U. S. Securities and Exchange Commission
Washington, D.C. 20549
AMENDMENT NO. 2
TO
FORM 10-SB
Surgical Safety Products, Inc.
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(Name of Small Business Issuer in its charter)
New York 65-0565144
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
2018 Oak Terrace
Sarasota, Florida 34231
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(Address of principal executive offices) (Zip Code)
Issuer's telephone number: (941) 927-7874
Securities to be registered under Section 12(b) of the Act:
Title of each class Name of each exchange on which
to be so registered each class to be registered
None
- ---------------------------------- ------------------------------
Securities to be registered under Section 12(g) of the Act:
Common Stock, $.001 par value
------------------------------------------
(Title of class)
Copies of Communications Sent to:
Mercedes Travis, Esq.
Mintmire & Associates
265 Sunrise Avenue, Suite 204
Palm Beach, FL 33480
Tel: (561) 832-5696
Fax: (561) 659-5371
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TABLE OF CONTENTS
PART I
Item 1. Description of Business 2
Item 2. Management's Discussion and Analysis or Results of Operations 63
Item 3. Description of Property 70
Item 4. Security Ownership of Certain Beneficial Owners and Management 71
Item 5. Directors, Executive Officers, Promoters and Control Persons 72
Item 6. Executive Compensation 79
Item 7. Certain Relationships and Related Transactions 88
PART II
Item 1. Market Price of and Dividends on the Registrant's Common
Equity and Other Shareholder Matters 93
Item 2. Legal Proceedings 94
Item 3. Changes in and Disagreements with Accountants 95
Item 4. Recent Sales of Unregistered Securities 95
Item 5. Indemnification of Directors and Officers 103
PART F/S 104
PART III
Item 1. Index to Exhibits 107
Item 2. Description of Exhibits 109
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Item 1: Description of Business:
(a) Business Development
Surgical Safety Products, Inc. (the "Company" or "Surgical") is
incorporated in the State of New York and qualified to do business as a foreign
corporation in the State of Florida. Surgical Safety Products, Inc. originally
was incorporated under the laws of the State of Florida on May 15, 1992. On
November 28, 1994 the Company merged into Sheffeld Acres Inc., a New York shell
corporation which had approximately 1,100 shareholders, but had never commenced
operations. Although Sheffeld Acres, Inc. was technically the surviving entity,
the Company changed its name after the merger to Surgical Safety Products, Inc.
Articles of Merger were filed with the State of Florida on October 12, 1994 and
a Certificate of Merger was filed with the State of New York on February 8,
1995. The Company filed to do business as a foreign corporation on April 11,
1995 in the State of Florida. The Company's Common Stock is quoted on the OTC
Bulletin Board under the symbol "SURG". The Company's executive offices are
presently located at 2018 Oak Terrace, Sarasota, Florida 34231, its telephone
number is (941) 927-7874 and its facsimile number is (941) 925-0515.
The Company is filing this Form 10-SB on a voluntary basis so that the
public will have access to the required periodic reports on Surgical's current
status and financial condition. The Company will file periodic reports in the
event its obligation to file such reports is suspended under the Securities and
Exchange Act of 1934 (the "Exchange Act".)
The Company was formed for the initial purpose of combating the
potential spread of bloodborne pathogen infections, such as HIV and hepatitis.
The founding philosophy arose from a concern regarding the occupational risks of
healthcare workers in the operating room. Since inception, the Company has
broadened its mission to include the research, development and production of
innovative products and services which create and maintain a safe surgical
environment for medical and hospital staff, healthcare workers and patients, as
well as enhance the level of surgical care available to patients.
The Company is engaged in product development, sales and services for
the medical industry. The Company is currently engaged in one line of business
which is divided into three (3) divisions each of which is involved with
specialty medical product research and development: (1) a division which
develops various medical-related services to be marketed to healthcare
facilities, including an entire family of computer software applications
designed to evaluate, track, organize and manage infection control data for
healthcare facilities and to provide multi-media information centers for a
facility's healthcare workers ("Data Systems Division"); (2) a division which
researches and develops medical products for sale in the marketplace ("Medical
Products Division"); and (3) a division which provides confidential consultation
services to third party developers of medical products, usually physicians and
healthcare technicians ("Medical Products Consultation Division"). The common
thread interwoven into each area requires medical research, education and a
commitment to safety issues. The Company has been making the transition from a
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research and development-oriented medical device company into a provider of
multi-media information centers and a device manufacturer and distributor.
In addition to its current activities, the Company also had operated a
diagnostic clinic specializing in women's health. On September 28, 1994 the
Company formed a wholly-owned subsidiary, Women's Diagnostic Center, Inc.
("WDC") under the laws of the State of Florida. WDC immediately acquired certain
personnel and assets, consisting of a diagnostic clinic specializing in women's
health, the Women's Ambulatory Services, Inc., a Florida corporation. WDC
catered exclusively to women and their specific healthcare needs. Patients were
attended to by an all female staff in order to provide a uniquely personal and
caring atmosphere while emphasizing women's healthcare education and awareness.
WDC specialized in mammography, ultrasounds, osteoporosis testing, chest x-rays
and comprehensive laboratory testing.
To focus the Company's growth efforts in the medical products and
services industry, the equipment, furniture, accounts receivable, trade name and
goodwill, net of related liabilities of WDC, were sold to Sarasota Memorial
Hospital on June 13, 1996. All business operations of WDC had ceased and the
corporation liquidated by December 31, 1996.
On May 30, 1995, the Company completed the preparation of a
self-directed private placement memorandum offering shares of the Company's
Common Stock and Warrants. This offering was conducted pursuant to Section 4(2)
of the Securities Act of 1933, as amended (the "Act"), and Rule 506 of
Regulation D promulgated thereunder ("Rule 506"). The offering was amended on
October 30, 1995. Initially, the offering required a minimum investment of
$5,000 in exchange for which an investor would receive 5,000 shares of common
stock, $.001 par value per share (the "Common Stock") and three-year warrants to
purchase 2,500 shares of the Company's Common Stock at an exercise price of
$1.50. Pursuant to this offering, the Company received gross proceeds in the
amount of $37,500, $5,000 of which was subsequently refunded. This refund was
made because certain paperwork and signatures were not properly executed. By
agreement with the investors, in lieu of the unit arrangement, the investors
each acquired shares at $.50 per share. A total of 65,000 shares of the
Company's Common Stock were issued pursuant to this offering. (See Part II, Item
4. "Recent Sales of Unregistered Securities.")
On December 8, 1997, the Company acquired all of the assets of Endex
Systems, Inc., d/b/a Interactive PIE ("Endex"), a Florida corporation. The
assets of Endex were valued at approximately $14,000 for which the Company
issued 250,000 shares of restricted common stock. Endex was a medical multimedia
software company, experienced in computer graphics related to the medical
industry. The acquisition was made to implement the Company's Data Systems
Division's development of its surgical safety, touch-screen network known as
OASiS. The President and Chief Executive Officer ("CEO") of Endex, Donald
Lawrence, became the Vice President of Sales and Marketing of the Company. Mr.
Lawrence has an employment contract with the Company which is renewable
annually. (See Part I, Item 4. "Security Ownership of Certain Beneficial Owners
and Management; Part I, Item 6. "Executive Compensation"; Part I, Item 7.
"Certain Relationships and Related Transactions and Part II, Item 4. Recent
Sales of Unregistered Securities.")
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From March through June 1998, the Company received gross proceeds in the
amount of $999,000 from the sale or exchange for services of a total of 920,000
shares of Common Stock in four (4) offerings . The Company undertook its first
offering of 400,000 shares of Common Stock pursuant to Rule 504 of Regulation D
("Rule 504") on March 1, 1998, exchanging shares with Stockstowatch.com, Inc.
("Stockstowatch") and its legal advisor in exchange for services, 300,000 shares
and 100,000 shares respectively; its second offering of 400,000 shares of Common
Stock pursuant to Rule 504 on April 1, 1998 upon the exercise of an option
granted pursuant to a Stock Option Agreement; its third offering of 60,000
shares of Common Stock pursuant to Rule 504 on June 8, 1998; and its fourth
offering of 60,000 shares of Common Stock pursuant to Rule 504 on June 18, 1998.
While no offering memorandum was used in connections with these offerings, the
business plan of the Company, which was disclosed to each prospective investor,
was for the provision of product development, sales and services for the medical
industry. The Securities and Exchange Commission ("SEC") has brought an action
against Stockstowatch alleging that it violated the anti-fraud and anti-touting
provisions of the federal securities laws with reference to shares which it
received for services to the Company. (See Part I, Item 1. "Description of
Business - (b) Business of Issuer - Employees and Consultants"; Part I, Item 7.
"Certain Relationships and Related Transactions" and Part II, Item 4. "Recent
Sales of Unregistered Securities.")
In April 1998, the Company issued 2,500 shares of restricted stock
subject to Rule 144 of the Act to an outside consultant in exchange for computer
consulting services valued at $4,375. The Company relied upon an exemption under
Section 4(2) of the Act. (See Part I, Item 7. "Certain Relationships and Related
Transactions" and Part II, Item 4. "Recent Sales of Unregistered Securities.")
In October 1998, the Company entered into an agreement with T.T.
Communications, Inc. to provide investor relations services for the Company.
T.T. Communications, Inc.'s receives monthly compensation and was granted
options to purchase 25,000 shares of the Company's Common Stock at an exercise
price of $1.50. The agreement continues on a month to month basis. The Company
issued these shares and granted these options pursuant to Section 4(2) of the
Act and Rule 506. (See Part I, Item 1. "Description of Business - (b) Business
of Issuer - Employees and Consultants"; and Part I, Item 7. "Certain
Relationships and Related Transactions."; and Part II, Item 4. "Recent Sales of
Unregistered Securities.")
In November 1998, the Company entered into a seven (7) year
collaborative agreement with Dr. William B. Saye, the Medical Director and CEO
of the Advanced Laparoscopy Training Center in Marietta, Georgia ("ALTC") under
which the Company acquired the "digital rights" of ALTC and the resulting
amalgam as it relates to surgical education and marketing rights to the ALTC
database. Under this agreement, Dr. Saye became a member of the Company's Board
of Directors and agreed to act as the Medical Director of ALTC VirtualLabs. Dr.
Saye is to be compensated for travel expenses and will be paid an honorarium of
$2,500 per day when his services are requested by Surgical. In addition, Dr.
Saye was awarded stock options to purchase up to 1,000,000 shares of the
Company's Common Stock over the period, options for 300,000 of which were issued
upon the execution of the agreement under the Company's 1998 Employee Stock
Option Plan, and the balance of which are issuable monthly. The Company issued
these shares and granted these options
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pursuant to Section 4(2) of the Act and Rule 506. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer - Data Systems Division"; Part
I, Item 4. "Security Ownership of Certain Beneficial Owners and Management; Part
I, Item 6, "Executive Compensation - Employee and Consultant Stock Option
Plans"; Part I, Item 7. "Certain Relationships and Related Transactions; and
Part II, Item 4. "Recent Sales of Unregistered Securities.")
In April 1999 the Company commenced a self-directed private placement
offering of its restricted Common Stock and warrants for which it received gross
proceeds of $475,000. Pursuant to such offering, 950,000 shares of restricted
Common Stock were issued and warrants to purchase 475,000 shares of the
Company's restricted Common Stock at an exercise price of $1.00 exercisable
within five (5) years were granted. Three directors purchased shares under this
offering. The Company conducted this offering pursuant to Section 4(2) of the
Act and Rule 506. No offering memorandum was used in connection with this
offering. Rather investors were provided with access to the Company's
Registration Statement on Form 10-SB, as amended, its Form 10-K and its Form 10Q
for the 1st Quarter 1999, all of which are filed with the Securities and
Exchange Commission ("SEC"). (See Part I, Item 4. "Security Ownership of Certain
Beneficial Owners and Management"; Part I, Item 7. "Certain Relationships and
Related Transactions;" and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
In April, 1999, the Company executed a Consulting and Assistance
Agreement with Koritz Group LLC., a Connecticut limited liability company
("Koritz") to identify sources of capital or potential business relationships
and to assist the Company in (i) raising equity or debt financing in the amount
of $15,000,000 (ii) arranging for trade financing for production, sale, lease,
rental or other disposal of the Company's products; and (iii) arranging for the
sale, merger, or consolidation of the Company or for joint ventures or strategic
alliances with other appropriate business. This agreement was terminated on July
30, 1999. (See Part I, Item 1. "Description of Business - (b) Business of Issuer
- - Employees and Consultants.")
In April 1999, the Company entered into an agreement with KJS Investment
Corporation of Tampa Florida ("KJS") to provide consulting services. KJS agreed
to accept 7,000 shares of the Company's common stock valued at the current bid
price of $.50 as part of an initial retainer with the balance of $1,500 to be
paid in cash at such time as KJS introduces the Company to five institutional
funding sources. The issuance was made pursuant to Section 4(2) of the Act and
Rule 506. (See Part I, Item 1. "Description of Business - (b) Business of Issuer
- - Employees and Consultants"; and Part I, Item 7. "Certain Relationships and
Related Transactions."; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
In April 1999, the Company issued 2,000 shares each to two consultants
of the Company for services relating to their production of a CD-Rom disc to be
used to promote OASiS. Such 4000 shares were valued at $2,250 which was based
upon the closing price for the shares on the dates the services were due to be
paid. Such issuance was made in reliance on Section 4(2) of the Act and Rule
506. (See Part I, Item 1. "Description of Business - (b) Business of Issuer -
Employees and Consultants"; and Part I, Item 7. "Certain Relationships and
Related Transactions."; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
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In May 1999, the Company entered into an agreement with Ten Peaks
Capital Corp. of Berkeley, California ("Ten Peaks") to pay a finder's fee for
successfully securing specifically defined financing for the Company. Ten Peaks
agreed to accept 6,000 shares of the Company's common stock in lieu of a
retainer provided such stock had a fair market value as reported on Bloomberg,
LLP on the date of execution of not less than $.66. The issuance was made
pursuant to Section 4(2) of the Act and Rule 506. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer Employees and Consultants";
and Part I, Item 7. "Certain Relationships and Related Transactions"; and Part
II, Item 4. "Recent Sales of Unregistered Securities.")
In May 1999, the Company issued a total of 46,000 shares of its
restricted Common Stock to Frank Clark and David Collins and 11,400 shares of
its restricted Common Stock to three (3) other employees in lieu of salary and
consulting fees due from the Company to each of them, which salary and
consulting fees were valued at $31,222 in the case of Mr. Clark and Mr. Collins
and at $7,832 in the case of the three (3) employees. The Company issued such
shares pursuant to Section 4(2) of the Act and Rule 506. (See Part I, Item 4.
"Security Ownership of Certain Beneficial Owners and Management"; Part I, Item
6. "Executive Compensation"; Part I, Item 7. "Certain Relationships and Related
Transactions;" and Part II, Item 4. "Recent Sales of Unregistered Securities.")
See (b) "Business of Issuer" immediately below for a description of the
Company's business.
(b) Business of Issuer.
General
The Company was formed in 1992, and until 1996, was primarily engaged in
women's healthcare, medical research and product development with a focus on
safety-related products geared to the reduction of occupational risks to
healthcare workers. To date, the Company has received four (4) patents on two
(2) products, is seeking patent protection on other products and is in the
process of developing or acquiring the rights to approximately nine (9)
additional medical products intended to be marketed to the healthcare community.
The concepts and designs of the additional medical products are at various
stages of development or negotiation. The Company has an exclusive five (5) year
manufacturing and supply agreement for a line of protective prescription
eyeglasses. The Company markets its product lines under the name, Compliance
Plus. (See Part I, Item 1. "Description of Business - (b) Business of Issuer -
Medical Products Division - and - Patents, Trademarks and Copyrights.")
The Company's premiere product in the Compliance Plus line, marketed
under the trade name, SutureMate(R), is a disposable Food and Drug
Administration ("FDA") approved, multi- function, suturing safety device for
surgery. Three (3) of the patents apply to this product. The original instrument
and its developmental variations facilitate advanced surgical techniques, which
increase surgical efficiency and reduce the occupational risk of exposure to
bloodborne pathogens such as HIV and hepatitis. The original product is
currently being re-released. The product has been re-engineered and updated
after feedback from over 4,000 surgeons and surgical technologists. New clinical
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advantages and significantly lower manufacturing costs create potential for this
patented, disposable surgical assist device which was originally designed to
facilitate the preferred one-handed suturing technique. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer - Medical Products Division -
and - Patents, Trademarks and Copyrights.")
The Company intends to market under the trade name, Prostasert(R), a FDA
listed product which was developed to improve the preparation of pregnant
patients for labor by providing a mechanism for applying and maintaining a
pharmaceutical gel to the cervix and vagina. One (1) of the patents applies to
this product. (See Part I, Item 1. "Description of Business - (b) Business of
Issuer - Medical Products Division - and - Patents, Trademarks and Copyrights.")
The Company has an exclusive marketing and supply agreement for a
semi-disposable, custom-made prescription protective eyewear for healthcare
workers which it markets under the trademark, MediSpecs Rx(TM), the initial term
of which terminates in September 2000. In addition, the Company intends to
market an infection control equipment kit for healthcare workers under the
trademark, IcePak(TM). (See Part I, Item 1. "Description of Business - (b)
Business of Issuer Medical Products Division - and - Patents, Trademarks and
Copyrights.")
The Company has two (2) additional products in the development stage:
Prepwiz(TM), which is a revolutionary surgical prep and drape system and
FingerSafe(TM), which is a multi-featured surgical thimble. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer - Medical Products Division.")
The Company aggressively protects its intellectual properties through
patents, trademarks and copyrights, as well as by proprietary software designs
(flow charts, algorithms, reports and databases). In addition to the utility and
design patents already issued to the Company, the Company has many other
products in various stages of development which have patent potential. (See Part
I, Item 1. "Description of Business - (b) Business of Issuer - Medical Products
Division - Research and Development.")
The Company had executed distributorship agreements for SutureMate(R)
with (1) Johnson & Johnson Medical Pty., Ltd with respect to the territories of
Australia, New Zealand, Papua, New Guinea in April 1995; (2) Medicor Corporation
with respect to the Netherlands in March 1995; and (3) ISC Group, a company
organized under the laws of the country of Saudi Arabia, with respect to Saudi
Arabia and the so-called GCC Nations (comprising of Oman, Yemen, United Arab
Emirates, Qatar, Bahrain and Kuwait) in December 1994. None of these agreements
are currently active since the original distribution was thwarted by the high
manufacturers suggested retail price. With the re- engineering of the product
and the lower cost of goods, it is anticipated that SutureMate(R) will receive a
more favorable market response. In December 1996, the Company executed an
exclusive seven (7) year distribution agreement for SutureMate(R) for the
European market with Noesis Capital Group ("Noesis") under which Noesis was to
recruit, hire and train European master distributors and distributor/dealer
networks throughout the European continent. This agreement is technically in
force but is currently inactive for the same reasons as the other
distributorship agreements. The inactivity of these agreements reduces the
current revenue potential of the Company. Based upon
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the relative number of surgical procedures performed in the United States and
abroad annually, it is estimated that the domestic market for SutureMate(R) is
15 to 20 million units and that the foreign markets could represent 70% to 80%
of the domestic market. In August, 1997, the Company entered into a distribution
agreement for the State of Florida for its MediSpecs Rx(TM) prescriptive eyewear
with Hospital News of Florida. Hospital News of Florida sold no MediSpecs Rx(TM)
units under the agreement and is no longer a publication. Since the Company is
disappointed with MediSpecs Rx(TM) sales, it is considering dropping the product
line. (See Part I, Item 1. "Description of Business - (b) Business of Issuer -
Sales and Marketing - Distribution of Products.")
In October 1996, the Company entered into a staff/client leasing
agreement whereby Staff Leasing II, L.P. ("Staff") leases all existing and new
employees to the Company. The initial term of the agreement was for one (1)
year. The agreement is automatically renewable on a monthly basis until renewed
for a fixed term or terminated. The agreement remains open on a monthly basis.
All of the persons described herein to be employees of the Company are covered
by this agreement. (See Part I, Item 1. "Description of Business - (b) Business
of Issuer - Employees and Consultants.")
In 1997, the Company focused on the creation and establishment of an
information system for multiple applications within healthcare. Formerly named
Surgical Safety Network, this information system is now marketed under the name
OASiS which is the acronym for Occupational Automated Services Information
System. In April 1998, the Company filed for two (2) patents on this system, one
related to this touch-access information system and the other related to a
technology transfer application. This touch access system has developed into a
platform for initially managing three areas of need: (1) exposure (to bloodborne
pathogen) management; (2) healthcare training; and (3) healthcare risk
management. Effective January 30, 1998, the Company entered a ten (10) year
lease arrangement with a leading Florida medical facility, the Sarasota Memorial
Hospital ("SMH"), under which four (4) OASiS kiosks were installed at the
healthcare site. (See Part I, Item 1. "Description of Business - (b) Business of
Issuer - Data Systems Division - and - Patents, Trademarks and Copyrights - and
- - Dependence on Major Customers.")
In January 1998, the Company entered into a clinical products testing
agreement with SMH whereby such facility will provide clinical testing of
designated products of the Company for a term of five (5) years. (See Part I,
Item 1. "Description of Business - (b) Business of Issuer - Medical Products
Division.")
In February 1998, the Company executed a letter of intent to joint
venture with U.S. Surgical Corporation ("US Surgical"), a major manufacturer of
surgical products which distributes its products worldwide, for the marketing of
the OASiS system. The parties executed a final agreement dated October 28, 1998
(the "Short Term Agreement"). On October 1, 1998, Tyco Healthcare Group LP
("Tyco") consummated a merger with US Surgical. On July 30, 1999 Surgical
entered into a private partner network agreement with US Surgical. Under the
July agreement, Surgical is to supply up to four hundred (400) OASiS systems to
US Surgical under licenses calling for installation in nominated hospitals (the
"Long Term Agreement"). (See Part I, Item 1. "Description of Business - (b)
Business of Issuer - Data Systems Division; Sales and Marketing - Distribution
of Products; and - Dependence on Major Customers.")
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In March 1998, the Company entered into an agreement with Stockstowatch to
provide investor relations services as a media consultant to the Company.
Stockstowatch was issued 300,000 shares of the Company's stock in exchange for
these services. (See Part I, Item 1. "Description of Business - (b) Business of
Issuer - Employees and Consultants; Part I, Item 7. "Certain Relationships and
Related Transactions"; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
In June 1998, the Company executed a letter of intent with Ad-vantagenet,
Inc. for the development of Version 2.0 software for the OASiS system. (See Part
I, Item 1. "Description of Business - (b) Business of Issuer - Data Systems
Division.")
In October 1998, the Company entered into an agreement with T.T.
Communications, Inc. to provide investor relations services for the Company.
(See Part I, Item 1. "Description of Business - (b) Business of Issuer -
Employees and Consultants"; and Part I, Item 7. "Certain Relationships and
Related Transactions.")
In November 1998, the Company committed to purchase twenty (20) OASiS units
from Kiosk Information Systems, Inc. on a purchase order basis. (See Part I,
Item 1. "Description of Business - (b) Business of Issuer - Data Systems
Division.")
The Company's other products and concepts in development generally fall
into the categories of occupational safety, infection control, obstetrics and
gynecology, and new "minimally invasive" surgery devices and techniques. Most of
these development projects originated from within the Company, although several
are being co-developed with outside third party inventors who are mainly
physicians and medical technicians for whom the Company provides consulting
services in new product development. (See Part I, Item 1. "Description of
Business - (b) Business of Issuer Medical Products Consultation Division.") The
Company markets its line of products under the trade name of Compliance Plus.
The FDA lists Surgical as a medical device specifier. Under FDA
Registration No. 1056687, as a medical device specifier, Surgical is permitted
to control the specifications of its products. The Company spent its formative
years in research and development and in obtaining patent protection on its core
products and services. Tangential to its core competency, the Company had found
it necessary to diversify its offerings, but has, over the past twelve (12) to
sixteen (16) months, refocused its efforts towards the commercialization of its
existing product lines. Additionally, the Company has enhanced its product lines
with the development of the touch-access information system, OASiS.
Surgical efficiency is highly valued in today's healthcare climate. With
the looming threat of bloodborne diseases such as HIV and hepatitis, safety
issues are also of critical importance. Hospitals and surgical teams have
required, and now demand, constant improvement in available products and
technology. In this rapidly growing market, new options for personal protective
equipment are not only valued by the surgical team and appreciated by patients,
but mandated by government agencies such as the Occupational Safety and Health
Administration ("OSHA"). (See Part I, Item 1. "Description of Business - (b)
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Business of Issuer - Sales and Marketing - Market Overview, Size and
Occupational Safety.")
The changing healthcare environment requires aggressive measures to
improve efficiency in medical care. This is especially true in high-tech areas
such as surgery, obstetrics, and emergency care. Time saving products and
techniques which improve patient care quality are of extreme value.
Surgical's medical device lines are designated for wholesaling to
domestic and international distributors. These products are focused on improved
efficiency and safety. A clinical research study on the original Compliance Plus
product, SutureMate(R), has demonstrated dramatic reductions in sharps injuries
(sharps injuries are injuries to healthcare workers or patients caused by suture
needles, syringes, intravenous catheters, scalpels, screws, wires and other
sharp instruments in the operating room) and a 60% to 85% decrease in bloodborne
pathogen exposure, while at the same time improving procedure efficiency. This
study was conducted by Donna Haiduven, BSN, MSN, CIC, a member of the Company's
OASiS Medical Advisory Panel. (See Part I, Item 5. "Directors, Executive
Officers, Promoters and Control Persons - OASiS Medical Advisory Panel.")
Surgical is attempting to secure a research-backed, OSHA mandate status
for its OASiS information system which would make the availability of the
Compliance Plus products required in hospitals and other medical facilities. The
Company's plan is to accumulate enough research on product lines to demonstrate
statistically their significant safety advantages to support such products
inclusion in OSHA requirements for workplace safety compliance. There can be no
assurance that such statistics will demonstrate such facts, or even if
demonstrated, that such products will be included in OSHA requirements.
Fourteen (14) OASiS unit are now installed in seven (7) hospitals. Lease
payments from OASiS currently are made directly to Surgical from the customer
hospital but may be made, in the future, through a third party leasing
intermediary. In the case of a third party intermediary arrangement, Surgical is
paid a lump sum at the front end of the lease and the hospital then makes its
payments to the leasing company. Selection of a leasing arrangement is made
based upon Surgical's current financial status and based upon the financial
strength of the hospital involved. SutureMate(R) was originally sold in limited
quantities and had limited success due to the high manufacturers suggested
retail price. New manufacturing arrangements will allow sales in the $5 to $6
range, more in keeping with disposable products. Due to limited sales, the
Company is considering dropping the MediSpecs Rx(TM) product line. Consulting
fees are derived from the Medical Consultation Division on an as needed basis.
The Company now is positioned to commercialize the Compliance Plus product line
and its proprietary OASiS system through its alliance with U.S. Surgical and
their full size international sales force. The Company is preparing other
alliances with one or more established industry leaders in healthcare. The
Company believes that recurring multiple revenue streams and a "cookie cutter"
program and network will allow for potentially rapid growth in the number of
OASiS system installations. When the OASiS system reaches the appropriate size,
the Company will consider the spin-off of a separate subsidiary for managing
this Internet-based healthcare information network and subsequently an initial
public offering related to the spun off subsidiary. If the Company grows and
attains its projected earnings, it intends to apply for listing on the NASDAQ
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Quotation System where it believes the market would apply an appropriate
multiple to the earnings per share. At such time, the Company will position
itself as an acquisition target for major medical or information system
entities.
The Company is seeking debt or equity financing in the amount of between
$2,000,000 and $5,000,000. In the event the Company is successful in securing
equity financing, the Company is unable to project the number of additional
shares of its Common Stock which will be required to secure such financing. As
of December 31, 1998, the Company has no short term debt. During the first
quarter of fiscal 1999, the Company drew down on its line of credit of $100,000.
In the event that the Company is successful in securing debt financing, the
amount of such financing, depending upon its terms, would increase either the
short or long term debt of the Company or both. The Company has entered into
consulting agreements with several potential funding sources; however, to date,
has not concluded terms for any financing which it feels appropriately meets the
requirements of the Company. (See Part I, Item 1. "Description of Business- (b)
Business of IssuerEmployees and Consultants.") In the event additional debt is
raised, it will incur future interest expense. In the event additional equity is
raised, management may be required to dilute the interest of existing
shareholders or forgo a substantial interest in revenues, if any.
Subject to the availability of additional financing, of which there can be
no assurance, the Company plans (1) to facilitate implementation of its sales
strategies, (2) to apply additional funding to existing new technology; and (3)
to apply additional funding to complimentary products and services through
corporate acquisition and exclusive licensing. (See Part I, Item 1. "Description
of Business - (b) Business of Issuer - Risk Factors - 3. Need for Additional
Capital; and 12. Future Capital Requirements.")
The Company currently employs, under the agreement with Staff and on a
full-time basis, seven (7) people, including its President, Vice President,
Treasurer and personnel added in 1998 to perform sales and marketing functions.
Total employee salaries for the year ending December 31, 1998 were $397,210 of
which $266,530 was paid as Executive Compensation including salaries and the
value of Common Stock and Options issued and granted to such executives. (See
Part I, Item 6. "Executive Compensation.") The Company's executive officers and
directors devote such time and effort as are necessary to participate in the
day-to-day management of the Company. (See Part I, Item 5. "Directors, Executive
Officers, Promoters and Control Persons - Executive Officers and Directors.").
During the fourth quarter of 1998, the Company employed one (1) additional
individual in the area of computer systems and continues to seek another
individual in the same area. Subject to the availability of additional funding,
of which there can be no assurance, the Company plans to add personnel as needed
to implement the Long Term Agreement with US Surgical and other growth plans.
The Company is dependent upon the services of three of its officers and
directors. Dr. G. Michael Swor, the founder and Chairman of the Board and the
Treasurer of the Company, is responsible for inventing all four (4) of the
patents, which patents were assigned to the Company in exchange for stock. Dr.
Swor is responsible for the overall corporate policy and the financing
activities of the Company. The Company is the beneficiary of a "key-man"
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insurance policy currently owned by Dr. Swor. In addition to his duties with the
Company, Dr. Swor is a board certified, practicing physician with a specialty in
Obstetrics and Gynecology. Frank M. Clark, a Director and President and Chief
Executive Officer, is responsible for the day to day management of the Company
and new product development and the manufacturing of the Company's products. In
addition, he manages new ventures for the Company including, mergers,
acquisitions, joint ventures, strategic alliances and licensing/distribution
agreements. After a nineteen (19) year career with Johnson & Johnson, Mr. Clark
became the president of R. P. Scherer and then went on to become a senior
partner in a consulting firm with responsibilities for business development with
Fortune 100 corporations. Donald K. Lawrence, a Director and Executive Vice
President, Sales and Marketing, is responsible for sales management, market
planning, advertising for the Company and acts as the Executive Director of
OASiS. Mr. Lawrence, in addition to nearly ten (10) years in medical device
sales, has extensive experience in computer graphics, multi-media and computer
equipment leasing programs. The Company plans to continue to use to its
advantage the reputations and skills of these three officers in the medical
industry. Nevertheless, while these officers have been successful in the past,
there can be no assurance that they will be successful in the continued
development of the Company which is needed for a successful operation of the
Company. The Company has employment agreements with each of these individuals.
(See Part I, Item 1. "Description of Business" (b) "Business of Issuer - Risk
Factors" and "Part I, Item 5. "Directors, Executive Officers, Promoters and
Control Persons - Executive Officers and Directors; and Employment Contracts and
Agreements.")
Data Systems Division
In 1997, the Company saw an opportunity to establish a landmark
information system for multiple applications within the healthcare industry.
This proprietary surveillance network, called OASiS, was originally designed to
export and track occupational safety emergencies such as needlesticks and fluid
exposures. The new Version 2 OASiS provides information consolidation in a
secure network of touchports located throughout a health care facility. At each
on-site location, a healthcare worker has touch access to multi-media
information. The OASiS system at its current level of development, is designed
to function in three areas: (1) exposure (to bloodborne pathogens) management;
(2) healthcare training; and (3) healthcare risk management.
In the area of exposure management, the healthcare industry is in need
of a standardized, efficient method for tracking, managing and analyzing
occupational safety emergencies such as needlesticks and other fluid exposures.
Standardized and accurate reporting methods result in superior prevention
controls and better post-exposure management for follow-up and counseling.
Information relating to the spread of bloodborne pathogens through exposures
varies widely and OASiS allows for cross-facility standardization. Healthcare
workers need and are now insisting they receive accurate, timely information
relating to exposures. Sharps injuries and other exposures occur frequently.
Current reporting protocols incorporated into the OASiS system involve a
typical chain of events necessary to create an estimated risk assessment and to
provide access to testing, treatment and follow-up.
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Under current non-computerized protocols, after an exposure, the injured
worker may be required to complete an incident report (provided by risk
management), meet with a supervisor and then leave the worksite to seek
evaluation, testing and treatment at an employee health facility or the
emergency room. Evaluation techniques, testing and available treatment and
follow-up recommendations are inconsistent, inefficient, not timely and breach
the employee's confidentiality due to the multiple points of contact which are
involved.
With the use of OASiS, the injured worker is provided with confidential
access to information, statistics and a preliminary risk assessment. The
healthcare worker begins the reporting process by "touching" their way through a
very detailed, yet easy to use, Occupational Safety Emergency Report. Data
collection for the exposure incident is mutually exclusive and exhaustive. The
system calculates the risk level based on data inputted into the system directly
by the healthcare worker. The worker receives a printed data sheet with risk
assessment (weighted towards higher risk) and a recommended testing, treatment
and follow-up plan. The worker then is directed to employee health or emergency
care for direct, complete and thorough assessment by a facility staff member
designated in that capacity. If the worker decides not to proceed, full
confidentiality is maintained while critical information for decision making is
provided to the healthcare facility and documented for it. If the worker
proceeds, then complete incident data is already collected in the system, sent
to the appropriate locations within the facility and printed for use by the
provider of counseling and treatment.
In the area of employee training, current training systems involve a
number of methods including small groups, large groups, video and other
audiovisuals. Staff training on required courses is commonly done in small
groups. New surgical equipment and techniques are typically done by way of small
groups by product representatives or other trainers and often are enhanced or
reinforced with printed materials or videotapes. This procedure requires the
worker to arrange his or her schedule around a predesignated time.
Practice also requires annual training on various subjects such as modes
of disease transmission, information on the epidemiology of disease, procedures
to follow in the event of a potential exposure, use of personal protective
equipment and standard precautions. Training is provided at the time of job
entry, at annual re-training and whenever tasks are modified which alter the
hazards posed. The person conducting the training must be knowledgeable, not
only on the subject matter, but also on how it relates to the emergency response
personnel. This procedure also requires rescheduling to a pre-designated time.
The Association of Operating Room Nurses ("AORN") regularly issues a
list of training recommendations on its website (AORN.org) or in the AORN
monthly journal. One such recommendation was a proposal to develop and evaluate
continuing education requirements to assure the continuing competence of
regulated healthcare professionals. Because of the rapid development of
technologic and scientific advances, AORN believes that one of the greatest
challenges is ensuring the continued competence of the workers providing nursing
care. The competent use of technology involves not only the understanding of the
equipment but also the decision making/critical thinking skills needed to use
the equipment effectively, safely and appropriately.
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Inadequate training has been implicated as a common cause of patient
safety incidents. This issue has gained increased publicity among consumer
advocacy groups. Recent surveys by the National Patient Safety Foundation
presented in or about August 1998 at the American Medical Association ("AMA")
indicate that 42% of those surveyed said they were involved in situations where
a medical mistake was made. Of these mistakes, 22% were made during a medical
procedure. The causes cited by the respondents included what they believed to be
carelessness, improper training and poor communications. The survey was
commissioned by the AMA to evaluate the need for initiatives to reduce errors in
the healthcare industry.
With the use of OASiS, the worker has access to a directory of various
succinct multimedia interactive training modules on the job and available when
the worker can assign the time to do the training. The Company produces these
modules using multimedia material provided by outside agencies, organizations
and product suppliers. Quick reference is accessible to important safetyrelated
features and key user information on medical devices and new techniques. The
system was designed to decrease the need for personal training and to improve
patient and worker safety by increasing the availability of critical
information. Improved awareness of new techniques and devices by healthcare
workers has shown improvement in the quality of care provided by the facility.
The Company believes that the use of the OASiS system benefits device
distributors and critical care departments and that better trained users of
devices should lower the rate of incidents occurring due to misuse of a device.
The system also provides a mechanism whereby alleged defective products may be
efficiently reported to the facility and manufacturer. This aspect is expected
to assist product distributors and manufacturers with field reporting. OASiS
training programs are designed to provide not only a thorough and cost effective
method for employee training, but also to provide the documentation of the
learner's comprehension of the subject. Further, an established network of OASiS
terminals within a facility also acts as a point-of-sale for the Company's other
medical devices such as SutureMate(R) and MediSpecs Rx(TM) semi disposable
prescription eye protection and for other medical providers' devices.
Each OASiS system involves "touch access" to a computer terminal
designed as a stand-alone kiosk. In essence, kiosks are computers equipped with
software designed to guide people to information, help them accomplish a task,
or effect a transaction. Kiosks can provide text information, graphical
presentations, and video and sound clips.
Each OASiS touch point is located strategically within the hospital
environment and is linked to a main center for accumulation of hospital data.
The system is designed to provide healthcare workers with previously unavailable
access to a wide variety of pertinent information. Unlike traditional systems
which require a certain level of computer aptitude (even if only using a mouse
or keyboard), OASiS' distinct advantage is its foundational design in a "touch
access" format. Virtually every command or task on OASiS is performed by
touching a user friendly icon driven interface. In other words, if one can point
to and touch a picture on a screen, then one has access to a world of valuable
and potentially life saving information through the OASiS network. By using
Apple Quicktime VR(TM) at an OASiS touchpoint, the system allows the user to
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touch an image on OASiS, drag their finger on the screen and view the image from
multiple angles. The Company markets this feature under the name "Virtual Touch
Reality".
Upon approaching OASiS, the healthcare worker may select from a menu of
icon based options including exposure reporting, hospital exposure policies,
device inservices, safety training, communicable disease information and safety
news and events. Each of these areas is accessed and navigated by a simple touch
of the screen. The graphic design of the system is designed to accommodate
workers with minimal reading skills and little computer experience.
The uniqueness of OASiS is not only the fact that it is a touch access
system, but that it is the first nationwide network for healthcare which is
totally independent of the facility's existing information system. Once thought
to be a disadvantage, the absence of integration into the facility's existing
systems is actually one of the features of OASiS which has gained praise for the
system from the Information Systems Department of SMH, the first installation of
OASiS.
The Company has applied for two (2) patents on the OASiS system which
cover propriety aspects of the software, algorithms and reports, as well as the
inservice training modules which are owned by the Company. OASiS is powered by a
Windows NT platform with full-multimedia, Pentium 233 processors operating at
each station. The stations connect to the OASiS server by way of the Internet
and send and receive data at prescheduled times. This allows the OASiS server to
send new information, training or updates to single stations or on a broadcast
basis to the entire network.
Hospitals employing OASiS will use an average of one (1) to three (3)
units initially. The units are strategically placed in varying hospital
departments. Pricing is structured so as to simplify the hospital's approval
process. The OASiS system can be leased to the hospitals on a three-year
contract arranged through Rockford Industries, Inc. of Santa Ana, California
("Rockford"), which acts as the third party lessor. After early stage
discounting to the hospital, the Company expects that leasing fees, industry
content production and use fees and software subscription fees will combine for
a per unit revenue of approximately $1,500 per month. After the three-year
period expires, the residual value of each OASiS will be added to the Company's
assets. The OASiS system will be upgraded at that time and it is anticipated
that additional gross revenue for each unit in place.
Under the leasing arrangement with Rockford, lease approval will be
based upon the credit-worthiness of the lessee hospital. Once approved, the
Company, as the supplier of the equipment, receives a discounted present value
of the lease income stream in advance. It is these funds which the Company will
use to cover the acquisition costs of the OASiS hardware delivered to the
lessee.
Fees also are anticipated in the future on a percentage of the product
sales made through the OASiS platform and on information sales of generic
occupational safety data. Market share is expected to increase for the Company
as it brings on additional facility users, additional industry content providers
and added on plug-in program modules developed by the Company in house or
through Company acquisitions.
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As an information system, OASiS production consists of an integration of
proprietary software with hardware from original equipment manufacturers
("OEM's"). The Company designed and is the sole owner of the software portion of
OASiS. This was as a result of approximately three (3) years of research and
development. The software presentation consists of the frontline user interface,
the programs and all supporting database gathering programs and administrative
"back office" facilities. The software exists as a user ready or standardized
foundation with widespread adaptability as the system is installed at the
hospital's facility. As of January 1998, Version 1.1 was fully operational at
the initial installation at SMH and was ready for installation in additional
facilities. OASiS Version 1 worked acceptably for accident reporting, but was
unacceptable for constant updating of content and from the administrative
monitoring standpoint. Version 2, now operational, uses nothing from Version 1.
Plans for additional upgrades to Version 2 are in progress and are being adapted
to the needs of the end-user market as they are discovered.
Within the original site installation, OASiS is being used for exposure
reporting, inservices and new technology, communicable disease information, news
and events, safety education and hospital policies. New installations will add
user identification log on capability, additional levels of news and events and
training with certification. Since Version 2.0 has become operational, the
Company has expanded the system with software plug-in integrations and advanced
data reporting and management.
In initially designing a system for a hospital facility, the Company
completes a site survey to determine the needs of the facility regarding OASiS
and system installation, as well as other pertinent information related to
station location within the facility and available telecommunication resources.
The site survey also includes details for customizing the software for the
specific facility's application.
The Company has determined that the most economical way to deliver the
integrated hardware/software product to the customer is through a full service
integration specialist (the "Integration Specialist"). The services and
responsibilities covered by such specialist will be: (1) hardware installation
into the OASiS kiosk and configuring the components; (2) software installation;
(3) software configuration; (4) 24-hour "burn in" and testing; (5) hardware
disassembly, packing and shipping; (6) on-site installation; (6) on-site
testing; and (7) three-year 24 hour turn around warranty on all hardware. Many
potential integrators exist and the Company had entered into preliminary
agreements with two initial candidates which were never reduced to writing.
Rather the Company operates on a purchase order basis with Kiosk Information
System and already has purchased units from them. The Company expects to use no
fewer than two integrators on a regular basis to ensure the quality, service and
performance required in a competitive situation.
The production cycle begins at the end of the initial sales cycle with
the completion of the site survey. Information regarding communications
availability, station location and on-site coordinator data is integrated into
the customization process. A purchase order is placed with the Integration
Specialist who in turn orders components from the various OEM's. The site survey
is then used by the integration house for coordination of on-site services such
as station location, service subcontractors and others.
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Effective January 30, 1998, the Company entered into a Prepaid Capital
Lease Agreement with Community Health Corporation (the "Lessee"), a Florida
not-for-profit corporation which acts in support of SMH ( the "SMH Lease
Agreement"). Since delivery under this agreement was in December 1997, the SMH
Lease Agreement was treated as income in 1997. SMH is the site of the initial
OASiS installation. Pursuant to the terms of the SMH Lease Agreement, SMH leased
four (4) OASiS kiosks and accompanying software and technical support for a term
of ten (10) years commencing on a date which was to follow an initial trial
period. The Company was required to install the kiosks within five (5) days of
the execution of the SMH Lease Agreement. SMH was entitled to review the
performance of the installations for a period of thirty (30) days after
installation. Provided the systems performed in accordance with pre-established
standards during such trial period, the SMH Lease Agreement term would commence
at the time of acceptance. Pursuant to the SMH Agreement, at acceptance, the
Lessee agreed to prepay all rent payments for the term of the SMH Lease
Agreement, which sum amounted to $250,000. All modifications, improvements,
additions and enhancements ("Modifications") which result from this installation
belong to the Company; however, in the event a Modification is proposed by SMH
and the Company incorporates it into the OASiS system, the Company will pay SMH
one half of one percent (.5%) of any net revenue the Company receives
attributable to such Modification. SMH has proposed no Modifications to date.
The Company is obligated during the term of the SMH Lease Agreement to provide
software maintenance, improvements and updates to the OASiS system and training
for the use of the units to SMH's personnel. In addition, the Company is
required to carry comprehensive general and products liability insurance in the
amount of $2,000,000 covering the use of the OASiS system and naming SMH and the
Lessee as co-insured parties. And further, the Company agreed to indemnify the
Lessee and SMH against any liens, liabilities or other damages incurred by the
Lessee or SMH as a result of the installation or use of the OASiS system. At the
end of the term, the Lessee has an option to purchase the four (4) OASiS kiosks
for the sum of $1. Neither party to the SMH Lease Agreement may assign nor
delegate any of the rights or obligations contained in the agreement The units
were installed and are operational. At the current time the SMH Lease Agreement
is in full force and effect. The Company received the payment due under the SMH
Lease Agreement on January 30, 1998.
Following a presentation before the Association of Infection Control
Professionals and Epidemiologist ("APIC") in May, 1998, the Company received
nearly a dozen applications from multi-facility hospital systems wanting to be a
part of the next wave of OASiS installations and inquires for at least four
times that many facilities seeking more information about the development of
OASiS. To date, none of these inquiries has resulted in an OASiS installation
agreement.
From March 31st through April 2nd, 1998, the Company, in conjunction
with U S Surgical, demonstrated the OASiS touch-access information system at the
AORN convention in Orlando, Florida. This is the largest nursing convention in
the world. OASiS accounted for over 21% of all leads generated by US Surgical at
AORN. Based upon the evaluation forms completed by the nurses, it was found that
(1) the most useful section of OASiS, as it now exists, is the device
inservices; (2) most of the nurses characterized the system as a convenient way
to receive inservices, while a few of them viewed it as a sales and marketing
tool for device manufacturers; (3) an overwhelming number of the nurses who
responded stated that they would rely on OASiS on a daily basis; (4) the most
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requested additional features were a Surgeons' Preference Card which is
scheduled for Version 3.x testing, electronic PDR and Latex sensitivity which is
under development; and (5) most of the nurses would recommend OASiS for their
operating room.
Following the AORN convention, the Company and US Surgical agreed to
terms for the further presentation of OASiS. On October 28, 1998, the parties
executed the Short Term Agreement for a term of three years under which US
Surgical was to arrange for the installation of ten (10) OASiS systems in
hospital facilities which US Surgical defines as "Centers of Excellence."
"Centers of Excellence" refers to US Surgical's designation given to their prime
hospital customers which are usually teaching facilities with a national
reputation. Following the merger in October 1998, US Surgical became a division
of Tyco Healthcare Group LP ("Tyco"). Tyco is a limited partnership organized
under the laws of the State of Delaware and having its principal office in
Norwalk, Connecticut.
Under the Short Term Agreement, each system installed includes thirty
(30) inservice training modules. Following an initial nine (9) month trial at
each of these facilities and subject to satisfactory performance by the system
and the technical support group, US Surgical has the right to have additional
systems installed in other healthcare facilities nationwide. US Surgical
financed the development and installation of the ten (10) systems. No decision
has been made as to which party will pay for such additional systems as US
Surgical elects to have installed. If it is the Company, additional capital may
be needed, the securing of which on favorable terms to the Company cannot be
assured. The Company receives a fee in the amount of $36,000 for the initial ten
(10) installations during the testing period and a fee in the amount of $108,000
for the balance of a three (3) year term for such initial installations. In
addition, the Company can generate profits on the sales of its products through
the point-of-sale facility in the OASiS system and from the fees it receives
from other device providers and training companies through the use of the
inservice modules. Provided US Surgical is not in default on any payment, at the
end of the term, they have the option to purchase the OASiS hardware at a price
of $8,500 for each Model 1062 unit. Although ten (10) units were to be installed
in November 1998, due to a delay caused by the acquisition of US Surgical by
Tyco and a strategic decision by them to delay the commencement of the
installations until after the holiday season, the Company has thus far installed
six (6) units in five (5) hospitals. The balance were to be completed in the
third quarter of 1999; however, such additional installations have been merged
into the Long Term Agreement. (See Part I, Item 1. "Description of Business (b)
Business of Issuer - Sales and Marketing - Distribution of Products - and
Dependence on Major Customers.")
On June 30, 1998, the Company executed a letter of intent with
Ad-vantagenet Inc. of Sarasota, Florida ("Ad-vantagenet"). Under the terms of
the letter of intent, Ad-vantagenet assisted in the creation of Version 2.0
OASiS software, including creating the art and graphics. Version 2.0 is designed
to allow for more dynamic features on the system including instant updates,
informationgathering and editing features. The Company chose Ad-vantagenet to
complete Version 2.0 after unsatisfactory results were achieved by Gambit, Inc.,
d/b/a MediaWorks. The functions Ad- vantagenet incorporated into Version 2.0
include features which had been requested of MediaWorks but were not provided.
The total projected cost of the Ad-vantagenet project was one-fourth of the cost
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which MediaWorks projected. The Company was in litigation with MediaWorks over
the termination of their agreement. (See Part II, Item 2. "Legal Proceedings.")
Subject to the successful completion of the letter of intent project with
Ad-vantagenet, the Company intends to enter into a more structured, long-term
agreement for further OASiS development with Ad- vantagenet or a similar
company.
In November 1998, the Company entered into a seven (7) year
collaborative agreement with Dr. William B. Saye, the Medical Director and CEO
of the Advanced Laparoscopy Training Center in Marietta, Georgia ("ALTC") under
which the Company acquired the "digital rights" of ALTC and the resulting
amalgam as it relates to surgical education and marketing rights to the ALTC
database. Under this agreement, Dr. Saye became a member of the Company's Board
of Directors and agreed to act as the Medical Director of ALTC VirtualLabs. Dr.
Saye is compensated for travel expenses and paid an honorarium of $2,500 per day
when his services are requested by Surgical. In addition, Dr. Saye was awarded
stock options to purchase up to 1,000,000 shares of the Company's Common Stock
over the term of the agreement, options for 300,000 of which were issued upon
the execution of the agreement, and the balance of which are issuable monthly.
The intention of the agreement is that any educational activity involving ALTC
or Dr. Saye on the Internet or other digital presence would become the property
of and under the control of Surgical. The purpose of the agreement is to shift
traditional training methods in advanced surgical techniques to a new
distance-based approach delivered through OASiS, the Internet and emerging
mediums. The goal is to educate and train a wide audience on safe and efficient
surgical techniques and procedures through the expansion of the OASiS network.
Dr. Saye has an existing agreement with Ethicon Endo-Surgery, a division of
Ethicon, Inc., which the parties do not believe will conflict with this
agreement. (See Part I, Item 1. "Description of Business- (b) Business of
Issuer- Competition"; Part I, Item 4. "Securities Ownership of Certain
Beneficial Owners and Management."; Part I, Item 7. "Certain Relationships and
Related Transactions; and Part II, Item 4. "Recent Sales of Unregistered
Securities."; Part 1, Item 6. "Executive Compensation- Employees and Consultants
Stock Option Plans.".)
In November 1998, the Company committed to purchase twenty (20) stand
alone kiosk OASiS units from Kiosk Information Systems, Inc. for a total
purchase price of $133,000 plus freight charges This commitment was in the form
of a purchase order from the Company. By December 31, 1998, the Company had paid
$66,500 and received a partial delivery under the agreement. To date, the
Company has paid $130,000 and is holding back the balance pending repairs on two
(2) of the units.
