2010 California Code
Health and Safety Code
Article 3. Definitions

125292.10.  As used in this chapter and in Article XXXV of the
California Constitution, the following terms have the following
meanings:
   (a) "Act" means the California Stem Cell Research and Cures Bond
Act constituting Chapter 3 (commencing with Section 125290.10) of
Part 5 of Division 106 of the Health and Safety Code.
   (b) "Adult stem cell" means an undifferentiated cell found in a
differentiated tissue in an adult organism that can renew itself and
may, with certain limitations, differentiate to yield all the
specialized cell types of the tissue from which it originated.
   (c) "Capitalized interest" means interest funded by bond proceeds.
   (d) "Committee" means the California Stem Cell Research and Cures
Finance Committee created pursuant to subdivision (a) of Section
125291.40.
   (e) "Constitutional officers" means the Governor, Lieutenant
Governor, Treasurer, and Controller of California.
   (f) "Facilities" means buildings, building leases, or capital
equipment.
   (g) "Floating-rate bonds" means bonds which do not bear a fixed
rate of interest until their final maturity date, including
commercial paper notes.
   (h) "Fund" means the California Stem Cell Research and Disease
Cures Fund created pursuant to Section 125291.25.
   (i) "Grant" means a grant, loan, or guarantee.
   (j) "Grantee" means a recipient of a grant from the institute. All
University of California grantee institutions shall be considered as
separate and individual grantee institutions.
   (k) "Human reproductive cloning" means the practice of creating or
attempting to create a human being by transferring the nucleus from
a human cell into an egg cell from which the nucleus has been removed
for the purpose of implanting the resulting product in a uterus to
initiate a pregnancy.
   (l) "Indirect costs" mean the recipient's costs in the
administration, accounting, general overhead, and general support
costs for implementing a grant or loan of the institute. NIH
definitions of indirect costs will be utilized as one of the bases by
the Scientific and Medical Research Standards Working Group to
create a guideline for recipients on this definition, with
modifications to reflect guidance by the ICOC and this act.
   (m) "Institute" means the California Institute for Regenerative
Medicine.
   (n) "Interim standards" means temporary standards that perform the
same function as "emergency regulations" under the Administrative
Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter
4.5, Sections 11371 et seq.) except that in order to provide greater
opportunity for public comment on the permanent regulations, remain
in force for 270 days rather than 180 days.
   (o) "Life science commercial entity" means a firm or organization,
headquartered in California, whose business model includes
biomedical or biotechnology product development and
commercialization.
   (p) "Medical ethicist" means an individual with advanced training
in ethics who holds a Ph.D., MA, or equivalent training and who
spends or has spent substantial time (1) researching and writing on
ethical issues related to medicine, and (2) administering ethical
safeguards during the clinical trial process, particularly through
service on institutional review boards.
   (q) "Pluripotent cells" means cells that are capable of
self-renewal, and have broad potential to differentiate into multiple
adult cell types. Pluripotent stem cells may be derived from somatic
cell nuclear transfer or from surplus products of in vitro
fertilization treatments when such products are donated under
appropriate informed consent procedures. These excess cells from in
vitro fertilization treatments would otherwise be intended to be
discarded if not utilized for medical research.
   (r) "Progenitor cells" means multipotent or precursor cells that
are partially differentiated but retain the ability to divide and
give rise to differentiated cells.
   (s) "Quorum" means at least 65 percent of the members who are
eligible to vote.
   (t) "Research donor" means a human who donates biological
materials for research purposes after full disclosure and consent.
   (u) "Research funding" includes interdisciplinary scientific and
medical funding for basic research, therapy development, and the
development of pharmacologies and treatments through clinical trials.
When a facility's grant or loan has not been provided to house all
elements of the research, therapy development, and/or clinical
trials, research funding shall include an allowance for a market
lease rate of reimbursement for the facility. In all cases, operating
costs of the facility, including, but not limited to, library and
communication services, utilities, maintenance, janitorial, and
security, shall be included as direct research funding costs. Legal
costs of the institute incurred in order to negotiate standards with
federal and state governments and research institutions; to implement
standards or regulations; to resolve disputes; and/or to carry out
all other actions necessary to defend and/or advance the institute's
mission shall be considered direct research funding costs.
   (v) "Research participant" means a human enrolled with full
disclosure and consent, and participating in clinical trials.
   (w) "Revenue positive" means all state tax revenues generated
directly and indirectly by the research and facilities of the
institute are greater than the debt service on the state bonds
actually paid by the General Fund in the same year.
   (x) "Stem cells" mean nonspecialized cells that have the capacity
to divide in culture and to differentiate into more mature cells with
specialized functions.
   (y) "Vital research opportunity" means scientific and medical
research and technologies and/or any stem cell research not actually
funded by the institute under subparagraph (C) of paragraph (1) of
subdivision (c) of Section 125290.60 which provides a substantially
superior research opportunity vital to advance medical science as
determined by at least a two-thirds vote of a quorum of the members
of the Scientific and Medical Research Funding Working Group and
recommended as such by that working group to the ICOC. Human
reproductive cloning shall not be a vital research opportunity.