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                                                      PRINTER'S NO. 1971

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 1614 Session of 2001


        INTRODUCED BY C. WILLIAMS, DeWEESE, VEON, COY, M. COHEN,
           D. EVANS, BELARDI, BEBKO-JONES, CALTAGIRONE, CAPPABIANCA,
           COLAFELLA, COSTA, DeLUCA, EACHUS, FRANKEL, GEORGE, GRUCELA,
           HALUSKA, HARHAI, HORSEY, JAMES, JOSEPHS, LaGROTTA, LEDERER,
           LUCYK, MANN, McCALL, MELIO, PALLONE, RIEGER, ROONEY, SAINATO,
           SANTONI, SHANER, SOLOBAY, STABACK, STEELMAN, SURRA, THOMAS,
           TRAVAGLIO, TRELLO, TRICH, WOJNAROSKI AND YUDICHAK,
           MAY 17, 2001

        REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, MAY 17, 2001


                                     AN ACT

     1  Establishing an institute for biomedical research and
     2     technology; and making an appropriation.

     3     The General Assembly of the Commonwealth of Pennsylvania
     4  hereby enacts as follows:
     5  Section 1.  Short title.
     6     This act shall be known and may be cited as the Biomedical
     7  Research and Technology Act.
     8  Section 2.  Definitions.
     9     The following words and phrases when used in this act shall
    10  have the meanings given to them in this section unless the
    11  context clearly indicates otherwise:
    12     "Board of directors."  The board of directors of the
    13  Institute for Biomedical Research and Technology established in
    14  this act.


     1     "Center."  A Regional Center for Biomedical Research and
     2  Technology Innovation established in this act.
     3     "Institute."  The Institute for Biomedical Research and
     4  Technology established in this act.
     5     "Master Settlement Agreement."  The settlement agreement and
     6  related documents entered into on November 23, 1998, by the
     7  Commonwealth and leading United States tobacco product
     8  manufacturers and approved by the court in Commonwealth v.
     9  Philip Morris, April Term, 1997, No.2443 (C.P. Philadelphia
    10  County), on January 13, 1999.
    11  Section 3.  Institute for Biomedical Research and Technology.
    12     (a)  Establishment.--There is hereby established an Institute
    13  for Biomedical Research and Technology.
    14     (b)  Function.--The institute shall establish Regional
    15  Centers for Biomedical Research and Technology Innovation within
    16  this Commonwealth; aid the centers in seeking private capital
    17  and other public investments; assist the center in developing
    18  licensing and royalty agreements and arranging clinical trials;
    19  provide technical, legal and administrative support; and
    20  coordinate and provide oversight of research activities
    21  performed by the regional centers.
    22     (c)  Board of directors.--The institute shall be governed by
    23  a board of directors consisting of:
    24         (1)  The Secretary of Community and Economic Development,
    25     who shall serve as chairperson.
    26         (2)  The Secretary of Health.
    27         (3)  The Secretary of Education.
    28         (4)  One member who shall be the director of a Ben
    29     Franklin Technology Partnership Center, who shall serve a
    30     term of two years and shall be replaced, on a rotating basis,
    20010H1614B1971                  - 2 -

     1     by the director of a different Ben Franklin Technology
     2     Partnership Center.
     3         (5)  Four members of the Senate, two of whom shall be
     4     appointed by the President pro tempore and two of whom shall
     5     be appointed by the Minority Leader.
     6         (6)  Four members of the House of Representatives, two of
     7     whom shall be appointed by the Speaker and two of whom shall
     8     be appointed by the Minority Leader.
     9         (7)  Five members appointed by the Governor, meeting the
    10     following criteria:
    11             (i)  Two members from either academic medical centers
    12         or cancer research centers; one of whom shall be a
    13         research scientist and one of whom shall have expertise
    14         in technology transfer, intellectual property rights or
    15         research licensing agreements.
    16             (ii)  One member from a trade association
    17         representing private pharmaceutical companies.
    18             (iii)  One member from a trade association
    19         representing private biotechnology companies.
    20             (iv)  One member from a regional technology council
    21         or an economic development organization.
    22     (d)  Terms of members.--The Secretary of Community and
    23  Economic Development, the Secretary of Health and the Secretary
    24  of Education shall serve on the board of directors for the
    25  length of their respective terms. Legislative appointments shall
    26  serve at the pleasure of the appointing authority. Except as
    27  otherwise indicated, other appointees shall serve for terms of
    28  three years and may not serve successive terms.
    29     (e)  Compensation and expenses.--Members of the board of
    30  directors shall serve without compensation but shall be
    20010H1614B1971                  - 3 -

