Intellectual Property Policy

1. Intellectual Property Policy
2. Guidelines On Intellectual Property and Technology Transfer
3. Useful Definitions in Discussions of Technology Management and Conflict of Interest

Effective: July 1, 1998
Amended: February 15, 2008
Washington University

1. Intellectual Property Policy

   1. Preamble.

      The primary functions of a university are education, research, the expansion of knowledge and the application of that knowledge to advance the common good. It is in the context of advancing the common good that Washington University supports and encourages efforts directed toward bringing the fruits of Washington University research in diverse fields of knowledge to public use and benefit.

      It is the policy of Washington University to publish research results and to foster the use of University inventions, discoveries and other works for the common good. In many cases, publication of research results and other scholarly works will be sufficient to serve this purpose. In other cases, to serve the common good, it will be necessary to secure protection of University intellectual property to encourage commerce and industry to invest their resources to develop and distribute products and processes for public use.

      Washington University has established this Intellectual Property Policy ("Policy") for the management of intellectual property to:

      1. Promote, preserve, encourage and aid scientific investigation and research;
      2. Provide an organizational structure and procedures through which inventions and discoveries made in the course of University research may be made readily available to the public through channels of commerce;
      3. Establish standards for determining the rights and obligations of the University, creators of intellectual property (e.g., inventors, developers, authors) and their sponsors with respect to inventions, discoveries and works created at the University;
      4. In its broad discretion and consistent with its overall mission, encourage, assist and reasonably attempt to provide mutually beneficial rewards to the University and members of the University community who transfer University intellectual property to the public through commercial channels under this Policy;
      5. Ensure compliance with applicable laws and regulations and enable the University to secure sponsored research funding at all levels of research; and
      6. Enhance the reputation of the University as an academic research institution and a member of society by pursuing the highest ideals of scholarship and teaching and by conferring the benefits of that scholarship and teaching on the University community and society.

   2. Application of Policy.

      This Policy applies to faculty, staff (including student employees), graduate students, post-doctoral fellows, and non-employees (including visiting faculty, affiliate and adjunct faculty, industrial personnel, fellows, etc.) who participate in research projects at Washington University.

   3. Ownership of Intellectual Property.

      Scientific research at major academic research institutions today is carried out in diverse technical and scientific fields. Such research can produce findings and results of exceptional academic interest as well as applications having a broad range of public uses and benefits. The University has a duty to promote the widest possible distribution of academic and public benefits and to facilitate the development of intellectual property, both to meet its social obligations as a tax-exempt institution of higher learning and to meet its obligations to disseminate the benefits of research funded by public grants and contracts. Effective dissemination and commercialization of such technology may require protection and licensing of University intellectual property.

      1. General Statement of Ownership. Except as noted below, all intellectual property (including lab notebooks, cell lines and other tangible research property) shall be owned by the University if significant University resources were used or if it is created pursuant to a research project funded through corporate, federal or other external sponsors administered by the University. Creators will provide, upon request by the Office of Technology Management, assignments or other documents necessary to perfect the University's ownership rights. Generally, creators and research investigators will retain custody of tangible research property while at the University.
      2. Exceptions to the General Statement of Ownership. The creator shall retain ownership of the following:
         1. All intellectual property developed without a significant use of University resources and without corporate, federal or other external sponsorship;
         2. All rights in artistic, literary and scholarly intellectual property, such as scholarly books, articles, and other publications (including those in electronic form), works of art, literature and music recordings are owned by their creators despite the use of University resources so long as such works are neither created under the direction and control of the University, nor developed in the performance of a sponsored research or other third party agreement; and
         3. All copyright in papers, theses and dissertations written as a student to earn credit in University courses or otherwise to satisfy University degree requirements.
      3. Other Ownership Options. Upon mutual agreement, a creator may assign intellectual property he or she would otherwise own under this Policy to the University to be managed by the Office of Technology Management. Creators may dedicate their University-owned inventions or discoveries to the public domain, thereby foreclosing the possibility of patenting and/or licensing, provided there is no conflict with the desires of co-creators, third party or University rights, or applicable laws and regulations. If the University cannot, or decides not to, proceed in a timely manner to protect and/or license University-owned intellectual property, it shall, upon written request by the Inventor(s) and to the extent permitted by law and third party agreements, assign ownership of either domestic only or domestic and foreign intellectual property rights to the Inventors while retaining research and education rights and obtaining protection from future disputes and litigation in order to safeguard the Academic Freedoms of the faculty and the University’s basic functions.
      4. Publication. Nothing in this Policy shall limit or restrict the right of University faculty and students to publish results of their research, subject to reasonable delays to preserve patent or other intellectual property rights. Delays in publication required by the University or third parties in sponsored research agreements, as a general rule, shall not exceed ninety days from initial disclosure of the intellectual property to the Research Office or the sponsor.
      5. Income Sharing. The University shall share royalties, equity and other income derived from the licensing of patented inventions and other transfers of technology (including licensing of non-patented technology, material transfer agreements, etc.) with the creator, unless prohibited or restricted by a third party agreement. Determination of the University's income sharing formula for the division of all intellectual property income shall be made by the Vice Chancellor for Research after consultation with University administration and representatives of the Committee for Faculty Oversight of Technology Transfer.

