PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

General Principles

A member of the faculty, staff or student body of the University who creates protectible intellectual property or any other individual subject to the Board of Regents' Policy on Intellectual Property (the "Intellectual Property Policy ") (a "Creator" under the terms of the Intellectual Property Policy) that potentially may be owned by the University (or by the sponsor of the work leading to the creation of the intellectual property) has the responsibility to promptly disclose, in writing, the existence of that intellectual property to the University through the office of Patents and Technology Marketing ("PTM"). The University will look to the Creator to decide in the first instance whether an invention or work is at a stage of development that disclosure to the University is advisable or required. That disclosure triggers PTM's review of sponsor requirements with respect to the intellectual property as well as an evaluation of the commercial potential of the intellectual property and its potential for protection. The disclosure is often the triggering event for creating a relationship between the Creator and the staff of PTM in assessing and developing the technology transfer potential of the intellectual property.

Procedures

1. When to disclose Intellectual Property. A Creator shall decide when to disclose to PTM the existence of a patentable invention once the Creator has conceived of the invention by having a mental picture of the invention or by being able to define the invention by its method of preparation, its physical or chemical properties or by whatever characteristics sufficiently distinguish it. A Creator shall decide when to disclose the existence of a copyrightable work once the work has been fixed in a tangible medium of expression. For Other Intellectual Property, prior to any disclosure to PTM, a Creator shall decide when to notify his or her immediate supervisor of the creation of such intellectual property. The University encourages Creators to consult with PTM in making the determination of when an intellectual property must be disclosed to the University under the Intellectual Property Policy. The Creator shall promptly submit to PTM an Invention Disclosure Form once a determination has been made that the intellectual property must be disclosed. The Invention Disclosure Form along with its Instructions are available at PTM's website at www.ptm.umn.edu.

2. Sufficiency of Disclosure. The Creator submitting an Invention Disclosure Form shall ensure the disclosure is sufficiently complete to allow the University to make a reasonable evaluation of the prospects for protecting and licensing the disclosed intellectual property. For this purpose, the disclosure must contain the following at minimum: a description of the intellectual property sufficient to determine what may be protected and the potential commercial value, including experimental results; a list of the people involved in the development of the intellectual property; the funding sources for the creation of the intellectual property; a list and copies of the Creator's publications and manuscripts relevant to the intellectual property, including the dates of actual or anticipated publication; and copies of publications by others relevant to the intellectual property of which the Creator is aware. PTM will determine if the disclosure is complete and sufficient for evaluation and will so inform the Creator.

3. University Review of Disclosure. PTM will determine whether to attempt to protect and license the intellectual property. PTM should normally complete its review within three months of receipt of the complete disclosure, but circumstances may require a longer or shorter period. For example, if it is important to contact companies to gauge commercial merit, three months may not be adequate to provide the information to companies and obtain their feedback. On the other hand, patenting deadlines or licensing opportunities may make quick decisions necessary.

4. University Waiver. If it determines not to proceed with protecting and licensing the intellectual property, PTM shall send each Creator of that intellectual property identified in the Invention Disclosure Form a written notice of the University's decision not to attempt commercialization, and if there are no contractual or other legal requirements preventing waiver of the intellectual property, PTM shall also notify each Creator of his or her right to request a waiver of the University's rights and interests in the intellectual property. (See Procedure on Intellectual Property: Waiver of University Rights or Acknowledgement of No University Rights.)

5. University Abandonment. Even after determining to protect and license an intellectual property, the University may abandon its efforts if it decides the intellectual property cannot be commercialized because the property cannot reasonably be adequately protected by law, the property is not expected to deliver a reasonable return to the University and the Creators, or for other appropriate reasons. In deciding whether to abandon an intellectual property, the University shall consult the Creators of the property.

Intellectual Property: Disclosure of Potential Conflict of Interest

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Office of the Vice President for Research

General Principles

The University and the University community have a strong interest and responsibility for preserving the University as an institution free of conflicts of interest that could cloud scientific and scholarly judgments, could improperly influence the distribution of resources within the University, and could undermine the public's confidence in the University as an institution of high integrity. The University's early review of potential conflicts of interest is especially important when licensing to business or commercial interests in which the Creator is an officer or holds an executive position or has significant financial interests. The University and the University community then have as a goal the elimination of actual and the management of potential conflicts of interest.

