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PROSPECTUS SUPPLEMENT NO. 3
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Filed pursuant to Rule 424(b)(3) |
(To Prospectus dated May 1, 2006)
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Registration No. 333-133072 |
UROPLASTY, INC.
1,918,809 Shares of Common Stock
and
1,180,928 Shares of Common Stock
Issuable Upon Exercise of Warrants
This prospectus supplement relates to shares of our common stock that may be sold at various times
by certain selling shareholders. You should read this prospectus supplement no. 3, the prior
prospectus supplements and the prospectus dated May 1, 2006, which are to be delivered with this
prospectus supplement. Our May 1, 2006 prospectus is a combined prospectus under Rule 429(a) of
the Securities Act of 1933, as amended, with our prior prospectus dated July 29, 2005 and
supplements thereto (See Registration No. 333-126737 filed with the Securities and Exchange
Commission on July 20, 2005 and declared effective on July 29, 2005).
This prospectus supplement contains our Annual Report on Form 10-KSB for the fiscal year ended
March 31, 2006. This report was filed with the Securities and Exchange Commission on June 29,
2006. The attached information supplements and supersedes, in part, the information contained in
the prospectus.
Our common stock is traded on the American Stock Exchange under the symbol UPI. On June 29, 2006,
the closing price of our common stock on the American Stock Exchange was $1.90 per share.
This investment is speculative and involves a high degree of risk. See Risk Factors on page 6 of
the prospectus to read about factors you should consider before buying shares of the common stock.
Neither the SEC nor any state securities commission has approved or disapproved these securities or
passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
Prospectus Supplement dated June 30, 2006
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-KSB
Annual
Report Pursuant To Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the Fiscal Year Ended March 31, 2006
Commission File No. 000-20989
UROPLASTY, INC.
(Name of Small Business Issuer in its Charter)
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Minnesota
(State or other jurisdiction of
incorporation or organization)
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41-1719250
(I.R.S. Employer
Identification No.) |
2718 Summer Street NE
Minneapolis, Minnesota 55413-2820
(Address of principal executive offices)
(612) 378-1180
(Issuers telephone number, including area code)
Securities registered under Section 12(g) of the Exchange Act: Common Stock, $.01 par value (Title of class)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during
the past 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
YES þ NOo
Check if disclosure of delinquent filers in response to Item 405 of Regulation S-B is not contained in this form, and no
disclosure will be contained, to the best of Companys knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES o NOþ
Issuers revenues for its most recent fiscal year: $6,142,612
The aggregate market value of the voting stock held by non-affiliates computed by reference to the price at which the stock
was sold or the average bid and asked prices of such stock as of June 1, 2006 was $9,514,884.
The number of shares outstanding of the issuers only class of common stock on June 1, 2006 was 6,961,206.
Documents Incorporated By Reference: Portions of the Companys Proxy Statement for its 2006 Annual Meeting of Shareholders
(the Proxy Statement), are incorporated by reference in Part III.
Transitional Small Business Disclosure Format: YES o NO þ
Indicate
by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act).
YES o NOþ
TABLE OF CONTENTS
PART I
Uroplasty, Inc. may from time to time make written or oral forward-looking statements, including
our statements contained in this report with the Securities and Exchange Commission and in our
reports to stockholders, as well as elsewhere. Forward-looking statements are statements such as
those contained in projections, plans, objectives, estimates, statements of future economic
performance, and assumptions related to any of the foregoing, and may be identified by the use of
forward-looking terminology, such as may, expect, anticipate, estimate, goal, continue
or other comparable terminology. By their very nature, forward-looking statements are subject to
known and unknown risks and uncertainties relating to our future performance that may cause our
actual results, performance or achievements, or industry results, to differ materially from those
expressed or implied in any such forward-looking statements.
Forward-looking statements are contained in the Managements Discussion and Analysis or Plan of
Operation and other sections of this report. Various factors and risks (not all of which are
identifiable at this time) could cause our results, performance or achievements to differ
materially from that contained in our forward-looking statements. We caution investors that any
forward-looking statement contained herein or elsewhere is qualified by and subject to the warnings
and cautionary statements contained above and in, particular, in the Risk Factors discussion
contained in the Description of Business section of this report.
We do not undertake and assume no obligation to update any forward-looking statement that we may
make from time to time.
ITEM 1. DESCRIPTION OF BUSINESS
Overview
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. Affecting urinary or fecal control, voiding
dysfunctions debilitate millions of adults worldwide and cost billions of healthcare dollars.
Since many of these dysfunctions are highly correlated with age, the aging population will demand
increasingly better, and less invasive, solutions for these conditions.
We have developed, and are developing, products primarily for the treatment of urinary and fecal
incontinence. Our products offer physicians and patients minimally invasive treatment options.
All products we currently market are CE marked for European Union clearance (similar to Food and
Drug administration (FDA) clearance in the U.S.). Our Macroplastique and other implantable tissue
bulking products have not yet been cleared for marketing in the United States.
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Macroplastique® Implants, a proprietary, implantable soft tissue bulking product is used
for the treatment of both male and female urinary incontinence. When Macroplastique is
injected into tissue around the urethra, it stabilizes and bulks tissues close to the
urethra, thereby providing the surrounding tissue with increased capability to control the
release of urine. Macroplastique is also used to treat vesicoureteral reflux,
predominately a pediatric condition in which urine flows backward from the bladder to the
kidney. Macroplastique has been sold, since 1991 in over 40 countries outside of the U.S.,
for urological indications. Our other proprietary, implantable soft tissue bulking agents
that we sell outside the United States include PTQ Implants for fecal incontinence, VOX
Implants for vocal cord rehabilitation and Bioplastique® Implants for dermal augmentation. |
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I-Stop Mid-Urethral Sling is a biocompatible, polypropylene, tension-free sling for the
treatment of female urinary incontinence. We are the exclusive distributor of this product
in the United Kingdom and in the United States. In August 2005 this product received
premarket clearance for sale within the United States. |
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The Urgent® PC neuromodulation system is a minimally invasive neuromodulation device
designed for office-based treatment of overactive bladder symptoms of urge incontinence,
urinary urgency and urinary frequency. Using percutaneous tibial nerve stimulation, the
product delivers an electrical pulse that travels to the sacral nerve plexus, a control
center for bladder function. In April 2005, we acquired the exclusive rights to
manufacture and distribute this product in the U.S., Canada and all countries recognizing
the CE mark. We received regulatory approvals for sale of this product in the United
States and Canada in October 2005, and in Europe in November 2005. Subsequently, we
launched the product for sale in those markets. |
Our goal is to develop and commercialize a portfolio of minimally invasive products for the
treatment of voiding dysfunctions. We believe that, with a suite of innovative products, we can
increasingly garner the attention of key physicians and distributors and enhance market acceptance
of our products. The key elements of our strategy are to:
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Pursue regulatory approval in the U.S. for our Macroplastique; |
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Expand our U.S. marketing and sales organization, using a combination of direct and independent reps; |
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Conduct multi-center, prospective clinical trials for the Urgent PC; |
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Expand distribution of our products outside of the U.S.; and |
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Acquire or license complimentary products if appropriate opportunities arise. |
We concluded a multi-center human clinical trial using Macroplastique Implants in a minimally
invasive, office-based procedure for treating adult female stress urinary incontinence resulting
from intrinsic sphincter deficiency, a weakening of the muscles that control the flow of urine from
the bladder. In December 2004, the FDA accepted for filing our pre-market approval submission
with respect to Macroplastique for the treatment of adult female stress urinary incontinence. This
submission is under review by the FDA and we continue to expect, as we indicated in July 2005, the
possible approval by the FDA in late 2007. We will incur substantial expenses in connection with
these regulatory activities. Even if we obtain regulatory approval, it may be only for limited
uses with specific classes of patients, which may limit the market for our product.
In the United States, we recently staffed our sales organization, consisting of a direct
field sales management team and independent sales representatives, and a marketing organization to
market our products directly to our customers. We anticipate further increasing, as needed, our
sales and marketing organization in the United States to support our sales growth. Outside of the
United States, we sell our products primarily through a direct sales organization in the United
Kingdom and through distributors in other markets.
Voiding Dysfunctions
Voiding dysfunctions affect urinary or fecal control and can result in unwanted leakage (urinary or
fecal incontinence) or uncontrolled sensations (overactive bladder symptoms). We believe we are
uniquely positioned to offer minimally invasive products to treat each of these voiding
dysfunctions.
The Problem of Urinary Incontinence
Urinary incontinence, the uncontrolled leakage of urine, is a problem suffered by millions of
people worldwide in varying degrees of severity. Because of the social stigma associated with this
condition, it is often underreported. It can result in a substantial decrease in a persons
quality of life, and is often the main reason a family moves an elderly person to nursing home
care. The Agency for Health Care Policy and Research (AHCPR), a division of the Public Health
Service, U.S. Department of Health and Human Services, estimates that urinary incontinence affects
about 13 million people in the United States, of which 85% (11 million) are women. The same agency
estimates the total cost of treating all types of incontinence (management and curative approaches)
in the United States to be $15 billion. Researchers at the University of California, Los Angeles
determined a 38% prevalence rate of urinary incontinence among the 23 million adult women surveyed
by the National Center for Health Statistics. We expect the incidence of urinary incontinence will
rise as the percentage of elderly population grows.
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Causes of Urinary Incontinence
The mechanisms of urinary continence are complicated and involve the interaction among several
anatomical structures. In females, urinary continence is controlled by the sphincter muscle and
pelvic floor support structures that maintain proper urethral position. The sphincter muscle
surrounds the urethra and provides constrictive pressure to prevent urine from flowing out of the
bladder. Urination occurs when the sphincter relaxes as the bladder contracts, allowing urine to
flow through the urethra. The urinary sphincter and pelvic floor support are also responsible for
maintaining continence during periods of physical stress. Incontinence may result when any part of
the urinary tract fails to function as intended. Incontinence may be caused by damage during
childbirth, pelvic trauma, spinal cord injuries, neurological diseases (e.g., multiple sclerosis
and poliomyelitis), birth defects (e.g., spina bifida) and degenerative changes associated with
aging.
For men, urinary incontinence is most often associated with prostate conditions or nerve problems,
such as complications arising from diabetes, stroke or Parkinsons disease. Enlargement of the
prostate gland (the gland surrounding the male urethra just below the bladder) may impact urinary
control. Approximately 400,000 prostate surgeries are performed
each year in the United States for prostate enlargement or for prostate cancer. Up to 20% of men
undergoing such surgery develop incontinence following the procedure.
Types of Urinary Incontinence
There are four types of urinary incontinence:
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Stress Urinary Incontinence - Stress urinary incontinence, or SUI, refers to the
involuntary loss of urine due to an increase in intra-abdominal pressure from ordinary
physical activities, such as coughing, sneezing, laughing, straining or lifting. For the
majority of women with SUI (9 million of the 11 million in the U.S.), their incontinence is
caused by urethral hypermobility. Urethral hypermobility abnormal movement of the bladder
neck and urethra occurs when the anatomic supports for the bladder neck and urethra have
weakened. This anatomical change is often the result of childbirth. Stress urinary
incontinence can also be caused by intrinsic sphincter deficiency, or the inability of the
sphincter muscle to function properly. Intrinsic sphincter deficiency can be due to
congenital sphincter weakness or can result from deterioration of the urethral muscular wall
due to changes of aging or damage following trauma, spinal cord lesion or radiation therapy.
The National Association for Continence (NAFC) estimates up to 15% of female stress urinary
incontinence is a result of intrinsic sphincter deficiency. For many women, their SUI is a
combination of urethral hypermobility and ISD. |
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Urge Incontinence - Urge incontinence refers to the involuntary loss of urine associated
with an abrupt, strong desire to urinate. Urge incontinence often occurs when neurological
problems cause the bladder to contract and empty with little or no warning. |
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Overflow Incontinence - Overflow incontinence is associated with an over-distention of
the bladder. This can be the result of an under-active bladder or an obstruction in the
bladder or urethra. |
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Mixed Incontinence - Mixed incontinence is the combination of both urge and stress
incontinence (and, in some cases, overflow). Clinicians estimate that 30% of women
suffering from stress urinary incontinence also exhibit symptoms of urge incontinence.
Since prostate enlargement often obstructs the urethra, older men often have urge
incontinence coupled with overflow incontinence. |
Management and Curative Treatment of Urinary Incontinence
There are two general approaches to dealing with urinary incontinence One approach is to manage
symptoms with products such as pads or diapers. The other approach is to undergo curative
treatments in an attempt to restore continence, such as injection of urethral tissue bulking agents
or by invasive surgeries. We believe the treatment of urinary incontinence should start first with
the least invasive therapy and then move to more invasive therapies only when needed.
Management of Urinary Incontinence
Absorbent Products. Absorbent products are the most common form of management for urinary
incontinence because men and women can use them without consulting a physician. The cost of adult
diapers and pads can be substantial and create a continuous financial burden for patients.
Additionally, this management technique may require frequent changing of diapers and pads to
control patient embarrassment due to odor or soiling.
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Behavior Modification. Techniques used in behavior modification include bladder training,
scheduled voiding and pelvic floor muscle exercises known as Kegels. Some of the tools used in
conjunction with these training regimes are vaginal cones or weights, biofeedback devices and
pelvic floor stimulation. Because these techniques rely on active, frequent participation of the
individual, these techniques are seldom effective.
Occlusion and Compression Devices. Penile clamps, pessaries and urethral occlusion devices are
typically reserved for temporary use. Complications such as tissue erosion, urinary tract
infections, edema, pain and obstruction are associated with extended or improper use.
Urinary Catheters and Collection Devices. The type and severity of incontinence and an
individuals physical and mental condition determine the choice of catheter. Catheters may be
inserted as needed for bladder drainage and may be a closed, indwelling system or an external
collection device.
Drug Therapy. Drug treatment is used to manage multiple types of urinary incontinence.
Therapeutic drug activity is matched to the individuals urinary dysfunction, e.g., activity
targeted to contract muscle tissue of the bladder or bladder neck or to improve the quality of the
bladder neck and urethra mucosal lining. Drugs are most often used to treat
symptoms of overactive bladder but drugs seldom cure stress urinary incontinence. Common side
effects of drugs include dry mouth, constipation and headache. Other potential side effects
include urinary retention, nausea, dizziness, blurred vision and the possibility of unwanted
interactions with other drugs.
Curative Treatment of Urinary Incontinence
Injectable Uretheral Tissue Bulking Agents. Urethral tissue bulking agents are inserted with a
needle into the area around the urethra, augmenting the surrounding tissue for increased capacity
to control the release of urine. Hence, these materials are often called bulking agents or
injectables. Urethral bulking agents may be either synthetic or biologically derived and are an
attractive alternative to surgery because they are considerably less invasive. Active women
benefit from the use of urethral bulking agents since they will often return to normal activities
in a matter of days instead of weeks of recovery following invasive surgical procedures. Bulking
agents also represent a desirable treatment option for the elderly or infirm who may not otherwise
be able to withstand the trauma and morbidity resulting from a fully invasive surgical procedure.
Additionally, the use of a urethral bulking agent does not preclude the use of more invasive
treatments if required.
Biologically derived bulking agents include a patients own fat cells, polysaccharides (not
commercially available in the United States) or bovine collagen. Fat injections involve complex,
invasive harvesting of the patients own fat cells and re-injecting them into the bladder neck.
Collagen injections require pre-treatment allergy skin tests and, since the body absorbs collagen
over time, the patient may require subsequent re-injections.
Synthetic bulking agents include solid silicone elastomers, pyrolytic carbon-coated beads, and DMSO
and polyvinyl alcohol.
Surgery. In women, stress urinary incontinence can be surgically corrected through a procedure in
which the physician elevates and stabilizes the urethra and bladder neck, often with a sling to
support these structures. Market adoption of sling procedures is demonstrated by over 10% annual
growth during the last five years. An estimated 180,000 sling procedures were performed in the
U.S. during 2005, with almost half of these procedures using a tension-free sling product, usually
implanted in an outpatient setting. Numerous publications cite sling procedure efficacy greater
than 85%.
In men, the surgical options for treating urinary incontinence are a male sling or an implanted
artificial urinary sphincter, a patient-controlled device that keeps the urethra closed until the
patient is ready to urinate. Surgery to place the artificial sphincter requires general or spinal
anesthesia.
Uroplasty Solutions for Urinary Incontinence
We believe that we are uniquely positioned with differentiable, minimally invasive products to
address both causes of SUI an injectable bulking agent to treat ISD and a tension-free type sling
to treat urethral hypermobility.
Macroplastique® Implants
Macroplastique® is an injectable soft-tissue bulking agent used to treat stress urinary
incontinence, the most common form of urinary incontinence in women. It is designed to restore the
patients urinary continence immediately following treatment.
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Additionally, men who experience
incontinence as a result of prostate surgery are also candidates for Macroplastique treatment.
Macroplastique is a soft-textured, permanent implant placed endoscopically around the urethra
distal to the bladder neck. It is a proprietary composition of heat vulcanized, solid, soft,
irregularly shaped polydimethylsiloxane (solid silicone) implants suspended in a biocompatible
carrier gel. We believe our compound is better than other commercially available bulking agents
because it does not degrade, is not absorbed into surrounding tissues and does not migrate from the
implant site due to its unique composition, shape and size. This reduces the need for follow-up
treatments. Additionally, there is no need for special storage, cumbersome preparation or mixing
for use or for patient allergy testing.
We currently market Macroplastique outside the U.S. Macroplastique is a outpatient, minimally
invasive treatment that offers lower surgical risk with shorter recovery time, and a less expensive
alternative when compared to invasive procedures. Its safety and efficacy are evidenced by over 14
years of successful use outside the United States with over 50,000 patients treated. We concluded
a multi-center human clinical trial using Macroplastique Implants in a minimally invasive,
office-based procedure for treating adult female stress urinary incontinence resulting from
intrinsic sphincter deficiency, a weakening of the muscles that control the flow of urine from the
bladder. In December 2004, the FDA accepted for filing our pre-market approval submission with
respect to Macroplastique for the treatment of adult female stress urinary incontinence. This
submission is under review by the FDA and we continue to expect, as we indicated in July 2005, the
possible approval by the FDA in late 2007. We will incur substantial expenses in connection with
these
regulatory activities. Even if we obtain regulatory approval, it may be only for limited uses with
specific classes of patients, which may limit the market for our product.
Although Macroplastique is traditionally implanted with the aid of an endoscope, we also market
outside the United States a patented, non-endoscopic product placement kit, or delivery kit, called
the Macroplastique Implantation System, or MIS, for office-based treatment of female stress
urinary incontinence. Our MIS enables easy and consistent product placement without the use of an
endoscope. Following FDA approval of Macroplastique, we intend to seek regulatory approval for the
MIS.
I-Stop Sling
We are the exclusive distributor in the United States and the United Kingdom of the I-Stop tape, a
biocompatible, tension-free, mid-urethral sling manufactured by CL Medical SAS of Lyon, France.
The I-Stop tape has received FDA premarket approval and is CE marked for the treatment of female
urinary incontinence due to urethral hypermobility. If the urethra is no longer appropriately
supported by the surrounding tissues and ligaments, the urethra may move too easily and may no
longer properly close. A sling provides a hammock-type support for the urethra to prevent its
downward movement, and associated leakage of urine, during periods of increased abdominal pressure.
I-Stop, the only synthetic, mid-urethral sling made of monofilament knitted polypropylene, has
closed loop edges, which we believe make it non-damaging to surrounding tissue without the need for
a delivery sheath. We also believe that the I-Stop design provides greater strength and controlled
flexibility, and improved resistance to fragmentation, stretching and deformity during the
outpatient implant procedure, than competitive sling devices. For patients, we believe that our
tape design results in less irritation and fewer overall complications. We believe our product is
competitively priced and we offer components to address the retropubic and transobturator surgical
approaches.
In May 2005, we entered into a one-year exclusive agreement with CL Medical to distribute the
I-Stop in the United Kingdom. The agreement is renewable for up to 2 years, subject to certain
performance requirements of us. We are required to purchase a minimum of $266,000 of units in the
12-month period following January 1, 2006, subject to periodic adjustment based on the value of the
euro. The purchase price is payable in euros. If we fail to reach our minimum purchase
requirement, CL Medical has the right to terminate our exclusive distribution rights in the United
Kingdom.
In February 2006 we entered into a six-year exclusive agreement with CL Medical to distribute the
I-Stop in the U.S. The agreement is renewable for successive five-year terms, subject to certain
performance requirements of us. We are required to purchase a minimum of $363,000 of units in the
first 12-month period following January 1, 2006, increasing to approximately $2.6 million of units
in the fifth year, for an aggregate commitment of approximately $6.5 million of units over the
five-year period, subject to periodic adjustment based on the value of the euro. The purchase
price is payable in euros. If we fail to reach our minimum purchase requirement in any 12-month
period, CL Medical has the right to terminate our exclusive distribution rights in the United
States. CL Medical has agreed to provide us, without additional charge, with any improvements or
modifications it makes to the I-Stop sling and has granted us a right of first refusal for
exclusive distribution rights in the United States to any new medical devices or procedures it
develops. We have agreed that during,
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and for one year after, the term of this agreement, we will
not manufacture our own, or market any other partys tension-free vaginal tape product for the
treatment of female stress urinary incontinence. If for some reason CL Medical is prohibited from
exporting the I-Stop into the United States, CL Medical is required to supply us with the
components necessary to manufacture, package and label the I-Stop for the United States market.
The Problem of Overactive Bladder
Overactive bladder (OAB) is a prevalent and challenging urologic problem affecting 16% of the adult
population. An estimated 34 million Americans suffer from overactive bladder, although fewer than
40% seek medical help. A survey of individuals with OAB estimated the total U.S. economic cost of
OAB (direct and indirect costs) to be $12 billion.
For individuals with overactive bladder, the nervous system control for bladder filling and urinary
voiding is incompetent. Signals to indicate a full bladder are sent early and frequently, triggers
to allow the bladder to relax for filling are ineffective and nervous control of the urethral
sphincter, to keep the bladder closed until an appropriate time, is inadequate. An individual with
OAB may exhibit one or all of the symptoms that characterize overactive bladder: urinary
urgency, urinary frequency and urge incontinence. Urgency is the strong, compelling need to
urinate. Frequency is a repetitive need to void. Normal urinary voiding is eight times per day.
Individuals with an overactive bladder may seek to void over 20 times per day and at least two
times during the night, thereby causing significant sleep pattern disturbances. Urge incontinence
is an immediate, compelling need to urinate that typically results in an accident before the
individual can reach the restroom.
Treatment of Overactive Bladder Symptoms
Drug Therapy. The most common treatment for OAB is drug therapy using an anticholinergic agent.
However, for some individuals, the drugs are ineffective or the side effects so bothersome that the
patient discontinues the medications. Common side effects include dry mouth, constipation and
headache.
Biofeedback and Behavioral Modification. Bladder training and scheduled voiding techniques, often
accompanied by the use of voiding diaries, are a non-invasive approach to managing OAB. Because
these techniques rely on the diligence and compliance of the individual, these techniques are
seldom effective. In addition, for OAB symptoms, these techniques may not affect the underlying
cause of the condition.
Neuromodulation. Normal urinary control is dependent upon properly functioning neural pathways and
coordination among the central and peripheral nervous systems, the nerve pathways, bladder and
sphincter. Unwanted, uncoordinated or disrupted signals along these pathways can lead to
overactive bladder symptoms. Therapy using neuromodulation incorporates electrical stimulation to
target specific neural tissue and jam the pathways transmitting unwanted signals. To alter
bladder function, the stimulation must be delivered to the sacral nerve plexus, the neural tissue
affecting bladder activity. Neuromodulation for OAB is presently conducted through sacral nerve
stimulation or percutaneous tibial nerve stimulation.
The sacral nerve stimulator uses a small device, a neurostimulator, to send mild electrical pulses
to the sacral nerve. The sacral nerve is located in the lower back, just above the tailbone. The
surgically implanted neurostimulator contains a battery and electronics to create the electrical
pulses and is connected to a neurostimulation lead (an insulated wire) containing electrodes
through which stimulation is delivered to the nerve. The device is most frequently placed under
the skin of the buttock, with the lead under the skin near the spine.
Alternatively, percutaneous tibial nerve stimulation (PTNS) delivers stimulation to the sacral
nerve plexus by temporarily applying electrical pulses to the tibial nerve. The tibial nerve is an
easily accessed nerve in the lower leg. Neuromodulation using PTNS has a similar therapeutic
effect as the implantable sacral nerve stimulator, but requires no surgery. PTNS is minimally
invasive, has a low risk of complication and is typically performed in a physicians office.
Uroplasty Solutions for Overactive Bladder
Urgent® PC Neuromodulation System
In April 2005, we entered into an exclusive manufacturing and distribution agreement with
CystoMedix, Inc., an Andover, Minnesota medical device company, the exclusive rights to manufacture
and market the Urgent® PC Neuromodulation System for the U.S., Canada and all countries recognizing
the CE mark. The Urgent PC is a minimally invasive nerve stimulation device designed for
office-based treatment of urge incontinence, urinary urgency and urinary frequency
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symptoms of an
overactive bladder. Using percutaneous tibial nerve stimulation near the ankle, the product
delivers an electrical pulse that travels to the sacral nerve plexus, a control center for bladder
function.
We believe that the Urgent PC system is the only non-surgical neuromodulation device in the U.S.
market for treatment of overactive bladder symptoms. Components of the Urgent PC system include a
hair-width needle electrode, a lead set and an external, handheld, battery-powered stimulator. For
each 30-minute office-based therapeutic session, the physician temporarily inserts the needle
electrode in the patients lower leg and connects the electrode to the stimulator. Typically, a
patient undergoes 12 treatment sessions at one-week intervals, with follow up treatments as
required to maintain symptom reduction.
Under our agreement with CystoMedix, we are responsible for regulatory applications and compliance
within all markets outlined in the agreement. Although the Urgent PC as marketed by CystoMedix was
CE marked and 510(k) cleared, following minor revisions to the product, we secured 510(k) clearance
for the device in October 2005 and CE mark in November 2005. Subsequently we launched the product
for sale. We have since then developed a second generation Urgent PC, and in June 2006, received
for it the 510(k) clearance, CE Mark and regulatory approval to sell in Canada.
In connection with the agreement with CystoMedix, we purchased 75% of CystoMedixs inventory of
component parts and subassemblies for $25,000. We paid an initial royalty payment of $225,000 in
May 2005 and paid an additional aggregate of $250,000 in royalties in monthly installments through
May 2006. During the agreements term, we will pay CystoMedix further royalties of 7% of our net
product revenues from the sale of licensed products, offset by payments made against the above
$250,000 royalty amount. We agreed to sell licensed products we manufacture back to CystoMedix, on
a non-exclusive basis, on terms and for such price as we may mutually negotiate for CystoMedixs
own sales outside of the territories exclusively licensed to us.
Our five-year agreement with CystoMedix provides no renewal provision. Between January 2006 and
June 2008, we may elect to purchase all of CystoMedixs assets. The option price is $3,485,000,
reduced by up to $50,000 of liabilities assumed by us. After April 2007 the option price will
increase at a rate of 10% per year. The option price is payable in
shares of our common stock valued at the average of the closing bid price of our shares for the 20
trading days prior to our exercise of the option. If we exercise our option, we also assume up to
$1.4 million of bridge loan advances made to CystoMedix by its Chairman. We would repay up to $1.1
million of the bridge loan advances at closing and would issue our common stock for the balance of
the bridge loan based on the above option price. We also have certain rights of first refusal to
acquire CystoMedixs assets in the event CystoMedix receives a third party offer in advance of any
exercise of our option.
The Problem of Fecal Incontinence
Fecal incontinence, prevalent in 2-6% of the adult population, with women suffering up to four
times more often than men, is an extremely disabling and embarrassing condition. Approximately 25%
of women with stress urinary incontinence are also diagnosed with fecal incontinence.
Fecal continence relies on an intact and functioning anal sphincter. The internal anal sphincter
(IAS) provides most of the resting anal pressure and is the main muscle responsible for the
prevention of anal leakage. Degeneration or disruption of the IAS characteristically leads to
fecal incontinence or soiling. Degeneration can result from childbirth, surgical trauma or
accident.
Treatment of Fecal Incontinence
The internal sphincter cannot be surgically repaired, as it is extremely thin (approximately 2-3
mm) and, as a circular muscle, is under tension. Antidiarrheal drugs and diet modification help
some patients, but this is not a satisfactory, long-term solution for most patients.
Uroplasty Solutions for Fecal Incontinence
We have, and are developing additional, minimally invasive products to address fecal incontinence.
Our PTQ Implants offer a minimally invasive treatment for patients with fecal incontinence. They
are soft-textured, permanent implants. For treatment of fecal incontinence, PTQ Implants are
implanted circumferentially into the submucosa of the anal canal. Injection creates a bulking
and supportive effect similar to that of Macroplastique injection for the treatment of stress
urinary incontinence. The product is CE marked and currently sold outside the U.S. in various
international markets. We also secured CE mark for the application of percutaneous tibial nerve
stimulation for the treatment of fecal incontinence. Our Urgent PC is sold for the treatment of
fecal incontinence in countries recognizing the CE mark.
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Other Uroplasty Products
In addition to urological applications, we market our proprietary tissue bulking material outside
the United States for reconstructive and cosmetic plastic surgery under the trade name
Bioplastique® Implants and for otolaryngology vocal cord rehabilitation applications under the
trade name VOX® Implants.
In The Netherlands and United Kingdom only, we distribute certain wound care products in accordance
with a distributor agreement. Under the terms of the distributor agreement, we are not obligated
to purchase any minimum level of wound care products.
Marketing, Distribution and Sales
We currently sell two products in the United States the I-Stop Sling and the Urgent PC
Neuromodulation System. We received regulatory approvals for sale of our Urgent® PC
Neuromodulation System, the only minimally invasive nerve stimulation device designed for
office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and
urinary frequency, in the United States and Canada in October 2005 and in Europe in November 2005.
Subsequently, we launched this product for sale in those markets.
Our U.S. sales organization consists of a direct field-based sales management group and a
nationwide network of independent sales representatives. We anticipate continuing to increase our
sales and marketing organization, as needed, to support the sales growth.
Outside of the United States, in addition to our UrgentÒ PC Neuromodulation system, we market
and sell Macroplastique and related ancillary products, PTQ Implants, VOX Implants and Bioplastique
Implants, and, in the United Kingdom we also sell the I-Stop sling. We sell our products primarily
through a direct sales organization in the United Kingdom. In all other markets we sell our
products primarily through distributors. International sales managers in The Netherlands manage
and train a network of distributors in approximately 40 countries, including Canada, Australia,
countries within Europe and Latin America. Each of our distributors has a territory-specific
distribution
agreement, including requirements indicating they may not sell injectable products that compete
directly with Macroplastique. Collectively, our distributors accounted for approximately 65% and
70% of total net sales for fiscal 2006 and 2005, respectively.
We use clinical studies and scientific community awareness programs to demonstrate the safety and
efficacy of our products. This data is important to obtain regulatory approval and to support our
sales staff and distributors in securing product reimbursement in their territories. Publications
of clinical data in peer-reviewed journals add to the scientific community awareness of our
products, including therapeutic applications, treatment techniques and expected outcomes. Our
clinical research department provides a range of activities designed to support surgeons in their
clinical evaluation study design, abstract preparation, manuscript creation and/or review and
submission. This team works closely with our sales and marketing and regulatory departments in the
area of technical support, submissions, literature review, and analysis and synopsis of technical
presentations and publications.
Researchers have designed clinical trials to provide outcome evidence on products developed by us.
These include randomized controlled trials on our PTQ Implants, Macroplastique Sling Support Kit
(MIS-SK) and a multi-center prospective study on the efficacy of the Urgent PC. Evidence-based
clinical research broadens the surgeons acceptance by providing detailed information related to
product safety and efficacy when applied to patient selection and comparative surgical and
non-surgical treatment regimens. Only by recognition of the complexity of our product,
indications, analysis of the contributing variables and presentation and publication of the
clinical outcomes, will we provide the physicians, patients and reimbursement systems with the
evidence they require to make informed decisions.
Manufacturing and Suppliers
We manufacture our tissue bulking products at our own facilities. We manufacture components in the
United States and finished products in The Netherlands. Our facilities utilize dedicated heating,
ventilation and high efficiency particulate air (HEPA) filtration systems to provide a controlled
working environment. Trained technicians perform all critical manufacturing processes in a
cleanroom environment according to validated written procedures. An outside vendor sterilizes our
products using validated methods and returns the products to us for final inspection and testing.
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Our manufacturing facilities and systems are periodically audited to ensure compliance with ISO
13485 (medical device quality management systems), and applicable European and Canadian medical
device requirements. Our facilities and systems were last audited by AMTAC Certification Services
in January 2005. No major deficiencies were noted, and we were found to be in compliance with all
standards and requirements audited.
Our facilities also need to be compliant with U.S. federal Quality System Regulations (QSR). While
we believe we are compliant with QSR, our facilities have not yet been audited by the FDA for such
compliance, and there can be no guarantee that we will pass the FDA compliance audit. We are also
subject to additional state, local, and U.S. federal government regulations applicable to the
manufacture of our products.
CL Medical designs and manufactures the I-Stop sling. Pursuant to our distribution agreements with
CL Medical, we are the exclusive distributor of the I-Stop sling in the United States and the
United Kingdom. Among other things, we are required to purchase a minimum number of I-Stop product
sets from CL Medical.
Under our manufacturing and distribution agreement with CystoMedix, Inc., we are responsible for
the manufacture of the Urgent PC device. We currently subcontract the manufacture of major
subassemblies for the product.
We purchase medical grade materials for use in our finished products from several single source
suppliers. Our quality department has qualified these suppliers. Although we believe our supply
sources could be replaced if necessary without due disruption, it is possible that the process of
qualifying suppliers for certain raw materials could cause an interruption in our ability to
manufacture our products, which could have a negative impact on sales.
Competition
The market for voiding dysfunction products is intensely competitive. Competitors offer management
and curative treatments, including commercialized tissue bulking agents, urethral sling products
and neurostimulation devices. Indirect and future competitors include drug companies and firms
developing new or improved treatment methods. We believe the principal decision factors among
treatment methods include physician and patient acceptance of the treatment method and cost,
availability of third-party reimbursement, marketing and sales coverage and the existence of
meaningful patent protection. In addition to addressing the decision factors, our ability to
effectively compete in this market will also depend on the consistency of our product quality as
well as delivery and product pricing. Other factors affecting our success include our product
development and innovation capabilities, clinical study results, ability to obtain required
regulatory approvals, ability to protect our proprietary technology, manufacturing and marketing
capabilities and ability to attract and retain skilled employees.
Soft-tissue injectable bulking agents competing directly with Macroplastique®, both outside and in
the U.S. include Contigen® and Tegress®, both FDA-approved bulking agents manufactured by C.R.
Bard, Inc.; Zuidex® and Deflux® (Deflex FDA approved for VUR use only) manufactured by Q-Med AB;
Durasphere® (FDA-approved for female SUI) manufactured by Carbon Medical Technologies; and
Coaptite® manufactured by BioForm, Inc. for Boston Scientific. In contrast to the competitors
products currently approved for sale, Macroplastique, marketed outside the United States since
1991, is a synthetic material that will not degrade, resorb or migrate, has no special preparation
or storage requirements and does not require the patient to have a skin test prior to the
procedure. The silicone-elastomer material has been studied for over 50 years in medical use for
such urological applications as artificial urinary sphincters, penile implants, stents and
catheters. Our patented Macroplastique® Implantation System offers a unique, non-endoscopic,
minimally invasive out-patient procedure that can be performed in the physicians office.
Sling procedures have become the preferred method for treating urethral hypermobility. The
tension-free sling market is dominated by Gynecares TVT Tension-free Support device. Other
companies competing in this market include American Medical Systems, C.R. Bard, Boston Scientific
and Mentor Corporation. We believe our I-Stop sling offers benefits of multiple surgical
approaches for the physician and a design to resist stretching, deformity and fragmentation.
The Urgent®PC neurostimulation device is an alternative to the more invasive Medtronic InterStim®
device. The Medtronic unit, which stimulates the sacral nerve, requires surgical implantation in
the upper buttocks or abdomen. In contrast, the Urgent PC device allows minimally invasive
stimulation of the sacral nerve plexus in an office-based setting without surgical intervention.
Neotonus markets a non-surgical device to deliver extracorporeal magnetic neuromodulation. In
addition, Boston Scientifics Bion® Microstimulator, a device implanted with a needle-like
instrument to stimulate the pudendal nerve, is CE mark approved for the treatment of urinary urge
incontinence and is undergoing clinical studies in the U.S.
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Many medications treat symptoms of overactive bladder, some by preventing unwanted bladder
contractions, others by tightening the bladder or urethra muscles and some by relaxing bladder
muscles. Sometimes, these drugs have unwanted side effects such as dry mouth, vision problems or
constipation. Among these medications are Detrol® (Pfizer Inc.), Ditropan® (Alza Corporation) and
Flomax® (Abbott Laboratories).
Many of our competitors and potential competitors have significantly greater financial,
manufacturing, marketing and distribution resources and experience than we have. In addition, many
of our competitors offer broader product lines within the urology market, which may give these
competitors the ability to negotiate exclusive, long-term supply contracts and to offer
comprehensive pricing for their products. It is possible other large health care and consumer
products companies may enter this industry in the future. Furthermore, smaller companies, academic
institutions, governmental agencies and other public and private research organizations will
continue to conduct research, seek patent protection and establish arrangements for commercializing
products. These products may compete directly with any products that we may offer in the future.
Government Regulation
The design, testing, manufacturing, promotion, marketing and distribution of our products in the
United States, Europe and other parts of the world are subject to regulation by numerous
governmental authorities, including the U.S. Food and Drug Administration, or FDA, the European
Union and other analogous agencies.
United States
Our products are regulated in the Unites States as medical devices by the FDA under the Food, Drug
and Cosmetic Act. Noncompliance with applicable requirements can result in, among other things:
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fines, injunctions, and civil penalties; |
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recall or seizure of products; |
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operating restrictions, or total or partial suspension of production; |
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denial of requests for 510(k) clearance or pre-market approval of new products; |
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withdrawal of existing approvals; and |
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criminal prosecution. |
Depending on the degree of risk posed by the medical device and the extent of controls needed to
ensure safety and effectiveness, there are two pathways for FDA marketing clearance of medical
devices. For devices deemed by FDA to pose relatively less risk (Class I or Class II devices),
manufacturers, in most instances, may submit a pre-market notification (510(k) clearance)
requesting permission for commercial distribution.. Devices deemed by the FDA to pose the greatest
risk (Class III devices), such as life-sustaining, life-supporting or implantable devices, or a
device deemed not to be substantially equivalent to a previously cleared 510(k) device, require the
submission of a pre-market approval (PMA) application. The FDA can also impose restrictions on the
sale, distribution or use of devices at the time of their clearance or approval, or subsequent to
marketing.
510(k) Clearance. To obtain 510(k) clearance, the pre-market notification must demonstrate that
the proposed device is substantially equivalent in intended use and in safety and effectiveness to
a previously 510(k) cleared device or a device that was commercially distributed before May 28,
1976 and for which FDA has not yet called for submission of a pre-market approval application. The
FDA attempts to respond to a 510(k) pre-market notification within 90 days of submission of the
notification, but the response may be a request for additional information, sometimes including
clinical data. As a practical matter, 510(k) clearance can take significantly longer than 90 days,
including up to one year or more.
After a device receives 510(k) clearance for a specific intended use, modifications or enhancements
that could significantly affect the safety or effectiveness of the device or that would constitute
a major change to the intended use of the device will require a new 510(k) pre-market notification
submission or, depending upon the changes, could require pre-market approval. The FDA requires
each manufacturer to make this determination initially, but the FDA can review any such decision.
If the FDA disagrees with a manufacturers determination that a new clearance or approval is not
required for a particular modification, the FDA can require the manufacturer to cease marketing or
recall the modified device until 510(k) clearance
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or pre-market approval is obtained. Also, in
these circumstances, a company may be subject to significant regulatory fines or penalties.