   4. University Responsibilities Associated with Intellectual Property.

      The University recognizes that the research and teaching missions of the University always take precedence. At the same time, the University encourages the development by industry of inventions and technology resulting from University research, and seeks to facilitate the transfer of such technology for the use and benefit of the public. To these ends, the University shall:

      • Educate faculty regarding intellectual property and tangible research property; Provide support as it deems necessary or desirable to obtain legal protection of University intellectual property; Facilitate the transfer of intellectual property to public use and develop mechanisms within the Office of Technology Management for the licensing and management of technology;
      • Provide legal support as it deems necessary and desirable to defend and protect the interests of the University and creators of the intellectual property against third party claims or unauthorized use; Share royalties, equity or other income derived from University intellectual property with the creators;
      • Report to research sponsors as required by research and licensing agreements, and applicable laws and regulations; In a timely manner, return to the creator the ownership of intellectual property which the Office of Technology Management cannot, or decides not to, patent and/or license; and
      • Provide a process for resolution of disputes that arise between and among the University, sponsors and creators regarding intellectual property.

   5. Responsibilities of the Creators of Intellectual Property.

      The creator of new intellectual property shall disclose in a thorough and timely manner all inventions, discoveries and other works that belong to the University as described in this Policy.

      The creator shall provide such assistance as may be necessary throughout the technology transfer process to protect and effectuate transfer of the intellectual property, including assignment or transfer of the intellectual property to the University, if necessary;

      The creator shall arrange for the retention of all records and documents that are necessary to the protection of the University's interest in the intellectual property;

      The creator shall abide by all commitments made in license, sponsored research and other agreements, and laws related to federally and privately funded research; and

      The creator shall promptly disclose all potential conflicts of interest to the appropriate Disclosure Review Committee in accordance with the Washington University Conflict of Interest Policies.

   6. Oversight of Technology Transfer Activities.

      The Vice Chancellor for Research will appoint a faculty committee to provide oversight of the University technology transfer activities and of the implementation of this Policy. Particular attention shall be paid by the committee to the technology transfer mission, budget, resolution of disputes and the division of intellectual property income. The committee will make recommendations to the Vice Chancellor for Research, will be named the Committee for Faculty Oversight of Technology Transfer and will be a standing committee representing all University faculty.

2. 1. Administration, Protection and Dissemination of Intellectual Property.

      1. Administration of University Intellectual Property.

         The goal of the University's Office of Technology Management ("OTM") is to promote the transfer of University technology for society's use and benefit while generating income to support research and education. A wide range of Intellectual Property, developed through industrially funded research, publicly funded research, the use of unrestricted funds, or by some other course of research or creative activity, may be managed by the OTM. The OTM evaluates, obtains proprietary protection for, and assists in the commercial development of selected technology. The protection and commercial distribution of intellectual property may require funding from a source outside of the OTM, such as the creator's school, department or an outside sponsor.

      2. Disclosure.

         Technology should be disclosed to the OTM in writing if the University has an ownership interest and the technology may be patentable or has potential for licensing. The OTM will provide disclosure forms on request. The creator should consult OTM with respect to their duties to disclose inventions and the manner and timeliness with which such disclosures should be made to the OTM.

         1. Sponsored Programs. The terms of the sponsored research and other agreements normally create obligations with respect to the reporting of inventions, technical data, and copyrightable works such as software. In particular, inventions or discoveries and copyrightable works developed under federally or privately sponsored research should be promptly disclosed to the OTM. Frequently, reporting to private sponsors can be accomplished directly by the creator. Reporting required actions to the federal government can be done by the OTM. Invention reporting to the federal government will be done within two months, or such other time as may be prescribed by federal regulation, of receipt of disclosure from the creator.
         2. Other Programs. Technology developed under University programs, either as a work-for-hire or with significant use of University resources, should also be disclosed to the OTM. Technology that is not developed under federally or privately sponsored research or with the use of significant University resources need not be disclosed to the OTM unless the creator desires the OTM to commercialize the technology.
         3. Form and Content of Disclosure. Disclosure is made by the creator(s) to the OTM in writing, on a form suggested by the OTM, within a reasonable time of conception or reduction to practice. The disclosure should contain sufficient detail to convey a clear understanding, to the extent known at the time of the disclosure, of the nature, purpose, operation and technical characteristics of the invention. The creator(s) should also disclose any publication or submission for publication, sale or offer of sale, or public use of the invention. Thus, the creator(s) have the responsibility to update the OTM in a timely manner of any developments involving publication, sale or use of which they become aware after the initial disclosure, and should take all reasonable efforts to make the initial disclosure to OTM well in advance of any publication, sale or public use.
         4. In the event of two or more Creators, the following procedure will apply. All Creators will execute a binding agreement at the time of disclosure that will delineate each Creator's personal share (percentage) of any income. The distribution to Creator'(s) schools will be in the same ratio as that distributed to the Creator(s).

      3. Intellectual Property Rights Determination.

         If the creator claims an ownership interest in intellectual property or has a question about whether an assignment must be made to the University, the property should be disclosed to the OTM and the claim or question clearly stated. The University, through the OTM, will provide a determination of rights within a reasonable time following submission, generally not to exceed 90 days. The determination may be appealed to the Vice Chancellor for Research for a final decision.

      4. Evaluation of Intellectual Property for Protection and Commercial Development.

         The OTM will evaluate inventions and other technology intellectual property disclosed to the OTM to suggest the form of intellectual property protection, if any, that should be considered and the potential for technology transfer through licensing.

         Copyright The OTM will review copyrightable University intellectual property, including software, disclosed to it. In other instances the OTM may consult with creators to help ensure that proper notices are affixed to a work and that registration is made in a timely manner.

