Scott Higdon Robert S. Keynton —2— Bioengineering The university continued its commitment to the mission of technology transfer by investing over $1.6 million in the technology transfer operation as a whole during FY07, including $750,000 in patent filings. From our Kentucky startup companies, — EndoProtech Inc., utilizing a novel ▼ AS A RESULT at least 57 full-time jobs, 16 part-time drug-delivery system to help prevent OF THIS jobs and 36 consultant positions exist- blood clots, among other applica- INVESTMENT: ed in FY07 in the commonwealth. tions — Claudio Maldonaldo, When you consider startups and young William D. Ehringer, Federico V. companies outside Kentucky, those Grossi, Gustavo Perez-Abadia were numbers greatly increase. its innovators. ROI: RETURN ON INVESTMENT ▼ ▼ More than $407,000 in license revenues One out-of-town startup was strength- and reimbursed patent expenses were ened with a license from the OTT. The received from OTT commercial activi- company and UofL innovators behind ties. the licensed technology are: The research activities of UofL investi- — Energetic Genomics Corp., commer- ▼ gators and clinicians received almost cializing an application that $1.9 million in sponsored programs enhances the ability to diagnose and clinical trials from companies that and monitor patients undergoing formed or developed relationships with treatments for cancer — Jonathan B. the university as a direct result of OTT Chaires, A. Bennett Jenson, Nichola activities. This created a total return of Garbett. nearly $2.3 million to the university in 114 material transfer agreements and ▼ FY07. 88 nondisclosure agreements were Equity stakes or membership interests processed, allowing faculty to receive ▼ for the University of Louisville were and supply the information and created in two new local companies research materials vital to success in and additional equity obtained in an competitive grant applications and existing licensee, creating and increas- other research activities. ing the possibility of future high value ▼ As of the close of FY07, UofL-related exit opportunities. startup companies had received more Two new local startup companies were than $19.7 million in seed and venture ▼ created in FY07 through license and capital funding rounds.* option agreements: Four “Proof of Concept” grants were ▼ — The Institute for Advanced Cancer awarded to further develop promising Therapeutics LLC, founded to help technologies. develop all oncology-related innovations and speed them into *According to information provided by Metacyte Business the marketplace. Labs and the Enterprise Corp. and reported in Business First. —3— INNOVATIONS AND RESEARCH DISCLOSURES INNOVATIONS REPORTED The University of Louisville received a total of 75 reported research disclosures on innovations developed in FY07, continuing our record of increasing growth in this important metric and reflecting an increased participation in the tech- nology transfer process. These innovations involved 108 Innovators in 35 UofL departments. Six university units engaged in the Technology Transfer process in FY07. In line with UofL’s invest- ment in life science research, School of Medicine innovators created 60 percent of the research dis- School of J.B. Speed School closures submitted, while the J.B. Speed School of Dentistry (5) of Engineering (24) Engineering continued its climb, contributing College of College of to 27 percent. The School of Dentistry showed an Business (1) Education increase of 6 percent, and the College of Arts & and Human Sciences had 5 percent of all disclosures. Development Additional contributions came from the College of (1) Business and the College of Education and College of Human Development. Arts & Sciences (4) School of Medicine (53) Thirty-five UofL innovators were involved in multiple research disclosures during FY07. Those contributing to four or more include: Six Disclosures: Four Disclosures: Robert Keynton Mark Crain John Naber A. Bennett Jenson Eugenia Wang Y. James Kang Jon Klein Five Disclosures: Michael Merchant Julia Abersold Thomas Roussel Douglas Jackson Henry Kaplan Kevin Walsh —4— The business unit continued to guide activities involved in the front end of research disclosure eval- uation and related marketing and commercial endeavors. Christopher Willson, assistant director, coordinates these functions. Working with him are director James Zanewicz, deputy director Melea East, Cassie Carmichael and Holly Symonds Clark on case management; Sudeep Basu, Andrew Williams and Katerina Smolenkova on marketing and evaluations; and Sandra Foster on data management and finan- cials. East and Willson conducted significant corporate outreach this fiscal year, targeting their efforts and meeting with 14 biotech companies one-on-one at BIO 2007 and many more companies at other events