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AMENDMENT NO. 1
TO
FORM 10-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 1999
OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
COMMISSION FILE NUMBER 0-19871
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STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
(Exact name of Registrant as specified in its charter)
DELAWARE 94-3078125
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
525 DEL REY AVENUE, SUITE C, SUNNYVALE, CA 94086
(Address of principal offices) (zip code)
701 GEORGE WASHINGTON HIGHWAY, LINCOLN, RI 02865
(Former address of principal executive offices) (zip code)
Registrant's telephone number, including area code: (408) 731-8670
Securities registered pursuant to Section 12(b) of the Act:
NONE
Securities registered pursuant to Section 12(g) of the Act:
COMMON STOCK, $.01 PAR VALUE
JUNIOR PREFERRED STOCK PURCHASE RIGHTS
Title of class
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes /X/ No / /
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. / /
Aggregate market value of Common Stock held by non-affiliates at March 20,
2000: $140,213,189.22. Inclusion of shares held beneficially by any person
should not be construed to indicate that such person possesses the power, direct
or indirect, to direct or cause the direction of management policies of the
registrant, or that such person is controlled by or under common control with
the Registrant. Common stock outstanding at March 20, 2000: 19,506,565 shares.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant's Definitive Proxy Statement for its 2000 Annual
Meeting of Shareholders are incorporated by reference into Part III of this
Report.
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FORWARD LOOKING STATEMENTS
This prospectus includes forward-looking statements. You can identify these
statements by forward-looking words such as "may," "will," "possibly," "expect,"
"anticipate," "project," "believe," "estimate" and "continue" or similar words.
You should read statements that contain these words carefully because they
discuss our future expectations, contain projections of our future results of
operations or of our financial condition, or state other "forward-looking"
information. We believe that it is important to communicate our future
expectations to our investors. However, there will be events in the future that
we have not been able to accurately predict or control and that may cause our
actual results to differ materially from those discussed. For example,
contaminations at our facilities, changes in the pharmaceutical or biotechnology
industries, competition and changes in government regulations or general
economic or market conditions could all have significant effects on our results.
These factors should be considered carefully and readers should not place undue
reliance on our forward-looking statements. Before you invest in our common
stock, you should be aware that the occurrence of the events described in the
"Risk Factors," "Management's Discussion and Analysis of Financial Condition and
Results of Operations" and "Business" sections and elsewhere in this prospectus
could harm our business, operating results and financial condition. All
forward-looking statements attributable to us or persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements and risk
factors contained throughout this prospectus. We are under no duty to update any
of the forward-looking statements after the date of this prospectus or to
conform these statements to actual results.
SEE "CAUTIONARY FACTORS RELEVANT TO FORWARD-LOOKING INFORMATION" FILED
HEREWITH AS EXHIBIT 99 AND INCORPORATED HEREIN BY REFERENCE.
2
BUSINESS
OVERVIEW
We are engaged in research aimed at the development of therapies that would
use stem and progenitor cells derived from fetal or adult sources to treat, and
possibly cure, human diseases and injuries such as Parkinson's disease,
hepatitis, diabetes, and spinal cord injuries. The body uses certain key cells
known as stem cells to produce all the functional mature cell types found in
normal organs of healthy individuals. Progenitor cells are cells that have
already developed from the stem cells, but can still produce one or more types
of mature cells within an organ.
Many diseases, such as Alzheimer's, Parkinson's, and other degenerative
diseases of the brain or nervous system, involve the failure of organs that
cannot be transplanted. Other diseases, such as hepatitis and diabetes, involve
organs such as the liver or pancreas that can be transplanted, but there is a
very limited supply of those organs available for transplant. We estimate, based
on information available to us from the Alzheimer's Association, the Centers for
Disease Control, the Family Caregiver's Alliance and the Spinal Cord Injury
Information Network, that these conditions affect more than 18 million people in
the United States and account for more than $150 billion annually in health care
costs.
Our proposed therapies are based on the transplanting of healthy human stem
and progenitor cells to repair or replace central nervous system, pancreas or
liver tissue that has been damaged or lost as a result of disease or injury,
potentially returning patients to productive lives and significantly reducing
health care costs. We believe that we have achieved significant progress in
research regarding stem cells of the central nervous system through the advances
we have made in the isolation, purification and transplantation of central
nervous system stem and progenitor cells. We have also made advances in our
research programs to discover the stem cells of the pancreas and of the liver.
We have established an intellectual property position in all three areas of our
stem cell research--the central nervous system, the pancreas and the liver--by
patenting our discoveries and entering into exclusive licensing arrangements. We
believe that, if successfully developed, our platform of stem cell technologies
may create the basis for therapies that would address a number of conditions
with significant unmet medical needs.
CELL THERAPY BACKGROUND
ROLE OF CELLS IN HUMAN HEALTH AND TRADITIONAL THERAPIES
Cells maintain normal physiological function in healthy individuals by
secreting or metabolizing substances, such as sugars, amino acids,
neurotransmitters and hormones, which are essential to life. When cells are
damaged or destroyed, they no longer produce, metabolize or accurately regulate
those substances. Impaired cellular function is associated with the progressive
decline common to many degenerative diseases of the nervous system, such as
Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis.
Recent advances in medical science have identified cell loss or impaired
cellular function as leading causes of degenerative diseases. Biotechnology
advances have led to the identification of some of the specific substances or
proteins that are deficient. While administering these substances or proteins as
medication does overcome some of the limitations of traditional pharmaceuticals
such as lack of specificity, there is no existing technology that can deliver
them to the precise sites of action and in the appropriate physiological
quantities or for the duration required to cure the degenerative condition.
Cells, however, do this naturally. As a result, investigators have
considered replacing failing cells that are no longer producing the needed
substances or proteins by implanting stem or progenitor cells capable of
regenerating the cell that the degenerative condition has damaged or destroyed.
Where there has been irreversible tissue damage or organ failure,
transplantation of stem cells offers the possibility of generating new and
healthy tissue, thus potentially restoring the organ function and the patient's
health.
3
THE POTENTIAL OF OUR STEM CELL-BASED THERAPY
We believe that, if successfully developed, stem cell-based therapy--the use
of stem or progenitor cells to treat diseases--has the potential to provide a
broad therapeutic approach comparable in importance to traditional
pharmaceuticals and genetically engineered biologics.
Stem cells are rare and only available in limited supply, whether from the
patients themselves or from donors. Cells obtained from the same person who will
receive them may be abnormal if the patient is ill or the tissue is contaminated
with disease-causing cells. Also, the cells can often be obtained only through
significant surgical procedures. The challenge, therefore, has been three-fold:
1) to identify the stem cells;
2) to create techniques and processes that can be used to expand these rare
cells in sufficient quantities for effective transplants; and
3) to establish a bank of normal human stem or progenitor cells that can be
used for transplantation into individuals whose own cells are not
suitable because of disease or other reasons.
We have developed and demonstrated a process, based on a proprietary IN
VITRO culture system in chemically defined media, that reproducibly grows normal
human central nervous system, or CNS, stem and progenitor cells. We believe this
is the first reproducible process for growing normal human CNS stem cells. More
recently, we have discovered markers on the cell surface that identify the human
CNS stem cells. This allows us to purify them and eliminate other unwanted cell
types. Together, these discoveries enable us to select normal human CNS stem
cells and to expand them in culture to produce a large number of pure stem
cells.
Because these cells have not been genetically modified, they may be
especially suitable for transplantation and may provide a safer and more
effective alternative to therapies that are based on cells derived from cancer
cells, from cells modified by a cancer gene to make them grow, from an
unpurified mixture of many different cell types, or from animal derived cells.
We believe our proprietary stem cell technologies may enable therapies to
replace specific cells that have been damaged or destroyed, permitting the
restoration of function through the replacement of normal cells where this has
not been possible in the past. In our research, we have shown that stem cells of
the central nervous system transplanted into hosts are accepted, migrate, and
successfully specialize to produce mature neurons and glial cells.
More generally, because the stem cell is the pivotal cell that produces all
the functional mature cell types in an organ, we believe these cells, if
successfully identified and developed for transplantation, may serve as
platforms for five major areas of regenerative medicine and biotechnology:
- tissue repair and replacement,
- correction of genetic disorders,
- drug discovery and screening,
- gene discovery and use, and
- diagnostics.
We will be pursuing key alliances in these areas.
4
OUR PLATFORM OF STEM CELL TECHNOLOGIES
Stem cells have two defining characteristics:
- some of the cells developed from stem cells produce all the kinds of
mature cells making up the particular organ; and
- they "self renew"--that is, other cells developed from stem cells are
themselves new stem cells, thus permitting the process to continue again
and again.
Stem cells are known to exist for many systems of the human body, including
the blood and immune system, the central and peripheral nervous systems
(including the brain), and the liver, pancreas endocrine, and the skin systems.
These cells are responsible for organ regeneration during normal cell
replacement and, to a more or less limited extent, after injury. We believe that
further research and development will allow stem cells to be cultivated and
administered in ways that enhance their natural function, so as to form the
basis of therapies that will replace specific subsets of cells that have been
damaged or lost through disease, injury or genetic defect.
We also believe that the person or entity that first identifies and isolates
a stem cell and defines methods to culture any of the finite number of different
types of human stem cells will be able to obtain patent protection for the
methods and the composition, making the commercial development of stem cell
treatment and possible cure of currently intractable diseases financially
feasible.
Our strategy is to be the first to identify, isolate and patent multiple
types of human stem and progenitor cells with commercial importance. Our
portfolio of issued patents includes a method of culturing normal human central
nervous system stem and progenitor cells in our proprietary chemically defined
medium, and our published studies show that these cultured and expanded cells
give rise to all three major cell types of the central nervous system. Also, a
separate study sponsored by us using these cultured stem and progenitor cells
showed that the cells are accepted, migrate, and successfully specialize to
produce neurons and glial cells.
More recently, we announced the results of a new study that showed that
human central nervous system stem cells can be successfully isolated by markers
present on the surface of freshly obtained brain cells. We believe this is the
first reproducible process for isolating highly purified populations of
well-characterized normal human central nervous system stem cells, and have
applied for a composition of matter patent. Because the cells are highly
purified and have not been genetically modified, they may be especially suitable
for transplantation and may provide a safer and more effective alternative than
therapies that are based on cells derived from cancer cells, or from cells
modified by a cancer gene to make them grow, or from an unpurified mixture of
many different cell types or cells derived from animals. We have also filed an
improved process patent for the growth and expansion of these purified normal
human central nervous system cells.
Neurological disorders such as Parkinson's disease, epilepsy, Alzheimer's
disease, and the side effects of stroke, affect a significant portion of the
U.S. population and there currently are no effective long-term therapies for
them. We believe that therapies based on our process for identifying, isolating
and culturing neural stem and progenitor cells may be useful in treating such
diseases. We are continuing our research into, and have initiated the
development of, human central nervous system stem and progenitor cell-based
therapies for these diseases.
We continue to advance our research programs to discover the islet stem cell
in the human pancreas and the liver stem cell. Islet cells are the cells that
produce insulin, so islet stem cells may be useful in the treatment of Type 1
diabetes and those cases of Type 2 diabetes where insulin secretion is
defective. Liver stem cells may be useful in the treatment of diseases such as
hepatitis, cirrhosis of the liver and liver cancer.
5
EXPECTED ADVANTAGES OF OUR STEM CELL TECHNOLOGY
NO OTHER TREATMENT
To the best of our knowledge, no one has developed an FDA-approved method
for replacing lost or damaged tissues from the human nervous system. Replacement
of tissues in other areas of the human body is limited to those few sites, such
as bone marrow or peripheral blood cell transplants, where transplantation of
the patient's own cells is now feasible. In a few additional areas, including
the liver, transplantation of donor organs is now used, but is limited by the
scarcity of organs available through donation. We believe that our stem cell
technologies have the potential to reestablish function in at least some of the
patients who have suffered the losses referred to above.
REPLACED CELLS PROVIDE NORMAL FUNCTION
Because stem cells can duplicate themselves, or self-renew, and specialize
into the multiple kinds of cells that are commonly lost in various diseases,
transplanted stem cells may be able to migrate limited distances to the proper
location within the body, to expand and specialize and to replace damaged or
defective cells, facilitating the return to proper function. We believe that
such replacement of damaged or defective cells by functional cells is unlikely
to be achieved with any other treatment.
RESEARCH EFFORTS AND PRODUCT DEVELOPMENT PROGRAMS
OVERVIEW OF RESEARCH AND PRODUCT DEVELOPMENT STRATEGY
We have devoted substantial resources to our research programs to isolate
and develop a series of stem and progenitor cells that we believe can serve as a
basis for replacing diseased or injured cells. Our efforts to date have been
directed at methods to identify, isolate and culture large varieties of stem and
progenitor cells of the human nervous system, liver and pancreas and to develop
therapies utilizing these stem and progenitor cells.
The following table lists the potential therapeutic indications for, and
current status of, our primary research and product development programs and
projects. The table is qualified in its entirety by reference to the more
detailed descriptions of such programs and projects appearing elsewhere in this
prospectus. We continually evaluate our research and product development efforts
and reallocate resources among existing programs or to new programs in light of
experimental results, commercial potential, availability of third party funding,
likelihood of near-term efficacy, collaboration success or significant
technology
6
enhancement, as well as other factors. Our research and product development
programs are at relatively early stages of development and will require
substantial resources to commercialize.
RESEARCH AND PRODUCT DEVELOPMENT PROGRAMS
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PROGRAM DESCRIPTION AND OBJECTIVE STAGE/STATUS(1)
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HUMAN NEURAL STEM CELL PRECLINICAL
Repair or replace damaged central - Demonstrated IN VITRO the ability to initiate and expand
nervous system tissue (including stem cell-containing human neural cultures and
spinal cord, degenerated retinas specialization into three types of central nervous system
and tissue affected by certain cells
genetic disorders) - Demonstrated the ability of neurosphere-initiating stem
cells from human brain
- Demonstrated in rodent studies that transplanted human
brain-derived stem cells are accepted and properly
specialized into the three major cell types of the
central nervous system.
PANCREAS ISLET STEM CELL RESEARCH
Repair or replace damaged pancreas - Identified markers on the surface of cells to identify,
islet tissue isolate and culture islet stem cells of the pancreas
- Commenced small animal testing
LIVER STEM CELL RESEARCH
Repair or replace damaged liver - Demonstrated the production of hepatocytes from purified
tissue including tissue resulting mouse hematopoietic stem cells
from certain metabolic genetic - Identified IN VITRO culture assay for growth of human
diseases bipotent liver progenitor cells that can produce both
bile duct and hepatocytes
- Showed that the in vitro culture of human bipotent liver
cells can also grow human hepatitis virus
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(1) "Research" refers to early stage research and product development activities
IN VITRO, including the selection and characterization of product candidates
for preclinical testing. "Preclinical" refers to further testing of a
defined product candidate IN VITRO and in animals prior to clinical studies.
RESEARCH AND DEVELOPMENT PROGRAMS
Our portfolio of stem cell technology results from our exclusive licensing
of central nervous system, stem and progenitor cell technology, animal models
for the identification and/or testing of stem and progenitor cells and our own
research and development efforts to date. We believe that therapies using stem
cells represent a fundamentally new approach to the treatment of diseases caused
by lost or damaged tissue. We have assembled an experienced team of scientists
and scientific advisors to consult with and advise our scientists on their
continuing research and development of stem and progenitor cells. This team
includes, among others, Irving L. Weissman, M.D., of Stanford University, Fred
H. Gage, Ph.D., of The Salk Institute and David Anderson, Ph.D., of the
California Institute of Technology.
BRAIN STEM AND PROGENITOR CELL RESEARCH AND DEVELOPMENT PROGRAM
We began our work with central nervous system stem and progenitor cell
cultures in collaboration with NeuroSpheres, Ltd., in 1992. We believe that
NeuroSpheres was the first to invent these cultures. We are the exclusive,
worldwide licensee from NeuroSpheres to such inventions and associated patents
and patent applications for all uses, including transplantation in the human
body as embodied in these patents. See "License Agreements and Sponsored
Research Agreements--NeuroSpheres, Ltd."
In 1997, our scientists invented a reproducible method for growing human
CNS, stem and progenitor cells in cultures. In preclinical IN VITRO and early IN
VIVO studies, we demonstrated that these cells specialize
7
into all three of the cell types of the central nervous system. Because of these
results, we believe that these cells may form the basis for replacement of cells
lost in certain degenerative diseases. We are continuing research into, and have
initiated the development of, our human CNS stem and progenitor cell cultures.
We have initiated the cultures and demonstrated that these cultures can be
expanded for a number of generations IN VITRO in chemically defined media. In
collaboration with us, Dr. Anders Bjorklund has shown that cells from these
cultures can be successfully transplanted and accepted into the brains of
rodents where they subsequently migrated and specialized into the appropriate
cell types for the site of the brain into which they were placed.
In 1998, we expanded our preclinical efforts in this area by initiating
programs aimed at the discovery and use of specific monoclonal antibodies to
facilitate identification and isolation of CNS and other stem and progenitor
cells or their specialized progeny. Also in 1998, our researchers devised
methods to advance the IN VITRO culture and passage of human CNS stem cells that
resulted in a 100-fold increase in CNS stem and progenitor cell production after
6 passages. We are expanding our preclinical efforts toward the goal of
selecting the proper indications to pursue.
In December 1998, we announced that the US Patent and Trademark Office had
granted patent No. 5,851,832, covering our methods for the human CNS cell
cultures containing central nervous system stem cells, for compositions of human
CNS cells expanded by these methods, and for use of these cultures in human
transplantation. These human CNS stem and progenitor cells expanded in culture
may be useful for repairing or replacing damaged central nervous system tissue,
including the brain and the spinal cord.
In October 1999, the US Patent and Trademark Office granted patent number
5,968,829 entitled "Human CNS Neural Stem Cells," covering our composition of
matter patent for human CNS stem cells, and also allowed a separate patent
application for our media for culturing human CNS stem cells.
Also in 1999, we announced the filing of a US patent application covering
our proprietary process for the direct isolation of normal human CNS stem cells
based on the markers found to be present on the surface of freshly obtained
brain cells. Since the filing of this patent application, our researchers have
completed a study designed to identify, isolate and culture human CNS stem cells
utilizing this proprietary process. In November 1999, we announced the study's
first results: Our researchers, by using our proprietary markers on the surface
of the cell, had succeeded in identifying, isolating and purifying human CNS
stem cells from brain tissue, and were able to expand the number of these cells
in culture.
We believe that this is the first study to show a reproducible process for
isolating highly purified populations of well-characterized normal human CNS
stem cells. Because the cells are normal human CNS stem cells and have not been
genetically modified, they may be especially suitable for transplantation and
may provide a safer and more effective alternative to therapies that are based
on cells derived from cancer cells or from an unpurified mix of many different
cell types, or from animal derived cells.
In January 2000, we reported what we regard as an even more important
result: In long term animal studies, our researchers were able to take these
purified and expanded stem cells and transplant them into normal mouse brain
hosts, where they take hold and grow into neurons and glial cells.
During the course of the study, the transplanted human CNS stem cells
survived for as long as one year and migrated to specific functional domains of
the host brain, with no sign of tumor formation or adverse effects on the animal
recipients; moreover, the cells were still dividing. These findings show that
when CNS stem cells isolated and cultured with our proprietary processes are
transplanted, they adopt the characteristics of the host brain and act like
normal stem cells. In other words, the study suggests the possibility of a
continual replenishment of normal human brain cells.
As noted above, human CNS stem and progenitor cells harvested and purified
and expanded using our proprietary processes may be useful for creating
therapies for the treatment of degenerative brain diseases such as Parkinson's,
Huntington's and Alzheimer's disease. These conditions affect more than
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5 million people in the United States and there are no effective long-term
therapies currently available. We believe the ability to purify human brain stem
cells directly from fresh tissue is important because:
- it provides an enriched source of normal stem cells, not contaminated by
other unwanted or diseased cell types, that can be expanded in culture
without fear of also expanding some unwanted cell types;
- it opens the way to a better understanding of the properties of these
cells and how they might be manipulated to treat specific diseases. For
example, in certain genetic diseases such as Tay Sachs and Gaucher's, a
key metabolic enzyme required for normal development and function of the
brain is absent. Brain-derived stem cell cultures might be genetically
modified to produce those proteins. The modified brain stem cells could be
transplanted into patients with these genetic diseases;
- the efficient acceptance of these non-transformed normal human stem cells
into host brains means that the cell product can be tested in animal
models for its ability to correct deficiencies caused by various human
neurological diseases. This technology could also provide a unique animal
model for the testing of drugs that act on human brain cells either for
effectiveness of the drug against the disease or its toxicity to human
nerve cells.
PANCREAS STEM CELLS DISCOVERY RESEARCH PROGRAMS
Our discovery program directed to the identification, isolation and
culturing of the pancreas stem and progenitor cells is currently being conducted
by Nora Sarvetnick, Ph.D., of The Scripps Research Institute, in collaboration
with some of our senior researchers.
According to diabetes and juvenile diabetes foundations, between 800,000 and
1.5 million Americans have Type 1 diabetes, which is often called "juvenile
diabetes" and most commonly diagnosed in childhood; and 30,000 new patients are
diagnosed with the disease every year. It is a costly, serious, lifelong
condition, requiring constant attention and insulin injections every day for
survival.
About 15 million other people in the United States have Type 2 diabetes
mellitus, which is also a chronic and potentially fatal condition; and more than
700,000 new patients are diagnosed annually.
In 1998, we obtained an exclusive, worldwide license from The Scripps
Research Institute to novel technology developed by Dr. Sarvetnick which may
facilitate the identification and isolation of pancreas stem and progenitor
cells by using a mouse model that continuously regenerates the pancreas. We
believe that stem cells produce the regeneration, in which case this animal
model may be useful for identifying specific markers on the cell surface unique
to the pancreas stem cells. We believe this may lead to the development of
cell-based treatments for Type 1 diabetes and that portion of Type 2 diabetes
characterized by defective secretion of insulin.
In 1999, advances in the research sponsored by us resulted in our obtaining
additional exclusive, worldwide licenses from The Scripps Research Institute to
novel markers on the cell surface identified by Dr. Sarvetnick and her research
team as being unique to the pancreas islet stem cell for which we have now filed
a US patent application. In collaboration with Dr. Sarvetnick, we continue to
advance the discovery program directed at the identification, isolation and
culturing of pancreas stem and progenitor cells utilizing this technology.
LIVER STEM CELLS DISCOVERY RESEARCH PROGRAMS
We initiated our discovery work for the liver stem and progenitor cell
through a sponsored research agreement with Markus Grompe, Ph.D., of Oregon
Health Sciences University. Dr. Grompe's work focuses on the discovery and
development of a suitable method for identifying and assessing liver stem and
progenitor cells for use in transplantation. We have also obtained a worldwide
exclusive license to a novel mouse model of liver failure for evaluating cell
transplantation developed by Dr. Grompe.
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Approximately 1 in 10 Americans suffers from diseases and disorders of the
liver for which there are currently no effective, long-term treatments.
In 1998, our researchers continued to advance methods for establishing
enriched cell populations suitable for transplantation in preclinical animal
models. We are focused on discovering and utilizing our proprietary methods to
identify, isolate and culture liver stem and progenitor cells and to evaluate
these cells in preclinical animal models.
In 1999, our researchers devised a culture assay that we will use in our
efforts to identify liver stem and progenitor cells. In addition to supporting
the growth of an early human liver bipotent progenitor cell, it is also possible
to infect this culture with human hepatitis virus, providing a valuable system
for study of the virus. This technology could also provide a unique IN VITRO
model for the testing of drugs that act on, or are metabolized by, human liver
cells.
An important element of our stem cell discovery program is the further
development of intellectual property positions with respect to stem and
progenitor cells. We have also obtained rights to certain inventions relating to
stem cells from, and are conducting stem cell related research at, several
academic institutions. We expect to expand our search for new stem and
progenitor cells and to seek to acquire rights to additional inventions relating
to stem and progenitor cells from third parties.
WIND-DOWN OF ENCAPSULATED CELL THERAPY RESEARCH AND DEVELOPMENT PROGRAMS
Until mid-1999, we engaged in research and development in encapsulated cell
therapy technology, or ECT, including a pain control program funded by
AstraZeneca Group plc. The results from the 85-patient double-blind,
placebo-controlled trial of our encapsulated bovine cell implant for the
treatment of severe, chronic pain in cancer patients did not, however, meet the
criteria AstraZeneca had established for continuing trials for the therapy, and
in June 1999, AstraZeneca terminated the collaboration.
Consequently, in July 1999, we announced plans for the restructuring of our
research operations to abandon all further ECT research and to concentrate our
resources on the research and development of our proprietary platform of stem
cell technology. We reduced our workforce by approximately 68 full-time
employees who had been focused on ECT programs, wound down our research and
manufacturing operations in Lincoln, Rhode Island, and relocated our remaining
research and development activities, and our corporate headquarters, to the
facilities of our wholly owned subsidiary, StemCells California, Inc., in
Sunnyvale, California. We are actively seeking to sublease, assign or sell our
interest in our former corporate headquarters building and our pilot
manufacturing and cell processing facility in Rhode Island.
In December 1999 we sold our intellectual property assets related to our ECT
to Neurotech S.A., a privately held French company, in exchange for a payment of
$3 million, royalties on future product sales, and a portion of certain revenues
Neurotech may in the future receive from third parties. We retained certain
non-exclusive rights to use the ECT in combination with our proprietary stem
cell technology, and in the field of vaccines for prevention and treatment of
infectious diseases.
In a related development, by mutual consent we and the Advanced Technology
Program of the National Institute of Standards and Technology terminated two
grants previously awarded to us for our encapsulated cell therapy and stem
cell-related research. The encapsulated cell therapy grant was obviated by the
sale of the technology to Neurotech. The funding agency has invited us to
resubmit a proposal consistent with the new directions we are taking in our
research and development of our platform of stem cell technologies.
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SUBSIDIARY
STEMCELLS CALIFORNIA, INC.
On September 26, 1997, we acquired by merger StemCells, Inc. (now StemCells
California, Inc.), a California corporation, in exchange for 1,320,691 shares of
our common stock and options and warrants for the purchase of 259,296 common
shares. Simultaneously with the acquisition, its President, Richard M. Rose,
M.D., became our President, Chief Executive Officer and a director, and Irving
L. Weissman, M.D., a founder of the California corporation, became a member of
our board of directors. We, as the sole stockholder of our subsidiary, voted on
February 23, 2000, to amend its Certificate of Incorporation to change its name
to StemCells California, Inc.
CORPORATE INVESTMENT
In July 1996, we, together with certain founding scientists, established
Modex Therapeutics SA, a Swiss biotherapeutics company, to pursue extensions of
our former technology of ECT for certain applications outside the central
nervous system. Modex, headquartered in Lausanne, Switzerland, was formed to
integrate technologies developed by us and by several other institutions to
develop products to treat diseases such as diabetes, obesity and anemia. After
our disposition of the encapsulated cell technology in December 1999, we no
longer had common research or development interests with Modex, but we held
approximate 17% of its stock. Modex completed an initial public offering on
June 23, 2000, in the course of which we realized a gain of approximately
$1.4 million from the sale of certain shares. We now own 126,193 shares, or
approximately 9%, of Modex's equity, subject to a lockup until December 23,
2000. The closing market price of Modex stock on the Swiss Neue Market exchange
on October 31, 2000, was 329.5 Swiss Francs, or approximately $183, per share.
LICENSE AGREEMENTS AND SPONSORED RESEARCH AGREEMENTS
We have entered into a number of license agreements with commercial and
non-profit institutions, as well as a number of research-plus-license agreements
with academic organizations. The research agreements provide that we will fund
certain research costs, and in return, will have a license or an option for a
license to the resulting inventions. Under the license agreements, we will
typically be subject to obligations of due diligence and the requirement to pay
royalties on products that use patented technology licensed under such
agreements.
ASTRAZENECA PLC
In March 1995, we signed a collaborative research and development agreement
with AstraZeneca plc for the development and marketing of certain
encapsulated-cell products to treat pain. Under the agreement, we conducted
research and development and received approximately $42 million, including
research and development funding, through June 1999 when, as noted above (SEE
WIND-DOWN OF ENCAPSULATED CELL TECHNOLOGY RESEARCH AND DEVELOPMENT PROGRAM),
AstraZeneca exercised its right to terminate the agreement. (SEE ALSO LIQUIDITY
AND CAPITAL RESOURCES UNDER MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS AND NOTE 17--"RESEARCH AGREEMENTS" TO THE
ACCOMPANYING FINANCIAL STATEMENTS.)
GENENTECH, INC.
In November 1996, we signed collaborative development and licensing
agreements with Genentech relating to the development of products using the
Company's ECT technology to deliver certain of Genentech's proprietary growth
factors to treat Parkinson's disease, Huntington's disease and amyotrophic
lateral sclerosis.
Under the terms of the agreement for Parkinson's disease, Genentech had the
right, at its discretion, to terminate the program at specified milestones. On
May 21, 1998, Genentech exercised its right to
11
terminate the Parkinson's collaboration. Pursuant to the terms of the agreement,
Genentech demanded that we redeem certain shares of the Company's redeemable
common stock held by them for approximately $3.1 million, at a price of $10.01
per share. This amount, per the agreement, was equal to the funds invested by
Genentech to acquire such stock less the amount we expended on the terminated
program. In March 2000, we announced a settlement of this claim at no cost to
us, and also terminated the Huntington's disease and ALS agreements. (FOR
FURTHER DETAILS AND INFORMATION REGARDING THIS SETTLEMENT, SEE LIQUIDITY AND
CAPITAL RESOURCES UNDER MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS.)
STATE OF RHODE ISLAND
In 1989 we entered into an agreement with the Rhode Island Partnership for
Science and Technology, or RIPSAT, for reimbursement of $1,172,000 for certain
research activities we funded at Brown University. Under the terms of this grant
we were obligated to pay royalties ranging from three to five percent of
revenues from products developed under the agreement, to a maximum of
$1,758,000. In July 1999, when we announced our plans to terminate ECT research,
wind down operations in Rhode Island and relocate research activities and
corporate headquarters to Sunnyvale, California, RIPSAT alleged that we were in
default under this funding agreement. While we believed that we were not in
default, in March 2000, we entered into a settlement of the claim. (FOR FURTHER
DETAILS AND INFORMATION REGARDING THIS SETTLEMENT, SEE LIQUIDITY AND CAPITAL
RESOURCES UNDER MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.)
NEUROSPHERES, LTD.
In March 1994, we entered into a Contract Research and License Agreement
with NeuroSpheres, Ltd., which was clarified in a License Agreement dated as of
April 1, 1997. Under the agreement as clarified, we obtained an exclusive patent
license from NeuroSpheres in the field of transplantation, subject to a limited
right of NeuroSpheres to purchase a nonexclusive license from us, which right
was not exercised and has expired. We have developed additional intellectual
property relating to the subject matter of the license. We entered into an
additional license agreement with NeuroSpheres as of October 31, 2000, under
which we obtained an exclusive license in the field of non-transplant uses, such
as drug discovery and drug testing, so that together the licenses are exclusive
for all uses of the technology. We will make up-front payments to NeuroSpheres
of 65,000 shares of our common stock and $50,000, and additional cash payments
when milestones are achieved in the non-transplant field, or in any products
employing NeuroSpheres patents for generating cells of the blood and immune
system from neural stem cells. Milestone payments would total $500,000 for each
product that is approved for market. Our agreements with NeuroSpheres will
terminate at the expiration of all patents licensed to us, but can terminate
earlier if we breach without curing our obligations under the agreement or if we
declare bankruptcy. We would have a security interest in the licensed technology
in the event that NeuroSpheres declares bankruptcy.
SIGNAL PHARMACEUTICALS, INC.
In December 1997, we entered into two license agreements with Signal
Pharmaceuticals, Inc. under which each party licensed to the other certain
patent rights and biological materials for use in defined fields. An initial
disagreement as to the interpretation of the licensed rights was resolved by the
parties, and the agreements are operating in accordance with their terms. Signal
has now been acquired by Celgene. Each agreement with Signal will terminate at
the expiration of all patents licensed under it, but the licensing party can
terminate earlier if the other party breaches its obligations under the
agreement or declares bankruptcy. Also, the party receiving the license can
terminate the agreement at any time upon notice to the other party. Under these
agreements, we must reimburse Signal for payments it must make to the University
of California based on products we develop and for 50% of certain other payments
Signal must make.
12
SPONSORED RESEARCH AGREEMENTS
When we decided to abandon further research and development of our ECT
technology in July 1999, we terminated our academic collaborations with Brown
University and Dr. Patrick Aebischer at the Centre Hospitalier Universitaire
Vaudois in Switzerland. Research and development expenses paid in connection
with these collaborations aggregated approximately $156,600, $701,000 and
$1,326,000 for the years ended December 31, 1999, 1998, and 1997, respectively.
Under Sponsored Research Agreements with The Scripps Research Institute and
Oregon Health Sciences University, we funded certain research in return for
licenses or options to license the inventions resulting from the research. We
have also entered into license agreements with the California Institute of
Technology. All of these agreements relate largely to stem or progenitor cells
and or to processes and methods for the isolation, identification, expansion or
culturing of stem or progenitor cells. We paid Scripps and Oregon respectively
approximately $77,000 and $28,000 in 1997, $307,000 and $251,000 in 1998, and
$309,000 and $172,000 in 1999 under these agreements.