In November 1998, the Company announced a planned enhancement to the
OASiS system called "Vendor Watch". Currently in development and testing, this
program is expected to aid the hospital administration in monitoring the
presence of vendors and sales representatives visiting the hospital. Also, it is
planned as a communications tool for sending messages to the vendors. Beta
testing is planned for late 1999.
OASiS Version 2.0 became operational at SMH in February, 1999. For the
installation, Surgical has outsourced Internet services to Verio, Inc. ("Verio")
, a provider of Internet services such as broadband connectivity, WEB hosting
solutions, virtual private networks, e-commerce and other enhanced Internet
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services. Verio provides OASiS with fast, reliable and secure access to the
Internet via Tier 1 connectivity. In February 1999, Surgical entered into an
agreement with Verio for access service at SMH. The agreement required payment
of a set up fee of $60 and monthly charges of $199. Surgical is responsible for
paying the monthly charges. A comparable agreement with Verio or other provider
is contemplated for each hospital at which OASiS is installed.
In February 1999, Surgical completed negotiations which had commenced in
the summer of 1998 to install OASiS units as a test site in St. Francis Hospital
in Trenton, New Jersey ("St. Francis Hospital"). Three units with Version 2.0
software were installed in February. The Company has an oral arrangement with
St. Francis Hospital under which the hospital pays Surgical $200 per month per
unit as a monthly software license fee and pays $50 per month per unit for "hot
swap" maintenance service based upon a monthly invoice.
In February 1999, the first installations under the US Surgical
agreement became operational, each with Version 2.0 software. One OASiS system
was installed at Atlanticare Hospital in Massachusetts and two OASiS systems
were installed at Columbia Presbyterian Hospital in New York. In addition, US
Surgical inservice modules were installed in the SMH system and in the system
installed at St. Francis Hospital.
In March 1999, the Company installed additional units under the US
Surgical agreement at the California Pacific Medical Center and the Kaiser
Permeante Medical Center, both in San Francisco, California.
In April, 1999, the Company shipped and did the preliminary installation
at three more US Surgical sites, a second California Pacific Medical Center in
San Francisco, the California Pacific Medical Center in Los Angeles, California
and the University of Washington in Seattle, Washington.
In April 1999, the Company attended the AORN convention where it
experienced more acceptance from potential content providers and users partly
because of the commencement of the arrangement with US Surgical.
In June 1999, the Company completed the installation and Internet
connection on the unit at the University of Washington in Seattle. The
preliminary preparations were completed for the units under the US Surgical
agreement at theCalifornia Pacific Medical Center sites in San Francisco and Los
Angeles. To date, these last two sites are not installed fully and are not
connected to the Internet.
On July 30, 1999, the Company entered into the Long Term Agreement with
US Surgical which is a private partner network agreement. Under the Long Term
Agreement, Surgical is to supply up to four hundred (400) OASiS systems to US
Surgical under licenses calling for installation in nominated hospitals. Each
license is for a term of three (3) years commencing with "substantial
installation: of such unit. "Substantial installation" is defined as delivery of
the OASiS unit to the hospital and connection to the Internet.
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Under the terms of the Long Term Agreement, US Surgical must license two
hundred (200) units within the first year, and subject to certain obligations on
the part of Surgical to license units to third parties, must license an
additional two hundred (200) units by the end of the second year to third
parties. Previously installed units under the Short Term Agreement are counted
toward the minimum units required. On August 10, 1999 US Surgical paid Surgical
$100,000.00 as an advance for such licenses. The first 200 licenses are $1,500
each and additional licenses are $1,000 each.
The Long Term Agreement further provides that neither Surgical, nor any
third party other than US Surgical, may place OASiS units in any of the
"protected departments" of the hospitals, unless it is installed prior to
receipt of a purchase order from US Surgical or unless US Surgical does not
exercise its right of first refusal after notice from Surgical for such
hospital. The Long Term Agreement defines "protected departments" as Operating
Room, Labor and Delivery, Emergency Room, Ambulatory/Same Day Surgery /
Outpatient, Nuclear Medicine, Intensive Care, Orthopedic / Ortho Casting Room,
and Dialysis. US Surgical is required to have each hospital bear the entire risk
of loss and damage to any OASiS system except if such is caused by the
negligence or wilful misconduct of Surgical. US Surgical must maintain casualty
insurance in amounts and with companies acceptable to Surgical on the OASiS
units and its related amenities with Surgical as the loss payee. US Surgical may
elect to have the OASiS systems installed in hospitals it nominates co- branded
with its name. Surgical has the discretion to select the content, related
services and in- service products for the OASiS systems installed under this
agreement; however, during the term of the agreement, US Surgical is required to
pay for and maintain a minimum of one hundred forty (140) product in-services
modules in an average of at least 80% of all OASiS systems installed in the
United States whether or not covered by this agreement and 100% on those that
are covered by the agreement. US Surgical's product-based modules produced by
Surgical become the property of US Surgical. Surgical retains the right to
display such modules on other OASiS units. All other modules remain the property
of Surgical. Surgical receives a fee for production of the modules. If Surgical
installs additional OASiS units in a designated hospital, US Surgical receives a
10% commission. Surgical receives a monthly maintenance fee for each unit, of
$149, unless paid a year in advance in which case it may be discounted up to
10%. (See Part I, Item 1. "Description of Business - (b) Business of Issuer -
Sales and Marketing - Distribution of Products - and Dependence on Major
Customers.")
The Company expected to complete the installation of the balance of the
US Surgical sites under the Short Term Agreement in 1999's third calendar
quarter; however, such installations have been merged into the Long Term
Agreement.
The Company knows of only one other system which is designed to
accumulate exposure data which is called Epinet, a single system designed to
track and report bloodborne pathogen exposure in the healthcare setting. (See
"Part I, Item 1. "Description of the Business - (b) Business of the Issuer -
Competition.") The Company believes that OASiS is the superior product and that
it represents the leader in the industry at this time. The basis for this belief
is that Epinet is a software only product and that the OASiS system can be
adapted to accept Epinet.
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Medical Products Division
Compliance Plus is the designation under which all the Company's
products are developed. The Company trademarked this term in order to indicate
that the criteria used in the research and development of every Surgical product
and service meets or exceeds compliance mandates set forth by the OSHA, the
Centers for Disease Control and Prevention ("CDC") and other governing bodies.
It is the goal of the Company to exceed existing standards in order to assume a
leadership role in the area of medical prevention and safety products.
The Compliance Plus Exposure Prevention Program includes several safety
engineered products dedicated to reducing exposure and cross contamination in
the operating room. These exposure prevention products are designed to maximize
surgical efficiency while reducing bloodborne pathogen exposure to healthcare
workers and improving patient care in a wide range of applications. The Company
has already introduced the first two Compliance Plus products into the market -
MediSpecs Rx(TM) and SutureMate(R). These are the only two Compliance Plus
products which it currently markets. Both of these products meet OSHA and CDC
mandates. There is no current timetable for the release of additional Compliance
Plus products. The remainder of the proposed Compliance Plus line will be added
through further in-house development and acquisitions, which are currently on
hold so that the Company can focus on the OASiS installations.
The Compliance Plus devices include: SutureMate(R), a patented
single-patient-use surgical assist device for safe and efficient suturing;
MediSpecs Rx(TM), a disposable prescription protective eyewear for healthcare
workers; Prostasert(TM), a patented obstetrics/gynecology ("OB/GYN")
pharmaceutical applicator; IcePak(TM), an infection control equipment kit for
healthcare workers; PrepWiz(TM), a revolutionary surgical preparation and drape
system (in development); and FingerSafe(TM), a multi-featured surgical thimble
(in development).
The Company believes that the use of Surgical's Compliance Plus exposure
prevention strategy provides numerous direct and indirect benefits. These
benefits relate to a significant reduction in bloodborne pathogen exposure from
needlesticks and glove perforations, as well as improved procedural efficiency.
The Company believes that prevention through the use of its products reduces
expenditures in employee health post-exposure work-up and treatment, and lost
employee time. The Company further believes that there are also benefits from
improved employee morale, community relations, and reduced liability and
workers' compensation costs.
In January 1998, the Company executed a clinical products testing
agreement with SMH for a term of five (5) years. Under the terms of the
agreement, Surgical would set up to ten (10) surgical and medical products to
SMH for clinical testing (the "SMH Clinical Testing Agreement.") Surgical is
required to reimburse SMH for certain designated budgeted costs and pay a fixed
amount of $25,000 for each study, payable in monthly increments over the term of
each study. Further, the agreement provides that Surgical is obligated to pay
SMH $250,000 over the term of the agreement in the event Surgical determines not
to have SMH perform the clinical testing. In addition, SMH will receive one half
of one percent (.5%) of the proceeds received by the Company from the sale of
the products tested. The products to be tested include SutureMate(R),
Prostasert(TM), PrepWiz(TM), FingerSafe(TM) and five (5) other products in
various stages of development.
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SutureMate(R)
SutureMate(R), a patented, disposable, surgical assist device, was
initially introduced in 1993. Its unique design facilitates the highly
recommended one-handed suturing technique which is advocated by occupational
safety experts. When one-handed suturing is not used, extra steps are required
by the surgeon or the assistant in cutting the needle free of the suture thread
and extra time and hand movements are required of the surgeon in manually
adjusting needles while using a needle holder in most suturing processes.
SutureMate(R) allows the surgeon to use a safer, more efficient method of
surgical stitching. The product has features which include a foam
needle-cushion, and a suture cutting slot.
SutureMate(R) can be used in a wide variety of specialties, including
surgery, OB/GYN, emergency room treatment, plastic surgery, podiatry and
dentistry. It was designed by Dr. Swor, the Company's Chairman, who is a surgeon
himself for use by surgeons and surgical assistants. The Company is not aware of
any comparable product on the market. New applications for its use are being
devised regularly and several variations of the original product are in
development, including a laparoscopic version, for use in the fast growing field
of minimally invasive surgery.
The product acts as a needle bank for temporarily "parking" suture
needles, and has a cutting slot for removing the needle from the suture thread.
Using the SutureMate(R) device enables the user to "free-up" the non-dominant
hand to engage in additional tasks such as holding instruments and exposing
tissues.
Data from the CDC indicates that seventy-seven percent (77%) of sharps
injuries are caused by suture needles. In one-third of all injuries to surgeons,
the sharp instrument was re-exposed to the patient. When one-handed suturing is
not used, the surgeon's non-dominant hand is particularly vulnerable. Sixty-six
(66%) percent of all suture needlesticks occur to the first two fingers of the
non-dominant hand. This is where SutureMate(R)'s application is most
significant.
Clinical data suggests that SutureMate(R) dramatically decreases
needlestick injuries and other exposures such as glove perforations. The cutting
slot feature enables the user to efficiently remove the needle from the suture
thread without the need for an assistant, and with greater efficiency than
traditional methods.
SutureMate(R) has been cited by safety advocates and infection control
specialists in several publications and manuals. A study from Canada by Drs.
Bebbington and Treissman was published in the October 1996 issue of the American
Journal of Obstetrics and Gynecology, Volume 175, No. 1, Part I. This study was
supported by the Company. The study concluded that there was a 71% reduction in
glove perforations when SutureMate(R)n was used and stated that the "surgical
assist device [SutureMate(R)] appeared to be useful in decreasing glove
perforations regardless of the degree of training and expertise of the
operator." The study concluded that the "use of this device significantly
reduced the number of glove perforations that occurred during vaginal repair
after delivery. Therefore it can be of benefit to the safety of operators during
an all-too-frequent procedure in obstetrics. This is especially true when
universal precautions are being advocated for all patients. A decrease in glove
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perforations deceases the exposure to potential pathogens." The study did state
that the reduction in glove perforations may not have been exclusively related
to the use of the device.
The need for sharps management in surgery has generated a number of
articles. In an article by Dr. Mark Davis which was published in the April 1995
issue of Infection Control & Sterilization Technology, Volume 1, No. 1, Dr.
Davis stated that "most percutaneous injuries can be prevented by the use of
currently available safety-engineered devices and by the application of known
safety protocols and techniques...Other techniques such as double gloving and
suturing with a device requiring one hand, offers some protection against the
growing threat of HIV, and hepatitis B and C." The one-handed suturing device
discussed in the article is SutureMate(R) which was being evaluated by the
surgical and OB/GYN staff at Dr. Davis' institution. Dr. Davis served on the
Scientific Advisory Board of the Company. (See Part I, Item. 5. "Description of
Business - Directors, Executive Officers, Promoters and Control Persons -
Scientific Advisory Board.")
SutureMate(R) research findings have been presented to several major
medical organizations including: the American College of Surgeons and Center of
Disease Control and Prevention ("CDC") at a joint meeting on the prevention of
bloodborne pathogens in surgery and obstetrics which was held in Atlanta,
Georgia in February 1994 (the "February 1994 Conference"); at the annual meeting
of the Society of Hospital Epidemiologist of America in Santa Clara, California
in March 1994; at the annual meeting of the Association of Surgical
Technologists in Atlanta, Georgia in May 1995; at the annual meeting of the
Society of Perinatal Obstetricians in Vancouver, Canada in February 1996; at the
annual meeting of the Association of Surgical Technologists in Atlanta, Georgia
in June 1996 and at the annual meeting of the ACORN in Atlanta, Georgia in April
1997. (See Part I, Item. 5. "Description of Business - Directors, Executive
Officers, Promoters and Control Persons - Scientific Advisory Board.")
The February 1994 Conference was the first joint conference of the American
College of Surgeons and the CDC. Donna J. Haiduven, an infection control
specialist and a member of the Company's Scientific Advisory Board, and Dr.
Maria D. Allo of Santa Clara Valley Medical Center presented an abstract
entitled "Evaluation of a one-handed surgical suturing device to decrease
intraoperative needlestick injuries and glove perforations." The study concluded
that the "[u]se of "Suture Mate" facilitates one-handed suturing technique,
resulting in less likelihood of glove perforations and intra-operative
needlestick injuries" and "[t]he "Suture Mate" device obviates the need for
two-handed suturing and provides a safe place to "bank" needles on the surgical
field."
The use of SutureMate(R) eliminates the need for the more expensive
"control release-type" sutures. By virtue of improved surgical safety
efficiency, the Company believes that the patient will experience significant
savings through reduced anesthesia and operating room time. In addition, the
Company believes that this product reduces the potential for cross contamination
which can save expenses related to surgical wound infection.
SutureMate(R) was recently re-released in late 1998. The product was
re-engineered and updated after feedback from over 4,000 surgeons and surgical
technologists who used or reviewed the product since its inception. As a
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result of the re-design, the Company believes that there will be new clinical
advantages and that the product can be produced at a significantly lower
manufacturing cost. These beliefs are based on the fact that the re-design
includes a tent-like configuration with a hidden cutting device contained
between the adhesive base and the holding device. This allows the surgeon to
separate the needle from the suture without a scrub nurse intervening with a
scissor. The cost reduction will result from the fact that the original version
cost approximately $6.00 per unit while the new version costs approximately
$1.10 per unit including packaging and sterilization, allowing it to be marketed
in the $5 to $6 range which is more in keeping with pricing for a disposable
product.
Currently, the re-designed SutureMate(R) is manufactured by the Hansen
Plastic Division of Tuthill Corporation at their plant located in Clearwater,
Florida ("Tuthill"). Tuthill manufactures each non-sterile unit at a cost of
$.902 per unit. The non-sterile product is then shipped to Gamma Services, Inc.
in Lakeland, Florida for sterilization. The cost per unit for the sterilization
process is $.172. This results in a total cost per unit of $1.074. The Company
currently is considering other manufacturing sources. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer Sources and Availability of
Raw Materials.")
MediSpecs Rx(TM)
MediSpecs Rx(TM) is a prescription protective eyewear which Surgical
co-developed for use in the operating room and related areas. The Company has an
exclusive, renewable 5-year, distribution agreement which covers the United
States with Morrison International, Inc., a Pennsylvania corporation with its
principal place of business in Sarasota, Florida ("Morrison"). The initial term
expires in September 2000. Under the terms of the agreement with Morrison
executed in September, 1996, the Company acquired the right to purchase,
promote, resell and distribute Morrison's trademarked glasses under the
Company's private label trademark, MediSpecs Rx(TM). The price for the product
is fixed for the initial five-year term and requires minimum purchases which are
scaled over the first five-year period from 2,750 units the first year to 56,000
the fifth year. Under the agreement, the Company its entitled to distribute the
product either directly or through other dealers. Although the Company is not
reaching its quotas, it has not been found in default by Morrison. Due to poor
sales, Morrison discontinued the manufacturing of this product; however it has
substantial inventory on hand for sale. (See Part I, Item 1. "Description of
Business - (b) Business of Issuer - Sources and Availability of Raw Materials.")
MediSpecs Rx(TM) are featherweight prescription glasses with
OSHA-recommended protective side shields. A proprietary manufacturing and
assembling process minimizes the cost of production and allows healthcare
workers to purchase prescription protective eyeglasses for dedicated use in an
occupational setting. The Company believes that users will purchase multiple
pairs of glasses. It is anticipated that each pair will have an average life of
approximately 50-100 uses. While an average pair of prescription eyeglasses
costs over $150, MediSpecs Rx(TM) glasses are being sold for approximately $25 a
pair and can be ordered by mail. The cost to the Company under the Morrison
agreement is $6.98 per pair.
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MediSpecs Rx(TM) glasses protect against splashing of blood and bodily
fluids into the user's eyes, thus reducing exposure risk. Medi-Specs Rx(TM) are
ultra lightweight, making it unnecessary to the user to wear the more cumbersome
eyewear currently available for eye protection.
In August 1997, the Company entered into a distribution agreement for
the sale of MediSpecs Rx(TM) in the State of Florida. This agreement was with
Hospital News, a Florida corporation with its principal place of business in
Tampa, Florida ("Hospital News"). SMH and Doctors Hospital of Sarasota were
excluded from the agreement and remain under the distributorship of the Company.
The initial term of the Hospital News agreement was through December 1997, and
was renewable by the parties for successive one (1) year periods. The price for
the product was fixed for the initial term at $12.95 per pair and requires
minimum purchases which was scaled over the first six (6) months from 0 units
the first month to 800 the sixth month. Under the agreement, Hospital News was
entitled to distribute the product either directly or through other dealers.
Although Hospital News had not met its quota, the Company elected to extend this
arrangement for an additional one (1) year period. Hospital News sold no units
and is no longer a publication. The Company is disappointed with MediSpec Rx(TM)
sales and is considering dropping the product line. (See Part I, Item 1.
"Description of Business - (b) Business of Issuer - Distribution of Products.")
Due to the price at which MediSpecs Rx(TM) may be offered to users and
the prevention of cross-case contamination, the Company believed that there
would be a large national and international market available for the use of this
product; however, such market has not materialized.
Prostasert(TM)
Prostasert(TM), originally named LaborMate, is a patented, disposable,
obstetrical/gynecological specialty device with many potential uses, including
use for patients undergoing the induction of labor. The product provides a
vaginal application of a precise dosage of pharmaceutical gel which is designed
to shorten and improve the labor and delivery process. Although simple in
design, the Company believes that Prostasert(TM) is unique in that it differs
from its competitors by allowing for a more site-specific application and
improved maintenance of the pharmaceutical gel used. Prostasert(TM), a FDA
listed device, is a specially designed medication delivery and maintenance
system which allows a physician to deliver the proper dosage and maintain that
dosage precisely. With over four (4) million births annually in the United
States alone, the Company estimates the potential market for obstetrical use of
this product to be approximately 200,000 to 400,000 cases annually. These
estimates are based on the fact that 10% to 20% of the four (4) million births
annually are induced (labor stimulated medically) and that such numbers of
induced births are increasing because of the lower risks and patient/doctor
convenience factors. Alternate uses and other applications for this product are
under development including treatment for cervical infections and PAP smear
abnormalities for which the market is estimated to be 1,000,000 cases per year.
No FDA clearance was needed for this product because it is assembled
from FDA approved parts. The product was listed by the FDA in June 1994.
Prostasert(TM) was approved for clinical research by the Institutional Review
Board of the SMH where it has been undergoing clinical trials
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for the past four (4) years to document the clinical usefulness of the product.
Testing continues and results are expected in Year 2000. Once such trials are
completed and provided additional funding is available (of which there can be no
assurance), the Company intends to make final engineering adjustments and plans
to market this product under a licensing arrangement with an independent company
for initial market entry in the United States. However, no timetable for this
entry into the market has been established. The Company is seeking a
distribution outlet for such licensing arrangement while the clinical trials are
being conducted.
Icepak(TM)
The Company is researching patent protection for this specialty product
and its accessory components. This product is a belt which is designed to carry
various infection control-related products providing healthcare workers with
easy access to personal protective supplies. The belt itself is a durable,
reusable product with consumable supplies attached. The Company intends to
market and sell this product primarily through catalogs, with a focus on
distribution to nurses. The Company will be required to develop arrangements
with suppliers of the consumable supplies to be used in the belt. A prototype
has been manufactured and the product is expected to enter the market if the
required agreements with potential manufacturers/suppliers have been completed
and if additional funding is available (of which there can be no assurance).
Accordingly, no timetable for release of this product has been set. There is no
requirement for regulatory approval of this product.
Research and Development
The Company previously engaged in extensive research and development of
new medical technology. Many product concepts and partially developed designs
have been accumulated from internal and external sources. As funding becomes
available, of which there can be no assurance, new products will be brought
through the development process. Initial products in development include:
RD91862: PrepWiz(TM): This is a multiple product for preparing the
patient's surgical site. The Company anticipates that this product will
potentially solve major efficiency, costs and safety problems. The Company
currently plans to co-develop this product line with a major medical
manufacturer and subsequently license it for sales and distribution. Currently,
pattern designs are in process and the Company received non-sterile samples
which it is currently evaluating. The samples were provided to a contract
converter who produced non-sterile disposable samples to be used in finalization
of the design.
RD121096: Finger-Safe(TM) Surgical Thimble: The Company is seeking
patent protection on this fingertip protection device. It is expected that this
product can be added to the Compliance Plus product line in the event that
Company secures additional capital, of which there can be no assurance. This
product is used much like a thimble for sewing, but has special features that
facilitate the suturing technique and also has special safety features and a
storage component. The product is designed to reduce further the risk of
needlesticks and glove perforations to the non- dominant hand.
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Both RD91862 and RD121096 require regulatory approval from the FDA.
PrepWiz(TM) is in the development phase and no application under 501(K) will be
undertaken until final designs and approvals have been executed. Finger-Safe(TM)
Surgical Thimble is on the shelf and no development activity is currently
underway.
Advanced Surgical Techniques
The Company has several products in development that are designed to
contribute to the rapidly growing market of "minimally invasive" surgery with
increasing emphasis on small incisions, laparoscopy, laser treatment, and more
efficient post-surgery convalescence. The Company believes that there is a
significant demand for improved technology to facilitate these newly developed
procedures. The Company has several concepts and projects in development related
to this type of surgery, and many of the new product ideas presented to the
Medical Products Consultation Division by third parties are included in this
group.
Medical Consultation Division
The Medical Consultation Division previously provided consulting services
to individual inventors on a fee basis. Dr. Swor, Mr. Clark and Mr. Stuart, a
Director of the Company, have provide such services depending upon the type of
expertise required. The principal function of the division is to find new ideas
and potential products which compliment the Company's product mix.
This division has been retained to conduct several research evaluations of
various proprietary medical products and has completed two such projects, one
for London International U.S. Holdings, Inc. (a study to determine the
spermicidal activity of several concentrations of nonoxynol-9 lubricated condom
products) and another for Purely Cotton (a study of a tissue made from cotton
rather than paper to determine whether the product was less irritating to people
with chronic skin conditions). Based upon the initial evaluation of these
products, the Company believes that one or more could be very successful and
lead to additional business for the Company.
Business Strategy
The Company's business strategy, which is dependent upon its obtaining
sufficient additional financing with which to enhance the commercialization of
existing and future products of the Compliance Plus exposure prevention and
surgical efficiency product line and the OASiS information system (of which
there is no assurance), is to provide innovative products and services which
create and maintain a safe surgical environment for medical and hospital staff,
healthcare workers and patients, as well as to enhance the level of surgical
care available to patients. The Company's revenues are based upon lease payments
and fees for display of inservice modules from its Data Systems Division, sale
of its products and distribution fees from the Medical Products Division and
consulting fees earned by the Medical Consultation Division. The Company's
revenues are dependent on the volume of sales from its products.
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Revenues from sales are recognized in the period in which sales are made.
The Company's gross profit margin will be determined in part by its ability to
estimate and control direct costs of manufacturing and its ability to
incorporate such costs in the price charged to clients.
The Company's objective is to become a dominant provider of medical devices
and systems which improve occupational safety, advance surgical techniques and
provide greater efficiency. To achieve this objective, and assuming that
sufficient operating capital becomes available, the Company intends to: (i)
develop international distribution channels and co-marketing alliances for the
Company's products and services; (ii) continue research and development and
acquisitions of synergistic products and software programs; and (iii) frequently
fine tune market strategies based upon ongoing evaluations of customer needs,
capital budgeting opportunities and market economy fluctuations.
Management believes that Surgical is poised to lead in the ever developing
surgical and medical safety market and plans to capitalize on the opportunity
while providing significant benefits to its customers and improving overall
patient care. Management expects, in the event Surgical continues to achieve
product acceptance, to increase the Company's market penetration through
additional acquisitions and potential merger opportunities with appropriate
bases of business development. However, such expansion presents certain
challenges and risks and there could be no assurance that Surgical, even if it
were successful in acquiring other bases of business development, would be
successful in profitably penetrating these potential markets.
Sales and Marketing
The following discussion of the medical industry, as it relates to the
Company's objectives, is of course pertinent only if the Company is successful
in obtaining sufficient debt and/or equity financing to commercialize its
existing products and OASiS, to add additional key personnel when needed and to
supplement new product and software program development. In addition, the
Company must be able to generate significant profits from operations (which are
not expected in the foreseeable future) and/or additional financing to continue
expanding the business and/or to fund the anticipated growth, assuming
Surgical's proposed expanded business is successful. There can be no assurance
such financing can be obtained or that the Company's proposed expanded business
will be successful.
Background
According to the World Health Organization, forty (40) million people will
be infected with HIV by the year 2000. There are nearly ten (10) million people
worldwide currently infected, including close to one (1) million children. Over
four (4) million Americans carry the HIV virus. Approximately ten percent (10%)
of individuals will contract this very serious illness when exposed by way of a
sharps injury.
Auto Immune Deficiency Syndrome ("AIDS") is now the top killer of men age
17 to 54 in the United States. The CDC and the National Institutes of Health
("NIH") have focused a great deal of effort and research into improving
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occupational safety and decreasing the risk of bloodborne pathogens in the
healthcare setting. The American Hospital Association reports that needlestick
injuries are the most common injury to healthcare workers and represent the
greatest risk of occupational exposure to AIDS, Hepatitis, and other viral
diseases. There are over two (2) dozen diseases that have been involved in
documented transmission by way of exposure. Over one and a quarter million
(1,250,000) Americans have chronic Hepatitis B and when their blood is exposed
to a healthcare worker's intact skin, the transmission rate is thirty percent
(30%). Since operating room personnel and surgeons are in particular high risk
categories, the Company has committed itself to developing products and
techniques to decrease the potential for deadly viral transmission to and from
healthcare workers and patients.
Market Overview, Size and Occupational Safety
Healthcare workers need secure and safe working conditions. The Company
seeks to provide solutions to meet that need in the critical care setting. Value
is built into Surgical's products by reducing costs of inefficient surgery,
occupational exposures and patient risks. Exposure to bloodborne diseases occurs
in up to fifty percent (50%) of surgical cases, with needlesticks and other
sharps injuries magnifying the risk. (See G. Pugliese, RN, MS, Blood Exposures
in the Operating Room: Risk and Prevention Strategies, APIC Journal of Infection
Control 1993; pps. 21 and 337-42; and Jagger J, Blackwell B, Fowler M, Carter K,
Funderburk S, Bradshaw E, Swapp J., Percutaneous injury surveillance in a
58-hospital network, Tenth international conference on AIDS, Yokohama, Japan,
8/9/94.) Up to 75% of sharps injuries in the operating room are related to
suturing. (See Journal of the American Medical Association, June 1992; Journal
of the American Medical Association, September 25, 1991; and Obstetrics and
Gynecology, Volume 77, 1991.) Currently used safety measures are inadequate,
with an unbelievable 23% exposure rate documented even in known or suspected HIV
cases. (See G. Michael Swor, M.D., A Touch Information System for Healthcare
Worker Exposure, Risk, and Training Management, Surgical Technology
International VII. 1998: pps. 48-56; and Tokars JI, Bell DM, Culver DH, et al.,
Percutaneous injuries during surgical procedures, Journal of the American
Medical Association 1992; ppgs. 262-288 and 904.) Hepatitis C is a new,
incurable threat and HIV is now the number one cause of death in 25 to 44
year-olds in the United States. (See Morbidity and Mortality Weekly Report,
Center for Disease Control, November 19, 1993/Vol 42/No 45.) Significant
resources are devoted to occupational risks, with over $3 billion expended
annually in the United States on sharps injuries and bloodborne exposures.
According to the Canadian Medical Association Journal, treating one HIV-infected
healthcare worker may cost in excess of $500,000. In addition to the risk of
exposure, significant pressures have been made to reduce costs in surgery and in
critical care units.
With the increased prevalence of HIV, hepatitis and other deadly diseases,
OSHA has set increasingly strong standards. Despite the standard use of
protective gloves and clothing, operating room personnel and surgeons are at a
particularly high risk. According to the United States Department of Health and
Human Services, healthcare workers contract more than 15,000 bloodborne
infections from occupational exposure per year, resulting in 300 deaths and
thousands of illnesses. Surgical wound infections are relatively common and
result in increased costs, longer hospital stays and increased morbidity in
patients. A Yale University study found that visible contact with patient's
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blood occurred in 63% of surgical cases and sharps injury rates range from 7% to
50%, depending on the type of case. At current rates, researchers from major
medical institutions have estimated the lifetime career risk of occupational HIV
infractions for surgeons as high as 20%, depending on the patient population.
Despite this data, HIV is overshadowed by Hepatis B and C which are 100 times
more infectious.
Due to increased awareness of these problems, there has been a movement
from healthcare workers themselves for facilities to provide adequate protection
and safety engineered technology. Hospitals also benefit from improved
technology and can significantly decrease post-exposure follow-up and treatment.
A large body of research and statistical evidence has been accumulated
over the last ten (10) years regarding the significant risk of bloodborne
diseases to healthcare workers. Similar kinds of risks exist regarding the
transmission of disease from health workers to patients. Since the AIDS virus
was discovered and blood testing became available in 1985, even greater
awareness has been focused on these problems. The Company has focused its
efforts on identifying occupational risks in the healthcare industry and seeking
to provide solutions to various problems regarding these risks.
As noted, the bloodborne pathogens which have received the most
attention are AIDS and Hepatitis. There are an estimated ten (10) million people
infected with the AIDS virus worldwide, and because of the nature of the
disease, it is impossible to determine infected individuals with certainty, even
with blood tests. (See Centers for Disease Control, Estimates of HIV prevalence
and projected AIDS cases, Morbidity and Mortality Weekly Report, 1990; pps. 39
and 110-119; World Health Organization, In Point of Fact, No. 74. Geneva, World
Health Organization, May 1991; Piot P, Plummer F, Mhalu FS, et al, AIDS: An
international perspective, Science 1998; pps. 239 and 573- 579; and Palca J.,
The Sobering Geography of AIDS, Science 1991; pps. 252 and 373.) Hepatitis is
even more widespread and, according to medical experts, much more contagious.
These diseases and others are transmitted by contact with blood or bodily fluids
and reports of infection through needlesticks, sharps injuries, and skin to skin
contact are accumulating. The American Hospital Association, in 1992, reported
over 800,000 occupational needlestick injuries in the United States each year,
and estimated that approximately 16,000 were contaminated by HIV. They also
estimated that as many as 60 healthcare workers may become infected annually
with HIV as a result of occupational exposure. There have been estimates as high
as 12,000 Hepatitis B infections annually to healthcare workers. (See Applegate
EJ., The Anatomy and Physiology Learning System, Philadelphia, PA: WB Saunders
Company; 1995, p.241.) A newer form of Hepatitis, Hepatitis C, is rapidly
becoming even more important and more serious.
OSHA now has strict guidelines for personal protective equipment, such
as gloves, gowns, and eyewear. However, with a reported rate of glove
perforation in surgery of up to 50%, sharps injuries of up to 25% and concerns
regarding the prevention of bloodborne pathogen transmission, healthcare
professionals, workers and patients are requesting more protection. Most
professionals agree that many sharps injuries in surgery are preventable with
changes in techniques and the use of new devices and protective equipment.
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The cost of these types of exposures is also a significant factor in the
Company's business. The direct financial burden that facilities bear for medical
evaluation and follow-up after a single needlestick injury is estimated to be
$200 to $1,300 ($3 billion in the United States as reported in Nursing
Economics, Vol. 12, No. 4, pp. 208-214 (1994) based upon 1987 date regarding the
cost of diagnosis and treatment of needlestick injuries in the United States).
According to the United States Department of Health and Human Services, the
average cost of treating an accidental needlestick is $1,300. This figure does
not include indirect costs such as time lost from work, medical expense and
potential liability loss. With annual expenditures in the United States on
medical and surgical supplies estimated by current medical journals at more than
$6 billion annually, there would appear to be a large budget for safety-related
products. Surprisingly, there have been few significant advances in new
technology regarding bloodborne pathogens. The Company is focusing its research
and development efforts directly on improvements in this area with operating
room, infection control and reporting, and personal safety equipment product
lines.
The Company's initial product, SutureMate(R), was designed primarily to
reduce the risk of needlestick and glove perforation during suturing. Infection
can also be transmitted by skin to skin (mucocutaneous) contact, and the
Company's Infection Control Equipment Pack (IcePak(TM)) product was developed
from the need to reduce this hazard. The Company's OASiS system is designed
primarily for accident reporting and training. Customer demand for the
Company's' products and services is expected to be stimulated further by recent
scientific data suggesting that the risks related to these hazards were
originally underestimated. In addition, new serious viral diseases are
discovered regularly.
With an estimated 25 million surgical procedures and 4 million births
annually in the United States alone (See Statistics published on health and
nutrition from the American Hospital Association's Hospital Statistics Annual,
Chicago, IL, 1990.), and a fertile international market as well, the Company is
focused upon the development of innovative reporting and training equipment,
efficiency related instruments, and cost efficient supplies for furthering the
concept for cost conscious safety in healthcare.
Hospitals are under increasing pressure to evaluate and adopt the use of
safety-related technology, especially with regards to sharps injuries. New
regulations, hospital policies, and federal guidelines will encourage any
efficient means of improving safety, especially with regard to HIV transmission.
Because of the size and demands of these markets, the Company believes that this
is an area of potentially significant growth if it can continue to strengthen
the market niche it has created.
Markets
The primary medical industry markets include hospitals, healthcare
facilities, surgeons, nurses, and technologists in procedure-oriented
specialties, including obstetricians, dentists, emergency room personnel and
other medical professionals.
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The potential global market for Surgical's products (devices and
information systems) is estimated at over $1.3 billion. This data was presented
in an article written by Dr. Swor which appeared in Surgical Technology
International, Vol. II where Dr. Swor was referencing an article from the
Florida Healthcare Report and Hospital News which appeared in December 1997.
The initial target market areas for the product side of the Company's
business are in the major metropolitan centers in the United States and abroad
that presently have large teaching programs, higher disease prevalence and acute
problem awareness. Entry into these target areas is expected by the Company to
significantly ease general market penetration.
The Company plans to export its products worldwide to markets including
Europe, South America and Asia, the Middle East and the Pacific Rim. Previously
it had exclusive distributorship agreements with Johnson & Johnson Medical Pty.
Ltd. with respect to the territories of Australia, New Zealand, Papua, New
Guinea and Fiji, with Medicor Corp. with respect to the Netherlands and with ISC
Group with respect to Saudi Arabia and the so-called GCC Nations which
agreements expired principally due to the Company's financial inability to
sustain sufficient levels of production under prior manufacturing arrangements.
Although technically in force, the agreement with Noesis relative to Europe is
inactive. The Company believes that it will be able to reactivate these
distribution arrangements with the re-designed SutureMate(R) under the
manufacturing arrangement with Tuthill or other suitable suppliers under
consideration, provided additional funding is available to the Company to
manufacturer adequate inventory. The basis of this belief is that initial
marketing efforts were thwarted by the high manufacturers suggested retail price
and in discussions with one of these distributors, it has been indicated that
such distributor would reinstate its agreement when adequate inventory is
available. There can be no assurance that such distribution arrangements can be
re-established or that there will be additional funding available to the
Company. (See Part I, Item 1. "Description of Business - (b) Business of Issuer
- - Distribution of Products.")
OASiS has been foundationally designed to accept multi-lingual
applications. The Company expects that this will not only facilitate acceptance
in the cosmopolitan markets within the United States, but also will enable
instant adaptations to international markets which traditionally follow the
United States leadership in developments of safety and exposure guidelines.
A major portion of the safety products and services currently ready for
marketing by the Company, including both device and information services, are
unique and are without apparent competition by design since they were specified
and designed by the Company to create previously unavailable products and
services. In most cases, Surgical's state-of-the-art products, techniques and
services position the Company as a pioneer in new markets. This is a direct
result of the Company's election to avoid the typical commodity sales of gloves,
gowns, shields, and other products of that type and to focus on innovative,
safety related products such as SutureMate(R), which was the first device of its
kind to provide for lower risk, one-handed suturing.
The market for Surgical's products is divided into three (3) segments:
end users, healthcare risk managers and medical-related companies.
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The primary end user market for the products and services of Surgical
include 8,000 hospitals, 100,000 surgeons and over 1,000,000 surgical nurses and
technologists. Secondary end user markets include out-patient clinics, dental
offices, emergency medical services, fire and rescue organizations, medical
offices and laboratories. This segment of the Company's market will be the
ultimate user of both the medical devices and OASiS and it is particularly
defined by the need for protection against bloodborne diseases from body fluids
and sharps injuries, such as needlesticks.
The healthcare risk manager market is defined by similar statistics as
the end user market. The major difference is that this segment is represented at
an administrative level. Additionally, it encompasses insurance companies and
other parties interested in capturing safety and occupational injury data. This
segment of the market focuses on ensuring a safer, more efficient workplace for
the healthcare worker and in obtaining previously unavailable information about
actual occurrences of bloodborne pathogen exposure and the management thereof.
The market segment for medical-related companies consists of
approximately 11,600 medical device manufacturers, 360 pharmaceutical companies
and 1,260 training and educational organizations. The Company believes that this
is a significant segment for them for three reasons. First, these companies will
be enlisted as content providers (a content provider supplies OASiS with device
information and other educational components) ("Content Providers"). Content
Providers are potential customers for the Company because they pay a reoccurring
fee to broadcast their information on OASiS. Secondly, this market segment is
desirous of the data collected by OASiS as it relates to the information
surrounding exposure occurrences. The Company already has received requests for
access to this (yet-to-be collected) data. The third reason the Company believes
this segment to be significant is that these companies are a key component to
the Company's sales strategy for its medical devices. The Company believes that
its relationship with US Surgical as a strategic partner is based on the
integration of OASiS and the Company's Compliance Plus line of products and the
venue potential for US Surgical products.
The Company believes that the criteria for another appropriate strategic
partner for an alliance with the Company would have a worldwide presence,
maintain a dedicated, highly trained sales force with access to the operating
room, be a respected and an acknowledged leader in the industry, be among the
Fortune 500 companies or equivalent and have an interest in diversification of
its existing product lines. In this regard, the Company believes that its long
term arrangements with US Surgical establishes a strategic alliance with a
company which meets these criteria.
Distribution of Products
SutureMate(R), MediSpecs Rx(TM) and OASiS are currently the Company's
only products in the marketplace. With reference to such products, the Company
has entered into a number of agreements regarding their distribution. See Part
I, Item 1. "Description of Business - (b) Business of Issuer Risk Factors."
In December 1994, the Company entered into a distributorship agreement
for a period of one (1) year with ISC Group, a corporation organized under the
laws of the country of Saudi Arabia, for the exclusive right to purchase,
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inventory, promote and re-sell SutureMate(R) in Saudi Arabia and the GCC
Nations. An initial order was placed and shipped.
In March 1995, the Company entered into a distribution agreement with
Medicor Corporation for the exclusive right to purchase and sell SutureMate(R)
in the Netherlands. An initial order was shipped pursuant to this agreement in
April 1995. The agreement had no term and the parties were awaiting evaluation
of the product in the marketplace.
In April 1995, the Company entered into a distributorship agreement with
Johnson & Johnson Medical Pty. Ltd. ("J&J") to exclusively sell SutureMate(R) in
Australia, New Zealand, Papua, New Guinea and Fiji. An initial order was placed.
Under the terms of the agreement, J&J had no sales quota for the first ninety
(90) days and the parties were to agree by July 1995 as to the sales quota for
the remaining term. J&J had a right to terminate this agreement on sixty (60)
days notice.
ISC Group, Medicor Corporation and Johnson & Johnson Medical Pty., Ltd.
are not currently distributing Surgical's product. The Company has not actively
pursued additional business from these companies since it has placed such
business on hold pending further developments in the Company. The Company
believes that it can reinstate these agreements and has discussed reinstatement
with one of these former distributors which advised that the agreement can be
reinstated when adequate inventory is available. However, there can be no
assurance that such distribution agreements can be re-activated. Further, since
each of these companies distribute many other products, there can be no
assurance that they will agree to distribute SutureMate(R) at such time as the
Company is ready for such additional distribution. And further, although the
Company currently plans to proceed with attempting to re-establish these
relationships at such time as the Company has sufficient funding to fully supply
the re-engineered SutureMate(R), there can be no assurance that such funding
will be available to it.
In December 1996, the Company entered into an exclusive distribution
agreement with Noesis Capital Corporation ("Noesis"), a Florida corporation, for
a term of seven (7) years for the European market under which Noesis was to
recruit, hire and train European master distributors and distributor/dealer
networks throughout the Continent for sales of SutureMate(R). Under the terms of
the agreement, the parties were to set minimum annual quantities which had to be
sold. The price per unit to Noesis was set at the greater of $1.50 or, in the
event of a cost increased to the Company for manufacturing, 150% of the
Company's revised cost. Although still technically in force, this contract is
not currently active and has been placed on hold by the Company pending further
developments, including the availability of the re-designed SutureMate(R)
currently being manufactured by Tuthill.
In July 1997, the Company entered into a distribution agreement with
Hospital News of Florida, a Florida corporation ("HNF"). Pursuant to this
agreement, HNF was granted the exclusive distributorship of the MediSpecs Rx(TM)
eyewear in the State of Florida. SMH was specifically excluded from this
agreement. The original agreement was to terminate on December 31, 1997, but
could be renewed if the parties so agreed for successive one (1) year periods.
The price of each pair of eyewear was set at $19.95 plus $4.95 for shipping and
handling. The Company agreed to pay HNF $7.00 for each pair sold and no
commission was due to HNF for any subsequent re-orders from an existing customer
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The agreement required HNF to generate 800 orders by December 1997. HNF was
responsible for soliciting, collecting and delivering completed order forms on
the form designated by the Company. Although HNF did not achieve its initial
quota, the Company elected to extend this arrangement. Hospital News made no
sales and is no longer a publication. Morrison has discontinued the
manufacturing of this product and is selling off existing inventory. The Company
is considering dropping this product line.
In February 1998, the Company executed a Letter of Intent with United
States Surgical Corporation ("U S Surgical"). Pursuant to such letter, U S
Surgical stated that, after investigation of the Company, it intends to pursue a
joint venture or equity buy-in relationship, subject to due diligence review.
Part of such due diligence review was to be observation of the healthcare
workers' reactions to the OASiS presentation at the AORN 1998 meeting. The
Company granted U S Surgical status as a Charter Sponsor of OASiS and a 33%
discount off the proposed retail value of services provided at the AORN meeting.
OASiS accounted for over 21% of all leads generated by US Surgical at AORN
meeting.
In July 1998, the parties agreed to terms of under the Short Term
Agreement which was executed October 28, 1998. Under the terms of the Short Term
Agreement, US Surgical obligated itself to arrange for the installation of ten
(10) OASiS systems in hospital facilities which US Surgical defines as "Centers
of Excellence", including initially Harvard and Yale. US Surgical continued to
change the centers and Harvard was replaced with Northwestern University Medical
Center. Each system includes thirty (30) inservice training modules with US
Surgical products. In addition, the Company is permitted to include modules for
other manufacturers subject to the approval of US Surgical. Following an initial
nine (9) month trial at each of these facilities and subject to satisfactory
performance by the system and the technical support group, US Surgical has the
right to have additional systems installed in other healthcare facilities
nationwide. US Surgical agreed to finance the development and installation of
the ten (10) systems. No decision has been made as to which party will pay for
the additional installations which US Surgical elects to have installed. In the
event the Company is required to pay, additional financing may be required from
outside sources, the securing of which cannot be assured. The Company receives a
fee in the amount of $36,000 for the initial ten (10) installations during the
testing period and a fee in the amount of $108,000 for the balance of a three
(3) year term for such initial installations. In addition, the Company is able
to earn profits on the sales of its products through the point-of-sale facility
in the OASiS system and from the fees it receives from other device providers
and training companies through the use of the inservice modules. Provided US
Surgical is not in default in any payment, at the end of the term, they have the
option to purchase the OASiS hardware at a price of $8,500 for each Model 1062
unit. Although ten (10) units were to be installed in November 1998, due to a
delay caused by the acquisition of US Surgical by Tyco and a strategic decision
by them to delay the commencement of the installations until after the holiday
season the Company has thus far installed six (6) units in five (5) hospitals.
The balance were to be completed in the third quarter of 1999; however, these
installations have been merged into the Long Term Agreement.
On July 30, 1999, the Company entered the Long Term Agreement, a private
partner network agreement, with US Surgical. Under the Long Term Agreement,
Surgical is to supply up to four hundred (400) OASiS systems to US Surgical
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under licenses calling for installation in nominated hospitals. Each license is
for a term of three (3) years commencing with "substantial installation" of such
unit. "Substantial installation" is defined as delivery of the OASiS unit to the
hospital and connection to the Internet.
Under the terms of the Long Term Agreement, US Surgical must license two
hundred (200) units within the first year, and subject to certain obligations on
the part of Surgical to license units to third parties, must license an
additional two hundred (200) units by the end of the second year to third
parties. Previously installed units under the October 1998 agreement are counted
toward the minimum units required. On August 10, 1999 US Surgical paid Surgical
$100,000.00 as an advance for such licenses. The first 200 licenses are $1,500
each and additional licenses are $1,000 each.
The Long Term Agreement further provides that neither Surgical, nor any
third party other than US Surgical, may place OASiS units in any of the
"protected departments" of the hospitals, unless it is installed prior to
receipt of a purchase order from US Surgical or unless US Surgical does not
exercise its right of first refusal after notice from Surgical for such
hospital. The Long Term Agreement defines "protected departments" as Operating
Room, Labor and Delivery, Emergency Room, Ambulatory/Same Day Surgery /
Outpatient, Nuclear Medicine, Intensive Care, Orthopedic / Ortho Casting Room,
and Dialysis. US Surgical is required to have each hospital bear the entire risk
of loss and damage to any OASiS system except if such is caused by the
negligence or wilful misconduct of Surgical. US Surgical must maintain casualty
insurance in amounts and with companies acceptable to Surgical on the OASiS
units and its related amenities with Surgical as the loss payee. US Surgical may
elect to have the OASiS systems installed in hospitals it nominates co- branded
with its name. Surgical has the discretion to select the content, related
services and in- service products for the OASiS systems installed under this
agreement; however, during the term of the agreement, US Surgical is required to
pay for and maintain a minimum of one hundred forty (140) product in-services
modules in an average of at least 80% of all OASiS systems installed in the
United States whether or not covered by this agreement and 100% on those that
are covered by the agreement. US Surgical's product-based modules produced by
Surgical become the property of US Surgical. Surgical retains the right to
display such modules on other OASiS units. All other modules remain the property
of Surgical. Surgical receives a fee for production of the modules. If Surgical
installs additional OASiS units in a designated hospital, US Surgical receives a
10% commission. Surgical receives a monthly maintenance fee for each unit, of
$149, unless paid a year in advance in which case it may be discounted up to
10%.
Methods of Distribution
Whether or not the Company is successful in raising additional capital
(of which there can be no assurance), since Surgical was successful in
completing the alliance with US Surgical, the Company intends to provide sales
support to such partner. The partner will manage the primary sales functions
with the Company acting as an additional resource for sales support. As to the
OASiS system, Surgical and its strategic partner will complete a site survey for
each customer facility. The Company also will seek additional strategic partners
for these functions. Surgical will coordinate the necessary follow-through with
the Integration Specialist.
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Notwithstanding the US Surgical contract and until such time as the
Company establishes alliances with additional strategic partners, Surgical will
continue to rely on a significant database and network of consultants,
international business contacts, researchers, medical advisors and potential
distributors, suppliers and manufacturers for sales of its products. The Company
has accumulated over 3,000 sales leads and customer contacts, with a majority
being United States based surgeons and operating room technologists. The Company
will continue to sell its products direct to hospitals and other medical care
providers.
In addition to sales by U.S. Surgical and distributors, the Company also
solicits orders through direct mail sales, trade publications and advertising by
targeting specific market groups. Since joining the Company, Mr. Clark has begun
an active campaign to establish repeat markets for Surgical's products. Customer
follow-up is currently handled by in-house sales staff of which there are five
(5). Orders obtained can be shipped from in-house inventory or warehousing
arrangements. The Company has the original SutureMate(R) and MediSpecs Rx(TM) in
stock and is finalizing manufacturing, sterilization and inspection procedures
for the re-designed SutureMate(R) so that inventory can be established.
Customers may return defective merchandise for a full refund, credit or
replacement. In recent years, such returns have been insignificant.
Status of Publicly Announced Products and Services
Based upon feedback from surgeons and operating room technologists since
the introduction of SutureMate(R) in 1993, this product has been re-engineered
and is currently ready for distribution, subject to the availability of
additional funding, of which there can be no assurance. The original
SutureMate(R) is available and on the market. The Company is seeking additional
distribution channels for this product.
MediSpecs Rx(TM) currently is available; however, the Company is
considering dropping the line due to poor sales.
Once trials are completed and subject to the availability of additional
funding, the Company intends to make final engineering adjustments to
Prostasert(TM) and then commence manufacturing for initial market entry in the
United States. There is no current timetable for such entry.
The OASiS system is fully operational at its initial sight at SMH in
Sarasota, Florida, at five (5) hospitals under the arrangements with US Surgical
and at St. Francis in Trenton, New Jersey. Although the Company expected to
complete the balance of the installations under the Short Term Agreement with US
Surgical installations in the third quarter 1999, such installations have been
merged into the Long Term Agreement. The Company is ready for additional
installations at other locations as soon as agreements can be completed. Version
2.0 is being installed at the US Surgical sites and is in final stages of test
trials.
A prototype of IcePak(TM) has been manufactured and the product is
expected to enter the market if the required agreements with potential
manufacturers/suppliers have been completed and additional funding is available.
There is no current timetable for such entry.
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Competition
There is intense competition in the markets in which the Company engages
in business. However, the Company believes that there is relatively little
competition for its products at this time.
