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Infectech Inc ˇ 10SB12G/A ˇ On 12/13/00

Filed On 12/13/00 11:31am ET   ˇ   SEC File 0-26423   ˇ   Accession Number 1014897-0-241

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  As Of               Filer                 Filing     As/For/On Docs:Pgs              Issuer               Agent

12/13/00  Infectech Inc                     10SB12G/A              2:45                                     Walker Jody M/FA

Amendment to Registration of Securities of a Small-Business Issuer   ˇ   Form 10-SB
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10SB12G/A   Amendment to Registration of Securities of a          44    158K 
                          Small-Business Issuer                                  
 2: EX-27       Financial Data Schedule                                1      3K 


10SB12G/A   ˇ   Amendment to Registration of Securities of a Small-Business Issuer
Document Table of Contents

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11st Page
2Item 1. Description of Business
14Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations:
16Item 3. Description of Property
"Item 4. Security Ownership of Certain Beneficial Owners and Management
17Item 5. Directors, Executive Officers, Promoters and Control Persons
20Item 6. Executive Compensation
21Item 7. Certain Relationships and Related Transactions
22Item 8. Description of Securities
23Item 1. Market Price of and Dividends on the Registrant's Common Equity and Related Stockholder Matters
"Item 2. Legal Proceedings
"Item 3. Changes in and Disagreements With Accountants
"Item 4. Recent Sales of Unregistered Securities
25Item 5. Indemnification of Directors and Officers
43Item 1. Index to Exhibits
"Item 2. Description of Exhibits
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2 SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10SB/A AMENDMENT 4 General Form for Registration of Securities of Small Business Issuers Under Section 12(b) or (g) of the Securities Exchange Act of 1934 INFECTECH, INC. (Exact name of Small Business Issuer in its charter) DELAWARE 34-1760019 (State or other jurisdiction of (I.R.S. Employer incorporation or organization Identification No.) Suite Two, 87 Stambaugh Avenue, Sharon, PA 16146 (Address of principal executive offices) (Zip Code) Registrant's Telephone number, including area code: (724) 346-1302 Securities to be registered pursuant to Section 12(b) of the Act: None Securities to be registered pursuant to Section 12(g) of the Act: Common Stock, $.02 par value Forward-Looking Statements and Associated Risk. This Registration Statement, including the information incorporated herein by reference, contains forward-looking statements including statements regarding, among other items, Infectech's growth strategies, and anticipated trends in Infectech's business and demographics. These forward- looking statements are based largely on Infectech's expectations and are subject to a number of risks and uncertainties, certain of which are beyond Infectech's control. Actual results could differ materially from these forward-looking statements.
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3 ITEM 1. DESCRIPTION OF BUSINESS A. Infectech was incorporated in June 1989 under the laws of the State of Delaware. Drs. Felder and Ollar began discussions on obtaining patents for important bacterial pathogens that utilized paraffin as their sole carbon source. They believed a method could be found to identify these faster and the symptoms treated more efficiently and effectively, thereby reducing the time patients spent being diagnosed for these illnesses. Infectech engaged in research and obtaining patents which we successfully began to obtain with our first patent being issued in 1992. We conducted additional research over several years leading to the development of more patents related to the use of paraffinophilic (paraffin-eating) bacteria which would then be used in testing devices, so that the presence of harmful bacteria could be more quickly detected then by conventional methods. In 1995, Infectech began testing and research at a laboratory facility in Milford, PA under the direction of Dr. Ollar. From 1995 to the present, Infectech has maintained the laboratory at which Dr. Ollar conducts research on the existing technology and developing related applications. On November 19, 1996, the Articles of Incorporation were amended to increase the authorized shares from 120,000 to 20,000,000 and a 50 to 1 stock split was declared. Infectech has remained a development stage company engaged in research and development of diagnostic tests and therapeutics for infectious human diseases. Infectech has obtained 30 patents on this technology. Infectech's technology has extended to the field of environmental bio-remediation which is the nontoxic degradation of pollutants and other harmful substances utilizing the same bacteria used in the medical diagnostic kit. Infectech has also applied this technology to a cancer therapy known as apoptosis involving the destruction of harmful cancer cells. Infectech is registering our common stock under the Exchange Act of 1934 to be eligible for the quotation of our stock on the NASD Bulletin Board. The Infectech Method. Infectech's research regarding paraffin as a sole carbon source led to the concept that paraffin-coated glass slides may be used to grow, identify and perform antibiotic sensitivity assays on paraffinophilic bacteria. Paraffinophilic bacteria are bacteria that use paraffin as their sole food source. Infectech then developed a technology that employs a paraffin carbon source that enables viable or living paraffinophilic organisms to be separated from viable non-paraffinophilic bacteria and from non-viable or dead bacteria. In this method only viable paraffinophilic bacteria grow on the paraffin coated glass slides. Those living or viable bacteria found on the surface of the paraffin coated slides may be stained and examined microscopically to determine the presence of suspect pathogens, or disease carrying organisms. Having identified the disease-causing bacterium, providing a patient cure is the next step. In a manner similar to identification of the pathogen, tests are conducted with a separate series of tubes containing antibiotics. Macroscopic and microscopic examination of the paraffin-coated slides indicate those tubes where there is an absence of bacterial growth on the paraffin slide surface. Such absence means that the antibiotic in question was able to kill the pathogen at a particular concentration of antibiotic. Infectech's patented technology will enable the medical community to conduct antibiotic sensitivity testing upon a pathogen once it has been identified, thereby enabling a more rapid and effective treatment of bacterial infections. This enables the hospital or doctor to determine the most appropriate antibiotic to use as well as the most effective in treating the patient. Infectech's paraffin slide culture technology provides a simple and inexpensive method for isolating, identifying and performing antibiotic sensitivity testing of paraffinophilic pathogens in markets ranging from the largest metropolitan urban hospitals to modest third world field laboratories. Of particular benefit to small hospitals, medical centers and third world field laboratories is the potential of using a variety of body fluids and fecal matter to provide samples for identification. The convenience, efficiency, and safety of this method also provide enhanced safety to the patient because of the non- intrusive nature of gathering the samples.