held at BIO, AUTM, OVALS and through various networking opportunities. The OTT completed seven license and option agreements in FY07. These represent activity with four local and one non- local startup companies (a fairly consistent 71percent of the commercial activity by the OTT), two of which were formed as a direct result of technologies that were or will be licensed or optioned out by the OTT. The remaining licenses represent activity with existing companies. As part of OTT’s ongoing efforts to broaden our COMMERCIAL ACTIVIT Y expertise and abilities with commercial assessments in FY07, we continued to utilize outside business expertise where appropriate and learn from the feed- back. To hone their skills, OTT staff attended the inaugural AUTM marketing course organized by Jane Muir, associate director of the University of Florida. Licensing royalty revenue, patent reimbursement and associated income all increased in FY07, growing the amount of all income received by nearly $250,000, or 12 percent. Start-up companies based on OTT commercial * * * licensing activities or existing companies that form relationships with UofL based on OTT licensing activities often fund clinical trials, sponsored * Significant increases due to larger amounts of research or service agreements (associated income) on the Associated Income. Associated Income includes licensed technology to best advance its development along income other than licensing revenue (i.e.: sponsored research, clinical trial, and service agreement the commercialization pathway. This is the early measura- revenue) received by UofL as a result of OTT ble return on biotech licenses, with royalty revenues arising interactions and activities. closer to the 10-year anniversary of the deal. —5— COMPANY Novera LLC: Pioneering the direct deliv- Visplex Association Inc.: Focused on ALLIES IN INNOVATION ALLIANCES ery of energy (ATP) to cells for wound- healing applications. research and development in the areas of “complexity science” and “visualiza- www.noveradrugs.com tion systems” as they apply to improving The OTT has many licensees, organizational performance. Novocell Inc.: Working to develop a optionees, sponsors of renewable source of specialized cells www.visplex.net research/clinical trials and other that can be used to treat chronic VitaTech LLC: Working on a variety of corporate alliances, including: cellular diseases using its proprietary applications for its product, VitaSol — cell encapsulation technology. from healing wounds to speeding the www.novocell.com production of proteins and enzymes in Antisoma Inc.: Specializing in the devel- Ocular Transplantation LLC: bioreactors, which would cut the cost of opment of novel drugs that target Developing proprietary products for the making drugs and other products. tumors by several different mechanisms treatment of vision loss in adults with www.vitatechonline.com and are intended for the treatment of a range of cancers. www.antisoma.co.uk degenerative retinal diseases. Assenti LLC: Designing technology to www.retinaltransplantation.com OTHER revolutionize care of individuals with OrthoData Technologies LLC: ALLIANCES glaucoma by accurately monitoring Developed a breakthrough diagnostic intraocular pressure levels, even outside system that will allow orthopaedic The OTT has many other the doctor’s office. www.assenti.net surgeons to accurately diagnose the alliances in Louisville and success of spinal fusion and eliminate Asterand PLC: A leading supplier of around the commonwealth: unnecessary exploratory surgery. high-quality human tissue and tissue- based services, with a mission to Peptides International Inc.: Specializes The Department of Commercialization accelerate target discovery and valida- in a wide variety of high-purity, biologi- and Innovation, headed by tion leading to new and improved cally active peptides and peptide-related Commissioner Deborah Clayton, therapeutics. www.asterand.com products and services; manufactures spearheaded Kentucky’s presence at and distributes biochemical products for ApoImmune Inc.: Committed to the BIO2007. The department continues to major research institutions worldwide. development of powerful new therapeu- develop cutting-edge statewide startup www.pepnet.com tics to treat chronic and acute life- strategies and has been very supportive threatening diseases and improve PGXL Laboratories: Provides testing of our university-originated companies. patients’ quality of life. that enables physicians to customize www.apoimmune.com medications to match patients’ drug Kentucky Science and Technology Corp. metabolisms, reducing possible adverse has supported UofL based innovations Biothera: Focused on developing drug reactions. www.pgxlab.com with many funded awards to our pharmaceuticals whose unique researchers and startup companies. mechanism