Notwithstanding its innovative product line, there are many major
companies which could compete with the Company due to their size and market
share in the medical products area. These include such companies as U S
Surgical, Ethicon, Inc. ("Ethicon"), a Johnson & Johnson subsidiary and
Sherwood-Davis & Geck, a division of American Home Products Corporation, all of
which have a wider range of other medical products and dominate much of the
markets for these other products. These companies focus on sutures and related
suturing devices. Traditionally such companies have not focused on safety
related products but they are now modifying the design of some sutures to reduce
needlesticks. Several medical products firms, including Johnson & Johnson and
Graphics Controls, Inc. ("Graphics Control") have operations in the surgical
safety product niche. Graphics Control sells approximately 50% of all safety
devices to the medical industry. The Company believes that these major companies
will continue their efforts to develop and market competitive devices. It is for
this reason that the Company has sought to align itself with a strategic partner
and has entered into the Long Term Agreement with US Surgical.
A major purveyor of safety devices is Devon Industries ("Devon") which
commands about 75% of this market. Devon's product line includes approximately
one hundred "me-too" type products; that is products designed to copy or which
copy products already in the market. Specialized Health Products International,
Inc. ("SHPI") designs and develops products to minimize the risk of accidental
needlesticks in order to reduce the spread of bloodborne diseases in heathcare
workers. SHPI's strategy is to become a single source provider for needle
protection devices. Many other device companies market these same products with
only slight variations. However, the Company believes that one of the major
pitfalls with these types of companies is that they have no distinctive new
product concepts to distinguish themselves from other companies in their
industry. The Company believes that its product line does distinguish Surgical
from other medical device providers. For example: (1) SutureMate(R) is the only
device of its kind which allows for one-handed suturing and its tent-like
configuration, combined with the adhesive backing and the hidden cutting device,
separates it from all competitive products; and (2) MediSpecs Rx(TM) is the only
low-cost, ultra-light prescriptive eyewear specifically designed to protect
against splashing blood and bodily fluids.
There is intense competition in sales of products for use in
gynocological, spinal, vascular, cardiovascular, interventional cardiology,
breast biopsy, urologic, orthopedic and oncological procedures. A broad range of
companies presently offer products or are developing products for the use in
such procedures. Many of these companies have significantly greater capital than
the Company and are expected to devote substantial resources to the development
of newer technologies which would be competitive with products which the Company
may offer. There are also a number of smaller companies which offer such
products which present additional competition.
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Many of the large chemical companies market solvents that are claimed to
be useful as a barrier protection to bloodborne pathogen infection. Some of
these companies are being scrutinized by the FDA because of a lack of proper
clinical research and statistics to substantiate barrier effectiveness.
The market for products for minimally invasive surgery is highly
competitive. The Company believes if it enters this market that it could gain a
significant share of the market as the result of its innovative efforts and
superior products. This is principally due to the Company's involvement with Dr.
Saye and the ALTC which is currently training surgeons in advanced laparoscopic
surgery since it is felt that if the Company develops a suitable product, it
could be incorporated into this training program. Ethicon, through a division
known as Ethicon Endo-Surgery, markets a line of endoscopic instruments directly
competitive with the Company's contemplated products and this company would be
Surgical's principal competitor in minimally invasive surgery. Ethicon
Endo-Surgery has an agreement with Dr. Saye. However, Dr. Saye's agreement with
the Company specifically provides that it will not compete with the Ethicon
agreement. Dr. Saye's agreement with Ethicon calls for him to travel to various
sites to conduct seminars and to provide teaching services for physicians. His
agreement with Surgical conveys to Surgical the right to market his Advanced
Laparoscopy Trauma Center database. Therefore it is believed that the two
arrangements do not compete. The Company understands that Ethicon devotes
considerable resources to research and development and sales efforts in this
field. Numerous other companies manufacture and distribute single use endoscopic
instruments. In addition, Richard Wolf Medical Instruments Corp. (a subsidiary
of Richard Wolf, GmbH) and Karl Storz Endoscopy-America, Inc. (a subsidiary of
Karl Storz, GmbH), would compete directly with the Company in this area.
Surgical faces competition in its data service line by a system
developed by the University of Virginia and promoted by the International
Healthcare Worker Safety Center. Designated EpiNet, this is a single system
designed to track and report bloodborne pathogen exposures in the healthcare
setting. It is installed in approximately seventy (70) healthcare facilities;
however, Company research indicates that EpiNet is actually used in only a
fraction of those facilities. This research was assembled by interviewing
healthcare workers who were users of the system at the American College of
Surgeons annual meeting and by interviews with members of the Medical Advisory
Panel who are familiar with the system. This system has been analyzed by
infection and systems control experts and has been found to be "non-user
friendly". That is because it is a DOS based systems which requires a
sophisticated user, it is limited to bloodborne pathogen programs and content,
it requires keyboard interface and is research based rather than user
information based. Although this system has been available for several years, it
has not achieved large market acceptance most likely because of the
characteristics which make it "non-user friendly". The Company is encouraged by
the fact that EpiNet has been installed in so many facilities as evidence that
computer aided reporting and services are desired by the healthcare community
and notwithstanding EpiNet's failure to gain large market acceptance, believes
that the Company's OASiS system could find greater acceptance because of its
ease of use due to the touch access concept and the broader availability of
information which OASiS can provide on site.
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There are approximately two hundred (200) companies with at least some
products designed to facilitate healthcare training. With a technology shift
toward computer based training ("CBT"), this market is undergoing some
redefinition. Certain companies are shifting from a VCR/booklet format to
multimedia applications. Other companies are new and were formed specifically to
develop CBT programs for healthcare training. The Company believes that these
competitors are relying upon the healthcare facility to provide the delivery
system, a personal computer, for such training programs. The Company believes
that OASiS, which offers a complete system, software and hardware, in a touch
access format, will have greater market attraction.
The Company's principal methods of competing are the development of
innovative products, the performance and breadth of its products, its
technically trained sales force, and its educational services, including
sponsorship of training programs. Most of the Company's potential major
competitors have greater financial resources than the Company. Some of its
potential competitors, particularly Ethicon, have engaged in substantial price
discounting and other significant efforts to gain market share, including
bundled contracts for a wide variety of healthcare products with group
purchasing organizations. In the current healthcare environment, cost
containment has become a significant factor in purchasing decisions by
hospitals. Additional cost effectiveness was one of the principle factors in the
redesign of SutureMate(R) and a principle consideration in the lease pricing
structure for OASiS.
Surgical's sales force is being trained on an ongoing basis to focus on
healthcare worker safety issues. In the ten (10) years prior to joining the
Company, its President, Mr. Clark, was instrumental in assisting three (3)
companies in establishing sales organizations within the healthcare industry. He
has recruited, trained and supervised these sales organizations. For these
reasons, the Company believes that it has the management expertise to have its
sales force distinguish itself from the competition. More specifically, the
Company is developing a clear and concise understanding of the inherent safety
risks associated with the healthcare worker's everyday work place. This
understanding is accomplished through its personnel which has extensive
experience in the healthcare industry, medical expertise, engineering
capabilities, communications skills with customers, as well as an understanding
of the medical marketplace and a variety of manufacturing practices. The Company
believes that the end result is that it is able to provide the customer with a
unique product or service specifically developed with individualized safety and
utility in mind, while providing that product or service to the customer so that
its value exceeds its cost.
One of the biggest attractions to the Company of a strategic alliance
with US Surgical is the fact that U S Surgical collaborates with some of the
most prestigious academic medical centers in the world to establish Centers of
Excellence for training in many diverse disciplines. These centers are devoted
to teaching residents and surgeons in the use of new instrumentation, developing
new technologies, conducting preclinical trials and other research projects.
Under the terms of the joint venture between the Company and U S Surgical, the
OASiS system was to be installed in a total of ten (10) of these Centers of
Excellence for an initial nine (9) month trial period. Although such trials have
not been completed, U S Surgical has entered into an additional agreement for
200 units and a potential of 200 more. In today's managed care environment,
these multi-center installations are expected to bring into sharper focus the
cost benefits of a wide range of the Company's products.
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The Company believes that the advantages of its various products and its
customer assistance programs will continue to provide the best value to its
customers. However, there is considerable competition in the industry and no
assurance can be given as to the Company's competitive position. The impact of
competition will likely have an effect on sales volumes and on prices charged by
the Company. In addition, increased cost consciousness has revived competition
from reusable instruments to some extent. The Company believes that single use
instruments are safer and more cost efficient for hospitals and the healthcare
system than reusable instruments, but it cannot predict the extent to which
reusable instruments will competitively impact the Company. The Company also
offers semi-disposable instruments, components of which may be reused a certain
number of times, to respond to the preferences of its customers.
Current and future customers were interviewed at major medical
organization exhibits. Overall statistics indicate that 50% of vascular,
thoracic and general surgeons found the Compliance Plus products to be useful,
safe and potentially cost effective. OB/GYN's urologists and plastic surgeons
gave a 90% favorable evaluations, while over 90% of surgical technologists gave
"high" to "very high" ratings to SutureMate(R) and MediSpecs Rx(TM). The Company
believes that it has chosen a developing market with no well-established
industry leaders at this time. Further it believes that its products are unique
and that by maintaining a relatively narrow market focus, combined with
technical expertise, that it can achieve rapid growth. (See Part I, Item 1.
"Description of Business (b) Business of the Issuer - Risk Factors.")
Sources and Availability of Raw Materials
Raw materials necessary for the hardware requirements of the OASiS
system are available from numerous third-party OEM's. The software integrated
into the assembled system is proprietary to the Company.
Raw materials necessary for the manufacturer of parts, components and
packaging supplies for all of the Company's products manufactured by the Medical
Products Division are readily available from numerous third-party suppliers.
The Company does not rely on any principal suppliers for any of its raw
materials. However, with regard to MediSpecs Rx(TM), the Company entered into a
manufacturing agreement with Morrison, the initial term of which expires in
September 2000 and, with regard to SutureMate(R), the Company has received a
price quotation from Tuthill for the manufacture of the redesigned
SutureMate(R). (See Part I, Item 1. "Description of Business - (b) Business of
the Issuer - Risk Factors.")
Dependence on Major Customers
At the current time, Surgical is reliant upon a few major customers for
several of its products. For the fiscal year ending December 31, 1997, the
Company derived approximately 99% of its revenue from sales of its OASiS to SMH.
For fiscal year ending December 31, 1998, the Company derived approximately 93%
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of its revenue from technical services it provided to US Surgical during a
medical products convention. (See Part I, Item 1. "Description of Business - (b)
Business of the Issuer - Risk Factors.")
With regard to the OASiS system, the Company is reliant upon its agreement
for the installation at SMH, its agreements with US Surgical for sales revenues
and further exploitation of the system, its arrangement with Rockford for the
financing of the leasing to facilities and its arrangement with Ad-vantagenet
for completion of the Version 2.0 software.
SutureMate(R) sales are currently principally reliant upon in-house
distribution and reestablishment of various distribution arrangements for
generating revenues for this product.
Due to the failure of the sales efforts by Hospital News of Florida, the
Company is reliant on in-house sales efforts for it MediSpecs Rx(TM) product
line and is considering dropping the line due to poor sales.
Subject to the availability of additional funding, of which there can be no
assurance, the Company believes that it can increase its customer base so that
the loss of any one client will not adversely impact upon the financial
condition of Surgical.
Research and Development
The Company believes that research and development is an important factor
in its future growth. The Company has engaged in extensive product research and
development. The Company's research and development group (currently consisting
of three (3) persons) has at least four (4) additional products for the medical
and healthcare community, all of which are in various stages of development,
from prototype to patent. The Company has in the past, and subject to the
availability of additional funding may devote a substantial amount of time to
the research and development of products within distinct product lines.
Substantially all of the products in research and development have been
designed, drawn, had preliminary market research conducted and have been
submitted for review to the Company's patent counsel.
As a natural by-product of an active research and development department,
some product concepts have been generated which do not fit the Company's chosen
focus. Several surgical and obstetrical devices have been designed and either
will be licensed or sold outright to appropriate corporate entities.
Patents, Copyrights and Trademarks
Patents are significant to the conduct of the Company's business. The
Company owns four (4) patents on two (2) products. Dr. Swor was the inventor who
originally secured the patents which he later assigned to the Company in
exchange for stock. (See Part II, Item 7. "Certain Relationships and Related
Transactions.")
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The Company's first medical device patent is United States Patent No.
4,969,893, issued on November 13, 1990 for SutureMate(R), The patent was filed
on June 16, 1989 and covers a unique surgical suturing device for its suture
cutting and needle rest utility. Additional patents (U. S. Patent No.'s Des.
353,672 and 5,385,569) were issued on December 20, 1994 and January 31, 1995 and
both were filed on May 21, 1993. The additional patents are for surgical
accessories to SutureMate(R) for both design and utility. Patents number 4969893
and 353,672 are for a term of seventeen (17) years from the issuance date; while
patent number 5,385,569 is for a term of fourteen (14) years from the issuance
date.
Prostasert(TM) is the Company's second medical device on which a patent was
issued. This patent, United States Patent No. 5,364,375, was issued on November
15, 1994 and filed on September 24, 1993. The patent covers a unique device
designed to introduce and maintain a precise amount of pharmaceutical material
to the uterine cervix and upper vagina. This patent is for a term of seventeen
(17) years from the issuance date.
The Company filed a Section 501(k) notification of intent to market
SutureMate(R) with the FDA. On May 19, 1998, the Company was granted permission
by the FDA to market this device. Prostasert(TM) was listed with the FDA under
its original name, LaborMate on June 2, 1994. No FDA clearance was required
because the components were all FDA approved prior to assembly in the
Prostasert(TM) format.
On June 1, 1998, the Company filed for two (2) patents on the OASiS system
which includes propriety aspects of the software, algorithms and reports, as
well as the inservice training modules which are owned by the Company. Neither
of these patents have been issued to date.
The Company currently has the rights to several new product concepts in
various stages of development. These products are surgical and obstetrical
devices for which patent protection is in progress or will be initiated in the
near future.
The patents held by the Company have expiration dates ranging from eight
(8) to thirteen (13) years.
The Company has an extensive library of copyrighted educational and
training material related to occupational safety and surgical techniques. These
include the Surgical Safety Manual published in 1994, which was revised in 1996.
The Company filed on July 1, 1993 for trademark registration with the
United States Patent and Trademark Office for SutureMate(R). This trademark was
registered on April 5, 1994.
The Company applied for trademark registration on the Compliance Plus on
December 6,1996. It was published for opposition on June 23, 1998. The Company
received an opposition and decided to withdraw its application.
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The Company applied for trademark registration for the OASiS Touch
Access Information on April 29, 1998 and the examination of this application is
pending.
The Company applied for trademark registration for TouchPort and
VirtualTouch Reality on November 16, 1998. Examination of these applications are
pending.
The Company is not a party to any actions claiming patent infringement
of any of its products.
Governmental Regulation
FDA Approval
Regulation by governmental authorities in the United States and foreign
countries is a significant factor in the development, manufacture and marketing
of the Company's proposed products and services and in its ongoing research and
product development activities. It is anticipated that virtually all of the
products developed by the Company's Medical Products Division will require
regulatory approval by governmental agencies prior to commercialization.
It is expected that many of the Company's products, as presently
contemplated, will be regulated as medical devices. Prior to entering commercial
distribution, all medical devices must undergo FDA review under one or two basic
review procedures: a Section 510(K) premarket notification ("510(K)") or a
premarket approval application ("PMA").
A 510(K) notification is generally a relatively straightforward filing
submitted to demonstrate that the device in question is "substantially
equivalent" to another legally marketed device. The term "substantially
equivalent" for 501(K) purposes does not mean that a product is not unique.
Rather it means that a product can be categorized with existing products for
sterilization and safety purposes. Pursuant to 21 C.F.R. 807.100(b), the "FDA
will determine that a device is substantially equivalent to a predicate device
using the following criteria: (1) [t]he device has the same intended use as the
predicate device; and (2) [t]he device: (i) [h]as the same technological
characteristics as the predicate device; or (ii)(A) [h]as different
technological characteristics, such as a significant change in the materials,
design, energy source, or other features of the device from those of the
predicate device; (B) [t]he data submitted establishes that the device is
substantially equivalent to the predicate device and contains information,
including clinical data if deemed necessary by the Commissioner, that
demonstrates that the device is as safe and as effective as a legally marketed
device; and (C) [d]oes not raise different questions of safety and effectiveness
than the predicate device." Approval under this procedure is typically granted
within ninety (90) days if the product qualifies, however, this procedure may
take longer.
When the product does not qualify for approval under the 510(K)
procedure, the manufacturer must file a PMA which shows that the product is safe
and effective based on extensive clinical testing among several diverse testing
sites and population groups, and shows acceptable sensitivity and specificity.
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This requires much more extensive prefiling testing than does the 510(K)
procedure and involves a significantly longer FDA review after the date of
filing.
In the past, the Company's products have been cleared by the FDA under
the 501(K) expedited form of pre-market review or have not required FDA
approval. While the industry had for several years experienced lengthy delays in
the FDA approval process, more recently, the timeliness of the FDA's review has
improved. Timely product approval is important to the Company's maintaining
and/or obtaining a technological competitive advantage. Other than FDA product
approval waiting periods, the Company has not encountered any other unusual
regulatory impediments to the introduction of new products.
To the extent the Company develops products for use in more advanced
surgical procedures, the regulatory process may be more complex and time
consuming. Some of the Company's potential future products may require lengthy
human clinical trials and the PMA application relating to class III medical
devices. The Company has no reason to believe that it will not be able to obtain
regulatory approval for its products, to the extent efficacy, safety and other
standards can be demonstrated, but the lengthy approval process will require
additional capital (of which there is no assurance that the Company will be able
to secure), risk of entry by competitors and risk of changes in the marketplace
prior to market approvals being obtained.
Overseas, the degree of government regulation affecting the Company
varies considerably among countries, ranging from stringent testing and approval
procedures in certain locations to simple registration procedures in others,
while in some countries there is virtually no regulation of the sale of the
Company's products. In the past, when the Company had active foreign
distribution agreements, it had not encountered material delays or unusual
regulatory impediments in marketing its products internationally. Establishment
of uniform regulations for European Economic Area nations took place on January
1, 1995. The new regulations subject the Company to a single regulatory scheme
for all of the participating countries. Once the Company's domestic channels are
satisfied, Surgical will commence its program for meeting regulatory
requirements internationally. The Company expects that it will be able to market
its products in Europe with a single registration applicable to all
participating countries. The Company also is establishing procedures to respond
to various local regulatory requirements existing in all other international
markets in which it intends to market its products should adequate financing be
available.
By letter dated May 19, 1993, the Company received notifications from
the FDA that the 510(K) notification of intent to market device related to
SutureMate(R) had been received and reviewed, and the FDA had determined that
the device was substantially equivalent to the devices marketed in interstate
commerce prior to May 28, 1976. The receipt of this letter allowed the Company
to immediately begin marketing and selling SutureMate(R). The Prostasert device
was listed with the FDA on June 2, 1994 under its original name, LaborMate.
OSHA Mandatory Reporting of Illness and Injury
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Federal rules administered by the OSHA require healthcare workers to
report if they have been accidentally stuck with a needle previously used by a
patient, or splashed by blood or bodily fluids.
On February 11, 1997, in the Federal Register, OSHA issued a final rule,
effective March 13, 1997, that amended the Occupational Injury and Illness
Reporting Regulation (29 CFR Part 1904) established in 1971. Under the 1971
regulation, employers were required to collect and maintain injury and illness
data and have it available for OSHA to examine when they came on site for an
inspection. It was determined that OSHA needed a separate provision for
collection of data by mail.
The final rule requires, employers, upon request, to report to OSHA
their illness and injury data, in addition to the number of workers and the
number of hours worked in a designated period. It establishes a mechanism for
OSHA to conduct an annual survey of ten (10) or more employers by mail or other
remote transmittal. The specific request may come directly from OSHA or its
designee, e.g., the National Institute of Occupational Safety and Health
("NIOSH").
The rule was finalized since OSHA believed that this comprehensive data
on worker injury and illness would provide more reliable data suited to OSHA's
needs than any other available source. The data also is planned to provide
information to target OSHA activities, including workplace inspections; to
evaluate the effectiveness of educational programs; and to determine the need
for additional standards.
Under the finalized rule, employers have thirty (30) days to submit
their data after the request is received. Regulations set forth the type of
information which needs to be collected. Much of the initial injury and illness
information reported was taken from records which employers already were
required to create, maintain, and post.
The finalized rule provides an additional incentive for healthcare
facilities to implement worker safety and health programs and to provide the
necessary safety equipment and supplies to reduce the risk of occupational
illness and injuries. Those healthcare facilities which have good health and
safety programs will likely benefit from this rule.
OSHA also initiated a number of partnerships with other federal and
national organizations in an effort to reduce the increasing number of
occupational illnesses and injuries among workers. This effort was prompted, in
part, by OSHA's inability to inspect and enforce worker safety in the
approximately five million (5,000,000) work sites in the United States and to
collect accurate worker injury and illness data to assist in targeting the
approximately 8,000 annual inspections in the face of continuing shrinking
budgets.
In August 1996, OSHA and the Joint Commission on Accreditation of
Healthcare Organizations ("JCAHO") announced a three-year partnership to reduce
the increasing number of healthcare worker-related illnesses and injuries. The
announced goal of this partnership is to foster improvement in the management of
safety and health issues in healthcare organizations. The result is that
healthcare organizations face an additional authority testing OSHA compliance.
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This partnership does not transfer any authority for enforcement of OSHA
standards to JCAHO. Rather, JCAHO continues to survey a healthcare
organization's performance against JCAHO's standards. JCAHO surveyors monitor
how compliance with JCAHO meshes with OSHA's expectations related to heath and
safety of employees. When deficiencies are identified, the JCAHO surveyor
provides guidance and educational materials.
A specific recommendation based on a JCAHO standard can be made only
when an OSHA citation has already been issued and the healthcare organization
has failed to take corrective action to clear the citation. If an immediate
threat to a worker's safety is found during a survey, the facility is cited by
JCAHO under their application standards. A determination is made regarding the
organization receiving conditional accreditation status in accordance with JCAHO
policies and procedures.
Most hazards to workers in healthcare organizations that have been
identified by both OSHA and JCAHO resulted from injuries and illness related to
patient handling; exposures to bloodborne pathogens, tuberculosis, hazardous
drugs and anesthetic gases; workplace violence; and fire and electrical hazards.
Example of JCAHO requirements that are linked to OSHA standards for
worker safety include many of the components of the Environment of Care
Standards (safety, hazardous material and waste, emergency preparedness, life
safety, medical equipment, utility systems) and the Infection Control Standards.
The 1997 JCAHO Accreditation Manual for hospitals includes a number of
OSHA-related examples of implementation of JCAHO standards to assist healthcare
organizations with compliance.
Healthcare organizations are able to demonstrate compliance with JCAHO
standards by advising the surveyors how they meet both OSHA and JCAHO
requirements and by showing them OSHA documents and reports such as the OSHA 200
log of occupational illness and injury, lockout/tag-out procedures, bloodborne
pathogen exposure control plans and records of Hepatitis B vaccination among
workers exposed to blood and body fluids.
In August 1996, OSHA also announced a seven-state initiative to protect
workers in nursing homes and personal care facilities, one of the nation's
largest growing industries. The seven states include Florida, Illinois,
Massachusetts, Missouri, New York, Ohio and Pennsylvania. Nationwide there are
1.6 million nursing home workers in more than 21,000 facilities. It is
anticipated that by the year 2005, the nursing home and personal care facilities
will be one of the largest industries in the United States. Potential nursing
home hazards include back injuries from incorrect and/or strenuous lifting of
residents, slips and falls, workplace violence and risks from bloodborne
pathogens, tuberculosis and other infectious diseases.
State and Local Licensing Requirements
Other than the governmental regulatory schemes listed above, the Company
is not subject to any other state or local regulations which apply to the
operation and business of the Company.
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Effect of Probable Governmental Regulation on the Business
The Company is not currently engaged in the development of any product
which would be categorized as therapeutic. Under the current regulatory scheme,
in the event any product of the Company were defined as therapeutic, then such
therapeutic product will be subject to regulation by the FDA and will require
FDA approval before it may be commercially marketed for human therapeutic use in
the United States. The Company believes that any therapeutic products to be
developed by it will be regulated either as biological products or as new drugs.
New drugs are subject to regulation under the Federal Food, Drug, and Cosmetic
Act (the "FFDC Act"), and biological products, in addition to being subject to
certain provisions of the FFDC Act, are regulated under the Public Health
Service Act. Both statutes and the regulations promulgated thereunder govern,
among other things, the testing, manufacturing, safety, efficacy, labeling,
storage, recordkeeping, advertising and other promotional practices involving
biologics or new drugs as the case may be. FDA approval or other clearances must
be obtained before clinical testing, and before manufacturing and marketing, of
biologics or other products. At the FDA, the Center for Biological Evaluation
and Research ("CBER") is responsible for the regulation of new biologics and the
Center for Drug Evaluation and Research ("CDER") is responsible for the
regulation of new drugs.
Obtaining FDA approval for therapeutic products has historically been a
costly and time consuming process. Generally, in order to gain approval from the
FDA, a developer first must conduct preclinical studies in the laboratory and in
animal model systems to gain preliminary information on a product's efficacy and
to identify any major safety problem. The results of these studies are submitted
as part of an Investigational New Drug ("IND") application, which the FDA must
review before human clinical trials of an investigational drug can start. The
IND application includes a detailed description of the clinical investigations
to be undertaken.
In order to commercialize any therapeutic products, the Company would be
required to prepare and to file an IND application. It must act as the sponsor
of product testing and will be responsible for planning, initiating and
monitoring human clinical studies which must be adequate to demonstrate safety
and efficacy. The Company will be responsible for selecting well-trained
physicians as clinical investigators to supervise the administration and
evaluation of new products. The Company, however will bear the responsibility
for monitoring the studies to ensure that they are conducted in accordance with
the general investigational plan and protocols contained in the IND. Human
clinical trials are normally done in three phases. Phase I trials, which are
concerned primarily with the safety and preliminary effectiveness of the drug,
involve fewer than 100 subjects, and may take from six months to over a year.
Phase II trials normally involve a few hundred patients and are designed
primarily to demonstrate effectiveness in treating or diagnosing the disease or
condition for which the drug is intended, although short-term side effects and
risks in people whose health is impaired may also be examined. Phase III trials
are expanded clinical trials with larger numbers of patients which are intended
to gather the additional information on safety and effectiveness needed to
clarify the drug's benefit-risk relationship, discover less common side effects
and adverse reactions, and generate information for proper dosage and labeling
of the drug. Human clinical trials generally take four to six years, but may
take longer, to complete.
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The FDA receives reports on the progress of each phase of human clinical
testing, and it may require the modification, suspension, or termination of
clinical trials if an unwarranted risk is presented to patients. There can be no
assurance as to the length of the clinical trial period or the number of
patients the FDA will require to be enrolled in the clinical trials in order to
establish the safety, efficacy, and potency of the products. In addition, it is
uncertain that the clinical data generated in these studies will be acceptable
to the FDA to support marketing approval.
After completion of clinical trials of a new therapeutic product, FDA
marketing approval must be obtained. If the product is regulated as a new
biologic, CBER will require the submission and approval of both a Product
License Application ("PLA") and an Establishment License Application ("ELA")
before allowing commercial marketing of the biologic. If the product is
classified as a new drug, the Company must file a New Drug Application ("NDA")
with CDER and receive approval before commercial marketing of the drug. The NDA
or PLA must include results of product development, preclinical studies and
clinical trials. The testing and approval processes require substantial time and
effort and there can be no assurance that any approval will be granted on a
timely basis, if at all. NDA's and PLA's submitted to the FDA can take, on
average, two years to receive approval. If questions arise during the FDA review
process, approval can take longer. Notwithstanding the submission of relevant
data, the FDA may ultimately decide that the NDA or PLA does not satisfy its
regulatory criteria for approval and require additional clinical studies. Even
if FDA regulatory clearances are obtained, a marketed product is subject to
continual review, and later discovery of previously unknown problems or failure
to comply with the applicable regulatory requirements may result in restrictions
on the marketing of a product or withdrawal of the product from the market as
well as possible civil or criminal sanctions.
Other than the government regulations previously discussed with
reference to FDA and OSHA, the Company does not believe that there are any other
effects from probable government regulation, including state or local laws, on
the business.
Cost of Research and Development
For fiscal years 1997 and 1998, the Company expended $113,740 and
$34,536 of its revenues, respectively, on research and development. These
expenditures represented 44.5% and 81.5%, respectively, of the total revenues of
the Company for such fiscal years. The principal decrease in the cost of
research and development for fiscal 1998 from 1997 was the reduction in cost,
time and expenses incurred through the use of Ad-Vantagenet as opposed to
MediaWorks for the enhancement of the OASiS system and the completion of Version
2.0.
At the current time, none of the costs associates with research and
development are bourne directly by the customer; however there is no guarantee
that such costs will not be bourne by customers in the future and, at the
current time, the Company does not know the extent to which such costs will be
bourne by the customer, if at all.
Cost and Effects of Compliance with Environmental Laws
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The Company's business also could be subject to regulation under the
state and Federal laws regarding environmental protection and hazardous
substances control, including the Occupational Safety and Health Act, the
Environmental Protection Act, and Toxic Substance Control Act. In 1992, the
United States Congress expressed increasing interest in the issues of sharp
injuries. The House Subcommittee on Regulation held hearings regarding
needlestick injuries and the implementation of mandated guidelines on safer
medical devices. However, the Company is unaware of any bills currently pending
in Congress on this issue. The Company believes that it is in material
compliance with the current and other applicable laws and that its continual
compliance therewith will not have a material adverse effect on its business.
Employees and Consultants
As of December 31, 1998, the Company employed seven (7) persons, under
its arrangement with Staff, on a full time basis, including personnel added in
1998 to perform sales and marketing functions. None of these employees are
represented by a labor union for purposes of collective bargaining. The Company
considers its relations with its employees to be excellent.
In October 1996, the Company entered into a staff/client leasing
agreement whereby Staff leases all existing and new employees to the Company.
The initial term of the agreement was for one (1) year. The agreement is
automatically renewable on a monthly basis until renewed for a fixed term or
terminated. The agreement remains open on a monthly basis. All of the persons
described herein to be employees of the Company are covered by this agreement,
since Staff and the Company treat these employees as co-employees.
Staff is licensed by the Florida Department of Business Regulation as an
Employee Leasing Company. Under the Florida Employee Leasing Licensing Act of
1991 (the "Florida Licensing Act"), not only must the employee leasing company
be licensed but their controlling persons must be as well. The Florida Licensing
Act mandates reporting requirements, allocates several employer responsibilities
and requires the payment of an annual licensing fee based upon gross payroll
amounts. The Florida Licensing Act also requires employee leasing companies such
as Staff to: (i) reserve the right of direction and control over leased
employees, (ii) enter into written agreements with their clients, (iii) pay
wages to leased employees, (iv) pay and collect payroll taxes, (v) maintain
authority to hire, terminate, discipline and reassign employees, and (vi)
reserve the right to direct and control the management of safety, risk and
hazard control at the worksite, including the right to perform safety
inspections, to promulgate and administer employment and safety policies, and to
manage Workers' Compensation claims, claims filings, and related procedures. A
recently enacted statutory provision allows employee leasing companies to
eliminate certain liability for acts of the employees who are under the actual
control of their client by assigning such actual control to the client.
Under the terms of the written agreement between Staff and the Company,
Staff pays the employees, collects and pays the payroll taxes, maintains the
authority to hire, terminate, discipline and reassign employees and reserves the
right to direct and control the employee, except for those acts which have been
specifically assigned pursuant to the amendment executed in September 1999.
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On March 30, 1998, the Company entered into a Consulting Agreement with
Stockstowatch whereby Stockstowatch agreed to provide investor relations
services as a media consultant to the Company in exchange for issuance of
300,000 share of the Company's Common Stock. The agreement was for a term of six
(6) months which was renewable at the option of the Company for an additional
six (6) months. The services were provided on a non-exclusive basis since
Stockstowatch is in the business of providing such services to companies. After
an initial due diligence period, Stockstowatch was responsible for all costs
associated with providing the services required under the agreement. The SEC
brought an action against Stockstowatch alleging that they violated the
anti-fraud and anti-touting provisions of the federal securities laws with
reference to the shares which it received from the Company for services. No
allegations have been made that the Company acted improperly with regard to the
alleged charges. The Company has terminated its dealing with this firm. (See
Part I, Item 7. "Certain Relationships and Related Transactions"; and Part II,
Item 4. "Recent Sales of Unregistered Securities.")
On June 30, 1998, the Company executed a letter of intent with
Ad-vantagenet. Under the terms of the letter of intent, Ad-vantagenet assisted
in the creation of version 2.0 OASiS software, including creating the art and
graphics. Version 2.0 is designed to allow for more dynamic features on the
system including instant updates, information-gathering and editing features.
The Company chose Ad-vantagenet to complete Version 2.0 after unsatisfactory
results were achieved by Gambit, Inc., d/b/a MediaWorks. The functions
Ad-vantagenet is currently incorporating into Version 2.0 include features which
had been requested of MediaWorks but were not provided. The total projected cost
of the Ad-vantagenet project is one-fourth of the cost which MediaWorks
projected. The Company was in litigation with MediaWorks over the termination of
their agreement. (See Part II, Item 2. "Legal Proceedings.") Subject to the
successful completion of the letter of intent project with Ad-vantagenet, the
Company intends to enter into a more structured, long-term agreement for further
OASiS development with Ad-vantagenet or similar company.
In October 1998, the Company entered into an agreement with T.T.
Communications, Inc. to provide investor relations services for the Company.
T.T. Communications, Inc.'s function is to contact investment and media people
throughout the United States and to participate in the preparation of
communication packages including annual and quarterly reports, news and press
releases and publicity and corporate profiles. The initial agreement was for a
period of three (3) months for which T.T. Communications, Inc. received $2,000
per month and reimbursement of out of pocket expenses. In addition, T.T.
Communications, Inc. was granted options to purchase 25,000 shares of the
Company's Common Stock at an exercise price of $1.50. In the event T. T.
Communications, Inc. introduces the Company to a suitable financing source, they
will be compensated by a cash finder's fee equal to 1.5% on the initial
financing and .75% on any subsequent financing. The agreement is cancelable by
either party with 30 days written notice. The Company continues to use T.T.
Communications, Inc. on a month to month basis.
In April, 1999, the Company executed a Consulting and Assistance Agreement
with Koritz Group LLC, a Connecticut limited liability company ("Koritz"). The
company exercised its right to cancel the agreement on July 30, 1999. Under the
terms of this agreement, Koritz was engaged to identify sources of capital or
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potential business relationships and to assist the Company in (i) raising equity
or debt financing in the amount of $15,000,000 (ii) arranging for trade
financing for production, sale, lease, rental or other disposal of the Company's
products; and (iii) arranging for the sale, merger, or consolidation of the
Company or for joint ventures or strategic alliances with other appropriate
business. This agreement was non-exclusive. In the event Koritz was successful,
the Company was to pay compensation to Koritz equal to 2.5% for any trade
financing and 10% of the value of each business arrangement. In the event
Investment Financing was secured, the Company was to pay compensation equal to
10% for any investment financing to the person or entity placing such
investment; provided such person or entity was qualified to receive such
compensation in the state of residence of the investor. The Company was free to
reject any offered financing or arrangements; however, in the event that the
Company entered any arrangement within 180 days of its written rejection, on
terms less favorable to the Company, Koritz was to receive a flat fee of
$100,000. In addition to the cash compensation, in the event the Company secured
investment financing, then the qualified, placing person or entity was to
receive warrants to purchase the Company's Common Stock exercisable for 36
months after the closing at the same price as the investment financing source
received, the number of which warrants would be equal to the amount of the
financing divided by the exercise price. Such warrants were to have
anti-dilution and piggyback registration rights. In the event the Company
"shopped" any offer of financing presented to it to other potential sources and
accepted such other financing, the Koritz was entitled to a success fee. Koritz
was to be reimbursed pre-approved disbursements and expenses. The agreement
provided for confidentiality and cross-indemnification . The agreement was
subject to cancellation by either party with five (5) days written notice. It
was under this provision that the Company terminated this agreement on July
30,1999. Any disputes under the agreement were required to be submitted to
arbitration, with costs payable by the losing party.
In April 1999, the Company entered into an agreement with KJS to provide
consulting services. The agreement is on a non-exclusive basis and has no
defined term. The agreement provides for such services to be performed in two
phases. Under phase one, KJS is to assist in the development of a comprehensive
business plan and assist the Company in positioning such plan with the capital
markets with a view towards finding potential business combinations, mergers and
compressed time tables for the Company's business strategy. The estimated cost
of this phase is $5,000. Under phase two, KJS is to identify appropriate
financial institutions and distribute the plan, analyze the initial feedback,
arrange meetings, evaluate all proposals, provide management with each proposal
and assist in the negotiations. Upon execution, the Company was required to
commit to pay a $5,000 retainer to cover the estimated phase one costs. KJS
agreed to accept 7,000 shares of the Company's common stock valued at the
current bid price of $.50 as part of such retainer and with the balance of
$1,500 to be paid in cash at such time as KJS introduces the Company to five
institutional funding sources. Phase two compensation will be paid in the form
of common stock equal to 1.5% of the funds raised from the capital markets in
the form of a spin-off of the OASiS division and 10% of any mezzanine financing
from any source introduced by KJS. (See Part I, Item 7. "Certain Relationships
and Related Transactions."; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
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In April 1999, the Company issued 2,000 shares each to David Utz and
Robert Wingate, two consultants of the Company, in lieu of cash, for services
relating to their production of a CD-Rom disc to be used promote OASiS in lieu
of cash. Such 4000 shares were valued at $2,250 which was based upon the closing
price for the shares on the dates the services were dut to be paid. Such
offering was made in reliance to Section 4(2) of the Act and Rule 506. (See Part
I, Item 7. "Certain Relationships and Related Transactions."; and Part II, Item
4. "Recent Sales of Unregistered Securities.")
In May 1999, the Company entered into an agreement with Ten Peaks to pay
a finder's fee for successfully securing specifically defined financing for the
Company. Such financing included finding a strategic partner and/or financial
partner who secures equity in the Company or a stake in future revenues. Ten
Peaks was to provide advice on long-term business, financial and strategic
decisions. The term of the agreement was for three (3) months from the execution
date and it expired on August 13, 1999. Upon execution of the agreement, the
Company was required to commit to pay a retainer of $4,000 to cover all
anticipated out of pocket expenses during the term. Ten Peaks agreed to accept
6,000 shares of the Company's common stock in lieu of such retainer provided
such stock had a fair market value as reported on Bloomberg, LLP on the date of
execution of not less than $.66. In the event the Company's shares were trading
for less, the difference between $4,000 and the value of the shares was to be
paid in cash. In the event the Company receives gross proceeds of up to
$2,000,000, Although obligated to issue such shares, the Company does not intend
to deliver them to Ten Peaks since the Company believes that Ten Peaks failed to
perform as agreed. Ten Peaks was to receive an amount equal to 5% of such
proceeds in the form of cash, equity or some combination thereof. Thereafter,
Ten Peaks was to receive a sliding scale equal to 4% of the next million, 3% of
the fourth million, 2% of the fifth million and 1% for each additional million.
In the event the Company entered into a transaction as a result of this
agreement, it was to enter into a consulting agreement with Ten Peaks for a term
of six months under which Ten Peaks was receive $5,000 in cash or equity. (See
Part I, Item 7. "Certain Relationships and Related Transactions."; and Part II,
Item 4. "Recent Sales of Unregistered Securities.")
Other than the commitments relative to the initial retainers, no other
payments have been made to either KJS or Ten Peaks. Since execution of the KJS
agreement the Company has been advised that fees and commissions related to
transactions in securities may only be paid to those legally qualified to
receive such payments in accordance with regulations under Federal and state
securities laws. The Company is in the process of modifying this agreement such
that only appropriate payments will be made in the event of placement of any
equity in the Company from sources identified by KJS. The Ten Peaks agreement
expired without any additional payments.
Facilities
The Company maintains its executive offices at 2018 Oak Terrace,
Sarasota, Florida 34231. Its telephone number is (941) 927-7874 and its
facsimile number is (941) 925-0515.
The Company leases 3500 square feet for its executive offices from
Savannah Leasing, a company owned by Dr. Swor and his wife. The lease is for a
term of two (2) years and is automatically renewable for an additional one (1)
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year period. The initial term of the lease expires in May 2000. The Company pays
monthly rent in the amount of $3,500 and the Landlord and the Company share the
costs of insurance. The Company is responsible for maintenance of the parking
area, while the Landlord otherwise maintains the property. The Company is
responsible for personal taxes only as the Landlord pays real estate taxes.
Savannah Leasing owns several adjacent properties and the Company has first
rights of refusal in the event additional space is required for the operation of
the Company's business. The Company believes that the rental payment and terms
under the lease are comparable to other properties in the area owned by property
owners other than Dr. Swor. In addition, the Company believes that the leased
property together with the property under the first rights of refusal are
sufficient for its requirements for the next ten (10) years. (See Part I, Item
3. "Description of Property.")
Risk Factors
Before making an investment decision, prospective investors in the
Company's Common Stock should carefully consider, along with other matters
referred to herein, the following risk factors inherent in and affecting the
business of the Company.
1. History of Losses. Although Surgical has been in business since May
15, 1992 it was in the development stage until July 7, 1993 when it began
commercial shipments of its first product. As of December 31, 1997, the Company
had total assets of $445,235, a net loss of $148,422 on revenues of $255,386 and
stockholders deficit of $59,043. As of December 31, 1998, the Company had total
assets of $373,514, a net loss of $797,662 on revenues of $42,393 and
stockholders equity of $318,183. Due to the Company's operating history and
limited resources, among other factors, there can be no assurance that
profitability or significant revenue will occur in the future. Moreover, the
Company expects to continue to incur operating losses through at least the first
half of 2000, and there can be no assurance that losses will not continue
thereafter. The ability of the Company to establish itself as a going concern is
dependent upon the receipt of additional funds from operations or other sources
to continue those activities. The Company is subject to all of the risks
inherent in the operation of a development stage business and there can be no
assurance that the Company will be able to successfully address these risks.
(See Part I, Item 1. "Description of Business.")
2. Minimal Assets, Working Capital and Net Worth. As of December 31,
1998, the Company's total assets in the amount of $373,514, consisted ,
principally, of the sum of $41,191 in cash, $58,700 in deposits and $26,898 in
inventory. As a result of its minimal assets and a net loss from operations, in
the amount of $797,662, as of December 31, 1998, the Company had a net worth of
$318,183. Further, there can be no assurance that the Company's financial
condition will improve. Even though management believes, without assurance, that
it will obtain sufficient capital with which to implement its expansion plan,
the Company is not expected to proceed with its expansion without an infusion of
capital. In order to obtain additional equity financing, management may be
required to dilute the interest of existing shareholders or forego a substantial
interest of its revenues, if any. (See Part I, Item 1. "Description of
Business")
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3. Need for Additional Capital. Without an infusion of capital or
profits from operations, the Company is not expected to proceed with its
expansion as planned. Accordingly, the Company is not expected to overcome its
history of losses unless additional equity and/or debt financing is obtained.
The Company does not anticipate the receipt of increased operating revenues
until management successfully implements its expansion plan, which is not
assured. Further, Surgical may incur significant unanticipated expenditures
which deplete its capital at a more rapid rate because of among other things,
the stage of its business, its limited personnel and other resources and its
lack of a widespread client base and market recognition. Because of these and
other factors, management is presently unable to predict what additional costs
might be incurred by the Company beyond those currently contemplated to obtain
additional financing and achieve market penetration on a commercial scale in its
expanded line of business, i.e. medical device supplier and risk exposure
systems developer. Surgical has no identified sources of funds, and there can be
no assurance that resources will be available to the Company when needed. (See
Part I, Item 1. "Description of Business - (b) Business of Issuer."
4. Dependence on Management. The possible success of the Company is
expected to be largely dependent on the continued services of its Founder,
Chairman and Treasurer, Dr. G. Michael Swor, its President, Frank M. Clark and
its Vice President of Sales & Marketing, Donald K. Lawrence. Virtually all
decisions concerning the marketing, distribution and sales of the Company's
products and services will be made or significantly influenced by the Company's
officers. These officers are expected to devote only such time and effort to the
business and affairs of the Company as may be necessary to perform their
responsibilities as executive officers and directors of Surgical. The loss of
the services of any of these officers, but particularly Dr. Swor, would
adversely affect the conduct of the Company's business and its prospects for the
future. The Company presently has employment agreements with Dr. Swor, Mr. Clark
and Mr. Lawrence and holds no key-man life insurance on the lives of, and has no
other agreement with any of these officers, except that the Company is the named
beneficiary of a key-man life insurance policy currently owned by Dr. Swor. (See
Part I, Item 1. "Description of Business - (b) Business of Issuer and Part I,
Item 5. "Directors, Executive Officers, Promoters and Control Persons."
5. Limited Distribution Capability. The Company's success depends in
large part upon its ability to distribute its products and services. As compared
to Surgical, which lacks the financial, personnel and other resources required
to compete with its larger, better-financed competitors, virtually all of the
Company's competitors have much larger budgets for securing customers. Although
the Company has entered into several distribution agreements for its medical
products, none are producing significant revenues at this time. Further, the
OASiS system currently is in a few locations. Depending upon the level of
funding obtained by the Company, management believes, without assurance, that it
will be possible for Surgical to attract additional customers for its products
and services. However, in the event that only limited funds are obtained, the
Company anticipates that its limited finances and other resources may be a
determinative factor in the decision to go forward with planned expansion. Until
such time, if ever, as the Company is successful in securing additional capital,
of which there is no assurance, it intends to continue marketing its products
through its current distribution arrangements. However, the fact that these
arrangement have not thus far produced significant revenue may adversely impact
the Company's chances for success. (See Part
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I, Item 1. "Description of Business," (b) "Business of Issuer - Sales and
Marketing- Distribution of Products.")
6. High Risks and Unforeseen Costs Associated with Surgical's Expanded
Entry into the Medical Device and Exposure Reporting Information Industries.
There can be no assurance that the costs for the establishment of a client base
for its products and services will not be significantly greater than those
estimated by Company management. Therefore, the Company may expend significant
unanticipated funds or significant funds may be expended by Surgical without
development of a commercially viable medical device or exposure reporting
information business. There can be no assurance that cost overruns will not
occur or that such cost overruns will not adversely affect the Company. Further,
unfavorable general economic conditions and/or a downturn in customer confidence
could have an adverse effect on the Company's business. Additionally,
competitive pressures and changes in customer mix, among other things, which
management expects the Company to experience in the uncertain event that it
achieves commercial viability, could reduce the Company's gross profit margin
from time to time. Accordingly, there can be no assurance that Surgical will be
capable of establishing itself in a commercially viable position in local,
state, nationwide and international medical device and exposure reporting
information markets. (See Part I, Item 1. "Description of Business," (b)
"Business of Issuer.")
7. Dependency on Securing a Suitable Strategic Partner. The Company's
ability to establish a sufficient customer base at a level sufficient to meet
the larger competition depends in part upon the ability of the Company to
capitalize on its joint venture with US Surgical with regard to OASiS and to
finalize a joint venture agreement with a suitable partner for its disposable
medical devices. The Company has no tentative agreements with any strategic
partner for expansion of its medical device business. There can be no assurance
that a qualified strategic arrangement will be found at the levels which
management believes are possible. Further, even if the Company receives
sufficient proceeds from equity and/or debt financing or otherwise, thus
enabling it to go forward with its planned expansion of its medical device
business, it will nevertheless be dependent upon the availability of a qualified
strategic partner to progress at the levels which the Company believes are
necessary. OASiS has only been in the marketplace for the past year and appears
to be meeting expectations; however, its market acceptance has not yet been
determined. SutureMate(R) had limited acceptance as originally marketed, which
limited acceptance the Company believes was due to the manufacturers suggested
retail price. SutureMate(R) has been redesigned and has been re-released at a
price more in keeping with disposal devices. MediSpecs RX(TM) has had limited
acceptance to date and due to poor sales, may be dropped by the Company. Unless
additional financing is available, the Company has elected to concentrate on
development of markets for OASiS rather than focusing on the expansion of the
markets for these two products and will rely on its existing markets for these
products. Although management believes that the acceptance of its products and
services will continue to find the market acceptance which has occurred in the
past, there can be no assurance that this will be so. (See Part I, Item 1.
"Description of Business," (b) Business of Issuer - Sales and Marketing.")
8. Significant Customer and Product Concentration. To date, a limited
number of customers and distributors have accounted for substantially all of the
Company's revenues with respect to product sales. The Company anticipates
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that the main focus of its selling efforts will be to continue to sell its
products to a relatively small group of medical products distributors with the
objective of having its products distributed on a large national and
international scale. Although the company entered into agreements with US
Surgical had an exclusive distributorship agreement with Hospital News and
believes it can reactivate its distributorship agreements with Johnson & Johnson
Medical Pty Ltd. to sell its SutureMate(R) product (in the territories of
Australia, New Zealand, Papua, New Guinea and Fiji), with the two other
distributors to sell such product in Saudi Arabia and the Netherlands and that
Noesis will generate sales, there is no assurance that the Company will be able
to obtain adequate distribution of its products to the intended end user. Most
medical product distributors carry an extensive line of products (some of which
they manufacture themselves) which they make available to end users (hospitals,
surgeons, healthcare workers) and various of these products may compete with
each other as to function, price or other factors. In addition, numerous medical
product distributors are not themselves well capitalized and their financial
condition may impact their ability to properly distribute the Company's
products. The Company's ability to achieve revenues in the future will depend in
significant part upon its ability to obtain orders from, maintain relationships
with and provide support to, existing and new distributors, as well as the
condition of its distributors. As a result, any cancellation, reduction or delay
in orders by or shipments to any customer or the inability of any customer to
finance its purchases of the Company's products may materially adversely affect
the Company's business, financial condition and results of operations. There can
be no assurance that the Company's revenues will increase in the future or that
the Company will be able to support or attract customers. See "Part I, Item. 1.
"Description of Business - (b) Business of Issuer - Sales and Marketing -
Distribution of Products; and - Dependence on Major Customers" and Part I, Item
2. Management's Discussion and Analysis of Financial Condition or Plan of
Operation - Revenues."
9. Fluctuations in Results of Operations. The Company has experienced
and may in the future experience significant fluctuations in revenues, gross
margins and operating results. On the medical products development side of its
business, the introduction of new products and the manufacture and marketing of
most of the Company's products is a lengthy (ranging from a minimum of six weeks
to an estimated maximum of eighteen (18) months from order to delivery) process
and the timing and amount of product sales is difficult to predict reliably. In
addition, a single customer's order scheduled for shipment in a fiscal quarter
can represent a significant portion of the Company's potential sales for such
quarter. As with many developing businesses, the Company expects to fail to
receive expected orders, and delivery schedules may have to be deferred as a
result of changes in customer requirements, among other factors. As a result,
the Company's operating results for a particular period have, to date, been and
may in the future be materially adversely affected by a delay, rescheduling or
cancellation of even one purchase order. Moreover, purchase orders are often
received and accepted substantially in advance of shipment, and the failure to
reduce actual costs to the extent anticipated or an increase in anticipated
costs before shipment could materially, adversely affect the gross margins for
such order, and as a result, the Company's results of operations. Moreover, a
majority of the Company's anticipated orders could be canceled since orders are
expected to be made substantially in advance of shipment, and even though the
Company's contracts do not typically provide that orders may be canceled, if an
important distributor wishes to cancel an order, the Company may be compelled,
due to competitive conditions, to accede to such request. As a result, backlog,
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if any, will not necessarily be indicative of future sales for any particular
period. Furthermore, a substantial portion of net sales may be realized near the
end of each quarter. A delay in a shipment near the end of a particular quarter,
due, for example, to an unanticipated shipment rescheduling, to cancellations or
deferrals by customers or to unexpected manufacturing difficulties experienced
by the Company, may cause net revenues in a particular quarter to fall
significantly below the company's expectations and may materially adversely
affect the Company's operating results for such quarter.