Our research agreement with Scripps expires on November 14, 2000 and we are
negotiating with Scripps to extend the term of this agreement or to enter into a
new agreement. As of the date of this report, we have not yet completed our
negotiations with Scripps and we cannot give any assurance that our negotiations
will be successful. If we are unable to extend the term of this agreement, we
will have to find a replacement to perform this research or we will have to
perform this research ourselves. In either case, we may experience delay and
additional expense in connection with this research effort. Our license
agreements with Scripps will terminate upon expiration, revocation or
invalidation of the patents licensed to us, unless governmental regulations
require a shorter term. These license agreements also will terminate earlier if
we breach without curing our obligations under the agreement or if we declare
bankruptcy, and we can terminate the license agreements at any time upon notice.
Upon the initiation of the Phase II trial for our first product using Scripps
licensed technology, we must pay Scripps $50,000 and upon completion of that
Phase II trial we must pay Scripps an additional $125,000. Upon approval of the
first product for sale in the market, we must pay Scripps $250,000.
Our license agreements with the California Institute of Technology will
expire upon expiration, revocation, invalidation or abandonment of the patents
licensed to us. We can terminate any of these license agreements by giving 30
days' notice to the California Institute of Technology. Either party can
terminate these license agreements upon a material breach by the other party. We
paid $10,000 to the California Institute of Technology upon execution of the
license agreements, and we must pay an additional $10,000 upon the issuance of
the patent licensed to us under the relevant agreement. We also will pay $5,000
on the anniversary of the issuance of the patent licensed to us under the
relevant agreement. These amounts are creditable against royalties we must pay
under the license agreements. The maximum royalties that we will have to pay to
the California Institute of Technology will be $2 million per year, with an
overall maximum of $15 million. Once we pay the $15 million maximum royalty, the
licenses will become fully paid and irrevocable.
MANUFACTURING
The keys to successful commercialization of brain stem and progenitor cells
are efficacy, safety, consistency of the product, and economy of the process. We
expect to address these issues by appropriate testing and banking representative
vials of large-scale cultures. Commercial production is expected to involve
expansion of banked cells and packaging them in appropriate containers after
formulating the cells in an effective carrier. The carrier may also be used to
improve the stability and acceptance of the stem cells or their progeny. Because
of the early stage of our stem and progenitor cell programs, all of the issues
that will affect manufacture of stem and progenitor cell products are not yet
clear.
13
MARKETING
We expect to market and sell our products primarily through co-marketing,
licensing or other arrangements with third parties. There are a number of
substantial companies with existing distribution channels and large marketing
resources who are well equipped to market and sell our products. It is our
intent to have the marketing of our products undertaken by such partners,
although we may seek to retain limited marketing rights in specific narrow
markets where the product may be addressed by a specialty or niche sales force.
PATENTS, PROPRIETARY RIGHTS AND LICENSES
We believe that proprietary protection of our inventions will be of major
importance to our future business. We have an aggressive program of vigorously
seeking and protecting our intellectual property which we believe might be
useful in connection with our products. We believe that our know-how will also
provide a significant competitive advantage, and we intend to continue to
develop and protect our proprietary know-how. We may also from time to time seek
to acquire licenses to important externally developed technologies.
We have exclusive or non-exclusive rights to a portfolio of patents and
patent applications related to various stem and progenitor cells and methods of
deriving and using them. These patents and patent applications relate mainly to
compositions of matter, methods of obtaining such cells, and methods for
preparing, transplanting and utilizing such cells. Currently, our U.S. patent
portfolio in the stem cell therapy area includes nineteen issued U.S. patents,
six of which have issued within the last year. An additional thirteen patent
applications are pending, one of which has been allowed.
We own or have filed patent applications which have been published for the
following U.S. patents: Patent Number 5,968,829 (Human CNS neural stem cells);
Patent Number 6,103,530 (Human CNS neural stem cells--culture media);
Application Number WO 99/11758 (Cultures of human CNS neural stem cells); and
Application Number WO 00/36091 (An animal model for identifying a common stem/
progenitor to liver cells and pancreatic cells).
We have licensed the following patents or pending patent applications from
Neurospheres Holdings Ltd.: Patent Number 5,851,832 (In vitro proliferation);
Patent Number 5,750,376 (In vitro genetic modification); Patent
Number 5,981,165 (In vitro production of dopaminergic cells from mammalian
central nervous system multipotent stem cell compositions); Patent Number
6,093,531 (Generation of hematopoietic cells from multipotent neural stem
cells); Application Number WO 93/01275 (Mammalian central nervous system
multipotent stem cell compositions); Application Number WO 94/09119
(Remyelination using mammalian central nervous system multipotent stem cell
compositions); Application Number WO 94/10292 (Biological factors useful in
differentiating mammalian central nervous system multipotent stem cell
compositions); Application Number WO 94/16718 (Genetically engineered mammalian
central nervous system multipotent stem cell compositions); Application Number
WO 96/15224 (Differentiation of mammalian central nervous system multipotent
stem cell compositions); and Application Number WO 96/15226 (In vitro production
of dopaminergic cells from mammalian central nervous system multipotent stem
cell composition).
We have licensed the following patents or pending patent applications from
the University of California, San Diego: Patent Number 5,776,948 (Method of
production of neuroblasts); Patent Number 6,013,521 (Method of production of
neuroblasts); Patent Number 6,020,197 (Method of production of neuroblasts); and
Application Number WO 94/16059 (Method of production of neuroblasts).
We have licensed the following patents or pending patent applications from
the California Institute of Technology: Patent Number 5,629,159 (Immortalization
and disimmortalization of cells); Application Number WO 96/40877
(Immortalization and disimmortalization of cells); Patent Number 5,935,811
(Neuron restrictive silencer factor proteins); Application Number WO 96/27665
(Neuron restrictive
14
silencer factor proteins); Patent Number 5,589,376 (Mammalian neural crest stem
cells); Patent Number 5,824,489 (Methods for isolating mammalian multipotent
neural crest stem cells); Application Number WO 94/02593 (Mammalian neural crest
stem cells); Patent Number 5,654,183 (Genetically engineered mammalian neural
crest stem cells); Patent Number 5,928,947 (Mammalian multipotent neural crest
stem cells); Patent Number 5,693,482 (In vitro neural crest stem cell assay);
Patent Number 6,001,654 (Methods for differentiating neural stem cells to
neurons or smooth muscle cells (TGFb)); Application Number WO 98/48001 (Methods
for differentiating neural stem cells to neurons or smooth muscle cells (TGFb));
Patent Number 5,672,499 (Methods for immortalizing multipotent neural crest stem
cells); Patent Number 5,849,553 (Immortalizing and disimmortalizing multipotent
neural crest stem cells); and Patent Number 6,033,906 (Differentiating mammalian
neural stem cells to glial cells using neuregulins).
We also rely upon trade-secret protection for our confidential and
proprietary information and take active measures to control access to that
information.
Our policy is to require our employees, consultants and significant
scientific collaborators and sponsored researchers to execute confidentiality
agreements upon the commencement of an employment or consulting relationship
with us. These agreements generally provide that all confidential information
developed or made known to the individual by us during the course of the
individual's relationship with us is to be kept confidential and not disclosed
to third parties except in specific circumstances. In the case of employees and
consultants, the agreements generally provide that all inventions conceived by
the individual in the course of rendering services to us shall be our exclusive
property.
We have obtained rights from universities and research institutions to
technologies, processes and compounds that we believe may be important to the
development of our products. These agreements typically require us to pay
license fees, meet certain diligence obligations and, upon commercial
introduction of certain products, pay royalties. These include exclusive license
agreements with NeuroSpheres, The Scripps Institute, the California Institute of
Technology and the Oregon Health Sciences University, to certain patents and
know-how regarding present and certain future developments in CNS and pancreas
stem cells.
COMPETITION
The targeted disease states for our initial products in some instances
currently have no effective long-term therapies. However, we do expect that our
initial products will have to compete with a variety of therapeutic products and
procedures. Major pharmaceutical companies currently offer a number of
pharmaceutical products to treat neurodegenerative and liver diseases, diabetes
and other diseases for which our technologies may be applicable. Many
pharmaceutical and biotechnology companies are investigating new drugs and
therapeutic approaches for the same purposes, which may achieve new efficacy
profiles, extend the therapeutic window for such products, alter the prognosis
of these diseases, or prevent their onset. We believe that our products, when
successfully developed, will compete with these products principally on the
basis of improved and extended efficacy and safety and their overall economic
benefit to the health care system.
The market for therapeutic products that address degenerative diseases is
large, and competition is intense. We expect competition to increase. We believe
that our most significant competitors will be fully integrated pharmaceutical
companies and more established biotechnology companies. Smaller companies may
also be significant competitors, particularly through collaborative arrangements
with large pharmaceutical or biotechnology companies. Many of these competitors
have significant products approved or in development that could be competitive
with our potential products.
Competition for our stem and progenitor cell products may be in the form of
existing and new drugs, other forms of cell transplantation, ablative and
simulative procedures, and gene therapy. We believe that some of our competitors
are also trying to develop stem and progenitor cell-based technologies. We
expect
15
that all of these products will compete with our potential stem and progenitor
cell products based on efficacy, safety, cost and intellectual property
positions.
We may also face competition from companies that have filed patent
applications relating to the use of genetically modified cells to treat disease,
disorder or injury. We may be required to seek licenses from these competitors
in order to commercialize certain of our proposed products.
Once our products are developed and receive regulatory approval, they must
then compete for market acceptance and market share. For certain of our
potential products, an important success factor will be the timing of market
introduction of competitive products. This is a function of the relative speed
with which we and our competitors can develop products, complete the clinical
testing and approval processes, and supply commercial quantities of a product to
market. These competitive products may also impact the timing of clinical
testing and approval processes by limiting the number of clinical investigators
and patients available to test our potential products.
While we believe that the primary competitive factors will be product
efficacy, safety, and the timing and scope of regulatory approvals, other
factors include, in certain instances, obtaining marketing exclusivity under the
Orphan Drug Act, availability of supply, marketing and sales capability,
reimbursement coverage, price, and patent and technology position.
GOVERNMENT REGULATION
Our research and development activities and the future manufacturing and
marketing of our potential products are, and will continue to be, subject to
regulation for safety and efficacy by numerous governmental authorities in the
United States and other countries.
In the United States, pharmaceuticals, biologicals and medical devices are
subject to rigorous Food and Drug Administration, or FDA, regulation. The
Federal Food, Drug and Cosmetic Act, as amended, and the Public Health Service
Act, as amended, the regulations promulgated thereunder, and other Federal and
state statutes and regulations govern, among other things, the testing,
manufacture, safety, efficacy, labeling, storage, export, record keeping,
approval, marketing, advertising and promotion of our potential products.
Product development and approval within this regulatory framework takes a
number of years and involves significant uncertainty combined with the
expenditure of substantial resources. In addition, the federal, state, and other
jurisdictions have restrictions on the use of fetal tissue.
FDA APPROVAL
The steps required before our potential products may be marketed in the
United States include:
STEPS CONSIDERATIONS
1. Preclinical laboratory and animal tests Preclinical tests include laboratory
evaluation of the product and animal studies
in specific disease models to assess the
potential safety and efficacy of the product
and our formulation as well as the quality
and consistency of the manufacturing process.
2. Submission to the FDA of an application The results of the preclinical tests are
for an Investigational New Drug Exemption, or submitted to the FDA as part of an IND, and
IND, which must become effective before U.S. the IND becomes effective 30 days following
human clinical trials may commence its receipt by the FDA, as long as there are
no questions, requests for delay or
objections from the FDA.
16
3. Adequate and well-controlled human Clinical trials involve the evaluation of the
clinical trials to establish the safety and product in healthy volunteers or, as may be
efficacy of the product the case with our potential products, in a
small number of patients under the
supervision of a qualified physician.
Clinical trials are conducted in accordance
with protocols that detail the objectives of
the study, the parameters to be used to
monitor safety and the efficacy criteria to
be evaluated. Any product administered in a
U.S. clinical trial must be manufactured in
accordance with clinical Good Manufacturing
Practices, or cGMP, determined by the FDA.
Each protocol is submitted to the FDA as part
of the IND. The protocol for each clinical
study must be approved by an independent
Institutional Review Board, or IRB, at the
institution at which the study is conducted
and the informed consent of all participants
must be obtained. The IRB will consider,
among other things, the existing information
on the product, ethical factors, the safety
of human subjects, the potential benefits of
the therapy and the possible liability of the
institution.
Clinical development is traditionally
conducted in three sequential phases, which
may overlap:
- In Phase I, products are typically
introduced into healthy human subjects or
into selected patient populations to test for
adverse reactions, dosage tolerance,
absorption and distribution, metabolism,
excretion and clinical pharmacology.
- Phase II involves studies in a limited
patient population to (i) determine the
efficacy of the product for specific targeted
indications and populations, (ii) determine
optimal dosage and dosage tolerance and (iii)
identify possible adverse effects and safety
risks. When a dose is chosen and a candidate
product is found to be effective and to have
an acceptable safety profile in Phase II
evaluations, Phase III trials begin.
- Phase III trials are undertaken to
conclusively demonstrate clinical efficacy
and to test further for safety within an
expanded patient population, generally at
multiple study sites.
The FDA continually reviews the clinical
trial plans and results and may suggest
changes or may require discontinuance of the
trials at any time if significant safety
issues arise.
4. Submission to the FDA of marketing The results of the preclinical studies and
authorization applications clinical studies are submitted to the FDA in
the form of marketing approval authorization
applications.
17
5. FDA approval of the application(s) prior The testing and approval process will require
to any commercial sale or shipment of the substantial time, effort and expense. The
drug. Biologic product manufacturing time for approval is affected by a number of
establishments located in certain states also factors, including relative risks and
may be subject to separate regulatory and benefits demonstrated in clinical trials, the
licensing requirement availability of alternative treatments and
the severity of the disease. Additional
animal studies or clinical trials may be
requested during the FDA review period which
might add to that time.
After FDA approval for the initial indications and requisite approval of the
manufacturing facility, further clinical trials may be required to gain approval
for the use of the product for additional indications. The FDA may also require
unusual or restrictive post-marketing testing and surveillance to monitor for
adverse effects, which could involve significant expense, or may elect to grant
only conditional approvals.
FDA MANUFACTURING REQUIREMENTS
Among the conditions for product licensure is the requirement that the
prospective manufacturer's quality control and manufacturing procedures conform
to the FDA's cGMP requirement. Even after product licensure approval, the
manufacturer must comply with cGMP on a continuing basis, and what constitutes
cGMP may change as the state of the art of manufacturing changes. Domestic
manufacturing facilities are subject to regular FDA inspections for cGMP
compliance which are normally held at least every two years. Foreign
manufacturing facilities are subject to periodic FDA inspections or inspections
by the foreign regulatory authorities with reciprocal inspection agreements with
the FDA. Domestic manufacturing facilities may also be subject to inspection by
foreign authorities.
ORPHAN DRUG ACT
The Orphan Drug Act provides incentives to drug manufacturers to develop and
manufacture drugs for the treatment of diseases or conditions that affect fewer
than 200,000 individuals in the United States. Orphan drug status can also be
sought for treatments for diseases or conditions that affect more than 200,000
individuals in the United States if the sponsor does not realistically
anticipate its product becoming profitable from sales in the United States. We
may apply for orphan drug status for certain of our therapies.
Under the Orphan Drug Act, a manufacturer of a designated orphan product can
seek tax benefits, and the holder of the first FDA approval of a designated
orphan product will be granted a seven-year period of marketing exclusivity in
the United States for that product for the orphan indication. While the
marketing exclusivity of an orphan drug would prevent other sponsors from
obtaining approval of the same compound for the same indication, it would not
prevent other types of products from being approved for the same use including,
in some cases, slight variations on the originally designated orphan product.
PROPOSED FDA REGULATIONS
Proposed regulations of the FDA and other governmental agencies would place
restrictions, including disclosure requirements, on researchers who have a
financial interest in the outcome of their research. Under the proposed
regulations, the FDA could also apply heightened scrutiny to, or exclude the
results of, studies conducted by such researchers when reviewing applications to
the FDA, which contain such research. Certain of our collaborators have stock
options or other equity interests in us that could subject such collaborators
and us to the proposed regulations.
Our research and development is based on the use of human stem and
progenitor cells. The FDA has published a "Proposed Approach to Regulation of
Cellular and Tissue-Based Products" which relates to the use of human cells. We
cannot now determine the effects of that approach or what regulatory actions
might be taken from it. Restrictions exist on the testing or use of cells,
whether human or non-human.
18
OTHER REGULATIONS
In addition to safety regulations enforced by the FDA, we are also subject
to regulations under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act and other present and potential
future foreign, Federal, state and local regulations.
Outside the United States, we will be subject to regulations which govern
the import of drug products from the United States or other manufacturing sites
and foreign regulatory requirements governing human clinical trials and
marketing approval for our products. The requirements governing the conduct of
clinical trials, product licensing, pricing and reimbursements vary widely from
country to country. In particular, the European Union, or EU, is revising its
regulatory approach to high tech products, and representatives from the United
States, Japan and the EU are in the process of harmonizing and making more
uniform the regulations for the registration of pharmaceutical products in these
three markets.
REIMBURSEMENT AND HEALTH CARE COST CONTROL
Reimbursement for the costs of treatments and products such as ours from
government health administration authorities, private health insurers and others
both in the United States and abroad is a key element in the success of new
health care products. Significant uncertainty often exists as to the
reimbursement status of newly approved health care products.
The revenues and profitability of some health care-related companies have
been affected by the continuing efforts of governmental and third party payers
to contain or reduce the cost of health care through various means. Payers are
increasingly attempting to limit both coverage and the level of reimbursement
for new therapeutic products approved for marketing by the FDA, and are
refusing, in some cases, to provide any coverage for uses of approved products
for disease indications for which the FDA has not granted marketing approval.
For example, in certain foreign markets, pricing or profitability of
prescription pharmaceuticals is subject to government control. In the United
States, there have been a number of Federal and state proposals to implement
government control over health care costs.
EMPLOYEES
As of August 15, 2000, we had twenty full-time employees, of whom five have
Ph.D. degrees, as well as two half-time employees. The equivalent of fifteen
full-time employees work in research and development and laboratory support
services. A number of our employees have held positions with other biotechnology
or pharmaceutical companies or have worked in university research programs. No
employees are covered by collective bargaining agreements.
SCIENTIFIC ADVISORY BOARD
Members of our Scientific Advisory Board provide us with strategic guidance
in regard to our research and product development programs, as well as
assistance in recruiting employees and collaborators. Each Scientific Advisory
Board member has entered into a consulting agreement with us. These consulting
agreements specify the compensation to be paid to the consultant and require
that all information about our products and technology be kept confidential. All
of the Scientific Advisory Board members are employed by employers other than us
and may have commitments to or consulting or advising agreements with other
entities that limit their availability to us. The Scientific Advisory Board
members have generally agreed, however, for so long as they serve as consultants
to us, not to provide any services to any other entities which would conflict
with the services the member provides to us. Members of the Scientific Advisory
Board offer consultation on specific issues encountered by us as well as general
advice on the directions of appropriate scientific inquiry for us. In addition,
Scientific Advisory Board members assist us
19
in assessing the appropriateness of moving our projects to more advanced stages.
The following persons are members of our Scientific Advisory Board:
- Irving L. Weissman, M.D., is the Karel and Avice Beekhuis Professor of
Cancer Biology, Professor of Pathology and Professor of Developmental
Biology at Stanford University. Dr. Weissman was a cofounder of
SyStemix, Inc., and Chairman of its Scientific Advisory Board. He has
served on the Scientific Advisory Boards of Amgen Inc., DNAX and T-Cell
Sciences, Inc. Dr. Weissman is Chairman of the Scientific Advisory Board
of StemCells, Inc.
- David J. Anderson, Ph.D., is Professor of Biology, California Institute of
Technology, Pasadena, California and Investigator, Howard Hughes Medical
Institute.
- Fred H. Gage, Ph.D., is Professor, Laboratory of Genetics, The Salk
Institute for Biological Studies, La Jolla, California and Adjunct
Professor, Department of Neurosciences, University of California, San
Diego, California.
ITEM 2. PROPERTIES
The Company's current research laboratories and administrative offices are
located in a leased 7,950 square-foot multipurpose building housing wet labs,
specialty research areas and administrative offices located in Sunnyvale,
California. The facilities are leased pursuant to lease agreements expiring
August 31, 2001, and we have certain renewal options. Our current facilities are
expected to be sufficient to accommodate our needs at least through the end of
2000.
We continue to be contractually obligated with respect to two facilities in
Lincoln, Rhode Island obtained in connection with our former encapsulated cell
technology. We leased our former research laboratory and corporate headquarters
building which contains 65,000 square feet of wet labs, specialty research areas
and administrative offices on a fifteen-year lease agreement which expires
October 2012. We also own a 21,000 square-foot pilot manufacturing facility and
a 3,000 square-foot cell processing facility financed by bonds issued by the
Rhode Island Industrial Facilities Corporation. We are actively seeking to
sublease, assign or sell our interests in these properties.
ITEM 3. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
20
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDERS MATTERS
The Common Stock of CytoTherapeutics is traded on the National Market System
of NASDAQ under the Symbol STEM (formerly CTII). The quarterly ranges of high
and low sales prices since January 1, 1997 are shown below:
2000 HIGH LOW
- ---- ------------- ------------
First Quarter (through March 20, 2000)...................... $20 $1 3/8
1999 HIGH LOW
- ------------------------------------------------------------ ------------- ------------
Fourth Quarter.............................................. $ 1 5/8 $1
Third Quarter............................................... $ 2 3/8 $ 11/16
Second Quarter.............................................. $ 1 3/8 $ 17/32
First Quarter............................................... $ 1 25/32 $1 5/32
1998 HIGH LOW
- ------------------------------------------------------------ ------------- ------------
Fourth Quarter.............................................. $ 2 17/32 $ 26/32
Third Quarter............................................... $ 1 19/32 $ 29/32
Second Quarter.............................................. $ 3 7/16 $1 1/16
First Quarter............................................... $ 4 3/8 $2 1/2
1997 HIGH LOW
- ------------------------------------------------------------ ------------- ------------
Fourth Quarter.............................................. $ 7 5/8 $3 7/16
Third Quarter............................................... $ 6 1/4 $4 5/8
Second Quarter.............................................. $ 8 3/4 $4 3/4
First Quarter............................................... $11 3/8 $7 1/2
No cash dividends have been declared on the Common Stock since the Company's
inception.
As of August 15, 2000, there were approximately 249 holders of record of the
Common Stock.
21
ITEM 6. SELECTED FINANCIAL DATA
YEAR ENDED DECEMBER 31,
----------------------------------------------------
1999 1998 1997 1996 1995
-------- -------- -------- -------- --------
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
STATEMENT OF OPERATIONS DATA
Revenue from collaborative agreements....... $ 5,022 $ 8,803 $ 10,617 $ 7,104 $11,761
Research and development expenses........... 9,991 17,659 18,604 17,130 14,730
Acquired research and development........... 8,344
ECT wind-down expenses...................... 6,048
Net loss.................................... (15,709) (12,628) (18,114) (13,759) (8,891)
Basic and diluted net loss per share........ (0.84) (0.69) (1.08) (0.89) (0.69)
Shares used in computing basic and diluted
net loss per share........................ 18,706 18,291 16,704 15,430 12,799
DECEMBER 31,
----------------------------------------------------
1999 1998 1997 1996 1995
-------- -------- -------- -------- --------
(IN THOUSANDS)
BALANCE SHEET DATA
Cash, cash equivalents and marketable
securities................................ $ 4,760 $ 17,386 $ 29,050 $ 42,607 $44,192
Total assets................................ 15,781 32,866 44,301 58,397 56,808
Long-term debt, including capitalized
leases.................................... 2,937 3,762 4,108 8,223 5,441
Redeemable common stock..................... 5,249 5,249 5,583 8,159
Stockholders' equity........................ 3,506 17,897 28,900 34,747 45,391
22
ITEM 7.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion of our financial condition and results of
operations for the years ended December 31, 1999, 1998, and 1997 should be read
in conjunction with our consolidated financial statements and their related
footnotes.
The statements contained in this report, other than statements of historical
fact, constitute forward-looking statements. Such statements include, without
limitation, all statements as to expectation or belief and statements as to the
Company's future results of operations, the progress of the Company's research
and product development programs, the need for, and timing of, additional
capital and capital expenditures, partnering prospects, the need for additional
intellectual property rights, effects of regulations, the need for additional
facilities and potential market opportunities. The Company's actual results may
vary materially from those contained in such forward-looking statements because
of risks to which the Company is subject, such as failure to obtain a corporate
partner or partners to support the development of the Company's stem cell
programs, the Company's ability to sell, assign or sublease its interest in its
facilities related to its encapsulated cell technology program, risks of delays
in research, development and clinical testing programs, obsolescence of the
Company's technology, lack of available funding, competition from third parties,
intellectual property rights of third parties, failure of the Company's
collaborators to perform, regulatory constraints, litigation and other risks to
which the Company is subject. See "Cautionary Factors Relevant to
Forward-Looking-Information" filed herewith as Exhibit 99 and incorporated
herein by reference.
RESULTS OF OPERATIONS
OVERVIEW
Since our inception in 1988 we have been primarily engaged in research and
development of human therapeutic products. As a result of a restructuring in the
second half of 1999, our sole focus is now on our stem cell technology. At the
beginning of last year, by contrast, our corporate headquarters, most of our
employees, and the main focus of our operations were primarily devoted to a
different technology--encapsulated cell technology, or ECT. Since that time, we
terminated a clinical trial of the ECT then in progress, we wound down our other
operations relating to the ECT, we terminated the employment of those who worked
on the ECT, sold the ECT and we relocated from Rhode Island to Sunnyvale,
California. Comparisons with last year's results are correspondingly less
meaningful than they may be under other circumstances.
We were known as CytoTherapeutics, Inc., until May 23, 2000, when we changed
our name to StemCells, Inc.
We have not derived any revenues from the sale of any products, and we do
not expect to receive revenues from product sales for at least several years. We
have not commercialized any product and in order to do so we must, among other
things, substantially increase our research and development expenditures as
research and product development efforts accelerate and clinical trials are
initiated. We have incurred annual operating losses since inception and expect
to incur substantial operating losses in the future. As a result, we are
dependent upon external financing from equity and debt offerings and revenues
from collaborative research arrangements with corporate sponsors to finance our
operations. There are no such collaborative research arrangements at this time
and there can be no assurance that such financing or partnering revenues will be
available when needed or on terms acceptable to us.
Our results of operations have varied significantly from year to year and
quarter to quarter and may vary significantly in the future due to the
occurrence of material, nonrecurring events, including without limitation the
receipt of one-time, nonrecurring licensing payments, and the initiation or
termination of
23
research collaborations, in addition to the winding-down of terminated research
and development programs referred to above.
YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997
Revenues from collaborative agreements totaled $5,022,000, $8,803,000 and
$10,617,000 for the years ending December 31, 1999, 1998 and 1997, respectively.
Revenues were earned primarily from a Development, Marketing and License
Agreement with AstraZeneca Group plc, which we signed in March 1995. The
decrease in revenues from 1998 to 1999 resulted primarily from the June 1999
termination of the AstraZeneca Agreement. 1997 revenues included a $3,000,000
milestone payment from AstraZeneca related to the Phase II clinical trials for
an ECT product.
Research and development expenses totaled $9,984,000 in 1999, as compared to
$17,659,000 in 1998 and $18,604,000 in 1997. The decrease of $7,668,000, or 43%,
from 1998 to 1999 was primarily attributable to the wind-down of research
activities relating to the ECT, precipitated by termination of the AstraZeneca
agreement. The decrease of $945,000, or 5%, from 1997 to 1998 was primarily
attributable to a reduction in spending on research agreements and a reduction
in research and development personnel.
Acquired research and development consists of a one-time charge of
$8,344,000 related to the acquisition of StemCells California, Inc., in 1997.
Commercialization of this technology will require significant incremental
research and development expenses over a number of years. With the recent
completion of the restructuring of our research operations, we are now focused
solely on the research and development of our platform of stem cell
technologies, which encompasses the technology acquired upon the acquisition of
StemCells California, Inc. and related technology we have developed or licensed.
General and administrative expenses were $4,927,303 for the year ended
December 31, 1999, compared with $4,603,000 in 1998 and $6,158,000 in 1997. The
1999 General and Administrative expenses were positively impacted by the
reduction in facility costs that were included in the wind-down ($239,000),
reduction in amortization of patents and intangible assets of approximately
$338,000, as well as reduced activities and related personnel costs estimated at
approximately $500,000 that were not incurred. This was due to the wind-down of
our ECT programs and relocation of our headquarters in October 1999. The
reduction of $1,555,000, or 25%, from 1997 to 1998 was primarily attributable to
a reduction in legal fees, recruiting and relocation expenses, as well as a
reduction in employees.
Wind-down and relocation expenses totaled $6,047,806 for the year ended
December 31, 1999; no such expenses were incurred in 1998 and 1997. These
expenses relate to the wind-down of our encapsulated cell technology research
and other Rhode Island operations and the transfer of our corporate headquarters
to Sunnyvale, California.
They include accruals of approximately $1,554,000 for employee severance
costs, $1,858,000 in losses and reserves for the write-down of related patents
and fixed assets, $1,172,000 for our estimate of the costs of settlement of a
1989 funding agreement with the Rhode Island Partnership for Science and
Technology, $702,000 of estimated additional carrying costs through an expected
June 30, 2000 disposition of the Rhode Island facilities, and other related
expenses totaling $762,000.
Interest income for the years ended December 31, 1999, 1998 and 1997 totaled
$564,000, $1,254,000 and $1,931,000, respectively. The average cash and
investment balances were $10,663,000, $21,795,000 and $33,343,000 in 1999, 1998
and 1997, respectively. The decrease in interest income from 1997 to 1998 to
1999 was attributable to lower average balances.
In 1999, interest expense was $335,000, compared with $472,000 in 1998 and
$438,000 in 1997. The decrease from 1998 to 1999 was attributable to lower
outstanding debt and capital lease balances. The increase from 1997 to 1998 was
primarily attributable to capitalization of $210,000 of interest on the new
facility in 1997.
24
In October 1997, we recognized a gain in the amount of $3,387,000 related to
the sale of 50 percent of the Company's interest in Modex Therapeutics, Ltd.
The net loss in 1999, 1998 and 1997 was $15,709,000, $12,628,000, and
$18,114,000, respectively. The loss per share was $0.84, $0.69 and $1.08 in
1999, 1998 and 1997, respectively. The increase from 1998 to 1999 is primarily
attributable to the elimination of revenue from the AstraZeneca agreement, which
was terminated in June 1999, as well as expenses related to the wind-down of our
ECT research and our other Rhode Island operations, the transfer of our
corporate headquarters to Sunnyvale, California and an accrual of approximately
$1,172,000 for our estimate of the costs of settlement of the funding agreement
with RIPSAT. The decrease from 1997 to 1998 was attributable to a one-time
charge of $8,344,000 for acquired research and development related to the
purchase of StemCells California, Inc. offset by the $3,387,000 gain on a
partial sale of the Company's interest in Modex in 1997.
The 1999 decrease in patents of $3,229,932 from 1998 was primarily due to
management's decision to wind down the ECT program and dispose of the related
intellectual property. During the fourth quarter of 1999 we sold the patents
related to our encapsulated cell technology to Neurotech for $3,000,000.
Accrued expenses increased by $1,584,949, primarily due to the accrual of
approximately $1,172,000 for our estimate of the costs of settlement of a 1989
funding agreement with the Rhode Island Partnership for Science and Technology
and $463,000 for the estimated lease payments and operating costs of the Rhode
Island facilities through an expected disposal date of June 30, 2000.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception, we have financed our operations through the sale of
common and preferred stock, the issuance of long-term debt and capitalized lease
obligations, revenues from collaborative agreements, research grants and
interest income.
We had unrestricted cash and cash equivalents totaling $4,760,000 at
December 31, 1999. Cash and cash equivalents are invested in money market funds.
We also hold 126,193 shares of Modex stock, which is publicly traded on the
Swiss Neue Market exchange. While our Modex stock had an estimated fair market
value of $27,204,333 on September 30, 2000 (and $23,128,598 on October 31,
2000), the fair market value of our Modex stock has varied significantly since
the Modex public offering and may continue to vary significantly based on
increases and decreases in the reported per share price, in Swiss francs, of the
Modex stock and on foreign currency exchange rates. We are prohibited under a
lock-up agreement entered into at the time of Modex's public offering from
selling any of our Modex shares until December 23, 2000. In addition, there is a
limited trading market for Modex stock, and if we were to attempt to sell any
significant portion of our Modex holdings, we would likely be able to do so only
at a significant discount to the then market price, if at all.
Our liquidity and capital resources were in the past significantly affected
by our relationships with corporate partners, which were related to our former
ECT. These relationships are now terminated, and we have not yet established
corporate partnerships with respect to our stem cell technologies.