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4 The IDENTIKIT TM process, from the perspective of the physician and the patient, will operate relatively simply. For example, a patient enters a hospital with serious burns. Since burn patients are at high risk for bacterial infection including Pseudomonas, a bacteria which causes pneumonia, blood poisoning and other life-threatening disease, the physician will order a sample of blood or sputum to be taken from the patient. The sample will then be added to a series of test tubes containing Infectech's patented growth media. Paraffin slides are then added to the tube, and, with respect to Pseudomonas, for example, within 24 hours (using the IDENTIKIT TM) a laboratory technician will be able to observe the growth of bacteria on the paraffin and perform biochemical tests on it which will enable the identification, specification and antibiotic sensitivity testing of the patient's strain of Pseudomonas. The physician will then be able to administer the most appropriate antibiotic treatment. Since 1997, Infectech has obtained over two dozen additional patents and has begun to use the Infectech technology at several research hospital facilities in the United States. Infectech has also developed applications of its technology in the non-medical use of environmental bio-remediation. In this application, the Infectech method is used to produce bacteria which feeds upon certain toxic pollutants. This allows the bio-remediation (or biological cleanups) of polluted areas and such harmful substances as TCE (tri- chloroethylene). Infectech has entered into a licensing agreement with a bio-remediation firm actively engaged in this field. Products. IDENTIKIT TM. Infectech intends to offer two types of IDENTIKITs TM, one utilizing non-genetic microbiology and one utilizing genetic and amplification technology. Both types of IDENTIKITs TM will be used for all applications outside of the body in a noninvasive technique and may be used without additional specialized equipment. Both types of IDENTIKITs TM can be used for identification, specification and antibiotic sensitivity testing. Both types of IDENTIKITs TM, non-genetic and genetic amplification technology can be tailored with design, composition and instructions intended to meet specific customer requirements in identifying one or more of the paraffinophilic, non-paraffinophilic and non- paraffinophic/hydrophobic (water repellent) microorganisms. The price of each kit will be dependent on the number of paraffinophilic microorganisms to be tested by the kit. For example, the cost of a kit designed to identify all known paraffinophilic microorganisms will exceed the cost of a kit specifically designed to identify one microorganism (e.g. an MAI IDENTIKIT TM). The Non-genetic Microbiology Identification (NMI) IDENTIKIT TM is of a standard design and suitable for identifying any number of paraffinophilic, nonparaffinophilic or nonparaffinophilic/hydrophobic microorganisms. This kit is suitable for 100 tests. The anticipated list price of the kit for this testing of one of the disease causing organisms is $200.00. The Non-genetic Microbiology Antibiotic Sensitivity (NMAS) IDENTIKIT TM is designed for determining the effectiveness of a drug or bacteria for a paraffinophilic microorganism. Any number of paraffinophilic microorganisms may be tested. This kit is also suitable for 100 tests and can be shipped from stock. The anticipated list price of the kit determining the effectiveness of a drug or bacteria is approximately $300.00. The Non-genetic Microbiology Antibiotic Sensitivity for NonParaffinophilic Hydrophobic Organisms (NMAS) IDENTIKIT TM is designed for determining antibiotic sensitivity for a specific nonparaffinophilic/hydrophobic microorganism. This kit is also suitable for 100 tests and can be shipped from stock. The anticipated list price of this kit is approximately $300.00. The Non-genetic Microbiology Antibiotic Sensitivity for Several Organisms (Paraffinophilic, Nonparaffinophilic, Nonparaffinophilic/hydrophobic) is designed for determining antibiotic sensitivity for several organisms (user's choice of organism). This kit is also suitable for 100 tests and will be approximately $500.00 list price. No additional research or development is necessary to complete the non- genetic paraffinophilic kits. Additional research is presently ongoing for the nonparaffinophilic and nonparaffinophilic/hydrophobic
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5 non-genetic kits. This research is currently being conducted at the VA Medical Center in New York City and at Infectech's laboratory in Milford, Pennsylvania. However, the manufacturing, marketing and sales will need to occur through a relationship with a large international corporation. See "Sales and Marketing." Once such relationship is established, sales of the non-genetic kit can begin in overseas markets and domestic experimental markets for use in laboratory research. With the exception of experimental markets, sales in the U.S. cannot occur until FDA approval is granted. Infectech has begun to obtain the requisite number of clinical trials at the VA Medical Center in New York. We intend to obtain the required clinical trials and to submit application for a 510-K (90 day) approval from the United States Food and Drug Administration. Genetic Based Probe/Amplification Technology for Identification (PATID) is designed to rapidly identify specific microorganisms. The kit is a genetic based system and components are specific for the type of organisms to be scanned for. One kit is suitable for 100 tests. Genetic Based Probe/ Amplification Technology for Antibiotic Sensitivity (PATAS) is designed to perform rapid antibiotic sensitivity testing for specific microorganisms. The kit genetic based procedure and components are specific for a type of organism to be assayed for antibiotic sensitivity testing. One kit is suitable for 100 tests. By using Infectech's non-genetic IDENTIKITs TM, physicians will be given better data earlier about their patients' conditions, freeing them to make more effective treatment decisions. The following chart illustrates comparisons of Infectech's method with conventional testing for two life-threatening diseases. [Enlarge/Download Table] Infectech Genetic Infectech IDENTIKIT Conventional Conventional Genetic Antibiotic Method of Antibiotic IDENTIKIT Sensitivity Identification Sensitivity Identification Testing Mycobacterium avium-intracellularae (MAI) 8-30 days An additional 18-25 days 4-21 days total 8 days Pseudomonas 24-48 hours An additional 24-48 hours 24 hours total 24 hours MAI is an infection which affects organs, often the respiratory and gastrointestinal tracts of AIDS patients and is often fatal. Pseudomonas is a disease-causing bacteria which affects cystic- fibrosis, burn unit patients and other persons suffering from immune deficiencies resulting in serious illness and death. Infectech believes that its patented testing method may be the only one available, which can be successfully used with amplification techniques for rapid antibiotic sensitivity testing. As a result, Infectech is presently performing experimentation to combine its patented method with amplification techniques in an easy-to-use amplification IDENTIKIT TM, resulting in even more accelerated identification and antibiotic sensitivity testing, as the following chart illustrates: [Download Table] Infectech Genetic Infectech IDENTIKIT Conventional Conventional Genetic Antibiotic Method of Antibiotic IDENTIKIT Sensitivity Identification Sensitivity Identification Testing MAI 8-18 days An additional 18-25 days 48-96 hours 48-72 hours Pseudomonas 24-48 hours An additional 24-48 hours 24 hours total 24 hours MD Diagnostics. In 1999, Infectech became interested in the use of the Internet for its diagnostics. Management believed that the Internet offered an excellent method of interpreting microbiology test results over distances for its own tests and other medical tests.