A large portion of the Company's expenses are fixed and difficult to
reduce should revenues not meet the Company's expectations, thus magnifying the
material adverse effect of any revenue shortfall. Furthermore, announcements by
the Company or its competitors of new products and technologies could cause
customers to defer purchases of the Company's products or a reevaluation of
products under development, which would materially adversely affect the
Company's business, financial condition and results of operations. Additional
factors that may cause the Company's revenues, gross margins and results of
operations to vary significantly from period to period include: product
development, patent processing, FDA processing, clinical trials, mix of products
sold; manufacturing efficiencies, costs and capacity; price discounts; market
acceptance and the timing of availability of new products by the Company or its
customers, usage of different distribution and sales channels; warranty and
customer support expenses; customization of systems; and general economic and
political conditions. In addition, the Company's results of operations are
influenced by competitive factors, including the pricing and availability of and
demand for, competitive products. All of the above factors are difficult for the
Company to forecast, and these or other factors could materially adversely
affect the Company's business, financial condition and results of operations. As
a result, the Company believes that period-to-period comparisons are not
necessarily meaningful and should not be relied upon as indications of future
performance. See Part I, Item. 2. "Management's Discussion and Analysis of
Financial Condition or Plan of Operation."
10. Potential for Unfavorable Interpretation of Government Regulation.
As a medical device specifier, the Company is subject to all federal, state and
local statutes and regulations governing its products, to the extent applicable.
The Company will not be subject to additional regulation unless it elects to
produce therapeutic drugs, in which case Surgical will be required to conduct
extensive clinical trials for FDA clearance which are not required for the
Company's products at this time. In such event the Company shall have all of the
uncertainties such clinical trials present including the risk of loss of
substantial capital in the event a product never receives the required
approvals.
Medical products are subject to extensive regulation by the United
States (U.S. Food and Drug Administration ("FDA") and U.S. Patent Office),
state, local and foreign laws and international treaties. The Company's products
must conform to a variety of domestic and international requirements. In order
for the Company to sell its products in a foreign jurisdiction, it must obtain
regulatory approval and comply with different regulations in each jurisdiction.
The delays inherent in this governmental approval process may cause the
cancellation, postponement or rescheduling of the purchase by the Company's
customers, which in turn may have a material adverse effect on the sale of such
products by the Company to such foreign customers. The failure to comply with
current or future domestic and foreign regulations or changes in the
interpretation of existing regulations could result in the suspension or
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cessation of product sales. Such regulations or such changes in interpretation
could require the Company to modify its products and incur substantial costs to
comply with such time-consuming regulations and changes.
The regulatory environment in which the Company operates is subject to
change. Regulatory changes, which are affected by political, economic and
technical factors, could significantly impact the Company's operations by
restricting development efforts by the Company and its customers, making current
products obsolete or increasing the opportunity for additional competition. Any
such regulatory changes could have a material adverse effect on the Company's
business, financial condition and results of operations. The Company might deem
it necessary or advisable to alter or modify its products to operate in
compliance with such regulations. Such modifications could be extremely
expensive and, especially if subject to regulatory review and approval,
time-consuming. (See Part I, Item 1. "Description of Business," (b) "Business of
Issuer - Governmental Regulation.")
11. No Assurance of Product Quality. Performance and Reliability. The
Company expects that its distributors and their customers will continue to
establish demanding specifications for quality, performance and reliability.
Although the Company attempts only to deal with manufacturers who adhere to good
manufacturing practice standards, there can be no assurance that problems will
not occur in the future with respect to quality, performance, reliability and
price. If such problems occur, the Company could experience increased costs,
delays in or cancellations or rescheduling of orders or shipments and product
returns and discounts, any of which would have a material adverse effect on the
Company's business, financial condition or results of operations.
12. Future Capital Requirements. The Company's future capital
requirements will depend upon many factors, including the development of new
medical products, requirements to maintain adequate manufacturing facilities,
the progress of the Company's research and development efforts, expansion of the
Company's marketing and sales efforts and the status of competitive products and
services. The Company believes that it will require additional funding in order
to fully exploit its plan for operations. There can be no assurance, however,
that the Company will secure such additional financing. There can be no
assurance that any additional financing will be available to the Company on
acceptable terms, or at all. If additional funds are raised by issuing equity
securities, further dilution to the existing stockholders will result. If
adequate funds are not available, the Company may be required to delay, scale
back or eliminate its research and development or manufacturing programs or
obtain funds through arrangements with partners or others that may require the
Company to relinquish rights to certain of its existing or potential products or
other assets. Accordingly, the inability to obtain such financing could have a
material adverse effect on the Company's business, financial condition and
results of operations. See Part I, Item 2. "Management's Discussion and Analysis
of Financial Condition or Plan of Operation."
13. Uncertainty Regarding Protection of Proprietary Rights. The Company
attempts to protect its intellectual property rights through patents,
trademarks, secrecy agreements, trade secrets and a variety of other measures.
However, there can be no assurance that such measures will provide adequate
protection for the Company's trade secrets or other proprietary information,
that disputes with respect to the ownership of its intellectual property rights
will not arise, that the Company's trade secrets or proprietary technology will
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not otherwise become known or be independently developed by competitors or that
the Company can otherwise meaningfully protect its intellectual property rights.
There can be no assurance that any patent owned by the Company will not be
invalidated, circumvented or challenged, that the rights granted thereunder will
provide competitive advantages to the Company or that any of the Company's
pending or future patent applications will be issued with the scope of the
claims sought by the Company, if at all. Furthermore, there can be no assurance
that others will not develop similar products, duplicate the Company's products
or design around the patents owned by the Company or that third parties will not
assert intellectual property infringement claims against the Company. In
addition, there can be no assurance that foreign intellectual property laws will
adequately protect the Company's intellectual property rights abroad. The
failure of the Company to protect its proprietary rights could have a material
adverse effect on its business, financial condition and results of operations.
Litigation may be necessary to protect the Company's intellectual
property rights and trade secrets, to determine the validity of and scope of the
proprietary rights of others or to defend against claims of infringement or
invalidity. Such litigation could result in substantial costs and diversion of
resources and could have a material adverse effect on the Company's business,
financial condition and results of operations. There can be no assurance that
infringement, invalidity, right to use or ownership claims by third parties or
claims for indemnification resulting from infringement claims will not be
asserted in the future. If any claims or actions are asserted against the
Company, the Company may seek to obtain a license under a third party's
intellectual property rights. There can be no assurance, however, that a license
will be available under reasonable terms or at all. In addition, should the
Company decide to litigate such claims, such litigation could be extremely
expensive and time consuming and could materially adversely affect the Company's
business, financial condition and results of operations, regardless of the
outcome of the litigation. See Part I, Item 1. Description of Business - (b)
Business of Issuer - Patents, Copyrights and Trademarks."
14. Ability to Grow. The Company expects to grow through its alliance
with US Surgical, one or more strategic alliances, acquisitions, internal growth
and by granting licenses for products which are not within the focuses defined
by management. There can be no assurance that the Company will be able to create
a greater market presence, or if such market is created, to expand its market
presence or successfully enter other markets. The ability of the Company to grow
will depend on a number of factors, including the availability of working
capital to support such growth, existing and emerging competition, one or more
additional qualified strategic alliances and the Company's ability to maintain
sufficient profit margins in the face of pricing pressures. The Company also
must manage costs in a changing regulatory environment, adapt its infrastructure
and systems to accommodate growth within the niche market which it has created.
The Company also plans to expand its business, in part, through
acquisitions. Although the Company will continuously review potential
acquisition candidates, it has not entered into any agreement, understanding or
commitment with respect to any additional acquisitions at this time. There can
be no assurance that the Company will be able to successfully identify suitable
acquisition candidates, complete acquisitions on favorable terms, or at all, or
integrate acquired businesses into its operations. Moreover, there can be no
assurance that acquisitions will not have a material adverse
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effect on the Company's operating results, particularly in the fiscal quarters
immediately following the consummation of such transactions, while the
operations of the acquired business are being integrated into the Company's
operations. Once integrated, acquisitions may not achieve comparable levels of
revenues, profitability or productivity as at then existing Company-owned
locations or otherwise perform as expected. The Company is unable to predict
whether or when any prospective acquisition candidate will become available or
the likelihood that any acquisitions will be completed. The Company will be
competing for acquisition and expansion opportunities with entities that have
substantially greater resources than the Company. In addition, acquisitions
involve a number of special risks, such as diversion of management's attention,
difficulties in the integration of acquired operations and retention of
personnel, unanticipated problems or legal liabilities, and tax and accounting
issues, some of all of which could have a material adverse effect on the
Company's results of operations and financial condition. (See Part I, Item 1.
"Description of Business (b) "Business Issuer.")
15. Potential Legal Liability. Providers of medical devices may be
subject to claims relating to their product. In addition, under the terms of the
agreement with SMH, the Company is required to indemnify and hold harmless SMH
and the Lessee against any and all claims regarding the use of the OASiS system.
Management has adopted and implemented policies and guidelines to reduce its
exposure to these risks; principally in the area of its initial product research
and development. However, the failure of any product to meet such policies and
guidelines may result in governmental intervention, negative publicity,
injunctive relief and the payment by the Company of money damages or fines.
There can be no assurance that the Company will not experience such problems.
(See - 8. "Potential for Unfavorable Interpretation of Government Regulations"
and Part I, Item 1. "Description of Business" (b) "Business of Issuer-Government
Regulation.")
At such time as the Company enters into licensing agreements for certain
products which it feels are not a proper mix but deserve exploitation, the
Company may be subject to claims asserting that it is vicariously liable for the
damages allegedly caused by the products produced by the licensees. Generally,
liability for the acts or inactions of its licensees are based on agency and
products liability concepts. The Company intends for its license agreements to
state that the parties are not agents, that the licensees control the
manufacturer and production of the product, and that any modifications are the
sole responsibility of the licensee. Despite these efforts to minimize the risk
of liability, there can be no assurance that a claim will not be made against
the Company.
16. Competition. The medical products and devices industry is highly
competitive, with several major companies involved. The exposure reporting
information industry has only one (1) known competitor at this time. The Company
will be competing with larger competitors in international, national, regional
and local markets. In addition, the Company may encounter substantial
competition from new market entrants. Many of the Company's competitors have
significantly greater name recognition and have greater marketing, financial and
other resources than the Company. There can be no assurance that the Company
will be able to compete effectively against such competitors in the future. (See
Part I. Item 1. "Description of Business," (b) "Business of IssuerCompetition.")
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17. Requirement for Response to Rapid Technological Change and
Requirement for Frequent New Product Introductions. The market for surgical
safety products and services is subject to rapid technological change, frequent
new product introductions and enhancements, product obsolescence and changes in
end-user requirements. The Company's ability to be competitive in this market
will depend in significant part upon its ability to successfully develop,
introduce and sell new innovative proprietary products, services and
enhancements thereof on a timely and cost-effective basis that respond to
changing customer requirements. Any success of the Company in developing new and
enhanced products and services will depend upon a variety of factors, including
new product selection, timely and efficient compliance with and completion of
the regulatory process (FDA and the U.S. Patent and Trademark Office), timely
and efficient completion of design, timely and efficient implementation of
manufacturing and assembly process, its cost reduction program and the
development, completion, performance, quality and reliability and development of
competitive products and services by competitors. The Company may experience
delays from time to time in completing development and introduction of new
products and services. Moreover, there can be no assurance that the Company will
be successful in selecting, developing, manufacturing and marketing new products
and services. There can be no assurance that defects will not be found in the
Company's products and services after commencement of commercial shipments,
which could result in the loss of or delay in market acceptance. The inability
of the Company to introduce in a timely manner new products and services that
contribute to revenues could have a material adverse effect on the Company's
business, financial condition and results of operations. See "Part I, Item. 1.
"Description of Business (b) Business of Issuer - Competition."
18. Possible Adverse Affect of Fluctuations in the General Economy and
Business of Customers. Historically, the general level of economic activity has
significantly affected the demand for new, disposable products. As demands for
economy have increased, reusable products have seen a resurgence of demand.
There can be no assurance that an economic downturn would not adversely affect
the demand for the Company's products and services. Further, hospitals and other
healthcare facilities have been required to adopt cost effective policies which
may cause them to reject any new information gathering system, notwithstanding
the need to collect accurate data. There can be no assurance that such cost
cutting factors will not adversely affect the development and market penetration
of the OASiS system.
19. Lack of Working Capital Funding Source. Other than revenues from the
licensing of OASiS and the sale of its products, which revenues have yet to
produce a net profit, the Company has no current source of working capital
funds, and should the Company be unable to secure additional financing on
acceptable terms, its business, financial condition, results of operations and
liquidity would be materially adversely affected.
20. Dependence on Contract Manufacturers; Reliance on Sole or Limited
Sources of Supply. As of the date hereof, the Company has no internal
manufacturing capacity. The Company has been utilizing contract manufacturers to
produce its products. In the case of SutureMate(TM), Tuthill and in the case of
MediSpecs Rx(TM), the Company has an agreement with Morrison. The Company also
may rely on outside vendors to manufacture certain components. Certain necessary
components and services anticipated to be necessary for the manufacture of the
Company's products could be required to be obtained from a sole supplier or a
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limited group of suppliers. There can be no assurance that the Company's
contract manufacturers, will be sufficient to fulfill the Company's orders.
Should the Company be required to rely solely on contract manufacturers
and a limited group of suppliers, such increasing reliance involves several
risks, including a potential inability to obtain an adequate supply of finished
products and required components, and reduced control over the price, timely
delivery, reliability and quality of finished products and components. The
Company does not believe that it is currently necessary to have any long-term
supply agreements with its manufacturers or suppliers but this may change in the
future. The Company has from time to time experienced and may in the future
experience delays in the delivery of and quality problems with its products and
certain components from vendors. Certain of the Company's suppliers have
relatively limited financial and other resources. Any inability to obtain timely
deliveries of acceptable quality or any other circumstances that would require
the Company to seek alternative sources of supply, or to manufacture its
finished products internally, could delay the Company's ability to ship its
products which could damage relationships with current or prospective customers
and have a material adverse effect on the Company's business, financial
condition and operating results. See "Part I, Item 1.
"Description of Business - (b) Business of Issuer."
21. Declining Average Selling Prices. The Company believes that, among
other factors, average selling prices and gross margins for its products may
decline in the long term as such products are in use in the market, as volume
price discounts in existing and future contracts take effect and as competition
intensifies. To offset declining average selling prices, the Company believes
that, among other actions, it must successfully introduce and sell new products
and services or adaptations of products and services on a timely basis, develop
new products and services with features that can be sold at higher average
selling prices and reduce the costs thereof through design improvements,
component cost reduction and in-house manufacturing. To the extent that new
products and services are not developed in a timely manner, do not achieve
customer acceptance or do not generate higher average selling prices, and the
Company is unable to offset declining average selling prices, the Company's
gross margins will decline, and such decline will have a material adverse effect
on the Company's business, financial condition and results of operations. The
Company believes that the redesign of SutureMate(R) will result in a reduction
in costs. See "Pat I, Item. 1. "Description of Business - (b) Business of Issuer
- - Medical Products Division - Research and Development" and Part I, item. 2.
"Management's Discussion and Analysis of Financial Condition or Plan of
Operations - Research and Development."
22. Uncertainty of Market Acceptance. The future operating results of
the Company depend to a significant extent upon the continued development of
products and services deemed necessary, useful, convenient, affordable and
competitive by medical professionals and their patients. There can be no
assurance that the Company has the ability to continuously introduce propriety
products and services into the marketplace which will achieve the market
penetration and acceptance necessary for the Company to grow and become
profitable on a sustained basis, especially given the fierce competition that
exists from companies more established and well financed than the Company. See
"Part I, Item 1. "Description of Business -(b) Business of Issuer -
Competition."
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To date, substantially all of the Company's product sales have been to
customers within the United States with a small portion of such sales generated
internationally. The Company's future results of operations will be dependent in
significant part on its ability to penetrate markets in the United States and
foreign countries in which the Company has not yet established a meaningful
presence. There can be no assurance that the Company will be successful in
penetrating these additional markets.
23. International Operations; Risks of Doing Business in Developing
Countries. Substantially all of the Company's revenues from product sales to
date have been made to customers located inside of the United States. The
Company anticipates that international sales may account, as a result of various
distribution agreements entered into, which were terminated but which may be
reactivated, for more of its revenues from product sales for the foreseeable
future. In such event, the Company's international sales may be denominated in
foreign or United States currencies. The Company does not currently have any
foreign trade or engage in foreign currency hedging transactions. Should it have
foreign trade denominated in foreign currencies, and not hedge, a decrease in
the value of foreign currencies relative to the United States dollar could
result in losses. With respect to the future international sales that are United
States dollar-denominated, such a decrease could make the Company's products
less price-competitive. Additional risks inherent in the Company's transacting
international business activities include changes in regulatory requirements,
costs and risks of local customers in foreign countries, availability of
suitable export financing, timing and availability of export licenses, tariffs
and other trade barriers, political and economic instability, difficulties in
staffing and managing foreign operations, difficulties in managing distributors,
potentially adverse tax consequences, foreign currency exchange fluctuations,
the burden of complying with a wide variety of complex foreign laws and treaties
and the possibility of difficulty in accounts receivable collections. If
reactivated, some of the Company's customer purchase agreements may be governed
by foreign laws, which may differ significantly from U.S. laws. Therefore, the
Company may be limited in its ability to enforce its rights under such
agreements and to collect damages, if awarded. There can be no assurance that
any of these factors will not have a material adverse effect on the Company's
business, financial condition and results of operations.
Some of the Company's potential markets consist of countries that
have not yet developed the technological and medical know-how to properly
utilize the Company's products, in which event the development of demand for the
Company's products in those countries will be limited or delayed. In doing
business in some of these markets, the Company also may face economic, political
and foreign currency fluctuations that are more volatile than those commonly
experienced in the United States and other areas. See "Part I, Item 1.
"Description of Business - (b) Business of Issuer - Sales and Marketing -
Distribution of Products."
24. No Dividends. While payments of dividends on the Common Stock rests
with the discretion of the Board of Directors, there can be no assurance that
dividends can or will ever be paid. Payment of dividends is contingent upon,
among other things, future earnings, if any, and the financial condition of the
Company, capital requirements, general business conditions and other factors
which cannot now be predicted. It is highly unlikely that cash dividends on the
Common Stock will be paid by the Company in the foreseeable future. (See Part I,
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Item 8. "Description of Securities - Description of Common Stock - Dividend
Policy.")
25. No Cumulative Voting. The election of directors and other questions
will be decided by a majority vote. Since cumulative voting is not permitted and
one-third of the Company's outstanding Common Stock constitute a quorum,
investors who purchase shares of the Company's Common Stock may not have the
power to elect even a single director and, as a practical matter, the current
management will continue to effectively control the Company. (See Part I, Item
8. "Description of Securities - Description of Common Stock.")
26. Control by Present Shareholders. The present shareholders of the
Company's Common Stock will, by virtue of their percentage share ownership and
the lack of cumulative voting, be able to elect the entire Board of Directors,
establish the Company's policies and generally direct its affairs. Accordingly,
persons investing in the Company's Common Stock will have no significant voice
in Company management, and cannot be assured of ever having representation on
the Board of Directors. (See Part I, Item 4. "Security Ownership of Certain
Beneficial Owners and Management.")
27. Potential Anti-Takeover and Other Effects of Issuance of Preferred
Stock May Be Detrimental to Common Shareholders. Potential anti-takeover and
other effects of issuance the of preferred stock may be detrimental to Common
Shareholders. The Company is authorized to issue shares of preferred stock.
("Preferred Stock"); none of which has been issued to date. The issuance of
Preferred Stock does not require approval by the shareholders of the Company's
Common Stock. The Board of Directors, in its sole discretion, has the power to
issue shares of Preferred Stock in one or more series and to establish the
dividend rates and preferences, liquidation preferences, voting rights,
redemption and conversion terms and conditions and any other relative rights and
preferences with respect to any series of Preferred Stock. Holders of Preferred
Stock may have the right to receive dividends, certain preferences in
liquidation and conversion and other rights; any of which rights and preferences
may operate to the detriment of the shareholders of the Company's Common Stock.
Further, the issuance of any shares of Preferred Stock having rights superior to
those of the Company's Common Stock may result in a decrease in the value of
market price of the Common Stock provided a market exists, and additionally,
could be used by the Board of Directors as an anti-takeover measure or device to
prevent a change in control of the Company. (See Part I, Item 1. "Description of
Securities - Description of Preferred Stock.")
28. No Secondary Trading Exemption. Secondary trading in the Common
Stock will not be possible in each state until the shares of Common Stock are
qualified for sale under the applicable securities laws of the state or the
Company verifies that an exemption, such as listing in certain recognized
securities manuals, is available for secondary trading in the state. There can
be no assurance that the Company will be successful in registering or qualifying
the Common Stock for secondary trading, or availing itself of an exemption for
secondary trading in the Common Stock, in any state. If the Company fails to
register or qualify, or obtain or verify an exemption for the secondary trading
of, the Common Stock in any particular state, the shares of Common Stock could
not be offered or sold to, or purchased by, a resident of that state. In the
event that a significant number of states refuse to permit secondary trading in
the Company's Common Stock, a public market for the Common Stock will fail to
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develop and the shares could be deprived of any value. The Company was listed in
Moody's OTC Industrial on April 28, 1998.
29. Possible Adverse Effect of Penny Stock Regulations on Liquidity of
Common Stock in any Secondary Market. Although trading volume indicates that a
secondary trading market has developed to a certain extent for the shares of
Common Stock of the Company, the Common Stock is expected to come within the
meaning of the term "penny stock" under 17 CAR 240.3a51-1 because such shares
are issued by a small company; are low-priced (under five dollars); and are not
traded on NASDAQ or on a national stock exchange. The SEC has established risk
disclosure requirements for broker-dealers participating in penny stock
transactions as part of a system of disclosure and regulatory oversight for the
operation of the penny stock market. Rule 15g-9 under the Securities Exchange
Act of 1934, as amended, obligates a broker-dealer to satisfy special sales
practice requirements, including a requirement that it make an individualized
written suitability determination of the purchaser and receive the purchaser's
written consent prior to the transaction. Further, the Securities Enforcement
Remedies and Penny Stock Reform Act of 1990 require a broker-dealer, prior to a
transaction in a penny stock, to deliver a standardized risk disclosure
instrument that provides information about penny stocks and the risks in the
penny stock market. Additionally, the customer must be provided by the
broker-dealer with current bid and offer quotations for the penny stock, the
compensation of the broker-dealer and the salesperson in the transaction and
monthly account statements showing the market value of each penny stock held in
the customer's account. For so long as the Company's Common Stock is considered
penny stock, the penny stock regulations can be expected to have an adverse
effect on the liquidity of the Common Stock in the secondary market, if any,
which develops.
Item 2. Management's Discussion and Analysis or Results of Operations.
Discussion and Analysis
The Company was founded in 1992 to combat the potential spread of
bloodborne pathogenic infections such as HIV and hepatitis. It has broadened its
mission to research, develop, manufacturing, marketing and selling medical
products and services to the healthcare community.
The Company was in the development stage until 1993 when it began
commercial shipments of SutureMate(R), its first product. From inception in
June, 1992 through December 31, 1998, the Company generated revenues of
approximately $1,100,000 from a limited number of customers. Since inception
through December 31, 1998, the Company has generated cumulative losses of
approximately $1,690,000. Although the Company has experienced a significant
percentage growth in revenues from fiscal 1992 to fiscal 1998, the Company does
not believe prior growth rates are indicative of future operating results,
especially in light of the contract with US Surgical to assist in the
introduction of OASiS. Due to the Company's operating history and limited
resources, among other factors, there can be no assurance that profitability or
significant revenues on a quarterly or annual basis will occur in the future.
Moreover, the Company expects to continue to incur operating losses through at
least the first half of 2000, and there can be no assurance that losses will not
continue after such date. The Company had commitments for installations in a
total of 12 hospitals on or before June 30, 1999, ten of which related to the
agreement with US Surgical and two are a result of the Company's sales
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department. As of the date hereof the Company has completed installations of
fourteen (14) units in seven (7) hospitals, five (5) of which are under the
Short Term Agreement. Installation of the remaining units under the US Surgical
Short Term Agreement have been merged into the Long Term Agreement.
With the implementation of its agreement with US Surgical and in the
event of the reactivation of its various distribution agreements and/or with the
establishment of one or more strategic alliances in addition to US Surgical, the
Company expects to experience a period of growth, which requires it to
significantly increase the scale of its operations. This increase will include
the hiring of additional personnel in the areas of (i) customer service to
provide technical support for the hospitals where installations are located and
(ii) technical staff to make changes requested by those hospitals. This will
result in significantly higher operating expenses. The increase in operating
expenses is expected to be partially funded by an increase in revenues. However,
the Company's net loss may continue to increase. Expansion of the Company's
operations may cause a significant strain on the Company's management, financial
and other resources. The Company's ability to manage recent and any possible
future growth, should it occur, will depend upon a significant expansion of its
sales and marketing, research and development, accounting and other internal
management systems and the implementation and subsequent improvement of a
variety of systems, procedures and controls. There can be no assurance that
significant problems in these areas will not occur. Any failure to expand these
areas and implement and improve such systems, procedures and controls in an
efficient manner at a pace consistent with the Company's business could have a
material adverse effect on the Company's business, financial condition and
results of operations. As a result of such expected expansion and the
anticipated increase in its operating expenses, as well as the difficulty in
forecasting revenue levels, the Company expects to continue to experience
significant fluctuations in its revenues, costs and gross margins, and therefore
its results of operations. (See Part I, Item 1. "Description of the Business -
(b) Business of the Issuers - Risk Factors - Fluctuations in Results of
Operations".)
The Company's plan of operations for the next twelve months is to focus
on building revenue from the installation of the OASiS system in the hospitals
designated by US Surgical under the Short Term Agreement and to install
additional OASiS systems in hospitals not under the US Surgical agreement but
with whom the Company has begun negotiations and in some cases reached a
commitment. Additionally, the Company intends to install the inservice modules
from US Surgical and other medical product manufacturers at both the US Surgical
and the other hospitals. The Company also is aggressively seeking strategic
alliances with targeted industry partners such as manufacturers of devices,
manufacturers of pharmaceuticals, professional organizations such as nursing
associations and hospital group purchasing organizations and integrated health
networks.
The Company estimates that if it is successful in consummating new
strategic alliances, the agreements will provide for infusion of sufficient
capital to fund ongoing operations for the balance of the year. The Company
estimates revenues from an expanded base of content providers and individual
installations may grow to the level where they can support ongoing operations.
The Company estimates that revenues will be sufficient to fund ongoing
operations at the current level when the number of OASiS installations reaches
approximately 100 to 125 and the total number
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of inservice modules reaches approximately 150. The Company has purchased 20
OASiS units from Kiosk Information Systems, Inc., which were installed under the
US Surgical agreements and at St. Francis Hospital. Based upon potential
additional commitments, the Company believes that if it were to order 20 more
units, that all such units would be placed by the end of 1999. The Company
already has 32 inservice modules under the US Surgical agreement and is in
discussion with various manufacturers interested in using OASiS to inservice
more than 50 of their products. The Company believes that each of the initial
installations should have a position as to long term acceptance within three (3)
to six (6) months and that this initial time is the test period to determine the
potential for market acceptance at that hospital. In the case of US Surgical
hospitals under the Short Term Agreement, this period will be for nine (9)
months by contract. At the end of such test period, the Company believes it will
be in a position to execute three (3) year leases and finance such leases
through a leveraged leasing arrangement with Rockford or a similar funding
source.
In the short term, to fund operations through the fourth quarter, 1999,
the Company will be required to seek additional funds from strategic alliances
with potential clients its shareholders, from a limited number of accredited
investors in a private placement of its restricted securities, from additional
third party financing or seek third party debt or equity financing other than
those planned by the current anticipated private placement. In the event no such
funding is available or only partial funding is available, the Company will be
required to scale back operations and to reduce its breakeven point by such
measures as salary reductions, staffing cuts, or the licensing or sale of some
of the Company's assets or product lines to third parties. Provided such funding
or scale back is successful, the Company believes that it can meet its capital
needs through the testing period and until such time as the Company has
sufficient additional long-term capital to expand. There can be no assurance
that the Company will be successful in these efforts.
Once the testing period is over, the Company will require between $2 and
$5 million in additional capital in the form of debt or equity to fund the
continued expansion of the OASiS system and its development to meet increased
demand and to implement its plans for increased marketing of its medical device
products. The Company has met with several venture capital firms, investment
bankers, factoring companies and traditional lending sources, each of whom have
expressed early interest and many of whom are awaiting the conclusion of the
testing period. The Company has accepted no definite offer. There can be no
assurance that such long-term financing will be available to the Company or that
it will be on terms that the Company may seek.
Results of Operations - Full Fiscal Years
Revenues
To date, a limited number of customers and distributors have accounted
for substantially all of the Company's revenues with respect to product sales.
For the fiscal year ending December 31, 1997, the Company derived approximately
99% of its revenue from sales of its OASiS to SMH. For fiscal year ending
December 31, 1998, the Company derived approximately 93% of its revenue for
product sales from technical services it provided to US Surgical during a
medical products convention.
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The Company anticipates that the main focus of its selling efforts will
be to focus on the US Surgical arrangement and to continue to sell its products
to a relatively small group of medical products distributors with the objective
of having its products distributed on a large national and international scale.
Although the Company had entered into an exclusive distributorship agreement
with Johnson & Johnson Medical Pty Ltd. to sell its SutureMate(R) product (in
the territories of Australia, New Zealand, Papua, New Guinea and Fiji), Noesis
for sales in Europe, and with two other distributors to sell such product in
Saudi Arabia and the Netherlands, none of these arrangements are currently
active. And, although the Company is currently engaged in a joint marketing
agreement with US Surgical, there is no assurance that the Company will be able
to obtain adequate distribution of its products to the intended end user. Most
medical product distributors carry an extensive line of products (some of which
they manufacture themselves) which they make available to end users (hospitals,
surgeons, healthcare workers) and various of these products may compete with
each other as to function, price or other factors. In addition, numerous medical
product distributors are not themselves well capitalized and their financial
condition may impact their ability to properly distribute the Company's
products.
The Company's ability to achieve revenues in the future will depend in
significant part upon its ability to obtain orders from, maintain relationships
with and provide support to, existing and new customers, as well as the
condition of its customers. As a result, any cancellation, reduction or delay in
orders by or shipments to any customer or the inability of any customer to
finance its purchases of the Company's products may materially adversely affect
the Company's business, financial condition and results of operations. There can
be no assurance that the Company's revenues will increase in the future. In
addition, the Company expects that the average selling price of a particular
product line also will decline as such products mature, and as competition
increases in the future. Accordingly, the Company's ability to maintain or
increase revenues will depend in part upon its ability to increase unit sales
volumes of its products and to introduce and sell products at prices sufficient
to compensate for reduced revenues resulting from declines in the average
selling price of the Company's more mature products. ( See Part I, Item 1.
"Description of the Business - (b), Business of the Issuers - Risk Factors -
Significant Customer and Product Concentration, Fluctuations in Results of
Operations, Declining Average Selling Prices and International Operations; Risks
of Doing business in Developing Countries.")
Net Sales
For the year ended December 31, 1997, net sales and cost of sales of
$248,760 and $22,002 respectively, related primarily to the sale of four (4)
units of the OASiS system to one customer. Net sales for the year ended December
31, 1998 of $16,545 are comprised of sales of the Company's proprietary
SutureMate(R) products, MediSpecs Rx(TM) eyewear and technical services provided
to US Surgical. Product sales and related cost of sales amounted to $1,203 and
$5,560, respectively for the year ended December 31, 1998. Cost of sales
includes a write-down of approximately $4,500 for defective units of the
re-designed SutureMate(R). There were no sales of the OASiS system during 1998
due to the Company's focus on enhancements to the product design and development
of a new version of the product.
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The Company has an ongoing program to reduce the costs of manufacturing
its products. As part of this program, the Company has been attempting to
achieve cost reductions principally through engineering and manufacturing
improvements, product economies and utilization of third party subcontractors
for the manufacture of the Company's products. Notwithstanding a delivery of
defective units, to date, it has been successful in substantially reducing such
costs by re-designing SutureMate(R). The success of these cost reduction
programs will not be known until production volumes are scaled up. There can be
no assurance that the Company's ongoing or future programs can be accomplished
or that they will increase gross profits.
To the extent the Company is unable to reduce its production costs or
introduce new products with higher margins, the Company's results of operations
could be materially adversely affected. The Company's results may also be
affected by a variety of other factors, including mix of products and services
sold; production, reliability or quality problems; price competition; and
warranty expenses and discounts.
Operating Expenses
Sales and Marketing: These expenses consist of advertising, meetings and
conventions and entertainment related to product exhibitions and the related
travel expenses. Since inception, the Company has spent approximately $359,000
on sales and marketing expenses. For the years ended December 31, 1997 and
December 31, 1998, sales and marketing expenses were $62,028 and $265,261,
respectively. In 1998, the Company increased its advertising particularly with
reference to OASiS and hired additional sales and marketing personnel during
1998. The Company has invested significant resources to expand its sales and
marketing effort, including the hiring of additional personnel and establishing
the infrastructure necessary to support future operations. The Company expects
that such expenses in 1999 will increase in absolute dollars as compared to
1998.
General and Administrative. These expenses consist primarily of the
general and administrative expenses for salaries, contract labor and other
expenses for management and finance and accounting, legal and other professional
services including ongoing expenses as a publicly owned Company related to
legal, accounting and other administrative services and expenses. Since
inception, the Company has spent approximately $1,562,000 on general and
administrative expenses. For the years ended December 31, 1997 and December 31,
1998, general and administrative expenses were $182,787 and $517,189,
respectively. The increase of $334,402 is due primarily to higher executive
compensation, legal and accounting fees associated with the Company's SEC
filings, higher depreciation and amortization and additional rent for the
Company's headquarters. The Company expects general and administrative expenses
to increase in absolute dollars in 1999 as compared to 1998, as the Company
continues to expand its operations.
Research and Development
These expenses consist primarily of costs associated with personnel and
equipment costs and field/clinical trials. The Company's research and
development activities include the development of the OASiS system and more than
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six (6) operating room, OB/GYN, advanced surgical and protective related
products including SutureMate(R) and MediSpecs RX(TM).
Since inception, the Company has spent approximately $156,000 on
research and development. For the years ended December 31, 1997 and December 31,
1998, research and development expenses were approximately $113,740 and $34,536,
respectively. During 1997, research and development expenses were significant as
the Company concentrated on the OASiS System. The Company made enhancements to
the software for the OASiS system in 1998, and the majority of these related
costs were capitalized and will be amortized over a period not to exceed five
(5) years. The Company intends to continue to invest significant resources to
continue the development of new products and expects that research and
development expenses in 1999 will increase in absolute dollars as compared to
1998.
Interest and Other Income (Expense), Net
Interest and other income (expense), consists primarily of interest
expenses accrued on the direct loan to the Company under a line of credit
agreement for $100,000, interest related to loans from the majority stockholder,
miscellaneous income and underwriting costs. In May 1997, the Company
established a line of credit in the amount of $100,000 with a financial
institution at 1.5% above the prime rate, interest only payments are due monthly
with an expiration date of May 2, 2017. The line is due on demand and is secured
by inventory, accounts receivable and equipment. There was no outstanding
balance as of December 31, 1998. The outstanding balance as of December 31, 1997
was $100,000. The interest rate at December 31, 1997 was 10.0%. The line of
credit is personally guaranteed by Dr. Swor. (See Part I, Item 2. "Management's
Discussion and Analysis or Results of Operations Financial Condition, Liquidity
and Capital Resources.")
The Company did not report any foreign currency gains or losses for the
years ended December 31, 1997 and 1998 since there were no contracts negotiated
in foreign currencies for those periods. In the event its contract with Johnson
& Johnson Medical Pty. Ltd., Noesis and the Company's distribution arrangements
in the Netherlands and in Saudi Arabia are reactivated, the Company may in the
future be exposed to the risk of foreign currency gains or losses depending upon
the magnitude of a change in the value of a local currency in an international
market. The Company does not currently engage in foreign currency hedging
transactions, although it may implement such transactions in the future.
Financial Condition, Liquidity and Capital Resources
At December 31, 1998, the Company had assets totaling $373,514 and
liabilities totaling $55,331. Since its inception in June of 1992, the Company
has financed its operations and met its capital requirements through sales of
its products, fees from OASiS, proceeds from the sale of or exchange for common
stock aggregating approximately $1,405,000, through borrowing from current
shareholders and through the $100,000 line of credit with the financial
institution which is guaranteed by Dr. Swor.
Operating activities used net cash of $216,991 and $441,458 in1997 and
1998, respectively.
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At December 31, 1998, the Company had a working capital of approximately
$73,000, including $41,000 of cash, $58,700 of deposits and $26,898 of
inventory. This represents an increase of approximately $315,000 over a working
capital deficiency of $242,411 at December 31, 1997.
At December 31, 1998, the Company's outstanding indebtedness consisted
of accounts payable in the amount of $35,262 and accrued expenses of $20,069.
The Company's principal commitments for capital expenditures are (1)
those associated with the arrangement with US Surgical under which the Company
will provide an additional number of units; (2) the Company's obligation to pay
SMH $25,000 for each of ten (10) studies or $250,000 over the term of the
clinical testing agreement if the Company determines not to have SMH perform
clinical testing; and (3) the Company's obligations to pay the balance due on
the order of twenty (20) OASiS units from Kiosk Information Systems, Inc. Since
December 31, 1998, the Company paid all but $3,000 of the amount due to Kiosk
Information Systems, Inc. (See Part I, Item 1. "Description of the Business -
(b) Business of Issuer - Data Systems Division; and - Medical Products
Division.") The sources of funds to meet these commitments has been partially
made through cash on hand from the prior year, use of the line of credit, a loan
from Dr. Swor, revenues generated by the Long Term Agreement with US Surgical,
private placement funds and other revenues which the Company believes it will
generate over the five (5) year term.
The Company's future capital requirements will depend upon many factors,
including the continued development of OASiS, its current products and new
products and services, the extent and timing of acceptance of the Company's
products and services in the market, requirements to maintain adequate
manufacturing arrangements, the progress of the Company's research and
development efforts, expansion of the Company's marketing and sales efforts, the
Company's results of operations and the status of competitive products and
services. In the short term, it is likely that the Company will require
additional financing. In addition, the Company may require additional financing
after such date to fund its operations. There can be no assurance that any
additional financing will be available to the Company on acceptable terms, or at
all, when required by the Company. If additional funds are raised by issuing
equity securities, further dilution to the existing stockholders will result. If
additional funds are raised by issuing debt securities future interest expense
will be incurred. If adequate funds are not available, the Company may be
required to delay, scale back the development of OASiS or scale back or
eliminate one or more of its research and development or manufacturing programs
or obtain funds through arrangements with partners or others that may require
the Company to relinquish rights to certain of its products or potential
products or other assets that the Company would not otherwise relinquish.
Accordingly, the inability to obtain such financing could have a material
adverse effect on the Company's business, financial condition and results of
operations.
Results of Operations for the Six Months Ended June 30, 1999 and June 30, 1998
Overview
From its inception, the Company has incurred losses from operations. As
of June 30, 1999, the Company had cumulative net losses totaling approximately
$2,070,000. Through fiscal 1997, the Company focused primarily on the design and
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development of its propriety products, as well as providing consulting services.
During fiscal 1998, management shifted its focus to aggressively marketing its
proprietary products.
Financial Position
Working capital as of June 30, 1999 was a deficit of $43,229, as
compared to working capital of $53,056 at December 31, 1998. This decrease is
primarily due to additional borrowings on the Company's line of credit and
increases in Notes payable-related parties, the transfer of deposits to property
and equipment, reduced by an increase in cash on hand from the receipts of the
securities sold in the private placement.
Revenues
For the three months ended June 30, 1999 and 1998, the Company had total
revenues of $13,157.00 and $3,159.00, respectively. For the three months ended
June 30, 1999, revenues were comprised primarily of fees received for Oasis unit
rentals and production fees for inservice modules. For the six months ended June
30, 1999, total revenues were $52,734.00 compared to $19,139.00 in the same
period last year. The increase of $33,595.00 or176% is due to revenue from the
1999 launch of Oasis. In 1998, Oasis was still under development.
Selling, General, and Administrative Expenses
For the three months ended June 30, 1999, operating expenses increased
by $30,244 or 13% from $227,672 for the three months ended June 30, 1998. This
increase is primarily related to marketing support expenditures to sustain the
launch of the Company's Oasis system. In accordance with the Company's marketing
plan for fiscal 1999, expenses related to promotion, trade shows, and
conventions were increased to enhance the industry awareness of the company's
products and services.
In the past, the Company has focused on the design and development of
proprietary products. For fiscal 1999, the Company has launched an aggressive
marketing plan that is designed to increase worldwide sales of its products.
Surgical believes that the increased operating expenses incurred during the six
(6) months ended June 30, 1999 will position the Company to generate increased
revenue in the fourth quarter of the 1999 fiscal year and throughout 2000.
Liquidity and Capital Resources
The Company's operations are being funded primarily from the $475,000
proceeds of the private placement and from cash flow of $177,500 from
shareholder loans and advances on the line of credit during the six months ended
June 30, 1999. This allowed the Company to purchase capital assets, enhance its
OASiS software and fund current operations. At June 30, 1999, the Company has a
$188,000 cash position.
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The Company has a line of credit in the amount of $100,000 that expires
in May 2017 and is guaranteed by Dr. Swor and his wife. As of June 30, 19999,
the line of credit had been used to fund operations on a short-term basis and
$100,000 was outstanding. As a result of the $100,000 payment from US Surgical
under the Long Term Agreement, the Company paid down the outstanding amount to
zero. Currently, the Company is using the line to fund ongoing operations and
$20,000 is outstanding as of the date hereof.
Net cash used for investing for the six months ended June 30, 1999 was
approximately $140,962, representing primarily OASiS units purchased and costs
related to the new version of OASiS which have been capitalized.
Revenue of $13,157 for the quarter ended June 30, 1999 has been
generated primarily from the leasing of OASiS units to various hospitals
pursuant to the Agreement with US Surgical. For the quarter ended June 30, 1998,
revenue totaled $3,159.
It is the Company's intention to pursue additional debt and or equity
financing in the range of $2,000,000 to $5,000,000 during the remainder of
fiscal 1999, however, there can be no assurance that they will be successful in
their efforts. Surgical believes that cash flows generated from operations and
borrowing capacity, combined with proceeds from future debt or equity financing
and equipment financing support from either potential future strategic alliances
or firms that specialize in equipment financing will provide adequate
flexibility for funding the Company's working capital obligations.
Impact of the Year 2000 Issue
The Year 2000 Issue is the result of potential problems with computer
systems or any equipment with computer chips that use dates where the date has
been stored as just two digits (e.g. 98 for 1998). On January 1, 2000, any clock
or date recording mechanism including date sensitive software which uses only
two digits to represent the year, may recognize the date using 00 as the year
1900 rather than the year 2000. This could result in a system failure or
miscalculations causing disruption of operations, including among other things,
a temporary inability to process transactions, send invoices, or engage in
similar activities.
Management has reviewed its current internal systems and is in the
process of upgrading its accounting system to be Year 2000 compliant. The
Company purchased new hardware in 1998 that is Year 2000 compliant. Its internal
systems are Year 200 compliant and the Company expects the testing of such
systems to be completed in the fourth quarter of 1999. Management does not
anticipate any significant additional costs that would relate to upgrading its
systems to support the Year 2000.
Further, management does not believe the Year 2000 will impact the
operation of the OASiS system since the software for this system does not rely
on legacy applications or subsystems. OASiS is designed to handle dates in the
form of a two digit month and day and a four digit year, thus avoiding the Year
2000 problem
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The Company believes that it has disclosed all required information
relative to Year 2000 issues relating to its business and operations. However,
there can be no assurance that the systems of other companies on which the
Company's systems rely also will be converted in a timely manner or that any
such failure to convert by another company would not have an adverse affect on
the Company's business, operations or financial condition.
Item 3. Description of Property:
The Company's executive offices are located at 2018 Oak Terrace,
Sarasota, Florida 34231. Its telephone number is (941) 927-7874 and its
facsimile number is (941) 925-0515.
The Company pays rent in the amount of $3500 per month which consists of
3,500 square feet of office space. The lease is for a term of two (2) years and
is automatically renewable for an additional year. The initial term of the lease
expires in May 2000. The property is owned by Savannah Leasing which is owned by
Dr. and Mrs. Swor. The Company first rights of refusal on surrounding properties
owned by Savannah Leasing and therefore believes that the leased space and the
property under the first rights of refusal will be sufficient for its corporate
offices for the next ten (10) years. (See Part I, Item 1. "Description of Issuer
- - (b) Business of Issuer - Facilities.")
The Company owns no real property and its personal property consists of
furniture, fixtures and equipment, prototype molds and leasehold improvements
with an original cost of $155,930 on December 31, 1998.
The Company currently employs its capital reserves in a money market
sweep account. Activity is monitored on a daily basis and for a month commencing
on August 1, 1999, had returned on average 4.1% on assets employed.
Additionally, Surgical has acquired stock in two (2) privately owned companies,
25,000 shares in ParView Inc. as part of its acquisition of Endex Systems Inc.
and 3,750 shares in Linters Inc. which was received as partial compensation for
clinical products research completed by the Medical Consultants Division. It is
the Company's strategy to engage in transactions which minimize dilution of the
Company's equity.
Item 4. Security Ownership of Certain Beneficial Owners and Management:
The following table sets forth information as of September 30, 1999,
regarding the ownership of the Company's Common Stock by each shareholder known
by the Company to be the beneficial owner of more than five percent (5%) of its
outstanding shares of Common Stock, each director and all executive officers and
directors as a group. Except as otherwise indicated, each of the shareholders
has sole voting and investment power with respect to the share of Common Stock
beneficially owned.
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<TABLE>
Name and Address of Title of Amount and Nature of Percent of
- --------------------------------------------------------------------------------
Beneficial Owner Class Beneficial Owner (1) Class
- --------------------------------------------------------------------------------
<S> <C> <C> <C>
Dr. G. Michael Swor Common 3,788,890 (2) 32.078%
Frank M. Clark Common 62,000 (3) .525%
Donald K. Lawrence Common 250,000 (4) 2.117%
James D. Stuart Common 730,198 (5) 6.182%
Irwin Newman Common -0- -0-
Sam Norton Common 103,400 (6) .875%
David Swor Common 523,445 (6) 4.432%
Dr. William B. Saye Common 50,000 (6) .423%
David Collins Common 34,000 (3) .288%
All Executive Officers and Directors 5,541,933 46.920%
as a Group (nine(9) persons)
- ----------
</TABLE>
(1) The percentages are based upon 11,811,373 shares of Common Stock
outstanding, including the 6,000 shares to Ten Peaks for which the
Company is obligated, but has not delivered due to its belief that Ten
Peaks has failed to perform. In addition to the shares owned by the
Executive Officers and Directors, said officers and directors own
(including those beneficially held) options to purchase 5,282,160 shares
of the Company's Common Stock (without regard to the additional options
to Dr. Saye which accrue at the rate of 8,333 per month after September
30, 1999) pursuant to Employee and Consultant Stock Option Plans adopted
in 1994, 1998 and 1999. In the event all such options to purchase were
exercised, this group would own a total of 10,824,093 shares of the
Company's Common Stock which would represent 63.32% of the total shares
of Common Stock outstanding. Under the 1994 ESOP, 1998 Revised ESOP and
1999 Revised ESOP, none of these options may be exercised within 60
days. (See Part I, Item 6. "Executive Compensation - Employee and
Consultant Stock Option Plans.")
(2) This includes 631,260 owned by Dr. Swor's wife of which he is deemed the
beneficial owner.
(3) In April 1999, Mr. Clark and Mr. Collins received 12,000 and 34,000
shares, respectively, of the Company's restricted Common Stock in lieu
of salary in the amount of $7,812 due to Mr. Clark and consulting fees
equal to $23,410 due to Mr. Collins. (See Part I, Item 6. "Executive
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Compensation; Part I, Item 7. "Certain Relationships and Related
Transactions."; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
(4) Mr. Lawrence received his shares of restricted Common Stock as part of
the acquisition of all of the assets of Endex by the Company.
(5) These shares are a portion of the 816,619 shares which Mr. Stuart
received as a gift from Dr. Swor in 1996.
(6) Each of these Directors purchased 50,000 shares of the Company's
restricted Common Stock and warrants to purchase 25,000 shares of the
Company's restricted Common Stock exercisable at the price of $1.00 for
a term of five (5) years on the same terms as other investors in a self-
directed private placement commenced by the Company in April 1999. (See
Part I, Item 7. "Certain Relationships and Related Transactions."; and
Part II, Item 4. "Recent Sales of Unregistered Securities.")
There are no arrangements which may result in the change of control of
the Company.
Item 5. Directors, Executive Officers, Promoters and Control Persons:
Executive Officers and Directors
Set forth below are the names, ages, positions, with the Company
and business experiences of the executive officers and directors of the Company.
Name Age Position(s) with Company
Dr. G. Michael Swor 41 Chairman and Treasurer
4485 S. Shade Avenue
Sarasota, FL 34237
Frank M. Clark (1) 67 Director, CEO and President
7313 Oak Leaf Way
Sarasota, FL 34241
Donald K. Lawrence (1) 37 Director, Executive Vice President
716 Edgemer Lane and Secretary
Sarasota, FL 34242
David Collins (1) 58 Director and Acting Chief Financial
6210 Sun Boulevard Officer (2)
St. Petersburg, FL 33715
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James D. Stuart 42 Director
880 Jupiter Park Drive
Suite 14
Jupiter, FL 33458
Irwin Newman 51 Director
1515 SW 22nd Avenue Circle
Boca Raton, FL 33486
Sam Norton 39 Director
1819 Main Street
Suite 610
Sarasota, FL 34236
David Swor 67 Director
6385 Presidential Court
Suite 104
Fort Meyers, FL 33919
Dr. William B.Saye (1) 60 Director and Medical Director of
4614 Chattahoochee Crossing ALTC VirtualLabs
Marietta, GA 30067
(1) Except for Mr. Clark, Mr. Lawrence, Dr. Saye and Mr. Collins, who had no
role in founding or organizing the Company, the above-named persons may be
deemed to be "promoters" and "parents" of the Company, as those terms are
defined under the Rules and Regulations promulgated under the Act.
(2) Mr. Collins is not engaged as a full time employee of the Company. He is
devoting and will continue to devote such time as required to fulfill the
obligations as the Company's Acting Chief Financial Officer. At such time
as the Company has sufficient additional revenue or is successful in
securing additional funding from outside sources, it is intended that Mr.
Collins will be employed by the Company as the Chief Financial Officer and
that he will devote his full time to the business of the Company.