         Patents The OTM will review invention disclosures and will consult with the inventor(s) and others as necessary to investigate the patentability and commercial potential of inventions. The OTM will also assist in determining whether a patent application should be filed.

      5. Commercial Development.

         The University, through the OTM, and the creator share responsibility for disclosing inventions and other licensable intellectual property and cooperating to make the intellectual property available commercially.

         1. Creator Responsibilities.
            1. The creator is required to disclose inventions, discoveries and other new intellectual property to the OTM in a thorough and timely manner as stated above.
            2. The creator should abide by all commitments made in license, sponsored research and other agreements and comply with all laws and regulations related to federally and privately funded research.
            3. The creator should also provide such assistance as may be necessary throughout the technology transfer process to realize the goals and objectives set forth in these Guidelines.
            4. The creator has the further responsibility to properly consider, disclose and manage any possible conflicts of interest arising from agreements to commercialize intellectual property. If multiple agreements exist, for example, when a company funds University research and also has a consulting arrangement with the creator, there may be conflicts created with respect to intellectual property rights. The creator should work with the OTM to resolve such conflict.
         2. The University, through the OTM, will establish processes for technology transfer to protect University intellectual property rights in order to carry out the University's missions set forth above. Acting within its broad discretion and in good faith, the University will seek to maximize the value of the intellectual property. To these ends, the OTM, in consultation with the creator, may:
            1. publish or advertise the technology as it deems appropriate;
            2. assist in finding a partner for the University or a sponsor for the creator;
            3. endeavor to negotiate and manage agreements that are consistent with the Intellectual Property Policy and Guidelines;
            4. as deemed necessary or desirable by the Office of the Executive Vice Chancellor and General Counsel, provide legal support, through OGC and/or outside counsel, for all technology transfer activities and initiatives;
            5. prepare legal instruments necessary to realize the technology transfer objective;
            6. provide legal and administrative support following such realization as needed; and
            7. cooperate with the Disclosure Review Committees in the management of conflicts of interest

      6. Dissemination of University Intellectual Property.

         1. Disclosure. Intellectual property in which Washington University has title should be disclosed to the OTM as provided in Section 1.2 above.
         2. Public Domain. A creator may request that the intellectual property he or she developed be published and made available to the public without restriction on use. The OTM will investigate whether such a request may be fulfilled or whether the intellectual property should be protected in some form. The creator's request will be considered by the OTM in its broad discretion, and accorded due weight and deference, consistent with the overall objectives of the IP Policy, requirements imposed by law, agreements with research sponsors, and the rights and interests of co-creators.
         3. Commercialization. When the OTM has determined that protection of intellectual property is likely to help commercialize property, it will recommend that the University seek protection. In addition, protection of intellectual property may be obtained or pursued although commercial potential is unknown, to preserve opportunities for commercialization in the future, or when required by an outside sponsor.
         4. Publication. Nothing in these Guidelines is intended to limit or restrict the right of creators to publish results of their research, subject to reasonable delays to preserve patent or other intellectual property rights. Delay of publication required by the University or third parties in sponsored research agreements should, as a general rule, not exceed ninety days from initial disclosure of the intellectual property to the OTM or the sponsor.
         5. Intellectual Property Reassignment. Consistent with the obligations to government funding sources and the practices of our peers, OTM must maintain an IP reassignment protocol that provides for timely waiver of title to patented or unpatented inventions back to federal grantor agencies as required by our grantee obligations. The protocol should also provide for the pursuit of title transfer from the government or WU to inventor assignees as allowed by such agencies. The protocol should require OTM to: 1) exhaust all foreseeable licensing opportunities, including faculty startup and patent clearinghouses; 2) determine research funding sources for all IP that is the subject of a proposed assignment back to the inventors including determining whether such sources affect WU’s ability to reassign; 3) working with the Office of the Executive Vice Chancellor and General Counsel, identify all purported Inventors to whom the IP would be assigned and summarize the investigation taken to make such a determination; and 4) prepare and maintain appropriate forms for the consistent and timely reassignment of IP to the inventors.
         6. Research Freedom. To protect the Academic Freedom of WU and its faculty and students, WU should retain or obtain, as part of an IP reassignment, at least the following:
            1. An irrevocable, non-exclusive license for research and education purposes that includes the right to grant sublicenses to non-profit entities for collaborative research purposes;
            2. representations and warranties that the purported inventors are the actual inventors and are all the actual inventors;
            3. protection for WU and its employees, faculty, students and staff from the costs of disputes among the inventors or otherwise arising from the reassignment of the IP;
            4. that the IP is taken "as is" and without warranties, including those of validity, enforceability and freedom to operate;
            5. protection for WU and its faculty, students and staff from the costs of product liability and other lawsuits arising from future commercialization of the IP; and;
            6. that revenue from future commercialization, if any, ensures the reimbursement of the OTM patent budget for patent expenses incurred prior to reassignment.

   2. A commercial organization (company) may interact in a variety of ways with a creator of Intellectual Property. Interactions are defined in a variety of agreements among the company, the creator and the University. A partial list of the agreements includes: consulting agreements, research agreements and licensing agreements. More than one agreement may be active concurrently, which requires great care in reconciling the terms of the agreements. Interactions may be divided into those in which there is no personal income to the creator and no uncommitted income to the University and those in which either the creator may receive personal income and/or the University may receive uncommitted income. In general, a consulting agreement between a creator and a company can result in direct personal income that does not pass through the University. A licensing agreement to develop a particular piece of intellectual property results in income (cash or equity) to the University, which is distributed as specified by the University's Intellectual Property Policy and these Guidelines (see section 3 below). This may result in direct personal income to the creator as well as income to the University that is not committed to a particular project. A research agreement provides funds to conduct agreed upon research, is administered by the University and includes no direct personal income.