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6 Infectech formed MD Diagnostics-com, Inc. in the state of Delaware on April 2000. MDD-com is developing a business plan that would offer medical diagnostic second opinions using specialists who would interpret a variety of medical tests, including CAT scans, EKGs and other tests. The MDD-com activities are not limited to Infectech- based medical technology and will be a resource for a wide range of medical tests. The Market. Markets for the Identikits TM include hospitals, clinical laboratories, medical research institutions, medical schools, pharmaceutical companies and physician's offices. There are over 9,000 hospitals and medical laboratories in the United States, all of which are logical customers for the Identikit TM products. It is anticipated that the Identikit TM can capture a large percentage of the worldwide market for identification of paraffinophilic pathogens due to its low cost and the rapidity with which an assay can be completed. At present, before FDA approval, both the non-genetic and the genetic amplification kit can be sold in overseas markets subject to regulatory requirements in a particular country, which vary. It can also be sold in domestic experimental markets for use in laboratory research. Marketing and Sales. Infectech is positioning itself to capture the market for MAI and Tuberculosis bacteria diagnosis and antibiotic sensitivity testing. Prior to the AIDS epidemic, MAI was a rare disease. After the advent of widespread AIDS infection, MAI was found to infect AIDS patients at a very high rate. According to the World Health Organization (Global Tuberculosis Control: March 1999) world health authorities have estimated that more than 70% of AIDS patients harbor an MAI infection. MAI affects the bone marrow, spleen, liver and lungs. It compromises the lymph nodes, thereby further destroying the patient's immune system. MAI also causes opportunistic infections among non-HIV infected children and the elderly. MAI is believed to be a major contributor to AIDS wasting syndrome. Based on in-house research, in addition to MAI, there are at least 20 other disease-causing paraffinophilic bacteria for which Infectech's Infectech method can be utilized. Infectech initially plans to market its products through licensing and distribution arrangements with large, well-established medical diagnostic companies. Infectech's markets will potentially include hospitals, clinical laboratories, medical research institutions, medical schools, pharmaceutical companies (antibiotic sensitivity testing methodology can be used to create new drugs to treat paraffinophilic microorganisms), and physicians' offices. Any contractual arrangements with others concerning the marketing and distribution of its products may result in a lack of control by Infectech over any or all of the marketing and distribution of such products. Although Infectech is currently engaged in preliminary efforts to establish such marketing arrangements, there can be no assurance that Infectech will be able to enter into any such arrangements on terms acceptable to Infectech, or at all. As part of its overall service to the technical medical community, Infectech is prepared to offer workshops and consultation in the general area of medical diagnostics. While these two activities are not large, they will produce minor amounts of revenue, but more importantly will serve as the focal point for the dissemination of information and training required for Infectech's. technology. Infectech's future growth and profitability will depend, in large part, on the success of its personnel and others in fostering acceptance by the medical community. Such acceptance will be substantially dependent on educating the medical community as to the distinctive characteristics and perceived benefits of Infectech's proposed products. There can be no assurance that Infectech's efforts or those of others will be successful, or that any of its products will receive the necessary acceptance by the medical community. Potential Markets for Infectech's Technology. Diagnostics. Infectech believes that significant demand exists for an inexpensive diagnostic test for pathogens that - does not need highly skilled manpower or technology to isolate and distinguish deadly bacteria - produces results rapidly and accurately, - limits pre-preparation requirements,
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7 - tests a broad range of specimens and - assays for antibiotic sensitivity to determine the optimal treatment method. Infectech believes that its patented slide culture technology meets these requirements. Infectech's technology provides for rapid and accurate identification of at least 20 life-threatening paraffinophilic pathogens. These pathogens include Pseudomonas, the major cause of death in intensive care and burn units and the second leading cause of death in cancer patients, Mycobacterium Avium Intracellular ("MAI"), the bacterial infection most often associated with AIDS in the developed world) and Mycobacterium Tuberculosis, a non-paraffinophilic hydrophobic pathogen that can be grown via Infectech's technology. Mycobacterium Tuberculosis is the causative agent of tuberculosis, the world's deadliest infection. Each year in the United States alone, more than 10,000,000 tests are conducted for Mycobacterium Tuberculosis, 5,000,000 tests are conducted for Pseudomonas and more than 1,000,000 tests are conducted for MAI. Using Infectech's patented slide-culture technology in combination with gene amplification methodologies, life-threatening bacteria can rapidly be identified. Using Infectech's proprietary baiting technology, the efficacy of potentially appropriate antibiotics (e.g., penicillin) to treat for these bacteria can be tested through rapid, inexpensive antibiotic sensitivity tests. Infectech believes that its patented testing method may be the only method available that can be successfully used with amplification techniques for rapid antibiotic sensitivity testing. According to the World Health Organization, approximately 1.7 billion people worldwide carry the Tuberculosis bacterium which equals approximately 1 in 3 persons in the world. Although the majority of these cases are in underdeveloped and developing countries, it is thought by experts that as many as 10 million Americans may be infected with TB. (Global Tuberculosis Control: March 1999) This widespread health problem indicates a huge need for diagnostic testing of those infected individuals. At an average testing cost of merely $.45 per individual, a potential global market of at least $200 million exists. Infectech is positioning itself to capture a significant share of the market for MAI and Tuberculosis bacteria diagnosis and bacteria sensitivity. Historically, the search for MAI and other members of the genus Mycobacterium Tuberculosis has been very difficult. These organisms grow slowly, and specimens require rigorous preparation to prevent overgrowth of other more rapidly growing organisms often found co-existing in specimens. Handling of mycobacterial specimens has required highly-trained technicians and specialized equipment. This is not true of Infectech's technology. The Identikit is a self-contained testing device which requires little preparation. The sample is simply added to the test tube. It is sealed and then examined. The examination can be performed by any laboratory technician who need only analyze the visual results on the test tube slide. In addition, Infectech's technology permits sampling of a variety of tissues, not just blood or sputum. Although MAI forms in the gastrointestinal tract, physicians using conventional methods are unable to detect the bacteria until they reach the bloodstream. Using Infectech's technology, physicians will be able to analyze fecal matter or urine to detect MAI where it begins, in the gastrointestinal tract thereby leading to earlier treatment of the disease. Management is of the opinion that the convenience, efficiency and safety of Infectech's patented slide culture technology will provide enhanced safety for patients because of the non-invasive nature of required procedures. Management believes that its slide-culture technology also can be used to detect the presence of non-paraffinophilic bacteria through use of non-paraffin-based carbon coatings in a clean-room environment and sampling of certain body fluids such as blood and spinal fluid. The Infectech patented technology of paraffin slide culture does not require the use of highly skilled manpower. Infectech's advantages in this user-friendly method are:
