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20070329144828
ACCESSION NUMBER: 0000893220-07-000986
CONFORMED SUBMISSION TYPE: 10-K
PUBLIC DOCUMENT COUNT: 9
CONFORMED PERIOD OF REPORT: 20061231
FILED AS OF DATE: 20070329
DATE AS OF CHANGE: 20070329
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: BIO IMAGING TECHNOLOGIES INC
CENTRAL INDEX KEY: 0000822418
STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-TESTING LABORATORIES [8734]
IRS NUMBER: 112872047
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 10-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-11182
FILM NUMBER: 07727264
BUSINESS ADDRESS:
STREET 1: 826 NEWTOWN-YARDLEY ROAD
CITY: NEWTOWN
STATE: PA
ZIP: 18940-1721
BUSINESS PHONE: 2677571360
MAIL ADDRESS:
STREET 1: 826 NEWTOWN-YARDLEY ROAD
CITY: NEWTOWN
STATE: PA
ZIP: 18940-1721
FORMER COMPANY:
FORMER CONFORMED NAME: WISE VENTURES INC
DATE OF NAME CHANGE: 19911023
10-K
1
w32201e10vk.htm
FORM 10-K
e10vk
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-K
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2006
Commission File
No. 1-11182
BIO-IMAGING TECHNOLOGIES,
INC.
(Exact name of
Registrant as specified in its Charter)
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Delaware
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11-2872047
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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826 Newtown-Yardley Road,
Newtown, Pennsylvania
(Address of Principal
Executive Offices)
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18940-1721
(Zip Code)
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(267) 757-3000
(Registrants Telephone
Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Exchange
Act:
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock $0.00025 par
value per share
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NASDAQ Global Market
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Securities registered pursuant to Section 12(g) of the
Exchange Act:
None
Check if the Registrant is a well-known seasoned issuer, as
defined in Rule 405 of the Securities
Act. Yes: o No: þ
Check if the Registrant is not required to file reports pursuant
to Section 13 or Section 15(d) of the
Act. Yes: o No: þ
Check whether the Registrant: (1) filed all reports
required to be filed by Section 13 or 15(d) of the
Securities Exchange Act 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: þ
No: o
Check if there is no disclosure of delinquent filers in response
to Item 405 of
Regulation S-K
contained in this form, and no disclosure will be contained, to
the best of Registrants 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. þ
Check if the Registrant is a larger accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
accelerated filer and larger accelerated filer in
Rule 12b-2
of the Exchange Act of 1934.
Large accelerated
filer o Accelerated
filer o Non-accelerated
filer þ
Check whether the Registrant is a shell company (as defined in
Rule 12b-2
of the Securities Exchange Act of
1934). Yes: o No: þ
The aggregate market value of the voting and non-voting common
equity held by non-affiliates of the Registrant was $27,391,181
on June 30, 2006, the last business day of the
Registrants most recently completed second fiscal quarter,
based on the average bid and asked prices on that date.
Indicate the number of shares outstanding of each of the
Registrants classes of common equity, as of
February 28, 2007:
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Class
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Number of Shares
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Common Stock, $.00025 par
value
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11,473,470
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The following documents are incorporated by reference into the
Annual Report on
Form 10-K:
Portions of the Registrants definitive Proxy Statement for
its 2007 Annual Meeting of Stockholders are incorporated by
reference into Part III of this Report.
PART I
General
Bio-Imaging Technologies, Inc., referred to herein as
we, us and our, is a global
pharmaceutical contract service organization, providing services
that support the product development process of the
pharmaceutical, biotechnology and medical device industries. We
specialize in assisting our clients in the design and management
of the medical imaging component of clinical trials for all
modalities, which consist of computerized tomography (CT),
magnetic resonance imaging (MRI), x-rays, dual energy x-ray
absorptiometry (DXA/DEXA), positron emission tomography (PET),
single photon emission computerized tomography (SPECT),
quantitative coronary angiography (QCA), cardiac MRI and CT,
intravascular ultrasound (IVUS), peripheral quantitative
angiography (QVA) and ultrasound.
We utilize proprietary processes and software applications in
providing our services to pharmaceutical companies conducting
clinical studies in which medical imaging modalities are used to
evaluate the efficacy and safety of pharmaceuticals, biologics
or medical devices. Our digital image processing and computer
analysis techniques enable technologists or radiologists to make
highly precise measurements and biostatistical inferences about
drug or device effects. The resulting data enables our clients
and regulatory reviewers, primarily the U.S. Food and Drug
Administration and comparable European agencies, to evaluate
product efficacy and safety. In addition, we have developed
specialized computer services and software applications that
enable independent radiologists and other medical specialists
involved in clinical trials to review medical image data in an
entirely digital format. Our services also include the
regulatory submission of medical images, quantitative data and
text.
We are directing our marketing and sales efforts towards those
clinical development areas that use medical imaging. These areas
include oncology, musculoskeletal, central nervous system,
neurovascular and cardiovascular, among others.
We have a European facility in Leiden, the Netherlands that
provides centralized image processing services for our European
clients. We manage our services for European-based clinical
trials from this facility. Our European facility has similar
processing and analysis capabilities as our United States
headquarters.
In February 2007, we acquired 100% of the stock of Theralys
S.A., referred to as Theralys, a privately held company located
in Lyon, France. Theralys is an imaging core lab providing
centralized blinded read services and customized image analysis
services primarily in the field of central nervous system
disorders and neurovascular diseases. Theralys proprietary
image processing software enables the introduction of
quantitative imaging markers in the design of clinical trials
for Neurovascular and CNS disorders, which include stroke,
secondary prevention drugs, multiple sclerosis and dementia,
including Alzheimers disease. Theralys proprietary
and validated software for clinical trials includes applications
that enable the automated quantitation of various imaging
parameters such as brain, white matter lesion and hippocampal
volumes and MRI diffusion and perfusion.
In December 2004, we acquired 100% of the stock of Heart Core
B.V., referred to as Heart Core, a privately held company
located in Leiden, the Netherlands. Heart Core is a global
provider of centralized imaging analysis services in the field
of cardiovascular, pulmonary and orthopedic clinical research.
We were incorporated in Delaware in 1987 under the name Wise
Ventures, Inc. Our name was changed to Bio-Imaging Technologies,
Inc. in 1991. The address of our principal executive offices is
826 Newtown-Yardley Road, Newtown, Pennsylvania, 18940, and our
telephone number is
267-757-3000.
Our Internet website is www.bioimaging.com. We also utilize the
Internet website www.capmed.com for the CapMed division of our
business. We make available on our Internet website all of our
public filings with the Securities and Exchange Commission, or
SEC. However, nothing on our Internet website is intended to be
incorporated by reference into this
Form 10-K
or any other filing made by us with the SEC. The public may read
or copy any filings Bio-Imaging, Technologies, Inc. files with
the SEC at the SEC Public Reference Room at 100 F. Street, N.E.,
Room 1580, Washington, D.C. 20549. The public can also
obtain information on the operation of the Public Reference Room
by calling the SEC at
1-800-SEC-0330.
1
Business
Services
Core
Laboratory Services
We are a leading provider of medical imaging management services
for clinical development purposes. Our imaging core laboratory
facilities in the United States and Europe provide centralized
image data collection, processing, analysis and archival
services for clinical trials conducted worldwide. The facilities
are designed for high-volume efficient processing of film and
digital image data in a secure environment that complies with
regulatory guidelines for clinical data management.
Medical image data are received by us from clinical trial sites,
located throughout the world. We have developed procedures for
data tracking and quality control that we believe to be of
significant value to our clients. Our facilities contain
specialized hardware and software for the digitization of films
and translation of digital data, enabling data to be
standardized, regardless of its source. We believe our ability
to handle most commercially available image file formats is a
valuable technical asset and an important competitive advantage
in gaining new business from large global multi-center clinical
trials.
We perform image analyses on client data using internally
developed or specially configured software. We measure key
indicators of drug efficacy in different organs and disease
states. The results from image analysis derived in our
facilities are transferred to databases that can be transmitted
electronically to our clients or integrated directly into our
Bio/ImageBasetm
package for regulatory submission on our clients behalf.
Information
Management Services
Our information management services focus on providing
specialized solutions for improving the quality, speed and
flexibility of image data management for clinical trials. We
believe that our Computer Assisted Masked Reading systems, or
CAMRtm
systems, offer numerous advantages over conventional film-based
medical image reading scenarios, including increased reading
speed, greater standardization of image reading, and reduced
error in the capture of reader interpretations.
Using our
CAMRtm
systems, independent medical specialists can review medical
image data from clinical trials in a digital format. The
CAMRtm
systems display all modalities of medical image data, regardless
of source equipment. In addition, the systems display either
translated digital data or digitized films. Such image reviews
are often required during clinical trials to evaluate
patients responses to therapy or to determine if patients
qualify for studies. By using the
CAMRtm
systems to read and evaluate image data, medical specialists
achieve greater reading speed than is possible with film and
perform evaluations in a more objective, reproducible manner.
We have also developed
remote CAMRtm
systems, or
rCAMRtm
systems, that are located on the premises, either home or
office, of the individual medical specialists who are engaged by
the sponsor to perform the analysis of the medical image data.
Historically, the
CAMRtm
systems have been utilized to determine efficacy of the
compounds being studied. More recently, clients are requesting
us to provide rapid turn-around reads for inclusion/exclusion
criteria. We believe that the
rCAMRtm
system is the optimal tool for this work because it allows us,
at our clients discretion, to provide the images to an
expert in the field to facilitate the review of the images from
the experts office or home.
We have developed an image database software application,
Bio/ImageBasetm,
that enables our clients to submit their medical images and
related clinical data to the FDA in a digital format. Using data
stored on CD-ROM or DVD disks,
Bio/ImageBasetm
allows clients and FDA medical reviewers to review medical
images and related clinical data. We believe that
Bio/ImageBasetm
offers the potential to decrease review time, resulting in
faster regulatory approvals and reduced
time-to-market
for new drugs, biologics and medical devices.
Our
Bio/ImageBasetm
software has been installed at client sites and on two
off-the-shelf
image reading and review computer systems at the FDA. We have
been using our
Bio/ImageBasetm
software to submit medical images and related data to the FDA
since mid-1993. In March 1996,
Bio/ImageBasetm
was cited in the FDAs 1996 Computer-Assisted Product
License Application Guidance Manual as an acceptable database
for submission of imaging data.
2
CapMed
Division
Our CapMed division includes the Personal Health Record
software, or PHR, which is a software application that enables
users to manage and store personal health information, including
their medical images, on the privacy of their desktop computer,
while linking directly to sponsor-directed resources such as
drug information, patient education or disease guidelines.
CapMed also includes the Personal
HealthKeytm
that plugs into a computers USB port, allowing doctors and
patients easy access to the patients medical record
without the need for additional hardware or software, and it is
password protected.
Other
Services
We provide technical consulting in the evaluation of the sites
that may participate in clinical trials. We also consult with
clients regarding regulatory issues involved in the design,
execution, analysis and submission of medical image data in
clinical trials.
Target
Markets
Our primary target market is comprised of pharmaceutical,
biotechnology and medical device companies whose clinical
development pipelines include drugs, biologics or devices that
are typically evaluated by medical imaging methods. This global
target market includes leading international pharmaceutical
companies and biotechnology companies with products currently in
the clinical development pipeline.
We focus our marketing on the following stages of clinical
development:
Phase II
Clinical Trials
Phase II clinical trials are generally conducted over six
months to two years and involve basic efficacy, safety and
dose-range testing in approximately 50 to 400 patients
suffering from the disease or condition under study. Such trials
help determine the best effective dose, confirm that the drug
works as expected and provide initial safety data.
Phase III
Clinical Trials
Phase III clinical trials are generally conducted over one
to four years and involve efficacy and safety studies in broader
populations of hundreds or thousands of patients and many
investigational sites, such as hospitals and clinics. These
trials are sometimes referred to as pivotal studies for
submission to the regulatory agencies. Generally, Phase III
studies are intended to provide additional information on drug
safety and efficacy, and the evaluation of the risk-benefit of
the drug and information for the adequate labeling of the
product.
Phase IV
Post Approval Studies
Phase IV studies are studies conducted after a
pharmaceutical drug or device has been approved for use. These
studies are generally conducted over a two to four year period
and involve either a continuation of a Phase III patient
population or the recruitment of a new patient population. As
there continues to be pressure to expedite approval of
pharmaceuticals and medical devices, there is an increase in the
number of conditional approvals based on the conduct of
additional Phase IV studies.
In addition, our experience spans a wide range of therapeutic
areas with a concentration in the following:
Cancer
Therapeutics
Many pharmaceutical companies are currently developing new
therapies for the treatment of cancer. For solid tumor studies,
medical imaging modalities are used to determine the response of
treated and untreated tumors. These medical images are evaluated
by medical specialists during the course of oncology clinical
trials to determine the extent of disease and changes in tumor
size over time.
The FDAs guidelines aimed at accelerating access to new
drugs for the review and approval of new cancer therapies place
greater emphasis on shrinkage of tumors as an early indicator of
anti-tumor efficacy. We believe that these FDA guidelines may
have a favorable impact on our business as pharmaceutical and
biotechnology companies
3
may have an increased need for regulatory compliant medical
imaging services to conduct their oncology clinical trials.
Musculoskeletal
Therapeutics
Anti-inflammatory clinical trials, such as those focused on
arthritis, include radiologic evaluation of the bones and joints
to determine drug efficacy. We believe that demand among
pharmaceutical companies for our services will increase as new
classes of biotechnology-derived drugs enter and progress
through the clinical development pipeline.
Osteoporosis is a disease characterized by thinning bones, which
leads to fractures in the elderly. The FDA guidance document for
developing treatments for this disease recognized DEXA as one of
the primary efficacy and safety measurement tools available.
Furthermore, all data needs to go through a quality assurance
laboratory. This is now standard practice in all studies using
DEXA instruments whether for osteoporosis, oncology or
anti-obesity, or muscle wasting assessment.
Central
Nervous System and Neurovascular Therapeutics
Many pharmaceutical companies are developing drugs for treatment
of neurovascular diseases and conditions of the central nervous
system, referred to as CNS, such as multiple sclerosis,
infectious diseases that target the CNS, stroke and
Alzheimers disease. For many of these diseases, the
diagnosis is largely dependent upon imaging, particularly MRI.
We believe that the central nervous system clinical trials
business may increase as more therapies progress through the
research pipeline and as baby boomers continue to age, driving
the demand for these products.
Cardiovascular
Therapeutics
We provide our services to clients developing drugs and medical
devices for the diagnosis and treatment of cardiovascular
diseases and conditions that are evaluated with the aid of
medical imaging. We offer various cardiovascular, quantitative,
image-analysis services including: quantitative coronary
angiography (QCA), cardiac MRI and CT, ultrasound, intravascular
ultrasound (IVUS) and peripheral quantitative angiography (QVA).
We have participated in numerous multinational trials for
leading pharmaceutical, biotechnology and medical device
companies throughout the world. In addition, as research
continues to advance, our collective knowledge base of the
underlying pathophysiology of cardiovascular disease will grow
as well as the need for advanced imaging technology to be used
in cardiovascular trials. For example, CT may be used to
identify coronary calcifications, which are considered to be a
predictor of cardiovascular risk. It follows that clinical
trials involving therapeutic interventions targeting coronary
calcifications will require imaging as an endpoint of efficacy.
Diagnostic
Imaging Agents
We provide our services to clients developing diagnostic imaging
agents that are designed to diagnose disease conditions more
quickly and accurately in their development in order to
facilitate earlier and more accurate treatment.
Market
Trends
We believe that a variety of favorable regulatory, technological
and market trends may positively impact the demand for medical
imaging management services, including:
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FDA initiatives to streamline the regulatory submission and
review process that are being implemented continue to have a
beneficial impact on us. The FDA is investing in new information
technology and is continuing the process of formulating and
disseminating guidelines for standardizing the submission of
electronic data, including medical images. We expect submission
of image data to continue to be a requirement in key therapeutic
and diagnostic areas for evaluating the effectiveness of a drug
or imaging agent.
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Consolidation, restructuring and downsizing in the
pharmaceutical industry in response to downward pressure on
certain pharmaceutical and biotechnology companies drug
prices has resulted in increased outsourcing of certain research
and development activities.
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Overall, growth in pharmaceutical and biotechnology research and
development spending is increasing. As a result, we believe that
the outsourcing of development activities should like-wise
increase.
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New classes of drugs to treat conditions traditionally evaluated
by imaging are entering or progressing through the clinical
development pipeline, leading to increased demand for medical
imaging-related services. In addition, we believe that digital
technologies for data acquisition and management are penetrating
the radiology community.
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We believe that as pharmaceutical and biotechnology companies
increasingly attempt to expand the market for new drugs by
conducting clinical trials and pursuing regulatory approval in
multiple countries simultaneously, contract service
organizations with a global presence and expertise will continue
to benefit.
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Due to several factors, including, without limitation,
competition from commercial competitors and academic research
centers, the risk of project cancellations, slowing of patient
enrollment in on-going studies or delay of future project
awards, among others, we cannot assure you that demand for our
services and technologies will grow, sustain growth, or that
additional revenue generating opportunities will be realized by
us.
Intellectual
Property
Proprietary protection for our computer-imaging programs,
processes and know-how is important to our business. We have
developed certain technically derived procedures and computer
software applications that are intended to increase the
effectiveness and quality of our services. We rely upon patents,
trademarks, copyrights, trade secrets, know-how and continuing
technological innovation to develop and maintain our competitive
position. We have claimed trademark protection for
Bio/ImageBasetm,
CAMRtm,
rCAMRtm,
Intelligent
Imagingtm
and Personal Health
Keytm.
We hold patents for the two DEXA phantoms, titled Spine and
Variable Composition Phantoms, which we sell to trial sites. We
have a patent pending on our Personal Health
Keytm.
We have registered our Stylized Man Design with the
U.S. Patent and Trademark Office. We cannot assure you that
we can limit unauthorized or wrongful disclosures of trade
secrets or otherwise confidential information. In addition, to
the extent we rely on trade secrets and know-how to maintain our
competitive technological position, we cannot assure you that
others may not develop independently the same, similar or
superior techniques. Although our intellectual property rights
are important to the results of our operations, we believe that
other factors, such as our independence, process knowledge,
technical expertise and experience are more important, and that,
overall, these technological capabilities offer significant
benefits to our clients.
Government
Regulation
The research and development, manufacture and marketing of drugs
and medical devices are subject to stringent regulation by the
FDA in the United States and by similar authorities in other
countries. In addition, regulations imposed by other federal
agencies, as well as state and local authorities, may impact
such research and development, manufacturing and marketing.
The FDA has established mandatory procedures and safety
standards that apply to the clinical testing, manufacturing and
marketing of drugs and medical devices. These procedures and
safety standards include, among other things, the completion of
adequate and well-controlled human clinical trials to establish
the safety and efficacy of the drug or device for its
recommended conditions or use. We advise our clients in the
execution of clinical trials and other drug and device
development tasks. We do not administer drugs to or utilize
medical devices on patients.
The success of our business is dependent upon continued
acceptance by the FDA and other regulatory authorities of the
data and analyses generated by our services in connection with
the evaluation of the safety and efficacy of new drugs and
devices. The FDA has formal guidelines that encourage the use of
surrogate measures, through submission of digital image data,
for evaluation of drugs to treat life- threatening or
debilitating conditions. We cannot assure you that the FDA or
other regulatory authorities will accept the data or analyses
generated by us in
5
the future and, even assuming acceptance, we cannot assure you
that the FDA or other regulatory authorities will require the
application of imaging techniques to numbers of patients and
over time periods substantially similar to those required of
traditional safety and efficacy techniques.
Changes in the FDAs policy for the evaluation of
therapeutic oncology agents may have a positive impact on the
time to market of such therapeutics. According to FDA
guidelines, approval times for new cancer therapies can be
shortened if evidence of tumor shrinkage is verifiable and
demonstrable through the use of objective measurement
techniques. These guidelines place greater reliance on the use
of medical image data to demonstrate objective tumor shrinkage.
In addition, the FDA has implemented guidelines aimed at
accelerating other therapeutic categories through the use of
imaging markers as surrogate endpoints for measuring therapeutic
effectiveness. We believe the FDAs initiatives to
streamline and accelerate the submission and review process of
therapeutic agents has had a favorable impact on our business.
We believe that our ability to achieve continued and sustainable
growth will be materially dependent upon, among other factors,
the continued stringent enforcement of the comprehensive
regulatory framework by various government agencies. Any
significant change in these regulatory requirements or the
enforcement thereof, especially relaxation of standards, could
adversely affect our prospects.
The current European market regulation is more fragmented than
in the United States. However, we believe that our expertise in
working with the standards of the FDA provides us with
experience when working with the various European regulatory
agencies.
Competition
We continue to experience competition from commercial
competitors and academic research centers. The biopharmaceutical
services industry is highly competitive, and we face numerous
potential competitors in our business, including hundreds of
contract research organizations. We primarily compete against
specialty contract research organizations, or CROs, and to a
lesser extent, universities and teaching hospitals. Certain of
these competitors are owned by or are divisions of larger
organizations, some of which have substantially greater
resources than we do. As competition increases, we will look to
provide value-added services and undertake marketing and sales
programs to differentiate our services based on our expertise
and experience in specific therapeutic and diagnostic areas, our
technical expertise, our regulatory and clinical development
experience, our quality performance and our international
capabilities. Our competitive position also depends upon our
ability to attract and retain qualified personnel and develop
and preserve proprietary technology, processes and know-how.
Competition in our industry has resulted in additional pressure
being placed on price, service and quality. Although we believe
that we are well positioned against our competitors due to our
experience in clinical trials and regulatory compliance along
with our international presence, we cannot assure you that our
competitors or clients will not provide or develop services
similar or superior to those provided by us. This competition
could have a material adverse impact on us.
Marketing
and Sales
We provide and market our services on an international basis
primarily to pharmaceutical, biotechnology and medical device
companies. Our sales and marketing activities are directed by a
Senior Vice President of Medical Affairs and a Vice President of
Global Business Development, supported by in-house staff and
field business development personnel.
Our selling efforts are focused on North America and Western
Europe. Our marketing activities include exhibiting at major
trade shows, advertising in trade journals and the sponsoring of
industry associations.
Significant
Clients
During fiscal 2006, contracts with one client, Novartis
Pharmaceutical, Inc., which encompassed 14 projects, represented
10.9% of our service revenues for the year ended
December 31, 2006, while for the year ended
December 31, 2005, no one client accounted for 10% or more
of our service revenues. These contracts are
6
terminable by our client at any time and for any reason. The
loss of this client, or a reduction in services provided to this
client, would have a material adverse effect on our business,
financial condition and results of operations.
Employees
As of December 31, 2006, we had 283 employees, four of whom
are executive officers.
Of our employees, as of December 31, 2006, 26 were engaged
in sales and marketing, 227 were engaged in client related
projects and 30 were engaged in administration and management. A
significant number of our management and professional employees
have prior industry experience. We believe that we have been
successful in attracting skilled and experienced personnel,
however, it remains a competitive market for recruiting such
personnel. Although all of our employees are covered by
confidentiality and non-competition agreements, we cannot assure
you that such agreements will be enforceable. As of
February 28, 2007, we have employment agreements with two
of our executive officers. See Item 11. Executive
Compensation. We consider relations with our employees to
be good.
The more prominent risks and uncertainties inherent in our
business are described below. However, additional risks and
uncertainties may also impair our business operations. If any of
the following risks actually occur, our business, financial
condition or results of operations may suffer. Investing in our
common stock involves a high degree of risk. Any of the
following factors could harm our business and future results of
operations and you could lose all or part of your investment.
Risks
Related to Our Company and Business
We may
incur financial losses because contracts may be delayed or
terminated or reduced in scope for reasons beyond our
control.
Our clients may terminate or delay their contracts for a variety
of reasons, including, but not limited to:
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unexpected or undesired clinical results;
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the clients decision to terminate the development of a
particular product or to end a particular study;
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insufficient patient enrollment in a study;
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insufficient investigator recruitment;
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failure to perform our obligations under the contract; or
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the failure of products to satisfy safety requirements.
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In addition, we believe that FDA-regulated companies may proceed
with fewer clinical trials or conduct them without assistance of
contract service organizations if they are trying to reduce
costs as a result of cost containment pressures associated with
healthcare reform, budgetary limits or changing priorities.
These factors may cause such companies to cancel contracts with
contract service organizations.
We cannot assure you that our clients will continue to use our
services or that we will be able to replace, in a timely or
effective manner, departing clients with new clients that
generate comparable revenues. Further, we cannot assure you that
our clients will continue to generate consistent amounts of
revenues over time.
The loss, reduction in scope or delay of a large contract or the
loss or delay of multiple contracts could materially adversely
affect our business, although our contracts entitle us to
receive all fees earned up to the time of termination. The loss
of business from our client, Novartis Pharmaceutical, Inc.,
would have a material adverse effect on our financial condition.
7
We
depend on a small number of industries and clients for all of
our business, and the loss of one such significant client could
cause revenues to drop quickly and unexpectedly.
We depend on research and development expenditures by
pharmaceutical, biotechnology and medical device companies to
sustain our business. Our operations could be materially and
adversely affected if:
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clients businesses experience financial problems or are
affected by a general economic downturn;
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consolidation in the pharmaceutical, biotechnology or medical
device industries leads to a smaller client base for us; or
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clients reduce their research and development expenditures.
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During fiscal 2006, contracts with one client, Novartis
Pharmaceutical, Inc., which encompassed 14 projects, represented
10.9% of our service revenues for the year ended
December 31, 2006, while for the comparable period last
year, no one client accounted for 10% or more of our service
revenues for the year ended December 31, 2005. The loss of
business from a significant client or our failure to continue to
obtain new business to replace completed or canceled projects
would have a material adverse effect on our business and
revenues.
Our
contracted/committed backlog may not be indicative of future
results.
Our reported contracted/committed backlog of $75.2 million
at December 31, 2006 is based on anticipated service
revenue from uncompleted projects with clients. Backlog is the
expected service revenue that remains to be earned and
recognized on signed and verbally agreed to contracts. Contracts
included in backlog are subject to termination by our clients at
any time. In the event that a client cancels a contract, we
would be entitled to receive payment for all services performed
up to the cancellation date and subsequent client authorized
services related to the cancellation of the project. The
duration of the projects included in our backlog range from less
than three months to seven years. We cannot assure that this
backlog will be indicative of future results. A number of
factors may affect backlog, including:
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the variable size and duration of the projects (some are
performed over several years);
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the loss or delay of projects;
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the change in the scope of work during the course of a
project; and
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the cancellation of such contracts by our clients.
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Also, if clients delay projects, the projects will remain in
backlog, but will not generate revenue at the rate originally
expected. Accordingly, the historical relationship of backlog to
revenues may not be indicative of future results.
We
have experienced substantial expansion in the past, and if we
fail to properly manage that expansion, our business may
suffer.
Our business has expanded substantially in the past. Our
continuing sales and marketing efforts have increased the number
of projects under management from 270 in fiscal 2005 to 284 in
fiscal 2006. In addition, we acquired Theralys in February 2007,
HeartCore in December 2004 and CapMed in November 2003.
Rapid expansion, internally or through acquisitions, could
strain our operational, human and financial resources. If we
fail to properly manage this expansion, our results of
operations and financial condition might be adversely affected.
In order to manage our expansion, we must:
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effectively market our services to pharmaceutical, biotechnology
and medical device companies;
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continue to improve operating, administrative and information
systems;
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accurately predict future personnel and resource needs to meet
client contract commitments;
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successfully integrate our acquired companies and businesses;
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track the progress of on-going client projects; and
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8
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attract and retain qualified management, sales, professional and
technical operating personnel.
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We will face additional risks in expanding foreign operations.
Specifically, we might find it difficult to:
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assimilate differences in foreign business practices and
regulations;
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hire and retain qualified personnel; and
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overcome language and cultural barriers.
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We may
engage in future acquisitions, which may be expensive and time
consuming and from which we may not realize anticipated
benefits.
We may acquire additional businesses, technologies and products
if we determine that these additional businesses, technologies
and products complement our existing business or otherwise serve
our strategic goals. If we do undertake transactions of this
sort, the process of integrating an acquired business,
technology or product may result in operating difficulties and
expenditures and may absorb significant management attention
that would otherwise be available for ongoing development of our
business. Moreover, we may never realize the anticipated
benefits of any acquisition. Future acquisitions could result in
potentially dilutive issuances of our securities, the incurrence
of debt and contingent liabilities and amortization expenses
related to intangible assets, which could adversely affect our
results of operations and financial condition.
On February 6, 2007, we acquired 100% of the outstanding
securities of Theralys, a privately held company headquartered
in Lyon, France. The aggregate purchase price was 2,731,257
Euros ($3,556,097 as determined by an agreed upon exchange
rate), of which 2,375,484 Euros ($3,092,881) was paid in cash
and 355,773 Euros ($463,216) was paid in 57,408 shares of
our common stock. In addition to the aggregate purchase price,
certain stockholders of Theralys received an aggregate of
36,000 shares of our common stock at an average price of
$8.06885 per share.
Loss
of key personnel, or failure to attract and retain additional
personnel, may cause the success and growth of our business to
suffer.
Future success depends on the personal efforts and abilities of
the principal members of our senior management to provide
strategic direction, develop business, manage operations and
maintain a cohesive and stable environment. Specifically, we are
dependent upon Mark L. Weinstein, President and Chief Executive
Officer, David A. Pitler, Senior Vice President Operations,
Colin G. Miller, Ph.D., Senior Vice President Medical
Affairs and Ted I. Kaminer, Senior Vice President and Chief
Financial Officer. Although we have employment agreements with
Mr. Weinstein and Mr. Kaminer, this does not
necessarily mean that they will remain with us. Although we have
executive retention agreements with our officers, we do not have
employment agreements with any other key personnel. Furthermore,
our performance also depends on our ability to attract and
retain management and qualified professional and technical
operating staff. Competition for these skilled personnel is
intense. The loss of services of any key executive, or inability
to continue to attract and retain qualified staff, could have a
material adverse effect on our business, results of operations
and financial condition. We do not maintain any key employee
insurance on any of our executives.
Our
revenues, earnings and operating costs are exposed to exchange
rate fluctuations.
In fiscal 2006, a portion of our service revenues were
denominated in foreign currency. Our financial statements are
denominated in United States dollars. In the event a greater
portion of our service revenues are denominated in a foreign
currency changes in foreign currency exchange rates could affect
our results of operations and financial condition. Fluctuations
in foreign currency exchange rates could materially impact the
operating costs of our European facility in Leiden, the
Netherlands which are primarily Euro denominated.
9
Risks
Related to Our Industry
Our
failure to compete effectively in our industry could cause our
revenues to decline.
Significant factors in determining whether we will be able to
compete successfully include:
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consultative and clinical trials design capabilities;
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reputation for on-time quality performance;
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expertise and experience in specific therapeutic areas;
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the scope of service offerings;
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strength in various geographic markets;
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the price of services;
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ability to acquire, process, analyze and report data in a
time-saving and accurate manner;
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ability to manage large-scale clinical trials both domestically
and internationally;
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our size; and
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the service and product offerings of our competitors.
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If our services are not competitive based on these or other
factors, our business, financial condition and results of
operations will be materially harmed.
The biopharmaceutical services industry is highly competitive,
and we face numerous competitors in our business, including
hundreds of contract research organizations. If we fail to
compete effectively, we will lose clients, which would cause our
business to suffer. We primarily compete against in-house
departments of pharmaceutical companies, full service contract
research organizations, or CROs, small specialty CROs, and to a
lesser extent, universities and teaching hospitals. Some of
these competitors have substantially greater capital, technical
and other resources than we do. In addition, certain of our
competitors that are smaller specialized companies may compete
effectively against us because of their concentrated size and
focus.
Changes
in outsourcing trends in the pharmaceutical and biotechnology
industries could adversely affect our operating results and
growth rate.
Service revenues depend greatly on the expenditures made by the
pharmaceutical and biotechnology industries in research and
development. Accordingly, economic factors and industry trends
that affect our clients in these industries also affect our
business. For example, the practice of many companies in these
industries has been to hire outside organizations like us to
conduct clinical research projects. This practice has grown
significantly in the last decade, and we have benefited from
this trend. However, if this trend were to change and companies
in these industries were to reduce the number of research and
development projects they outsource, our business could be
materially adversely affected.
Additionally, numerous governments have undertaken efforts to
control growing healthcare costs through legislation, regulation
and voluntary agreements with medical care providers and
pharmaceutical companies. If future regulatory cost containment
efforts limit the profits that can be derived on new drugs, our
clients might reduce their research and development spending,
which could reduce our business.
Failure
to comply with existing regulations could result in increased
costs to complete clinical trials.
Our business is subject to numerous governmental regulations,
primarily relating to pharmaceutical product development and the
conduct of clinical trials. In particular, we are subject to
21 CFR Part 11 of the Code of Federal Regulations that
provides the criteria for acceptance by the FDA of electronic
records. If we fail to comply with these governmental
regulations, it could result in the termination of ongoing
clinical research or the disqualification of data for submission
to regulatory authorities. We also could be barred from
providing clinical trial services in the
10
future or be subjected to fines. Any of these consequences would
harm our reputation, our prospects for future work and our
operating results.
Our
CapMed division may not reach profitability.
Our CapMed division had a loss from operations of $1,554,564 in
fiscal 2006. If our CapMed division continues to incur such
losses, our businesses, results of operations and financial
condition will be materially adversely affected.
Changes
in governmental regulation could decrease the need for the
services we provide, which would negatively affect our future
business opportunities.
In recent years, the United States Congress and state
legislatures have considered various types of healthcare reform
in order to control growing healthcare costs. The United States
Congress and state legislatures may again address healthcare
reform in the future. We are unable to predict what legislative
proposals will be adopted in the future, if any. Similar reform
movements have occurred in Europe and Asia.
Implementation of healthcare reform legislation that results in
additional costs could limit the profits that can be made by
clients from the development of new products. This could
adversely affect our clients research and development
expenditures, which could, in turn, decrease the business
opportunities available to us both in the United States and
abroad. In addition, new laws or regulations may create a risk
of liability, increase costs or limit service offerings. We
cannot predict the likelihood of any of these events.
