UNIVERSITY OF PITTSBURGH POLICY 11-02-03

CATEGORY:         RESEARCH ADMINISTRATION
SECTION:          Technology Management
SUBJECT:          Commercialization of Inventions Through Independent Companies
EFFECTIVE DATE:   July 1, 2005 Revised
PAGE(S):          6

I.    SCOPE

      The University’s main missions are teaching, research, and public service.
      As part of its public service mission, the University has a charge to help 
      with the economic development of the region and the nation.  In part to 
      address this issue of economic development, the faculty, staff, and 
      students are encouraged to explore options to commercialize inventions 
      through independent companies (start-up companies) that are based on 
      technology that has been developed in their laboratories.  The focus of 
      the faculty, staff, and students, however, must remain clearly on the 
      mission of the University when pursuing these largely independent 
      ventures.

      The following is a policy and guidelines to facilitate and manage the 
      process of company start-up by University faculty, staff, and students.  
      Policy 11-01-03, Conflict of Interest - Research/Teaching, and Policy and 
      Procedure 11-02-01, Patent Rights and Technology Transfer, are applicable 
      with respect to this policy.  This policy is an extension of those 
      policies.  The Entrepreneurial Oversight Committee and the Director of 
      Technology Management and associates will ensure that the details of the 
      policy are implemented in an efficient and expeditious fashion.  The 
      Entrepreneurial Oversight Committee and the Director of Technology 
      Management and associates also serve in an advisory capacity to the 
      Chancellor.  All of the activity under this policy must also comply with 
      applicable statutes, regulations, and other governmental guidance.

II.   POLICY

      A.    Ownership of Equity by Faculty, Staff, and Students and Members of
            Their Immediate Family*

            Ordinarily, faculty, staff, and students should be permitted to hold 
            equity in companies that license their technologies provided that:

            1.    the relationship has been reviewed and approved by the 
                  Department Chair, Dean, and Entrepreneurial Oversight 
                  Committee.

            2.    caps are placed on the percentage of stock held by University 
                  faculty, staff, and students in the start-up company up to 20% 
                  ownership by all University faculty, staff, and students in 
                  the aggregate.**   (Exceptions may be considered for 
                  development stage companies that do not have products in 
                  clinical trials or products being sold.)***

            3.    the stock is not traded or otherwise sold until the occurrence
                  of a triggering event or date to be specified by the 
                  Entrepreneurial Oversight Committee.  Depending on the nature 
                  of the company and its products, the Committee may prohibit 
                  the trading or purchase of stock or receipt of stock options 
                  or warrants by University faculty, staff, and students:

                  a.    during clinical studies, until the results of the 
                        studies are published;

                  b.    until two years have elapsed from the first commercial 
                        sales of the licensed product;

                  c.    until the company is sold; or

                  d.    until the stock is publicly traded.

            4.    the faculty, staff, and students do not hold management or
                  operating positions in the company.

            5.    financial disclosures are provided by faculty, staff, and
                  students annually, and as relationships change, to Department 
                  Chair or Dean and the Entrepreneurial Oversight Committee.  
                  These disclosures, which also need to be submitted for grants,
                  contracts, etc., should be in line with the applicable 
                  University Conflict of Interest policy forms.  Particular 
                  attention needs to be paid to accurate reporting of conflicts 
                  of interest and commitments.

            6.    involved faculty/staff/students sign consent forms that 
                  certify that they understand applicable policies and agree to 
                  cooperate in their implementation.

      B.    Institutional Ownership of Equity

            The University should be permitted to take stock in licensee 
            companies that do not have the financial resources to make full 
            license payments in cash, but licensees should be required to pay 
            for out-of-pocket patenting and related expenses.  Equity should not 
            be held in sufficient amounts to confer management power, which 
            generally would limit ownership to less than 20% of voting stock.  
            Review and approval of acquiring stock should be provided by the 
            Entrepreneurial Oversight Committee and the Executive Vice 
            Chancellor.  Should the University wish to invest funds in start-up 
            companies, this should be implemented through an independent entity 
            that is friendly to the University but that is not controlled by the 
            University and is managed by outside participants.

      C.    Company-Sponsored Research at the University

            Sponsored research related to the business of the start-up company 
            should generally be permitted in the University laboratories of the 
            scientists who developed the technology provided that:

            1.    research proposals are reviewed by the Entrepreneurial 
                  Oversight Committee prior to approval;

            2.    periodic reports are provided to the Entrepreneurial Oversight 
                  Committee on the research methodologies and results;

            3.    faculty, staff, and students with equity and other potential 
                  financial benefits from success of the start-up company (for 
                  example, royalties, consulting fees or profit sharing) cannot
                  be the principal investigator on such sponsored research or be
                  the attending physician in clinical trials, nor record patient 
                  data.  The faculty, staff, and students generally should not 
                  be permitted to negotiate a research contract or grant from 
                  the start-up company to the University, and faculty, staff, 
                  and students are prohibited from purchasing goods or services 
                  from the company on behalf of the University.  Any such 
                  research contract or grant shall be negotiated on behalf of 
                  the University by the Office of Technology Management in 
                  collaboration with the Office of Research.