A Creator's business or financial interest (be it as a shareholder, partner, or other holder of an present or future ownership interest, or as a director, officer, employee or consultant) in or with a company, does not constitute, standing alone, a conflict of interest. However, because of the potential for both personal and institutional financial benefit, transactions involving University-based intellectual property require careful consideration and review to ensure that potential conflicts of interest do not rise to the level of actual conflicts. The Board of Regents' Policy on Conflict of Interest (the "Conflict of Interest Policy"), as well as the Procedures for implementing the policy, applies to potential and actual conflicts of interest arising from University-based Intellectual Property. The procedures presented below provide a supplementary framework for intellectual property-based potential conflicts of interest.

Procedures

1. Creator's Disclosures. A Creator shall disclose to the University all of the Creator's business and financial interests reportable to the University under the Conflict of Interest Policy (i) when the Creator submits an Invention Disclosure Form to Patents and Technology Marketing ("PTM"), (ii) when the University enters into an agreement to license or otherwise transfer some or all of its rights in the Development disclosed in the Invention Disclosure Form, and (iii) when the University agrees to waive its rights in the Development to the Creator, the Creator shall make these disclosures using the Report on External Professional Activities ("AREPA") form. At each reporting juncture, the Creator should review his or her most recently submitted AREPA and determine if it accurately and completely discloses all the Creator's reportable business and financial interests. The Creator shall submit an updated AREPA if the most recently submitted version is inaccurate or incomplete. The staff of PTM will review with each Creator the accuracy and completeness of the disclosures in the Creator's AREPA. During this review, the Creator shall disclose to and discuss with PTM any additional business or financial interests of the Creator that could potentially create a conflict of interest. If such additional interests exist, the Creator shall update her AREPA and shall ensure it is reviewed by her departmental and collegiate administration so that adequate management of the potential conflict will occur.

2. Prohibition on Licensing. The University will not enter into any license or other agreement to transfer some or all of its rights in an intellectual property until (i) after each Creator of that property has submitted to the University an accurate and complete AREPA, disclosing all of each Creator's business and financial interests reportable to the University under the Conflict of Interest Policy as of the date of or a date just before the date of such license or agreement; (ii) after each Creator's departmental and collegiate administration has reviewed the updated AREPA(s); (iii) after the development and implementation of a plan to manage any reportable conflicts of interest, and (iv) in those instances in which the Provost's or the Senior Vice President for the Academic Health Center's Conflict Review Committees (CRCs) approval is required, after such approval has been given and is subsequently reviewed by the Creator's collegiate administration.

Intellectual Property: Clarifying Definitions

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Office of the Vice President for Research

Definition of "Course Requirement"

"Course Requirement," as defined in the Board of Regents' Policy on Intellectual Property, means "[i]ntellectual property created solely for the purpose of satisfying a course requirement . . . . " (Section VI, Subd. 2). The term refers to intellectual property created solely as a requirement for completion of a formal organized course offered and conducted by the University of Minnesota. The term does not apply to work required in individual studies or research courses. In particular, the term does not apply to work conducted in order to complete a thesis or a dissertation.

Definition of "Other Intellectual Property"

"Other Intellectual Property," as defined in the Board of Regents' Policy on Intellectual Property (the "Intellectual Property Policy "), is "intellectual property disclosed to and licensed or otherwise transferred by the University's technology transfer unit and not covered by [Section VIII] subdivision 1 and 2 . . . . " (Section VIII, Subd. 3). For example, if the University required an employee, as part of his or her employment duties, to write a software application program, the program would be "Other Intellectual Property" and net income from a sale or licensing of it would be governed by Section VIII, Subd. 3 of the Policy on Intellectual Property. The term does not refer to, and expressly excludes, intellectual property which is the result of Academic Research or Scholarly Study or intellectual property created by a member of the faculty, staff or student body of the University or any other individual subject to the Intellectual Property Policy pursuant to and in conformance with the terms of the Board of Regents' Policy on Outside Consulting, Service Activities and Other Work.

Definition of "Out-of-Pocket Expenditures"

Net Income, as defined in the Board of Regents' Policy on Intellectual Property, is the "gross monetary payments the University receives as a result of transferring rights in intellectual property less the University's out-of-pocket expenditures (including legal fees) directly attributable to protecting, developing and transferring that intellectual property." (Section III, Subd. 3) The term means cash or other consideration paid to entities not owned by the University, including the fees and expenses of consultants and lawyers. In addition, expenses for levels of service and support provided by a University of Minnesota unit that are well beyond that customarily provided to support Patents and Technology Marketing or Sponsored Projects Administration in the process of protecting, developing and transferring that intellectual property may be treated as out-of-pocket expense. Such payments will be made with the approval of the Vice President for Research and will be subject to review by the President. In no case will service provided by a unit reporting to the Vice President for Research be considered for payment as an out-of-pocket expenditure.

