The following words and terms, when used in this chapter, shall
have the following meanings, unless the context clearly indicates
otherwise.
  (1) Advisory Committee--a committee of experts, including
practitioners and patient advocates, created by the Oversight Committee
to advise the Oversight Committee on issues related to cancer.
  (2) Allowable Cost--a cost that is reasonable, necessary
for the proper and efficient performance and administration of the
project, and allocable to the project.
  (3) Annual Public Report--the report issued by the
Institute pursuant to Texas Health and Safety Code §102.052 outlining
Institute activities, including Grant Awards, research accomplishments,
future Program directions, compliance, and Conflicts of Interest actions.

  (4) Authorized Expense--cost items including honoraria,
salaries and benefits, consumable supplies, other operating expenses,
contracted research and development, capital equipment, construction
or renovation of state or private facilities, travel, and conference
fees and expenses.
  (5) Approved Budget--the financial expenditure plan
for the Grant Award, including revisions approved by the Institute
and permissible revisions made by the Grant Recipient. The Approved
Budget may be shown by Project Year and detailed budget categories.
  (6) Authorized Signing Official (ASO)--the individual,
named by the Grant Applicant, who is authorized to act for the Grant
Applicant or Grant Recipient in submitting the Grant Application and
executing the Grant Contract and associated documents or requests.
  (7) Bylaws--the rules established by the Oversight
Committee to provide a framework for its operation, management, and
governance.
  (8) Cancer Prevention--a reduction in the risk of developing
cancer, including early detection, control and/or mitigation of the
incidence, disability, mortality, or post-diagnosis effects of cancer.
  (9) Cancer Prevention and Control Program--effective
strategies and interventions for preventing and controlling cancer
designed to reduce the incidence and mortality of cancer and to enhance
the quality of life of those affected by cancer.
  (10) Cancer Prevention and Research Fund--the dedicated
account in the general revenue fund consisting of legislative appropriations,
gifts, grants, other donations, and earned interest.
  (11) Cancer Research--research into the prevention,
causes, detection, treatments, and cures for all types of cancer in
humans, including basic mechanistic studies, pre-clinical studies,
animal model studies, translational research, and clinical research
to develop preventative measures, therapies, protocols, medical pharmaceuticals,
medical devices or procedures for the detection, treatment, cure or
substantial mitigation of all types of cancer and its effects in humans.

  (12) Chief Compliance Officer--the individual employed
by the Institute to monitor and report to the Oversight Committee
regarding compliance with the Institute's statute and administrative
rules. The term may also apply to an individual designated by the
Chief Compliance Officer to fulfill the duty or duties described herein,
unless the context clearly indicates otherwise.
  (13) Chief Executive Officer--the individual hired
by the Oversight Committee to perform duties required by the Institute's
Statute or designated by the Oversight Committee. The term may apply
to an individual designated by the Chief Executive Officer to fulfill
the duty or duties described herein, unless the context clearly indicates
otherwise.
  (14) Chief Prevention Officer--the individual hired
by the Chief Executive Officer to oversee the Institute's Cancer Prevention
program, including the Grant Review Process, and to assist the Chief
Executive Officer in collaborative outreach to further Cancer Research
and Cancer Prevention. The term may also apply to an individual designated
by the Chief Prevention Officer to fulfill the duty or duties described
herein, unless the context clearly indicates otherwise.
  (15) Chief Product Development Officer--the individual
hired by Chief Executive Officer to oversee the Institute's Product
Development program for drugs, biologicals, diagnostics, or devices
arising from Cancer Research, including the Grant Review Process,
and to assist the Chief Executive Officer in collaborative outreach
to further Cancer Research and Cancer Prevention. The term may apply
to an individual designated by the Chief Product Development Officer
to fulfill the duty or duties described herein, unless the context
clearly indicates otherwise.
  (16) Chief Scientific Officer--the individual hired
by the Chief Executive Officer to oversee the Institute's Cancer Research
program, including the Grant Review Process, and to assist the Chief
Executive Officer in collaborative outreach to further Cancer Research
and Cancer Prevention. The term may apply to an individual designated
by the Chief Scientific Officer to fulfill the duty or duties described
herein, unless the context clearly indicates otherwise.
  (17) Code of Conduct and Ethics--the code adopted by
the Oversight Committee pursuant to Texas Health and Safety Code §102.109
to provide guidance related to the ethical conduct expected of Oversight
Committee Members, Program Integration Committee Members, and Institute
Employees.
  (18) Compliance Program--a process to assess and ensure
compliance by the Oversight Committee Members and Institute Employees
with applicable laws, rules, and policies, including matters of ethics
and standards of conduct, financial reporting, internal accounting
controls, and auditing.
  (19) Conflict(s) of Interest--a financial, professional,
or personal interest held by the individual or the individual's Relative
that is contrary to the individual's obligation and duty to act for
the benefit of the Institute.
  (20) Encumbered Funds--funds that are designated by
a Grant Recipient for a specific purpose.
  (21) Financial Status Report--form used to report all
Grant Award related financial expenditures incurred in implementation
of the Grant Award. This form may also be referred to as "FSR" or
"Form 269-A."
  (22) Grant Applicant--the public or private institution
of higher education, as defined by §61.003, Texas Education Code,
research institution, government organization, non-governmental organization,
non-profit organization, other public entity, private company, individual,
or consortia, including any combination of the aforementioned, that
submits a Grant Application to the Institute. Unless otherwise indicated,
this term includes the Principal Investigator or Program Director.
  (23) Grant Application--the written proposal submitted
by a Grant Applicant to the Institute in the form required by the
Institute that, if successful, will result in a Grant Award.
  (24) Grant Award--funding, including a direct company
investment, awarded by the Institute pursuant to a Grant Contract
providing money to the Grant Recipient to carry out the Cancer Research
or Cancer Prevention project in accordance with rules, regulations,
and guidance provided by the Institute.
  (25) Grant Contract--the legal agreement executed by
the Grant Recipient and the Institute setting forth the terms and
conditions for the Cancer Research or Cancer Prevention Grant Award
approved by the Oversight Committee.
  (26) Grant Management System--the electronic interactive
system used by the Institute to exchange, record, and store Grant
Application and Grant Award information.
  (27) Grant Mechanism--the specific Grant Award type.
  (28) Grant Program--the functional area in which the
Institute makes Grant Awards, including research, prevention and product
development.
  (29) Grant Progress Report--the required report submitted
by the Grant Recipient at least annually and at the close of the grant
award describing the activities undertaken to achieve the goals and
objectives of the funded project and including information, data and
program metrics. Unless the context clearly indicates otherwise, the
Grant Progress Report also includes other required reports such as
a Historically Underutilized Business and Texas Supplier form, a single
audit determination form, an inventory report, a single audit determination
form, a revenue sharing form, and any other reports or forms designated
by the Institute.
  (30) Grant Recipient--the entire legal entity responsible
for the performance or administration of the Grant Award pursuant
to the Grant Contract. Unless otherwise indicated, this term includes
the Principal Investigator, Program Director, or Company Representative.