In March 1995, we signed a collaborative research and development agreement
with AstraZeneca plc for the development and marketing of certain
encapsulated-cell products to treat pain. AstraZeneca made an initial,
nonrefundable payment of $5,000,000, included in revenue from collaborative
agreements in 1995, a milestone payment of $3,000,000 in 1997 and was to remit
up to an additional $13,000,000 subject to achievement of certain development
milestones. Under the agreement, we were obligated to conduct certain research
and development pursuant to a four-year research plan agreed upon by the
parties. Over the term of the research plan, we originally expected to receive
annual payments of $5 million to $7 million from AstraZeneca, which was to
approximate the research and development costs we incurred under the plan.
Subject to the successful development of such products and obtaining necessary
regulatory approvals, AstraZeneca was obligated to conduct all clinical trials
of products arising from the collaboration and to
25
seek approval for their sale and use. AstraZeneca had the exclusive worldwide
right to market products covered by the agreement. Until the later of either the
expiration of all patents included in the licensed technology or a specified
fixed term, we were entitled to a royalty on the worldwide net sales of such
products in return for the marketing license granted to AstraZeneca and our
obligation to manufacture and supply products. AstraZeneca had the right to
terminate the original agreement beginning April 1, 1998. On June 24, 1999,
AstraZeneca informed us of the results of their analysis of the double-blind,
placebo-controlled trial of a potential ECT product, an encapsulated bovine cell
implant for the treatment of severe, chronic pain in cancer patients.
AstraZeneca determined that, based on criteria it established, the results from
the 85-patient trial did not meet the minimum statistical significance for
efficacy established as a basis for continuing worldwide trials for the therapy.
AstraZeneca therefore indicated that it did not intend to further develop the
bovine cell-containing implant therapy and exercised its right to terminate the
agreement. (See also Note 16 --"Research Agreements" to the Accompanying
Consolidated Financial Statements.)
In the third quarter of 1999, we announced restructuring plans for the
wind-down of operations relating to our ECT and to focus our resources on the
research and development of our platform of proprietary stem cell technologies.
We terminated approximately 68 full time employees and, in October 1999,
relocated our corporate headquarters to Sunnyvale, California. We recorded
$6,047,806 in wind-down expenses including employee separation and relocation
costs during 1999.
On December 30, 1999 we sold our ECT and assigned our intellectual property
assets in it to Neurotech S.A. for a payment of $3,000,000, royalties on future
product sales, and a portion of certain Neurotech revenues from third parties.
In addition, we retained certain non-exclusive rights to use ECT in combination
with our proprietary stem cell technologies and in the field of vaccines for
prevention and treatment of infectious diseases. We received $2,800,000 of the
initial payment on January 3, 2000 with a remaining balance of $200,000 placed
in escrow, to be released to us upon demonstration satisfactory to Neurotech
that certain intellectual property is not subject to other claims.
As part of our restructuring of operations and relocation of corporate
headquarters to Sunnyvale, California, we identified a significant amount of
excess fixed assets. In December of 1999, we completed the disposition of those
excess fixed assets, from which we received more than $746,000. The proceeds are
being used to fund our continuing operations.
In July 1999, as a result of our decision to close our Rhode Island
Facilities, the Rhode Island Partnership for Science and Technology, or RIPSAT,
alleged that we were in default under a June, 1989 Funding Agreement and
demanded payment of approximately $2.6 million. While we believed we were not in
default under the Funding Agreement, we deemed it best to resolve the dispute
without litigation, and on March 3, 2000 entered into a settlement agreement
with RIPSAT, the Rhode Island Industrial Recreational Building Authority, or
IRBA, and the Rhode Island Industrial Facilities Corporation, or RIIFC. We
agreed to pay RIPSAT $1,172,000 in full satisfaction of all of our obligations
to them under the Funding Agreement. At the same time, IRBA agreed to return to
us the full amount of our debt service reserve, comprising approximately
$610,000 of principal and interest relating to the bonds we had with IRBA and
RIIFC. The $610,000 debt service reserve was transferred directly to RIPSAT,
leaving the remainder of approximately $562,000 to be paid by us. We made this
payment in March of 2000.
Our liquidity and capital resources could have also been affected by a claim
by Genentech, Inc., arising out of their collaborative development and licensing
agreement with us relating to the development of products for the treatment of
Parkinson's disease; however, the claim was resolved with no effect on our
resources. On May 21, 1998 Genentech exercised its right to terminate the
Parkinson's collaboration and demanded that we redeem certain shares of our
redeemable common stock held by Genentech for approximately $3,100,000.
Genentech's claim was based on provisions in the agreement requiring us to
redeem, at the price of $10.01 per share, the shares representing the difference
between the funds invested by Genentech to acquire such stock, and the amount
expended by us on the terminated program less an
26
additional $1,000,000. In March 2000, we entered into a Settlement Agreement
with Genentech under which Genentech released us from any obligation to redeem
any shares of our common stock held by Genentech, without cost to us.
Accordingly, the $5.2 million of redeemable common stock shown as a liability in
the Company's December 31, 1999 balance sheet was transferred to equity in
March, 2000, without any impact on our liquidity and capital resources. We and
Genentech also agreed that all collaborations between us were terminated, and
that neither of us had any rights to the intellectual property of the other.
In May 1996, we secured an equipment loan facility with a bank in the amount
of $2,000,000. On August 5, 1999 we made a payment of approximately $752,000 of
principal and interest to the bank to retire this loan facility rather than seek
a waiver by the bank of our violation of a loan covenant requiring us to
maintain unrestricted liquidity in an amount equal to or in excess of $10
million.
We continue to have outstanding obligations in regard to our former
facilities in Lincoln, Rhode Island, including lease payments and operating
costs of approximately $950,000 per year associated with our former research
laboratory and corporate headquarters building, and debt service payments and
operating costs of approximately $1,000,000 per year with respect to our pilot
manufacturing and cell processing facility. We are actively seeking to sublease,
assign or sell our interests in these facilities. Failure to do so within a
reasonable period of time will have a material adverse effect on our liquidity
and capital resources.
On April 13, 2000 we sold 1,500 shares of our 6% cumulative convertible
preferred stock plus a warrant for 75,000 shares of our common stock to two
members of our Board of Directors for $1,500,000, on terms more favorable to us
than we were able to obtain from outside investors. The face value of the shares
of preferred stock is convertible at the option of the holders into common stock
at $3.77 per share. The holders of the preferred stock have liquidation rights
equal to their original investment plus accrued but unpaid dividends. The
investors would be entitled to make additional investments in our securities on
the same terms as those on which we complete offerings of our securities with
third parties within 6 months, if any such offerings are completed. They have
waived that right with respect to the common stock transactions described below.
If offerings totaling at least $6 million are not completed during the
6 months, the investors have the right to acquire up to a total of 1,126
additional shares of convertible preferred stock, the face value of which is
convertible at the option of the holders into common stock at $6.33 per share.
Any unconverted preferred stock is converted, at the applicable conversion
price, on April 13, 2002 in the case of the original stock and two years after
the first acquisition of any of the additional 1,126 shares, if any are
acquired. The warrants expires on April 13, 2005.
On August 3, 2000, we completed a $4 million common stock financing
transaction with Millennium Partners, LP, or the Fund, an investment fund with
more than a billion dollars in assets under management. We received $3 million
of the purchase price at the closing and will receive the remaining $1 million
upon effectiveness of a registration statement covering the shares purchased by
the Fund. The Fund purchased our common stock at $4.33 per share. The Fund may
be entitled, pursuant to an adjustable warrant issued in connection with the
sale of common stock to the Fund, to receive additional shares of common stock
on eight dates beginning six months from the closing and every three months
thereafter. The number of additional shares the Fund may be entitled to on each
date will be based on the number of shares of common stock the Fund continues to
hold on each date and the market price of our common stock over a period prior
to each date. We will have the right, under certain circumstances, to cap the
number of additional shares by purchasing part of the entitlement from the Fund.
The Fund also received a warrant to purchase up to 101,587 shares of common
stock at $4.725 per share. This warrant is callable by us at $7.875 per
underlying share.
In addition, the Fund has the option for twelve months to purchase up to
$3 million of additional common stock. On August 23, 2000 the Fund exercised
$1,000,000 of its option to purchase additional common stock at $5.53 per share.
The Fund paid $750,000 of the purchase price in connection with the
27
closing on August 30, 2000, and will pay the remaining $250,000 upon
effectiveness of a registration statement covering the shares owned by the Fund.
At the closing on August 30, 2000, we issued to the Fund an adjustable warrant
similar to the one issued on August 3, 2000. This adjustable warrant was
canceled by agreement between us and the Fund on November 1, 2000. The Fund also
received a warrant to purchase up to 19,900 shares of common stock at $6.03 per
share. This warrant is callable by us at $10.05 per underlying share.
We have limited liquidity and capital resources and must obtain significant
additional capital resources in the future in order to sustain our product
development efforts. Substantial additional funds will be required to support
our research and development programs, for acquisition of technologies and
intellectual property rights, for preclinical and clinical testing of our
anticipated products, pursuit of regulatory approvals, acquisition of capital
equipment, laboratory and office facilities, establishment of production
capabilities and for general and administrative expenses. Our ability to obtain
additional capital will be substantially dependent on our ability to obtain
partnering support for our stem cell technology and, in the near term, on our
ability to realize proceeds from the sale, assignment or sublease of our
facilities in Rhode Island. Failure to do so will have a material adverse effect
on the Company's liquidity and capital resources. Until our operations generate
significant revenues from product sales, we must rely on cash reserves and
proceeds from equity and debt offerings, proceeds from the transfer or sale of
our intellectual property rights, equipment or facilities, government grants and
funding from collaborative arrangements, if obtainable, to fund our operations.
We intend to pursue opportunities to obtain additional financing in the
future through equity and debt financings, grants and collaborative research
arrangements. The source, timing and availability of any future financing will
depend principally upon market conditions, interest rates and, more
specifically, on our progress in our exploratory, preclinical and future
clinical development programs. Lack of necessary funds may require us to delay,
reduce or eliminate some or all of our research and product development programs
or to license our potential products or technologies to third parties. Funding
may not be available when needed--at all, or on terms acceptable to the Company.
While our cash requirements may vary, as noted above, we currently expect
that our existing capital resources, including income earned on invested
capital, will be sufficient to fund our operations into the first quarter of
2001. Our cash requirements may vary, however, depending on numerous factors.
Lack of necessary funds may require us to delay, scale back or eliminate some or
all of our research and product development programs and/or our capital
expenditures or to license our potential products or technologies to third
parties.
YEAR 2000
The Company tested its material software applications to determine whether
each program was prepared to accommodate date information for the year 2000 and
beyond, and found them to be year 2000 compliant. The Company also tested the
status of its facilities systems such as phones, voice mail, heating/ air
conditioning, electricity and security systems and its laboratory and
manufacturing equipment, and polled its major suppliers and vendors, to
determine if they are year 2000 compliant, again without identifying any
problems. Company has not to date encountered any significant year 2000
problems, but is continuing to monitor for potential issues. The costs of
testing and monitoring have been and are expected to continue to be immaterial
to the Company's operating results, but there can be no assurance that no
problem will reveal itself in the future, or that if a problem does occur it
will not have an adverse effect on the Company's operations or financial
results.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of the year ended December 31, 1999, the Company did not maintain any
investments that were exposed to market risk from changes in interest rates or
the fair market value of such investments. Interest
28
rate risk with respect to the Company's short and long-term debt is considered
to be immaterial. As of the year ended December 31, 1999, the Company did not
maintain any hedge positions.
Our investment in 126,193 shares of Modex Therapeutics Ltd. Stock was not
exposed to market risk as of December 31, 1999, however Modex shares were
offered in an IPO on the Swiss Neue Market on June 23, 2000 at a price of 168.00
Swiss francs. At June 30, 2000 our shares were valued at $19,220,165, based on
the per share price of $152.31 which we converted from the market price of
247.50 Swiss francs on June 30, 2000. The market price of the Modex stock on
October 31, 2000 was 329.50 Swiss francs, which converts to $183.28 using
exchange rates on that date, which represents an estimated fair market value of
$23,128,598 for our holdings. Our value in this investment is subject to both
equity price risk and foreign currency exchange risk. From the date of the
Modex IPO to the date hereof, the Modex closing share price has fluctuated from
a low of 200.00 Swiss francs on June 23, 2000 to a high of 390.00 Swiss francs
on October 6, 2000. If we were to seek to liquidate all or part of our
investment in Modex, our proceeds would depend on the share price and foreign
currency exchange rates at the time of conversion. Additionally, if we sell a
sizable portion of our holdings, we may have to sell these shares at a discount
to market price. We are restricted from any sale of our shares in Modex until
December 23, 2000.
The company's sole market risk sensitive instrument is:
MARKET VALUE EXPECTED
ASSOCIATED AT JUNE 30, FUTURE
NO. OF SHARES DESCRIPTION RISKS 2000 CASH FLOWS
123,193 Modex Equity/Foreign $19,220,165 (1)
Therapeutics Currency
Translation
- ------------------------
(1) Although the company has not formally adopted a liquidation plan for this
investment, liquidation may be necessary to meet operating cash flow
requirements. Under the agreement with Modex, the company is restricted from
selling its holding through December 23, 2000.
29
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
REPORT OF INDEPENDENT AUDITORS
Stockholders and Board of Directors
CytoTherapeutics, Inc.
We have audited the accompanying consolidated balance sheets of
CytoTherapeutics, Inc. as of December 31, 1999 and 1998, and the related
consolidated statements of operations, changes in redeemable common stock and
stockholders' equity and cash flows for each of the three years in the period
ended December 31, 1999. These financial statements are the responsibility of
the Company's management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with auditing standards. Those
standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly,
in all material respects, the consolidated financial position of
CytoTherapeutics, Inc. at December 31, 1999 and 1998, and the consolidated
results of its operations and its cash flows for each of the three years in the
period ended December 31, 1999, in conformity with accounting principles
generally accepted in the United States.
ERNST & YOUNG LLP
Providence, Rhode Island
April 14, 2000
30
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
CONSOLIDATED BALANCE SHEETS
DECEMBER 31,
-----------------------------
1999 1998
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents................................. $ 4,760,064 $ 7,864,788
Marketable securities..................................... -- 9,520,939
Accrued interest receivable............................... 42,212 206,609
Technology sale receivable................................ 3,000,000 --
Debt service fund......................................... 609,905 --
Other current assets...................................... 558,674 841,674
------------- -------------
Total current assets........................................ 8,970,855 18,434,010
Property held for sale...................................... 3,203,491 --
Property, plant and equipment, net.......................... 1,747,885 8,356,009
Other assets, net........................................... 1,858,768 6,075,663
------------- -------------
Total assets................................................ $ 15,780,999 $ 32,865,682
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable.......................................... $ 631,315 $ 710,622
Accrued expenses.......................................... 2,605,068 1,020,119
Deferred revenue.......................................... -- 2,500,000
Current maturities of capitalized lease obligations....... 324,167 317,083
Current maturities of long-term debt...................... -- 1,000,000
------------- -------------
Total current liabilities................................... 3,560,550 5,547,824
Capitalized lease obligations, less current maturities...... 2,937,083 3,261,667
Long-term debt, less current maturities..................... -- 500,000
Deposits.................................................... 26,000 --
Deferred Rent............................................... 502,353 222,673
Commitments and contingencies
Redeemable common stock, $.01 par value; 524,337 shares
issued and outstanding at December 31, 1999 and 1998...... 5,248,610 5,248,610
Common stock to be issued................................... -- 187,500
Stockholders' equity:
Convertible preferred stock, $.01 par value; 1,000,000
shares authorized; no shares issued and outstanding..... -- --
Common stock, $.01 par value; 45,000,000 shares
authorized; 18,635,565 and 17,800,323 shares issued and
outstanding at December 31, 1999 and 1998,
respectively............................................ 186,355 178,003
Additional paid-in capital................................ 123,917,758 122,861,606
Accumulated deficit....................................... (119,372,710) (103,664,084)
Unrealized losses on marketable securities................ -- (5,198)
------------- -------------
Accumulated total comprehensive loss...................... (119,372,710) (103,669,282)
------------- -------------
Deferred compensation..................................... (1,225,000) (1,472,919)
------------- -------------
Total stockholders' equity.................................. 3,506,403 17,897,408
------------- -------------
Total liabilities and stockholders' equity.................. $ 15,780,999 $ 32,865,682
============= =============
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
31
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
CONSOLIDATED STATEMENTS OF OPERATIONS
YEAR ENDED DECEMBER 31,
------------------------------------------
1999 1998 1997
------------ ------------ ------------
Revenue from collaborative agreements............... $ 5,021,707 $ 8,803,163 $ 10,617,443
Operating expenses:
Research and development.......................... 9,984,027 17,658,530 18,603,523
Acquired research and development................. -- -- 8,343,684
General and administrative........................ 4,927,303 4,602,758 6,158,410
Encapsulated cell therapy wind down and corporate
relocation...................................... 6,047,806 -- --
------------ ------------ ------------
20,959,136 22,261,288 33,105,617
------------ ------------ ------------
Loss from operations................................ (15,937,429) (13,458,125) (22,488,174)
Other income (expense):
Interest income................................... 564,006 1,253,781 1,931,260
Interest expense.................................. (335,203) (472,400) (437,991)
Gain on partial sale of Modex..................... -- -- 3,386,808
Loss on sale/leaseback............................ -- -- (342,014)
Loss on equity investment......................... -- -- (105,931)
Other income (expense)............................ -- 48,914 (57,538)
------------ ------------ ------------
228,803 830,295 4,374,594
------------ ------------ ------------
Net loss............................................ $(15,708,626) $(12,627,830) $(18,113,580)
============ ============ ============
Basic and diluted net loss per share................ $ (.84) $ (.69) $ (1.08)
============ ============ ============
Shares used in computing basic and diluted net loss
per share......................................... 18,705,838 18,290,548 16,704,144
============ ============ ============
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
32
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE COMMON STOCK AND STOCKHOLDERS'
EQUITY (CONTINUED)
REDEEMABLE
COMMON STOCK COMMON STOCK ADDITIONAL
---------------------- --------------------- PAID-IN ACCUMULATED
SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT
------ ----------- ---------- -------- ------------ -------------
Balances, December 31, 1996............. 815,065 $ 8,158,798 15,614,333 $156,144 $107,649,659 $ (72,922,674)
Issuance of common stock................ -- -- 307,548 3,074 1,552,432 --
Issuance of common stock under the stock
purchase plan......................... -- -- 31,822 319 180,103 --
Deferred compensation recorded in
connection with the granting of stock
options............................... -- -- -- -- 1,750,000 --
Common stock issued pursuant to employee
benefit plan.......................... -- -- 25,588 256 169,196 --
Issuance of common stock--StemCells..... -- -- 1,219,381 12,194 7,381,206 --
Redeemable common stock lapses.......... (257,311) (2,575,688) 257,311 2,573 2,573,115 --
Exercise of stock options............... -- -- 75,237 752 244,427 --
Deferred compensation--amortization and
cancellations......................... -- -- (5,000) (50) (27,294) --
Change in unrealized losses on
marketable securities................. -- -- -- -- -- --
Change in cumulative translation
adjustment............................ -- -- -- -- -- --
Net loss................................ -- -- -- -- -- (18,113,580)
Comprehensive loss......................
-------- ----------- ---------- -------- ------------ -------------
Balances, December 31, 1997............. 557,754 $ 5,583,110 17,526,220 $175,262 $121,472,844 $ (91,036,254)
OTHER COMPREHENSIVE
INCOME
---------------------------
UNREALIZED
GAINS
(LOSSES) CUMULATIVE TOTAL
ON MARKETABLE TRANSLATION DEFERRED STOCKHOLDERS'
SECURITIES ADJUSTMENTS COMPENSATION EQUITY
------------- ----------- ------------- -------------
Balances, December 31, 1996............. $ 14,760 $(60,416) $ (90,118) $ 34,747,355
Issuance of common stock................ -- -- -- 1,555,506
Issuance of common stock under the stock
purchase plan......................... -- -- -- 180,422
Deferred compensation recorded in
connection with the granting of stock
options............................... -- -- (1,750,000) --
Common stock issued pursuant to employee
benefit plan.......................... -- -- -- 169,452
Issuance of common stock--StemCells..... -- -- -- 7,393,400
Redeemable common stock lapses.......... -- -- -- 2,575,688
Exercise of stock options............... -- -- -- 245,179
Deferred compensation--amortization and
cancellations......................... -- -- 137,298 109,954
Change in unrealized losses on
marketable securities................. (23,637) -- -- (23,637)
Change in cumulative translation
adjustment............................ -- 60,416 -- 60,416
Net loss................................ -- -- -- (18,113,580)
------------
Comprehensive loss...................... (18,076,081)
-------- -------- ----------- ------------
Balances, December 31, 1997............. $ (8,877) -- $(1,702,820) $ 28,900,155
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
33
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE COMMON STOCK AND STOCKHOLDERS'
EQUITY (CONTINUED)
UNREALIZED
REDEEMABLE GAINS
COMMON STOCK COMMON STOCK ADDITIONAL (LOSSES)
---------------------- --------------------- PAID-IN ACCUMULATED ON MARKETABLE
SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT SECURITIES
------ ----------- ---------- -------- ------------ ------------- -------------
Issuance of common stock........... -- -- -- -- -- -- --
Issuance of common stock under the
stock purchase plan.............. -- -- 43,542 $ 436 $ 83,622
Deferred compensation recorded in
connection with the granting of
stock options.................... -- -- -- -- -- -- --
Common stock issued pursuant to
employee benefit plan............ -- -- 84,812 848 143,025 -- --
Issuance of common
stock--StemCells................. -- -- 101,320 1,013 505,587 -- --
Redeemable common stock lapses..... (33,417) (334,500) 33,417 334 334,166 -- --
Exercise of stock options.......... -- -- 11,012 110 1,254 -- --
Deferred compensation--amortization
and cancellations................ -- -- -- -- 321,108 -- --
Change in unrealized losses on
marketable securities............ -- -- -- -- -- -- 3,679
Net loss........................... -- -- -- -- -- (12,627,830) --
Comprehensive loss.................
-------- ----------- ---------- -------- ------------ ------------- --------
Balances, December 31, 1998........ 524,337 $ 5,248,610 17,800,323 $178,003 $122,861,606 $(103,664,084) $ (5,198)
======== =========== ========== ======== ============ ============= ========
TOTAL
DEFERRED STOCKHOLDERS'
COMPENSATION EQUITY
------------- -------------
Issuance of common stock........... -- --
Issuance of common stock under the
stock purchase plan.............. $ 84,058
Deferred compensation recorded in
connection with the granting of
stock options.................... -- --
Common stock issued pursuant to
employee benefit plan............ -- 143,873
Issuance of common
stock--StemCells................. -- 506,600
Redeemable common stock lapses..... -- 334,500
Exercise of stock options.......... -- 1,364
Deferred compensation--amortization
and cancellations................ 229,901 551,009
Change in unrealized losses on
marketable securities............ -- 3,679
Net loss........................... -- (12,627,830)
------------
Comprehensive loss................. (12,624,151)
----------- ------------
Balances, December 31, 1998........ $(1,472,919) $ 17,897,408
=========== ============
34
STEMCELLS, INC.
(FORMERLY, CYTOTHERAPEUTICS, INC.)
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE COMMON STOCK AND STOCKHOLDERS'
EQUITY (CONTINUED)
UNREALIZED
REDEEMABLE GAINS
COMMON STOCK COMMON STOCK ADDITIONAL (LOSSES)
---------------------- --------------------- PAID-IN ACCUMULATED ON MARKETABLE
SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT SECURITIES
------ ----------- ---------- -------- ------------ ------------- -------------
Issuance of common stock........... -- -- 196,213 $ 1,962 $ 318,221 -- --
Issuance of common stock under the
stock purchase plan.............. -- -- 57,398 574 41,619
Deferred compensation recorded in
connection with the granting of
stock options.................... -- -- -- -- -- -- --
Common stock issued pursuant to
employee benefit plan............ -- -- 90,798 908 102,502 -- --
Issuance of common
stock--StemCells................. -- -- -- -- -- -- --
Redeemable common stock lapses..... -- -- -- --
Exercise of stock options.......... -- -- 490,833 4,908 513,534 -- --
Deferred compensation--amortization
and cancellations................ -- -- -- -- 80,276 -- --
Change in unrealized losses on
marketable securities............ -- -- -- -- -- -- 5,198
Net loss........................... -- -- -- -- -- (15,708,626) --
Comprehensive loss.................
-------- ----------- ---------- -------- ------------ ------------- --------
Balances, December 31, 1999........ 524,337 $ 5,248,610 18,635,565 $186,355 $123,917,758 $(119,372,710) $ --
======== =========== ========== ======== ============ ============= ========
TOTAL
DEFERRED STOCKHOLDERS'
COMPENSATION EQUITY
------------- -------------
Issuance of common stock........... -- $ 320,183
Issuance of common stock under the
stock purchase plan.............. 42,193
Deferred compensation recorded in
connection with the granting of
stock options.................... -- --
Common stock issued pursuant to
employee benefit plan............ -- 103,410
Issuance of common
stock--StemCells.................
Redeemable common stock lapses.....
Exercise of stock options.......... -- 518,442
Deferred compensation--amortization
and cancellations................ 247,919 328,195
Change in unrealized losses on
marketable securities............ -- 5,198
Net loss........................... -- (15,708,626)
------------
Comprehensive loss................. (15,703,428)
----------- ------------
Balances, December 31, 1999........ $(1,225,000) $ 3,506,403
=========== ============
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
35
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEAR ENDED DECEMBER 31,
------------------------------------------
1999 1998 1997
------------ ------------ ------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss.................................................... $(15,708,626) $(12,627,830) $(18,113,580)
Adjustments to reconcile net loss to net cash used for
operating activities:
Depreciation and amortization............................. 1,717,975 2,244,146 1,968,234
Acquired research and development......................... -- 551,009 8,343,684
Amortization of deferred compensation..................... 328,195 -- 109,954
Fair market adjustment for property held for sale......... 300,000 -- --
Other non-cash charges.................................... 320,183 410,173 105,931
Gain on investment........................................ -- -- (3,386,808)
Loss on sale of fixed assets.............................. 1,117,286 -- 413,856
Loss on sale of intangibles............................... 440,486
Changes in operating assets and liabilities:
Accrued interest receivable............................. 164,397 346,577 100,004
Other current assets.................................... 283,000 (265,665) (232,604)
Accounts payable and accrued expenses................... 1,344,142 (2,378,613) (1,233,501)
Deferred rent........................................... 279,680 -- --
Deferred revenue........................................ (2,500,000) 2,483,856 (1,842,948)
------------ ------------ ------------
Net cash used in operating activities....................... (11,913,282) (9,236,347) (13,767,778)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of Modex, net of cash disposed........... -- -- 2,958,199
Purchases of marketable securities.......................... (4,397,676) (18,982,387) (14,182,521)
Proceeds from sales of marketable securities................ 13,923,813 22,573,625 23,736,242
Purchases of property, plant and equipment.................. (192,747) (2,153,525) (7,710,126)
Proceeds on sale of fixed assets............................ 746,448 -- 8,003,926
Purchase of other investment................................ -- -- (250,000)
Acquisition of other assets................................. (558,311) (400,219) (1,599,418)
Disposal of other assets.................................... 440,486 -- --
Acquisition of StemCells assets............................. -- -- (640,490)
Advance to Cognetix......................................... -- -- (250,000)
Repayment from Cognetix..................................... -- -- 250,000
------------ ------------ ------------
Net cash provided by investing activities................... 9,962,013 1,037,494 10,315,812
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of redeemable common stock........... -- -- --
Proceeds from issuance of common stock...................... 145,603 227,931 1,905,380
Proceeds from the exercise of stock options and warrants.... 518,442 1,364 245,179
Proceeds from debt financings............................... -- 1,259,300 --
Repayments of debt and lease obligations.................... (1,817,500) (1,366,655) (2,496,849)
------------ ------------ ------------
Net cash provided by (used in) financing activities......... (1,153,455) 121,940 (346,290)
Effect of exchange rate changes on cash and cash
equivalents............................................... -- -- (181,627)
------------ ------------ ------------
Decrease in cash and cash equivalents....................... (3,104,724) (8,076,913) (3,979,883)
Cash and cash equivalents, January 1........................ 7,864,788 15,941,701 19,921,584
------------ ------------ ------------
Cash and cash equivalents, December 31...................... $ 4,760,064 $ 7,864,788 $ 15,941,701
============ ============ ============
Supplemental disclosure of cash flow information:
Interest paid............................................. $ 335,203 $ 444,047 $ 436,461
Non-cash transaction:
In December 1999, the Company sold intellectual property related to its
encapsulated cell technology. In association with the transaction, the Company
recorded a receivable of $3,000,000 and reduced intangible assets.
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
36
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1999
1. NATURE OF BUSINESS
StemCells, Inc. (formerly CytoTherapeutics, Inc.) (the "Company") is a
biopharmaceutical company engaged in the development of novel stem cell
therapies designed to treat human diseases and disorders.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include accounts of the Company and
StemCells California, Inc., a wholly owned subsidiary. Significant intercompany
accounts have been eliminated in consolidation.
USE OF ESTIMATES
The preparation of the consolidated financial statements in conformity with
generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those
estimates.
CASH EQUIVALENTS AND MARKETABLE SECURITIES
Cash equivalents include funds held in investments with original maturities
of three months or less when purchased. The Company's policy regarding selection
of investments, pending their use, is to ensure safety, liquidity, and capital
reservation while obtaining a reasonable rate of return. Marketable securities
consist of investments in agencies of the U.S. government, investment grade
corporate notes and money market funds. The fair values for marketable
securities are based on quoted market prices.
The Company determines the appropriate classification of cash equivalents
and marketable securities at the time of purchase and reevaluates such
designation as of each balance sheet date. The Company classifies such holdings
as available-for-sale securities, which are carried at fair value, with
unrealized gains and losses reported as a separate component of stockholders'
equity.
PROPERTY HELD FOR SALE
As a result of the Company's decision to exit the encapsulated cell
technology and relocate its corporate headquarters to Sunnyvale, CA, certain
property considered by management to no longer be necessary has been made
available for sale or lease. The aggregate carrying value of such property has
been reviewed by management, subject to appraisal and adjusted downward to
estimated market value.
PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, including that held under capitalized lease
obligations, is stated at cost and depreciated using the straight-line method
over the estimated life of the respective asset, as follows:
Buildings and improvements.................................. 3-15 years
Machinery and equipment..................................... 3-10 years
Furniture and fixtures...................................... 3-10 years
37
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
PATENT COSTS
The Company capitalizes certain patent costs related to patent applications.
Accumulated costs are amortized over the estimated economic life of the patents,
not to exceed 17 years, using the straight-line method, commencing at the time
the patent is issued. Costs related to patent applications are written off to
expense at the time such patents are deemed to have no continuing value. At
December 31, 1999 and 1998, total costs capitalized were $718,000 and $4,285,000
and the related accumulated amortization were $9,000 and $347,000, respectively.
Patent expense totaled $539,000, $3,000, and $365,000 in 1999, 1998 and 1997,
respectively.
In December 1999, the Company sold its Encapsulated Cell Technology ("ECT")
to Neurotech, S.A. for an initial payment of $3,000,000, royalties on future
product sales, and a portion of certain Neurotech revenues from third parties,
in return for the assignment to Neurotech of intellectual property assets
relating to ECT. In addition, the Company retained certain non-exclusive rights
to use ECT in combination with its proprietary stem cell technology and in the
field of vaccines for prevention and treatment of infectious diseases. The
patent portfolio that was sold had a net book value of $3,180,000. The loss on
this transaction and expenses related to the write-down of ECT are included in
wind-down expenses on the Company's Consolidated Statement of Operations.
STOCK BASED COMPENSATION
The Company grants qualified stock options for a fixed number of shares to
employees with an exercise price equal to the fair market value of the shares at
the date of grant. The Company accounts for stock option grants in accordance
with APB Opinion No. 25, ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES, and,
accordingly, recognizes no compensation expense for qualified stock option
grants.
For certain non-qualified stock options granted to non-employees, the
Company accounts for these grants in accordance with FAS No. 123--ACCOUNTING FOR
STOCK-BASED COMPENSATION AND EITF96-18--ACCOUNTING FOR EQUITY INSTRUMENTS THAT
ARE ISSUED TO OTHER THAN EMPLOYEES FOR ACQUIRING, OR IN CONJUNCTION WITH
SELLING, GOODS OR SERVICES, and accordingly, recognizes as consulting expenses
the estimated fair value of such options as calculated using the Black-Scholes
valuation model. Fair value is determined using methodologies allowable by FAS
No. 123. The cost is amortized over the vesting period of each option or the
recipient's contractual arrangement, if shorter.
INCOME TAXES
The liability method is used to account for income taxes. Deferred tax
assets and liabilities are determined based on differences between financial
reporting and income tax bases of assets and liabilities, as well as net
operating loss carry forwards, and are measured using the enacted tax rates and
rates under laws that are expected to be in effect when the differences reverse.
Deferred tax assets may be reduced by a valuation allowance to reflect the
uncertainty associated with their ultimate realization.
REVENUE FROM COLLABORATIVE AGREEMENTS
Revenues from collaborative agreements are recognized as earned upon either
the incurring of reimbursable expenses directly related to the particular
research plan or the achievement of certain
38
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
development milestones as defined within the terms of the collaborative
agreement. Payments received in advance of research performed are designated as
deferred revenue. Recorded revenues are not refundable in the event research
efforts are considered unsuccessful.
