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1 BERKELEY, CA - JUNE 16: Researchers conduct testing at Caribou Biosciences in

1 BERKELEY, CA - JUNE 16: Researchers conduct testing at Caribou Biosciences in Berkeley, CA. (Photo by Don Feria/AP Images for Caribou Biosciences) COPYRIGHT:Image © 2014 Don Feria www.ipira.berkeley.edu Entrepreneurs’ Startup Guide Ipira.berkeley.edu 2 www.ipira.berkeley.edu Table of Contents Introduction 3 Licensing from the University 4 The Mission of University Technology Transfer 4 The Licensing Process 6 Managing Conflict of Interest 7 Forming the Company 8 Frequently Asked Questions 19 3 www.ipira.berkeley.edu Introduction Universities, with their significant investment in research, discovery, and problem solving, are a fertile ground for innovations that can potentially be used to create novel products and services that will benefit the public. A significant investment of both time and resources is required to translate an academic discovery into the marketplace as new technology and products and success is not guaranteed. To encourage development, university technology transfer offices secure intellectual property rights that can protect the investment required to bring a new technology to market. Successful technology transfer allows research programs at universities to achieve greater impact and concretely improve the lives of our citizens, while also generating revenue, which can support future research programs and provide a return or stakeholders such as inventors, research programs, and the taxpayers who initially supported the research. This document is intended for university researchers, as well as students and others who might partner with the University to create start-up companies based on novel university technologies. This guide is intended to help University researchers, including faculty and students, understand the process involved in starting a company around a university innovation. Many innovations made at research universities fail to achieve the full flower of their potential because they require resources that lie outside of the university in order to do so. Starting up a company is one way for innovations to “graduate” from the University and take on a life of their own - while creating benefits to everyone who helped make that happen along the way. This guide will also identify resources available on your campus, in your local community and around the state of California that can help you develop a plan to go from where you are to where you want to be, and to address and understand topics like conflict of interest and how to manage it, utilization of university resources, external resources for startups; university intellectual property rights and policies, and more. Ekso Bionics, a Berkeley Startup, helps survivors of lower extremity weakness to walk again. 4 www.ipira.berkeley.edu Licensing from the University The Mission of University Technology Transfer One significant aspect of the UC’s public service mission is to ensure that the results of its research are made available for public use and benefit. For over 45 years, UC’ has maintained an active and productive technology transfer program to encourage the development of commercial products and services based on UC’s academic discoveries. A few examples of products that have been commercialized from UC research include drugs to treat cancer, malaria therapies, search engines, surgical devices, clean water treatments and energy-efficient light bulbs. Given that University results are often basic research results from academic studies, they are far from being a commercial product. The road to commercialization is truly a long and winding one. Typically, a series of steps are required to bring a research discovery to the point of practical application and many players play a role in the process. This process is often referred to as one form of technology transfer from universities. In this schematic, some of the categories of steps are shown. In a generalized depiction, basic research results are translated into applied research and development with the aim of creating commercial goods and services. The timeline to successfully develop a commercial product from an academic discovery can vary widely but is most often between 3-10 years. Importantly, in the case of drug development, the commercialization process can take well over 10 years and can cost several billion dollars. UC is a nonprofit research university, not a company. The UC does not directly commercialize our own research discoveries (we don’t manufacture products to a commercial standard and are nonprofit institutions). In order to assure our research is developed into beneficial products and service, the UC secures intellectual property rights, when appropriate, and then license those rights to companies in the private sector who develop the commercially available products and services. Page 30 IP Licensing: Commitment = f (Risk) Partner Commitment Market IP Evaluate Opportunity Letter Agreement Option Agreement License Agreement • Confidential Agreement • Comm Plan • Patent Costs • + below • Annual Fee • Diligence Terms • + below • Issue Fee (& equity) • Earned Royalties • Min Annual Royalties • Indemnification • + below Commitment incrementally increases as risk decreases 6/25/15 UC Berkeley Innovation Commercialization Common Steps (simplified) 5 www.ipira.berkeley.edu In this context, a license is a contract from UC that grants to an industry licensee (i.e., the start up company) the right to commercialize a patented invention or copyrighted work to make a product or offer a service. A patent is a form of intellectual property protection that grants to the owner (a licensee) the right to exclude others from making, using, selling and importing products based on a patented invention. The U.S. patent system provides a limited period of time, 20 years, to the patent owner to protect the invention. A copyright provides a similar ability to exclude, and is the primary form of intellectual property protection for computer software, educational curriculum, books, music and other art forms. The term of copyright is much longer— if owned by a corporation or university, 95 years from first publication or 120 years from creation, whichever expires first. Companies with a license to university intellectual property (typically referred to as a “licensee”) invest enormous sums in risky R&D; manufacturing and regulatory approvals to bring early stage discoveries to the point of practical application. Without the protection afforded by the patent license industry would not risk funds & resources on lengthy R&D programs that are necessary to commercialize products and the benefits of university research risk remaining unused in the “ivory tower.” If, at the end of a long and arduous R&D process a licensee AND its competitors could reap the benefits of the R&D investment, then no company would make the investment to begin with. The bottom line is that IP licensing gives industry an incentive to invest. Inventors and entrepreneurs who wish to license IP rights from the University to form a new entity, a startup company, are often best suited to commercialize the IP rights—after all, entrepreneurs have the expertise, know-how and the passion, drive and singular focus that is necessary to commercialize the rights. The UC defines a startup company as a company that was founded to commercialize UC IP rights under license. In FY2013 UC formed approximately 71 startups from university research. In FY2013 U.S. universities produced a total of 818 startup companies from university research. Nearly all IP licenses to startup companies are exclusive to provide an incentive to invest in high-risk research and development and to reward entrepreneurs for their commitment to the commercialization process. Innovation is a virtuous cycle of creation, translation, value creation, and reinvestment in research 6 www.ipira.berkeley.edu The Licensing Process Because the University must locate research funding from a variety of diverse organizations, often, the university will owe obligations to the research funder that must be included in a license agreement. The most common source of research funding is the federal government. The U.S. Bayh-Dole Act, which grants universities title to the patentable inventions they create under a federal grant or contract, requires the university to manage federally funded intellectual property in accordance with certain rules. For example, Bayh-Dole requires universities to grant a non-exclusive license to the U.S. federal government for its own use, distribute a portion of net revenues to inventors and, when the university issues an exclusive license to a federally-funded invention, it is required to assure the license contains commercial diligence terms, “preference for US industry” conditions, and march-in rights of the U.S. government. If a licensing term is a condition of the funding used to create the intellectual property, the university is legally bound to include that term in its licenses. There are several different forms of licensing arrangements that can be explored by a start-up company: Letter Agreement A letter agreement is a simple, one to two page agreements, in a letter format with minimal “legalese,” where the university promises to negotiate the terms of a license for a short period of time (3-12 months, depending on campus practices). In exchange, the company typically reimburses the cost of certain patent cost incurred by the university for the licensed invention and will pay a one-time, relatively modest fee. A letter agreement can be an effective tool to secure access to a patent or copyright while the company is being formed, seeking initial funding and conducting a detailed analysis of the business opportunity. Option Agreement An option agreement uploads/Litterature/ startup-guide.pdf