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8 1. Eliminates the need for many processing steps currently needed to decontaminate and concentrate specimens. Since only a few types of organisms grow on paraffin, overgrowth due to specimen contamination is not a problem. This avoids the need for highly-trained mycobacteriologists who are customarily required to manipulate the slow growing organisms. 2. The system eliminates the need for expensive and sophisticated machinery like centrifuges. 3. As a self-contained system, the Infectech technology can be used even in facilities in which electrical power and refrigeration are not available. The test media utilized can be stored in a dehydrated state at room temperature. In addition, Infectech has filed a patent for a method of inducing apoptosis, a method of controlled cell-death or cell "suicide", with hydrophobic hydrocarbons, notably paraffin. Many types of cancer therapy use drugs to kill cells. The use of paraffin to induce cell death has important advantages, since paraffin is non-toxic and its effect is local. Dr. Richard A. Lockshin, Ph.D., of St. John's University, President of the Cell Death Society, has agreed to collaborate with Infectech on electron microscopy work necessary on this project. Bio-remediation of Chlorine-contaminated Aquifers, Air and Soil. Infectech believes that its utility patent for use of Compound C in baiting paraffinophilic micro-organisms has broad application in environmental bio-remediation of chlorine compounds such as TriChloroEthylene. Infectech has granted a world wide exclusive license to use this technology for bio-remediation to a Hermitage Pennsylvania-based company, Bio-remedial Technologies, Inc. BRT received a $250,000 grant from the state of Pennsylvania to treat contaminated air streams containing styrene and other hazardous air pollutants identified by the United States Environmental Protection Agency, utilizing Infectech's patented technology in 1998. BRT continues to use the Infectech method in its TCE degradation. Veterinary Applications. Infectech intends to develop a kit to test for Johne's Disease (caused by Mycobacterium Paratuberculosis) in cattle, a possible cause of Crohn's Disease in humans. Federal Drug Administration approval is not required for this product. Proprietary Slide-culture Technology. Infectech has found that paraffin-coated slides can be used to grow, identify and perform antibiotic sensitivity assays on paraffinophilic bacteria. Infectech has developed a technology utilizing a paraffin carbon source that enables viable or living paraffinophilic organisms to be separated from viable non-paraffinophilic bacteria grown on the paraffin-coated glass slides. Living or viable bacteria can then be stained and examined microscopically to determine the present of suspect pathogens. Efficacy of an antibiotic can be tested on disease-causing bacteria in a manner similar to identification of the pathogen. Test tubes in which there is an absence of bacterial growth can be determined. Absence of bacterial growth indicates that the antibiotic was able to kill the pathogen at a particular concentration. Presence of bacterial growth can indicate lack of effectiveness of the antibiotics to treat for the pathogen. The technology also enables the user to determine appropriate concentration of the antibiotic. These features make Infectech's technology ideal for markets ranging from large urban hospitals to third-world field laboratories. Infectech believes that its technology can contribute to reducing healthcare costs and significantly improving patient care. Rapid Detection Advantage of Infectech's Slide-culture Technology. By using Infectech's technology, laboratories will be able to accurately identify and perform antibiotic sensitivity testing for multiple pathogens in less time than conventional methods and with greater accuracy. Using Infectech's technology, management anticipates that: Infectech's methods permit the sampling of a variety of tissue samples (not just blood or sputum) with minimal preparation. The significance of this may be seen, for example, in the current state of the art in identifying and treating MAI, the bacterial infection most often
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9 associated with AIDS patients in the developed world. Although MAI forms in the gastrointestinal tract, physicians normally cannot detect it until it reaches the bloodstream using conventional methods. Through analyzing fecal matter or urine, physicians using Infectech's methods can detect MAI where it begins in the gastrointestinal tract, leading to earlier treatment which can sometimes make the difference between life and death in an AIDS patient. Infectech's methods do not require specialized equipment or highly skilled personnel to perform the protocols, unlike the existing conventional methodologies. In fact, Infectech's methods may be automated, resulting in a faster, more precise and cheaper diagnostic process for the more than 9,000 hospitals and medical laboratories in the United States, and similar customers throughout the world. Infectech's solution can contribute to reducing health care costs, which are continually rising. Manufacturing. Before any sales of the Genetic Based Probe/Amplification Technology kits can occur, Infectech must reach an agreement with a large international corporation to manufacture, market and sell the product. Once this occurs, sales of the Genetic Based Probe/Amplification Technology kits can begin in overseas markets and domestic experimental markets for use in laboratory research. Infectech has entered into an exclusive, worldwide license and royalty agreement for the manufacture and distribution of the PARASLC/TM with Erie Scientific, Inc. The PARA SL/CTM is the paraffin-coated slide used solely as a central component of the IDENTIKIT TM. Erie is the largest manufacturer and distributor of medical glass slides in North America, and a wholly owned subsidiary of Sybron International Corporation. The license and royalty agreement calls for a net royalty of 15% to be paid to Infectech on all worldwide sales of the PARASLC/TM by Erie. In addition, Infectech has agreed to provide to Erie consulting services for the paraffin slide culture technology. To date, the production has been limited to several thousand slide units due to the developmental state of Infectech. Although Infectech is currently engaged in preliminary efforts to establish other manufacturing arrangements with respect to certain of its proposed products, there can be no assurance that the Company will be able to enter into any such additional arrangements, on acceptable terms or at all, or that any manufacturer will be able to meet any demand for such products on timely basis. Competition. Infectech believes that most existing methodologies for identification and antibiotic sensitivity testing of paraffinophilic bacteria are expensive and time-consuming. Infectech further believes that there is limited competition in the field of antibiotic sensitivity testing combined with amplification techniques for paraffinophilic microorganisms. While the principal components of Infectech's technology are patented, there can be no assurance that larger, better-financed companies will not enter the market or that others will not develop competing technologies. Currently, the market for manufacture and distribution of diagnostic kits for each of these pathogens is highly concentrated. The competitors for manufacture and sale of kits for growing the pathogen for tuberculosis on conventional solid media are Difco and Remel. Difco has been consolidated into Becton Dickinson, which holds the majority of the market for diagnostic tests for Tuberculosis using continuous monitoring methods, which are utilized, extensively in major urban U.S. areas. Similarly, the market for testing for Pseudomonas and MAI is concentrated in Becton Dickinson, which sells petri-dish- based diagnostic tests. Licensing/Transactions. On September 14, 1999, Infectech and BRT signed an exclusive licensing agreement for the licensing of certain intellectual property and patents relating to the application in bio- remediation fields. BRT is a company which specializes in the biodegradation of chlorinated compounds and hydrocarbons. Unlike other bio-remediation companies, BRT uses specially prepared microbes to degrade volatile organic compounds from air, ground water and soil. The term of the exclusive licensing agreement with BRT is for a period of ten years. BRT will utilize Infectech's intellectual property solely as it applies in the field of bio-remediation for the creation of
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10 microbes for the specific task of bio-remediation. Infectech shall receive a royalty of 15% per bio-remediation project during the licensing period. Infectech allows BRT the ability to maintain intellectual property protection for methodologies involved in degrading VOC air emission, and ground water and solid remediation. The technology will remain that of Infectech with the application or enhancement of BRT being additional. Infectech's management believes that there will be a likelihood of success based upon early in-house laboratory studies performed in conjunction with BRT which showed Infectech's methodology to be superior to any current competing procedure in degrading TriChloroEthylene (TCE). TCE is the most abundant groundwater contaminant in the United States. TCE is not utilized as a food or energy source by the microorganisms in the soil or groundwater. As a result, the chemical accumulates in the environment and generates a public health risk. BRT will require EPA approval for all site projects involving bio-remediation. The exclusive licensing agreement can be terminated early if - either the assets or stock of BRT are acquired; - BRT attempts to assign, sub-license, lease or otherwise transfer its license without prior express written approval by Company. - insolvency of BRT - disqualification of BRT to conduct business; - material adverse change in the financial condition of BRT - BRT defaults on any provision of the agreement and does not cure the default within 15 business days after written notice is received. On October 15, 1997 Infectech signed a letter of intent (LOI) with the Erie Scientific Company (a wholly owned subsidiary of Sybron International) for the development of Infectech's Paraffin Slide Culture (Para SL/Ctm) technology into a commercially marketable product for the detection and susceptibility testing of pathogenic Mycobacteria. If development efforts are completed and all the requisite pre- marketing regulatory approvals for any proposed products are obtained, Infectech will need to establish manufacturing and marketing capabilities, either directly or through contractual arrangements with others, such as joint venture, licensing or similar collaborative agreements in order to commercialize any such products. Infectech is currently engaged in preliminary efforts to establish manufacturing and marketing capabilities with respect to certain of its proposed products; however, there can be no assurance that Infectech will be able to enter into such arrangements or that it will be able to obtain the necessary financing to manufacture and market such products directly. Once a suitable manufacturing relationship is established, the non- genetic and genetic amplification IDENTIKITsTM are essentially ready for production.