Pre-market Approval. A pre-market approval application must be submitted if the device cannot be
cleared through the 510(k) process. The pre-market approval process is much more demanding than
the 510(k) notification process. A pre-market approval applicant must provide extensive
preclinical and clinical trial data as well as information about the device and its components
regarding, among other things, device design, manufacturing and labeling. As part of the
pre-market approval process, applicants must file an Investigational Device Exemption, or IDE,
application prior to commencing human clinical trials. If the IDE application is approved by the
FDA, human clinical trials may begin at a specific number of investigational sites with a maximum
number of patients. The results of clinical testing may not be sufficient to obtain approval of
the product.
After the FDA determines that a pre-market approval application is complete, the FDA accepts the
application and begins an in-depth review of the submitted information. The FDA, by statute and
regulation, has 180 days to review an accepted pre-market approval application, although the review
generally occurs over a significantly longer period of time, and can take up to several years.
During this review period, the FDA may request additional information or clarification of
information already provided. Also during this review period, an advisory panel of experts from
outside the FDA may be convened to review and evaluate the application and provide recommendations
to the FDA as to the approvability of the device. In addition, the FDA will conduct a pre-approval
inspection of the manufacturing facility to ensure compliance with the Quality System Regulations.
New pre-market approval applications or supplemental pre-market approval applications are required
for significant modifications to the manufacturing process, labeling, use and design of a device
that is approved through the pre-market approval process. Pre-market approval supplements often
require submission of the same type of information as a pre-market approval, except that the
supplement is limited to information needed to support any device changes not covered by the
original pre-market approval application, and may not require as extensive clinical data as the
original submission or the convening of an advisory panel.
Continuing FDA Regulation. After a device is placed on the market, numerous regulatory
requirements apply. These include:
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Quality System Regulations, which require manufacturers to follow design, testing,
control, documentation and other quality assurance procedures during the manufacturing
process; |
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labeling regulations, which govern product labels and labeling, prohibit the promotion
of products for unapproved or off-label uses and impose other restrictions on labeling
and promotional activities; |
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medical device reporting regulations, which require that manufacturers report to the FDA
if their device may have caused or contributed to a death or serious injury or
malfunctioned in a way that would likely cause or contribute to a death or serous injury if
it were to recur; |
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post-market surveillance activities monitor use of the products placed in the market place; and |
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notices of correction or removal, and recall regulations. |
FDA Approval Status of Our Products. The FDA has determined that urethral tissue bulking agents,
such as Macroplastique, are Class III devices and require FDA clearance of a pre-market approval
application. In 1999, the FDA approved our IDE application for the use of Macroplastique in a
clinical study for the treatment of stress urinary incontinence. In 2000, we commenced human
clinical trials at multiple sites. We concluded the 12-month patient follow up visits for this
study and, in 2004 submitted a pre-market approval application. This submission is under review by
the FDA and we continue to expect, as we indicated in July 2005, the possible approval by the FDA
in late 2007. Even if we obtain regulatory approval, it may be only for limited uses with specific
classes of patients, which may limit the market for our product.
In August 2005, the I-Stop product received premarket clearance for sale within the United States.
The Urgent PC device previously received 510(k) clearance for U.S. marketing by the FDA. However,
following product revisions, we submitted our 510(k) pre-market application in August 2005. We
received 510(k) clearance in October 2005 for our version of the Urgent PC device. Following
development of our second generation of the Urgent PC, in May 2006 we submitted a special 510(k)
pre-market application. With regards to our second generation Urgent PC, in June 2006, we received
the CE mark and approval from Therapeutic Products Directorate of Health to sell in Canada.
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FDA Oversight of Manufacturing Operations. The Food, Drug and Cosmetics Act requires that medical
devices be designed and manufactured in accordance with the FDAs current Quality System
Regulations, which require, among other things, that we:
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regulate our design and manufacturing processes and control them by the use of written procedures; |
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investigate any deficiencies in our manufacturing process or in the products we produce; |
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keep detailed records and maintain a corrective and preventative action plan; and |
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allow the FDA to inspect our manufacturing facilities on a periodic basis to monitor our
compliance with Quality System Regulations. |
Although our manufacturing facilities and processes have been inspected and certified in compliance
with ISO 13485, applicable European medical device directives, and Canadian Medical Device
Requirements, they have not been inspected by the FDA for compliance with Quality System
Regulations. We will be required to have a FDA inspection prior to the pre-market approval of our
Macroplastique product for sale in the U.S. We cannot assure you that our facilities and processes
will be found to comply with Quality System Regulations and there is a risk that approval will,
therefore, be delayed by the FDA until such compliance is achieved.
European Union and Other Regions
The European Union has adopted rules that require that medical products receive the right to affix
the CE mark, which stands for Conformité Européenne. The CE mark demonstrates adherence to quality
assurance standards and compliance with relevant European medical device directives. Products that
bear the CE mark can be imported to, sold or distributed within, the European Union.
We received CE marking approval for Macroplastique in 1996 for the treatment of male and female
stress urinary incontinence and vesicoureteral reflux; for the Urgent PC for the treatment of fecal
incontinence, and overactive bladder symptoms of urinary urgency, urinary frequency and urge
incontinence. In addition, we received CE marking for PTQ Implants in 2002 for the treatment of
fecal incontinence; for VOX Implants in 2000 for vocal cord rehabilitation applications; and for
Bioplastique Implants in 1996 for dermal augmentation applications. The I-Stop sling received CE
marking approval in July 2002. Our European manufacturing facilities and processes have been
inspected and certified by AMTAC Certification Services, a recognized Notified Body, testing and
certification firm based in the United Kingdom.
We currently sell our products in approximately 40 foreign countries, including those within the
European Union. Requirements pertaining to medical devices vary widely from country to country,
ranging from no health regulations to detailed submissions such as those required by the FDA. We
have obtained regulatory approval where required for us to sell our products in the country. We
believe the extent and complexity of regulations for medical devices are increasing worldwide. We
anticipate that this trend will continue and that the cost and time required to obtain approval to
market in any given country will increase.
Third-Party Reimbursement
In both U.S. markets and markets outside the U.S., sales of our products will depend in part on the
availability of reimbursement from third-party payors. Outside of the United States, government
managed health care systems and private insurance control reimbursement for devices and procedures.
Reimbursement systems in international markets vary significantly by country. In the European
Union, reimbursement decision-making is neither regulated nor integrated at the European Union
level. Each country has its own system, often closely protected by its corresponding national
government. Reimbursement for Macroplastique and other tissue bulking products has been successful
in multiple international markets where hospitals and physicians have been able to get budgets
approved by fund-holder trusts or global hospital budgets.
In the U.S., third-party payors consist of government programs, such as Medicare, private health
insurance plans, managed care organizations and other similar programs. For any product, three
factors are critical to reimbursement:
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coding, which ensures uniform descriptions of procedures, diagnoses and medical
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coverage, which is the payors policy describing the clinical circumstances under which
it will pay for a given treatment; and |
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payment amount. |
Reimbursment for tension-free sling products has been previously addressed by numerous competitors.
As a result coding, coverage and payment for the I-Stop Mid-Urethral Sling is already
well-established.
As a relatively new therapy, nerve simulation using the Urgent PC has not been assigned a
reimbursement code unique to the technology. However, a number of practitioners are using an
existing reimbursement code that closely describes the procedure. In addition, Aetna and Blue
Cross Blue Shield of Minnesota and Maryland have published policies providing coverage for PTNS
under an existing reimbursement code. We will need to continue to work with third-party payers for
coverage policies and the American Medical Association to develop definitive and uniform
reimbursement for the theraphy. In addition, we will need to provide customer reimbursement
support as we market the product and secure medical community acceptance.
We believe, but cannot confirm, that there are appropriate codes available to describe endoscopic
use of Macroplastique to treat female SUI. We expect that, upon FDA approval to market
Macroplastique, we will need to foster coverage policies and payer acceptance to support the U.S.
launch. There is no guarantee that Macroplastique will be reimbursed at the levels expected by
us, if at all.
Patents, Trademarks and Licenses
Our success depends in part on our ability to obtain and maintain patent protection for our
products, preserve our trade secrets and operate without infringing the proprietary rights of third
parties. We seek to protect our technology by filing patent applications for technologies
important to the development of our business following an analysis of the cost of obtaining a
patent, the likely scope of protection, the relative benefits of patent protection compared to
trade secret protection and other business considerations.
We hold multiple patents covering our Macroplastique materials, processes and applications. As of
the date of this report, we have four issued U.S. patents and 19 granted patents in the United
Kingdom, Japan, Germany, France, Spain, Italy, Portugal, The Netherlands and Canada. Our patents
will expire in the U.S. at various times between 2011 and 2016 and in other countries between 2009
and 2017. There can be no assurance any of our issued patents are of sufficient scope or strength
to provide meaningful protection of our products. In addition, there can be no assurance any
current or future U.S. and foreign patents of ours will not be challenged, narrowed, invalidated or
circumvented by competitors or others, or that our patents will provide us with any competitive
advantage. Any legal proceedings to maintain, defend or enforce our patent rights could be lengthy
and costly, with no guarantee of success. CystoMedix and CL Medical also have certain patent
rights which they licensed to us as part of their respective manufacturing and distribution
agreements. We are awaiting prosecution of the patent protection applications we filed in 2006 for
the Urgent PC.
In 1992, we agreed to settle alleged patent infringement claims by Collagen Corporation (now Inamed
Corporation). Under the settlement agreement, we pay Collagen a royalty of 5% of net sales in the
U.S. of Macroplastique products with a minimum, through May 1, 2006, of $50,000 per year.
Although we intend to apply for additional patents and vigorously defend issued patents, management
believes our business success will depend primarily upon our development and sales and marketing
skills, and the quality and economic value of our products rather than on our ability to obtain and
defend patents.
We also seek to protect our trade secrets by requiring employees, consultants, and other parties to
sign confidentiality agreements and noncompetition agreements, and by limiting access by outside
parties to confidential information. There can be no assurance, however, these measures will
prevent the unauthorized disclosure or use of this information or that others will not be able to
independently develop this information.
We have registered Macroplastique®, Uroplasty® and Bioplastique® as trademarks with the U.S. Patent
and Trademark Office. Our non-registered trademarks include VOX and PTQ, for which trademark
registration applications are pending in the U.S. Patent and Trademark Office and in European
countries. In addition, Macroplastique is registered in numerous European countries. CystoMedix
has U.S. registration of the Urgent®PC trademark and has licensed the mark to
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us as part of our
exclusive manufacturing and distribution agreement. In addition, CL Medical has licensed its
non-registered trademark for the I-Stop sling to us as part of our agreement with it.
We have a royalty agreement with three individuals, two of whom are former officers and directors.
Under this royalty agreement, we pay aggregate royalties of three to five percent of net sales of
Macroplastique and Bioplastique, subject to a monthly minimum of $4,500. The royalties payable
under this agreement will continue until the patent referenced in the agreement expires in 2010.
In October 1998, we received an absolute assignment from a British surgeon of a patent relating to
the Macroplastique Implantation System in return for a royalty of £10 for each unit sold during the
life of the patent. We began commercialization of the product outside the U.S. in March 2000.
Research and Development
We have a research and development program to develop new incontinence products. We are also
continually evaluating product potential improvements, and new methods and devices for the
implantation of and new applications for Macroplastique. Research and development expenses also
include the costs of clinical studies and regulatory compliance. Our expenditures for research and
development totaled $3.3 and $2.3 million for fiscal 2006 and 2005, respectively. None of these
costs were borne directly by customers.
Product Liability
The medical device industry is subject to substantial litigation. As a manufacturer of a long-term
implantable device, we face an inherent risk of liability for claims alleging adverse effects to
the patient. We currently carry $2 million of worldwide product liability insurance, plus another
policy specific to the United Kingdom only. There can be no assurance, however, our existing
insurance coverage limits are adequate to protect us from any liabilities we might incur. There
can be no assurance that liability claims will not exceed coverage limits. Product liability
insurance is expensive and in the future may not be available to us on acceptable terms, if at all.
Furthermore, we do not expect to be able to obtain insurance covering our costs and losses as a
result of any product recall. A successful claim in excess of our insurance coverage could
materially deplete our assets. Moreover, any claim against us could generate negative publicity,
which could decrease the demand for our products and our ability to generate revenues.
Compliance with Environmental Laws
Compliance by us with applicable environmental requirements during fiscal years 2006 and 2005 has
not had a material effect upon our capital expenditures, earnings or competitive position.
Dependence on Major Customers
During fiscal 2006, two customers accounted for approximately 14% and 11% of our net sales. During
fiscal 2005, the same two customers accounted for approximately 15% and 11% of our net sales.
Employees
As of March 31, 2006, we had 55 employees, of which 51 were full-time and 4 were part-time. No
employee has a collective bargaining agreement with us. We believe we maintain good relations with
our employees.
Incorporation and Current Subsidiaries
We were incorporated in January 1992 as a Minnesota corporation and a wholly owned subsidiary of
our original parent. In February 1995, we became a stand-alone, privately held company pursuant to
a Plan of Reorganization confirmed by the U.S. Bankruptcy Court. We became a reporting company
pursuant to a registration statement filed with the Securities and Exchange Commission in July
1996.
Our wholly owned foreign subsidiaries and their respective principal functions are as follows:
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Uroplasty BV
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Incorporated in The Netherlands, distributes the Urgent PC,
is the manufacturer of Macroplastique, Bioplastique, VOX
Implants, PTQ Implants and of all their accessories,.
Products are sold primarily through distributors. |
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Uroplasty LTD
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Incorporated in the United Kingdom and acts as the sole
distributor of Urgent PC, Macroplastique, Bioplastique, PTQ
Implants, all of their accessories, and wound care products
in the United Kingdom and Ireland. Also distributes the
I-Stop in the United Kingdom. Products are sold primarily
through a direct sales organization. |
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Bioplasty BV
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Incorporated in The Netherlands and is the distributor of
Bioplastique to subdistributors, and distributes wound care
products in The Netherlands. We plan to merge this
subsidiary with Uroplasty BV in fiscal 2007. |
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the
risk factors set forth below and all other information contained in this Annual Report on Form
10-KSB before purchasing our common stock. If the following risks actually occur, our business,
financial condition and results of operations could be seriously harmed, the price of our common
stock could decline and you could lose part or all of your investment.
We continue to incur losses and may never reach profitability
We have incurred net losses in each of the last five fiscal years. As of March 31, 2006, we had an
accumulated deficit of approximately $11 million primarily as a result of costs relating to the
development, including seeking regulatory approvals, and commercialization of our Macroplastique,
I-Stop tape, Urgent® PC neuromodulation system and related products. We expect our operating
expenses relating to sales and marketing activities and product development, including seeking
United States regulatory approval for Macroplastique, will continue to increase during the
foreseeable future. To achieve profitability, we must generate substantially more revenue than we
have in prior years. Our ability to achieve significant revenue growth will depend, in large part,
on our ability to obtain FDA approval to market Macroplastique, and our ability to achieve
widespread market acceptance for our products, which we cannot guarantee will happen. We may never
realize significant revenue from the sale of our products or be profitable.
If we fail to receive or experience a significant delay in receiving regulatory approvals for sale
of our products, our ability to generate revenues will be limited and our business prospects may
suffer.
We cannot sell Macroplastique in the United States until we obtain the requisite FDA approvals. If
we suffer delays in obtaining or fail to receive regulatory approvals, our ability to generate
revenues from the sale of these products will be limited and our future growth may be significantly
hampered.
In the U.S., we have submitted a pre-market approval application with respect to Macroplastique.
The pre-market approval process is very expensive, uncertain and time-consuming and could
materially delay our product coming to market. This submission is under review by the FDA and we
continue to expect, as we indicated in July 2005, the possible approval by the FDA in late 2007.
We will incur substantial expenses in connection with these regulatory activities. Even if we
obtain regulatory approval, it may be only for limited uses with specific classes of patients,
which may limit the market for our product.
We are primarily dependent on sales of one product and our business would suffer if sales of this
product decline.
We are dependent on sales of our products that contain our Macroplastique bulking agent. Our
Macroplastique product line accounted for 67% and 76%, respectively, of total net sales during
fiscal 2006 and 2005. If our Macroplastique products were no longer available for sale in any key
market because of regulatory, intellectual property or any other reason, our net sales from these
products would significantly decline. A significant decline in our net sales could also negatively
impact our product development activities and therefore our business prospects.
We are unable to predict how quickly or how broadly our products will be accepted by the market.
If demand for our products fails to develop as we expect, our revenues will decline or we may be
unable to increase our revenues and be profitable.
Although some our products received FDA approval, market acceptance is uncertain. Our failure to
achieve sufficient market acceptance will significantly limit our ability to generate revenue and
be profitable. Market acceptance of our
products will depend on our ability to demonstrate the safety, clinical efficacy, perceived
benefits and cost-effectiveness of our products
16
compared to products or treatment options of our
competitors, and to train physicians in the proper application of our products. We cannot assure
you that we will be successful in educating the marketplace about the benefits of using our
products. Even if customers accept our products, this acceptance may not translate into sales if
our competitors have developed similar products that our customers prefer. If our products do not
achieve increasing market acceptance in the U.S. and internationally, our revenues will decline or
we may be unable to increase our revenues and be profitable.
Our products and facilities are subject to extensive regulation with which compliance is costly and
which exposes us to penalties for non-compliance. We may not be able to obtain required regulatory
approvals for our products in a cost-effective manner or at all, which could adversely affect our
business and results of operations.
The production and marketing of our products and our ongoing research and development, preclinical
testing and clinical trial activities are subject to extensive regulation and review by numerous
governmental authorities both in the United States and abroad. U.S. and foreign regulations
applicable to medical devices are wide-ranging and govern, among other things, the testing,
marketing and pre-market review of new medical devices, in addition to regulating manufacturing
practices, reporting, advertising, exporting, labeling and record keeping procedures. We are
required to obtain FDA approval or clearance before we can market our products in the United States
and certain foreign countries. The regulatory process requires significant time, effort and
expenditures to bring our products to market, and we cannot assure that any of our products will be
approved for sale. Any failure to obtain regulatory approvals or clearances could prevent us from
successfully marketing our products, which could adversely affect our business and results of
operations. Our failure to comply with applicable regulatory requirements could result in
governmental agencies:
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imposing fines and penalties on us; |
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preventing us from manufacturing or selling our products; |
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bringing civil or criminal charges against us; |
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delaying the introduction of our new products into the market; |
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enforcing operating restrictions; |
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recalling or seizing our products; or |
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withdrawing or denying approvals or clearances for our products. |
If any or all of the foregoing were to occur, we may not be able to meet the demands of our
customers and our customers may cancel orders or purchase products from our competitors, which
could adversely affect our business and results of operations.
Even if we receive regulatory approval or clearance of a product, the approval or clearance could
limit the uses for which we may label and promote the product, which may limit the market for our
products. Further, for a marketed product, its manufacturer and manufacturing facilities are
subject to periodic reviews and inspections by FDA and foreign regulatory authorities. Subsequent
discovery of problems with a product, manufacturer or facility may result in restrictions on the
product, manufacturer or facility, including withdrawal of the product from the market or other
enforcement actions. In addition, regulatory agencies may not agree with the extent or speed of
corrective actions relating to product or manufacturing problems.
If additional regulatory requirements are implemented in the foreign countries in which we sell our
products, the cost of developing or selling our products may increase. In addition, we may rely on
our distributors outside the United States in seeking regulatory approval to market our devices in
particular countries. To the extent we do so, we are dependent on persons outside of our direct
control to make regulatory submissions and secure approvals, and we do or will not have direct
access to health care agencies in those markets to ensure timely regulatory approvals or prompt
resolution of regulatory or compliance matters. If our distributors fail to obtain the required
approvals or do not do so in a timely manner, our net sales from our international operations and
our results of operations may be adversely affected.
In addition, our business and properties are subject to federal, state and local laws and
regulations relating to the protection of the environment, natural resources and worker health and
safety and the use, management, storage, and disposal of hazardous substances, wastes, and other
regulated materials. The costs of complying with these various environmental requirements, as they
now exist or may be altered in the future, could adversely affect our financial condition and
results of operations.
17
If third parties claim that we infringe upon their intellectual property rights, we may incur
liabilities and costs and may have to redesign or discontinue selling the affected product.
The medical device industry is litigious with respect to patents and other intellectual property
rights. Companies operating in our industry routinely seek patent protection for their product
designs, and many of our principal competitors have large patent portfolios. Companies in the
medical device industry have used intellectual property litigation to gain a competitive advantage.
Whether a product infringes a patent involves complex legal and factual issues, the determination
of which is often uncertain. We face the risk of claims that we have infringed on third parties
intellectual property rights. Our efforts to identify and avoid infringing on third parties
intellectual property rights may not always be successful. Any claims of patent or other
intellectual property infringement, even those without merit, could:
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be expensive and time consuming to defend; |
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result in us being required to pay significant damages to third parties; |
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cause us to cease making or selling products that incorporate the challenged intellectual property; |
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require us to redesign, reengineer or rebrand our products, if feasible; |
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require us to enter into royalty or licensing agreements in order to obtain the right to
use a third partys intellectual property, which agreements may not be available on terms
acceptable to us or at all; |
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divert the attention of our management; or |
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result in our customers or potential customers deferring or limiting their purchases or
use of the affected products until resolution of the litigation. |
In addition, new patents obtained by our competitors could threaten a products continued life in
the market even after it has already been introduced.
If we are unable to adequately protect our intellectual property rights, we may not be able to
compete effectively and we may not be profitable.
Our success depends in part on our ability to protect our proprietary rights to the technologies
used in our products. We rely on patent protection, as well as a combination of trademark laws and
confidentiality, noncompetition and other contractual arrangements to protect our proprietary
technology. However, these legal means afford only limited protection and may not adequately
protect our rights or permit us to gain or keep any competitive advantage. Our patents and patent
applications if issued, may not be broad enough to prevent competitors from introducing similar
products into the market. Our patents, if challenged or if we attempt to enforce them, may not
necessarily be upheld by the courts of any jurisdiction. In addition, patent protection in foreign
countries may be different from patent protection under U.S. laws and may not be favorable to us.
As a result, we may not be able to compete effectively.
We also rely on unpatented proprietary technology. We cannot assure you that we can meaningfully
protect all of our rights in our unpatented proprietary technology or that others will not
independently develop substantially equivalent products or processes or otherwise gain access to
our unpatented proprietary technology. We attempt to protect our trade secrets and other
unpatented proprietary technology through the use of confidentiality agreements and noncompetition
agreements with our current employees and with other parties to whom we have divulged trade
secrets. However, these agreements may not be enforceable or may not provide meaningful protection
for our proprietary information in the event of unauthorized use or disclosure or other breaches of
the agreements or in the event competitors discovery or independently develop similar proprietary
information.
Product liability claims could adversely affect our business and results of operations.
The manufacture and sale of medical devices exposes us to significant risk of product liability
claims, some of which may have a negative impact on our business. Our existing products were
developed relatively recently and defects or risks that we have not yet identified may give rise to
product liability claims. Our existing $2 million of worldwide product liability insurance coverage
may be inadequate to protect us from any liabilities we may incur or we may not be able to maintain
adequate product liability insurance at acceptable rates. If a product liability claim or series of
claims is brought against us for
18
uninsured liabilities or in excess of our insurance coverage and
it is ultimately determined that we are liable, our business could suffer. Additionally, we could
experience a material design or manufacturing failure in our products, a quality system failure,
other safety issues or heightened regulatory scrutiny that would warrant a recall of some of our
products. A recall of any of our products likely would be costly, would be uninsured and could
also result in
increased product liability claims. Further, while we train our physician customers on the proper
usage of our products, we cannot ensure that they will implement our instructions accurately. If
our products are used incorrectly by our customers, injury may result and this could give rise to
product liability claims against us. Any losses that we may suffer from any liability claims, and
the effect that any product liability litigation may have upon the reputation and marketability of
our products, may divert managements attention from other matters and may have a negative impact
on our business and our results of operations.
If we are not able to successfully scale-up production of our products, our sales and revenues will
suffer.
In order to commercialize our products in the United States and international markets, we need to
be able to produce, or subcontract the production, of our products in a cost-effective way on a
large scale to meet demand, while maintaining high standards for quality and reliability. If we
fail to successfully commercialize our products, we will not be profitable.
We may experience manufacturing and control problems as we begin to scale-up our future
manufacturing operations, and we may not be able to scale-up manufacturing in a timely manner or at
a reasonable cost to enable production in sufficient quantities. If we experience any of these
problems, we may not be able to have our products manufactured and delivered in a timely manner.
The I-Stop sling is designed and manufactured by CL Medical in France for our distribution in the
United States and the United Kingdom. If CL Medical experiences problems with manufacturing or
control, encounters regulatory or compliance problems, or incurs delays, we may not receive the
I-Stop product in a timely manner. This would limit our ability to generate revenues.
The loss or interruption of materials from any of our key suppliers could slow down the manufacture
of our products, which would limit our ability to generate sales and revenues.
We currently purchase several key materials used in our products from single source suppliers. Our
reliance on a limited number of suppliers subjects us to several risks, including an inability to
obtain an adequate supply of required materials, price increases, untimely delivery and
difficulties in qualifying alternative suppliers. We cannot be sure that acceptable alternative
arrangements could be made on a timely basis. Additionally, the qualification of materials and
processes as a result of a supplier change could be deemed as unacceptable to regulatory
authorities and cause delays and increased costs due to additional test requirements. A
significant interruption in the supply of materials, for any reason, could delay the manufacture
and sale of our products, which would limit our ability to generate revenues.
If we are not able to maintain sufficient quality controls, approval of our products by the
European Union, the FDA or other relevant authorities could be delayed or denied and our sales and
revenues will suffer.
Approval of our products could be delayed by the FDA, European Union or other related authorities
if our manufacturing facilities do not comply with applicable manufacturing requirements. The
FDAs Quality System Regulations impose elaborate testing, control, document and other quality
assurance procedures. Canada and the European Union also impose requirements on quality control
systems of manufacturers, which are inspected and certified on a periodic basis and may be subject
to additional unannounced inspections. Failure by us or CL Medical to comply with these
requirements could prevent us from obtaining FDA approval for our products and from marketing our
products in the United States. We cannot assure you that our manufacturing facilities will comply
with applicable requirements on a timely basis or at all.
Even with approval to market our products in the European Union, the United States and other
countries, we must continue to comply with relevant manufacturing requirements. If violations of
applicable requirements are noted during periodic inspections of our manufacturing facilities, we
may not be able to continue to market our products and our revenues could be materially adversely
affected.
If we are not able to increase our sales force and expand our distribution channels, our sales and
revenues will suffer.
To date, we have sold our products in foreign markets through a network of independent distributors
and our direct sales force. Our ability to increase product sales in foreign markets will largely
depend on our ability to develop and maintain relationships with our existing and additional
distributors and to recruit additional sales personnel. We may not be able to attract distributors
who are willing to commit the necessary resources to market and sell our products to the level of
our
19
expectations. In the United States, we have a sales organization consisting of a direct sales
management group and a nationwide network of independent sales representatives and a marketing
organization to market our products directly and support our distributor organizations. We
anticipate continuing to expand our sales and marketing organization, as needed to support our
growth. We have and will continue to incur significant continued and additional expenses to
support this organization. We will need to raise additional debt or equity financing to expand our
sales and marketing organizations. We have incurred and likely will incur some additional related
expenses in advance of any anticipated
regulatory approval, which we could not recoup if we do not receive such approval. We also may not
be able to hire, train and motivate qualified sales and marketing personnel. Failure to expand our
distribution and sales channels will adversely affect our sales and revenues.
If we are not able to acquire or license other products, our business and future growth prospects
could suffer.
As part of our growth strategy, we intend to acquire or license additional products and product
candidates for development and commercialization. The success of this strategy depends upon our
ability to identify, select and acquire the right products. In fact, we have an option to acquire
the assets of CystoMedix, Inc., the company that has licensed the Urgent® PC technology to us.
Any product candidate we license or acquire may require additional development efforts prior to
sale, including clinical testing and approval by the FDA. Product candidates may fail to receive
or experience a significant delay in receiving FDA approval. In addition, we cannot assure you
that any approved products that we acquire or license will be manufactured economically,
successfully commercialized or widely accepted in the marketplace. Other companies, including
those with greater financial, marketing and sales resources, may compete with us for the
acquisition or license of product candidates or approved products. We may not be able to acquire
or license the right to other products on terms that we find acceptable, or at all.
Even if we complete future acquisitions (including that of CystoMedix, of which there is no
assurance), our business, financial condition and the results of operations could be negatively
affected because:
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we may be unable to integrate the acquired business successfully and realize anticipated
economic, operational and other benefits in a timely manner; and |
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the acquisition may disrupt our ongoing business, distract our management and divert our
resources. |
The loss of our key customers could result in a material loss of revenues.
During fiscal 2006, we had two customers that accounted for approximately 14% and 11% of our net
sales. During fiscal 2005, the same two customers accounted for approximately 15% and 11% of our
net sales. As a result, we face the risk that one or more of our key customers may decrease its or
their business with us or terminate its or their relationships with us. Any decrease in business
from these customers, if we are unable to replace them, could result in a material decrease in our
revenue. This could adversely affect our financial condition.
Negative publicity regarding the use of silicone material in medical devices could harm our
business and result in a material decrease in revenues.
Macroplastique is comprised of medical grade, heat-vulcanized polydimethylsiloxane, which results
in a solid, flexible silicone elastomer. In the early 1990s, the United States breast implant
industry became the subject of significant controversies surrounding the possible effects upon the
human body of the use of silicone gel in breast implants, resulting in product liability litigation
and leading to the bankruptcy of several companies, including our former parent, Bioplasty, Inc.
We use only medical grade solid silicone material in our tissue bulking products and not
semi-liquid silicone gel, as was used in breast implants. Negative publicity regarding the use of
silicone materials in our products or in other medical devices could have a significant adverse
affect on the overall acceptance of our products. We cannot assure you that the use by us and
others of solid silicone in medical devices implanted in the human body will not result in negative
publicity.
The risks inherent in operating internationally and the risks of selling and shipping our products
and of purchasing our components and products internationally may adversely impact our net sales,
results of operations and financial condition.
We still derive substantially all of our net sales from operations in international markets. We
expect non-United States sales to continue to represent a significant portion of our revenues until
we achieve sufficient market acceptance from United
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States customers of the already FDA-approved
products and we obtain requisite FDA approvals for the remaining products. The sale and shipping
of our products and services across international borders, as well as the purchase of components
and products from international sources, subject us to extensive U.S. and foreign governmental
trade regulations. Compliance with such regulations is costly and exposes us to penalties for
non-compliance. Any failure to comply with applicable legal and regulatory obligations could
impact us in a variety of ways that include, but are not limited to, significant criminal, civil
and administrative penalties, including imprisonment of individuals, fines and penalties, denial of
export privileges, seizure of shipments, restrictions on certain business activities, and exclusion
or debarment from government contracting. Also, the failure to comply with applicable legal and
regulatory obligations could result in the disruption of our shipping and sales activities.
In addition, most of the countries in which we sell our products are, to some degree, subject to
political, economic and/or social instability. Our international sales operations expose us and
our representatives, agents and distributors to risks inherent in operating in foreign
jurisdictions. These risks include:
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the imposition of additional U.S. and foreign governmental controls or regulations; |
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the imposition of costly and lengthy new export licensing requirements; |
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the imposition of U.S. and/or international sanctions against a country, company, person
or entity with whom the company does business that would restrict or prohibit continued
business with the sanctioned country, company, person or entity; |
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political and economic instability; |
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fluctuations in the value of the U.S. dollar relative to foreign currencies; |
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a shortage of high-quality sales people and distributors; |
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loss of any key personnel that possess proprietary knowledge, or who are otherwise
important to our success in certain international markets; |
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changes in third-party reimbursement policies that may require some of the patients who
receive our products to directly absorb medical costs or that may necessitate the reduction
of the selling prices of our products; |
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changes in duties and tariffs, license obligations and other non-tariff barriers to trade; |
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the imposition of new trade restrictions; |
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the imposition of restrictions on the activities of foreign agents, representatives and distributors; |
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scrutiny of foreign tax authorities which could result in significant fines, penalties
and additional taxes being imposed on us; |
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pricing pressure that we may experience internationally; |
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laws and business practices favoring local companies; |
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longer payment cycles; |
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difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; |
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difficulties in enforcing or defending intellectual property rights; and |
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exposure to different legal and political standards due to our conducting business in
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We cannot assure you that one or more of these factors will not harm our business. Any material
decrease in our international sales would adversely impact our net sales, results of operations and
financial condition. Our international sales
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are predominately in Europe. In Europe, health care
regulation and reimbursement for medical devices vary significantly from country to country. This
changing environment could adversely affect our ability to sell our products in some European
countries.
Fluctuations in foreign exchange rates could negatively impact our results of operations.
Because our international sales are denominated primarily in euros, currency fluctuations in
countries where we do business may render our products less price competitive than those of
competing companies whose sales are denominated in weaker currencies. We report our financial
results in U.S. dollars, and fluctuations in the value of either the dollar or the currencies in
which we transact business can have a negative impact on our results of operations and financial
condition. Consequently, we have exposure to foreign currency exchange risks. We do not hedge any
of our foreign currency risk.
If we are unable to continue to develop and market new products and technologies, we may experience
a decrease in demand for our products or our products could become obsolete, and our business would
suffer.
We are continually engaged in product development and improvement programs, and we expect new
products to represent a significant component of our future business. We may not be able to
compete effectively with our competitors unless we can keep up with existing or new products and
technologies in the urinary and fecal incontinence market. If we do not continue to introduce new
products and technologies, or if those products and technologies are not accepted, we may not be
successful and our business would suffer. Moreover, our clinical trials have durations of several
years and it is possible that competing therapies, such as drug therapies, may be introduced while
our products are still undergoing clinical trials. This could reduce the potential demand for our
products and negatively impact our business prospects. Additionally, our competitors new products
and technologies may beat our products to market, may be more effective or less expensive than our
products or render our products obsolete.
The marketing of our products requires a significant amount of time and expense and we may not have
the resources to successfully market our products, which would adversely affect our business and
results of operations.
The marketing of our products requires a significant amount of time and expense in order to
identify the physicians who may use our products, invest in training and education and employ a
sales force that is large enough to interact with the targeted physicians. We may not have
adequate resources to market our products successfully against larger competitors which have more
resources than we do. If we cannot market our products successfully, our business and results of
operations would be adversely affected.
The size and resources of our competitors may allow them to compete more effectively than we can,
which could adversely affect our potential profitability.
Our products compete against similar medical devices and other treatment methods, including drugs,
for treating urinary and fecal voiding dysfunctions. Many of our competitors have significantly
greater financial, research and development, manufacturing and marketing resources than we have.
Our competitors could use these resources to develop or acquire products that are safer, more
effective, less invasive, less expensive or more readily accepted than our products. Their
products could make our technology and products obsolete or noncompetitive. Our competitors could
also devote greater resources to the marketing and sale of their products and adopt more aggressive
pricing policies than we can. If we are not able to compete effectively, then we may not be
profitable.
We are dependent on the availability of third-party reimbursement for our revenues.
Our success depends on the availability of reimbursement for the cost of our products from
third-party payors, such as government health authorities, private health insurance plans and
managed care organizations. There is no uniform policy for reimbursement in the United States and
foreign countries. We believe that the ease of obtaining, and the amount of, reimbursement for
urinary incontinence treatment has a significant impact on the decisions of health care providers
regarding treatment methods and products. Accordingly, changes in the extent of coverage or a
reduction in reimbursement rates under any or all third-party reimbursement programs may cause a
decline in purchases of our products, which would materially adversely affect the market for our
products. Alternatively, we might respond to reduced reimbursement rates by reducing the prices of
our products, which could also reduce our revenues.
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If physicians do not recommend and endorse our products, our sales may decline or we may be unable
to increase our sales and profits.
In order for us to sell our products, physicians must recommend and endorse them. We may not
obtain the necessary recommendations or endorsements from physicians. Acceptance of our products
depends on educating the medical community as to the distinctive characteristics, perceived
benefits, safety, clinical efficacy, cost-effectiveness and reimburseability of our products
compared to products of our competitors, and on training physicians in the proper application of
our products. If we are not successful in obtaining the recommendations or endorsements of
physicians for our products, our sales may decline or we may be unable to increase our sales and
profits.
Our business strategy relies on assumptions about the market for our products, which, if incorrect,
would adversely affect our business prospects and profitability.
We are focused on the market for minimally invasive therapies used to treat voiding dysfunctions.
We believe that the aging of the general population will continue and that these trends will
increase the need for our products. However, the projected demand for our products could
materially differ from actual demand if our assumptions regarding these trends and acceptance of
our products by the medical community prove to be incorrect or do not materialize. Actual demand
for
our products could also be affected if drug therapies gain more widespread acceptance as a viable
alternative treatment, which in each case would adversely affect our business prospects and
profitability.
Proposals to modify the health care system in the U.S. or other countries could affect the pricing
of our products. If we cannot sell our products at the prices we plan to, our margins and
profitability could be adversely affected.
Proposals to modify the current health care system in the United States to improve access to health
care and control its costs are continually being considered by the federal and state governments.
We anticipate that the U.S. Congress and state legislatures will continue to review and assess
alternative health care reform proposals. We cannot predict whether these reform proposals will be
adopted, when they may be adopted or what impact they may have on us if they are adopted. Any
spending decreases or other significant changes in government programs such as Medicare could
adversely affect the pricing of our products.
Like the United States, foreign countries have considered health care reform proposals and could
materially alter their government-sponsored health care programs by reducing reimbursement rates.
Any reduction in reimbursement rates under United States or foreign health care programs could
negatively affect the pricing of our products. If we are not able to charge a sufficient amount
for our products, our margins and our profitability will be adversely affected.
If our information systems fail or if we experience an interruption in their operation, our
business and results of operations could be adversely affected.
The efficient operation of our business is dependent on our management information systems. We
rely on our management information systems to effectively manage accounting and financial
functions, order entry, order fulfillment and inventory replenishment processes, and to maintain
our research and development and clinical data. The failure of our management information systems
to perform as we anticipate could disrupt our business and product development and could result in
decreased sales, increased overhead costs, excess inventory and product shortages, causing our
business and results of operations to suffer. In addition, our management information systems are
vulnerable to damage or interruption from:
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earthquake, fire, flood and other natural disasters; |
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terrorist attacks and attacks by computer viruses or hackers; and |
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power loss or computer systems, Internet, telecommunications or data network failure. |
Any such interruption could adversely affect our business and results of operations.
If we lose the services of our chief executive officer or other key personnel, we may not be able
to manage our operations and meet our strategic objectives.
Our future success depends, in large part, on the continued service of our senior management. We
have no key person insurance with respect to any of our senior managers, and any loss or
interruption of their services could significantly reduce our ability to effectively manage our
operations and implement our strategy. Also, we depend on the continued service of key managerial,
scientific, sales and technical personnel, as well as our ability to continue to attract and retain
additional highly qualified personnel. We compete for such personnel with other companies,
academic institutions, government entities and other organizations. Any loss or interruption of
the services of our other key personnel could also significantly reduce
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our ability to effectively
manage our operations and meet our strategic objectives because we cannot assure you that we would
be able to find an appropriate replacement should the need arise.
We also compete for experienced medical device sales personnel. If we are unable to hire and
retain qualified sales personnel, our sales could be negatively impacted.
We will require additional financing in the future which may not be available to us when required,
or may be available only on unfavorable terms.