      1. No Personal Income to the Creator and No Uncommitted Income to the University.

         1. Patent Costs. A company may agree to pay the cost of patent prosecution plus U.S. and foreign patent maintenance fees as part of a licensing agreement.
         2. Equipment Grants. A company may provide equipment or access to equipment for use, possibly for a defined set of studies.
         3. Exchange of Personnel Between University and Company. A company may send personnel to be trained, or provide for University personnel to work in company facilities.
         4. Research Support Agreements. A company may provide support to the University for research conducted by the creator, either as a contract (with specified performance criteria) or a grant (to support an endeavor).

      2. Personal Income to a Creator and/or Uncommitted Income to the University.

         1. Licensing Income. Licensing income is most commonly received in the form of royalties from sales or guaranteed payments.
         2. Milestone Payments. These payments are made when particular steps are made, ranging from obtaining a particular research result to reaching a particular stage in drug development.
         3. Equity Interest. In some cases, particularly with start-up companies, licensing income or milestone payments are made in the form of equity rather than cash. The equity may be in a variety of forms, including publicly tradable shares, privately held shares, or options to acquire shares.
         4. Creator as Compensated Consultant. A creator may also be retained as a paid consultant to a company, through a personal consulting agreement.
         5. Creator as Compensated Officer. A creator may have a position in the company, most often in the case of a start-up company formed by the creator, or formed around the creator's intellectual property.

      3. Basic Guidelines for Interactions Among Companies, Creators and the University.

         There are basic principles that must be observed in the structuring of interactions among the creator, the University and a company.

         1. Publication. Public dissemination of research results must not be compromised. The publication of research results must not be hampered by agreements made to commercialize intellectual property. However, a minimal and defined delay to protect intellectual property through patent applications may be included. It is also the case that creators may be required to observe confidentiality and non-disclosure agreements covering defined company intellectual property. The covered property must be clearly identified in the agreement.
         2. Educational Mission. The educational mission of the University must not be compromised. Trainees (students, fellows, associates) must have access to the best guidance and choice of research opportunities that the faculty member can provide. They also must have the ability to publish the results of their research and should not be prohibited from continuing work on a project when they leave a laboratory, as a result of an agreement to develop intellectual property.
         3. Scientific Integrity. The scientific integrity of the creator must not be compromised. Any agreement should not compromise or appear to compromise the design, conduct or reporting of research conducted by the creator or the University.
         4. Patient Care. Patient care must not be compromised. Patients must receive the best and most appropriate advice and treatment, and must also perceive that their care is not compromised by other concerns.
         5. Contracts. Agreements must conform with statutes and regulations. The terms of any agreement must be in conformance with applicable laws and regulations, including the tax code to avoid jeopardizing the University's tax-exempt status. The terms of an agreement must not be in conflict with existing licensing or research agreements.
         6. Indemnification. Indemnification of the University is needed. A company will normally be required to indemnify the University with respect to general liability, product liability and/or infringement claims related to licensed intellectual property to be used in any product.

      4. Potential Financial Conflicts of Interest Arising from Commercial Development.

         The possibility of a financial conflict of interest is inherent in the commercial development of intellectual property. Washington University has adopted Conflict of Interest (COI) Policies applicable to all faculty and staff and has established Disclosure Review Committees to develop and implement mechanisms to manage, reduce, or eliminate, when necessary, such financial conflicts for individuals engaged in research. These policies and guidelines are available at http://htcoi.wustl.edu/ or http://mscoi.wustl.edu/.

         Financial interests that could be related to an individual's research must be disclosed to the appropriate Disclosure Review Committee (DRC). Special consideration must be given to licensing agreements that could be related to an individual's research. Regardless of value, these must be disclosed to the DRC to determine risk and appropriate management strategies.

         It is important to note that the University may also have institutional conflicts of interest, which must be evaluated by the OTM and other responsible parties. Such conflicts are handled on an ad hoc basis and are outside the purview of the Disclosure Review Committee.

         In general, the following factors increase the perceived level of risk present in a material conflict of interest:

         1. increasing magnitude of personal compensation;
         2. increasing number of financial relationships between a creator and a company;
         3. increasing commitment of a creator's time to a company;
         4. holding of equity in a company;
         5. involvement of trainees or students; and
         6. involvement of patients or human subjects.

         A factor of particular relevance to interactions during the development of intellectual property is the ability of the creator to influence the value of a financial interest. For example, in the case of royalty payments from an established technology no longer being actively investigated at the University, the creator has little ability to change the amount of income. However, in the case of an ownership interest in a small company whose intellectual property portfolio is based on the creator's technology, particular results of studies performed under the direct supervision of the creator might have a significant effect on the value of that ownership interest.

         The management strategies are graded with the degree of perceived risk. Management strategies include (but are not limited to) disclosure to all parties, concurrent review and negotiation of all relevant agreements, escrow of equity, and/or divestiture. In the event a conflict of interest cannot be effectively managed, the University may be unable to enter into an agreement.

         The overall concern, and hence the level of management required, also increases as more risk enhancing factors are present. As a rough guide, the following interactions between a company and a creator are ranked in terms of increasing risk.