In addition to healthcare reform proposals, the expansion of
managed care organizations in the healthcare market may result
in reduced spending on research and development. Managed care
organizations efforts to cut costs by limiting
expenditures on pharmaceuticals and medical devices could result
in pharmaceutical, biotechnology and medical device companies
spending less on research and development. If this were to
occur, we would have fewer business opportunities and our
revenues could decrease, possibly materially.
Governmental agencies throughout the world, but particularly in
the United States, strictly regulate the drug
development/approval process. Our business involves helping
pharmaceutical and biotechnology companies navigate the
regulatory drug approval process. Changes in regulation, such as
relaxation in regulatory requirements or the introduction of
simplified drug approval procedures or an increase in regulatory
requirements that we may have difficulty satisfying could
eliminate or substantially reduce the need for our services. If
these changes in regulations were to occur, our business,
results of operations and financial condition could be
materially adversely affected. These and other changes in
regulation could have a material adverse impact on our available
business opportunities.
If
governmental agencies do not accept the data and analyses
generated by our services, the need for our services would be
eliminated or substantially reduced.
The success of our business is dependent upon continued
acceptance by the FDA and other regulatory authorities of the
data and analyses generated by our services in connection with
the evaluation of the safety and efficacy of new drugs and
devices. The FDA has formal guidelines that encourage the use of
surrogate measures through submission of digital
image data, for evaluation of drugs to treat life-threatening or
debilitating conditions. We cannot assure you that the FDA or
other regulatory authorities will accept the data or analyses
generated by us in the future and, even assuming acceptance, the
FDA or other regulatory authorities may not require the
application of imaging techniques to numbers of patients and
over time periods substantially similar to those required of
traditional safety and efficacy techniques. If the governmental
agencies do not accept data and analyses generated by our
services in connection with the evaluation of new drugs and
devices, the need for our services would be eliminated or
substantially reduced, and, as a result, our business, results
of operations and financial condition could be materially
adversely affected.
11
We may
be exposed to liability claims as a result of our involvement in
clinical trials.
We may be exposed to liability claims as a result of our
involvement in clinical trials. We cannot assure you that
liability claims will not be asserted against us as a result of
work performed for our clients. We maintain liability insurance
coverage in amounts that we believe are sufficient for the
pharmaceutical services industry. Furthermore, we cannot assure
you that our clients will agree to indemnify us, or that we will
have sufficient insurance to satisfy any such liability claims.
If a claim is brought against us and the outcome is unfavorable
to us, such outcome could have a material adverse impact on us.
Risks
related to our common stock
Your
percentage ownership and voting power and the price of our
common stock may decrease as a result of events that increase
the number of our outstanding shares.
As of December 31, 2006, we had the following capital
structure:
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Common stock outstanding
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11,309,550
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Common stock issuable upon:
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Exercise of options which are
outstanding
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1,870,662
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Exercise of options which have not
been granted
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714,216
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Total common stock outstanding
assuming exercise or conversion of all of the above
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13,894,428
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As of December 31, 2006, we had outstanding options to
purchase 1,870,662 shares of common stock at exercise
prices ranging from $0.63 to $7.03 per share (exercisable
at a weighted average of $2.61 per share), of which
1,690,362 options were then exercisable. Exercise of our
outstanding options into shares of our common stock may
significantly and negatively affect the market price for our
common stock as well as decrease your percentage ownership and
voting power. In addition, we may conduct future offerings of
our common stock or other securities with rights to convert the
securities into shares of our common stock. As a result of these
and other events, such as future acquisitions, that increase the
number of our outstanding shares, your percentage ownership and
voting power and the price of our common stock may decrease.
Shares
of our common stock eligible for public sale may have a negative
impact on its market price.
Future sales of shares of our common stock by existing holders
of our common stock or by holders of outstanding options, upon
the exercise thereof, could have a negative impact on the market
price of our common stock. As of December 31, 2006, we had
11,309,550 shares of our common stock issued and
outstanding, all of which are currently freely tradable. On
March 1, 2006, in connection with his employment agreement
dated March 28, 2005, we issued 14,850 shares of
restricted stock to our President and Chief Executive Officer,
this was net of 10,150 shares withheld for withholding
taxes associated with the issuance of the shares.
We are unable to estimate the number of shares that may be sold
because this will depend on the market price for our common
stock, the personal circumstances of the sellers and other
factors. Any sale of substantial amounts of our common stock or
other securities in the open market may adversely affect the
market price of the securities offered hereby and may adversely
affect our ability to obtain future financing in the capital
markets as well as create a potential market overhang.
There
are a limited number of shareholders who have significant
control over our common stock, allowing them to have significant
influence over the outcome of all matters submitted to our
stockholders for approval, which influence may conflict with our
interests and the interests of our other
stockholders.
Our directors, officers and principal stockholders (stockholders
owning 10% or more of our common stock), including Covance Inc.,
beneficially owned 34% of the outstanding shares of common stock
and stock options that could have been converted to common stock
at December 31, 2006, and such stockholders will have
significant influence over the outcome of all matters submitted
to our stockholders for approval, including the election of our
directors and other corporate actions. In addition, such
influence by these affiliates could have the effect of
12
discouraging others from attempting to take us over, thereby
increasing the likelihood that the market price of the common
stock will not reflect a premium for control.
Because
we do not intend to pay dividends, stockholders will benefit
from an investment in our common stock only if it appreciates in
value.
We have never declared or paid any cash dividends on our common
stock. We currently intend to retain our future earnings, if
any, to finance further research and development and do not
expect to pay any cash dividends in the foreseeable future. As a
result, the success of an investment in our common stock will
depend upon any future appreciation in its value. There is no
guarantee that our common stock will appreciate in value or even
maintain the price at which stockholders have purchased their
shares.
Trading
in our common stock may be volatile, which may result in
substantial declines in its market price.
The market price of our common stock has experienced historical
volatility and might continue to experience volatility in the
future in response to
quarter-to-quarter
variations in:
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operating results;
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analysts reports;
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market conditions in the industry;
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changes in governmental regulations; and
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changes in general conditions in the economy or the financial
markets.
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The overall market (including the market for our common stock)
has also experienced significant decreases in value in the past.
This volatility and potential market decline could affect the
market prices of securities issued by many companies, often for
reasons unrelated to their operating performance, and may
adversely affect the price of our common stock. Between
January 1, 2006 and December 31, 2006, our common
stock has traded at a low of $3.11 per share and a high of
$8.10 per share. Between January 1, 2007 and
February 28, 2007, our common stock has traded at a low of
$6.78 per share and a high of $9.40 per share.
Our common stock began trading on the NASDAQ Global Market,
formerly called the NASDAQ National Market, on December 18,
2003 and has a limited trading market. We cannot assure that an
active trading market will develop or, if developed, will be
maintained. As a result, our stockholders may find it difficult
to dispose of shares of our common stock and, as a result, may
suffer a loss of all or a substantial portion of their
investment.
Certain
provisions of our charter and Delaware law could make a takeover
difficult and may prevent or frustrate attempts by our
stockholders to replace or remove our management
team.
We have an authorized class of 3,000,000 shares of
undesignated preferred stock, of which 1,250,000 shares
were previously issued, and the remaining 1,750,000 shares
may be issued by our board of directors, on such terms and with
such rights, preferences and designation as the Board may
determine. Issuance of such preferred stock, depending upon the
rights, preferences and designations thereof, may have the
effect of delaying, deterring or preventing a change in control
of our company. In addition, we are subject to provisions of
Delaware corporate law which, subject to certain exceptions,
will prohibit us from engaging in any business
combination with a person who, together with affiliates
and associates, owns 15% or more of our common stock for a
period of three years following the date that the person came to
own 15% or more of our common stock unless the business
combination is approved in a prescribed manner.
These provisions of our certificate of incorporation, and of
Delaware law may have the effect of delaying, deterring or
preventing a change in control of our company, may discourage
bids for our common stock at a premium over market price and may
adversely affect the market price, and the voting and other
rights of the holders, of our common stock. In addition, these
provisions make it more difficult to replace or remove our
current
13
management team in the event our stockholders believe this would
be in the best interest of our company and our stockholders.
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Item 1B.
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Unresolved
Staff Comments.
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None.
We lease 54,400 square feet of office space located in
Newtown, Pennsylvania. This lease expires June 2010 and provides
for a fixed base rent of $93,000 per month with an annual
inflation increase. We lease 7,447 square feet of
additional office space located in Newtown, Pennsylvania for
$6,100 per month in base rent expiring November 2008. In
addition, we lease 15,500 square feet of office space in
Leiden, the Netherlands. This lease, denominated in Euro,
expires in May 2008 and provides for a base rent of
$30,500 per month, based upon the conversion rate as of
December 31, 2006, with an annual inflation increase. We
believe that these facilities will be adequate for our needs for
the foreseeable future.
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Item 3.
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Legal
Proceedings.
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In the normal course of business, we may be a party to legal
proceedings. We are not currently a party to any material legal
proceedings.
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Item 4.
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Submission
of Matters to a Vote of Security Holders.
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None.
PART II
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Item 5.
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Market
for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities.
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Our common stock began trading on the NASDAQ Global Market,
formerly called the NASDAQ National Market, on December 18,
2003 under the symbol BITI. Prior to listing on the NASDAQ
Global Market, our common stock was traded on the American Stock
Exchange under the symbol BIT from February 25, 2003. Our
common stock was quoted on the NASD OTC Bulletin Board
under the symbol BITI prior to being listed on the American
Stock Exchange.
The following table sets forth the high and low bid quotations
for our common stock as reported on the NASDAQ Global Market for
each of the quarters from the quarter ended March 31, 2005
through December 31, 2006. Such quotations reflect
interdealer prices, without retail
mark-up,
mark-down or commission and may not represent actual
transactions.
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Common
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Stock
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Quarter Ended
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High
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Low
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March 31, 2005
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5.51
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2.59
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June 30, 2005
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3.15
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2.49
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September 30, 2005
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3.55
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2.72
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December 31, 2005
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3.29
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2.10
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March 31, 2006
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4.73
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3.11
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June 30, 2006
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4.83
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3.80
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September 30, 2006
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4.54
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3.51
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December 31, 2006
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8.10
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4.03
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14
As of February 28, 2007, the number of holders of record of
our common stock was 93 and the approximate number of beneficial
holders of our common stock was 1,700.
On February 6, 2007, we acquired 100% of the outstanding
securities of Theralys, a privately held company headquartered
in Lyon, France. The aggregate purchase price was 2,731,257
Euros ($3,556,097 as determined by an agreed upon exchange
rate), of which 2,375,484 Euros ($3,092,881) was paid in cash
and 355,773 Euros ($463,216) was paid in 57,408 shares of
our common stock. In addition to the aggregate purchase price,
certain stockholders of Theralys received an aggregate of
36,000 shares of our common stock at an average price of
$8.06885 per share.
On March 1, 2006, in connection with his employment
agreement dated March 28, 2005, we issued
14,850 shares of restricted stock to our President and
Chief Executive Officer, which was net of 10,150 shares
withheld for withholding taxes associated with the issuance of
the shares.
We believe that the issuance of the foregoing securities was
exempt from registration under Section 4(2) of the
Securities Act of 1933, as amended, as transactions not
involving a public offering. Each of the recipients were
sophisticated or accredited investors, acquired the securities
for investment purposes only and not with a view to distribution
and had adequate information about our company.
We have neither paid nor declared dividends on our common stock
since our inception and do not plan to pay dividends on our
common stock in the foreseeable future. We expect that any
earnings which we may realize will be retained to finance our
growth.
On November 9, 2005, our Compensation Committee of the
Board of Directors recommended, and our Board of Directors
approved, the acceleration of vesting of all
out-of-the-money
unvested options to purchase shares of our common stock with an
exercise price greater than $7.00 held by our current employees
and executive officers (but excluding any options granted to
members of our Board of Directors). These options were
previously awarded to our employees on February 4, 2004,
pursuant to the 2002 Stock Incentive Plan, and would still have
been unvested at January 1, 2006. Options to purchase
107,691 shares of common stock are subject to this
acceleration. The exercise price per share for these options was
$7.03, while the closing price per share on November 9,
2005 was $2.20.
The following table summarizes the options subject to
acceleration:
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Aggregate Number of
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Shares Issuable
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Under Accelerated
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Exercise Price
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Options
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per Share
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Date of Grant
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Employees as a group (other than
executive officers)
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69,722
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$
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7.03
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February 4, 2004
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Executive officers as a group
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37,969
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$
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7.03
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February 4, 2004
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The acceleration of vesting of these
out-of-the
money options is being undertaken primarily to eliminate any
future compensation expense our company would otherwise
recognize in its income statement with respect to these options
with the implementation of the Financial Accounting Standard
Board (FASB) statement Share-Based Payment
(FAS 123R) effective for our company on January 1,
2006. We estimate this compensation expense, before tax, would
be approximately $402,763 in aggregate future expenses based on
calculations using the Black-Scholes methodology.
15
STOCK
PRICE PERFORMANCE GRAPH
Our common stock is listed for trading on the NASDAQ Global
Market under the symbol BITI. The Stock Price
Performance Graph set forth below compares the cumulative total
stockholder return on the our common stock for the period from
December 31, 2001 through December 31, 2006, with the
cumulative total return of the NASDAQ U.S. Stock Index and
the NASDAQ Health Services Index over the same period. The
comparison assumes $100 was invested on December 31, 2001
in our common stock, in the NASDAQ U.S. Stock Index and in
the NASDAQ Health Services Index and assumes reinvestment of
dividends, if any.
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|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
Bio-Imaging Technologies,
Inc.
|
|
|
$
|
100.00
|
|
|
|
$
|
169.23
|
|
|
|
$
|
479.23
|
|
|
|
$
|
421.54
|
|
|
|
$
|
248.46
|
|
|
|
$
|
620.00
|
|
NASDAQ U.S. Stock Index
|
|
|
$
|
100.00
|
|
|
|
$
|
69.14
|
|
|
|
$
|
103.37
|
|
|
|
$
|
112.49
|
|
|
|
$
|
114.88
|
|
|
|
$
|
126.23
|
|
NASDAQ Health Services
|
|
|
$
|
100.00
|
|
|
|
$
|
86.16
|
|
|
|
$
|
131.76
|
|
|
|
$
|
166.06
|
|
|
|
$
|
228.23
|
|
|
|
$
|
227.90
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The foregoing Stock Price Performance Graph and related
information shall not be deemed soliciting material
or to be filed with the SEC, nor shall such
information be incorporated by reference into any future filing
under the Securities Act of 1933 or Securities Exchange Act of
1934, each as amended, except to the extent that we specifically
incorporate if by reference into such filing.
16
|
|
Item 6.
|
Selected
Financial Data.
|
The following table presents selected consolidated financial
data. This data is derived from our audited consolidated
financial statements and should be read in conjunction with the
Managements Discussion and Analysis of Financial
Condition and Results of Operations and the consolidated
financial statements and related footnotes included in this
Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended,
|
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
Dec. 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
|
|
|
(Dollars in thousands, except per share data and number of
employees)
|
|
|
OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue
|
|
$
|
31,857
|
|
|
$
|
23,712
|
|
|
$
|
25,069
|
|
|
$
|
21,748
|
|
|
$
|
17,190
|
|
Total revenue
|
|
$
|
40,519
|
|
|
$
|
30,486
|
|
|
$
|
29,691
|
|
|
$
|
25,211
|
|
|
$
|
20,879
|
|
Income (loss) from operations
|
|
|
1,115
|
|
|
|
(4,335
|
)
|
|
|
1,604
|
|
|
|
2,198
|
|
|
|
1,551
|
|
Net income (loss)
|
|
|
1,004
|
|
|
|
(2,545
|
)
|
|
|
949
|
|
|
|
2,338
|
|
|
|
1,140
|
|
Basic earnings (loss) per share
|
|
|
0.09
|
|
|
|
(0.23
|
)
|
|
|
0.09
|
|
|
|
0.25
|
|
|
|
0.14
|
|
Diluted earnings (loss) per share
|
|
|
0.08
|
|
|
|
(0.23
|
)
|
|
|
0.08
|
|
|
|
0.22
|
|
|
|
0.12
|
|
FINANCIAL POSITION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
|
|
$
|
16,166
|
|
|
$
|
10,554
|
|
|
$
|
9,650
|
|
|
$
|
13,289
|
|
|
$
|
2,563
|
|
Working capital
|
|
|
10,219
|
|
|
|
8,055
|
|
|
|
13,121
|
|
|
|
12,966
|
|
|
|
1,442
|
|
Total assets
|
|
|
34,108
|
|
|
|
28,791
|
|
|
|
28,374
|
|
|
|
25,907
|
|
|
|
11,440
|
|
Long-term debt
|
|
|
97
|
|
|
|
551
|
|
|
|
907
|
|
|
|
771
|
|
|
|
1,379
|
|
Stockholders equity
|
|
|
18,842
|
|
|
|
17,197
|
|
|
|
19,518
|
|
|
|
17,426
|
|
|
|
3,619
|
|
OTHER DATA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
$
|
2,232
|
|
|
$
|
1,871
|
|
|
$
|
1,849
|
|
|
$
|
1,641
|
|
|
$
|
992
|
|
Depreciation and amortization
|
|
|
2,035
|
|
|
|
2,312
|
|
|
|
1,760
|
|
|
|
1,076
|
|
|
|
738
|
|
Number of employees (not audited)
|
|
|
283
|
|
|
|
264
|
|
|
|
269
|
|
|
|
223
|
|
|
|
175
|
|
Weighted average shares used in
computing:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share
|
|
|
11,219
|
|
|
|
11,114
|
|
|
|
10,812
|
|
|
|
9,276
|
|
|
|
8,361
|
|
Diluted earnings (loss) per share
|
|
|
12,364
|
|
|
|
11,114
|
|
|
|
12,229
|
|
|
|
10,849
|
|
|
|
9,828
|
|
|
|
Item 7.
|
Managements
Discussion and Analysis of Financial Condition and Results of
Operations.
|
Overview
Pharmaceutical
Contract Services
We are a global pharmaceutical contract service organization,
providing services that support the product development process
of the pharmaceutical, biotechnology and medical device
industries. We specialize in assisting our clients in the design
and management of the medical imaging component of clinical
trials for all modalities, which consist of computerized
tomography (CT), magnetic resonance imaging (MRI), x-rays, dual
energy x-ray absorptiometry (DXA/DEXA), positron emission
tomography (PET), single photon emission computerized tomography
(SPECT), quantitative coronary angiography (QCA), cardiac MRI
and CT, intravascular ultrasound (IVUS), peripheral quantitative
angiography (QVA) and ultrasound. We provide services that
include the processing and analysis of medical images and the
data-basing and regulatory submission of medical images,
quantitative data and text.
Our sales cycle, referring to the period from the presentation
by us to a potential client to the engagement of us by such
client, has historically ranged from three to twelve months. In
addition, the contracts under which we perform services
typically cover a period of 12 to 60 months and the volume
and type of services performed by us generally vary during the
course of a project. We cannot assure you that our service
revenues will remain at levels
17
sufficient to maintain profitability. Service revenues were
generated from 128 clients encompassing 284 distinct projects
for fiscal 2006. This compares to 115 clients encompassing 270
distinct projects for fiscal 2005.
Our contracted/committed backlog, referred to as backlog, is the
expected service revenue that remains to be earned and
recognized on both signed and verbally agreed to contracts. Our
backlog was $75.2 million as of December 31, 2006.
This compares to $58.4 million as of December 31,
2005, an increase of 28.8%. This increase is primarily due to
our sales and marketing efforts for fiscal 2006 and an overall
market growth for medical-imaging related services for clinical
trials. Contracts included in backlog are subject to termination
by our clients at any time. In the event that a contract is
cancelled by the client, we would be entitled to receive payment
for all services performed up to the cancellation date. The
duration of the projects included in our backlog range from less
than three months to seven years. We believe that our backlog
assists our management as an indicator of our long-term
business. However, we do not believe that backlog is a reliable
predictor of near-term results because service revenues may be
incurred in a given period on contracts that were not included
in the previous reporting periods backlog
and/or
contract cancellations or project delays may occur in a given
period on contracts that were included in the previous reporting
periods backlog.
We believe that demand for our services and technologies will
continue to grow as the use of digital technologies for data
acquisition and management increases in the radiology and drug
development communities. We also believe that there is a growing
recognition within the bio-pharmaceutical industry of the
advantages in using an independent centralized core laboratory
for analysis of medical-imaging data and compliance with the
regulatory demands for the submission of such data and this may
lead to a growth in our market share for these services. The FDA
is also requiring more robust studies and additional data for
clinical trials. In addition, the FDA continues to develop
sophisticated guidelines for computerized submission of clinical
trial data, including medical images. Furthermore, we believe
that the increased use of digital medical images in clinical
trials, especially for important drug classes such as
anti-inflammatory, neurologic and oncologic therapeutics and
diagnostic image agents, generate large amounts of image data
from a large number of imaging sources. These studies require
processing, analysis, data management and submission services
best handled by vendors with scalable logistical capabilities
and extensive experience working with research facilities
worldwide. However, due to several factors, including, without
limitation, competition from commercial competitors and academic
research centers and the risk of project cancellations, slowing
of patient enrollment in on-going studies or delay of future
project awards, among others, we cannot assure you that demand
for our services and technologies will grow, sustain growth, or
that additional revenue generating opportunities will be
realized by us.
CapMed
Division
Our CapMed division offers the Personal Health Record software,
referred to as PHR, and the patent-pending Personal
HealthKeytm
technology. The PHR is a software application that enables users
to manage and store personal health information, including their
medical images, on the privacy of their desktop computer, while
linking directly to sponsor-directed resources such as drug
information, patient education, or disease guidelines. The
Personal
HealthKeytm
plugs into a computers USB port, allowing doctors and
patients easy access to the patients medical record
without the need for additional hardware or software, and it is
password protected.
We intend to expand our CapMed division through partnerships and
marketing efforts devoted to the PHR and Personal
HealthKeytm
products. We believe that continued emphasis on improving
patient care and reducing cost will contribute to the growth of
the personal electronic medical records market. CapMed continues
to progress towards the completion of its
dot-net
conversion and development of its web portal strategy, which
includes a web-based PHR. Once completed, our customers will
have the choice of managing their health through an on-line PHR,
from their desktop PC or from our patent-pending USB Healthkey,
which we believe will further enhance value in the marketplace
and reduce the lengthy sales cycle typical in this space. We
continue to be encouraged by the long-term prospects for this
division although the adoption rate has been slower than
anticipated.
Forward
Looking Statements
Certain matters discussed in this
Form 10-K
are forward-looking statements intended to qualify
for the safe harbors from liability established by the Private
Securities Litigation Reform Act of 1995. Such forward-looking
18
statements may be identified by, among other things, the use of
forward-looking terminology such as believes,
expects, may, will,
should or anticipates or the negative
thereof or other variations thereon or comparable terminology,
or by discussions of strategy that involve risks and
uncertainties. In particular, our statements regarding: our
projected financial results; growth potential for our CapMed
division; the demand for our services and technologies; growing
recognition for the use of independent centralized core
laboratories; trends toward the outsourcing of imaging services
in clinical trials; realized return from our marketing efforts;
increased use of digital medical images in clinical trials;
integration of our acquired companies and businesses; expansion
into new business segments; the success of any potential
acquisitions and the integration of current acquisitions; and
the level of our backlog are examples of such forward-looking
statements. The forward-looking statements include risks and
uncertainties, including, but not limited to, the timing of
revenues due to the variability in size, scope and duration of
projects, estimates made by management with respect to our
critical accounting policies, regulatory delays, clinical study
results which lead to reductions or cancellations of projects,
and other factors, including general economic conditions and
regulatory developments, not within our control. The factors
discussed in this
Form 10-K
and expressed from time to time in our filings with the SEC, as
well as the risk factors set forth in this
Form 10-K,
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
The forward-looking statements are made only as of the date of
this filing, and we undertake no obligation to publicly update
such forward-looking statements to reflect subsequent events or
circumstances.
Critical
Accounting Policies, Estimates and Risks
Our discussion and analysis of our financial condition and
results of operations are based upon our Consolidated Financial
Statements, which have been prepared in accordance with
accounting principles generally accepted in the United States.
The preparation of financial statements in accordance with
generally accepted accounting principles in the United States
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, including
the recoverability of tangible and intangible assets, disclosure
of contingent assets and liabilities as of the date of the
financial statements and the reported amounts of revenues and
expenses during the reported period.
On an on-going basis, we evaluate our estimates. The most
significant estimates relate to the recognition of revenue and
profits based on the proportional performance method of
accounting for fixed service contracts, allowance for doubtful
accounts and income taxes.
We believe the following critical accounting policies affect our
more significant judgments and estimates used in the preparation
of our Consolidated Financial Statements:
Revenue Recognition. Service revenues are
recognized over the contractual term of our customer contracts
using the proportional performance method, which is based on
hours incurred as a percentage of total estimated hours. Service
revenues are not recognized until we have a signed contract from
a customer which: (i) contains fixed or determinable fees;
and (ii) collectability of such fees is reasonably assured.
Any change to recognized service revenue as a result of
revisions to estimated total hours are recognized in the period
the estimate changes. Our revenue recognition policy entails a
number of estimates including an estimate of the total hours
that are expected to be incurred on a project, which is used as
the basis for determining the portion of our revenue to be
recognized for each period. The revenue recognized in any period
might have been materially affected if different assumptions or
conditions prevailed. The timing of our recognition of revenue
would be revised if there were changes in the total estimated
hours (other than scope changes in a project which typically
result in a revision to the contract). We review our total
estimated hours monthly. Provisions for losses expected to be
incurred on contracts, based on our monthly estimates, are
recognized in full in the period in which it is determined that
a loss will result from performance of the contractual
arrangement.
We enter into contracts that contain fixed or determinable
fees. The fees in the contracts are based on the
scope of work we are contracted to perform. There are unitized
fees per service and fixed fees with a total estimated for the
contract based upon the estimated unitized service expected to
be performed, as well as the service to be delivered under the
fixed fee component of the contract. The units are estimated
based on the information provided by the customer, and we bill
the customer for actual units completed in accordance with
19
the terms of the contract. In the event that a contract is
cancelled by the client, we would be entitled to receive payment
for all services performed up to the cancellation date.
Long-lived Assets, Intangibles and
Goodwill. Management annually evaluates the net
realizable value of long-lived assets, including property and
equipment, intangibles and goodwill relying on a number of
factors including operating results, business plans, economic
projections and anticipated future cash flows. If these factors
indicate that the carrying value of a long lived asset exceeds
the net realizable value, the Company will record an impairment
and reduce the carrying value of the asset to the net realizable
value.
Capitalized Software Development. We
capitalize development costs for a software project once the
preliminary project stage is completed, we have committed to
fund the project and it is probable that the project will be
completed and the software will be used to perform the function
intended. We cease capitalization at such time as the computer
software project is substantially complete and ready for its
intended use. The determination that a software project is
eligible for capitalization and the ongoing assessment of
recoverability of capitalized software development costs require
considerable judgment by us with respect to certain external
factors including, but not limited to, anticipated future
revenue, estimated economic life and changes in software and
hardware technologies.
Income Taxes. We evaluate the need to record a
valuation allowance to reduce our deferred tax assets to an
amount that is more likely than not to be realized. In assessing
the need for the valuation allowance, we consider our future
taxable income and on-going prudent and feasible tax planning
strategies. In the event that we were to determine that, in the
future, we would be able to realize our deferred tax assets in
excess of its net recorded amount, an adjustment to the deferred
tax asset would be made, thereby increasing net income in the
period such determination was made. Likewise, should we
determine that it is more likely than not that we will be unable
to realize all or part of our net deferred tax asset in the
future, an adjustment to the deferred tax asset would be
charged, thereby decreasing net income in the period such
determination was made. We recognize contingent liabilities for
any tax related exposures when those exposures are both probable
and estimable.
Derivatives. We use derivative financial
instruments to reduce the risk caused by interest rate
fluctuations. The derivative instruments are not held for
trading purposes. Derivatives are accounted for in accordance
with FAS No. 133, Accounting for Derivative
Instruments and Hedging Activities. We recognize
derivative instruments as either assets or liabilities in our
balance sheet and measure them at fair value. If designated as a
cash flow hedge, the corresponding changes in fair value are
recorded in stockholders equity (as a component of comprehensive
income/expense).
Stock-based compensation costs. Effective
January 1, 2006, we account for stock-based compensation
costs in accordance with SFAS 123R, which requires the
measurement and recognition of compensation expense for all
stock-based payment awards made to our employees and directors.
Under the fair value recognition provisions of SFAS 123R,
stock-based compensation cost is measured at the grant date
based on the value of the award and is recognized as expense
over the vesting period. Determining the fair value of the
stock-based awards at the grant date requires considerable
judgment. In addition, judgment is also required in estimating
the amount of stock-based awards that are expected to be
forfeited. If the actual experience differs significantly from
the assumptions used to compute our stock-based compensation
cost, or if different assumptions had been used, we may have
recorded too much or too little stock-based compensation cost.
Foreign
Currency Risks
Our financial statements are denominated in U.S. dollars.
Fluctuations in foreign currency exchange rates could materially
increase the operating costs of our facility in the Netherlands,
which are primarily Euro denominated. At December 31, 2006
and December 31, 2005, a 10% increase or decrease in the
Euro to U.S. dollar spot exchange rate would result in a
change of $41,600 and $60,000 to our net asset position,
respectively. In addition, certain of our contracts are
denominated in foreign currency. We believe that any adverse
fluctuation in the foreign currency markets relating to these
contracts will not result in any material adverse effect on our
financial condition or results of operations. In the event we
derive a greater portion of our service revenues from
international operations, factors associated with international
operations, including changes in foreign currency exchange
rates, could affect our results of operations and financial
condition.
20
We do hedge our foreign currency exposure. Our foreign currency
financial instruments primarily consist of cash, trade
receivables, prepaid expenses, fixed assets, trade payables and
accrued expenses and were in a net asset position at
December 31, 2006 and December 31, 2005. An increase
in the exchange rate would result in less net assets when
converted to U.S. dollars. Conversely, if we were in a net
liability position, a decrease in the exchange rate would result
in more net liabilities when converted to U.S. dollars.
Results
of Operations
The results of operations for our CapMed segment is not material
to the trend of the our financials and therefore, the results of
operations discussed below includes both our Pharmaceutical
Contract Services and CapMed segments.
Year
Ended December 31, 2006 Compared with Year Ended
December 31, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of
|
|
|
|
|
|
% of
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
Total
|
|
|
|
|
|
%
|
|
|
|
2006
|
|
|
Revenue
|
|
|
2005
|
|
|
Revenue
|
|
|
$ Change
|
|
|
Change
|
|
|
Service revenues
|
|
$
|
31,856,558
|
|
|
|
78.6
|
%
|
|
$
|
23,712,141
|
|
|
|
77.8
|
%
|
|
$
|
8,144,417
|
|
|
|
34.3
|
%
|
Reimbursement revenues
|
|
|
8,662,235
|
|
|
|
21.4
|
%
|
|
|
6,773,500
|
|
|
|
22.2
|
%
|
|
|
1,888,735
|
|
|
|
27.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
40,518,793
|
|
|
|
100.0
|
%
|
|
|
30,485,641
|
|
|
|
100.0
|
%
|
|
|
10,033,152
|
|
|
|
32.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
28,156,579
|
|
|
|
69.5
|
%
|
|
|
25,087,575
|
|
|
|
82.3
|
%
|
|
|
3,069,004
|
|
|
|
12.2
|
%
|
General and administrative expenses
|
|
|
5,507,518
|
|
|
|
13.6
|
%
|
|
|
4,960,378
|
|
|
|
16.3
|
%
|
|
|
547,140
|
|
|
|
11.0
|
%
|
Sales and marketing expenses
|
|
|
5,739,303
|
|
|
|
14.2
|
%
|
|
|
4,772,223
|
|
|
|
15.7
|
%
|
|
|
967,080
|
|
|
|
20.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and
expenses
|
|
|
39,403,400
|
|
|
|
97.2
|
%
|
|
|
34,820,176
|
|
|
|
114.2
|
%
|
|
|
4,583,224
|
|
|
|
13.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
1,115,393
|
|
|
|
2.8
|
%
|
|
|
(4,334,535
|
)
|
|
|
(14.2
|
)%
|
|
|
5,449,928
|
|
|
|
(125.7
|
)%
|
Interest income
|
|
|
559,816
|
|
|
|
1.4
|
%
|
|
|
189,609
|
|
|
|
0.6
|
%
|
|
|
370,207
|
|
|
|
195.2
|
%
|
Interest expense
|
|
|
(56,338
|
)
|
|
|
(0.1
|
)%
|
|
|
(106,287
|
)
|
|
|
(0.3
|
)%
|
|
|
49,949
|
|
|
|
(47.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
tax
|
|
|
1,618,871
|
|
|
|
4.0
|
%
|
|
|
(4,251,213
|
)
|
|
|
(13.9
|
)%
|
|
|
5,870,084
|
|
|
|
(138.1
|
)%
|
Income tax provision (benefit)
|
|
|
614,772
|
|
|
|
1.5
|
%
|
|
|
(1,705,841
|
)
|
|
|
(5.6
|
)%
|
|
|
2,320,613
|
|
|
|
(136.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
1,004,099
|
|
|
|
2.5
|
%
|
|
$
|
(2,545,372
|
)
|
|
|
(8.3
|
)%
|
|
$
|
3,549,471
|
|
|
|
(139.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues were $31,856,558 for fiscal 2006 and
$23,712,141 for fiscal 2005, an increase of $8,144,417, or
34.3%. The increase in service revenues was due to an increase
in work performed from our increased contract signings in fiscal
2005 and 2006. Our backlog at December 31, 2006 increased
to $75.2 million from $58.4 million at
December 31, 2005, an increase of 28.8%. We believe this
increase in backlog is an indicator that the overall market
growth for medical-imaging related services for clinical trials
continues to be positive, subject to project cancellations,
slowing of patient enrollment in on-going studies and delays of
future project awards. Service revenues were generated from 128
clients encompassing 284 distinct projects for fiscal 2006. This
compares to 115 clients encompassing 270 distinct projects for
fiscal 2005. Contracts with one client, Novartis Pharmaceutical,
Inc., which encompassed 14 projects, represented 10.9% of our
service revenues for the year ended December 31, 2006,
while no one client accounted for 10% or more of our service
revenues for the year ended December 31, 2005. Service
revenues generated from our client base, while still
concentrated as measured by the number of clients, has continued
to become more dispersed over time, and we believe more
diversification is evident when revenue concentration is
measured by the number of individual projects. Our primary scope
of work in both periods included medical-imaging core laboratory
services and image-based information management services.