Our future liquidity and capital requirements will depend on numerous factors, including:
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the timing and cost associated with obtaining FDA approval of Macroplastique; |
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the timing and cost involved in manufacturing scale-up and in expanding our sales,
marketing and distribution capabilities in the U.S. market; |
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the cost and effectiveness of our marketing and sales efforts with respect to our
existing products in international markets; |
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the effect of competing technologies and market and regulatory developments; and |
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the cost involved in protecting our proprietary rights. |
We will need to raise additional debt or equity financing to continue funding for product
development and continued expansion of our sales and marketing activities, and ultimately, we will
need to achieve profitability and generate positive cash flows from operations to fund our
operations and grow our business. As such we plan to raise additional equity capital in fiscal
2007, but there can be no guarantee that we will be successful. We currently have no committed
sources of, or other arrangements with respect to, additional financing except for the recently
established credit lines for $1.3 million and a term loan of $100,000 as described in Note 9,
Subsequent Events, to the financial statements. We cannot assure you that we will be able to
obtain additional financing on acceptable terms or at all. Our failure to obtain financing when
needed could have a material adverse effect on us. Any equity financing could substantially dilute
your equity interests in our company and any debt financing could impose significant financial and
operational restrictions on us.
You may be unable to sell your investment.
There is only a limited trading market for our common stock, which is quoted on the AMEX.
Transactions in our common stock may lack the volume, liquidity and orderliness necessary to
maintain a liquid and active trading market. Accordingly, an investor should consider the
potential lack of liquidity before investing in our common stock.
Further, our common stock is subject to the penny stock rules under The Securities and Exchange
Act of 1934. The penny stock rules require brokers who sell penny stocks to persons other than
established customers and institutional accredited investors to complete required documentation,
make suitability inquiries and provide investors with information concerning the risks of trading
in the security. The additional burdens imposed on brokers by these requirements could discourage
brokers from effecting transactions in our common stock. Consequently, an investor is likely to
find it more difficult to sell our common stock.
Our stock price may fluctuate and be volatile.
The market price of our common stock may be subject to significant fluctuation due to the following
factors, among others:
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variations in our quarterly financial results; |
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developments regarding FDA approval of Macroplastique; |
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market acceptance of our products; |
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the success of our efforts to acquire or license additional products;
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24
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announcements of new products or technologies by us or our competitors; |
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developments regarding our patents and proprietary rights or those of our competitors; |
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developments in U.S. or international reimbursement systems; |
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changes in accounting standards, policies, guidance or interpretations; |
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sales of substantial amounts of our stock by existing shareholders; and |
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general economic conditions. |
The stock market in recent years has experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of affected companies. These
broad market fluctuations may cause the price of our common stock to fall abruptly or remain
significantly depressed.
Future sales of our common stock in the public market could lower our share price.
The market price of our common stock could decline due to sales by our existing shareholders of a
large number of shares of our common stock or the perception that these sales could occur. These
sales could also make it more difficult for us to raise capital through the sale of common stock at
a time and price we deem appropriate.
We have filed a registration statement under the Securities Act covering the issuance of up to
806,218 shares of common stock that certain existing security holders may acquire upon the exercise
of outstanding warrants. The registration statement has not yet been declared effective therefore
these shares are currently not freely tradeable. As of May 31, 2006, we have outstanding 1,180,928
shares of registered common stock issuable upon exercise of warrants granted to the security
holders in connection with our April 2005 private placement.
As of May 31, 2006, we had 949,327 shares of common stock subject to outstanding options granted
under our former 1995, 1997 and 2002 Stock Option Plans. These shares are registered for public
resale by the holders of those options. As of May 31, 2006 we had 38,000 shares of common stock
subject to outstanding options granted under our 2006 Stock and Incentive Plan. In addition, as of
May 31, 2006 we had 1,240,000 shares of common stock subject to outstanding options granted from
various stock option plans. Further, if we exercise our option to acquire the assets of
CystoMedix, we will need to issue our common stock to CystoMedix for the purchase price. As of May
31, 2006, 1,832,643 outstanding options are immediately exercisable.
We will be exposed to risks relating to evaluations of controls required by Section 404 of the
Sarbanes-Oxley Act.
Changing laws, regulations and standards relating to corporate governance and public disclosure,
including the Sarbanes-Oxley Act and related regulations implemented by the SEC, are creating
uncertainty for public companies, increasing legal and financial compliance costs and making some
activities more time consuming. We will be evaluating our internal controls systems to allow
management to report on, and our independent auditors to attest to, our internal controls. We will
be performing the system and process evaluation and testing (and any necessary remediation)
required to comply with the management certification and auditor attestation requirements of
Section 404 of the Sarbanes-Oxley Act. While we anticipate being able to fully implement the
requirements relating to internal controls and all other aspects of Section 404 by our March 31,
2008 deadline, we cannot be certain as to the timing of completion of our evaluation, testing and
remediation actions or the impact of the same on our operations. If we are not able to implement
the requirements of Section 404 in a timely manner or with adequate compliance, we may be subject
to sanctions or investigation by regulatory authorities, including the SEC. This type of action
could adversely affect our financial results or investors confidence in our company and our
ability to access capital markets and could cause our stock price to decline. In addition, the
controls and procedures that we will implement may not comply with all of the relevant rules and
regulations of the SEC. If we fail to develop and maintain effective controls and procedures, we
may be unable to provide the required financial information in a timely and reliable manner.
Further, if we acquire any company in the future, we may incur substantial additional costs to
bring the acquired companys systems into compliance with Section 404.
25
Changes in accounting standards regarding stock option plans could limit the desirability of
granting stock options, which could harm our ability to attract and retain employees, and would
also negatively impact our results of operations.
The Financial Accounting Standards Board has issued Statement No. 123(R), Share-Based Payments,
SFAS 123(R), which requires all companies to treat the fair value of stock options granted to
employees as an expense, beginning in the first fiscal year that begins after December 15, 2005,
for small business issuers. Accordingly, SFAS 123(R) is effective for us beginning in fiscal 2007.
For fiscal 2006 and prior years, we generally have not recorded compensation expense in connection
with stock option grants to employees. Because in the future we will expense the fair value of
employee stock option grants, granting stock options is less attractive because of the additional
expense recognized associated with these grants, which will negatively impact our results of
operations. If we had adopted the fair value method for fiscal 2006 and 2005, our net loss for the
respective fiscal years would have been $3,062,324, and $2,321,745 higher than reported and net
loss per share would have increased by $0.46, and $0.50 per common share, respectively.
Nevertheless, stock options are an important employee recruitment and retention tool, and we may
not be able to attract and retain key personnel if we reduce the scope of our employee stock option
program.
In February 2006, our Board of Directors approved a plan to accelerate, effective February 2, 2006,
the vesting of out-of-the-money, unvested stock options previously granted to our employees,
officers and directors. An option was considered out-of-the-money if the stated exercise price
exceeded $2.85, the then closing price of our common stock. Pursuant to this action, options to
purchase approximately 0.4 million shares of our common stock with a weighted average exercise
price of $4.49 per share became exercisable immediately.
We accelerated the vesting of these options to minimize the amount of compensation expense we must
recognize upon adoption of SFAS No. 123(R). None of these options had intrinsic value at the
acceleration date under APB 25. We expect that the acceleration of the vesting of these options
reduced the pre-tax stock option expense by approximately $1.4 million, in the aggregate, calculated using the Black-Scholes option valuation model, that we
would have otherwise recognized over the next three fiscal years, upon adoption of SFAS No. 123(R).
We have included the charge attributed to the accelerated vesting of the options in the pro forma
disclosures to our consolidated financial statements for the fiscal year ended March 31, 2006.
However, certain outstanding options, with a cashless exercise provision, and certain outstanding
options classified as liabilities, could result in a significant charge to compensation expense in
future periods, as we will mark those options to fair value at each reporting period until
settlement. Also, additional options as granted to attract or retain new employees could result in
significant charge to compensation expense.
Our corporate documents and Minnesota law contain provisions that could discourage, delay or
prevent a change in control of our company.
Provisions in our articles of incorporation may discourage, delay or prevent a merger or
acquisition involving us that our stockholders may consider favorable. For example, our articles
of incorporation authorize our board of directors to issue up to 20 million shares of stock which,
without stockholder approval, the board of directors has the authority to attach special rights,
including voting and dividend rights. With these rights, the holders of such shares could make it
more difficult for a third party to acquire us. In addition, our articles of incorporation
provides for a staggered board of directors, whereby directors serve for three year terms, with
approximately one third of the directors coming up for reelection each year. Having a staggered
board will make it more difficult for a third party to obtain control of our board of directors
through a proxy contest, which may be a necessary step in an acquisition of us that is not favored
by our board of directors.
We are also subject to the anti-takeover provisions of Section 302A.673 of the Minnesota Business
Corporation Act. Under these provisions, if anyone becomes an interested shareholder, we may not
enter into a business combination with that person for four years without special approval, which
could discourage a third party from making a takeover offer and could delay or prevent a change of
control. For purposes of Section 302A.673, interested shareholder means, generally, someone
owning 10% or more of our outstanding voting stock or an affiliate of ours that owned 10% or more
of our outstanding voting stock during the past four years, subject to certain exceptions.
We do not intend to declare dividends on our stock in the foreseeable future.
We have never declared or paid cash dividends on our common stock. We currently intend to retain
all future earnings, if any, for the operation and expansion of our business and, therefore, do not
anticipate declaring or paying cash dividends on our common stock in the foreseeable future. Any
payment of cash dividends on our common stock will be at the discretion of our board of directors
and will depend upon our results of operations, earnings, capital requirements, financial
condition, future prospects, contractual restrictions and other factors deemed relevant by our
board of directors. Therefore, you should not expect to receive dividend income from shares of our
common stock.
26
ITEM 2. DESCRIPTION OF PROPERTY
We currently lease on a month-to-month basis a 13,705 square-foot (reduced to 6,205 square feet in
July 2006) office, warehouse, laboratory and production facility for our corporate headquarter in
Minneapolis, Minnesota. Effective May 2006 we entered into an eight-year lease for an 18,259
square foot facility in Minnetonka, Minnesota for our new corporate headquarter. We expect to
fully relocate to our new corporate headquarter in the third calendar quarter of 2006. We own
9,774 square feet of office and warehouse space in Geleen, The Netherlands and lease 2,330 square
feet of office, warehouse, laboratory and manufacturing space through June 2007 in Eindhoven, The
Netherlands. In addition, we lease 5,230 square feet of office and warehouse space through
September 2011 (subject to our right to terminate the lease in September 2006) in Reading, United
Kingdom. We intend to terminate this lease in September 2006 and consolidate our operations in
Geleen, The Netherlands.
ITEM 3. LEGAL PROCEEDINGS
There are no material pending legal proceedings other than ordinary routine litigation incidental
to our business.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
We did not submit any matter to a vote of our security holders during the fourth quarter of our
recently completed fiscal year.
27
PART II
ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information. As of the date hereof, there is only a limited public trading market for our
Common Stock.
In October 2005, we listed our common stock on the American stock Exchange under the symbol UPI.
Previously, our common stock was quoted on the OTC Bulletin Board under the symbol UPST.OB.
The following table sets forth the high and low closing prices for our common stock for our fiscal
year ended March 31, 2006, as reported on the American Stock Exchange and the high and low bid
prices for our common stock as reported by the OTC Bulletin Board, as applicable, for the periods
indicated. The OTC quotations represent interdealer prices, without retail markup, mark down or
commission, and do not necessarily represent actual transactions.
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Fiscal Quarters |
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Low |
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High |
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First Quarter |
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$ |
3.91 |
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$ |
4.90 |
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Second Quarter |
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2.60 |
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5.80 |
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Third Quarter |
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2.60 |
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3.80 |
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Fourth Quarter |
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2.30 |
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3.14 |
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As of March 31, 2006, approximately 523 holders held our Common Stock of record. Registered
ownership includes nominees who may hold securities on behalf of multiple beneficial owners.
Securities Authorized for Issuance Under Equity Compensation Plans. The following table provides
particular information regarding our equity compensation plans as of March 31, 2006.
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Number of Securities |
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Remaining Available for |
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Future Issuance Under |
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Number of Securities to |
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Weighted-Average |
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Equity Compensation |
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be Issued Upon Exercise |
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Exercise Price of |
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Plans (Excluding |
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of Outstanding Options, |
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Outstanding Options, |
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Securities Reflected |
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Warrants and Rights |
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Warrants and Rights |
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in the First Column) |
Equity Compensation
Plans Approved by
Security Holders |
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624,993 |
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$ |
3.25 |
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39,100 |
(2) |
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Equity Compensation
Plans Not Approved
by Security Holders
(1) |
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1,363,334 |
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$ |
4.07 |
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10,431 |
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Total |
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1,988,327 |
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$ |
3.81 |
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49,531 |
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(1) |
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The following is a brief description of the various equity compensation plans not
approved by our stockholders. |
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Our 1995 Stock Option Plan provides for the grant only of non-qualified stock options to
our employees, directors, non-employees and consultants. At March 31, 2006, 340,000
unexercised options were outstanding, and we have not granted additional options
subsequently under this plan. This plan was terminated on May 3, 2006 and no new option
grants may be awarded from this plan. |
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We have also granted options from outside of our 1995 Stock Option Plan. In January
2005, we granted options to acquire 400,000 and 100,000 shares of our common stock at an
exercise price of $5.19 per share, respectively, to Sam B. Humphries, our former
President and Chief Executive Officer, pursuant to an employment agreement, and Daniel
G. Holman, our former Chairman, for his service as a member of the Board, pursuant to an
employment and consulting agreement. The options for both executives are fully
vested and have a term of 10 years. In April 2003, we entered into a consulting
agreement with Executive Advisory Group (EAG) for general business advisory services
and assistance. Mr. Humphries is President of EAG. We granted EAG a five-year option
to purchase up to 50,000 shares of our Common Stock, exercisable at $2.80 per share. In
April 2003, we entered into a consulting agreement with C.C.R.I. Corporation for
investor relations services and issued five-year warrants to purchase 100,000 of our
shares. Half of these warrants are exercisable at $3.00 per share and the other half
are exercisable at $5.00 per share. In November 2005, we granted options to acquire
100,000 shares of our common stock at an exercise price of $3.00 per share to Mahedi A.
Jiwani, our Chief Financial Officer, pursuant to an employment agreement. These options
are fully vested and have a term of 10 years. In May 2006, we granted options to
acquire 300,000 shares of our common stock (of which 100,000 are vested as of May 31,
2006) at an exercise price of $2.50 per share to David B. Kaysen, our President and
Chief Executive Officer, pursuant to an employment agreement. These options have a term
of 10 years. In addition, we have outstanding an aggregate of 850,000 stock options (of
which 778,665 are vested as of May 31, 2006) to our directors and executive officers for
their services, generally exercisable for five years from the date of grant at exercise
prices ranging between $1.10 and $10.50. |
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(2) |
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All option plans previously approved by our shareholders were terminated, and no new
option grants may be awarded from those plans, upon adoption on May 3, 2006 of our 2006
Stock and Incentive Plan at a special meeting of our shareholders. As of May 31, 2006,
1,162,000 securities remain available for future issuance under our 2006 plan. |
28
ITEM 6. MANAGEMENTS DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
THIS DISCUSSION OF THE FINANCIAL CONDITION AND THE RESULTS OF OPERATIONS OF THE COMPANY SHOULD BE
READ IN CONJUNCTION WITH, AND IS QUALIFIED IN ITS ENTIRETY BY, THE CONSOLIDATED FINANCIAL
STATEMENTS AND NOTES THERETO INCLUDED ELSEWHERE WITHIN THIS ANNUAL REPORT, THE MATERIAL CONTAINED
IN THE RISK FACTORS AND DESCRIPTION OF BUSINESS SECTIONS OF THIS ANNUAL REPORT, AND THE
CAUTIONARY DISCLOSURE ABOUT FORWARD-LOOKING STATEMENTS AT THE FRONT OF PART I OF THIS ANNUAL
REPORT.
Overview
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. We have developed, and are developing,
minimally invasive products primarily for the treatment of urinary and fecal incontinence and
overactive bladder symptoms. All products we currently sell have received CE marking and are being
sold outside the United States in approximately 40 countries, including Europe, Canada, Australia
and Latin America. In the U.S. we have received 510(k) clearance for two of our products (I-Stop
and Urgent PC). Our Macroplastique and other implantable tissue bulking products have not been
cleared for marketing in the United States. We are pursuing FDA approval (PMA) for our
Macroplastique product.
Our goal is to develop and commercialize a portfolio of minimally invasive products for the
treatment of voiding dysfunctions. We believe that, with a suite of innovative products, we can
increasingly garner the attention of key physicians and distributors and enhance market acceptance
of our products. The key elements of our strategy are to:
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Pursue regulatory approval in the U.S. for our Macroplastique products. |
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Expand our U.S. marketing and sales organization, using a combination of direct and independent reps; |
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Conduct multi-center, prospective clinical trials for the Urgent PC; |
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Expand distribution of our products outside of the U.S.; and |
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Acquire or license complimentary products if appropriate opportunities arise. |
We concluded a multi-center human clinical trial using Macroplastique Implants in a minimally
invasive, office-based procedure for treating adult female stress urinary incontinence resulting
from intrinsic sphincter deficiency, a weakening of the muscles that control the flow of urine from
the bladder. In December 2004, the FDA accepted for filing our pre-market approval submission with
respect to Macroplastique for the treatment of female stress urinary incontinence. This submission
is under review by the FDA and we continue to expect, as we indicated in July 2005, the possible
approval by the FDA in late 2007. We will incur substantial expenses in connection with these
regulatory activities. Even if we obtain regulatory approval, it may be only for limited uses with
specific classes of patients, which may limit the market for our product.
In the United States, we recently staffed our sales organization, consisting of a direct field
sales management team and independent sales representatives, and a marketing organization to market
our products directly to our customers. We anticipate further increasing, as needed, our sales
and marketing organization in the United States to support our sales growth. Outside of the United
States, we sell our products primarily through a direct sales organization in the United Kingdom
and primarily through distributors in other markets.
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with U.S. generally accepted
accounting principles, which require us to make estimates and assumptions in certain circumstances
that affect amounts reported. In preparing these consolidated financial statements, we have made
our best estimates and judgments of certain amounts, giving due consideration to materiality. We
believe that of our significant accounting policies, the following are particularly important to
the portrayal of our results of operations and financial position. They may require the
application of a higher level of judgment by Uroplasty management, and as a result are subject to
an inherent degree of uncertainty.
Revenue Recognition. The Securities and Exchange Commissions Staff Accounting Bulletin (SAB) No.
104, Revenue Recognition in Financial Statements, provides guidance on the application of
generally accepted accounting principles to selected revenue recognition issues. We believe our
revenue recognition policies comply with SAB 104. We market and distribute our products through a
network of distributors and through direct sales to end-users in the United Kingdom and The
Netherlands. We recognize revenue upon shipment of product to our distributors and direct
customers. We have no customer acceptance provisions or installation obligations. Our sales terms
to our distributors and customers provide no right of return outside of our standard warranty, and
payment terms consistent with industry standards apply. Sales terms and pricing to our distributors
are governed by the respective distribution agreements. Our distribution partners purchase the
Uroplasty products to meet sales demand of their end-user customers as well as to fulfill their
internal requirements associated with the sales process and, if applicable, contractual purchase
requirements under the respective distribution agreements. Internal and other requirements include
purchases of products for training, demonstration and evaluation purposes, clinical evaluations,
product support, establishing inventories, and meeting minimum purchase commitments. As a result,
the level of our net sales during any period is not necessarily indicative of our distributors
sales to end-user customers during that period, which we estimate
29
are not substantially different
than our sales to those distributors in each of the last two years. Our distributors level of
inventories of our products, their sales to end-user customers and their internal product
requirements may impact our future revenue growth.
Accounts Receivable. We carry our accounts receivable at the original invoice amount less an
estimate made for doubtful receivables based on a periodic review of all outstanding amounts. We
determine the allowance for doubtful accounts based on customer health, and both historical and
expected credit loss experience. We write off our accounts receivable when we deem them
uncollectible. We record recoveries of accounts receivable previously written off when received.
Inventories. We state inventories at the lower of cost or market using the first-in, first-out
method. We provide lower of cost or market reserves for slow moving and obsolete inventories based
upon current and expected future product sales and the expected impact of product transitions or
modifications. While we expect our sales to grow, a reduction in sales could reduce the demand for
our products and may require additional inventory reserves.
Foreign Currency Translation/Transactions. The financial statements of our foreign
subsidiaries were translated in accordance with the provisions of SFAS No. 52 Foreign Currency
Translation. Under this Statement, we translate all assets and liabilities using period-end
exchange rates, and we translate statements of operations items using average exchange rates for
the period. We record the resulting translation adjustment within accumulated other comprehensive
loss, a separate component of shareholders equity. We recognize foreign currency transaction gains
and losses in the statement of operations, including unrealized gains and losses on short-term
intercompany obligations using period-end exchange rates, resulting in an increase in the
volatility of our consolidated statements of operations. We recognize unrealized gains and losses
on long-term intercompany obligations within accumulated other comprehensive loss, a separate
component of shareholders equity.
Impairment of Long-Lived Assets. Long-lived assets at March 31, 2006 consist of property, plant and
equipment and intangible assets. We review our long-lived assets for impairment whenever events or
business circumstances indicate that the carrying amount of an asset may not be recoverable. We
measure the recoverability of assets to be held and used by a comparison of the carrying amount of
an asset to future undiscounted net cash flows expected to be generated by the asset. If we
consider such assets impaired, we measure the impairment to be recognized by the amount by which
the carrying amount of the assets exceeds the fair value of the assets. We report assets to be
disposed of at the lower of the carrying amount or fair value less costs to sell.
Stock Based Compensation and Accelerated Vesting. We accounted for our stock option grants under
APB Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees, and related interpretations.
No stock-based compensation cost is reflected in net loss, as all options granted under these
plans had an exercise price equal to the market value of the
underlying common stock on the date of grant. We also grant options to non-employees for goods and
services and in conjunction with certain agreements. These grants are accounted for under
Financial Accounting Standards Board (FASB) Statement No. 123 based on the grant date fair
values.
In December 2004, FASB published Statement No. 123 (revised 2004), Share-Based Payment (FAS
123(R) or the Statement).
FAS 123(R) requires that the compensation cost relating to share-based
payment transactions, including grants of employee stock options, be recognized in financial
statements. That cost will be measured based on the fair value of the equity or liability
instruments issued. FAS 123(R) covers a wide range of share-based compensation arrangements
including stock options, restricted share plans, performance-based awards, share appreciation
rights, and employee share purchase plans. FAS 123(R) is a replacement of Statement No. 123,
Accounting for Stock-Based Compensation, and supersedes APB 25, and its related interpretive
guidance.
This Statement will require entities to measure the cost of employee services received in exchange
for stock options based on the grant-date fair value of the award, and to recognize the cost over
the period the employee is required to provide services for the award. FAS 123(R) permits entities
to use any option-pricing model that meets the fair value objective in the Statement. We will be
required to apply FAS 123(R) beginning in the first quarter of fiscal year 2007. FAS 123(R) allows
two methods for determining the effects of the transition: the modified prospective and the
modified retrospective. We have adopted the modified prospective transition method beginning April
1, 2006. The pro forma compensation costs presented previously and in our prior filings have been
calculated using a Black-Scholes option pricing model and may not be indicative of amounts which
should be expected in future years.
In February 2006, our Board of Directors approved a plan to accelerate, effective February 2, 2006,
the vesting of out-of-the-money, unvested stock options previously granted to our employees,
officers and directors. An option was considered out-of-
30
the-money if the stated exercise price
exceeded $2.85, the then closing price of our common stock. We accelerated the vesting of these
options to minimize the amount of compensation expense we must recognize upon adoption of SFAS No.
123(R). None of these options had intrinsic value at the acceleration date under APB 25. We
expect that the acceleration of the vesting of these options reduced our pre-tax stock option
expense by approximately $1.4 million, in the aggregate, calculated using the Black-Scholes option
valuation model, that we would otherwise have recognized over the next three fiscal years, upon
adoption of SFAS No. 123(R). We do not expect the remaining options, to result in a significant
charge to compensation expense upon adoption of SFAS 123(R) under the modified prospective
application method. However, certain outstanding options that permit cashless exercise and certain
options classified as liabilities could result in a significant charge to compensation expense, as
we will mark those options to fair value at each reporting period until settlement. Also,
additional options as granted to attract or retain new employees could result in a significant
charge to compensation expense.
Income Taxes. Deferred tax assets and liabilities are recognized for future tax consequences
attributable to differences between the financial carrying amounts of existing assets and
liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using
enacted tax rates expected to be applied to taxable income in the years in which those temporary
differences are expected to be recovered or settled. We have generated approximately $15,423,000
in U.S. net operating loss carryforwards that cannot be used to offset taxable income in foreign
jurisdictions. We recognize a valuation allowance when it is more likely than not a portion of the
deferred tax asset will not be realized. We have established a valuation allowance for U.S. and
certain foreign deferred tax assets due to the uncertainty that enough income will be generated in
those taxing jurisdictions to utilize the assets.
In addition, U..S. tax rules impose limitations on the use of net operating loss following certain
changes in ownership change. Such a change in ownership may limit the amount of these benefits
that would be available to offset future taxable income each year, starting with the year of
ownership change.
Set forth below is managements discussion and analysis of the financial condition and results of
operations for the fiscal years ended March 31, 2006 and 2005. See Note 7 to our Consolidated
Financial Statements for business segment information.
Results of Operations
Net Sales. In fiscal 2006, net sales of all products were $6.1 million, representing an 8%
decrease when compared to net sales of $6.7 million for fiscal 2005. Excluding fluctuations in
foreign currency exchange rates, we had a sales decrease of approximately 5% primarily due to a
$0.8 million decline in sales of our Macroplastique products offset by a $0.5 million net increase
in all of our other products. We attribute this decline primarily to adverse changes in
reimbursement policies of the insurers and the increase in pricing competition. We expect these
reimbursement changes and the increase in price competition to adversely impact our future sales in
those markets. In these markets we have launched a strategy to increase sales of our existing
products, and to expand our platform of products for the treatment of voiding dysfunctions. We are
conducting training workshops targeted to our sales personnel, distributors and key incontinence
surgeons, and we are sponsoring scientific podium presentations and seminars at key international
incontinence
congresses. We are also seeking to broaden our patient base to include Urgent PC treatment for
symptoms of overactive bladder (OAB), the I-Stop sling procedure for treatment of female stress
urinary incontinence (SUI) and hypermobility and PTQ Implants and Urgent PC treatments for fecal
incontinence. We cannot assure that these initiatives will increase sales.
Gross Profit. Gross profit was $4.3 million and $4.9 million for the fiscal years ended March 31,
2006 and 2005, respectively, or 70% and 74% of net sales. The decline in gross profit percent is
attributed primarily to the decline in sales of the above-average gross margin Macroplastique
product, and certain one-time costs related to updating our manufacturing quality systems. Gross
profit as a percentage of net sales between periods fluctuates based on the following factors: our
unit sales, our utilization of manufacturing capacity, the mix of products sold with different
gross margins, the mix of customers (and different discounts to them), the mix of direct sales
versus sales through distributors (with higher margins on direct sales), and currency fluctuations.
Historically, our gross margin has ranged from approximately 70-80% of net sales.
General and Administrative Expenses. General and administrative (G&A) expenses increased from
$2.3 million during fiscal 2005 to $3.0 million during fiscal 2006. The increase in expense is
attributed to: $590,000 increase in salary costs, including $150,000 for severance pay and $100,000
option expense for former executives, $170,000 increase in information (IT) expense, $100,000
increase in legal and accounting fees, $80,000 increase in recruiting costs, $50,000 of expenses
related to listing the company on the American Stock exchange, $110,000 increase in depreciation
and amortization expense, general price increases and fluctuations in foreign currency exchange
rates, offset by a decrease in bad debt expense of $330,000. The IT consulting expense relates to
the implementation of a new computer software system, including training and post-implementation
support.
31
Research and Development Expenses. Research and development expenses increased 47% from $2.3
million during fiscal 2005 to $3.3 million during fiscal 2006. The increase in expense is
attributed to a $350,000 increase in salary costs, including $170,000 for severance pay to a former
executive, and $770,000 for consulting expense for product development and regulatory approvals,
offset by a $130,000 reduction in costs for clinical trials and testing.
Selling and Marketing Expenses. Selling and marketing expenses increased 69% from $2.0 million
during fiscal 2005 to $3.4 million during fiscal 2006. The increase in expenses is attributed to
$940,000 for expansion of our direct sales force and marketing organizations in the U.S., $190,000
for increase in costs for travel, trade-shows and conventions, $90,000 for increase in consulting
expense, and general price increases and fluctuations in foreign currency exchange rates.
Other Income (Expense). Other income (expense) includes interest income, interest expense, warrant
expense or benefit, foreign currency exchange gains and losses and other non-operating costs when
incurred. Our financial results are subject to material fluctuations based on changes in currency
exchange rates. Other income (expense) was $788,597 and $(11,510) for fiscal 2006 and fiscal 2005,
respectively.
In July 2002, we conducted a rights offering pursuant to which our stockholders purchased certain
units consisting of shares of our common stock and common stock purchase warrants exercisable for
two years at $2.00 per share. However, we suspended the exercise of the warrants when we delayed
the filing of our annual report on Form 10-KSB for the fiscal year ended March 31, 2004. As a
result, 706,218 of the warrants lapsed unexercised at July 31, 2004. In April 2005, we granted a
like number of new common stock purchase warrants to the holders of the expired warrants. The new
warrants will be exercisable at $2.00 per share for 90 days after the effective date of a new
registration statement covering the resale of the shares underlying these warrants. We have filed
a registration statement covering such warrants on Form SB-2 with the Securities and Exchange
Commission (SEC). In April 2005, we recognized a liability and equity charge of $1.4 million
associated with the grant of these warrants. A net warrant benefit of $707,320 for fiscal 2006 is
included in the statement or operations which represents the change in the fair value of the
warrants since their issuance due to the change in value of the common stock which may be acquired
by the exercise of these warrants.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated short-term
intercompany obligations between us and our foreign subsidiaries. We recognized foreign currency
losses of $31,195 and $15,744 for fiscal 2006 and fiscal 2005, respectively.
Income Tax Expense. Our Dutch subsidiaries recorded income tax expense (benefit) of $(46,873) and
$91,503 for fiscal 2006 and fiscal 2005, respectively. We cannot use the U.S. net operating loss
carry forwards to offset taxable income in foreign jurisdictions. For fiscal 2006, the Dutch income
tax rate was 25.5% for 22,689 (approximately $27,500) of profit and 29.6% for amounts above
22,689 compared to 27% and 31.5% in fiscal 2005, respectively.
Liquidity and Capital Resources
Cash Flows. As of March 31, 2006, our cash and cash equivalent and short-term investments balances
totaled $2.7 million.
At March 31, 2006, we had working capital of approximately $2.7 million. In fiscal 2006, we used
$4.6 million of cash in operating activities, compared to $1.3 million of cash used in the same
period of fiscal 2005. The usage of cash was primarily attributable to the net loss incurred of
$4.5 million. Inventory increased by $280,000, due to production planning requirements,
manufacturing lead times and the introduction of additional products. Accounts receivable, other
current assets, accounts payable and accrued expenses fluctuated due to the timing of payments and
fluctuations in foreign currency exchange rates.
Fluctuations in foreign currency exchange rates, weak economic conditions in foreign markets where
we sell and distribute our products, changes in regulatory environment and changes in third-party
reimbursement polices could materially affect our financial condition and results of operations.
The effects of these conditions could include reduced unit sales and reduced sales in dollars when
converted from foreign currency amounts and material gains and losses on transactions denominated
in foreign currencies. Furthermore, because our U.S. operations are funded by sales denominated in
foreign currency, strengthening of the U.S. dollar against the euro and/or the British pound could
have an adverse effect on our cash flow and results of operations.
32
Sources of Liquidity. In April 2005, we conducted a private placement of common stock in which we
sold 2,147,142 shares of our common stock at a price per share of $3.50, together with warrants to
purchase 1,180,928 shares of common stock, for an aggregate purchase price of approximately $7.5
million. The stock sale proceeds are offset by costs of approximately $935,000, resulting in net
proceeds of approximately $6.6 million. The warrants are exercisable for five years at an exercise
price of $4.75 per share.
In connection with our April 2005 private placement, we agreed to file a registration statement
with the SEC covering the resale of the shares (including those underlying the warrants) that we
sold. We also agreed that, for each month after May 21, 2005, that we failed to file this
registration statement, and for each month after July 20, 2005 that the SEC did not declare it
effective, we would pay liquidated damages at a rate of 1% of the aggregate investment. We filed
the registration statement on July 20, 2005 and the SEC declared it effective on July 29, 2005.
Accordingly, in January 2006, as settlement of liquidated damages and interest in the amount of
$174,054, we issued 57,381 shares of our common stock and paid cash in the amount of $23,077.
Commitments and Contingencies. We believe that our current resources, funds generated from sale of
our products and remaining proceeds from the private placement completed earlier this year together
with the recent credit facilities (see Note 9, Subsequent Events, to the financial statements) will
be adequate to meet our cash flow needs, including regulatory activities associated with existing
products, through the end of the next fiscal year. We will need to raise additional debt or equity
financing to continue funding for product development and continued expansion of our sales and
marketing activities, and ultimately, we will need to achieve profitability and generate positive
cash flows from operations to fund our operations and grow our business. As such we plan to raise
additional equity capital in fiscal 2007, but there can be no
guarantee that we will be successful. In the event that such required financing is not immediately available, management is prepared
to curtail planned product development activities and other expenditures to ensure adequate working
capital is available through fiscal 2007.
We expect to continue to incur significant costs for regulatory activities associated with
obtaining regulatory approval in the United States for Macroplastique. For fiscal 2007, we expect
to incur significant research and development expenses, including those in connection with the
regulatory approval activities for Macroplastique. We also expect that during fiscal 2007, we will
continue to incur significant expenses as we expand our selling and marketing organization in the
U.S. to market our products. In addition, we expect general and administrative expenses in fiscal
2007 to increase as we increasingly prepare to implement the provisions of Section 404 of the
Sarbanes-Oxley Act of 2002.
In April 2005, we entered into an exclusive manufacturing and distribution agreement with
CystoMedix for the Urgent PC product. The agreement required us to pay CystoMedix an initial
payment of $225,000 and an additional payment of $250,000 in 12 monthly installments of $20,833.
We capitalized the aggregate amount as licensed technology and are amortizing it over the term of
the agreement. We will also pay CystoMedix a 7% royalty on product sales. However, the 7% royalty
is first offset against the monthly royalty installments.
CystoMedix has also granted us an exclusive option to acquire its assets. The purchase price is
$3,485,000, reduced by up to $50,000 of liabilities assumed by us. However, the $3,485,000 amount
used to compute the purchase price will increase at a rate of 10% per year after April 2007. The
purchase price is payable in shares of our common stock valued at the average of the closing bid
price of our shares for the 20 trading days prior to our exercise of the option. We may exercise
the option between January 2006 and June 2008. If we exercise the option, we will also assume up
to $1.4 million of bridge loan advances made to CystoMedix by its Chairman. We would repay up to
$1.1 million of the bridge loan advances at closing and would issue our common stock for the
balance of the bridge loan based on the above option
price. We also have certain rights of first refusal to acquire CystoMedixs assets in the event
CystoMedix receives a third party offer in advance of any exercise of our option. We will need to
raise additional equity or debt funds in order to consummate the CystoMedix acquisition, should we
elect to do so.
We have two exclusive distribution agreements with CL Medical allowing us to market and sell the
I-Stop urethral sling: effective February 2006, a six-year agreement, with a right to renew it for
successive five-year terms, for distribution in the United States and, effective May 2005, a
one-year agreement with automatic renewal for up to two years, for distribution the in United
Kingdom. Under the agreements, we are required to purchase a minimum of $630,000 of units in the
first 12-month period following January 1, 2006, increasing to $2.6 million of units in the fifth
year of the agreement, for an aggregate commitment of approximately $6.7 million of units over the
five-year period, subject to periodic adjustment based on the value of the euro.
We are obligated to pay royalties of 5% of net sales of Macroplastique products in the U.S. with a
minimum of $50,000 per year. The duration of this royalty agreement is through May 1, 2006. Under
another royalty agreement we pay royalties, in the aggregate, of three to five percent of net sales
of Macroplastique, Bioplastique, and PTQ Implants subject to a monthly minimum of $4,500. The
royalties payable under this agreement will continue until the patent referenced in the agreement
33
expires in 2010. Under a license agreement for the Macroplastique Implantation System, we pay a
royalty of 10 British pounds for each unit sold during the life of the patent.
We have a pension plan covering 16 employees in The Netherlands, reported as a defined benefit
plan. We pay premiums to an insurance company to fund annuities for these employees. However, we
are responsible for funding additional annuities based on continued service and future salary
increases. We closed this defined benefit plan for new employees in April 2005. As of that date,
the Dutch subsidiary established a defined contribution plan that now covers new employees. We also
closed our UK subsidiarys defined benefit plan to further accrual for all employees effective
December 31, 2004. In March 2005, the UK subsidiary established a defined contribution plan that
now covers new employees.
In January 2006, we entered into a long-term lease with Liberty Property Limited Partnership for an
18,258 square foot facility for our U.S. headquarters located at 5420 Feltl Road, Minnetonka,
Minnesota. The lease effective date was May 1, 2006, has a term of 96 months, requires average
annual minimum rent payments of approximately $140,000 and requires payments for operating expenses
estimated to be approximately $82,000 in the first 12 months.
On May 31, 2006, we entered into a promissory note with Venture Bank with a principal amount of
$100,000, interest rate of 8.25% per annum, and a maturity date of May 31, 2009. The amount is
used for certain capital expenditures relating to the relocation of our facility to our Minnetonka,
Minnesota location.
Repayments of our contractual obligations as of March 31, 2006, consisting of royalties, notes
payable (inclusive of interest), and operating leases, including the January 20, 2006 lease noted
above, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
|
|
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
|
|
|
|
2008 and |
|
|
2010 and |
|
|
2012 and |
|
|
|
Total |
|
|
Fiscal 2007 |
|
|
2009 |
|
|
2011 |
|
|
thereafter |
|
Minimum royalty payments |
|
$ |
318,333 |
|
|
$ |
124,833 |
|
|
$ |
108,000 |
|
|
$ |
85,500 |
|
|
$ |
|
|
Minimum purchase agreement |
|
|
6,676,416 |
|
|
|
735,283 |
|
|
|
2,016,715 |
|
|
|
3,924,418 |
|
|
|
|
|
Notes payable |
|
|
655,665 |
|
|
|
92,087 |
|
|
|
187,212 |
|
|
|
102,468 |
|
|
|
273,898 |
|
Operating lease commitments |
|
|
1,445,492 |
|
|
|
327,768 |
|
|
|
394,824 |
|
|
|
285,773 |
|
|
|
437,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
9,095,906 |
|
|
$ |
1,279,971 |
|
|
$ |
2,706,751 |
|
|
$ |
4,398,159 |
|
|
$ |
711,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recent Accounting Pronouncements
Statement of Financial Accounting Standards 154, Accounting Changes and Error Corrections
In May 2005, the Financial Accounting Standards Board, or FASB, issued Statement of Financial
Accounting Standards, or SFAS, 154, Accounting Changes and Error Corrections. This new standard
replaces APB Opinion No. 20, Accounting Changes, and FASB Statement No. 3, Reporting Accounting
Changes in Interim Financial Statements. Among other changes, Statement 154 requires retrospective
application of a voluntary change in accounting principle with all prior period financial
statements presented on the new accounting principle, unless it is
impracticable to do so. Statement 154 also requires accounting for a change in method of depreciating or amortizing a
long-lived nonfinancial asset as a change in estimate (prospectively) affected by a change in
accounting principle. Further, the Statement requires that correction of errors in previously
issued financial statements be termed a restatement. The new standard is effective for
accounting changes and correction of errors made in fiscal years beginning after December 15, 2005.
Early adoption of this standard is permitted for accounting changes and correction of errors made
in fiscal years beginning after June 1, 2005. We do not believe the adoption of FASB Statement 154
will have a material effect on our financial position or results of operations.
Statement of Financial Accounting Standards 151, Inventory Costs
In November 2004, the FASB, issued SFAS 151, Inventory Costs, An Amendment of Accounting Research
Bulletin No. 43, Chapter 4, which adopts wording from the International Accounting Standards
Boards, or IASB, IAS 2 Inventories in an effort to improve the comparability of cross-border
financial reporting. The new standard requires us to treat abnormal freight, handling costs and
wasted materials (spoilage) as current period charges rather than as a portion of inventory cost.