RESEARCH AND DEVELOPMENT COSTS
The company expenses all research and development costs as incurred.
NET LOSS PER SHARE
Net loss per share is computed using the weighted average number of shares
of common stock outstanding. Common equivalent shares from stock options and
warrants are excluded, as their effect is antidilutive.
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
The Securities Exchange Commission's recently issued Staff Accounting
Bulletin No. 101 provides guidance on revenue recognition that may impact the
Company's future reporting relative to recognizing revenues received from
collaborative and similar agreements. The Company does not expect this guidance
to result in significant changes to its existing revenue recognition policy,
subject to the specific terms of each individual collaborative agreement.
3. SALE OF 6% CUMULATIVE CONVERTIBLE PREFERRED STOCK
On April 13, 2000, the Company completed arrangements to sell 1,500 shares
of 6% cumulative convertible preferred stock plus a warrant for 75,000 shares of
the Company's common stock to two members of its Board of Directors for
$1,500,000, on terms more favorable to the Company than it was then able to
obtain from outside investors. The shares are convertible at the option of the
holders into common stock at $3.77 per share (based on the face value of the
preferred shares). The conversion price may be below the trading market price of
the stock at the time of conversion. The Company has valued the beneficial
conversion feature using the intrinsic value method reflecting the April 13,
2000 commitment date and the most beneficial per share discount available to the
preferred shareholders. Such value was $265,000 and will be treated as a deemed
dividend as of the commitment date. The holders of the preferred stock have
liquidation rights equal to their original investment plus accrued but unpaid
dividends. The investors would be entitled to make additional investments in the
Company on the same terms as those on which the Company completes offerings of
its securities with third parties within 6 months, if any such offerings are
completed. If offerings totaling at least $6 million are not completed during
the 6 months, the investors have the right to acquire up to 1,126 additional
shares of convertible preferred stock at $6.33 per share. Any unconverted
preferred stock is converted (based on the face value of the preferred shares),
at the applicable conversion price, on April 13, 2002 in the case of the
original stock and two years after the first acquisition of any of the
additional 1,126 shares, if any are acquired. The warrant expires on April 13,
2005.
39
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
4.WIND-DOWN OF ENCAPSULATED CELL TECHNOLOGY RESEARCH AND DEVELOPMENT PROGRAM
Until mid-1999, the Company engaged in research and development in
encapsulated cell therapy technology, including a pain control program funded by
AstraZeneca Group plc. The results from the 85-patient double-blind,
placebo-controlled trial of our encapsulated bovine cell implant for the
treatment of severe, chronic pain in cancer patients did not, however, meet the
criteria AstraZeneca had established for continuing trials for the therapy, and
in June 1999 AstraZeneca terminated the collaboration, as allowed under the
terms of the original collaborative agreement signed in 1995.
As a result of termination, management determined in July 1999 to
restructure its research operations to abandon all further encapsulated cell
technology research and concentrate its resources on the research and
development of its proprietary platform of stem cell technologies.
The Company wound down its research and manufacturing operations in Lincoln,
Rhode Island, and relocated its remaining research and development activities,
and its corporate headquarters, to the facilities of its wholly owned
subsidiary, StemCells California, Inc., in Sunnyvale, California, in
October 1999. The Company terminated legal, professional and consulting
contractual arrangements in support of ECT research. The Company had used these
legal, professional and consulting contractual arrangements to meet regulatory
requirements in support of its research work, to support contractual
arrangements with clinical sites, to provide assistance at clinical sites in
administering therapy and documenting activities, and to assist in compliance
with FDA and other regulations regarding its clinical trials. ECT related patent
law work was also terminated. The Company also engaged professional consultants
in connection with the determination to exit its ECT activities and restructure
is operations, which concluded with the exit from ECT activities and relocation
of its corporate headquarters to California. The Company reduced its workforce
by approximately 58 employees who had been focused on ECT programs and 10
administrative employees. As a result, the Company sold excess furniture and
equipment in December 1999 and is seeking to sublease the science and
administrative facility and to sell the pilot manufacturing facility.
Wind-down expenses totaled approximately $6,048,000 for the year ended
December 31, 1999; no such expenses were incurred in 1998 and 1997. These
expenses relate to the wind-down of the Company's encapsulated cell technology
research and development program and the Company's other Rhode Island
operations, and the transfer of the Company's corporate headquarters to
Sunnyvale, California.
40
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
4.WIND-DOWN OF ENCAPSULATED CELL TECHNOLOGY RESEARCH AND DEVELOPMENT PROGRAM
(CONTINUED)
A description of these expenses, including the amounts and periods of
recognition, are as follows:
TOTAL
THIRD QUARTER FOURTH QUARTER WIND-DOWN
1999 1999 EXPENSE
------------- -------------- ----------
Employee severance costs............................... $1,554,000 $ -- $1,554,000
Impairment losses(1):
Fixed assets......................................... 800,000 -- 800,000
ECT patents.......................................... 260,000 -- 260,000
---------- ---------- ----------
1,060,000 -- 1,060,000
Rhode Island facilities carrying costs(2):
Corporate headquarters............................... 702,000 -- 702,000
Pilot manufacturing plant............................ 562,000 -- 562,000
---------- ---------- ----------
1,264,000 -- 1,264,000
Employee outplacement.................................. 200,000 -- 200,000
RIPSAT settlement(3)................................... -- 1,172,000 1,172,000
Loss on sale of assets(4):
Fixed assets......................................... -- 318,000 318,000
ECT patents.......................................... -- 180,000 180,000
---------- ---------- ----------
-- 498,000 498,000
Write-down of pilot plant(5)........................... -- 300,000 300,000
---------- ---------- ----------
$4,078,000 $1,970,000 $6,048,000
========== ========== ==========
- ------------------------
(1) Management's estimate of the fixed asset impairment was derived from
communications with an outside auction house. The patent impairment loss was
based on preliminary negotiations with parties interested in acquiring the
patents.
(2) Facilities carrying costs include the operating lease payments, utilities,
property taxes, insurance, maintenance, interest and other non-employee
related expenses necessary to maintaining these facilities through the
expected date of disposition (June 30, 2000).
(3) The Company originally received funding from the Rhode Island Partnership
for Science and Technology (RIPSAT) for purposes of conducting ECT
activities conditioned upon maintaining the operating within the state.
RIPSAT claimed that the Company's decision to exit ECT activities and close
the Rhode Island operation was in violation of the funding arrangement and
that the Company was obligated to return a portion of the funding proceeds.
Although the Company disputed these claims, during the fourth quarter of
1999, management determined it was in the best interest of the company to
settle the issue.
(4) The Company held an auction to sell all ECT fixed assets. Proceeds from that
sale resulted in a loss, which was related to machinery and equipment
($292,000), and furniture and fixtures ($26,000).
41
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
4.WIND-DOWN OF ENCAPSULATED CELL TECHNOLOGY RESEARCH AND DEVELOPMENT PROGRAM
(CONTINUED)
(5) The write-down of the pilot plant was based on an independent property
appraisal, which was not available during the third quarter, when the
Company reached a decision to exit ECT activities and relocate the corporate
headquarters.
At December 31, 1999, the Company's $1.6 million wind-down reserve included
approximately $1.2 million for the RIPSAT settlement and approximately
$0.4 million for Rhode Island facility costs.
Property held for sale at December 31, 1999, consisted of $3.2 million
relating to the Company's pilot plant facility located in Lincoln, Rhode Island.
The Company suspended depreciation of these assets totalling approximately
$140,000 for the quarter ended December 31, 1999. The balance reflected the
$300,000 write-down included as part of the additional wind-down expenses
recognized during the fourth quarter, in accordance with Financial Accounting
Standards Board Statement 121, which requires that long-lived assets be reviewed
for impairment whenever events or circumstances indicate that the carrying value
of the asset may not be recoverable. There were no such assets at December 31,
1998.
5. STEMCELLS CALIFORNIA, INC.
In September 1997, a merger of a wholly owned subsidiary of the company and
StemCells California, Inc. was completed in the form of a purchase. Through the
merger, the Company acquired StemCells California, Inc. for a purchase price
totaling approximately $9,475,000, consisting of 1,320,691 shares of the
Company's common stock, valued at $6,600,000 and options and warrants for the
purchase of 259,296 common shares at nominal consideration, valued at
$1,300,000, the assumption of certain liabilities of $934,000 and transaction
costs of $641,000. Options and warrants were valued utilizing the intrinsic
method, and the resultant value approximated the value determined using the
Black-Scholes method. The purchase price was allocated, based upon an asset
valuation study using income approach methods, to license agreements valued at
$1,131,000 to be amortized over three years and acquired research and
development of $8,344,000, which was expensed. The acquired research and
development had not reached scientific feasibility and had no alternative future
uses. As part of the acquisition of StemCells, Richard M. Rose, M.D., became
President, Chief Executive Officer and director of the Company and Dr. Irving
Weissman became a director of the Company.
Upon consummation of the merger, the Company entered into consulting
arrangements with the principal scientific founders of StemCells: Dr. Irving
Weissman, Dr. Fred H. Gage and Dr. David Anderson. Additionally, in connection
with the merger, the Company was granted an option by the former shareholders of
StemCells to repurchase 500,000 of the Company's shares of Common Stock
exchanged for StemCells shares, upon the occurrence of certain events.
To attract and retain Drs. Rose, Weissman, Gage and Anderson, and to
expedite the progress of the Company's stem cell program, the Company awarded
these individuals options to acquire a total of approximately 1.6 million shares
of the Company's common stock, at an exercise price of $5.25 per share, the
quoted market price at the grant date. Under the original grants, approximately
100,000 of these options were exercisable immediately on the date of grant,
1,031,000 of these options would vest and become exercisable only upon the
achievement of specified milestones related to the Company's stem cell
development program and the remaining 469,000 options would vest over eight
years. The expense associated with the grants that vested immediately was
considered non-employee compensation and was
42
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
5. STEMCELLS CALIFORNIA, INC. (CONTINUED)
based on the fair value of the options granted. The expense was considered
immaterial. In connection with the 469,000 options issued to a non-employee,
Dr. Anderson, the Company recorded deferred compensation of $1,750,000, the fair
value of such options at the date of grant, which will be amortized over an
eight-year period. The fair value was determined using the Black-Scholes method
with the following inputs: volatility .594, expected life 8 years, dividend
yield 0.0%, risk free rate 5.98%. If the milestones specified relating to the
1,031,000 option granted to non-employees, Drs. Weissman and Gage, are achieved,
at that time the company will record compensation expense for the fair market
value of such options determined using the Black-Scholes method. The company has
also designated a pool of 400,000 options to be granted to persons in a position
to make a significant contribution to the success of the stem cell program.
Stem cell research is conducted pursuant to the provisions of an agreement
between the company and Drs. Weissman and Gage providing for a two-year research
plan. If the goals of the research plan are accomplished, the Company has agreed
to fund continuing stem cell research. Increases in stem cells research funding
of not more than 25% a year will be funded by the Company as long as the goals
of the research plan are being met. However, the Company will retain the option
of (i) ceasing or reducing brain stem cell research even if all research plan
goals are met, but will be required to accelerate the vesting of all
still-achievable performance based stock options, and (ii) ceasing or reducing
non-brain stem cell research even if all plan goals are being met by affording
the scientific research founders the opportunity to continue development of the
non-brain stem cell research by licensing the technology related to such
research to the founders in exchange for a payment to the Company equal to all
prior Company funding for such research, plus royalty payments.
6. MODEX
In October 1997, the Company completed a series of transactions, which
resulted in the establishment of its previously 50%-owned Swiss subsidiary,
Modex Therapeutics, Ltd. (Modex), as an independent company. In the
transactions, the Company reduced its ownership interest from 50% to
approximately 25% in exchange for $4 million cash and elimination of its prior
contingent obligation to contribute an additional Sfr 2.4 million (approximately
$1.7 million) to Modex in July 1998. In the transactions, all of the put and
call arrangements between the Company and other stockholders of Modex were
eliminated and the Company forgave $463,000 due from Modex to the Company. The
Company recorded a gain on the transactions of $3,387,000.
In April 1998, Modex completed an additional equity offering, in which the
Company did not participate. This resulted in a reduction in the Company's
ownership to less than 20% ownership; therefore, the Company accounted for this
investment under the cost method at December 31, 1999.
The pre-existing royalty-bearing Cross License Agreement between the Company
and Modex was assigned by the Company to Neurotech S.A., a privately held French
company, as part of the sale of the intellectual property assets related to the
Company's encapsulated cell therapy technology to Neurotech. Under the terms of
the sale to Neurotech, the Company will receive a portion of revenues Neurotech
receives from Modex under the Cross License Agreement.
43
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
7. MARKETABLE SECURITIES
During 1999, the Company sold all of its remaining marketable equitable
securities. At December 31, 1999, all of the Company's available funds were held
in cash and cash equivalents. The following is a summary of available-for-sale
securities held at December 31, 1998:
DECEMBER 31, 1998
---------------------------------------------------
GROSS GROSS
UNREALIZED UNREALIZED ESTIMATED
COST GAINS LOSSES FAIR VALUE
----------- ---------- ---------- -----------
U.S. government securities..................... $ 1,500,994 $1,720 $ (504) $ 1,502,210
U.S. corporate securities...................... 9,225,095 3,244 (9,658) 9,218,681
----------- ------ -------- -----------
Total debt securities.......................... $10,726,089 $4,964 $(10,162) 10,720,891
=========== ====== ========
Debt securities included in cash and cash
equivalents.................................. (1,199,952)
===========
Debt securities included in marketable
securities................................... $ 9,520,939
===========
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following:
DECEMBER 31,
-----------------------
1999 1998
---------- ----------
Building and improvements............................ $ 665,890 $5,665,077
Machinery and equipment.............................. 1,691,096 9,887,251
Furniture and fixtures............................... 219,260 869,831
---------- ----------
2,576,286 16,422,159
Less accumulated depreciation and amortization....... 828,401 8,066,150
---------- ----------
$1,747,885 $8,356,009
========== ==========
Depreciation and amortization expense was $1,436,000, $1,720,000, and
$1,778,000 for the years ending December 31, 1999, 1998 and 1997, respectively.
As part of the Company's restructuring of its operations, sale of its
encapsulated cell technology ("ECT"), and relocation of its corporate
headquarters to Sunnyvale, California, the Company identified fixed assets
associated with the ECT or otherwise no longer needed. In December of 1999, the
Company disposed of these excess fixed assets, realizing proceeds of
approximately $746,000. At the time of the sale, these assets had a net book
value of approximately $1,063,000 after a third quarter write-down of $800,000,
which was based on management's estimate of expected sale proceeds. The third
quarter write-down and actual fourth quarter loss were included as wind-down
expenses.
Certain property, plant and equipment have been acquired under capitalized
lease obligations. These assets totaled $5,827,000 and $6,587,000, at
December 31, 1999 and 1998, respectively, with related accumulated amortization
of $2,747,000 and $2,860,000 at December 31, 1999 and 1998, respectively. As a
44
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
8. PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
result of the Company's decision to exit ECT and relocate to Sunnyvale, CA, this
property has been classified as held for sale at December 31, 1999.
9. OTHER ASSETS
Other assets are as follows:
DECEMBER 31,
-----------------------
1999 1998
---------- ----------
Patents, net......................................... $ 708,823 $3,938,755
License agreements, net.............................. 282,750 659,750
Security deposit--building lease..................... 750,000 750,000
Restricted cash...................................... -- 603,467
Deferred financing costs, net........................ 117,195 123,701
---------- ----------
$1,858,768 $6,075,663
========== ==========
The decrease in patents from 1999 to 1998 was primarily due to management's
decision to exit encapsulated cell technology and dispose of the related
intellectual property. Management reached this decision during the third quarter
of 1999, and established a reserve that included $260,000 directly related to
the write-down of encapsulated cell technology patents. During the fourth
quarter, management established an additional reserve that included a $180,000
loss associated with the sale of encapsulated cell technology patents worth
$3,180,000.
At December 31, 1999 and 1998, accumulated amortization was $857,000 and
$818,000, respectively, for patents and license agreements.
10. ACCRUED EXPENSES
Accrued expenses are as follows:
DECEMBER 31,
-----------------------
1999 1998
---------- ----------
Wind-down expenses................................... $1,634,522 $ --
External services.................................... 97,439 412,253
Employee compensation................................ 306,342 262,679
Collaborative research............................... 222,140 196,505
Other................................................ 344,625 148,682
---------- ----------
$2,905,068 $1,020,119
========== ==========
The reserve for wind-down expenses included approximately $1,172,000
relating to the RIPSAT settlement (Notes 4 and 11) and approximately $463,000
for the estimated six months of lease payments and operating costs for the Rhode
Island Facilities through an expected disposal date of June 30, 2000.
45
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
11. LEASES
The Company has undertaken direct financing transactions with the State of
Rhode Island and received proceeds from the issuance of industrial revenue bonds
totaling $5,000,000 to finance the construction of its pilot manufacturing
facility. The related leases are structured such that lease payments will fully
fund all semiannual interest payments and annual principal payments through
maturity in August 2014. Fixed interest rates vary with the respective bonds'
maturities, ranging from 5.1% to 9.5%. The bonds contain certain restrictive
covenants which limit, among other things, the payment of cash dividends and the
sale of the related assets. In addition, the Company was required to maintain a
debt service reserve until December 1999. On March 3, 2000 the Company entered
into a settlement agreement with RIPSAT, the Rhode Island Industrial
Recreational Building Authority ("IRBA") and the Rhode Island Industrial
Facilities Corporation ("RIIFC"). The Company agreed to pay RIPSAT $1,172,000 in
full satisfaction of all obligations of the Company to RIPSAT under the Funding
Agreement dated as of June 22, 1989. On execution and delivery of this
Agreement, IRBA agreed to return to the Company the full amount of the Company's
debt service reserve ("Reserve Funds"), approximately $610,000 of principal and
interest, relating to the bonds the Company has with IRBA and RIIFC. Such amount
has been classified as debt service funds in current assets of the consolidated
balance sheet. In order to avoid the loss of interest on the Reserve Funds due
to early termination of certain investments, the parties agreed that the Company
would render a net payment to RIPSAT in the amount of approximately $562,000.
In 1997, the Company completed construction of a new headquarters and
laboratory facility. In November 1997, the Company entered into sale and
leaseback agreements with a real estate investment trust. Under the terms of
these agreements, the Company sold its new facility for $8,000,000, incurring a
$342,000 loss on the sale. The Company simultaneously entered into a
fifteen-year lease for the facility. The lease agreement calls for minimum rent
of $750,000 for the first five years, $937,500 for years six to ten, $1,171,900
for years eleven to fourteen and $1,465,000 in year fifteen, with a $750,000
security deposit held for the term of the lease. The Company is recognizing rent
expense on a straight line basis. At December 31, 1999, the Company has incurred
$426,790 in deferred rent expense.
Future minimum capitalized lease obligations with non-cancelable terms in
excess of one year at December 31, 1999, are as follows:
2000........................................................ $ 606,268
2001........................................................ 589,217
2002........................................................ 519,719
2003........................................................ 436,909
2004........................................................ 425,713
Thereafter.................................................. 2,577,826
----------
Total minimum lease payments................................ 5,302,407
Less amounts representing interest.......................... 2,041,157
----------
Present value of minimum lease payments..................... 3,261,250
Less current maturities..................................... 324,167
----------
Capitalized lease obligations, less current maturities...... $2,937,083
==========
46
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
11. LEASES (CONTINUED)
Rent expense for the years ended December 31, 1999, 1998 and 1997, was
$947,000, $1,052,000 and $499,000, respectively.
12. LONG-TERM DEBT
Long-term debt is as follows:
DECEMBER 31,
-----------------------
1999 1998
---------- ----------
Term note payable, interest at the prime rate plus
1/2% (8.75% at December 31, 1998), principal
payments commence in August 1998, due ratably
through May 2000; secured by certain equipment
(prepaid during 1999).............................. $ -- $1,500,000
Current maturities of long-term debt................. -- 1,000,000
---------- ----------
Long-term debt, less current maturities.............. -- $ $500,000
========== ==========
13. REDEEMABLE COMMON STOCK
In November 1996, the Company signed certain collaborative development and
licensing agreements with Genentech, Inc, including one under which Genentech
purchased 829,171 shares of redeemable common stock for $8.3 million to fund
development of products to treat Parkinson's disease. The Agreement also
provided that Genentech had the right, at its discretion, to terminate the
Parkinson's program at specified milestones in the program, and that if the
program were terminated, Genentech had the right to require the Company to
repurchase from Genentech the shares of the Company's common stock having a
value equal to the amount by which the $8.3 million exceeded the expenses
incurred by the Company in connection with such program by more than
$1 million, based upon the share price paid by Genentech. Accordingly, the
common stock is classified as redeemable common stock until such time as the
related funds are expended. At December 31, 1998, $3,051,000 had been spent on
the collaboration with Genentech and, accordingly, the Company has reclassified
those common shares and related value to stockholders' equity. On May 21, 1998,
Genentech exercised its right to terminate the collaboration and negotiations
ensued with respect to the amount of redeemable common stock to be redeemed in
accordance with the agreement and the method of such redemption. In March 2000,
the Company reached a settlement of this matter with Genentech. Under the
settlement agreement, Genentech released the Company from any obligation to
redeem any shares of the Company's Common Stock held by Genentech. Accordingly,
the Company will reclassify the amount currently recorded as Redeemable Common
Stock ($5,248,000) to Stockholders' Equity in March 2000. The Company and
Genentech also agreed that all of the agreements between them were terminated
and that neither had any claim to the intellectual property of the other.
47
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
14. COMMON STOCK TO BE ISSUED
In 1998, the Company entered into an agreement with a Company advisor, under
which the advisor prepared a strategic and business overview and provided
related implementation support for the Company. The advisor agreed to accept
cash and the Company's common stock as partial payment for its services. In
1999, the Company issued the $187,500 of common stock due to the advisor.
15. STOCKHOLDERS' EQUITY
STOCK OPTION AND EMPLOYEE STOCK PURCHASE PLANS
The Company has adopted several stock plans that provide for the issuance of
incentive and nonqualified stock options, performance awards and stock
appreciation rights, at prices to be determined by the Board of Directors, as
well as the purchase of Common Stock under an employee stock purchase plan at a
discount to the market price. In the case of incentive stock options, such price
will not be less than the fair market value on the date of grant. Options
generally vest ratably over four years and are exercisable for ten years from
the date of grant or within three months of termination. At December 31, 1999,
the Company had reserved 2,603,736 shares of common stock for the exercise of
stock options.
The following table presents the combined activity of the Company's stock
option plans (exclusive of the plans noted below) for the years ended
December 31:
1999 1998 1997
-------------------------- --------------------------- --------------------------
WEIGHTED WEIGHTED WEIGHTED
AVERAGE AVERAGE AVERAGE
OPTIONS EXERCISE PRICE OPTIONS EXERCISE PRICE OPTIONS EXERCISE PRICE
--------- -------------- ---------- -------------- --------- --------------
Outstanding at January 1...... 1,654,126 $3.62 2,446,573 $7.48 2,423,025 $8.34
Granted....................... 536,078 1.08 1,174,118 1.70 679,074 5.33
Exercised..................... (604,362) 1.50 (11,012) .12 (82,737) 2.96
Canceled...................... (646,507) 5.31 (1,955,553) 7.08 (572,789) 9.21
--------- ----- ---------- ----- --------- -----
Outstanding at December 31.... 939,335 $2.65 1,654,126 $3.62 2,446,573 $7.48
========= ===== ========== ===== ========= =====
Options exercisable at
December 31................. 594,216 $3.44 1,108,936 $4.33 1,338,163 $7.79
========= ===== ========== ===== ========= =====
On July 10, 1998, the Company re-priced 751,018 outstanding stock options.
No compensation expense was recorded since the re-priced options carried an
exercise price equal to the market price of the Company's common stock on the
date of the re-pricing.
In addition to the options noted above, in conjunction with the StemCells
California merger, StemCells California options originally issued under a prior
StemCells California options plan were exchanged for options to purchase 250,344
shares of the Company's common stock at $.01 per share; 75,384 of these options
are exercisable at December 31, 1997, 96,750 of these options vest and become
exercisable only upon achievement of specified milestones, and the remaining
78,210 options vest over three years from the date of grant. The value of such
options utilizing the intrinsic method, which approximated the value determined
using the Black-Scholes method, was accounted for as part of the StemCells
California acquisition price. Additionally, the Company adopted the 1997
CytoTherapeutics, Inc. StemCells California Research Stock Option Plan (the
StemCells California Research Plan)
48
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
15. STOCKHOLDERS' EQUITY (CONTINUED)
whereby an additional 2,000,000 shares of Common Stock have been reserved.
During 1997, the Company awarded options under the StemCells Research Plan to
purchase 1.6 million shares of the Company's common stock to the Chief Executive
Officer and scientific founders of StemCells at an exercise price of $5.25 per
share. Under the original grants, approximately 100,000 of these options were
exercisable immediately on the date of grant, 1,031,000 of these options would
vest and become exercisable only upon achievement of specified milestones and
the remaining 469,000 options would vest over eight years. Options granted to
Dr. Rose, in his capacity as Chief Executive Officer, were valued using the
intrinsic value method, in accordance with the provisions of APB 25, ACCOUNTING
FOR STOCK ISSUED TO EMPLOYEES. Options granted to non-employees Drs. Weissman,
Gage and Anderson were accounted for using the fair value method in accordance
with the provisions of Statement of Financial Accounting Standards No. 123,
ACCOUNTING FOR STOCK-BASED COMPENSATION.
FAS 123 DISCLOSURES
The Company has adopted the disclosure provisions only of Statement of
Financial Accounting Standards No. 123, ACCOUNTING FOR STOCK-BASED COMPENSATION
("FAS 123") and accounts for its stock option plans in accordance with the
provisions of APB 25, ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES.
The following table presents weighted average price and life information
about significant option groups outstanding at December 31, 1999:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
------------------------------------ ----------------------
WEIGHTED
AVERAGE WEIGHTED WEIGHTED
REMAINING AVERAGE AVERAGE
RANGE OF NUMBER CONTRACTUAL EXERCISE NUMBER EXERCISE
EXERCISE PRICES OUTSTANDING LIFE (YRS.) PRICE EXERCISABLE PRICE
- ------------------------------------------------ ----------- ----------- -------- ----------- --------
Less than $5.00................................. 755,398 8.50 $1.12 411,945 $ 1.02
$5.01--$10.00................................... 90,687 4.56 6.55 89,021 6.55
Greater than $10.00............................. 93,250 2.54 11.18 93,250 11.18
------- -------
939,335 594,216
======= =======
Pursuant to the requirements of FAS 123, the following are the pro forma net
loss and net loss per share amounts for 1999, 1998, and 1997, as if the
compensation cost for the option plans and the stock purchase plan had been
determined based on the fair value at the grant date for grants in 1999, 1998,
and 1997, consistent with the provisions of FAS 123:
1999 1998 1997
--------------------------- --------------------------- ---------------------------
AS REPORTED PRO FORMA AS REPORTED PRO FORMA AS REPORTED PRO FORMA
------------ ------------ ------------ ------------ ------------ ------------
Net loss............. $(15,708,626) $(15,764,569) $(12,627,830) $(14,919,389) $(18,113,580) $(19,924,437)
Net loss per share... $(.84) $(.84) $(.69) $(.82) $(1.08) $(1.19)
The weighted average fair value per share of options granted during 1999,
1998 and 1997 was $.88, $.82 and $3.40, respectively. The fair value of options
and shares issued pursuant to the stock purchase
49
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
15. STOCKHOLDERS' EQUITY (CONTINUED)
plan at the date of grant were estimated using the Black-Scholes model with the
following weighted average assumptions:
OPTIONS STOCK PURCHASE PLAN
------------------------------------ ------------------------------------
1999 1998 1997 1999 1998 1997
-------- -------- -------- -------- -------- --------
Expected life (years)........................ 5 5 5 5 .5 .5
Interest rate................................ 5.5% 5.2% 6.2% 5.0% 4.64% 5.5%
Volatility................................... 96.7% 63.5% 59.0% 96.7% 63.5% 59.0%
The Company has never declared nor paid dividends on any of its capital
stock and does not expect to do so in the foreseeable future.
The effects on 1999, 1998 and 1997 pro forma net loss and net loss per share
of expensing the estimated fair value of stock options and shares issued
pursuant to the stock purchase plan are not necessarily representative of the
effects on reporting the results of operations for future years as the period
presented includes only four, three or two years, respectively, of option grants
under the Company's plans. As required by FAS 123, the Company has used the
Black-Scholes model for option valuation, which method may not accurately value
the options described.
STOCK WARRANTS
In conjunction with StemCells California merger, the Company exchanged
StemCells California warrants for warrants to purchase 8,952 shares of Company
common stock at $4.71 per share; such warrants were valued using the intrinsic
value method which approximated the value determined using the Black-Scholes
method, and were accounted for as part of the purchase price. In conjunction
with various equipment leasing agreements, the Company had outstanding warrants
to purchase 31,545 shares of common stock at prices ranging from $4.00 to $9.00
per share. The warrants expired in October 2000.
In connection with a public offering of common stock in April 1995, the
Company issued warrants to purchase 434,500 shares of common stock at $8 per
share. The warrants are nontransferable and expired in April 2000, subject to
certain required exercise provisions. In addition to the foregoing rights, the
holder of such warrants has the right, in the event the Company issues
additional shares of common stock or other securities convertible into common
stock, to purchase at the then market price of such common stock, sufficient
additional shares of common stock to maintain the warrant holder's percentage
ownership of the Company's common stock at 15%. This right, subject to certain
conditions and limitations, expires in April 2000.
COMMON STOCK RESERVED
The Company has reserved 6,461,846 shares of common stock for the exercise
of options, warrants and other contingent issuances of common stock.
50
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
16. RESEARCH AGREEMENTS
In November 1997, StemCells California, Inc., a wholly owned subsidiary of
the Company, signed a Research Funding and Option Agreement with The Scripps
Research Institute ("Scripps") relating to certain stem cell research. Under the
terms of the Agreement, StemCells agreed to fund research in the total amount of
approximately $931,000 at Scripps over a period of three years. StemCells paid
Scripps approximately $77,000 in 1997, $307,000 in 1998, and $309,000 in 1999.
In addition, the Company agreed to issue to Scripps 4,837 shares of the
Company's common stock and a stock option to purchase 9,674 shares of the
Company's Common Stock with an exercise price of $.01 per share upon the
achievement of specified milestones. Under the Agreement, StemCells has an
option for an exclusive license to the inventions resulting from the sponsored
research, subject to the payment of royalties and certain other amounts, and is
obligated to make payments totaling $425,000 for achievement of certain
milestones.
In April 1997, the Company entered into an agreement with
Neurospheres, Ltd., which superseded all previous licensing agreements and
settled a dispute with Neurospheres. Under the terms of the settlement, the
Company has an exclusive royalty bearing license for growth-factor responsive
stem cells for transplantation. Neurospheres had an option to acquire
co-exclusive rights but did not exercise by the April 1998 deadline. The Company
retains exclusive rights for transplantation. The parties have no further
research obligations to each other, and the Company is under no obligation to
provide additional funding.
In February 1997, CytoTherapeutics and Cognetix, Inc. entered into a
Collaboration and Development Agreement related to the Company's former
encapsulated cell technology. As part of the agreement with Cognetix, the
Company purchased $250,000 of Cognetix preferred stock and, subject to certain
milestones, was obligated to purchase as much as $1,500,000 of additional
Cognetix stock over the next year. In July 1997, the Company loaned $250,000 to
Cognetix which was repaid with interest in October 1997. In October 1998, the
Company sold the $250,000 of preferred stock back to Cognetix for $298,914. The
Company is under no obligation to provide additional funding under the
agreement.
In 1996, the Company signed certain collaborative development and licensing
agreements with Genentech, Inc. Under the terms of one of those agreements,
Genentech purchased 829,171 shares of redeemable common stock for $8.3 million
to fund development of products to treat Parkinson's disease. Genentech had the
right, at its discretion, to terminate the Parkinson's program at specified
milestones in the program. The Agreement also provided that if the Parkinson's
program were terminated and the funds of the Company received from the sale of
stock to Genentech pursuant to the Parkinson's agreement exceeded the expenses
incurred by the Company in connection with such program by more than
$1 million, Genentech had the right to require the Company to repurchase from
Genentech shares of the Company's common stock having a value equal to the over
funding, based upon the share price paid by Genentech. As such, the common stock
purchased by Genentech has been classified as redeemable common stock until the
funds are expended on the program. On May 21, 1998, Genentech exercised its
right to terminate the collaboration and negotiations ensued with respect to the
amount of redeemable common stock to be redeemed in accordance with the
agreement and the method of such redemption. In March 2000 the Company announced
the settlement of this matter with Genentech and at that time the redeemable
common stock was reclassified to common stock. The Company is under no
obligation to provide additional funding to Genentech, Inc.
In March 1995, the Company signed a collaborative research and development
agreement with AstraZeneca for the development and marketing of certain
encapsulated-cell products to treat pain.