Intellectual Property: Handling Net Income Derived from "Other Intellectual Property"

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

General Principles

The Board of Regents' Policy on Intellectual Property (the "Intellectual Property Policy") distinguishes intellectual property created as part of Academic Research or Scholarly Study from Other Intellectual Property owned by the University under Section V of the Intellectual Property Policy or law. The Board of Regents authorized the administration of the University to develop rules for determining if or how the University would distribute to Creators a share of the moneys earned from Other Intellectual Property. The University is under no obligation to distribute to Creators any portion of the moneys earned in connection with Other Intellectual Property. This Procedure sets forth the process under which the University shall determine the amount of any distribution to Creators of Other Intellectual Property.

• Opportunities for generation of net income from Other Intellectual Property are to be promptly disclosed to Patents and Technology Marketing (PTM) by the supervisor responsible for the work as soon as there is a belief by the supervisor that the work may have specific potential to generate net income.

• The supervisor functions in the role of principal investigator in making disclosures to PTM. PTM recognizes that supervisors may not have the expertise of a principal investigator and will work closely with the supervisor to explain the process and evaluate the opportunity.

• It is important to recognize the contributions of employees who develop Other Intellectual Property and to consider the difficulty of the work, the potential to generate net income and the level of innovation in determining the type of recognition. It is appropriate to provide monetary recognition in the form of a bonus or a series of bonuses for work that generates significant income.

• It is appropriate to provide a portion of the net income to the unit performing the work. The use of the net income should be determined by the unit and the funds used in a manner consistent with University policies and procedures. The receipt of the net income should not affect the unit's otherwise budgeted allocation of funds.

1. After the Creator's disclosure to the University of the Other Intellectual Property, the Creator's supervisor and the Assistant Vice President for Research of PTM (or his or her designee) shall jointly author a letter to the Creator's departmental personnel file that describes the Creator's role in developing the Other Intellectual Property and commends the Creator.

2. After the submission to PTM of an Invention Disclosure Form for the Other Intellectual Property and a determination by PTM that the Other Intellectual Property is commercially marketable, the Creator's immediate supervisor shall recommend to PTM how much, if any, of the Net Income from the University's granting of a license or otherwise entering into an agreement to transfer its rights in the Other Intellectual Property should be distributed to each Creator.

3. The University may distribute to a Creator a portion of the Net Income from the University's granting of a license or otherwise entering into an agreement to transfer its rights in the Other Intellectual Property. In deciding whether and, if so, how much to remunerate a Creator for the creation of the Other Intellectual Property, the University shall consider (i) the general importance of recognizing the contributions of employees who develop Other Intellectual Property; (ii) the difficulty of the work, (iii) the potential to generate significant net income, (iv) the level of innovation in determining the type of recognition, and (v) other appropriate factors. The University shall make such a determination each academic year the University expects to receive significant Net Income from the Other Intellectual Property.

4. The University may allocate to the unit or department of the Creator a portion of the Net Income from the University's granting of a license or otherwise entering into an agreement to transfer its rights in the Other Intellectual Property.

5. After PTM's receipt of the supervisor's recommended income distribution, the Vice President for Research, in consultation with PTM, shall decide how much, if any, of the Net Income from the University's granting of a license or otherwise entering into an agreement to transfer its rights in the Other Intellectual Property should be distributed to each Creator and to each Creator's department or unit.

6. The Vice President for Research's decision as to the distribution of Net Income from Other Intellectual Property shall be final and non-grievable. No provision of these Procedures shall cancel, limit or otherwise affect the right to grieve the University's failure to adhere to the notice and related procedural terms of these Procedures.

Intellectual Property: Waiver of University Rights or Acknowledgement of No University Rights

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

General Principles

The University will waive intellectual property claims to the Creator if the University determines not to protect and attempt to license that intellectual property. The University will also waive intellectual property to the Creator if it determines to abandon all efforts to protect and commercialize that intellectual property. The University will grant no waiver of intellectual property to the Creator if there are any contractual or other legal requirements that prevent the waiver. The University will acknowledge that it does not have rights to intellectual property at the request of the Creator if the factual circumstances of the development of the intellectual property support such conclusion and are verified. Patents and Technology Marketing (PTM) shall be the responsible office for such waivers and acknowledgements.