         1. Patent costs paid by licensee (very low).
         2. Cash royalties on sales paid by licensee (low). The payments occur only after a product is taken to market, and the income is largely independent of the actions of the creator.
         3. Research support paid by licensee (low). No direct payment to the creator is involved.
         4. Cash consulting fees paid by licensee (low). These fees are not linked to any performance criteria, and are not directly associated with professional activities conducted by the creator at the University.
         5. Milestone payment by licensee for a research deliverable (medium to high). These payments may be predicated on work performed by others (for example, company in-house animal studies), in which case the risk is reduced. Alternatively, the payment may be made based on a particular research result obtained in the creator's University laboratory, in which case the risk is intensified and may be difficult to manage.
         6. Equity ownership in a company concurrent with its support of research (medium to high). In general, the value of equity holdings may be influenced by the actions of the creator. A mechanism for escrow of equity exists, and will be a likely management strategy. The risk presented by equity ownership is particularly severe in small companies, in which the intellectual property developed by a creator may represent a significant part of the intellectual portfolio of the company.
         7. Creator is a company principal concurrent with the company's support of related research (high). The risk is viewed as difficult to manage.
         8. Equity ownership in a company concurrent with active participation in clinical trials (high). The risk is viewed as so high as to essentially preclude participation of an equity holder in clinical trials.

   3. Division of Intellectual Property Income.

      Washington University policy encourages the commercialization of the technology developed by its faculty, trainees and staff and provides for the sharing of any income derived with the creators of the ideas that produced the technology. The mechanism for the division of this income is here described in detail according to a resolution of the faculty Technology Transfer Committee.

      The gross income from a particular intellectual property owned by the University is reduced by all technology transfer expenses that can be directly linked to it. The result is the net intellectual property income. Net income shall be calculated annually by OTM unless mutually agreed otherwise. The shares of net income shall be divided as follows:

      1. 25% OTM
      2. 35% Creator(s)
      3. 40% Creators' School

      The creators' share may be taken as personal income or may be waived in part or in total by the creator.

      The share distributed to the creators' school shall be divided according to a policy determined by the administration of the school. However, this division shall include the creators' laboratory, the creators' department and other school budgets.

      The Bayh-Dole amendment prescribes the sharing of intellectual property income derived from federally funded research with the inventors of patented ideas. Washington University policy extends the plan for the division of income to the creators of non-patentable ideas.

      At times it may be difficult to determine what expenses can be directly charged to the gross income of a particular technology transfer agreement. Legal and patent expenses associated with a licensed invention are easy to allocate. However, delayed expenses, expenses associated with the realization of equity or expenses associated with related, but unlicensed inventions are often more difficult to allocate. In making these difficult determinations the following principles should apply:

      1. Distributions to creators are final and shall not be affected by unanticipated expenses, except for simple adjustments necessary to correct clerical errors.
      2. Prior to the determination of the distribution of net income, the creator shall receive a statement of direct expenses charged against the gross income derived from a technology transfer agreement.
      3. Subject to the above principles, all reasonable expenses associated with a particular agreement should be charged to the gross income derived from that agreement.

      The distribution of income shall, as closely as possible, follow the plan for division in force when the intellectual property was licensed. When an agreement with a sponsor includes equity to be held either by the creator, the University or both, such shares of the equity may be placed in escrow for the duration of the sponsor's support of University research and for a year thereafter, as determined by the DRC. Even though the determination of the creator's or the University's income from equity held in commercial ventures involved in technology transfer activities is complicated by the length of time usually required to determine the value of the equity and applicable tax and security laws and regulations, the appropriate plan for income division shall still be followed as closely as possible.

      In the case of the division of income in the form of equity, as well as in the case of all intellectual property income, the creator may continue to receive income upon termination of employment with Washington University. Furthermore, income will pass to the creator's heirs as directed by the creator's estate.

   4. Dispute Resolution.

      Any disputed issues related to intellectual property, or the interpretation of the Washington University Intellectual Property Policy, shall first be reviewed by the OTM. Any disputed issues that cannot be resolved with the assistance of the OTM shall be referred to the Vice Chancellor for Research. The Vice Chancellor for Research may refer disputed issues to the Faculty Oversight Committee for its recommendations and advice. The Vice Chancellor for Research is the final arbiter of any disputed issues related to intellectual property, income distribution or the interpretation of the Policy.

   5. Committee for Faculty Oversight of Technology Transfer.

      The Washington University Intellectual Property Policy states that the Vice Chancellor for Research shall appoint a faculty committee to provide oversight of the University technology transfer activities. It is the responsibility of this committee to:

      1. Monitor the implementation of the University Intellectual Property Policy.
      2. Verify that the OTM carries out its mission in accordance with the Policy and these Guidelines.
      3. Review requests from the Vice Chancellor for Research for the interpretation of the Policy and make written recommendations regarding such requests.
      4. Review annually the financial results of OTM with particular attention to the expenditure of the OTM share of intellectual property income.
      5. Provide advice to the Vice Chancellor for Research regarding disputes between creators and OTM.
      6. Every two years review and possibly recommend to the Vice Chancellor for Research adjustment of the University's plan for the division of intellectual property income.

      Members of the Committee for Faculty Oversight of Technology Transfer shall be selected to be representative of the faculty as a whole, shall serve for staggered three-year terms and shall be a standing committee. The committee and its chair shall be selected by the Vice Chancellor for Research.

   6. Report to Senate Council.

      The Vice Chancellor for Research shall report annually to the Senate Council on the University's technology transfer program. This report shall include the program's financial results and a brief description of patenting and licensing activities. Included in the report shall be comments and recommendations from the Committee for Faculty Oversight of Technology Transfer.