51
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
16. RESEARCH AGREEMENTS (CONTINUED)
AstraZeneca made an initial, nonrefundable payment of $5,000,000, included in
revenue from collaborative agreements in 1995, a milestone payment of $3,000,000
in 1997 and was to remit up to an additional $13,000,000 subject to achievement
of certain development milestones. Under the agreement, the Company was
obligated to conduct certain research and development pursuant to a four-year
research plan agreed upon by the parties. Over the term of the research plan,
the Company originally expected to receive annual payments of $5 million to
$7 million from AstraZeneca, which was to approximate the research and
development costs incurred by the Company under the plan. Subject to the
successful development of such products and obtaining necessary regulatory
approvals, AstraZeneca was obligated to conduct all clinical trials of products
arising from the collaboration and to seek approval for their sale and use.
AstraZeneca had the exclusive worldwide right to market products covered by the
agreement. Until the later of either the expiration of all patents included in
the licensed technology or a specified fixed term, the Company was entitled to a
royalty on the worldwide net sales of such products in return for the marketing
license granted to AstraZeneca and the Company's obligation to manufacture and
supply products. AstraZeneca had the right to terminate the original agreement
beginning April 1, 1998. On June 24, 1999, AstraZeneca informed the Company of
the results of AstraZeneca's analysis of the double-blind, placebo-controlled
trial of the Company's encapsulated bovine cell implant for the treatment of
severe, chronic pain in cancer patients. AstraZeneca determined that, based on
criteria it established, the results from the 85-patient trial did not meet the
minimum statistical significance for efficacy established as a basis for
continuing worldwide trials for the therapy. AstraZeneca therefore indicated
that it did not intend to further develop the bovine cell-containing implant
therapy and executed its right to terminate the agreement. The Company has no
additional funding obligations with AstraZeneca.
The Company has entered into other collaborative research agreements whereby
the Company funds specific research programs. Pursuant to such agreements, the
Company is typically granted rights to the related intellectual property or an
option to obtain such rights on terms to be agreed, in exchange for research
funding and specified royalties on any resulting product revenue. The Company's
principal academic collaborations had been with Brown University and
Dr. Aebischer and Centre Hospitalier Universitaire Vaudois in Switzerland.
However, with the termination of the Company's Encapsulated Cell Technology
program and its focusing on the stem cell field, its principal academic
collaborations are now with the Scripps Institute and the Oregon Health Science
University. Research and development expenses incurred under these
collaborations amounted to approximately $868,000, $1,259,000, and $1,326,000
for the years ended December 31, 1999, 1998 and 1997, respectively. The Company
has no other significant collaborative research funding obligations.
17. INCOME TAXES
Due to net losses incurred by the Company in each year since inception, no
provision for income taxes has been recorded. At December 31, 1999, the Company
had tax net operating loss carry forwards of $96,195,000 and research and
development tax credit carry forwards of $4,035,000 which expire at various
times through 2019. Due to the "change in ownership" provisions of the Tax
Reform Act of 1986, the Company's utilization of its net operating loss carry
forwards and tax credits may be subject to annual limitation in future periods.
52
STEMCELLS, INC.
(FORMERLY CYTOTHERAPEUTICS, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31, 1999
17. INCOME TAXES (CONTINUED)
Significant components of the Company's deferred tax assets and liabilities
are as follows:
DECEMBER 31,
---------------------------
1999 1998
------------ ------------
Deferred tax assets:
Capitalized research and development costs................ $ 4,331,000 $ 28,124,000
Net operating losses...................................... 38,478,000 10,786,000
Research and development credits.......................... 4,035,000 3,646,000
Other..................................................... 928,000 235,000
------------ ------------
47,772,000 42,791,000
Deferred tax liabilities:
Patents................................................... (246,000) (1,537,000)
------------ ------------
47,526,000 41,254,000
Valuation allowance....................................... (47,526,000) (41,254,000)
------------ ------------
Net deferred tax assets..................................... $ -- $ --
============ ============
Since there is uncertainty relating to the ultimate use of the loss carry
forwards and tax credits, a valuation allowance has been recognized at
December 31, 1999 and 1998, to fully offset the Company's deferred tax assets.
The valuation allowance increased $6,272,000 in 1999, due primarily to the
increases in net operating loss carry forwards and tax credits offset by
reduction in capitalized research and development costs .
18. EMPLOYEE RETIREMENT PLAN
The Company has a qualified defined contribution plan covering substantially
all employees. Participants are allowed to contribute a fixed percentage of
their annual compensation to the plan and the Company may match a percentage of
that contribution. The Company matches 50% of employee contributions, up to 6%
of employee compensation, with the Company's common stock. The related expense
was $103,000, $146,000, and $169,000 for the years ended December 31, 1999, 1998
and 1997, respectively.
19. CONTINGENCIES
The Company is routinely involved in arbitration, litigation and other
matters as part of the ordinary course of its business. While the resolution of
any matter may have an impact on the Company's financial results for a
particular reporting period, management believes the ultimate disposition of
these matters will not have a materially adverse effect on the Company's
consolidated financial position or results of operations.
20. SUBSEQUENT EVENTS
On April 13, 2000, the Company completed arrangements to sell 1,500 shares
of 6% cumulative convertible preferred stock plus a warrant for 75,000 shares of
the Company's common stock to a member of its Board of Directors for $1,500,000,
on terms more favorable than it was then able to obtain from outside investors.
(SEE NOTE 3--"SALE OF 6% CUMULATIVE CONVERTIBLE PREFERRED STOCK.")
53
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT, PROMOTERS AND
CONTROL
DIRECTORS AND EXECUTIVE OFFICERS
The sections entitled "Election of Directors" and "Executive Officer" in the
Company's definitive proxy statement for its 2000 Annual Meeting of Shareholders
are hereby incorporated by reference.
ITEM 11. EXECUTIVE COMPENSATION
The section entitled "Executive Compensation" in the Company's definitive
proxy statement for its 2000 Annual Meeting of Shareholders is hereby
incorporated by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The section entitled "Share Ownership" in the Company's definitive proxy
statement for its 2000 Annual Meeting of Shareholders is hereby incorporated by
reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The section entitled "Certain Relationships and Related Transactions" in the
Company's definitive proxy statement for its 2000 Annual Meeting of Shareholders
is hereby incorporated by reference.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Documents filed as part of this Form 10-K.
(1) Financial Statement Schedules:
Schedules not included herein are omitted because they are not applicable or
the required information appears in the Financial Statements or Notes thereto.
(2) Exhibits.
EXHIBIT NO. TITLE OR DESCRIPTION
----------- --------------------
3.1* Restated Certificate of Incorporation of the Registrant.
3.2++ Amended and Restated By-Laws of the Registrant.
4.1* Specimen Common Stock Certificate.
4.2++++ Form of Warrant Certificate issued to a certain purchaser of
the Registrant's Common Stock in April 1995.
10.4* Amendment to Registration Rights dated as of February 14,
1992 among the Registrant and certain of its stockholders.
10.15* Form of at-will Employment Agreement between the Registrant
and most of its employees.
10.20* Form of Agreement for Consulting Services between the
Registrant and members of its Scientific Advisory Board.
10.21* Form of Nondisclosure Agreement between the Registrant and
its Contractors.
54
EXHIBIT NO. TITLE OR DESCRIPTION
----------- --------------------
10.28* Master Lease and Warrant Agreement dated April 23, 1991
between the Registrant and PacifiCorp Credit, Inc.
10.29* 1988 Stock Option Plan.
10.30* 1992 Equity Incentive Plan.
10.31* 1992 Stock Option Plan for Non-Employee Directors.
10.32* 1992 Employee Stock Purchase Plan.
10.41**!!!! Development and Supply Agreement dated December 1993 between
Registrant and AKZO Faser AG.
10.43##** Research Agreement dated as of February 1, 1994 between
Genentech, Inc. and Registrant.
10.44##** Research Agreement dated as of March 16, 1994 between
NeuroSpheres, Ltd. and Registrant.
10.47++ Term Loan Agreement dated as of September 30, 1994 between
The First National Bank of Boston and Registrant.
10.48++ Lease Agreement between the Registrant and Rhode Island
Industrial Facilities Corporation, dated as of August 1,
1992.
10.49++ First Amendment to Lease Agreement between Registrant and
The Rhode Island Industrial Facilities Corporation dated as
of September 15, 1994.
10.50++ Supplementary Agreement dated as of July 1, 1994 between
Akzo Nobel Faser AG and the Registrant.
10.51**++++ Development, Marketing and License Agreement, dated as of
March 30, 1995 between Registrant and Astra AB.
10.52++++ Form of Unit Purchase Agreement to be executed by the
purchasers of the Common Stock and Warrants offered in April
1995.
10.53+++ Form of Common Stock Purchase Agreement to be executed among
the Registrant and certain purchasers of the Registrant's
Common Stock.
10.54!** Research and Commercialization Agreement dated as of
September 4, 1995 among the Company, Dr. Patrick Aebischer
and Canton of Vaud, Switzerland.
10.57!! Convertible loan agreement dated as of July 10, 1996 between
the Company and Modex Therapeutiques SA.
10.58### Lease Agreement dated as of November 21, 1997 by and between
Hub RI Properties Trust, as Landlord, and CytoTherapeutics,
Inc., as Tenant.
10.59!! Modex Therapeutiques SA stockholders voting agreement dated
as of July 10, 1996 among Modex, the Company, the Societe
Financiere Valoria SA and the other stockholders listed
therein.
10.60!! CTI individual stockholders option agreement dated as of
July 10, 1996 among the Company and the individuals listed
therein.
10.61!! CTI Valoria option agreement dated of July 10, 1996 between
the Company and the Societe Financiere Valoria SA.
10.64!!! Term Loan Agreement dated as of October 22, 1996 between The
First National Bank of Boston and the Registrant.
10.65*** Agreement and Plan of Merger dated as of August 13, 1997
among StemCells, Inc., the Registrant and CTI Acquisition
Corp.
10.67*** Consulting Agreement dated as of September 25, 1997 between
Dr. Irving Weissman and the Registrant.
10.68### Letter Agreement among each of Dr. Irving Weissman and Dr.
Fred H. Gage and the Registrant.
10.69** Amended and Restated Cross License Agreement dated as of
October 29, 1997 between Modex Therapeutiques SA and the
Registrant.
10.70### Letter Agreement dated as of September 30, 1997 between Dr.
Seth Rudnick and the Registrant.
10.71**** StemCells, Inc. 1996 Stock Option Plan.
55
EXHIBIT NO. TITLE OR DESCRIPTION
----------- --------------------
10.72**** 1997 StemCells Research Stock Option Plan (the "1997 Plan").
10.73**** Form of Performance-Based Incentive Option Agreement issued
under the 1997 Plan.
10.74### Employment Agreement dated as of September 25, 1997 between
Dr. Richard M. Rose and the Registrant.
10.75### Employment agreement dated as of April 17, 1997, between
John S. McBride and the Registrant.
10.78### Loan Agreement dated as of May 15, 1996 between Fleet
National Bank and the Registrant, together with the related
Promissory Note executed by the Registrant, and an
amendatory agreement dated as of May 15, 1997.
10.79[*] Rights Agreement, dated as of July 27, 1998 between Bank
Boston, N.A. as Rights Agent and the Registrant.*
10.80Section** Employment Agreement dated as of June 8, 1998 between Philip
K. Yachmetz and the Registrant.
10.81Section** Consulting Services Agreement dated as of July 27, 1998, as
amended December 19, 1998 between Dr. John J. Schwartz and
the Registrant.
10.82Section** Letter Agreement dated as of December 19, 1998 between
John J. Schwartz and the Registrant.
10.83Section** License Agreement dated as of October 27, 1998 between The
Scripps Research Institute and the Registrant.
10.84Section** License Agreement dated as of October 27, 1998 between The
Scripps Research Institute and the Registrant.
10.85Section** License Agreement dated as of November 20, 1998 between The
Scripps Research Institute and the Registrant.
10.87SectionSection** Purchase Agreement and License Agreement dated as of
December 29, 1999 between Neurotech S.A. and the Registrant.
10.88** License Agreement dated as of June 1999 between The Scripps
Research Institute and the Registrant.
10.89** License Agreement dated as of June 1999 between The Scripps
Research Institute and the Registrant.
10.90 Employment Agreement dated as of June 8, 1998, as amended
and restated as of June 8, 1999, between Philip K. Yachmetz
and the Registrant.
10.91 Letter Agreement dated as of July 1, 1999 between John J.
Schwartz and the Registrant.
10.92 Severance Agreement dated as of April 2, 1999 between John
McBride and the Registrant.
10.93 Severance Agreement dated as of August 30, 1999 between
Moses Goddard, M.D. and the Registrant.
10.95 Employment Agreement dated as of November 17, 1999 between
George W. Dunbar Jr. and the Registrant.
10.96 Agreement dated as of November 17, 1999 between iCEO, LLC
and the Registrant.
21 Subsidiaries of the Registrant.
23.1 Consent of Ernst & Young LLP, Independent Auditors.
27 Financial Data Schedule for fiscal year ended December 31,
1999.
99 Cautionary Factors Relevant to Forward-Looking Information.
56
- ------------------------
++ Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Registration Statement on Form S-1, File No. 33-85494.
+++ Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Registration Statement on Form S-3, File No. 33-97272.
++++ Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Registration Statement on Form S-1, File No. 33-91228.
* Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, Registration
Statement on Form S-1, File No. 33-45739.
# Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Annual Report on Form 10-K for fiscal year ended
December 31, 1992 and filed March 30, 1993.
** Confidential treatment requested as to certain portions. The
term "confidential treatment" and the mark "**" as used
throughout the indicated Exhibits mean that material has
been omitted and separately filed with the Commission.
## Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Quarterly Report on Form 10-Q for the quarter ended
March 31, 1994 and filed on May 14, 1994.
+ Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Annual Report on Form 10-K for the fiscal year ended
December 31, 1993 and filed on March 30, 1994.
! Previously filed with the Commission as an Exhibit to and
incorporated by reference to, the Registrant's Quarterly
Report on Form 10-Q for the quarter ended March 31, 1996.
!! Previously filed with the Commission as an Exhibit to and
incorporated by reference to, the Registrant's Quarterly
Report on Form 10-Q for the quarter ended September 30,
1996.
!!! Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
Annual Report on Form 10-K for the fiscal year ended
December 31, 1996 and filed on March 31, 1997.
!!!! Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
Annual Report on Form 10-K for the fiscal year ended
December 31, 1995.
*** Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Quarterly Report on Form 10-Q for the quarter ended
September 30, 1997 and filed on November 14, 1997.
**** Previously filed with the Commission as Exhibits to, and
incorporated herein by reference to, the Registrant's
Registration Statement on Form S-8, File No. 333-37313.
### Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
annual report on Form 10-K for the fiscal year ended
December 31, 1997 and filed on March 30, 1998.
[*] Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
current report on Form 8-K filed on August 3, 1998.
Section Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
annual report on Form 10-K for the fiscal year ended
December 31, 1998 and filed on March 31, 1999.
SectionSection Previously filed with the Commission as an Exhibit to, and
incorporated herein by reference to, the Registrant's
current report on Form 8K on January 14, 2000.
(b) Current Reports on Form 8-K.
None
57
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on
behalf by the undersigned, thereunto duly authorized.
STEMCELLS, INC.
BY: /S/ GEORGE W. DUNBAR, JR.
-----------------------------------------
George W. Dunbar, Jr.
ACTING PRESIDENT AND CHIEF EXECUTIVE
OFFICER
Dated: December 5, 2000
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
SIGNATURE CAPACITY DATE
--------- -------- ----
Acting President And Chief
/s/ GEORGE W. DUNBAR, JR. Executive Officer
------------------------------------------- (principal executive December 5, 2000
George W. Dunbar, Jr. officer)
Controller and Acting Chief
/s/ GEORGE KOSHY Financial Officer
------------------------------------------- (principal financial December 5, 2000
George Koshy officer and principal
accounting officer)
/s/ MARK J. LEVIN Director
------------------------------------------- December 5, 2000
Mark J. Levin
/s/ DONALD KENNEDY, PH.D. Director
------------------------------------------- December 5, 2000
Donald Kennedy, Ph.D.
/s/ JOHN J. SCHWARTZ, PH.D. Director, Chairman of the
------------------------------------------- Board December 5, 2000
John J. Schwartz, Ph.D.
/s/ IRVING L. WEISSMAN, M.D. Director
------------------------------------------- December 5, 2000
Irving L. Weissman, M.D.
58
Exhibit 10.88
LICENSE AGREEMENT
This License Agreement is entered into and made effective as of this
____day of June, 1999, by and between THE SCRIPPS RESEARCH INSTITUTE, a
California nonprofit public benefit corporation ("Scripps") located at 10550
North Torrey Pines Road, La Jolla, California 92037, and STEMCELLS, INC., a
California corporation ("Licensee") with offices at 701 George Washington
Highway, Lincoln, Rhode Island 02865, a wholly-owned subsidiary of
CytoTherapeutics, Inc. ("CTI"), with respect to the facts set forth below.
RECITALS
A. Scripps and Licensee have entered into a Research Funding and Option
Agreement effective as of November 14, 1997 (the "Research Agreement"), pursuant
to which Licensee agreed to fund certain research conducted in Dr. Nora
Sarvetnick's laboratory at Scripps (the "Research Program").
B. Scripps is engaged in fundamental scientific biomedical and biochemical
research, including research relating to pancreatic stem and progenitor cells,
as more particularly described herein.
C. Licensee is engaged in research and development of stem and progenitor
cells for the diagnosis, treatment and prophylaxis of diseases and other
conditions in humans and animals.
D. Scripps has disclosed to Licensee certain technology described in that
certain invention disclosure, a copy of which is attached hereto as Exhibit A
and incorporated herein by reference (the "Invention(s)")
E. Scripps has the exclusive right to grant a license to the technology
described in Exhibit A, subject to certain rights of the U.S. Government to use
such technology for its own purposes, resulting from the receipt by Scripps of
certain funding from the U. S. Government.
F. Scripps desires to grant to Licensee, and Licensee wishes to acquire,
an exclusive worldwide right and license to the technology described in the
Exhibit A and to certain patent rights and know-how of Scripps with respect
thereto, subject to the terms and conditions set forth herein, with a view to
developing and marketing products within the Field (as defined below).
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and conditions
set forth herein, Scripps and Licensee hereby agree as follows:
1. Definitions. Capitalized terms shall have the meaning set forth below.
1
1.1 Affiliate. The term "Affiliate" shall mean any entity which directly
or indirectly controls, is controlled by or is under common control with
Licensee. The term "control" as used herein means the possession of the power to
direct or cause direction of the management and the policies of an entity,
whether through the ownership of a majority of the outstanding voting securities
or by contract or otherwise.
1.2 Confidential Information. The term "Confidential Information" shall
mean any and all proprietary or confidential information of Scripps or Licensee
which may be exchanged between the parties at any time and from time to time
during the term of this Agreement. Information shall not be considered
confidential to the extent that it:
(a) Is publicly disclosed through no fault of any party hereto,
either before or after it becomes known to the receiving party; or
(b) Was known to the receiving party prior to the date of this
Agreement, which knowledge was acquired independently and not from another
party hereto (or such party's employees); or
(c) Is subsequently disclosed to the receiving party in good faith
by a third party who has a right to make such disclosure; or
(d) Has been published by a third party as a matter of right.
1.3 Field. The term "Field" shall mean all medical applications of the
Scripps Patent Rights and Scripps Technology in humans and animals.
1.4 Licensed Product. The term "Licensed Product" shall mean a product,
the manufacture, sale or use of which would but for the license granted herein,
infringe a Valid Claim in the country for which such product is sold. Without
limiting the foregoing, Licensed Product shall also include a product the
manufacture, sale or use of a particular product would but for the license
granted herein infringe a Valid Claim in the United States and at least two (2)
Major Countries, in such case irrespective of where such product is made, sold
or used and irrespective of whether such product is covered by a Valid Claim in
the country where sold.
1.5 Major Countries. The term "Major Countries" shall mean France,
Germany, Italy and the United Kingdom.
1.6 Net Sales. The term "Net Sales" shall mean the total amount invoiced
to third parties on sales of Licensed Products by Licensee, its Affiliates, or
Sublicensees, for which royalties are due under Article 3 below, less the
following reasonable and customary deductions to the extent applicable to such
invoiced amounts: (i) all trade, cash and quantity credits, discounts, refunds
or government rebates; (ii) amounts for claims, allowances or credits for
returns, retroactive price reductions, or chargebacks; (iii) packaging, handling
fees and prepaid freight, sales taxes, duties and other governmental charges
(including value added tax); and (iv) provisions for uncollectible accounts
determined in accordance with reasonable accounting practices, consistently
applied to all
2
products of the selling party; provided, however, that in the case of
Patient-Specific Licensed Products, "Net Sales" shall equal thirty percent (30%)
of the foregoing amounts (after the deductions described in (i) through (iv)
above). For purposes of the foregoing, it is understood that Net Sales shall
include only the amount invoiced for materials consisting of Licensed Products
(less the foregoing deductions and adjustments) and shall not include charges
related to services (other than cell separation and expansion) performed in
connection with the sale of such Licensed Products; accordingly, Net Sales shall
not include, without limitation, charges for apheresis, reinfusion, surgical
procedures, hospital stays or the like. For the removal of doubt, Net Sales
shall not include sales by Licensee to its Affiliates for resale, provided that
if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall
include the amounts invoiced by such Affiliate to third parties on the resale of
such Licensed Product. In the event that Licensee grants a sublicense hereunder,
and receives payments based upon the Sublicensee's sales of Licensed Products,
Licensee may upon approval by Scripps, which approval shall not be unreasonably
withheld, substitute the definition of "Net Sales," used by the Sublicensee to
calculate payments to Licensee in place of the foregoing definition of "Net
Sales" for purposes of calculating royalties payable to Scripps on such
Sublicensee's sales.
1.7 Patient-Specific Licensed Product. The term "Patient-Specific Licensed
Product shall mean a Licensed Product that includes either (i) autologous cells
from the patient; or (ii) nonautologous cells that otherwise are not intended
for use in all patients (such as Licensed Products that are fetal cells
expressing an HLA-type compatible with the particular patient but not optimally
compatible with patients who have a different HLA type).
1.8 Scripps Patent Rights. The term "Scripps Patent Rights" shall mean all
rights resulting from:
(a) all worldwide patent and patent applications claiming the
Scripps Technology described in Exhibit A hereto (the "Existing Patents");
and
(b) all divisions, continuations, continuations-in-part, patents of
addition, and substitutions of the Existing Patents, together with all
registrations, reissues, reexaminations or extensions of any kind with
respect to any of the foregoing patents to the extent the same claim
Scripps Technology.
From time to time during the term of this Agreement the parties agree to
record and update on Exhibit B all patents and patent applications within the
Scripps Patent Rights
In the event that Scripps and Licensee are joint owners of an invention by
reason of the fact that personnel of both Scripps and Licensee are joint
inventors of such invention, it is understood that the Scripps Patent Rights
include only Scripps' rights as a joint owner of the patent applications and
patents that claim such joint invention.
1.9 Scripps Technology. The term "Scripps Technology" shall mean so much
of the technology as is proprietary to Scripps that was developed in performance
of the Research Program and in the disclosure provided to Licensee pursuant to
Section 3.2 or 3.3 of the Research
3
Agreement, a copy of which is attached as Exhibit A hereto and incorporated
herein by reference, together with materials, information and know-how related
thereto from the Research Program as described Exhibit A whether or not the same
is eligible for protection under the patent laws of the United States or
elsewhere, and whether or not any such processes and technology, or information
related thereto, would be enforceable as a trade secret or the copying of which
would be enjoined or restrained by a court as constituting unfair competition.
1.10 Sublicensee. The term "Sublicensee" shall mean any non-Affiliate
third party to whom Licensee has granted the right to manufacture and sell
Licensed Products, with respect to Licensed Products made and sold by such third
party.
1.11 Valid Claim. The term "Valid Claim" shall mean a claim of an issued
and unexpired patent or a claim of a pending patent application within the
Scripps Patent Rights which has not been held unpatentable, invalid or
unenforceable by a court or other government agency of competent jurisdiction
and has not been admitted to be invalid or unenforceable through reissue,
reexamination, disclaimer or otherwise; provided, however, that if the holding
of such court or agency is later reversed by a court or agency with overriding
authority, the claim shall be reinstated as a Valid Claim with respect to Net
Sales made after the date of such reversal. Notwithstanding the foregoing
provisions of this Section 1.11, if a claim of a pending patent application
within the Scripps Patent Rights has not issued as a claim of an issued patent
within the Scripps Patent Rights, within five (5) years after the filing date
from which such claim takes priority, such pending claim shall not be a Valid
Claim for purposes of this Agreement.
2. License Terms and Conditions.
2.1 Grant of License.
(a) Scripps hereby grants to Licensee an exclusive, worldwide license,
including the right to sublicense, to: make, use, sell, import, export or
otherwise distribute Licensed Products; practice any method, process or
procedure, and otherwise exploit the Scripps Patent Rights; and to have any of
the foregoing performed on its behalf by a third party, in each case solely
within the Field, subject to the terms of this Agreement.
(b) Scripps hereby grants to Licensee a non-exclusive, worldwide license,
including the right to sublicense to and under the Scripps Technology for the
purpose of exercising its rights and licenses under the Scripps Patent Rights.
2.2 Royalties. In consideration for the exclusive license granted pursuant
to Section 2.1 hereof, Licensee shall pay to Scripps a continuing royalty the
following percentages of Net Sales of each Licensed Product by Licensee, its
Affiliates and Sublicensees: (i) two percent (2%) of Net Sales in Patent
Countries and (ii) one percent (1%) in Non-Patent Countries. For purposes of
calculating royalties due hereunder, a "Patent Country" shall mean, with respect
to a particular Licensed Product, a country in which at the time of the sale of
such Licensed Product in such country, the manufacture, use or sale of such
Licensed Product would infringe a Valid Claim in
4
such country; and a "Non-Patent Country" shall mean, with respect to such
Licensed Product, a country which a the time of sale of such Licensed Product in
such country is not a Patent Country.
2.3 Milestone Payments. As additional consideration for the exclusive
license granted pursuant to Section 2.1 hereof, Licensee agrees to pay to
Scripps upon the first occurrence of each milestone specified below for the
first Licensed Product to meet such milestone:
MILESTONES PAYMENT
---------- -------
1. First initiation of Phase II Trials for the first $50,000
Licensed Product.
2. First initiation of Phase III Trials for the first $125,000
Licensed Product.
3. First receipt of government approval to $250,000
market and distribute the first Licensed
Product in the United States or the first Major
Country.
For purposes of the foregoing milestones, "Phase II Trials" shall mean that
portion of the clinical studies for the FDA submission and approval process
which provides for the initial trials of a Licensed Product for the purposes of
determining the efficacious therapeutic dose range and evaluating safety in the
proposed therapeutic indication as more fully defined in 21 C.F.R. ss.
312.21(b), or a similar clinical study in a country other than the United
States; and "Phase III Trials" shall mean that portion of the clinical studies
for the FDA submission and approval process which provides for trials of a
Licensed Product on sufficient numbers of patients to establish the safety and
efficacy of such Licensed Product to support regulatory approval in the proposed
application as more fully defined in 21 C.F.R. ss. 3122.21(c), or similar
clinical study in a country other than the United States.
2.4 Combination Products.
2.4.1 Definition of Combination Product. As used herein, the term
"Combination Product" shall mean a Licensed Product which cannot be
manufactured, used or sold without infringing Scripps Patent Rights licensed
hereunder in the country where sold which is sold with another product,
component or service for which no royalty would be due hereunder if sold
separately.
2.4.2 Royalty Payable on Combination Products. The royalty payable
on Combination Products shall be the royalty rate set forth in Section 2.2 above
based on a pro rata portion of Net Sales of Combination Products in accordance
with the following formula:
A
X= -
5
A + B, where
X = the pro rata portion of Net Sales attributable to Scripps
Patent Rights or other Scripps Technology licensed herein
(expressed as a percentage), and
A = the fair market value of the Licensed Product component,
and
B = the fair market value of all other components (product,
component or service) in the Combination Product.
The fair market values described above shall be determined by the parties hereto
in good faith. Notwithstanding the foregoing, in the event that there is no
separate fair market values of the Licensed Product and such other product(s),
component(s) and/or services(s), then the Net Sales shall be as reasonably
allocated by Licensee between such Licensed Product and such other product(s),
component(s) and/or service(s), based upon their relative importance and
proprietary position, subject to the consent of Scripps, which consent shall not
be unreasonably withheld.
2. 5 Multiple Royalties. If Licensee, its Affiliate or Sublicensee is
required to pay a non-Affiliate third party amounts with respect to a Licensed
Product under agreements for patent rights or other technologies which Licensee,
its Affiliate or Sublicensee, in its reasonable judgment, determines are
necessary or desirable to license or acquire with respect to such Licensed
Product, Licensee may deduct such amount owing to such non-Affiliate third
parties (prior to any reductions) from the royalty owing to Scripps for the sale
of such Licensed Product pursuant to Section 2.2 above. Notwithstanding the
foregoing provisions of this Section 2.5, in no event shall the royalties due to
Scripps pursuant to Section 2.2 above be so reduced to less than fifty percent
(50%) of the amount that would otherwise be due Scripps thereunder.
2.6 Quarterly Payments.
2.6.1 Sales by Licensee. With regard to Net Sales made by Licensee
or its Affiliates, royalties shall be payable by Licensee quarterly, within
sixty (60) days after the end of each calendar quarter, based upon the Net Sales
of Licensed Products during such preceding calendar quarter, commencing with the
calendar quarter in which the first commercial sale of any Licensed Product is
made.
2.6.2 Sales by Sublicensees. With regard to Net Sales made by
Sublicensees of Licensee or its Affiliates, royalties shall be payable by
Licensee quarterly, within ninety (90) days after the end of each calendar
quarter, based upon the Net Sales of Licensed Products by such Sublicensee
during such preceding calendar quarter, commencing with the calendar quarter in
which the first commercial sale of any Licensed Product is made by such
Sublicensee.
2. 7 Term of License. Unless terminated sooner in accordance with the
provisions of this Agreement, the term of this license shall expire when the
last of the royalty obligations set forth has expired (i.e., until expiration,
revocation or invalidation of the last patent or the abandonment of the
6
last application within the Scripps Patent Rights, whichever is later).
Notwithstanding the foregoing, if applicable government regulations require a
shorter term and/or a shorter term of exclusivity than provided for herein, then
the term of this License Agreement shall be so shortened or this License
Agreement shall be amended to provide for a non-exclusive license, and, in such
event, the parties shall negotiate in good faith to reduce appropriately the
royalties payable as set forth under the section heading "Royalties" hereof.
Notwithstanding anything herein to the contrary, Licensee's license under
Section 2.l(b) with respect to the Scripps Technology shall survive the
expiration, (but not an earlier termination, except as provided in Section 8.6
below) of this Agreement.
2.8 Sublicense. Licensee shall have the sole and exclusive right to grant
sublicenses to any party with respect to the rights conferred upon Licensee
under this Agreement, provided, however, that any such sublicense shall be
subject in all respects to the restrictions, exceptions, royalty obligations,
reports, termination provisions, and other provisions contained in this
Agreement. Without limiting the foregoing, Licensee agrees to provide Scripps a
copy of each such sublicense agreement within thirty (30) days of the execution
thereof. Licensee shall pay Scripps, or cause its Affiliate or Sublicensee to
pay Scripps, the same royalties on all Net Sales of such Affiliate or
Sublicensee the same as if said Net Sales had been made by Licensee. Each
Affiliate and Sublicensee shall report its Net Sales to Scripps through
Licensee, which Net Sales shall be aggregated with any Net Sales of Licensee for
purposes of determining the Net Sales upon which royalties are to be paid to
Scripps.
2.9 Reports. Licensee shall furnish to Scripps at the same time as each
royalty payment is made by Licensee, a detailed written report of Net Sales of
the Licensed Products and the royalty due and payable thereon, including a
description of any offsets or credits deducted therefrom, on a
product-by-product and country-by-country basis, for the calendar quarter upon
which the royalty payment is based.
2.10 Records. Licensee shall keep, and cause its Affiliates and
Sublicensees to keep, full, complete and proper records and accounts of all
sales of Licensed Products in sufficient detail to enable the royalties payable
on Net Sales of each Licensed Product to be determined. Scripps shall have the
right to appoint an independent certified public accounting firm approved by
Licensee, which approval shall not be unreasonably withheld, to audit the
records of Licensee, its Affiliates and Sublicensees as necessary to verify the
royalties payable pursuant to this Agreement. Licensee, its Affiliates and
Sublicensees shall pay to Scripps an amount equal to any additional royalties to
which Scripps is entitled as disclosed by the audit, plus interest thereon at
the rate of one and one-half percent (1.5%) per month. Such audit shall be at
Scripps' expense; provided, however, that if the audit discloses that Scripps
was underpaid royalties with respect to the period covered by the audit by at
least five percent (5%), then Licensee, its Affiliates or Sublicensee, as the
case may be, shall reimburse Scripps for all reasonable out-of-pocket audit
costs. Scripps may exercise its right of audit as to each of Licensee, its
Affiliates or Sublicensees no more frequently than once in any calendar year.
The accounting firm shall disclose to Scripps only information relating to the
accuracy of the royalty payments. Licensee, its Affiliates and Sublicensees
shall preserve and maintain all such records required for audit for a period of
three (3) years after the calendar quarter to which the record applies.