All directors hold office until the next annual meeting of the Company's
shareholders and until their successors have been elected and qualify. Officers
serve at the pleasure of the Board of Directors. The officers and directors will
devote such time and effort to the business and affairs of the Company as may be
necessary to perform their responsibilities as executive officers and/or
directors of the Company.
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Family Relationships
There are no family relationships between or among the executive officers
and directors of the Company except that David Swor is Dr. G. Michael Swor's
father.
Business Experience
G. Michael Swor, M.D., M.B.A, age 41, has served as Chairman of the Board
and Medical/Technical Advisor of the Company since its inception in 1992 and has
served as Treasurer to the Company since June, 1998.
Dr. Swor, a board certified, practicing physician with a specialty in
OB/GYN, is the founder of Surgical. From 1992 until June 12, 1998, Dr. Swor also
served as President and CEO. With a Masters in Business Administration, Dr.
Swor's duties for the Company include investor relations, corporate financing,
and overall corporate policy and management. He is a clinical assistant
professor in the OB/GYN department at University of South Florida. Dr. Swor was
the inventor of SutureMate(R) and Prostasert(TM) and the original holder of the
patents issued to each of these products. Dr. Swor has written numerous
articles, published the "Surgical Safety Handbook," and given numerous lectures
on safety and efficiency in the surgical environment. His professional
affiliations include American College of Surgeons, American College of
Obstetrics and Gynecology and the Florida Medical Association. From 1996 until
the present, Dr. Swor has acted as an independent consultant for Concise Advise
which provides consulting services related to product development, patent,
research, distribution, joint venture, mergers and other business issues. From
1994 through 1996, Dr. Swor oversaw the operation of WDC. From 1987 through
1995,Dr. Swor was the managing partner of Women's Care Specialists/Physicians
Services Inc. where he oversaw four (4) physicians, two (2) practitioners and a
staff of over twenty five (25). From 1987 through 1992, Dr. Swor was a partner
and board member of Women's Ambulatory Services, Inc., a diagnostic testing
facility. From 1982 through 1985, Dr. Swor was the President of University of
Florida at Jacksonville, Health Sciences Center resident staff association with
over 200 members. Dr. Swor received a B.A degree in 1978 from the University of
South Florida, a M.D. degree from the University of South Florida College of
Medicine in 1981, and an M.B.A. degree from the University of South Florida in
1998. From 1981 through 1985 he received his training in OB/GYN from the
University of Florida Department of Obstetrics and Gynecology in Jacksonville,
Florida. He has received several special achievement awards including being
honored by the University of South Florida in May, 1998 with the Alumni Award
for Professional Achievement.
Frank M. Clark, age 67, has served as a Director, CEO and President since
June, 1998.
Mr. Clark is responsible for the day to day operations of the Company and
is responsible for new product development and manufacturing and manages new
business ventures, including mergers, acquisitions, joint ventures, strategic
alliances and licensing/distribution agreements for the Company. Mr. Clark also
serves on the Board of GenSci Regeneration Sciences, Inc. From 1991 to 1997, Mr.
Clark was Chairman and CEO of Corporate Consulting Services Group where his
primary activities were providing consulting services to start-up companies,
under-performing companies and training people in career transitions. From 1984
to 1991, Mr. Clark was COO and Executive Vice President of Right Associates, a
consulting firm with responsibilities for business development with Fortune 100
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corporations for which he acted. He acquired a Los Angeles based consulting firm
and became the Managing Principal. From 1981 to 1984, Mr. Clark was a Vice
President of National Medical Care, a subsidiary of W.R. Grace, Inc. where his
innovative marketing leadership helped the company recapture a dominant share of
the dialysis market. From 1978 to 1981, Mr. Clark served as President, Corporate
Vice President and a Director of R.P. Scherer, Inc., the world's leading
producer of soft gelatin capsules where he was in charge of worldwide
businesses. From 1959 to 1978, Mr. Clark was employed by Johnson & Johnson,
Inc., first with Ethicon, Inc. where he served as a Vice President and Director,
then with Ethnor Medical Products where he was a Vice President, General Manager
and a Director and then with Stimulation Technology, where he served as
Executive Vice President and a Director. From 1956 to 1958, Mr. Clark was
employed by Federated Department stores in the executive training program at
Bloomingdales in New York City. Mr. Clark received a certificate from Teachers
College in Connecticut in 1955.
Donald K. Lawrence, age 37, has served as a Director, Vice President,
Sales & Marketing and Secretary since May, 1997 and Executive Vice President
since January, 1998.
Mr. Lawrence's responsibilities include sales management, market
planning, advertising, and management for Compliance Plus products and most
recently he has become the Executive Director of OASiS. His arrival to the
Company was facilitated by the Company's acquisition in 1997 of InterActive PIE
Multimedia, Inc., of which Mr. Lawrence was founder and Chief Executive Officer.
From February 1996 until February 1997, Mr. Lawrence was the CEO of InterActive
PIE. From December 1991 until February 1996, Mr. Lawrence was employed by
Ethicon Endo-Surgery/Johnson & Johnson as a surgical sales representative. From
July 1989 until December 1991, Mr. Lawrence acted as a surgical sales
representative for Davis and Geck. Prior to entering the area of medical device
sales, from February 1985 until July 1989, Mr. Lawrence was an account executive
with DHL Worldwide Express. During college, Mr. Lawrence was an independent
dealer for Southwestern Publishing Co. Mr Lawrence received a B.S degree in
Marketing and Communications in 1984 from Appalachian State University.
David Collins, age 58, has served as a Director since January 1999 and
its Acting Chief Financial Officer since March 1999.
Mr. Collins responsibilities include overseeing the financial affairs of
the Company on a part time basis and he is currently engaged as a consultant to
the Company. Mr. Collins devotes such time as is necessary to fulfill his duties
to the Company. During 1997 and 1998, Mr. Collins was Controller for the Sales
and Marketing Division for GES Exposition Services, a subsidiary of the NYSE
listed Viad Corporation. From 1993 to 1996, Mr. Collins was General Manager and
Chief Financial Officer of Spectra Services Corporation. From 1989 to 1992, Mr.
Collins was a Partner and Consultant to Quantum Corporation, a venture capital
firm. From 1977 to 1988, Mr. Collins rose from Controller to Vice President of
Finance (1982) and then to Vice President of Finance and Chief Financial Officer
(1984) of R.P. Scherer Corporation, a NYSE listed company. From 1975 to 1977,
Mr. Collins was Vice President and Controller of Wheelhorse Products, a
subsidiary of American Motors/Chrysler. From 1971 to 1975, Mr. Collins rose from
Controller of the Midwest Dental Division to Vice President and Controller of
the American Hospital Division of American Hospital Supply Corporation (1974).
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From 1969 to 1971, Mr. Collins was a Senior Auditor and Consultant in Public
Accounting with Deloitte & Touche. Mr. Collins received a BSBA from Northwestern
University in 1964 and a MBA from the Kellogg Graduate School of Management at
Northwestern University in 1967. He became a Certified Public Accountant in the
State of Illinois in 1971.
James D. Stuart, age 42, has served as a Director since 1993, initially
acting as Director of Marketing and Sales.
Mr. Stuart served as Executive Vice President from 1993 until June, 1998
and initially acted as the Director of Marketing and Sales. During his time as
an officer of the Company, Mr. Stuart was responsible for new product
development and manufacturing and manages new business ventures, including
mergers, acquisitions, joint ventures, strategic alliances and
licensing/distribution agreements for the Company. From November 1994 until July
1996, Mr. Stuart acted as President and CEO of WDC and was responsible for
managing and operating the facility. From March 1986 until May 1993, Mr. Stuart
was employed by Liquid Air Corporation, Buld Gases Division first as a Business
Manager for South Florida and then as a Program Manager for Food Freezing. From
February 1981 until February 1986, Mr. Stuart was employed by NCR Corporation in
the Systemedia Division initially as a Territory Manager and then as a Senior
Account Manager. Mr. Stuart received a B.A. degree in marketing in 1980 from the
University of South Florida.
Irwin Newman, age 51, has served as a Director since 1993
Currently, Mr. Newman provides financial advisory services to the Board of
Directors. From 1993 to the present, Mr. Newman has served as the President and
CEO of Jenex Financial Services, Inc. ("Jenex"). Mr. Newman is the principal of
Jenex. Mr. Newman is and has been a practicing attorney since 1973. From 1993 to
1998, Mr. Newman served as Vice President and General Counsel for Boca Raton
Capital Corporation, a publicly owned, NASDAQ listed investment holding company
where he completed an Initial Public Offering for a $4 million subsidiary,
completed a $3.5 million secondary offering and was responsible for shareholder
and investor relations. From 1983 to 1988, Mr. Newman served with the New York
Stock Exchange firms of Gruntal & Co. and Butcher and Signer, specializing in
common and preferred stocks, options, municipal and corporate bonds and GNMA's.
During part of this period, he broadcast a daily television market comments
program over the Financial News Network. Mr. Newman received a B.S. degree in
Business Administration from Syracuse University in 1970 and a J.D. degree from
the University of Florida in 1973.
Sam Norton, age 39, has served as a Director since 1992.
Mr. Norton provides business and legal advisory services to the Board of
Directors. Mr. Norton is an attorney with the firm Norton, Gurley, Hammersley &
Lopez, P.A. in Sarasota, Florida. Mr. Norton practices primarily in the areas of
real estate, banking, corporate and business transactions and is a Florida Bar
board certified real estate specialist, having earned such certification in
1991. He has practiced law in Sarasota since 1985 and is the past Chairman of
the Joint Committee of the Sarasota Board of Realtors/Sarasota County Bar
Association. Mr. Norton is active in Sarasota civic organizations and currently
serves as a member of the Board of Directors of Sarasota Bank. Mr. Norton
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graduated from the University of Florida in 1981 and earned a J.D. degree from
Stetson University School of Law in 1984 where he graduated Cum Laude. While in
law school, Mr. Norton was chosen to serve on the Law Review. He was admitted to
the Florida Bar in 1985.
David Swor, age 67, has served as a Director since 1992.
Mr. Swor, who is the father of Dr. Swor, provides business advisory
services for the Board of Directors. From 1985 until the present, Mr. Swor had
been engaged in the real estate brokerage business as the owner of Swor, Inc.
The firm specializes in the development of commercial real estate properties
along with operating other related business interest, holdings and investment
properties. From 1992 to the present, Mr. Swor has been a member of the Board of
Directors of SunTrust Bank in Sarasota, Florida. From 1974 until 1985, Mr. Swor
was a co-owner of the real estate firm of Swor & Santini, Inc. which specialized
in commercial real estate and investments. From 1973 until 1975, Mr. Swor was a
realtor with Russ Gorgone, Inc. From 1971 until 1973, Mr. Swor was Vice
President and co-owner of Carroll Oil Company, which operated a Texaco
distributorship in Fort Myers, Florida. From 1959 until 1971, Mr. Swor was a
salesman for Texaco and from 1958 until 1959, Mr. Swor was in advertising sales
for the Orlando Sentinel Star. Mr. Swor received a B.A. degree from the
University of Kentucky in 1955 and holds teaching certificates from the states
of Kentucky and Florida.
William B. Saye, MD, FACOG, FACS, age 60, has served as Medical Director of
ALTC VirtualLabs since November 1998 and as a Director since January, 1999.
Dr. Saye is the founder, CEO and Medical Director of ALTC. ALTC was started
in 1990. Dr. Saye is also the Clinical Assistant Professor of OB/GYN for Emory
University School of Medicine in Atlanta, Georgia. Dr. Saye, with another
pioneering surgeon, made medical history when he performed the first
laparoscopic cholecystectomy (removal of the gall bladder) in the United States.
In the past nine (9) years, Dr. Saye has been instrumental in training more than
15,000 surgeons in various laparoscopic techniques and spearheaded the
development of a new minimally invasive therapy, laparoscopic Doderlien
hysterectomy. Dr. Saye received a BS from Georgia Institute of Technology in
1962 and his MD degree from Tulane University Medical School in 1965. Dr. Saye
is board certified in Obstetrics and Gynecology and in Advance Operative
Paparoscopy. Dr. Saye is the author of numerous articles on laparoscopic surgery
and techniques.
Scientific Advisory Board
In addition to the officers and directors of the Company, Surgical has a
scientific advisory board which has provided advisory input on products,
research and educational projects for the Company. Inactive members of this
board can be called on to address issues which arise in ongoing research and
development projects. Active/Inactive status depends upon the level of
participation in the Company's current activities. Scientific Advisory Board
members receive no salaries for their services but are compensated for any
reasonable out of pocket expenses incurred on behalf of the Company. Included on
such board are the following:
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Mark Davis, M.D.
OB/GYN Physician & Safety Consultant
DeKalb Medical Center
Atlanta, Georgia
Donna Haiduven, RN/C.I.C.
Infection Control Specialist
Santa Clara Valley Medical Center
San Jose, California
Robert Morrison, M.D.
Optometrist/Chairman, Morrison International
New York, New York
Gail Lebovic, M.D. (Inactive)
Breast Surgeon
Co-Founder, Bay Area Breast Center
Palo Alto, California
Sharon Tolhurst, RN, MBA
Director, Cape Surgery Center
Sarasota, Florida
John Nora, M.D.
General Surgeon
Sarasota, Florida
George Maroulis, M.D. (Inactive)
Professor, University of South Florida
College of Medicine, Department of OB/GYN
Marguerite Barnett, M.D. (Inactive)
Plastic Surgeon
Venice, Florida
Ruth Dyal, M.D. (Inactive)
OB/GYN, Women's Care Specialists
Sarasota, Florida
Neil Pollack, M.D.
OB/GYN, Women's Care Specialists
Sarasota, Florida
Michael Shroder, M.D.
84
<PAGE>
OB/GYN, Women's Care Specialists
Sarasota, Florida
Galen Swartzendruber, M.D.
OB/GYN, Women's Care Specialists
Sarasota, Florida
Phyliss Barber
FDA Compliance Consultant
Sarasota, Florida
Anne Johnson, O.R.T.
Surgical Technician
Columbus, Ohio
Andrew Garlisi, M.D.
Emergency Medicine
LaPorte, Indiana
Dr. Nathan Belkin
Former Researcher and Author in the infection control field
Scott Silverstein, M.D.
Occupational Health and Information Systems Specialist
Wilmington, Delaware
Gail Vallone
Operating Room Technologist
Las Vegas, Nevada
OASiS Medical Advisory Panel
In addition to the officers and directors of the Company, Surgical has a
medical advisory panel which approves, edits and contributes to content
information for the OASiS system. Medical Advisory Panel members receive no
salaries for their services but are compensated for any reasonable out of pocket
expenses incurred on behalf of the Company. Included on such panel are the
following:
Michael Abidin, MD
Nathan Belkin, PhD
Trish Carlson, RN, CEN, CFRRN
Dorothy Corrigan, RN
Mark Davis, MD
Donna Haiduven, BSN, MSN, CIC
Pamela Hart, CLS
85
<PAGE>
Richard Howard, MD
James Li, MD
Mark Lipman, MD
James A. McGregor, MD CM
Trista Negele, MD
Heidi M. Stephens, MD
Pam Tenaerts, MD
Steven Weinstein, MT
Item 6. Executive Compensation:
Through June 30, 1999:
<TABLE>
<CAPTION>
Long Term Compensation
Annual Compensation Awards Payout
s
----------
(a) (b) (c) (d) (e) (f) (g) (h) (i)
Other Restricted Securities
Name and Annual Stock Underlying All Other
Principal Compen- Award(s) Options/ LTIP Compen-
Position Year Salary ($) Bonus ($) sation ($) ($) SARs (f) Payouts sation ($)
- ----------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
(1)
G. 1996 - 5,280
Michael 1997 - 4,877
Swor, 1998 32,500 5,400
Chairman 1999 30,000
of the
Board
and
Treasurer
(2)
- ----------------------------------------------------------------------------------------------------------
Frank M. 1996 -
Clark 1997 -
President 1998 32,731 50,000 70,417
and CEO 1999 26,000
(3)(4)
- ----------------------------------------------------------------------------------------------------------
</TABLE>
86
<PAGE>
<TABLE>
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Donald 1996 -
K. 1997 16,675 13,657
Lawrence 1998 57,278 17,604
Executive 1999 25,000
Vice
President
(5)
- ----------------------------------------------------------------------------------------------------------
James D. 1996 49,536 8,944
Stuart 1997 47,166 5,676
Former 1998 6,000 4,020
Executive
Vice
President
(6)
- ----------------------------------------------------------------------------------------------------------
David 1999 17,000
Collins,
Acting
Chief
Financial
Officer
(4)
- ----------------------------------------------------------------------------------------------------------
</TABLE>
(1) All other compensation includes certain health and life insurance
benefits paid by the Company on behalf of its employee.
(2) Dr. Swor did not receive any salary prior to June 1998 at which time the
Company and he executed an Employment Agreement for a salary of $60,000
per year. Other compensation includes life insurance paid by the
Company.
(3) Mr. Clark executed an Employment Agreement with the Company in June 1998
for an annual salary of $60,000. As a signing bonus, Mr. Clark received
50,000 shares of restricted stock in the Company which is valued at
$50,000 and options to purchase 200,000 shares of the Company's Common
Stock at an exercise price of $1.75 per share. The Company's options
have no current trading value.
(4) In April 1999, Mr. Clark and Mr. Collins received 12,000 and 34,000
shares of the Company's restricted Common Stock in lieu of salary in the
amount of $7,812 due to Mr. Clark and consulting fees equal to $23,410
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<PAGE>
due to Mr. Collins. (See Part I, Item 7. "Certain Relationships and
Related Transactions." and Part II, Item 4."Recent Sales of Unregistered
Securities.")
(5) Mr. Lawrence executed an Employment Agreement with the Company in May
1997 for an annual salary of $50,000. Effective in January 1998, the
salary of Mr. Lawrence was increased to $100,000 per year; however, he
agreed to defer receipt of the additional amounts until a mutually
agreed date. The Company began installment payments of the deferred
amount on September 1, 1999. As consideration for the acquisition of the
assets of Endex, Mr. Lawrence received 250,000 shares of restricted
stock in the Company. Such shares were valued at the asset value of
$13,657. In June 1998, the Company granted Mr. Lawrence options to
purchase 100,000 shares of the Company's Common Stock at an exercise
price of $1.75 per share. The Company's options have no current trading
value.
(6) Mr. Stuart acted as the Executive Vice President of the Company until
June, 1998. Other compensation includes a portion of his health
insurance premiums which were paid by the Company and life insurance.
Year End Option Values for Executive Officers
<TABLE>
Name Exercised Value Realized No. of Value of
Unexercised Unexercised
Exercisable/ Exercisable/
Unexercisable Unexercisable
- -----------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
G. Michael 0 0 3,850,686/ 473,634/
Swor 0 0
Frank M. Clark 0 0 200,000/ 0/
0 0
Donald K. 0 0 100,000/ 0/
Lawrence 0 0
James D. Stuart 0 0 (1) (1)
</TABLE>
(1) Mr. Stuart was not an executive officer at the year end 1998 and the
number of unexercised exercisable/unexercised and the value of
unexercised exercisable/unexercised options were not included in this
table.
88
<PAGE>
In November 1998, the Company entered into a seven (7) year collaborative
agreement with Dr. William B. Saye, the Medical Director and CEO of the Advanced
Laparoscopy Training Center in Marietta, Georgia ("ALTC") under which the
Company acquired the "digital rights" of ALTC and the resulting amalgam as it
relates to surgical education and marketing rights to the ALTC database. Under
this agreement, Dr. Saye became a member of the Company's Board of Directors and
agreed to act as the Medical Director of ALTC VirtualLabs. Dr. Saye is
compensated for travel expenses and paid an honorarium of $2,500 per day when
his services are requested by Surgical. In addition, Dr. Saye was awarded stock
options to purchase up to 1,000,000 shares of the Company's Common Stock over
the period, 300,000 of which were issued upon the execution of the agreement,
and the balance of which are issuable monthly. The intention of the agreement is
that any educational activity involving ALTC or Dr. Saye on the Internet or
other digital presence would be the property of and under the control of
Surgical. (See Part I, Item 7. "Certain Relationships and Related
Transactions.")
Except for certain shares of the Company's Common Stock issued and sold and
options granted to the nine (9) executive officers and/or directors of the
Company in consideration for various cash, loans and services performed for the
Company by each of them, and rent paid to a company controlled by Dr. Swor for
the Company's facility, cash or non-cash compensation in the amount of $276,083
was awarded to, earned by or paid to executive officers or directors of the
Company for all services rendered in all capacities to the Company for the
period January 1, 1996 through December 31, 1998..
The Company has adopted an Employee Stock Option Plan and a Consultant
Stock Option Plan. See Part I, Item 6. "Executive Compensation - Employee and
Consultants Stock Option Plans."
Employee Contracts and Agreement
The Company has entered into Employee Agreements with Dr. Swor, Mr. Clark
and Mr. Lawrence, all of whom Staff and the Company treat as co-employees.
The agreement with Dr. Swor was entered into on June 15, 1998 which was
renewed June 1999. Dr. Swor is employed as the Treasurer and Medical Director of
the Company at an annual salary of $60,000. The agreement is for a term of one
(1) year, which term is renewable year to year unless either party provides
notice to the other within fourteen (14) days prior to the expiration that it
seeks to terminate the agreement. Dr. Swor is required to devote such time as is
required to fulfill his duties to the Company. Dr. Swor is reimbursed reasonable
and necessary expenses incurred on behalf of the Company. Prior to the execution
of this agreement, Dr. Swor received no salary for his services to the Company
since its inception.
The agreement with Mr. Clark was entered into on June 15, 1998 which was
renewed June 1999. Mr. Clark is employed as the President and CEO of the Company
for a term of one (1) year at a salary of $60,000, which term is renewable year
to year unless either party provides notice to the other within fourteen (14)
days prior to the expiration that it seeks to terminate the agreement. Mr. Clark
is required to devote such time as is required to fulfill his duties to the
Company. Mr. Clark is reimbursed reasonable and necessary expenses incurred on
behalf of the Company. Mr. Clark received a signing bonus of 50,000 shares of
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<PAGE>
restricted stock in the Company and was granted options to purchase 200,000
shares of the Company's Common Stock at an exercise price of $1.75 per share.
The agreement with Mr. Lawrence was entered into on April 1, 1997 which was
renewed April 1998 and April 1999. Mr. Lawrence is employed as the Marketing
Director of the Company for a term of one (1) year at a salary of $50,000, which
term is renewable year to year unless either party provides notice to the other
within fourteen (14) days prior to the expiration that it seeks to terminate the
agreement. Commencing January 1, 1998, Mr. Lawrence became the Executive Vice
President of the Company. Effective January 1998, Mr. Lawrence's salary was
increased to $100,000 per year; however, he agreed to defer receipt of the
additional amount until a mutually agreed date. The Company began installment
payments on the deferred amount of September 1, 1999. Mr. Lawrence is required
to devote such time as is required to fulfill his duties to the Company. Mr.
Lawrence is reimbursed reasonable and necessary expenses incurred on behalf of
the Company.
Key Man Life Insurance
The Company currently does not maintain key-man life insurance coverage on
any of its officers or directors. However, the Company is the named beneficiary
of a key-man life insurance policy currently owned by Dr. Swor.
Employee and Consultants Stock Option Plans
Employee Stock Option Plans
On July 21, 1994, the Board of Directors adopted an Employee Stock Option
Plan which is available to employees and Directors of the Company ("ESOP").
Pursuant to the ESOP, employees are given the opportunity to purchase a
designated number of shares of the Company's common stock at a pre-set flat
rate. The options are granted for a period of seven (7) years and are not
transferable except by will or laws of descent and distribution. The options may
not be exercised unless the Company has filed an effective registration
statement on Form S-8 relating to the shares underlying the option. As to
employees who are not also directors, such employees must agree to remain with
the Company for a period of two (2) years from the date the option is granted.
In the event that such employee is terminated during such two (2) year period
for cause or at the request of the employee, to the extent any options have not
been exercised, the options terminate immediately upon the termination of the
employee. If termination is for any other reason, the employee has two (2)
months from the date of termination to exercise. In the case of death, the
options must be exercised within the lesser of (i) three (3) years from the date
of death or (ii) five (5) years from the option issuance date. In the case of
the capital restructure of the Company, the options are effective as if
exercised prior to the capital restructuring event. The employee is limited to
exercise the equivalent of $100,000 of Common Stock in the Company in any
calendar year.
In January, 1998, the Board of Directors revised the term of the ESOP
("1998 Revised ESOP"). Under the revised plan, the term is now determined by a
Committee consisting of Frank Clark and Sam Norton (the "Stock Option
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<PAGE>
Committee"). The Stock Option Committee is evaluating recommendations for
adjusting stock compensation for the Company employees and consultants.
In January, 1999, the Board of Directors further revised the ESOP ("1999
Revised ESOP"). Under the further revised plan which is designated the "Surgical
Safety Products 1999 Stock Option Plan", employees qualify for issuance of
Incentive Stock Options under Section 422 of the Internal Revenue Code, as
amended, Non-incentive Stock Options and Reload Options. Directors, consultants
and advisors who are issued options under the plan only qualify for
Non-incentive Stock Options and Reload Options. All of the options under this
plan terminate ten (10) years (except those issued to 10% or more shareholders,
in which case they terminate in five (5) years) from issuance and vest for
employees at the rate of one-third each year for three (3) years and vest as
established by the Stock Option Committee for Directors, Consultants and
Advisors. The plan is overseen by the Board of Directors or the Stock Option
Committee and all issuances are at fair market value as defined in the plan (and
110% of fair market value in the case of a 10% or more shareholder). The plan
provides the exercise rights on death, disability or termination of employment.
The Company may, at its option, provide change of control rights to designated
persons and if granted, the option holder is entitled to certain cash payments
on all options granted whether or not vested if the Company changes control.
Pursuant to the ESOP, the Company has granted options to purchase 4,166,316
shares of the Company's Common Stock representing proceeds on exercise of
$1,320,000 under the 1994 ESOP, 683,330 shares of the Company's Common Stock
representing proceeds on exercise of $683,330 under the 1998 Revised ESOP
(without regard to the additional options to Dr. Saye which accrue at the rate
of 8,333 per month) and 30,000 shares of the Company's Common Stock representing
proceeds on exercise of $30,000 under the 1999 Revised ESOP to date as follows:
<TABLE>
Employee Date Option No. of Shares Exercise Term
Granted subject to Exercise Price Years
1994 ESOP (1)(2)
<S> <C> <C> <C> <C>
G. Michael Swor (3) 07/21/94 3,850,686 $.317 7
Irwin Newman (4) 07/21/94 63,126 $.317 7
James D. Stuart 07/21/94 63,126 $.317 7
Samuel Norton 07/21/94 63,126 $.317 7
David Swor 07/21/94 63,126 $.317 7
Thomas DeCesare (5) 07/21/94 63,126 $.317 7
</TABLE>
91
<PAGE>
<TABLE>
1998 Revised ESOP(2)
<S> <C> <C> <C> <C>
Frank M. Clark (6) 06/15/98 200,000 $1.00 7
Donald L. Lawrence (6) 06/15/98 100,000 $1.00 7
William B. Saye (7) 11/20/98 383,330 $1.00 7
1999 Revised ESOP (2)
G. Michael Swor (3) 01/01/99 10,000 $1.00 10
Frank M. Clark 01/01/99 10,000 $1.00 10
Donald L. Lawrence 01/01/99 10,000 $1.00 10
- ----------------------------------------------------------------------------------------------
</TABLE>
(1) The options granted under the 1994 ESOP have been adjusted to reflect
the new conversion rate in accordance with the capital restructuring
provision which came into effect when Surgical Safety Products, Inc. of
Florida merged into Sheffeld Acres, Inc., the surviving New York
corporation.
(2) The Company relied upon Section 4(2) of the Act, Section 517.061(11) of
the Florida Code and Section 10-5-9 (13) of the Georgia Code for the
grant of these options.
(3) Dr. Swor received options for 63,126 shares of the Company's Common
Stock as a Director and options for 3,787,560 shares of the Company's
Common Stock in exchange for transfer of patents and rights to existing
patent concepts. Dr. Swor was granted Non Incentive Stock Options under
the 1999 Revised ESOP.
(4) In addition to the options granted to Mr. Newman for 63, 126 shares of
the Company's Common Stock as a Director of the Company, options to
purchase up to 315,630 shares of the Company's Common Stock were granted
to Jenex Financial Services, Inc., a company of which Mr. Newman is the
principal. Jenex is a financial service company which was issued the
options under the Company's 1994 CSOP.
(5) Mr. DeCesare resigned as director on May 4, 1999 due to personal
considerations.
(6) Each of these persons received their options as a bonus; Mr. Clark's as
an additional incentive to join the Company as its CEO and Mr. Lawrence
in consideration of outstanding services to the Company for the prior
year. Although the options granted to Mr. Clark Aand Mr. Lawrence were
exercisable at $1.75 per share, the Board of Directors on January 20,
1999 voted to reduce the exercise price to $1.00. Since the change was
made after December 31, 1998, the original exercise price was used in
the financial statements for purposes of determining weighted
92
<PAGE>
averages. In addition, the Board of Director at the January 1999 meeting
increased the term of Mr. Clark's options from one (1) to seven (7)
years.
(7) Dr. Saye received 300,000 issued on November 20, 1998. Dr. Saye receives
additional 100,000 options per year on a monthly basis. Accordingly,
8,333 options are attributable for the each month from December 1998
through September 1999. The exercise price for the options is $1.00 for
year one, $1.50 for year two, $2.00 for year three and $2.50 for years 4
through 7.
Consultant Stock Option Plans
On July 21, 1994, the Board of Directors also adopted a Consultant Stock
Option Plan which is available to certain consultants who provide services to
the Company ("CSOP"). Pursuant to the CSOP, consultants are given the
opportunity to purchase a designated number of shares of the Company's common
stock at a pre-set flat rate. The options are granted for a period of seven (7)
years and are not transferable except by will or laws of descent and
distribution. The options may not be exercised unless the Company has filed an
effective registration statement on Form S-8 relating to the shares underlying
the option. In the event the consultant's services are terminated, such
consultant has two (2) months from the date of termination in which to exercise
and in the case of death, the estate has the lesser of (i) three (3) years from
the date of death or (ii) five (5) years from the option issuance date in which
to exercise. In the case of the capital restructure of the Company, the options
are effective as if exercised prior to the capital restructuring event. There
are no yearly limitation on the amount of options which may be exercised by
consultants.
In January, 1998, the Board of Directors revised the term of the CSOP
("1998 Revised CSOP"). Under the revised plan, the term is now determined by the
Stock Option Committee. The 1998 CSOP requires that the options are not
exercisable for a period of two (2) years from issuance
In January, 1999, the Board of Directors adopted the 1999 Revised ESOP
which covers consultants and advisors to the Company.
Pursuant to the CSOP, the Company has granted options to purchase
346,115 shares of the Company's Common Stock representing proceeds of $110,700
to the Company under the 1994 CSOP, options to purchase 129,000 shares of the
Company's Common Stock representing proceeds of $114,500 to the Company under
the 1998 Revised CSOP and 278,000 shares of the Company's Common Stock
representing proceeds of $278,000 under the 1999 Revised ESOP to date as
follows:
<TABLE>
Consultant/ Date Option No. of Shares Exercise Term
Services Rendered Granted subject to Exercise Price Years
1994 CSOP(1)(2)
<S> <C> <C> <C> <C>
Danielle Chevalier 07/21/94 3,156 $.317 7
For marketing assistance
at conventions
</TABLE>
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<PAGE>
<TABLE>
<S> <C> <C> <C> <C>
Donna Haiduven 07/21/94 15,782 $.317 7
For medical advisory and
clinical studies
Jenex Financial Services
Inc. (3) 07/21/94 315,630 $.317 7
For financial advisory and
corporate financing
consulting services
Leann Swor 07/21/94 6,313 $.317 7
For marketing assistance
at conventions
Loren Schuman 07/21/94 4,734 $.480 7
For marketing consulting
services
Bruce Cohen 01/24/95 500 $.90 7
Performed business
valuations of acquisition
candidates
1998 Revised CSOP (2)
Danielle Chevalier 01/01/98 2,000 $.50 7
For marketing assistance
at conventions
Leann Swor 01/01/98 2,000 $.050 7
For marketing assistance
at conventions
Stacy Quaid (4) 01/01/98 50,000 $.50 7
For assistance in
becoming a reporting
company
Mike Williams (4) 08/03/98 50,000 $1.00 7
As a signing bonus
T.T. Communications 10/15/98 25,000 $1.50 7
For investor relations
services
</TABLE>
94
<PAGE>
<TABLE>
1999 Revised ESOP (2)
<S> <C> <C> <C> <C>
David Collins (5) 01/01/99 10,000 $1.00 10
For financial consulting
services
Mike Williams (6) 1/01/99 5,000 $1.00 10
As a performance bonus
Mike Williams (6) 1/08/99 50,000 $1.00 10
As a performance bonus
Leann Lafko-Spofford (6) 1/01/99 5,000 $1.00 10
As a performance bonus
Leann Lafko-Spofford (6) 1/08/99 50,000 $1.00 10
As a performance bonus
Stacy Quaid (6) 1/01/99 3,500 $1.00 10
As a performance bonus
Stacy Quaid (6) 1/08/99 21,500 $1.00 10
As a performance bonus
Eric Hill (6) 1/01/99 3,000 $1.00 10
As a performance bonus
Eric Hill (6) 1/08/99 25,000 $1.00 10
As a performance bonus
Scott Heap, Ad-Vantagenet 01/8/99 20,000 $1.00 10
For OASiS development
services
Ray Villares, Ad-Vantagenet 01/8/99 20,000 $1.00 10
For OASiS development
services
David Collins (5) 01/19/99 65,000 $1.00 10
For financial consulting
services
- ----------------------------------------------------------------------------------------------
</TABLE>
95
<PAGE>
(1) The options granted under the 1994 CSOP have been adjusted to reflect
the new conversion rate in accordance with the capital restructuring
provision which came into effect when Surgical Safety Products, Inc. of
Florida merged into Sheffeld Acres, Inc., the surviving New York
corporation.
(2) The Company relied upon Section 4(2) of the Act and Section 517.061(11)
of the Florida Code for the grant of these options.
(3) These options were granted to Jenex in exchange for certain financial
services provided to the Company. Mr. Newman, a Director of the Company,
is the principal of Jenex. Mr. Newman is deemed the beneficial owner of
these options.
(4) Each of these persons received their options as a bonus; Ms. Quaid in
consideration of outstanding services to the Company for the prior year
in assisting with the Company's registration as a reporting company and
Mr. Williams as an additional incentive to join the Company as the Sales
Manager. Although the options granted to Mr. Williams were exercisable
at $1.75 per share, the Board of Directors on January 20, 1999 voted to
reduce the exercise price to $1.00. Since the change was made after
December 31, 1998, the original exercise price was used in the financial
statements for purposes of determining weighted averages.
(5) David Collins received these options as a consultant to the Company
prior to his election to the Board of Directors on January 20, 1999.
(6) Each of these persons is covered by the Staff agreement and is treated
as a co-employee; however, for purposes of qualification under the 1999
Revised ESOP, such person has been treated as a consultant and advisor
to the Company who qualifies for non-incentive stock options.
Compensation of Directors
The Company has no standard arrangements for compensating the directors
of the Company for their attendance at meetings of the Board of Directors.
Item 7. Certain Relationships and Related Transactions:
On June 1, 1992, the Company issued 11,300 shares of the Company's
restricted stock to Dr. Swor and 2,000 shares to Mrs. Swor (of which Dr. Swor is
deemed the beneficial owner) each in exchange for services rendered to Surgical
valued at a total of $1,400. Following the merger with Sheffeld Acres, Inc.,
these shares were converted into 4,197,879 shares in the restructured company.
In July 1996, Dr. Swor received options to purchase 63,126 of the Company's
Common Stock as a Director and options to purchase 3,787,560 shares of the
Company's Common Stock in exchange for transfer of patents and rights to
existing patent concepts. In 1996, Dr. Swor received 478,630 shares of
restricted stock as payment of debt and related interest on loans which Dr. Swor
made to the Company totaling $239,315. In 1996, Dr. Swor gifted 816,619 of
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<PAGE>
his shares to James D. Stuart. In September, 1996 Savannah Leasing purchased the
Company's executive office building at 2018 Oak Terrace with cash from Dr. Swor
and 50,000 shares of his stock which were valued at $0.50 per share. These
shares were transferred to the third party seller. At December 31, 1997, the
Company was indebted to Dr. Swor in the amount of $197,720. In addition, the
Company was indebted to Savannah Leasing, a company owned by Dr. and Mrs. Swor.
The amount owed at December 31, 1997 was $36,000. Interest on the notes was
10.0%. At December 31, 1997, interest payable on these loans totaled $17,667.
Out of the proceeds of the sale of the Company's Common Stock during the period
of March 1998 through June 1998, the Company made repayment of principal and
interest on the 1997 indebtedness. During fiscal 1998, Dr. Swor loaned the
Company an additional $23,000. The balance of these notes payable was repaid
during fiscal 1998 and at December 31, 1998, there were no amounts due to Dr.
Swor. Interest expense relating to these notes amount to $9,882 and $15,314 for
the years ended December 31, 1998 and 1997 respectively. The Company has a line
of credit in the amount of $100,000 which expires in May 2017 and is guaranteed
by Dr. Swor and his wife. In fiscal 1999, the line of credit has been used to
fund operations on a short term basis and $20,000 is currently outstanding. Dr.
Swor has a year to year employment contract with the Company.
On June 1, 1992, the Company issued 1,500 shares of restricted stock to
David Swor for which it received $15,000. Following the merger with Sheffeld
Acres, Inc., these shares were converted into 473,445 shares in the restructured
company.
On November 5, 1992, the Company issued 120 shares of the Company's
restricted stock to Sam Norton for which it received $6,000. On March 1, 1993,
the Company issued 34 shares of the Company's restricted stock to Sam Norton for
which it received $2,000. Following the merger with Sheffeld Acres, Inc., these
shares were converted into 48,607. In 1996, the Company issued 4,793 shares of
the Company's restricted stock to Mr. Norton as payment for legal services
valued at $4,793.
On March 1, 1993, the Company issued 100 shares of the Company's
restricted stock to James D. Stuart and David Stuart jointly for which it
received $6,000. On May 9, 1993, the Company issued 100 shares of the Company's
restricted stock to Mr. Stuart in exchange for services rendered valued at par.
Following the merger with Sheffeld Acres, Inc., each 100 shares was converted to
31,563 for a total of 63,126 shares. In 1996, Mr. Stuart received 816,619 shares
of restricted stock from Dr. Swor as a gift.
On March 1, 1993, the Company issued 30 shares of the Company's
restricted stock to Tom DeCesare (then a Director), in exchange for services
rendered valued at par. Following the merger with Sheffeld Acres, Inc., these
shares were converted into 9,469.
On July 21, 1994, the Board of Directors adopted the 1994 ESOP and
awarded options to purchase the post-merger equivalent of 63,126 shares of the
Company's Common Stock to each of the Company's six (6) directors at an exercise
price of $.317. There was no value attached to the grant of such options. At the
same time, the Company awarded Dr. Swor options to purchase 3,787,560 shares of
the Company's Common Stock at an exercise price of $.317 in exchange for the
transfer of certain patents and rights to previously patented concepts to the
97
<PAGE>
Company, which patents and rights were valued at approximately $1,200,000.
On July 21, 1994, the Board of Directors also adopted the 1994 CSOP
under which it awarded options to purchase the post-merger equivalent of a total
of 346,115 shares of the Company's Common Stock. These options were granted to
consultants in consideration of services valued; however, there was no value
attached to the grant of such options.
On December 8, 1997, the Company acquired all of the assets of Endex
Systems, Inc., d/b/a InterActive PIE ("Endex"), a Florida corporation. The
assets of Endex were valued at approximately $14,000 for which the Company
issued 250,000 shares of restricted common stock. Endex was a medical multimedia
software company, experienced in computer graphics related to the medical
industry. The acquisition was made to implement the Company's Data Systems
Division's development of its surgical safety, touch-screen network known as
OASiS. The President and Chief Executive Officer ("CEO") of Endex, Donald
Lawrence, became the Vice President of Sales and Marketing of the Company. Mr.
Lawrence has a year to year employment contract with the Company. (See Part I,
Item 6. "Executive Compensation - Employee Contracts".) In consideration of
outstanding service to the Company in 1997, Mr. Lawrence was granted an option
to purchase 100,000 shares of the Company's Common Stock at a price of $1.75
under the 1998 Revised ESOP. In January 1999, the Board voted to reduce the
exercise price on the option to $1.00 per share. There was no value attached to
the grant of such options.
In March 1998, the Company entered into an agreement with Stockstowatch,
whereby Stockstowatch agreed to provide investor relations services as a media
consultant to the Company in exchange for issuance of 300,000 shares of the
Company's Common Stock valued at $45,000. On October 27, 1998, the SEC brought
an action against Stockstowatch and its principal, Steven A. King, for
injunctive and other relief to enjoin the defendants from touting and "scalping"
securities in violation of the anti-fraud and anti-touting provisions of the
federal securities laws (Securities and Exchange Commission v. Stockstowatch.com
and Steven A. King, United States District Court, Middle District of Florida,
Tampa Division, Case No. 98-2198-CIV-T-26B). The SEC alleges that since October
1997, the defendants touted the securities of at least five "microcap"
companies, one of which is Surgical, over the Internet through e-mail sent to
over 200,000 subscribers and on the defendant's website. The SEC has taken no
action against Surgical nor has it made any allegations that the Company
directly or indirectly acted improperly in this matter or was in any way
involved in the alleged violations.
In the Stockstowatch complaint, the SEC further alleges that almost
every stock touted by the defendants (1) the volume and/or price increased
sharply, sometimes as much as 200% shortly after the defendants' buy
recommendations; and (2) the defendants took advantage of the market interest
they created by selling into the inflated market large amounts of the stock they
received in consideration of their promotional services. Further the SEC alleges
that the defendants realized profits in excess of $1 million from sales of these
securities. The SEC alleges that the defendants failed to disclose that they had
received stock as compensation from the issuers of the securities they touted
and did not disclose that they intended to sell the stock in contravention of
their buy recommendations which is a fraudulent practice known as "scalping".
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The SEC is seeking permanent injunctive and equitable relief, including an
accounting, disgorgement of gains with pre-judgement interest and civil
penalties against each defendant. The SEC alleges, with reference to Surgical,
that Surgical entered into a consulting agreement with Stockstowatch on March
19, 1998 in which Stockstowatch agreed to profile Surgical in exchange for
300,000 free-trading shares of its Common Stock. On the date the contract was
executed, Surgical's Common Stock was trading at $.145. The shares were received
by Stockstowatch on April 9, 1998, on which date Surgical's Common Stock closed
at $.87. According to the Complaint, on April 21, 1998, Stockstowatch e-mailed
the Surgical Profile to its subscribers. In the profile, Stockstowatch stated
that Surgical "represents the most positive upside potential of any company we
have profiled." This profile continued: "[a]s a result of our own independent
due diligence, our industry insiders believe this stock will be a $20.00 stock
within 18 months." The SEC states in its complaint that there was a small print
disclaimer which accompanied the profile which stated that Stockstowatch had
entered into a compensation agreement valued at $43,500, but that such
disclaimer did not disclose that Stockstowatch received Surgical's Common Stock
and that it intended to sell the stock after the profile.
In March 1998, the Company issued 100,000 shares of the Company's Common
Stock valued at $15,000 to Mintmire & Associates in exchange for legal services.
In April 1998, the Company issued 2,500 shares of restricted stock to
Xavier Calderon in exchange for computer consulting services valued at $4,375.
On June 15, 1998, the Company engaged Frank M. Clark to act as the
President of the Company. As such he received 50,000 shares of the Company's
Common Stock as a signing bonus valued at $50,000 and options to purchase up to
200,000 shares of the Company's Common Stock at a price of $1.75 per share under
the 1998 Revised ESOP. In January 1999, the Board voted to reduce the exercise
price on the option to $1.00 per share and to increase the exercise term. Mr.
Clark's shares were valued at $50,000 and there was no value attached to the
grant of his options. Mr. Clark has a year to year employment contract with the
Company.
In October 1998, the Company entered into an agreement with T.T.
Communications, Inc. to provide investor relations services for the Company.
T.T. Communications, Inc.'s function is to contact investment and media people
throughout the United States and to participate in the preparation of
communication packages including annual and quarterly reports, news and press
releases and publicity and corporate profiles. The initial agreement was for a
period of three (3) months for which T.T. Communications, Inc. receives $2,000
per month and reimbursement of out of pocket expenses. In addition, T.T.
Communications, Inc. was granted options to purchase 25,000 shares of the
Company's Common Stock at an exercise price of $1.50. In the event T. T.
Communications, Inc. introduces the Company to a suitable financing source, they
will be compensated by a cash finder's fee equal to 1.5% on the initial
financing and .75% on any subsequent financing. The agreement is cancelable by
either party with 30 days written notice. The agreement continues on a month to
month basis.
In November 1998, the Company entered into a seven (7) year collaborative
agreement with Dr. William B. Saye, the Medical Director and CEO of the Advanced
Laparoscopy Training Center in Marietta, Georgia ("ALTC") under which the
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Company acquired the "digital rights" of ALTC and the resulting amalgam as it
relates to surgical education and marketing rights to the ALTC database. Under
this agreement, Dr. Saye became a member of the Company's Board of Directors and
agreed to act as the Medical Director of ALTC VirtualLabs. Dr. Saye is to be
compensated for travel expenses and will be paid an honorarium of $2,500 per day
when his services are requested by Surgical. In addition, Dr. Saye was awarded
stock options to purchase up to 1,000,000 shares of the Company's Common Stock
over the period, 300,000 of which were issued upon the execution of the
agreement, and the balance of which are issuable monthly. The intention of the
agreement is that any educational activity involving ALTC or Dr. Saye on the
Internet or other digital presence would be the property of and under the
control of Surgical.
Pursuant to a settlement agreement dated December 1, 1998 with
MediaWorks, a former consultant to the Company, relative to the litigation
between the parties, the Company agreed to make two types of payments in
exchange for the dismissal of the action with prejudice: (1) to pay MediaWorks
$50,000 and (2) to issue 40,000 shares of Rule 144 stock. (See Part II, Item 2.
"Legal Proceedings."; and Part II, Item 4. "Recent Sales of Unregistered
Securities.")
In April 1999 the Company commenced a self-directed private placement
offering of its restricted Common Stock and warrants for which it received gross
proceeds of $475,000, for which Directors Sam Norton, David Swor and Dr. Saye
each purchased 50,000 shares and were granted warrants to purchase 25, 000
shares on the same terms as outside investors. Pursuant to such offering, a
total of 950,000 shares of restricted Common Stock were issued and warrants to
purchase 475,000 shares of the Company's restricted Common Stock at an exercise
price of $1.00 exercisable within five (5) years were granted. (See Part II,
Item 4. "Recent Sales of Unregistered Securities.")
In April 1999, the Company entered into an agreement with KJS to provide
consulting services. KJS agreed to accept 7,000 shares of the Company's common
stock valued at the current bid price of $.50 as part of an initial retainer
with the balance of $1,500 to be paid in cash at such time as KJS introduces the
Company to five institutional funding sources. (See Part II, Item 4. "Recent
Sales of Unregistered Securities.")
In April 1999, the Company issued 2,000 shares each to David Utz and
Robert Wingate, two consultants of the Company in lieu of cash for services
relating to their production of a CD-Rom disc to be used to promote OASiS. Such
4000 shares were valued at $2,250 which was based upon the closing price for the
shares on the dates the services were due to be paid. Such offering was made in
reliance on Section 4(2) of the Act and Rule 506. (See Part II, Item 4. "Recent
Sales of Unregistered Securities.")
In May 1999, the Company entered into an agreement with Ten Peaks to pay
a finder's fee for successfully securing specifically defined financing for the
Company. Ten Peaks agreed to accept 6,000 shares of the Company's common stock
in lieu of a retainer provided such stock had a fair market value as reported on
Bloomberg, LLP on the date of execution of not less than $.66. Although
obligated to issue such shares, the Company has decided not to deliver such
shares since it believes that Ten Peaks did not perform as required. The
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offering was made pursuant to Section 4(2) of the Act and Rule 506. (See Part
II, Item 4. "Recent Sales of Unregistered Securities.")
In May 1999, the Company issued a total of 46,000 shares of its
restricted Common Stock to Frank Clark and David Collins and 11,400 shares of
its restricted Common Stock to three (3) other employees in lieu of salary and
consulting fees due from the Company to each of them, which salary and
consulting fees were valued at $31,222 in the case of Mr. Clark and Mr. Collins
and at $7,832 in the case of the three (3) employees. The Company issued such
shares pursuant to Section 4(2) of the Act and Rule 506. (See Part II, Item 4.
"Recent Sales of Unregistered Securities.")
Item 8. Description of Securities:
Description of Capital Stock
The Company's authorized capital stock consists of 20,000,000 shares of
Common Stock, $.001 par value per share and authorized the Board of Directors to
issue shares of Preferred Stock, the aggregate number of which, the class or
series of classes, whether a class is with or without par value, the relative
rights and preferences and the limitations, if any, as it may determine.
Although the Board of Directors is authorized to issue shares of Preferred Stock
and to set the par value and other rights thereon, none has been issued to date.
Description of Common Stock
All shares of Common Stock have equal voting rights and, when validly
issued and outstanding, are entitled to one vote per share in all matters to be
voted upon by shareholders. The shares of Common Stock have no preemptive,
subscription, conversion or redemption rights and may be issued only as
fully-paid and non-assessable shares. Cumulative voting in the election of
directors is not permitted; which means that the holders of a majority of the
issued and outstanding shares of Common Stock represented at any meeting at
which a quorum is present will be able to elect the entire Board of Directors if
they so choose and, in such event, the holders of the remaining shares of Common
Stock will not be able to elect any directors. In the event of liquidation of
the Company, each shareholder is entitled to receive a proportionate share of
the Company's assets available for distribution to shareholders after the
payment of liabilities and after distribution in full of preferential amounts,
if any, to be distributed to holders of the Preferred Stock. All shares of the
Company's Common Stock issued and outstanding are fully-paid and nonassessable.
Dividend Policy
Holders of shares of Common Stock are entitled to share pro rata in
dividends and distribution with respect to the Common Stock when, as and if
declared by the Board of Directors out of funds legally available therefore,
after requirements with respect to preferential dividends on, and other matters
relating to, the Preferred Stock, if any, have been met. The Company has not
paid any dividends on its Common Stock and intends to retain earnings, if any,
to finance the development and expansion of its business. Future dividend policy
is subject to the discretion of the Board of Directors and will depend upon a
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number of factors, including future earnings, capital requirements and the
financial condition of the Company.
Description of Preferred Stock
Shares of Preferred Stock may be issued from time to time in one or more
series as may be determined by the Board of Directors. The voting powers and
preferences, the relative rights of each such series and the qualifications,
limitations and restrictions thereof shall be established by the Board of
Directors, except that no holder of Preferred Stock shall have preemptive
rights. The Company has not issued any shares of Preferred Stock to date. The
Board of Directors has no plan to issue any shares of Preferred Stock for the
foreseeable future unless the issuance thereof shall be in the best interests of
the Company.
Transfer Agent and Registrar
The Transfer Agent and Registrar for the Company's Common Stock is
Signature Stock Transfer, Inc. which is located at Office in the Park, 14675
Midway Road, Suite 221, Dallas, Texas 75244, telephone (972) 788-4193, facsimile
(972) 788-4194.