     1  reimbursed for actual and reasonable expenses incurred in the
     2  performance of their official duties.
     3     (f)  Staffing.--The institute shall be served by the existing
     4  staff of the Department of Community and Economic Development.
     5  Section 4.  Regional Centers for Biomedical Research and
     6                 Technology Innovation.
     7     (a)  Establishment.--The institute shall establish three
     8  regional centers, located within this Commonwealth, to
     9  facilitate the enhancement of biomedical research and
    10  technology.
    11     (b)  Advisory board.--Each regional center, upon selection of
    12  application by the board of directors, shall establish an
    13  advisory board, comprised of no fewer than three but no more
    14  than nine members, including the president, chancellor, or chief
    15  executive officer of the academic medical center, research
    16  university, cancer research center or other biomedical research
    17  center, who shall serve as chairperson.
    18     (c)  Functions of centers.--The regional centers shall
    19  develop and implement biomedical and technology research
    20  projects which promote and coordinate research in this
    21  Commonwealth in order to:
    22         (1)  Create or enhance biomedical research, biotechnology
    23     and other related industries in Pennsylvania.
    24         (2)  Develop high quality and commercially useful patents
    25     that will generate future revenue for the continued operation
    26     of the regional centers.
    27         (3)  Attract venture capital investments from various
    28     public, private, nonprofit and for-profit sources.
    29         (4)  Attract and retain leading research scientists,
    30     physicians and other high technology professionals throughout
    20010H1614B1971                  - 4 -

     1     this Commonwealth.
     2         (5)  Encourage training and educational programs.
     3         (6)  Develop regional research specialties, including,
     4     but not limited to, biological and pharmacological research,
     5     medical biotechnology, nonmedical biotechnology and
     6     bioengineering, bio-informatics and tissue engineering and
     7     addiction research.
     8         (7)  Implement the commercial development of new research
     9     discoveries.
    10         (8)  Work with other area institutions, organizations and
    11     companies to advance technology and overall community and
    12     economic development within the region where each center is
    13     located.
    14         (9)  Create and retain quality jobs for the residents of
    15     this Commonwealth.
    16     (d)  Application for selection.--The board shall solicit and
    17  receive applications for selection as a regional center from
    18  academic medical centers, research universities, cancer research
    19  centers and other biomedical research centers. Each application
    20  for consideration shall include the following:
    21         (1)  A listing of the for-profit and nonprofit
    22     institutions and organizations that will comprise the
    23     nonprofit corporation and that will own and operate the
    24     regional center.
    25         (2)  The names and affiliations of the members of the
    26     advisory board for the regional center.
    27         (3)  The proposed programs, activities and categories of
    28     research to be conducted at the center.
    29         (4)  The plans for marketing the research center to
    30     regional institutions and corporations to build awareness,
    20010H1614B1971                  - 5 -

     1     encourage participation, and establish sources for additional
     2     funding.
     3         (5)  The proposed location of the research center and
     4     physical facilities available for use of the regional center.
     5         (6)  A proposed budget for the first year of operation of
     6     the facility including projected infrastructure costs and
     7     projections on permanent staff to be employed at the regional
     8     center.
     9         (7)  The anticipated health, scientific, commercial and
    10     economic development outcomes to be achieved by specialty
    11     research undertaken at the regional center.
    12         (8)  The amount of funds or infrastructure to be
    13     contributed by each participating entity involved in the
    14     regional center.
    15         (9)  Any other information deemed necessary by the board
    16     of directors or the Secretary of Community and Economic
    17     Development.
    18     (e)  Selection of regional centers.--The board shall approve
    19  three applications, from those submitted for review, for
    20  selection as regional centers. The board shall evaluate
    21  applications on a competitive basis and shall consider the
    22  applicant's expertise in the subject area selected, ability to
    23  attract private investment, quality of research facilities,
    24  strength of the technology transfer program, intellectual
    25  property rights policy and prior success of the applicant in
    26  licensing products and securing patents. Priority consideration
    27  shall be given to applicants which draw upon the resources of
    28  multiple institutions.
    29     (f)  Participation, guidelines and procedures.--In order to
    30  participate in research or product development at a regional
    20010H1614B1971                  - 6 -