21
Reimbursement revenues consist of payments received from the
customer for reimbursable costs. Reimbursement revenues
fluctuate significantly over the course of any given project and
quarter to quarter variations are a reflection of this project
timing. Therefore, our management believes that reimbursement
revenues are not a significant indicator of our overall
performance trends. At the request of our clients, we may
directly pay the independent radiologists who review our
clients imaging data. In such cases, per contractual
arrangement, these costs are billed to our clients and are
included in Reimbursement Revenue and Cost of Revenues.
Cost of revenues was $28,156,579 for fiscal 2006 and $25,087,575
for fiscal 2005, an increase of $3,069,004, or 12.2%. Cost of
revenues for fiscal 2006 and 2005 was comprised of professional
salaries and benefits, allocated overhead and pass-through
costs. The increase in cost of revenues is primarily due to the
increase in reimbursement costs for fiscal 2006 and consulting
costs associated with project related revenues. The decrease in
cost of revenues as a percentage of total revenues to 69.5% for
fiscal 2006 from 82.3% for fiscal 2005 is primarily attributable
to the reduced revenue in 2005 as a result of the contract
cancellations in 2004 and process improvement efforts during
fiscal 2006. The cost of revenues as a percentage of total
revenues also fluctuates due to work-flow variations in the
utilization of staff and the mix of services provided by us in
any given period. We expect that our cost of revenues will
continue to increase in fiscal 2007 as reimbursement revenues
and service revenues increase.
General and administrative expenses were $5,507,518 for fiscal
2006 and $4,960,378 for fiscal 2005, an increase of $547,140, or
11.0%. General and administrative expenses in fiscal 2006 and
2005 consisted primarily of salaries and benefits, depreciation
and amortization, professional and consulting services, office
rent and corporate insurance. The increase is primarily due to
an increase in professional and consulting services. We expect
that our general and administrative expense will increase in
2007 due to anticipated additional expenditures for compliance
with the Sarbanes-Oxley Act of 2002. The decrease in general and
administrative expenses as a percentage of total revenues to
13.6% for fiscal 2006 from 16.3% for fiscal 2005 is primarily
due to a greater increase in our total revenues for fiscal 2006.
Sales and marketing expenses were $5,739,303 for fiscal 2006 and
$4,772,223 for fiscal 2005, an increase of $967,080, or 20.3%.
Sales and marketing expenses in fiscal 2006 and 2005 were
comprised of direct sales and marketing costs, salaries and
benefits and allocated overhead. The increase is due to an
increase associated with our CapMed division of $349,000,
$135,000 in expenses associated with tradeshow appearances and
$479,000 in personnel costs and sales commissions due to the
increase in contract signings for fiscal 2006 as compared to
fiscal 2005. We expect that sales and marketing expenses will
increase in fiscal 2007 as we continue to expand our market
presence in the United States and Europe. The decrease in sales
and marketing expenses as a percentage of total revenues to
14.2% for fiscal 2006 from 15.7% for fiscal 2005 is primarily
due to a greater increase in our total revenues for fiscal 2006.
Net interest income was $503,478 for fiscal 2006 and net
interest income was $83,322 for fiscal 2005, an increase of
$420,156, or 504.3%. This increase is primarily due to a higher
investable cash balances and higher interest rates on short term
investments. Also, interest expense has decreased as our capital
leases are maturing. Net interest income and expense for 2006
and 2005 is comprised of interest income earned on our cash
balance and interest expense incurred on equipment lease
obligations. Interest income may decrease in fiscal 2007 if we
utilize cash for acquisitions.
Income before income taxes was $1,618,871 for fiscal 2006, and
we had a loss before income tax of $4,251,213 for fiscal 2005,
an increase of $5,870,084 or 138.1%. The increase was due to the
reduction of $5,449,928 of operating loss from the prior year
from greater service revenue while expenses increased at a
slower rate due to our process improvement efforts during fiscal
2006.
Our income tax provision for fiscal 2006 was $614,772 versus an
income tax benefit for fiscal 2005 of $1,705,841. The income tax
benefit in fiscal 2005 resulted from recording a deferred tax
benefit for the future tax savings anticipated from using the
net operating loss carryforwards available at December 31,
2005. Our effective tax rate is approximately 37.4% for fiscal
2006 and 40% for fiscal 2005. The decrease in the effective tax
rate is due to the mix of pre-tax income in the U.S. versus
the Netherlands, which has a lower corporate income tax rate.
22
Year
Ended December 31, 2005 Compared with Year Ended
December 31, 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of
|
|
|
|
|
|
% of
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
Total
|
|
|
|
|
|
%
|
|
|
|
2005
|
|
|
Revenue
|
|
|
2004
|
|
|
Revenue
|
|
|
$ Change
|
|
|
Change
|
|
|
Service revenues
|
|
$
|
23,712,141
|
|
|
|
77.8
|
%
|
|
$
|
25,068,670
|
|
|
|
84.4
|
%
|
|
$
|
(1,356,529
|
)
|
|
|
(5.4
|
)%
|
Reimbursement revenues
|
|
|
6,773,500
|
|
|
|
22.2
|
%
|
|
|
4,622,105
|
|
|
|
15.6
|
%
|
|
|
2,151,395
|
|
|
|
46.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
30,485,641
|
|
|
|
100.0
|
%
|
|
|
29,690,775
|
|
|
|
100.0
|
%
|
|
|
794,866
|
|
|
|
2.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
25,087,575
|
|
|
|
82.3
|
%
|
|
|
20,451,633
|
|
|
|
68.9
|
%
|
|
|
4,635,942
|
|
|
|
22.7
|
%
|
General and administrative expenses
|
|
|
4,960,378
|
|
|
|
16.3
|
%
|
|
|
4,452,535
|
|
|
|
15.0
|
%
|
|
|
507,843
|
|
|
|
11.4
|
%
|
Sales and marketing expenses
|
|
|
4,772,223
|
|
|
|
15.7
|
%
|
|
|
3,182,125
|
|
|
|
10.7
|
%
|
|
|
1,590,098
|
|
|
|
50.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and
expenses
|
|
|
34,820,176
|
|
|
|
114.2
|
%
|
|
|
28,086,293
|
|
|
|
94.6
|
%
|
|
|
6,733,883
|
|
|
|
24.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
(4,334,535
|
)
|
|
|
(14.2
|
)%
|
|
|
1,604,482
|
|
|
|
5.4
|
%
|
|
|
(5,939,017
|
)
|
|
|
(370.2
|
)%
|
Interest income
|
|
|
189,609
|
|
|
|
0.6
|
%
|
|
|
132,273
|
|
|
|
0.4
|
%
|
|
|
57,336
|
|
|
|
43.3
|
%
|
Interest expense
|
|
|
(106,287
|
)
|
|
|
(0.3
|
)%
|
|
|
(129,409
|
)
|
|
|
(0.4
|
)%
|
|
|
23,122
|
|
|
|
(17.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
tax
|
|
|
(4,251,213
|
)
|
|
|
(13.9
|
)%
|
|
|
1,607,346
|
|
|
|
5.4
|
%
|
|
|
(5,858,559
|
)
|
|
|
(364.5
|
)%
|
Income tax (benefit) provision
|
|
|
(1,705,841
|
)
|
|
|
(5.6
|
)%
|
|
|
658,434
|
|
|
|
2.2
|
%
|
|
|
(2,364,275
|
)
|
|
|
(359.1
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
(2,545,372
|
)
|
|
|
(8.3
|
)%
|
|
$
|
948,912
|
|
|
|
3.2
|
%
|
|
$
|
(3,494,284
|
)
|
|
|
(368.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues were $23,712,141 for fiscal 2005 and
$25,068,670 for fiscal 2004, a decrease of $1,356,529, or 5.4%.
The decrease in service revenues was due to a significantly
higher than historical norm cancellation rate in the fourth
quarter of fiscal 2004, which resulted in a loss of revenue from
anticipated projects for fiscal 2005. The cancellations were the
result of sponsors halting studies for clinical or strategic
considerations. Our backlog at December 31, 2005 increased
to $58.4 million from $38.5 million at
December 31, 2004, an increase of 52%. Service revenues
were generated from 115 clients encompassing 270 distinct
projects for fiscal 2005. This compares to 84 clients
encompassing 224 distinct projects for fiscal 2004. No one
client accounted for 10% or more of our service revenues for
fiscal 2005, while for the comparable period last year, one
client, Novartis Pharmaceuticals Corp., encompassing 18 distinct
projects represented 10.4% of our service revenues. No other
client accounted for more than 10% of service revenues in fiscal
year 2004.
Cost of revenues was $25,087,575 for fiscal 2005 and $20,451,633
for fiscal 2004, an increase of $4,635,942, or 22.7%. Cost of
revenues for fiscal 2005 and 2004 was comprised of salaries and
benefits, allocated overhead and pass-through costs. The
increase in cost of revenues is primarily due to the increase in
reimbursement revenues for fiscal 2005 of $2,151,395 and an
increase of $1,900,000 attributable to the expansion of our
European facility to expand our global capabilities and further
develop our therapeutic expertise in the cardiovascular area,
including the additional personnel and costs from the Heart Core
acquisition, which occurred on December 10, 2004. The
increase in cost of revenues as a percentage of total revenues
to 82.2% for fiscal 2005 from 68.9% for fiscal 2004 is primarily
attributable to the increase in reimbursement revenue, lower
service revenues for fiscal 2005 due to cancellations from the
fourth quarter of 2004 and the increase in cost from the
expansion of our European facility.
General and administrative expenses were $4,960,378 for fiscal
2005 and $4,452,535 for fiscal 2004, an increase of $507,843, or
11.4%. General and administrative expenses in fiscal 2005 and
2004 consisted primarily of salaries and benefits, depreciation
and amortization, professional and consulting services, office
rent and corporate insurance. The increase is primarily due to
an increase in professional and consulting services.
The increase in general and administrative expenses as a
percentage of total revenues to 16.3% for fiscal 2005 from 15.0%
for fiscal 2004 is primarily due to an increase in professional
and consulting services.
23
Sales and marketing expenses were $4,772,223 for fiscal 2005 and
$3,182,125 for fiscal 2004, an increase of $1,590,098, or 50.0%.
Sales and marketing expenses in fiscal 2005 and 2004 were
comprised of direct sales and marketing costs, salaries and
benefits and allocated overhead. The increase is due to an
increase associated with our CapMed division of $610,000,
$207,000 in fees and expenses associated with our Scientific
Advisory Board and $765,000 of other sales and marketing
expenses, including an increase of $322,000 in personnel costs
and sales commissions due to the increase in contract signings
for fiscal 2005 as compared to fiscal 2004.
The increase in sales and marketing expenses as a percentage of
total revenues to 15.7% for fiscal 2005 from 10.7% for fiscal
2004 is primarily due to increased expenses associated with our
CapMed division and Scientific Advisory Board and an increase in
personnel.
Net interest income was $83,322 for fiscal 2005 and net interest
income was $2,864 for fiscal 2004, an increase of $80,458, or
2,809.3%. This increase is primarily due to the payment of the
promissory note issued by us to Quintiles, Inc., referred to as
the Quintiles Note, in November 2004, and, therefore, we did not
incur this interest expense for fiscal 2005. Net interest income
and expense for 2005 and 2004 is comprised of interest income
earned on our cash balance and interest expense incurred on
equipment lease obligations. Net interest income and expense for
fiscal 2004 also included interest expense incurred on the
Quintiles Note.
The loss before income taxes was $4,251,213 for fiscal 2005, and
we had income before income tax of $1,607,346 for fiscal 2004, a
decrease of $5,858,559, or 364.5%. This decrease is due to the
loss in anticipated service revenues from contracts cancelled in
the fourth quarter of 2004 resulting from a cancellation rate
during that quarter that was significantly higher than
historical norms. The cancellations were the result of sponsors
halting studies for clinical or strategic considerations. The
convergence of cancellation rates higher than historical norms,
an overall slowing of patient enrollment in ongoing studies and
the delay of several anticipated projects combined with the
operating expense increases described above resulted in our
unfavorable fiscal 2005 results.
Our income tax benefit for fiscal 2005 was $1,705,841 versus an
income tax provision for fiscal 2004 of $658,434. The income tax
benefit in fiscal 2005 resulted from recording a deferred tax
benefit for the future tax savings anticipated from using the
net operating loss carryforwards available at December 31,
2005. As a result, our effective income tax rate was 40% for
fiscal 2005.
Liquidity
and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
Net cash provided by operating
activities
|
|
$
|
8,528,685
|
|
|
$
|
3,118,144
|
|
Net cash used in investing
activities
|
|
$
|
(2,232,461
|
)
|
|
$
|
(1,870,978
|
)
|
Net cash used in financing
activities
|
|
$
|
(683,628
|
)
|
|
$
|
(343,638
|
)
|
At December 31, 2006, we had cash and cash equivalents of
$16,166,264. Working capital at December 31, 2006 was
$10,218,505 as compared to working capital at December 31,
2005 of $8,055,374.
Net cash provided by operating activities for fiscal 2006 was
$8,528,685 as compared to net cash provided by operating
activities of $3,118,144 for fiscal 2005. This increase is
primarily due to the net collection of our accounts receivable
of $1,050,597 during fiscal 2006 and from the increase in our
deferred revenue of $3,196,192 at December 31, 2006 from
December 31, 2005 due to advance deposits received from our
clients for new contract signings. In addition, we had a net
income of $1,004,099 for fiscal 2006.
Net cash used in investing activities primarily represents our
investment in capital and leasehold improvements of $2,232,461.
We currently anticipate that capital expenditures for fiscal
2007 will be approximately $2.5 million. These expenditures
primarily represent additional upgrades in our networking, data
storage and core laboratory capabilities for both the United
States and European operations as well as capitalization of
software costs.
Net cash used in financing activities is primarily attributable
to payments on capital leases of $874,267.
24
The following table lists our cash contractual obligations as of
December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
Less Than
|
|
|
|
|
|
|
|
|
More Than
|
|
Contractual Obligations
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
|
Capital lease obligations
|
|
$
|
731,113
|
|
|
$
|
634,077
|
|
|
$
|
97,036
|
|
|
$
|
|
|
|
$
|
|
|
Facility rent operating leases
|
|
$
|
4,538,640
|
|
|
$
|
1,425,461
|
|
|
$
|
2,501,098
|
|
|
$
|
612,081
|
|
|
$
|
|
|
Employment agreements
|
|
$
|
678,833
|
|
|
$
|
323,000
|
|
|
$
|
355,833
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations
|
|
$
|
5,948,586
|
|
|
$
|
2,382,538
|
|
|
$
|
2,953,967
|
|
|
$
|
612,081
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On May 17, 2005, we renewed and amended our agreement with
Wachovia Bank, N.A. The renewed and amended agreement was for an
unsecured committed line of credit of $5,000,000. Interest was
payable at the LIBOR Market Index Rate plus 2.0%. The agreement
required us, among other things, to maintain certain financial
covenants. The committed line of credit matured June 30,
2006 and because of our cash balance at that time, we decided
not to incur the expense associated with renewing the line, and
therefore, did not renew the credit line.
On February 6, 2007, we acquired 100% of the outstanding
securities of Theralys, SA, referred to as Theralys, a privately
held company headquartered in Lyon, France. The aggregate
purchase price was 2,731,257 Euros ($3,556,097 as determined by
an agreed upon exchange rate), of which 2,375,484 Euros
($3,092,881) was paid in cash and 355,773 Euros ($463,216) was
paid in 57,408 shares of our common stock. In addition to
the aggregate purchase price, certain stockholders of Theralys
received an aggregate of 36,000 shares of our common stock
at an average price of $8.06885 per share.
We have neither paid nor declared dividends on our common stock
since our inception and do not plan to pay dividends on our
common stock in the foreseeable future.
We have not entered into any off-balance sheet transactions,
arrangements or other relationships with unconsolidated entities
or other persons.
We anticipate that our existing capital resources together with
cash flow from operations will be sufficient to meet our
foreseeable cash needs. However, we cannot assure you that our
operating results will continue to achieve profitability on an
annual basis in the future. The inherent operational risks
associated with:
|
|
|
|
|
our ability to gain new client contracts;
|
|
|
|
project cancellations;
|
|
|
|
the variability of the timing of payments on existing client
contracts; and
|
|
|
|
other changes in our operating assets and liabilities
|
may have a material adverse affect on our future liquidity.
We may seek to raise additional capital from equity or debt
sources in order to take advantage of unanticipated
opportunities, such as more rapid expansion, acquisitions of
complementary businesses or the development of new services. We
cannot assure you that additional financing will be available,
if at all, on terms acceptable to us.
Our fiscal year 2007 operating plan contains assumptions
regarding revenue and expenses. The achievement of our operating
plan depends heavily on the timing of work performed by us on
existing projects and our ability to gain and perform work on
new projects. Project cancellations or delays in the timing of
work performed by us on existing projects or our inability to
gain and perform work on new projects could have an adverse
impact on our ability to execute our operating plan and maintain
adequate cash flow. In the event actual results do not meet the
operating plan, our management believes it could execute
contingency plans to mitigate these effects. Considering the
cash on hand and based on the achievement of the operating plan
and managements actions taken to date, management believes
it has the ability to continue to generate sufficient cash to
satisfy our operating requirements in the normal course of
business for at least the next 12 months and the
foreseeable future.
25
Recently
Issued Accounting Statements
In September 2006, the FASB issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair Value
Measurements. This statement clarifies the definition of
fair value, establishes a framework for measuring fair value,
and expands the disclosures on fair value measurements.
SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007. We are currently evaluating the
impact of its adoption on its consolidated financial statements.
In June 2006, the Financial Accounting Standards Board issued
Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (FIN 48). FIN 48 prescribes a
more likely than not threshold for financial
statement recognition and measurement of a tax position taken or
expected to taken in a tax return. This interpretation also
provides guidance on other topics related to accounting for
income tax assets and liabilities, interest and penalties
associated with tax positions and income taxes in interim
periods as well as income tax disclosures. This interpretation
is effective as of January 1, 2007. We are currently
evaluating FIN 48 and the related impact on our financial
position and results of operations.
Existing
Contracts
As of December 31, 2006, we had entered into agreements
with 79 companies, encompassing 179 projects, to provide
services in the aggregate amount of $134.7 million through
April 2013, of which services valued at $75.2 million
remain to be completed. Such contracts are subject to
termination by us or our clients at any time or for any reason.
In addition, clients clinical trials or other projects are
subject to timing and scope changes. Therefore, total service
revenue generated by us during the life of these contracts may
be less than initial contract values.
Item 7a. Quantitative
and Qualitative Disclosures About Market Risk.
Interest
Rate Risk
We invest in high-quality financial instruments, primarily money
market funds, federal agency notes, asset backed securities,
corporate debt securities and United States treasury notes, with
an effective duration of the portfolio of less than nine months
and no security with an effective duration in excess of two
years, which we believe are subject to limited credit risk. We
currently do not hedge our interest rate exposure. Due to the
short-term nature of our investments, we do not believe that we
have any material exposure to interest rate risk arising from
our investments.
Foreign
Currency Risk
See Managements Discussion and Analysis of Financial
Condition and Results of Operations Foreign Currency
Risks for a more detailed discussion of our foreign
currency risks and exposures.
26
|
|
Item 8.
|
Financial
Statements and Supplementary Data.
|
|
|
|
|
|
Index to Consolidated Financial Statements
|
|
Page
|
|
|
|
|
28
|
|
|
|
|
29
|
|
|
|
|
30
|
|
|
|
|
31
|
|
|
|
|
32
|
|
|
|
|
33
|
|
27
Report of
Independent Registered Public Accounting Firm
To the Board of Directors
And Stockholders of
Bio-Imaging Technologies, Inc.:
In our opinion, the accompanying consolidated balance sheets and
the related consolidated statements of income and comprehensive
income, of shareholders equity and of cash flows, present
fairly, in all material respects, the financial position of
Bio-Imaging Technologies, Inc. and its subsidiaries at
December 31, 2006 and 2005, and the results of their
operations and their cash flows for each of the three years in
the period ended December 31, 2006 in conformity with
accounting principles generally accepted in the United States of
America. These financial statements are the responsibility of
the Companys management. Our responsibility is to express
an opinion on these financial statements based on our audits. We
conducted our audits of these statements in accordance with the
standards of the Public Company Accounting Oversight Board
(United States). 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,
assessing the accounting principles used and significant
estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
As discussed in Note 7 to the consolidated financial
statements, the Company changed the manner in which it accounts
for share-based compensation in 2006.
/s/ PricewaterhouseCoopers LLP
March 29, 2007
28
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
16,166,264
|
|
|
$
|
10,553,668
|
|
Accounts receivable, net of
allowance for doubtful accounts of $14,000 and $3,295,
respectively
|
|
|
5,564,748
|
|
|
|
6,631,477
|
|
Prepaid expenses and other current
assets
|
|
|
1,237,405
|
|
|
|
991,840
|
|
Deferred income taxes
|
|
|
2,210,800
|
|
|
|
715,217
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
25,179,217
|
|
|
|
18,892,202
|
|
Property and equipment, net
|
|
|
5,908,281
|
|
|
|
5,108,693
|
|
Intangibles and goodwill
|
|
|
2,227,438
|
|
|
|
2,518,812
|
|
Deferred income taxes
|
|
|
272,954
|
|
|
|
1,844,171
|
|
Other assets
|
|
|
519,821
|
|
|
|
427,055
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
34,107,711
|
|
|
$
|
28,790,933
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,720,481
|
|
|
$
|
1,680,922
|
|
Accrued expenses and other current
liabilities
|
|
|
3,334,554
|
|
|
|
2,026,612
|
|
Deferred revenue
|
|
|
9,451,219
|
|
|
|
6,255,027
|
|
Current maturities of capital
lease obligations
|
|
|
454,458
|
|
|
|
874,267
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
14,960,712
|
|
|
|
10,836,828
|
|
Long-term capital lease obligations
|
|
|
97,036
|
|
|
|
551,494
|
|
Other liability
|
|
|
208,208
|
|
|
|
205,787
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
15,265,956
|
|
|
|
11,594,109
|
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies
|
|
|
|
|
|
|
|
|
Stockholders
equity:
|
|
|
|
|
|
|
|
|
Preferred stock
$.00025 par value; authorized 3,000,000 shares, 0
issued and outstanding at December 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
Common stock
$.00025 par value; authorized 18,000,000 shares,
issued and outstanding 11,309,550 and 11,167,737 shares at
December 31, 2006 and 2005, respectively
|
|
|
2,827
|
|
|
|
2,792
|
|
Additional paid-in capital
|
|
|
22,864,390
|
|
|
|
22,302,328
|
|
Accumulated deficit
|
|
|
(4,042,619
|
)
|
|
|
(5,046,718
|
)
|
Accumulated other comprehensive
gain (loss)
|
|
|
17,157
|
|
|
|
(61,578
|
)
|
|
|
|
|
|
|
|
|
|
Stockholders
equity
|
|
|
18,841,755
|
|
|
|
17,196,824
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
34,107,711
|
|
|
$
|
28,790,933
|
|
|
|
|
|
|
|
|
|
|
29
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Service revenues
|
|
$
|
31,856,558
|
|
|
$
|
23,712,141
|
|
|
$
|
25,068,670
|
|
Reimbursement revenues
|
|
|
8,662,235
|
|
|
|
6,773,500
|
|
|
|
4,622,105
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
40,518,793
|
|
|
|
30,485,641
|
|
|
|
29,690,775
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
28,156,579
|
|
|
|
25,087,575
|
|
|
|
20,451,633
|
|
General and administrative expenses
|
|
|
5,507,518
|
|
|
|
4,960,378
|
|
|
|
4,452,535
|
|
Sales and marketing expenses
|
|
|
5,739,303
|
|
|
|
4,772,223
|
|
|
|
3,182,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and
expenses
|
|
|
39,403,400
|
|
|
|
34,820,176
|
|
|
|
28,086,293
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
1,115,393
|
|
|
|
(4,334,535
|
)
|
|
|
1,604,482
|
|
Interest income
|
|
|
559,816
|
|
|
|
189,609
|
|
|
|
132,273
|
|
Interest expense
|
|
|
(56,338
|
)
|
|
|
(106,287
|
)
|
|
|
(129,409
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
tax
|
|
|
1,618,871
|
|
|
|
(4,251,213
|
)
|
|
|
1,607,346
|
|
Income tax provision (benefit)
|
|
|
614,772
|
|
|
|
(1,705,841
|
)
|
|
|
658,434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
1,004,099
|
|
|
$
|
(2,545,372
|
)
|
|
$
|
948,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per common
share
|
|
$
|
0.09
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares
|
|
|
11,219,283
|
|
|
|
11,114,483
|
|
|
|
10,812,185
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per common
share
|
|
$
|
0.08
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equivalent shares
|
|
|
12,364,041
|
|
|
|
11,114,483
|
|
|
|
12,228,746
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Comprehensive
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Accumulated
|
|
|
Gain
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
(Loss)
|
|
|
Equity
|
|
|
Balance at December 31, 2003
|
|
|
10,710,481
|
|
|
$
|
2,678
|
|
|
$
|
20,873,968
|
|
|
$
|
(3,450,258
|
)
|
|
$
|
|
|
|
$
|
17,426,388
|
|
Stock options exercised
|
|
|
140,986
|
|
|
|
35
|
|
|
|
129,625
|
|
|
|
|
|
|
|
|
|
|
|
129,660
|
|
Shares issued for acquisition
|
|
|
175,853
|
|
|
|
44
|
|
|
|
847,831
|
|
|
|
|
|
|
|
|
|
|
|
847,875
|
|
Tax benefit on exercise of stock
options
|
|
|
|
|
|
|
|
|
|
|
164,807
|
|
|
|
|
|
|
|
|
|
|
|
164,807
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
948,912
|
|
|
|
|
|
|
|
948,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
11,027,320
|
|
|
|
2,757
|
|
|
|
22,016,231
|
|
|
|
(2,501,346
|
)
|
|
|
|
|
|
|
19,517,642
|
|
Stock options exercised
|
|
|
110,417
|
|
|
|
28
|
|
|
|
93,265
|
|
|
|
|
|
|
|
|
|
|
|
93,293
|
|
Restricted shares issued
|
|
|
30,000
|
|
|
|
7
|
|
|
|
42,245
|
|
|
|
|
|
|
|
|
|
|
|
42,252
|
|
Stock based compensation
|
|
|
|
|
|
|
|
|
|
|
70,587
|
|
|
|
|
|
|
|
|
|
|
|
70,587
|
|
Tax benefit on exercise of stock
options
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
|
|
|
|
|
|
|
|
|
|
80,000
|
|
Unrealized loss on foreign
currency options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,578
|
)
|
|
|
(61,578
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,545,372
|
)
|
|
|
|
|
|
|
(2,545,372
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
11,167,737
|
|
|
|
2,792
|
|
|
|
22,302,328
|
|
|
|
(5,046,718
|
)
|
|
|
(61,578
|
)
|
|
|
17,196,824
|
|
Stock options exercised
|
|
|
126,963
|
|
|
|
32
|
|
|
|
153,254
|
|
|
|
|
|
|
|
|
|
|
|
153,286
|
|
Restricted shares issued
|
|
|
14,850
|
|
|
|
3
|
|
|
|
(5,132
|
)
|
|
|
|
|
|
|
|
|
|
|
(5,129
|
)
|
Stock based compensation
|
|
|
|
|
|
|
|
|
|
|
362,510
|
|
|
|
|
|
|
|
|
|
|
|
362,510
|
|
Tax benefit on exercise of stock
options
|
|
|
|
|
|
|
|
|
|
|
51,430
|
|
|
|
|
|
|
|
|
|
|
|
51,430
|
|
Unrealized gain on foreign
currency options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
78,735
|
|
|
|
78,735
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,004,099
|
|
|
|
|
|
|
|
1,004,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
11,309,550
|
|
|
$
|
2,827
|
|
|
$
|
22,864,390
|
|
|
$
|
(4,042,619
|
)
|
|
$
|
17,157
|
|
|
$
|
18,841,755
|
|
31
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
1,004,099
|
|
|
$
|
(2,545,372
|
)
|
|
$
|
948,912
|
|
Adjustments to reconcile net
income (loss) to net cash provided by Operating activities, net
of acquisition:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
2,035,096
|
|
|
|
2,311,853
|
|
|
|
1,759,789
|
|
Provision (benefit) for deferred
income taxes
|
|
|
24,203
|
|
|
|
(1,817,041
|
)
|
|
|
364,648
|
|
Sales leaseback deferred gains
|
|
|
|
|
|
|
16,518
|
|
|
|
34,018
|
|
Bad debt benefit (provision)
|
|
|
16,132
|
|
|
|
(10,872
|
)
|
|
|
(12,654
|
)
|
Non-cash stock based compensation
expense
|
|
|
357,381
|
|
|
|
71,729
|
|
|
|
13,704
|
|
Loss on foreign currency options
|
|
|
81,513
|
|
|
|
29,100
|
|
|
|
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in accounts
receivable
|
|
|
1,050,597
|
|
|
|
1,337,131
|
|
|
|
(3,155,821
|
)
|
Increase in prepaid expenses and
other current assets
|
|
|
(234,266
|
)
|
|
|
(91,796
|
)
|
|
|
(334,663
|
)
|
(Increase) decrease in other assets
|
|
|
(92,766
|
)
|
|
|
(108,835
|
)
|
|
|
82,034
|
|
(Decrease) increase in accounts
payable
|
|
|
(271,290
|
)
|
|
|
411,067
|
|
|
|
284,857
|
|
Increase (decrease) in accrued
expenses and other current liabilities
|
|
|
1,359,373
|
|
|
|
262,159
|
|
|
|
(297,372
|
)
|
Increase in deferred revenue
|
|
|
3,196,192
|
|
|
|
3,178,397
|
|
|
|
6,272
|
|
Increase in other liabilities
|
|
|
2,421
|
|
|
|
74,106
|
|
|
|
23,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
operating activities
|
|
|
8,528,685
|
|
|
|
3,118,144
|
|
|
|
(282,942
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(2,232,461
|
)
|
|
|
(1,870,978
|
)
|
|
|
(1,848,927
|
)
|
Net cash paid for acquisitions
|
|
|
|
|
|
|
|
|
|
|
(1,213,411
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(2,232,461
|
)
|
|
|
(1,870,978
|
)
|
|
|
(3,062,338
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments under equipment lease
obligations
|
|
|
(874,267
|
)
|
|
|
(825,778
|
)
|
|
|
(659,513
|
)
|
Payments under promissory note
|
|
|
|
|
|
|
|
|
|
|
(666,666
|
)
|
Premiums paid for foreign currency
options
|
|
|
(14,077
|
)
|
|
|
(118,032
|
)
|
|
|
|
|
Proceeds from exercise of stock
options
|
|
|
153,286
|
|
|
|
93,300
|
|
|
|
129,660
|
|
Excess tax benefit related to
stock options
|
|
|
51,430
|
|
|
|
|
|
|
|
|
|
Proceeds from sales leaseback
|
|
|
|
|
|
|
506,872
|
|
|
|
902,486
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing
activities
|
|
|
(683,628
|
)
|
|
|
(343,638
|
)
|
|
|
(294,033
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash
and cash equivalents
|
|
|
5,612,596
|
|
|
|
903,528
|
|
|
|
(3,639,313
|
)
|
Cash and cash equivalents at
beginning of period
|
|
|
10,553,668
|
|
|
|
9,650,140
|
|
|
|
13,289,453
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period
|
|
$
|
16,166,264
|
|
|
$
|
10,553,668
|
|
|
$
|
9,650,140
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash
flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for
interest
|
|
$
|
56,338
|
|
|
$
|
106,287
|
|
|
$
|
129,409
|
|
Cash paid during the period for
income taxes
|
|
$
|
97,625
|
|
|
$
|
228,169
|
|
|
$
|
270,225
|
|
Supplemental schedule of
noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Equipment purchases under capital
lease obligations
|
|
$
|
|
|
|
$
|
622,531
|
|
|
$
|
902,486
|
|
32
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
|
|
1.
|
Organization
and Summary of Significant Accounting Policies
|
Description
of Business
Bio-Imaging Technologies, Inc. and Subsidiaries
(Bio-Imaging or the Company) is a
pharmaceutical contract services organization, operating in two
business segments, the pharmaceutical services division and the
CapMed division. The pharmaceutical services division provides
services that support the product development process of the
pharmaceutical, biotechnology and medical device industries. The
Company specializes in assisting its clients in the design and
management of the medical-imaging component of clinical trials
for all modalities which consist of computerized tomography
(CT), magnetic resonance imaging (MRI),
x-rays, dual energy x-ray absorptiometry (DEXA),
positron emission tomography (PET), single photon
emission computerized tomography (SPECT),
quantitative coronary angiography (QCA), cardiac MRI
and CT, intravascular ultrasound (IVUS), peripheral
quantitative angiography (QVA) and ultrasound. The
Company provides services which include the processing and
analysis of medical images and the data-basing and regulatory
submission of medical images, quantitative data and text. The
Companys CapMed division includes the Personal Health
Record (PHR) software and the patent-pending
Personal
HealthKeytm
technology. The PHR is a software application that enables users
to manage and store personal health information, including their
medical images, on the privacy of their desktop computer, while
linking directly to sponsor-directed resources such as drug
information, patient education, or disease guidelines. The
Personal
HealthKeytm
plugs into a computers USB port, allowing doctors and
patients easy access to the patients medical record
without the need for additional hardware or software, and it is
password protected.