of action engages immune Potentia Pharmaceuticals Inc.: Matt McGarvey, vice president of com- cells not normally involved in the fight Developing novel therapeutics, primarily mercialization and venture finance, and against cancer. in the area of macular degeneration. his team come to UofL whenever neces- www.biotherapharma.com www.potentiapharma.com sary to discuss venture funding opportu- Energetic Genomics Corp.: Developing Pradama Inc.: Development and nities from KSTC’s various programs. a novel micro-differential scanning commercialization of products to treat device that will be used for high- bone diseases, initially focused on MetaCyte Business Labs works with throughput drug screening applying osteoporosis. www.pradama.com UofL researchers to help them form UofL’s serum proteomic technology. companies, find financing and move Regenerex LLC: Develop, commercial- many university-owned technologies EndoProtech Inc: Utilizes a novel ize and market bioservice bone marrow from the mind to the marketplace. drug-delivery system to help prevent products to treat blood disorders and blood clots, among other applications autoimmune diseases, induce tolerance The Enterprise Corp. functions for solid organ transplants and provide as Louisville’s innovation and commer- Galleon Pharmaceuticals Inc.: regenerative therapies for disease relat- cialization center and helps startup Developing a major new class of medi- ed to damaged tissue. companies position themselves for and cines for sleep apnea and other condi- tions related to the body’s regulation of RhinoCyte Inc.: Focused on developing acquire venture funding. breathing. www.galleonpharma.com diagnostic tools and therapies for nasal- The Ohio Valley Affiliates for Life derived stem cell treatment of multiple Institute for Advanced Cancer Sciences continues its work to establish degenerative and traumatic neurological Therapeutics, LLC (IACT): Founded to the Ohio Valley region as a biotech cor- diseases. www.rhinocyte.com help develop oncology-related innova- ridor. tions and speed them onto the market. Strategic Health Systems LLC: Helping health-care providers standardize the The Louisville Medical Center MacuSight: Developing a new pharma- Development Corp. works to attract life way immunizations are administered ceutical therapy, based on a small mole- science companies to Louisville and to and recorded. cule drug already approved by the FDA provide adequate facilities and space for for another indication, to arrest neovas- SureGene, LLC: Utilizes modern startup companies. cularization associated with age-related genetic technology to discover the macular degeneration. underlying genetic basis for psychiatric www.macusight.com diseases. suregene.net NeoStem, Inc.: Specializes in the col- lection, processing and long-term stor- age of adult stem cells for future thera- peutic use. www.neostem.com —6— OTT filed 69 patent applications in FY07, a record number representing a 28 percent increase over FY06 fil- ings, and an investment in patent filings of more than $760,000. OTT continued to keep a watchful eye on control- ling patent expenses and also to take advantage of the U.S. Patent and Trademark Office rules for fil- ing provisional patent applications. These rules allow a shortened form of the formal full patent application to be prepared and filed, which must then be converted to a full patent application within one year of filing. The OTT determines which innovations to protect with patents on a case-by-case basis. We do this through team meetings to ensure the best possible course of action is taken for each innovation and the univer- sity as a whole. Nine patents were awarded in FY07, a steady rate from FY06. They include the following patents and their UofL innovators: 7 U.S. PATENTS — Application of a Viral Complement Inhibitory Protein in the Treatment and Diagnosis of Alzheimer’s Disease — James Daly, Girish J. Kotwal — System and Method for 3-D Digital Reconstruction of an Oral Cavity from a Sequence of 2D Images — Aly A. Farag, David Tasman, Sameh M. Yamany — Shape Analysis Of Surfaces — Edward Essock, Michael J. Sinai — Microarrays to Screen Regulatory Genes — Eugenia Wang — Direct Synthesis of Oxide Nanostructures of Low- Melting Metals — Mahendra K. Sunkara, Shashank Sharma — Bone Targeting Compounds for Delivering Agents to the Bone for Interaction Therewith — Leonard C. Waite, K. Grant Taylor, William M. Pierce — A Direct Cellular Energy Delivery System — Sufan Chien, William D. Ehringer 2 FOREIGN PATENTS PATENT S — Australia: Immune Modulation with Death Receptor- Induced Apoptosis — Haval Shirwan — European Union: Implantation Instrument and Method — Magdalene J. Seiler, Robert Aramant —7— CONTR ACTS AND COMPLIANCE The Contract and Compliance Unit continued to handle reporting for federally funded