            4.    prior approval is obtained from Department Chair and Dean on 
                  use of graduate and undergraduate students.  In addition, the 
                  faculty, staff, and students in carrying out confidential 
                  research for the start-up company should not delay or inhibit 
                  publication of research findings beyond the normally specified 
                  time designated in Policy and Procedure 11-02-01, Patent 
                  Rights and Technology Transfer.

      D.    Faculty Consulting for Companies in Which They Have an Interest

            Consulting should normally be permitted, in accordance with the 
            policy on Consulting and Outside Professional Service contained in
            the Faculty Handbook, provided that there is prior approval from the 
            Department Chair, Dean, and the Entrepreneurial Oversight Committee.  
            Attention needs to be paid to the use of University resources for 
            purposes other than University business as stated in Policy 05-08-
            01, Personal Use of University Resources.

      E.    Other Affiliation Issues Between Faculty, Staff, and Students and 
            Start-up Companies

            Board position:  Prohibited.

            Scientific Advisory Board:  Permitted with disclosure to, and 
            ongoing review by, Entrepreneurial Oversight Committee.

            Honoraria:  Permitted, with review by Entrepreneurial Oversight 
            Committee.

            Use of University name:  Prior written approval required as stated 
            in Policy 08-01-01, Licensing and Use of University Name, Logos, 
            Trademarks, and Service Marks.

            Management of multiple funding sources:  Proposals for corporate 
            funding through which rights to technology are created in the 
            research sponsor should receive prior review and approval from the 
            Department Chair, Dean, and the Entrepreneurial Oversight Committee.

            Disclosure in publications and consent forms:  Corporate funding of
            the research, equity ownership, or other potential financial 
            benefits to the researcher from the success of the company should be 
            disclosed in all related publications and in patient informed 
            consent forms.

      F.    Operation of Entrepreneurial Oversight Committee

            The Chair of the Entrepreneurial Oversight Committee shall be 
            appointed by the Provost and Senior Vice Chancellor for Health 
            Sciences.  The Entrepreneurial Oversight Committee shall be 
            appointed by the Provost and Senior Vice Chancellor for Health 
            Sciences in consultation with the President of the Senate.  The 
            membership should consist of administrators, faculty, staff, and 
            students involved in activities pertinent to the process of 
            commercialization of inventions and knowledgeable in the research 
            and commercial environment.  The Entrepreneurial Oversight Committee 
            should review disclosures submitted pursuant to this policy and 
            should convene subcommittees to investigate potentially problematic 
            situations.

            Guidelines for Review by Entrepreneurial Oversight Committee

            1.    Initial Review

                  The initial review will consider the proposed relationships 
                  between the faculty/staff/student-entrepreneurs, the company, 
                  and the University to ensure that adequate safeguards are in 
                  place to protect against inappropriate use of University 
                  resources, employees, students or fellows; failure to perform 
                  expected duties the University; or other violations of law, 
                  ethical standards or University policy.  The Committee will 
                  either recommend changes in the proposed relationship or 
                  provide a statement that the proposed relationships have been 
                  found to be satisfactory.  In either case, the Committee will 
                  establish standards for events that would trigger subsequent 
                  review by the Committee.

                  Specific information to be provided two weeks prior to the
                  meeting of the Committee:

                  a.    List of all University employees and members of their 
                        immediate families involved in the creation of the
                        company, with departmental affiliations and curricula 
                        vitae.

                  b.    List of individuals from other institutions,
                        entrepreneurs, and investors involved in the creation of 
                        the company, with brief descriptions of the role that 
                        each will play, and curricula vitae for those filling 
                        management positions in the company.

                  c.    Description of products or services that will be
                        developed and/or sold by the company, including 
                        information on current developmental status, 
                        intellectual property status, and sources of prior and 
                        current funding.

                  d.    Description of proposed ownership structure for the 
                        company, with composition of Board of Directors and 
                        Scientific Advisory Board, if any.  This should include 
                        a description of proposed equity holdings of the 
                        University and its faculty/staff/ students and their 
                        immediate families, and expectations as to how ownership 
                        percentages held may evolve as additional investors, 
                        managers, and/or researchers participate in the company.