   7. Amendment of the Guidelines.

      These Guidelines may be amended by the Vice Chancellor for Research upon recommendation by the Committee for Faculty Oversight of Technology Transfer.

   8. Conflicts Between Policy and Guidelines.

      In all instances of real or apparent conflict between University policies, including the Washington University Intellectual Property Policy and the Policy on Conflict of Interest, and these Guidelines, the policies will control.

3. Useful Definitions in Discussions of Technology Management and Conflict of Interest

   Academic Freedom : A privilege of scholars to choose their own research field, to enter into collaborations with others, and to communicate with others regarding their scholarly efforts. A core University principle.

   Assignment : The transfer of rights and title in real, personal or Intellectual Property by a written instrument with the result that the assignee is vested with rights of ownership. A federal statute requires that the University obtain Assignment of Inventions that have been conceived or created in a project supported by federal funds. Other Intellectual Property may be assigned to the University, or to other parties pursuant to a Research or License Agreement. If the Invention is not one that must be assigned to the University by law or University policy, the Invention ownership may remain in the Inventor(s).

   Commercial Venture : A start-up company, partnership, joint venture, corporation or any other enterprise entity that has obtained a License to University technology in exchange for equity in the enterprise entity.

   Conception : Creation in the Inventor's mind of a new and useful way to solve a problem; the act of visualizing an Invention, complete in all essential detail; this occurs when a solution is formulated, not when a problem is recognized. Conception is the unequivocal mental discovery of an invention.

   Confidentiality Agreement : May be a separate agreement between disclosing and recipient parties, or may be a term in a Research Contract or License Agreement. When it applies to information disclosed by a company to a University employee, the recipient employee may agree to be personally bound not to release the company confidential information unless expressly permitted by the company. When it applies to information disclosed by a University employee to a company, it is usually meant to prevent the company from using the information without permission, and to protect the patentability of any Invention, or trade value of other technology, disclosed by the University Inventor or Creator to the company. University Contracts protect the right of faculty, students and other employees to publish the results of their work, but may allow for brief delays to file Patent applications or otherwise protect Intellectual Property.

   Conflict of Interest : Conflict of interest exists if an employee's position or authority may be used to influence or make decisions that lead to any form of financial or personal gain for that employee or for his or her family. A conflict of interest is material if an ordinary person would take it into account in making a decision. In academic research, the term conflict of interest refers especially to situations in which financial or other personal considerations may compromise, or may have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods.

   Contract : A legally binding mutual agreement between two or more parties in which an exchange of value (consideration) occurs, and which obligates each party to certain duties covering this exchange. Those signing such an agreement must be authorized to bind the entity that they represent.

   Copyright : As provided in Copyright law, a Copyright owner has the exclusive right to reproduce the work, prepare derivative works, distribute by sale or otherwise, and display or perform the work publicly. Under federal Copyright law, Copyright exists in "original works of authorship" fixed in any tangible medium of expression, now known or later developed from which the work can be communicated in some manner. Copyright does not protect mere ideas, concepts, procedures, systems, methods or principles. Copyright does protect the expression of ideas, concepts, etc., in the forms of a literary work, musical work, computer program, video, motion picture or sound recording, photograph, sculpture, and so forth. The exclusive rights enumerated above are subject to certain statutory limitations including fair use, library and archival reproduction, and transfer of a particular book or a phonorecord by its owner. Copyright vests initially in the author(s) of a work, or the employer if the work was made for hire. Generally, Copyright subsists from creation and endures for a term consisting of the life of the author plus fifty years. The duration is seventy-five years from the year of first publication for anonymous and pseudonymous works and works made for hire. Though Copyright vests automatically, certain steps must be taken to reserve some important rights against infringers: a notice must be displayed on all published and distributed copies of a Copyrighted work. The notice must contain the symbol ©, the year of first publication, and an identification of the Copyright owner. The Copyright must be registered with the U.S. Copyright Office to reserve certain statutory remedies for infringement.

   Creator : Person or persons, who may be faculty, staff or student, either Inventors or those who do not meet established legal standards of inventorship and thus may not be named on a Patent application, but who have participated in the creation of an Invention, discovery or advancement of some technology.

   Creator's Laboratory : The University facilities which provide the means and opportunity for experimentation, observation and/or practice in the Creator's particular field of study.

   Creator's Notebook : Usually a bound workbook. Details should be entered in ink, dated, entered regularly and witnessed; the notebook may become crucial in a court proceeding or in research integrity investigations.

   Creator's Share : The Creator's Share of Net Income is determined by University policy. If there is more than one Creator, each receives an equal portion of the Creator's Share, unless the co-Creators agree to a different distribution.

   Disclosure : The sharing of information with one or more individuals.

   Confidential Disclosure : Sharing of proprietary information (such as the description of an Invention), that is protected against unauthorized disclosure by a Confidentiality Agreement between the disclosing and receiving parties.

   Disclosure of Financial Interest : An employee's description of his/her income from or ownership interest in an unrelated party, if such financial interest might create or appear to create a Conflict of Interest. This Disclosure is required by University Conflict of Interest policy.

   Enabling Disclosure : A description of an Invention, in a Patent application or in a Publication, that could allow a person skilled in the art to replicate the Invention.

   Invention Disclosure : Typically used to describe a formal (written) description of an Invention that is confidentially made by the Inventor to his/her employer. At Washington University an Invention Disclosure should be an enabling one, should include details as to co-inventors and funding sources and should be sent to the Office of Technology Management by an Inventor. Such a Disclosure is the "first alert" to the University that an Invention has been made.