Additionally, the standard clarifies that we should allocate fixed production overhead based on the
normal capacity of a
34
production facility. The statement is effective for us beginning in fiscal
2007. We do not expect adoption to have a material impact on our consolidated financial
statements.
Statement of Financial Accounting Standards 123(R), Share-Based Payment
In December 2004, the FASB issued SFAS 123(R), Share-Based Payment, which is a revision of SFAS
123, Accounting for Stock-Based Compensation, and supersedes APB Opinion 25, Accounting for Stock
Issued to Employees. SFAS 123(R) requires all share-based payments to employees, including grants
of employee stock options, to be valued at fair value on the date of grant, and to be expensed over
the applicable vesting period. SFAS 123(R) is effective for us beginning on April 1, 2006. Please
refer to discussion in Stock Based Compensation and Accelerated Vesting under critical account
policies.
Financial Accounting Standards Board Interpretation No. 47
In March 2005, the FASB issued FASB Interpretation No.47, or FIN 47, which clarifies terminology
in FASB Statement No. 143, Accounting for Asset Retirement Obligations. FIN 47 clarifies when an
entity has sufficient information to reasonably estimate the fair value of an asset retirement
obligation. FIN 47 was effective for us in fiscal 2006. Adoption of FIN 47 did not have a
material impact on our consolidated financial statements.
ITEM 7. FINANCIAL STATEMENTS
The information contained under the headings Consolidated Statements of Operations, Consolidated
Balance Sheets, Consolidated Statements of Shareholders Equity and Comprehensive Income (Loss),
Consolidated Statements of Cash Flows, Notes to Consolidated Financial Statements and Reports
of Independent Registered Public Accounting Firms is incorporated herein by reference.
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 8A. CONTROLS & PROCEDURES
Disclosure Controls and Procedures. As of the end of the period covered by this report, we
conducted an evaluation, under the supervision and with the participation of our principal
executive officer and principal financial officer, of our disclosure controls and procedures as
defined in Rules 13(a)-15(e) under the Securities Exchange Act of 1934 (the Exchange Act). Based
on this evaluation, the principal executive officer and principal financial officer concluded that
our disclosure controls and procedures are effective to ensure that information required to be
disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in Securities and Exchange Commission
rules and forms.
Internal Control Matters. We also maintain a system of internal accounting controls designed to
provide reasonable assurance that our books and records accurately reflect our transactions and
that our policies and procedures are followed. There have been no changes in our internal control
over financial reporting during the fiscal quarter ended March 31, 2006, or thereafter, that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
In connection with our review of our consolidated financial statements for the year ended March 31,
2005 and the audit of those statements by our independent registered public accounting firm, we
determined that our year-end financial
statement closing process did not ensure our adequate review of all significant elements of our
consolidated financial statements. In our post-closing and audit processes, we and our independent
registered public accounting firm discovered certain issues that resulted in adjustments to our
consolidated financial statements, specifically with respect to our inventory valuation and income
tax provision. We discovered these matters before our consolidated financial statements were
completed, and they are properly accounted for in our financial statements. However, we have
concluded that the failure to discover these items in our regular closing process is a result of a
significant deficiency, resulting primarily from a lack of segregation of duties due to the size of
our company and the geographic distance between our key financial personnel, that constitutes a
material weakness in the design or operation of our internal controls over financial reporting.
|
|
|
A significant deficiency is defined as a control deficiency, or combination of
deficiencies, that adversely affects a companys ability to initiate, authorize, record,
process or report external financial data reliably in accordance with |
35
|
|
|
generally accepted
accounting principles such that there is more than a remote likelihood that a misstatement
of the companys financial statements that is more than inconsequential will not be
prevented or detected. |
|
|
|
|
A material weakness is a significant deficiency, or combination of significant
deficiencies, that result in more than a remote likelihood that a material misstatement of
the financial statements will not be prevented or detected. |
Although the items described above were properly accounted for before completing our consolidated
financial statements for fiscal year 2005, we have concluded that the failure to discover these
items in our regular closing process was a material weakness because the elements of our
consolidated financial statements that were not adequately reviewed are material to our
consolidated financial statements and there is more than a remote likelihood that a material
misstatement of our consolidated financial statements would not be prevented or detected.
We discussed the material weakness described above with our Audit Committee. We have implemented
corrective actions where required to improve the effectiveness of our internal controls, including
the enhancement of our systems and procedures. Specifically, we have enhanced and formalized our
period-end closing processes to ensure we adequately review all significant elements of our
consolidated financial statements.
Any control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. The design of a control
system inherently has limitations, and the benefits of controls must be weighed against their
costs. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Therefore, no
evaluation of a cost-effective system of controls can provide absolute assurance that all control
issues and instances of fraud, if any, will be detected.
ITEM 8B. OTHER INFORMATION
None.
36
PART III
ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION
16(a) OF THE EXCHANGE ACT
The information contained under the heading Management in the Proxy Statement is incorporated
herein by reference.
ITEM 10. EXECUTIVE COMPENSATION
The information contained under the heading Executive Compensation in the Proxy Statement is
incorporated herein by reference.
ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
The information contained under the heading Principal Shareholders in the Proxy Statement is
incorporated herein by reference.
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information contained under the heading Certain Transactions in the Proxy Statement is
incorporated herein by reference.
ITEM 13. EXHIBITS AND REPORTS
(a) Exhibits incorporated by reference.
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|
Number |
|
Description |
|
2.1
|
|
First Amended Joint Plan of Reorganization (Modified) dated
January 31, 1994 (Incorporated by reference to Exhibit 8.1 to
Registrants Registration Statement on Form 10SB) |
|
|
|
|
|
3.1
|
|
Articles of Incorporation of Uroplasty, Inc. (Incorporated by
reference to Exhibit 2.1 to Registrants Registration
Statement on Form 10SB) |
|
|
|
|
|
3.2
|
|
Bylaws of Uroplasty, Inc. (Incorporated by reference to
Exhibit 2.2 to Registrants Registration Statement on Form
10SB) |
|
|
|
|
|
4.1
|
|
Form of Stock Certificate representing shares of our Common
Stock (Incorporated by reference to Exhibit 3.1 to
Registrants Registration Statement on Form 10SB) |
|
|
|
|
|
4.2
|
|
Form of Warrant (Incorporated by reference to Exhibit 4.2 to
Registrants Registration Statement on Form SB-2, Registration
No. 333-128313) |
|
|
|
|
|
10.1
|
|
Settlement Agreement and Release dated November 30, 1993 by
and between Bioplasty, Inc., Bio-Manufacturing, Inc.,
Uroplasty, Inc., Arthur A. Beisang, Arthur A. Beisang III, MD
and Robert A. Ersek, MD (Incorporated by reference to Exhibit
6.1 to Registrants Registration Statement on Form 10SB) |
|
|
|
|
|
10.2
|
|
Purchase and Sale Agreement dated December 1, 1995 by and
among Bio-Vascular, Inc., Bioplasty, Inc., and Uroplasty, Inc.
(Incorporated by reference to Exhibit 6.2 to Registrants
Registration Statement on Form 10SB) |
|
|
|
|
|
10.3
|
|
License Agreement dated December 1, 1995 by and between
Bio-Vascular, Inc. and Uroplasty, Inc. (Incorporated by
reference to Exhibit 6.3 to Registrants Registration
Statement on Form 10SB) |
|
|
|
|
|
10.4
|
|
Lease Agreement dated January 10, 1995 between Summer Business
Center Partnership and Uroplasty, Inc. (Incorporated by
reference to Exhibit 6.4 to Registrants Registration
Statement on Form 10SB) |
|
|
|
|
|
10.5
|
|
Unsecured $640,000 Promissory Note dated March 30, 1994 by and
between Bioplasty, Inc., Uroplasty, Inc. and Bioplasty Product
Claimants Trust (Incorporated by reference to Exhibit 6.5 to
Registrants Registration |
37
|
|
|
|
|
Number |
|
Description |
|
|
|
Statement on Form 10SB) |
|
|
|
|
|
10.6
|
|
Agreement and Satisfaction dated January 30, 1995 by and
between Bioplasty Product Claimants Trust and Bioplasty, Inc.
(Incorporated by reference to Exhibit 6.6 to Registrants
Registration Statement on Form 10SB) |
|
|
|
|
|
10.7
|
|
Asset Sale and Satisfaction of Debt Agreement dated June 23,
1995 by and between Bioplasty, Inc. and Uroplasty, Inc.
(Incorporated by reference to Exhibit 6.7 to Registrants
Registration Statement on Form 10SB) |
|
|
|
|
|
10.8
|
|
Executory Contract Assumption Stipulation dated December 28,
1993 by and between Bioplasty, Inc., Uroplasty, Inc., and
Collagen Corporation (Incorporated by reference to Exhibit 6.8
to Registrants Registration Statement on Form 10SB) |
|
|
|
|
|
10.9
|
|
Settlement and License Agreement dated July 23, 1992 by and
between Collagen Corporation, Bioplasty, Inc., and Uroplasty,
Inc. (Incorporated by reference to Exhibit 6.9 to Registrants
Registration Statement on Form 10SB) |
|
|
|
|
|
10.10
|
|
Employment Agreement between Uroplasty, Inc. and Christopher
Harris dated December 7, 1999. (Incorporated by reference to
Exhibit 10.11 to Registrants Form 10-KSB for the year ended
03-31-2000.) |
|
|
|
|
|
10.11
|
|
Employment Agreement between Uroplasty, Inc. and Susan Holman
dated December 7, 1999. (Incorporated by reference to Exhibit
10.13 to Registrants Form 10-KSB for the year ended
03-31-2000.) |
|
|
|
|
|
10.12
|
|
Employment Agreement between Uroplasty, Inc. and Larry
Heinemann dated December 7, 1999. (Incorporated by reference
to Exhibit 10.14 to Registrants Form 10-KSB for the year
ended 03-31-2000.) |
|
|
|
|
|
10.13
|
|
Agreement, dated October 14, 1998, by and between Uroplasty,
Inc. and Samir M. Henalla (pertaining to Macroplastique
Implantation System). (Incorporated by reference to Exhibit
10.15 to Registrants Form 10-KSB/A for the year ended
03-31-2001) |
|
|
|
|
|
10.14
|
|
Employment Agreement between Uroplasty, Inc. and Mr. Marc
Herregraven dated November 15, 2002. (Incorporated by
reference to Exhibit 10.15 to Registrants Form 10-KSB for the
year ended 03-31-2003) |
|
|
|
|
|
10.15
|
|
Consulting Agreement between Uroplasty, Inc. and CCRI
Corporation dated April 1, 2003. (Incorporated by reference to
Exhibit 10.18 to Registrants Form 10-KSB for the year ended
03-31-2003) |
|
|
|
|
|
10.16
|
|
Form of Manufacturing and Distribution Agreement with CL
Medical SAS (Incorporated by reference to Exhibit 10.19 to
Registrants Form 10-QSB for the period ended September 30,
2004) |
|
|
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10.17
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Employment Agreement between Uroplasty, Inc. and Sam B.
Humphries dated January 1, 2005 (Incorporated by reference to
Exhibit 10.1 to Registrants Form 10-QSB for the period ended
December 31, 2004) |
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10.18
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Employment and Consulting Agreement between Uroplasty, Inc.
and Daniel G. Holman dated January 1, 2005 (Incorporated by
reference to Exhibit 10.2 to Registrants Form 10-QSB for the
period ended December 31, 2004) |
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10.19
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Exclusive Manufacturing and Distribution Agreement, dated as
of April 18, 2005, by and between Uroplasty, Inc. and
CystoMedix, Inc. (Incorporated by reference to Exhibit 10.19
to Registrants Form 8-K dated April 18, 2005) |
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10.20
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Form of Securities Purchase Agreement, dated as of April 21,
2005, by and among Uroplasty, Inc., and the investors
identified on the signature pages thereto (Incorporated by
reference to Exhibit 10.20 to Registrants Form 8-K dated
April 21, 2005) |
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10.21
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Form of Warrant (Incorporated by reference to Exhibit 10.21 to
Registrants Form 8-K dated April 21, 2005) |
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10.22
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Form of Registration Rights Agreement dated as of April 21,
2005, by and among Uroplasty, Inc., and the investors named
therein (Incorporated by reference to Exhibit 10.22 to
Registrants Form 8-K dated April 21, 2005) |
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10.23
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Business Loan Agreement and related Promissory Note dated
March 24, 2005 with Venture Bank (Incorporated by reference to
Exhibit 10.26 to Registrants Form 10-KSB for the year ended
March 31, 2005) |
38
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Number |
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Description |
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10.24
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Employment Agreement between Uroplasty, Inc. and Mahedi A.
Jiwani dated November 14, 2005 (Incorporated by reference to
Exhibit 10.24 to Registrants Form 10-QSB for the period ended
September 30, 2005) |
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10.25
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Lease Agreement between Uroplasty, Inc. and Liberty Property
Limited Partnership dated January 20, 2006 (Incorporated by
reference to Exhibit 10.25 to Registrants Form 8-K dated
January 24, 2006) |
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10.26
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Form of Distribution Agreement between Uroplasty, Inc. and CL
Medical SARL, dated February 15, 2006 (Incorporated by
reference to Exhibit 10.26 to Registrants Form SB-2/A dated
February 21, 2006 |
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10.27
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Letter Agreement between Daniel G. Holman and Uroplasty, Inc.,
amending terms of Employment Agreement dated January 1, 2005
(Incorporated by reference to Exhibit 10.26 to Registrants
Form 8-K dated March 27, 2006) |
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10.28
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Letter Agreement pursuant to separation arrangements between
Sam B. Humphries and Uroplasty, Inc., dated April 26, 2006
(Incorporated by reference to Exhibit 10.28 to Registrants
Amendment No. 1 to Form SB-2 dated April 27, 2006). |
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10.29
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Letter Agreement between Uroplasty, Inc. and Daniel G. Holman
dated April 26, 2006 (Incorporated by reference to Exhibit
10.29 to Registrants Amendment No. 1 to Form SB-2 dated April
27, 2006). |
(b) The following exhibits are filed as part of this report:
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Number |
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Description |
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10.30
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Employment Agreement between Uroplasty, Inc. and David B.
Kaysen dated May 17, 2006. |
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10.31
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Business Loan Agreement and related Promissory Note dated May
31, 2006 with Venture Bank |
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13
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Financial Statements |
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21.0
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List of Subsidiaries |
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23.1
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Consent of Independent Registered Public Accounting Firm
McGladrey & Pullen, LLP |
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31
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Certifications by the CEO and CFO pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002 |
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32
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Certifications by the CEO and CFO pursuant to 18 USC Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 |
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information contained under the heading Independent Registered Public Accounting Firm in the
Proxy Statement is incorporated herein by reference.
39
SIGNATURES
In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant
caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Dated: June 29, 2006 |
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UROPLASTY, INC. |
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By
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/s/ David B. Kaysen |
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David B. Kaysen |
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President and Chief Executive Officer |
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In accordance with 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.
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Name |
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Title / Capacity |
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Date |
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/s/ David B. Kaysen
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President, Chief Executive
Officer and Director |
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David B. Kaysen
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(Principal Executive Officer)
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June 29, 2006 |
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/s/ Mahedi A. Jiwani
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Vice President, Chief Financial Officer |
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Mahedi A. Jiwani
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and Treasurer
(Principal Financial and
Accounting Officer)
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June 29, 2006 |
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/s/ Arie J. Koole |
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Arie J. Koole
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Controller
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June 29, 2006 |
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/s/ Sam B. Humphries |
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Sam B. Humphries
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Director
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June 29, 2006 |
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/s/ Joel R. Pitlor |
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Joel R. Pitlor
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Director
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June 29, 2006 |
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/s/ R. Patrick Maxwell |
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R. Patrick Maxwell
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Director
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June 29, 2006 |
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/s/ Thomas E. Jamison |
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Thomas E. Jamison
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Director
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June 29, 2006 |
40
Exhibit 10.30
EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT (the Agreement) is made and entered into by and between Uroplasty,
Inc., a Minnesota corporation (the Company), and David B. Kaysen (the Executive) effective as
of the 17th day of May, 2006.
R E C I T A L S:
WHEREAS, Uroplasty is a medical device company that develops, manufactures and markets
innovative, proprietary products for the treatment of voiding dysfunctions; and
WHEREAS, the Company and the Executive desire to set forth in this Agreement the terms under
which Executive will serve as President and Chief Executive Officer of the Company;
NOW, THEREFORE, the parties hereto agree as follows:
1. Employment and Duties. The Company hereby agrees to employ the Executive, and the
Executive hereby accepts the Companys offer to serve, as President and Chief Executive Officer of
the Company beginning on May 21, 2006 (the Start Date). As such, the Executive shall have
responsibilities, duties and authority reasonably accorded to and expected of such an officer of
the Company and will report directly to the Companys Board of Directors. The Executive agrees to
devote the Executives full business time, attention and efforts to promote and further the
business of the Company. The Executive will faithfully adhere to, execute and fulfill all policies
established by the Companys Board of Directors. The Executive also agrees to serve as a director
of the Company (without additional consideration other than provided by this Agreement) until the
Executives successor is duly elected and qualified or until the Executives earlier resignation,
removal or death.
The Executive will not, during the Term of Executives employment hereunder, be engaged in any
other business activity pursued for gain, profit or other pecuniary advantage if such activity
interferes with the Executives duties and responsibilities hereunder. The foregoing limitations
will not be construed to prohibit the Executive from making personal investments in such form or
manner as will neither require the Executives services in the operation or affairs of the
companies or enterprises in which such investments are made nor violate the terms of Section 4
hereof. The Executive may also continue to serve as a board member for the three other public
companies on whose boards he currently serves.
2. Compensation. For all services rendered by the Executive on and after the Start Date
hereof, the Company will compensate the Executive as follows:
(a) Base Salary. Commencing on the Start Date hereof, the base salary payable to the
Executive shall be $255,000 per year, payable on a regular basis in accordance with the
Companys standard payroll procedures but not less than semi-monthly. Such base salary will
be subject to annual review and adjustment by the Companys Compensation Committee.
(b) Incentive Bonus Plan. During the Term, the Executive is entitled to an annual
cash bonus (the Annual Bonus), a part of which will be based on attainment of particular
financial milestones (the Financial Milestones) and the other part of which will be based on
attainment of particular business milestones (the Business Milestones). The Annual Bonus is
computed as a percentage (not exceeding 50%) of the Executives base salary for the fiscal year for
which achievement of the Financial and Business Milestones relate.
(i) Financial and Business Milestones. The Executive and the Companys Compensation
Committee shall mutually agree upon the Financial and Business Milestones (and the percentages of
the Executives base salary payable upon various levels of achievement) for each fiscal year by May
1 of each year (except as to the balance of fiscal 2007, by July 31, 2006). The Financial
Milestones shall be based on line items regularly appearing on the Companys audited financial
statements.
(ii) Special Fiscal 2007 Annual Bonus. On a one-time basis, and conditioned on the
Executives continuous full-time employment through the balance of the Companys fiscal year ending
on March 31, 2007, the Company will pay the Executive a minimum Annual Bonus for such fiscal year
equal to 25% of the Executives base salary paid during such fiscal year (the Special Fiscal 2007
Annual Bonus). The Special Fiscal 2007 Annual Bonus will be deducted from any Annual Bonus
otherwise earned by the Executive for fiscal 2007.
(iii) Payment. Each Annual Bonus amount is payable within 15 days of the completion
of the audit of the financial statements for the related fiscal year.
(c) Executive Perquisites, Benefits and Other Compensation. Commencing on the Start
Date hereof, the Executive shall be entitled to receive additional benefits and compensation from
the Company in such form and to such extent as specified below:
(i) Payment of premiums for coverage for the Executive and the Executives dependent family
members under health, hospitalization and dental insurance plans that the Company may have in
effect from time to time, at the levels, and with the co-payments, as established by the Company
under such plans.
(ii) Reimbursement of up to $11,500 on an annual basis for the premiums for Executives
personal life and disability insurance policies.
(iii) Reimbursement for all business travel and other out-of-pocket expenses reasonably
incurred by the Executive in the performance of the Executives services pursuant to this
Agreement. All reimbursable expenses shall be appropriately documented in reasonable
-2-
detail by the Executive upon submission of any request for reimbursement, and in a format and
manner consistent with the Companys expense reporting policy.
(iv) Four weeks of paid vacation during each calendar year. If the Executive does not utilize
all vacation time during a year, it is forfeited.
3. Stock Options. The Company hereby grants to the Executive options (the Options), to
acquire 300,000 shares of the Companys Common Stock, par value $.01 per share (the Common
Stock), at an exercise price per share (the Exercise Price) equal to the closing price of the
Companys Common Stock on the American Stock Exchange as reported by bigcharts.com for the date of
this Agreement. The Options are not pursuant to the Companys 2006 Stock and Incentive Plan. The
Options will not be treated as incentive options within the meaning of Section 422 of the Code.
(a) Anti-Dilution Adjustments. The Options are subject to adjustment as provided in
this subsection (a).
(i) Exercise Price Adjustments. The Exercise Price shall be adjusted from time to
time such that in case the Company shall hereafter:
(A) pay any dividends on any class of stock of the Company payable in Common Stock or
securities convertible into Common Stock;
(B) subdivide its then outstanding shares of Common Stock into a greater number of shares; or
(C) combine outstanding shares of Common Stock, by reclassification or otherwise;
then, in any such event, the Exercise Price in effect immediately prior to such event shall (until
adjusted again pursuant hereto) be adjusted immediately after such event to a price (calculated to
the nearest full cent) determined by dividing (A) the number of shares of Common Stock outstanding
immediately prior to such event, multiplied by the then existing Exercise Price, by (B) the total
number of shares of Common Stock outstanding immediately after such event (including in each case
the maximum number of shares of Common Stock issuable in respect of any securities convertible into
Common Stock), and the resulting quotient shall be the adjusted Exercise Price per share. An
adjustment made pursuant to this subsection shall become effective immediately after the record
date in the case of a dividend or distribution and shall become effective immediately after the
effective date in the case of a subdivision, combination or reclassification. If, as a result of
an adjustment made pursuant to this subsection, the Executive shall become entitled to receive
shares of two or more classes of capital stock or shares of Common Stock and other capital stock of
the Company, the Board of Directors (whose determination shall be conclusive) shall determine the
allocation of the adjusted Exercise Price between or among shares of such classes of capital stock
or shares of Common Stock and other
-3-
capital stock. All calculations under this subsection shall be made to the nearest cent or to the
nearest 1/100 of a share, as the case may be. In the event that at any time as a result of an
adjustment made pursuant to this subsection, the Executive shall become entitled to receive any
shares of the Company other than shares of Common Stock, thereafter the Exercise Price of such
other shares so receivable upon exercise of any Options shall be subject to adjustment from time to
time in a manner and on terms as nearly equivalent as practicable to the provisions with respect to
Common Stock contained in this subsection.
(ii) Share Adjustments. Upon each adjustment of the Exercise Price pursuant to
subsection (a)(i) above, the Executive shall thereafter (until another such adjustment) be entitled
to purchase at the adjusted Exercise Price the number of shares, calculated to the nearest full
share, obtained by multiplying the number of shares covered by the Options (as adjusted as a result
of all adjustments in the Exercise Price in effect prior to such adjustment) by the Exercise Price
in effect prior to such adjustment and dividing the product so obtained by the adjusted Exercise
Price.
(iii) Reorganization Events. In case of any consolidation or merger to which the
Company is a party other than a merger or consolidation in which the Company is the continuing
corporation, or in case of any sale or conveyance to another corporation of the property of the
Company as an entirety or substantially as an entirety, or in the case of any statutory exchange of
securities with another corporation (including any exchange effected in connection with a merger of
a third corporation into the Company), there shall be no adjustment under subsection (a)(i) above;
but the Executive shall have the right thereafter to convert the Options into the kind and amount
of shares of stock and other securities and property which the Executive would have owned or have
been entitled to receive immediately after such consolidation, merger, statutory exchange, sale or
conveyance had the Options been converted immediately prior to the effective date of such
consolidation, merger, statutory exchange, sale or conveyance and, in any such case, if necessary,
appropriate adjustment shall be made in the application of the provisions set forth in this
subsection with respect to the rights and interests thereafter of the Executive, to the end that
the provisions set forth in this subsection shall thereafter correspondingly be made applicable, as
nearly as may reasonably be, in relation to any shares of stock and other securities and property
thereafter deliverable on the exercise of the Options. The provisions of this subsection shall
similarly apply to successive consolidations, mergers, statutory exchanges, sales or conveyances.
(iv) Notice of Adjustments. Upon any adjustment of the Exercise Price, then and in
each such case, the Company shall give written notice thereof, by first-class mail, postage
prepaid, addressed to the Executive, which notice shall state the Exercise Price resulting from
such adjustment and the increase or decrease, if any, in the number of shares of Common Stock
purchasable at such price upon the exercise of the Options, setting forth in reasonable detail the
method of calculation and the facts upon which such calculation is based.
(b) Vesting; Change of Control. Notwithstanding anything else, the Executive may
exercise the Options only to the extent that the Executive is vested in them. Vested Options will
-4-
be exercisable for ten (10) years from the date hereof. The Options will vest in installments of
1/3rd on each of the Start Date hereof and the first and second anniversaries of the date hereof;
provided, however, that the Executive must continue in the employ of the Company through the
applicable anniversary date in order to vest in the Options for such anniversary date. Despite the
foregoing, the Options will fully vest upon a Change of Control, which will be deemed to occur as
of the first day after the date hereof that any one or more of the following conditions is
satisfied:
(i) any person or entity, or group of persons or entities acting together, other than the
Company or an employee benefit plan of the Company, acquires directly or indirectly the beneficial
ownership (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended)
of any voting security of the Company and, immediately after such acquisition, such person, entity
or group is, directly or indirectly, the beneficial owner of voting securities representing a
majority of the total voting power of all of the then-outstanding voting securities of the Company
and has a larger percentage of voting securities of the Company than any other person, entity or
group holding voting securities of the Company;
(ii) the following individuals no longer constitute a majority of the members of the Board:
(A) Daniel G. Holman, Sam B. Humphries, Joel R. Pitlor, Thomas E. Jamison, R. Patrick Maxwell and
the Executive (the Original Directors); (B) the individuals who thereafter are elected to the
Companys Board of Directors and whose election, or nomination for election, to the Board of
Directors was approved by a vote of at least a majority of the Original Directors then still in
office (such directors becoming Additional Original Directors immediately following their
election); and (C) the individuals who are elected to the Board of Directors and whose election,
or nomination for election, to the Board of Directors was approved by a vote of at least a majority
of the Original Directors and Additional Original Directors then still in office (such directors
also becoming Additional Original Directors immediately following their election);
(iii) the stockholders of the Company approve a merger, consolidation, recapitalization or
reorganization of the Company, or a reverse stock split of outstanding voting securities, other
than any such transaction which results in at least a majority of the total voting power
represented by the voting securities of the surviving entity outstanding immediately after such
transaction being beneficially owned by at least a majority of the holders of outstanding voting
securities of the Company immediately prior to the transaction, with the voting power of each such
continuing holder relative to other such continuing holders not substantially altered in the
transaction; or
(iv) the stockholders of the Company approve a plan of complete liquidation of the Company or
an agreement for the sale or disposition by the Company of all or a substantial portion of the
Companys assets (i.e., 50% or more of the total assets of the Company).
-5-
However, no Change in Control will be deemed to have occurred with respect to Executive if
Executive is part of a purchasing group which consummates the Change in Control transaction. The
Executive will be deemed part of a purchasing group for purposes of the preceding sentence if the
Executive is an equity participant in the purchasing company or group except for (i) passive
ownership of less than three percent (3%) of the stock of the purchasing company or (ii) ownership
of an equity participation in the purchasing company or group which is otherwise not significant,
as determined prior to the Change in Control by a majority of the Original and Additional Original
Directors.
(c) Payment of Exercise Price and Required Withholding Taxes. The Executive may
exercise the Options by cash payment (including by check or wire transfer). The Company may
condition any exercise upon the Executives payment of the minimum required withholding taxes. As
to the minimum required withholding taxes, the Executive may pay such amount in cash or by
instructing the Company to cancel a number of otherwise then exercisable Options equal in value to
the minimum required withholding taxes. In determining the number of Options so cancelable, each
Option is deemed to have a value equal to (i) the Market Price (as defined below) of a share of
Common Stock as of the close of business on the date of the Option exercise less (ii) the Exercise
Price per share.
The term Market Price with respect to shares of Common Stock of any class or series means
the last reported sale price or, if none, the average of the last reported closing bid and asked
prices on any national or regional securities exchange or quoted in the National Association of
Securities Dealers, Inc.s Automated Quotations System (Nasdaq), or if not listed on a national
or regional securities exchange or quoted in Nasdaq, the closing price as reported by bigcharts.com
(or if this service is discontinued, such other reporting service acceptable to the Holder), or if
no quotations in such Common Stock are available, the fair market value of the shares as determined
in good faith by the Board of Directors of the Company.
(d) Subscription Representations; Transfer Restrictions. The Executive understands
that the Options, and the shares of Common Stock issuable upon their exercise, are and will be
restricted securities within the meaning of the Securities Act of 1933, as amended (the Act).
Accordingly, even if the Executive is fully vested in the Options, the Executive may never be able
to resell the underlying shares for a profit, or at all. In any event, the Executive will be able
to resell or otherwise transfer the underlying shares only if the sale or other transfer is
registered under the Act and applicable state securities laws or there is an available exemption
from this registration. The Executive confirms that Executive can bear the loss of Executives
entire investment in the Company.
The Executive agrees and acknowledges that (i) none of the Options may be sold, transferred,
pledged, assigned or otherwise alienated or hypothecated, other than by will or by the laws of
decent and distribution and then only to Executives spouse and/or children (or a trust for their
benefit) and (ii) the vested Options may be exercised during the Executives lifetime only by the
Executive or the Executives legal representative.
-6-
(e) Lock-Up Agreement. The Executive agrees that, in the event of each future public
offering of the Companys equity securities (an Offering), the Executive will agree to such
restrictions on the resale of any shares of the Companys Common Stock (including the shares
underlying the Options) then beneficially owned by Executive as requested by the managing
underwriter or underwriters of the Offering; provided, however, that such restrictions run no
longer than the period of resale restriction imposed by such underwriters on the Companys other
executive officers and directors. The Executive agrees not to sell or otherwise transfer
(including upon death) any of the shares underlying the Options, or any other shares beneficially
owned by the Executive, unless the purchaser or recipient agrees in writing to be bound by the
foregoing lock-up agreement.
(f) Stock Certificate Restrictions. The Executive acknowledges that the Company will
place a restrictive legend on any certificate representing the shares underlying the Options, and a
stop transfer order with any transfer agent of the Companys securities, barring the sale or
other transfer of such shares without registration under the Act or an exemption therefrom, and
noting the existence of the lock-up agreement above.
(g) Registration of Shares Underlying the Options. Notwithstanding the above
provisions, the Company shall use its best efforts, at its expense, to register the issuance or
resale of the shares underlying the Options on Form S-8 under the Act and under applicable state
securities laws, and to maintain the effectiveness of the Form S-8 registration statement during
the Term of this Agreement and for two years thereafter.
4. Non-Competition and Non-Solicitation.
(a) Basic Terms. The Executive will not, during the period of the Executives
employment with the Company and for a period of one (1) year immediately following the termination
of the Executives employment under this Agreement, for any reason whatsoever, directly or
indirectly, for the Executive or on behalf of or in conjunction with any other person, persons,
entity, company, business, partnership, corporation, limited liability company or limited liability
partnership of whatever nature:
(i) engage anywhere worldwide (the Territory) as an officer, director, shareholder, owner,
partner, joint venturer or in a managerial capacity, whether as an employee, independent
contractor, consultant or advisor or as a sales representative, in the development, manufacturing,
licensing, marketing or distribution of products or services for the diagnosis or treatment of
urinary or fecal voiding dysfunctions (the Uroplasty Line of Business) or in any other business
in competition with the Company;
(ii) initiate or enter into any agreement or other arrangement to develop, manufacture,
license, market, distribute or acquire any technology, business or entity in the Uroplasty Line of
Business, or participate in discussions or provide information relating to or in anticipation of
such an agreement or arrangement;
-7-
(iii) call upon or solicit any person who is at that time within the Territory an employee of
the Company for the purpose or with the intent of enticing such employee away from or out of the
employ of the Company;
(iv) call upon or solicit any person or entity which is, at that time, or which has been,
within one (1) year prior to that time, a customer or prospective customer (such prospective status
being determined by whether the Company within the prior year solicited such person or entitys
business) of the Company within the Territory for the purpose of selling products or services in
the Uroplasty Line of Business or otherwise in competition with the Company within the Territory;
or
(v) call upon or solicit any prospective acquisition candidate, on the Executives own behalf
or on behalf of any competitor, which candidate was, to the Executives actual knowledge after due
inquiry, either called upon by the Company or for which the Company made an acquisition analysis,
for the purpose of acquiring such entity or its assets.
Notwithstanding the above, the Executive may acquire as a passive investment not more than two
percent (2%) of the capital stock of a competing business, whose stock is traded on a national
securities exchange or over-the-counter.
(b) Equitable Relief. Because of the difficulty of measuring economic losses to the
Company as a result of a breach of the foregoing covenants, and because of the immediate and
irreparable damage that could be caused to the Company for which it would have no other adequate
remedy, the Executive agrees that the foregoing covenants may be enforced by the Company in the
event of breach by the Executive by injunctions and restraining orders.
(c) Severability and/or Reformation. The covenants in this Section 4 are severable
and separate, and the unenforceability of any specific covenant shall not affect the provisions of
any other covenant. Moreover, in the event any court of competent jurisdiction determines that the
scope, time or territorial restrictions set forth are unreasonable, then it is the intention of the
parties that such restrictions be enforced to the fullest extent which the court deems reasonable,
and the Agreement shall be reformed in accordance therewith.
(d) Independently Enforceable. All of the covenants in this Section 4 shall be
construed as an agreement independent of any other provision in this Agreement, and the existence
of any claim or cause of action of the Executive against the Company, whether predicated on this
Agreement or otherwise, shall not constitute a defense to the enforcement by the Company of such
covenants. It is specifically agreed that the period of one (1) year following termination of
employment stated at the beginning of this Section 4, during which the agreements and covenants of
the Executive made in this Section 4 shall be effective, shall be computed by excluding from such
computation any time during which the Executive is in violation of any provision of this Section 4.
-8-
5. Term; Termination; Rights on Termination.
The term of Executives employment under this Agreement begins on the Start Date hereof and
continues through May 16, 2007, and, unless terminated sooner as herein provided, will continue
thereafter on a year-to-year basis on the same terms and conditions contained herein in effect as
of the time of renewal. As used herein, the word Term means (i) during the initial period
referred to in the preceding sentence, such initial period and (ii) during any one-year renewal
pursuant to the terms hereof, such one-year period. This Agreement and the Executives employment
may be terminated in any one of the following ways:
(a) Death. The Executives death will immediately terminate this Agreement. The
Company will pay the Executives estate any of Executives accrued base salary and any earned, but
unpaid, Annual Bonus (at the time otherwise payable under this Agreement) through the date of
termination and reimbursement of expenses.
(b) Disability. If, as a result of incapacity due to physical or mental illness or
injury, as reasonably determined by the Executives physician, the Executive is absent from the
Executives full-time duties hereunder for four (4) consecutive months, then thirty (30) days after
receiving written notice (which notice may occur before or after the end of such four (4) month
period, but which will not be effective earlier than the last day of such four (4) month period),
the Company may terminate the Executives employment hereunder; provided that the Executive is
unable to resume the Executives full-time duties at the conclusion of such notice period. The
Company will pay the Executive any of the Executives accrued base salary and any earned, but
unpaid, Annual Bonus (at the time otherwise payable under this Agreement) through the date of
termination and reimbursement of expenses.
(c) Good Cause. The Company may terminate this Agreement ten (10) days after
delivery of written notice to the Executive for good cause, which is (i) the Executives willful,
material and irreparable breach of this Agreement; (ii) the Executives gross negligence in the
performance or intentional nonperformance (continuing for thirty (30) days after receipt of written
notice of need to cure) of any of the Executives material duties and responsibilities under this
Agreement; (iii) the Executives willful dishonesty, fraud or misconduct with respect to the
business or affairs of the Company which materially and adversely affects the operations or
reputation of the Company; or (iv) the Executives conviction of a felony crime which materially
and adversely affects the operations or reputation of the Company. Upon any termination for good
cause above, the Executive will receive no severance compensation other than base salary accrued
through the date of termination and reimbursement of expenses.
(d) Without Good Cause. At any time, either the Executive or the Company may
terminate this Agreement and the Executives employment, effective thirty (30) days after written
notice is provided to the other. If (i) the Company terminates the Executives employment without
good cause during or at the end of any Term, (ii) this Agreement expires or otherwise terminates at
the end of a Term without renewal, (iii) the Executive voluntarily terminates employment with the
Company as a result of the Companys imposition of material
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and adverse changes, without the Executives consent, in the Executives principal duties,
(iv) the Executive voluntarily terminates employment after the Company moves its principal
executive offices more than 100 miles from its current location without the Executives consent or
(v) in connection with a Change of Control, the Company terminates the Executives employment
without good cause during the Term, the Executive will receive from the Company any base salary
accrued through the date of termination and reimbursement of expenses. In addition, in any of
these circumstances, and conditioned on the Executives continuing compliance with the other
provisions of this Agreement, including Section 4 above, the Company shall pay the Executive, as
severance pay, an aggregate amount equal to 100% (160% if the termination is covered by
circumstance (v)) of Executives base salary in effect at the time of termination. The severance
payments will be subject to customary tax withholdings.
The severance payments will be payable in equal monthly installments on the first day of each
month over the first year after the date of termination; provided, however, that if the Company
determines in its discretion that the Executive is a specified employee (as defined in Section
409A(a)(2)(B)(i) of the Internal Revenue Code of 1986, as amended (the Code)) as of the date of
termination and that Section 409A of the Code applies with respect to a payment to Executive
pursuant to this Section 5(d), the severance payments will commence on the six-month anniversary of
the date of termination. The Company reserves the right to revise the timing of any payments
hereunder in order to comply with Section 409A of the Code. As a condition to receiving the
severance payments provided in this Section 5(d), the Company may require the Executive to execute
a full release and waiver of all claims against Employer (excluding claims for amounts required
under this Agreement to be paid upon severance and any then existing indemnification obligations to
Executive) in a form reasonably acceptable to the Company. If the Company requires such a release,
the Company will further delay the commencement of severance payments until the period of
rescission for the release has lapsed.
6. Excise Tax Limitation. Notwithstanding anything contained in this Agreement to the
contrary, to the extent that the payments and benefits provided under this Agreement and benefits
provided to, or for the benefit of, the Executive under any other Company plan or agreement (such
payments or benefits are collectively referred to as the Payments) would be subject to the excise
tax (the Excise Tax) imposed under Section 4999 of the Code, the Payments shall be reduced (but
not below zero) if and to the extent necessary so that no Payment to be made or benefit to be
provided to Executive shall be subject to the Excise Tax (such reduced amount is hereinafter
referred to as the Limited Payment Amount). Unless the Executive shall have given prior written
notice specifying a different order to the Company to effectuate the foregoing, the Company shall
reduce or eliminate the Payments, by first reducing or eliminating the portion of the Payments
which are not payable in cash and then by reducing or eliminating cash payments, in each case in
reverse order beginning with payments or benefits which are to be paid the farthest in time from
the Determination (as hereinafter defined). Any notice given by Executive pursuant to the
preceding sentence shall take precedence over the provisions of any other plan, arrangement or
agreement governing the Executives rights and entitlements to any benefits or compensation.