Principles
of Consolidation
The accompanying consolidated financial statements include the
accounts of the Company and its wholly-owned subsidiaries,
Oxford Bio-Imaging Research, Inc. and Bio-Imaging Technologies
Holding B.V. All intercompany transactions and balances have
been eliminated.
Use of
Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates.
Fair
Value of Financial Instruments
The carrying values of the Companys financial instruments,
which include cash equivalents, accounts receivable, accounts
payable and other accrued expenses approximate their fair values
due to their short maturities. Based on borrowing rates
currently available to the Company for loans with similar terms,
the carrying value of capital lease obligations approximate fair
value.
Cash
and Cash Equivalents
The Company maintains cash in excess of FDIC insurance limits in
certain financial institutions. The Company considers cash
equivalents to be highly liquid investments with a maturity at
the time of purchase of three months or less.
The Company has a standby letter of credit which approximated
$166,000 at December 31, 2006 and 2005. This letter of
credit represents an irrevocable guarantee to fulfill the office
facilities operating lease obligation.
33
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Revenue
Recognition
Service revenues are recognized over the contractual term of the
Companys customer contracts using the proportional
performance method, which is based on hours incurred as a
percentage of total estimated hours. Service revenues are first
recognized when the Company has a signed contract from a
customer which: (i) contains fixed or determinable fees;
and (ii) collectability of such fees is reasonably assured.
Any change to recognized service revenue as a result of
revisions to estimated total hours are recognized in the period
the estimate changes.
The Company enters into contracts that contain fixed or
determinable fees. The fees in the contracts are based on the
scope of work we are contracted to perform; there are unitized
fees per service and fixed fees with a total estimated for the
contract based upon the estimated unitized service expected to
be performed, as well as the service to be delivered under the
fixed fee component of the contract. The units are estimated
based on the information provided by the customer, and the
Company bills the customer for actual units completed in
accordance with the terms of the contract. In the event that a
contract is cancelled by the client, we would be entitled to
receive payment for all services performed up to the
cancellation date.
The Companys revenue recognition policy entails a number
of estimates including an estimate of the total hours that are
expected to be incurred on a project, which is used as the basis
for determining the portion of the Companys revenue to be
recognized for each period. The revenue recognized in any period
might have been materially affected if different assumptions or
conditions prevailed. The timing of the Companys
recognition of revenue would be revised if there were changes in
the total estimated hours (other than scope changes in a project
which typically result in a revision to the contract). The
Company reviews its total estimated hours monthly. Provisions
for losses expected to be incurred on contracts are recognized
in full in the period in which it is determined that a loss will
result from performance of the contractual arrangement.
The Company also incurs direct costs at the outset of a customer
service arrangement prior to receiving a final signed contract.
Accordingly, the Company defers these costs and delays the
recording of any revenue until the contract is executed. If a
customer does not execute the contract, the Company immediately
expenses the deferred costs, offset by any deferred service
revenue associated with these costs.
Unbilled services represent revenue recognized which pursuant to
contractual terms have not yet been billed to the client. In
general, amounts become billable pursuant to contractual
milestones or in accordance with predetermined payment
schedules. Unbilled services are generally billable within one
year from the respective balance sheet date. Deferred revenue is
recorded for cash received from clients for services that have
not yet been earned at the respective balance sheet date.
34
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Allowance
For Doubtful Accounts
The Company maintains allowances for doubtful accounts on a
specific identification method for estimated losses resulting
from the inability of its customers to make required payments.
If the financial condition of its customers were to deteriorate,
resulting in an impairment of the customers ability to make
payments, additional allowances may be required. The Company
does not have any off-balance-sheet credit exposure related to
its customers and the trade accounts receivable does not bear
interest.
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Billed trade accounts receivable
|
|
$
|
4,781,682
|
|
|
$
|
5,030,642
|
|
Unbilled trade accounts receivable
|
|
|
771,818
|
|
|
|
1,600,155
|
|
Employee receivables
|
|
|
11,248
|
|
|
|
3,975
|
|
|
|
|
|
|
|
|
|
|
Total receivables
|
|
$
|
5,564,748
|
|
|
$
|
6,634,772
|
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward:
|
|
|
|
|
|
|
|
|
Balance at January 1, 2005
|
|
$
|
14,167
|
|
|
|
|
|
Additions
|
|
|
10,155
|
|
|
|
|
|
Recoveries
|
|
|
(21,027
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
3,295
|
|
|
|
|
|
Additions
|
|
|
14,000
|
|
|
|
|
|
Recoveries
|
|
|
(3,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
$
|
14,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and Equipment
Property and equipment is recorded at historical cost and
depreciated over the estimated useful lives of the respective
assets. Amortization of leasehold improvements is provided for
over the lesser of the related lease term, or the useful lives
of the related assets. The cost and related accumulated
depreciation of assets fully depreciated, sold, retired or
otherwise disposed of are removed from the respective accounts
and any resulting gains or losses are included in the statements
of income.
Management annually evaluates the net realizable value of
long-lived assets, including property and equipment, relying on
a number of factors including operating results, business plans,
economic projections and anticipated future cash flows. If these
factors indicate that the carrying value of a long lived asset
exceeds the net realizable value, the Company will record an
impairment and reduce the carrying value of the asset to the net
realizable value.
Capitalized
Software Development
The Company capitalizes development costs for a software project
once the preliminary project stage is completed, management
commits to funding the project and it is probable that the
project will be completed and the software will be used to
perform the function intended. The Company ceases capitalization
at such time as the computer software project is substantially
complete and ready for its intended use. The determination that
a software project is eligible for capitalization and the
ongoing assessment of recoverability of capitalized software
development costs require considerable judgment by management
with respect to certain external factors including, but not
limited to, anticipated future revenue, estimated economic life
and changes in software and hardware technologies. The Company
capitalized software development costs of $1,518,684 and
$849,044 for the year ended December 31, 2006, and 2005
respectively. Amortization expense related to capitalized
computer software costs
35
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
amounted to $357,281, $311,458, and $196,257 at
December 31, 2006, 2005, and 2004 respectively. Capitalized
software development costs are included as a component of
property and equipment.
Income
Taxes
The Company accounts for income taxes under the provisions of
SFAS No. 109, Accounting for Income Taxes,
which utilizes the liability method. Deferred taxes are
determined based on the estimated future tax effects of
differences between the financial statement and tax bases of
assets and liabilities at currently enacted tax laws and rates.
A valuation allowance is provided against the carrying value of
deferred tax assets when management believes it is more likely
than not that the deferred tax assets will not be realized. The
Company recognizes contingent liabilities for any tax related
exposures when those exposures are both probable and estimable.
Foreign
Currency Translation
The United States Dollar is the functional currency for the
Companys foreign subsidiaries.
Earnings
Per Share
SFAS No. 128 Earnings per Share requires
the presentation of basic earnings per share and diluted
earnings per share. Basic earnings per common share are
calculated by dividing the net income available to Common
Stockholders by the weighted average number of shares of Common
Stock outstanding during the period. Diluted earnings per common
share is calculated by dividing net income by the weighted
average number of shares of Common Stock outstanding, adjusted
for the effect of potentially dilutive securities using the
treasury stock method.
The computation of basic earnings per common share and diluted
earnings per common share is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Net income (loss) basic
|
|
$
|
1,004,099
|
|
|
$
|
(2,545,372
|
)
|
|
$
|
948,912
|
|
Interest expense on convertible
note
|
|
|
|
|
|
|
|
|
|
|
27,336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
diluted
|
|
|
1,004,099
|
|
|
|
(2,545,372
|
)
|
|
|
976,248
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares
|
|
|
11,219,283
|
|
|
|
11,114,483
|
|
|
|
10,812,185
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per common
share
|
|
$
|
0.09
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares
|
|
|
11,219,283
|
|
|
|
11,114,483
|
|
|
|
10,812,185
|
|
Common share equivalents of
outstanding stock options
|
|
|
967,896
|
|
|
|
|
|
|
|
1,284,894
|
|
Common share equivalents of
unrecognized compensation expense
|
|
|
176,862
|
|
|
|
|
|
|
|
|
|
Common share equivalents related
to the convertible promissory note
|
|
|
|
|
|
|
|
|
|
|
131,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equivalent shares
|
|
|
12,364,041
|
|
|
|
11,114,483
|
|
|
|
12,228,746
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per common
share
|
|
$
|
0.08
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, 2005, options to purchase
1,360,358 shares of the Companys Common Stock have
been excluded from the calculation of diluted earnings per
common share as they were antidilutive.
36
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Also, we excluded options to purchase 412,450 and
205,900 shares of our common stock for the twelve months
ended December 31, 2006 and 2004, respectively, since they
were
out-of-the-money
and antidilutive.
Derivatives
The Company uses derivative financial instruments to reduce the
risk caused by interest rate fluctuations. The derivative
instruments are not held for trading purposes. Derivatives are
accounted for in accordance with FAS No. 133,
Accounting for Derivative Instruments and Hedging
Activities. The Company recognizes derivative instruments
as either assets or liabilities in the balance sheet and
measures them at fair value. If designated as a cash flow hedge,
the corresponding changes in fair value are recorded in
stockholders equity (as a component of comprehensive
income/expense).
Recently
Issued Accounting Statements
In September 2006, the FASB issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair Value
Measurements. This statement clarifies the definition of
fair value, establishes a framework for measuring fair value,
and expands the disclosures on fair value measurements.
SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007. The Company is currently
evaluating the impact of its adoption on its consolidated
financial statements.
In June 2006, the Financial Accounting Standards Board issued
Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (FIN 48). FIN 48 prescribes a
more likely than not threshold for financial
statement recognition and measurement of a tax position taken or
expected to taken in a tax return. This interpretation also
provides guidance on other topics related to accounting for
income tax assets and liabilities, interest and penalties
associated with tax positions and income taxes in interim
periods as well as income tax disclosures. This interpretation
is effective as of January 1, 2007. The Company is
currently evaluating FIN 48 and the related impact on its
financial position and results of operations.
On December 10, 2004, the Company acquired 100% of the
stock of Heart Core B.V. (Heart Core), a privately
held company located in Leiden, the Netherlands. Heart Core
provides centralized imaging analysis services in the field of
cardiovascular, pulmonary and orthopedic clinical research. In
connection with the Heart Core acquisition, the Company paid
total consideration of $2,258,025, consisting of $1,410,150 and
175,853 shares of the Companys common stock.
$1,269,135 and 158,268 shares of common stock were issued
directly to the sellers, and $141,015 and 17,585 shares of
common stock were issued to an escrow agent pursuant to the
terms of the acquisition. The escrow is being held as security
for the payment of any unknown claims and will be released in
December 2007. The Company also incurred acquisition costs of
$275,319.
The following unaudited consolidated pro forma information has
been prepared assuming Heart Core was acquired as of
January 1, 2004, with pro forma adjustments for interest
expense and income taxes. The pro forma information is presented
for informational purposes only and is not indicative of what
would have occurred if the Heart Core acquisition had been made
on January 1, 2004.
|
|
|
|
|
|
|
2004
|
|
|
Total revenue
|
|
$
|
30,715,877
|
|
Net income
|
|
$
|
1,051,519
|
|
Basic earnings per share
|
|
$
|
0.10
|
|
Diluted earnings per share
|
|
$
|
0.09
|
|
37
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
3.
|
Property
and Equipment
|
Property and equipment, at cost, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
Estimated
|
|
|
|
2006
|
|
|
2005
|
|
|
Useful Life
|
|
|
Equipment
|
|
$
|
5,412,801
|
|
|
$
|
4,772,557
|
|
|
|
5 years
|
|
Equipment under capital leases
|
|
|
4,332,486
|
|
|
|
4,332,486
|
|
|
|
5 years
|
|
Furniture and fixtures
|
|
|
744,501
|
|
|
|
710,434
|
|
|
|
7 years
|
|
Leasehold improvements
|
|
|
708,826
|
|
|
|
557,939
|
|
|
|
5 years
|
|
Computer software costs
|
|
|
4,317,828
|
|
|
|
2,600,954
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,516,442
|
|
|
|
12,974,370
|
|
|
|
|
|
Less: Accumulated depreciation and
amortization
|
|
|
(9,608,161
|
)
|
|
|
(7,865,677
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
5,908,281
|
|
|
$
|
5,108,693
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated depreciation related to equipment acquired under
capital leases amounted to $3,056,588, $2,389,076, and
$1,677,758 at December 31, 2006, 2005 and 2004,
respectively. Accumulated amortization related to capitalized
computer software costs amounted to $904,984, $547,704, and
$236,246 at December 31, 2006, 2005 and 2004, respectively.
Depreciation expense for the year ended December 31, 2006,
2005 and 2004 were $1,742,484, $1,963,242, and $1,552,000,
respectively.
Included in other assets, the following is the acquired
intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
Estimated
|
|
|
|
2006
|
|
|
2005
|
|
|
Useful Life
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Technology
|
|
$
|
406,502
|
|
|
$
|
406,502
|
|
|
|
5 years
|
|
Trademarks
|
|
|
372,130
|
|
|
|
372,130
|
|
|
|
5 years
|
|
Customer backlog
|
|
|
165,900
|
|
|
|
165,900
|
|
|
|
3 years
|
|
Non-competition agreement
|
|
|
175,190
|
|
|
|
175,190
|
|
|
|
3 years
|
|
Non-competition agreement
|
|
|
76,953
|
|
|
|
76,953
|
|
|
|
2 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,196,675
|
|
|
|
1,196,675
|
|
|
|
|
|
Accumulated amortization
|
|
|
(842,943
|
)
|
|
|
(550,330
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
353,732
|
|
|
$
|
646,345
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
$
|
1,872,467
|
|
|
$
|
1,872,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company has evaluated the goodwill and has determined that
there is no impairment of the values at December 31, 2006.
Amortization expense for the year ended December 31, 2006,
2005 and 2004 were $292,612, $332,343 and $201,802, respectively.
38
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Future amortization of the intangible assets is as follows:
|
|
|
|
|
|
|
Year Ending
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2007
|
|
$
|
210,983
|
|
2008
|
|
|
142,749
|
|
2009
|
|
|
|
|
2010
|
|
|
|
|
2011
|
|
|
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
$
|
353,732
|
|
|
|
|
|
|
Accrued expenses and other current liabilities at
December 31, 2006 and 2005 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Accrued compensation
|
|
$
|
1,825,330
|
|
|
$
|
1,538,192
|
|
Accrued consulting fees
|
|
|
75,932
|
|
|
|
63,025
|
|
Accrued income taxes
|
|
|
435,576
|
|
|
|
125,214
|
|
Accrued other
|
|
|
997,716
|
|
|
|
300,181
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,334,554
|
|
|
$
|
2,026,612
|
|
|
|
|
|
|
|
|
|
|
|
|
6.
|
Capital
Lease Obligations
|
Capital lease obligations consist of equipment lease obligations
at December 31, 2006 and 2005. The equipment lease
obligations are payable in monthly installments ranging from
$400 to $15,614 for 2006 and from $400 to $24,957 for 2005. I
Interest rates range from 5.35% to 7.50%, through August 2008,
and are collateralized by the related equipment.
On May 17, 2005, the Company renewed and amended its
agreement with Wachovia Bank, National Association. The renewed
and amended agreement is for an unsecured committed line of
credit of $5,000,000. Interest is payable at the LIBOR Market
Index Rate plus 2.0%. The agreement requires the Company, among
other things, to maintain certain financial covenants. The
committed line of credit matured June 30, 2006 and the
Company decided not to renew the credit line.
In June 2004, the Company entered into a $339,567 sale-leaseback
transaction whereby the Company sold and leased back computer
equipment and furniture. The resulting lease is being accounted
for as a capital lease. There was no gain or loss recorded on
the sale. The lease term is 3 years with an interest rate
of 5.35%.
In September 2004, the Company entered into a $332,536
sale-leaseback transaction whereby the Company sold and leased
back computer equipment and furniture. The resulting lease is
being accounted for as a capital lease. There was a gain
recorded on the sale in the amount of $20,964 which is being
deferred over the life of the lease. The lease term is for
3 years with an interest rate of 5.87%.
In December 2004, the Company entered into a $230,384
sale-leaseback transaction whereby the Company sold and leased
back computer equipment and furniture. The resulting lease is
being accounted for as a capital lease. There was a gain
recorded on the sale in the amount of $13,054 which is being
deferred over the life of the lease. The lease term is for
3 years with an interest rate of 6.44%.
39
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In May 2005, the Company entered into a $506,872 sale-leaseback
transaction whereby the Company sold and leased back computer
equipment, software, and furniture. The resulting lease is being
accounted for as a capital lease. There was a gain recorded on
the sale in the amount of $16,518 which is being deferred over
the life of the lease. The lease term is for 3 years with
an interest rate of 6.10%
In August 2005, the Company entered into a $115,659 transaction
whereby the Company leased media equipment. The resulting lease
is being accounted for as a capital lease. The lease term is for
3 years with an interest rate of 7.50%
The following is a schedule, by year, of the future minimum
payments under capital leases, together with the present value
of the net minimum payments as of December 31, 2006:
|
|
|
|
|
2007
|
|
$
|
454,458
|
|
2008
|
|
|
97,036
|
|
2009
|
|
|
|
|
2010
|
|
|
|
|
2011 and thereafter
|
|
|
|
|
|
|
|
|
|
Total minimum capital lease
payments
|
|
|
551,494
|
|
Less amount representing interest
|
|
|
(21,596
|
)
|
|
|
|
|
|
Total present value of minimum
payment
|
|
|
529,898
|
|
Less current portion of such
obligations
|
|
|
(435,213
|
)
|
|
|
|
|
|
Long-term capital lease obligations
|
|
|
94,685
|
|
|
|
|
|
|
|
|
7.
|
Stock
Based Compensation
|
Effective January 1, 2006, we adopted the provisions of
Statement of Financial Accounting Standards No. 123R,
Share-Based Payment (SFAS 123R),
which establishes the financial accounting and reporting
standards for stock-based compensation plans. SFAS 123R
requires the measurement and recognition of compensation expense
for all stock-based awards made to employees and directors. The
stock-based compensation cost is measured at the grant date,
based on the calculated fair value of the award, and is
recognized as an expense on a straight-line basis over the
requisite service period of the entire award. This period is
generally the vesting period of the corresponding award. We have
adopted the forfeiture rate on stock option grants issued after
January 1, 2006 and the application of the forfeiture rate
on unvested stock options at January 1, 2006 was immaterial
to our financial statement and therefore, no cumulative gain was
recognized.
At December 31, 2006, the Company has one stock-based
employee compensation plan. The compensation cost that has been
recorded to income under the plan for the year ended
December 31, 2006 was $357,381, of which $167,079 is a
result of the expensing of stock options pursuant to
FAS 123R.
On November 9, 2005, the Compensation Committee of the
Board of Directors of the Company recommended, and the
Companys Board of Directors approved, the acceleration of
vesting of all
out-of-the-money
unvested options to purchase shares of common stock of the
Company with an exercise price greater than $7.00 held by
current employees and executive officers of the Company (but
excluding any options granted to members of the Companys
Board of Directors). These options were previously awarded to
employees of the Company on February 4, 2004, pursuant to
the 2002 Stock Incentive Plan, and would still have been
unvested at January 1, 2006. Options to purchase
107,691 shares of common stock were subject to this
acceleration. The exercise price per share for these options was
$7.03, while the closing price per share on November 9,
2005 was $2.20.
40
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the options subject to
acceleration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate Number of
|
|
|
|
|
|
|
Shares Issuable
|
|
|
|
|
|
|
Under Accelerated
|
|
Exercise Price
|
|
|
|
|
Options
|
|
per Share
|
|
Date of Grant
|
|
Employees as a group (other than
executive officers)
|
|
|
69,722
|
|
|
$
|
7.03
|
|
|
|
February 4, 2004
|
|
Executive officers as a group
|
|
|
37,969
|
|
|
$
|
7.03
|
|
|
|
February 4, 2004
|
|
The acceleration of vesting of these
out-of-the
money options is being undertaken primarily to eliminate any
future compensation expense the Company would otherwise
recognize in its income statement with respect to these options
with the implementation of the Financial Accounting Standard
Board (FASB) statement Share-Based Payment
(FAS 123R) effective for the Company on January 1,
2006. We estimate this compensation expense, before tax, would
be approximately $402,763 in aggregate future expenses based on
calculations using the Black-Scholes methodology.
Prior to January 1, 2006, we accounted for our stock-based
employee compensation plan under the recognition and measurement
principles of APB Opinion No. 25. No stock based employee
compensation cost was reflected in net income, as all options
granted under this plan had an exercise price equal to or
greater than the fair market value of the underlying common
stock on the date of grant. The following table sets forth the
computation of basic and diluted loss per share for the years
ended December 31, 2005 and 2004 and illustrates the effect
on net loss and loss per share as if we had applied the fair
value recognition provisions of SFAS 123R to its stock
plans:
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2005
|
|
|
2004
|
|
|
Net (loss) income, as reported
|
|
$
|
(2,545,372
|
)
|
|
$
|
948,912
|
|
Add: Stock-based employee
compensation expense included in reported net (loss) income, net
of related tax effects
|
|
|
689
|
|
|
|
8,222
|
|
Deduct: Stock-based employee
compensation expense determined under SFAS 123R, net of
related tax effects
|
|
|
(421,407
|
)
|
|
|
(744,091
|
)
|
|
|
|
|
|
|
|
|
|
Pro forma
|
|
$
|
(2,966,090
|
)
|
|
$
|
213,043
|
|
|
|
|
|
|
|
|
|
|
(Loss) Earnings per share:
|
|
|
|
|
|
|
|
|
Basic as reported
|
|
$
|
(0.23
|
)
|
|
$
|
0.09
|
|
Basic pro forma
|
|
$
|
(0.27
|
)
|
|
$
|
0.02
|
|
Diluted as reported
|
|
$
|
(0.23
|
)
|
|
$
|
0.08
|
|
Diluted pro forma
|
|
$
|
(0.27
|
)
|
|
$
|
0.02
|
|
The following table presents the total stock-based compensation
expense resulting from stock options and restricted stock unit
awards:
|
|
|
|
|
|
|
For the Year Ended
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
Cost of revenues
|
|
$
|
255,374
|
|
General and administrative
|
|
|
49,952
|
|
Sales and marketing
|
|
|
52,055
|
|
|
|
|
|
|
Stock-based compensation expense
before income taxes
|
|
$
|
357,381
|
|
|
|
|
|
|
41
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The fair value of each option granted is estimated on the date
of grant using the Black-Scholes option pricing model with the
following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Risk-free interest rate (range)
|
|
|
4.61 - 4.94
|
%
|
|
|
3.85
|
%
|
|
|
3.50
|
%
|
Dividend yield
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Expected volatility
|
|
|
58.00
|
%
|
|
|
56.00
|
%
|
|
|
67.00
|
%
|
Expected term (in years)
|
|
|
4.00
|
|
|
|
4.00
|
|
|
|
4.00
|
|
Expected Volatility. Expected volatility is
calculated on a weekly basis over the expected term of the
option using the companys common stock close price.
Expected Term. The expected term is based on
historical observations of employee exercise patterns during our
history.
Risk-Free Interest Rate. The interest rate
used in valuing awards is based on the yield at the time of
grant of a U.S. Treasury security with an equivalent
remaining term.
Dividend Yield. The Company has never paid
cash dividends, and does not currently intend to pay cash
dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting Forfeitures. Estimates of
pre-vesting option forfeitures are based on our experience. We
used a 10% forfeiture rate assumption. We will adjust our
estimate of forfeitures over the requisite service period based
on the extent to which actual forfeitures differ, or are
expected to differ, from such estimates. The cumulative effect
resulting from initially applying the provisions of
SFAS 123R to nonvested equity awards was not significant.
Stock
Options
Fiscal
Year 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
Stock Options
|
|
Shares
|
|
|
Price
|
|
|
Term
|
|
|
Value
|
|
|
Outstanding at December 31,
2005
|
|
|
1,831,308
|
|
|
$
|
2.34
|
|
|
|
5.33
|
|
|
$
|
1,629,864
|
|
Granted
|
|
|
198,100
|
|
|
$
|
4.00
|
|
|
|
7.14
|
|
|
$
|
792,886
|
|
Exercised
|
|
|
126,963
|
|
|
$
|
1.21
|
|
|
|
|
|
|
$
|
870,036
|
|
Forfeited or Expired
|
|
|
31,783
|
|
|
$
|
1.83
|
|
|
|
|
|
|
$
|
197,950
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31,
2006
|
|
|
1,870,662
|
|
|
$
|
2.61
|
|
|
|
4.78
|
|
|
$
|
10,192,916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at December 31, 2006
|
|
|
180,300
|
|
|
$
|
4.05
|
|
|
|
6.13
|
|
|
$
|
723,468
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31,
2006
|
|
|
1,690,362
|
|
|
$
|
2.46
|
|
|
|
4.55
|
|
|
$
|
9,469,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted
for the years ended December 31, 2006, 2005 and 2004 was
$4.06, $1.06 and $3.40, respectively. Cash received from option
exercises for the years ended 2006, 2005 and 2004 was $153,285,
$93,300, and $129,636, respectively.
As of December 31, 2006, there was $201,597 of total
unrecognized compensation cost related to nonvested stock
options. That cost is expected to be recognized over a period of
4.17 years.
In the first quarter of 2002, the Companys Board of
Directors and stockholders approved the adoption of the 2002
Bio-Imaging Technologies, Inc. Stock Option Plan and authorized
the issuance of 950,000 shares of the Companys Common
Stock under the plan. In May 2005, the Companys Board of
Directors and stockholders
42
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
approved an amendment to the 2002 Bio-Imaging Technologies, Inc.
Stock Option Plan and authorized the issuance of an additional
750,000 shares of the Companys Common Stock under the
plan.
Each option is exercisable into one share of Common Stock.
Options granted pursuant to the plan may be qualified incentive
stock options, as defined in the Internal Revenue Code, or
nonqualified options. The exercise price of qualified incentive
stock options may not be less than the fair market value of the
Companys Common Stock at the date of grant. The term of
such stock options granted under the plan shall not exceed ten
years and the vesting schedule of such stock option grants
varies from immediate vesting on date of grant to vesting over a
period of up to five years.
The following table summarizes the transactions pursuant to the
Companys stock option plan for the year ended
December 31, 2006.:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Number of Shares
|
|
|
Option Grant Date
|
|
|
|
Underlying Options
|
|
|
Fair Value
|
|
|
Non-vested at December 31,
2005
|
|
|
77,750
|
|
|
|
2.83
|
|
Granted
|
|
|
198,100
|
|
|
|
3.53
|
|
Vested
|
|
|
(95,550
|
)
|
|
|
3.04
|
|
Non-vested at December 31,
2006
|
|
|
180,300
|
|
|
|
3.49
|
|
1,690,362, 1,753,558 and 1,613,000 options are exercisable at
December 31, 2006, 2005 and 2004, respectively, at a
weighted average exercise price of $2.46, $2.30 and $1.51,
respectively.
The intrinsic value of stock options exercised for the years
ended December 31, 2006, 2005 and 2004 respectively, were
$470,731, $242,476 and $708,176.
At December 31, 2006, by range of exercise prices, the
number of shares represented by outstanding options with their
weighted average exercise price and weighted average remaining
contractual life, in years, and the number of shares represented
by exercisable options with their weighted average exercise
price are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Average
|
|
Weighted
|
|
|
|
|
|
Average
|
|
Weighted
|
|
|
|
|
|
|
|
Remaining
|
|
Average
|
|
|
|
|
|
Remaining
|
|
Average
|
|
Range of Exercise
|
|
|
Number
|
|
|
Contractual
|
|
Exercise
|
|
|
Number
|
|
|
Contractual
|
|
Exercise
|
|
Prices
|
|
|
Outstanding
|
|
|
Life
|
|
Price
|
|
|
Exercisable
|
|
|
Life
|
|
Price
|
|
|
$
|
0.63-$0.88
|
|
|
|
629,687
|
|
|
2.77 years
|
|
$
|
0.70
|
|
|
|
629,687
|
|
|
2.77 years
|
|
$
|
0.70
|
|
$
|
1.00-$1.16
|
|
|
|
204,000
|
|
|
4.95 years
|
|
$
|
1.11
|
|
|
|
204,000
|
|
|
4.95 years
|
|
$
|
1.11
|
|
$
|
1.25-$1.31
|
|
|
|
188,000
|
|
|
1.72 years
|
|
$
|
1.26
|
|
|
|
188,000
|
|
|
1.72 years
|
|
$
|
1.26
|
|
$
|
1.85-$2.80
|
|
|
|
86,375
|
|
|
6.10 years
|
|
$
|
2.80
|
|
|
|
86,375
|
|
|
6.10 years
|
|
$
|
2.80
|
|
$
|
3.05-$5.10
|
|
|
|
571,800
|
|
|
6.96 years
|
|
$
|
4.19
|
|
|
|
391,500
|
|
|
6.96 years
|
|
$
|
4.26
|
|
$
|
7.03
|
|
|
|
190,800
|
|
|
7.12 years
|
|
$
|
7.03
|
|
|
|
190,800
|
|
|
7.12 years
|
|
$
|
7.03
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
0.63-$7.03
|
|
|
|
1,870,662
|
|
|
4.78 years
|
|
$
|
2.61
|
|
|
|
1,690,362
|
|
|
4.55 years
|
|
$
|
2.46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock Units: On March 1, 2006,
we entered into an employment agreement with our President and
Chief Executive Officer that expires on February 28, 2009.
This agreement amended and restated the prior agreement that
originally expired January 31, 2007 and extended the term
of service through February 28, 2009. Pursuant to this
employment agreement our President and Chief Executive Officer
can potentially receive up to 25,000 restricted shares of the
companys common stock for fiscal 2006. Based on
managements assumptions, we recognized the related
proportionate expense of $201,500 for 25,000 shares of
these restricted stock units for fiscal 2006 based on a fair
value of $8.06 at December 31, 2006. These restricted
shares are service and performance-based and the value is
determined by its fair value (as if underlying shares were
vested and issued).
43
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
On December 10, 2004, the Company acquired 100% of the
stock of Heart Core.
In connection with the Heart Core acquisition, the Company
issued 158,268 shares of common stock directly to the
sellers and 17,585 shares of common stock were issued to an
escrow agent pursuant to the terms of the acquisition. The
market value of the Companys common stock was $4.82 at the
time of issuance.
The Company has entered into non-cancelable operating leases for
office facilities which expire through June 2010.
Future minimum aggregate rental payments on the noncancelable
portion of the lease are as follows:
|
|
|
|
|
|
|
Year Ending
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2007
|
|
$
|
1,425,462
|
|
2008
|
|
|
1,293,717
|
|
2009
|
|
|
1,207,381
|
|
2010
|
|
|
612,080
|
|
2011
|
|
|
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,538,640
|
|
|
|
|
|
|
Rent expense charged to operations for the year ended
December 31, 2006, 2005 and 2004 was $1,649,766, $1,590,759
and $1,364,000, respectively.
On March 1, 2006, the Company entered into an employment
agreement with its President and Chief Executive Officer that
expires on February 28, 2009. This agreement amended and
restated the prior agreement that originally expired
January 31, 2007. In addition, the Company has an
employment agreement with its Chief Financial Officer that
expires February 5, 2008. The aggregate amount due from
January 1, 2006 through the expiration under these
agreements was $1,176,317. At December 31, 2006, the
Company has recorded compensation of $201,500, which we believe
will be paid in stock, to its President and Chief Executive
Officer pursuant to his employment agreement.
|
|
10.
|
Employee
Benefit Plan
|
The Company sponsors the Bio-Imaging Technologies, Inc.
Employees Savings Plan (the 401(k) Plan), a
defined contribution plan with a cash or deferred arrangement.
Under the terms of the 401(k) Plan, eligible employees may elect
to reduce their annual compensation up to the annual limit
prescribed by the Internal Revenue Service. The Company may make
discretionary matching contributions in cash, subject to plan
limits. The Company made contributions of $54,450, $43,062 and
$40,942 for the year ended December 31, 2006, 2005 and
2004, respectively.
During fiscal 2006, Novartis Pharmaceutical, Inc., encompassing
14 projects represented 10.9% of our service revenues for the
year ended December 31, 2006, while for the comparable
period last year, no one client accounted for 10% or more of our
service revenues for the year ended December 31, 2005. No
other customers accounted for more than 10% of service revenues
in fiscal year 2006.
44
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
No customer accounted for more than 10% of accounts receivable
at December 31, 2006 and one customer accounted for 12% of
accounts receivable at December 31, 2005. No other
customers accounted for more than 10% of accounts receivable.