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11 On November 18, 1993, Infectech entered into an exclusive worldwide license and royalty agreement for the manufacture and distribution of the PARA SL/CTM with Erie Scientific, Inc. The PARA SL/CTM is the paraffin-coated slide used solely as a major component of the IDENTIKIT TM. Erie Scientific, Inc., is the largest manufacturer and distributor of medical glass slides in North American, and is a wholly owned subsidiary of Sybron International Corporation. The license and royalty agreement calls for a net royalty of 15% paid to Infectech of all worldwide sales of the PARA SL/CTM Erie. In addition, Infectech has agreed to provide to Erie consulting services for the IDENTIKIT TM. Patents and Proprietary Rights. Infectech has been issued and granted thirty (30) U.S. patents, including: [Enlarge/Download Table] Patent No. Issue Date Title 5,153,119* October 6, 1992 Method For Speciating And Identifying MAI (Mycobacterium Avium- Intracellular) 5,316,918 May 31, 1994 Method and Apparatus For Testing MAI (Mycobacterium Avium-Intracellulare) For Antimicrobial Agent Sensitivity 5,472,877 December 5, 1995 Apparatus For Determining The Presence Or Absence of MAI (Mycobacterium Avium- Intracellular) 5,569,592 October 29,1996 Apparatus For Testing MAI (Mycobacterium Avium- Intracellular) For Antimicrobial Agent Sensitivity 5,637,5011 June 10, 1997 Method And Apparatus For Automatically Testing The Antibiotic Sensitivity Of A Paraffinophilic Microorganism 5,639,675 June 17, 1997 A Method Of Identifying A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus*** 5,641,645 June 24, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus 5,654,194 August 5, 1997 A Method Of Identifying A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus 5,663,056 September 2, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism And An Associated Apparatus*** 5,668,010 September 16, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus
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12 5,667,169 October 14, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism And An Associated Apparatus 5,698,414 December 16, 1997 Method And Apparatus For Testing Paraffinophilic Microorganisms For Antimicrobial Agent Sensitivity 5,707,824 January 13, 1998 Method of Determining The Presence Or Absence Of A Paraffinophilic Microorganism*** 5,721,112 February 24, 1998 A Method Of Determining The Presence Or Absence Of A Nonparaffinophilic Microorganism In A Specimen And An Associated Apparatus 5,726,030 March 10, 1998 Method for automatically testing the antibiotic sensitivity of a nonparaffinophilic microorganism 5,750,363 May 12, 1998 Method for determining the antibiotic agent sensitivity of a nonparaffinphilic microorganism and an associated apparatus 5,776,722 July 7, 1998 Method of testing a body specimen taken from a patient for the presence or absence of a microorganism and a further associated method and associated apparatus 5,801,009 September 1, 1998 Method for determining the antimicrobial sensitivity of a paraffinophilic microorganism using various milous and an associated apparatus 5,804,406 September 8, 1998 Determining sensitivity of paraffinophilic microorganisms to antimicrobials 5,846,760 December 8, 1998 Method for determining a presence of a nonparaffinophilic hydrophobia microorganism in a body specimen and an associated apparatus 5,854,013 December 29, 1998 Method of determining presence or absence of a nonparaffinophilic microorganism in a specimen 5,854,014 December 29, 1998 Apparatus for testing paraffinophilic microorganisms for antimicrobial sensitivity 5,882,919 March 16, 1999 Apparatus for determining the presence or absence of a nonparaffinophilic microorganism in a specimen 5,882,920 March 16, 1999 Apparatus for determining the presence or absence of a nonparaffinophilic microorganism 5,891,662 April 6, 1999 Method for determining the antimicrobial agent sensitivity of a nonparaffinophilic hydrophobic microorganism 5,962,306 Method of determining the presence or absence of a nonparaffinophilic microorganism in a specimen and an associated apparatus. 5,989,902 Method for determining the antimicrobial agent sensitivity of a nonparaffinophilic hydrophobic microorganism and an associated apparatus.
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13 5,935,806 Method and apparatus for speciating and identifying MAI, (mycobacterium avium-intracellulare) and testing the same for antibiotic sensitivity 5,981,210 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen by using a DNA extraction procedure and a novel DNA extraction procedure 5,994,120 Method of bioremediating an organic hazardous substance
* Corresponding patents in Australia (parent and divisional) and Europe (parent and divisional); corresponding application in Canada *** Corresponding patent in South Africa as of November 27, 1996 1 Corresponding applications will be filed in AU/BR/CA/CH/EP/JP/MX/NZ/RF/SK 2 Corresponding applications will be filed in AU/BR/CA/CH/EP/JP/MX/NZ/RF/SK 3 Term of patent shall not extend beyond expiration of Patent 5,677,169 4 Term of patent shall not extend beyond expiration of Patent 5,654,194 Each of the above patents expire seventeen years after the date of grant. Infectech is presently allowing its patented technology to be used at the VA Medical Center of New York to perform research confirming the efficacy of the IDENTIKIT TM and to perform additional research with amplification techniques. It is anticipated that the technique will increase the rapidity with which both bacterial identifications and antibiotic sensitivities can be determined, reducing the time required by one or two orders of magnitude. The slide culture technology may be automated. Infectech is presently in negotiation with several diagnostic companies for the automation of the paraffin baiting method. Infectech has been granted a patent for the automation method. This will potentially lower the cost for identification and antibiotic sensitivity testing for MAI and for all other paraffinophilic microorganisms. There can be no assurance that any issued patents will provide Infectech with significant competitive advantages, or that challenges will not be instituted against the validity or enforceability of any patent owned by Infectech or, if instituted, that such challenges will not be successful. The cost of litigation to uphold the validity and prevent infringement can be substantial. Furthermore, there can be no assurance that others will not independently develop similar technologies or duplicate Infectech's technologies or design around the patented aspects of Infectech's technologies. While obtaining patents is deemed important to Infectech, patents are not considered essential to the success of its business. However, if further patents do not issue from present or future applications, Infectech may be subject to greater competition. Infectech also relies on a combination of non-competition and confidentiality agreements with its employees, licensing agreements, trademarks and trade secret laws to establish and protect proprietary rights to its technologies. There can be no assurance that trade secrets will be established, that secrecy obligations will be honored, or that others will not independently develop similar or superior technologies. Dependence on One or a Few Major Customers. Infectech does not expect that any single customer will account for more than ten percent of its business. Employees. Infectech employs four full time persons and six part time persons. Infectech shall employ additional individuals as required. Governmental Regulation. In order to gain broad acceptance, Infectech's diagnostic kits will require approval from the United States Food and Drug Administration ("FDA") and regulatory bodies outside of the United States. Infectech intends to apply for FDA
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14 approval based upon clinical testing programs conducted at major medical centers including the New York's VA Hospital, the University of West Virginia School of Medicine and the State University of New York School of Medicine. Data obtained from these institutions will enable Infectech to apply for FDA approval process testing kits through the 510-K application process.. No assurance can be given that Infectech will successfully develop or commercialize any proposed applications of its technology. With the exception of experimental markets, sales in the United States cannot occur until FDA approval is granted. FDA approval will take no less than one year. This includes 4-5 months of research, 4-5 months of clinical trials and the 2-3 months for review by the FDA. The research associated with the FDA approval will cost approximately $200,000. Regulatory requirements for the FDA include: Device Classifications - The device clarification is under 510K regulations for a non-invasive device. Investigational device exemptions - There would be no exemptions except for utilization of these devises used solely for experimental purposes. Clinical investigator monitoring - Infectech technology is being monitored for clinical investigation at the Bronx VA in New York. Institutional review board approval - The Infectech product reviewed at the VA Medical Center will have the Lutine review board method of approval. Premarket approval applications and conditions of approval - Medical articles have already been written by the University of West Virginia School of Medicine and articles are being prepared for peer-review journals by the VA Medical Center in New York and St. Vincent's Hospital in New York. Registration and Listing - will occur on completion of FDA testing at the VA medical Center. Labeling - The labeling will take approximately one month after the FDA approval for this noninvasive test. Manufacturing, including design controls - controlled by the Sybron Corporation and its Erie Scientific Division which is a wholly owned subsidiary of Sybron Corporation. Post-market obligations, including medical device reporting (MDR) and recalls - Infectech shall be governed by the FDA and its medical reporting apparatus. Import and export requirements - These will be fulfilled according to the jurisdiction of each foreign country in which Infectech intends to market its products. Penalties and legal remedies available to the FDA for violations of the Federal Device and Cosmetic Act and the regulations promulgated under its authority - These will be routine penalties and legal remedies available to the FDA for a noninvasive device under 510K regulations. These various FDA regulatory requirements bear certain inherent risks in any type of activity involving noninvasive medical devices unique to Infectech but are generally applicable to all providers of similar products in the medical diagnostics field. While Infectech does not have unique requirements, this field is highly regulated and subject to FDA oversight and monitoring which poses risk in this type of activity which would include the suspension of sales activities and distribution of the products should the government exercise those remedies. The broad range of actions the FDA can utilize would include the suspension of further production distribution and sales. In addition to working on obtaining the necessary governmental approvals to bring the product to market and looking for additional marketing arrangements through established distribution channels, the Company plans to perform contract experimental work testing for the efficacy of chemotherapeutic agents against paraffinophilic microorganisms. Infectech has no specific time-frame for performing experimental work for this testing. Infectech expects to begin clinical trials of its slide-culture technology in early 2001 and expects to receive approval of its technology from the FDA before the summer of 2002 through the 510-K application process. Infectech expects to begin marketing its test kits internationally during the first quarter of 2001.