PART II
Item 1. Market Price of and Dividends on the Registrant's Common Equity and
Other Shareholder Matters.
(a) Market Information.
The Common Stock of the Company is quoted on the OTC Bulletin Board
under the symbol "SURG". The high and low bid information for each quarter for
the years ending December 31, 1996, December 31, 1997 and December 31, 1998 and
for the first two quarters of 1999 are as follows:
<TABLE>
Quarter High Bid Low Bid Average Bid
<S> <C> <C> <C>
First Quarter 1996 1/4 3/16 .218
Second Quarter 1996 3/4 1/8 .445
Third Quarter 1996 1/4 1/8 .177
Fourth Quarter 1996 1/4 1/8 .176
First Quarter 1997 1/4 3/32 .135
Second Quarter 1997 1/4 3/32 .106
Third Quarter 1997 3/8 1/8 .183
Fourth Quarter 1997 9/64 1/8 .132
First Quarter 1998 29/32 9/64 .215
Second Quarter 1998 3-1/8 11/16 2.299
Third Quarter 1998 2-9/64 1-9/64 1.646
Fourth Quarter 1998 31/32 17/32 .750
</TABLE>
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<TABLE>
<S> <C> <C> <C>
First Quarter 1999 13/16 1/3 .57
Second Quarter 1999 1-7/8 7/16 1.156
</TABLE>
The quotations may reflect inter-dealer prices, without retail mark-up,
mark-down or commissions and may not reflect actual transactions.
(b) Holders.
As of September 30, 1999, the Company has 1,090 shareholders of record of
its 11,811,373 outstanding shares of Common Stock (6,000 of which are
attributable to the Ten Peaks agreement which the Company, although obligated to
pay, is holding back for what it considers non-performance), 7,078,329 of which
are restricted Rule 144 shares and 4,720,044 of which are free-trading. As of
the date hereof, the Company has outstanding options to purchase 6,107,261
shares of Common Stock (without regard to the additional options to Dr. Saye
which accrue after September 30, 1999 at the rate of 8,333 per month). Of the
Rule 144 shares, 5,391,933 shares have been held by affiliates of the Company
for more than one (1) year.
(c) Dividends.
The Company has never paid or declared any dividends on its Common Stock
and does not anticipate paying cash dividends in the foreseeable future.
There are no limitations on the ability of the Company to declare
dividends; except those set forth in New York Statute 510 which prohibits
dividends if the Company is insolvent or would be made insolvent by the
declaration of a dividend and all dividends must be made out of surplus only.
Item 2. Legal Proceedings.
In August 5, 1997, the Company entered into an agreement with Gambit, Inc.,
d/b/a MediaWorks ("MediaWorks") as a producer of record of the Surgical Safety
Network, now known as OASiS. Pursuant to the agreement, MediaWorks estimated the
cost of its work on the project at no more than $217,000, a portion of which was
to be paid over a three (3) month period against billable hours, with the
balance less $60,000 payable after the third payment at an amount equal to not
less than fifty percent (50%) of Surgical's revenue stream after operating
expenses, sales, marketing and hardware equipment costs for all installations
after the SMH contract. Subject to on-time delivery of the work to be performed,
Surgical agreed to pay, as a performance bonus, unrestricted Common Stock equal
to twenty five percent (25%) of the total cost of the SMH project, with the
number of shares determined by the value of the Company's Common Stock at the
time of issuance. Further, it was understood that all material and production
rights, including source codes and related documentation, upon completion of the
presentation and payment of the outstanding balance, would become the property
of Surgical.
On July 13, 1998, the Company was served with a Summons and Complaint for
an action brought against it by MediaWorks. (Gambit, Inc. d/b/a MediaWorks v.
Surgical Safety Products, Inc., Circuit Court of the Twelfth Judicial Circuit,
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Sarasota County, Florida, Case No. 98-4022-CA-01) The Complaint sets forth three
(3) causes of action: an action for specific performance demanding that Surgical
issue 289,720 shares unrestricted shares based upon the twenty five percent
(25%) of the cost of the SMH installation divided by the share price on February
20, 1998 of the Company's Common Stock; in the alternative seeking damages in
the amount of $732,993 which was the number of shares determined by the formula
multiplied by the share price on July 1, 1998 of the Company's Common Stock; and
seeking an accounting based upon a dissolution of the partnership which
MediaWorks alleges was formed with Surgical.
On or about July 31, 1998, the Company filed Motions to Dismiss and for
a More Definite Statement of Count II of the Company. The purpose of the Motion
for a More Definite Statement was so that the plaintiff will clarify how they
contended they are entitled to the stock bonus so that Surgical could frame its
defense and show defects, delays and deficiencies in the performance by
MediaWorks. Surgical believed that MediaWorks failed to perform on the contract
since the OASiS version 1 software had problems and that MediaWorks failed to
meet performance and delivery requirements as agreed. Therefore, the Company
believed that it had just and meritorious defenses and counterclaims to this
action. Pursuant to a settlement agreement dated December 1, 1998, the Company
agreed to make two types of payments in exchange for dismissal of the action
with prejudice: (1) to pay MediaWorks $50,000 and (2) to issue 40,000 shares of
Rule 144 stock. See Part II, Item 4. "Recent Sales of Unregistered Securities."
MediaWorks was permitted to remove its software from SMH and agreed to return a
computer to the Company. The suit was dismissed with prejudice and each party
paid their own costs of the case.
The Company knows of no other legal proceedings to which it is a party
or to which any of its property is the subject which are pending, threatened or
contemplated or any unsatisfied judgments against the Company.
Item 3. Changes in and Disagreements with Accountants:
The Company has used the accounting firm of Kerkering, Barberio & Co.,
P.A. since 1993. There address is 1858 Ringling Boulevard, Sarasota, Florida
34236. This firm began providing audited financial statements for the Company in
1994. There has been no change in the Company's independent accountant during
the period commencing with the Company's retention of Kerkering, Barberio & Co.,
P.A. through the date hereof.
Item 4. Recent Sales of Unregistered Securities:
On June 1, 1992, the Company issued 11,300 shares of the Company's
restricted stock to Dr. Swor and 2,000 shares to Mrs. Swor (of which Dr. Swor is
deemed the beneficial owner) each in exchange for services rendered to Surgical
valued at a total of $1,400. Following the merger with Sheffeld Acres, Inc.,
these shares were converted into 4,197,879 shares in the restructured company.
In July 1994, Dr. Swor received options to purchase 3,850,686 shares of the
Company's Common Stock at $0.317 per share, options to purchase 63,126 shares as
a Director and options to purchase 3,787,560 shares in exchange for transfer of
all rights in four (4) patents and other patentable ideas. In 1996, Dr. Swor
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received 478,630 shares of restricted stock as payment of debt and related
interest on loans which Dr. Swor made to the Company totaling $239,315. In 1996,
Dr. Swor gifted 816,619 of his shares to James D. Stuart. In September, 1996
Savannah Leasing purchased the Company's executive office building at 2018 Oak
Terrace with cash from Dr. Swor and 50,000 shares of his stock which were valued
at $0.50 per share. These shares were transferred by Savannah Leasing to the
third party seller. In each case, Dr. Swor relied upon Section 4(1) of the Act
which exempts transactions by a person other than the issuer, an underwriter or
a dealer.
On June 1, 1992, the Company issued 1,500 shares of restricted stock to
David Swor for which it received $15,000. Following the merger with Sheffeld
Acres, Inc., these shares were converted into 473,445 shares in the restructured
company.
On November 5, 1992, the Company issued 120 shares of the Company's
restricted stock to Sam Norton for which it received $6,000. On March 1, 1993,
the Company issued 34 shares of the Company's restricted stock to Sam Norton for
which it received $2,000. Following the merger with Sheffeld Acres, Inc., these
shares were converted into 48,607. In 1996, the Company issued 4,793 shares of
the Company's restricted stock to Mr. Norton as payment for legal services
valued at $4,793.
On March 1, 1993, the Company issued 100 shares of the Company's
restricted stock to James D. Stuart and David Stuart jointly for which it
received $6,000. On May 9, 1993, the Company issued 100 shares of the Company's
restricted stock to Mr. Stuart in exchange for services rendered valued at par.
Following the merger with Sheffeld Acres, Inc., each 100 shares was converted
into 31,563 shares for a total of 63,126 shares. In 1996, Mr. Stuart received
816,619 shares of restricted stock from Dr. Swor as a gift.
For the transactions with Dr. Swor (except for the gifts to Mr. Stuart
and Savannah Leasing), Mrs. Swor, David Swor, Mr. Norton, James and David Stuart
and Mr. DeCesare, then a Director, the Company relied upon the exemption under
Section 4(2) of the Act and Section 517.061(11) of the Florida Code. Such
reliance upon Section 4(2) of the Act was based upon the fact that (i) the
issuance of the shares did not involve a public offering and (ii) each of the
parties is a sophisticated purchaser and had full access to the information on
the Company necessary to make an informed investment decision by virtue of his
or her position as an officer and director of the Company and or as an a party
related to an officer or director. The basis of reliance upon Section
517.061(11) of the Florida Code were (i) sales of the shares of Common Stock
were not made to more than 35 persons; (ii) neither the offer nor the sale of
any of the shares was accomplished by the publication of any advertisement;
(iii) all purchasers either had a preexisting personal or business relationship
with one or more of the executive officers of Surgical or, by reason of their
business or financial experience, could be reasonably assumed to have the
capacity to protect their own interests in connection with the transaction; (iv)
each purchaser represented that he was purchasing for his own account and not
with a view to or for sale in connection with any distribution of the shares;
and (v) prior to sale, each purchaser had reasonable access to or was furnished
all material books and records of the Company, all material contracts and
documents relating to the proposed transaction, and had an opportunity to
question the executive officers of the Company. Dr. Swor relied upon Rule 144
promulgated under the Act for his gifts to Mr. Stuart and Savannah Leasing.
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On May 30, 1995, the Company completed the preparation of a
self-directed private placement memorandum offering shares of the Company's
Common Stock and Warrants. This offering was conducted pursuant to Section 4(2)
of the Act and Rule 506 promulgated under Regulation D of the Act to not more
than thirty five (35) non accredited investors, Section 49:3-50(b)(9) of the New
Jersey Code to not more than 10 New Jersey investors and Section 517.061(11) of
the Florida Code. The offering was amended on October 30, 1995. The basis for
reliance upon the Section 4(2) exemption in connection with this transaction was
(i) the sale of the shares of Common Stock did not constitute a public offering
and (ii) the investors were sophisticated investors who had access to
information on the Company necessary to make an informed investment decision by
virtue of the disclosure in the offering memorandum and its amendment and the
availability to ask questions of management of the Company. Although required by
Regulation D under which Rule 506 offerings are made within fifteen (15) days of
the first sale, the Company did not file a Form D with the SEC until September
1999. In addition, one sale was made in the State of New York for which no
registration was made and no exemption was available. The basis for reliance
upon Section 49:3-50(b)(9) of the New Jersey Code was (i) there were not more
than 10 purchasers in the State of New Jersey; (ii) no commissions were paid for
the sales in New Jersey; (iii) there was no form of general solicitation; and
(iv) the purchaser acquired the shares with an investment purpose. The basis of
reliance upon Section 517.061(11) of the Florida Code were (i) sales of the
shares of Common Stock were not made to more than 35 persons; (ii) neither the
offer nor the sale of any of the shares was accomplished by the publication of
any advertisement; (iii) all purchasers either had a preexisting personal or
business relationship with one or more of the executive officers of Surgical or,
by reason of their business or financial experience, could be reasonably assumed
to have the capacity to protect their own interests in connection with the
transaction; (iv) each purchaser represented that he was purchasing for his own
account and not with a view to or for sale in connection with any distribution
of the shares; and (v) prior to sale, each purchaser had reasonable access to or
was furnished all material books and records of the Company, all material
contracts and documents relating to the proposed transaction, and had an
opportunity to question the executive officers of the Company. Initially, the
offering required a minimum investment of $5,000 in exchange for which an
investor would receive 5,000 shares of Common Stock, $.001 par value per share
and three-year warrants to purchase 2,500 shares of the Company's Common Stock
at an exercise price of $1.50. Pursuant to this offering, the Company received
gross proceeds in the amount of $37,500, $5,000 of which was subsequently
refunded. This refund was made because certain paperwork and signatures were not
properly executed. By agreement with the investors, in lieu of the unit
arrangement, the investors each acquired shares at $.50 per share. A total of
65,000 shares of the Company's Common Stock were issued pursuant to this
offering.
On December 8, 1997, the Company acquired all of the assets of Endex
which were valued at approximately $14,000 for which the Company issued 250,000
shares of restricted common stock. Endex was a medical multimedia software
company, experienced in computer graphics related to the medical industry. The
acquisition was made to implement the Company's Data Systems Division's
development of its surgical safety, touch-screen network known as OASiS. The
President and Chief Executive Officer ("CEO") of Endex, Donald Lawrence, became
the Vice President of Sales and Marketing of the Company. The Company relied
upon the exemption under Section 4(2) of the Act and Section 517.061(11) of the
Florida Code. Such reliance upon Section 4(2) of the Act was based upon the fact
that (i) the issuance of the shares did not involve a public offering and (ii)
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Endex is a sophisticated purchaser and had full access to the information on the
Company necessary to make an informed investment decision by virtue of his due
diligence during the negotiating process and his position as an officer of the
Company. The basis of reliance upon Section 517.061(11) of the Florida Code
were(i) sales of the shares of Common Stock were not made to more than 35
persons; (ii) neither the offer nor the sale of any of the shares was
accomplished by the publication of any advertisement; (iii) all purchasers
either had a preexisting personal or business relationship with one or more of
the executive officers of Surgical or, by reason of their business or financial
experience, could be reasonably assumed to have the capacity to protect their
own interests in connection with the transaction; (iv) each purchaser
represented that he was purchasing for his own account and not with a view to or
for sale in connection with any distribution of the shares; and (v) prior to
sale, each purchaser had reasonable access to or was furnished all material
books and records of the Company, all material contracts and documents relating
to the proposed transaction, and had an opportunity to question the executive
officers of the Company.
From March through June 1998, the Company received gross proceeds in the
amount of $999,000 from the sale of a total of 920,000 shares of Common Stock in
four (4) offerings . The Company undertook its first offering of 400,000 shares
of Common Stock pursuant to Rule 504 on March 1, 1998, exchanging 300,000 shares
with an independent consultant (Stockstowatch) for the Company and 100,000
shares to its legal advisor in exchange for services; its second offering of
400,000 shares of Common Stock pursuant to Rule 504 on April 1, 1998 upon the
exercise of an option granted pursuant to a Stock Option Agreement; its third
offering of 60,000 shares of Common Stock pursuant to Rule 504 on June 8, 1998;
and its fourth offering of 60,000 shares of Common Stock pursuant to Rule 504 on
June 18, 1998. The SEC has brought an action against Stockstowatch alleging that
they violated anti-fraud and anti-touting provisions of the federal securities
laws with reference to the shares it received for services. While no offering
memorandum was used in connections with these offerings, the business plan of
the Company, which was disclosed to each prospective investor, was for the
provision of product development, sales and services for the medical industry.
The Company claimed the exemption from registration in connection with each of
these offerings under Section 3(b) of the Act and Rule 504 of Regulation D
promulgated thereunder and Section 517.061(11) of the Florida Code.
The facts relied upon by the Company to make the federal exemption
available include the following: (i) the aggregate offering price of the
offering of the shares of Common Stock did not exceed $1,000,000, less the
aggregate offering price for all securities sold within the twelve months before
the start of and during the offering of shares in reliance on any exemption
under Section 3(b) of, or in violation of Section 5(a) of the Act; (ii) no
general solicitation or advertising was conducted by the Company in connection
with the offering of any of the shares; (iii) the fact the Company has not been
since its inception (a) subject to the reporting requirements of Section 13 or
15(d) of the Securities Act of 1934, as amended, (b) an "investment company"
within the meaning of the Investment Company Act of 1940, as amended, or (c) a
development stage company that either has no specific business plan or purpose
or has indicated that its business plan is to engage in a merger or acquisition
with an unidentified company or companies or other entity or person; and (iv)
the required number of manually executed originals and true copies of Form D
were duly and timely filed with the SEC.
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The facts relied upon to make the Florida exemption available include
the following: (i) sales of the shares of Common Stock were not made to more
than 35 persons; (ii) neither the offer nor the sale of any of the shares was
accomplished by the publication of any advertisement; (iii) all purchasers
either had a preexisting personal or business relationship with one or more of
the executive officers of Surgical or, by reason of their business or financial
experience, could be reasonably assumed to have the capacity to protect their
own interests in connection with the transaction; (iv) each purchaser
represented that he was purchasing for his own account and not with a view to or
for sale in connection with any distribution of the shares; and (v) prior to
sale, each purchaser had reasonable access to or was furnished all material
books and records of the Company, all material contracts and documents relating
to the proposed transaction, and had an opportunity to question the executive
officers of the Company. Pursuant to Rule 3E-500.005, in offerings made under
Section 517.061(11) of the Florida Statutes, an offering memorandum is not
required; however each purchaser (or his representative) must be provided with
or given reasonable access to full and fair disclosure of material information.
An issuer is deemed to have satisfied this rule if such purchaser or his
representative has been given access to all material books and records of the
issuer; all material contracts and documents relating to the proposed
transaction; and an opportunity to question the appropriate executive officer.
In that regard, the Company supplied such information and was available for such
questioning.
In April 1998, the Company issued 2,500 shares of restricted stock to
Xavier Calderon in exchange for computer consulting services valued at $4,375.
The Company relied upon the exemption under Section 4(2) of the Act and Section
517.061(11) of the Florida Code. Such reliance on Section 4(2) of the Act was
based upon the fact that (i) the issuance of the shares did not involve a public
offering and (ii) M. Calderon is a sophisticated purchaser and had full access
to the information on the Company necessary to make an informed investment
decision by virtue of his position as a consultant of the Company. The facts
relied upon to make the Florida exemption available include the following: (i)
sales of the shares of Common Stock were not made to more than 35 persons; (ii)
neither the offer nor the sale of any of the shares was accomplished by the
publication of any advertisement; (iii) the purchasers either had a preexisting
personal or business relationship with one or more of the executive officers of
Surgical; (iv) the purchaser represented that he was purchasing for his own
account and not with a view to or for sale in connection with any distribution
of the shares; and (v) prior to sale, the purchaser had reasonable access to or
was furnished all material books and records of the Company, all material
contracts and documents relating to the proposed transaction, and had an
opportunity to question the executive officers of the Company.
On June 15, 1998, the Company engaged Frank M. Clark to act as the
President of the Company. As such he received 50,000 shares of the Company's
Common Stock as a signing bonus valued at $50,000 and options to purchase up to
200,000 shares of the Company's Common Stock at a price of $1.75 per share under
the 1998 Revised ESOP. For such issuance and grant, the Company relied upon the
exemption under Section 4(2) of the Act and Section 517.061(11) of the Florida
Code. Such reliance upon Section 4(2) of the Act was based upon the fact that
(i) the issuance of the shares did not involve a public offering and (ii) Mr.
Clark is a sophisticated purchaser and had full access to the information on the
Company necessary to make an informed investment decision by virtue of his due
diligence prior to becoming an officer and director of the Company. The facts
relied upon to make the Florida exemption available include the following: (i)
sales of the shares of Common Stock were not made to more than 35 persons; (ii)
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<PAGE>
neither the offer nor the sale of any of the shares was accomplished by the
publication of any advertisement; (iii) the purchasers had a preexisting
personal or business relationship with one or more of the executive officers of
the Company; (iv) the purchaser represented that he was purchasing for his own
account and not with a view to or for sale in connection with any distribution
of the shares; and (v) prior to sale, the purchaser had reasonable access to or
was furnished all material books and records of the Company, all material
contracts and documents relating to the proposed transaction, and had an
opportunity to question the executive officers of the Company.
In October 1998, the Company entered into an agreement with T.T.
Communications, Inc. to provide investor relations services for the Company.
T.T. Communications, Inc.'s function is to contact investment and media people
throughout the United States and to participate in the preparation of
communication packages including annual and quarterly reports, news and press
releases and publicity and corporate profiles. The initial agreement was for a
period of three (3) months for which T.T. Communications, Inc. receives $2,000
per month and reimbursement of out of pocket expenses. In addition, T.T.
Communications, Inc. was granted options to purchase 25,000 shares of the
Company's Common Stock at an exercise price of $1.50. In the event T. T.
Communications, Inc. introduces the Company to a suitable financing source, they
will be compensated by a cash finder's fee equal to 1.5% on the initial
financing and .75% on any subsequent financing. The agreement is cancelable by
either party with 30 days written notice. The agreement continues on a month to
month basis. The Company relied upon the exemption under Section 4(2) of the Act
and Section 109.13(k) of the Texas Code. Such reliance on Section 4(2) of the
Act was based upon the fact that (i) the issuance of the shares did not involve
a public offering and (ii) T.T Communications, Inc. is a sophisticated purchaser
and had full access to the information on the Company necessary to make an
informed investment decision by virtue of its position as a consultant of the
Company. The facts relied upon to make the Texas exemption available are that
Texas exempts from registration any offer or sale of securities offered or sold
in compliance with the Act and Rule 506 offerings under Regulation D.
In November 1998, the Company entered into a seven (7) year
collaborative agreement with Dr. William B. Saye, the Medical Director and CEO
of the Advanced Laparoscopy Training Center in Marietta, Georgia ("ALTC") under
which the Company acquired the "digital rights" of ALTC and the resulting
amalgam as it relates to surgical education and marketing rights to the ALTC
database. Under this agreement, Dr. Saye became a member of the Company's Board
of Directors and agreed to act as the Medical Director of ALTC VirtualLabs. Dr.
Saye is compensated for travel expenses and paid an honorarium of $2,500 per day
when his services are requested by Surgical. In addition, Dr. Saye was awarded
stock options to purchase up to 1,000,000 shares of the Company's Common Stock
over the period, options for 300,000 of which were issued upon the execution of
the agreement under the Company's 1998 Employee Stock Option Plan, and the
balance of which are issuable monthly. The Company issued these shares and
granted the options pursuant to Section 4(2) of the Act and Section 10-5-9 (13)
of the Georgia Code. Such reliance on Section 4(2) of the Act was based upon the
fact that (i) the issuance of the shares did not involve a public offering and
(ii) Dr. Saye is a sophisticated purchaser and had full access to the
information on the Company necessary to make an informed investment decision by
virtue of his position as a consultant of the Company. The facts relied upon to
make the Georgia exemption available include the following: is that (i) there
were 15 or less purchasers in the state in a 12-month period, (ii) there was
109
<PAGE>
no form of general solicitation or advertising, (iii) any certificate or other
document representing the security bears the Georgia restrictive legend, and
(iv) each investor confirmed in writing that they were purchasing with
investment intent. The basis for reliance upon Section 10-5-9(13) of the Georgia
Code in connection with this offering is that (i) there were 15 or less
purchasers in the state in a 12-month period, (ii) there was no form of general
solicitation or advertising, (iii) any certificate or other document
representing the security bears the Georgia restrictive legend, and (iv) each
investor confirmed in writing that they were purchasing with investment intent.
In December 1998, the Company settled all litigation with MediaWorks.
The 40,000 shares agreed as part of the settlement were issued on December 8,
1998. Such shares were valued at the average of the closing prices of Surgical's
shares for the dates between the settlement (December 1, 1998) and the issuance
(December 8, 1998) at $.76 per share for a total of $36,000. The Company relied
upon the exemption under Section 4(2) of the Act and Section 517.061(11) of the
Florida Code. Such reliance upon Section 4(2) of the Act was based upon the fact
that (i) the issuance of the shares did not involve a public offering and (ii)
MediaWorks is a sophisticated purchaser and had full access to the information
on the Company necessary to make an informed investment decision by virtue of
its position as a consultant to the Company. The facts relied upon to make the
Florida exemption available include the following: (i) sales of the shares of
Common Stock were not made to more than 35 persons; (ii) neither the offer nor
the sale of any of the shares was accomplished by the publication of any
advertisement; (iii) the purchasers had a preexisting personal or business
relationship with one or more of the executive officers of Surgical; (iv) the
purchaser represented that he was purchasing for his own account and not with a
view to or for sale in connection with any distribution of the shares; and (v)
prior to sale, the purchaser had reasonable access to or was furnished all
material books and records of the Company, all material contracts and documents
relating to the proposed transaction, and had an opportunity to question the
executive officers of the Company.
In April 1999 the Company commenced a self-directed private placement
offering of its restricted Common Stock and warrants for which it received gross
proceeds of $475,000. Pursuant to such offering, 950,000 shares of restricted
Common Stock were issued and warrants to purchase 475,000 shares of the
Company's restricted Common Stock at an exercise price of $1.00 exercisable
within five (5) years were granted. Three directors purchased shares under this
offering. The Company conducted this offering pursuant to Section 4(2) of the
Act and Rule 506 and Section 517.061(11) of the Florida Code; Section 10-5-9(13)
of the Georgia Code; Regulation 130.293 of the Illinois Code; Section 292.410(h)
of the Kentucky Code and Section 201.[70 P.S. 1.201] of the Pennsylvania Code.
No offering memorandum was used in connection with this offering. Rather
investors were provided with access to the Company's Registration Statement on
Form 10-SB, as amended, its Form 10-K and its Form 10Q for the 1st Quarter 1999,
all of which are filed with the Securities and Exchange Commission ("SEC"). The
Company filed a Form D with relation to this offering.
Such reliance upon Section 4(2) of the Act was based upon the fact that
(i) the issuance of the shares did not involve a public offering and (ii) the
investors were sophisticated purchasers and had full access to the information
on the Company necessary to make an informed investment decision by virtue of
the public filings under Form 10K and Form 10Q.
110
<PAGE>
The facts relied upon to make the Florida exemption available include
the following: (i) sales of the shares of Common Stock were not made to more
than 35 persons; (ii) neither the offer nor the sale of any of the shares was
accomplished by the publication of any advertisement; (iii) all purchasers
either had a preexisting personal or business relationship with one or more of
the executive officers of Surgical or, by reason of their business or financial
experience, could be reasonably assumed to have the capacity to protect their
own interests in connection with the transaction; (iv) each purchaser
represented that he was purchasing for his own account and not with a view to or
for sale in connection with any distribution of the shares; and (v) prior to
sale, each purchaser had reasonable access to or was furnished all material
books and records of the Company, all material contracts and documents relating
to the proposed transaction, and had an opportunity to question the executive
officers of the Company.
The basis for reliance upon Section 10-5-9(13) of the Georgia Code in
connection with this offering is that (i) there were 15 or less purchasers in
the state in a 12-month period, (ii) there was no form of general solicitation
or advertising, (iii) any certificate or other document representing the
security bears the Georgia restrictive legend, and (iv) each investor confirmed
in writing that they were purchasing with investment intent.
The basis for reliance upon Regulation 130.293 is that Illinois does not
require registration of federally exempted Rule 506 securities.
The basis for reliance upon Section 292.410(h) of the Kentucky Code in
connection with this offering is (i) neither the offer nor the sale of any of
the shares has been or will be accomplished by any form of general solicitation;
(ii) the Company has received or will receive a written representation from the
purchaser that he is acquiring the securities for his own investment and is
aware of any and all restrictions imposed on transferability and that the
certificates and warrants do and shall bear a restrictive legend; (iii) sales of
the shares of restricted Common Stock and warrants has been or will be made to
not more than fifteen (15) persons in Kentucky all of whom will be or are
accredited investors; and (iv) there are no commissions, finders fees or other
remuneration being paid in connection with the sales.
The basis for reliance upon Section 201.[70 P.S. 1.201] is that
Pennsylvania does not require registration of federally exempted Rule 506
securities.
In April 1999, the Company entered into an agreement with KJS to provide
consulting services. KJS agreed to accept 7,000 shares of the Company's common
stock valued at the current bid price of $.50 as part of an initial retainer
with the balance of $1,500 to be paid in cash at such time as KJS introduces the
Company to five institutional funding sources. The issuance was made pursuant to
Section 4(2) of the Act and Rule 506. Such reliance upon Section 4(2) of the Act
was based upon the fact that (i) the issuance of the shares did not involve a
public offering and (ii) KJS is a sophisticated purchaser and had full access to
the information on the Company necessary to make an informed investment decision
by virtue of its position as a consultant to the Company. The facts relied upon
to make the Florida exemption available include the following: (i) sales of the
shares of Common Stock were not made to more than 35 persons; (ii) neither the
offer nor the sale of any of the shares was
111
<PAGE>
accomplished by the publication of any advertisement; (iii) the purchasers had a
preexisting personal or business relationship with one or more of the executive
officers of Surgical; (iv) the purchaser represented that he was purchasing for
his own account and not with a view to or for sale in connection with any
distribution of the shares; and (v) prior to sale, the purchaser had reasonable
access to or was furnished all material books and records of the Company, all
material contracts and documents relating to the proposed transaction, and had
an opportunity to question the executive officers of the Company.
In April 1999, the Company issued 2,000 shares each to David Utz and
Robert Wingate, two consultants of the Company in lieu of cash for services
relating to their production of a CD-Rom disc to be used promote OASiS. Such
4000 shares were valued at $2,250 which was based upon the closing price for the
shares on the dates the services were due to be paid. Such issuance was made in
reliance to Section 4(2) of the Act and Rule 506 and Section 517.061(11) of the
Florida Code. Such reliance upon Section 4(2) of the Act was based upon the fact
that (i) the issuance of the shares did not involve a public offering and (ii)
Mr. Utz and Mr. Wingate are sophisticated purchasers and had full access to the
information on the Company necessary to make an informed investment decision by
virtue of their familiarity with the Company's operations. The facts relied upon
to make the Florida exemption available include the following: (i) sales of the
shares of Common Stock were not made to more than 35 persons; (ii) neither the
offer nor the sale of any of the shares was accomplished by the publication of
any advertisement; (iii) each purchaser either had a preexisting personal or
business relationship with one or more of the executive officers of Surgical;
(iv) each purchaser represented that he was purchasing for his own account and
not with a view to or for sale in connection with any distribution of the
shares; and (v) prior to sale, each purchaser had reasonable access to or was
furnished all material books and records of the Company, all material contracts
and documents relating to the proposed transaction, and had an opportunity to
question the executive officers of the Company.
In May 1999, the Company entered into an agreement with Ten Peaks to pay
a finder's fee for successfully securing specifically defined financing for the
Company. Ten Peaks agreed to accept 6,000 shares of the Company's common stock
in lieu of a retainer provided such stock had a fair market value as reported on
Bloomberg, LLP on the date of execution of not less than $.66. Although
obligated to issue such shares, the Company has decided not to deliver such
shares since it believes that Ten Peaks did not perform as required. The
issuance was made pursuant to Section 4(2) of the Act and Rule 506 and Rule
260.103 of the California Code. Such reliance upon Section 4(2) of the Act was
based upon the fact that (i) the issuance of the shares did not involve a public
offering and (ii) Ten Peak's is a sophisticated purchaser and had full access to
the information on the Company necessary to make an informed investment decision
by virtue of its position as a consultant to the Company. The facts relied upon
to make the California exemption available include the following: In California,
the company relied upon Rule 260.103. The facts upon which the Company relied
are that the issuance was an exchange of securities with its existing security
holders exclusively, and that the transaction, had it involved the issuance of a
new security containing the changed rights, preferences, privileges, or
restrictions, or a new issuance of the exchange security, would have been exempt
from the provisions of Section 25110 of the Code by any of the subdivisions of
subdivisions of Section 25102 of the Code or Section 260.105.14 of these rules.
112
<PAGE>
In May 1999, the Company issued a total of 46,000 shares of its
restricted Common Stock to Frank Clark and David Collins and 11,400 shares of
its restricted Common Stock to three (3) other employees in lieu of salary and
consulting fees due from the Company to each of them, which salary and
consulting fees were valued at $31,222 in the case of Mr. Clark and Mr. Collins
and at $7,832 in the case of the three (3) employees. The Company issued such
shares pursuant to Section 4(2) of the Act and Rule 506 and Section 517.061(11)
of the Florida Code. Such reliance upon Section 4(2) of the Act was based upon
the fact that (i) the issuance of the shares did not involve a public offering
and (ii) Mr. Clark, Mr. Collins and the three (3) employees are sophisticated
purchasers and had full access to the information on the Company necessary to
make an informed investment decision by virtue of their positions as officers,
directors and employees of the Company. The facts relied upon to make the
Florida exemption available include the following: (i) sales of the shares of
Common Stock were not made to more than 35 persons; (ii) neither the offer nor
the sale of any of the shares was accomplished by the publication of any
advertisement; (iii) each purchaser had a preexisting personal or business
relationship with one or more of the executive officers of Surgical; (iv) each
purchaser represented that he was purchasing for his own account and not with a
view to or for sale in connection with any distribution of the shares; and (v)
prior to sale, each purchaser had reasonable access to or was furnished all
material books and records of the Company, all material contracts and documents
relating to the proposed transaction, and had an opportunity to question the
executive officers of the Company.
In granting the balance of the options under the 1994 ESOP, 1998 Revised
ESOP, 1999 Revised ESOP, 1994 CSOP and the 1998 Revised CSOP Plans, the Company
relied upon Section 4(2) of the Act, Section 517.061(11) of the Florida Code.
Such reliance upon Section 4(2) of the Act was based upon the fact that (i) the
issuance of the shares did not involve a public offering and (ii) the recipients
are sophisticated purchasers and had full access to the information on the
Company necessary to make an informed investment decision by virtue of their
positions as officers, directors, employees and consultants of the Company. The
facts relied upon to make the Florida exemption available include the following:
(i) sales of the shares of Common Stock were not made to more than 35 persons;
(ii) neither the offer nor the sale of any of the shares was accomplished by the
publication of any advertisement; (iii) each purchaser had a preexisting
personal or business relationship with one or more of the executive officers of
Surgical; (iv) each purchaser represented that he was purchasing for his own
account and not with a view to or for sale in connection with any distribution
of the shares; and (v) prior to sale, each purchaser had reasonable access to or
was furnished all material books and records of the Company, all material
contracts and documents relating to the proposed transaction, and had an
opportunity to question the executive officers of the Company.
Item 5. Indemnification of Directors and Officers.
Article VI of the Company's Articles of Incorporation contains
provisions providing for the indemnification of directors of the Company as
follows:
"The personal liability of directors to the corporation or its
shareholders for damages for any breach of duty in such capacity is hereby
eliminated except that such personal liability shall not be eliminated if a
judgment or other final adjudication adverse to such director establishes that
his acts or omissions were in bad faith or involved intentional misconduct or a
knowing violation of law or that he personally gained in fact a financial
113
<PAGE>
profit or other advantage to which he was not legally entitled or that his acts
violated Section 719 of the Business Corporation Law.
Article VI of the Company's By-Laws contains provisions providing for
the indemnification of directors and officers of the Company as follows:
Each director and officer of this corporation shall be indemnified by
the corporation against all costs and expenses actually and necessarily incurred
by him or her in connection with the defense of any action, suit or proceeding
in which he or she may be involved or to which he or she may be made a party by
reason of his or her being or having been such director or officer, except in
relation to matters as to which he or she shall be finally adjudged in such
action, suit or proceeding to be liable for negligence or misconduct in the
performance of duty.
The Company has no other agreements with any of its directors or
executive offices providing for indemnification of any such persons with respect
to liability arising out of their capacity or status as officers and directors.
At present, there is no pending litigation or proceeding involving a
director or officer of the Company as to which indemnification is being sought.
PART F/S
The Financial Statements of Surgical required by Regulation S-X commence
on page F-1 hereof in response to Part F/S of this Registration Statement on
Form 10-SB.
114
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
INDEPENDENT AUDITORS' REPORT,
FINANCIAL STATEMENTS AND
SUPPLEMENTARY INFORMATION
DECEMBER 31, 1998 AND 1997
115
<PAGE>
CONTENTS
Page
INDEPENDENT AUDITORS' REPORT F-1
FINANCIAL STATEMENTS
Balance Sheets F-2
Statements of Operations F-4
Statements of Changes in Stockholders' Equity (Deficit) F-5
Statements of Cash Flows F-7
Notes to Financial Statements F-9
SUPPLEMENTARY INFORMATION
Independent Auditors' Report on Supplementary Information F-18
Schedules of Operating Expenses F-19
<PAGE>
INDEPENDENT AUDITORS' REPORT
The Board of Directors
Surgical Safety Products, Inc.
We have audited the accompanying balance sheets of Surgical Safety Products,
Inc. as of December 31, 1998 and 1997, and the related statements of operations,
changes in stockholders' equity (deficit) and cash flows for the years then
ended. These financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Surgical Safety Products, Inc.
as of December 31, 1998 and 1997, and the results of its operations and its cash
flows for the years then ended in conformity with generally accepted accounting
principles.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 10 to the
financial statements, the Company's significant operating losses raise
substantial doubt about its ability to continue as a going concern. Management's
plans regarding those matters are also described in Note 10. These financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
/s/ Kerkering, Barberio & Co.
- --------------------------------
KERKERING, BARBERIO & CO., PA
Sarasota, Florida
March 12, 1999
F-1
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
BALANCE SHEETS
DECEMBER 31, 1998 AND 1997
<TABLE>
<CAPTION>
Assets 1998 1997
------ ---- ----
<S> <C> <C>
Current Assets
Cash $ 41,191 $
Trade receivables 250,125
Other receivables 1,941
Deposits 58,700
Inventory 26,898 11,742
------- -------
Total current assets 128,730 261,867
------- -------
Furniture and equipment, net 92,429 71,368
------ ------
Other Assets
Deferred loan costs, net 317 412
Intangible assets, net 48,915 45,102
Software development costs, net 92,873 52,486
Investments 9,750 13,500
Deposits 500 500
------- -------
Total other assets 152,355 112,000
------- -------
Total Assets $ 373,514 $ 445,235
======= =======
</TABLE>
The accompanying notes are an integral
part of these financial statements.
F-2
<PAGE>
<TABLE>
<CAPTION>
Liabilities and Stockholders' Equity (Deficit) 1998 1997
- ---------------------------------------------- ---------- -----------
<S> <C> <C>
Current Liabilities
Bank overdraft $ $ 13,984
Line of credit 100,000
Notes payable - related parties 233,720
Accounts payable 35,262 117,776
Accrued expenses 20,069 21,131
Accrued interest 17,667
---------- -----------
Total current liabilities 55,331 504,278
---------- -----------
Stockholders' Equity (Deficit)
Common stock, $.001 par value,
20,0000,000 shares authorized;
10,786,973 and 9,774,473 shares
issued and outstanding in 1998
and 1997, respectively 10,787 9,775
Additional paid-in capital 1,998,242 824,366
Accumulated deficit (1,690,846) (893,184)
---------- -----------
Total stockholders' equity (deficit) 318,183 (59,043)
---------- -----------
Total Liabilities and Stockholders' Equity (Deficit) $ 373,514 $ 445,235
========= ==========
</TABLE>
The accompanying notes are an integral part of
these financial statements.
F-3
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 1998 AND 1997
<TABLE>
<CAPTION>
1998 1997
---------- -----------
<S> <C> <C>
Revenue
Net sales $ 16,545 $ 248,760
Other income 16,564 6,626
Interest income 9,284
---------- -----------
Total revenue 42,393 255,386
---------- -----------
Costs and expenses
Cost of medical products sold 5,560 22,002
Operating expenses 782,450 244,815
Research and development expenses 34,536 113,740
Interest expense 13,759 15,651
Other 3,750
Underwriting costs 7,600
---------- -----------
Total costs 840,055 403,808
---------- -----------
Net loss before income taxes (797,662) (148,422)
---------- ------------
Provision for income taxes - -
---------- -----------
Net loss $ (797,662) $ (148,422)
========== ==========
Net loss per share $ (0.076) $ (0.016)
========== ==========
</TABLE>
The accompanying notes are an integral part of
these financial statements.
F-4
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)
YEARS ENDED DECEMBER 1998 AND 1997
<TABLE>
<CAPTION>
Common Stock
Shares Amount
<S> <C> <C>
Balances - December 31, 1996 9,524,473 $ 9,525
Issuance of common stock for acquisition of assets 250,000 250
Net loss
Balances - December 31, 1997 9,774,473 9,775
Issuance of common stock for cash 520,000 520
Issuance of common stock for services 492,500 492
Stock options granted to employees
Net loss
Balances - December 31, 1998 10,786,973 $ 10,787
========== ===========
</TABLE>
The accompanying notes are an integral part of
these financial statements.
F-5
<PAGE>
<TABLE>
<CAPTION>
Total
Additional Stockholders'
Paid-in Accumulated Equity
Capital Deficit (Deficit)
<S> <C> <C>
$ 810,959 $ (744,762) $ 75,722
13,407 13,657
(148,422) (148,422)
824,366 (893,184) (59,043)
938,476 938,996
144,287 144,779
91,113 91,113
(797,662) (797,662)
$ 1,998,242 $ (1,690,846) $ 318,183
=========== ============== =============
</TABLE>
The accompanying notes are an integral part of
these financial statements.
F-6
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 1998 AND 1997
<TABLE>
<CAPTION>
1998 1997
---------- -----------
<S> <C> <C>
Cash Flows From Operating Activities
Net loss $ (797,662) $ (148,422)
--------- ----------
Adjustments to reconcile net loss to cash
used in operating activities
Depreciation and amortization 57,461 20,557
Common stock issued for services 144,779
Stock option compensation expense 91,113
Write-down of investments 3,750
Gain on disposal of assets (396)
Decrease (increase) in operating assets
Receivables 250,125 (220,553)
Other receivables (1,941)
Inventory (15,156) (6,658)
Deposits (58,700)
Increase (decrease) in operating liabilities
Bank overdraft (13,984) 13,984
Accounts payable (82,514) 103,747
Accrued expenses (1,062) 15,131
Accrued interest (17,667) 10,619
Stock subscription proceeds (5,000)
---------- -----------
Total Adjustments 356,204 (68,569)
---------- -----------
Net cash used in operating activities (441,458) (216,991)
---------- -----------
Cash Flows From Investing Activities
Proceeds from disposal of assets 1,100
Furniture and equipment purchased (57,294) (65,958)
Software development additions (56,256) (55,248)
Patent and trademark costs (9,077) (2,386)
---------- -----------
Net cash used in investing activities (122,627) (122,492)
---------- -----------
Cash Flow From Financing Activities
Proceeds from related party loans 23,000 233,720
Advances/(repayments) on line of credit, net (100,000) 100,000
Repayment of stockholder loans (256,720)
Proceeds from issuance of common stock 938,996
---------- -----------
Net cash provided by financing activities 605,276 333,720
---------- -----------
Net increase (decrease) in cash 41,191 (5,763)
Cash at beginning of year - 5,763
---------- -----------
Cash at end of year $ 41,191 $ -
========== ===========
</TABLE>
The accompanying notes are an integral part of
these financial statements.
F-7
<PAGE>
<TABLE>
<S> <C> <C>
1998 1997
---------- -----------
Supplemental Cash flow Information:
Cash paid for interest $ 31,426 $ 5,032
========== ===========
</TABLE>
For purposes of the statement of cash flows, management considers all deposits
and financial instruments with original maturities of less than three months to
be cash and cash equivalents.
Material non-cash transactions not reflected in the statement of cash flows
include:
Year Ended December 31, 1998
There were no material non-cash transactions not reflected in the
statemenduring the fiscal year ending December 31, 1998.
Year Ended December 31, 1997
Purchase of assets of Endex Systems, Inc. through issuance of stock valued
at $13,657.
The accompanying notes are an integral part of
these financial statements.
F-8
<PAGE>
SURGICAL SAFETY PRODUCTS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 1998 AND 1997
Note 1 - Summary of Significant Accounting Policies
Business Activities
Surgical Safety Products, Inc. (Company) is engaged in product development,
sales and services for the medical industry. The Company is primarily focused on
medical research and product development. It has developed a product, OASiS,
designed to reduce the occupational risks of bloodborne diseases in the
operating room and other related areas. In 1997, the Company enhanced its OASiS
system for multiple applications within health care, including exposure
management, health care training, and health care risk management. Its medical
products are sold to health care providers within the United States.
Financial Statements
The financial statements and notes are representations of the Company's
management who is responsible for their integrity and objectivity. The
accounting policies conform to generally accepted accounting principles and have
been consistently applied in the preparation of the financial statements.
Preparation of financial statements in accordance with generally accepted
accounting principles requires the use of management's estimates. Actual results
could differ from those estimates.
Accounts Receivable
Accounts receivable consist of amounts due from customers. There were no
outstanding accounts receivable from customers at December 31, 1998. The balance
of $250,125 at December 31, 1997 was due primarily from one customer in the
amount of $250,000.
Inventory
Inventory is stated at the lower of cost (first-in, first-out) or market (net
realizable value) and consists of finished goods.
Investments
Investments are valued at cost and represent shares of common stock in
privately-held companies. Management believes the value of the investments are
not below cost. Fair market value is not determinable.
Property and Equipment
Purchases of property and equipment are recorded at cost. Expenditures for
maintenance and repairs which extend the useful life are charged to operations
as incurred. Depreciation is provided on an accelerated method over the assets'
useful lives which range from three to seven years. Leasehold improvements are
being amortized over the life of the lease term which is two years.
F-9
<PAGE>
Note 1 - Summary of Significant Accounting Policies (Continued)
Intangible Assets
Intangible assets subject to amortization include goodwill, organization costs,
trade names and patent costs. Organization costs are being amortized on the
straight-line method over five years. Patent costs are being amortized on the
straight-line method over seventeen years from the granting of the patent. The
other assets are being amortized on the straight-line method over fifteen years.
Software Development Costs
Certain software development costs are capitalized when incurred. Capitalization
of software development costs begins upon the establishment of technological
feasibility. The establishment of technological feasibility and the ongoing
assessment of recoverability of capitalized software development costs require
considerable judgement by management with respect to certain external factors,
including, but not limited to, anticipated future revenues, estimated economic
life, and changes in software and hardware technologies.
Amortization of capitalized software development costs is calculated using the
straight-line method over a period of five years. All other research and
development costs are charged to expense in the period incurred.
Income Taxes
The Company accounts for income taxes using the asset and liability method in
accordance with Statement of Financial Accounting Standards (SFAS) No. 109,
"Accounting for Income Taxes."
Long-Lived Assets
Statement of Financial Accounting Standards No. 121, "Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of,"
requires that long-lived assets, including certain identifiable intangibles, and
the goodwill related to those assets, be reviewed for impairment whenever events
or changes in circumstances indicate that the carrying value amount of the asset
in question may not be recoverable. Management has reviewed the Company's
long-lived assets and has determined that there are no events requiring
impairment loss recognition.
Revenue Recognition
The Company recognizes revenue at the point of passage of title of inventory,
which is generally at the time of shipment to the customer. Revenue related to
services is recognized at the point the service has been rendered.
F-10
<PAGE>
Note 1 - Summary of Significant Accounting Policies (Continued)
Net Loss Per Share
Net loss per share has been computed in accordance with Statement of Financial
Accounting Standards (FASB) No. 128, "Earnings Per Share," by dividing net loss
by the weighted average number of shares outstanding during the period. Common
stock equivalents have not been included in the computation of weighted average
number of shares outstanding since the effect would have been anti-dilutive.
Stock Based Compensation
The Company grants stock options for a fixed number of shares to employees and
consultants. The Company accounts for stock option grants in accordance with APB
Opinion No. 25, "Accounting for Stock Issued to Employees" (APB 25) and related
Interpretations because the company believes the alternative fair value
accounting provided under FASB Statement No. 123, "Accounting for Stock Based
Compensation," requires the use of option valuation models that were not
developed for use in valuing employee stock options. Under APB 25, the Company
only recognized compensation expense to the extent that the fair value of the
shares exceeds the exercise price of the stock option at the date of grant.
The Company recorded compensation expense related to the issuance of stock
options in the amount of $91,113 for the year ended December 31, 1998. There
were no stock options issued during the year ended December 31, 1997.
Impact of Recently Issued Accounting Standards
In June 1998, the FASB issued Statement No. 133, "Accounting for Derivative
Instruments and Hedging Activities." The Company expects to adopt the new
Statement effective January 1, 2000. The Statement will require the Company to
recognize all derivatives on the balance sheet at fair value. This Statement is
not applicable to the Company as of December 31, 1998.
Note 2 - Property and Equipment
Property and equipment consisted of the following at December 31:
<TABLE>
<S> <C> <C>
1998 1997
---------- -----------
Property and equipment $ 90,703 $ 38,982
Prototype molds 59,652 82,778
Leasehold improvements 5,575
---------- -----------
155,930 121,760
Less accumulated depreciation 63,501 50,392
---------- -----------
Furniture and equipment, net $ 92,429 $ 71,368
========== ===========
</TABLE>
Total depreciation and amortization expense amounted to $36,234 and $14,014 for
1998 and 1997, respectively.
Note 3 - Line-of-Credit
Effective May 1997, the Company had established a line-of-credit in the amount
of $100,000 with a financial institution at 1.5% above the prime rate, interest
only payments are due monthly with an expiration date of May 2, 2017. The line
is due on demand and is secured by inventory, accounts receivable, and
equipment. The outstanding balance at December 31, 1998 and 1997 was $0 and
F-11
<PAGE>
$100,000, respectively. The interest rate at December 31, 1997 was 10.00%. The
line-of-credit is personally guaranteed by the major stockholder.
Note 4 - Related Party Transactions
At December 31, 1997, the Company was indebted to the major stockholder in the
amount of $197,720. In addition, the Company was indebted to an affiliated
company owned by the major stockholder. The amount owed at December 31, 1997 was
$36,000. Interest on the notes was 10.00%. At December 31, 1997, interest
payable on these loans totaled $17,667. During fiscal 1998, an additional
$23,000 was loaned to the Company by the major stockholder. The balance of the
notes payable was repaid during fiscal 1998, and at December 31, 1998 there are
no amounts due to related parties. Interest expense relating to these notes
amounted to $9,882 and $15,314 for the years ended December 31, 1998 and 1997,
respectively.
The Company leases office space from an entity owned by a major stockholder. See
Note 13.
Note 5 - Software Development Costs
During the fiscal year ended December 31, 1997, the Company focused its efforts
in developing the software for its major product, OASiS. The company engaged the
services of a software development company, and incurred significant costs
related to the design and development of the software. The Company achieved
technological feasibility in its development of the software in fiscal 1997.
For the year ended December 31, 1998, the Company incurred and capitalized
expenditures relating to the enhancement of the software in the amount of
$56,256. For the year ended December 31, 1997, the Company incurred expenditures
related to software development of $162,409, of which $54,653 was capitalized,
and the remainder of $107,756 was expensed. Amortization expense of software
development costs amounted to $21,227 and $6,543 for the years ended December
31, 1998 and 1997, respectively.
F-12
<PAGE>
Note 6 - Intangible Assets
Intangible assets consisted of the following at December 31:
<TABLE>
<S> <C> <C>
1998 1997
---------- -----------
Goodwill $ 32,762 $ 32,762
Organization costs 11,502 11,502
Trademarks 11,658 6,917
Patents 16,328 11,995
---------- -----------
72,250 63,176
Less: Accumulated amortization 23,335 18,074
---------- -----------
Intangible assets, net $ 48,915 $ 45,102
========== ===========
</TABLE>
Note 7 - Stock Option Plans
Options granted under the 1994 and 1998 stock option plans are exercisable only
after the respective vesting period which is two years from the date of grant
under the 1994 plan, and determined by the Company's stock option committee
under the 1998 plan. Options expire seven years from the date of grant.