  (31) Grant Review Cycle--the period that begins on
the day that the Request for Applications is released for a particular
Grant Mechanism and ends on the day that the Oversight Committee takes
action on the Grant Award recommendations.
  (32) Grant Review Process--the Institute's processes
for Peer Review, Program Review and Oversight Committee approval of
Grant Applications.
  (33) Indirect Costs--the expenses of doing business
that are not readily identified with a particular Grant Award, Grant
Contract, project, function, or activity, but are necessary for the
general operation of the Grant Recipient or the performance of the
Grant Recipient's activities.
  (34) Institute--the Cancer Prevention and Research
Institute of Texas or CPRIT.
  (35) Institute Employee--any individual employed by
the Institute, including any individual performing duties for the
Institute pursuant to a contract of employment. Unless otherwise indicated,
the term does not include an individual providing services to the
Institute pursuant to a services contract.
  (36) Intellectual Property Rights--any and all of the
following and all rights in, arising out of, or associated therewith,
but only to the extent resulting from the Grant Award:
    (A) The United States and foreign patents and utility
models and applications therefore and all reissues, divisions, re-examinations,
renewals, extensions, provisionals, continuations and such claims
of continuations-in-part as are entitled to claim priority to the
aforesaid patents or patent applications, and equivalent or similar
rights anywhere in the world in Inventions and discoveries;
    (B) All trade secrets and rights in know-how and proprietary
information;
    (C) All copyrights, whether registered or unregistered,
and applications therefore, and all other rights corresponding thereto
throughout the world excluding scholarly and academic works such as
professional articles and presentations, lab notebooks, and original
medical records; and
    (D) All mask works, mask work registrations and applications
therefore, and any equivalent or similar rights in semiconductor masks,
layouts, architectures or topography.
  (37) Invention--any method, device, process or discovery
that is conceived and/or reduced to practice, whether patentable or
not, by the Grant Recipient in the performance of work funded by the
Grant Award.
  (38) License Agreement--an understanding by which an
owner of Technology and associated Intellectual Property Rights grants
any right to make, use, develop, sell, offer to sell, import, or otherwise
exploit the Technology or Intellectual Property Rights in exchange
for consideration.
  (39) Matching Funds--the Grant Recipient's Encumbered
Funds equal to one-half of the Grant Award available and not yet expended
that are dedicated to the research that is the subject of the Grant
Award. For public and private institutions of higher education, this
includes the dollar amount equivalent to the difference between the
indirect cost rate authorized by the federal government for research
grants awarded to the Grant Recipient and the five percent (5%) Indirect
Cost limit imposed by §102.203(c), Texas Health and Safety Code.
  (40) Numerical Ranking Score--the score given to a
Grant Application by the Review Council that is substantially based
on the final Overall Evaluation Score submitted by the Peer Review
Panel, but also signifies the Review Council's view related to how
well the Grant Application achieves program priorities set by the
Oversight Committee, the overall Program portfolio balance, and any
other criteria described in the Request for Applications.
  (41) Overall Evaluation Score--the score given to a
Grant Application during the Peer Review Panel review that signifies
the reviewers' overall impression of the Grant Application. Typically
it is the average of the scores assigned by two or more Peer Review
Panel members.
  (42) Oversight Committee--the Institute's governing
body, composed of the nine individuals appointed by the Governor,
Lieutenant Governor, and the Speaker of the House of Representatives.
  (43) Oversight Committee Member--any person appointed
to and serving on the Oversight Committee.
  (44) Patient Advocate--a trained individual who meets
the qualifications set by the Institute and is appointed to a Scientific
Research and Prevention Programs Committee to specifically represent
the interests of cancer patients as part of the Peer Review of Grant
Applications assigned to the individual's committee.
Cont'd...