7
2.11 Foreign Sales. The remittance of royalties payable on sales outside
the United States shall be payable to Scripps in United States Dollar
equivalents at the official rate of exchange of the currency of the country from
which the royalties are payable, as quoted in the Wall Street Journal for the
last business day of the calendar quarter in which the royalties are payable. If
the transfer of or the conversion into the United States Dollar equivalents of
any such remittance in any such instance is not lawful or possible, the payment
of such part of the royalties as is necessary shall be made by the deposit
thereof, in the currency of the county where the sale was made on which the
royalty was based to the credit and account of Scripps or its nominee in any
commercial bank or trust company of Scripps' choice located in that country,
prompt written notice of which shall be given by Licensee to Scripps and except
as set forth in Section 2.10 above, Licensee shall have no further obligation
with respect to such royalties.
2.12 Foreign Taxes. Any tax required to be withheld by Licensee under the
laws of any foreign country for the accounts of Scripps shall be promptly paid
by Licensee for and on behalf of Scripps to the appropriate governmental
authority, and Licensee shall use its best efforts to furnish Scripps with proof
of payment of such tax together with official or other appropriate evidence
issued by the applicable government authority. Any such tax actually paid on
Scripps' behalf shall be deducted from royalty payments due Scripps hereunder.
2.13 Single Payments. The parties hereto acknowledge that the parties may
enter into multiple license agreements with respect to technologies arising out
of the Research Agreement, including this Agreement (collectively, the "Scripps
License Agreements") pursuant to which Licensee will owe royalties and milestone
payments. Notwithstanding anything herein to the contrary, with respect to any
unit of Licensed Product only a single royalty shall be due to Scripps at the
highest applicable rate for such unit regardless if such Licensed Product is
covered by more than one Valid Claim or would be a Licensed Product under more
than one Scripps License Agreement. (For example, if a product sold by Licensee
is a Licensed Product under this Agreement for which Licensee owes Scripps a
royalty of 2% of Net Sales and Licensee would otherwise owe Scripps a royalty of
1% of Net Sales of such product under another Scripps License Agreement,
Licensee's royalty obligation to Scripps shall be fulfilled by paying Scripps 2%
of Net Sales with respect to sales of such License Product.) Likewise, with
respect to the milestone payments under Section 2.3 above, once such milestone
payment has been paid for a Licensed Product under any Scripps License Agreement
then Licensee's obligation to pay such milestone shall be deemed to be fulfilled
with respect to all Scripps License Agreement, regardless of whether the product
for which such a milestone payment was paid was a "Licensed Product" for
purposes of a particular Scripps License Agreement or not. (For example, if a
Licensee initiates Phase II Trials for a product, which product falls within the
definition of "Licensed Product" under this Agreement and pays Scripps the
corresponding $50,000 payment, Licensee shall have no further obligation to pay
any amounts to Scripps with respect to any other product under any Scripps
License Agreement upon the initiation of Phase II Trials for a Licensed Product
whether or not the product for which Licensee initially paid such milestone
payment is a Licensed Product for purposes of any other Scripps License
Agreement.)
3. Patent Matters.
8
3.1 Patent Prosecution and Maintenance. From and after the date of this
Agreement, the provisions of this Section 3 shall control the prosecution and
maintenance of any patent or patent application included within Scripps Patent
Rights. Subject to the requirements, limitations and conditions set forth in
this Agreement, Scripps shall direct and control (i) the preparation, filing and
prosecution of the United States and foreign patent applications within Scripps
Patent Rights (including any interferences and foreign oppositions) and (ii)
maintain the patents issuing therefrom. Scripps shall select the patent
attorney, subject to Licensee's written approval, which approval shall not be
unreasonably withheld. Both parties hereto agree that Scripps may, at its sole
discretion, utilize Scripps' Office of Patent Counsel in lieu of outside counsel
for patent prosecution and maintenance described herein, and the fees and
expenses incurred by Scripps with respect to work done by such Office of Patent
Counsel shall be paid as set forth below. Licensee shall have full rights of
consultation with the patent attorney so selected on all matters relating to
Scripps Patent Rights. Scripps shall use its best efforts to implement all
reasonable requests made by Licensee with regard to the preparation, filing,
prosecution and/or maintenance of the patent applications and/or patents within
Scripps Patent Rights.
3.2 Information to Licensee. Scripps agrees to use reasonable efforts to
(i) keep Licensee informed as to the filing, prosecution and maintenance of
patents and patent applications within the Scripps Patent Rights, (ii) furnish
to Licensee copies of documents relevant to any such filing, prosecution and
maintenance and (iii) allow Licensee reasonable opportunity to comment on
documents filed with any patent office which would affect the Scripps Patent
Rights or Licensee' rights hereunder.
3.3 Patent Costs. Licensee acknowledges and agrees that Scripps does not
have independent funding to cover patent costs, and that the license granted
hereunder is in part in consideration for Licensee's assumption of patent costs
and expenses as described herein. Licensee shall pay for all expenses incurred
by Scripps pursuant to Section 3.1 hereof. In addition, Licensee agrees to
reimburse Scripps for all patent costs and expenses paid or incurred by Scripps
to date inconnection with Scripps Patent Rights licensed hereunder. Licensee
agrees to pay all such past and future patent expenses directly or to reimburse
Scripps for the payment of such expenses within sixty (60) days after Licensee
receives an itemized invoice therefor. In the event Licensee elects to
discontinue payment for the filing, prosecution and/or maintenance of any patent
application and/or patent within Scripps Patent Rights, any such patent
application or patent shall be excluded from the definition of Scripps Patent
Rights and from the scope of the license granted under this Agreement, and all
rights relating thereto shall revert to Scripps and may be freely licensed by
Scripps. Licensee shall give Scripps at least sixty (60) days' prior written
notice of such election. No such notice shall have any effect on Licensee's
obligations to pay expenses incurred up to the effective date of such election.
3.4 Ownership. Subject to any joint or mutual ownership of Licensee by
virtue of joint inventorship of inventions covered therein, the patent
applications filed and patent applications obtained by Scripps pursuant to
Section 3.1 hereof shall be owned solely by Scripps, assigned to Scripps and
deemed a part of Scripps Patent Rights.
9
3.5 Scripps Right to Pursue Patent. If at any time during the term of this
Agreement, Licensee's rights with respect to Scripps Patent Rights are
terminated, Scripps shall have the right to take whatever action Scripps deems
appropriate to obtain or maintain the corresponding patent protection at its own
expense. If Scripps pursues patents under this Section 3.5, Licensee agrees to
cooperate fully, including by providing, at no charge to Scripps, all
appropriate technical data and executing all necessary legal documents.
3.6 Prosecution by Licensee. If Scripps elects not to file, prosecute or
maintain any patent application or patent within the Scripps Patent Rights or
pay any fee related thereto, in any country Scripps shall promptly notify
Licensee of such election, but in no case later than sixty (60) prior to any
required action relating to the filing, prosecution or maintenance of such
patent application or patent. In such event, if Licensee elects to take over the
filing, prosecution and/or maintenance of one or more patents or patent
applications within the Scripps Patent Rights, Licensee shall have the right, at
its option, to control the filing, prosecution and/or maintenance of any such
patent applications or patents within the Scripps Patent Rights at its own
expense. In which case Licensee shall keep Scripps reasonably informed on
matters regarding such filing, prosecution and maintenance.
3.7 Infringement.
3 .7.1 Enforcement. If either party determines that a third party is
making, using or selling a product that may infringe the Scripps Patent Rights,
that party shall notify the other party in writing.
(a) Licensee shall have the first right (itself or through others),
at its sole option, to bring suit to enforce the Scripps Patent Rights, and/or
to defend any declaratory judgment action with respect thereto, in each case
with respect to the manufacture, sale or use of a product within the Field;
provided, however, that Licensee shall keep Scripps reasonably informed as to
the defense and/or settlement of such action. Scripps shall have the right to
participate in any such action with counsel of its own choice at its own
expense.
(b) In the event Licensee elects not to initiate an action to
enforce the Scripps Patent Rights against a commercially significant
infringement by a third party within the Field, within one (1) year of a request
by Scripps to do so, (or within such shorter period which may be required to
preserve the legal rights of Scripps under the laws of the relevant government),
Scripps may initiate such action at its expense with Licensee's prior written
consent, which consent shall not be unreasonably withheld. Licensee shall have
the right to participate in any such action with counsel of its own choice at
its own expense.
(c) All recoveries received by a party from an action to enforce the
Scripps Patent Rights shall be first applied to reimburse the controlling
party's and then the non-controlling party's unreimbursed expenses, including
without limitation, reasonable attorney's fees and court costs. Any remainder
shall, to the extent the same pertains to an infringement of the Scripps Patent
Rights, be divided seventy percent (70%) to Licensee and thirty percent (30%) to
Scripps.
10
3.7.2 Defense. If Licensee, its Affiliate, Sublicensee, distributor
or other customer is sued by a third party charging infringement of patent
rights that dominate a claim of the Scripps Patent Rights or that cover other
Related Material with respect to the manufacture, use, distribution or sale of a
Licensed Product, Licensee will promptly notify Scripps. As between the parties
to this Agreement, Licensee will be entitled to control the defense in any such
action(s) and withhold one-half (1/2) of the royalties related to such Licensed
Product otherwise payable to Scripps and use the withheld royalties to reimburse
the legal defense costs, attorneys' fees and liability incurred in such
infringement suit(s). Notwithstanding the foregoing, Licensee agrees to withhold
only that portion of such royalties as may reasonably be necessary to reimburse
amounts in accordance with this Section 3.7.2. If Licensee is required to pay a
royalty to a third party to make and/or sell a Licensed Product as a result of a
final judgment or settlement, such amounts may be deducted from the running
royalties payable to Scripps hereunder in relation to such Licensed Product;
provided that such royalties shall not be so reduced by more than fifty percent
(50%). Subject to the provisions of Section 4.3 below, Licensee agrees to
indemnify and hold Scripps harmless from any costs, expenses or liability
arising out of all such infringements or charges of infringement.
3.7.3 Cooperation. In any suit, action or other proceeding in
connection with enforcement and/or defense of the Scripps Patent Rights, each
party hereto agrees to cooperate fully, including without limitation by joining
as a party plaintiff and executing such documents as the other party may
reasonably request. Without limiting the foregoing, upon the request of and, at
the expense of a party controlling any suit, action or other proceeding pursuant
to this Article 3, the other party shall make available at reasonable times and
under appropriate conditions all relevant personnel, records, papers,
information, samples, specimens and other similar materials in such other
party's possession.
3.7.4 No Implied Obligations. Except as expressly provided in this
Section 3.7, neither party has any obligation to bring or prosecute actions or
suits against any third party for patent infringement.
4. Obligations Related to Commercialization.
4.1 Commercial Development Obligation. In order to maintain the license
granted hereunder in force, Licensee shall use reasonable efforts and due
diligence to develop Scripps Technology and Scripps Patent Rights which are
licensed hereunder into commercially viable Licensed Products, as promptly as is
reasonably and commercially feasible, and thereafter to produce and sell
reasonable quantities of Licensed Products. Licensee shall keep Scripps
generally informed as to Licensee's progress in such development, production and
sale, including its efforts, if any, to sublicense Scripps Technology and
Scripps Patent Rights, and Licensee shall deliver to Scripps an annual written
report and such other reports as Scripps may reasonably request. The parties
hereto acknowledge and agree that achievement of mutually agreeable milestones
shall be evidence of compliance by Licensee with its commercial development
obligations hereunder. Notwithstanding the foregoing, if Licensee believes that
it cannot, within the exercise of prudent and reasonable business judgment,
perform any mutually agreed upon milestones within the time period required
therefor, Licensee may request an extension of time for the performance date to
a date that Licensee believes to be reasonable and prudent and Scripps shall
agree to any requested
11
extension which is not more than one (l) year in length from the originally
required date and will not unreasonably withhold consent to requests for longer
extensions. In the event Scripps has a reasonable basis to believe that Licensee
is not using reasonable efforts and due diligence as required hereunder, upon
notice by Scripps to Licensee which specifies the basis for such belief, Scripps
and Licensee shall negotiate in good faith to attempt to mutually resolve the
issue. In the event Scripps and Licensee cannot agree upon any matter related to
Licensee's commercial development obligations, the parties agree to utilize
arbitration pursuant to Section 10.2 hereof in order to resolve the matter. If
the arbitrator determines that Licensee has not complied with its obligations
hereunder, and such default is not cured within sixty (60) days after the
arbitrator's decision, Scripps may terminate Licensee's rights under this
Agreement.
4.2 Governmental Approvals and Marketing of Licensed Products. Licensee
shall be responsible for obtaining all necessary governmental approvals for the
development, production, distribution, sale and use of any Licensed Product, at
Licensee's expense, including, without limitation, any safety studies. Licensee
shall have sole responsibility for any warning labels, packaging and
instructions as to the use of Licensed Products and for the quality control for
any Licensed Product.
4.3 Indemnity. Licensee hereby agrees to indemnify, defend and hold
harmless Scripps and any parent, subsidiary or other affiliated entity and their
trustees, officers, employees, scientists and agents from and against any
liability or expense arising from any product liability claim asserted by any
party as to any Licensed Product or any claims arising from the use of any
Scripps Patent Rights or Scripps Technology pursuant to this Agreement. Such
indemnity and defense obligation shall apply to any product liability or other
claims, including without limitation, personal injury, death or property damage,
made by employees, subcontractors, sublicensees, or agents of Licensee, as well
as any member of the general public. Notwithstanding the foregoing, Licensee's
obligation to provide indemnification under this Section 4.3 shall be subject to
each party seeking indemnification hereunder (i) promptly notify Licensee in
writing of any claim, suit or proceeding with respect to which the party intends
to claim such indemnification, (ii) give Licensee sole control of the defense
and/or settlement thereof, and (iii) provide Licensee, at Licensee's expense,
with reasonable assistance and full information with respect to such claim, suit
or proceeding. Licensee shall not settle any claim, suit or proceeding subject
to this Section 4.3 or otherwise consent to an adverse judgment in such claim,
suit or proceeding if the same materially diminishes the rights or interests of
the indemnified party without the express written consent of such party.
Licensee shall have no obligation for any claim, suit or proceeding if the party
seeking indemnification makes any settlement regarding such claim, suit or
proceeding without the prior written consent of Licensee, which consent shall
not be unreasonably withheld. Licensee shall use its best efforts to have
Scripps and any parent, subsidiary or other affiliated entity and their
trustees, officers, employees, scientists and agents named as additional insured
parties on any product liability insurance policies maintained by Licensee, its
Affiliates and sublicensees applicable to Licensed Products.
4.4 Patent Marking. To the extent required by applicable law, Licensee
shall mark all Licensed Products or their containers in accordance with the
applicable patent marking laws.
12
4.5 No Use of Name. Except as required by law, the use of the name "The
Scripps Research Institute", " Scripps", or any variation thereof in connection
with the advertising or sale of Licensed Products is expressly prohibited.
4.6 U.S. Manufacture. To the extent required by applicable United States
laws, if at all, Licensee agrees that Licensed Products will be manufactured in
the United States, or its territories, subject to such waivers as may be
required, or obtained, if at all, from the United States Department of Health
and Human Services, or its designee.
4.7 Foreign Registration. Licensee agrees to register this Agreement with
any foreign governmental agency which requires such registration, and Licensee
shall pay all costs and legal fees in connection therewith. In addition,
Licensee shall assure that all foreign laws affecting this Agreement or the sale
of Licensed Products are fully satisfied.
5. Limited Warranty. Scripps hereby represents and warrants that subject to the
rights of the United States Government (i) it has sole right and power to enter
into this Agreement and grant the rights and licenses granted herein; (ii)
Scripps is and shall be the owner of the entire right, title, and interest in
and to the Scripps Patent Rights; (iii) Scripps has not previously granted and
will not grant any rights in the Scripps Patent Rights that are inconsistent
with the rights and licenses granted to Licensee herein; and (iv) to the best of
its knowledge, there are no claims of third parties that would call into
question the rights of Scripps to grant to Licensee the rights contemplated
hereunder. EXCEPT AS PROVIDED IN THIS SECTION 5, NEITHER PARTY MAKES ANY
WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT
TO THE SUBJECT MATTER HEREOF. SPECIFICALLY, SCRIPPS MAKES NO OTHER WARRANTIES
CONCERNING SCRIPPS PATENT RIGHTS OR SCRIPPS TECHNOLOGY COVERED BY THIS
AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO SCRIPPS PATENT RIGHTS,
SCRIPPS TECHNOLOGY OR ANY LICENSED PRODUCT. SCRIPPS MAKES NO WARRANTY OR
REPRESENTATION AS TO THE VALIDITY OR SCOPE OF SCRIPPS PATENT RIGHTS, OR THAT ANY
LICENSED PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN
ANY WAY INFRINGING SCRIPPS PATENT RIGHTS OR SCRIPPS TECHNOLOGY COVERED BY THIS
AGREEMENT.
6. Interests in Intellectual Property Rights.
6.1 Preservation of Title. Scripps shall retain full ownership and title
to Scripps Technology, and Scripps Patent Rights licensed hereunder and shall
use its reasonable best efforts to preserve and maintain such full ownership and
title, subject to Licensee fully performing all of its obligations under this
Agreement.
6.2 Royalty-free License to Improvements. Licensee hereby grants to
Scripps a non-exclusive, royalty-free license to any improvement to Scripps
Technology developed by Licensee
13
during the term of this Agreement, to use for Scripps own non-commercial
research purposes or grant to other nonprofit institutions for their
non-commercial research purposes.
6.3 Governmental Interest. Licensee and Scripps acknowledge that Scripps
has received, and expects to continue to receive, funding from the United States
Government in support of Scripps' research activities. Licensee and Scripps
acknowledge and agree that their respective rights and obligations pursuant to
this Agreement shall be subject to Scripps' obligations and the rights of the
United States Government, if any, which arise or result from Scripps' receipt of
research support from the United States Government, including without
limitation, the grant by Scripps to the United States a non-exclusive,
irrevocable, royalty-free license to Scripps Technology and Scripps Patent
Rights licensed hereunder for governmental purposes.
6.4 Reservation of Rights. Scripps reserves the right to use for any
non-commercial research purposes and the right to allow other nonprofit
institutions to use for any non-commercial research purposes any Scripps
Technology and Scripps Patent Rights licensed hereunder, without Scripps or such
other institutions being obligated to pay Licensee any royalties or other
compensation.
7. Confidentiality and Publication.
7.1 Treatment of Confidential Information. The parties agree that during
the term of this Agreement and for ten ( 10) years thereafter, a party receiving
Confidential Information of the other party will (i) maintain in confidence such
Confidential Information to the same extent such party maintains its own
proprietary industrial information, (ii) not disclose such Confidential
Information to any third party without prior written consent of the other party
and (iii) not use such Confidential Information for any purpose except those
permitted by this Agreement.
7.2 Permitted Usage. Notwithstanding the provisions of Section 7.1 above,
the receiving party may use or disclose Confidential Information of the
disclosing party to the extent necessary to exercise its rights hereunder
(including commercialization and/or sublicensing of Scripps Patent Rights and
Scripps Technology) or fulfill its obligations and/or duties hereunder and in
filing for, prosecuting or maintaining any proprietary rights, prosecuting or
defending litigation, complying with applicable governmental regulations and/or
submitting information to tax or other governmental authorities; provided that
if the receiving party is required by law to make any public disclosures of
Confidential Information of the disclosing party, to the extent it may legally
do so, it will give reasonable advance notice to the disclosing party of such
disclosure and will use its reasonable efforts to secure confidential treatment
of Confidential Information prior to its disclosure (whether through protective
orders or otherwise).
7.3 Publications. Licensee agrees that Scripps shall have a right to
publish in accordance with its general policies and subject to Section 6.2 of
the Research Agreement.
7.4 Publicity. Except as otherwise provided herein or required by law, no
party shall originate any publication, news release or other public
announcement, written or oral, whether in the public press, stockholders'
reports, or otherwise, relating to this Agreement or to any sublicense
14
hereunder, or to the performance hereunder or any such agreements, without the
prior written approval of the other party, which approval shall not be
unreasonably withheld. Scientific publications published in accordance with
Section 7.3 of this Agreement shall not be construed as publicity governed by
this Section 7.4.
8. Term and Termination.
8.1 Term. Unless terminated sooner in accordance with the terms set forth
herein, this Agreement, and the license granted hereunder, shall terminate as
provided in Section 2.7 hereof.
8.2 Termination Upon Default. Any one or more of the following events
shall constitute an event of default hereunder: (i) the failure of a party to
pay any amounts when due hereunder and the expiration of thirty (30) days after
receipt of a written notice requesting the payment of such amount; (ii) the
failure of a party to perform any material obligation required of its to be
performed hereunder, and the failure to cure within sixty (60) days after
receipt of notice from the other party specifying in reasonable detail the
nature of such default. Upon the occurrence of any event of default, the
non-defaulting party may deliver to the defaulting party written notice of
intent to terminate, such termination to be effective upon the date set forth in
such notice.
Such termination rights shall be in addition to and not in substitution
for any other remedies that may be available to the non-defaulting party.
Termination pursuant to this Section 8.2 shall not relieve the defaulting party
from liability and damages to the other party for breach of this Agreement.
Waiver by either party of a single default or a succession of defaults shall not
deprive such party of any right to terminate this Agreement arising by reason of
any subsequent default.
Notwithstanding the foregoing provisions of this Section 8.2, if the party
alleged to be in default of this Agreement disputes in good faith such default
within the applicable cure period, the other party's right to terminate shall be
stayed until it has been determined in accordance with Section 10.2 below of
this Agreement that the party alleged to be in default was actually in default
and such defaulting party fails to comply with its obligations hereunder within
the applicable cure period.
8.3 Termination Upon Bankruptcy or Insolvency. This Agreement may be
terminated by Scripps giving written notice of termination to Licensee upon the
filing of bankruptcy or bankruptcy of Licensee or the appointment of a receiver
of any of Licensee's assets, or the making by Licensee of any assignment for the
benefit of creditors, or the institution of any proceedings against Licensee
under any bankruptcy law which proceeding is not dismissed with prejudice within
ninety (90) days from its initiation. Termination shall be effective upon the
date specified in such notice.
8.4 Termination by Licensee. Any provision herein notwithstanding,
Licensee may terminate this Agreement, in its entirety or as to any particular
patent or patent application within the Scripps Patent Rights, or as to any
particular Licensed Product, at any time by giving Scripps at least ninety (90)
days prior written notice. From and after the effective date of a termination
under this Section 8.4 with respect to a particular patent or application, such
patent(s) and patent
15
application(s) in the particular country shall cease to be within the Scripps
Patent Rights for all purposes of this Agreement, and all rights and obligations
of Licensee with respect to such patent(s) and patent application(s) shall
terminate. From and after the effective date of a termination under this Section
8.3 with respect to a particular Licensed Product, the license granted under
Section 2.1 above shall terminate with respect to such Licensed Product, and the
same shall cease to be a Licensed Product for all purposes of this Agreement.
Upon a termination of this Agreement in its entirety under this Section 8.4, all
rights and obligations of the parties shall terminate, except as provided in
Section 8.5 below.
8.5 Rights Upon Expiration. Neither party shall have any further rights or
obligations upon the expiration of this Agreement upon its regularly scheduled
expiration date with respect to this Agreement, other than the obligation of
Licensee to make any and all reports and payments for the final quarter period.
Provided, however, that upon such expiration, each party shall be required to
continue to abide by its non-use and non-disclosure obligations as described in
Section 7.1, and Licensee shall continue to maintain records under Section 2.10
and abide by its obligation to indemnify Scripps as described in Section 4.3 and
by its obligations under Section 6.2 hereof.
8.6 Rights Upon Termination.
8.6.1 Accrued Obligations. Termination of this Agreement for any
reason shall not release either party hereto from any liability which at the
time of such termination has already accrued to the other party.
8.6.2 Inventory. In the event this Agreement is terminated for any
reason, Licensee shall provide Scripps with a written inventory of all Licensed
Products that Licensee and its Affiliates have in process of manufacture, in use
or in stock and Licensee and its Affiliates shall have the right to sell or
otherwise dispose of such Licensed Products for a period not to exceed six (6)
months from the effective date of such termination, all subject to the payment
to Scripps royalties and provision of reports pursuant to this Agreement.
8.6.3 Sublicenses. Upon termination of this Agreement by Scripps for
any reason, any sublicense granted by Licensee hereunder shall survive, provided
that upon request by Scripps, such Sublicensee promptly agrees in writing to be
bound by the applicable terms of this Agreement.
8.6.4 Survival. Sections 2.10, 4.3, 6.2, 7.1 and 10 shall survive
any termination of this Agreement. Except as otherwise provided in this Section
8, all rights and obligations of the parties under this Agreement shall
terminate upon termination of this Agreement.
9. Assignment; Successors.
9.1 Assignment. Neither this Agreement nor any rights granted hereunder
may be assigned or transferred by Licensee except (i) to an Affiliate of
Licensee or (ii) to a successor in interest to all or substantially all of the
business assets of Licensee, whether by way of a merger, consolidation, sale of
all or substantially all of Licensee's assets, change of control or similar
transaction, without the prior written consent of Scripps.
16
9.2 Binding Upon Successors and Assigns. Subject to the limitations on
assignment herein, this Agreement shall be binding upon and inure to the benefit
of any successors in interest and assigns of Scripps and Licensee. Any such
successor or assignee of Licensee's interest shall expressly assume in writing
the performance of all the terms and conditions of this Agreement to be
performed by Licensee.
10. General Provisions.
10.1 Independent Contractors. The relationship between Scripps and
Licensee is that of independent contractors. Scripps and Licensee are not joint
venturers, partners, principal and agent, master and servant, employer or
employee, and have no other relationship other than independent contracting
parties. Scripps and Licensee shall have no power to bind or obligate each other
in any manner, other than as is expressly set forth in this Agreement.
10.2 Arbitration. Any controversy or claim arising out of or relating to
this Agreement, or the breach thereof, shall be settled by binding arbitration
in accordance with the Commercial Arbitration Rules of the American Arbitration
Association ("AAA"), and the procedures set forth below. In the event of any
inconsistency between the Rules of AAA and the procedures set forth below, the
procedures set forth below shall control. Judgment upon the award rendered by
the arbitrators may be enforced in any court having jurisdiction thereof.
10.2.1 Location. The location of the arbitration shall be in the
County of San Diego in the State of California.
10.2.2 Selection of Arbitrators. The arbitration shall be conducted
by a panel of three neutral arbitrators who are independent and disinterested
with respect to the parties, this Agreement, and the outcome of the arbitration.
Each party shall appoint one neutral arbitrator, and these two arbitrators so
selected by the parties shall then select the third arbitrator. If one party has
given written notice to the other party as to the identity of the arbitrator
appointed by the party, and the party thereafter makes a written demand on the
other party to appoint its designated arbitrator within the next ten days, and
the other party fails to appoint its designated arbitrator within ten days after
receiving said written demand, then the arbitrator who has already been
designated shall appoint the other two arbitrators.
10.2.3 Discovery. Unless the parties mutually agree in writing to
some additional and specific pre-hearing discovery, the only pre-hearing
discovery shall be (a) reasonably limited production of relevant and
non-privileged documents, and (b) the identification of witnesses to be called
at the hearing, which identification shall give the witness's name, general
qualifications and position, and a brief statement as to the general scope of
the testimony to be given by the witness. The arbitrators shall decide any
disputes and shall control the process concerning these pre-hearing discovery
matters. Pursuant to the Rules of AAA, the parties may subpoena witnesses and
documents for presentation at the hearing.
17
10.2.4 Case Management. Prompt resolution of any dispute is
important to both parties; and the parties agree that the arbitration of any
dispute shall be conducted expeditiously. The arbitrators are instructed and
directed to assume case management initiative and control over the arbitration
process (including scheduling of events, pre-hearing discovery and activities,
and the conduct of the hearing), in order to complete the arbitration as
expeditiously as is reasonably practical for obtaining a just resolution of the
dispute.
10.2.5 Remedies. The arbitrators may grant any legal or equitable
remedy or relief that the arbitrators deem just and equitable, to the same
extent that remedies or relief could be granted by a state or federal court,
provided however, that no punitive damages may be awarded. No court action may
be maintained seeking punitive damages. The decision of any two of the three
arbitrators appointed shall be binding upon the parties.
10.2.6 Expenses. The expenses of the arbitration, including the
arbitrators' fees, expert witness fees, and attorney's fees, may be awarded to
the prevailing party, in the discretion of the arbitrators, or may be
apportioned between the parties in any manner deemed appropriate by the
arbitrators. Unless and until the arbitrators decide that one party is to pay
for all (or a share) of such expenses, both parties shall share equally in the
payment of the arbitrators' fees as and when billed by the arbitrators.
10.2.7 Confidentiality. Except as set forth below, the parties shall
keep confidential the fact of the arbitration, the dispute being arbitrated, and
the decision of the arbitrators. Notwithstanding the foregoing, the parties may
disclose information about the arbitration to persons who have a need to know,
such as directors, trustees, management employees, witnesses, experts,
investors, attorneys, lenders, insurers, and others who may be directly
affected. Additionally, if a party has stock which is publicly traded, the party
may make such disclosures as are required by applicable securities laws.
Further, if a party is expressly asked by a third party about the dispute or the
arbitration, the party may disclose and acknowledge in general and limited terms
that there is a dispute with the other party which is being (or has been)
arbitrated. Once the arbitration award has become final, if the arbitration
award is not promptly satisfied, then these confidentiality provisions shall no
longer be applicable.
10.3 Entire Agreement Modification. This Agreement sets forth the entire
agreement and understanding between the parties as to the subject matter hereof.
There shall be no amendments or modifications to this Agreement, except by a
written document which is signed by both parties. It is understood that the
Research Agreement is separate and independent from this Agreement and
termination of either agreement shall not operate to terminate or otherwise
effect the rights and obligations of the parties under the other agreement.
10.4 California Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of California.
10. 5 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY OR ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL
DAMAGES (INCLUDING LOST OR ANTICIPATED
18
REVENUES OR PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO
THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING
NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS
ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.
10.6 No Implied Obligations. Licensee's sole obligation to exploit the
Scripps Patent Rights and Scripps Technology is as set forth in Section 4.1.
Nothing in this Agreement shall be deemed to require Licensee to otherwise
exploit the Scripps Patent Rights or Scripps Technology nor prevent Licensee
from commercializing products similar to or competitive with a Licensed Product.
10.7 Headings. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
article or section.
10.8 Severability. Should any one or more of the provisions of this
Agreement be held invalid or unenforceable by a court of competent jurisdiction,
it shall be considered severed from this Agreement and shall not serve to
invalidate the remaining provisions thereof. The parties shall make a good faith
effort to replace any invalid or unenforceable provision with a valid and
enforceable one such that the objectives contemplated by them when entering this
Agreement may be realized.
10.9 No Waiver. Any delay in enforcing a party's rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of such party's rights to the future enforcement of its
rights under this Agreement, excepting only as to an express written and signed
waiver as to a particular matter for a particular period of time.
10.10 Name. Whenever there has been an assignment by Licensee as permitted
by this Agreement, the term "Licensee" as used in this Agreement shall also
include and refer to, if appropriate, such assignee.
10.11 Notices. Any notices required by this Agreement shall be in writing,
shall specifically refer to this Agreement and shall be sent by registered or
certified airmail, postage prepaid, or by telefax, telex or cable, charges
prepaid, or by overnight courier, postage prepaid and shall be forwarded to the
respective addresses set forth below unless subsequently changed by written
notice to the other party:
For Scripps The Scripps Research Institute
10550 North Torrey Pines Road, TPC-9
La Jolla, California 92037
Attn: Director, Technology Development
Fax No.: (619) 784-9910
For Licensee: StemCells, Inc.
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701 George Washington Highway
Lincoln, Rhode Island 02865
Attn: Research Director
Fax No.: (401) 333-0684
with a copy to: CytoTherapeutics, Inc.
701 George Washington Highway
Lincoln, Rhode Island 02865
Attn: General Counsel
Fax No.: (401) 334-9152
Notice shall be deemed delivered upon the earlier of (i) when received, (ii)
three (3) days after deposit into the mail, or (iii) the date notice is sent via
telefax, telex or cable, (iv) the day immediately following delivery to
overnight courier (except Sunday and holidays).
20
10.12 Compliance with U. S. Laws. Nothing contained in this Agreement
shall require or permit Scripps or Licensee to do any act inconsistent with the
requirements of any United States law, regulation or executive order as the same
may be in effect from time to time.
IN WITNESS WHEREOF, the parties have executed this Agreement by their duly
authorized representatives as of the date set forth above.
SCRIPPS: LICENSEE:
THE SCRIPPS RESEARCH INSTITUTE STEMCELLS, INC.
By: _______________________________ By: _______________________________
Name: _____________________________ Philip K. Yachmetz
Title: ____________________________ Senior Vice President
21
EXHIBIT 10.90
EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT is made as of this 8th day of June, 1998 (the
"Effective Date"), as amended and restated as of June 8, 1999, by and between
CytoTherapeutics, Inc., a Delaware corporation ("Employer") having its principal
place of business at 701 George Washington Highway, Lincoln, Rhode Island 02865
and PHILIP K. YACHMETZ ("Employee") with a principal residence at 7 North
Koewing Place, West Orange, New Jersey 07052-4014, collectively referred to as
the "parties."