-10-
The determination of whether the Payments shall be reduced to the Limited Payment Amount
pursuant to this Agreement and the amount of such Limited Payment Amount shall be made, at the
Companys expense, by a reputable accounting firm selected by the Executive and reasonably
acceptable to the Company (the Accounting Firm). The Accounting Firm shall provide its
determination (the Determination), together with detailed supporting calculations and
documentation, to the Company and the Executive within ten (10) days after the end of the Term
hereof, if applicable, or such other time as specified by mutual agreement of the Company and the
Executive. If the Accounting Firm determines that no Excise Tax is payable by the Executive with
respect to the Payments, it shall furnish the Executive with an opinion reasonably acceptable to
the Executive that no Excise Tax will be imposed with respect to any such Payments. The
Determination shall be binding, final and conclusive upon the Company and the Executive.
7. Return of Company Property. All records, designs, tradenames and trademarks, service
names and service marks, patents, business plans, financial statements, manuals, memoranda,
customer and other lists and other property delivered to or compiled by the Executive by or on
behalf of the Company, or its representatives, vendors or customers which pertain to the business
of the Company are and will remain the property of the Company, and be subject at all times to its
discretion and control. Likewise, all correspondence, reports, records, charts, advertising and
marketing materials and other similar data pertaining to the business, activities or future plans
of the Company which is collected by or in the possession of the Executive shall be delivered
promptly to the Company without request by it upon termination of the Executives employment.
8. Inventions. The Executive will disclose promptly to the Company any and all significant
conceptions and ideas for inventions, improvements and valuable discoveries, whether patentable or
not, which are conceived or made by the Executive, solely or jointly with another, during the
period of employment, and which are directly related to the business or activities of the Company
and which the Executive conceives as a result of the Executives employment by the Company. The
Executive hereby assigns and agrees to assign all of the Executives interests therein to the
Company or its nominee. Whenever requested to do so by the Company, the Executive will execute any
and all applications, assignments or other instruments that the Company shall deem necessary to
apply for and obtain letters patent of the United States or any foreign country or to otherwise
protect the Companys interest therein. Nothing in this Agreement shall apply to an invention for
which no equipment, supplies, facility or trade secret information of the Company was used and
which was developed entirely on the Executives own time and (i) which does not relate (a) directly
to the business of the Company or (b) to the Companys actual or demonstrably anticipated research
or development or (ii) which does not result from any work performed by the Executive for the
Company.
9. Trade Secrets. The Executive will not, other than as required by court order, during or
after employment with the Company, disclose the confidential terms of the Companys relationships
or agreements with its significant vendors or customers or any other significant and
-11-
material trade secret of the Company to any person, firm, partnership, corporation or business for
any reason or purpose whatsoever.
10. Complete Agreement. This Agreement is the final, complete and exclusive statement and
expression of the agreement between the Company and the Executive and of all the terms of this
Agreement, and it cannot be varied, contradicted or supplemented by evidence of any prior or
contemporaneous oral or written agreements. This document may not be later modified except by a
written instrument signed by a duly authorized officer of the Company and the Executive, and no
term of this Agreement may be waived except by a written instrument signed by the party waiving the
benefit of such term.
11. Notice. Whenever any notice is required hereunder, it shall be given in writing
addressed as follows:
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To the Company:
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Uroplasty, Inc.
5420 Feltl Road
Minnetonka, Minnesota 55343
Attention: Daniel G. Holman, Chairman |
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To the Executive:
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David B. Kaysen
8725 Sandro Road
Bloomington, Minnesota 55438 |
Notice is given and effective three (3) days after the deposit in the U.S. mail of a writing
addressed as above and sent first class mail, certified, return receipt requested, or when actually
received. Either party may change the address for notice by notifying the other party of such
change in accordance with this Section 10.
12. Arbitration. Except as to matters of injunctive or equitable relief (over which the
parties agree that the federal and state courts located in Minneapolis, Minnesota will have
exclusive jurisdiction and are deemed to be of proper venue and convenience to the parties), any
unresolved dispute or controversy arising under or in connection with this Agreement will be
settled exclusively by arbitration, conducted before a panel of three (3) arbitrators in
Minneapolis, Minnesota, in accordance with the rules of the American Arbitration Association then
in effect. The arbitrators will not have the authority to add to, detract from or modify any
provision hereof nor to award punitive damages to any injured party. A decision by a majority of
the arbitration panel will be final and binding. Judgment may be entered on the arbitrators award
in any court having jurisdiction. The direct expense of any arbitration proceeding will be borne
by the Company.
[continued on next page]
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13. Binding Effect; Governing Law. This Agreement will inure to the benefit of
the successors or assigns of the Company. The Company agrees that, as a condition of any merger of
the Company into or with, or the sale of all or substantially all of the Companys assets to,
another person, firm or entity, it will require the successor expressly to assume the Companys
obligations hereunder. This Agreement shall be governed by and construed in accordance with the
laws of the State of Minnesota, exclusive of its conflicts of laws rules.
IN WITNESS WHEREOF, the undersigned have hereunto affixed their signatures.
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UROPLASTY, INC. |
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EXECUTIVE |
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By
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/s/ Thomas E. Jamison
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/s/ David B. Kaysen |
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Thomas E. Jamison, Chairman
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David B. Kaysen |
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Compensation Committee |
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EXHIBIT
10.31
PROMISSORY NOTE
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Principal |
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Loan Date |
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Maturity |
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Loan No |
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Call / Coll |
Account |
Officer |
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Initials |
$1,000,000.00
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05-31-2006
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06-02-2007
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11808 |
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10022 |
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References in the shaded area are for Lenders use only and do not limit the applicability of
this document to any particular loan or item.
Any item above containing *** has been omitted due to text length limitations.
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Borrower:
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Uroplasty, Inc.
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Lender:
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Venture Bank |
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5420 Feltl Road
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5601 Green Valley Drive, Suite 120 |
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Minnetonka, MN 55343
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Bloomington, MN 55437 |
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Principal Amount: $1,000,000.00
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Initial Rate: 9.000%
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Date of Note: May 31, 2006 |
PROMISE TO PAY. Uroplasty, Inc. (Borrower) promises to pay to Venture Bank (Lender), or
order, in lawful money of the United States of America, the principal amount of One Million &
00/100 Dollars ($1,000,000.00) or so much as may be outstanding, together with Interest on the
unpaid outstanding principal balance of each advance. Interest shall be calculated from the date of
each advance until repayment of each advance.
PAYMENT.
Borrower will pay this loan in one payment of all outstanding principal plus all accrued
unpaid interest on June 2, 2007. In addition, Borrower will pay regular monthly payments of all
accrued unpaid interest due as of each payment date, beginning July 2, 2006, with all subsequent
interest payments to be due on the same day of each month after that. Unless otherwise agreed or
required by applicable law, payments will be applied first to any accrued unpaid interest; then to
principal; then to any unpaid collection costs; and then to any late charges. The annual interest
rate for this Note is computed on a 365/360 basis; that is, by applying the ratio of the annual
interest rate over a year of 360 days, multiplied by the outstanding principal balance, multiplied
by the actual number of days the principal balance is outstanding. Borrower will pay Lender at
Lenders address shown above or at such other place as Lender may designate in writing.
VARIABLE INTEREST RATE. The interest rate on this Note is subject to change from time to time based
on changes in an independent index which is the Prime rate of interest as published each business
day in the money rates section of The Wall Street Journal (the Index). The Index is not
necessarily the lowest rate charged by Lender on its loans. If the Index becomes unavailable during
the term of this loan, Lender may designate a substitute index after notice to Borrower. Lender
will tell Borrower the current Index rate upon Borrowers request. The interest rate change will
not occur more often than each day. Borrower understands that Lender may make loans based on other
rates as well. The Index currently is 8.000% per annum. The interest rate to be applied to the
unpaid principal balance of this Note will be at a rate of 1.000 percentage point over the index,
resulting in an initial rate of 9.000% par annum. Notwithstanding the foregoing, the variable
interest rate or rates provided for in this Note will be subject to the following minimum and
maximum rates. NOTICE: Under no circumstances will the interest rate on this Note be less than
7.000% per annum or more than the maximum rate allowed by applicable law.
PREPAYMENT. Borrower agrees that all loan fees and other prepaid finance charges are earned fully
as of the date of the loan and will not be subject to refund upon early payment (whether voluntary
or as a result of default), except as otherwise required by law. Except for the foregoing, Borrower
may pay without penalty all or a portion of the amount owed earlier than it is due. Early payments
will not, unless agreed to by Lender in writing, relieve Borrower of Borrowers obligation to
continue to make payments of accrued unpaid interest. Rather, early payments will reduce the
principal balance due. Borrower agrees not to send Lender payments marked paid in full, without
recourse, or similar language. If Borrower sends such a payment, Lender may accept it without
losing any of Lenders rights under this Note, and Borrower will remain obligated to pay any
further amount owed to Lender. All written communications concerning disputed amounts, including
any check or other payment instrument that indicates that the payment constitutes payment in full
of the amount owed or that is tendered with other conditions or limitations or as full satisfaction
of a disputed amount must be mailed or delivered to: Venture Bank, 5601 Green Valley Drive
Bloomington, MN 55437.
LATE
CHARGE. If a payment is 10 days or more late, Borrower will be charged 5.000% of the unpaid
portion of the regularly scheduled payment.
INTEREST AFTER DEFAULT. Upon default, including failure to pay upon final maturity, Lender, at its
option, may, if permitted under applicable law, increase the variable interest rate on this Note to
5.000 percentage points over the Index. The interest rate will not exceed the maximum rate
permitted by applicable law.
DEFAULT. Each of the following shall constitute an event of default (Event of Default) under
this Note:
Payment Default. Borrower fails to make any payment when due under this Note.
Other Defaults. Borrower fails to comply with or to perform any other term, obligation, covenant or
condition contained in this Note or in any of the related documents or to comply with or to perform
any term, obligation, covenant or condition contained in any other agreement between Lender and
Borrower.
False Statements. Any warranty, representation or statement made or furnished to Lender by Borrower
or on Borrowers behalf under this Note or the related documents is false or misleading in any
material respect, either now or at the time made or furnished or becomes false or misleading at any
time thereafter.
Insolvency. The dissolution or termination of Borrowers existence as a going business, the
insolvency of Borrower, the appointment of a receiver for any part of Borrowers property, any
assignment for the benefit of creditors, any type of creditor workout, or the commencement of any
proceeding under any bankruptcy or insolvency laws by or against Borrower.
Creditor or Forfeiture Proceedings. Commencement of foreclosure or forfeiture proceedings, whether
by judicial proceeding, self-help, repossession or any other method, by any creditor of Borrower or
by any governmental agency against any collateral securing the loan. This includes a garnishment of
any of Borrowers accounts, including deposit accounts, with Lender. However, this Event of Default
shall not apply if there is a good faith dispute by Borrower as to the validity or reasonableness of the
claim which is the basis of the creditor or forfeiture proceeding and if Borrower gives Lender
written notice of the creditor or forfeiture proceeding and deposits with Lender monies or a surety
bond for the creditor or forfeiture proceeding, in an amount determined by Lender, in its sole
discretion, as being an adequate reserve or bond for the dispute.
Events Affecting Guarantor. Any of the preceding events occurs with respect to any guarantor,
endorser, surety, or accommodation party of any of the indebtedness or any guarantor, endorser,
surety, or accommodation party dies or becomes incompetent, or revokes or disputes the validity of,
or liability under, any guaranty of the indebtedness evidenced by this Note. In the event of a
death, Lender, at its option, may, but shall not be required to, permit the guarantors estate to
assume unconditionally the obligations arising under the guaranty in a manner satisfactory to
Lender, and, in doing so, cure any Event of Default.
Change In Ownership. Any change in ownership of Fifty percent (50%) or more of the common stock of
Borrower.
Adverse Change. A material adverse change occurs in Borrowers financial condition, or
Lender believes the prospect of payment or
PROMISSORY NOTE
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Loan No: 11808
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(Continued)
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Page 2 |
performance of this Note is impaired.
Insecurity. Lender in good faith believes itself insecure.
Cure Provisions. If any default, other than a default in payment is curable and if Borrower has not
been given a notice of a breach of the same provision of this Note within the preceding twelve (12)
months, it may be cured if Borrower, after receiving written notice from Lender demanding cure of
such default: (1) cures the default within fifteen (15) days; or (2) if the cure requires more
than fifteen (15) days, immediately initiates steps which Lender deems in Lenders sole discretion
to be sufficient to cure the default and thereafter continues and completes all reasonable and
necessary steps sufficient to produce compliance as soon as reasonably practical.
LENDERS RIGHTS. Upon default, Lender may declare the entire unpaid principal balance on this Note
and all accrued unpaid interest immediately due, and then Borrower will pay that amount.
ATTORNEYS FEES; EXPENSES. Lender may hire or pay someone else to help collect this Note if
Borrower does not pay. Borrower will pay Lender that amount. This includes, subject to any limits
under applicable law, Lenders reasonable attorneys fees and Lenders legal expenses, whether or
not there is a lawsuit, including reasonable attorneys fees, expenses for bankruptcy proceedings
(including efforts to modify or vacate any automatic stay or injunction), and appeals. If not
prohibited by applicable law, Borrower also will pay any court costs, in addition to all other sums
provided by law.
GOVERNING LAW. This Note will be governed by federal law applicable to Lender and, to the
extent not preempted by federal law, the laws of the State of Minnesota without regard to its
conflicts of law provisions. This Note has been accepted by Lender in the State of Minnesota.
RIGHT
OF SETOFF. To the extent permitted by applicable law, Lender reserves a right of setoff
in all Borrowers accounts with Lender (whether checking, savings, or some other account). This
includes all accounts Borrower holds jointly with someone else and all accounts Borrower may open
in the future. However, this does not include any IRA or Keogh accounts, or any trust accounts for
which setoff would be prohibited by law. Borrower authorizes Lender, to the extent permitted by
applicable law, to charge or setoff all sums owing on the indebtedness against any and all such
accounts, and, at Lenders option, to administratively freeze all such accounts to allow Lender to
protect Lenders charge and setoff rights provided in this paragraph.
COLLATERAL. Borrower acknowledges this Note is secured by All Business Assets per Commercial
Security Agreement dated 5/31/06.
LINE OF CREDIT. This Note evidences a revolving line of credit. Advances under this Note, as well
as directions for payment from Borrowers accounts, may be requested orally or in writing by
Borrower or by an authorized person. Lender may, but need not, require that all oral requests be
confirmed in writing. Borrower agrees to be liable for all sums either: (A) advanced in accordance
with the instructions of an authorized person or (B) credited to any of Borrowers accounts with
Lender. The unpaid principal balance owing on this Note at any time may be evidenced by
endorsements on this Note or by Lenders internal records, including daily computer print-outs.
Lender will have no obligation to advance funds under this Note if: (A) Borrower or any guarantor
is in default under the terms of this Note or any agreement that Borrower or any guarantor has with
Lender, including any agreement made in connection with the signing of this Note; (B) Borrower or
any guarantor ceases doing business or is insolvent; (C) any guarantor seeks, claims or otherwise
attempts to limit, modify or revoke such guarantors guarantee of this Note or any other loan with
Lender; (D) Borrower has applied funds provided pursuant to this Note for purposes other than those
authorized by Lender; or (E) Lender in good faith believes itself insecure.
LOAN AGREEMENT. A document titled, Loan Agreement, is attached to this Promissory Note.
PRIOR NOTE. This note amends and restates the note # 11307 dated 3/24/05, in the original amount of
$500,000.00 given by Uroplasty, Inc. to Venture Bank and is not intended to discharge the
indebtedness evidenced by such other note.
SUCCESSOR INTERESTS. The terms of this Note shall be binding upon Borrower, and upon Borrowers
heirs, personal representatives, successors and assigns, and shall inure to the benefit of Lender
and its successors and assigns.
GENERAL PROVISIONS. If any part of this Note cannot be enforced, this fact will not affect the rest
of the Note. Lender may delay or forgo enforcing any of its rights or remedies under this Note
without losing them. In addition, Lender shall have all the rights and remedies provided in the
related documents or available at law, in equity, or otherwise. Except as may be prohibited by
applicable law, all of Lenders rights and remedies shall be cumulative and may be exercised
singularly or concurrently. Election by Lender to pursue any remedy shall not exclude pursuit of any other remedy, and an election to
make expenditures or to take action to perform an obligation of Borrower shall not affect Lenders
right to declare a default and to exercise its rights and remedies. Borrower and any other person
who signs, guarantees or endorses this Note, to the extent allowed by law, waive presentment,
demand for payment, and notice of dishonor. Upon any change in the terms of this Note, and unless
otherwise expressly stated in writing, no party who signs this Note, whether as maker, guarantor,
accommodation maker or endorser, shall be released from liability. All such parties agree that
Lender may renew or extend (repeatedly and for any length of time) this loan or release any party
or guarantor or collateral; or impair, fail to realize upon or perfect Lenders security interest
in the collateral; and take any other action deemed necessary by Lender without the consent of or
notice to anyone. All such parties also agree that Lender may modify this loan without the consent
of or notice to anyone other than the party with whom the modification is made. The obligations
under this Note are joint and several.
SECTION DISCLOSURE. To the extent not preempted by federal law, this loan is made under Minnesota
Statutes, Section 47.59.
PRIOR TO SIGNING THIS NOTE, BORROWER READ AND UNDERSTOOD ALL THE PROVISIONS OF THIS NOTE,
INCLUDING THE VARIABLE INTEREST RATE PROVISIONS. BORROWER AGREES TO THE TERMS OF THE NOTE.
BORROWER ACKNOWLEDGES RECEIPT OF A COMPLETED COPY OF THIS PROMISSORY NOTE.
BORROWER:
UROPLASTY, INC.
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By:
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/s/ Mahedi A. Jiwani
Mahedi A. Jiwani, CFO/Treasurer of Uroplasty, Inc.
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COMMERCIAL SECURITY AGREEMENT
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Principal |
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Loan Date |
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Maturity |
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Loan No. |
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Call/Coll |
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Account |
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Officer |
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Initials |
$1,000,000.00
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05-25-2006
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05-25-2007
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11808 |
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10022 |
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References in the shaded area are for Lenders use only and do not limit the applicability of
this document to any particular loan or item.
Any item above containing * * * has been omitted due to text length limitations.
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Grantor:
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Uroplasty, Inc.
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Lender:
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Venture Bank |
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5420 Feltl Road
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5601 Green Valley Drive, Suite 120 |
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Minnetonka, MN 55343
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Bloomington, MN 55437 |
THIS COMMERCIAL SECURITY AGREEMENT dated May 25, 2006, is made and executed between Uroplasty, Inc.
(Grantor) and Venture Bank (Lender).
GRANT OF SECURITY INTEREST. For valuable consideration, Grantor grants to Lender a security
interest in the Collateral to secure the Indebtedness and agrees that Lender shall have the rights
stated in this Agreement with respect to the Collateral, in addition to all other rights which
Lender may have by law.
COLLATERAL DESCRIPTION. The word Collateral as used in this Agreement means the following
described property, whether now owned or hereafter acquired, whether now existing or hereafter
arising, and wherever located, in which Grantor is giving to Lender a security interest for the
payment of the Indebtedness and performance of all other obligations under the Note and this
Agreement:
All inventory, equipment, accounts (Including but not limited to all health-care-insurance
receivables), chattel paper, instruments (including but not limited to all promissory notes),
letter-of-credit rights, letters of credit, documents, deposit accounts, investment property,
money, other rights to payment and performance, and general intangibles (including but not limited
to all software and all payment intangibles); all oil, gas and other minerals before extraction;
all oil, gas, other minerals and accounts constituting as-extracted collateral; all fixtures; all
timber to be cut; all attachments, accessions, accessories, fittings, increases, tools, parts,
repairs, supplies, and commingled goods relating to the foregoing property, and all additions,
replacements of and substitutions for all or any part of the foregoing property; all insurance
refunds relating to the foregoing property; all good will relating to the foregoing property; all
records and data and embedded software relating to the foregoing property, and all equipment,
inventory and software to utilize, create, maintain and process any such records and data on
electronic media; and all supporting obligations relating to the foregoing property; all whether
now existing or hereafter arising, whether now owned or hereafter acquired or whether now or
hereafter subject to any rights in the foregoing property; and all products and proceeds (including
but not limited to all insurance payments) of or relating to the foregoing property.
In addition, the word Collateral also includes all the following, whether now owned or hereafter
acquired, whether now existing or hereafter arising, and wherever located:
(A) All accessions, attachments, accessories, tools, parts, supplies, replacements of and additions
to any of the collateral described herein, whether added now or later.
(B) All products and produce of any of the property described in this Collateral section.
(C) All accounts, general intangibles, instruments, rents, monies, payments, and all other rights,
arising out of a sale, lease, consignment or other disposition of any of the property described in
this Collateral section.
(D) All proceeds, (including insurance proceeds) from the sale, destruction, loss, or other
disposition of any of the property described in this Collateral section, and sums due from a third
party who has damaged or destroyed the Collateral or from that partys insurer, whether due to
judgment, settlement or other process.
(E) All records and data relating to any of the property described in this Collateral section,
whether in the form of a writing, photograph, microfilm, microfiche, or electronic media, together
with all of Grantors right, title, and interest in and to all computer software required to
utilize, create, maintain, and process any such records or data on electronic media.
CROSS-COLLATERALIZATION. In addition to the Note, this Agreement secures all obligations, debts and
liabilities, plus interest thereon, of Grantor to Lender, or any one or more of them, as well as
all claims by Lender against Grantor or any one or more of them, whether now existing or hereafter
arising, whether related or unrelated to the purpose of the Note, whether voluntary or otherwise,
whether due or not due, direct or indirect, determined or undetermined, absolute or contingent, liquidated or
unliquidated, whether Grantor may be liable individually or jointly with others, whether obligated
as guarantor, surety, accommodation party or otherwise, and whether recovery upon such amounts may
be or hereafter may become barred by any statute of limitations, and whether the obligation to
repay such amounts may be or hereafter may become otherwise unenforceable.
RIGHT OF SETOFF. To the extent permitted by applicable law, Lender reserves a right of setoff in
all Grantors accounts with Lender (whether checking, savings, or some other account). This
includes all accounts Grantor holds jointly with someone else and all accounts Grantor may open in
the future. However, this does not include any IRA or Keogh accounts, or any trust accounts for
which setoff would be prohibited by law. Grantor authorizes Lender, to the extent permitted by
applicable law, to charge or setoff all sums owing on the Indebtedness against any and all such
accounts, and, at Lenders option, to administratively freeze all such accounts to allow Lender to
protect Lenders charge and setoff rights provided in this paragraph.
GRANTORS REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE COLLATERAL. With respect to the
Collateral, Grantor represents and promises to Lender that:
Perfection of Security Interest. Grantor agrees to take whatever actions are requested by Lender to
perfect and continue Lenders security interest in the Collateral. Upon request of Lender, Grantor
will deliver to Lender any and all of the documents evidencing or constituting the Collateral, and
Grantor will note Lenders interest upon any and all chattel paper and instruments if not delivered
to Lender for possession by Lender. This is a continuing Security Agreement and will continue in
effect even though all or any part of the Indebtedness is paid in full and even though for a period
of time Grantor may not be indebted to Lender.
Notices to Lender. Grantor will promptly notify Lender in writing at Lenders address shown above
(or such other addresses as Lender may designate from time to time) prior to any (1) change in
Grantors name; (2) change in Grantors assumed business name(s): (3) change in the management of
the Corporation Grantor; (4) change in the authorized signer(s); (5) change in Grantors principal
office address; (6) change in Grantors state of organization; (7) conversion of Grantor to a new
or different type of business entity; or (8) change in any other aspect of Grantor that directly or
indirectly relates to any agreements between Grantor and Lender. No change in Grantors name or
state of organization will take effect until after Lender has received notice.
No Violation. The execution and delivery of this Agreement will not violate any law or agreement
governing Grantor or to which Grantor is
COMMERCIAL SECURITY AGREEMENT
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a party, and its certificate or articles of incorporation and bylaws do not prohibit any term
or condition of this Agreement.
Enforceability of Collateral. To the extent the Collateral consists of accounts, chattel paper, or
general intangibles, as defined by the Uniform Commercial Code, the Collateral is enforceable in
accordance with its terms, is genuine, and fully complies with all applicable laws and regulations
concerning form, content and manner of preparation and execution, and all persons appearing to be
obligated on the Collateral have authority and capacity to contract and are in fact obligated as
they appear to be on the Collateral. At the time any account becomes subject to a security interest
in favor of Lender, the account shall be a good and valid account representing an undisputed, bona
fide indebtedness incurred by the account debtor, for merchandise held subject to delivery
instructions or previously shipped or delivered pursuant to a contract of sale, or for services
previously performed by Grantor with or for the account debtor. So long as this Agreement remains
in effect, Grantor shall not, without Lenders prior written consent, compromise, settle, adjust,
or extend payment under or with regard to any such Accounts. There shall be no setoffs or
counterclaims against any of the Collateral, and no agreement shall have been made under which any
deductions or discounts may be claimed concerning the Collateral except those disclosed to Lender
in writing.
Location of the Collateral. Except in the ordinary course of Grantors business, Grantor agrees to
keep the Collateral (or to the extent the Collateral consists of intangible property such as
accounts or general intangibles, the records concerning the Collateral) at Grantors address shown
above or at such other locations as are acceptable to Lender. Upon Lenders request, Grantor will
deliver to Lender in form satisfactory to Lender a schedule of real properties and Collateral
locations relating to Grantors operations, including without limitation the following: (1) all
real property Grantor owns or is purchasing; (2) all real property Grantor is renting or leasing;
(3) all storage facilities Grantor owns, rents, leases, or uses; and (4) all other properties where
Collateral is or may be located.
Removal of the Collateral. Except in the ordinary course of Grantors business, including the sales
of inventory, Grantor shall not remove the Collateral from its existing location without Lenders
prior written consent. To the extent that the Collateral consists of vehicles, or other titled
property, Grantor shall not take or permit any action which would require application for
certificates of title for the vehicles outside the State of Minnesota, without Lenders prior
written consent. Grantor shall, whenever requested, advise Lender of the exact location of the
Collateral.
Transactions Involving Collateral. Except for inventory sold or accounts collected in the ordinary
course of Grantors business, or as otherwise provided for in this Agreement, Grantor shall not
sell, offer to sell, or otherwise transfer or dispose of the Collateral. While Grantor is not in
default under this Agreement, Grantor may sell inventory, but only in the ordinary course of its
business and only to buyers who qualify as a buyer in the ordinary course of business. A sale in
the ordinary course of Grantors business does not include a transfer in partial or total
satisfaction of a debt or any bulk sale. Grantor shall not pledge, mortgage, encumber or otherwise
permit the Collateral to be subject to any lien, security interest, encumbrance, or charge, other
than the security interest provided for in this Agreement, without the prior written consent of
Lender. This includes security interests even if junior in right to the security interests granted under this Agreement, Unless waived by Lender, all proceeds from any disposition of the
Collateral. (for whatever reason) shall be held in trust for Lender and shall not be commingled with
any other funds; provided however, this requirement shall not constitute consent by Lender to any
sale or other disposition. Upon receipt, Grantor shall immediately deliver any such proceeds to
Lender.
Title. Grantor represents and warrants to Lender that Grantor holds good and marketable title to
the Collateral, free and clear of all liens and encumbrances except for the lien of this Agreement
No financing statement covering any of the Collateral is on file in any public office, other than
those which reflect the security interest created by this Agreement or to which Lender has
specifically consented. Grantor shall defend Lenders rights in the Collateral against the claims
and demands of all other persons.
Repairs and Maintenance. Grantor agrees to keep and maintain, and to cause others to keep and
maintain, the Collateral in good order, repair and condition at all times while this Agreement
remains in effect. Grantor further agrees to pay when due all claims for work done on, or services
rendered or material furnished in connection with the Collateral so that no lien or encumbrance may
ever attach to or be filed against the Collateral.
Inspection of Collateral. Lender and Lenders designated representatives and agents shall have the
right at all reasonable times to examine and inspect the Collateral wherever located.
Taxes, Assessments and Liens. Grantor will pay when due all taxes, assessments and liens upon the
Collateral, its use or operation, upon this Agreement, upon any promissory note or notes evidencing
the Indebtedness, or upon any of the other Related Documents. Grantor may withhold any such payment
or may elect to contest any lien if Grantor is in good faith conducting an appropriate proceeding
to contest the obligation to pay and so long as Lenders interest in the Collateral is not
jeopardized in Lenders sole opinion. If the Collateral is subjected to a lien which is not
discharged within fifteen (15) days, Grantor shall deposit with Lender cash, a sufficient corporate
surety bond or other security satisfactory to Lender in an amount adequate to provide for the
discharge of the lien plus any interest, costs, reasonable attorneys fees or other charges that
could accrue as a result of foreclosure or sale of the Collateral. In any contest Grantor shall
defend itself and Lender and shall satisfy any final adverse judgment before enforcement against
the Collateral. Grantor shall name Lender as an additional obligee under any surety bond furnished
in the contest proceedings. Grantor further agrees to furnish Lender with evidence that such taxes,
assessments, and governmental and other charges have been paid in full and in a timely manner.
Grantor may withhold any such payment or may elect to contest any lien if Grantor is in good faith
conducting an appropriate proceeding to contest the obligation to pay and so long as Lenders
interest in the Collateral is not jeopardized.
Compliance with Governmental Requirements. Grantor shall comply promptly with all laws, ordinances,
rules and regulations of all governmental authorities, now or hereafter in effect, applicable to
the ownership, production, disposition, or use of the Collateral, including all laws or regulations
relating to the undue erosion of highly-erodible land or relating to the conversion of wetlands for
the production of an agricultural product or commodity. Grantor may contest in good faith any such
law, ordinance or regulation and withhold compliance during any proceeding, including appropriate
appeals, so long as Lenders interest in the Collateral, in Lenders opinion, is not jeopardized.
Hazardous Substances. Grantor represents and warrants that the Collateral never has been, and never
will be so long as this Agreement remains a lien on the Collateral, used in violation of any
Environmental Laws or for the generation, manufacture, storage, transportation, treatment,
disposal, release or threatened release of any Hazardous Substance. The representations and
warranties contained herein are based on Grantors due diligence in investigating the Collateral
for Hazardous Substances. Grantor hereby (1) releases and waives any future claims against Lender
for indemnity or contribution in the event Grantor becomes liable for cleanup or other costs under
any Environmental Laws, and (2) agrees to indemnify and hold harmless Lender against any and all
claims and losses resulting from a breach of this provision of this Agreement. This obligation to
indemnify shall survive the payment of the Indebtedness and the satisfaction of this Agreement.
Maintenance of Casualty Insurance. Grantor shall procure and maintain all risks insurance,
including without limitation fire, theft and liability coverage together with such other insurance
as Lender may require with respect to the Collateral, in form, amounts, coverages and basis
reasonably acceptable to Lender and issued by a company or companies reasonably acceptable to
Lender. Grantor, upon request of Lender, will deliver to Lender from time to time the policies or
certificates of insurance in form satisfactory to Lender, including stipulations that coverages
will not be cancelled or diminished without at least ten (10) days prior written notice to Lender
and not including any disclaimer of the insurers liability for failure to give such a notice. Each
insurance policy also shall include an endorsement providing that
COMMERCIAL SECURITY AGREEMENT
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coverage in favor of Lender will not be impaired in any way by any act, omission or default of
Grantor or any other person. In connection with all policies covering assets in which Lender holds
or is offered a security interest. Grantor will provide Lender with such loss payable or other
endorsements as Lender may require. If Grantor at any time fails to obtain or maintain any
insurance as required under this Agreement, Lender may (but shall not be obligated to) obtain such
insurance as Lender deems appropriate, including if Lender so chooses single interest insurance,
which will cover only Lenders interest in the Collateral.
Application of Insurance Proceeds. Grantor shall promptly notify Lender of any loss or damage to
the Collateral if the estimated cost of repair or replacement exceeds $$1,000.00, whether or not
such casualty or loss is covered by insurance. Lender may make proof of loss if Grantor fails to do
so within fifteen (15) days of the casualty. All proceeds of any insurance on the Collateral,
including accrued proceeds thereon, shall be held by Lender as part of the Collateral. If Lender
consents to repair or replacement of the damaged or destroyed Collateral, Lender shall, upon
satisfactory proof of expenditure, pay or reimburse Grantor from the proceeds for the reasonable
cost of repair or restoration. If Lender does not consent to repair or replacement of the
Collateral, Lender shall retain a sufficient amount of the proceeds to pay all of the indebtedness,
and shall pay the balance to Grantor. Any proceeds which have not been disbursed within six (6)
months after their receipt and which Grantor has not committed to the repair or restoration of the
Collateral shall be used to prepay the indebtedness.
Insurance Reserves. Lender may require Grantor to maintain with Lender reserves for payment of
insurance premiums, which reserves shall be created by monthly payments from Grantor of a sum
estimated by Lender to be sufficient to produce, at least fifteen (15) days before the premium due
date, amounts at least equal to the insurance premiums to be paid. If fifteen (15) days before
payment is due, the reserve funds are insufficient, Grantor shall upon demand pay any deficiency to
Lender. The reserve funds shall be held by Lender as a general deposit and shall constitute a
non-interest-bearing account which Lender may satisfy by payment of the insurance premiums required
to be paid by Grantor as they become due. Lender does not hold the reserve funds in trust for
Grantor, and Lender is not the agent of Grantor for payment of the insurance premiums required to
be paid by Grantor. The responsibility for the payment of premiums shall remain Grantors sole
responsibility.
Insurance Reports. Grantor, upon request of Lender, shall furnish to Lender reports on each
existing policy of insurance showing such information as Lender may reasonably request including
the following: (1) the name of the insurer; (2) the risks insured; (3) the amount of the policy;
(4) the property insured; (5) the then current value on the basis of which insurance has been
obtained and the manner of determining that value; and (6) the expiration date of the policy. In
addition, Grantor shall upon request by Lender (however not more often than annually) have an
independent appraiser satisfactory to Lender determine, as applicable, the cash value or
replacement cost of the Collateral.
Financing Statements. Grantor authorizes Lender to file a UCC financing statement, or
alternatively, a copy of this Agreement to perfect Lenders security interest. At Lenders request,
Grantor additionally agrees to sign all other documents that are necessary to perfect, protect, and
continue Lenders security interest in the Property. Grantor will pay all filing fees, title
transfer fees, and other fees and costs involved unless prohibited by law or unless Lender is
required by law to pay such fees and costs. Grantor irrevocably appoints Lender to execute
documents necessary to transfer title if there is a default. Lender may file a copy of this
Agreement as a financing statement. If Grantor changes Grantors name or address, or the name or
address of any person granting a security interest under this Agreement changes, Grantor will
promptly notify the Lender of such change.
GRANTORS RIGHT TO POSSESSION AND TO COLLECT ACCOUNTS. Until default and except as otherwise
provided below with respect to accounts, Grantor may have possession of the tangible personal
property and beneficial use of all the Collateral and may use it in any lawful manner not
inconsistent with this Agreement or the Related Documents, provided that Grantors right to
possession and beneficial use shall not apply to any Collateral where possession of the Collateral
by Lender is required by law to perfect Lenders security interest in such Collateral. Until
otherwise notified by Lender, Grantor may.collect any of the Collateral consisting of accounts. At
any time and even though no Event of Default exists, Lender may exercise its rights to collect the
accounts and to notify account debtors to make payments directly to Lender for application to the
Indebtedness. If Lender at any time has possession of any Collateral, whether before or after an
Event of Default, Lender shall be deemed to have exercised reasonable care in the custody and
preservation of the Collateral if Lender takes such action for that purpose as Grantor shall
request or as Lender, in Lenders sole discretion, shall deem appropriate under the circumstances,
but failure to honor any request by Grantor shall not of itself be deemed to be a failure to
exercise reasonable care. Lender shall not be required to take any steps necessary to preserve any
rights in the Collateral against prior parties, nor to protect, preserve or maintain any security
interest given to secure the Indebtedness.
LENDERS EXPENDITURES. If any action or proceeding is commenced that would materially affect
Lenders interest in the Collateral or if Grantor fails to comply with any provision of this
Agreement or any Related Documents, including but not limited to Grantors failure to discharge or
pay when due any amounts Grantor is required to discharge or pay under this Agreement or any
Related Documents, Lender on Grantors behalf may (but shall not be obligated to) take any action
that Lender deems appropriate, including but not limited to discharging or paying all taxes, liens,
security interests, encumbrances and other claims, at any time levied or placed on the Collateral
and paying all costs for insuring, maintaining and preserving the
Collateral. All such expenditures
incurred or paid by Lender for such purposes will then bear interest at the rate charged under the
Note from the date incurred or paid by Lender to the date of repayment by Grantor. All such
expenses will become a part of the Indebtedness and, at Lenders option, will (A) be payable on
demand; (B) be added to the balance of the Note and be apportioned among and be payable with any
installment payments to become due during either (1) the term of any applicable insurance policy;
or (2) the remaining term of the Note; or (C) be treated as a balloon payment which will be due and
payable at the Notes maturity. The Agreement also will secure payment of these amounts. Such right
shall be in addition to all other rights and remedies to which Lender may be entitled upon Default.
DEFAULT. Each of the following shall constitute an Event of Default under this Agreement:
Payment Default. Grantor fails to make any payment when due under the Indebtedness.
Other Defaults. Grantor fails to comply with or to perform any other term, obligation, covenant or
condition contained in this Agreement or in any of the Related Documents or to comply with or to
perform any term, obligation, covenant or condition contained in any other agreement between Lender
and Grantor.
False Statements. Any warranty, representation or statement made or furnished to Lender by Grantor
or on Grantors behalf under this Agreement or the Related Documents is false or misleading in any
material respect, either now or at the time made or furnished or becomes false or misleading at any
time thereafter.
Defective Collateralization. This Agreement or any of the Related Documents ceases to be in full
force and effect (including failure of any collateral document to create a valid and perfected
security interest or lien) at any time and for any reason.
Insolvency. The dissolution or termination of Grantors existence as a going business, the
insolvency of Grantor, the appointment of a receiver for any part of Grantors property, any
assignment for the benefit of creditors, any type of creditor workout, or the commencement of any
proceeding under any bankruptcy or insolvency laws by or against Grantor.
COMMERCIAL SECURITY AGREEMENT
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Creditor of Forfeiture Proceedings. Commencement of foreclosure or forfeiture proceedings,
whether by judicial proceeding, self-help, repossession or any other method, by any creditor of
Grantor or by any governmental agency against any collateral securing the Indebtedness. This
includes a garnishment of any of Grantors accounts, including deposit accounts, with Lender.
However, this Event of Default shall not apply if there is a good faith dispute by Grantor as to
the validity or reasonableness of the claim which is the basis of the creditor or forfeiture
proceeding and if Grantor gives Lender written notice of the creditor or forfeiture proceeding and
deposits with Lender monies or a surety bond for the creditor or forfeiture proceeding, in an
amount determined by Lender, in its sole discretion, as being an adequate reserve or bond for the
dispute.
Events Affecting Guarantor. Any of the preceding events occurs with respect to any guarantor,
endorser, surety, or accommodation party of any of the Indebtedness or guarantor, endorser, surety,
or accommodation party dies or becomes incompetent or revokes or disputes the validity of, or
liability under, any Guaranty of the indebtedness.
Adverse Change. A material adverse change occurs in Grantors financial condition, or Lender
believes the prospect of payment or performance of the indebtedness is impaired.
Insecurity. Lender in good faith believes itself insecure.
Cure Provisions. If any default, other than a default in payment is curable and if Grantor has not
been given a notice of a breach of the same provision of this Agreement within the preceding twelve
(12) months, it may be cured if Grantor, after receiving written notice from Lender demanding cure
of such default: (1) cures the default within fifteen (15) days: or (2) if the cure requires more
than fifteen (15) days, immediately initiates steps which Lender deems in Lenders sole discretion
to be sufficient to cure the default and thereafter continues and completes all reasonable and
necessary steps sufficient to produce compliance as soon as reasonably practical.
RIGHTS AND REMEDIES ON DEFAULT. If an Event of Default occurs under this Agreement, at any time
thereafter, Lender shall have all the rights of a secured party under the Minnesota Uniform Commercial Code. In addition and without
limitation, Lender may exercise any one or more of the following rights and remedies:
Accelerate Indebtedness. Lender may declare the entire Indebtedness, including any prepayment
penalty which Grantor would be required to pay, immediately due and payable, without notice of any
kind to Grantor.