The income tax provision (benefit) consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
121,411
|
|
|
$
|
50,414
|
|
|
$
|
18,451
|
|
State and local
|
|
|
207,228
|
|
|
|
9,862
|
|
|
|
135,937
|
|
Foreign
|
|
|
210,500
|
|
|
|
50,924
|
|
|
|
139,398
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
539,139
|
|
|
$
|
111,200
|
|
|
$
|
293,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
268,717
|
|
|
|
(1,373,792
|
)
|
|
|
344,082
|
|
State and local
|
|
|
(129,084
|
)
|
|
|
(443,249
|
)
|
|
|
20,566
|
|
Foreign
|
|
|
(64,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,633
|
|
|
|
(1,817,041
|
)
|
|
|
364,648
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit)
|
|
$
|
614,772
|
|
|
$
|
(1,705,841
|
)
|
|
$
|
658,434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys reconciliation of the expected federal
provision (benefit) rate to the effective income tax rate is as
follows:
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Tax provision at statutory rate
|
|
|
34.0
|
%
|
|
|
(34.0
|
)%
|
State and local income taxes, net
of federal benefit
|
|
|
4.4
|
%
|
|
|
(6.9
|
)%
|
Permanent differences
|
|
|
1.6
|
%
|
|
|
0.4
|
%
|
Foreign rate difference
|
|
|
(1.1
|
)%
|
|
|
(0.3
|
)%
|
Other
|
|
|
(1.6
|
)%
|
|
|
0.7
|
%
|
|
|
|
|
|
|
|
|
|
Effective income tax rate
|
|
|
37.3
|
%
|
|
|
(40.1
|
)%
|
|
|
|
|
|
|
|
|
|
The Companys domestic and foreign income (loss) before
income tax is as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Domestic income (loss) before
income tax
|
|
$
|
1,187,448
|
|
|
$
|
(4,651,156
|
)
|
Foreign income before income tax
|
|
|
431,423
|
|
|
|
399,943
|
|
|
|
|
|
|
|
|
|
|
Total income (loss) before income
tax
|
|
|
1,618,871
|
|
|
|
(4,251,213
|
)
|
|
|
|
|
|
|
|
|
|
45
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The components of net deferred tax assets consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Accrued expenses
|
|
$
|
28,936
|
|
|
$
|
29,318
|
|
Allowance for doubtful accounts
|
|
|
|
|
|
|
1,338
|
|
AMT credit
|
|
|
145,376
|
|
|
|
12,847
|
|
Deferred revenue
|
|
|
2,381,677
|
|
|
|
998,905
|
|
Federal net operating loss
carryforwards
|
|
|
943,760
|
|
|
|
2,761,007
|
|
Restricted stock
|
|
|
81,796
|
|
|
|
16,686
|
|
Stock Options
|
|
|
67,823
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
3,649,368
|
|
|
|
3,820,101
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Excess of tax over book
depreciation
|
|
|
(323,025
|
)
|
|
|
(514,096
|
)
|
Amortization of acquisition costs
|
|
|
(85,159
|
)
|
|
|
(7,586
|
)
|
Prepaid expenses
|
|
|
(349,430
|
)
|
|
|
(331,030
|
)
|
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities
|
|
|
(757,614
|
)
|
|
|
(852,712
|
)
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
|
(408,000
|
)
|
|
|
(408,000
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
2,483,754
|
|
|
$
|
2,559,389
|
|
|
|
|
|
|
|
|
|
|
The Company records a valuation allowance to reduce its deferred
tax assets to an amount that is more likely than not to be
realized. In assessing the need for the valuation allowance, the
Company considers future taxable income and on-going prudent and
feasible tax planning strategies. In the event that the Company
was to determine that, in the future, they would be able to
realize the deferred tax assets in excess of its net recorded
amount, an adjustment to the deferred tax asset would be made,
thereby increasing net income in the period such determination
was made. Likewise, should the Company determine that it is more
likely than not that it will be unable to realize all or part of
the net deferred tax asset in the future, an adjustment to the
deferred tax asset would be charged, thereby decreasing net
income in the period such determination was made.
The Company has accumulated tax losses, which include allowable
deductions related to exercised employee stock options,
generating federal and state net operating loss (NOL) credit
carryforwards of $2.8 million as of December 31, 2006
and $7.4 million as of December 31, 2005. These losses
will expire, if unused, in the years 2009 through 2022. Under
limitations imposed by Internal Revenue Code Section 382,
certain potential changes in ownership of the Company, which may
be outside the Companys knowledge or control, may restrict
future utilization of these carryforwards. Due to such ownership
changes that have occurred in prior years, the Company has
estimated that $1.1 million of the current federal net
operating loss will likely expire unused due to Internal Revenue
Code Section 382 limitations. The current and long-term
deferred tax assets are comprised of the NOL carryforwards with
a tax effected value of $1.1 as of December 31, 2006.
Generally accepted accounting principles require that the
Company establish a valuation allowance for any portion of its
deferred tax assets for which management believes it is more
likely than not the Company will be unable to utilize the asset
to offset future taxes. The Company will continue to evaluate
the potential use of its deferred tax assets and the need for a
valuation allowance by considering future taxable income and
on-going prudent and feasible tax planning strategies.
Subsequent revisions to the estimated realizable value of the
deferred tax assets could cause the provision for income taxes
to vary significantly from period to period, although the cash
tax payments would remain unaffected until the NOL credit
carryforward is fully utilized or has expired. At
December 31, 2006, management has
46
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
determined that there is sufficient future taxable income to
more likely than not utilize the unlimited net operating loss
carryforward at December 31, 2006.
The Company recognizes contingent liabilities for any tax
related exposures when those exposures are both probable and
estimable.
The tax benefit of the stock option deductions have been
recorded to additional paid in capital in the amount of $51,430
and $80,000 for the year ended December 31, 2006 and 2005,
respectively.
The Company has not provided for U.S. federal income and
foreign withholding taxes on approximately $1.4 million of
undistributed earnings from its
non-U.S. operations
as of December 31, 2006 because such earnings are intended
to be reinvested indefinitely outside of the United States.
The Company, in the normal course of conducting business,
maintains certain tax positions that may be subject to review by
the Internal Revenue Service. The Company has not recorded any
contingent liabilities for these tax exposures at
December 31, 2006 and 2005, since they are not believed to
be probable of occurring.
All derivatives are recognized in our Consolidated Statement of
Operations and in other comprehensive income on the Balance
Sheet at fair value and are reported in prepaid expenses and
other current assets on the Balance Sheet. To qualify for hedge
accounting in accordance with SFAS No. 133,
Accounting for Derivative Instruments and Hedging
Activities, as amended by SFAS No. 138,
Accounting for Certain Derivative Instruments and Certain
Hedging Activities, (SFAS No. 133), we require
that the instruments are effective in reducing the risk exposure
that they are designated to hedge. For instruments that are
associated with the hedge of cash flows, hedge effectiveness
criteria also require that it be probable that the underlying
transaction will occur. Instruments that meet established
accounting criteria are formally designated as hedges at the
inception of the contract. These criteria demonstrate that the
derivative is expected to be highly effective at offsetting
changes in fair value or cash flows of the underlying exposure
both at inception of the hedging relationship and on an ongoing
basis. The assessment for effectiveness is formally documented
at hedge inception and reviewed at least quarterly throughout
the designated hedge period.
In accordance with our current foreign exchange rate risk
management policy, since inception, we have purchased twenty
monthly Euro call options. Nineteen monthly call options are in
the amount of 250,000 Euros each and one call option is for
200,000 Euros for anticipated additional costs in May, 2006. The
first expiration was on July 27, 2005 and the last
expiration is in March 2007 with a strike price ranging from
$1.26 to $1.27. These options are to hedge against the exposure
to variability in our cash flows due to the Euro denominated
costs for our Netherlands subsidiary. We paid a total premium of
$132,109 for the options and at December 31, 2006 have
recorded an Accumulated Other Comprehensive Gain of $17,157 in
the stockholders equity section of the Balance Sheet due
to changes in the value of this derivative.
During the twelve months ended December 31, 2006, we
exercised seven of the thirteen options. A loss of $10,784 was
recognized in the Consolidated Statement of Operations on the
exercised options during fiscal 2006. During the twelve months
ended December 31, 2005, no options were exercised.
Upon expiration or ineffectiveness of the derivative, we will
record a gain or loss from the derivative that is deferred in
stockholders equity to cost of revenues and general and
administrative expenses in the Consolidated Statement of
Operations based on the nature of the underlying cash flow
hedged.
Foreign customers accounted for 28% and 24% of service revenues
for the year ended December 31, 2006 and 2005, respectively.
47
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
FASB Statement No. 131, Disclosures about Segments of
an Enterprise and Related Information, requires companies
to provide certain information about their operating segments.
In November 2003, the Company acquired the intellectual property
of CapMed Corporation. Accordingly, the Company now has two
reportable segments: pharmaceutical contract services and the
CapMed division. The pharmaceutical contract service segment
provides services that support the product development process
of the pharmaceutical, biotechnology and medical device
industries. The CapMed segment offers a software application
that enables users to manage and store personal health
information, including their medical images, on the privacy of
their desktop computer, while linking directly to
sponsor-directed resources such as drug information, patient
education, or disease guidelines. The operating segments are
managed separately because each offers different services and
applications to different markets. Management evaluates the
performance of each segment based upon operating earnings or
losses before interest and income taxes.
Summarized financial information concerning the Companys
reportable segments is shown in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical
|
|
|
CapMed
|
|
|
Consolidated
|
|
|
|
Contract Services
|
|
|
Division
|
|
|
Total
|
|
|
Fiscal 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
40,256,454
|
|
|
|
262,339
|
|
|
|
40,518,793
|
|
Total cost and expenses
|
|
|
37,586,497
|
|
|
|
1,816,903
|
|
|
|
39,403,400
|
|
Income (loss) from operations
|
|
|
2,669,957
|
|
|
|
(1,554,564
|
)
|
|
|
1,115,393
|
|
Total assets at December 31,
2006
|
|
|
32,418,588
|
|
|
|
1,689,123
|
|
|
|
34,107,711
|
|
Fiscal 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
30,125,893
|
|
|
$
|
359,748
|
|
|
$
|
30,485,641
|
|
Total cost and expenses
|
|
$
|
33,352,578
|
|
|
$
|
1,467,598
|
|
|
$
|
34,820,176
|
|
Loss from operations
|
|
$
|
(3,226,685
|
)
|
|
$
|
(1,107,850
|
)
|
|
$
|
(4,334,535
|
)
|
Total assets at December 31,
2005
|
|
$
|
27,605,712
|
|
|
$
|
1,185,221
|
|
|
$
|
28,790,933
|
|
Fiscal 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
29,579,645
|
|
|
$
|
111,130
|
|
|
$
|
29,690,775
|
|
Total cost and expenses
|
|
$
|
27,145,793
|
|
|
$
|
940,500
|
|
|
$
|
28,086,293
|
|
Income (loss) from operations
|
|
$
|
2,433,852
|
|
|
$
|
(829,370
|
)
|
|
$
|
1,604,482
|
|
Total assets at December 31,
2004
|
|
$
|
27,377,774
|
|
|
$
|
996,040
|
|
|
$
|
28,373,814
|
|
The Company maintains offices in Newtown, Pennsylvania and
Leiden, the Netherlands. Total assets located in Newtown,
Pennsylvania were $31,059,973 and $27,643,632 at
December 31, 2006 and 2005, respectively. Net fixed assets
located in Leiden, the Netherlands were $1,358,615 and $725,716
at December 31, 2006 and 2005, respectively.
48
BIO-IMAGING
TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
16.
|
Related
Party Transactions
|
At December 31, 2006, Covance, Inc. owned 20.8% of the
Companys outstanding Common Shares. The Company and
Covance, Inc. have entered into various services agreements, for
Covances clients that sponsor clinical trials, in the
ordinary course of business. The Companys service revenues
include $820,955, $307,016 and $804,509 for the year ended
December 31, 2006, 2005 and 2004, respectively. At
December 31, 2006 and 2005, the amounts due from Covance,
Inc. were $212,323 and $97,834, respectively.
On February 6, 2007, the Company acquired 100% of the
outstanding securities of Theralys, SA (Theralys), a
privately held company headquartered in Lyon, France. The
aggregate purchase price was 2,731,257 Euros ($3,556,097 as
determined by an agreed upon exchange rate), of which 2,375,484
Euros ($3,092,881) was paid in cash and 355,773 Euros ($463,216)
was paid in 57,408 shares of the Companys common
stock, $0.00025 par value per share (the Common
Stock). In addition to the aggregate purchase price,
certain stockholders of Theralys received an aggregate of
36,000 shares of Common Stock at an average price of
$8.06885 per share.
49
|
|
Item 9.
|
Changes
in and Disagreements with Accountants on Accounting and
Financial Disclosure.
|
None.
|
|
Item 9A.
|
Controls
and Procedures.
|
Evaluation of disclosure controls and
procedures. Based on their evaluation of our
disclosure controls and procedures (as defined in
Rules 13a-14(c)
and
15d-14(c)
under the Securities Exchange Act, as amended, or the Exchange
Act) as of a date within 90 days of the filing date of this
Annual Report on
Form 10-K,
our President and Chief Executive Officer (principal executive
officer) and our Chief Financial Officer (principal accounting
and financial officer) have concluded that our disclosure
controls and procedures are designed to ensure that information
required to be disclosed by us in the reports that we file or
submit under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the SECs
rules and forms and are operating in an effective manner for the
period covered by this report.
Changes in internal controls. There were no
changes in our internal controls over financial reporting in the
fourth quarter of 2006 that has materially affect, or are
reasonably likely to materially affect, our internal controls
over financial reporting.
|
|
Item 9B.
|
Other
Information.
|
None.
PART III
|
|
Item 10.
|
Directors,
Executive Officers and Corporate Governance.
|
The information relating to our directors, nominees for election
as directors and executive officers under the headings
Election of Directors and Executive
Officers in our definitive proxy statement for the 2007
Annual Meeting of Stockholders is incorporated herein by
reference to such proxy statement.
We have adopted a written code of business conduct and ethics
that applies to our principal executive officer and principal
financial and accounting officer, or persons performing similar
functions. We intend to disclose any amendments to, or waivers
from, our code of business conduct and ethics that are required
to be publicly disclosed pursuant to rules of the SEC and the
NASDAQ Global Market by filing such amendment or waiver with the
SEC.
|
|
Item 11.
|
Executive
Compensation.
|
The discussion under the heading Executive
Compensation in our definitive proxy statement for the
2007 Annual Meeting of Stockholders is incorporated herein by
reference to such proxy statement.
|
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters.
|
The discussion under the heading Security Ownership of
Certain Beneficial Owners and Management in our definitive
proxy statement for the 2007 Annual Meeting of Stockholders is
incorporated herein by reference to such proxy statement.
|
|
Item 13.
|
Certain
Relationships and Related Transactions, and Director
Independence.
|
The discussion under the headings Certain Relationships
and Related Transactions and Election of
Directors in our definitive proxy statement for the 2007
Annual Meeting of Stockholders is incorporated herein by
reference to such proxy statement.
50
|
|
Item 14.
|
Principal
Accounting Fees and Services.
|
The discussion under the heading Independent Registered
Public Accounting Firm Fees and Other Matters in our
definitive proxy statement for the 2007 Annual Meeting of
Stockholders is incorporated herein by reference to such proxy
statement.
|
|
Item 15.
|
Exhibits,
Financial Statement Schedules.
|
(a)(1) Financial Statements. The financial
statements filed as part of this report are listed on the Index
to the Consolidated Financial Statements.
(a)(2) Financial Statement
Schedules. Schedules are omitted because they are
not applicable or the required information is shown in the
consolidated financial statements or notes thereto.
(a)(3) Exhibits. Reference is made to the
Exhibit Index on page 53. The exhibits are included,
or incorporated by reference, in the Annual Report on
Form 10-K
and are numbered in accordance with Item 601 of
Regulation S-K.
51
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 its behalf by the undersigned,
thereunto duly authorized this 29th day of March, 2007.
BIO-IMAGING TECHNOLOGIES, INC.
|
|
|
|
By:
|
/s/ Mark
L. Weinstein
|
Mark L. Weinstein, President and Chief
Executive Officer
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
|
|
Title
|
|
Date
|
|
/s/ Mark
L. Weinstein
Mark
L. Weinstein
|
|
President and Chief
Executive Officer and Director
(principal executive officer)
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ Ted
I. Kaminer
Ted
I. Kaminer
|
|
Senior Vice President and
Chief Financial Officer
(principal financial
and accounting officer)
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ Jeffrey
H. Berg, Ph.D.
Jeffrey
H. Berg, Ph.D.
|
|
Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ Richard
F. Cimino
Richard
F. Cimino
|
|
Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ E.
Martin Davidoff, Esq.,
CPA
E.
Martin Davidoff, Esq., CPA
|
|
Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ David
E. Nowicki, D.M.D.
David
E. Nowicki, D.M.D.
|
|
Chairman of the
Board and Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ David
Stack
David
Stack
|
|
Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ James
A. Taylor, Ph.D.
James
A. Taylor, Ph.D.
|
|
Director
|
|
March 29th, 2007
|
|
|
|
|
|
/s/ Paula
B. Stafford
Paula
B. Stafford
|
|
Director
|
|
March 29th, 2007
|
52
EXHIBIT INDEX
|
|
|
|
|
Exhibit
|
|
|
No.
|
|
Description of Exhibit
|
|
|
2
|
.1
|
|
Asset Purchase Agreement dated
October 25, 2001, by and between Bio-Imaging Technologies,
Inc. and Quintiles, Inc. Incorporated by reference to
Exhibit 2.1 of our Current Report on
Form 8-K
dated October 25, 2001.
|
|
3
|
.1
|
|
Restated Certificate of
Incorporation of Bio-Imaging Technologies, Inc. Incorporated by
reference to Exhibit 3.1 of our Registration Statement on
Form S-1
(File
Number 33-47471),
which became effective on June 18, 1992. Amendments
incorporated by reference to Exhibit 3.1 of our Annual
Report on
Form 10-K
for the year ended September 30, 1993 and to
Exhibit 3.1 of our Quarterly Report on
Form 10-QSB
for the quarter ended March 31, 1995.
|
|
3
|
.2
|
|
Amended and Restated By-Laws of
Bio-Imaging Technologies, Inc. Incorporated by reference to
Exhibit 3.1 of our Quarterly Report on
Form 10-QSB
for the quarter ended June 30, 2001.
|
|
4
|
.1
|
|
Specimen Common Stock Certificate.
Incorporated by reference to Exhibit 4.1 of our
Registration Statement on
Form S-1
(File
Number 33-47471),
which became effective on June 18, 1992.
|
|
4
|
.2
|
|
Registration Agreement dated
October 13, 1994, between Bio-Imaging Technologies, Inc.
and Corning Pharmaceuticals Services Inc., now Covance Inc.
Incorporated by reference to Exhibit 4.1 of our Current
Report on
Form 8-K
dated October 13, 1994.
|
|
4
|
.3
|
|
Registration Rights Agreement
dated as of October 25, 2001, by and between Bio-Imaging
Technologies, Inc. and Quintiles, Inc. Incorporated by reference
to Exhibit 2 of our Current Report on
Form 8-K/A
dated October 25, 2001.
|
|
10
|
.1*
|
|
2002 Stock Incentive Plan, adopted
by the stockholders of Bio-Imaging Technologies, Inc. on
February 27, 2002, as amended and restated on
April 14, 2005. Incorporated by reference to
Exhibit 99.1 of our Registration Statement on
Form S-8
dated December 21, 2006.
|
|
10
|
.2*
|
|
401(k) Plan. Incorporated by
reference to Exhibit 10.7 of our Registration Statement on
Form S-1
(File
Number 33-47471),
which became effective on June 18, 1992.
|
|
10
|
.3
|
|
Form of Employees Invention
Assignment, Confidential Information and Non-Competition
Agreement. Incorporated by reference to Exhibit 10.9 of our
Annual Report on
Form 10-K
for the fiscal year ended September 30, 1992.
|
|
10
|
.4
|
|
Stock Purchase Agreement dated
October 13, 1994, between Bio-Imaging Technologies, Inc.
and Covance Inc. Incorporated by reference to Exhibit 10.2
of our Current Report on
Form 8-K
dated October 13, 1994.
|
|
10
|
.5*
|
|
Invention Assignment and
Confidential Information Agreement dated January 20, 2000,
by and between Bio-Imaging Technologies, Inc. and Mark L.
Weinstein. Incorporated by reference to Exhibit 10.1 of our
Quarterly Report on
Form 10-QSB
for the quarter ended December 31, 1999.
|
|
10
|
.6
|
|
Amended and Restated Employment
Agreement dated March 1, 2006, by and between Bio-Imaging
Technologies, Inc. and Mark L. Weinstein. Incorporated by
reference to Exhibit 10.2 of our Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2006.
|
|
10
|
.7
|
|
First Modification of Office Space
Lease between 826 Newtown Associates, LP and Bio-Imaging
Technologies, Inc. dated January 11, 2002. Incorporated by
reference to Exhibit 10.2 of our Quarterly Report on
Form 10-QSB
for the quarter ended June 30, 2002.
|
|
10
|
.8
|
|
Office Space Lease dated
September 22, 1999, between Yardley Road Associates, L.P.
and Bio-Imaging Technologies, Inc. Incorporated by reference to
Exhibit 10.9 of our Annual Report on
Form 10-KSB
for the fiscal year ended September 30, 1999.
|
|
10
|
.9
|
|
Office Space Lease dated
September 11, 2000, between Angelo Investment Company and
Bio-Imaging Technologies, Inc. Incorporated by reference to
Exhibit 10.11 of our Annual Report on
Form 10-KSB
for the fiscal year ended September 30, 2000.
|
|
10
|
.10*
|
|
Employment Agreement dated
February 6, 2003, by and between Bio-Imaging Technologies,
Inc. and Ted I. Kaminer. Incorporated by reference to
Exhibit 10.1 of our Quarterly Report on
Form 10-QSB/A
for the quarter ended March 31, 2003.
|
|
10
|
.11
|
|
Securities Purchase Agreement
dated September 15, 2003, by and between Bio-Imaging
Technologies, Inc. and certain institutional investors.
Incorporated by reference to Exhibit 10.1 of our Current
Report on
Form 8-K
dated September 15, 2003.
|
53
|
|
|
|
|
Exhibit
|
|
|
No.
|
|
Description of Exhibit
|
|
|
10
|
.12
|
|
Registration Rights Agreement
dated September 15, 2003, by and between Bio-Imaging
Technologies, Inc. and certain institutional investors.
Incorporated by reference to Exhibit 10.2 of our Current
Report on
Form 8-K
dated September 15, 2003.
|
|
10
|
.13*
|
|
Form of Amended Executive
Retention Agreement by and between Bio-Imaging Technologies,
Inc. and certain executive officers. Incorporated by reference
to Exhibit 10.1 of our Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2006.
|
|
10
|
.14
|
|
Asset Purchase Agreement, dated
November 20, 2003, by and between Bio-Imaging Technologies,
Inc. and CapMed, Inc. Incorporated by reference to
Exhibit 10.16 of our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2005.
|
|
10
|
.15
|
|
Stock Purchase Agreement, dated
December 10, 2004, by and between Bio-Imaging Technologies,
Inc. and Heart Core B.V. Incorporated by reference to
Exhibit 10.17 of our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2005.
|
|
10
|
.16
|
|
Fourth Modification of Office
Space Lease between 826 Newtown Associates, LP and Bio-Imaging
Technologies, Inc. dated September 29, 2004. Incorporated
by reference to Exhibit 10.18 of our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2005.
|
|
10
|
.17
|
|
Stock Purchase Agreement, dated
February 6, 2007, by and between Bio-Imaging Technologies,
Inc. and Theralys, S.A. Incorporated herewith.
|
|
10
|
.18
|
|
Development and Supply Agreement
dated June 20, 2005 between CapMed, a division of
Bio-Imaging Technologies, Inc., and Medic Alert Foundation
United States, Inc. (Portions of this exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission on August 15, 2005). Incorporated by reference
to Exhibit 10.2 of our Quarterly Report on
Form 10-Q
for the quarter ended June 30, 2005.
|
|
21
|
|
|
List of Subsidiaries of
Registrant. Incorporated by reference to Exhibit 21.1 of
our Annual Report on
Form 10-KSB
for the fiscal year ended September 30, 1997.
|
|
23
|
.1
|
|
Consent of PricewaterhouseCoopers
LLP.
|
|
31
|
.1
|
|
Certification of principal
executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31
|
.2
|
|
Certification of principal
financial and accounting officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002.
|
|
32
|
.1
|
|
Certification of principal
executive officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350.
|
|
32
|
.2
|
|
Certification of principal
financial and accounting officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350.
|
|
|
|
* |
|
A management contract or compensatory plan or arrangement
required to be filed as an exhibit pursuant to Item 13(a)
of
Form 10-K. |
|
|
|
Included herewith. |
|
|
|
Included herewith, revised confidential treatment. |
54
EX-10.17
2
w32201exv10w17.htm
SHARE PURCHASE AGREEMENT
exv10w17
EXECUTION COPY
SHARE PURCHASE AGREEMENT
among
BIO-IMAGING TECHNOLOGIES, INC.
(Purchaser)
and
THE SHAREHOLDERS OF THERALYS SA
(Sellers)
dated February 6, 2007
Morgan Lewis
Page
2
BETWEEN THE UNDERSIGNED:
1. |
|
Mr. Chahin PACHAI, born on April 27, 1972 in Teheran, Iran, residing at 40 avenue Lacassagne,
69003 Lyon and married under the regime of separation as to property, |
2. |
|
Mr. Fabrice VINCENT, born on February 1, 1972 in Lyon, residing at 8 rue Millon, 69100
Villeurbanne and married under the regime of partnership of acquests, |
3. |
|
Mr. Philippe DOUEK, born on July 27, 1958 in Neuilly sur Seine, residing at 23 rue Felix
Jacquier, 69006 Lyon and married under the regime of separation as to property, |
4. |
|
Mr. Emmanuel OLART, born on 7, March 1978 in Villefranche sur Saône, residing at 27 bis rue
de lEgalité, residence les Bosquets, 69120 Vaulx en Velin and married under the regime of
partnership of acquests, |
Parties 1 to 4, acting jointly (conjointement), are hereinafter collectively referred to as the
Founders,
AND
5. |
|
GIE VALOREZ, a French Groupement dIntérêt Economique organized under the laws of France,
with a share capital of EUR 16,000, having its registered offices at 66 bvd Niels Bohr CEI
69100 Villeurbanne, registered with the Registre du Commerce de Lyon Trade Registry under the
number 439 787 714, represented by Gérard POSA, member of the Directoire of Ezus-Lyon 1 S.A.
and Joseph GNIEWEK, member of the Directoire of Insavalor S.A., duly empowered for the
purposes hereof, |
6. |
|
Mr. Jean-Claude MOREL, born on February 22, 1936 in Brest, residing at Les Sabines, n°31,
69130 Ecully and married under the regime of community of property, |
7. |
|
Mr. Laurent GERFAULT, born on November 8, 1970 in Angers, residing at 42A rue de la Meije,
38500 Voiron and unmarried, |
8. |
|
Ms. Marcela HERNANDEZ-HOYOS, born on September 23, 1970 in Bogota, Colombia, residing at
Calle 30 No. 3 A 15. Apto 401. Bogota, D.C., Colombia and divorced, |
9. |
|
Mr. Nicolas ROGNIN, born on December 28, 1974 in Voiron, residing at 3 avenue de Genève,
74160 Saint Julien en Genevois and married under the regime of partnership of acquests, |
10. |
|
Mr. Jérôme VINCENT, born on May 14, 1970 in Saint Vallier, residing at 51 route de Combes,
07100 Boulieu and married under the regime of partnership of acquests, |
Parties 1 to 10, are hereinafter collectively referred to as the Shareholders A,
Page 3
AND
11. |
|
RHONE-ALPES CREATION, a French société anonyme with a share capital of 9,478,616 euros,
having its registered offices at 10, Chemin du Château dEau 69410 CHAMPAGNE AU MONT DOR
registered with the Lyon Trade Registry under number 352 014 559, represented by Mr. Guy
RIGAUD, Président du Directoire, himself being represented by Ms. Karine LIGNEL, |
12. |
|
AMORCAGE RHONE-ALPES, société par actions simplifiée with a share capital of 5,645.580 euros
having its registered offices at 10, Chemin du Château dEau 69140 CHAMPAGNE AU MONT DOR,
registered with the Lyon Trade Registry under number 433 995 719, represented by Ms. Karine
LIGNEL, Directeur dInvestissement, duly empowered for the purposes hereof by Mr. Guy RIGAUD,
Directeur Général, |
13. |
|
CREDIT AGRICOLE CREATION, a French société par actions simplifiée, with a share capital of
2,418,472 euros, having its registered offices at 1, rue Pierre de Truchis de Lays, Champagne
au Mont dOr, registered with the Lyon Trade Registry under the number 419 319 322,
represented by Maurice BERNARD, duly empowered for the purposes hereof, |
14. |
|
RHONE DAUPHINE DEVELOPPEMENT, a French société anonyme, with a share capital of 10,495,800
euros, having its registered offices at 2, chemin du Vieux Chêne, 38240 Meylan, registered
with the Grenoble Trade Registry under the number 345 158 117, represented by Pierre JOURDAIN,
duly empowered for the purposes hereof, |
15. |
|
LE LANCEUR, a Fonds Commun de Placement à Risques represented by its société de gestion
SOFIMAC PARTNERS, a French société anonyme with a share capital of 161,000 euros, having its
registered offices at 24, avenue de lAgriculture, Domaine de Mon Désir, 63100 Clermont
Ferrand, registered with the Clermont Ferrand Trade Registry under the number 424 562 445,
represented by Philippe VUAGNAT, Directeur Général, duly empowered for the purposes
hereof, |
Parties 11 to 15 are hereinafter collectively referred to as the Shareholders B,
16. |
|
Mr. Luc BRACOUD, born on March 29, 1978 in Lyon, residing at 61 rue François Peissel, 69300
Caluire and unmarried, |
Parties 1 to 16 are hereinafter collectively referred to as the Sellers,
AND
17. |
|
Bio-Imaging Technologies Inc., a US corporation organized under the laws of Delaware, having
its principal office 826, Newtown-Yardley Road, Newtown, PA 18940, United States of America,
represented by M. Ted Kaminer, duly empowered for the purposes hereof, |
hereinafter referred to as the Purchaser or Bio-Imaging Inc.,
The Purchaser and the Sellers are hereinafter collectively referred to as the Parties and
individually referred to as a Party.
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TABLE OF CONTENTS
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ARTICLE 1 DEFINITIONS
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5 |
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ARTICLE 2 PURCHASE AND SALE
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ARTICLE 3 PURCHASE PRICE PAYMENT OF THE PURCHASE PRICE
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ARTICLE 4 COMPLETION
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ARTICLE 5 REPRESENTATIONS AND WARRANTIES
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ARTICLE 6 REPRESENTATIONS AND WARRANTIES OF THE OTHER
SELLERS AND
OF THE PURCHASER
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ARTICLE 7 COVENANTS
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ARTICLE 8 INDEMNIFICATION
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ARTICLE 9 CONFIDENTIALITY PUBLICITY
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ARTICLE 10 EXPENSES
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ARTICLE 11 SELLERS REPRESENTATIVE NOTICES
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ARTICLE 12 SEVERABILITY
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ARTICLE 13 ENTIRE AGREEMENT
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ARTICLE 14 SUCCESSORS AND ASSIGNS
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ARTICLE 15 LANGUAGE
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ARTICLE 16 APPLICABLE LAW JURISDICTION
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Page 5
WHEREAS
A. |
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The Sellers are the owners of the Securities (as defined in Article 1 below) representing
100% of the issued and outstanding share capital and voting rights in THERALYS, a société
anonyme incorporated under the laws of France, with a share capital of 72,340 euros having its
registered offices at Bioparc, 60 avenue Rockfeller 69008 Lyon (France), registered with the
Lyon Trade Registry under n° 439 429 440 (hereinafter referred to as the Company as defined
in Article 1 below). The Companys share capital is divided into two categories of shares. |
B. |
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Exhibit A indicates the number and the category of Securities held by each Seller at
the date hereof. |
C. |
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The Company is specialised in diagnostic and therapeutics image analysis in clinical trials
(hereafter referred to as the Activity). |
D. |
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The Sellers desire to sell the Sold Shares and the Purchaser desires to buy the Sold Shares
from the Sellers. The purpose of the Agreement is to set forth the terms and conditions of
such sale and purchase of the Sold Shares (hereinafter referred to as the Sale). |
E. |
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Simultaneously to the Sale, the Founders shall contribute the Contributed Shares to
Bio-Imaging Inc. by a separate agreement. In return, the Founders shall receive 36,000 newly
issued restricted shares of Bio-Imaging Inc. common stock. |
NOW THEREFORE IT HAS BEEN AGREED AS FOLLOWS:
ARTICLE 1 DEFINITIONS
The following words shall have the meanings set out hereafter but only when the corresponding words
begin with capital letters.
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Affiliate
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of any person shall mean (i) any
other person that directly or
indirectly, through one or more
intermediaries, controls, is
controlled by, or is under common
control with, the first mentioned
person, or (ii) any other person
with whom such person or an entity
controlling, controlled by, or under
common control with such person
entered into a shareholders
agreement, joint venture agreement
or any agreement with similar
effects; a person shall be deemed to
control another person if such first
mentioned person owns, directly or
indirectly, fifty percent (50%) or
more of the voting rights of the
second mentioned person; |
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Agreement
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This sale and purchase agreement; |
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Balance Sheet Date
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means December 31, 2006; |
Page 6
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Bio-Imaging Inc.