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15 Compliance with Environmental Laws. Infectech has no material costs or effects of compliance with federal, state or local environmental laws. Seasonal Nature of Business Activities. Infectech's business activities are not seasonal. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations: Trends and Uncertainties. Demand for Infectech's products will be dependent on, among other things, market acceptance of Infectech's concept, the quality of its products, government approval and general economic conditions, which are cyclical in nature. Inasmuch as a major portion of Infectech's activities will be the receipt of revenues from the sales of its products, Infectech's business operations may be adversely affected by Infectech's competitors and prolonged recessionary periods. Capital and Source of Liquidity. Infectech requires substantial capital in order to meet its ongoing corporate obligations and in order to continue and expand its current and strategic business plans. Initial working capital has been obtained by the private sale of Infectech's common shares from November 1996 to present. For the nine months ended September 30, 1999, Infectech received proceeds from the issuance of common stock of $133,234 resulting in net cash provided by financing activities of $133,234 for the nine months ended September 30, 1999. For the nine months ended September 30, 1998, Infectech had proceeds from the issuance of common stock of $270,074. As a result, Infectech had net cash provided by financing activities of $270,074 for the nine months ended September 30, 1998. For the nine months ended September 30, 1999, Infectech had patent costs of $55,997, purchase of equipment of $2,450 and an increase in deposits of $51 resulting in net cash used in investing activities of $58,498. Infectech anticipates that costs associated with product testing and development will continue to increase. For the nine months ended September 30, 1998, Infectech received $200,000 from the redemption of certificate of deposit. Infectech purchased equipment for $4,505 and had patent costs of $179,554 for the nine months ended September 30, 1998. Infectech had an increase in deposits of $82 and had deferred merger and offering costs of $76,070 for that same period. As a result, Infectech had net cash used in investing activities of $60,211 for the nine months ended September 30, 1998. Infectech has a $10,500 line of credit, all of which was available at September 30, 1999. The line of credit is collateralized by the personal guarantee of a stockholder. On a long-term basis, liquidity is dependent on continuation and expansion of operation and receipt of revenues, additional infusions of capital and debt financing. Infectech believes that additional capital and debt financing in the short term will allow Infectech to increase its marketing and sales efforts and thereafter result in increased revenue and greater liquidity in the long term. However, there can be no assurance that Infectech will be able to obtain additional equity or debt financing in the future, if at all. Results of Operations. Since inception, Infectech has not received any material revenues from operations. Research and development expenses were $49,352 for the nine months ended September 30, 1999 versus $65,266 for the nine months ended September 30,, 1998. This decrease was due to research activities for its patents being shifted to work done internally in 1999. Wages increased to $86,592 for the nine months ended September 30, 1999 from $29,470 for the nine months ended September 30, 1998. This was the result from one employee working full time in research and development starting the later part of 1998. Legal and accounting decreased to $19,726 for the nine months ended September 30, 1999 versus $52,239 for the nine months ended September 30, 1998. The 1999 decrease was due to a change in law firms to a less costly firm and less usage during 1999.
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16 Consulting and professional fees increased to $116,059 for the nine months ended September 30, 1999 from $12,000 for the nine months ended September 30, 1998. This increase is due to increasing activity with consultants regarding marketing and commercialization of Infectech's product. Insurance expense decreased from $5,536 for the nine months ended September 30, 1998 to $51 for the nine months ended September 30, 1999 since Infectech discontinued life insurance coverage on its officers. Public relation expenses were $30,188 for the nine months ended September 30, 1999 versus -0- for the nine months ended September 30, 1998. This is due again to Infectech starting to market its product. Infectech incurred $30,614 in expenses for the nine months ended September 30, 1999 in connection with starting a subsidiary, MD- Diagnostics.com, Inc. to develop internet sites for medical diagnostics. Infectech had sales of $3,669 for 1998 versus -0- for 1997 and 1996. The revenue was due to a royalty payment earned in 1998. Research and development expenses increased to $92,004 for 1998 from $60,697 for 1997 and $17,500 for 1996. This was due to increasing research activities for its patents. Wages increased to $121,092 for 1998 from $24,568 for 1997 and $16,000 for 1996. This was the result from one employee working full time in research and development for 1998. Legal and accounting was $61,556 for 1998, $60,938 for 1997 and $80,711 for 1996. The 1998 and 1997 decrease was due to a change in law firms to a less costly firm. Travel expenses were $11,467 for 1998, $27,053 for 1997 and $9,310 for 1996. The increase travel expenses for 1997 was due to more trips to biotech companies and investment bankers. Consulting and professional fees increased to $183,466 for 1998 from $104,971 for 1997 and $43,360 for 1996. These increases are due to increasing activity with consultants regarding marketing and commercialization of Infectech's product. Plan of Operation. Infectech is in the development stage and has not conducted any significant operations to date and has received only minimal royalty revenues. Infectech may experience problems; delays, expenses and difficulties sometimes encountered by an enterprise in Infectech's stage of development, many of which are beyond Infectech's control. These include, but are not limited to, unanticipated problems relating to product development, testing, regulatory compliance, manufacturing costs, production and marketing problems, additional costs and expenses that may exceed current estimates and competition. Infectech has funding needs of approximately $1.2 million. Infectech shall seek equity or debt financing for intellectual Property ($30,000), research and development for Tuberculosis Pseudomonas ($814,400), legal expense for patents ($263,419) and internet research and development ($50,000). This does not include Infectech's working capital need. Research and development expenses will be dependent on the availability of funds. Infectech does not expect any additional purchases of plant and equipment. There are no expected significant changes in the number of employees. If Infectech obtained funding, support type of employees such as secretarial, etc, may be required. As of September 30, 1999, Infectech had working capital of $47,964. Infectech expects to use this capital to continue research and development of patents and for the costs associated with executing an initial public stock offering. Infectech believes that the net proceeds from equity financing together with revenues from operations, if any, will be sufficient to meet its anticipated cash needs for working capital and capital expenditures until approximately December 1999. There can be no assurance, however, that the net proceeds from equity financing will not be expended prior thereto due to unanticipated changes in economic conditions or other unforeseen circumstances. Unless growth in Infectech's revenues from operations substantially exceeds management's current expectations, by approximately December 1999, Infectech will be required to seek additional equity or debt financing to fund the costs of its operations, including continued development of its products. There can be no assurance that additional financing will be available or that, if available, such financing will be on acceptable terms to enable Infectech to complete development of or commercialize any of its proposed products or technologies.