Pro forma information regarding net income and earnings per share is required by
Statement 123, and has been determined as if the Company had accounted for its
stock options under the fair value method of that Statement. The fair value for
these options was estimated at the date of grant using a Black-Scholes option
pricing model with the following assumptions for 1998: risk-free interest rate
of 5.0%; dividend yield of 0%; volatility factor of the expected market price of
the Company's common stock of .20; and a weighted-average expected life of the
option of three years. There were no options granted during the fiscal year
ended December 31, 1997.
The Black-Scholes option valuation model was developed for use in estimating the
fair value of traded options which have no vesting restrictions and are fully
transferable. In addition, option valuation models require the input of highly
subjective assumptions including the expected stock price volatility. Because
the Company's stock options have characteristics significantly different from
those of traded options, and because changes in the subjective input assumptions
can materially affect the fair value estimate, in management's opinion, the
existing models do not necessarily provide a reliable single measure of the fair
value of its stock options.
For purposes of pro forma disclosures, the estimated fair value of the options
is charged to expense over the options' vesting period. The Company's pro forma
information for the fiscal year ended December 31, 1998 is as follows:
Proforma net loss $ (827,315)
-----------
Pro forma earnings per common share:
Basic $ (0.079)
-----------
Note 7 - Stock Option Plans (Continued)
A summary of the Company's stock option activity and related information for the
years ended December 31 follows:
F-13
<PAGE>
<TABLE>
<CAPTION>
1998 1997
------------------------------------------------------------
Weighted Weighted
Average Average
Exercise Exercise
Options Price Options Price
- ---------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Outstanding at the beginning
of the year 4,512,431 $ 0.38 4,512,431 $ 0.38
Granted 1,129,000 1.49
Exercised 400,000 1.75
----------- ----------- ---------- -----------
Outstanding at the end
of the year 5,241,431 $ 0.57 4,512,431 $ 0.38
=========== =========== ========== ===========
Exercisable at the end of
the year 4,512,431 $ 0.38 4,512,431 $ 0.38
=========== =========== ========== ===========
Weighted-average fair value of
options granted during the
year $ 1.51 $ -
=========== ===========
</TABLE>
The weighted-average exercise price and weighted-average fair value of options
granted during 1998 was $1.37 and $0.85, respectively, for options whose
exercise price exceeded the market price of the stock on the grant date. The
weighted average exercise price and weighted-average fair value of options
granted during 1998 was $1.75 and $2.33, respectively, for options whose
exercise price was less than the market price of the stock on the grant date.
The following table summarizes information about the options outstanding at
December 31, 1998:
<TABLE>
<CAPTION>
Weighted
Average
Remaining Weighted
Number Contractual Average
Exercise Price Outstanding Life Exercise Price
<S> <C> <C> <C>
$ 0.32 to 0.48 4,511,931 2.50 years $ 0.32
0.50 54,000 6.00 years 0.50
0.90 to 1.00 300,500 6.87 years 1.00
1.50 to 1.75 375,000 6.53 years 1.73
--------------- ---------------
0.32 to 1.75 5,241,431 3.07 years $ 0.57
=============== ===============
</TABLE>
Note 8 - Common Stock Issuance
During the fiscal year ended December 31, 1998, the Company issued 492,500
shares of common stock in exchange for legal, computer hardware and software
consulting services, and public relations services. Of the total issued, 90,000
shares were restricted stock. The value of the shares issued ranged from $0.15 -
$1.75 per share based on either the fair market value of the shares at the time
the agreement for services was executed, or the value of the services received,
whichever was more estimable.
The Company also issued 520,000 shares of common stock in exchange for cash. The
F-14
<PAGE>
value of the shares issued ranged from $1.75 - $2.19 per share based on the fair
market value of the shares at the time of issuance.
During the year ended December 31, 1997, the Company issued 250,000 shares of
restricted common stock in exchange for the acquisition of the assets of Endex
Systems, Inc. (See Note 9). The shares could not be sold for a period of two
years; therefore the shares issued were valued at $.06 per share based on the
value of the assets received.
Note 9 - Income Taxes
At December 31, 1998, the Company has net operating loss carryforwards of
approximately $1,300,000 which expire during the years 2008 through 2012. The
1998 and 1997 tax benefits relating to the losses incurred in each year amounted
to approximately $158,000 and $29,800, respectively. Based on the Company's
financial history, there is no basis to conclude that the tax benefits will be
realized. Therefore, the tax benefit that has been recorded in the accompanying
financial statements for the years ended December 31, 1998 and 1997 has been
offset by an allowance equal to the benefit.
Note 10 - Asset Purchase
On December 8, 1997, the Company purchased the assets of Endex Systems, Inc. for
which it issued 250,000 shares of restricted common stock based on the fair
value of the assets received. The Company purchased furniture, equipment and
investments valued at approximately $14,000.
Note 11 - Realization of Assets
The accompanying financial statements have been prepared in conformity with
generally accepted accounting principles, which contemplate the continuation of
the Company as a going concern. The Company has sustained substantial losses and
has minimal revenues for the current fiscal year.
In view of the matters described in the preceding paragraph, recoverability of a
major portion of the recorded asset amounts shown in the accompanying balance
sheet is dependent upon the Company's ability to achieve profitable operations
and to obtain additional sources of funds. Management believes the Company's
prospects for profitability are significant, based on the development of OASiS,
a proprietary product. The Company has aggressively promoted this
Note 11 - Realization of Assets (Continued)
product during fiscal year 1998 and anticipates revenues in fiscal 1999 related
to the leasing of these units to medical facilities. Management is considering
both equity and debt financing in the range of $2 to $5 million. Management
believes these factors will provide the basis for significant growth and
profitability in the near term.
Note 12 - Commitments
On January 30, 1998, the Company entered into an agreement with a health care
provider in which the provider will perform clinical testing of ten surgical or
medical products submitted by the Company. The agreement is for a term not to
exceed five years and requires the Company to pay the health care provider a
fixed amount of $25,000 for each of the ten studies. The agreement further
provides that the Company is obligated to pay the provider $250,000 over the
term of the agreement in the event the Company determines not to have the
F-15
<PAGE>
provider perform the clinical testing. The Company did not submit any products
for clinical testing during the fiscal year ended December 31, 1998.
In November 1998, the Company entered into an agreement with a vendor to
manufacture 20 units of it OASiS system for a total of $133,000. At December 31,
1998, the Company had paid 50% or $66,500 to the vendor and received a partial
shipment of units. The remaining balance of $66,500 is payable upon receipt of
the remaining units.
Note 13 - Concentrations
During the year ended December 31, 1998, the company derived 93% of its revenue
from technical services provided to one customer. The Company derived 99% of its
revenues from the sale of medical products sold to one customer during the year
ended December 31, 1997.
Note 14 - Lease Commitments
On June 1, 1998, the Company entered into an agreement to lease office space
from an affiliated entity. The lease term expires on May 21, 2000 with automatic
one year renewals. Minimum lease payments are as follows for the fiscal years
ending:
1999 $ 42,000
2000 $ 17,500
Rent expense for the fiscal years ending December 31, 1998 and 1997 amounted to
$30,750 and $6,912, respectively.
The Company also leases office equipment. The lease term is for 60 months and
expires October 2003. Monthly payments are $344.
Note 14 - Lease Commitments (Continued)
Minimum lease payments are as follows for the fiscal years ending:
1999 $ 4,128
2000 4,128
2001 4,128
2002 4,128
2003 3,440
Note 15 - Year 2000 Issue
The Year 2000 Issue is the result of potential problems with computer systems or
any equipment with computer chips that use dates where the date has been stored
as just two digits (e.g. 98 for 1998). On January 1, 2000, any clock or date
recording mechanism, including date sensitive software which uses only two
digits to represent the year, may recognize the date, using 00, as the year 1900
rather than the year 2000. This could result in a system failure or
miscalculations causing disruption of operations, including among other things,
a temporary inability to process transactions, send invoices, or engage in
similar activities.
F-16
<PAGE>
Management has reviewed its current internal systems and is in the process of
upgrading its accounting system to be Year 2000 compliant. The Company purchased
new hardware in 1998 that is Year 2000 compliant. Management does not anticipate
any significant additional costs that would relate to upgrading its systems to
support the Year 2000.
Further, management does not believe the Year 2000 will impact the operation of
the OASiS system since the software for this system does not rely on legacy
applications or subsystems. OASiS is designed to handle dates in the form of a
two digit month and day and a four digit year, thus avoiding the Year 2000
problem.
The Company believes it has disclosed all required information relative to Year
2000 issues relating to its business and operations. However, there can be no
assurance that the systems of other companies on which the Company's systems
rely also will be timely converted or that any such failure to convert by
another company would not have an adverse affect on the Company's operations or
financial condition.
F-17
<PAGE>
SUPPLEMENTARY INFORMATION
<PAGE>
INDEPENDENT AUDITORS' REPORT ON SUPPLEMENTARY INFORMATION
The Board of Directors
Surgical Safety Products, Inc.
We have audited the accompanying financial statements of Surgical Safety
Products, Inc. as of and for the years ended December 31, 1998 and 1997, and
have issued our report thereon dated March 12, 1999. Our audits were made for
the purpose of forming an opinion on the financial statements taken as a whole.
The supplementary schedules of operating expenses are presented for purposes of
additional information and are not a required part of the financial statements.
Such information has been subjected to the auditing procedures applied in the
examination of the financial statements and, in our opinion, is fairly stated in
all material respects in relation to the financial statements taken as a whole.
KERKERING, BARBERIO & CO., PA
Sarasota, Florida
March 12, 1999
F-18
<PAGE>
<TABLE>
<CAPTION>
SURGICAL SAFETY PRODUCTS, INC.
SCHEDULES OF OPERATING EXPENSES
YEARS ENDED DECEMBER 31, 1998 AND 1997
1998 1997
----------- -----------
<S> <C> <C>
Accounting and legal $ 58,260 $ 16,761
Advertising 103,281 12,507
Contract labor 28,950 2,137
Meetings/conventions 27,694 9,749
Depreciation and amortization 57,461 20,557
Salaries and related expenses 368,417 115,193
Travel and entertainment 18,087 8,426
Postage 4,953 5,772
Insurance 11,542 9,479
Equipment rental 7,724 3,778
General and administrative 18,201 11,428
Rent 30,750 6,912
Repairs and maintenance 4,188 5,467
Samples and supplies 3,195
Supplies 22,606 8,416
Taxes 1,615 998
Telephone 15,526 6,397
Utilities 838
----------- -----------
$ 782,450 $ 244,815
=========== ===========
</TABLE>
F-19
<PAGE>
CONTENTS
Condensed Balance Sheets as of June 30, 1999 and December 31, 1998 F-2
Condensed Statements of Operations for the Three and Six Months Ended
June 30, 1999 and 1998 F-3
Statements of Cash Flows for the Six Months Ended
June 30, 1999 and 1998 F-4
Notes to the Condensed Financial Statements F-6
<PAGE>
<TABLE>
<CAPTION>
SURGICAL SAFETY PRODUCTS, INC.
CONDENSED BALANCE SHEETS
- --------------------------------------------------------------------------------------------
Assets (Unaudited)
Current Assets June 30, 1999 December 31, 1998
- ------------------------------------------ ------------------------ ------------------------
<S> <C> <C>
Cash $188,000 $41,191
Accounts receivable 9,981 1,941
Deposits 0 58,700
Inventory 6,119 6,555
Prepaid Expense 7,500 0
----------- -----------
Total current assets 211,600 108,837
----------- -----------
- ------------------------------------------ ------------------------ ------------------------
Property and equipment, net 221,524 112,772
----------- -----------
- ------------------------------------------ ------------------------ ------------------------
Other Assets
Intangible assets, net 45,551 49,232
Software development costs, net 129,451 92,873
Other assets 10,250 10,250
---------- -----------
Total other assets 185,252 152,355
---------- -----------
- ------------------------------------------ ------------------------
Total Assets $618,376 $373,514
=======
- ------------------------------------------ ------------------------ ------------------------
Liabilities and Stockholders' Equity
- ------------------------------------------ ------------------------ ------------------------
Current Liabilities
Line of credit $ 100,000 $ 0
Notes payable - related parties 77,500 0
Accounts payable and accrued expenses 69,829 55,331
------------- -----------
Total current liabilities 247,329 55,331
------------- -----------
- ------------------------------------------ ------------------------ ------------------------
Stockholders' Equity
Common stock, $.001 par value,
20,000,000 shares authorized;
11,811,373 shares issued and
outstanding in 1999 and 10,786,973 in 1998 11,812 10,787
Additional paid-in capital 2,429,907 1,998,242
(2,070,672)
Accumulated deficit ---------------- (1,690,846)
371,047 ----------------
Total stockholders' equity ---------------- 318,183
----------------
- ------------------------------------------ ------------------------ ------------------------
Total Liabilities and Stockholders' Equity $ 618,376 $373,514
========= ========
- ------------------------------------------ ------------------------ ------------------------
</TABLE>
The accompanying notes are an integral part of these financial
statements.
F-2
<PAGE>
<TABLE>
<CAPTION>
SURGICAL SAFETY PRODUCTS, INC.
CONDENSED STATEMENTS OF OPERATIONS
THREE AND SIX MONTHS ENDED JUNE 30, 1999 AND 1998
(UNAUDITED)
-----------------------------------
Six Months Ending June 30 Three Months Ending June
1999 1998 1999 1998
- -------------------------------- ----------------------------- ------------- -------------
<S> <C> <C> <C> <C>
Revenue
$ 52,734 $ 19,139 $ 13,157 $ 3,159
- -----------------------------------------------------------------------------------------
Costs and expenses
Cost of medical products sold 8,135 1,278 7,874 1,125
Operating expenses 396,900 290,946 257,916 227,672
Research and development expenses 20,085 9,771 13,418 4,633
Interest expense 7,440 13,825 5,919 12,482
----------- ----------- ----------- -----------
Total costs 432,560 315,820 285,127 245,912
----------- ----------- ----------- -----------
Net loss before income taxes (379,826) (296,681 (271,970) (242,753)
Provision for income taxes 0 0 0 0
----------- ----------- ----------- -----------
- -------------------------------- ------------- ---------------
Net loss $ (379,826) $ (296,681) $ (271,970) $ (242,753)
======== ======= ======== =======
- -------------------------------- ------------- ---------------
Net loss per share $ (0.04) $ (0.03) $ (0.02) $ (0.02)
======== ======= ======== =======
- -------------------------------- ------------- --------------- -------------- -----------
</TABLE>
The accompanying notes are an integral part of these financial
statements.
F-3
<PAGE>
<TABLE>
<CAPTION>
SURGICAL SAFETY PRODUCTS, INC.
STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED JUNE 30, 1999 AND 1998
(UNAUDITED)
- -------------------------------------------------------------------------------------------
1999 1998
----- -----
- ------------------------------------------ ------------------------ -----------------------
<S> <C> <C>
Cash Flows From Operating Activities
Net loss $ (379,826) $ (346,682)
---------------- -----------
Adjustments to reconcile net loss to cash
used in operating activities
Depreciation and amortization 58,013 23,345
Common stock issued for services 41,303 141,875
Stock option compensation expense (91,113)
Decrease (increase) in operating assets
Receivables (8,040) 248,740
Inventory 436 (2,869)
Increase (decrease) in operating liabilities
Accounts payable and accrued expenses 14,498 (11,926)
-------------- -------------
Total adjustments (15,097) 399,165
-------------- ------------
Net cash used in operating activities (364,729) 52,483
-------------- ------------
- ------------------------------------------ ------------------------ -----------------------
Cash Flows From Investing Activities
Furniture and equipment purchased (92,039) (31,971)
Software development additions (48,923) (36,270)
Patent and trademark costs
----------- -----------
Net cash used in investing activities (140,962) (68,241)
----------- -----------
- ------------------------------------------ ------------------------ -----------------------
Cash Flows From Financing Activities
Proceeds from related party loans 77,500
Advances (repayments) on line of credit, net 100,000 (100,000)
Repayment of stockholder loans (233,720)
Proceeds from issuance of common stock 475,000 939,000
------------ -------------
Net cash provided by financing activities 652,500 605,280
------------ -------------
- ------------------------------------------ ------------------------ -----------------------
Net increase (decrease) in cash 146,809 589,522
Cash at beginning of year 41,191 -
-------------- ------------
Cash at end of year $ 188,000 $ 589,522
======== =======
- ------------------------------------------ ------------------------ -----------------------
Supplemental Cash Flow Information: $ 4,647 $ 31,492
Cash paid for interest ======== ======
- ------------------------------------------ ------------------------ -----------------------
</TABLE>
The accompanying notes are an integral part of these financial
statements.
F-4
<PAGE>
For the purposes of the statement of cash flows, management considers all
deposits and financial instruments with original maturities of less than three
months to be cash and cash equivalents.
Material non-cash transactions not reflected in the statement of cash flows
include:
For the Six Months Ended June 30, 1999
The Company received fixed assets in the amount of $ 58,700 for which it
had recorded deposits of such amount at December 31, 1998.
For the Six Months Ended June 30, 1998
The Company issued common stock for prepaid media consulting services in
the amount of $ 22,500.
The accompanying notes are an integral part of these financial
statements.
F-5
<PAGE>
Notes to the Condensed Financial Statements
Note 1 - Account Policies
Basis of Presentation
The condensed financial statements of Surgical Safety Products, Inc. (Company)
have been prepared without audit, pursuant to the rules and regulations of the
Securities and Exchange Commission. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted pursuant to such
rules and regulations. These consolidated financial statements should be read in
conjunction with the financial statement and notes thereto included in the
Company's Annual Report on Form 10-KSB for the year ended December 31, 1998.
The results of operations for the six month period ended June 30, 1999 are not
necessarily indicative of the results to be expected for any other period or for
the full year.
In the opinion of Company's management the accompanying unaudited financial
statements contain all adjustments, consisting of only normally recurring
adjustments, necessary to present fairly the financial position as of June 30,
1999, the results of operations and cash flows for the three and six months
ended June 30, 1999 and June 30, 1998.
Net Loss Per Share
Net loss per share has been computed in accordance with Statement of Financial
Accounting Standards (FASB) no. 128, "Earnings Per Share," by dividing net loss
by the weighted average number of shares outstanding during the period. Common
stock equivalents have not been include in the computation of weighted average
number of shares outstanding since the effect would have been anti-dilutive.
Reclassifications
Certain reclassifications have been made in the prior year's financial
statements to conform to the current period presentations.
Note 2 - Stock Compensation Expense
During fiscal year 1998, the Company issued stock options with an exercise price
that was below market to certain of its employees. Accordingly, the Company
recorded $91,113 of compensation expense related to the issuance for the year
ended December 31, 1998.
In the first quarter of 1999, the Company canceled these stock options and
issued options with an exercise price above that of market. Accordingly, the
Company decreased its payroll expenses by $91,113 for the cancellation of these
options for the six months ended June 30, 1999. In addition, during the three
and six months ended June 30, 1999, the Company issued common stock valued at
$39,053 to certain of its employees and $7,500 to certain consultants in lieu of
cash compensation for services. The common stock was valued based on the fair
market value for the shares on the dates the compensation would have been paid
F-6
<PAGE>
PART III
Item 1. Index to Exhibits
Item No. Description
3.(I).1 Articles of Incorporation of Surgical Safety Products, Inc., a
Florida corporation filed May 15, 1992
3.(I).2 Articles of Amendment filed December 9, 1992
3.(I).3 Articles of Amendment filed July 19, 1994
3.(I).4 Articles of Amendment filed October 11, 1994
3.(I).5 Articles of Incorporation of Sheffeld Acres, Inc.,
a New York Corporation filed May 7, 1993
3.(I).6 Articles of Merger filed in the State of Florida October 12, 1994
3.(I).7 Certificate of Merger filed in the State of New York February 8, 1995
3.(I).8 Certificate to Do Business in the State of Florida
filed April 11, 1995
3.(I).9 Certificate of Amendment filed May 1, 1998
3.(II).1 Bylaws of Sheffeld Acres, Inc., now known as
Surgical Safety Products, Inc.
3.(II).2 Amended Bylaws of Surgical Safety Products, Inc.
10.1 Acquisition of Endex Systems, Inc. d/b/a/ InterActive PIE
dated December 8, 1997
10.2 Prepaid Capital Lease Agreement with Community Health Corporation
relative to Sarasota Medical Hospital OASiS Installation
dated January 30, 1998
10.3 Letter of Intent with United States Surgical Corporation
dated February 12, 1998
10.4 Form of Rockford Industries, Inc. Rental Agreement and Equipment
Schedule to Master Lease Agreement
10.5 Ad-Vantagenet Letter of Intent dated June 19, 1998
10.6 Distribution Agreement with Morrison International Inc.
dated September 30, 1996
<PAGE>
10.7 Distribution Agreement with Hospital News dated August 1, 1997
10.8 Clinical Products Testing Agreement with Sarasota Memorial Hospital
dated January 30, 1998
10.9 Real Estate Lease for Executive Offices effective June 1, 1998
10.10 Employment Agreement with Donald K. Lawrence dated April 1, 1997
10.11 Employment Agreement with G. Michael Swor dated June 15, 1998
10.12 Employment Agreement with Frank M. Clark dated June 15, 1998
10.13 Agreement for Consulting Services with Stockstowatch.com Inc.
dated March 30, 1988
10.14 Form of Employee Option Agreement dated July 1994
10.15 Form of Employee Option Agreement dated 1998
10.16 Form of Consultants Option Agreement dated July 1994
10.17 Form of Consultants Option Agreement dated 1998
10.18 Confidential Private Offering Memorandum dated May 30, 1995
10.19 Supplement to Private Offering Memorandum dated October 30, 1995
10.20 Stock Option Agreement with Bay Breeze Enterprises LLC
dated April 9, 1998
10.21 Revolving Loan Agreement, Revolving Note, Security Agreement with
SouthTrust Bank dated May 2, 1997
10.22 Agreement between the Company and T. T. Communications, Inc.
dated October 15, 1998
10.23 Agreement between the Company and U.S. Surgical Corporation
dated October 28, 1998.
10.24 Collaborative Agreement between the Company and
Dr. William B. Saye dated November 16, 1998.
10.25 Kiosk Information System, Inc. Purchase Order dated November 3, 1998
10.26 Surgical Safety Products 1999 Stock Option Plan adopted January 1999
<PAGE>
10.27 Form of the Employee Option Agreement under the Surgical Safety
Products 1999 Stock Option Plan dated January 1999
10.28 Form of the Director, Consultant and Advisor Option Agreement under
the Surgical Safety Products 1999 Stock Option Plan
dated January 1999
10.29 Verio, Inc. Access Service Agreement dated February 16, 1999.
10.30 Form of Investor Subscription Documents and Agreements relative
to the April 1999 Self Directed Private Placement Offering under
Rule 506 of Regulation D.
10.31 Form of the Warrant issued pursuant to the April 1999 Self
Directed Private Placement Offering under Rule 506 of Regulation
D.
10.32 Consulting Agreement dated April 1999 with Koritz Group, LLC.
10.33 Agreement dated April 1999 with KJS Investment Corporation.
10.34 Agreement dated May 1999 with Ten Peaks Capital Corp.
10.35 * Private Partner Network Agreement dated July 30, 1999
with US Surgical
10.36 * Staff/Client Leasing Agreement dated October 16, 1999, as
amended September 15, 1999
27.1 * Financial Data Sheet
Item 2. Description of Exhibits
The documents required to be filed as Exhibits Number 2 and 6 and in Part
III of Form 1-A filed as part of this Registration Statement on Form 10-SB are
listed in Item 1 of this Part III above. No documents are required to be filed
as Exhibit Numbers 3 , 5 or 7 in Part III of Form 1-A and the reference to such
Exhibit Numbers is therefore omitted. The following additional exhibits are
filed hereto:
23.1 * Accountants' Consent from Kerkering, Barberio & Co., P.A., etc.
23.2 Publisher's Consent and Article- Michael W. Bebbington, MD, MHSc and Mark
J. Treissman, MD. The Use of a Surgical Assist Device to Reduce Glove
Perforations in Postdelivery Vaginal Repair: A Randomized Controlled Trial.
American Journal of Obstetrics and Gynecology, Vol. 175, No. 1, Part I,
October 1996 [previously denominated 10.2]
23.3 Author's Consent and Abstract - Donna J. Haiduven, BSN, MSN, CIC and Maria
D. Allo, MD. Evaluation of a One-Handed Surgical Suturing Device to
Decrease ---------------------------------------------------------------
Intraoperative Needlestick Injuries and Glove Perforations: Phases I & II,
-------------------------------------------------------------------------
<PAGE>
Conference on Prevention of Transmission of Bloodborne Pathogens in Surgery
and Obstetrics Sponsored by the American College of Surgeons and the Center
for Disease Control and Prevention, February 13-15, 1994, Atlanta, GA.
[previously denominated 10.3]
23.4 Publisher's Consents and Article - Mark S. Davis, MD. Sharps Management in
Surgery. Infection Control & Sterilization Technology, Vol. 1, No. 4, April
1995. [previously denominated 10.4] ----------
(* Filed herewith, all other exhibits previously filed with Form 10SB, Amendment
No. 1 to Form 10SB, Form 10K, Form 10K/A or Form 10Q for the quarters ended
3/31/99 and 6/30/99)
SIGNATURES
In accordance with Section 12 of the Securities Exchange Act of 1934,
the registrant caused this Registration Statement to be signed on its behalf by
the undersigned, thereunto duly authorized.
Surgical Safety Products, Inc.
(Registrant)
Date: October 13, 1999 By:/s/ Frank M. Clark
--------------------
Frank M. Clark, President and CEO
By:/s/ Donald K. Lawrence
-------------------------
Donald K. Lawrence
Vice President and Secretary
By:/s/ G. Michael Swor
-------------------------
G. Michael Swor
Treasurer
By:/s/ David Collins
--------------------------
David Collins
Acting Chief Financial Officer
Exhibit 10.35
PRIVATE PARTNER NETWORK AGREEMENT
This Private Partner Network Agreement is made and entered into
effective this ____ day of July, 1999, by and between SURGICAL SAFETY PRODUCTS,
INC., a corporation organized under the laws of the State of New York and having
its principal office at 2018 Oak Terrace, Suite 400, Sarasota, FL 34231
(hereinafter referred to as "SSP") and United States Surgical, a division of
Tyco Healthcare Group LP, a limited partnership organized under the laws of the
State of Delaware and having its principal office at 150 Glover Avenue, Norwalk,
CT 06856 (hereinafter referred to as "USS").
W I T N E S S E T H:
WHEREAS, SSP is the owner of the rights to the Oasis Touch-Access
Information System which is a network of interactive touchports containing
content for use by healthcare workers and others ("Oasis"); and
WHEREAS, SSP and USS desire to enter into an agreement whereby SSP shall
supply the Oasis system to USS or its nominees all in accordance with the terms
and conditions set forth herein.
NOW THEREFORE, in consideration of the mutual promises and covenants
contained herein and other good and valuable considerations, the receipt and
sufficiency of which are hereby acknowledged, SSP and USS do hereby agree as
follows:
1. Rights Granted. SSP hereby grants to USS the right and license to
purchase 400 Oasis Touchport system licenses (the "Licenses") and to designate
400 Hospital nominees that shall each receive one or more such Touchport systems
under such Licenses, each in form and content specified by SSP together with
wiring and other components ("Touchport"). USS agrees
<PAGE>
that it shall purchase a minimum of 200 Licenses during the first year of this
Agreement, but in any event, subject to the time schedule for installation set
forth on page 5 herein below. Such Licenses shall be purchased by purchase order
issued by USS to SSP; Licenses shall be paid for within thirty (30) days
following substantial installation of the Touchports covered by such Licenses.
The initial purchase order will list the 200 minimum Licenses. USS may alter the
Hospital nominees for installation of the Touchports covered by such Licenses at
any time prior to their installation by issuance of an amended purchase order,
as long as the total Licenses to be purchased during the first year of this
Agreement remains at least 200. Notwithstanding the foregoing, USS may not alter
any more than ten (10) Hospital nominees in any calendar quarter without the
prior written consent of SSP. For purposes of this Agreement, "Hospital" shall
mean a named hospital at a defined physical location receiving at least one
Touchport pursuant to this Agreement. It is understood and acknowledged that
some Hospitals have multiple locations, each of which will require, if
nominated, a separate License.
USS shall purchase 200 additional Hospital locations for Touchports at
any time during the first twenty-four (24) months of this Agreement by issuing
additional purchase orders to SSP within the Twenty-four (24) month period
commencing on the Effective Date. The schedule of installation for such
additional Touchports shall follow the outline set forth on page 5 of this
Agreement, except that each use of the words "Effective Date" shall be replaced
by the words "First Anniversary of this Agreement or date of purchase order,
whichever is later" as to such additional locations.
Notwithstanding the foregoing, USS may elect not to proceed with the
second purchase of Licenses for the 200 additional Hospitals in the event that
SSP has failed to enter into agreements for the installation of, or actually
installs, Touchports in at least 200 other hospitals
<PAGE>
or surgery centers in the United States (other than Hospitals) as of the first
anniversary date of this Agreement. Any such election must be made by USS in
writing to SSP within 30 days following the said first anniversary date. To the
extent that USS orders more than 200 Licenses during the first year of this
Agreement, however, USS shall be entitled to elect not to proceed with ordering
only 200 additional Hospitals less the number of such additional Licenses
already ordered. By way of example, if USS orders 210 Licenses (200 initial
order plus 10 additional Licenses) during the first year of this Agreement, USS
may elect only to not proceed with ordering 190 additional Hospitals within 30
days following the said first anniversary date, and shall be bound to its order
for the 10 additional Licenses ordered during such first year. In addition, to
the extent that USS orders more than 200 Licenses during the first year hereof,
the number of additional non-USS hospitals in which SSP must install Touchports
(or enter into agreements for the installation thereof) pursuant to the first
sentence of this paragraph shall be reduced by the number of Licenses over 200
so ordered by USS.
SSP agrees that neither SSP nor any third party other than USS may place
any Touchports in any of the Protected Departments of the said 400 Hospitals
designated in the aforementioned USS purchase orders, unless installed prior to
the receipt of a purchase order or unless USS does not exercise its right of
first refusal set forth below. The following departments shall be considered
"Protected Departments" for purposes of this Agreement:
OR
Labor & Delivery
ER
Ambulatory / Same Day Surgery / Outpatient
Nuclear Medicine
Intensive Care
Orthopedic / Ortho Casting Room
Dialysis (attached or unattached)
<PAGE>
If SSP receives a request from a third party or if SSP elects to place
one or more Touchports in a Protected Department in a Hospital already reserved
by USS, SSP shall give ten (10) days written notice thereof to USS. USS shall
have a right of first refusal to place a Touchport in such location under the
terms and conditions set forth herein. If USS decides to exercise its right of
first refusal, it shall notify SSP in writing of its decision to do so with ten
(10) days of its receipt of such notice. Failure to provide notification shall
be deemed a waiver of the right of first refusal as it relates to said location
and SSP shall be free to place a Touchport in the said location notwithstanding
anything contained herein to the contrary. USS shall pay the License fee for
each such Touchport placed pursuant to this paragraph within thirty (30) days
after exercising its right of first refusal. Notwithstanding the foregoing, if
USS is notified of third-party proposed placements exceeding ten (10) locations
in any month of this Agreement, and exercises its right of first refusal in
relation thereto, USS may pay the License fees for such Touchports in three
installments thirty (30), sixty (60) and ninety (90) days after exercising its
right of first refusal. No payments shall be due under this paragraph, however,
unless and until SSP confirms that it has sufficient Touchports in stock, or
will have a sufficient number in stock within thirty days, to supply the
designated new locations.
The date of full execution of this agreement shall be the "Effective
Date". On or before ninety (90) days from the Effective Date, USS shall provide
SSP with written notification of the names and addresses of the 200 Hospital
nominees which shall receive the initial 200 Touchports under the Licenses
described herein above, together with the associated USS sales representatives
and the contact persons located at such Hospitals. The Hospitals installed to
date pursuant to the Collaborative Agreement between the parties dated October
28, 1998 shall each be counted toward the said 200 License minimum. Said
Touchports shall be installed by SSP
<PAGE>
and become substantially operational in accordance with the following schedule:
* On or before ninety (90) days from the Effective Date, USS shall
furnish to SSP the names of the Hospital nominees.
* On or before ninety (90) days from the Effective Date, USS
representatives shall be trained by SSP. SSP shall be responsible for all of
SSP's expenses incurred in providing such training.
* On or before one hundred twenty (120) days from the Effective Date,
field presentations shall be made by USS to Hospital nominees and Hospitals will
have acknowledged by way of an Oasis site survey substantially similar to the
form attached hereto as Exhibit "A" their acknowledgment of responsibilities as
outlined in Paragraph 2(C) herein below.
* On or before one hundred eighty (180) days from the date each Hospital
has acknowledged said site survey, installations and in services shall be
completed at Hospital nominees.
All nominated Hospitals must meet with SSP's written approval, which
approval may not be unreasonably withheld. Upon receipt of nominations, SSP
shall determine the order of installations with input from USS.
At all times during the term of this agreement, the Touchports shall
remain the property of SSP and the Hospital shall merely have a sublicense from
USS to utilize the Touchport and its related amenities. Prior to installation of
the Touchport, USS shall cause each Hospital to execute a Site Sub-License
Agreement substantially similar to the form annexed hereto and made a part
hereof as Exhibit B. In the event of any approved move of any Touchport, USS
shall execute and cause the Hospital at the new location to execute a new Site
Sub-License Agreement. Upon the expiration of this agreement, whether by
termination or expiration of the
<PAGE>
term hereof, the Site Sub-License Agreements shall automatically terminate and
the Touchport systems and related amenities shall remain the property of SSP.
Each Hospital receiving a sub-license hereunder shall agree to use each
Touchport subject to this Agreement or cause such Touchport to be used in a
careful and proper manner and in accordance with any and all documentation and
manuals provided by SSP, and shall comply with all laws, ordinances, and
regulations relating to the possession, use, or maintenance of such Touchport.
2. Installation. The following shall be the obligations of the parties
with respect to the installation process:
A. SSP. SSP shall make arrangements for the shipping of each
Touchport via a carrier selected by USS. USS shall be responsible for and shall
pay all costs of shipment and transportation of the Touchport systems from the
production facilities to their intended destination. SSP shall coordinate and
manage the installations of each Touchport, and shall pay for all its personnel
required to install the Touchport system upon its arrival at the Hospital,
excluding any wiring and Internet connectivity infrastructure. Risk of loss
shall be born by USS and the Hospital upon shipment from the production
facility, except for losses caused by the negligence or wilful misconduct of SSP
or its employees or agents. SSP shall be responsible for filing any insurance
claims connected with any damage to such Touchports during shipment.
B. USS. USS shall cause representatives of USS to be available
for training as reasonably required by SSP. USS sales representatives will make
the initial sales presentations and provide general sales assistance as needed
to SSP sales representatives. It is the intent of all parties that the training
by SSP be accomplished in a series of four to six regional meetings, each party
bearing their own expense.One person within USS shall be designated as the point
<PAGE>
of contact for coordinating any Hospital activities and in service production
activities.
C. Hospitals. Each Hospital must appoint an Oasis coordinator to
coordinate the maintenance and operation of the Oasis system. Each Hospital
shall also appoint a technical point of contact for coordinating installation
and Internet connectivity. Each Hospital must provide Internet connectivity at
such Hospital's sole cost and expense as specified in a schedule to be provided
by SSP, which shall include appropriate wiring. Each Hospital must work with the
appropriate local exchange carrier (LEC/CLEC) to coordinate alternative Internet
connectivity.
D. Inspection. SSP shall, at any and all times during regular
business hours, have the right to enter into and on the premises where a
Touchport may be located for the purpose of inspecting the same or observing its
use. USS shall give SSP (or cause such to be given to SSP by the Hospital where
the Touchport is located) immediate notice of any attachment or other judicial
process affecting any item of the Touchport and shall, whenever requested by
SSP, advise SSP of the exact location of a Touchport.
E. Risk of Loss. USS shall require each Hospital receiving a
sub-license hereunder to assume and bear the entire risk of loss and damage to
any Touchport or any part thereof which shall impair any obligations of USS or
such Hospital under this Agreement or the applicable sub-license, except for
loss or damage caused by the negligence or wilful misconduct of SSP or its
employees or agents. In the event of loss or damage of any kind to any Touchport
or part thereof, except where caused by the negligence or wilful misconduct of
SSP or its employees or agents, such Hospital shall pay to SSP the cost of
placing the same in good repair, condition, and working order, or in the event
such cannot be repaired, the replacement cost thereof.
<PAGE>
F. Personal Property of SSP. The Touchports and any attachments,
improvements and/or modifications thereto are, and shall at all times be and
remain the personal property of SSP, and not be deemed a fixture,
notwithstanding that the Touchports or any part thereof may now be, or
hereinafter become, in any manner affixed or attached to, or embedded in, or
permanently resting on, real property or any building thereon, or attached in
any manner to that which is permanent as by means of cement, plaster, nails,
bolts, screws, or otherwise.
3. Identification of Hospitals. USS shall identify the Hospitals to
receive the Touchports within the time period referenced herein by written
notification to SSP. If, at any time prior to receipt of such notification, SSP
has received notification from another private partner network participant or
has otherwise agreed to install a Touchport in a Hospital selected by or
nominated by USS, the Hospital selected by USS shall not receive the Touchport
pursuant to this agreement and USS shall nominate another Hospital in its place
within fourteen (14) days of receipt of notification from SSP. Each Hospital
shall be entitled to receive such number of Touchports as USS and SSP shall
determine, however, only one of said Touchports shall count towards the 400
minimum Licenses required hereunder. The location of the Touchport(s) within
each hospital shall be within a surgical environment and be subject to SSP's
approval, which shall not be unreasonably withheld. USS is not permitted to move
any Unit without the express written consent of SSP.
4. Co-Branding. At the election of USS (which said election shall be
made at or prior to the time of nomination of a Hospital) the Touchports to be
installed may be co-branded as follows: "Oasis, by United States Surgical". Such
co-branding shall be reflected on the exterior of the Touchport.
5. Content Participation. All content, method of operation and other
<PAGE>
material to be furnished and supplied by SSP through the Touchport shall be
subject to the absolute control of SSP. SSP shall select any and all content and
materials to be provided through the Touchport together with any related
services. SSP shall have the right to provide product in services, E-Commerce
and other products and services from manufacturers, suppliers and distributors
selected by SSP. During the term of this agreement, USS shall pay for and
maintain a minimum of one hundred forty (140) product in-services on an average
of at least 80% of Oasis system Touchports installed in hospitals and surgery
centers in the United States by SSP (i.e. not limited to the Hospitals
designated hereunder) and 100% of those Touchports installed in the Hospitals
nominated hereunder. Each product in service shall be developed by SSP with
USS's assistance and shall be subject to the fee schedule referenced below.
For purposes of this agreement, product in services are defined as
individual modules designed to educate healthcare workers or others on capital
equipment, medical devices and pharmaceuticals. These modules may exist in the
current Oasis format or may be presented in a different design based on the
subject. USS shall provide all raw media assets required to create the in
service module. SSP will build the in service using USS-approved content,
subject to reasonable content review and approval by the SSP Medical Advisory
Panel. None of the members of said Panel shall be employees of or consultants
for any USS competitors. USS is responsible for approval of final in service
modules. The estimated time periods for creating modules is as follows:
A. Within sixty (60) days from the Effective Date, USS shall select
in service topics.
B. Within ninety (90) days from the Effective Date, USS and SSP
shall create an outline of key points and identify media assets
needed.
C. Within one hundred twenty (120) days from the Effective Date, USS
shall have provided SSP with media assets.
D. Within one hundred fifty (150) days from the Effective Date, SSP
shall have built in service and posted a reasonable facsimile of
the assets to the Internet for USS to view.
<PAGE>
E Within one hundred eighty (180) days from Effective Date, USS
shall have viewed, via Internet, in service draft and approved or
made reasonable changes.
F On or before two hundred ten (210) days from Effective Date, SSP
shall have implemented changes and posted to Internet for final
approval.
G Thereafter, SSP shall have released in service module for network
distribution.
Product based modules produced by SSP for USS shall become the sole
property of USS. SSP shall retain the right to display USS modules in SSP
hardware for the term hereof, but shall cease to actively display USS modules in
SSP Touchports upon the termination of this Agreement, except upon the prior
written consent of an authorized representative of USS. SSP may, however, use
USS Modules for demonstration, education and development purposes.
All other types of modules shall remain the sole property of SSP. SSP will
bill for the fees associated with delivered product in service modules as
provided for in Paragraph 7(E) below on the first day of the month following the
date of delivery of the product in service module and payment shall be due
within ten (10) days. Said billing shall be for the inservice modules delivered
multiplied by $2.00 (monthly fee) further multiplied by a sum equal to 400 plus
the number of non-USS hospitals containing Touchports which will receive the
inservice modules. By way of clarification, Number of inservice modules x $2.00
x (400 + the number of hospitals not covered by this agreement) = monthly fee.
Notwithstanding the foregoing, USS shall pay to SSP the balance due for the 140
guaranteed inservice units on the 211th day following the execution of this
Agreement, unless any of such units have not been delivered as of that date due
to delays caused by SSP.
6. Term and Termination. The license to utilize the Touchports
referenced herein shall commence upon the substantial installation of a
Touchport and shall continue for a period of three (3) years thereafter for each
Touchport installed. It is understood and
<PAGE>
acknowledged that the Touchports will be installed in phases and that the
license rights for each particular Touchport shall commence upon substantial
installation. Substantial installation shall mean delivery of the Touchport to
the Hospital and connection to the Internet. The Hospitals and USS shall not
delay this process. Upon expiration of the three (3) year period, as it relates
to each Touchport, the Touchport shall be removed from the Hospital and shipped
to a destination selected by SSP and at SSP's expense.
Upon the expiration of the three (3) year period for the last
Touchport to be installed pursuant to this agreement, the obligation of USS to
maintain the product inservices as required by Paragraph 5 above shall terminate
unless otherwise agreed to between SSP and USS.
During the term of this agreement, USS shall cause its sub-licensing
Hospitals to cause the Touchports to be fully operational and to function in the
ordinary course of business subject to the maintenance obligations of SSP
provided for herein. During the term of this agreement and following termination
of this agreement, USS will not use any sign or materials containing the name
and trademark of SSP and Oasis or any other trademark owned by SSP unless
otherwise agreed to in writing by SSP.
If USS with regard to any Touchport, module or modification (i) fails to
pay any amount due hereunder within ten (10) days after the same is due and
payable, or (ii) if any execution of any other writ of process shall be issued
in any action or proceeding against USS whereby said equipment may be seized,
taken, or detained, or (iii) if a proceeding in bankruptcy, receivership, or
insolvency shall be instituted by or against USS, or (iv) if USS shall enter
into any arrangement or composition with its creditors, or (v) if USS, with
regard to any Touchport or Touchports, fails to observe, keep, or perform any
other provision of this Agreement required to be observed, kept, or performed by
USS, SSP shall, if such default shall continue for thirty (30)
<PAGE>
days after written notice thereof to USS, and such default shall not have been
cured within said thirty (30) days, have the right to exercise any one or more
of the following remedies:
1. To declare the entire amount of license fees and any other
monies due hereunder (together with estimated fees for inservice modules and
maintenance over the remainder of the term) immediately due and payable as to
any or all Touchports, without notice or demand to USS.
2. To sue for and recover all license fees and any other payments
then accrued or thereafter accruing, with respect to any or all Touchports.
3. To take possession of any or all Touchports, without demand or
notice, wherever the same may be located, without any court order or other
process of law. USS hereby waives any and all damages occasioned by such taking
of possession.
(4) To terminate this Agreement as to any or all Touchports. (5)
To pursue any other remedy at law or in equity available to SSP.
Notwithstanding any repossession, or any other action which SSP may
take, USS shall be and remain liable for the full performance of all obligations
to be performed by USS under this Agreement. All such remedies are cumulative,
and may be exercised concurrently or separately at the sole option of SSP .
7. Fees. The following fees shall be due with respect to this agreement,
paid by wire transfer to the account designated by SSP or otherwise by cleared
funds which shall be due on the dates indicated and deemed paid upon receipt by
SSP:
A. Initial Investment. On or before August 10, 1999, USS shall
pay to SSP the sum of $100,000.00.
<PAGE>
B. Price of Licenses. Each of the first 200 Licenses purchased by
USS shall be at a price of $1,500. For Licenses purchased above 200, the price
shall be $1,000 which shall be paid for at the times set forth in Paragraph 1
above.
C. Monthly Maintenance Fee. Commencing on the date of substantial
installation of each Touchport and payable on the first day of each month
thereafter during the term of this agreement (with any partial months being
prorated), the Hospital which has sub-licensed the License shall pay to SSP a
monthly maintenance fee of $149.00 per month per Touchport, which payment shall
be due and payable in advance. USS may offer a 10% discount on such pricing to
any Hospital that makes annual up-front payments for each year of the
sublicense. In the event a Hospital fails to make a monthly maintenance fee
payment, then, and in that event, SSP shall notify USS within 30 days of its due
date. Within 30 days of receipt of written notification, USS shall relocate the
Touchport in another hospital acceptable to SSP. USS shall be responsible for
any Monthly Maintenance Fee following an initial 60 days of delinquency, but in
no event shall SSP be required to waive claims for such initial 60 days Fees
more than 40 times for the 400 Touchports collectively during the term hereof.
D. Non USS Touchports. Any additional Touchports installed in a
Hospital at the request of USS or the Hospital shall be billed pursuant to a
separate agreement.
E. Sales and Use Tax. USS shall be responsible for any sales and
use taxes associated with the installation of the Touchports, monthly
maintenance fee or otherwise due with respect to this agreement. USS shall keep
all of the Touchports free and clear of all levies, liens, and encumbrances and
shall pay all license fees, registration fees, assessments, charges, and taxes
which may now or hereafter be imposed on the leasing, renting, possession, or
use of the Touchports.
<PAGE>
F. Product Inservices. With respect to each product inservice
module provided, USS shall pay to SSP the following fees:
(i) Production fees for USS during the term of this agreement
shall be charged by SSP at the rate of $1,000.00 per product delivered. Payment
shall be due within ten (10) days. Production shall mean the formulation of the
module for display on the Touchport as designed by SSP from time to time.
Production shall mean the formulation of the module for display on the Touchport
as designed by SSP from time to time.
(ii) Monthly fees (which shall be paid in advance on the first
day of each month) for inservices, per product, which shall be calculated in
accordance with the formula set forth in Paragraph 5 above shall be $2.00 per
month.
(iii) Update fees for production inservices shall be charged at
the rate of $150.00 an hour with a one hour minimum time.
In the event that a Touchport ceases to be active and in operation in
any particular designated Hospital, then, and in that event, the fees due
hereunder shall continue notwithstanding such inactivity, unless same arises out
of the willful or negligent acts of SSP, or SSP's failure to comply with any of
its obligations hereunder. Within ninety (90) days from the discontinuance of
operation of any particular Touchport during the term hereof, USS shall cause
the Touchport to be shipped at USS's sole cost and expense to another designated
Hospital acceptable to SSP and USS for installation within such designated
Hospital with connection being completed within said ninety (90) day period.
In consideration for the $149.00 per month maintenance fee required by
Paragraph 7(B) above, during the term of this agreement, SSP or its agents,
shall provide appropriate maintenance of the Touchports in order to service same
as necessary with an anticipated
<PAGE>
turnaround time not to exceed 72 hours from written notification. This
maintenance shall include all necessary repairs excluding those caused by
willful or negligent handling of the Touchports. Notwithstanding anything
contained herein to the contrary, SSP shall not be responsible for any delays or
inactivity resulting from acts of God, strikes, shortage of materials or labor
or other matters beyond SSP's control.
8. Rebates. In consideration for the payment of the fees referenced in
Paragraph 7 hereof and full compliance by USS under the terms of this agreement,
USS shall be entitled to the following rebates so long as USS is not in breach
of this agreement:
A. National Rebate. USS shall receive a rebate of three percent
(3%) of the gross Content Provider Revenue (exclusive of sales and use taxes)
received by SSP from non-USS content providers for each Touchport located in a
surgical application area. A surgical application area shall be deemed to be an
area where a Touchport is located within a hospital operating room or same day
surgery area within the United States. This shall not relate to revenues
generated from Touchports in any other Touchport locations. "Content Provider
Revenue" shall mean revenue received by SSP for the display of individual
modules designed to educate health workers on capital equipment, medical devices
and pharmaceuticals excluding any production costs or revenues. Content Provider
Revenue does not include revenue from any other Hospital applications or any
revenue relating to E-Commerce but is merely the revenue paid to SSP by Content
Providers for the display of information on the Touchport relating to medical
devices, capital equipment and pharmaceuticals. Further, this shall not include
any revenue received by SSP in the way of a commission or percentage of sales by
such content providers.
B. USS Rebate. USS shall receive a rebate equal to twelve percent
(12%) of
<PAGE>
the gross Content Provider Revenue received from the surgical application
Touchports located within each designated Hospital. The definition of Content
Provider Revenue shall be identical to that referenced in Subparagraph (A)
above. The USS rebate shall be in lieu of the National Rebate referenced in
Subparagraph (A) above for any Hospital for which such USS rebate is paid.
C. Commission. If, during the term of this agreement, SSP
installs an additional Touchport in a designated Hospital (other than those
Touchports designated by USS), USS shall receive, as a commission, ten percent
(10%) of the retail sale price of the Touchport unit (exclusive of sales tax,
monthly maintenance fees and other services) charged to the Hospital by SSP,
which commission shall be paid within ninety (90) days of substantial
installation of such additional Touchport. USS is responsible for compensating
its sales representatives for any work performed by them.
The rebates referenced in this Section shall commence upon the
substantial installation of the first Touchport covered by this agreement and
terminate upon termination of this agreement. Notwithstanding the foregoing, the
USS Rebate shall terminate, with respect to any designated Hospital, upon the
removal of the Touchport from said Hospital. SSP shall provide USS with
reasonable advance notice of the removal of any Touchport covered by this
Section. All rebates are based upon retail prices of inservices. Accordingly,
SSP may change the prices at anytime.
9. Insurance. At all times during the term of this agreement, USS shall
maintain casualty insurance in amounts and with companies acceptable to SSP on
the Touchport systems and its related amenities showing SSP as the loss payee.
Delivery of the Touchport shall be "FOB" place of shipment which means USS shall
bear the risk of loss of the Touchport upon placing such Touchports in the
custody of a carrier for shipment to the designated Hospital or
<PAGE>
recipient. SSP shall in no event have any responsibility for any damage caused
to the Touchports during shipment. It shall be the sole responsibility of SSP to
file any appropriate claims for reimbursement from the carrier. USS shall
inspect each Touchport within seven (7) days after installation. Unless USS,
within said period of time, gives written notice to SSP, specifying any defect
in or other proper objection to the Unit, USS agrees that it shall be presumed
conclusively, as between the SSP and USS, that (i) USS has fully inspected and
acknowledged that the Unit is in good condition and repair, (ii) USS is
satisfied as to the condition and repair of said Unit, and (iii) USS has
accepted the Unit.
10. Updates/Content/Modification of Touchports. During the term of this
agreement, SSP reserves the right to install any updates and make any
modifications to the Touchports and their related hardware and controls all
rights with respect to the content provided via the Touchports. It is understood
and acknowledged that within the Touchport, SSP may be selling other products
and services and USS shall have no rights relative to same other than as set
forth herein. SSP, its employees and agents, shall have reasonable access to the
Touchports for inspection of same and maintenance where required hereunder.
