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Office of Research Administration

Intellectual Property Policy

Guidelines

Purpose
The School of Hygiene and Public Health strives to support its faculty, staff, and certain students in securing commercial development of intellectual property resulting from their research so that the benefits of that research may reach society at the earliest opportunity. This effort is consistent with the University's mission of developing new knowledge and facilitating the practical application of such knowledge for the benefit of the public. The Policies summarized in these Guidelines provide incentives for faculty to commercialize their research while protecting the integrity of research emanating from this institution.

Applicability
The Policies, which shall be interpreted in a manner consistent with federal and state statutes and implementing regulations, apply to all School of Hygiene and Public Health faculty, staff, and students, if the students are 1) receiving remuneration for services, 2) working on federally-funded and other research projects, or 3) voluntarily assigning their inventions to the University. Faculty, staff, and students are referred to as "faculty" throughout these Guidelines.

The royalty and equity Policies summarized in these Guidelines apply to all new inventions disclosed to the University Patent Officer after June 8, 1992, as well as to all inventions licensed after June 8, 1992, regardless of the date of disclosure. The Policy on Conflict of Interest applies to all transactions with outside organizations regardless of the date of the transactions and regardless of whether an invention is involved.

Definitions: Invention and Intellectual Property
An invention is a creation of intellectual property which did not exist previously. Intellectual property is defined as any new and useful process, machine, composition of matter, life form, article of manufacture, software, copyrighted work or tangible property. It includes such things as new or improved devices, chemical compounds, drugs, genetically-engineered biological organisms, data sets, software, or unique and innovative uses of existing inventions. Intellectual property may or may not be patentable or copyrightable, and it can be created by one or more persons, each of whom, to be an inventor, must have conceived of an essential element of the intellectual property or have contributed substantially to its conceptual development.

Faculty Responsibilities
Faculty members who create intellectual property shall 1) disclose promptly to the Director of the Office of Technology Transfer the creation of intellectual property; 2) assign the intellectual property to the University, if the University elects to accept title; 3) conduct technology transfer activities in a manner consistent with University and School of Hygiene and Public Health Policies, including those governing conflicts of interest; and 4) cooperate with the University in defending and prosecuting patents and in legal actions taken in response to infringement.

Ownership of Intellectual Property
the University has the right to obtain title to intellectual property developed as a result of support either directly from or channeled through the University. In the absence of such University support, rights of ownership of intellectual property remain with the inventor, including copyright to and royalty from literary or scholarly works in tangible or electronic form. The University may decline to accept any rights of ownership by assignment or otherwise, in which case all rights revert to the inventor or, if applicable, the research sponsor.

Disclosure of Inventions
Inventions, whether or not patentable, may have commercial utility. Inventions there-fore should be disclosed to the Director of the Office of Technology Transfer at Ext. 6-8137. Prompt and detailed disclosure is necessary to avoid loss of patent rights and to meet the University's responsibilities to federal and non-federal research sponsors.

Royalty Distribution
As explained below in the section on conflict of interest, all licensing agreements which provide for cash royalties in exchange for inventions must be reviewed by the Committee on Conflict of Interest. Such royalties shall be distributed in the manner specified in the chart on page 11. The distribution formula provides for a tiered division of annual net invention income among the inventor, the inventor's laboratory, the inventor's Department, the School of Hygiene and Public Health and the University. Annual net invention income is defined as annual gross invention income minus unreimbursed patent prosecution expenses, associated external expenses, and maintenance and processing fees. A one-time processing fee of $10,000 shall be charged to the licensee. All license agreements will include a yearly maintenance fee of $3,000.

Equity Holdings
Agreements with companies that involve equity participation by the University and/or its faculty are permitted, under appropriate circumstances. Proposed equity trans-actions shall be reviewed by the School of Hygiene and Public Health's Committee on Conflict of Interest, which shall make a recommendation to the Dean for a final decision as to whether they are permissible. Stock that is received in approved transactions will be divided according to the distribution formula on page 12.

Committee on Conflict of Interest
In permitting the University and its faculty to receive royalty and/or to hold stock under appropriate circumstances, the new Policies summarized in these Guidelines are aimed at minimizing actual or perceived conflicts of interest as well as opportunities for stock manipulation and speculation.

Trigger Date
In cases where the Committee on Conflict of Interest recommends allowance of the holding of equity, the Committee also is charged with the responsibility of recommending to the Dean a future "trigger date" that must be reached before any stock is sold and converted to cash. that date must be sufficiently removed in time from the actual research (e.g., two years after the first commercial sale of an FDA-approved product based on an invention resulting from the research) to avoid any actual or perceived conflicts of interest. All equity holdings recommended by the Committee and approved by the Dean shall be held in escrow by the University until the trigger date.

Preservation of the Right to Publish
The University and its faculty shall only enter into research contracts or other binding commitments to perform work that can reasonably be expected to be publishable, provide educational opportunities, and/or be in the public interest. Such agreements must permit the disclosure and publication of research, although delays in publication of up to 120 days may be agreed to in order to provide time for the filing of patent applications. However, a sponsor may not prohibit the disclosure of the existence of such agreements.

Disclosure of Commercial Involvement
Contracts for external research support often provide the research sponsor with an option to negotiate an exclusive, worldwide, royalty-bearing or equity-bearing license to inventions made in the course of the research. When an inventor publishes a report (printed or oral) of the results of such sponsored research, he/she must make an appropriate disclosure in that publication indicating his/her potential to earn royalties from a license. In addition, when an inventor publishes the results of research involving a company in which he/she owns equity, he/she must make an appropriate disclosure in that publication of his/her stock ownership.


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