RECITALS
Whereas Employer desires to employ Employee at its Lincoln, Rhode Island
Facility and Employee desires to be so employed,
The parties enter this Agreement to set forth the terms and conditions of
Employee's employment by Employer, to address certain matters related to
Employee's employment with Employer, and Employee's loyalty and commitment to
Employer.
NOW THEREFORE, in consideration of these promises and the parties'
material covenants, representations, and warranties made herein, the parties
agree as follows:
STATEMENT OF AGREEMENT
SECTION 1. EMPLOYMENT
a. Position. Employer wishes to employ and Employee hereby accepts the
position of Senior Vice President - Business Development, General Counsel and
Secretary for the term of this Agreement. Employee shall report directly to
Employer's Chief Executive Officer. Such employment shall be at a primary work
location in the Northeastern United States (subject to such travel as the
Employer may reasonably request).
b. Employee's Commitment. Employee shall consider his employment by
Employer as his principal employment, shall devote his full business time and
attention to his duties and responsibilities under this Agreement, and shall
perform them to the best of his abilities. While subject to any provision of
this Agreement, Employee shall maintain loyalty to Employer, and shall take no
action that would directly or indirectly promote any competitor or injure
Employer's interests. Subject to the foregoing, employee may engage in other
charitable or business activities to the extent that they do not interfere or
create a conflict with his obligations under this Agreement; provided that
Employee first discloses any such activities to Employer, and that Employee's
continued participation in any such activity shall be subject to Employer's
ongoing approval, which may be withheld at Employer's sole discretion.
c. Duties. Employee's primary duties and responsibilities as Senior Vice
President - Business Development, General Counsel and Secretary shall be to:
(1) Direct and oversee all legal matters pertaining to CTI, including
contractual relationships, general corporate and securities matters, patent,
copyright and the coordination of any legal matters handled by outside counsel.
(2) Direct the research and analysis of such business opportunities,
strategic partnerships, alliances and collaborations, including the
establishment and recommendation of strategic initiatives as directed by the
Employer's CEO from time to time; responsible for implementation of such
strategic initiatives of Senior Management as directed by the Employer's CEO
from time to time, including the negotiation of agreements related to external
alliances, direct the policies and programs related to corporate licensing
objectives for the acquisition of licensing opportunities and techniques.
(3) Serve as corporate secretary of the Company and its subsidiaries.
SECTION 2. COMPENSATION, BENEFITS AND EXPENSES
a. Salary. Subject to Subsection 2b, Employer shall pay Employee as salary
of Two Hundred Fifty Thousand dollars ($250,000.00) annually, payable in
accordance with Employer's payroll practices in effect from time to time.
b. Bonus.
(1) Employee shall receive a "sign on" bonus of Fifteen Thousand
Dollars ($15,000) payable, $10,000 in cash and $5,000 in registered shares of
Employer's common stock (3,906 shares), calculated at the price per share of
$1.28 per share, the closing price of the Employer's common stock as quoted on
the Nasdaq stock exchange for the Effective Date of Employment.
(2) In addition, Employee shall be eligible (in the sole discretion
of the Employer) to receive performance related bonuses at the end of each
calendar year, including 1998, in a percentage amount of base salary similar to
that for which other members of the Employer's senior management are eligible or
are awarded under guidelines in effect at such time. Employee's bonus shall be
based on (i) the reduction in comparable outside legal fees versus the base
period of January 1, 1998 through June 30, 1998, (ii) the level of cash funding
received by Employer from business development transactions with third parties
in which Employee is materially involved, and (iii) the attainment of other
specific performance objectives mutually agreed with Employer's Chief Executive
Officer. The payment and amount of any such bonus shall be determined in the
sole discretion of the Employer and its Board of Directors.
c. Stock Options and Grants. (i) Through the Employer's 1992 Equity
Incentive Plan (the "Incentive Plan") and subject to the terms and conditions
set forth herein, Employee is hereby granted, as of the Effective Date of this
Agreement, an option to acquire 75,000 shares of the common stock of the
Employer at a strike price, subject to
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the approval of the Employer's Board of Directors, of $1.281 per share, or such
other strike price as may be specified by the Board of Directors (the
"Time-Based Option"). The time-based option will vest as follows: (A) 30,000 of
the shares will vest on the Effective Date, and (B) the remaining 45,000 shares
shall vest at the rate of 3,000 shares per month on each monthly anniversary of
the Effective Date so long as Employee continues to be employed hereunder.
Employee shall have one (1) year from the last such vesting date within which to
exercise such option (e.g.: September 10, 2000). The expiration of the Initial
Term of this Agreement shall not effect the validity, the vesting schedule or
the exercise period of such Time-Based Option granted Employee. (ii) Through the
Incentive Plan, upon the approval of the Employer's Board of Directors, Employee
is hereby granted a second option to acquire 12,000 shares of the common stock
of the Employer at a strike price equal to the closing price for the Employer's
Common Stock on the date of the approval of this grant by the Company's Board
(the "Time-Based Option II"). The Time-Based Option II will vest at the rate of
1,500 shares per month on the 1st day of each month commencing with September 1,
1999 and ending with April 1, 2000. Employee shall have one (1) year from the
Termination Date of this Agreement to exercise the option to purchase the shares
subject to the Time-Based Option and the Time-Based Option II (e.g.: April 1,
2001.
The compensation set forth in Sections 2a, 2b and 2c may be increased from time
to time at the will and discretion of Employer.
d. Relocation. As soon as reasonably practicable following the Effective
Date, Employee will establish his principal office at the Company's offices in
Lincoln, Rhode Island and a temporary residence within driving distance of such
office. The Employer shall pay or reimburse Employee up to an amount not to
exceed $2,500 per month for all costs of such temporary housing and related
expenses, including, but not limited to, apartment rent and security deposit,
furniture rental, utilities, cable television, basic telephone service and
similar expenses, for the term of this Agreement and for such additional period
while Employee is still rendering services to the Employer pursuant to Section
4.a.(1) (collectively the "Temporary Residence Period"). Employer shall also
during the Temporary Residence Period pay or reimburse Employee for two (2)
round trip airfares per month to the New Jersey/New York area for use by
Employee or his daughter. Until such time as Employee has established his
temporary residence in Rhode Island, Employer shall reimburse Employee for
hotel, travel, meal and related costs to and from New Jersey. The cost of
Employee's temporary housing and the cost of the two (2) round trips airfares
set forth above are hereinafter collectively referred to as the "Temporary
Relocation Expenses."
e. Benefits. Employee will be entitled to participate in any and all
employee benefit plans from time to time in effect for senior management of the
Employer generally, including, but not limited to, medical, dental and
hospitalization plans, retirement and 401(k) savings plans, life insurance and
accidental death plans, disability plans, etc., except to the extent that such
plans provide duplicative benefits or a lower level of benefits than that
specifically provided Employee herein. Additionally, Employee shall be entitled
to participation similar to that provided other members of Employer's senior
management in
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any supplemental stock or option grants, stock appreciation rights awards,
phantom stock rights, "golden parachute" or "golden handcuff" policies of the
Employer in effect as of the Effective Date or adopted by Employer thereafter
for the general benefit of its senior management. Employee's participation shall
be subject to (i) the terms of the applicable plan documents, (ii) generally
applicable policies of the Employer, and (iii) the discretion of the Board of
Directors of the Employer and plan administrators, as provided for or
contemplated by such plan. Employee will be entitled to four (4) weeks' vacation
for the period ending on the first anniversary of this Agreement and two (2)
weeks' vacation for the period from the first anniversary of this Agreement
through the Termination Date. Employer will provide Employee with a leased
automobile at a cost to be approved by Employer's CEO, cover the cost of up to
three (3) state bar memberships per year and the cost of professional
association memberships consistent with Employer's policy for its senior
management.
f. Withholdings, "Gross Up" of Compensation. (i) Employer shall withhold
from any amounts payable as compensation all federal, state, municipal, or other
taxes as are required by any law, regulation, or ruling. (ii) Employer shall
"gross up" any and all Temporary Relocation Expenses paid or reimbursed to
Employee during the Temporary Residence Period by 36% in order to offset any and
all income tax liability to Employee for the payment or reimbursement of these
expenses by Employer. (iii) In addition, in the event Employee sustains an
increased state income tax liability due to the payment of state income taxes in
both Rhode Island and New Jersey versus Employee's paying only New Jersey state
income tax, then Employer shall "gross up" the compensation paid to Employee
hereunder in order to reimburse and offset any and all incremental increase in
Employee's state income tax liability.
g. Business Expenses. Employer shall reimburse Employee for expenses
reasonably incurred in the course of his employment, in accordance with
Employer's policies in effect from time to time.
SECTION 3. TERM
a. Initial Term. The term of Employee's employment shall commence on the
Effective Date and shall expire on October 31, 1999 (the "Term"), after which
the provisions of Section 4 shall apply. For purposes of this Agreement, the
"Termination Date" shall mean October 31, 1999 or the effective date of an early
termination pursuant to section 3.b below.
b. Early Termination. Notwithstanding any other provision of this
Agreement, Employee's employment shall terminate at any time, as follows:
(1) Employer may terminate your employment upon thirty (30) days written
notice to Employee in the event you become disabled during your employment
through any illness, injury, accident or condition of either a physical or
psychological nature and, as a result, you are unable to perform
substantially all of your duties and responsibilities hereunder for ninety
(90) consecutive days during
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the Initial Term. In that event, the Employer shall pay Employee the
severance set forth in Section 4.
(2) Employee's employment may also be terminated by Employer at any time
without prior notice upon a showing of "reasonable cause." Should Employee
be terminated by Employer for "reasonable cause," no severance pay will be
paid to Employee nor will his health insurance benefits be continued by
Employer at its expense for any period of time as addressed in Section 4
of this Agreement. "Reasonable cause" shall be defined for the purposes of
this Agreement as being: (a) any act of fraud, embezzelement or other
material dishonesty by Employee with respect to the Employer which is
proven to be directly detrimental to Employer's best interest; (b)
Employee's willful failure to perform material duties and responsibilities
described in Section 1 (c) above, after receiving notice and a reasonable
opportunity to cure; (c) Employee's conviction of, or plea of nolo
contendre to, any act that constitutes a felony under the laws of the
state of Rhode Island or the United States; or (d) Employee's material
breach of Section 5 of this Agreement.
(3) Employee may terminate his employment with immediate effect at any
time "with cause" upon written notice to Employer, in which event the
provisions of Section 4 shall apply. The following shall constitute "with
cause" for the puposes of this Agreement: (a) material breach by Employer
of any provision of this Agreement, includng without limitation any
material diminution of Employee's position, authorities or
responsibilities from that contemplated hereby or as in effect by practice
during the Term of this Agreement, or (b) a Change of Control, being
defined as the execution of agreements, the consummation of an agreed
transaction or the pending consummation of a tender offer which will
result in (i) a consolidation or merger in which the Employer is not the
surviving corporation, or (ii) a transaction or series of transactions
that result in acquisition of fifty percent (50%) or more of the
Employer's outstanding Common Stock by a single person or entity or a
group of persons or entities acting in concert, or (iii) the sale or
transfer of all or substantially all of the Employer's assets.
SECTION 4. SEVERANCE
a. Severance Payments and Benefits. Upon the expiration of the Term or
upon the early termination of the Term pursuant to Sections 3.b.(1) or 3.b.(3),
Employee shall receive the following Severance Payments and Benefits from
Employer:
(1) A payment equal to nine (9) month's of Employee's regular salary as
of the date of the Termination Date, such lump sum shall be payable
at Employee's sole election in either a lump sum on the Termination
Date or in periodic payments specified by Employee. In the event the
early termination is pursuant to Section 3.b.(1), such lump sum
payment and related benefits hereunder shall be deemed to be made as
compensation for Employee's past services to Employer.
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(2) Employer will pay to Employee the balance of any accrued and unused
vacation earned by Employee through the Termination Date.
(3) Employer will pay any accrued but unpaid bonus, if any, under
Section 2.b.(2) for the period ending with the Termination Date or
any prior fiscal period, if any, or any such other bonus, if any,
which may be agreed between Employer and Employee or to which
Employee may become entitled to prior to the Termination Date.
(4) Employer will continue to pay or reimburse Employee for the
Temporary Relocation Expenses pursuant to Section 2.d for the period
through the Termination Date and for any residual notice period
occasioned by the termination provisions of those obligations which
extends beyond the Termination Date. Such payment or reimbursement
shall continue to be subject to the "gross up" provisions of Section
2.f.(ii) until final such payment shall be made.
(5) Employer will pay for the first twelve (12) months of Employee's
COBRA coverage or, if such COBRA is unavailable, Employer shall pay
to Employee the cash value of such twelve (12) months of COBRA
coverage.
(6) Employer will also "gross up" the ordinary and severance
compensation paid to Employee hereunder in order to reimburse and
offset any and all incremental increase in Employee's state income
tax liability pursuant to the provisions of Section 2.f.(iii)
hereof.
(7) To facilitate the consulting obligations of Employee under Section
4.a.(8) below, Employee will be permitted to retain possession of
the Sony Vaio desktop and portable computer equipment, and related
equipment (monitor, printer, fax machine, etc.), assigned to
Employee as of the Termination Date. Employee may retain such
equipment upon the expiration of his consulting obligations
hereunder.
(8) For the period of November 1, 1999 through April 30, 2000, Employer
shall pay Employee Two Thousand Five Hundred Dollars ($2,500) per
month as a retainer, payable within the first ten (10) days of each
month, for up to twelve (12) hours per month of business
development, management, legal and related consulting services to be
rendered by Employee with respect to Employer's business. Subject to
Employee's availability, additional consulting services may be
provided to Employer at the rate of $1,500 per day.
b. Reference Letter Upon Separation of Employment. Employer agrees to
provide Employee with a letter of recommendation upon Employee's separation of
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employment, granted that Employee's separation of employment from Employer is
for any reason other than "reasonable cause."
SECTION 5. CONFIDENTIALITY
a. Confidential Information. "Confidential Information" means information
in whatever form, including information that is written, electronically stored,
orally transmitted, or memorized, that is of commercial value to Employer and
that was created, discovered, developed, or otherwise becomes known to Employee,
or in which property rights are held, assigned to, or otherwise acquired by or
conveyed to Employer, including any Employee Invention (as subsequently defined)
or idea, knowledge, know-how, process, system, method, technique research and
development, technology, software, technical information, trade secret, as
defined in state statute, trademark, copyrighted material, reports, records,
documentation, data, customer or supplier lists, tax or financial information,
business or marketing plans, strategy or forecast. Confidential Information does
not include information that is or becomes generally known within Employer's
industry through no act or omission by Employee, provided, however, that the
compilation, manipulation, or other exploitation of generally known information
may constitute Confidential Information.
b. Employee Invention. "Employee Invention" means any idea, invention,
software, technique, modification, process, improvement, or similar item,
whether or not reduced to writing or stored electronically or otherwise, and
whether or not protectible by patent, trademark, copyright, or other
intellectual property law, that is crated, conceived, or developed by Employee
or under his direction, whether solely or with others, during or after his
employment by Employer, that relates in any way to, or is useful in any manner
in, the business now or then conducted or proposed to be conducted by Employer
or which is based upon or otherwise derives from or makes use of the
Confidential Information.
c. Ownership; Disclosure. Any Confidential Information, whether or not
developed by Employee, shall at all times be Employer's exclusive property.
Employee shall promptly disclose any Employee Invention to Employer in writing.
d. Restrictions. During the term of this Agreement, and for ten (10) years
thereafter, Employee shall not, without Employer's prior written consent:
(1) Use any Confidential Information for the benefit of himself of any
other party other than Employer or disclose it to any other person or
entity;
(2) Remove any Confidential Information or other documentation, device,
plan or other record or evidence pertaining to Employer's business from
Employer's premises, except when specifically authorized to do so in
pursuit of Employer's business; or
e. Purpose. The parties acknowledge and agree that the Confidential
Information is a valuable business asset, and that this Section is necessary to
protect Employer's legitimate business interests.
-7-
SECTION 6. ADDITIONAL REPRESENTATIONS AND WARRANTIES
In addition to his other representation and warranties set forth in this
Agreement, Employee further represents and warrants as follows:
a. Employee's performance of this Agreement shall not breach any agreement
to which he is or was a party that requires him to hold any information in
confidence or in trust;
b. Employee has not and shall not breach any such Agreement;
c. Employee shall not bring to Employer or use in connection with his
employment any confidential or proprietary information belonging to another
entity without first delivering a written release of that information to
Employer; and
d. Employee has provided Employer with an original or true copy of any
employment, non-competition, confidential or proprietary information, or similar
agreement to which he is or has been a party which is now in effect or which may
be in effect during the term of this Agreement.
SECTION 7. REMEDIES
a. Irreparable Harm. The parties acknowledge and agree that irreparable
harm would result in the event of a breach or threat of a breach by Employee of
Section 5 or the making of any untrue representation or warranty by Employee in
this Agreement. Therefore, in such an event, and notwithstanding any other
provision of this Agreement:
(1) Employer shall be entitled to a restraining order, order of specific
performance, or other injunctive relief, without showing actual damage and
without bond or other security; and
(2) Employer's obligation to make any payment or provide any benefit under
this Agreement, including without limitation any severance benefits, shall
immediately cease.
b. Remedies Not Exclusive. Employer's remedies under this Section are not
exclusive, and shall not prejudice or prohibit any other rights or remedies
under this Agreement or otherwise. To the extent required to be enforceable by
applicable law, the cessation of Employer's obligation to make payments or
continue benefits under this Section shall be deemed to be in the nature of
liquidated damages and not a penalty.
c. Cessation of Payments. In the event Employer obtains relief as provided
in this Section, or in the event of Employee's breach of Section 5 or the making
of any untrue representation or warranty by Employee in this Agreement,
Employer's obligation
-8-
to make any payment or provide any benefit under this Agreement, including any
severance benefits, shall immediately cease.
SECTION 8. LEGAL COUNSEL
a. Understanding, Voluntary Agreement. Employee represents and warrants
that he has been afforded a reasonable opportunity to review this Agreement, to
understand its terms, and to discuss it with an attorney of his choice, and that
he knowingly and voluntarily enters this Agreement.
b. Waiver of Separate Representation. To the extent Employee has not
engaged separate legal counsel to represent him in connection with this
Agreement, the parties acknowledge an agree that their respective interest in
this Agreement are in conflict, that they have the right to retain independent
counsel, that they have been fully informed about this right and conflicts of
interest that arise from retaining the same legal counsel to represent both of
them, and that this Section constitutes written disclosure of these conflicts.
The parties further affirm that they are waiving separate representation freely,
voluntarily, and with full knowledge of the effect of this waiver. NO party
shall at any time claim that this Agreement is void or unenforceable in any
respect because of the lack of use of independent counsel, or that the legal
counsel who prepared this Agreement acted improperly in doing so.
SECTION 9. CONFIDENTIAL AGREEMENT
This Agreement is confidential, Employee and Employer shall keep its provisions
confidential and shall not disclose them to anyone, including any past, present,
or prospective employee of Employer; provided, that this Section shall not
prohibit Employee from discussing this Agreement in confidential communications
with his family members, attorneys, accountants, or other professional advisors,
provided that the provisions of Section 5 shall at all times apply to
communications with any such persons, and provided Employer may disclose the
terms of this Agreement to the extent it is required by federal or state law,
rule or regulation.
SECTION 10. MISCELLANEOUS PROVISIONS
a. Waivers. No assent, express or implied, by any party to any breach or
default under this Agreement shall constitute a waiver of or assent to any
breach or default of any other provision of this Agreement or any breach or
default of the same provision on any other occasion.
b. Entire Agreement, Modification. This Agreement constitutes the entire
agreement of the parties concerning its subject matter and supersedes all other
oral or written understandings, discussions, and agreements, and may be modified
only in a writing signed by both parties.
-9-
c. Binding Effect; No Third Party Beneficiaries This Agreement shall bind
and benefit the parties and their respective heirs, devisees, beneficiaries,
grantees, donees, legal representatives, successors, and assigns. Nothing in
this Agreement shall be construed to confer any rights or benefits on third
parties.
d. Assignment. Neither party may assign its interest in this Agreement
without the other's prior written consent; provided that Employer may assign its
interest to another entity which controls, is controlled by, or is under common
control with Employer.
e. Severability. If any provision of this Agreement, including the
restriction on time and geographic area contained in the Covenant Not to Compete
and Confidential Information provisions of this Agreement, is found in binding
arbitration or by a court or other tribunal of competent jurisdiction to be
invalid or unenforceable, the attempt shall first be made to read that provision
in such a way to make it valid and enforceable in light of the parties' apparent
intent as evidenced by this Agreement. If such a reading is impossible, the
tribunal having jurisdiction may revise the provision in any reasonable manner,
to the extent necessary to make it binding and enforceable. If no such revision
is possible, the offending provision shall be deemed stricken from the
Agreement, and every other provision shall remain in full force and effect.
f. Forum. All lawsuits, actions, and other proceedings arising from this
Agreement or the transactions it contemplates shall be prosecuted in the
appropriate court in New Jersey and all parties agree to both subject matter and
in personam jurisdiction in that forum.
g. Governing Law. This Agreement shall be governed by and construed under
the laws of the State of Rhode Island.
h. Legal Counsel. The parties acknowledge that they have read and fully
understand the contents of this Agreement and execute it after having had an
opportunity to consult with legal counsel.
IN WITNESS WHEREOF, the partied have executed this Agreement to be
effective as specified above.
PHILIP K. YACHMETZ CYTOTHERAPEUTICS, INC.
BY: _____________________________ BY: __________________________
Philip K. Yachmetz Richard M. Rose, MD
President & CEO
-10-
EXHIBIT 10.91
CYTOTHERAPEUTICS, INC.
701 GEORGE WASHINGTON HIGHWAY
LINCOLN, RHODE ISLAND 02865
As of July 1, 1999
John Schwartz
110 Atherton Avenue
Atherton, California 94027
Dear John:
This letter will confirm our agreement with respect to the amendment, with
effect from July 1, 1999, of your Letter Agreement with CytoTherapeutics, Inc.
(the "Company"), dated December 19, 1999 (the "Agreement").
Section 2. "Compensation; Time Commitment" shall be modified such that
subsection 2.a.(iii) shall read:
"(iii) One Hundred Thirty Two Thousand Dollars ($132,000) per year,
plus a fee of One Thousand Five Hundred Dollars ($1,500) per Board meeting
or Committee meeting (if held at a date and time separate from the Board
meeting) where you are physically present, plus Five Hundred Dollars
($500) per Board meeting or Committee meeting (if held at a date and time
separate from the Board meeting) held by conference call, payable
quarterly in arrears (this cash compensation plus any other compensation
provided for herein shall be referred to as the "Compensation"). "
Section 2. " Compensation; Time Commitment" shall be further modified such
that Subsection b. shall read:
"b. As Chairman of the Board of Directors, you will be expected to
devote no less than thirty (30) business days per calendar quarter to the
performance of your duties and responsibilities collectively under this
Agreement and the Consulting Agreement (hereinafter "Duties and
Responsibilities"). In the event you devote more than thirty (30) days in
any calendar quarter to the performance of your
John J. Schwartz
July 1, 1999
Page 2
Duties and Responsibilities, you shall, within thirty (30) days of the end
of the calendar quarter, provide an accounting to the President and Chief
Executive Officer of the Company detailing the actual time spent during
such preceding calendar quarter. After review and approval by the
President and Chief Executive Officer of the Company you will be promptly
further compensated for additional days exceeding thirty (30) in any
calendar quarter at the rate of One Thousand Five Hundred Dollars ($1,500)
per day. All such additional payments made shall be promptly reported by
the President and Chief Executive Officer to the Compensation Committee of
the Board (the "Compensation Committee") for subsequent ratification by
such Compensation Committee, such ratification not to delay the payment of
any such additional payments."
Except as specifically modified hereby, all other terms and conditions of the
Agreement remain in full force and effect
If the foregoing is acceptable to you, please sign the enclosed copy of this
letter in the space provided below and return it to me, whereupon this letter
and such copy will constitute a binding amendment of the Agreement between you
and the Company on the basis set forth above as of the date first above written.
Sincerely yours,
CYTOTHERAPEUTICS, INC.
By: __________________________________
Richard M. Rose, M.D.
President &
Accepted and Agreed: Chief Executive Officer
_______________________________
John J. Schwartz
Date: ___________________
Page 2 of 2
EXHIBIT 10.93
CYTOTHERAPEUTICS, INC.
701 George Washington Highway
Lincoln, RI 02865
401-288-1000
August 30, 1999
Moses Goddard, MD
155 Pelletier Lane
Tiverton, RI 02878
Dear Moses:
As we have discussed, we have determined that it is in our mutual best
interests to effect a voluntary end to your employment with CytoTherapeutics,
Inc. ("CTI" or the "Company"). If accepted by you, this letter will confirm that
you hereby resign as Vice President, Chief Technical Officer--Cell Encapsulation
& General Manager Cell Encapsulation, Director and employee of CTI and from all
other positions you hold in CTI and its Affiliates (as defined herein),
effective as of August 31, 1999. It is understood that CTI will take actions in
reliance on your resignation and that it shall become irrevocable on the
effective date of this Agreement. In consideration of your resignation from your
employment with CTI effective on August 31, 1999, CTI is offering you the
severance package set forth below. If you accept it, this letter will constitute
the agreement between you and CTI concerning your severance arrangements, as
follows:
1. During the period from the date of this letter, written above, through
August 31, 1999 you will continue to be employed by the Company at your current
rate of pay.
2. (a) CTI will provide you on or before August 31, 1999 with a lump-sum
payment equal to (i) two months salary at your final base rate of pay, plus (ii)
the amount payable to you under the Company severance policy currently in effect
calculated through October 31, 1999, provided that you also shall receive a
pro-rated portion of the amount payable per year of service under the severance
policy for the partial year of service ended October 31, 1999, plus (iii) all
vacation time earned but not used through and including August 31, 1999, reduced
by the amount of any Company loan or loans outstanding under the Company's
401(k) Plan. You agree that from August 31, 1999 through October 31, 1999 (the
"Transitional Period"), at the Company's request, you will provide up to ten
(10) days of consulting services relating to the Company's encapsulated
-1-
cell therapy technology and transactions related thereto at no cost to the
Company. If the time commitment required of you during the Transitional Period
exceeds ten (10) days, you shall be compensated at the rate of $1,000 per day.
After the Transitional Period you agree to remain available, at the request of
the Company, for consulting services relating to the Company's encapsulated cell
therapy technology and transactions related thereto for which you will be
compensated at the rate of $1,500 per day, plus expenses.
(b) In addition to the above, upon the approval of the Company's
Board of Directors, you will receive an option to acquire 18, 000 shares of the
common stock of the Company, at a strike price equal to the price per share of
the Company's common stock of the date of the approval of the grant by the
Company's Board of Directors. This time-based option will vest at a rate of
1,500 shares per month on the first day of each month for the twelve months
commencing with November 1, 1999, provided that you continue to remain available
for the consulting services discussed above. The Company may terminate the
consulting arrangement on no less than sixty (60) days written notice to you.
Any options which remain unvested as of the termination date cited in the
Company's notice to you shall expire as of such date. You shall have six (6)
months from the last vesting date of options under this grant within which to
exercise such option.
3. During the Transitional Period, the Company will continue your
participation in those Company employee benefit plans and which you are
currently a participant, to the extent permitted by the terms of those plans and
generally applicable Company policies. Except for the options granted to you
under Section 2.(b) above, stock options granted to you and not yet expired,
exercised, canceled or otherwise become unexercisable shall continue to vest
through August 31, 1999, but not thereafter. In addition, subject to approval by
the Company's Board of Directors, the exercise period for all of the options
previously granted to you which shall have vested as of August 31, 1999 shall be
extended to February 28, 2000 (the "Exercise Period Extension"), provided,
however, that all such options shall be exercisable only for so long as you
continue to comply with your obligations under this Agreement, including,
without limitation, your obligations under paragraph 9 of this Agreement. I will
strongly recommend approval of the Exercise Period Extension at a meeting of the
Board of Directors to be held prior to August 31, 1999.
4. To the extent permitted by the terms of the Company's group health and
dental plans and by its health and dental plan insurers or providers, as
applicable, the Company will continue your participation and that of your
eligible dependents in its group health and dental plan to the same extent as
you and they currently participate and will pay the premium costs of such
participation to the same extent currently paid, from August 31, 1999 through
the earlier of (i) November 30, 1999 or (ii) the date you commence other
employment and become eligible for coverage under the plans of your new
employer. If the Company is unable to provide the continuations contemplated in
the first sentence of this section, you may exercise your right to continue your
coverage and that of your eligible dependents in the Company's group health and
dental plan under the federal law known as COBRA, provided you are eligible to
do so, and, if you are eligible and so elect, then, until the earlier of
November 30, 1999 or the date you cease to be eligible for continuation under
COBRA,
-2-
the Company will pay the premium costs of your coverage and that of your
eligible dependents. Alternatively, the Company may satisfy its obligations to
you under this paragraph by paying to you on October 31, 1999 a lump sum amount
equal to the cost to the Company of your previous month's group health plan
insurance coverage, and, shall so satisfy its obligation to you in the event
that the Company has no group health plan willing to provide COBRA coverage to
you on terms comparable to those in effect on the date of this agreement.
Coverage under all other benefit plans of the Company, including, without
limitation, the Company's group life insurance plan, shall cease as of August
31, 1999.
5. The Company will pay for the costs of the four month outplacement
services program to be rendered to you by Executive Destinations in accordance
with their agreement with the Company.
6. All payments by the Company under this Agreement will be reduced by all
taxes and other amounts that the Company is required to withhold under
applicable law and all other deductions authorized by you.
7. In signing this agreement, you acknowledge that, on receipt by you of
the payments to be provided you in accordance with Sections 1 and 2 hereof, you
will have received payment in full of any and all sums which are now, or might
hereafter have become, owing to you from CTI, whether for services rendered by
you during your employment with CTI or otherwise, including without limitation
any and all salary, vacation pay, severance pay and bonuses.
8. You agree that you will not disclose this agreement or any of its terms
or provisions, directly or by implication, except to members of your immediate
family and to your legal and tax advisors, and then only on condition that they
agree not to further disclose this agreement or any of its terms or provisions
to others.
9. You agree that you will not disparage CTI or any of its Affiliates or
any of their directors, trustees, officers or employees; and that you will not
otherwise do or say anything that could disrupt the good morale of the employees
of CTI and its Affiliates or otherwise harm the interests or reputation of CTI
or any of its Affiliates. "Affiliates" means all persons and entities directly
or indirectly controlling, controlled by or under common control with CTI, where
control may be by management authority, equity interest, trusteeship, membership
or otherwise. Affiliates of CTI include, without limitation, StemCells, Inc.
10. In signing this agreement, you give CTI assurance that on or prior to
August 31, 1999 you will return to CTI any and all documents, materials and
information related to the business, whether present or otherwise, of CTI and
its Affiliates, and all keys and other property of CTI and its Affiliates in
your possession or control (other than the cellular telephone previously
provided to you by the Company, which you may retain, subject to your paying all
service charges therefor after August 31, 1999). Recognizing that your
employment with CTI will have been terminated, you
-3-
agree that after August 31, 1999 you will not, for any purpose, attempt to
access or use any computer or computer network or system of CTI or any of its
Affiliates, including without limitation their electronic mail system(s).
Notwithstanding the above, during the period that you are consulting with the
Company pursuant to Paragraph 2(a), you shall continue to have access to, and
are allowed to maintain copies of, documents, materials and information related
to the Company's business and shall continue to have access to the Company's
premises.
11. You have signed an agreement with the Company dealing with, among
other matters, confidentiality, inventions and noncompetition (the "Employee
Agreement"). You agree to meet all of your obligations under the Employee
Agreement, both during the remainder of your employment with the Company and
following termination of your employment, in accordance with the terms of the
Employee Agreement; provided, however, that if you meet all of your obligations
under this agreement, then the Company will relieve you of those obligations of
the Employee Agreement which prohibit your competition with the Company.
12. You agree to cooperate with CTI at any time within three years
hereafter with respect to all matters arising during or related to your
employment, including but not limited to all matters in connection with any
governmental investigation, litigation or regulatory or other proceeding which
may have arisen or which may arise following the signing of this agreement. CTI
shall reimburse you for any reasonable, documented lodging, travel or similar
normally reimbursable out-of-pocket expenses incurred by you in fulfilling your
obligations under this paragraph.
13. In order to be certain that this agreement will resolve any and all
concerns that you might have, CTI requests that you carefully consider its
terms, including the release of claims set forth below and, in that regard,
encourages you to seek the advice of an attorney before signing this agreement.
14. This Agreement and the exhibits hereto constitutes the entire
agreement between you and CTI and supersedes any and all prior and
contemporaneous communications, agreements and understandings, whether written
or oral, with respect to your employment by CTI, the termination of that
employment and all matters pertaining thereto, excluding only the Employee
Agreement (modified as provided above), the parties' obligations under CTI's
1992 Equity Incentive Plan, any other obligations which you may have to CTI or
any of its Affiliates with respect to confidential information, non-competition,
assignment of intellectual property or the like under contract or applicable
law. In signing this Agreement, you represent and affirm that you have not
relied on any promises or representations, written or oral, express or implied,
by anyone connected with CTI or any of its Affiliates that are not set forth
expressly in this Agreement.