   Equity or Equity Shares : Shares of common or preferred stock, warrants, options, convertible instruments, units of a limited partnership, or any other instrument conveying ownership interest in a Commercial Venture.

   Escrow : In the University, this is a means to sequester tradable Equity during the period of a high level Conflict of Interest, such as the ownership of more than 5% of the financial interest of a licensee company that also supports research in the laboratory of the Creator(s) of the licensed technology.

   Federal Ownership Rights: These rights cover both data and software and arise from certain federal grants and Contracts. They require that Intellectual Property (other than patented Inventions) that are developed under those Contracts be owned by the federal government. When such Contracts are in force, the University must require faculty and employees working under such funding to assign ownership of the Intellectual Property (e.g., software or data) to the University for conveyance to the federal government: The regulations covering such Intellectual Property are not uniform across federal agencies, and sometimes waivers may be sought in advance, or a petition for greater rights may be entertained.

   Financial Interest : Any relationship, including a consulting relationship, entered into by the employee or his or her family, other than employment by the University, that could result in financial gain for the employee or his or her family.

   Income : Funds received by the University under a License Agreement.

   Gross Income : Funds obtained from commercialization of technology under a License Agreement. Gross Income may include License Fees, milestone payments, minimum annual Royalties, earned or running Royalties, Equity, equipment, or reimbursement of Patent expenses and fees. Does not include research support in a mixed purpose Research Contract/License Agreement.

   Net Income : Net Income is Gross Income less unreimbursed University expenses for Patent prosecution and licensing expenses associated with a particular License Agreement (e.g., travel made expressly to negotiate a particular License Agreement). Net Income may be subject to sharing with Inventors and Creators and is distributed in accordance with University policy.

   Intellectual Property : Ownership and associated rights relating to scientific discoveries, technological advances, compilations, and original works of art, literature or music. Intellectual Property includes Patents, Trademarks, Copyrights, Trade Secrets and other species such as computer software, Mask Work, printed material, or Tangible Property. The formal protections provided by Patents, Copyrights or Trademarks may be used to preserve some Intellectual Property from unauthorized use or misappropriation or seek remedies therefor. Secrecy and confidentiality may be used to sustain other properties. Intellectual Property is created when something new and valuable has been conceived or developed, or when unusual, unexpected, or non-obvious results have been discovered with existing technology and which can be applied to some useful purpose. Intellectual Property can be created by one person or co-created by several.

   Artistic Intellectual Property : Aesthetic, decorative, illustrative elements protected primarily by Copyright.

   Intellectual Property Enforcement : Unauthorized use of a patented Invention, Copyright, Trademark, or other Intellectual Property is an infringement of rights or misappropriation of property for which legal remedies may be sought. The decision to enforce Intellectual Property rights is complex and highly dependent on factors such as the commercial value of the rights in question. University owners of Intellectual Property may be sued when they or their licensees infringe rights belonging to an unrelated party, or a university may bring suit against an unrelated party for infringement of Intellectual Property rights belonging to that university.

   Literary Intellectual Property : Literary works of authorship protected by Copyright.

   Technology Intellectual Property : Practical scientific knowledge embodied in a Patent, Patent application, Copyright, Mask Work or Trade Secret.

   Invention : A creation of Intellectual Property which did not exist previously. Also, more specifically, the Conception and reduction to practice of a useful, novel and non-obvious product or process, or improvement thereon, for which a Patent may be obtained.

   Inventor : An Inventor is as defined by United States patent statutes and case law. Generally speaking, an Inventor is an individual who has contributed to the conception of the intellectual property. Final and non-appealable Inventor determinations shall be made by the Vice Chancellor for Research or that office’s designee, with the assistance of the OTM and the Office of the Executive Vice Chancellor and General Counsel.

   Joint Patent Ownership : Equal and non-accountable (to each other) ownership of Patent rights.

   Know-how : The knowledge, innovations, practices, expertise, processes or procedures, and secrets of individuals regarding the use of a material, product or

   License : A License is a Contract which awards to a party other than the owner(s) of the Intellectual Property the right to make, use, sell or import products or services based on the owner's Intellectual Property. Licenses may be awarded on an exclusive or non-exclusive basis and may provide for payment of License Fees, Milestones, Royalties, or other Income to the owner(s) of the Intellectual Property.

   License Agreement : A License is frequently called a License Agreement.

   License Fee : Generally, the money paid by a licensee to the licensor at the time License is signed. Can also be called a License Issue Fee.

   License Option : A Contract between the University and another party which conveys to that party the right to negotiate for a License to certain Intellectual Property, generally on terms within certain specified parameters. If the option is exclusive, the University agrees to refrain from granting a License to a third party during the option period. Exclusive options on future Inventions are often offered in return for the agreement of the unrelated party to pay for Patent costs and/or to support research. Not to be confused with stock options, which are agreements that require conveyance of Equity. (see also: Right of First Refusal)

   Mask Work : A series of related images embodying the original, pre-determined three-dimensional topography of a semiconductor chip product, regardless of how the topography may be encoded (an optical mask on glass or an electronic mask in a computer). A Mask Work must be fixed in a chip substrate from which it can be perceived or reproduced. Protection endures for ten years from registration with the Copyright Office or from commercial exploitation, whichever occurs first. A Mask Work must be registered with the Copyright Office within two years of commercial exploitation to be protected under the statute. Notice is permissive (not prerequisite to protection or enforcement). The electronic circuitry embodied in a chip may be patented, but the design or layout itself, protectable as a Mask Work, generally lacks the requisite level of inventiveness to be patented. There is a reverse engineering privilege in the chip protection law similar to the fair use doctrine in Copyright law.