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17 Infectech is not delinquent in any of its obligations even though Infectech has generated limited operating revenues. Infectech intends to market its products utilizing cash made available from the private and public sale of its securities. Infectech's management is of the opinion that revenues from the sale of its products and the proceeds of the sales of its securities will be sufficient to pay its expenses until its business plan can be fully implemented. Year 2000 Issues. To date, Infectech has had no material effects from the Year 2000 issues. ITEM 3. DESCRIPTION OF PROPERTY Infectech will operate out of two locations. The corporate headquarters will remain in Sharon, Pennsylvania and the clinical lab will continue in Milford, Pennsylvania. These offices consist of 3100 square feet. Infectech pays approximately $2,500 per month for use of these two locations. Infectech may consolidate operations to a single location once clinical testing is successfully completed. Also, Infectech will use the offices of Dr. Felder as its corporate headquarters. Dr. Felder will sublease a portion of his offices at a rate of approximately $550 per month to partially cover the cost of rent, office equipment, utilities and office personnel. Infectech retains the right to increase these payments in accordance with any rental time and increased need for office equipment, utilities and office personnel at both locations. ITEM 4. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The following tabulates holdings of shares of Infectech by each person who, subject to the above, at the date of this prospectus, holds of record or is known by Management to own beneficially more than 5.0% of the Common Shares and, in addition, by all directors and officers of Infectech individually and as a group. Each named beneficial owner has sole voting and investment power with respect to the shares set forth opposite his name. Shareholdings at Date of This Prospectus [Download Table] Percentage of Number & Class(1) Outstanding Name and Address of Shares Common Shares Mitchell S. Felder, M.D. (2) (3) 2,252,589 31.75% Suite 2 87 Stambaugh Avenue Sharon, PA 16146 Robert Ollar, Ph.D. (2) 1,697,322 23.92% 122 Cornelia Lane Milford, PA 18337 David Bernstein, Esq. (2) (3) 246,837 3.48% 33111 Seneca Drive Solon, OH 44139 Susan Felder (2) 382,967 5.40% Suite 2 87 Stambaugh Avenue Sharon, PA 16146 Stephen Lewis 100,000 1.41% 112 Mehard Avenue Greenville, PA 16125 Thomas Inman 0 0.00% 27 Garrett Lane Mercer, PA 16137 William Moder 0 0.00% Kerrwood Place, Suit 104 2500 Highland Road Hermitage, PA 16148
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18 All Directors & Officers as a group (7 persons) 4,679,715 65.96%
(1)Pursuant to Rule 13d-3 under the Securities Exchange Act of 1934, as amended, beneficial ownership of a security consists of sole or shared voting power (including the power to vote or direct the voting) and/or sole or shared investment power (including the power to dispose or direct the disposition) with respect to a security whether through a contract, arrangement, understanding, relationship or otherwise. Unless otherwise indicated, each person indicated above has sole power to vote, or dispose or direct the disposition of all shares beneficially owned, subject to applicable unity property laws. (2)Assumes exercise of all outstanding stock options. Includes for each of Dr. Felder, Dr. Ollar, Mr. Bernstein and Mrs. Felder, 42,535, 23,368, 37,978 and 29,167 shares, respectively, which such person has the right to acquire under options issued to him/her under the 1996 Stock Option Plan at a purchase price of $1.20 per share. (3)Includes for each of, Dr. Felder and Mr. Bernstein, 77,500 and 10,000 shares, respectively, for repayment of loans made to Infectech. Stock Options. The Corporation has issued options for the purchase of up to 828,852 shares of common stock to fourteen persons. The options are "non-qualified stock options" which are not qualified for treatment under Section 422 of the Internal Revenue Code of 1986, as amended. The term of the options has generally been up to ten years from the date of grant, and provide for vesting over a period of three years from the date of grant. The Corporation's 1996 Stock Option Plan provides for the issuance of options for the purchase of 1,182,750 shares of the Corporation's Common Stock to employees and consultants. In lieu of salary for past services, certain employees have received stock options to purchase up to 322,406 shares at a purchase price of $1.20 per share under the Stock Option Plan. Of the total 322,406 shares eligible for purchase pursuant to options, Dr. Felder, Dr. Ollar, Thomas Inman, William Moder II, David Bernstein, Steve Lewis, and Susan Felder have options to purchase a total of 227,200 shares. The remaining 95,116 shares eligible for purchase pursuant to options were distributed among 8 other employees. The Corporation's 1998 Stock Option Plan provides for the issuance of options for the purchase of 1,200,000 shares of the Corporation's Common Stock to employees and consultants. Currently no options have been issued under the 1998 Stock Option Plan. ITEM 5. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS. Board of Directors. The following persons listed below have been retained to provide services as director until the qualification and election of his successor. All holders of Common Stock will have the right to vote for Directors of Infectech. The Board of Directors has primary responsibility for adopting and reviewing implementation of the business plan of Infectech, supervising the development business plan, review of the officers' performance of specific business functions. The Board is responsible for monitoring management, and from time to time, to revise the strategic and operational plans of Infectech. Directors receive no cash compensation or fees for their services rendered in such capacity. The Executive Officers and Directors are: [Download Table] Name Position Term(s) of Office Mitchell S. Felder, M.D. age 47 CEO, President and Inception Treasurer and Director to present
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19 Robert A. Ollar, Ph.D. age 52 Executive Vice President Inception and Chief of Scientific to present Affairs and Product Development and Director Susan Felder age 46 General Manager and Director Inception to present David Bernstein, age 39 Corporate General Counsel and Director Stephen R. Lewis, age 40 Director 1995 to present
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Thomas Inman, age 45 Secretary and Controller June 1995 to present William J. Moder, III, age 48 Director Sept. 1998 to present