Procedures

1. University Waiver. A Creator if only one individual created the intellectual property or all the Creators if two or more individuals created the intellectual property may submit to PTM a written request the University waive its rights and interests. This request may be submitted at any time after the University has determined the Invention Disclosure Form for the intellectual property is complete and after the University has delivered to each Creator a written notice of the University's intention not to commercialize the intellectual property.

The University may waive its rights and interests in a properly disclosed intellectual property if the University determines that the intellectual property cannot be commercialized because the property cannot reasonably be adequately protected by law, the property is not expected to deliver a reasonable return to the University and the Creators, or for other appropriate reasons. If the University waives its rights in an intellectual property, the University shall also assign its intellectual property rights existing at the time of the waiver, such as patent applications, or copyrights, to the Creator. PTM will cooperate with the Creator to effect such assignments.

The University will generally not grant waivers to intellectual property that is simply an idea with no associated proof of principle or significant test result. The University will also have discretion to determine the form and jurisdiction for pursuing protection for the intellectual property, and will not waive other forms or jurisdictions of protection. The University will not grant partial waivers, waiving to a Creator some but not all of the University's rights in a Development. For example, the University may pursue copyright protection only but will not waive any patent rights or the University may pursue patent rights in the U.S. only but will not waive European patent rights.

PTM shall promptly inform each Creator in writing if PTM determines to abandon all efforts to protect or maintain protection for the intellectual property. This written notice shall include an offer to waive if there are no contractual or other legal requirements preventing waiver (a decision to abandon some forms or some jurisdictions of protection while maintaining others shall not require an offer to waive). If a Creator requests the waiver, PTM shall promptly provide them a suitable written form and specify any known obligations to which the waiver is subject.

2. University Acknowledgment of No Rights. A Creator may request in writing to PTM that the University confirm that it does not have rights to specific intellectual property. Such request must explain the circumstances of the creation of the intellectual property in sufficient detail for PTM to determine that the intellectual property either does not fall within the scope of Section V of the Intellectual Property Policy or that it falls within one of the exceptions detailed in Section VI of the policy. A form for making such a request is available at www.ptm.umn.edu. PTM need not evaluate a Creator's request for acknowledgment of no rights until after the Creator's department head or other relevant supervisor has certified the accuracy and completeness, to the best of the department head's or supervisor's knowledge, of the representations in the Creator's request. Promptly after receipt of such request and certification, PTM will evaluate the information contained in the request and, if appropriate, generate a written acknowledgment that the University does not have rights in the intellectual property. Such acknowledgment will be contingent upon the accuracy of the information contained in the request.

3. Routine requests from publishers. Increasingly, publishers are requesting that the University provide documentation that it will make no claims on copyrighted materials such as scholarly papers and monographs be provided prior to publication (or even review). As this practice has becomes more widespread, the process described clearly does not scale for the very high volume of scholarly production of the University of Minnesota faculty. A form letter acknowledging that the University of Minnesota exercises no claims to rights or ownership in intellectual property created as a Regular Academic Work Product (unless assigned in writing)is available at www.ptm.umn.edu. Regular Academic Work Product is defined in the Regents' Policy on Intellectual Property in Section III, Subd. 4.

Intellectual Property: Notifying Sponsors

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

General Principles

The principal investigator on a grant has the responsibility of knowing and understanding the sponsor's requirements for reporting intellectual property. The principal investigator shall promptly disclose to Patents and Technology Marketing (PTM) any intellectual property subject to reporting to the sponsor. PTM shall be responsible for making the appropriate report to the sponsor.

Procedures

Specific procedures for principal investigators to make disclosures to meet sponsor requirements may be found at www.ospa.umn.edu.

Intellectual Property: Material Transfer Agreements

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

Office of Sponsored Projects Administration

General Principles

The University encourages the transfer of biological and research materials. It is important that such transfers do not violate the terms of any contract or law. The University's Office of Sponsored Projects Administration (OSPA) and Patents and Technology Marketing (PTM) are responsible for ensuring the University meets these goals. A member of the faculty, staff or student body of the University who intends to receive biological or other research materials from a source that requires the University enter into a written material transfer agreement should route that request to the Office of Sponsored Projects Administration (OSPA). A member of the faculty, staff or student body of the University who intends to deliver biological or other research materials that they believe ought to be covered by a material transfer agreement should contact Patents and Technology Marketing (PTM).