15. You agree that this agreement shall be in complete and final
settlement of any and all causes of action, rights or claims that you have had
in the past, now have, or might now have, in any way related to, connected with
or arising out of your employment by the Company or service as a director of the
Company or the termination thereof or pursuant to Title VII of the Civil Rights
-4-
Act, the Americans with Disabilities Act, the Age Discrimination in Employment
Act, or any other federal, state or local employment law, regulation or other
requirement and you, on your own behalf and on behalf of your heirs, executors,
administrators, personal representatives and assigns, hereby release and forever
discharge CTI and its Affiliates and all of their respective past and present
directors, shareholders, officers, employees, agents, successors and assigns and
all others connected with any of them, both individually and in their official
capacities, from any and all such causes of action, rights or claims. Nothing
contained herein shall modify or eliminate any right you may have to
indemnification as a result of your status as executive officer or director of
the Company or your rights to enforce the provisions of this Agreement or your
rights as a stockholder in the Company.
16. In signing this agreement, you give CTI assurance that you have signed
it voluntarily and with a full understanding of its terms and that you have had
sufficient opportunity to consider this agreement before signing it. This
Agreement, including the release of claims contained in the Section immediately
above, contains binding legal obligations. This Agreement may be amended only by
a writing signed by you and an expressly authorized representative of CTI.
If the terms of this agreement are acceptable to you, please sign, date
and return it to me within twenty-one days of the date you receive it. You may
revoke this agreement at any time during the seven-day period immediately
following the date of your signing. If you do not do so, then, at the expiration
of that seven-day period, this letter will take effect as a legally binding
agreement between you and CTI (and each party's successors and assigns) on the
basis set forth above, to be enforced under and construed in accordance with the
laws of the State of Rhode Island without regard to the conflict of law
principles thereof. The enclosed copy of this letter, which you should also sign
and date, is for your records.
Sincerely,
Philip K. Yachmetz, Esquire
Senior Vice President, Business Development
and General Counsel
Accepted and agreed:
Signature: __________________________________
Moses Goddard
Date: ______________________________________
-5-
Date: ______________________________________
-6-
EXHIBIT 10.95
525 Del Rey Avenue, Suite C
Sunnyvale, CA 94086
CytoTherapeutics
November 17, 1999
Mr. George Dunbar
Dear George:
On behalf of StemCells, Inc. (the "Company"), I am pleased to invite you to join
the Company as Acting President of StemCells, Inc. reporting to the Company's
Board of Directors. The effective date of your employment will be November 8,
1999.
The terms of this offer of employment are as follows:
1. Compensation. Your Base Salary will be $6,730.77 biweekly ($175,000 per
year) subject to review and adjustment from time to time. Your salary will begin
as of the effective date of employment.
2. Responsibilities. Your responsibilities as Acting President will be to
perform such services as are customarily performed by the President of a
biotechnology company, as requested by the Board from time to time. Specific
responsibilities will be to provide the management and leadership role on behalf
of the Board to accelerate the timely and cost effective exit from its parent's
Rhode Island operations, and to establish consolidated corporate headquarters
around the existing Sunnyvale, California facility. The priorities in Rhode
Island include the early sale and disposition of the Lincoln, Rhode Island ECT
pilot plant, leasing the existing science and administration facility,
appropriate partnering of the ECT technology, and the sorting out with the State
of Rhode Island any dispute that might exist regarding their initial "seed loan"
to the Company's parent, CytoTherapeutics, Inc. The corporate relocation
priorities are to initiate the minimum infrastructure necessary to manage the
ongoing scientific and medical infrastructure necessary to manage the ongoing
scientific and medical activities with limited disruption and to ensure all
public company obligations are being met. Attention to other business
development and shareholder drivers will be discussed and reviewed at the
discretion of the Board. It is understood by the parties that the terms of this
letter, including any provisions for compensation, stock options and benefits,
all have to do with this interim position, and that if you were to become a
permanent officer the terms and conditions would first be renegotiated.
3. Stock Options. Subject to the approval of the Board of Directors of
CytoTherapeutics, you will be granted the following shares of CytoTherapeutics'
stock at a price equal to the fair market value at the time of your
countersigning this letter:
Mr. George Dunbar
November 17, 1999
Page 2 of 3
o A stock option for 4,000 shares each month. In its absolute
discretion, each quarter the Board of Directors will also consider
an additional grant of up to 3,000 additional options if, it deems
the services provided by you to be truly outstanding.
4. At Will Employment. You should be aware that your employment with the
Company is for no specified period and constitutes "at-will" employment. As a
result, you are free to terminate your employment at any time, for any reason or
for no reason. Similarly, the Company is free to terminate your employment at
any time, for any reason or for no reason. In the event of termination of your
employment, you will not be entitled to any payments, benefits, damages or
compensation.
5. Employment Agreement. As a condition of accepting this offer of
employment, you will be required to complete, sign and return the Company's
standard form of Employment Agreement.
6. Immigration Laws. For the purposes of federal immigration laws, you
will be required to provide to the Company documentary evidence of your identity
and eligibility for employment in the United States. Such documentation must be
provided within 3 (three) business days of the effective date of your
employment, or your employment relationship with the Company may be terminated.
7. General. This offer letter, the Employment Agreement and the Employee
Stock Option Agreement, when signed by you, sets forth the terms of your
employment with the Company and supersedes any and all prior representations and
agreements, whether written or oral. This agreement can only be amended in a
written document signed by you and an officer of the Company. This agreement
will be governed by California law.
We look forward to you joining the Company. If the foregoing terms are
agreeable, please indicate your acceptance by signing both enclosed copies of
this letter in the space below, keeping one copy for your files and returning
one copy to me.
Sincerely,
___________________________
John Schwartz
Chairman of the Board
CytoTherapeutics, Inc.
AGREED AND ACCEPTED:
Mr. George Dunbar
November 17, 1999
Page 3 of 3
_____________________________________ This _____ day of November, 1999
enc: Offer Letter Copy
Employee Information Agreement
I-9 Form
525 Del Rey Avenue, Suite ^
Sunnyvale, CA 94086
CytoTherapeutics
EXHIBIT 10.96
November 17, 1999
Dr. Kenneth D. Coleman
President/CEO
Mr. David Powell
Chairman
iCEO, L.L.C.
Re: Mr. George Dunbar
Dear Ken and David:
CTI would very much like to engage George Dunbar to serve as Acting President of
StemCells, Inc., a subsidiary of CTI, on the following terms:
1. We would expect George to sign our normal Employment Offer letter and
Employment Agreement, substantially in the form attached.
2. The Acting President's responsibilities will be to perform such services
as are customarily performed by the President of a biotechnology company,
as requested by the Board from time to time. Specific responsibilities
will be to provide the management and leadership role on behalf of the
Board to accelerate the timely and cost effective exit from its parent's
Rhode Island operations, and to consolidate corporate headquarters around
the existing Sunnyvale, California facility. The priorities in Rhode
Island include the early sale and disposition of the Lincoln, Rhode Island
ECT pilot plant, leasing the existing science and administration facility,
appropriate partnering of the ECT technology, and the sorting out with the
State of Rhode Island any dispute that might exist regarding their initial
"seed loan" to CTI. The corporate relocation priorities are to initiate
the minimum infrastructure necessary to manage the ongoing scientific and
medical infrastructure necessary to manage the ongoing scientific and
medical activities with limited disruption and to ensure all CTI's public
company obligations are being met. Attention to other business development
and shareholder drivers will be discussed and reviewed at the discretion
of the Board. CTI acknowledges and understands that iCEO, L.L.C. cannot
and does not guarantee that CTI will obtain funding that it deems
acceptable or adequate as a result of the Acting President's performance
of services.
3. George would begin as of November 7, 1999, and, of course, would commit to
the time necessary to carry out his responsibilities, as you said. We
would, as you also note, want to meet with you and George as necessary to
discuss any issues that arise in connection with this appointment.
George's employment will
Dr. Kenneth D. Coleman CONFIDENTIAL
November 1, 1999
Page 2 of 3
be at will, continuing until terminated by either him or us, neither party
having any obligation to give the other party advance notice, as reflected
in the enclosed engagement letter.
4. We will pay at the total annual rate of $250,000 so long as George is in
our employ as Acting President. We will pay iCEO, L.L.C. that part of the
total rate that you direct. The remainder will constitute George's salary;
we will also pay the employer's share of payroll taxes, and withhold taxes
and other amounts as appropriate, on the amounts paid to George. George
will be paid on the same schedule as all CTI employees, which is currently
every two weeks, and iCEO will bill us for its share on the 15th and the
last day of the month for the prior period, amounts to be due on receipt.
5. We will grant options to purchase a total of 8,000 shares of CTI stock
every month; every three months, the CTI Board of Directors will also
consider an additional grant of up to a total of 6,000 additional options
if, in its absolute discretion, it deems the services provided by George
are truly outstanding. The shares will be divided between George and iCEO
as you direct in your reply to this letter. The strike price for all
options will be the price of the shares at the close of business on the
date of grant, which will occur at CTI's first Board meeting in November,
1999.
6. We will reimburse George promptly for his reasonable expenses incurred on
behalf of StemCells. We will, of course, require that he follow normal
business practices with respect to receipts and advance authorization
where required.
7. I have left space below for you to let us know how the monetary payment
and the options should be divided up. We will use that information to
complete the engagement letter, and send you a copy of the completed
package once the remaining documents are fully executed.
8. CTI agrees that if, within 120 days following the termination of George's
employment as Acting President of StemCells, it or StemCells should engage
George on a permanent basis rather than as Acting President, it will pay
iCEO, L.L.C. an amount equal to one third of his first year's targeted
cash compensation, including base salary and bonus, in such permanent
position.
9. It is understood by all parties that the terms of this agreement, as well
as the Employment Offer letter and Employment Agreement, all have to do
with an interim position, and that if George were to become CEO of CTI on
a permanent basis the terms and conditions would first be renegotiated. It
is further understood that George has certain consulting agreements which
have been disclosed and which are listed in Exhibit B to the Employment
Agreement, and it is agreed that in light of the interim nature of this
appointment, he is entitled to continue to provide services under those
agreements so long as their performance does not interfere in any way with
his carrying out of his responsibilities toward StemCells or its parent.
It is also understood and agreed that George is free to interview with
other companies during his appointment as Acting President, again so long
as this does not interfere in any way with his
Dr. Kenneth D. Coleman CONFIDENTIAL
November 1, 1999
Page 3 of 3
carrying out of his responsibilities toward StemCells or its parent.
Moreover, if at any time during the duration of his appointment as Acting
President of StemCells George should be dissatisfied with his compensation
because he finds his responsibilities significantly different from what he
now believes they will be, he and you should feel free to meet with the
Chairman of the Board of CTI to discuss the problem and how it could be
ameliorated.
I believe this obviates the need for Exhibit A to your letter, but if I have
omitted anything of importance, please let me know.
Sincerely,
John Schwartz
Chairman of the Board
Enclosures
Accepted, with the condition that $6,250 per month of the annual amount of
$250,000 referred to in paragraph 4 (i.e., thirty percent) above be paid to
iCEO, L.L.C., and fifty percent of the options for 8,000 shares of CTI stock
(i.e., 4,000 shares) per month and fifty percent of any additional options
granted as set out in paragraph 5 above, be granted to iCEO Diversified Stock
Fund.
____________________________
by:
iCEO, L.L.C.
EXHIBIT 21
SUBSIDIARIES OF STEMCELLS, INC.
NAME JURISDICTION OF INCORPORATION
- ---- -------------------------------------
StemCells California, Inc. California
Exhibit 23.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the use of our report dated April 14, 2000, included in the
Annual Report on Form 10-K of StemCells, Inc. (formerly CytoTherapeutics, Inc.)
for the year ended December 31, 1999, with respect to the consolidated financial
statements, as amended, included in this Form 10-K/A.
/s/ Ernst & Young LLP
Providence, Rhode Island
December 1, 2000
5
YEAR
DEC-31-1999
DEC-31-1999
4,760,064
0
3,000,000
0
0
8,970,855
5,779,777
(828,401)
15,780,999
3,560,550
2,937,083
0
0
186,355
3,320,048
15,780,999
0
5,021,707
0
0
20,959,136
0
335,203
(15,708,626)
0
(15,708,626)
0
0
0
(15,708,626)
(.84)
(.84)
EXHIBIT 99
CAUTIONARY FACTORS RELEVANT TO FORWARD-LOOKING INFORMATION
You should carefully consider the risks described below before making an
investment decision regarding StemCells, Inc. We may face other risks not
described below that we do not presently know about or that we currently deem
immaterial.
Our business, financial condition or results of operations could be
materially adversely affected by any of these risks. Consequentially, the
trading price of our common stock could decline, resulting in the loss of all or
part of your investment.
OUR TECHNOLOGY IS AT AN EARLY STAGE OF DISCOVERY AND DEVELOPMENT AND WE MAY
FAIL TO DEVELOP ANY PRODUCTS.
Our stem cell technology is at the early pre-clinical stage for the brain
stem cell and at the discovery phase for the liver and pancreas stem cells and
has not yet led to the development of any proposed product. We may fail to
discover the stem cells we are seeking, to develop any products, to obtain
regulatory approvals, to enter clinical trials, or to commercialize any
products. Any product using stem cell technology may fail to (i) survive and
persist in the desired location, (ii) provide the intended therapeutic benefits,
(iii) properly integrate into existing tissue in the desired manner, or (iv)
achieve benefits therapeutically equal to or better than the standard of
treatment at the time of testing. In addition, any such product may cause
undesirable side effects. Results of early pre-clinical research may not be
indicative of the results that will be obtained in later stages of preclinical
or clinical research. If the appropriate regulatory authorities do not approve
our products, or if we fail to maintain regulatory compliance, we would have
limited ability to commercialize our products, and our business and results of
operations would be harmed. Furthermore, since stem cells are a new form of
therapy, the marketplace may not accept any products we may develop.
If we do succeed in developing products, we will face many potential
obstacles such as the need to obtain regulatory approvals, and to develop or
obtain manufacturing, marketing and distribution capabilities. In addition, we
will face substantial additional risks such as product liability.
WE HAVE LIMITED LIQUIDITY AND CAPITAL RESOURCES AND MAY NOT OBTAIN THE
SIGNIFICANT CAPITAL RESOURCES WE WILL NEED TO SUSTAIN OUR RESEARCH AND
DEVELOPMENT EFFORTS.
We have limited liquidity and capital resources and must obtain substantial
additional capital to support our research and development programs, for
acquisition of technology and intellectual property rights, and, to the extent
we decide to undertake these activities ourselves, for pre-clinical and clinical
testing of our anticipated products, pursuit of regulatory approvals,
establishment of production capabilities, establishment of marketing and sales
capabilities and distribution channels, and general administrative expenses.
Even though we owned 126,193 shares of Modex Therapeutics Ltd., stock with
an estimated fair market value on June 30, 2000 of $19,220,165 based on the per
share price of approximately $152.00, which we converted from a market price of
247.50 Swiss francs on June 30, 2000, we are restricted from selling these
shares until December 23, 2000. On October 31, 2000, the market price on Modex
stock was 329.50 Swiss francs, which converts to $183.28 using the exchange
rates on that date, and represents an estimated fair market value of $23,128,598
for our holdings. The performance of Modex stock since Modex's initial public
offering does not predict its future value and the value of our holdings is
subject to change and could decrease significantly. If we decide to sell our
Modex shares, due to the relatively small trading volume in Modex shares and the
relatively large size of our holding, or other factors, we may not be able to
sell our Modex shares at their market value or at all, and we may have to sell
these shares at a significant discount to the market price. In addition,
fluctuations in currency exchange rates could decrease the proceeds we might
realize on a potential sale of Modex shares.
We intend to pursue our needed capital resources through equity and debt
financings, corporate alliances, grants and collaborative research arrangements.
Our ability to complete any such arrangements successfully will depend upon
market conditions and, more specifically, on continued progress in our
research and development efforts. We may fail to obtain the necessary capital
resources from any such sources when needed or on terms acceptable to us. If we
do not obtain the necessary capital resources, we may have to delay, reduce or
eliminate some or all of our research and development programs or license our
technology or any potential products to third parties rather than
commercializing them ourselves.
WE HAVE PAYMENT OBLIGATIONS RESULTING FROM REAL PROPERTY OWNED OR LEASED BY
US IN RHODE ISLAND, WHICH ADVERSELY AFFECT OUR ABILITY TO FUND OUR STEM CELL
RESEARCH AND DEVELOPMENT.
Prior to our reorganization in 1999 and the resulting consolidation of all
functions in California, we carried out our former encapsulated cell therapy
programs at facilities in Lincoln, Rhode Island, where we also had our
administrative offices. Although we have vacated these facilities, we have
continuing obligations for lease payments and operating costs of approximately
$950,000 per year for our former science and administrative facility, which we
have leased through June 30, 2013, and debt service payments and operating costs
of approximately $1,000,000 per year for our former encapsulated cell therapy
pilot manufacturing facility. We are currently seeking to sublease the science
and administrative facility and to sell the pilot manufacturing facility, but
may not be able to do so. These continuing costs significantly reduce our cash
resources and adversely affect our ability to fund further development of our
stem cell technology. The lease for the science and administrative facility
contains a provision requiring occupancy of the premises and we currently are in
violation of this provision. The landlord has agreed not to take any action as a
result of this violation until November 19, 2000. We intend to seek an
additional period of forebearance from the landlord, but we cannot give any
assurance that the landlord will grant this additional forebearance or that we
will be able to sublease the premises during any additional period of time. If
the landlord decides to pursue its rights after any period of forebearance, we
may be required to pay the landlord the entire amount due for the rest of the
lease period.
WE MAY NEED BUT FAIL TO OBTAIN PARTNERS TO SUPPORT OUR STEM CELL DEVELOPMENT
EFFORTS AND TO COMMERCIALIZE OUR TECHNOLOGY.
Equity and debt financings alone may not be sufficient to fund the cost of
developing our stem cell technologies and we may need to rely on our ability to
reach partnering arrangements to provide financial support for our stem cell
discovery and development efforts. In addition, in order to successfully develop
and commercialize our technology, we may need to enter into a wide variety of
arrangements with corporate sponsors, pharmaceutical companies, universities,
research groups and others. While we have engaged, and expect to continue to
engage, in discussions regarding such arrangements, we have not reached any
agreement regarding any such arrangement and we may fail to obtain any such
agreement on terms acceptable to us, if at all. Even if we enter into these
arrangements, we may not be able to satisfy our obligations under them or renew
or replace them after their original terms. Furthermore, these arrangements may
require us to grant certain rights to third parties, including exclusive
marketing rights to one or more products, or may have other terms that are
burdensome to us, and may involve the acquisition of our securities. If any of
our collaborators terminates its relationship with us or fails to perform its
obligations in a timely manner, the development or commercialization of our
technology and potential products may be adversely affected.
We entered into a sponsored Research Agreement with the Scripps Research
Institute under which we funded certain research in return for license or
options to license the inventions resulting from the research. This agreement
expired on November 14, 2000 and we are negotiating with Scripps to extend the
term of this agreement or to enter into a new agreement. As of the date of this
report, we have not yet completed our negotiations with Scripps and we cannot
give any assurance that our negotiations will be successful. If we are unable to
extend the term of this agreement or enter into a new agreement, we will have to
find a replacement to perform this research or we will have to perform this
research ourselves. In either case, we may experience delay and additional
expense in connection with this research effort.
WE HAVE A HISTORY OF OPERATING LOSSES AND WE MAY FAIL TO OBTAIN REVENUES OR
BECOME PROFITABLE.
We have incurred $124,237,900 in operating losses through September 30, 2000
and expect to continue to incur substantial operating losses in the future in
order to conduct our research and development activities, and if those
activities are successful, to fund clinical trials and other expenses. These
expenses
include the cost of acquiring technology, product testing, acquiring regulatory
approvals, establishing production, marketing, sales and distribution programs,
and administrative expenses. We have not earned any revenues from sales of any
product. All of our past revenues have been derived from, and any revenues we
may obtain for the foreseeable future are expected to be derived from,
cooperative agreements, research grants, investments and interest on invested
capital. We have no cooperative agreements and we have received only two
research grants for our stem cell technology, and we may not obtain any such
agreements or additional grants in the future, or receive any revenues from
them.
WE DO NOT ANTICIPATE RECEIVING FUTURE REVENUES FROM THE SALE OF OUR
ENCAPSULATED CELL TECHNOLOGY.
In December 1999, we sold our encapsulated cell therapy technology to
Neurotech S.A. While under the terms of the sale we may receive royalty and
other payments from Neurotech under certain circumstances, we do not anticipate
receiving any material payments from Neurotech in the near future, if at all.
WE DEPEND ON PATENTS AND PROPRIETARY RIGHTS TO PROTECT OUR INTELLECTUAL
PROPERTY FROM INFRINGEMENT. NEVERTHELESS, SUCH PROTECTION IS UNCERTAIN AND, IF
GAINED, MAY OFFER ONLY LIMITED PROTECTION. IF WE ARE UNABLE TO PROTECT OUR
PATENTS AND PROPRIETARY RIGHTS, OUR BUSINESS, FINANCIAL CONDITION AND RESULTS OF
OPERATIONS WILL BE HARMED.
We own or license a number of patents or pending patent applications
covering human nerve stem cell cultures, central nervous system stem cell
cultures, neuroblast cultures, peripheral nervous system stem cell cultures, and
an animal model for liver failure. Patent protection for products such as those
we propose to develop is highly uncertain and involves complex and continually
evolving factual and legal questions. The governmental authorities that consider
patent applications can deny or significantly reduce the patent coverage
requested in an application before or after issuing the patent. Consequently, we
do not know whether any of our pending applications will result in the issuance
of patents, or if any existing or future patents will provide sufficient
protection or significant commercial advantage or if others will circumvent
these patents. Since patent applications are secret until patents are issued in
the United States or until the applications are published in foreign countries,
and since publication of discoveries in the scientific or patent literature
often lags behind actual discoveries, we cannot be certain that we were the
first to make the inventions covered by each of our pending patent applications
or that we were the first to file patent applications for such inventions. Our
patents may not issue from our pending or future patent applications or, if
issued, may not be of commercial benefit to us, or may not afford us adequate
protection from competing products. In addition, third parties may challenge our
patents or governmental authorities may declare them invalid. In the event that
a third party has also filed a patent application relating to inventions claimed
in our patent applications, we may have to participate in proceedings to
determine priority of invention. This could result in substantial uncertainties
and cost for us, even if the eventual outcome is favorable to us, and the
outcome might not be favorable to us. Even if a patent issues, a court could
decide that the patent was issued invalidly.
IF OTHERS ARE FIRST TO DISCOVER AND PATENT ANY STEM CELLS WE ARE SEEKING TO
DISCOVER, WE COULD BE BLOCKED FROM FURTHER WORK ON THAT STEM CELL, AND OUR
BUSINESS WOULD BE HARMED.
Because the first person or entity to discover and obtain a valid patent to
a particular stem or progenitor cell may effectively block all others, it will
be important to our development efforts for us or our collaborators to be the
first to discover any stem cell that we are seeking. Failure to be the first
could prevent us from commercializing all of our research and development
related to such stem cell and have a material adverse effect on the Company.
WE MAY NEED TO OBTAIN LICENSES TO THIRD PARTY PATENTS, AND MAY NOT BE ABLE
TO GET THEM.
A number of pharmaceutical, biotechnology and other companies, universities
and research institutions have filed patent applications or have received
patents relating to cell therapy, stem cells and other technologies potentially
relevant to or necessary for our expected products. We cannot predict which, if
any, of the applications will issue as patents. We are also aware of a number of
patent applications and patents claiming use of genetically modified cells to
treat disease, disorder or injury. We are aware of three patents issued to two
competitors claiming certain methods for enriching central nervous system stem
cells through gene modification of in vitro cultured cells. These patents were
issued or licensed to NeuralStem
and Layton Bioscience. It is possible that NeuralStem or Layton Bioscience will
be able to produce commercially available stem cell products before we can.
These genetically modified cells may be effective in treating defective,
diseased or damaged central nervous system tissue.
If third party patents or patent applications contain claims infringed by
our technology and these claims are valid, we may be unable to obtain licenses
to these patents at a reasonable cost, if at all, and may also be unable to
develop or obtain alternative technology. If we are unable to obtain such
licenses at a reasonable cost, our business could be significantly harmed. We
may have to to defend ourselves in court against allegations of infringement of
third party patents. Patent litigation is very expensive and could consume
substantial resources and create significant uncertainties. An adverse outcome
in such a suit could subject us to significant liabilities to third parties,
require disputed rights to be licensed from third parties, or require us to
cease using such technology.
Proprietary trade secrets and unpatented know-how are also important to our
research and development activities. We cannot be certain that others will not
independently develop the same or similar technologies on their own or gain
access to our trade secrets or disclose such technology, or that we will be able
to meaningfully protect our trade secrets and unpatented know-how and keep them
secret.
We require our employees, consultants, and significant scientific
collaborators and sponsored researchers to execute confidentiality agreements
upon the commencement of an employment or consulting relationship with us. These
agreements may, however, fail to provide meaningful protection or adequate
remedies for us in the event of unauthorized use, transfer or disclosure of such
information or inventions.
We have obtained rights from universities and research institutions to
technologies, processes and compounds that we believe may be important to the
development of our products. Licensors may cancel our licenses or convert them
to non-exclusive licenses if we fail to use the relevant technology or otherwise
breach these agreements. Loss of such licenses could expose us to the risks of
third party patents and/or technology. We can give no assurance that any of
these licenses will provide effective protection against our competitors.
WE COMPETE WITH COMPANIES THAT HAVE SIGNIFICANT ADVANTAGES OVER US.
The market for therapeutic products that address degenerative diseases is
large and competition is intense. We expect competition to increase. We believe
that our most significant competitors will be fully integrated pharmaceutical
companies and more established biotechnology companies, such as Biogen, Inc. and
Genzyme, an Elan Corporation. These companies already produce or are developing
treatments for degenerative diseases that are not stem-cell based, and they have
significantly greater capital resources and expertise in research and
development, manufacturing, testing, obtaining regulatory approvals and
marketing than we do. Many of these potential competitors have significant
products approved or in development that could be competitive with our potential
products, and also operate large, well-funded research and development programs.
In addition, we expect to compete with smaller companies such as NeuralStem and
Layton Bioscience and with universities and other research institutions who are
developing treatments for degenerative diseases that are stem-cell based.
Our competitors may succeed in developing technologies and products that are
more effective than those being developed by us, or that would render our
technology obsolete or non-competitive.
The relative speed with which we and our competitors can develop products,
complete the clinical testing and approval processes, and supply commercial
quantities of a product to market will affect our ability to gather market
acceptance and market share. With respect to clinical testing, competition may
delay progress by limiting the number of clinical investigators and patients
available to test our potential products.
DEVELOPMENT OF OUR TECHNOLOGY WILL BE SUBJECT TO EXTENSIVE GOVERNMENT
REGULATION.
Our research and development efforts, as well as any future clinical trials,
and the manufacturing and marketing of any products we may develop, will be
subject to extensive regulation by governmental authorities in the United States
and other countries. The process of obtaining U.S. Food and Drug
Administration and other necessary regulatory approvals is lengthy, expensive
and uncertain. We or our collaborators may fail to obtain the necessary
approvals to commence or continue clinical testing or to manufacture or market
our potential products in reasonable time frames, if at all. In addition, the
United States Congress and other legislative bodies may enact regulatory reforms
or restrictions on the development of new therapies that could adversely affect
the regulatory environment in which we operate or the development of any
products we may develop.
We base our research and development on the use of human stem and progenitor
cells obtained from fetal tissue. The federal and state governments and other
jurisdictions impose restrictions on the use of fetal tissue. These restrictions
change from time to time and may become more onerous. Additionally, we may not
be able to identify or develop reliable sources for the cells necessary for our
potential products--that is, sources that follow all state and federal
guidelines for cell procurement. Further, we may not be able to obtain such
cells in the quantity or quality sufficient to satisfy the commercial
requirements of our potential products. As a result, we may be unable to develop
or produce our products in a profitable manner.
We may apply for status under the Orphan Drug Act for certain of our
therapies, in order to gain a seven year period of marketing exclusivity for
those therapies. The U.S. Congress in the past considered, and in the future
again may consider, legislation that would restrict the extent and duration of
the market exclusivity of an orphan drug. If enacted, such legislation could
prevent us from obtaining some or all of the benefits of the existing statute
even if we were to apply for and be granted orphan drug status with respect to a
potential product.
WE DEPEND ON A LIMITED NUMBER OF KEY PERSONNEL.
We are highly dependent on the principal members of our management and
scientific staff and certain of our outside consultants, including the members
of our scientific advisory board, our chief executive officer, each of our vice
presidents and the directors of our neural stem cell and liver stem cell
programs. Although we have entered into employment agreements with some of these
individuals, they may terminate their agreements at any time. We currently have
outside consultants and interim personnel in key management and scientific
positions who are not permanent employees. Loss of services of any of these
individuals could have a material adverse effect on our operations, because
these individuals possess management experience or specialized scientific skills
which we do not otherwise have and which we may not be able to replace. In
addition, our operations are dependent upon our ability to attract and retain
additional qualified scientific and management personnel. More generally, we may
not be able to attract and retain the personnel we need on acceptable terms
given the competition for experienced personnel among pharmaceutical,
biotechnology and health care companies, universities and research institutions.
If we lose the services of these key personnel or are unable to attract and
retain additional qualified personnel, we may have to delay, reduce or eliminate
some or all of our research and development programs.
On September 22, 2000 we announced that George Dunbar, our acting President
and Chief Executive Officer, would be phasing out his service. Mr. Dunbar will
continue in his position on a reduced time basis during this transition period.
We are actively seeking to hire a permanent chief executive officer, but we can
give no assurance that we will be able to find a candidate possessing the
necessary qualifications. If we are unable to hire and retain a qualified chief
executive officer, our business and operations could suffer materially.
HEALTHCARE INSURERS AND OTHER ORGANIZATIONS MAY NOT PAY FOR OUR PRODUCTS OR
MAY IMPOSE LIMITS ON REIMBURSEMENTS.
In both domestic and foreign markets, sales of potential products are likely
to depend in part upon the availability and amounts of reimbursement from third
party health care payor organizations, including government agencies, private
health care insurers and other health care payors such as health maintenance
organizations and self-insured employee plans. There is considerable pressure to
reduce the cost of therapeutic products, and government and other third party
payors are increasingly attempting to contain health care costs by limiting both
coverage and the level of reimbursement for new therapeutic products,
and by refusing, in some cases, to provide any coverage for uses of approved
products for disease indications for which the Food and Drug Administration has
not granted marketing approval. Significant uncertainty exists as to the
reimbursement status of newly approved health care products. We can give no
assurance that reimbursement will be provided by such payors at all or without
substantial delay, or, if such reimbursement is provided, that the approved
reimbursement amounts will be sufficient to enable us to sell products we
develop on a profitable basis. Changes in reimbursement policy could also
adversely affect the willingness of pharmaceutical companies to collaborate with
us on the development of our stem cell technology.
In certain foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to government control. We expect that there will
continue to be a number of Federal and state proposals to implement government
control over health care costs. Efforts at healthcare reform are likely to
continue in future legislative sessions. We do not know what legislative
proposals Federal or state governments will adopt or what actions Federal, state
or private payers for healthcare goods and services may take in response to
healthcare reform proposals or legislation. We cannot predict the effect
government control and other healthcare reforms may have on our business.
OUR QUARTERLY OPERATING RESULTS MAY FLUCTUATE.
Our operating results have varied, and may in the future continue to vary,
significantly from quarter to quarter due to a variety of factors. These factors
include the receipt of one-time license or milestone payments under
collaborative agreements, costs associated with the wind-down of our
encapsulated cell therapy programs, variation in the level of expenses related
to our research and development efforts, receipt of grants or other support for
our research and development efforts, and other factors. Quarterly comparisons
of our financial results are not necessarily meaningful and you should not rely
upon them as an indication of future performance. Our stock price may be
volatile and this volatility could result in lawsuits or make it difficult to
raise capital. The market price for our common stock has been volatile and could
decline below the offering price for the shares. We believe that the market
price for our common stock could fluctuate substantially due to some or all of
the risk factors enumerated above.
The stock market has recently experienced extreme price and volume
fluctuations. These fluctuations have especially affected the market price of
the stock of many high technology and health care-related companies. Such
fluctuations have often been unrelated to the operating performance of these
companies. Nonetheless, these broad market fluctuations may negatively affect
the market price of our common stock. In the past, companies that have
experienced volatility in the market price of their stock have been the objects
of securities class action litigation. If we were the object of securities class
action litigation, we could incur material costs and suffer a diversion of our
management's attention and resources. In addition, volatility in our stock price
may make it difficult for us to obtain additional capital resources through
financings on terms acceptable to us.
EVENTS WITH RESPECT TO OUR SHARE CAPITAL COULD CAUSE THE PRICE OF OUR COMMON
STOCK TO DECLINE.
Sales of substantial amounts of our common stock on the open market, or the
availability of such shares for sale, could adversely affect the price of our
common stock. In particular, as of October 31, 2000, we had outstanding stock
options to purchase approximately 2,566,530 shares of common stock, at an
average exercise price of approximately $4.402 per share, subject to adjustment
in certain circumstances. Of this total, options covering approximately 941,309
shares are currently exercisable at an average exercise price of approximately
$4.742 per share.