Assemble Collateral. Lender may require Grantor to deliver to Lender all or any portion of the
Collateral and any and all certificates of title and other documents relating to the Collateral.
Lender may require Grantor to assemble the Collateral and make it available to Lender at a place to
be designated by Lender. Lender also shall have full power to enter upon the property of Grantor to
take possession of and remove the Collateral. If the Collateral contains other goods not covered by
this Agreement at the time of repossession, Grantor agrees Lender may take such other goods,
provided that Lender makes reasonable efforts to return them to Grantor after repossession.
Sell the Collateral. Lender shall have full power to sell, lease, transfer, or otherwise deal with
the Collateral or proceeds thereof in Lenders own name or that of Grantor. Lender may sell the Collateral at public auction or private sale.
Unless the Collateral threatens to decline speedily in value or is of a type customarily sold on a recognized market, Lender will give
Grantor, and other persons as required by law, reasonable notice of the time and place of any public sale, or the time after which any private
sale or any other disposition of the Collateral is to be made. However, no notice need be provided to any person who, after Event of Default occurs,
enters into and authenticates an agreement waiving that persons right to notification of sale. The Requirements of reasonable
notice shall be met if such notice is given at
least ten (10) days before the time of the sale or disposition. All expenses relating to the
disposition of the Collateral, including without
limitation the expenses of retaking, holding, insuring, preparing for sale and selling the
Collateral, shall become a part of the Indebtedness
secured by this Agreement and shall be payable on demand, with interest at the Note rate from date
of expenditure until repaid.
Appoint Receiver. Lender shall have the right to have a receiver appointed to take possession of
all or any part of the Collateral, with the power to protect and preserve the Collateral, to
operate the Collateral preceding foreclosure or sale, and to collect the Rents from the Collateral
and apply the proceeds, over and above the cost of the receivership, against the Indebtedness. The
receiver may serve without bond if permitted by law. Lenders right to the appointment of a
receiver shall exist, whether or not the apparent value of the Collateral exceeds the Indebtedness
by a substantial amount. Employment by Lender shall not disqualify a person from serving as a
receiver.
Collect Revenues, Apply Accounts. Lender, either itself or through a receiver, may collect the
payments, rents, income, and revenues from the Collateral. Lender may at any time in Lenders
discretion transfer any Collateral into Lenders own name or that of Lenders nominee and receive
the payments, rents, income, and revenues therefrom and hold the same as security for the
Indebtedness or apply it to payment of the indebtedness in such order of preference as Lender may
determine. Insofar as the Collateral consists of accounts, general intangibles, insurance policies,
instruments, chattel paper, choses in action, or similar property, Lender may demand, collect,
receipt for, settle, compromise, adjust, sue for, foreclose, or realize on the Collateral as Lender
may determine, whether or not Indebtedness or Collateral is then due. For these purposes, Lender
may, on behalf of and in the name of Grantor, receive, open and dispose of mail addressed to
Grantor; change any address to which mail and payments are to be sent; and endorse notes, checks,
drafts, money orders, documents of title, instruments and items pertaining to payment, shipment, or
storage of any Collateral. To facilitate collection, Lender may notify account debtors and obligors
on any Collateral to make payments directly to Lander.
Obtain Deficiency. If Lender chooses to sell any or all of the Collateral, Lender may obtain a
judgment against Grantor for any deficiency remaining on the Indebtedness due to Lender after
application of all amounts received from the exercise of the rights provided in this Agreement.
Grantor shall be liable for a deficiency even if the transaction described in this subsection is a
sale of accounts or chattel paper,
Other Rights and Remedies. Lender shall have all the rights and remedies of a secured creditor
under the provisions of the Uniform Commercial Code, as may be amended from time to time, in
addition, Lender shall have and may exercise any or all other rights and remedies it may have
available at law, in equity, or otherwise.
Election of Remedies. Except as may be prohibited by applicable law, all of Lenders rights and
remedies, whether evidenced by this Agreement, the Related Documents, or by any other writing,
shall be cumulative and may be exercised singularly or concurrently. Election by Lender to pursue
any remedy shall not exclude pursuit of any other remedy, arid an election to make expenditures or
to take action to perform an obligation of Grantor under this Agreement, after Grantors failure to
perform, shall not affect Lenders right to declare a default and exercise its remedies.
MISCELLANEOUS PROVISIONS. The following miscellaneous provisions are a part of this Agreement:
Amendments. This Agreement, together with any Related Documents, constitutes the entire
understanding and agreement of the parties as to the matters set forth in this Agreement. No
alteration of or amendment to this Agreement shall be effective unless given in writing and signed
by the party or parties sought to be charged or bound by the alteration or amendment.
Attorneys Fees; Expenses. Grantor agrees to pay upon demand all of Lenders costs and expenses,
including Lenders reasonable attorneys fees and Lenders legal expenses, incurred in connection
with the enforcement of this Agreement. Lender may hire or pay
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someone else to help enforce this Agreement, and Grantor shall pay the costs and expenses of
such enforcement. Costs and expenses include Lenders reasonable attorneys fees and legal expenses
whether or not there is a lawsuit, including reasonable attorneys fees and legal expenses for
bankruptcy proceedings (including efforts to modify or vacate any automatic stay or injunction),
appeals, and any anticipated post-judgment collection services. Grantor also shall pay all court
costs and such additional fees as may be directed by the court.
Caption Headings. Caption headings in this Agreement are for convenience purposes only and are not
to be used to interpret or define the provisions of this Agreement.
Governing Law. This Agreement will be governed by federal law applicable to Lender and, to
the extent not preempted by federal law, the laws of the State of Minnesota without regard to its
conflicts of law provisions. This Agreement has been accepted by Lender in the State of
Minnesota.
No Waiver by Lender. Lender shall not be deemed to have waived any rights under this Agreement
unless such waiver is given in writing and signed by Lender. No delay or omission on the part of
Lender in exercising any right shall operate as a waiver of such right or any other right. A waiver
by Lender of a provision of this Agreement shall not prejudice or constitute a waiver of Lenders
right otherwise to demand strict compliance with that provision or any other provision of this
Agreement. No prior waiver by Lender, nor any course of dealing between Lender and Grantor, shall
constitute a waiver of any of Lenders rights or of any of Grantors obligations as to any future
transactions. Whenever the consent of Lender is required under this Agreement, the granting of such
consent by Lender in any instance shall not constitute continuing consent to subsequent instances
where such consent is required and in all cases such consent may be granted or withheld in the sole
discretion of Lender.
Notices. Any notice required to be given under this Agreement shall be given in writing, and shall
be effective when actually delivered, when actually received by
telefacsimile (unless otherwise
required by law), when deposited with a nationally recognized overnight courier, or, if mailed,
when deposited in the United States mail, as first class, certified or registered mail postage
prepaid, directed to the addresses shown near the beginning of this Agreement. Any party may change
its address for notices under this Agreement by giving formal written notice to the other parties,
specifying that the purpose of the notice is to change the partys address. For notice purposes,
Grantor agrees to keep Lender informed at all times of Grantors current address. Unless otherwise
provided or required by law, if there is more than one Grantor, any notice given by Lender to any
Grantor is deemed to be notice given to all Grantors.
Power of Attorney. Grantor hereby appoints Lender as Grantors irrevocable attorney-in-fact for the
purpose of executing any documents necessary to perfect, amend, or to continue the security
interest granted in this Agreement or to demand termination of filings of other secured parties.
Lender may at any time, and without further authorization from Grantor, file a carbon, photographic
or other reproduction of any financing statement or of this Agreement for use as a financing
statement. Grantor will reimburse Lender for all expenses for the perfection and the continuation
of the perfection of Lenders security interest in the Collateral.
Saverability. If a court of competent jurisdiction finds any provision of this Agreement to be
illegal, invalid, or unenforceable as to any circumstance, that finding shall not make the
offending provision illegal, invalid, or unenforceable as to any other circumstance. If feasible,
the offending provision shall be considered modified so that it becomes legal, valid and
enforceable. If the offending provision cannot be so modified, it shall be considered deleted from
this Agreement. Unless otherwise required by law, the illegality, invalidity, or unenforceability
of any provision of this Agreement shall not affect the legality, validity or enforceability of any
other provision of this Agreement.
Successors
and Assigns. Subject to any limitations stated in this Agreement on transfer of
Grantors interest, this Agreement shall be binding upon and inure to the benefit of the parties,
their successors and assigns. If ownership of the Collateral becomes vested in a person other than
Grantor, Lender, without notice to Grantor, may deal with Grantors successors with reference to
this Agreement and the Indebtedness by way of forbearance or extension without releasing Grantor
from the obligations of this Agreement or liability under the Indebtedness.
Survival of Representations and Warranties. All representations, warranties, and agreements made by
Grantor in this Agreement shall survive the execution and delivery of this Agreement, shall be
continuing in nature, and shall remain in full force and effect until such time as Grantors
Indebtedness shall be paid in full.
Time is of the Essence. Time is of the essence in the performance of this Agreement.
DEFINITIONS. The following capitalized words and terms shall have the following meanings when used
in this Agreement. Unless specifically stated to the contrary, all references to dollar amounts
shall mean amounts in lawful money of the United States of America. Words and terms used in the
singular shall include the plural, and the plural shall include the singular, as the context may
require. Words and terms not otherwise defined in this Agreement shall have the meanings attributed
to such terms in the Uniform Commercial Code:
Agreement. The word Agreement means this Commercial Security Agreement, as this Commercial
Security Agreement may be amended or modified from time to time, together with all exhibits and
schedules attached to this Commercial Security Agreement from time to time.
Borrower. The word Borrower means Uroplasty, Inc. and includes all co-signers and co-makers
signing the Note and all their successors and assigns.
Collateral. The word Collateral means all of Grantors right, title and interest in and to all
the Collateral as described in the Collateral Description section of
this Agreement.
Default. The word Default means the Default set forth in this Agreement in the section titled
Default.
Environmental Laws. The words Environmental Laws mean any and all state, federal and local
statutes, regulations and ordinances relating to the protection of human health or the environment,
including without limitation the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980, as amended, 42 U.S.C. Section 9601, et seq. (CERCLA), the Superfund Amendments and
Reauthorization Act of 1986, Pub. L. No. .99-499 (SARA), the Hazardous Materials Transportation
Act, 49 U.S.C. Section 1801, et seq., the Resource Conservation and Recovery Act, 42 U.S.C. Section
6901, et seq., or other applicable state or federal laws, rules, or regulations adopted pursuant
thereto or common law, and shall also include pollutants, contaminants, polychlorinated biphenyls,
asbestos, urea formaldehyde, petroleum and petroleum products, and agricultural chemicals.
Event of Default. The words Event of Default mean any of the events of default set forth in this
Agreement in the default section of this Agreement.
Grantor. The word Grantor means Uroplasty, Inc..
Guaranty. The word Guaranty means the guaranty from guarantor, endorser, surety, or accommodation
party to Lender, including without limitation a guaranty of all or part of the Note.
Hazardous Substances. The words Hazardous Substances mean materials that, because of their
quantity, concentration or physical, chemical or infectious characteristics, may cause or pose a
present or potential hazard to human health or the environment when
COMMERCIAL SECURITY AGREEMENT
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Loan No: 11808
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(Continued)
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improperly used, treated, stored, disposed of, generated, manufactured, transported or
otherwise handled. The words Hazardous Substances are used in their very broadest sense and
include without limitation any and all hazardous or toxic substances, materials or waste as defined
by or listed under the Environmental Laws. The term Hazardous Substances also includes, without
limitation, petroleum and petroleum by-products or any fraction thereof and asbestos.
Indebtedness. The word Indebtedness means the indebtedness evidenced by the Note or Related
Documents, including all principal and interest together with all other indebtedness and costs and
expenses for which Grantor is responsible under this Agreement or under any of the Related
Documents. Specifically, without limitation, Indebtedness includes all amounts that may be
indirectly secured by the Cross-Collateralization provision of this Agreement.
Lender. The word Lender means Venture Bank, its successors and assigns.
Note. The word Note means the Note executed by Uroplasty, Inc. in the principal amount of
$1,000,000.00 dated May 31, 2006, together with all renewals of, extensions of, modifications of,
refinancings of, consolidations of, and substitutions for the note or credit agreement.
Property. The word Property means all of Grantors right, title and interest in and to all the
Property as described in the Collateral Description section of this Agreement.
Related Documents. The words Related Documents mean all promissory notes, credit agreements, loan
agreements, environmental agreements, guaranties, security agreements, mortgages, deeds of trust,
security deeds, collateral mortgages, and all other instruments, agreements and documents, whether
now or hereafter existing, executed in connection with the Indebtedness.
GRANTOR HAS READ AND UNDERSTOOD ALL THE PROVISIONS OF THIS COMMERCIAL SECURITY AGREEMENT AND AGREES
TO ITS TERMS. THIS AGREEMENT IS DATED MAY 31, 2006.
GRANTOR:
UROPLASTY, INC.
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By:
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/s/ Mahedi A. Jiwani
Mahedi A. Jiwani, CFO/Treasurer of Uroplasty, Inc.
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LASER
PRO Lending, Ver. 5.30.10.001 Copr. Harland Financial Solutions,
Inc.1997, 2006. All Rights Reserved. -MN c:\APPS\CFI\CFI\LPL\E40.FC TR-2211 PR-20
Attachment
Attachment to loan documents dated 5-31-2006 and any renewals or extensions thereof. All terms
used in this attachment are as defined in the commercial security agreement dated 5-31-2006.
The foregoing loan documents reference hazardous substances. Lender hereby acknowledges that from
time to time, in the normal course of business, the borrower may have substances on its premises
which would be considered hazardous substances. Borrower warrants that these hazardous substances
are handled, stored, transported and disposed of according to applicable environmental laws.
This acknowledgment does not change any warranties or releases provided by the borrower/grantor to
the lender in the foregoing loan documents.
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/s/ Christine Young
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/s/ Mahedi A. Jiwani |
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Christine Young,
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Mahedi A. Jiwani, |
AVP/Commercial Loan Officer
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CFO/Treasurer |
Venture Bank
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Uroplasty |
BUSINESS LOAN AGREEMENT (ASSET BASED)
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Principal |
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Loan Date |
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Maturity |
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Loan No. |
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Call / Coll |
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Account |
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Officer |
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Initials |
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$1,000,000.00 |
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05-25-2006 |
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05-25-2007 |
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11808 |
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10022 |
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References
in the shaded area are for Lenders use only and do not limit
the applicability of this document to any particular loan or item. Any item above containing *** has been omitted due to
text length limitations.
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Borrower:
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Uroplasty, Inc.
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Lender:
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Venture Bank |
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5420 Feltl Road
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5601 Green Valley Drive, Suite 120 |
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Minnetonka, MN 55343
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Bloomington, MN 55437 |
THIS
BUSINESS LOAN AGREEMENT (ASSET BASED) dated May 25, 2006, is made and executed between Uroplasty, Inc. (Borrower) and Venture Bank (Lender) on the
following terms and conditions. Borrower has received prior commercial loans from Lender or has applied to Lender for a commercial loan or loans or other
financial accommodations, including those which may be described on
any exhibit or schedule attached to this Agreement (Loan). Borrower understands and agrees
that: (A) in granting, renewing, or extending any Loan, Lender is relying upon Borrowers representations, warranties, and agreements as set forth in this
Agreement; (B) the granting, renewing, or extending of any Loan by Lender at all times shall be subject to Lenders sole judgment and discretion; and (C) all
such Loans shall be and remain subject to the terms and conditions of this Agreement.
TERM. This Agreement shall be effective as of May 25, 2006, and shall continue in full force and effect until such time as all of Borrowers Loans in favor of
Lender have been paid in full, including principal, interest, costs, expenses, attorneys fees, and other fees and charges, or until such time as the parties may
agree in writing to terminate this Agreement.
LINE OF CREDIT. Lender agrees to make Advances to Borrower from time to time from the date of this Agreement to the Expiration Date, provided the aggregate
amount of such Advances outstanding at any time does not exceed the
Borrowing Base. Within the foregoing limits, Borrower may borrow, partially or wholly prepay,
and reborrow under this Agreement as follows:
Conditions Precedent to Each Advance. Lenders obligation to make any Advance to or for the account of Borrower under this Agreement is subject to the following
conditions precedent, with all documents, instruments, opinions, reports, and other items required under this Agreement to be in form and substance satisfactory to
Lender:
(1) Lender shall have received evidence that this Agreement and all Related Documents have been duly authorized, executed, and delivered by Borrower to Lender.
(2) Lender shall have received such opinions of counsel, supplemental opinions, and documents as Lender may request.
(3) The
security interests in the Collateral shall have been duly authorized, created, and perfected with first lien priority and shall be in full force and effect.
(4) All guaranties required by Lender for the credit facility(ies) shall have been executed by each Guarantor, delivered to Lender, and be in full force and
effect.
(5) Lender, at its option and for its sole benefit, shall have conducted an audit of Borrowers Accounts, Inventory, books, records, and operations, and Lender
shall be satisfied as to their condition.
(6) Borrower
shall have paid to Lender all fees, costs, and expenses specified in this Agreement and the Related Documents as are then due and payable.
(7) There shall not exist at the time of any Advance a condition which would constitute an Event of Default under this Agreement, and Borrower shall have delivered
to Lender the compliance certificate catted for in the paragraph below titled Compliance Certificate.
Making
Loan Advances. Advances under this credit facility, as well as directions for payment from Borrowers accounts, may be requested orally or in writing by
authorized persons. Lender may, but need not, require that all oral requests be confirmed in writing. Each Advance shall be conclusively deemed to have been made
at the request of and for the benefit of Borrower (1) when credited to any deposit account of Borrower maintained with Lender or (2) when advanced in accordance
with the instructions of an authorized person. Lender, at its option,
may set a cutoff time, after which all requests for Advances will be treated as having been
requested on the next succeeding Business Day.
Mandatory Loan Repayments. If at any time the aggregate principal amount of the outstanding Advances shall exceed the applicable Borrowing Base, Borrower,
immediately upon written or oral notice from Lender, shall pay to Lender an amount equal to the difference between the outstanding principal balance of the
Advances and the Borrowing Base. On the Expiration Date, Borrower shall pay to Lender in full the aggregate unpaid principal amount of all Advances then
outstanding and all accrued unpaid interest, together with all other applicable fees, costs and charges, if any, not yet paid.
Loan Account. Lender shall maintain on its books a record of account in which Lender shall make entries for each Advance and such other debits and credits as shall
be appropriate in connection with the credit facility. Lender shall provide Borrower with periodic statements of Borrowers account, which statements shall be
considered to be correct and conclusively binding on Borrower unless Borrower notifies Lender to the contrary within thirty (30) days after Borrowers receipt of
any such statement which Borrower deems to be incorrect.
COLLATERAL. To secure payment of the Primary Credit Facility and performance of all other Loans, obligations and duties owed by Borrower to Lender, Borrower (and
others, if required) shall grant to Lender Security Interests in such property and assets as Lender may require. Lenders Security Interests in the Collateral
shall be continuing liens and shall include the proceeds and products of the Collateral, including without limitation the proceeds of any insurance. With respect
to the Collateral, Borrower agrees and represents and warrants to Lender:
Perfection of Security Interests. Borrower agrees to execute all documents perfecting Lenders Security Interest and to take whatever actions are requested by
Lender to perfect and continue Lenders Security Interests in the Collateral. Upon request of Lender, Borrower will deliver to Lender any and all of the documents
evidencing or constituting the Collateral, and Borrower will note Lenders interest upon any and all chattel paper and instruments if not delivered to Lender for
possession by Lender. Contemporaneous with the execution of this Agreement, Borrower will execute one or more UCC financing statements and any similar statements
as may be required by applicable law, and Lender will file such financing statements and all such similar statements in the appropriate location or locations.
Borrower hereby appoints Lender as its irrevocable attorney-in-fact for the purpose of executing any documents necessary to perfect or to continue any Security
Interest. Lender may at any time, and without further authorization from Borrower, file a carbon, photograph, facsimile, or other reproduction of any financing
statement for use as a financing statement. Borrower will reimburse Lender for all expenses for the perfection, termination, and the continuation of the
perfection of Lenders security interest in the Collateral. Borrower promptly will notify Lender before any change in Borrowers name including any change to the
assumed business names of Borrower. Borrower also promptly will notify Lender before any change in Borrowers Social Security Number or Employer Identification
Number. Borrower further agrees to notify Lender in writing prior to any change in address or location of Borrowers principal governance office or should
Borrower merge or
BUSINESS LOAN AGREEMENT (ASSET BASED)
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Loan No: 11808
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(Continued)
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consolidate With any other entity.
Collateral Records. Borrower does now, and at all times hereafter shall, keep correct and accurate
records of the Collateral, all of which records shall be available to Lender or Lenders
representative upon demand for inspection and copying at any reasonable time. With respect to the
Accounts, Borrower agrees to keep and maintain such records as Lender may require, including
without limitation information concerning Eligible Accounts and Account balances and agings.
Records related to Accounts (Receivables) are or will be
located at. With respect to the Inventory, Borrower agrees to keep and maintain such records as
Lender may require, including without limitation information concerning Eligible Inventory and
records itemizing and describing the kind, type, quality, and
quantity of Inventory, Borrowers
Inventory costs and selling prices, and the daily withdrawals and additions to Inventory. Records
related to Inventory are or will be located at. The above is an accurate and complete list of all
locations at which Borrower keeps or maintains business records concerning Borrowers collateral.
Collateral Schedules. Concurrently with the execution and delivery of this Agreement, Borrower
shall execute and deliver to Lender schedules of Accounts and Inventory and schedules of Eligible
Accounts and Eligible Inventory in form and substance satisfactory to the Lender. Thereafter
supplemental schedules shall be delivered according to the following schedule:
Representations and Warranties Concerning Accounts. With respect to the Accounts, Borrower
represents and warrants to Lender: (1) Each Account represented by Borrower to be an Eligible
Account for purposes of this Agreement conforms to the requirements of the definition of an
Eligible Account; (2) All Account information listed on schedules delivered to Lender will be true
and correct, subject to immaterial variance; and (3) Lender, its assigns, or agents shall have the
right at any time and at Borrowers expense to inspect, examine, and audit Borrowers records and
to confirm with Account Debtors the accuracy of such Accounts.
Representations and Warranties Concerning Inventory. With respect to the Inventory, Borrower
represents and warrants to Lender: (1) All Inventory represented by Borrower to be Eligible
Inventory for purposes of this Agreement conforms to the requirements of the definition of Eligible
Inventory; (2) All Inventory values listed on schedules delivered to Lender will be true and
correct, subject to immaterial variance; (3) The value of the Inventory will be determined on a
consistent accounting basis; (4) Except as agreed to the contrary by Lender in writing, all
Eligible Inventory is now and at all times hereafter will be in Borrowers physical possession and
shall not be held by others on consignment, sale on approval, or sale or return; (5) Except as
reflected in the Inventory schedules delivered to Lender, all Eligible Inventory is now and at all
times hereafter will be of good and merchantable quality, free from defects; (6) Eligible Inventory
is not now and will not at any time hereafter be stored with a bailee, warehouseman, or similar
party without Lenders prior written consent, and, in such event. Borrower will concurrently at the
time of bailment cause any such bailee, warehouseman, or similar party to issue and deliver to
Lender, in form acceptable to Lender, warehouse receipts in Lender name evidencing the storage of
Inventory; and (7) Lender, its assigns, or agents shall have the right at any time and at
Borrowers expense to inspect and examine the Inventory and to check and test the same as to
quality, quantity, Value, and condition.
CONDITIONS PRECEDENT TO EACH ADVANCE. Lenders obligation to make the initial Advance and each
subsequent Advance under this Agreement shall be-subject to the fulfillment to Lenders
satisfaction of all of the conditions set forth in this Agreement and in the Related Documents.
Loan Documents. Borrower shall provide to Lender the following documents for the Loan: (1) the
Note; (2) Security Agreements granting to Lender security interests in the Collateral; (3)
financing statements and all other documents perfecting Lenders Security interests; (4) evidence
of insurance as required below; (5) together with all such Related Documents as Lender may require
for the Loan; all in form and substance satisfactory to Lender and
Lenders counsel.
Borrowers Authorization. Borrower shall have provided in form and substance satisfactory to Lender
properly certified resolutions, duly authorizing the execution and delivery of this Agreement, the
Note and the Related Documents. In addition, Borrower shall have provided such other resolutions,
authorizations, documents and instruments as Lender or its counsel,
may require.
Fees and Expenses Under This Agreement. Borrower shall have paid to Lender all fees, costs, and
expenses specified in this Agreement and the Related Documents as are then due and payable.
Representations and Warranties. The representations and warranties set forth in this Agreement, in
the Related Documents, and in any document or certificate delivered to Lender under this Agreement
are true and correct.
No Event of Default. There shall not exist at the time of any Advance a condition which would
constitute an Event of Default under this Agreement or under any Related Document.
REPRESENTATIONS AND WARRANTIES. Borrower represents and warrants to Lender, as of the date of this
Agreement, as of the date of each disbursement of loan proceeds, as of the date of any renewal,
extension or modification of any Loan, and at all times any Indebtedness exists:
Organization. Borrower is a corporation for profit which is, and at all times shall be, duly
organized, validity existing, and in good standing under and by virtue of the laws of the State of
Minnesota. Borrower is duly authorized to transact business in all other states in which Borrower
is doing business, having obtained all necessary filings, governmental licenses and approvals for
each state in which Borrower is doing business. Specifically, Borrower is, and at all times shall
be, duly qualified as a foreign corporation in all states in which the failure to so qualify would
have a material adverse effect on its business or financial condition. Borrower has the full power
and authority to own its properties and to transact the business in which it is presently engaged
or presently proposes to engage. Borrower maintains an office at 5420 Felti Road, Minnetonka, MN
55343. Unless Borrower has designated otherwise in writing, the principal office is the office at
which Borrower keeps its books and records its including its records concerning the Collateral.
Borrower will notify Lender prior to any change in the location of Borrowers state of organization
or any change in Borrowers name. Borrower shall do all things necessary to preserve and to keep in
full force and effect its existence, rights and privileges, and shall comply with all regulations,
rules, ordinances, statutes, orders and decrees of any governmental or quasi-governmental authority
or court applicable to Borrower and Borrowers business activities.
Assumed Business Names. Borrower has filed or recorded all documents or filings required by law
relating to all assumed business names used by Borrower. Excluding the name of Borrower, the
following is a complete list of all assumed business names under which Borrower does business:
None.
Authorization. Borrowers execution, delivery, and performance of this Agreement and all the
Related Documents have been duly authorized by all necessary action by Borrower and do not conflict
with, result in a violation of, or constitute a default under (1) any provision of (a) Borrowers
articles of incorporation or organization, or bylaws, or (b) any agreement or other instrument
binding upon Borrower or (2) any law, governmental regulation, court decree, or order applicable to
Borrower or to Borrowers properties.
Financial Information. Each of Borrowers financial statements supplied to Lender truly and
completely disclosed Borrowers financial condition as of the date of the statement, and there has
been no material adverse change in Borrowers financial condition subsequent to the date of the
most recent financial statement supplied to Lender. Borrower has no material contingent obligations
except as disclosed in such financial statements.
BUSINESS LOAN AGREEMENT (ASSET BASED)
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Loan No: 11808
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(Continued)
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Page 3 |
Legal Effect. This Agreement constitutes, and any instrument or agreement Borrower is required
to give under this Agreement when delivered will constitute legal, valid, and binding obligations
of Borrower enforceable against Borrower in accordance with their respective terms.
Properties. Except as contemplated by this Agreement or as previously disclosed in Borrowers
financial statements or in writing to Lender and as accepted by Lender, and except for property tax
liens for taxes not presently due and payable, Borrower owns and has good title to all of
Borrowers properties free and clear of all Security Interests, and has not executed any security
documents or financing statements relating to such properties. Ail of Borrowers properties are
titled in Borrowers legal name, and Borrower has not used or filed a financing statement under any
other name for at least the last five (5) years.
Hazardous Substances. Except as disclosed to and acknowledged by Lender in writing. Borrower
represents and warrants that: (1) During the period of Borrowers ownership of the Collateral,
there has been no use, generation, manufacture, storage, treatment, disposal, release or threatened
release of any Hazardous Substance by any person on, under, about or from any of the Collateral.
(2) Borrower has no knowledge of, or reason to believe that there has been (a) any breach or
violation of any Environmental Laws; (b) any use, generation, manufacture, storage, treatment,
disposal, release or threatened release of any Hazardous Substance on, under, about or from the
Collateral by any prior owners or occupants of any of the Collateral; or (c) any actual or
threatened litigation or claims of any kind by any person relating to such matters. (3) Neither
Borrower nor any tenant, contractor, agent or other authorized user of any of the Collateral shall
use, generate, manufacture, store, treat, dispose of or release any Hazardous Substance on, under,
about or from any of the Collateral; and any such activity shall be conducted in compliance with
all applicable federal, state, and local laws, regulations, and ordinances, including without
limitation all Environmental Laws. Borrower authorizes Lender and its agents to enter upon the
Collateral to make such inspections and tests as Lender may deem appropriate to determine
compliance of the Collateral with this section of the Agreement. Any inspections or tests made by
Lender shall be at Borrowers expense and for Lenders purposes only and shall not be construed to
create any responsibility or liability on the part of Lender to Borrower or to any other person.
The representations and warranties contained herein are based on Borrowers due diligence in
investigating the Collateral for hazardous waste and Hazardous Substances. Borrower hereby (1)
releases and waives any future claims against Lender for indemnity or contribution in the event
Borrower becomes liable for cleanup or other costs under any such
laws, and (2) agrees to indemnify
and hold harmless Lender against any and all claims, losses, liabilities, damages, penalties, and
expenses, including attorneys fees, consultants fees, and costs which Lender may directly or
indirectly sustain or suffer resulting from a breach of this section of the Agreement or as a
consequence of any use, generation, manufacture, storage, disposal, release or threatened release
of a hazardous waste or substance on the Collateral. The provisions of this section of the
Agreement, including the obligation to indemnify, shall survive the payment of the Indebtedness and
the termination, expiration or satisfaction of this Agreement and shall not be affected by Lenders
acquisition of any interest in any of the Collateral, whether by foreclosure or otherwise.
Litigation and Claims. No litigation, claim, investigation, administrative proceeding or similar
action (including those for unpaid taxes) against Borrower is pending or threatened, and no other
event has occurred which may materially adversely affect Borrowers financial condition or
properties, other than litigation, claims, or other events, if any, that have been disclosed to and
acknowledged by Lender in writing.
Taxes. To the best of Borrowers knowledge, all of Borrowers tax returns and reports that are or
were required to be filed, have been filed, and all taxes, assessments and other governmental
charges have been paid in full, except those presently being or to be contested by Borrower in good
faith in the ordinary course of business and for which adequate reserves have been provided.
Lien Priority. Unless otherwise previously disclosed to Lender in writing, Borrower has not entered
into or granted any Security Agreements, or permitted the fling or attachment of any Security
Interests on or affecting any of the Collateral directly or indirectly securing repayment of
Borrowers Loan and Note, that would be prior or that may in any way be superior to tenders
Security Interests and rights in and to such Collateral.
Binding Effect. This Agreement, the Note, all Security Agreements (if any), and all Related
Documents are binding upon the signers thereof, as well as upon their successors, representatives
and assigns, and are legally enforceable in accordance with their respective terms.
AFFIRMATIVE COVENANTS. Borrower covenants and agrees with Lender that, so long as this Agreement
remains in effect, Borrower will:
Notices of Claims and Litigation. Promptly inform Lender in writing of (1) all material adverse
changes in Borrowers financial condition, and (2) all existing and all threatened litigation,
claims, investigations, administrative proceedings or similar actions affecting Borrower or any
Guarantor which could materially affect the financial condition of Borrower or the financial
condition of any Guarantor.
Financial Records. Maintain its books and records in accordance with GAAP, applied on a consistent
basis, and permit Lender to examine and audit Borrowers books
and records at all reasonable times.
Financial Statements. Furnish Lender with the following:
Additional Requirements.
1. As soon as available, but in no event later than thirty (30) days after the end of each
quarter the Borrowers Accounts Receivable Aging.
2. As soon as available, but in no event later than one-hundred-thirty five (135)days after the
end of each fiscal year, Borrowers 10-K for the year ended.
3. As soon as available, but in no event later than sixty (60)days after end of each quarter,
Borrowers 10-Q for the period ended, prepared by Borrower.
All financial reports required to be provided under this Agreement shall be prepared in accordance
with GAAP, applied on a consistent basis, and certified by Borrower as being true and correct.
Additional Information. Furnish such additional information and statements, as Lender may request
from time to time.
Financial Covenants and Ratios. Comply with the following covenants and ratios:
Other Requirements.
1. Inventory cap of $500,000.00 on Advances
2. Line advances up to $250,000.00, minimum equity of $500,000.00
3. Line advances greater than $250,000.00, minimum equity $1,000,000.00
4. Primary deposit relationship to be held at Venture Bank.
Except as provided above, all computations made to determine compliance with the requirements
contained in this paragraph shall be
BUSINESS LOAN AGREEMENT (ASSET BASED)
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Loan No: 11808
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(Continued)
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made in accordance with generally accepted accounting principles, applied on a consistent
basis, and certified by Borrower as being true and correct.
Insurance. Maintain fire and other risk insurance, public liability insurance, and such other
insurance as Lender may require with respect to Borrowers properties and operations, in form,
amounts, coverages and with insurance companies acceptable to Lender. Borrower, upon request of
Lender, will deliver to Lender from time to time the policies or certificates of insurance in form
satisfactory to Lender, including stipulations that coverages will not be cancelled or diminished
without at least ten (10) days prior written notice to Lender. Each insurance policy also shall
include an endorsement providing that coverage in favor of Lender will not be impaired in any way
by any act, omission or default of Borrower or any other person. In connection with all policies
covering assets in which Lender holds or is offered a security interest for the Loans, Borrower
will provide Lender with such lenders loss payable or other endorsements as Lender may require.
Insurance Reports. Furnish to Lender, upon request of Lender, reports on each existing insurance
policy showing such information as Lender may reasonably request, including without limitation the
following: (1) the name of the insurer; (2) the risks insured; (3) the amount of the policy; (4)
the properties insured; (5) the then current property values on the basis of which insurance has
been obtained, and the manner of determining those values; and (6) the expiration date of the
policy. In addition, upon request of Lender (however not more often than annually), Borrower will
have an independent appraiser satisfactory to Lender determine, as applicable, the actual cash
value or replacement cost of any Collateral. The cost of such appraisal shall be paid by Borrower.
Other Agreements. Comply with all terms and conditions of all other agreements, whether now or
hereafter existing, between Borrower and any other party and notify Lender immediately in writing
of any default in connection with any other such agreements.
Loan Proceeds. Use all Loan proceeds solely for Borrowers business operations, unless specifically
consented to the contrary by Lender in writing.
Taxes, Charges and Liens. Pay and discharge when due all of its indebtedness and obligations,
including without limitation all assessments, taxes, governmental charges, levies and liens, of
every kind and nature, imposed upon Borrower or its properties, income, or profits, prior to the
date on which penalties would attach, and all lawful claims that, if unpaid, might become a lien or
charge upon any of Borrowers properties, income, or profits.
Performance. Perform and comply, in a timely manner, with all terms, conditions, and provisions set
forth in this Agreement, in the Related Documents, and in all other instruments and agreements
between Borrower and Lender. Borrower shall notify Lender immediately in writing of any default in
connection with any agreement.
Operations. Maintain executive and management personnel with substantially the same qualifications
and experience as the present executive and management personnel; provide written notice to Lender
of any change in executive and management personnel; conduct its business affairs in a reasonable
and prudent manner.
Environmental Studies. Promptly conduct and complete, at Borrowers expense, all such
investigations, studies, samplings and testings as may- be requested by Lender or any governmental
authority relative to any substance, or any waste or by-product of any substance, defined as toxic
or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or
directive, at or affecting any property or any facility owned, leased or used by Borrower.
Compliance with Governmental Requirements. Comply with all laws, ordinances, and regulations, now
or hereafter in effect, of all governmental authorities applicable to the conduct of Borrowers
properties, businesses and operations, and to the use or occupancy of the Collateral, including
without limitation, the Americans With Disabilities Act. Borrower may contest in good faith any
such law, ordinance, or regulation and withhold compliance during any proceeding, including
appropriate appeals, so long as Borrower has notified Lender in writing prior to doing so and so
long as, in Lenders sole opinion, Lenders interests in the Collateral are not jeopardized. Lender
may require Borrower to post adequate security or a surety bond, reasonably satisfactory to Lender,
to protect Lenders interest.
Inspection. Permit employees or agents of Lender at any reasonable time to inspect any and all
Collateral for the Loan or Loans and Borrowers other properties and to examine or audit Borrowers
books, accounts, and records and to make copies and memoranda of Borrowers books, accounts, and
records. If Borrower now or at any time hereafter maintains any records (including without
limitation computer generated records and computer software programs for the generation of such
records) in the possession of a third party, Borrower, upon request of Lender, shall notify such
party to permit Lender free access to such records at all reasonable times and to provide Lender
with copies of any records it may request, all at Borrowers expense.
Compliance Certificates. Unless waived in writing by Lender, provide Lender at least annually, with
a certificate executed by Borrowers chief financial officer, or other officer or person acceptable
to Lender, certifying that the representations and warranties set forth in this Agreement are true
and correct as of the date of the certificate and further certifying that, as of the date of the
certificate, no Event of Default exists under this Agreement.
Environmental Compliance and Reports. Borrower shall comply in all respects with any and all
Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional
action or omission on Borrowers part or on the part of any third party, on property owned and/or
occupied by Borrower, any environmental activity where damage may result to the environment, unless
such environmental activity is pursuant to and in compliance with the conditions of a permit issued
by the appropriate federal, state or local governmental authorities; shall furnish to Lender
promptly and in any event within thirty (30) days after receipt thereof a copy of any notice,
summons, lien, citation, directive, letter or other communication from any governmental agency or
instrumentality concerning any intentional or unintentional action or omission on Borrowers part
in connection with any environmental activity whether or not there is damage to the environment
and/or other natural resources.
Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds
of trust, security agreements, assignments, financing statements, instruments, documents and other
agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and
to perfect all Security Interests.
LENDERS EXPENDITURES. If any action or proceeding is commenced that would materially affect
Lenders interest in the Collateral or if Borrower fails to comply with any provision of this
Agreement or any Related Documents, including but not limited to Borrowers failure to discharge or
pay when due any amounts Borrower is required to discharge or pay under this Agreement or any
Related Documents, Lender on Borrowers behalf may (but shall not be obligated to) take any action
that Lender deems appropriate, including but not limited to discharging or paying all taxes, liens,
security interests, encumbrances and other claims, at any time levied or placed on any Collateral
and paying all costs for insuring, maintaining and preserving any Collateral. All such expenditures
incurred or paid by Lender for such purposes will then bear interest at the rate charged under the
Note from the date incurred or paid by Lender to the date of repayment by Borrower. All such
expenses will become a part of the Indebtedness and, at Lenders option, will (A) be payable on
demand; (B) be added to the balance of the Note and be apportioned among and be payable with any
installment payments to become due during either (1) the term of any applicable insurance policy;
or (2) the remaining term of the Note; or (C) be treated as a balloon payment which will be due and
payable at the Notes maturity.
NEGATIVE COVENANTS. Borrower covenants and agrees with Lender that while this Agreement is in
effect, Borrower shall not, without the
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prior written consent of Lender:
Indebtedness and Liens. (1) Except for trade debt incurred in the normal course of business and
indebtedness to Lender contemplated by this Agreement, create, incur or assume indebtedness for
borrowed money, including capital leases, (2) sell, transfer, mortgage, assign, pledge, tease,
grant a security interest in, or encumber any of Borrowers assets (except as allowed as Permitted
Liens), or (3) sell with recourse any of Borrowers accounts, except to Lender.