11. Notice. All written notices required or permitted hereunder shall be
deemed effective and duly given:
(i) when personally delivered;
(ii) when sent by telephone facsimile (the sender shall also send
a "hard copy" following the facsimile, however, the notice shall be effective
upon the transmission of the facsimile if confirmed by Sender with words
"Confirming delivery of notice from
- ----------------");
(iii) one day after depositing in the custody of a nationally
recognized receipted overnight delivery service; or
(iv) at least three (3) days after posting in the United States
first class, registered or certified mail; and, in the case of (iii) or (iv)
above with postage prepaid and addressed to the
<PAGE>
recipient at its address as set forth as follows:
TO SSP: Surgical Safety Products, Inc. ("SSP")
2018 Oak Terrace, Suite 400
Sarasota, FL 34231
Telecopier Number: (954) 925-0515
With a copy to: Sam D. Norton, Esq.
Norton, Gurley, Hammersley & Lopez
1819 Main Street, Suite 610
Sarasota, FL 34236
Telecopier Number: (941) 954-2128
TO USS: United States Surgical
Legal Department
150 Glover Avenue
Norwalk, CT 06856
Telecopier Number: (203) 846-5988
Either party may change its address by giving notice of such change in
the manner prescribed above.
12. Relationship of the Parties. During the term hereof, the
relationship between SSP and USS is that of Licensor and Licensee. USS, the
designated Hospital, its agents and employees shall, under no circumstances, be
deemed agents or representatives of SSP. Nothing contained herein shall be
construed as a joint venture or partnership between SSP, USS or any designated
Hospital. Nothing contained herein shall grant to USS or any designated Hospital
exclusive rights with respect to the Oasis Touchport system and the content
provided therein.
During the term of this agreement, USS and the designated Hospital shall
not install or maintain any other kiosk or computer based information access
system similar to or in competition with SSP or the Oasis Touchport.
13. Termination of Prior Agreements. Each party acknowledges that no
representation or statement, and no understanding or agreement, has been made,
or exists and
<PAGE>
that entering into this agreement, it has not relied upon anything done or said
or upon any presumption in fact or in law, with respect to this agreement, or
with respect to the relationship between the parties, other than as expressly
set forth in this agreement. This agreement terminates and supercedes all prior
agreements, if any, between the parties with respect hereto.
14. Indemnification of SSP. USS hereby agrees to indemnify and hold SSP,
its employees, officers, directors and agents harmless with respect to any
losses, liability or costs incurred by SSP, its officers, employees, directors
or agents arising out of any product liability or other malfunction of any
products sold or displayed pursuant to the product inservices referenced herein.
SSP shall be entitled to place disclaimers in a conspicuous manner on the
Touchports deemed acceptable to SSP and USS.
15. Assignment. This agreement may not be assigned, encumbered or
transferred by USS (with the exception of the designation of the Hospitals
subject to the approval of SSP as provided above) without the prior written
consent of SSP. This agreement shall be binding upon the successors of USS. SSP
may assign this agreement without the consent of USS.
16. Entire Agreement. This Agreement constitutes the entire agreement
between SSP and USS respecting the subject matter hereof. It shall not be
amended, altered, or changed except by a written agreement signed by the parties
hereto.
17. Governing Law. This agreement and the site sublicense agreements
shall be governed by and construed in accordance with the laws of the State of
Florida. The venue of any action brought to enforce this agreement or any site
sublicense agreement shall be Sarasota County, Florida.
18. Attorney's Fees. In the event of litigation arising out of this
agreement or the site sublicense agreements, the prevailing party shall be
entitled to an award of its reasonable
<PAGE>
attorney's fees and costs incurred both at the trial and appellate levels.
19. Confidentiality. SSP understands and acknowledges that USS and USS
understands and acknowledges that SSP operates under the laws, statutes and
regulations of various state and federal agencies, some of which are unique to
the security-sensitive medical industry. Both SSP and USS shall endeavor, to the
extent permitted by law, make reasonable efforts to comply with the reasonable
written instructions and reasonable written requests of the other regarding
security and confidentiality pertaining to this Agreement and all other aspects
of the relationship between the parties and information that is exchanged,
shared or handled by either party to this Agreement.
Both parties agree and do hereby agree that all information which could
reasonably be considered "Confidential" by the other will not be distributed to
their employees, affiliates or to the general public, except on a "Need to Know
Basis."
For the purposes of this section only, Confidential Information shall
include any non-public information that the disclosing party reasonably
designates as confidential, or which under the circumstances surrounding
disclosure, should reasonably be considered confidential. Confidential
information includes, but is not limited to information relating to a Party's
released or unreleased software and hardware products, business policies and
practices including all tangible and intangible materials containing information
that is not public or not known to the public whether or not it is in written or
printed form or whether it is machine or user readable or not.
20. Breach. In the event of a breach of this agreement, the parties
shall have all rights and remedies provided for at law and in equity. The
obligation to pay the fees referenced herein shall be the obligation of USS.
<PAGE>
21. Miscellaneous. Nothing contained in this agreement shall be
construed as conferring by implication, estoppel or otherwise upon USS or any
designated Hospital, any license under any trade secrets or know-how of SSP and
no such license or other rights shall arise from this agreement or from any
acts, statements or dealings resulting in the execution of this agreement. SSP
retains all ownership rights with respect to the Touchport system, its contents
now existing or as may be developed in the future. No representation or warranty
has been or is made by SSP with respect to any services or products sold or
provided through the Touchport system by others, it being understood that SSP
shall not be liable for any loss, damage or expense arising from any claim with
respect to services or products provided via the Touchport by those other than
SSP.
IN WITNESS WHEREOF, the undersigned have executed this agreement
effective the day and year set forth above.
SURGICAL SAFETY PRODUCTS, INC.,
a New York Corporation
By: _____________________________
Print Name: _________________________
As Its: ______________________________
"SSP"
<PAGE>
United States Surgical, a division of Tyco
Healthcare Group, LP, a Delaware Limited Partnership
By: _____________________________
Print Name: _________________________
As Its: ______________________________
"USS"
<PAGE>
Exhibit A - Site Survey
OASIS
[GRAPHIC OMITTED]
HOSPITAL PROFILE
- --------------------------------------------------------------------------------
Name of Hospital:
- --------------------------------------------------------------------------------
Address of Hospital
installation:
- --------------------------------------------------------------------------------
Size of Hospital: Beds: Rooms in Rooms
Main OR: in L/D:
- --------------------------------------------------------------------------------
Description of Hospital: (i.e.
IHN, GPO, etc.)
- --------------------------------------------------------------------------------
Detailed description of current procedures for reporting bloodborne pathogen
exposures (attach policy if available, obtain from Infection Control
Department): Example: worker notifies Supervisor, calls needlestick hotline,
reports to Employee Health Services.:
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
Description of current methods used for training staff on new techniques,
procedures, devices, etc. (Obtain from OR department): Example: Weekly/monthly
manufacturer inservices.
- --------------------------------------------------------------------------------
Description of annual training required for employees (Obtain from Employee
Health Services department): Example: Safety training, 12 modules due on annual
review.
- --------------------------------------------------------------------------------
The most identifiable Employee ID # Social Other
identification number for Security #
Hospital personnel is: This
is the logon ID to be used
for OASiS.
============================= =================== =============== =============
<PAGE>
- --------------------------------------------------------------------------------
NETWORK/QUESTIONS: Please circle yes or no below.
(Information Systems Department should
know this information)
1. Does your Hospital have a LAN (local are network) installed?
(If no, go to question 4.)
Yes No
- --------------------------------------------------------------------------------
2. Do you have Internet access from the LAN? Yes No
- --------------------------------------------------------------------------------
3. What is the connection speed/type (i.e. T1, T3, ADSL, etc)?
- --------------------------------------------------------------------------------
4. Would it be possible to provide Internet access (via cable, Yes No
modem, ADSL, etc.) from the proposed TouchPort location?
====================================== ===================== ==================
CONTACT INFORMATION
Contacts Name Title Phone Email
- --------------------------------------------------------------------------------
Key Contact for
this project:
- --------------------------------------------------------------------------------
Employee
Health:
- --------------------------------------------------------------------------------
Infection
Control:
- --------------------------------------------------------------------------------
Risk
Management:
- --------------------------------------------------------------------------------
Education:
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
Surgery:
- --------------------------------------------------------------------------------
Labor &
Delivery:
- --------------------------------------------------------------------------------
Emergency:
- --------------------------------------------------------------------------------
CEO:
- ---------------------
COO:
- ---------------------
CFO:
- ---------------------
Information
Systems
(network):
- --------------------------------------------------------------------------------
Marketing
Communication
s:
- --------------------------------------------------------------------------------
Other Key
Personnel:
- --------------------------------------------------------------------------------
Other Key
Personnel:
- --------------------------------------------------------------------------------
If you have questions, please call Surgical Safety Products at 1-800-953-7889.
Please attach information and comments you feel to be pertinent for the
installation process of OASiS. Thank you! Mail the completed form (with
attachments) to:
Surgical Safety Products, Inc.
2018 Oak Terrace
Sarasota, FL 34231
<PAGE>
Name of Hospital personnel filling out form
Name of USS Representative filling out form
<PAGE>
Hospital Technical Requirements: OASiS Touch-Access Information
Hospitals must provide OASiS with Internet connectivity and basic
network infrastructure. The connectivity may be through an existing Internet
gateway, or an alternative Internet connection.
<PAGE>
Preferred Connectivity:
[ALL GRAPHICS HAVE BEEN OMITTED]
Existing Internet Gateway
To use an existing gateway the Hospital must provide an Ethernet port at the
location of each TouchPort. The existing gateway must have continuous, full
bandwidth (50kb/s per TouchPort) throughput without firewalls that would prevent
OASiS administrators from communicating with the OASiS terminal. In the event of
poor data throughput, packet loss, or any manifestation indicative of a slow
network, the Hospital must provide alternative Internet connectivity.
Alternative Connectivity:
Based on Hospital Location
Where a suitable existing gateway is not available the Hospital must accommodate
an alternative Internet connection with the appropriate network infrastructure.
These alternatives will be selected based upon availability and cost. OASiS will
coordinate the installation of these alternatives.
<PAGE>
Cabling from the demarcation point to the proper router port is needed. This
must be in accordance with the particular connectivity solution provided by the
LEC/CLEC. The Hospital is responsible for providing and installing Cat 5 10baseT
Ethernet cable (fully tested and verified using a Cat 5 Ethernet test kit) from
the router port to each TouchPort in a straight through configuration. If there
are more TouchPorts than Ethernet ports, a hub will be required to aggregate
multiple TouchPorts to one port. If the distance between a TouchPort and the
router port or hub port is greater than 328 feet, a repeater will be necessary.
(IEEE 8023)
Acknowledged
<PAGE>
Exhibit B -- Site Sub-License Agreement
OASiS Touch-Access Information Service Site/Software License Agreement (3/99)
This software ("Software") and the associated hardware ("TouchPorts") is being
sublicensed to you by United States Surgical pursuant to its license agreement
with Surgical Safety Products, Inc. ("SURG") as Version 2.x and is provided on
an "AS IS" basis, for your facilities use only. You agree not to reverse
engineer, decompile, disassemble, alter, duplicate, make copies of, distribute
or provide others with the software. You may not use this software on any
computer other than SURG supplied and approved TouchPorts.
By accepting the terms of this sublicense agreement you agree that SURG is
permitted to limit, deny or cancel some or all of the functionality of this
version at any time, without prior notice.
As part of this software version SURG is granting a limited access to the OASiS
network, servers, directories, listings, information and databases ("OASiS
Services and Information").
You agree to pay to SURG $149.00 per month for the use of each SURG Touchport
placed in your facilities during the term of this sub-license agreement. Failure
to make timely payment of such fee shall entitle United States Surgical to
terminate this sub-license on ten (10) days written notice to you. You shall be
responsible for any and all sales and use taxes associated with the fees due
hereunder.
At all times during the term of the agreement, the Touchports shall remain the
property of SURG and all content, method of operation and other materials to be
furnished and supplied by SURG through the Touchport shall be subject to the
absolute control of SURG.
The OASiS Service and Information may also be accessible by other software
applications and may be published on the SURG or OASiS websites. SURG makes no
warranty or guarantee as to the availability or reliability of the OASiS
Services and Information to you or any other user.
This access granted to you or any other user can be terminated, limited or
denied at any time, temporarily or permanently, with no advance notice. The
OASIS network, servers, directories and databases functionality may be changed,
reduced or limited at any time.
<PAGE>
SURG may elect to grant different grade of service, different levels of access
or no access at all and different priorities to different users or to different
functions, at any time without prior notice at its sole discretion.
SURG may elect in its sole discretion to condition the continuation of access to
server, on you accepting software improvements, corrections, adaptations, or
changes to the OASIS program, or to the OASIS numbers (UIN).
By using the OASIS Software or the OASIS Services and Information, you agree to
and acknowledge the following: 1) Information, other than employee and
Hospital identification numbers, your employees elect to post on the various
OASIS Directories, during the registration procedure or thereafter become
the property of SURG. 2) SURG may choose to provide third parties with the
content which is available to the public on the OASIS directories and
listings or any part thereof. 3) SURG may gather statistics and other
information concerning the use of, and originated from the OASIS Software,
OASIS Servers, the OASIS network, the SURG and OASIS websites as well as
registration parameters provided by you, your software and configuration,
provided that if published will be done only in aggregate form without user
names or identification numbers; 4) Not to exclusively use or soley rely on
the OASIS software SURG and OASIS websites, the OASIS Services and
Information or any other program, information or service whatsoever related
thereto for "mission critical" applications and use. "Mission critical"
applications and use shall mean applications and use that may result in
damage if failed;
All information you and employees of your facility access by using the OASIS
software or the OASIS Various Directories and Listings ,or the website, or
information sent to you by other users, is provided by the users, and is not
endorsed by SURG.
By using the OASIS Software, system, network or the OASIS various directories
and listings you agree to: 1) Determine whether the Information complies
with your needs; 2) Determine whether you have adequate legal rights to
store, reproduce or otherwise make use of Information in the manner
contemplated by you; 3) Comply with any legal obligations, including but not
limited to, obligations imposed by copyright, secrecy, defamation, decency,
privacy and export laws; 4) Use each Touchport subject to this Agreement or
cause such Touchport to be used in a careful and proper manner and in
accordance with any and all documentation and manuals provided by SSP, and
to comply with all laws, ordinances, and regulations relating to the
possession, use, or maintenance of such Touchport.
<PAGE>
THE VARIOUS OASIS DIRECTORIES, LISTINGS AND DATABASE INFORMATION ARE PROVIDED ON
AN "AS IS, AS AVAILABLE" BASIS. SURG MAKES NO WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, THOSE OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE, WITH RESPECT TO THE OASIS SOFTWARE, THE OASIS PROGRAM, THE
OASIS NETWORK, SERVERS' SOFTWARE, SERVICE OR ANY INFORMATION OF THE OASIS
VARIOUS DIRECTORIES,LISTINGS AND DATABASES OR ANY KIND OF INFORMATION DELIEVERED
OR SENT BY USERS THROUGH THE OASIS SOFTWARE, SERVERS' SOFTWARE, THE WEBSITE, THE
OASIS NETWORK OR THE OASIS VARIOUS DIRECTORIES AND LISTINGS.
SURG DOES NOT WARRANT, GUARANTEE OR MAKE ANY REPRESENTATIONS REGARDING THE USE
OR THE RESULTS OF THE USE OF THE OASIS SOFTWARE, THE OASIS NETWORK,THE SERVICE
AND THE ACCESS TO THE SERVERS, OR THE INFORMATION PROVIDED BY THE OASIS VARIOUS
DIRECTORIES, LISTINGS AND DATABASES IN TERMS OF THE ACCURACY, RELIABILITY,
QUALITY, VALIDITY, STABILITY, COMPLETENESS, CURRENTNESS, OR OTHERWISE OF THEIR
CONTENTS OR PRODUCTS. THE ENTIRE RISK AS TO THE RESULTS AND PERFORMANCE OF THE
SOFTWARE, THE SERVICE, THE OASIS NETWORK, THE OASIS PROGRAM, AND ACCESS TO THE
SERVERS, OR THE OASIS VARIOUS DIRECTORIES AND LISTINGS DATA, IS ASSUMED BY USER.
<PAGE>
SURG does not warrant or guarantee that the functions or services performed by
SURG will be uninterrupted or error-free or that defects in the OASIS program
and the OASIS Services and Information will be corrected.
You acknowledge that you are aware of security and privacy limitations including
but not restricted to the limitation of security, privacy and authentication
measures in this system.
SURG is not responsible for any special, incidental, indirect or consequential
damages.
In no event will SURG's liability with respect to this sublicense agreement
exceed the amount you paid (if you paid) to SURG for the software or of the
charge of one-month fee for using the server's service.
In no event shall SURG be liable to anyone for any delays, inaccuracies, errors
or omissions with respect to the Information or the transmission or delivery of
all or any part thereof, for any damage arising therefrom or occasioned thereby,
or for the results obtained from the use of the Information.
The entire risk as to the quality and performance of the SURG' service the OASIS
Software, the OASIS network and the OASIS Services and Information and the
accuracy, adequacy, completeness, correctness, validity and quality thereof or
of any other Information is with the user.
YOU AGREE TO ASSUME AND BEAR THE ENTIRE RISK OF LOSS AND DAMAGE TO ANY TOUCHPORT
OR ANY PART THEREOF WHICH SHALL IMPAIR ANY OBLIGATION OF SURG OR USS UNDER THIS
AGREEMENT, EXCEPT FOR LOSS OR DAMAGE CAUSED BY THE NEGLIGENCE OR WILFUL
MISCONDUCT OF SURG OR USS OR ITS EMPLOYEES OR AGENTS. IN THE EVENT OF LOSS OR
DAMAGE OF ANY KIND TO ANY TOUCHPORT OR PART THEREOF, EXCEPT WHERE CAUSED BY THE
NEGLIGENCE OR WILFUL MISCONDUCT OF SURG, USS, OR THEIR EMPLOYEES OR AGENTS, YOU
SHALL PAY TO SURG OR USS, AS THE CASE MAY BE, THE COST OF PLACING THE SAME IN
GOOD REPAIR, CONDITION, AND WORKING ORDER, OR IN THE EVENT SUCH CANNOT BE
REPAIRED, THE REPLACEMENT COST THEREOF.
IN NO EVENT WILL SURG BE LIABLE TO ANY PARTY (i) FOR ANY DIRECT, INDIRECT,
SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT
LIMITED TO, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF
PROGRAMS OR INFORMATION, AND THE LIKE), OR ANY OTHER DAMAGES ARISING IN ANY WAY
OUT OF THE AVAILABILITY, USE, RELIANCE ON, OR INABILITY TO USE THE PROGRAM, THE
SERVICE, THE OASIS
<PAGE>
SOFTWARE, THE OASIS NETWORK, THE OASIS SERVICES AND INFORMATION OR ANY OTHER
'INFORMATION', EVEN IF SURG SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES, AND REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT, OR
OTHERWISE; OR (ii) FOR ANY CLAIM ATTRIBUTABLE TO ERRORS, OMISSIONS, OR OTHER
INACCURACIES IN, OR DESTRUCTIVE PROPERTIES OF ANY INFORMATION.
SURG shall have the right to enforce the collection of any amounts due hereunder
and any of your obligations with respect to the Touchports, and you shall be
responsible for any and all reasonable attorney's fees and costs associated with
the enforcement of this sublicense agreement.
This agreement shall be governed by and construed in accordance with the laws of
the State of Florida. The venue of any action brought to enforce this agreement
or any site sublicense agreement shall be Sarasota County, Florida.
Exhibit 10.36
STAFF/CLIENT LEASING AGREEMENT
1. The Parties: This Agreement is made between Surgical Safety Products,
Inc. ("Client") with its principal office located at 2018 Oak Terrace, Suite
400, Sarasota, FL 3421 and
[ ] Staff Leasing, L.P., [X] Staff Leasing II., L.P., [ ] Staff Leasing
III, L.P., [ ] Staff Leasing IV, L.P., or [ ] Staff Leasing V, L.P.
("Staff"), a Delaware limited partnership, with its principal office located at
600 301 Boulevard West, Bradenton, Florida 34205 or such other location as shall
be identified in a written notice addressed to Client. Collectively, Client and
Staff are referred to as "the parties".
2. Proposal means the Proposal for services presented to Client by Staff.
That Proposal is attached hereto and made an integral part hereof in accordance
with ss.19 of this Agreement.
1Leasing Relationship:
A. The parties agree that Staff will lease employees to Client and that
this leasing arrangement will apply to all existing employees of Client employed
in Florida as well as to any new employees in Florida that are leased to Client
by Staff. Client and Staff shall enter into separate Agreements with Staff or an
affiliate of Staff with respect to employees of Client that are employed by
Client in other states. Pursuant to Florida Statutes Chapter 468, Staff reserves
a right of direction and control over the leased employees. While Staff has a
statutory right to reserve direction and control over the leased employees, the
parties recognize that these employees will work at Client's site under the
actual control or direction of Client. Staff has the authority to hire,
terminate, discipline and reassign the lease employees. However, Client has the
right to accept or cancel the assignment of any leased employee, provided that
such rejection or cancellation is not otherwise prohibited by law (including,
but not limited to, applicable anti-discrimination laws). Client also has the
right to direct and control the leased employees in order to conduct its
business, discharge fiduciary responsibilities or comply with any licensure,
regulatory, statutory or other legal requirement. Client is solely responsible
for the quality, adequacy and safety of all goods produced or services performed
by the leased employees.
B. If an employment decision is to be made regarding any leased
employee, Client will provide the information necessary for Staff to make a
reasonable and informed decision. If Staff finds it necessary to conduct an
investigation before a decision can be made, Client shall cooperate fully in
that investigation. If Client does not comply with any of these obligations, or
if Client fails to provide adequate or accurate information for Staff to make an
informed decision or if Client unilaterally chooses to make a decision regarding
a leased employee, Client will be fully responsiblefor the decision in question.
<PAGE>
C. Staff will only provide the services set forth herein and will not
provide any other services, including but not limited to the making of decisions
related to strategic, operational or other matters concerning Client's business.
Such decisions shall exclusively be the responsibility of Client, and Staff
shall bear no responsibility or liability for any actions or inaction by Client.
When implementing such decisions as are outside the scope of this Agreement,
even if the actions are implemented by leased employees, Client shall be acting
solely on its own volition and responsibility. Further, if Staff provides lease
or Staff supervisors to Client, such supervisors' scope of employment is
strictly limited. Supervisors' actions which are in violation of law will be
outside the scope of their responsibility.
D. Staff will give written notice of the relationship between Staff and
Client to each leased employee it assigns to perform services at Clients' work
site. If for any reason this Agreement is terminated, Staff will notify all
leased employees of the termination of this Agreement and Client also shall
notify all employees of the termination of this Agreement and shall inform them
that they are no longer covered by Staff's benefits or workers' compensation
policy.
E. Client agrees that, since it controls the work site and the
scheduling of employees, it will obtain and accurately report to Staff the total
number of hours worked by each employee and their exempt and non-exempt status,
and it will verify such hours and report them in accordance with the
requirements of the Fair Labor Standards Act and/or any applicable state or
local law. Client assumes full responsibility for the accuracy of such reports
and shall maintain such records of hours worked for a period of seven (7) years.
Client shall not withhold a payment of wages absent express permission from an
assigned employee and it will not violate any applicable law pertaining to the
payment of wages. Client shall not make any taxable payment of any kind, except
profit sharing or pension plan distributions pursuant to the terms of a
qualified plan, to any assigned employee. Client agrees to immediately forward
to Staff any garnishment orders, involuntary deduction orders, notices of IRS
liens and other forms of legal process affecting the payment of wages to
assigned employees and to cooperate with Staff in responding thereto.
F. If pursuant to state, local or federal law, an employee is required
to possess or maintain a special license, Client will be responsible for
verifying such licensure or providing such required supervision, unless Staff
specifically agrees to a different arrangement.
G. Client shall be responsible for the implementation and enforcement of
any and all work site procedures that exist for the purpose of preventing the
misappropriation, theft or embezzlement of Client's personal, real or
intellectual property.
(D) Regulatory Compliance:
A. Staff: For any employee leased to Client under this Agreement Staff
is responsible for and hereby agrees to comply with the following:
(i) all rules and regulations governing the reporting, collection
<PAGE>
and payment of federal and state payroll taxes on wages paid under this
Agreement, including, but not limited to a) federal income tax withholding
provisions of the Internal Revenue Code; b) state and/or local income tax
withholding provisions, if applicable; c) Federal Insurance Contributions Act
(FICA); d) Federal Unemployment Tax Act (FUTA) and e) applicable state
unemployment tax provisions;
(ii) applicable workers' compensation laws including, but not
limited to: a) procuring workers' compensation insurance; b) completing and
filing all required reports; and c) administering, managing and otherwise
processing claims and related procedures;
(iii) the Fair Labor Standards Act;
(iv) Internal Revenue Code ss.4980B (COBRA);
(v) Section 1324A(b) of the Immigration Reform and Control Act of
1986, assuming that Client has provided to Staff all necessary and accurate
documentation required by law;
(vi) the Consumer Credit Protection Act, Title III; and
(vii) all rules and regulations governing administration,
procurement and payment of all other employee benefits specified in the Proposal
or covered by this Agreement. Because of requirements imposed by law, Client
will be required to furnish Staff with certain information regarding its
ownership structure and compensation packages of its principal and key
executives. Client warrants that to the best of its knowledge and belief that
such information will be correct.
B. Client:For any employee leased to Client under this Agreement, Client
is responsible for and hereby agrees to comply with the following:
(i) the Occupational Safety and Health Act (OSHA) and related or
similar federal, state or local regulations;
(ii)government contracting requirements as regulated by, including,
but not limited to, a) Executive Order 11246, b) Vocational Rehabilitation Act
of 1973 c) Vietnam Era Veterans' Readjustment Assistance Act of 1974, d)
Walsh-Healy Public Contracts Act, e) Davis- Bacon Act, f) the Service Contract
Act of 1965 and g) any and all similar, related or like federal, state, or local
laws, regulations, ordinances and statutes;
(iii) professional licensing and liability;
(iv) fidelity bonding requirements;
(v) Internal Revenue Code ss.ss.414(m), (n), & (o). Client agrees
to integrate and coordinate the terms of any extent Client-sponsored benefit
plans so that Staff's plans remain in compliance with all applicable laws;
<PAGE>
(vi) Worker Adjustment and Retraining Notification Act ("WARN");
(vii) laws affecting assignment of and ownership of intellectual
property rights including, but not limited to, inventions, whether patentable or
not and patens resulting therefrom, copyrights and trade secrets;
(viii) laws affecting the maintenance, storage and disposal of
hazardous materials. Client shall properly maintain all Material Safety Data
Sheets on an on-going basis during the term of this Agreement; and
(ix) the Fair Labor Standards Act, Title VII of the Civil Rights
Act of 1964, as amended, the Family and Medical Leave Act of 1993, the Age
Discrimination in Employment Act, the Americans With Disabilities Act (including
provisions thereunder relating to Client's premises), the Florida Civil Rights
Act, the Florida AIDS Act and any other federal, state, county, or local laws,
regulations, ordinances and statutes which govern the employer/employee
relationship.
5. Full Disclosure: Staff's obligations hereunder are expressly
conditioned upon Client's full and accurate disclosure of any and all
information requested by Staff both before and after the execution of this
Agreement. Client's failure to provide full and accurate information shall be a
breach of this Agreement.
6. Term of Agreement: This Agreement shall commence on the date it is
executed and shall remain in full force and effect for a term of one (1) year
("Initial Term"). Following the Initial Term, this Agreement shall remain in
full force and effect for successive monthly terms (the "Extended Term") until
either (i) the Agreement is renewed for an additional term of a fixed duration
(the "Fixed Term") or (ii) the Agreement is terminated.
7. Client Deposit: If Staff has requested a deposit as a condition
precedent to entering into this Agreement, then any monies of Client on deposit
with Staff shall be applied by Staff to any default in payment by Client under
the terms of this Agreement. On termination of this Agreement, any balance
remaining in the deposit account of Client shall be remitted to Client on or
before sixty (60) days after termination of this Agreement, provided that Client
has performed all of its obligations under the terms of this Agreement.
8. Client Check: Client specifically authorizes Staff to conduct a
credit and background reference check on Client and such officers or owners of
Client as Staff deems appropriate.
9. Payment:
A. Client will pay Staff the amount(s) specified in the Proposal,
which will be invoiced on a periodic basis. Any amounts not paid when due are
subject to a late penalty of up to 10% of the amount due per month or fraction
thereof that remains outstanding (should the 10% late penalty exceed the maximum
allowed by law, the late penalty shall be the maximum amount allowed by law).
Under no circumstances shall any amounts advanced by Staff and which are not
paid by
<PAGE>
Client on a timely basis, be deemed a loan to Client. Past due amounts are
delinquent obligations. Staff assumes responsibility for the payment of wages to
the leased employees without regard to payments by Client to Staff, although in
doing so Staff does not waive or limit any claim against Client. If Client
defaults in paying the amounts due Staff and Staff continues to pay wages to
leased employees at a rate not below the statutory minimum wage, Client shall
fully indemnify and hold Staff harmless from any and all claims made by
employees for wages in excess of the amount paid by Staff and any and all legal
fees and expenses incurred in defense of such claims. Unless agreed otherwise in
writing, Client agrees to collect, verify and transmit to Staff's administrative
office no less than three (3) business days before each Staff payroll date any
information required to determine correctly and accurately the amount of the
payment due Staff. Additionally, Client must immediately inform Staff of any
situation in which payment will not be immediately forthcoming, and Staff has
the discretion in such circumstances to require a Client to terminate the
employment of persons for whom payment by Client to Staff will not be made.
B. Client shall pay for services rendered under this Agreement
with bank wire transfers, through Automatic Clearing House (ACH) transfer,
negotiable bank drafts, cashier's check or other method acceptable to Staff.
Payment shall have been made only when Staff has received final, irrevokable
credit at its bank.
C. Staff may adjust the fees set forth in the Proposal to Client
as a result of any statutory changes in the minimum wage, employee taxes, sales
tax or workers' compensation rates, which adjustment shall be effective on the
date of the mandated change.
10. No Collective Bargaining Agreements: Client warrants that there are
no collective bargaining agreements binding upon Client or affecting employees
who are or may be leased and that there are no pending or threatened organizing
efforts affecting the same or unfair labor practices against Client.
11. Workers' Compensation:
A. Insurance Coverage: Employees leased by Staff to Client shall
be covered by workers' compensation insurance in compliance with applicable law,
and as specified in the Proposal. Client understands and agrees that Staff shall
not cover any employee with workers' compensation insurance coverage until that
employee has completed and submitted to Staff an employment information report
and the report has been reviewed, the employee approved for hire and an employee
identification number has been issued by Staff. For employees hired on a day
that is not a business day, coverage will be deemed to have been provided as of
the date of hire so long as the appropriate information is submitted to Staff
before noon of the first business day following the date of hire. Client shall
indemnify and hold Staff harmless from the consequences of (i) employing any
person who has not been hired in accordance with Staff's employment and hiring
procedures and (ii) utilizing any independent contractor on Client's worksite.
Further, client agrees to require any independent contractor it utilizes to
provide evidence of workers' compensation coverage before the independent
contract commences at the worksite. Client acknowledges that Staff's workers'
compensation carrier or Staff is entitled to periodically audit the employee
classification lists, employee rolls and financial records relating thereto for
each client location to
<PAGE>
make sure that employees are classified properly and all employees are being
reported for workers' compensation purposes. In the event that Staff finds that
employees have been misclassified or have not been reported, Client will
promptly reimburse Staff, upon invoice, for charges which otherwise would have
been payable by Client had such employees been properly classified or reported.
Staff retains the responsibility for the management of workers' compensation
claims, claims filings and related procedures. Client agrees to cooperate with
Staff in that regard, including in regard to the notification of injuries
required by this Agreement or by law.
B. Notification of Injury; Reinstatement of Workers:If an
employee is injured at an assigned worksite, Client agrees to notify Staff or
Staff's workers' compensation carrier within forty-eight (48) hours and to
cooperate in conducting any investigation following the accident, to provide
transportation to a medical facility and, if required due to medical
restrictions, to permit the employee (where reasonably possible and permitted by
law) to work in a modified-duty capacity until such time as the employee is no
longer medically restricted from resuming duties performed prior to the
accident. Further, Client agrees to cooperate with Staff in making reasonable
accommodations which may be required by either of them by the Americans With
Disabilities Act in providing any leave required of either of them by the Family
and Medical Leave Act or any other applicable law and in restoring a leased
employee to his or her job at the conclusion of any such leave.
12. Employee Benefits:
A. Staff will provide benefits to those employees covered by this
Agreement who are determined by Staff to be in an eligible class pursuant to the
provisions of each applicable benefit plan as outlined in the Proposal. In
addition to the standard benefit package, Staff may make available additional
optional benefits for those employees covered by this Agreement. In order to be
eligible for such benefits, the employee must meet the eligibility requirements
established by the insurance plan designated in the Proposal. If for any reason
the participation requirements are not met, Staff has the right to terminate
this Agreement or to modify it by striking this provision.
B. Client shall retain responsibility for the current COBRA
participants on Client's group health plan in effect on the effective date of
this Agreement.
13. Insurance:
A. Automobile: Client shall obtain and maintain automobile
liability insurance for all owned, non-owned and hired vehicles used in
connection with the work performed on its premises or in connection with its
business, and will cause its insurance carrier to issue a Certificate of
Insurance evidencing same to Staff and allowing not less than thirty (30) days'
notice of cancellation or material change. The policy shall insure against
liability for bodily injury and property damage, with a minimum combined single
limit of Three Hundred Thousand Dollars ($300,000.00) and Uninsured Motorist or
PIP equivalent coverage of at least the minimum limits required by the state
where a "no fault" law shall apply.
B. General Liability: Client shall obtain and maintain general
<PAGE>
liability insurance and cause its insurance carrier to issue a Certificate of
Insurance evidencing same to Staff and allowing not less than thirty (30) days'
notice of cancellation or material change. The minimum requirement shall be
Three Hundred Thousand Dollars ($300,000.00) combined single limit including,
but not limited to, where applicable, premises, operations, products, completed
operations, contract and broad form property damage, independent contractors,
personal injury, host liquor, and fully liquor liability. If Client renders
professional services, it shall obtain and maintain its insurance carrier to
issue a Certificate of Insurance evidencing same to Staff allowing not less than
thirty (30) days' notice of cancellation or material change. Unless otherwise
agreed to, such policy shall have a combined single limit of not less than Three
Hundred Thousand Dollars ($300,000.00). With regard to insurance referenced in
this paragraph, additional coverage may be required at Staff's discretion based
on size or nature of Client's business.
14. Subrogation and Indemnification: Each party hereby waives any claim
in its favor against the other party by way of subrogation or indemnification
which may arise during the term of this Agreement for any and all loss of or
damage to any of its property or for bodily injury, which loss, damage, or
bodily injury is covered by insurance to the extent that such loss or damage is
recovered under such policies of insurance as required herein. The subrogation
and indemnification concept set forth in this provision is intended to apply
only to insurance matters, and nothing in this provision is intended to alter
the indemnification rights set forth elsewhere in this Agreement.
15. Employee Safety: Where required by applicable state law, Staff shall
retain a right of direction and control over the management of safety, risk and
hazard control involving leased employees performing work at client's work
sites. Such retained right includes the right to perform safety inspections of
Client's equipment and premises and to promulgate and administer employment and
safety practices. However, liability for employee safety is a responsibility for
Client, who controls the worksite and its business operations. Client
acknowledges that it is responsible for maintaining a safe working environment,
and shall provide, at its expense, all necessary personal protective equipment
and training required under federal or state law or regulation and shall
establish and maintain such safety programs, safety policies and safety
committees as may be required by law. Staff, Staff's workers' compensation and
liability insurance carriers or their assignees have the right to survey the
Client's worksite(s) to look for unsafe conditions or unsafe acts which may lead
to accidents. However, the retention of such right by Staff does not relieve
Client of any obligations that it has pursuant to Federal or Florida's
Occupational Safety and Health Act or any other federal, state or local law
intended to provide employees at Client's worksite with a safe work environment.
Upon notification by Staff to Client of an unsafe working condition, Client
shall within a reasonable period of time take the necessary steps to rectify the
unsafe condition or correct the violation.
16. Indemnification: Client agrees to indemnify, hold harmless, protect
and defend Staff, all of Staff's subsidiaries, affiliates and parent entities
and Staff's partners, agents, attorneys and employees from any and all claims,
out of pocket expenses, damages (including compensatory and punitive damages)
and liabilities arising from or related to (i) alleged acts, errors or omissions
by Client; (ii) alleged violations of any statute, law or regulation by Client;
(iii) breaches of contract attributed to any leased employee or Client; (iv)
Client's failure to perform any of its obligations under this Agreement ; or (v)
alleged failure to pay severance payments to leased employees. Staff agrees to
indemnify, hold harmless, protect and defend Client, all of Client's
subsidiaries, affiliates
<PAGE>
and parent entities and Client's shareholders, agents, attorneys and employees
from any and all claims, out of pocket expenses, damages (including compensatory
and punitive damages) and liabilities arising from or related to Staff's failure
to perform any of its obligations under this Agreement. All indemnity
obligations hereunder are without monetary limit and without regard to the cause
thereof, including the negligence of either party, whether the negligence of
either party, whether the negligence is sole, joint, comparative or
contributory. If such indemnification is for any reason not available or
insufficient to hold the indemnitor harmless, the indemnitor agrees to
contribute to the lessee involved in such proportion as is appropriate to
reflect the relative benefits received (or anticipated to be received) by each
party with respect to the matters contemplated by this Agreement or, if such
allocation is judicially determined to be unavailable, in such proportion as is
appropriate or reflect not only such relative benefits, but also other equitable
considerations such as the relative fault of Client, on the one hand, and of
Staff, on the other hand.
17. Termination:
A. This Agreement is terminable by either party with thirty (30)
days' written notice. Any breach, violation or default of any term or condition
of this Agreement by Client shall give Staff the absolute right to terminate
this Agreement by giving written notice of termination to Client. The
termination date shall be deemed to be the date on which the breach, violation
or default occurred, notwithstanding the fact that Staff delivers notice of
termination to Client subsequent to the date of such incident.
B. In addition to any other breach, violation or default by
Client hereunder, the following shall be deemed breaches, violations or defaults
under the terms of this Agreement:
(i) Client's failure to pay any moneys required under the terms
and conditions of this Agreement when due;
(ii) Client's failure to comply with any reasonable directive
regarding health and safety from Staff, Staff's Workers' Compensation carrier or
any government agencies;
(iii) Client's failure to provide any insurance required under
the terms of this Agreement;
(iv) Client's misrepresentation of workers' compensation
classifications or inaccurate reporting of employment rolls, employee payroll
hours, pay rate or salary;
(v) any situation requiring that Client issue a notice under
WARN;
(vi) the filing by or against Client of a petition for
reorganization or bankruptcy, receivership, insolvency or the making by Client
of any assignment for the benefit or creditors; and/or
(vii)at Staff's discretion, Client's failure to report payroll
<PAGE>
for a period in excess of one payroll period or the closing by Client of any
facility or operation.
C. If this Agreement is terminated, the provision for health care
continuation coverage shall be governed by Internal Revenue Code ss.4980B
(COBRA). Both parties shall cooperate to avoid the possibility of a loss of
employment qualifying event under Internal Revenue Code ss.4980B.
D. If this Agreement is terminated and if, and only if, the affected
employees are entitled to the payment of any accrued vacation, sick or personal
leave, Client shall be liable for the payment thereof and will make such
payments directly to Staff. However, if Client continues to employ such affected
employee(s) after termination of this Agreement, Client shall be liable, if at
all, to the employee(s) for same.
E. The indemnification and contribution provisions of this Agreement
shall survive indefinitely the expiration or other termination of this
Agreement.
F. Upon the termination of this Agreement for any reason, the parties
shall continue to have the following obligations through and including the
termination date:
(i) Staff shall have the obligation for wages and benefits payable to
the employees through and including the termination date. If for any reason
(whether or not required by applicable law) Staff makes any payment to any of
the employees after this Agreement has been terminated, Staff shall be entitled
to full reimbursement for such expenditures:
(ii) All obligations of Staff under this Agreement to maintain
workers' compensation insurance coverage and health care coverage on behalf of
the employees shall cease, effective as of the termination date. All such
employees shall be immediately informed by Client that they are no longer
covered by Staff's workers' compensation policy. Client shall immediately assume
all federal, state and local obligations of an employer to the employees which
are not in conflict with state or federal law and shall immediately assume full
responsibility for providing workers' compensation coverage. Staff shall
immediately be released from such obligations as are permitted by law. It is the
intent of the parties that, to the extent allowed by law, they be placed in
their respective positions immediately before their entry into this Agreement in
the event of a termination or Client's failure to pay Staff; and
(iii) Client shall have the obligation to pay all fees payable in
in accordance with the provisions of this Agreement which are attributable to
the period ending on the termination date.
18. Third Party Rights: This Agreement is intended solely for the mutual
benefit of the parties hereto and does not create any rights of any kind in a
third party. Staff reserves the right to from time to time assign its rights,
duties and obligations hereunder to any entity that is under common ownership
and control with Staff or its successors.
19. Integration: This Agreement constitutes the entire agreement between
<PAGE>
the parties with regard to this subject matter and supersedes any and all
agreements, whether oral or written, between the parties with respect to its
subject matter. Client acknowledges that it has not been induced to enter into
this Agreement by any representation or warranty not set forth in this
Agreement, including but not limited to any statement made by any marketing
agent of Staff. Client acknowledges that Staff has made no representation that
Staff's services will improve the performance of Client's business.
20. Waiver: Failure by either party at any time to require performance
by the other party or to claim a breach of any provision of this Agreement will
not be construed as a waiver of any subsequent breach nor affect the
effectiveness of this Agreement, nor any part thereof, nor prejudice either
party as regards to any subsequent action.
21. Attorney's Fees: In the event that any action is brought by either
party hereto as a result of a breach or default in any provision of this
Agreement, the prevailing party in such action shall be awarded attorneys' fees
and costs incurred by such party in such action in addition to any other relief
to which the party may be entitled.
22. Governing Laws: This Agreement shall be governed by and construed in
accordance with the laws of the State of Florida, without regard to principles
of conflicts of law. Client hereby irrevocably submits itself to the personal
jurisdiction of the courts in and for Manatee County, Florida or in the United
States District Court for the Middle District of Florida, unless a party elects
to arbitrate a dispute as provided in P. 23, and Client hereby waives, to the
extent permitted by law, any objection that it may now or hereafter have to the
laying of venue of any such action in such court and any claim that any such
action, suit or proceeding has been brought in an inconvenient forum. The
parties hereby (i) agree not to elect a trial by jury of any issue triable of
right by a jury, and (ii) waive any right to trial by jury fully to the extent
that any such right shall now or hereafter exist. This waiver of right to trial
by jury is separately given, knowing and voluntarily, by each of the parties
hereto, and this waiver is intended to encompass individually each instance and
each issue as to which the right to a jury trial would otherwise accrue.
Further, Client hereby certifies that no representative or agent of Staff has
represented, expressly or otherwise, that Staff will not seek to enforce this
waiver of right to jury trial provision.
23. Arbitration: If there is a dispute between the parties concerning
any aspect of their relationship , either party to such dispute may elect to
arbitrate the dispute by serving written notice upon the other. Once arbitration
is elected by a party, such election is binding on both parties and the dispute
shall be resolved by an arbitrator selected from a panel provided by the
American Arbitration Association. The cost of arbitration shall be borne equally
by the parties. If both parties agree, the first panel may be rejected in its
entirety, and a second panel may be sought. The Commercial Arbitration Rules of
the American Arbitration Association and the Federal Arbitration Act shall be
applied to and govern the arbitration. The arbitrator's decision shall be final,
conclusive and binding, except as permitted by the Federal Arbitration Act.
24. Intellectual Property Rights:Client shall own any and all
intellectual property rights incident to any and all process, products,
inventions and so on that are created or invented by an individual leased to
Client and who was directed by Client to create or develop such process,
<PAGE>
product, etc. Client shall bear any and all costs associated with any copyrights
or trademarks that Client chooses to obtain to protect Client's intellectual
property rights.
25. Duty to Cooperate: If an employee or a government agency or entity
files any type of claim, lawsuit or charge against Staff, Client or both then
Client and Staff shall cooperate with each other in the defense of any such
claim, lawsuit or charge. Staff and Client will make available to each other
upon request any and all documents that either party has in its possession which
relate to any such claim, lawsuit or charge. However, neither party shall have
the duty to cooperate with the other if the dispute is between the parties and
themselves nor shall this provision preclude the raising of cross claims or
third party claims between Client and Staff, if the circumstances justify such
proceedings. The parties agree that this provision shall survive the termination
of this Agreement.
26. Severability: Should any term, warranty, covenant, condition, or
provision of this Agreement be held to be invalid or unenforceable, the balance
of this Agreement shall remain in force and shall stand as if the unenforceable
part did not exist. The captions in this Agreement are provided for convenience
only and are not part of the terms of this Agreement.
27. Modification and Implementation: Any modifications to this Agreement
must be in writing and executed by Staff and Client to be enforceable.
28. Remedies not Exclusive: The rights and remedies of this Agreement
herein provided shall not be exclusive and Staff shall have rights and remedies
now or hereafter provided by law in addition to those provided for in this
Agreement. Institution of an action to effect collection of payment of an amount
in default at law or the obtaining of a judgment in such action shall not be
deemed to be an election by Staff nor shall it bar Staff from pursuing other
remedies available to it at law or in equity.
29. No Partnership or Agency: Nothing set forth herein shall be deemed
to create a partnership or joint venture between Client and Staff, and no
fiduciary duty shall arise from the relationship created herein. In no event may
Client act as an agent of Staff unless specifically authorized to do so in
writing.
30. Counterparts: This Agreement may be signed in one or more
counterparts, each of which when executed shall be deemed an original and
together shall constitute one and the same instrument.
CLIENT STAFF
/s/Jim Stuart _________________________
- ------------------
Signature Signature
Jim Stuart _________________________
- ------------------
Typed/Printed Name Typed/Printed Name
<PAGE>
Executive VP/COD __________________________
Date:10/16/96 Date: ______________________
Florida Department of Business and Professional Regulation Employee Leasing
Company Group License #GL 22 SL SAL 7 REV 05/96
<PAGE>
SURGICAL SAFETY PRODUCTS
13920
MANASOTA STAFF
LEASING
September 1999
Dear Valued Client:
Our Client Services Agreement has been regularly revised to reflect the concerns
of our clients and to keep pace with changes in the relatively young and rapidly
growing PEO industry as it evolves and matures. Please find enclosed an addendum
to the service agreement that you previously signed.
The addendum addresses the following:
o First, this addendum provides what many of you have asked for - a
clear statement that you have retained actual control over your work
site employees.
o Second, Staff Leasing clients in certain locations now have the option
to use a credit card to pay for our services. This option will be
available to you if the disclosure concerning method of payment
contained in this addendum is added to your agreement.
o Third, we are adding a provision that will enable us to update the
agreement automatically when necessary. As consideration for these
changes, you will have the right to terminate our agreement with a
shorter notice period than you currently have.
Please read the attached addendum then sign and return it to your Staff Leasing
account representative or return it to our courier when your next payroll is
delivered.
Call your account representative at your local Staff Leasing branch office if
you have any questions regarding the changes contained in this addendum.
Sincerely,
/s/ Richard A. Goldman
- -----------------------
Richard A. Goldman
President
Attachment
<PAGE>
Client: Surgical Safety Products SL Branch Location:
13920
Client # Manasota
ADDENDUM TO STAFF/CLIENT SERVICES AGREEMENT
This Addendum applies to all Staff/Client leasing and services agreement(s)
(including any and all prior written addendum thereto, "Agreement[s]") between
Staff Leasing II, L.P. and its affiliated limited partnerships (collectively,
"Staff"), as one party and the Client identified above by its name and Staff
account number and, if applicable, its affiliated entities under common
ownership and control (individually and collectively, "Client") as the other
party. The parties agree that the Agreement remains in full force and effect and
that this Addendum modifies, amends and supplements the Agreement and is an
integral part thereof. If any provision in this Addendum conflicts with a
provision in the Agreement, the provision in this Addendum shall prevail. It is
the parties' intent that provisions in the Agreement that are inconsistent
herewith shall be revoked and superseded. The numbers and captions of the
paragraphs below are for convenience only. In consideration of the mutual
promises and benefits to be derived, the parties agree to add the following
provisions to the Agreement effective as of the effective date of the Agreement.
1. Control Over Employees.
Notwithstanding Staff's reservation, under F.S. ss.468.525, of a right to direct
and control leased employees, in accordance with F.S. ss.768.098 Staff assigns
to Client the actual control over (i) the day-to-day job duties of leased
employees, and (ii) the portion of all jobs sites at which and from which leased
employees work. Client (a) accepts the assignment of actual control as set forth
in the foregoing sentence, (b) understands that Client has actual control over
leased employees' job duties and job sites at which and from which leased
employees work, and (c) agrees that Staff is absolved of actual control over the
leased employees' job duties and job sites at which and from which leased
employees work. Client is required to report to Staff all complaints,
allegations or incidents of any tortious misconduct or workplace safety
violations, regardless of the source, and Client agrees to timely report all
such complaints, allegations and incidents to Staff.
2. Methods of Payment.
The leasing fees agreed to in the Agreement and its Proposal, if any, reflect a
discount for payments made with a bank draft, ACH transfer, wire transfer and
similar commercial banking methods of payments acceptable to Staff. The discount
is not available if Client pays for Services with a credit card.
3. Written Notice of Modification.
<PAGE>
In addition to other means of modification provided for in the Agreement, Staff
may amend the terms and conditions of the Agreement by giving Client written
notice at least 30 days prior to the effective date of the amendment.
4. Notice Period.
In exchange for and in consideration of the aforementioned matters, Client may
terminate the Agreement without cause by giving Staff five (5) days written
notice notwithstanding any provision in the Agreement requiring a longer period
of notice.
STAFF CLIENT
/s/ Dawn M. Cockrell
Signature Signature
/s/ Dawn M. Cockrell
Printed Name Printed Name
Office Administrator
Title Title
9-15-99
Date Date
Exhibit 23.1
KERKERING
BARBARIO & CO., P.A.
CERTIFIED PUBLIC ACCOUNTANTS
INDEPENDENT AUDITIORS' CONSENT
We consent to the inclusion in the Registration Statement of Surgical
Safety Products, Inc. on Form 10-SB to be filed with the Securities and Exchange
Commission our report dated March 12, 1999 on the financial statements of
Surgical Safety Products, Inc. for the years ended December 31, 1998 and 1997.
/s/ Kerkering Barbario & Co.
KERKERING, BARBERIO & CO., P.A.
Sarasota, Florida
October 11, 1999
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 12-MOS
<FISCAL-YEAR-END> Dec-31-1998
<PERIOD-START> Jan-01-1998
<PERIOD-END> Dec-31-1998
<CASH> 41,191
<SECURITIES> 0
<RECEIVABLES> 60,641
<ALLOWANCES> 0
<INVENTORY> 26,898
<CURRENT-ASSETS> 128,730
<PP&E> 115,930
<DEPRECIATION> 36,234
<TOTAL-ASSETS> 373,514
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0
0
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</TABLE>