                  e.    Description of proposed sponsored research relationship 
                        between the start-up company and the University, if any, 
                        including description of any use of University 
                        resources, equipment, personnel, and undergraduate and 
                        graduate students. Description of any restrictions on 
                        prompt communication or publication of research results.

                  f.    Description of the terms of any proposed intellectual 
                        property licenses between the University and the start-
                        up company.

                  g.    Description of any proposed role of University employees
                        or students in performing services for the company 
                        beyond the scope of sponsored research agreements with 
                        the University, e.g., consulting with or without 
                        compensation.  Also describe the impact the proposed 
                        relationships may have on the ability the University 
                        employees and students to perform their academic and 
                        research obligations and time commitments.

                  h.    Itemization of all extramural funding (including that 
                        from the entrepreneurial company) taking place in the 
                        laboratories of the involved faculty, including source, 
                        dollar amounts, space usage, and dates of contract.  
                        This should also include a description of how the 
                        existing sponsored research activities are distinguished 
                        from the product development strategy proposed by the 
                        entrepreneurial group.

                  i.    Abstracts of all pending collaborative grant 
                        applications, with detailed budgets.

                  j.    Statements from each involved faculty/staff/student 
                        member, specifically requesting approval for their 
                        proposed relationships, and stating that they understand 
                        and will comply with relevant University policies.

            2.    Subsequent Review

                  Subsequent review will be required annually and upon the 
                  occurrence of specified triggering events.  Changes in faculty 
                  relationships the University or with the company will also be 
                  reviewed.

                  Specific triggering events for subsequent review:

                  a.    Prior review of collaborative grant applications, 
                        proposed, and proposed allocation of University and 
                        company resources to perform the scope of work.

                  b.    Change in relationships between University employee and
                        the company.

                  c.    Prior review of proposals to be submitted to other 
                        corporate sponsors, where there is potential for overlap 
                        in technical focus or use of personnel.

                  d.    Change in ownership structure of company.

                  e.    Change in management structure of company.

                  f.    Specific request from relevant Dean or Department Chair
                        for review of allocation of effort of involved staff.

      G.    Licensing of University Technology to a Company in Which Faculty, 
            Staff, or Students Have an Interest

            The University, through the Office of Technology Transfer and 
            Intellectual Property, has established a common format for licensing 
            of technology.  Future rights to all technologies out of a lab 
            ordinarily will not be granted.  Prior licensee and sponsoring 
            companies will be given the opportunity to review new technologies 
            per agreement.  Broad marketing by the technology transfer staff 
            will occur.  Attention is also called to the responsibilities of 
            faculty, staff, and students set out above under the topics of 
            equity, company-sponsored research, and consulting in sections B, C, 
            and D.

      H.    Entrepreneurial Leave

            The Faculty Handbook addresses the issue of faculty leaves of 
            absence.  The pursuit of entrepreneurial endeavors is a valid reason 
            for application for a faculty leave of absence.

      I.    Information Programs for Technology Transfer

            Seminars should be conducted for faculty, staff, and students 
            involved in technology transfer situations to explain University 
            policies and the commercialization processes.  Other outreach 
            mechanisms should be instituted to promote technology transfer 
            activities and compliance with University policies.

      J.    Product Liability

            In order to control the risk of product liability, there shall be a 
            disclaimer of warranties to the licensee company, along with 
            comprehensive insurance requirements.  Automatic indemnification of 
            the University by the licensee is required.  These items will not be 
            waived by the University in the case of a company in which faculty, 
            staff, and students have an interest.

      K.    Appeals of decisions under this policy will follow the Conflict of 
            Interest - Research/Teaching policy appeals procedures.

      L.    All exceptions to this policy must be approved by a Senior Vice 
            Chancellor.

III.  REFERENCES

      Policy 05-08-01, Personal Use of University Resources

      Policy 08-01-01, Licensing and Use of University Name, Logos, Trademarks, 
      and Service Marks

      Policy 11-01-03, Conflict of Interest - Research/Teaching

      Policy 11-02-01, Patent Rights and Technology Transfer

      Procedure 11-02-01, Patent Rights and Technology Transfer


____________________

* Dependents, the spouse, and all members of the household are considered
members of the immediate family.  In all future references to faculty, staff,
and students in this document, members of the immediate family are included.  
Ownership shall be deemed to mean actual or beneficial ownership.

** It should be recognized that equity dilution occurs with multiple rounds of 
financing.  The ownership percentage will be treated on a fully diluted basis.

*** Development stage companies are those that do not yet have products in 
clinical trials or in the commercial marketplace.  It may be necessary for 
University personnel to play an important role in the early stage of company 
formation, but it is expected that this role will be reduced as the company 
matures and outside management and investment are brought in.