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Bio-Imaging Technologies Inc., a US
corporation having its principal
office 826, Newtown-Yardley Road,
Newtown, PA 18940 United States of
America and registered under the
laws of Delaware (USA); |
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Business Day(s)
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Any day(s) on which banks are open
for business in France or in the
United States of America; |
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Category A Shares
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The 4,000 Category A shares of the
Company held by the Shareholders A
in the proportions mentioned in
Exhibit A; |
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Category B Shares
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The 3,234 Category B shares of the
Company held by the Shareholders B
in the proportions mentioned in
Exhibit A; |
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Company
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THERALYS, a société anonyme
incorporated under the laws of
France, with a share capital of
72,340, having its registered
offices at Bioparc, 60 avenue
Rockfeller 69008 Lyon (France),
registered with the Lyon Trade
Registry under n° 439 429 440; |
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Completion Date
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The date of completion of the
transfer of the Securities as per
section 4.1 hereafter; |
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Contribution Agreement
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The Share Contribution Agreement
among the Purchaser and the
Founders, dated February 6, 2007,
executed simultaneously to the
Agreement; |
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Contributed Shares
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400 Category A shares of the
Company, with a par value of ten
(10) euros each held by the Founders
in the proportions mentioned in
Exhibit A and contributed to
Bio-Imaging Inc. under a separate
Contribution Agreement; |
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Exhibit(s)
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Any exhibit attached to this
Agreement, it being specified that
each time that the Representations
contained in a section of this
Agreement need to be documented,
this is done via an Exhibit carrying
the same number as the relevant
representation; |
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Founders
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means collectively MM Chahin Pachai,
Fabrice Vincent, Philippe Douek and
Emmanuel Olart; |
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Governmental Entity
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means any state, authority or any
court of competent jurisdiction,
administrative agency or commission
or other governmental authority or
instrumentality, domestic or
foreign, including but not limited
to any court, administrative agency,
commission or other organ of the
European Union or the United States
of America; |
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Lien
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means any mortgage, lien, pledge,
charge, encumbrance or any other
security interest; |
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Representations and Warranties
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The representations and warranties
to be delivered by each of the
Founders on a joint basis
(conjointement) to the Purchaser, as
per Article 5 below; |
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Restricted Shares
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means newly issued unregistered
shares of Bio-Imaging Technologies
Inc., regulated under the Securities
Act of 1933, and in particular by
the Rule 144 promulgated thereunder,
permitting those Restricted Shares
to be sold after the one-year
holding period; provided, however,
the number of shares that may be
sold during any three-month period
cannot exceed the greater of (i) 1%
of the shares of common stock
outstanding at that time, or (ii)
the average reported weekly trading
volume during the four weeks
preceding the filing a notice of the
sale on Form 144. Bio-Imaging shall
accomplished all relevant
formalities in the interest of a
holder of Restricted Shares allowing
them to sell their Restricted Shares
as soon as possible in respect of US
securities law, and will bear all
reasonable expenses relating to a
transfer or sale of such Restricted
Shares pursuant to Rule 144 so long
as the holder of such Restricted
Shares provides Bio-Imaging with all
documentation reasonably requested
by Bio-Imaging; |
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Shareholders Agreement
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The agreement entered into between
the Sellers on December 16, 2002 in
respect of the Company; |
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Share(s)
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Any share(s) issued by the Company; |
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Securities
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means collectively the Sold Shares,
the Contributed Shares and the
Warrants, representing on Completion
Date 100% of the issued and
outstanding share capital and voting
rights of the Company, together
granting the Purchaser a direct and
indirect ownership of 100% of the
Companys issued and outstanding
share capital and voting rights; |
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Sold Shares
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means collectively (i) 3,600
Category A Shares of the Company
with a par value of ten (10) euros
each held by the Shareholders A and
(ii) 3,234 Category B Shares of the
Company with a par value of ten (10)
euros each held by the Shareholders
B, and sold to the Purchaser in the
proportions mentioned in Exhibit A; |
Page 8
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Warrants
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means the 412 warrants in form of
"bons de souscription de parts de
créateur dentreprise (BSPCE) held
by the Warrants Holders as defined
below and to be exercised until
April 26, 2009 pursuant to the
decisions of the Companys
shareholders meeting held on April
26, 2004. The Warrants give right to
subscribe to one (1) Category A
Shares of the Company in
consideration of a subscription
price of 170 euros each; |
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Warrants Holders
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means collectively MM Chahin Pachai,
Fabrice Vincent, Luc Bracoud and
Emmanuel Olart. |
ARTICLE 2 PURCHASE AND SALE
2.1.1 |
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Subject to the terms and conditions hereof, the Sellers agree to sell the Sold Shares to the
Purchaser and the Purchaser agrees to purchase the Sold Shares from the Sellers. The detailed
allocation of the Sold Shares (together with the sub-allocation between the Sellers) is set
forth in Exhibit B. |
2.1.2 |
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Subject to the terms and conditions hereof, the Warrant Holders agree to waive their rights
attached to the Warrants and the Purchaser agrees to indemnify the Warrants Holders from such
waiver. The detailed allocation of the Warrants (together with the sub-allocation between the
Warrant Holders) is set forth in Exhibit C. |
2.1.3 |
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The Sold Shares shall be transferred free and clear of all Liens and with all dividend
rights now and then attaching thereto, including the right to all dividends for the 2006
fiscal year. |
ARTICLE 3 PURCHASE PRICE PAYMENT OF THE PURCHASE PRICE
The aggregate purchase price for the Sold Shares and for the indemnification for the waiver
of the rights attached to the Warrants by the Warrants Holders (hereinafter referred to as
the Purchase Price) shall be allocated among the Sellers as follows:
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1,344,515 euros for the 3,600 Category A Shares held by the
Shareholders A; and |
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1,304,448 euros for all the Category B Shares held by the
Shareholders B, payable in cash and by issuance of Restricted Shares of
Bio-Imaging Inc. common stock in accordance with Article 3.2 (v) below; and |
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82,294 euros for the Warrants held by the Warrants Holders in
consideration of the waiver of their rights to exercise the Warrants. |
Details of the allocation of the Purchase Price between the Sellers and their respective
categories are set forth in Exhibits B and C.
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3.2 |
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Closing Payment and Escrow |
On Completion Date, the Purchaser shall:
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pay in cash to the Shareholders A an aggregate amount of 1,204,515 euros by
means of bank checks; |
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deposit 140,000 euros (the Escrow Amount) which constitute part of the
Purchase Price to be paid to the Founders into one or more escrow accounts to be held
and disbursed by US Bank National Association as escrow agent (the Escrow Agent).
The Escrow Amount shall be held by the Escrow Agent until August 6, 2008 pursuant to
the escrow agreement(s) set forth as Exhibit D hereto (the Escrow
Agreement). The Escrow Amount will be subject to set-off for any indemnification
claims notified by the Purchaser to the Founders pursuant to Article 8 below. The
Purchaser shall bear the fees and expenses related to the setting up of the escrow. |
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(iii) |
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pay in cash to the Warrant Holders an aggregate amount of 82,294 euros by
means of bank checks; |
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(iv) |
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pay in cash to the Shareholders B an aggregate amount of 948,689 euros
corresponding to 2,352 Category B Shares, by means of bank checks; |
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(v) |
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issue 57,408 newly issued Restricted Shares of Bio-Imaging Inc. common stock
(the Purchasers Common Stock) in exchange of 882 Category B Shares. The Purchasers
Common Stock will be subject to US securities laws. This payment shall be allocated
among the concerned Shareholders B as set forth in Exhibit 3.2 (v). |
Transfer of ownership of the Sold Shares and payment of the Purchase Price shall take place
at the date hereof (the Completion Date).
4.2 |
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Instruments to be signed and delivered on Completion Date |
4.2.1 |
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At the date hereof, the Sellers shall deliver to the Purchaser: |
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original executed copies of share transfer forms (ordres de mouvement) selling,
assigning and delivering to the Purchaser all of the Sold Shares free and clear from
all Liens together with duly related executed tax forms n° 2759; |
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the updated stock transfer register (registres des mouvements de titres) and
stockholders individual accounts (comptes dactionnaires), the shareholders decisions
book (registre des procès-verbaux des assemblées générales) the board of directors
decisions book (registre des procès-verbaux du conseil dadministration) and all
attendance sheets to the shareholders and board of directors meetings of the Company; |
Page 10
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the original executed copies of the resignation letters effective as of the
Completion Date from the Company s members of the board of directors, the names of
which are set out in Exhibit 4.2.1, said letters specifying that the resigning
members have no claim whatsoever against the Company; |
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the original executed copy of the resignation letter effective as of the
Completion Date from Mr. Fabrice Vincent concerning its functions of Directeur Général
Délégué, said letter specifying that Mr. Fabrice Vincent has no claim whatsoever
against the Company; |
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the original executed copies of the relevant minutes evidencing that the
persons listed in Exhibit 4.2.1 (or such other persons as the Purchaser may
designate replacement therefore) shall have been elected or designated directors,
effective as of Completion Date; |
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the irrevocable and unconditional waiver by each and all Sellers of all rights
under the Shareholders Agreements including the acknowledgment that said agreement will
cease to be of any effect as from the Completion Date; |
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the irrevocable and unconditional waiver by each and all Warrant Holders of
their rights to exercise any and all of the Warrants and that all the Warrants will
become null and void as from as from the Completion Date; |
4.2.2 |
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Following delivery of the documents referred to in section 4.2.1 above, the Purchaser shall
deliver: |
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bank checks to each Seller for the amounts set forth in Exhibit 4.2.2. |
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any documents evidencing the issuance of the Purchasers Common Stock, such as
a copy of an instruction letter and/or a legal opinion of Morgan, Lewis & Bockius LLP
to the transfer agent, effective as from the Completion Date. The original stock
certificates of the Purchasers Common Stock will be delivered to the beneficiaries
within ten (10) days as from the Completion Date. |
4.2.3 |
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Related Agreements: |
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The Founders, the Purchaser and the Escrow Agent shall execute the Escrow
Agreement in the form attached hereto as Exhibit D; |
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The Company and the Founders at the date hereof and the Company and other
Employees within five (5) days following the Completion Date shall execute new
employment agreements in the forms attached hereto as Exhibit E; |
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The Founders and the Purchaser shall execute the Contribution Agreement related
to the Contributed Shares in the form attached hereto as Exhibit F. |
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ARTICLE 5 REPRESENTATIONS AND WARRANTIES |
The Founders, acting jointly (conjointement), represent and warrant to the Purchaser as of the date
hereof as follows.
The representations and warranties made by the Founders in this Article 5 (the Representations and
Warranties) shall be construed subject to the facts or information which are disclosed in the
Agreement or its applicable Exhibits.
Conversely, for the avoidance of doubt, the Representations and Warranties made by the Founders
shall not be limited by documents or information provided to Bio-Imaging Inc. or its advisers prior
to the date hereof that are not explicitly and clearly restated in the Agreement or its Exhibits.
The Founders have the full corporate power and authority required to enter into the Agreement and
to transfer and deliver the Sold Shares they own as provided in the Agreement and to waive all
their rights under the Warrants they own.
5.2 |
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Corporate Status |
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5.2.1 |
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The Company is a société anonyme duly organized and validly existing under the laws of
France and in compliance with the French commercial code and French decree n° 67-236 of March
23, 1967 on commercial companies. The Companys by-laws as set forth in Exhibit 5.2.1
are accurate as at the date hereof. |
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5.2.2 |
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The Company has never been in a state of insolvency or suspension of payments, nor have they
made a voluntary or courtordered arrangement or similar agreement with some or all of their
creditors. They are not subject to any administration, insolvency, reorganization, windingup,
bankruptcy or similar proceedings (procédure et sauvegarde, règlement amiable, redressement ou
liquidation judiciaire). |
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5.2.3 |
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The Company has all requisite corporate power to own its properties and carry on its
business as now conducted. All corporate laws and regulations applicable to the Company have
been complied with. All corporate formalities and compulsory disclosure requirements have been
duly fulfilled. The Companys business (fonds de commerce) is not the object of any leasing
agreement (contrat de location-gérance). |
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5.2.4 |
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The Company has never had any subsidiaries and has never owned directly or indirectly any
capital stock of, or other equity interests in, any corporation, partnership, or other entity.
The Company has never been a member of or a participant in any partnership, joint venture or
similar enterprise. The Company has no set up any branch (succursale) or secondary office
(établissement secondaire). |
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5.3 |
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Capital Stock and Ownership |
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5.3.1 |
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The Companys issued share capital amounts to 72,340 euros divided into 7,234 shares of a
nominal value of 10 euros each. All the shares have been duly and validly issued and are fully
paid up. The shares are divided into two (2) categories as follows: |
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4,000 of Category A, and |
Page 12
Exhibit 5.3.1 sets forth the amount of the Companys share capital, detailing all
the Securities issued by the Company, the categories and respective rights thereof and
holders thereof. The Securities represent 100% of the issued and outstanding capital
and voting rights of the Company, on a fully diluted basis and are freely transferable.
5.3.2 |
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The Company has not issued any securities or other rights (including options de souscription
dactions or bons de souscription de parts de créateurs dentreprise) entitling their holders
to acquire, immediately or at a future date, a fraction (quotité) of the Companys share
capital other than the Warrants and being specified that all the outstanding convertible bonds
issued by the Company have been converted into Category B Shares prior to the date hereof. |
No authorization voted by the general shareholders meeting to issue securities or
other rights to a fraction (quotité) of the Companys share capital is in effect.
5.3.3 |
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No shareholders agreement has been entered into relating to the Company other than the
Shareholders Agreement, which will terminate at Completion Date. |
5.3.4 |
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At Completion Date, the Sellers will have, and will transfer, good and marketable title to
the Sold Shares and to all of the rights afforded thereby, free of any Lien, and upon
consummation of the transactions contemplated hereby, the Purchaser will hold 100% of the
Securities of the Company following the simultaneous realization of both the Agreement and the
Contribution Agreement. |
5.4.1 |
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Exhibit 5.4.1 contains the audited annual balance sheet and profit and loss
statement of the Company together with the notes and annexes thereto as of December 31, 2005
(the 2005 Accounts), which, as well as for the preceeding four years, were certified without
qualifications by the Companys statutory auditors and approved by the Companys annual
shareholders meeting without reserves. |
5.4.2 |
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Exhibit 5.4.2 contains the interim balance sheet and profit and loss statement
(bilan et comptes de résultat intermédiaires) of the Company as of the Balance Sheet Date,
which were prepared by the Company and perused by the Companys statutory auditors (the
Interim Accounts). |
5.4.3 |
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The 2005 Accounts and the Interim Accounts have been prepared in accordance with the
accounting principles generally accepted in France and in particular with those described in
Exhibit 5.4.3 applied consistently with past practice and present a true and fair view
(une image fidèle et sincère) of the financial condition and results of operations of the
Company as at their respective date. |
5.4.4 |
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The Company is not bound by any off balance sheet liability (engagements hors bilan) except
as clearly disclosed in the notes to the Interim Accounts or in Exhibit 5.4.4. |
5.4.5 |
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The Interim Accounts reflect all liabilities (whether absolute, accrued, contingent or
otherwise) of the Company required to be recorded thereon or in the annexes or notes thereto
in accordance with the accounting principles as at the respective date thereof. |
Page 13
5.4.6 |
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The Interim Accounts reflect all accrued and unpaid wages, compensation and other obligation
of the Company with respect to their employees as of the date of the Interim Accounts. |
Since the Balance Sheet Date, the Company has been managed in the ordinary course of
business consistent with past practice and with a reasonable degree of care (en bon père de
famille), the Company has sufficient working capital to manage its activities at the current
level and no change has occurred which adversely affects the assets or the condition
(financial or otherwise), results of operations or prospects of the business of the Company.
In particular and except as set forth in Exhibit 5.5, it has not:
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sold or transferred any of its assets or committed to do so, except in
the ordinary course of business consistent with past practice; |
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(ii.) |
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acquired any other business or entered into any lease agreement,
licensing arrangement or joint venture, other than leases or licenses in favor of
the Company pertaining to Movable Property having an individual value of no more
than 6,000 euros and an aggregate value of no more than 20,000 euros, or software
used in the ordinary course of business of the Company consistent with past
practice; |
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(iii.) |
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authorized, declared, set aside, made or paid any dividend or other distribution
in respect of its capital stock or otherwise purchased or redeemed, directly or
indirectly, any shares of its capital stock; |
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(iv.) |
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issued or sold any Shares of any class of its capital stock, or any
securities convertible into or exchangeable for any such shares, or issued, sold,
granted or entered into any subscriptions, options, warrants, conversion or other
rights, agreements, commitments, arrangements or understandings of any kind,
contingently or otherwise, to purchase or otherwise acquire any such shares or any
securities convertible into or exchangeable for any such shares; |
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(v.) |
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incurred any indebtedness for borrowed money, issued or sold any debt
securities or prepaid any debt (including, without limitation, any borrowings from
or prepayments to the Sellers), except for borrowings and repayments in the
ordinary course of business; |
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(vi.) |
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mortgaged, pledged or otherwise subjected to any Lien, any of its
assets, tangible or intangible; |
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(vii.) |
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forgiven, canceled, compromised, waived or released any debts, claims or rights,
except for debts, claims and rights forgiven, canceled, compromised, waived or
released in the ordinary course of business; |
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(viii.) |
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modified any existing contract or entered into (x) any agreement, commitment or
other transaction, other than agreements entered into in the ordinary course of
business and involving an expenditure by the Company of more than 30,000 euros in
each case and 50,000 euros in the aggregate, |
Page 14
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or (y) any agreement or commitment that, pursuant to its terms, may not be
terminated without penalty on less than 30 days notice; |
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(ix.) |
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increased the compensation of its officers or employees, or modified
the terms and conditions of their offices or contracts of employment, or permitted
any such modification, except pursuant to collective bargaining agreements, nor
paid any bonus to any officer, director, or employee, except as otherwise agreed in
written with the Purchaser; |
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(x.) |
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amended its statuts, articles of association, by-laws or any other
organizational documents; |
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(xi.) |
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changed in any respect its accounting practices, policies or
principles; |
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(xii.) |
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transferred or granted any rights or licenses under, or entered into any
settlement regarding the infringement of intellectual property or entered into any
licensing or similar agreements or arrangements; |
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(xiii.) |
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taken any action or omitted to take any action that would result in the
occurrence of any of the foregoing. |
There is no lawsuit, arbitration or proceeding pending or threatened against the Company
before any court, arbitration tribunal or governmental authority and there is no outstanding
judgment, order, decree, award or injunction against the Company.
The Company does not own any real property. The only lease entered into by the Company with
respect to real property (the Real Property) is a lease of premises located at Bioparc, 60
avenue Rockfeller, 69008 Lyon (France) which will expire on February 15, 2006 (the Current
Lease). Constructions on the Real Property are structurally sound with no material defects,
subject to normal wear and tear. The parties to the Current Lease have complied with all
their respective obligations contained therein and the Real Property has been regularly
maintained.
The Company has concluded prior to Completion Date a new short-term lease (the New Lease)
set forth in Exhibit 5.7. The New Lease has been concluded in compliance with French
law (and in particular with Article L. 145-5 of the French Commercial Code) and zoning and
internal building regulations (including the Laennec buildings selection criteria and the
decision of the specific committee of the Communauté Urbaine de Lyon). The New Lease will
start on February 16, 2007 and will expire on January 15, 2009.
The Company does not own any movable property the net book value of which is in excess of
3,000 euros (the Movable Property). The Movable Property is structurally sound,
adequate for the conduct of the business of the Company as it has been and is proposed to be
conducted, subject to normal wear and tear.
Page 15
The activities of the Company have been conducted in compliance with all applicable
environmental laws and regulations.
5.10 |
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Taxes, customs and social security contributions |
5.10.1 |
|
The Company has duly and timely filed with the appropriate Governmental Entities all tax,
customs and social security returns and reports required to be filed in respect of the
activities of the Company and has timely and fully paid all taxes, customs or social security
contributions due by it prior to the date hereof. |
5.10.2 |
|
The amounts of the tax loss carry forwards and deferred depreciation (amortissements réputés
différés) declared by the Company in its tax returns are accurate and such tax loss carry
forwards and deferred depreciation are offsetable against future taxable profits. The Company
has kept the documentation required to justify the existence of these tax loss carry forwards
and deferred depreciation. |
Losses shall be equal to the product of the corporate income tax rate in force at the time
of the reassessment and the global amount of the tax losses carry forwards and deferred
depreciation, the deduction of which is challenged by the tax authorities.
5.10.3 |
|
The Company is neither a party to any action or proceeding by any Governmental Entity for
assessment and collection of taxes, customs or social security contributions, nor has received
notice of any claim for such assessment and collection of taxes, customs or social security
contributions in respect of its activities. |
5.10.4 |
|
Apart from those expounded in 5.10.5 and 5.10.6 below, the Company has not benefited from
any favorable regime in terms of taxes, customs and social security contributions. |
5.10.5 |
|
The Company had not unduly benefited from the tax and social advantages deriving from the
Young Innovative Enterprise status (Jeunes Entreprises Innovantes). The loss of the Young
Innovative Enterprise status as a result of the sale of the Securities will not trigger any
refund obligation for the Company. According to that status, the Companys changes of control
will generate that it will no longer be allowed to keep that status from January 1, 2007. |
5.10.6 |
|
The Company had not unduly benefited from the advantages and deriving from the research tax
credit (Crédit dimpôt recherche). |
5.10.7 |
|
The Company has been duly authorized for years 2006, 2007 and 2008 by the Research and
Innovation Department (Direction Générale de la Recherche et de lInnovation) of the Ministry
of Education and Research (Ministère de lEducation Nationale, de lEnseignement Supérieur et
de la Recherche) as a research entity (organisme de recherche privé) thereby entitling its
customers to benefit from the research tax credit regime for the research works carried out by
the Company on behalf of said customers. |
5.10.8 |
|
There are no outstanding adjustments for purposes of taxes or social charges applicable to
the Company required as a result of changes in methods of accounting. There are no material
elections or requests for rulings for purposes of taxes or social |
Page 16
|
|
charges made by the Company that are currently
in force or by which the Company or is bound.
The Company has never been a member of any tax
consolidated group. |
5.11 |
|
Intellectual Property |
5.11.1 |
|
The Company has full, exclusive and valid title, through direct ownership or a license, to
the use of all invention, patent, patent application, know-how, trade secret, trademark,
trademark application, trade name, company name, logo, domain name, copyright, copyright
application, design, software (including all documentation relating to the computer systems
and application software and the latest revisions of all related object and source codes
therefor) and other intellectual property rights used, held for use in connection with, or
necessary to the daily operation or development of its business (the Intellectual Property
Rights). Exhibit 5.11.1 provides a list of such Intellectual Property Rights, which
specifies for each such item whether it is owned or licensed and, if licensed, indicates the
full title, the parties thereto and the expiration date of the relevant license agreement.
Each of such licenses is in full force and effect, the Company is in compliance with each of
such licenses and no default exists by any other party thereto. The consummation of the
transactions contemplated hereby will neither violate nor result in the breach, modification,
cancellation, termination or suspension of such licenses |
5.11.2 |
|
Neither the Sellers, nor any current or former employee nor any manager or officer of the
Company nor any of their former employers holds any rights in the Intellectual Property
Rights. Further, no contractual or other obligation or restriction of any nature whatsoever
prevents any employee, manager or officer of the Company from using for the benefit of the
Company the experience and skills acquired by him while employed by any other company or
entity. |
5.11.3 |
|
All Intellectual Property Rights owned by the Company have been properly registered and
maintained and are duly opposable to third parties. |
5.11.4 |
|
There is no outstanding claim or threat thereof relating to the Intellectual Property Rights
against the Company with respect to facts having occurred prior to the date of this Agreement,
and the operation of the Company as at the date hereof does not infringe the intellectual
property rights of any third party. Conversely, the Founders are unaware of the violation or
infringement by any third party of the Intellectual Property Rights. |
5.11.5 |
|
Except as set forth in Exhibit 5.11.5, the Company has not granted to any third
party any option, license, pledge or other restrictions, user rights, or other rights
whatsoever, whether or not for compensation, with respect to the Intellectual Property Rights,
nor formed, directly or indirectly, any agreement with any third parties in relation to the
same other than licenses granted to customers or resellers in the ordinary course of business. |
5.11.6 |
|
All of the Companys employment and/or sub-contractor agreements contain the provisions
necessary to ensure, to the fullest extent permitted by applicable laws, that all intellectual
property rights on the work carried out by its employees and/or subcontractors as from the
date of their hiring belong to the Company. The Company has timely compensated its employees
for their inventions developed and used by the |
Page 17
|
|
Company before the date hereof, in accordance with the requirements of French law and the
collective bargaining agreement applicable to the employees of the Company. |
5.11.7 |
|
Immediately after the Completion Date, the Company will own all of the Intellectual Property
Rights owned by the Company immediately prior to the Completion Date and will have a right to
use all other Intellectual Property Rights on the same contractual terms and conditions as in
effect prior to the Completion Date, free and clear of all Liens, except as set forth in
Exhibit 5.11.5, and on the same terms and conditions as in effect prior to the
Completion Date. |
5.12.1 |
|
Exhibit 5.12.1 contains a list of all outstanding, oral or written contracts or
agreements entered into by the Company which (i) provide for payments or guarantees for
payment by or to the Company in excess of 10,000 euros over any 12-month period, (ii) has a
term equal to one year or more from the date hereof (not including any optional or tacit
renewal period), (iii) has been entered into by the Company with any of its top 10 customers
or suppliers, (iv) guarantees the indebtedness of another person, (v) restricts its ability to
develop its business or compete with any person, (vi) grants exclusive rights to any third
party, or (vii) is a convention réglementée within the meaning of article L. 225-86 of the
French commercial code or has been entered into by the Company with any of the Sellers or any
of their Affiliates (the Material Contracts). As an exception to the foregoing, Exhibit
5.12.1 does not list the employment agreements of the Company with its Employees. |
5.12.2 |
|
The Material Contracts are valid and enforceable by the Company. The Company and its
co-contractors thereunder have performed all their obligations required to be performed
thereunder. |
5.12.3 |
|
There are no facts or information indicating, nor any other reason to believe, that any of
the customers or suppliers of the Company will not continue to be respectively customers or
suppliers of the Company after Completion Date at the same level as heretofore. |
5.12.4 |
|
Except as set forth in Exhibit 5.12.4, the Company is not a party to any contract or
agreement under the terms of which, as a result of the Companys change of control or any
other transaction contemplated in this Agreement: |
|
(i.) |
|
such contract would terminate at an earlier date than the stated date of
termination in the absence of such change; |
|
|
(ii.) |
|
the Companys commitments would become due and payable prior to the normal
term thereof as a result of such change; |
|
|
(iii.) |
|
less favorable terms than those the Company would have benefited from in the absence
of such change would apply as a result of such change; or |
|
|
(iv.) |
|
any other party to such contract or agreement would be entitled to terminate
such contract or agreement earlier than it would have been entitled to do so in the
absence of such change, or would be entitled to make the Companys commitments become
due and payable prior to the stated term thereof or to |
Page 18
|
|
|
require the application of less favorable terms than those the Company would have
benefited from in the absence of such change. |
Exhibit 5.13 contains all insurance policies entered into by the Company (the
Insurance Policies). The Insurance Policies provide for a coverage that is customary in
connection with the business, assets and liabilities of the Company and are subject to
deductible and exclusions set forth in the Insurance Policies. The Insurance Policies held
by the Company are in full force and effect and corresponding premiums have been paid when
due. The Company has not experienced over the last 3 years any suspension of coverage or
cancellation of insurance policies relating to its respective business, assets and
liabilities.
5.14 |
|
Accounts Receivables and payables Cash balance |
All debts owed by third parties to the Company as of the Balance Sheet Date are reflected in
the Interim Accounts. Such debts are good and collectable, 70% of them shall be recoverable
within a maximum six-month (6) period from Completion Date and the remaining 30% shall be
recoverable within a maximum ten-month (10) period from Completion Date and so without
litigation or resort to any other methods of recovery and without set-offs, counterclaims or
other deductions or, in the opposite case, are sufficiently reserved against in the Interim
Accounts. Exhibit 5.14 sets forth each and all of the accounts receivables as of the
Balance Sheet Date.
The Company has no outstanding obligation, debt or liability, fixed or contingent, which is
not specifically referred to in the Interim Accounts and all accounting debts have been
properly paid on the relevant due date and the Company is not liable as a result for any
interest for late payment, penalty or indemnity of any sort. Exhibit 5.14bis sets
forth each and all of the accounts payables and each and all of other payables as of the
Balance Sheet Date.
Further, the cash balance (trésorerie nette) of the Company as of the Balance Sheet Date is
at least of 100,000 euros.
Exhibit 5.15 contains a true and complete list of the outstanding bank loans, credit
lines, discount facilities and other short and long term indebtedness. The Company has not
guaranteed repayment of the debt or amount owed by any other person, and has no obligation,
fixed or contingent, as a surety or otherwise, to pay any such debt or amount.
The Company is under the benefits of 400.000 of reimbursable support (contrat ANVAR), as
set forth in Exhibit 5.15 arising 280.000 of potential debt outstanding.
5.16 |
|
Governmental permits Compliance with laws |
No permit or authorization is necessary to conduct the business of the Company. The Company
is not in violation in any material respect of any applicable law or
Page 19
regulation. No agreement, permit or authorization prevents the consummation by the Company
or the Founders of any of the transactions contemplated by this Agreement.
5.17.1 |
|
The Company has complied with all statutory or regulatory requirements with respect to its
managers and employees (the Employees), including without limitation, working time
requirements, working conditions, health and safety, social security, personnel representation
laws and regulations. |
5.17.2 |
|
All the employment contracts entered into between the Company and its Employees and in force
at the date hereof are set forth in Exhibit 5.17.2. There are no pension or
retirement benefits, bonus, profit sharing, stock purchase or stock option plans, company
savings plans or employee funds of the Company other than those which are mandatory under
French law or the applicable collective bargaining agreement. |
5.17.3 |
|
The Founders and the Employees other than the Founders are entirely free from any
non-compete or similar clause which may impair in whole or in part their ability to contribute
to the Companys business and operations. |
5.17.4 |
|
The Company has not entered into any employment contracts providing for a termination notice
greater than the minimum provided by French law or the applicable collective bargaining
agreement, or for the payment of a termination or retirement indemnity exceeding that provided
by law or the applicable collective bargaining agreement. |
5.17.5 |
|
The Company has no pending obligations to any of its corporate officers (mandataires
sociaux), whether current or former, or its current or former managers and employees, in
particular in the form of immediate or deferred compensation, including pension, retirement
supplement, or surviving spouse pension, salaries, salary ancillaries, indemnities of any
nature whatsoever or any other sum which may arise out of or be due in respect of the
performance or termination of an employment agreement, other than the obligations which are
mandatory and compulsory pursuant to French laws and regulations and the applicable collective
bargaining agreement. |
5.17.6 |
|
No Employee will be entitled to receive any payment or benefit directly as a consequence of
the completion of the transactions contemplated herein. No Employee is entitled to receive
compensation proportional to profits or turnover other than as a result of mandatory legal
provisions (including the applicable collective bargaining agreement) |
5.17.7 |
|
No consultation of any Employees representatives is required to be made in connection with
the transaction contemplated hereby. |
Except as set forth in Exhibit 5.18, (a) there are no warranties express or implied,
written or oral, with respect to the business of the Company and (b) there are no pending or
threatened claims with respect to any such warranty, and the Company has no liability with
respect to any such warranty accrued and due.
Page 20
At the Completion Date, the inventory of the Company will only consist of items which are
useable and saleable in the normal course of business of the Company, as conducted on or
prior to the date hereof. The Company does not have any commitment to purchase inventories
in amounts greater than required in the ordinary course of business consistent with past
practices.
The Sellers have not used the services of any broker, finder, financial advisor or other
person, firm or corporation who would be entitled to receive any brokerage or finders or
financial advisory fee from the Purchaser or the Company in connection with the transactions
contemplated by the Agreement.
5.21 |
|
Transactions with Affiliates |
With the exception of the Shareholders Agreement, there are no agreements between the
Company and its executive officers or shareholders.
5.22 Full disclosure
Any fact the disclosure of which would be material in the context of the transactions
contemplated herein, or which would be necessary to not make the above representations
misleading, has been disclosed in the Agreement.
ARTICLE 6 REPRESENTATIONS AND WARRANTIES OF THE OTHER SELLERS AND OF THE PURCHASER
6.1 |
|
Representations and warranties of each Seller other than the Founders (the Other
Sellers) |
Each Other Seller represents and warrants to the Purchaser as of the date hereof, and covenants to
the Purchaser, as follows:
6.1.1 |
|
Each of the Other Sellers has, and will transfer to the Purchaser pursuant to this
Agreement, good and marketable title to the number of Sold Shares set forth next to
his/her/its name in Exhibit 6.1.1 and to all of the rights afforded thereby, free and
clear of all Liens. |
6.1.2 |
|
The Other Sellers which are individuals and their respective representatives for the purpose
hereof have the full capacity and authority required to enter into this Agreement and any
other documents contemplated hereby and to transfer, assign and deliver the Sold Shares they
own as provided in the Agreement. Mr. Bracoud has the full capacity and authority required to
waive all the rights attached to the Warrants he owns. |
6.1.3 |
|
The Other Sellers which are legal entities or investment funds have the full corporate power
and authority required to enter into this Agreement and to transfer, assign and deliver the
Sold Shares they own as provided in the Agreement. The execution and delivery of the Agreement
and the consummation by them of the transactions |
Page 21
|
|
contemplated hereby have been duly authorized by their respective competent corporate
bodies. |
6.1.4 |
|
The Agreement constitutes a valid obligation of each of the Other Sellers enforceable
against him/her/it in accordance with its terms. |
6.1.5 |
|
The Other Sellers as listed in Exhibit 6.1.5 have been advised that the Purchasers
Common Stock they will receive will be deemed to be Restricted Shares under the Securities Act
of 1933, as amended and that a restrictive legend in substantially the following form shall be
placed on the certificates representing such shares: |
The Securities represented hereby have not been registered under
the Securities Act of 1933, as amended (the 1933 Act), or the
Securities Act of any State and may not be offered, sold or otherwise
transferred, pledged or hypothecated unless and until registered under
the 1933 Act or applicable State Securities Acts or, in the opinion of
counsel in form and substance satisfactory to the issuer of these
securities, such offer, sale or transfer, pledge or hypothecation is
in compliance therewith
6.2 |
|
Representations and warranties of the Purchaser |
6.2.1 |
|
The Purchaser has the full corporate power and authority required to enter into and perform
the Agreement. The execution and delivery of the Agreement and the consummation of the
transactions contemplated hereby have been duly authorized by its competent corporate bodies. |
6.2.2 |
|
The Agreement constitutes a valid and binding obligation of the Purchaser enforceable
against the Purchaser in accordance with its terms. |
ARTICLE 7 COVENANTS
The Sellers acknowledge that the foregoing covenants are made by them in consequence of and
as an inducement to Bio-Imaging Inc. to acquire the Securities and to protect and preserve
to Bio-Imaging Inc. the benefit of its bargain in the acquisition of the Securities; that
each of the foregoing covenants is reasonable and necessary to protect and preserve the
benefits of such purchase; and that irreparable loss and injury would result should the
Sellers breach any of the foregoing covenants.
Except as consented to by the Purchaser in writing, from the date hereof to the Completion
Date, the Sellers shall cause the Company to conduct its business and operations only in the
ordinary course consistent with past practice. The Sellers shall promptly
notify the Purchaser of any event, condition or circumstance that, individually or in the
aggregate, would have or result in an adverse effect on the finance or perspectives of the
Company.