Continuity of Operations. (1) Engage in any business activities substantially different than those
in which Borrower is presently engaged, (2) cease operations, liquidate, merge, transfer, acquire
or consolidate with any other entity, change its name, dissolve or transfer or sell Collateral out
of the ordinary course of business, or (3) pay any dividends on Borrowers stock (other than
dividends payable in its stock), provided, however that notwithstanding the foregoing, but only so
long as no Event of Default has occurred and is continuing or would result from the payment of
dividends, if Borrower is a Subchapter S Corporation (as defined in the internal Revenue Code of
1986, as amended), Borrower may pay cash dividends on its stock to its shareholders from time to
time in amounts necessary to enable the shareholders to pay income taxes and make estimated income
tax payments to satisfy their liabilities under federal and state law which arise solely from their
status as Shareholders of a Subchapter S Corporation because of their ownership of shares of
Borrowers stock, or purchase or retire any of Borrowers outstanding shares or alter or amend
Borrowers capital structure.
Loans, Acquisitions and Guaranties. (1) Loan, invest in or advance money or assets to any other
person, enterprise or entity, (2) purchase, create or acquire any interest in any other enterprise
or entity, or (3) incur any obligation as surety or guarantor other than in the ordinary course of
business.
Agreements. Borrower will not enter into any agreement containing any provisions which would be
violated or breached by the performance of Borrowers obligations under this Agreement or in
connection herewith.
CESSATION OF ADVANCES. If Lender has made any commitment to make any Loan to Borrower, whether
under this Agreement or under any other agreement, Lender shall have no obligation to make Loan
Advances or to disburse Loan proceeds if: (A) Borrower or any Guarantor is in default under the
terms of this Agreement or any of the Related Documents or any other agreement that Borrower or any
Guarantor has with Lender; (B) Borrower or any Guarantor dies, becomes incompetent or becomes
insolvent, files a petition in bankruptcy or similar proceedings, or is adjudged a bankrupt; (C)
there occurs a material adverse change in Borrowers financial condition, in the financial
condition of any Guarantor, or in the value of any Collateral securing any Loan; or (D) any
Guarantor seeks, claims or otherwise attempts to limit, modify or revoke such Guarantors guaranty
of the Loan or any other loan with Lender; or (E) Lender in good faith deems itself insecure,
even though no Event of Default shall have occurred.
RIGHT OF SETOFF. To the extent permitted by applicable law, Lender reserves a right of setoff in
all Borrowers accounts with Lender (whether checking, savings, or some other account). This
includes all accounts Borrower holds jointly with someone else and all accounts
Borrower may open in the future. However, this does not include any IRA or Keogh accounts, or any
trust accounts for which setoff would be prohibited by law. Borrower authorizes Lender, to the
extent permitted by applicable law, to charge or setoff all sums owing on the Indebtedness against
any and all such accounts, and, at Lenders option, to administratively freeze all such accounts to
allow Lender to protect Lenders charge and setoff rights provided in this paragraph.
DEFAULT. Each of the following shall constitute an Event of Default under this Agreement:
Payment Default. Borrower fails to make any payment when due under the Loan.
Other Defaults. Borrower fails to comply with or to perform any other term, obligation, covenant or
condition contained in this Agreement or in any of the Related Documents or to comply with or to
perform any term, obligation, covenant or condition contained in any other agreement between Lender
and Borrower.
False Statements. Any warranty, representation or statement made or furnished to Lender by Borrower
or on Borrowers behalf under this Agreement or the Related Documents is false or misleading in any
material respect, either now or at the time made or furnished or becomes false or misleading at any
time thereafter.
Insolvency. The dissolution or termination of Borrowers existence as a going business, the
insolvency of Borrower, the appointment of a receiver for any part of Borrowers property, any
assignment for the benefit of creditors, any type of creditor workout, or the commencement of any
proceeding under any bankruptcy or insolvency laws by or against Borrower.
Defective Collateralization. This Agreement or any of the Related Documents ceases to be in full
force and effect (including failure of any collateral document to create a valid and perfected
security interest or lien) at any time and for any reason.
Creditor or Forfeiture Proceedings. Commencement of foreclosure or forfeiture proceedings, whether
by judicial proceeding, self-help, repossession or any other method, by any creditor of Borrower or
by any governmental agency against any collateral securing the Loan. This includes a garnishment of
any of Borrowers accounts, including deposit accounts, with Lender. However, this Event of Default
shall not apply if there is a good faith dispute by Borrower as to the validity or reasonableness
of the claim which is the basis of the creditor or forfeiture proceeding and if Borrower gives
Lender written notice of the creditor or forfeiture proceeding and deposits with Lender monies or a
surety bond for the creditor or forfeiture proceeding, in an amount determined by Lender, in its
sole discretion, as being an adequate reserve or bond for the dispute.
Events Affecting Guarantor. Any of the preceding events occurs with respect to any Guarantor of any
of the indebtedness or any Guarantor dies or becomes incompetent, or revokes or disputes the
validity of, or liability under, any Guaranty of the indebtedness. In the event of a death, Lender,
at its option, may, but shall not be required to, permit the
Guarantors estate to assumes
unconditionally the obligations arising under the guaranty in a manner satisfactory to Lender, and,
in doing so, cure any Event of Default.
Change in Ownership. Any change in ownership of twenty-five percent (25%) or more of the common
stock of Borrower.
Adverse Change. A material adverse change occurs in Borrowers financial condition, or Lender
believes the prospect of payment or performance of the Loan is impaired.
Insecurity. Lender in good faith believes itself insecure.
Right to Cure. If any default, other than a default on Indebtedness, is curable and if Borrower or
Grantor, as the case may be, has not been given a notice of a similar default within the preceding
twelve (12) months, it may be cured if Borrower or Grantor, as the case may be, after receiving
written notice from Lender demanding cure of such default: (1) cure the default within fifteen (15)
days; or (2) if the cure requires more than fifteen (15) days, immediately initiate steps which
Lender deems in Lenders sole discretion to be sufficient to cure the default and thereafter
continue and complete all reasonable and necessary steps sufficient to produce compliance as soon
as reasonably practical.
EFFECT OF AN EVENT OF DEFAULT. If any Event of Default shall occur, except where otherwise
provided in this Agreement or the Related Documents, all commitments and obligations of Lender
under this Agreement or the Related Documents or any other agreement immediately will
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terminate (including any obligation to make further Loan Advances or disbursements), and, at
Lenders option, all indebtedness immediately will become due and payable, all without notice of
any kind to Borrower, except that in the case of an Event of Default of the type described in the
Insolvency subsection above, such acceleration shall be automatic and not optional. In addition,
Lender shall have all the rights and remedies provided in the Related Documents or available at
law, in equity, or otherwise. Except as may be prohibited by applicable law, all of Lenders rights
and remedies shall be cumulative and may be exercised singularly or concurrently. Election by
Lender to pursue any remedy shall not exclude pursuit of any other remedy, and an election to make
expenditures or to take action to perform an obligation of Borrower or of any Grantor shall not
affect Lenders right to declare a default and to exercise its rights and remedies.
MISCELLANEOUS PROVISIONS. The following miscellaneous provisions are a part of this Agreement:
Amendments. This Agreement, together with any Related Documents, constitutes the entire
understanding and agreement of the parties as to the matters set forth in this Agreement. No
alteration of or amendment to this Agreement shall be effective unless given in writing and signed
by the party or parties sought to be charged or bound by the alteration or amendment.
Attorneys Fees; Expenses. Borrower agrees to pay upon demand all of Lenders costs and expenses,
including Lenders reasonable attorneys fees and Lenders legal expenses, incurred in connection
with the enforcement of this Agreement. Lender may hire or pay someone else to help enforce this
Agreement, and Borrower shall pay the costs and expenses of such enforcement. Costs and expenses
include Lenders reasonable attorneys fees and legal expenses whether or not there is a lawsuit,
including reasonable attorneys fees and legal expenses for bankruptcy proceedings (including
efforts to modify or vacate any automatic stay or injunction), appeals, and any anticipated
post-judgment collection services. Borrower also shall pay all court costs and such additional fees
as may be directed by the court.
Caption Headings. Caption headings in this Agreement are for convenience purposes only and are not
to be used to interpret or define the provisions of this Agreement.
Consent to Loan Participation. Borrower agrees and consents to Lenders sale or transfer, whether
now or later, of one or more participation interests in the Loan to one or more purchasers, whether
related or unrelated to Lender. Lender may provide, without any limitation whatsoever, to any one
or more purchasers, or potential purchasers, any information or knowledge Lender may have about
Borrower or about any other matter relating to the Loan, and Borrower hereby waives any rights to
privacy Borrower may have with respect to such matters. Borrower additionally waives any and all
notices of sale of participation interests, as well as all notices of any repurchase of such
participation interests. Borrower also agrees that the purchasers of any such participation
interests will be considered as the absolute owners of such interests in the Loan and will have all
the rights granted under the participation agreement or agreements governing the sale of such participation interests. Borrower further waives all rights of offset or counterclaim that it may
have now or later against Lender or against any purchaser of such a participation interest and unconditionally agrees that either Lender or such purchaser may enforce Borrowers obligation under
the Loan irrespective of the failure or insolvency of any holder of any interest in the Loan.
Borrower further agrees that the purchaser of any such participation interests may enforce its
interests irrespective of any personal claims or defenses that Borrower may have against Lender.
Governing Law. This Agreement will be governed by federal law applicable to Lender and, to
the extent not preempted by federal law, the laws of the State of Minnesota without regard to its
conflicts of law provisions. This Agreement has been accepted by Lender in the State of Minnesota.
No Waiver by Lender. Lender shall not be deemed to have waived any rights under this Agreement
unless such waiver is given in writing and signed by Lender. No delay or omission on the part of
Lender in exercising any right shall operate as a waiver of such right or any other right. A waiver
by Lender of a provision of this Agreement shall not prejudice or constitute a waiver of Lenders
right otherwise to demand strict compliance with that provision or any other provision of this
Agreement. No prior waiver by Lender, nor any course of dealing between Lender and Borrower, or
between Lander and any Grantor, shall constitute a waiver of any of Lenders rights or of any of
Borrowers or any Grantors obligations as to any future transactions. Whenever the consent of
Lender is required under this Agreement, the granting of such consent by Lender in any instance
shall not constitute continuing consent to subsequent instances where such consent is required and
in all cases such consent may be granted or withheld in the sole discretion of Lender.
Notices. Any notice required to be given under this Agreement shall be given in writing, and shall
be effective when actually delivered, when actually received by telefacsimile (unless otherwise
required by law), when deposited with a nationally recognized overnight courier, or, if mailed,
when deposited in the United States mail, as first class, certified or registered mail postage
prepaid, directed to the addresses shown near the beginning of this Agreement. Any party may change
its address for notices under this Agreement by giving formal written notice to the other parties,
specifying that the purpose of the notice is to change the partys address. For notice purposes,
Borrower agrees to keep Lender informed at all times of Borrowers current address. Unless
otherwise provided or required by law, if there is more than one Borrower, any notice given by
Lender to any Borrower is deemed to be notice given to all Borrowers.
Severability. If a court of competent jurisdiction finds any provision of this Agreement to be
illegal, invalid, or unenforceable as to any circumstance, that finding shall not make the
offending provision illegal, invalid, or unenforceable as to any other circumstance. If feasible,
the offending provision shall be considered modified so that it becomes legal, valid and
enforceable. If the offending provision cannot be so modified, it shall be considered deleted from
this Agreement. Unless otherwise required by law, the illegality, invalidity, or unenforceability
of any provision of this Agreement shall not affect the legality, validity or enforceability of any
other provision of this Agreement.
Subsidiaries and Affiliates of Borrower. To the extent the context of any provisions of this
Agreement makes it appropriate, including without limitation any representation, warranty or
covenant, the word Borrower as used in this Agreement shall include all of Borrowers
subsidiaries and affiliates. Notwithstanding the foregoing however, under no circumstances shall
this Agreement be construed to require Lender to make any Loan or other financial accommodation to
any of Borrowers subsidiaries or affiliates.
Successors and Assigns. All covenants and agreements by or on behalf of Borrower contained in this
Agreement or any Related Documents shall bind Borrowers successors and assigns and shall inure to
the benefit of Lender and its successors and assigns. Borrower shall not, however, have the right
to assign Borrowers rights under this Agreement or any interest therein, without the prior written
consent of Lender.
Survival of Representations and Warranties. Borrower understands and agrees that in extending Loan
Advances, Lender is relying on all representations, warranties, and covenants made by Borrower in
this Agreement or in any certificate or other instrument delivered by Borrower to Lender under this
Agreement or the Related Documents. Borrower further agrees that regardless of any investigation
made by Lender, all such representations, warranties and covenants will survive the extension of
Loan Advances and delivery to Lender of the Related Documents, shall be continuing in nature, shall
be deemed made and redated by Borrower at the time each Loan Advance is made, and shall remain in
full force and effect until such time as Borrowers Indebtedness shall be paid in full, or until
this Agreement shall be terminated in the manner provided above, whichever is the last to occur.
Time is of the Essence. Time is of the essence in the performance of this Agreement.
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DEFINITIONS. The following capitalized words and terms shall have the following meanings when
used in this Agreement. Unless specifically stated to the contrary, all references to dollar
amounts shall mean amounts in lawful money of the United States of America. Words and terms used in
the singular shall include the plural, and the plural shall include the singular, as the context
may require. Words and terms not otherwise defined in this Agreement shall have the meanings
attributed to such terms in the Uniform Commercial Code. Accounting words and terms not otherwise
defined in this Agreement shall have the meanings assigned to them in accordance with generally
accepted accounting principles as in effect on the date of this Agreement:
Account. The word Account means a trade account, account receivable, other receivable, or other
right to payment for goods sold or services rendered owing to Borrower (or to a third party grantor
acceptable to Lander).
Advance. The word Advance means a disbursement of Loan funds mads, or to be made, to Borrower or
on Borrowers behalf under the terms and conditions of this Agreement.
Agreement. The word Agreement means this Business Loan Agreement (Asset Based), as this Business
Loan Agreement (Asset Based)
may be amended or modified from time to time, together with all exhibits and schedules attached to
this Business Loan Agreement (Asset Based) from time to time.
Borrower. The word Borrower means Uroplasty, Inc. and includes all co-signers and co-makers
signing the Note and all their successors and assigns.
Borrowing Base. The words Borrowing Base mean, as determined by Lender from time to time, the
lesser of (1) $1,000,000.00 or (2) the sum of (a) 80.000% of the aggregate amount of Eligible
Accounts, plus (b) 50.000% of the aggregate amount of Eligible Inventory.
Business Day. The words Business Day mean a day on which commercial banks are open in the State
of Minnesota.
Collateral. The word Collateral means all property and assets granted as collateral security for
a Loan, whether real or personal property, whether granted directly or indirectly, whether granted
now or in the future, and whether granted in the form of a security interest, mortgage, collateral
mortgage, deed of trust, assignment, pledge, crop pledge, chattel mortgage, collateral chattel
mortgage, chattel trust, factors lien, equipment trust, conditional sale, trust receipt, lien,
charge, lien or title retention contract, lease or consignment intended as a security device, or
any other security or lien interest whatsoever, whether created by law, contract, or otherwise. The
word Collateral also includes without limitation all collateral described in the Collateral section
of this Agreement.
Eligible Accounts. The words Eligible Accounts mean at any time, all of Borrowers Accounts which
contain selling terms and conditions acceptable to Lender. The net amount of any Eligible Account
against which Borrower may borrow shall exclude all returns, discounts, credits, and offsets of any
nature. Unless otherwise agreed to by Lender in writing, Eligible Accounts do not include:
(1) Accounts with respect to which the Account Debtor is employee or agent of Borrower.
(2) Accounts with respect to which the Account Debtor is a subsidiary of, or affiliated with
Borrower or its shareholders, officers, or
directors.
(3) Accounts with respect to which goods are placed on consignment, guaranteed sale, or other terms
by reason of which the payment by the Account Debtor may be conditional.
(4) Accounts with respect to which Borrower is or may become liable to the Account Debtor for goods
sold or services rendered by the Account Debtor to Borrower.
(5) Accounts which are subject to dispute, counterclaim, or setoff.
(6) Accounts with respect to which the goods have not been shipped or delivered, or the
services have not been rendered, to the Account Debtor.
(7) Accounts with respect to which Lender, in its sole discretion, deems the creditworthiness or
financial condition of the Account Debtor to be unsatisfactory.
(8) Accounts of any Account Debtor who has filed or has had filed against it a petition in
bankruptcy or an application for relief under any provision of any state or federal bankruptcy,
insolvency, or debtor-in-relief acts; or who has had appointed a trustee, custodian, or receiver
for the assets of such Account Debtor; or who has made an assignment for the benefit of creditors
or has become insolvent or fails generally to pay its debts (including its payrolls) as such debts
become due.
(9) Accounts which have not been paid in full within 90 Days from the invoice date.
(10) Domestic.
Eligible Inventory. The words Eligible Inventory mean, at any time, all of Borrowers Inventory
as defined below, except:
(1) Inventory which is not owned by Borrower free and clear of all security interests, liens,
encumbrances, and claims of third parties.
(2) Inventory which Lender, in its sole discretion, deems to be obsolete, unsalable, damaged,
defective, or unfit for further processing.
Environmental Laws. The words Environmental Laws mean any and all state, faderal and local
statutes, regulations and ordinances relating to the protection of human health or the environment,
including without limitation the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980, as amended, 42 U.S.C. Section 9601, et seq. (CERCLA), the Superfund Amendments and
Reauthorization Act of 1986, Pub. L. No. 99-499 (SARA), the Hazardous Materials Transportation
Act, 49 U.S.C. Section 1801, et seq., the Resource Conservation and Recovery Act, 42 U.S.C. Section
6901, et seq., or other applicable state or federal laws, rules, or regulations adopted pursuant
thereto or common law, and shall also include pollutants, contaminants, polychlorinated biphenyls,
asbestos, urea formaldehyde, petroleum and petroleum products, and agricultural chemicals.
Event of Default. The words Event of Default mean any of the events of default set forth in this
Agreement in the default section of this Agreement.
Expiration Date. The words Expiration Date mean the date of termination of Lenders commitment to
lend under this Agreement.
GAAP. The word GAAP means generally accepted accounting principles.
Grantor. The word Grantor means each and all of the persons or entities granting a Security
Interest in any Collateral for the Loan, including without limitation all Borrowers granting such a
Security Interest.
Guarantor. The word Guarantor means any guarantor, surety, or accommodation party of any or all
of the Loan.
Guaranty. The word Guaranty means the guaranty from Guarantor to Lender, including without
limitation a guaranty of all or part of the
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Note.
Hazardous Substances. The words Hazardous Substances mean materials that, because of their
quantity, concentration or physical, chemical or infectious characteristics, may cause or pose a
present or potential hazard to human health or the environment when improperly used, treated,
stored, disposed of, generated, manufactured, transported or otherwise handled. The words
Hazardous Substances are used in their very broadest sense and include without limitation any and
all hazardous or toxic substances, materials or waste as defined by or listed under the
Environmental Laws. The term Hazardous Substances also includes, without limitation, petroleum
and petroleum by-products or any fraction thereof and asbestos.
Indebtedness. The word Indebtedness means the indebtedness evidenced by the Note or Related
Documents, including all principal and interest together with all other indebtedness and costs and
expenses for which Borrower is responsible under this Agreement or under any of the Related
Documents.
Inventory. The word Inventory means all of Borrowers raw materials, work in process, finished
goods, merchandise, parts and supplies, of every kind and description, and goods held for sale or
lease or furnished under contracts of service in which Borrower now has or hereafter acquires any
right, whether held by Borrower or others, and all documents of title, warehouse receipts, bills of
lading, and all other documents of every type covering all or any part of the foregoing. Inventory
includes inventory temporarily out of Borrowers custody or possession and all returns on Accounts.
Lender. The word Lender means Venture Bank, its successors and assigns.
Loan. The word Loan means any and all loans and financial accommodations from Lender to Borrower
whether now or hereafter existing, and however evidenced, including without limitation those loans
and financial accommodations described herein or described on any exhibit or schedule attached to
this Agreement from time to time.
Note. The word Note means the Note executed by Uroplasty, Inc. in the principal amount of
$1,000,000.00 dated May 31, 2006, together with all renewals of, extensions of, modifications of,
refinancings of, consolidations of, and substitutions for the note or credit agreement.
Permitted Liens. The words Permitted Liens mean (1) liens and security interests securing
Indebtedness owed by Borrower to Lender; (2) liens for taxes, assessments, or similar charges
either not yet due or being contested in good faith; (3) liens of materialmen, mechanics,
warehousemen, or carriers, or other like liens arising in the ordinary course of business and
securing obligations which are not yet delinquent; (4) purchase money liens or purchase money
security interests upon or in any property acquired or held by Borrower in the ordinary course of
business to secure indebtedness outstanding on the date of this Agreement or permitted to be
incurred under the paragraph of this Agreement titled Indebtedness and Liens; (5) liens and
security interests which, as of the date of this Agreement, have been disclosed to and approved by
the Lender in writing; and (6) those liens and security interests which in the aggregate constitute
an immaterial and insignificant monetary amount with respect to the net value of Borrowers assets.
Primary Credit Facility. The words Primary Credit Facility mean the credit facility described in
the Line of Credit section of this Agreement.
Related Documents. The words Related Documents mean all promissory notes, credit agreements, loan
agreements, environmental agreements, guaranties, security agreements, mortgages, deeds of trust,
security deeds, collateral mortgages, and all other instruments, agreements and documents, whether
now or hereafter existing, executed in connection with the Loan.
Security Agreement. The words Security Agreement mean and include without limitation any
agreements, promises, covenants, arrangements, understandings or other agreements, whether created
by law, contract, or otherwise, evidencing, governing, representing, or creating a Security
Interest.
Security Interest. The words Security Interest mean, without limitation, any and all types of
collateral security, present and future, whether in the form of a lien, charge, encumbrance,
mortgage, deed of trust, security deed, assignment, pledge, crop pledge, chattel mortgage,
collateral chattel mortgage, chattel trust, factors lien, equipment trust, conditional sale, trust
receipt, lien or title retention contract, lease or consignment intended as a security device, or
any other security or lien interest whatsoever whether created by law, contract, or otherwise.
BORROWER ACKNOWLEDGES HAVING READ ALL THE PROVISIONS OF THIS BUSINESS LOAN
AGREEMENT (ASSET BASED) AND BORROWER AGREES TO ITS TERMS. THIS BUSINESS LOAN AGREEMENT
(ASSET BASED) IS DATED MAY 31, 2006.
BORROWER:
UROPLASTY, INC.
|
|
|
By:
|
|
/s/ Mahedi A. Jiwani
Mahedi
A. Jiwani, CFO/Treasurer of Uroplasty, Inc. |
|
|
|
LENDER: |
|
|
|
VENTURE BANK |
|
|
|
|
|
|
By:
|
|
/s/ Christine Young
Authorized
Signer |
LASER
PRO Lending, Ver. 5.300.10.001 Copr. Harland Financial Solutions,
Inc. 1997, 2006. All Rights Reserved. MN C:\APPS\CFI\LPL\C 40.FC
TR-2211 PR-20
DISBURSEMENT REQUEST AND AUTHORIZATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal |
|
Loan Date |
|
|
Maturity |
|
|
Loan No |
|
|
Call / Cell |
|
|
Account |
|
|
Officer |
|
|
Initials |
|
$1,000,000.00 |
|
|
05-31-2006 |
|
|
|
06-02-2007 |
|
|
11808 |
|
|
|
|
|
|
|
|
|
|
10022 |
|
|
|
|
|
References in the shaded area are for Lenders use only and do not limit the applicability of
this document to any particular loan or item.
Any item above containing *** has been omitted due to text length limitations.
|
|
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|
|
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|
Borrower:
|
|
Uroplasty, Inc.
|
|
Lender:
|
|
Venture Bank |
|
|
5420 Feltl Road
|
|
|
|
5601 Green Valley Drive, Suite 120 |
|
|
Minnetonka, MN 55343
|
|
|
|
Bloomington, MN 55437 |
LOAN TYPE. This is a Variable Rate Nondisclosable Revolving Line of Credit Loan to a Corporation
for $1,000,000.00 due on June 2, 2007. The reference rate (Prime rate of interest as published each
business day in the money rates section of The Wall Street Journal, with an interest rate floor of
7.000% currently 8.000%) is added to the margin of 1.000%, resulting in an initial rate of 9.000.
PRIMARY PURPOSE OF LOAN. The primary purpose of this loan is for:
o Maintenance of Borrowers Primary Residence.
o Personal, Family or Household Purposes or Personal Investment.
o Agricultural Purposes.
þ Business Purposes.
SPECIFIC PURPOSE. The specific purpose of this loan is: Working Capital.
DISBURSEMENT INSTRUCTIONS. Borrower understands that no loan proceeds will be disbursed until all
of Lenders conditions for making the loan have been satisfied. Please disburse the loan proceeds
of $1,000,000.00 as follows:
|
|
|
|
|
Undisbursed Funds: |
|
$ |
1,000,000.00 |
|
|
|
|
|
Note Principal:. |
|
$ |
1,000,000.00 |
|
CHARGES PAID IN CASH. Borrower has paid or will pay in cash as agreed the following charges:
|
|
|
|
|
Prepaid Finance Charges Paid in Cash: |
|
$ |
5,000.00 |
|
$5,000.00 Loan Origination Fee |
|
|
|
|
Other Charges Paid in Cash: |
|
$ |
100.00 |
|
$100.00 Loan Documentation Fee |
|
|
|
|
|
|
|
|
Total Charges Paid in Cash: |
|
$ |
5,100.00 |
|
FINANCIAL CONDITION. BY SIGNING THIS AUTHORIZATION, BORROWER REPRESENTS AND WARRANTS TO LENDER THAT
THE INFORMATION PROVIDED ABOVE IS TRUE AND CORRECT AND THAT THERE HAS BEEN NO MATERIAL ADVERSE
CHANGE IN BORROWERS FINANCIAL CONDITION AS DISCLOSED IN BORROWERS MOST RECENT FINANCIAL STATEMENT
TO LENDER. THIS AUTHORIZATION IS DATED MAY 31, 2006.
BORROWER:
UROPLASTY, INC.
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ Mahedi A. Jiwani
Mahedi A. Jiwani, CFO/Treasurer of Uroplasty, Inc.
|
|
|
LASER PRO Lending, Ver. 5.30.10.001 Copr. Harland Financial Solutions, Inc. 1997, 2006. All Rights Reserved. -MN
c:\APPS\CFI\CFI\LPL\I20.FC TR-2211 PR-20
Exhibit 13
UROPLASTY, INC. AND SUBSIDIARIES
Consolidated Financial Statements
March 31, 2006 and 2005
TABLE OF CONTENTS
|
|
|
|
|
Page(s) |
|
Report of Independent Registered Public Accounting Firm |
|
F-2 |
|
|
|
Financial Statements: |
|
|
|
|
|
Consolidated Balance Sheets |
|
F-3 F-4 |
|
|
|
Consolidated Statements of Operations |
|
F-5 |
|
|
|
Consolidated Statements of Shareholders Equity and Comprehensive
Loss |
|
F-6 |
|
|
|
Consolidated Statements of Cash Flows |
|
F-7 |
|
|
|
Notes to Consolidated Financial Statements |
|
F-8 F-20 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders
Uroplasty, Inc.
Minneapolis, Minnesota
We have audited the consolidated balance sheets of Uroplasty, Inc. and Subsidiaries as of March 31,
2006 and 2005, and the related consolidated statements of operations, shareholders equity and
comprehensive loss, and cash flows for the years then ended. These consolidated financial
statements are the responsibility of the Companys management. Our responsibility is to express an
opinion on these consolidated financial statements based on our audits.
We conducted our audits 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. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Uroplasty, Inc. and subsidiaries as of March 31, 2006
and 2005, and the results of their operations and their cash flows for the years then ended in
conformity with accounting principles generally accepted in the United States of America.
/s/ McGladrey & Pullen, LLP
Minneapolis, Minnesota
June 27, 2006
F-2
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,563,433 |
|
|
$ |
1,405,324 |
|
Short-term investments |
|
|
1,137,647 |
|
|
|
87,360 |
|
Accounts receivable, net |
|
|
716,587 |
|
|
|
944,527 |
|
Income tax receivable |
|
|
270,934 |
|
|
|
114,189 |
|
Inventories |
|
|
757,062 |
|
|
|
547,476 |
|
Other |
|
|
353,178 |
|
|
|
161,920 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
4,798,841 |
|
|
|
3,260,796 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,079,438 |
|
|
|
1,040,253 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net of accumulated
amortization of $327,586 and $225,090,
respectively |
|
|
411,604 |
|
|
|
39,100 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
111,361 |
|
|
|
103,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
6,401,244 |
|
|
$ |
4,443,224 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities notes payable |
|
$ |
41,658 |
|
|
$ |
44,606 |
|
Accounts payable |
|
|
506,793 |
|
|
|
362,994 |
|
Accrued liabilities: |
|
|
|
|
|
|
|
|
Compensation and payroll taxes |
|
|
350,558 |
|
|
|
284,255 |
|
Sales tax |
|
|
16,791 |
|
|
|
181 |
|
Royalties |
|
|
12,748 |
|
|
|
24,710 |
|
Clinical |
|
|
21,350 |
|
|
|
12,702 |
|
Audit and tax-consulting |
|
|
109,255 |
|
|
|
45,566 |
|
Legal |
|
|
24,791 |
|
|
|
22,750 |
|
Warrant liability |
|
|
665,356 |
|
|
|
|
|
Other |
|
|
382,488 |
|
|
|
88,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,131,788 |
|
|
|
886,282 |
|
|
|
|
|
|
|
|
|
|
Notes payable less current maturities: |
|
|
389,241 |
|
|
|
461,265 |
|
Accrued pension liability |
|
|
473,165 |
|
|
|
303,781 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,994,194 |
|
|
|
1,651,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock $.01 par value; 20,000,000
shares authorized, 6,937,786 and
4,699,597 shares issued and outstanding
at March 31, 2006 and 2005,
respectively |
|
|
69,378 |
|
|
|
46,996 |
|
Additional paid-in capital |
|
|
14,831,787 |
|
|
|
9,366,644 |
|
Accumulated deficit |
|
|
(11,034,100 |
) |
|
|
(6,491,387 |
) |
Accumulated other comprehensive loss |
|
|
(460,015 |
) |
|
|
(130,357 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
3,407,050 |
|
|
|
2,791,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
6,401,244 |
|
|
$ |
4,443,224 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Years ended March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Net sales |
|
$ |
6,142,612 |
|
|
$ |
6,657,726 |
|
Cost of goods sold |
|
|
1,837,716 |
|
|
|
1,755,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
4,304,896 |
|
|
|
4,902,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
General and administrative |
|
|
2,958,982 |
|
|
|
2,260,240 |
|
Research and development |
|
|
3,324,201 |
|
|
|
2,258,127 |
|
Selling and marketing |
|
|
3,399,896 |
|
|
|
2,015,655 |
|
|
|
|
|
|
|
|
|
|
|
9,683,079 |
|
|
|
6,534,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(5,378,183 |
) |
|
|
(1,631,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Warrant benefit |
|
|
707,320 |
|
|
|
|
|
Interest income |
|
|
142,379 |
|
|
|
30,168 |
|
Interest expense |
|
|
(29,494 |
) |
|
|
(25,934 |
) |
Foreign currency exchange loss |
|
|
(31,195 |
) |
|
|
(15,744 |
) |
Other |
|
|
(413 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
788,597 |
|
|
|
(11,510 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(4,589,586 |
) |
|
|
(1,643,262 |
) |
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
(46,873 |
) |
|
|
91,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,542,713 |
) |
|
$ |
(1,734,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
6,746,412 |
|
|
|
4,651,732 |
|
See accompanying notes to consolidated financial statements.
F-5
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Years ended March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at March 31, 2004 |
|
|
4,584,802 |
|
|
$ |
45,848 |
|
|
$ |
9,130,580 |
|
|
$ |
(4,756,622 |
) |
|
$ |
(315,573 |
) |
|
$ |
4,104,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
38,300 |
|
|
|
383 |
|
|
|
67,638 |
|
|
|
|
|
|
|
|
|
|
|
68,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants conversion |
|
|
68,395 |
|
|
|
684 |
|
|
|
136,107 |
|
|
|
|
|
|
|
|
|
|
|
136,791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee retirement
savings plan contribution |
|
|
8,100 |
|
|
|
81 |
|
|
|
32,319 |
|
|
|
|
|
|
|
|
|
|
|
32,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,734,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional pension
liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,711 |
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,549,549 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2005 |
|
|
4,699,597 |
|
|
|
46,996 |
|
|
|
9,366,644 |
|
|
|
(6,491,387 |
) |
|
|
(130,357 |
) |
|
|
2,791,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from private
placement |
|
|
2,147,142 |
|
|
|
21,471 |
|
|
|
7,493,526 |
|
|
|
|
|
|
|
|
|
|
|
7,514,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of private placement |
|
|
|
|
|
|
|
|
|
|
(934,679 |
) |
|
|
|
|
|
|
|
|
|
|
(934,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reissuance of warrants |
|
|
|
|
|
|
|
|
|
|
(1,372,676 |
) |
|
|
|
|
|
|
|
|
|
|
(1,372,676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant registration costs |
|
|
|
|
|
|
|
|
|
|
(21,324 |
) |
|
|
|
|
|
|
|
|
|
|
(21,324 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidated damages
settlement shares |
|
|
57,381 |
|
|
|
574 |
|
|
|
150,403 |
|
|
|
|
|
|
|
|
|
|
|
150,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
33,666 |
|
|
|
337 |
|
|
|
45,362 |
|
|
|
|
|
|
|
|
|
|
|
45,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extension of employee
options after termination |
|
|
|
|
|
|
|
|
|
|
104,531 |
|
|
|
|
|
|
|
|
|
|
|
104,531 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,542,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(206,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional pension
liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(123,302 |
) |
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,872,371 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
6,937,786 |
|
|
$ |
69,378 |
|
|
$ |
14,831,787 |
|
|
$ |
(11,034,100 |
) |
|
$ |
(460,015 |
) |
|
$ |
3,407,050 |
|
|
See accompanying notes to consolidated financial statements.
F-6
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years ended March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,542,713 |
) |
|
$ |
(1,734,765 |
) |
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
261,496 |
|
|
|
163,879 |
|
Loss on disposal of assets |
|
|
1,343 |
|
|
|
3,751 |
|
Stock-based severance expense |
|
|
104,531 |
|
|
|
|
|
Warrant benefit |
|
|
(707,320 |
) |
|
|
|
|
Deferred tax assets |
|
|
(16,015 |
) |
|
|
23,680 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
163,701 |
|
|
|
168,779 |
|
Inventories |
|
|
(280,505 |
) |
|
|
21,896 |
|
Other current assets |
|
|
(362,009 |
) |
|
|
78,867 |
|
Accounts payable |
|
|
158,381 |
|
|
|
162,526 |
|
Accrued liabilities |
|
|
585,992 |
|
|
|
(221,646 |
) |
Accrued pension liability |
|
|
192,759 |
|
|
|
(38,909 |
) |
Additional pension liability |
|
|
(130,305 |
) |
|
|
36,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(4,570,664 |
) |
|
|
(1,335,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchase of short-term investments |
|
|
(4,768,323 |
) |
|
|
(87,360 |
) |
Proceeds from short-term |
|
|
3,718,036 |
|
|
|
|
|
Payments for property, plant and equipment |
|
|
(252,238 |
) |
|
|
(74,966 |
) |
Payments relating to intangible assets |
|
|
(454,167 |
) |
|
|
(7,277 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(1,756,692 |
) |
|
|
(169,603 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Repayment of notes payable |
|
|
(41,847 |
) |
|
|
(43,356 |
) |
Net proceeds from issuance of common stock and warrants |
|
|
6,604,693 |
|
|
|
204,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
6,562,846 |
|
|
|
161,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(77,381 |
) |
|
|
51,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
158,109 |
|
|
|
(1,292,346 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of year |
|
|
1,405,324 |
|
|
|
2,697,670 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
1,563,433 |
|
|
$ |
1,405,324 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the year for interest |
|
$ |
21,299 |
|
|
$ |
24,751 |
|
Cash paid during the year for income taxes |
|
$ |
94,442 |
|
|
$ |
304,018 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Shares issued for 401(k) plan profit sharing contribution |
|
$ |
|
|
|
$ |
32,400 |
|
Shares issued for liquidated damages settlement |
|
$ |
150,977 |
|
|
$ |
|
|
Additional pension liability, net of tax |
|
$ |
123,302 |
|
|
$ |
(34,711 |
) |
See accompanying notes to consolidated financial statements.
F-7
UROPLASTY, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2006 and 2005
1. |
|
Summary of Significant Accounting Policies |
Nature of Business. Uroplasty, Inc. and subsidiaries (the Company) is a medical device company
that develops, manufactures and markets innovative, proprietary products for the treatment of
voiding dysfunctions. The Company has developed, and is developing, minimally invasive products
primarily for the treatment of urinary and fecal incontinence and overactive bladder symptoms. The
Company currently sells its products in and outside of the United States and is pursuing regulatory
approvals to market additional products in the United States. The Company recently staffed its
sales and marketing organization in the United States. The Company is currently seeking FDA
approval for one of its products and the regulatory process can be costly, lengthy and uncertain.
Principles of Consolidation. The consolidated financial statements include the accounts of the
Company and its wholly owned foreign subsidiaries. All significant intercompany accounts and
transactions have been eliminated.
Revenue Recognition. The Company recognizes revenue upon shipment of product to customers. Upon
shipment, the risks and rewards of ownership are passed on to the buyer. There are no customer
acceptance provisions. The Company sells its products to end users and to distributors who sell to
other distributors and end users. Sales to distributors were approximately $4,000,000 and
$4,700,000 in fiscal 2006 and 2005, respectively, or 65% and 70%, respectively, of net sales.
Payment terms range from prepayment to 60 days. The distributor payment terms are not contingent on
the distributor selling the product to other distributors or end users. Customers do not have the
right to return unsold products to the Company except for warranty claims. The Company offers
customary product warranties. During fiscal 2006, two customers accounted for approximately 14% and
11% of the Companys net sales. During fiscal 2005, the same two customers accounted for
approximately 15% and 11% of the Companys net sales.
Use of Estimates. The preparation of financial statements in conformity with U.S. generally
accepted accounting principles 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 these estimates. The Companys significant
accounting policies and estimates include revenue recognition, accounts receivable, valuation of
inventory, foreign currency translation/transactions, and the determination of recoverability of
long-lived and intangible assets.
Disclosures About Fair Value of Financial Instruments. The following methods and assumption were
used to estimate the fair value of each class of certain financial instruments for which it is
practicable to estimate that value:
|
|
|
Cash equivalents and short-term investments: The carrying amount approximates fair
value because of the short maturity of these instruments. |
|
|
|
|
Notes payable: The fair value of the Companys notes payable are estimated based on the
current rates offered to the Company for similar instruments with the same remaining
maturities and similar collateral requirements. At March 31, 2006 and 2005, the fair value
of the Companys notes payable approximated their carrying value. |
Cash and Cash Equivalents. The Company considers highly liquid debt instruments purchased with an
original maturity of three months or less to be cash equivalents. The Company maintains its cash in
bank accounts, which, at times, exceed federally insured limits. The Company has not experienced
any losses in such accounts.
Short-term Investments. Short-term investments consist of certificates of deposit that mature
within the next twelve months. Based on the short-term nature of these investments their cost
approximates their fair market value.
Accounts Receivable. Accounts receivable are carried at the original invoice amount less an
estimate made for doubtful receivables based on a periodic review of all outstanding amounts. The
Company determines the allowance for doubtful accounts based on customer financial condition, and
both historical and expected credit loss experience. Accounts receivable are written off when
deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when
received. The allowance for doubtful accounts was $42,000 and $218,000 at March 31, 2006 and 2005,
respectively.