Resumes: Mitchell S. Felder, M.D., is a co-founder of Infectech, a founding member of Infectech's Scientific Advisory Board, and serves as Vice Chairman of Infectech's board of directors. Dr. Felder is a contributor to certain of the patent applications for Infectech's products, and has worked in Infectech's clinical medical effort. He received his M.D. degree from the University of Rome, Italy in 1983, and has been an attending Neurologist at the Horizon Hospital System in Greenville, Pennsylvania since 1997. Dr. Felder is married to Susan Felder and is a first cousin of Mr. Bernstein. Robert A. Ollar, Ph.D. is a co-founder of Infectech, a founding member of Infectech's Scientific Advisory Board, and has served as Chairman of the board of directors of Infectech since 1989. Dr. Ollar received his Ph.D. degree from the University of Surrey, England, United Kingdom in 1993. Prior to that, he received his Master of Science Degree majoring in Microbiology in 1984 from the University of Glasgow, Great Britain. Prior to that, he performed research at the Institute Pasteur Du Brabant in Brussels, Belgium. Dr. Ollar is the inventor of Infectech's slide culture technology. Dr. Ollar is presently an Assistant Professor of Neurology at the New York Medical College. Susan Felder has served as General Manager and director of Infectech since its inception in 1989. From 1978 to 1989 she had progressive analyst responsibilities with the Insurance Services Office, Inc. leading to the position of Computer Programmer which she held until 1989. From 1978 to 1979 she held the position of Marketing Research Analyst for the Continental Insurance Company. She received her B.A. in Economics from Rutgers College in 1976. She is the wife of Dr. Felder. David Bernstein, Attorney-at-Law, is Corporate Counsel for Infectech and is a director of Infectech. Mr. Bernstein is a sole practitioner practicing law in Cleveland, Ohio. Prior to engaging in sole practice, Mr. Bernstein was an attorney at Bekaert Corporation, a manufacturing company. He received his Juris Doctor of Law from The University of Akron in 1983 and his Bachelor's Degree in Accounting from Kent State University in 1980. Mr. Bernstein is a first cousin of Dr. Felder. Stephen R. Lewis has served as a director of Infectech since 1995. Mr. Lewis is an investment broker with, and shareholder of Butler Wick & Co., Inc. of Sharon, Pennsylvania since 1988. He received his Bachelor's Degree in Finance from Indiana University of Pennsylvania in 1983. Thomas L. Inman was the Corporate Controller for Infectech, having served from June 1995 to September 1999. Mr. Inman is the Secretary of Infectech. Since 1999, Mr. Inman is employed by the Mercer County Agency on Aging and was previously employed as an internal auditor for the County of Mercer in Pennsylvania from 1990 to 1999. William Moder, III is General Counsel for Infectech and has been a director of Infectech since September, 1998. Mr. Moder is an attorney engaged in private practice in Hermitage, Pennsylvania. He has advised
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Infectech as local counsel, primarily on contract issues. Prior to entering private practice, Mr. Moder was corporate counsel for First National Bank of Pennsylvania, a subsidiary of F.N.B. Corporation, for 14 years. He is a 1974 graduate of Edinboro University of Pennsylvania and earned his juris doctorate degree in 1980 from the University of Akron. The Corporation has not established any committees, other than the Compensation Committee and the Stock Option Plan Committee, which administers the issuance of options under the Corporation's 1996 and 1998 Stock Option Plans. The Compensation Committee is composed of Dr. Felder, Dr. Ollar, Mr. Shardy. and Mr. Moder. The Stock Option Plan Committee consists of Dr. Felder and Dr. Ollar Scientific Advisory Board. In July 1995 Dr. Ollar and Dr. Felder founded the Corporation's Scientific Advisory Board, which in addition to them consists of the following members: Nancy D. Connell, Ph.D., Assistant Professor, Dept. Of Microbiology and Molecular Genetics, UMDNJ/New Jersey Medical School Carl Gene Coin, M.D., Department of Radiology, University of Miami School of Medicine Joseph Giordano, M.D., Attending Internist, Sharon Regional Health System Vincent LaBombardi, Ph.D. Chief of the Department of Microbiology, St. Vincent's Hospital New York, New York; Assistant Professor of Microbiology, New York Medical College. Richard Steinfeld, M.D., Attending Internist, Sharon Regional Health System Benjamin M. Blumberg, Ph.D., Professor of Neurology, University of Rochester Medical School Joseph H. Kite, Jr., M.D., Professor of Microbiology; State University at Buffalo School of Medicine and Biomedical Sciences Jane Pascale, M.D., Assistant Professor of Microbiology; State University at Buffalo, NY Sheldon Brown, M.D., Assistant Professor of Medicine; Mt. Sinai School of Medicine, NY, NY; Attending Physician Infectious Diseases; Bronx V.A. Hospital Dale Pokorney, M.D., Assistant Professor of Dermatology, Case Western Reserve School of Medicine Pattisapu R.J. Gangadharam, Ph.D., Professor of Medicine, Microbiology and Pathology, Director of Mycobacteriology research, University of Illinois at Chicago Thomas Kelly, Ph.D., Professor of Microbiology Laboure College; Boston, MA David Sklansky*, Author of seven books on probability theory and wagers. Zsuzua (Susan), Polgar*, Women's World Chess Champion. Ms. Polgar and Mr. Sklansky do not have a scientific background. Each member of the Scientific Advisory Board has received an option to purchase six hundred fifty (650) shares of stock at $4.50 per share. Such options vest over a three-year period beginning on December 6, 1996, and expire without further vesting within ninety (90) days after each member's termination of Scientific Advisory Board service. ITEM 6. EXECUTIVE COMPENSATION No executive officer of Infectech, except for Dr. Robert Ollar, received any cash compensation for the fiscal year ended December 31, 1997. Dr. Ollar received cash compensation of $23,333 during fiscal year ended December 31, 1997. When operations allow, Dr. Ollar will receive a salary of $60,000 per year based on his full time work at
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Infectech's laboratory; and Dr. Felder will receive a salary of $60,000 per year based upon part-time work. Infectech retains the right to increase or decrease the cash compensation of its employees as necessitated by business conditions. In lieu of salary for past services, certain employees have received options to purchase up to 322,406 shares of Infectech's common stock at a price of $1.20 per share. [Enlarge/Download Table] Long Term Compensation Annual Compensation Awards (a) (b) (c) (d) (e) (f) (g) Name Securities And Other Annual Restricted Stock Underlying Principle Cal. Salary Bonus Compensation Award(s) Options Position Yr. ($) ($) ($) ($) (#) Dr. Felder 1998 0 0 75,175 CEO 1997 0 0 179,756 1996 0 0 0 0 Dr. Ollar 1998 $36,395 0 0 Executive 1997 $23,333 0 92,189 Vice Pres. 1996 $16,000 0 0 0 Aggregate Option Exercises in Last Fiscal Year and FY-End Option Values [Enlarge/Download Table] (a) (b) (c) (d) (e) Shares Number of securities underlying Value of Unexercised In-the Acquired Unexercised Options/SARs at Money Options at On Exercise Value FY-End (#) FY-End($) Name # Realized Exercisable/Unexercisable Exercisable/Unexercisable Dr. Felder 0 0 114,895/110,036 $47,833/$35,867 Dr. Ollar 6,250 7,438 55,209/30,730 $12,396/$39,666 Option in Last Fiscal Year (1998) Individual Grants [Enlarge/Download Table] (a) (b) (c) (d) (e) Number of Securities % of Total Underlying Options Exercise or Expiration O