7.2 |
|
Access to Information |
The Sellers shall (i) afford, and shall cause the Company to afford, the Purchaser
and its representatives access to all the facilities and books and records of the Company,
Page 22
(ii) furnish the Purchaser and its representatives with all the financial and
operating data and other information with respect to the business and operations of the
Company that the Sellers have in their possession, (iii) instruct the employees of
the Sellers, the Company, and counsel, financial advisors and accountants of the foregoing,
to cooperate with the Purchaser and its representatives with their investigation of the
Company, and (iv) keep, and shall cause the Company to keep, the Purchaser generally
informed as to the business and operations of the Company. Any investigation pursuant to
this section 7.2 shall be conducted in such manner as not to interfere unreasonably with the
conduct of the business and operations of Company.
The Founders and Luc Bracoud agree that for a period of (i) three (3) years after the
Completion Date for Mr. Pachai and (ii) two (2) years after the Completion Date for Luc
Bracoud and the other Founders, none of them will in France, United States of America,
United Kingdom, Germany, The Netherlands and Switzerland at the date hereof manage, become
engaged or financially interested, either as employee, shareholder, director, manager or
consultant or in any manner whatsoever, in businesses or activities directly competing with
those conducted by the Company and/or Bio-Imaging at the date hereof, which are
contractually defined for the purposes hereof as diagnostic and therapeutics image analysis
in clinical trials.
Each of the Sellers irrevocably undertakes not to use to its own profit or disclose to any
third party any tradename or logo owned or used by the Company (including the use of the
name Theralys or any abbreviation thereof or any combination including name and/or logo),
any commercial secret, know-how or other non-public information belonging to the Company or
acquired by it/his/her in the course of their employment, office or investment with the
Company until such time as such commercial secret, know-how or confidential information has
fallen into the public domain.
From the date hereof until (i) three (3) years for Mr. Pachai and (ii) two (2) years
for Luc Bracoud and the other Founders, the Founders and Luc Bracoud shall not directly or
indirectly through any person, enterprise or entity, for their own account or for any other
person, enterprise or entity, in association with or in the employment of any other person,
firm, company or organization, interfere with, solicit or endeavor to entice away from the
Company, any person, firm, company or organization currently employed by the Company.
ARTICLE 8 INDEMNIFICATION
8.1 |
|
Indemnification by the Founders |
Subject to the conditions and limitations set forth below, the Founders (the Indemnifying
Parties) agree to indemnify by way of a price reduction and hold the Purchaser harmless
from any and all liabilities, obligations, damages, deficiencies, losses, claims, actions,
lawsuits, proceedings, judgments, demands and costs
Page 23
(including penalties, late interest, majorations) (Losses) suffered or incurred by the
Purchaser or the Company as a result of, in connection with or relating to any breach or
inaccuracy of any Representation or Warranty or covenants of the Founders contained herein.
The Founders and the Purchaser take for it granted that, for the purposes of assessing the
Losses (if any), any Loss incurred by the Company will lead to corresponding decrease in
value of the Shares in the Company, so that any such Loss will therefore lead to a
corresponding reduction of the Purchase Price according to the provisions set forth below.
The Founders shall be jointly (conjointement) liable for 100 % of the Losses and each
Founder shall be jointly (conjointement) liable for the percentage of Losses set forth next
to his name in Exhibit 8.1,
For the purpose of the indemnification provision, Mr. Chahin Pachai, who accepts, is hereby
appointed by each of the Founders in order to act on their behalf to send or receive any
notice pursuant to this Article 8 and to take on their behalf any further actions that are
necessary, proper or advisable to carry out the conditions of this Article 8.2 and,
generally, do whatever may be necessary (the Founders Representative).
Indemnification under this Article 8 shall be payable with respect to any claim concerning a
Loss upon the earlier of (a) the resolution of such claim by mutual agreement between the
Founders Representative and the Purchaser, (b) the issuance of a final judgment, award,
order or other ruling (which is not subject to appeal or with respect to which the time for
appeal has elapsed) by a court or arbitral tribunal having jurisdiction over the parties and
the subject matter of such claim or to which such claim was submitted for resolution by
joint agreement between the Founders Representative and the Purchaser or (c) the final
settlement of such claim with a third party pursuant to mutual authorization by the
Founders Representative and the Purchaser. Any sum due by the Founders pursuant to a claim
for indemnification will be paid to the Purchaser within thirty (30) days from the date when
such claim for indemnification becomes final and payable, being specified that any sum due
pursuant to this indemnification provision shall be set off against any part of the Escrow
Amount.
8.3 |
|
Limitations on Indemnification |
8.3.1 |
|
The indemnification obligations of the Founders under Article 8.1 above for Losses shall not
exceed the total sum of 280,000 euros, breakdown between the Founders as follows: |
|
- |
|
190,400 euros for Mr. Pachai;
|
|
|
- |
|
33,600 euros for Mr. Vincent;
|
|
|
- |
|
28,000 euros for Mr. Olart; and
|
|
|
- |
|
28,000 euros for Mr. Douek. |
8.3.2 |
|
The Founders obligation hereunder is subject to a deductible (franchise) of 50,000 euros.
If this deductible is reached, only the excess shall be payable. |
Page 24
8.3.3 |
|
The amount of any indemnity payable hereunder on account of a Loss shall be reduced by any
insurance proceeds received by the Indemnified Party with respect thereto. |
8.3.4 |
|
The Purchaser shall not be entitled to make a claim for indemnification for Losses against
the Founders in respect of any assessment for taxes which merely modifies the tax period
during which a deductible charge or amortization may be taken or in respect of any VAT
assessment (except if such VAT is not recoverable and cannot be recharged to the customers). |
8.3.5 |
|
The Purchaser shall not be entitled to make a claim for indemnification against the Founders
in respect of any Loss for which a specific provision or reserve (provision) has been made in
the limit of that Loss, as a line item in, or in the notes to, the Interim Accounts. If the
Loss is superior to the amount of the specific provision or reserve, the Purchaser shall be
entitled to make a claim for indemnification against the Founders only for the difference
between the amount of such specific provision of reserve and the noted Loss. |
8.3.6 |
|
The limitations set forth in this Article 8.3 shall however not apply to any Losses
resulting from events or circumstances which the Founders failed to disclose to the Purchaser
in the Agreement or its Exhibits. They shall further not apply to any legal or other expenses,
such as attorneys or other experts fees reasonably incurred by the Purchaser or the Company
in pursuing a claim against the Founders on the ground of a Loss, nor shall they apply to any
interest which might be due by the Founders on the amount of indemnification. |
8.4 |
|
Notification of Claims; Third Party Claims |
8.4.1 |
|
In order for the Purchaser (the Indemnified Party) to be entitled to the indemnification
of any Loss under the Agreement, the Indemnified Party must send a notification (the Claim
Notice) to the Founders Representative in writing within thirty (30) days from the date on
which the Purchaser shall have knowledge of a matter which could give rise to indemnification,
except in case of a Third Party Claim which requires a response in a shorter period where such
time frame shall be reduced to fifteen (15) days. |
For the purposes of the Agreement, a Third Party Claim shall mean a claim which a third
party has assessed in writing against the Purchaser and/or the Company.
8.4.2 |
|
The Claim Notice shall specify (a) the grounds for the possible claim and (b) an estimate of
the amounts claimed in respect of the Loss if readily assessable. |
In the event the claim by the Indemnified Party involves or arises out of a Third Party
Claim, the Claim Notice shall include copies of such Third Party Claim as well as of any
documents attached thereto; provided that for the purpose of the Agreement,
any tax reassessment notice shall be considered as a Third Party Claim.
8.4.3 |
|
The Founders Representative shall, within thirty (30) days (reduced to ten (10) days in case
of a Third Party Claim which requires a response in a shorter period) following the Claim
Notice, either agree or refuse, in whole or in part, to indemnify the Purchaser (the
Response). In the event of partial or total refusal, the Founders Representative shall
notify the Purchaser of its decision within the above mentioned periods, and indicate the
grounds for such refusal. |
Page 25
8.4.4 |
|
If a Third Party Claim is made against the Indemnified Party or the Company, the following
provisions shall apply: |
|
(i) |
|
as long as the amount of any Third Party Claim does not exceed the Escrow
Amount and subject to paragraph (ii) below, the Founders will have the option (and the
Founders Representative shall indicate such option in the Response mentioned in Article
8.4.3) to assume control of the procedure at its sole cost and expense, provided that
the Purchaser will be entitled to participate in such defense with counsel of its
choice and at their own expense; and |
|
|
(ii) |
|
as soon as the amount of any Third Party Claim reaches or exceeds the Escrow
Amount, the Purchaser may, at its option and through counsel of its choice, assume
control of such defense provided that the Founders shall be entitled to participate in
such defense with counsel of its choice and at their own expense, |
it being specified that the Founders and/or the Purchaser shall assume the defense of the
Company exclusively within the Companys corporate interest.
8.5 |
|
Survival of indemnification |
The right of the Purchaser to make a claim for a breach of the Founders Representations or
Warranties under the Agreement shall survive for a period of eighteen (18) months as from
the Completion Date except that (i) claims for indemnification based on
Article 5.10 shall survive until January 31, 2010 and (ii) claims for indemnification based
on Article 5.11 shall survive until
December 31, 2010.
Any limitation period with respect to a claim shall be interrupted by a notification of such
claim pursuant to Article 8.4; in this case, the provisions of this Article 8 shall remain
in force with respect to such claim until it is finally determined as set forth in Article
8.2 above.
ARTICLE 9 CONFIDENTIALITY PUBLICITY
Each of the Parties hereto shall treat the contents of the Agreement as well as any information
obtained from the other parties as confidential and shall refrain from disclosing this Agreement,
in whole or in part, to any third party, except as required by law or the rules or regulations of
any Governmental Entity in which case the disclosing party shall give prior notice to the other
Parties.
The Sellers and the Purchaser agree that no public release or announcement concerning the
transactions contemplated herein shall be issued by either Party without the prior consent of the
Purchaser and the Sellers Representative (which consent shall not be unreasonably withheld),
except as such release or announcement may be required by law or the rules or regulations of any
Governmental Entity, in which case the party required to make the release or announcement shall
give prior notice to the other parties.
ARTICLE 10 EXPENSES
Save as otherwise expressly provided herein, the Parties hereto shall bear their own respective
expenses (if any) incurred in connection with the preparation and execution of the Agreement
Page 26
and the consummation of the transactions contemplated herein provided that all transfer
taxes and stamp duties in connection with the purchase of the Sold Shares shall be borne by the
Purchaser.
ARTICLE 11 SELLERS REPRESENTATIVE NOTICES
11.1 |
|
Representative of the Sellers |
For the purpose of the Agreement, Mr. Chahin Pachai, who accepts, is hereby appointed by
each of the Sellers in order to act on their behalf to send or receive any notice pursuant
to the Agreement and to take on their behalf any further actions that are necessary, proper
or advisable to carry out the purposes of the Agreement and, generally, do whatever may be
necessary (the Sellers Representative). If for any reason the Sellers Representative
shall cease to be the representative of the Sellers, then within one month commencing from
the date of termination of the Sellers Representatives functions, the Sellers shall
appoint another representative. Failing appointment of a new agent within said period, all
notices and requests hereunder shall be validly given or made to any of the Sellers.
All notices and other communications required or authorized hereunder shall be in writing
and validly made if either delivered via courier or sent by registered letter (return
receipt requested), e-mail or facsimile (provided that it be confirmed by same day
registered letter, return receipt requested or courier on an expedited basis for notices
sent across international boundaries, in case of an e-mail or facsimile) addressed as
follows:
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if to the Purchaser: |
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Bio Imaging Inc, Inc. |
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Attn:
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Mr. Ted Kaminer, |
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Address:
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826, Newtown-Yardley Road, |
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Newtown, PA 18940 (USA) |
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Facsimile:
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00 1 267 757 31 89 |
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E-mail:
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tkaminer@bioimaging.com |
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with a copy to: |
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Pierre-Antoine Dubecq |
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Morgan Lewis |
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68, rue du Faubourg St Honoré |
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75008 Paris (France) |
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Facsimile:
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(33) 1 53 30 43 01 |
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E-mail:
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pdubecq@morganlewis.com |
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if to the Sellers: |
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Mr. Chahin Pachai |
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Sellers Representative |
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Address:
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40 avenue Lacassagne, |
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69003 Lyon (France), |
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E-mail:
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cpachai@gmail.com |
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with a copy to: |
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Eric Baroin |
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Lamy & Associés |
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6, square de lOpéra Louis-Jouvet |
Page 27
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75009 Paris (France) |
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Facsimile:
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(33) 1 53 05 91 99 |
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E-mail:
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eric.baroin@lamy-associes.com |
Any change in address or representative for the purposes hereof shall be notified by the
concerned Party to the other Parties as provided above.
Notices and other communications delivered via courier shall be effective as of their date
of delivery, as evidenced by the delivery receipt, or as of the next Business Day if the
date of delivery is not a Business Day.
Notices and other communications sent by registered mail, return receipt requested, shall be
effective as of their date of first presentation to the addressee.
Notices and other communications sent by e-mail or facsimile shall be deemed effective as of
the date thereof, or as of the next Business Day if such e-mail or facsimile is sent other
than on a Business Day, provided that they be confirmed by same day registered mail, return
receipt requested, or courier on an expedited basis for notices sent across international
boundaries.
ARTICLE 12 SEVERABILITY
Should any of the provisions of the Agreement be held null and void or unenforceable for any reason
whatsoever, the Parties undertake to consult each other to remedy the causes of such nullity, so
that the Agreement remain in force without any discontinuity to the full possible extent.
ARTICLE 13 ENTIRE AGREEMENT
This Agreement, the recitals and the Exhibits attached hereto represent the entire understanding
and agreement of the parties and supersede all prior agreements, understandings or arrangements
among the parties hereto with respect to the subject matter hereof including, in particular, the
letter of intent sent by the Purchaser to the Sellers and the Company on December 15, 2006. It can
be amended, supplemented or changed, and any provision hereof can be waived, only by written
instrument making specific reference to the Agreement signed by each Party against whom enforcement
of such amendment, supplement, modification or waiver is sought.
ARTICLE 14 SUCCESSORS AND ASSIGNS
The Purchaser may freely transfer the Securities and all of their rights and obligations hereunder
to any of its Affiliates at any time, in which case the transferee shall be subrogated in all of
the Purchasers rights and obligations hereunder. The rights resulting from the Representations and
Warranties set forth in Article 5 above are not transferable by the Purchaser (or its assignees),
except to an Affiliate.
All rights and obligations of the Parties shall be binding upon and inure to the benefit of their
respective successors and assigns, jointly and indivisibly with the Party concerned and among
themselves.
Page 28
ARTICLE 15 LANGUAGE
The Purchaser and the Sellers acknowledge that the French translation of the Agreement has been
prepared solely for information purposes and that only the English version of the Agreement shall
be the contractually-binding agreement entered into between the Parties, in particular in case of a
difference in the interpretation of the terms used in the two versions.
ARTICLE 16 APPLICABLE LAW JURISDICTION
This Agreement shall be governed by and construed in accordance with the laws of France.
Any dispute arising in connection with the Agreement or as a result or consequence thereof and not
otherwise settled shall be subject to the exclusive jurisdiction of the Commercial Court (tribunal
de commerce) of Paris.
[Remainder of Page Intentionally Left Blank]
Page 29
Executed in 8 original copies
In Lyon
On February 6, 2007
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/s/ Mr. Chahin Pachai
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/s/ Mr. Fabrice Vincent |
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Mr Chahin PACHAI
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Mr Fabrice VINCENT |
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/s/ Mr. Philippe Douek
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/s/ Mr. Emmanuel Olart |
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Mr Philippe DOUEK
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Mr Emmanuel OLART |
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/s/ Mr. Joseph Gniewek
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/s/ Mr. Jean Claude Morel |
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GIE VALOREZ
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Mr Jean Claude MOREL |
By
[ ] |
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/s/ Mr. Laurent Gerfault
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/s/ Ms. Marcela Hernadez-Hoyos |
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Mr Laurent GERFAULT
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Ms Marcela HERNADEZ-HOYOS |
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/s/ Mr. Nicolas Rognin
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/s/ Mr. Jérôme Vincent |
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Mr Nicolas ROGNIN
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Mr Jérôme VINCENT |
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/s/ Mr. Luc Bracoud
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/s/ Ted Kaminer |
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Mr Luc BRACOUD
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BIO IMAGING Inc |
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Ted Kaminer |
Page 30
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RHÔNE-ALPES CRÉATION |
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By:
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/s/ Ms. Karine Lignel |
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Name: Ms. Karine Lignel
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Title: |
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AMORÇAGE RHÔNE ALPES |
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By:
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/s/ Ms. Karine Lignel |
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Name: Ms. Karine Lignel
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Title: |
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CRÉDIT AGRICOLE
CRÉATION |
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By:
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/s/ Mr. Maurice Bernard |
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Name: Mr. Maurice Bernard
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Title: |
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RHÔNE-DAUPHINÉ DÉVELOPPEMENT |
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By:
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/s/ Mr. Pierre Jourdain |
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Name: Mr. Pierre Jourdain
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Title: |
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SOFIMAC PARTNERS / LE LANCEUR |
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By:
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/s/ Mr. Philippe Vuagnat |
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Name: Mr. Philippe Vuagnat
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Title: |
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EX-10.18
3
w32201exv10w18.htm
DEVELOPMENT AND SUPPLY AGREEMENT
exv10w18
Confidential Treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions are designated as
**. A complete version of this exhibit has been filed separately with the Securities and Exchange
Commission.
MEDICALERT® PHR SYSTEM
DEVELOPMENT AND SUPPLY AGREEMENT
This MEDICALERT® PHR SYSTEM DEVELOPMENT AND SUPPLY AGREEMENT (Agreement) is made and
entered to be effective as of June 16, 2005, by and between CapMed, a division of Bio-Imaging
Technologies, Inc., a Delaware corporation (CapMed), with its principal place of business
located at 826 Newton-Yardley Road, Newtown, Pennsylvania 18940, and Medic Alert Foundation United
States, Inc., a California nonprofit public benefit corporation doing business as MedicAlert
Foundation International (MedicAlert), with its principal place of business located at
2323 Colorado Avenue, Turlock, California 95382.
WHEREAS, CapMed has developed the proprietary CapMed PHR System for locally storing, managing,
transporting and communicating personal health records and medical information on a personal
computer and portable flash memory device;
WHEREAS, MedicAlert desires that CapMed develop the MedicAlert® PHR Software that will
incorporate all of the features and functions of the CapMed PHR System with the additional features
and functions of storing, managing, and bi-directional synchronizing of multiple users personal
health records and medical information on both the MedicAlert remote server and each discrete
users local computer and portable flash memory device;
WHEREAS, the parties desire that CapMed be the exclusive United States OEM supplier and
nonexclusive worldwide OEM supplier of the MedicAlert PHR Software and the Documents and the
nonexclusive worldwide OEM supplier of portable flash memory devices for the MedicAlert® PHR
System, and that MedicAlert have the exclusive, worldwide right and license to use and resell the
MedicAlert® PHR System as a MedicAlert® branded product and service; and,
WHEREAS, the parties desire to cross-market their respective goods and services.
NOW, THEREFORE, in consideration of these premises, of the covenants and conditions in this
Agreement, and of other good and valuable consideration, the receipt and sufficiency of which are
acknowledged, CapMed and MedicAlert covenant and agree as follows:
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(a) |
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CapMed PHR Software means one or more client, server, or portable flash
memory device resident personal health records management computer programs or program
modules, and all embedded computer programs or program modules, and all compilations and
derivative works thereof, which secure or manage the data stored on the device, including,
without limitation, the partitioning, data-encryption, password protection, auto launching
of user designated information, and data importation, and includes the CapMed server
resident hub programs or program modules required for each discrete remote user to
upgrade the CapMed PHR Software or to access the embedded third party content |
MedicAlert® PHR System Development and Supply Agreement
Page 1 of 19
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on each discrete users remote computer or portable flash memory device as may be necessary
to make the CapMed PHR System fully functional, whether developed as an original, derivative
or compilation work by CapMed under this Agreement and whether integrated with existing
software or embedded computer programs or program modules in the CapMed PHR Software and all
related source code, machine code, schematics, updates, modifications, bug fixes, update
enhancements or other modifications, compilations or derivative works, but excludes the
MedicAlert® Software. |
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(b) |
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CapMed PHR System means the integrated data base management system designed
to store, manage, transport and communicate personal health and medical information
described in the Patent Application or the Copyright, including the CapMed PHR Software,
the HealthKey, and all related intellectual property, including, without limitation,
software, trade secrets and know-how. |
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(c) |
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Copyright means the United States Copyright Registration Number TXu-905-251
entitled Personal Health Record for a computer program, and all compilations or derivative
works thereof. |
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(d) |
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CPT means carriage paid to and as more fully defined by the International
Chamber of Commerce as an Incoterm. |
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(e) |
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Documentation means all instructions, manuals, diagrams or other written
materials, in printed or binary formats, that describe the functionality or assist in the
use of the CapMed PHR Software, the CapMed PHR System, the HealthKey, the MedicAlert® PHR
System and the MedicAlert PHR Software. |
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(f) |
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HealthKey means CapMeds proprietary portable flash memory device trademarked
as the Personal HealthKey. |
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(g) |
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machine code means computer programs or program modules assembled or compiled
in binary form on software media that are readable and usable by machines, but not
generally readable by humans without reverse-assembly, reverse-compiling, or
reverse-engineering techniques. |
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(h) |
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MedicAlert® enabled offer means the joint promotional effort of the parties
to modify the packaging and the CapMed PHR System to promote MedicAlert® membership and the
MedicAlert® PHR System. Users of the MedicAlert® enabled CapMed PHR System will be able to
subscribe to become a MedicAlert® member and convert to the MedicAlert® PHR System through
various means, including, without limitation, printing out a form and mailing to
MedicAlert, calling a toll-free telephone number or by accessing the MedicAlert Internet
server through the CapMed PHR Software via an Internet connection. |
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(i) |
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MedicAlert® PHR Software means the fully functional personal health records
data base management software that is modified in order to integrate all of the features,
functions, and specifications of the CapMed PHR Software, the CapMed PHR System and the
HealthKey with the MedicAlert® Software, in order to support the MedicAlert PHR System. |
MedicAlert® PHR System Development and Supply Agreement
Page 2 of 19
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(j) |
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MedicAlert® PHR System means the fully functional personal health records
data base management system that integrates all of the features, functions, and
specifications of the CapMed PHR System, the MedicAlert® Software and the MedicAlert PHR
Software. |
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(k) |
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MedicAlert® Software means one or more server resident programs or program
modules required to verify the remote users identity and to process and synchronize
incoming and outgoing user personal health and medical information on a local MedicAlert
server with a remote client computer or portable flash memory device as may be necessary to
make the MedicAlert® PHR System fully functional, whether developed as an original,
derivative or compilation work by MedicAlert or CapMed under this Agreement and whether
integrated with existing software or embedded computer programs or program modules in the
CapMed PHR Software and all related source code, machine code, schematics, updates,
modifications, bug fixes, update enhancements or other modifications, compilations or
derivative works. |
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(l) |
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OEM means the original equipment manufacturer and supplier of goods or
services for use and resale as a MedicAlert® branded product. |
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(m) |
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Patent Application means the United States Patent Application 10/393,751
entitled System, apparatus and method for storage and transportation of personal health
records; all issued patents thereon; all divisions, reissues, continuations and
continuation-in-part patents and patent applications; all corresponding foreign patents and
patent applications; and all related foreign patents and patent applications owned by
Bio-Imaging Technologies, Inc., or its parent or affiliate companies. |
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(n) |
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Portable flash memory device or portable flash memory device means a portable
nonvolatile electrically erasable programmable read-only memory device that can be
repeatedly erased and written to and from a personal computer via an industry standard
Universal Serial Bus (USB) port, which has been approved by CapMed, such approval not to be
unreasonably withheld. |
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(o) |
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Software or software means computer program or program modules in
source code or machine code, schematics, updates, modifications, bug fixes, update
enhancements, or other modifications, and all related compilations and derivative works. |
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(p) |
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Source code or source code means computer programs or program modules on
software media that are human readable without reverse-assembly, reverse-compiling, or
reverse-engineering techniques, and includes, the compiler/assembler/linker. |
2. |
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Description of Goods and Services. |
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(a) |
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This Agreement is for the development and OEM supply of the MedicAlert® PHR Software.
On MedicAlerts acceptance of the fully functional commercial version of the MedicAlert®
PHR Software, CapMed will become the exclusive United States and nonexclusive worldwide OEM
supplier of client or portable flash memory device personal health records management
computer programs or program modules that integrates all of the features, functions, and
specifications of the CapMed PHR System as it may be modified to perform the functions and
meet the specifications of the MedicAlert® PHR System, and the nonexclusive worldwide OEM
supplier of portable flash memory devices, and MedicAlert will have the exclusive,
worldwide right and |
MedicAlert® PHR System Development and Supply Agreement
Page 3 of 19
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license to use and resell the MedicAlert® PHR System as a MedicAlert® branded product and
service (provided, however, such nonexclusive worldwide OEM suppliers shall not be permitted
to supply a personal health record system to MedicAlert outside the United States for sale
or distribution in the United States). CapMed will supply MedicAlert with individual
commercial units of the MedicAlert PHR Software on CD-ROM with and subject to CapMeds
standard end-user shrink-wrap software license, and individual commercial units of the
HealthKey in such quantities and packaging as MedicAlert may from time to time specify. |
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(b) |
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During the term of this Agreement, the parties may, from time to time, desire that
CapMed supply additional goods developed or manufactured by CapMed. The terms and
conditions of the parties agreement governing such additional goods, including, without
limitation, product specifications, manufacturing, delivery, terms of payment, warranties,
default, and remedies upon default, will be governed by the parties separate agreement and
will not be incorporated in this Agreement without the parties express written consent. |
3. |
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MedicAlert Development. |
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(a) |
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MedicAlert intends to launch publicly the MedicAlert® PHR System as a MedicAlert®
branded product on July 25, 2005. MedicAlert is, by this Agreement, reasonably relying
upon CapMeds technical skills and expertise for the technical success of the MedicAlert®
PHR System as a MedicAlert® branded product. To the extent that the MedicAlert® PHR System
will be a MedicAlert® branded product, CapMed acknowledges that the development,
improvements, and maintenance of the MedicAlert® PHR Software will be tied directly to the
goodwill associated with the MedicAlert® trademark and trade name, and will ensure that the
MedicAlert® PHR Software will meet MedicAlerts high standards for quality and that it
charges MedicAlert its most competitive pricing for all finished goods. |
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(b) |
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CapMed will be the exclusive United States developer and nonexclusive worldwide
developer, and MedicAlert will be the exclusive worldwide licensee, user, and reseller of
the MedicAlert® PHR Software as a MedicAlert® branded product and service. CapMed will
promptly use its best efforts as a high priority matter to develop, to maintain and to
integrate seamlessly all of the features, functions and specifications of its most current
version of the CapMed PHR Software and the CapMed PHR System, with the MedicAlert® Software
to allow generally, among other things: |
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(i) |
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A user to enter, update, or manage his or her personal health or health care
information on the users local computer, to cause the local computer to automatically
and transparently upload and synchronize such information with the users personal
health and health care information stored on the users local portable flash memory
device, and to cause the local computer to automatically and transparently upload and
synchronize such information via an Internet connection with the users personal health
and health care information stored in the users account on a remote server; |
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(ii) |
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A remote server operator to enter, update, or manage a users personal health
or health care information to the users account on the remote server, to cause the |
MedicAlert® PHR System Development and Supply Agreement
Page 4 of 19
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remote server to automatically and transparently upload and synchronize such
information via an Internet connection with the users personal health and health
care information stored on the users local computer, and to cause the users local
computer to automatically and transparently upload and synchronize such information
with the users personal health and health care information stored on the users
local portable flash memory device; and, |
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(iii) |
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Such other customizations as MedicAlert may reasonably request or require that
are generally available to the CapMed PHR System, including, without limitation,
Profile Customizations, Profile Element Customizations, Pick List Customizations, Web
Link customizations, and Field Level Links customizations. Any additional
customizations or unique product upgrades and/or improvements as MedicAlert may
reasonably request may be provided by CapMed; provided, however, CapMed shall reserve
the right to charge an additional fee to be mutually agreed upon for such
customizations. |
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(c) |
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Within forty-five (45) days of the effective date of this Agreement, CapMed and
MedicAlert will exercise their good faith and best commercial efforts to make and enter a
software escrow agreement pursuant to Section 18 below, and within five (5) days of the
effective date of this Agreement will finalize and execute the attached Schedule A to this
Agreement that will define the scope, project requirements and development responsibilities
to develop, implement and commercially launch a robust, stable and fully functional
commercial version of the MedicAlert® PHR System. The Schedule A will also set forth an
objective milestone driven development, field test, acceptance, implementation and product
launch schedule. All of the terms, conditions and schedules set forth in software escrow
agreement and Schedule A shall be incorporated as material terms and conditions of this
Agreement. |
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(d) |
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If for any reason either party is unable to meet any of the development or performance
milestones of Schedule A, such party shall be in material breach of this Agreement and the
other party may, but is not obligated to, terminate this Agreement with no further duty or
obligation except as may be expressly set forth in this Agreement. In the event either
party waives this provision as to any specified development or performance milestone, such
waiver will not affect such partys right to terminate this Agreement on the other partys
failure to meet any subsequently specified development or performance milestone. |
4. |
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Upgrades and Improvements. |
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(a) |
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CapMed will continually **. CapMed will make **. |
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(b) |
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Any maintenance, including error correction, debugging or other technical assistance
required to remedy any defects in or other malfunctions of the CapMed PHR System which have
a material impact on the MedicAlert® PHR System will be undertaken by CapMed immediately,
commencing ** hours of notification by MedicAlert, and CapMed will ensure that all
personnel necessary to commence and complete as quickly as possible such maintenance are
made available for these purposes. CapMed will **. |
MedicAlert® PHR System Development and Supply Agreement
Page 5 of 19
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(c) |
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CapMed will make available all version upgrades and improvements as soon as they are
commercially available to all MedicAlert® PHR System users of the CapMed PHR Software in
machine code via Internet download from the Check for Updates and Update Now tabs on
the Tools menu in the drop down navigation bar of the CapMed PHR Software . For purposes
of this Agreement, version upgrade shall include all CapMed versions, updates,
modifications, bug fixes, enhancements, improvements and other modifications to the CapMed
PHR Software or the MedicAlert PHR Software that are not exclusively developed for the
unique requirements of any other CapMed licensee. |
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(a) |
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CapMed will promptly upon delivery of each version or version upgrade of the CapMed
PHR Software provide to MedicAlert, at a designated MedicAlert facility, the technical
assistance, training and know-how necessary for MedicAlert to use and maintain the client
and portable flash memory device versions of the MedicAlert® PHR System. MedicAlert will
reimburse CapMed for all reasonable costs associated with such training. |
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(b) |
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MedicAlert will, at its sole cost and expense, provide primary call center customer
service and support to the users of the MedicAlert® PHR System. |
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(c) |
|
CapMed will provide secondary call center customer service and support to MedicAlerts
customer service representatives during normal business hours (EST/EDT), and will provide
secondary twenty-four (24) hour call center customer service and support on one hundred
twenty (120) day notice after predetermined minimum subscription volumes are achieved. |
6. |
|
MedicAlert® PHR System Cross-Licenses. |
|
(a) |
|
CapMed hereby grants to MedicAlert the exclusive, worldwide right and license to
undertake, or authorize others to undertake on MedicAlerts behalf, the use and sale of the
MedicAlert® PHR Software, and all corresponding rights under all patent, copyright,
trademark, trade secret and other laws necessary or appropriate for the full enjoyment of
the rights granted hereby. |
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(b) |
|
MedicAlert hereby grants to CapMed the exclusive United States and nonexclusive
worldwide right and license to undertake, or authorize others to undertake on MedicAlerts
behalf, the use of the MedicAlert® Software to the extent it may be integrated in the
MedicAlert® PHR System, and all corresponding rights under all patent, copyright,
trademark, trade secret and other laws necessary or appropriate for the full enjoyment of
the rights granted hereby. CapMed will not, directly or indirectly (such as through
authorization of third parties by way of license or otherwise) distribute or otherwise
exploit the MedicAlert® Software. |
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(c) |
|
The licensed rights granted by each party to the other include the rights: |
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(i) |
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To reproduce and authorize others to reproduce the MedicAlert® PHR Software; |
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(ii) |
|
To publicly distribute and authorize others to publicly distribute machine code
copies of the MedicAlert® PHR Software; |
MedicAlert® PHR System Development and Supply Agreement
Page 6 of 19
|
(iii) |
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To grant sublicenses authorizing others to publicly distribute machine code
copies of the MedicAlert® PHR Software; |
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|
(iv) |
|
To publicly display and perform and authorize others to publicly display and
perform portions of the MedicAlert® PHR System for the purpose of promoting the
distribution and sale of the MedicAlert® PHR System and to reproduce and publicly
distribute machine code copies of the MedicAlert® PHR Software for such purposes. |
|
(d) |
|
Notwithstanding the foregoing, and subject to the restrain against assignment as set
forth more fully in Section 20, below, nothing in this Agreement shall be interpreted or
construed to allow either party to sub-license or assign any of the licensee right granted
herein to any third party; provide, however, that either party may delegate their licensee
rights of Section 6(c) above to their agents or employees, and, provided further, that upon
such delegation the delegating licensee shall remain liable to the other party for the act
of its agents or employees under the terms of this Agreement. |
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|
(e) |
|
Notwithstanding the foregoing, nothing in this Agreement will otherwise limit or
restrict CapMed from selling or licensing all or any part of the CapMed PHR Software, the
HealthKey, or CapMed PHR System to any third party, and nothing in this Agreement will
otherwise limit or restrict MedicAlert from selling or licensing all or any part of the
MedicAlert® Software to any third party. |
|
(a) |
|
Title to the CapMed PHR System, including any enhancements, modifications or
derivatives thereto, other than the MedicAlert® PHR Software, (including all intellectual
property rights pertaining thereto) shall at all times remain and vest solely with CapMed.