Income Taxes. Deferred tax assets and liabilities are recognized for future tax consequences
attributable to differences between the financial carrying amounts of existing assets and
liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using
enacted tax rates expected to be applied to taxable income in the years in which those
F-8
temporary differences are expected to be recovered or settled. During fiscal 2006 and 2005 the Companys
Dutch subsidiaries recorded income tax expense (benefit) of $(46,873) and $91,503 respectively, as
they have fully utilized their
net operating loss carryforwards. The U.S. net operating loss carryforwards cannot be used to
offset taxable income in foreign jurisdictions.
Product Warranty. The Company warrants its new products to be free from defects in material and
workmanship under normal use and service for a period of twelve months after date of sale. Under
the terms of these warranties, the Company is obligated to repair or replace the products it deems
to be defective due to material or workmanship. The Company does not have an accrual for warranty
costs, as warranty claims are infrequent and immaterial.
Inventories. Inventories are stated at the lower of cost (first-in, first-out method) or market
(net realizable value) and consist of the following at March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
340,268 |
|
|
$ |
193,980 |
|
Work-in-process |
|
|
26,183 |
|
|
|
75,337 |
|
Finished goods |
|
|
390,611 |
|
|
|
278,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
757,062 |
|
|
$ |
547,476 |
|
|
|
|
|
|
|
|
Property, Plant, and Equipment. Property, plant, and equipment are carried at cost and consist of
the following at March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
148,402 |
|
|
$ |
158,861 |
|
Building |
|
|
662,882 |
|
|
|
692,646 |
|
Equipment |
|
|
1,531,926 |
|
|
|
1,391,516 |
|
|
|
|
|
|
|
|
|
|
|
2,343,210 |
|
|
|
2,243,023 |
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation |
|
|
(1,263,772 |
) |
|
|
(1,202,770 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,079,438 |
|
|
$ |
1,040,253 |
|
|
|
|
|
|
|
|
Depreciation is provided using the straight-line method over useful lives of three to seven years
for equipment and 40 years for the building. Maintenance and repairs are charged to expense as
incurred. Renewals and improvements are capitalized and depreciated over the shorter of their
estimated useful service lives or the remaining lease term.
Intangible Assets. Intangible assets are comprised of patents, trademarks and licensed technology
which are amortized on a straight-line basis over their estimated useful lives or contractual
terms, whichever is less.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2006 |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Estimated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
Lives (Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
|
5 |
|
|
$ |
501,290 |
|
|
$ |
111,183 |
|
|
$ |
390,107 |
|
Patents and inventions |
|
|
6 |
|
|
|
237,900 |
|
|
|
216,403 |
|
|
|
21,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
739,190 |
|
|
$ |
327,586 |
|
|
$ |
411,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2005 |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
19,718 |
|
|
$ |
6,572 |
|
Patents and inventions |
|
|
6 |
|
|
|
237,900 |
|
|
|
205,372 |
|
|
|
32,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
264,190 |
|
|
$ |
225,090 |
|
|
$ |
39,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-9
Estimated annual amortization for these assets for the years ending March 31, are as follows:
|
|
|
|
|
2007 |
|
$ |
99,000 |
|
2008 |
|
|
97,000 |
|
2009 |
|
|
96,000 |
|
2010 |
|
|
94,000 |
|
2011 |
|
|
26,000 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
412,000 |
|
|
|
|
|
Impairment of Long-Lived Assets. Long-lived assets at March 31, 2006 consist of property, plant and
equipment and intangible assets. The Company reviews its long-lived assets for impairment whenever
events or business circumstances indicate that the carrying amount of an asset may not be
recoverable. Recoverability of assets to be held and used is measured by a comparison of the
carrying amount of an asset to future undiscounted net cash flows expected to be generated by the
asset. If such assets are considered to be impaired, the impairment to be recognized is measured by
the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets
to be disposed of are reported at the lower of the carrying amount or fair value less costs to
sell.
Foreign Currency Translation. All assets and liabilities are translated using period-end
exchange rates and statements of operations items are translated using average exchange rates for
the period. The resulting translation adjustment is recorded within accumulated other
comprehensive loss, a separate component of shareholders equity. Foreign currency transaction
gains and losses are recognized currently in the consolidated statement of operations, including
unrealized gains and losses on short-term inter-company obligations using period-end exchange
rates. Unrealized gains and losses on long-term inter-company obligations are recognized within
accumulated other comprehensive loss, a separate component of shareholders equity.
Exchange gains and losses are recognized primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of the Companys subsidiaries), as well as their effect on the dollar denominated
intercompany obligations between the Company and its foreign subsidiaries. The Company recognized
net foreign currency losses of $31,195 and $15,744 for the years ended March 31, 2006 and 2005,
respectively.
Stock-Based Compensation. The Company applies the intrinsic-value method under APB Opinion No. 25
(APB 25) to account for employee stock-based compensation. As such, compensation expense, if any,
is determined on the date of grant if the current market price of the underlying stock exceeds the
exercise price.
The Company accounts for stock-based instruments granted to non-employees under the fair value
method of Statement of Financial Accounting Standards No.123, Accounting for Stock-Based
Compensation (SFAS No. 123) and Emerging Issues Task Force (EITF) 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. Under SFAS No. 123, options are recorded at their fair value on the measurement
date, which is typically the vesting date.
F-10
Had the Company determined compensation cost based on the fair value at the grant date for its
stock options under SFAS No. 123, the Companys net loss would have changed to the pro forma
amounts shown below:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Net loss As reported |
|
$ |
(4,542,713 |
) |
|
$ |
(1,734,765 |
) |
|
|
|
|
|
|
|
|
|
Deduct: Total stock-based employee compensation
expense determined under fair value based
method for all awards |
|
|
(3,062,324 |
) |
|
|
(2,321,745 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss Pro forma |
|
$ |
(7,605,037 |
) |
|
$ |
(4,056,510 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share As reported: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share Pro forma: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.13 |
) |
|
$ |
(0.87 |
) |
In February 2006, the Companys Board of Directors approved a plan to accelerate the vesting of
out-of-the-money, unvested stock options previously granted to the Companys employees, officers
and directors. An option was considered out-of-the-money if the stated exercise price exceeded
$2.85, the then closing price of the Companys common stock. Pursuant to this action, options to
purchase approximately 0.4 million shares of the Companys common stock with a weighted average
exercise price of $4.49 per share became exercisable immediately.
The Company accelerated the vesting of options to minimize the amount of compensation expense it
would otherwise recognize upon adoption of SFAS No. 123(R) on April 1, 2006. None of these options
had intrinsic value at the acceleration date under APB 25. The Company estimates that acceleration
of the vesting of these options reduced the pre-tax stock option expense by approximately $1.4
million, in the aggregate, calculated using the Black-Scholes option valuation model, that it would
have otherwise recognized over the next three fiscal years, upon adoption of SFAS No. 123(R). This
amount is reflected in the 2006 proforma computation above.
The per share weighted-average fair value of stock options granted during 2006 and 2005 was $2.74
and $4.63, respectively, on the date of grant using the Black-Scholes option-pricing model with the
following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Risk-free interest rate |
|
|
4.39 |
% |
|
|
3.40 |
% |
Expected volatility |
|
|
116 |
% |
|
|
117 |
% |
Expected life, in years |
|
|
6.52 |
|
|
|
7.40 |
|
Basic and Diluted Net Loss per Common Share. Basic per common share amounts are calculated by
dividing net loss by the weighted-average common shares outstanding. Diluted per common share
amounts are computed similar to basic per common share amounts except that the weighted-average
shares outstanding are increased to include additional shares for the assumed exercise of stock
options and warrants, if dilutive. Because the Company had a loss in fiscal 2006 and 2005, diluted
shares were the same as basic shares since the effect options and warrants would have been
anti-dilutive. The following options and warrants outstanding at March 31, 2006 and 2005 to
purchase shares of common stock were excluded from diluted loss per share as their impact would be
anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Range of |
|
|
|
Options/Warrants |
|
|
exercise prices |
|
Years ended: |
|
|
|
|
|
|
|
|
March 31, 2006 |
|
|
3,875,473 |
|
|
$ |
0.90-10.50 |
|
March 31, 2005 |
|
|
1,820,859 |
|
|
$ |
0.90-10.50 |
|
New Accounting Pronouncements.
Statement of Financial Accounting Standards No. 154, Accounting Changes and Error Corrections.
In May 2005, the Financial Accounting Standard Board, or FASB, issued Statement of Financial
Accounting Standards, or SFAS, No. 154, Accounting Changes and Error Corrections. This new standard
replaces APB Opinion No. 20, Accounting Changes, and FASB Statement No. 3, Reporting Accounting
Changes in Interim Financial Statements. Among other
F-11
changes, Statement 154 requires that a
voluntary change in accounting principle be applied retrospectively with all prior period financial
statements presented on the new accounting principle, unless it is impracticable to do so.
Statement 154 also provides that (1) a change in method of depreciating or amortizing a long-lived
nonfinancial asset be accounted for as a change in estimate (prospectively) that was effected by a
change in accounting principle, and (2) correction of errors in previously issued financial
statements should be termed a restatement. The new standard is effective for accounting changes
and correction of errors made in fiscal years beginning after December 15, 2005. Early adoption of
this standard is permitted for accounting changes and correction of errors made in fiscal years
beginning after June 1, 2005. The Company does not believe the adoption of FASB Statement 154 will have a material
effect on its financial position or results of operations.
Statement of Financial Accounting Standards No. 151, Inventory Costs
In November 2004, the FASB issued SFAS 151, Inventory Costs, An Amendment of Accounting Research
Bulletin No. 43, Chapter 4, which adopts wording from the International Accounting Standards
Boards, or IASB, IAS 2 Inventories in an effort to improve the comparability of cross-border
financial reporting. The new standard requires the Company to treat abnormal freight, handling
costs and wasted materials (spoilage) as current period charges rather than as a portion of
inventory cost. Additionally, the standard clarifies that we should allocate fixed production
overhead based on the normal capacity of a production facility. The statement is effective for the
Company beginning in fiscal 2007. The Company does not expect adoption to have a material impact
on its consolidated financial statements.
Statement of Financial Accounting Standards No. 123(R), Share-Based Payment,
In December 2004, FASB published Statement No. 123 (revised 2004), Share-Based Payment (FAS
123(R) or the Statement). FAS 123(R) requires that the compensation cost relating to share-based
payment transactions, including grants of employee stock options, be recognized in financial
statements. That cost will be measured based on the fair value of the equity or liability
instruments issued. FAS 123(R) covers a wide range of share-based compensation arrangements
including stock options, restricted share plans, performance-based awards, share appreciation
rights, and employee share purchase plans. FAS 123(R) is a replacement of Statement No. 123,
Accounting for Stock-Based Compensation, and supersedes APB 25, and its related interpretive
guidance.
This Statement will require entities to measure the cost of employee services received in exchange
for stock options based on the grant-date fair value of the award, and to recognize the cost over
the period the employee is required to provide services for the award. FAS 123(R) permits entities
to use any option-pricing model that meets the fair value objective in the Statement. We will be
required to apply FAS 123(R) beginning in the first quarter of fiscal year 2007. FAS 123(R) allows
two methods for determining the effects of the transition: the modified prospective transition
method and the modified retrospective method of transition. We have adopted the modified
prospective transition method beginning April 1, 2006. The pro forma compensation costs presented
previously and in our prior filings have been calculated using a Black-Scholes option pricing model
and may not be indicative of amounts which should be expected in future years.
In February 2006, the Companys Board of Directors approved a plan to accelerate the vesting of
out-of-the-money, unvested stock options previously granted to its employees, officers and
directors. The Company accelerated the vesting of options to minimize the amount of compensation
expense it would otherwise recognize upon adoption of SFAS No. 123(R). None of these options had
intrinsic value on at the acceleration date under APB 25. The Company does not expect the
remaining outstanding options to result in a significant charge to compensation expense upon
adoption of SFAS 123(R) under the modified prospective application method. However, certain
outstanding options, that permit cashless exercise of the options, and certain options classified
as liabilities, could result in a significant charge to compensation expense in future periods, as
those options will need to be marked to fair value at each reporting period until settlement.
Also, additional options as granted to attract or retain new employees could result in significant
charge to compensation expense.
F-12
Notes payable consist of the following at March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Mortgage note, monthly payments of $2,938 plus
interest through November 2017, 5 year fixed rate
interest at 4.7% from May 2006 until April 2011
(rate at March 31, 20054.3%) |
|
$ |
415,422 |
|
|
$ |
482,467 |
|
|
|
|
|
|
|
|
|
|
Note payable, monthly payments of $534 plus fixed
rate interest through August 2008 (rate until
August 20084.4%) |
|
|
15,477 |
|
|
|
23,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430,899 |
|
|
|
505,871 |
|
|
|
|
|
|
|
|
|
|
Less current maturities |
|
|
41,658 |
|
|
|
44,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
389,241 |
|
|
$ |
461,265 |
|
|
|
|
|
|
|
|
Future approximate payments of long-term debt for the years ended March 31, are as follows:
|
|
|
|
|
2007 |
|
$ |
42,000 |
|
2008 |
|
|
42,000 |
|
2009 |
|
|
38,000 |
|
2010 |
|
|
35,000 |
|
2011 |
|
|
35,000 |
|
Thereafter |
|
|
239,000 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
431,000 |
|
|
|
|
|
In March 2005, the Company entered into a business loan agreement with Venture Bank, pursuant to
which it may borrow up to $500,000 on a revolving basis. All amounts which the bank advances to
the Company are due in March 2006, unless the bank renews the agreement. Amounts advanced to the
Company accrue interest at a variable rate of 1% in excess of the published prime rate in the Wall
Street Journal, with a minimum rate of 6% per annum. The Company is obligated to pay interest
monthly on the outstanding principal balance. Advances under this agreement are secured by
substantially all of the Companys assets. At March 31, 2006 and 2005, the Company had no
outstanding balances under the agreement.
Stock Options. The Company has outstanding an aggregate of 1,888,327 options to purchase shares of
common stock granted to employees, directors, consultants, and independent contractors under its
various stock option plans.
The Company has outstanding 964,993 options to purchase shares of common stock granted under the
1995, 1997 and 2002 option plans. Options granted under these plans generally expire five years
from date of grant and vest at varying rates ranging up to five years. There were no additional
options granted under these plans subsequent to March 31, 2006. The Company terminated these
plans, and no new options may be granted from these plans, upon adoption on May 3, 2006 of the 2006
Stock and Incentive Plan at a special meeting of the shareholders.
The Company has outstanding 923,334 options to purchase shares of common stock granted from outside
of the 1995, 1997 and 2002 plans, that expire up to ten years from date of grant and vest at
varying rates ranging up to five years.
The Company grants options at the discretion of the directors. Options are exercisable at a price
equal to or greater than the fair market value of the Companys common stock at date of grant. The
plans generally provide for the exercise of options during a limited period following termination
of employment, death or disability.
F-13
Stock option activity under these plans is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Shares |
|
|
exercise price |
|
|
|
Outstanding |
|
|
per share |
|
Balance at March 31, 2004 |
|
|
854,353 |
|
|
$ |
2.80 |
|
Granted |
|
|
1,047,400 |
|
|
|
5.24 |
|
Exercised |
|
|
(38,300 |
) |
|
|
1.78 |
|
Cancelled |
|
|
(142,594 |
) |
|
|
7.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2005 |
|
|
1,720,859 |
|
|
|
3.96 |
|
Granted |
|
|
330,000 |
|
|
|
3.20 |
|
Exercised |
|
|
(33,666 |
) |
|
|
1.36 |
|
Cancelled |
|
|
(128,866 |
) |
|
|
4.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
1,888,327 |
|
|
$ |
3.80 |
|
|
|
|
|
|
|
|
|
The following table summarizes information concerning currently outstanding and exercisable options
by price.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
Number |
|
|
remaining |
|
|
|
|
|
|
|
of shares |
|
|
life in |
|
|
Number |
|
Price |
|
outstanding |
|
|
years |
|
|
exercisable |
|
$0.90 |
|
|
|
1,200 |
|
|
|
1.60 |
|
|
|
800 |
|
1.10 |
|
|
|
350,200 |
|
|
|
1.30 |
|
|
|
288,500 |
|
2.25 |
|
|
|
30,000 |
|
|
|
7.05 |
|
|
|
18,000 |
|
2.40 |
|
|
|
147,526 |
|
|
|
0.84 |
|
|
|
140,026 |
|
2.70 |
|
|
|
10,000 |
|
|
|
4.95 |
|
|
|
2,500 |
|
2.80 |
|
|
|
60,000 |
|
|
|
2.41 |
|
|
|
53,334 |
|
2.85 |
|
|
|
70,000 |
|
|
|
4.85 |
|
|
|
23,332 |
|
2.90 |
|
|
|
40,000 |
|
|
|
4.76 |
|
|
|
40,000 |
|
3.00 |
|
|
|
100,000 |
|
|
|
4.50 |
|
|
|
100,000 |
|
3.50 |
|
|
|
10,000 |
|
|
|
2.51 |
|
|
|
10,000 |
|
3.75 |
|
|
|
5,000 |
|
|
|
3.29 |
|
|
|
5,000 |
|
3.80 |
|
|
|
23,334 |
|
|
|
3.88 |
|
|
|
23,334 |
|
4.10 |
|
|
|
500 |
|
|
|
3.86 |
|
|
|
500 |
|
4.20 |
|
|
|
50,000 |
|
|
|
4.07 |
|
|
|
50,000 |
|
5.19 |
|
|
|
500,000 |
|
|
|
8.76 |
|
|
|
500,000 |
|
5.30 |
|
|
|
488,900 |
|
|
|
3.62 |
|
|
|
488,900 |
|
10.50 |
|
|
|
1,667 |
|
|
|
0.17 |
|
|
|
1,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,888,327 |
|
|
|
|
|
|
|
1,745,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
In March, 2006, the Company granted a one year extension to certain option held by the former
Chairman of the Board. As a result of this modification of terms, the fair value of the underlying
options was remeasured using the Black-Scholes option-pricing model and additional compensation
expense of approximately $105,000 was recorded.
Warrants. As a result of the Companys suspension of the exercise of the 706,218 warrants
originally issued in July 2002, in April 2005, the Company granted a like number of new common
stock purchase warrants to the holders of the expired
F-14
warrants. The new warrants will be
exercisable at $2.00 per share for 90 days after the effective date of this registration statement
covering the shares underlying these warrants. As of March 31, 2006, the Securities and Exchange
Commission had not declared this registration statement effective. In April 2005, the Company
recognized a liability and a charge to equity of approximately $1.4 million associated with the
grant of these new warrants. The Company determined the fair value of these warrants using the
Black-Scholes option-pricing model. The Company has since reduced the reported liability by
approximately $707,000 due to the decrease in the fair value of these warrants from their date of
issuance through March 31, 2006, which is reflected as warrant benefit in the 2006 statement of
operations. The Company will continue to remeasure the value of this liability in relation to its
fair value and adjust accordingly until such time as the warrants are exercised or expire.
In connection with the Companys April 2005 private placement, as of May 31, 2006, the Company
issued 1,180,928 warrants to purchase shares of common stock and registered the public resale of
the underlying shares for the security holders. The warrants are exercisable for five years at an
exercise price of $4.75.
As part of a consulting agreement with CCRI Corporation, the Company issued a warrant to purchase
50,000 shares of common stock at a price of $3.00 per share on April 1, 2003, and an additional
warrant to purchase 50,000 shares at a price of $5.00 on November 2, 2003. At March 31, 2006, all
of these warrants were outstanding and expire five years from date of issue.
Other Comprehensive Loss. Other comprehensive loss consists of accumulated translation adjustment,
and accumulated additional pension liability as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Accumulated |
|
|
|
|
|
|
translation |
|
|
additional pension |
|
|
|
|
|
|
adjustment |
|
|
liability |
|
|
Total |
|
Balance at March 31, 2004 |
|
|
(215,078 |
) |
|
|
(100,495 |
) |
|
|
(315,573 |
) |
Translation adjustment |
|
|
150,505 |
|
|
|
|
|
|
|
150,505 |
|
Additional pension liability |
|
|
|
|
|
|
34,711 |
|
|
|
34,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2005 |
|
$ |
(64,573 |
) |
|
$ |
(65,784 |
) |
|
$ |
(130,357 |
) |
Translation adjustment |
|
|
(206,356 |
) |
|
|
|
|
|
|
(206,356 |
) |
Additional pension liability |
|
|
|
|
|
|
(123,302 |
) |
|
|
(123,302 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
$ |
(270,929 |
) |
|
$ |
(189,086 |
) |
|
$ |
(460,015 |
) |
|
|
|
|
|
|
|
|
|
|
4. |
|
Commitments and Contingencies |
Royalties. The Company has received an absolute assignment of a patent relating to the
Macroplastique Implantation System from a British surgeon, in return for a royalty for each unit
sold during the life of the patent. The aggregate amount of royalty expense recognized by the
Company pursuant to such royalty agreement during the fiscal years ended March 31, 2006 and 2005
was $14,091 and $18,042, respectively.
Under the terms of an agreement with former officers and directors of the Company, the Company pays
royalties equal to between three percent and five percent of the net sales of certain products,
subject to a specified monthly minimum of $4,500. The royalties payable under this agreement will
continue until the patent referenced in the agreement expires in 2010. Total expense recognized
under the agreement was $154,287 and $181,598 for the fiscal years ended March 31, 2006 and 2005,
respectively.
In 1992, the Company agreed to settle alleged patent infringement claims by Collagen Corporation
(now Inamed Corporation). Under the settlement agreement, the Company pays Collagen a royalty of
5% of net sales in the U.S. of Macroplastique products with a minimum of $50,000 per year. The
agreement is through May 1, 2006.
In April 2005, the Company entered into an exclusive manufacturing and distribution agreement with
CystoMedix for the Urgent PC product. The Company paid CystoMedix an initial royalty payment of
$225,000 and paid an additional $250,000
F-15
in 12 monthly installments of $20,833 through April 2006.
The Company will also pay CystoMedix a 7% royalty on product sales. However, the 7% royalty is
first offset against the monthly royalty installments.
Option for Asset Acquisition. CystoMedix has granted the Company an exclusive option to acquire
CystoMedixs assets. The option price is $3,485,000, reduced by up to $50,000 of liabilities
assumed by the Company. However, the $3,485,000 amount used to compute the option price will
increase at a rate of 10% per year after April 2007. The option price is payable in shares of the
Companys common stock valued at the average of the closing bid price of the Companys shares for
the 20 trading days prior to its exercise of the option. The Company may exercise the option
between January 2006 and June 2008. If the Company exercises the option, the Company will also
assume up to $1.4 million of bridge loan advances made to CystoMedix by its Chairman. The Company
would repay up to $1.1 million of the bridge loan advances at closing and would issue its common
stock for the balance of the bridge loan based on the above option price. The Company also has
certain rights of first refusal to acquire CystoMedixs assets in the event CystoMedix receives a
third party offer in advance of any exercise of the Companys option.
Purchase Requirements. The Company has agreed to purchase its entire requirement of I-Stop
products from CL Medical. Under the agreements, the Company is required to purchase a minimum of
$630,000 of units in the first 12-month period following January 1, 2006, increasing to $2.6
million of units in the fifth year of the agreement for an aggregate commitment of approximately
$6.7 million of units over the five-year period, subject to periodic adjustment based on the value
of the euro.
Operating Lease Commitments. The Company leases office, warehouse, and production space under
three operating leases and leases various automobiles for its European employees. At March 31,
2006, approximate minimum lease payments under noncancelable operating leases with an initial term
in excess of one year for the ensuing years ending March 31 are as follows:
|
|
|
|
|
2007 |
|
$ |
328,000 |
|
2008 |
|
|
217,000 |
|
2009 |
|
|
178,000 |
|
2010 |
|
|
144,000 |
|
2011 |
|
|
142,000 |
|
Thereafter |
|
|
437,000 |
|
|
|
|
|
|
|
$ |
1,446,000 |
|
|
|
|
|
Total rent expense paid for operating leases was $355,340 and $386,614 in fiscal 2006 and 2005,
respectively.
Employment Agreements. The Company has entered into employment agreements with certain officers,
the terms of which, among other things, specify a base salary subject to annual adjustment by
mutual agreement of the parties, and a severance payment to the employee upon employment
termination without cause. The Company provides for various severance amounts payable under the
agreements after employment termination. Contemporaneously with the execution of their employment
agreement, some of the officers executed an Employee Confidentiality, Inventions, Non-Solicitation,
and Non-Compete Agreement. This agreement prohibits the employee from disclosing confidential
information, requires the employee to assign to the Company without charge all intellectual
property relating to the Companys business which is created or conceived during the term of
employment, prohibits the employee from encouraging employees to leave the employment of the
Company for any reason and prohibits competition with the Company during the term of employment and
for a specified term thereafter.
Product Liability. The medical device industry is subject to substantial litigation. As a
manufacturer of a long-term implantable device, we face an inherent risk of liability for claims
alleging adverse effects to the patient. We currently carry $2 million of worldwide product
liability insurance, plus another policy specific to the United Kingdom only. There can be no
assurance, however, that our existing insurance coverage limits are adequate to protect us from any
liabilities we might incur.
5. |
|
Savings and Retirement Plans |
The Company sponsors various plans for eligible employees in the United States, the United Kingdom
(UK), and The Netherlands. The Companys retirement savings plan in the United States conforms to
Section 401(k) of the Internal Revenue Code and participation is available to substantially all
employees. The Company may also make discretionary
F-16
contributions ratably to all eligible
employees. The Companys contributions in fiscal 2006 and 2005 in the United States were made in
the form of Company common stock and became fully vested when made. The total contribution expense
associated with these plans in the United States was $44,407 and $32,481 for the fiscal years ended
March 31, 2006 and 2005, respectively.
The Companys international subsidiaries have defined benefit retirement plans for eligible
employees. These plans provide benefits based on the employees years of service and compensation
during the years immediately preceding retirement, termination, disability, or death, as defined in
the plans. The UK subsidiarys defined benefit plan was frozen on December 31, 2004. On March 10,
2005, the UK subsidiary established a defined contribution plan. The Dutch defined benefit
retirement plan was closed for new participants as of April 1, 2005. On April 1, 2005, the Dutch
subsidiary established a defined contribution plan for new employees. The total contribution
expense associated with the defined contribution plans in the The Netherlands and the United
Kingdom was $46,079 for the fiscal year ended March 31, 2006.
The cost for the Companys defined benefit retirement plans in The Netherlands and United Kingdom
include the following components for the years ended March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Gross service cost, net of employee contribution |
|
$ |
170,319 |
|
|
$ |
141,745 |
|
Interest cost |
|
|
99,773 |
|
|
|
89,031 |
|
Management cost |
|
|
23,112 |
|
|
|
|
|
Expected return on assets |
|
|
(57,730 |
) |
|
|
(56,001 |
) |
Amortization |
|
|
34,698 |
|
|
|
56,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
270,172 |
|
|
$ |
231,169 |
|
|
|
|
|
|
|
|
The following summarizes the change in benefit obligation and the change in plan assets for the
years ended March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Projected benefit obligation, beginning of year |
|
$ |
2,062,036 |
|
|
$ |
1,503,534 |
|
Service cost |
|
|
170,319 |
|
|
|
141,745 |
|
Interest cost |
|
|
99,773 |
|
|
|
89,031 |
|
Other |
|
|
11,486 |
|
|
|
(11,759 |
) |
Actuarial result |
|
|
278,123 |
|
|
|
254,618 |
|
Foreign currency translation |
|
|
(145,785 |
) |
|
|
84,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected benefit obligation, end of year |
|
$ |
2,475,952 |
|
|
$ |
2,062,036 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plan assets, beginning of year |
|
$ |
1,246,402 |
|
|
$ |
998,620 |
|
Contributions to plan |
|
|
201,184 |
|
|
|
210,124 |
|
Benefits paid |
|
|
|
|
|
|
(9,415 |
) |
Management cost |
|
|
(23,112 |
) |
|
|
|
|
Actual return on assets |
|
|
70,681 |
|
|
|
(3,588 |
) |
Foreign currency translation |
|
|
(88,838 |
) |
|
|
50,661 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plan assets, end of year |
|
$ |
1,406,317 |
|
|
$ |
1,246,402 |
|
|
|
|
|
|
|
|
F-17
The funded status of the Companys pension retirement plans at March 31, 2006 and 2005, are as
follows:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Funded status |
|
$ |
(1,069,635 |
) |
|
$ |
(815,634 |
) |
Unrecognized net loss |
|
|
824,876 |
|
|
|
638,579 |
|
Minimum pension liability |
|
|
(228,406 |
) |
|
|
(126,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued pension liability |
|
$ |
(473,165 |
) |
|
$ |
(303,781 |
) |
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Discount rate |
|
|
4.25-5.00 |
% |
|
|
4.50-5.50 |
% |
Expected return on assets |
|
|
4.00-5.00 |
% |
|
|
4.00-5.00 |
% |
Expected rate of increase in future compensation |
|
|
|
|
|
|
|
|
general |
|
|
3 |
% |
|
|
3 |
% |
individual |
|
|
0%-3 |
% |
|
|
0%-3 |
% |
The components of income tax expense (benefit) for the years ended March 31, 2006 and 2005,
consist of the following:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Income tax provision: |
|
|
|
|
|
|
|
|
Current: |
|
|
|
|
|
|
|
|
U.S. and state |
|
$ |
|
|
|
$ |
|
|
Foreign |
|
|
(36,744 |
) |
|
|
79,585 |
|
Deferred: |
|
|
|
|
|
|
|
|
U.S. and state |
|
|
|
|
|
|
|
|
Foreign |
|
|
(10,129 |
) |
|
|
11,918 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total income tax expense (benefit) |
|
$ |
(46,873 |
) |
|
$ |
91,503 |
|
|
|
|
|
|
|
|
Effective tax expense (benefit) differs from statutory federal income tax expense (benefit) for the
year ended March 31, 2006 and 2005 as follows:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Statutory federal income tax benefit |
|
$ |
(1,560,459 |
) |
|
$ |
(589,820 |
) |
State tax benefit |
|
|
26,822 |
|
|
|
|
|
Valuation allowance increase |
|
|
1,437,790 |
|
|
|
792,685 |
|
UK temporary differences not previously
tax effected |
|
|
|
|
|
|
(109,983 |
) |
Other |
|
|
48,974 |
|
|
|
(1,379 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(46,873 |
) |
|
$ |
91,503 |
|
|
|
|
|
|
|
|
F-18
Deferred taxes as of March 31, 2006 and 2005 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Pension liability |
|
$ |
93,368 |
|
|
$ |
110,405 |
|
Other reserves and accruals |
|
|
39,201 |
|
|
|
70,619 |
|
Deferred profit on intercompany sales |
|
|
99,350 |
|
|
|
186,166 |
|
Net operating loss carryforwards |
|
|
5,599,391 |
|
|
|
4,018,044 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,831,310 |
|
|
|
4,385,234 |
|
|
|
|
|
|
|
|
|
|
Less valuation allowance |
|
|
(5,719,949 |
) |
|
|
(4,282,159 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
111,361 |
|
|
$ |
103,075 |
|
|
|
|
|
|
|
|
At March 31, 2006, the Company had U.S. net operating loss carryforwards (NOL) of approximately
$15,423,000 for U.S. income tax purposes, which expire in 2013 through 2024, and NOLs in the U.K.
of $212,000, which can be carried forward indefinitely. U.S. net operating loss carryforwards
cannot be used to offset taxable income in foreign jurisdictions. In addition, U.S. tax rules
impose limitations on the use of net operating losses following certain changes in ownership. Such
a change in ownership may limit the amount of these benefits that would be available to offset
future taxable income each year, starting with the year of ownership change.
A valuation allowance is provided when it is more likely than not a portion of the deferred tax
assets will not be realized. The Company has established a valuation allowance for U.S. and
certain foreign deferred tax assets due to the uncertainty that enough income will be generated in
those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any
benefit of such net operating loss carryforwards in the accompanying financial statements. The
deferred tax asset increased by $1,447,000 and $770,000, respectively in fiscal 2006 and 2005. The
related valuation allowance increased by $1,438,000 and $791,000, respectively, in fiscal 2006 and
2005.
On October 22, 2004, the President signed the American Jobs Creation Act of 2004 (the Act).
The Act creates a temporary incentive for the company to repatriate earnings accumulated outside
the U.S. by allowing the company to reduce its taxable income by 85 percent of certain eligible
dividends received from non-U.S. subsidiaries by the end of the companys fiscal year ended March
31, 2006. In order to benefit from this incentive, the company must reinvest the qualifying
dividends in the U.S. under a domestic reinvestment plan approved by the chief executive officer
and board of directors. During the year, the company repatriated approximately $926,000 from its
foreign subsidiaries pursuant to the Act.
7. |
|
Business Segment Information |
The Company sells proprietary products for the treatment of voiding dysfunctions. Its current
primary product is Macroplastique®, a soft tissue bulking material used for the treatment of
urinary incontinence and vesicoureteral reflux. In addition, the Company markets its soft tissue
bulking material for additional indications, including the treatment of vocal cord rehabilitation,
fecal incontinence and soft tissue facial augmentation. At this time, all sales for the tissue
bulking agent products are outside the United States. The Macroplastique product line accounted
for 67% and 76%, respectively, of total net sales during fiscal 2006 and 2005.
The U.S. Food and Drug Administration (FDA) 510(k) premarket clearance of the Companys I-Stop
polypropylene, tension-free, mid-urethral sling for the treatment of female urinary incontinence
was received in August 2005. The Company distributes this product in the United States and the
United Kingdom. In October 2005, the Company received U.S. FDA 510(k) premarket clearance of its
Urgent® PC Neuromodulation System, a minimally invasive nerve stimulation device designed for
office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and
urinary frequency. The Company started selling the Urgent PC device in November 2005 in the United
States, and in December 2005 in Europe and Canada. The Urgent PC is also indicated for the
treatment of fecal incontinence outside the United States. In addition, the Company is a
distributor of specialized wound care products in The Netherlands and
United Kingdom. Sales for these product lines represented, in the
aggregate, 14% and 8%, respectively, of the total net sales in fiscal
2006 and 2005.
Based upon the above, the Company operates in only one reportable segment consisting of medical
products primarily for the urology market.
F-19
Information regarding operations in different geographies for the years ended March 31, 2006 and
2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
United |
|
The |
|
United |
|
and |
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
eliminations |
|
Consolidated |
Fiscal 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
94,755 |
|
|
$ |
4,830,203 |
|
|
$ |
1,711,586 |
|
|
$ |
(493,932 |
) |
|
$ |
6,142,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit) |
|
|
|
|
|
|
(46,873 |
) |
|
|
|
|
|
|
|
|
|
|
(46,873 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(4,572,337 |
) |
|
|
(99,012 |
) |
|
|
(107,828 |
) |
|
|
236,464 |
|
|
|
(4,542,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
at March 31, 2006 |
|
|
767,984 |
|
|
|
717,692 |
|
|
|
5,366 |
|
|
|
|
|
|
|
1,491,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
|
|
|
$ |
5,612,250 |
|
|
$ |
1,703,365 |
|
|
$ |
(657,889 |
) |
|
$ |
6,657,726 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
|
|
|
|
91,503 |
|
|
|
|
|
|
|
|
|
|
|
91,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(1,855,416 |
) |
|
|
153,977 |
|
|
|
21,990 |
|
|
|
(55,316 |
) |
|
|
(1,734,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
at March 31, 2005 |
|
|
277,780 |
|
|
|
791,121 |
|
|
|
10,452 |
|
|
|
|
|
|
|
1,079,353 |
|
The Companys future liquidity and capital requirements will depend on numerous factors, including among other things, the timing and cost of obtaining FDA approval for Macroplastique and expanding the sales, marketing and distribution capabilities in the U.S. market. The Company will need to raise additional debt or equity financing to continue funding for product development and continued expansion of its sales and marketing
activities, and ultimately, will need to achieve profitability and generate positive cash
flows from operations. As such, the Company is exploring opportunities to raise additional capital in
fiscal 2007, but there can be no guarantee that it will be successful.
Aside from the recently established credit lines indicated below, the Company currently has no
committed resources of, or other arrangements with respect to, additional financing.
In the event that such required financing is not immediately available, management is prepared to
curtail planned product development activities and other expenditures to ensure adequate working
capital is available throughout fiscal 2007.
In May 2006 the Company entered into a business loan agreement with Venture Bank. The agreement
provides for a credit line of up to $1 million secured by the assets of the Company. The Company
may borrow up 50% of the value of the inventory on hand in the U.S. and 75% of the U.S. accounts
receivable value; provided however, no amount can be borrowed if the consolidated equity declines
below $0.5 million. The maximum $1 million can only be borrowed if the consolidated equity is not
less than $1 million. For consolidated equity in excess of $0.5 million but less than $1 million,
the maximum that can be borrowed is $250,000. Interest on the loan is charged at the rate of 1
percentage point over the prime rate; provided however the minimum interest rate charged may not be
less than 7% per annum.
In June 2006, the Company also entered into a $100,000 3-year, term loan agreement with Venture
Bank, at an interest rate of 8.25% per annum. In addition, Uroplasty BV, one of the Companys
subsidiaries entered into an arrangement with Rabobank of The Netherlands for a 200,000
(approximately $258,500) credit line.
F-20
Exhibit 21.0
UROPLASTY, INC. AND SUBSIDIARIES
Subsidiaries of the Company
The following are wholly owned subsidiaries of Uroplasty, Inc:
Uroplasty BV
Hofkamp 2
6161 DC Geleen
The Netherlands
Bioplasty BV
Hofkamp2
6161 DC Geleen
The Netherlands
Uroplasty, Ltd
Unit 3, Woodside Business Park
Whitley Wood Lane, Reading
Berkshire, RG2 8LW
United Kingdom
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Uroplasty, Inc.:
We consent to the incorporation by reference in the registration statements (Nos. 333-107110 and
333-30372) on Form S-8 of Uroplasty, Inc. and Subsidiaries of our
report dated June 27, 2006, with
respect to the consolidated financial statements which appear in this annual report on Form 10-KSB
of Uroplasty, Inc. for the year ended March 31, 2006.
/s/ McGladrey & Pullen, LLP
Minneapolis, Minnesota
June 29, 2006
Exhibit 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David B. Kaysen, certify that:
1. I have reviewed this report on Form 10-KSB for the year ended March 31, 2006 of Uroplasty, Inc.
(the Registrant);
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) 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
(c) disclosed in this report any change in the Registrants internal control over financial
reporting that occurred during the Registrants most recent fiscal quarter 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 function):
(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.
Date: June 29, 2006.
|
|
|
|
|
|
|
|
|
|
By
|
|
/s/ David B. Kaysen |
|
|
|
|
|
|
|
David B. Kaysen
|
|
|
President and Chief Executive Officer |
|
|
Exhibit 31.2
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mahedi A. Jiwani, certify that:
1. I have reviewed this report on Form 10-KSB for the year ended March 31, 2006 of Uroplasty, Inc.
(the Registrant);
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) 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
(c) disclosed in this report any change in the Registrants internal control over financial
reporting that occurred during the Registrants most recent fiscal quarter 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 function):
(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.
Dated: June 29, 2006
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By
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/s/ Mahedi A. Jiwani |
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Mahedi A. Jiwani |
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Vice President, Chief Financial Officer and Treasurer |
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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 of Uroplasty, Inc. (the Company) on Form 10-KSB for the year
ended March 31, 2006 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, David B. Kaysen, President and Chief Executive Officer of the Company, certify,
pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, 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 result of operations of the Company.
Dated: June 29, 2006
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By
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/s/ David B. Kaysen |
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David B. Kaysen |
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President and Chief Executive Officer |
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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 of Uroplasty, Inc. (the Company) on Form 10-KSB for the year
ended March 31, 2006 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, Mahedi A. Jiwani, Chief Financial Officer of the Company, certify, pursuant to 18
U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, 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 result of operations of the Company.
Dated: June 29, 2006
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By
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/s/ Mahedi A. Jiwani |
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Mahedi A. Jiwani |
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Vice President, Chief Financial Officer and Treasurer |
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