   Material Transfer Agreements : The transfer of proprietary Tangible Property, often biological materials, is covered by a contract called a Materials Transfer Agreement. Such contracts may cover materials coming into the University from academic or industrial sources, or may cover materials going out from the University to academic or industrial recipients. Negotiated terms of such agreements may cover the use of the original materials, progeny materials produced by self-replication of the original sample, and modifications of the original materials. Points of contention in negotiations include preservation of Publication rights, preservation of ownership, disposition of liability arising from hazardous materials, and ownership of new Inventions arising from the use of the materials. Materials Transfer Agreements (MTAs) may significantly affect the ability of the faculty to collaborate with or accept funding from unrelated parties.

   Patent : A U.S. Patent is a grant which gives the owner of the Invention covered by the Patent the right to exclude all others from making, using, selling or importing the Invention in the United States. In the United States, a utility Patent provides that exclusive right for twenty years from the date of filing (if the application is filed on or after June 8, 1995) or seventeen years from date of issuance (if the application was filed prior to that date). To qualify for U.S. Patent protection, an Invention must comprise a machine, article of manufacture, process, composition of matter, or some improvement on those. It must be deemed useful, novel, and non-obvious to one skilled in the art, and must not have been in public use or on sale in the United States or described in a Publication as defined below, anywhere in the world for more than one year prior to the filing date of the U.S. Patent application.

   Patent Ownership : (also, Patent Title) In the case of a Patent, the owner is the entity which holds the Patent Assignment. Ownership originally vests in the Inventor(s), but law or agreement may require that Patents be assigned to an employer or another.

   Patent Rights : The right to obtain a Patent in many foreign countries can be lost if there has been any public Enabling Disclosure of the Invention, verbal or written, anywhere in the world prior to filing the foreign Patent application. However, if the U.S. Patent application has been filed prior to any Enabling Disclosure of the Invention, Patent applications may still be filed in foreign countries within one year of the U.S. filing date in those countries which adhere to an international convention even if there has been an intervening Publication. Loss of Patent Rights results from the operation of legal events frequently called "bars" or "statutory bars". The Patent laws of the U.S. and many foreign countries provide for bars to patentability. Questions about bars may be addressed to the Office of Technology Management.

   Publication : As related to Inventions and Patents, a Publication is a public Enabling Disclosure of an Invention, and may be verbal or printed. Printed Publications include abstracts, student theses and, in certain instances, grant proposals, whether funded or unfunded. A public Enabling Disclosure is a non-privileged, non-confidential communication. It is important to emphasize that such a Publication may jeopardize the ability to obtain a Patent, in the U.S. and abroad. Publication usually limits the potential Patent to the U.S., and then only if an application is filed before the expiration of one year from Publication. Questions about the implications of Publication can be addressed to the Office of Technology Management.

   Research Contract or Agreement : A separate agreement to fund and conduct research, which research may or may not be related to licensed technology.

   Right of First Refusal : Similar to a License Option. In return for research funding and/or payment of Patent costs, the University may agree that it will not execute a License with any other party without offering such License to the company supporting the University. The terms offered to the supporting company are the same terms as those offered to a third party. The optionee then has the first right to accept a License based on the proffered terms.

   Royalties : Royalties are compensation for rights in Intellectual Property and are usually expressed as a percentage of revenue received by the licensee from sales of a product.

   Service Agreement : A contract between the University and a company in which the University agrees to perform certain tasks, such as evaluation, field testing, or clinical trials, using the protocols, either directly specified by the company or developed by the University, to meet very specific criteria and data requirements set by the company. Often, the products or processes being tested are already covered by dominant Intellectual Property protection belonging to the company, and improvements made by the University participants are usually assigned to the company. Publication rights are sought by the University in all such agreements.

   Tangible Property : Tangible Property is anything having a physical embodiment (e.g., cell lines, software, devices, compositions of matter) whether or not patentable or copyrightable.

   Trade Secret : Trade Secrets comprise confidential data, information or compilations used in research, business, commerce or industry. Universities, government agencies, business entities and individuals may own and use Trade Secrets. The information may include confidential scientific and technical data and business, commercial or financial information not publicly known which is useful in an enterprise and that confers competitive advantage on one having a right to use such information. The secrecy of the information must be maintained to conserve its Trade Secret status. Trade Secret information may be disclosed or shared under the terms of a Confidentiality Agreement. Confidential information may be created in sponsored research projects; the sponsor will generally require the University and the Creator to preserve the secrecy of the information. Trade Secrets in the form of know-how and show-how may be vital to the practice of patented Inventions and other innovations. Trade Secret information may have considerable value by itself or in conjunction with other forms of Intellectual Property. Trade Secrets and related legal remedies are governed primarily by state law. Federal public contract law may apply to Trade Secrets in the form of technical data created under federally funded research projects (Federal Ownership Rights).

   Trademark : A trade or service mark consists of a word, symbol, phrase or design, or combination of these, and exists for the exclusive use of the holder in identifying the source of a product or service. Marks are identified by the symbols ®, ™ or SM. Marks have no necessary relation to Invention or discovery. Unlike Patents and Copyrights, marks can exist for an indefinite time. Marks can be registered in the U.S. Patent and Trademark Office.

   Trigger Date : The date Equity held in Escrow by the University is no longer subject to restrictions imposed by the University to mitigate Conflict of Interest.

Copyright 2000-2008, Washington University in St. Louis