     1  center, an applicant shall make financial or other substantially
     2  equivalent in-kind matching contributions to the research being
     3  conducted in an amount or percentage established by the
     4  Department of Community and Economic Development. All other
     5  guidelines and procedures for the distribution of funds shall be
     6  established by the department. Each regional center shall
     7  develop royalty agreements or other revenue streams to fund
     8  continuing operations of the regional center and shall also
     9  reach agreement with the Department of Community and Economic
    10  Development on allowing access to and commercialization of
    11  intellectual property. Intellectual property shall include work
    12  of the mind or intellect associated with an idea, invention,
    13  trade secret, process, program, data, formula, patent, copyright
    14  or trademark, or an application, right or registration relating
    15  thereto.
    16         (1)  The Department of Community and Economic Development
    17     shall reach agreement with the advisory board of each
    18     regional center regarding the amount of capital to be raised
    19     from the for-profit and nonprofit participants prior to
    20     disbursement of any State funds.
    21         (2)  Regarding that portion of revenue which will be
    22     returned to the Commonwealth due to royalty agreements and
    23     other revenue streams resulting from successful new
    24     inventions or new patents issued as a result of research
    25     undertaken at the research center.
    26     (g)  Continuing Research Fund.--
    27         (1)  There is hereby established, within the Department
    28     of Community and Economic Development, a Continuing Research
    29     Fund to provide for further funding of research activities at
    30     the regional centers.
    20010H1614B1971                  - 7 -

     1         (2)  All revenue from royalty and licensing agreements or
     2     any other revenue streams generated by this act shall be
     3     deposited into the Continuing Research Fund.
     4         (3)  Any money placed in the Continuing Research Fund may
     5     be distributed to a regional center, at the discretion of the
     6     Department of Community and Economic Development, in
     7     consultation with the board of directors, under the
     8     guidelines and procedures established by the department. Any
     9     money distributed to a regional center from the Continuing
    10     Research Fund shall be considered separate from any other
    11     source of State funds.
    12     (h)  Personnel.--A regional center may hire personnel to
    13  coordinate research projects undertaken pursuant to this act.
    14     (i)  Review and report.--
    15         (1)  Each regional center shall be subject to annual
    16     review by the board of directors and the Department of
    17     Community and Economic Development.
    18         (2)  Each regional center shall annually submit a report
    19     to the board of directors, the Department of Community and
    20     Economic Development, the Department of Health, the chairman
    21     and the minority chairman of the Appropriations Committee of
    22     the Senate, the chairman and minority chairman of the
    23     Appropriations Committee of the House of Representatives, the
    24     chairman and minority chairman of the Community and Economic
    25     Development Committee of the Senate and the chairman and
    26     minority chairman of the Commerce and Economic Development
    27     Committee of the House of Representatives. This report shall
    28     be in a form and manner developed by the Department of
    29     Community and Economic Development working in cooperation
    30     with the Department of Health and shall include the
    20010H1614B1971                  - 8 -

     1     following:
     2             (i)  The current members of the advisory board for
     3         the regional center.
     4             (ii)  A description of the research facilities,
     5         including space and equipment, and a list of personnel
     6         involved in projects receiving State funds.
     7             (iii)  The regional center's current policies for the
     8         management and development of intellectual property and
     9         ownership of new inventions created during the course of
    10         research undertaken at the center.
    11             (iv)  The regional center's current policies for the
    12         distribution of State funds to projects undertaken at the
    13         center.
    14             (v)  A listing and brief description of all current
    15         projects receiving State funds pursuant to this act.
    16             (vi)  The research center's policies on conflicts of
    17         interest and the handling of confidential and other
    18         sensitive material.
    19             (vii)  A listing of all organizations, for-profit and
    20         nonprofit institutions utilizing the services of the
    21         research center during the prior year.
    22             (viii)  A listing of any licenses or other
    23         contractual obligations in effect, or anticipated, for
    24         the intellectual property developed at the research
    25         center during the prior year.
    26             (ix)  A listing of any new inventions, any new patent
    27         applications or patents issued as a result of research
    28         undertaken at the center during the prior year, and any
    29         estimated revenue or anticipated revenue from
    30         corresponding royalty and licensing agreements with the
    20010H1614B1971                  - 9 -

     1         regional center.
     2             (x)  A copy of the annual operating budget for the
     3         year, including a listing of the sources of all funds
     4         including financial and in-kind personnel, equipment or
     5         other material donations and contributions by all parties
     6         involved in the regional center, grants obtained, Federal
     7         funds leveraged and expenditures made including
     8         infrastructure expenditures, administrative and staffing
     9         costs, and any other relevant information
    10     (j)  Expiration.--This act shall expire five years from its
    11  effective date.
    12  Section 5.  Appropriation.
    13     The sum of $35,000,000 is hereby appropriated from the
    14  payments received by the Commonwealth pursuant to the Master
    15  Settlement Agreement for the fiscal year July 1, 2001, to June
    16  30, 2002, to carry out the provisions of this act.
    17  Section 6.  Effective date.
    18     This act shall take effect in 60 days.








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