Procedures

1. Receiving materials. Requests for material transfer agreements to cover materials received by the University should be routed by the recipient to OSPA using the routing form available at www.ospa.umn.edu. OSPA is responsible for determining the appropriate agreement to use (the Uniform Biological Materials Transfer Agreement is used whenever possible), for ensuring that the agreement will not conflict with any sponsor rights for the projects specified by the recipient in which the material will be used, and for negotiating appropriate terms as applicable. The recipient will be responsible for knowing and understanding the terms of the material transfer agreement and ensuring that they are met, including using and monitoring the material as specified in the agreement, and invention reporting and other reporting as required. The recipient will not use the material for any project other than the projects specified in the routing form to OSPA.

2. Sending materials. A member of the faculty, staff or student body of the University or any other individual subject to the Board of Regents' Policy on Intellectual Property (the "Intellectual Property Policy") who plans to send biological or other research materials to another university, a company or some other entity not owned by the University of Minnesota, prior to the delivery of the material, shall contact PTM if (i) the materials reasonably have potential commercial marketability or significant research potential; or (ii) if the materials were developed under a agreement granting some other entity rights in the materials (for example a funding agreement or material transfer agreement). In all other instances, the University encourages members of the faculty, staff or student body of the University and any other individual subject to the Intellectual Property Policy to contact PTM prior to the delivery of the materials if it is important or necessary for the transfer to be recounted in a written agreement.

In consultation with the member of the faculty, staff or student body of the University or the other individual subject to the Intellectual Property Policy who proposes to deliver biological or other research materials, PTM shall determine whether it is required or desirable for the University and the proposed recipient to enter into a written material transfer agreement. PTM is responsible for determining the appropriate written agreement to use (the Uniform Biological Materials Transfer Agreement is used whenever possible) and for negotiating appropriate terms as applicable. In order to fulfill contractual requirements concerning the material or in order to evaluate the material for purposes of determining appropriate means to handle the transfer, the University may require a Creator to submit to PTM an Invention Disclosure Form for the material.

Intellectual Property: Resolution of Disputes

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Office of the Vice President for Research

Procedures

Disputes or unresolved questions may arise concerning the application of the Board of Regents' Policy on Intellectual Property and related procedures. Such disputes or questions should be raised with the Vice President for Research. The Vice President shall consult with the Office of General Counsel, the Senate Committee on Research and others as may be appropriate in order to resolve the dispute or question. The Vice President for Research will annually report to the Senate Research Committee on the number, nature and resolution of such disputes and questions. Consistent with University policy and state or federal law, other policies and procedures for addressing grievances arising from application of the Intellectual Property Policy (and its related procedures) may be invoked.

Intellectual Property: Intellectual Property Policy Acknowledgment

PROCEDURE x.x.x.x

Responsible University Officer
Vice President for Research

Responsible Office
Patents and Technology Marketing

Office of Human Resources

General Principles

The federal government mandates (Part 37 of the Code of Federal Regulations Section 401.14) that the University require, by written agreement, employees to disclose intellectual property created under federal sponsorship and that employees cooperate in the execution of paperwork necessary to protect that intellectual property.

Broad dissemination of the Board of Regents' Policy on Intellectual Property ( the "Intellectual Property Policy") is necessary not only to comply with federal regulations but also to protect the interests of the University and members of its community. Faculty, including visiting faculty, scholars and researchers, and all employees of the University are governed by the Intellectual Property Policy.

Procedures

1. New Employees. At the time of appointment, new faculty members, professional and administrative employees, graduate assistants and others judged likely by their supervisors to have a reasonable potential to create intellectual property will be provided with a copy of the Intellectual Property Policy.

2. Continuing Employees. Discussion of the Intellectual Property Policy is a component of the required training for Principal Investigators in the Responsible Conduct of Research. A copy of the policy will be provided to each participant in the RCR training. Each participant will be instructed to review the policy.

3. Visiting Faculty, Visiting Scholars or Visiting Researchers. Visiting Faculty or Visiting Scholars supported on funds administered by the University of Minnesota are subject to the provisions of the Intellectual Property Policy. Because such visitors may also be subject to Intellectual Property policies of their principal employers, it is important that visitors be provided with a copy of the Intellectual Property Policy prior to arrival on campus. If there is a conflict in institutional policies, the Office of Patent and Technology Marketing will work with the visitor and his/her home institution to prepare an agreement to accommodate the visit while protecting the interests of the University and its research sponsors.