MedicAlert agrees that it will not claim or assert title to any such materials or attempt
to transfer any title to End-Users or any third parties. |
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|
(b) |
|
Title to the MedicAlert® Software, whether as an original, compilation or derivative
work, and any enhancements, modifications or derivatives thereto, (including all
intellectual property rights pertaining thereto) shall at all times remain and vest solely
with MedicAlert. CapMed agrees that it will not claim or assert title to any such
materials or attempt to transfer any title to End-Users or any third parties. |
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|
(c) |
|
The MedicAlert® PHR System and the MedicAlert PHR Software is a collective, compilation
or derivative work. Title to the MedicAlert® PHR System and the MedicAlert PHR Software
shall at all times remain and vest with MedicAlert; provided however, that title to the
MedicAlert® PHR System and the MedicAlert PHR Software shall not extend to the separate
property contributed by the parties under this cross-license for the sole and limited
purpose of creating the collective, compilation or derivative work. CapMed agrees that it
will not claim or assert title to any such materials or attempt to transfer any title to
End-Users or any third parties. |
|
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(d) |
|
Each partys proprietary and intellectual property rights (including patent, trademark,
copyright, trade secret and other rights) not expressly licensed to the other party under
this agreement shall remain the separate property of such party. |
MedicAlert® PHR System Development and Supply Agreement
Page 7 of 19
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(e) |
|
The CapMed PHR Software, either as a stand alone product or as incorporated into the
MedicAlert® PHR System, shall be marked with such copyright, patent or other notices,
proprietary legends, or restrictions as CapMed requires in this agreement or subsequent
written notice by CapMed to MedicAlert. CapMed shall place CapMeds proprietary notices on
each copy of the CapMed PHR Software media and between the title and table of contents in
each copy of the Documentation. In addition to the foregoing, MedicAlert will ensure that
any portable flash memory device that includes the embedded MedicAlert PHR Software and is
covered within the scope of CapMeds pending Patent Application will be marked as patent
pending and, when such patent is actually issued, will be marked as patented with the
patent number. |
8. |
|
Trademark and Trade Name License. |
|
(a) |
|
CapMed hereby grants to MedicAlert, and MedicAlert hereby grants to CapMed, the
nonexclusive, worldwide, right and license to use, publicly display, and publicly
distribute each others trademarks, service marks, trade names or trade dress in their
individual and joint marketing and sales promotional material in connection with the
MedicAlert® PHR systems; provided, however, that neither party will have the right to use
the others names or marks without having first obtained the others express written
approval, which will be in such partys sole and absolute discretion, to the nature and
content of the marketing or sales promotional materials, the use of such partys trademarks
or trade names in such materials, and the conformity of the trademarks or trade names to
the standardized marks and names used by such party. |
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(b) |
|
Subject to the pre-release approval provisions of subparagraph (a), MedicAlert hereby
grants to CapMed the nonexclusive, worldwide, right and license to modify the CapMed PHR
Software and packaging to promote and include the MedicAlert® enabled offer in all CapMed
branded copies of the CapMed PHR Software. |
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(c) |
|
Each party represents and warrants that all trademarks, service marks, trade names, or
trade dress designated by such party to be used on or in any product packaging or labeling,
or in any sales or marketing promotional materials have been properly authorized for such
use by the owner of such rights, and that the others use of such marks or dress will not
infringe the rights of any third party. |
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(d) |
|
Each party will defend, indemnify, and hold the other party harmless against any and
all claims, demands, or liability, including attorney fees and costs, arising out of or
relating to its breach of any representation or warranty set forth in this section. |
|
(a) |
|
The MedicAlert® PHR System |
|
(i) |
|
The MedicAlert® PHR System will be priced on ** basis and will include access
to all version upgrades and improvements during the subscription term. The initial **
will be in an amount not to exceed ** on ** subject to ** up to ** on **. Beginning in
the second year, the ** price will be in an amount equal to ** of the MedicAlert **
charged by MedicAlert to the **. Based upon the current pricing model, the ** would be
equal to **. |
MedicAlert® PHR System Development and Supply Agreement
Page 8 of 19
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(ii) |
|
The hardware component of the HealthKey will be priced on a ** basis in an
amount not to exceed **. CapMed will use reasonable commercial efforts to work with
its OEM suppliers to reduce the HealthKey costs and increase performance.
Notwithstanding the forgoing, nothing in this Agreement shall prohibit or restrict
MedicAlert from purchasing portable flash memory devices direct from any OEM,
including, without limitation, any OEM that CapMed may be purchasing its HealthKey. |
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(iii) |
|
In the event MedicAlert desires to purchase portable flash memory devices
directly from an OEM, MedicAlert shall notify CapMed at least thirty (30) days in
advance and shall provide CapMed with a sample unit of the portable flash memory
device. CapMed will promptly use good faith and its best efforts as a high priority
matter to qualify the portable flash memory device as compatible with the CapMed PHR
Software and the MedicAlert® PHR System, and MedicAlert will pay CapMed the reasonable
cost associated with qualifying such portable flash memory device. |
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(iv) |
|
MedicAlert pay CapMed a ** fee in an amount equal to ** for ** to ** other than
a ** in Section 9(a)(i) ** of the product. |
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(b) |
|
The MedicAlert® enabled offer |
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(i) |
|
The MedicAlert® enabled offer will be priced on a ** basis in an amount equal
to ** who becomes **. |
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(ii) |
|
In the event of a conversion through the MedicAlert® enabled offer, ** will
be **. Beginning in **, the ** will be ** as ** under Section 9(a)(i), above. |
|
(c) |
|
All prices exclude packaging. Packaging will be priced in an amount not to exceed **. |
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(d) |
|
In the event a MedicAlert® PHR System user terminates their subscription, MedicAlert
will promptly notify CapMed of such termination and the parties shall block such terminated
subscribers ability to access the MedicAlert server and the CapMed server. In the event
such terminated subscriber resubscribes to the MedicAlert® PHR System, MedicAlert will
promptly notify CapMed of such resubscription and the parties shall again allow the
resubscribed user to access the MedicAlert server and the CapMed server. Notwithstanding
the foregoing, if any subscriber remains inactive for at least two (2) years, then such
subscriber shall be deemed to be a new subscriber for purposes of this Agreement. All
resubscriptions will be priced, and royalties paid, as a renewal subscription. |
|
(a) |
|
MedicAlert will provide CapMed with the packaging specifications and any necessary
artwork no later than sixty (60) days in advance of the earliest scheduled shipping date.
If such special packaging will delay the scheduled shipping date, or increase CapMeds cost
to manufacture and/or ship, CapMed will, within fifteen (15) days of receipt of
MedicAlerts notice, provide MedicAlert with notice of any shipping delay or cost increase.
Within ten (10) days of receipt of CapMeds notice, MedicAlert will provide CapMed with
written notice of its acceptance or rejection of any such shipping delay or |
MedicAlert® PHR System Development and Supply Agreement
Page 9 of 19
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|
|
cost increase. In the event MedicAlert rejects any such shipping delay or cost increase,
CapMed will be under no obligation to include such special packaging in the order. Unless
otherwise agreed to by the parties, MedicAlert bear all of the costs and expenses related to
packaging. |
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(b) |
|
CapMed will place such MedicAlert or MedicAlert health insurance marketing partner
notices, trademarks, symbols and/or legends on or with respect to all copies and all
components of the MedicAlert® PHR System as MedicAlert may reasonably designate in writing,
including, without limitation, in a manner which will cause such material to appear on an
initial screen display upon activation of the MedicAlert® PHR System client software. |
|
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(c) |
|
CapMed will place such CapMed copyright or patent notices, symbols and/or legends on or
with respect to all copies and all components of the MedicAlert® PHR System as MedicAlert
may reasonably consent in writing, including, without limitation, in a manner which will
cause such material to appear on the About screen from the Help menu of the drop down
navigation bar of the MedicAlert® PHR System client software; provided, however, that
CapMed will not place any CapMed trademark, service mark, symbol and/or legend to brand any
such copy or component as a CapMed product or to otherwise designate the origin of any such
copy or component as other than MedicAlert. |
11. |
|
Product Order and Confirmation. |
|
(a) |
|
All orders will be made in accordance with forms agreed by both parties. Each order
will indicate the goods and quantity of each of the goods to be purchased, as well as the
desired schedule of delivery date(s). |
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(b) |
|
Within 3 business days of receipt of such purchase order, CapMed will provide
MedicAlert with a written confirmation of such order, which confirm the goods and quantity
of each of the goods, and fix a schedule of delivery dates(s) as close as commercially
practicable to the desired schedule of delivery date(s). |
|
12. Delivery and Terms of Payment. |
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(a) |
|
CapMed will use its best efforts to meet MedicAlerts orders, and will give such orders
first priority in distributing its available stock and in manufacturing new stock,
regardless of whether the terms and conditions for MedicAlerts purchase is on less
favorable terms than other customers of CapMed. If CapMed for any reason is not able to
ship on the scheduled shipping date, CapMed will notify MedicAlert in writing at least five
(5) business days before the scheduled shipping date, such written notification will also
include an estimate of the rescheduled shipping quantities and dates. |
|
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(b) |
|
The delivery of all goods under this Agreement will be CPT MedicAlerts principal place
of business. |
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|
(c) |
|
Payments: |
|
(i) |
|
All payments under this Agreement are due net of any relevant taxes within **. |
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(ii) |
|
All payments under this Agreement for HealthKeys are due, net of any relevant
taxes as follows: |
MedicAlert® PHR System Development and Supply Agreement
Page 10 of 19
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(1) |
|
** due at **; and |
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(2) |
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** due within **. |
13. |
|
Inspection on Receipt and Replacements. MedicAlert will, within seven (7) business
days of delivery receipt, inspect the goods and packaging and inform CapMed in writing of any
nonconformance with the specification or any express CapMed warranty hereunder. Such written
notice will include the method of inspection, the details and nature of the discovered
defects, and request replacements. MedicAlert will, at CapMeds expense, return the defective
goods to CapMed, and within a commercially reasonable time for the first priority
manufacturing of new goods from CapMeds receipt of the returns, CapMed will deliver
replacements to MedicAlert. Any replacements will also be subject to these inspection and
acceptance procedures. |
|
(a) |
|
As a material inducement to this Agreement, CapMed represents and warrants to
MedicAlert that: |
|
(i) |
|
the MedicAlert® PHR System will strictly comply with the descriptions
(including performance capabilities, completeness, specifications, configurations, and
function) in this Agreement; |
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|
(ii) |
|
all computer programs or program modules will operate in conformance with the
specifications; |
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(iii) |
|
all Documents will be functional and comprehensible for their intended users; |
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(iv) |
|
all delivered goods will be merchantable and will be fit for their intended
purpose, and will be free from defects in materials and manufacturing for a period of
twelve (12) months of normal use from the date of each individual users subscription; |
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(v) |
|
CapMed has good title to the CapMed PHR System; |
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(vi) |
|
the CapMed PHR System is free and clear of any and all third party liens,
judgments, or encumbrances; |
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(vii) |
|
the CapMed PHR System will not violate or in any way infringe upon the rights
of third parties, including property, contractual, employment, fiduciary, trade
secrets, proprietary information and nondisclosure rights, or any trademark, service
mark, trade name, trade dress, copyright, or issued patent rights;. |
|
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(viii) |
|
MedicAlerts intended use or resale of all delivered goods will not violate or in any
way infringe upon the rights of third parties, including, without limitation, property,
contractual, employment, trade secret, proprietary information and nondisclosure
rights, or trademark, copyright or patent rights. |
|
(b) |
|
As a material inducement to this Agreement, MedicAlert represents and warrants to
CapMed that: |
MedicAlert® PHR System Development and Supply Agreement
Page 11 of 19
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(i) |
|
the MedicAlert® Software will strictly comply with the descriptions (including
performance capabilities, completeness, specifications, configurations, and function)
in this Agreement; |
|
|
(ii) |
|
it has good title to the MedicAlert® Software; |
|
|
(iii) |
|
the MedicAlert® Software is free and clear of any and all third party liens,
judgments, or encumbrances; |
|
|
(iv) |
|
the MedicAlert® Software will not violate or in any way infringe upon the
rights of third parties, including property, contractual, employment, fiduciary, trade
secrets, proprietary information and nondisclosure rights, or any trademark, service
mark, trade name, trade dress, copyright, or patent rights; |
|
(c) |
|
CapMed will provide MedicAlert with repaired or replacement units free of charge for
all defective goods during the warranty period. All costs and expenses arising out of or
related to any such warranty repair or replacement will be borne by CapMed. |
15. |
|
Defense and Indemnification. |
|
(a) |
|
Each party (the Indemnifying Party) will defend, indemnify and hold harmless the
other party (the Indemnified Party) from and against any claims, demands, or liability,
including attorney fees and costs, of any nature, whether accrued, absolute, contingent or
otherwise, arising from or relating to the failure or breach of any of the warranties,
covenants or agreements made by the Indemnifying Party in this Agreement. |
|
|
(b) |
|
CapMed (the Indemnifying Party) will defend, indemnify and hold harmless MedicAlert
(the Indemnified Party) from and against any claims, demands, or liability, including
attorney fees and costs, of any nature, whether accrued, absolute, contingent or otherwise,
arising from or relating to any allegation that the MedicAlert® PHR System or any CapMed
component thereof (excluding only the MedicAlert developed MedicAlert® Software) or that
any activity involving the MedicAlert® PHR System or any CapMed component thereof
(excluding only the MedicAlert developed MedicAlert® Software) violates or in any way
infringes upon the patent rights of third parties. Notwithstanding the foregoing, CapMed
will have no obligation to indemnify MedicAlert against any ** damages as a result of
conduct by MedicAlert which has been finally determined ** to have been ** CapMed will **
MedicAlert **, CapMed will ** as may be necessary **. The defense and indemnity
obligations of this subparagraph are a material inducement to this Agreement, are made
after review and consultation with legal counsel, and constitute the bargained for
allocation of risk between the parties. |
|
|
(c) |
|
Within a reasonable time after the written assertion against the Indemnified Party by a
third person of a claim or liability which would entitle the Indemnified Party to a
defense and indemnification under this Agreement, the Indemnified Party will give the
Indemnifying Party written notice of the claim. The failure or delay of any such notice
that is materially prejudicial to the Indemnifying Partys ability to defend or indemnify
against such claim or liability shall relieve the Indemnifying Party of any obligation of
defense or indemnification with respect to such claim or liability. |
MedicAlert® PHR System Development and Supply Agreement
Page 12 of 19
|
(d) |
|
Upon receipt of timely notice, the Indemnifying Party shall undertake the
responsibility for the defense of such claim, at its own cost and expense. If, within
fifteen (15) days after delivery of the notice of claim by the Indemnified Party, the
Indemnifying Party fails to advise the Indemnified Party of its agreement to contest and
defend against any such claim or if the Indemnifying Party does not participate in such
litigation, proceeding or settlement negotiations, for any reason, then the Indemnified
Party shall have the right, at the Indemnifying Partys cost and expense, to take such
action as the Indemnified Party deems appropriate to defend, contest, settle or compromise
any such claim or liability, and the Indemnifying Party agrees to be bound by any and all
rulings, judgments, compromises, and settlements reached by the Indemnified Party in good
faith, in the same manner as if the Indemnifying Party participated therein. In addition,
in the event that the use or sale of all or any part of the MedicAlert PHR System, other
than the MedicAlert PHR Software, is enjoined, or is likely to be enjoined as a result of a
suit based on alleged infringement or misappropriation of third party intellectual property
rights, MedicAlert agrees that CapMed shall have the option at CapMeds sole cost and
expense to either: (i) procure for itself and MedicAlert the right to continue to use the
MedicAlert PHR System, or (ii) replace or modify the infringing or misappropriating
software so that it becomes non-infringing provided that the replaced or modified software
shall conform in all respects with the specifications required by this Agreement and shall
be subject to all of the terms and conditions of this Agreement, including, without
limitation, all of the express and implied CapMed representations and warranties. |
|
|
(e) |
|
The Indemnified Party shall have the right to participate at its own expense and
through counsel of its own choosing in contesting and defending against any such claim and
in any litigation, proceedings or settlement negotiations with respect thereto. If, upon
advice of the Indemnified Partys counsel, the Indemnified Party would not be adequately
represented by the Indemnifying Partys counsel because of a conflict of interest,
inability to present a defense that would otherwise be available to the Indemnified Party ,
or lack of experience or expertise in matters similar to the underlying claim, the
Indemnified Party shall have the right to be represented by counsel of its own choosing at
its own expense. |
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(f) |
|
Without the written consent of the Indemnified Party, the Indemnifying Party may not
consent to the entry of any judgment with respect to the matter or enter into any
settlement that does not include a provision by which the plaintiff or claimant in the
matter releases the Indemnified Party from all liability with respect to the matter;
provided, however, that in the event that a plaintiff or claimant refuses to release the
Indemnified Party from all liability with respect to the matter after the Indemnifying
Party has exercised its best commercial efforts to obtain a negotiated settlement or
consensual judgment that includes such release, the Indemnifying Party may consent to an
entry of judgment or enter a settlement that does not release the Indemnified Party if
prior to the entry of any such judgment or settlement the Indemnifying Party reasonably
establishes to the Indemnified Party that it can immediately satisfy the judgment or
settlement on entry and irrevocably provides for the immediate satisfaction of the judgment
or settlement on entry. |
MedicAlert® PHR System Development and Supply Agreement
Page 13 of 19
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(g) |
|
The Indemnifying Party will reimburse the Indemnified Party within thirty (30) days
after presentation of an itemized statement of costs and/or damages for such
indemnification claim as set forth above. |
16. |
|
Limitation of Liability. |
|
(a) |
|
CAPMED DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTIES AS TO THE SUITABILITY OR MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE OF THE MEDICALERT® SOFTWARE OR ANY PORTABLE FLASH MEMORY DEVICE OTHER
THAN A HEALTHKEY. IN NO EVENT SHALL CAPMED BE LIABLE TO MEDICALERT FOR ANY MEDICALERT LOST
OR ANTICIPATED PROFITS, OR ANY INCIDENTAL, EXEMPLARY, SPECIAL, OR CONSEQUENTIAL DAMAGES,
REGARDLESS OF WHETHER IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES IN CONNECTION WITH
THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, EITHER THE MEDICALERT PHR SYSTEM OR
MEDICALERT PHR SOFTWARE. THE LIMITATION OF LIABILITY CONTAINED HEREIN REFLECTS AN
ALLOCATION OF RISK BETWEEN THE PARTIES AND WILL SURVIVE AND APPLY EVEN IF ANY LIMITED
REMEDY FAILS OF ITS ESSENTIAL PURPOSE. |
|
(a) |
|
All intellectual property, knowledge, information, documents, materials, or such other
proprietary information, received by a party from the other party, whether or not it is
designated as confidential or proprietary will, except as specified below, be considered
confidential information. Confidential information includes, without limitation, the
CapMed PHR System, the MedicAlert PHR Software, the identity, personal health records, and
medical information of MedicAlert® members and MedicAlert® PHR System subscribers. The
party receiving such information will refrain from directly or indirectly taking any action
that would constitute or facilitate the unauthorized use or disclosure of such information,
will take any and all lawful measures to prevent the unauthorized use and disclosure of
such information, and will prevent unauthorized persons or entities from obtaining or using
such information. |
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|
(b) |
|
The provisions of this Section do not apply to any knowledge, information, documents,
materials, or the like, which the receiving party can conclusively establish: (i) has
entered the public domain without the receiving partys breach of any obligation owed to
the disclosing party; (ii) has become known from a source other than the disclosing party
and other than by breach of an obligation of confidentiality owed to the disclosing party
or a third party; (iii) is disclosed by the disclosing party to a third party without
restrictions on its disclosure; or, (iv) is independently developed by the receiving party
without breach of this Agreement. |
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|
(c) |
|
Notwithstanding the foregoing, nothing in this Agreement will be construed to limit
either partys right to independently develop or acquire one or more goods or services that
are similar to or competitive with the goods or services contemplated by or embodied in the
other partys confidential or proprietary information, or to acquire, by purchase or
license, any rights, organizations or assets thereof, provided that the developing party |
MedicAlert® PHR System Development and Supply Agreement
Page 14 of 19
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|
|
does not use the other partys confidential or proprietary information in violation of this
Agreement; including, without limitation, MedicAlerts pre-existing right to include a one
page summary of its individual members critical personal health information substantially
in the same form and content as the existing MedicAlert® MED Software (including, without
limitation, name, date of birth, address, health insurance provider and policy number, drug
allergies, and known medical conditions) on a portable flash memory device that is not
integrated in the MedicAlert® PHR System. Each party understands that the other party
evaluates, designs, develops and acquires software and other goods or services, and that the
existing or planned goods or services independently developed, evaluated, designed,
developed or acquired by the other party may contain ideas and concepts similar to those
contained in the goods or services received by the other party. Nothing in this Agreement
will preclude the other party from marketing such developed, designed or acquired goods or
services to others. Each party reserves the right to deal with any other vendor, supplier,
or purchaser on any terms and with respect to any subject matter. |
|
|
(d) |
|
Promptly upon the request of a party, the other party will deliver all copies, notes,
packages, diagrams, computer memory media, and all other materials containing any
confidential or proprietary information of the other party, and destroy all compilations,
analyses and other materials which contain any such confidential information; provided,
however, that the destroying party may retain one copy of the confidential information in a
file accessible only to legal counsel for the sole purpose, in the event of a future
dispute, of proving what information it did or did not receive. |
|
|
(e) |
|
Neither party shall disclose the commercial and financial terms of this Agreement
without the consent of the other party, which consent shall not be unreasonably withheld;
provided, however, if required by law, upon advice from its counsel, CapMed shall be
permitted to disclose the terms of this Agreement upon notice to MedicAlert but without the
consent of MedicAlert; provided, further, that CapMed shall use its commercially reasonable
efforts to keep such confidential information as confidential as possible. |
|
|
(f) |
|
The provisions of this Section will survive the term of this Agreement. |
18. |
|
Term and Termination. |
|
(a) |
|
The term of this Agreement and any licenses related thereto will be five (5) years from
the effective date of this Agreement, and will automatically renew for successive one (1)
year terms, unless terminated earlier |
|
(i) |
|
by the mutual consent of both parties; |
|
|
(ii) |
|
by either party for any reason upon one year written notice prior to
termination; |
|
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(iii) |
|
by a party ceasing to do business with no successor assuming all of such
partys obligations under this Agreement; |
|
|
(iv) |
|
by the insolvency of a party, however such insolvency is evidenced, including,
without limitation, by a general assignment for the benefit of its creditors, or by a
voluntarily or involuntarily filing of a petition in bankruptcy; |
MedicAlert® PHR System Development and Supply Agreement
Page 15 of 19
|
(v) |
|
by the dissolution or liquidation of a party, unless such dissolution or
liquidation is the result of a merger or consolidation with a controlling or affiliated
company; |
|
|
(vi) |
|
by either party on thirty (30) days written notice of the other partys
material breach of a substantive term of this Agreement if such breach is curable
within thirty (30) days and is not cured within such time; or, |
|
|
(vii) |
|
by either party on commercially reasonable written notice of the other partys
material breach of a substantive term of this Agreement if such breach is not curable
within thirty (30) days and the party declared in breach is not then using its best
efforts and acting in good faith to cure such breach as promptly as practicable within
such commercially reasonable notice period. |
|
(b) |
|
During the ** period immediately following the termination date, MedicAlert and the
MedicAlert® PHR System subscribers will have the limited exclusive, worldwide right and
license to use all and any component of the MedicAlert® PHR Software, and all corresponding
rights under all patent, copyright, trademark, trade secret and other laws as may be
necessary or appropriate for the sole and limited purpose of transferring the MedicAlert®
PHR System subscribers to alternative goods or services that may be competitive with the
CapMed PHR System or the MedicAlert® PHR System and that were not developed in violation of
this Agreement. |
|
|
(c) |
|
In the event that this Agreement is terminated by CapMed without cause, or by
MedicAlert on the insolvency, dissolution or uncured material breach of CapMed, MedicAlert
shall have the irrevocable right and option to purchase an irrevocable, fully paid up,
royalty free, worldwide license to make, use, modify, enhance, further develop, sell, and
sublicense all and any component of the MedicAlert® PHR Software, and all corresponding
rights under all patent, copyright, trademark, trade secret and other laws as may be
necessary or appropriate for the full enjoyment of the rights otherwise granted under this
Agreement. |
|
|
(d) |
|
If the parties are unable to agree on the purchase price within thirty (30) calendar
days of the termination date, each party shall appoint, within thirty (30) calendar days
thereafter, one appraiser and the two appraisers shall within a period of five (5)
additional days, agree on and appoint an additional appraiser. The appraisers shall be
experienced in valuing licenses. The three appraisers shall, within sixty (60) calendar
days after the appointment of the third appraiser, determine the fair market value of the
license in writing and submit their report to all the parties. The fair market value shall
be determined by taking the arithmetic mean of the two closest appraisers valuations,
shall be final, and shall not be subject to appeal. Each party shall pay for the services
of the appraiser selected by it, plus one-half of the fee charged by the third appraiser.
MedicAlert shall have five (5) days from the appraisal determination of fair market value
to give CapMed written notice of its intent to exercise or waive its rights to exercise the
option. In the event that MedicAlert elects to exercise its option, the purchase price may
be paid by a promissory note secured by the license over a period not to exceed five (5)
years with interest at a rate equal to the Prime Rate. |
|
|
(e) |
|
On completion of all Schedule A milestones and pursuant to the software escrow
agreement, CapMed will deposit with a reputable escrow company previously agreed to |
MedicAlert® PHR System Development and Supply Agreement
Page 16 of 19
|
|
|
by the parties, the Patent, the Copyright, the full and complete CapMed PHR Software in
source code and all related computer files (such as executable program files, compiler,
linker, third-party libraries, etc.), and all Documentation agreed to between the parties as
may be necessary to develop, utilize and understand the CapMed PHR System, and thereafter
shall promptly deposit full and complete documents and source code for any new version,
upgrade, or bug fix. In the event this agreement is terminated for any reason, the escrow
company will deliver all materials held in escrow to MedicAlert under the terms and
conditions of the escrow agreement for MedicAlerts post-termination licensed use under this
Section |
19. |
|
Warranty of Corporate Authority. Each party represents and warrants to the other
that it is a corporation duly organized, validly existing, and in good standing under the laws
of the jurisdiction of formation, and has all requisite corporate power and authority to make
and enter this Agreement. |
20. |
|
Non-Assignability. Neither party may assign, transfer, or otherwise dispose of this
Agreement in whole or in part to any person, firm, or corporation without the prior written
consent of the other party, unless such assignment or transfer is to a parent, subsidiary, or
affiliate company. |
21. |
|
No Special Relationship Between Parties. Nothing in this Agreement creates an agency
relationship, partnership, joint-venture or any other form of special relationship between the
parties. |
22. |
|
Severability. If any provision of this Agreement is held by any court of competent
jurisdiction to be illegal, void, or unenforceable, such provision will be of no force or
effect, and the court will restructure or amend such provision to the minimum extent possible
to be enforceable according to the parties intent as set forth herein. The illegality or
unenforceability of such provision will have no effect upon and will not impair the
enforceability of any other provision of this Agreement. |
23. |
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Integration. This Agreement, together with all attached exhibits and schedules and
all ancillary agreements between the parties hereto, represent the complete agreement and
understanding of the parties relating to the subject matter hereof and supersede any prior or
contemporaneous agreements, understandings, or representations of the parties, whether oral or
in writing. This Agreement may not be amended or modified except by a writing signed by both
parties. |
24. |
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Notices. All commercial notices for the order, manufacture, and delivery of goods or
services will be in a commercially reasonable manner consistent with industry standards. All
notices, requests, demands and other communications regarding any partys default under or the
termination of this Agreement will be in writing and will be sufficient in all respects (a) if
delivered personally or by telecopy or email transmission when so delivered, or (b) if given
by an internationally reputable overnight air courier service, two (2) business days after the
date delivered to such courier, delivery charges prepaid. |
25. |
|
Entire Agreement. This Agreement represent the complete agreement and understanding
of the parties relating to the subject matter hereof and supersede any prior or
contemporaneous |
MedicAlert® PHR System Development and Supply Agreement
Page 17 of 19
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agreements, understandings, or representations of the parties, whether oral or written. This
Agreement may not be amended or modified except by a writing signed by both parties. |
26. |
|
Governing Law & Jurisdiction. This Agreement is made in Turlock, California, and
shall in all respects be deemed a contract of such State governed by the laws of the United
States of America and the State of California. The parties expressly agree to use their best
efforts to informally, among themselves, resolve any dispute arising from or relating to this
Agreement before initiating any litigation. |
27. |
|
Counterparts. This Agreement may be executed in two or more original or telecopy
counterparts, each of which shall be deemed an original and all of which together shall
constitute but one and the same document. |
28. |
|
Captions. Captions are for the convenience of the parties and shall not be used in
interpreting the provisions of this Agreement. |
IN WITNESS WHEREOF, the parties hereto have made and entered this Agreement as of the date and
year last set forth below to be effective as of the date and year first set forth above.
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Bio-Imaging Technologies, Inc. |
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Medic Alert Foundation United States, Inc. |
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By: |
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/s/ Mark L. Weinstein |
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/s/ Paul Kortschak |
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Mark L. Weinstein
President and CEO
Bio-Imaging Technologies, Inc. |
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Paul Kortschak
President and CEO
Medic Alert Foundation United States, Inc. |
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Date:
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June 20, 2005
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June 20, 2005 |
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MedicAlert® PHR System Development and Supply Agreement
Page 18 of 19
SCHEDULE A
TO
MEDICALERT® PHR SYSTEM
DEVELOPMENT AND SUPPLY AGREEMENT
MedicAlert E-HealthKey Product Development
MedicAlert Development Team
Responsibilities and Milestones
Field Test Milestones and Implementation Schedule
**
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Bio-Imaging Technologies, Inc. |
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Medic Alert Foundation United States, Inc. |
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/s/ Mark L. Weinstein |
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/s/ Paul Kortschak |
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Mark L. Weinstein
President and CEO
Bio-Imaging Technologies, Inc. |
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Paul Kortschak
President and CEO
Medic Alert Foundation United States, Inc. |
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Date:
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June 20, 2005
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June 20, 2005 |
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Page 19 of 19
EX-23.1
4
w32201exv23w1.htm
CONSENT OF PRICEWATERHOUSECOOPERS LLP
exv23w1
Exhibit 23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the
Registration Statement on
Form S-3
(No. 333-109702)
and
Form S-8
(No. 333-85394)
of Bio-Imaging Technologies, Inc. and its subsidiaries of our
report dated March 29, 2007 relating to the financial
statements and financial statement schedules, which appears in
this
Form 10-K.
/s/ PricewaterhouseCoopers
LLP
Philadelphia, Pennsylvania
March 29, 2007
EX-31.1
5
w32201exv31w1.htm
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO SECTION 302
exv31w1
EXHIBIT 31.1
CERTIFICATION
I, Mark L. Weinstein, President and Chief Executive Officer of
Bio-Imaging Technologies, Inc., certify that:
1. I have reviewed this Annual Report on
Form 10-K
of Bio-Imaging Technologies, Inc.
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the periods presented in this report;
4. The registrants other certifying officer and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
for the registrant and have:
a) Designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b) [Paragraph omitted in accordance with SEC transition
instructions contained in SEC Release
34-47986]
c) Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d) Disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting; and
5. The registrants other certifying officer and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of the registrants board
of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in
the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b) Any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
Mark L. Weinstein, President and Chief
Executive Officer
(Principal Executive Officer)
Dated: March 29, 2007
EX-31.2
6
w32201exv31w2.htm
CERTIFICATION OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER PURSUANT TO SECTION 302
exv31w2
EXHIBIT 31.2
CERTIFICATION
I, Ted I. Kaminer, certify that:
1. I have reviewed this Annual Report on
Form 10-K
of Bio-Imaging Technologies, Inc.
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the periods presented in this report;
4. The registrants other certifying officer and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
for the registrant and have:
a) Designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b) [Paragraph omitted in accordance with SEC transition
instructions contained in SEC Release
34-47986]
c) Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d) Disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting; and
5. The registrants other certifying officer and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of the registrants board
of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in
the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b) Any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
Ted I. Kaminer, Senior Vice President
and Chief Financial Officer
(Principal Financial and Accounting Officer)
Dated: March 29, 2007
EX-32.1
7
w32201exv32w1.htm
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO SECTION 1350
exv32w1
EXHIBIT 32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on
Form 10-K
of Bio-Imaging Technologies, Inc. (the Company) for
the year ended December 31, 2006 as filed with the
Securities and Exchange Commission on the date hereof (the
Report), the undersigned, Mark L. Weinstein,
President and Chief Executive Officer of the Company, hereby
certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) The Report fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of
1934; and
(2) The information contained in the Report fairly
presents, in all material respects, the financial condition and
results of operations of the Company.
Mark L. Weinstein, President and Chief
Executive Officer
(Principal Executive Officer)
Dated: March 29, 2007
|
|
* |
A signed original of this written statement required by
section 906 has been provided to the Company and will be
retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.
|
EX-32.2
8
w32201exv32w2.htm
CERTIFICATION OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER PURSUANT TO SECTION 1350
exv32w2
EXHIBIT 32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on
Form 10-K
of Bio-Imaging Technologies, Inc. (the Company) for
the year ended December 31, 2006 as filed with the
Securities and Exchange Commission on the date hereof (the
Report), the undersigned, Ted I. Kaminer, Chief
Financial Officer of the Company, hereby certifies, pursuant to
18 U.S.C. Section 1350, that:
(1) The Report fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of
1934; and
(2) The information contained in the Report fairly
presents, in all material respects, the financial condition and
results of operations of the Company.
Ted I. Kaminer, Senior Vice President
and Chief Financial Officer
(Principal Financial and Accounting Officer)
Dated: March 29, 2007
|
|
* |
A signed original of this written statement required by
section 906 has been provided to the Company and will be
retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.
|
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`
end
-----END PRIVACY-ENHANCED MESSAGE-----