research disclosures, and drafted and negotiated agreements for the OTT including option, license, nondisclosure and material transfer agreements (MTAs). In addition to her other office-wide responsibilities, deputy director Melea East oversees and guides the strategy for the Contract and Compliance Unit. The unit also supports other SVPR offices by negotiating intellectual property issues in sponsored research and clinical trial agreements. East handled several complex license and option deals in FY07, while Matthew Hawthorne took point negotiating all MTAs and providing support to other SVPR offices to provide consistency in service and specialized expertise. Charlene Williams carried out federal reporting functions (over 249 actions reported to the government in FY07), in addition to her duties managing patent activities. Long-term projects initiated in FY07 include continued educational outreach by Hawthorne regarding the obstacles and opportunities of MTAs, representation by East on national policy committees and continued evaluation of best practices in structuring license agreements with companies, including beginning an analysis of the practical effect of terms in our existing agreements. The number of MTAs remained fairly steady at 114 while the ever-increasing research base required a growth in support for negotiated agree- ments (205 reviewed in FY07, representing a 25 percent increase), requiring OTT to continue pro- viding personnel dedicated to these issues. Negotiated agreements include confidentiality, research, clinical trial and other types of agree- ments with industry and other entities. —8— LOOKING AHEAD: F Y08 ▼ The OTT will remain focused on various ways of Integrating OTT activities with the new UofL generating benefit to the university and society, strategic research plan. appropriately centered on the theme of impact. Implementing the Wellspring web-based ▼ In line with the university missions of public database, including online disclosure forms benefit and economic development, this focus and marketing portals. on impact drives us to negotiate reasonable Continuing to investigate best practices for ▼ deals for our innovations and also to invest in optimal software licensing models, including other activities that are worthy but don’t neces- a possible web-based version. sarily generate a benefit measured in terms of Taking an active role in tracking and shaping ▼ “dollars.” federal policy issues that affect technology Specific activities will include: transfer offices and university startup compa- nies. ▼ Acting as lead on the planning of the OVALS ’08 conference and aligning it with a Hosting the Mad Scientist Mixer, Business ▼ community celebration to showcase both the Bootcamp and other informational and edu- university and the city of Louisville. cational sessions. ▼ ▼ Increasing the size of OTT’s staff to Maintaining focus on the societal benefit of maintain proper service levels. university technologies through licensing Benchmarking core licensing values with the terms that enhance end-user access to cer- ▼ “Nine Points to Consider” whitepaper. tain treatments. ▼ Increase return on investment from licenses and options. —9— FAST FACTS INTELLECTUAL PROPERTY AND LICENSING STATISTICS BY FISCAL YEAR 1997 2000 2003 2005 2006 2007 Disclosures Received and Processed 12 31 38 63 72 75 Material Transfer Agreements1 24 49 77 116 116 114 Patent Applications (per year) 1 20 31 48 61 69 Patent Applications (cumulative) 5 36 120 206 267 336 Patents Awarded (per year) 3 4 1 4 9 9 Patents Awarded (cumulative) 15 23 30 37 46 55 License/Option Agreements (per year) 1 3 6 8 8 7 License/Option Agreements (cumulative) 11 22 36 47 55 62 Negotiated Agreements2 12 84 175 241 164 205 Royalties $31,000 $53,929 $30,406 $80,923 $50,651 $87,629 Associated Income3 N/A $77,341 N/A $525,975 $1,796,525 $1,884,740 Patent Reimbursement Income * * * $153,288 $205,926 $319,956 All Income (royalties, associated, reimbursed) $31,000 $131,290 $30,406 $760,187 $2,053,102 $2,292,325 1 - Material transfer agreements are contracts that procure or provide materials vital to conducting research. 2 - Negotiated agreements include nondisclosure/confidentiality agreements and agreement review support for grants management and industry contracts. 3 - Associated income includes industry sponsored research negotiated as part of licensing/marketing activity or from startups that are based on ULRF-owned IP. * Significant increases due to larger amounts of associated income. Associated income includes income other than licensing revenue (i.e., sponsored research, clinical trial and service agreement revenue) received by UofL as a result of OTT interactions and activities. 31277—11-07; The University of Louisville is an equal opportunity institution.
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