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United Guardian
Filed March 23, 1998

TABLE OF CONTENTS


UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-KSB
(Mark One) |X| ANNUAL REPORT UNDER SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1998. OR |_| TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 [No Fee Required] For the transition period from __________ to ____________ For the transition period from __________ to ____________ Commission file number 0-7855 UNITED-GUARDIAN, INC. (Name of small business issuer in its charter) Delaware 11-1719724 --------------------------- ---------------- State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 230 Marcus Blvd., Hauppauge, NY 11788 --------------------------------------- --------- (Address or principal executive offices) (Zip Code) Issuer's telephone number, including area code: (516) 273-0900 -------------------- Securities registered pursuant to Section l2(b) of the Exchange Act: Title of each class Name of each exchange on which registered ---------------------------- ----------------------------------------- Common Stock, $.10 par value American Stock Exchange Securities registered pursuant to Section l2(g) of the Exchange Act: None Check whether the issuer: (1) filed all reports required to be filed by Section 13 or l5(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes |X| No |_| Indicate by check mark if there is no disclosure herein of delinquent filers pursuant to Item 405 of Regulation S-B, and if, to the best of registrant's knowledge, no disclosure will be contained in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. |_| The Registrant's revenues for the fiscal year ended December 31, 1998 were $8,769,738. On March 8, 1999 the aggregate market value of the Registrant's Common Stock (based upon the closing sales price of such shares on the American Stock Exchange as reported in The Wall Street Journal) held by non-affiliates of the Registrant was approximately $9,693,041. (Aggregate market value has been estimated solely for the purposes of this report. For the purpose of this report it has been assumed that all officers and directors of the Registrant are affiliates of the Registrant and no person, other than Alfred R. Globus, is an affiliate by virtue of his stockholdings. The statements made herein shall not be construed as an admission for determining the affiliate status of any person.) On March 8, 1999 the Registrant had issued and outstanding 4,883,139 shares of Common Stock, $.10 par value per share ("Common Stock"). Transitional Small Business Disclosure Format (check one): Yes |_| No |X| DOCUMENTS INCORPORATED BY REFERENCE: Certain information required by Part III (portions of Item 9, as well as Items 10 and 11) is incorporated by reference to the Registrant's definitive proxy statement (the "1999 Proxy Statement") in connection with its 1999 annual meeting of stockholders, which is to be filed no later than April 30, 1999 with the Securities and Exchange Commission pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended. This annual report on Form 10-KSB contains both historical and "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements by the Registrant about its expectations or beliefs concerning future events, such as financial performance, business prospects, and similar matters. The Registrant desires to take advantage of such "safe harbor" provisions and is including this statement for that express purpose. Words such as "anticipates", "believes", "expects", "intends", "future", and similar expressions identify forward-looking statements. Any such "forward-looking" statements in this report reflect the Registrant's current views with respect to future events and financial performance, and are subject to a variety of factors that could cause Registrant's actual results or performance to differ materially from historical results or from the anticipated results or performance expressed or implied by such forward-looking statements. Because of such factors, there can be no assurance that the actual results or developments anticipated by the Registrant will be realized or, even if substantially realized, that they will have the anticipated results. The risks and uncertainties that may affect Registrant's business include, but are not limited to: economic conditions, governmental regulations, technological advances, pricing and competition, acceptance by the marketplace of new products, retention of key personnel, the sufficiency of financial resources to sustain and expand Registrant's operations, and other factors described in this report and in prior filings with the Securities and Exchange Commission. Readers should not place undue reliance on such forward-looking statements, which speak only as of the date hereof, and should be aware that except as may be otherwise legally required of Registrant, Registrant undertakes no obligation to publicly revise any such forward-looking statements to reflect events or circumstances that may arise after the date hereof.

United Guardian (UG) AMEX

INDEXED 10-K For the fiscal year ended December 31, 1998


PART I

Item 1. Description of Business

Item 2. Description of Property

Item 3. Legal Proceedings

Item 4. Submission of Matters to a Vote of Security Holders


PART II

Item 5. Market for Common Equity and Stockholder Matters

Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Financial Statements

Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure


PART III

Item 9. Management

Item 10. Executive Compensation

Item 11. Security Ownership of Certain Beneficial Owners and Management

Item 12. Certain Relationships and Related Transactions


PART IV

Item 13. Exhibits, Financial Statement Schedules, and Reports on Form 8-K

Financial Index
PART I Item 1. Description of Business. (a) General Development of Business The Registrant is a Delaware corporation that conducts research, product development, manufacturing and marketing of pharmaceuticals, cosmetics, health care products, medical devices, and proprietary industrial products. The Registrant also distributes a line of over 3,000 fine organic chemicals, research chemicals, test solutions, indicators, dyes and reagents. The Registrant operates in two business segments: (1) The Guardian Laboratories Division ("Guardian") conducts research, development, manufacturing, and marketing of a variety of pharmaceuticals, medical devices, health care and cosmetic products, and proprietary specialty chemical products. The Research and Development Department of Guardian engages in research and development in the fields of cosmetics, health care products, and specialty industrial chemical products, for the purpose of developing new products, and refining existing products that will be marketed or licensed by Guardian. Many of the products manufactured by Guardian, particularly its LUBRAJEL(R) line of products, are marketed worldwide through a network of distributors, and are currently used by many of the major multinational cosmetic companies. The Registrant presently has a broad range of products, some of which are currently marketed, some of which are marketable but are not currently marketed by the Registrant, and some of which are still in the developmental stage. Of the products being actively marketed, the two largest product lines are Registrant's LUBRAJEL(R) line of cosmetic ingredients, which accounted for approximately 50% of the Registrant's sales in 1998, and its RENACIDIN(R) IRRIGATION, a pharmaceutical product that accounted for approximately 20% of the Registrant's sales in 1998. The Registrant actively seeks other companies as potential marketers for its products, particularly for those products that are not yet being actively marketed by the Registrant. (2) Eastern Chemical Corporation ("Eastern"), a wholly-owned subsidiary of the Registrant, distributes an extensive line of fine organic chemicals, research chemicals, test solutions, indicators, dyes, stains, and reagents. Since the Registrant's business activities and marketing efforts over the past several years have focused increasingly on the Guardian division, which the Registrant believes has greater growth potential, the Registrant has explored the possibility of selling the Eastern division. The Registrant concluded in 1997 that the Eastern operation would be more marketable if Eastern could reduce its inventory and focus its marketing efforts on the inventory items that sell more regularly. Registrant is continuing to implement these changes, and anticipates that Eastern's future sales may be lower than in prior years as a result of these changes. (b) Narrative Description of Business Guardian Laboratories Division Guardian conducts research, product development, manufacturing and marketing of many different personal care products, pharmaceuticals, medical devices, health care products, cosmetic bases, and proprietary specialty chemical products, all of which are developed by the Registrant, and many of which have unique properties. The products manufactured by Guardian are marketed through marketing partners, distributors, direct advertising, mailings, and trade exhibitions. Guardian's proprietary cosmetic and specialty chemical products are sold through marketing partners and distributors and are incorporated into products marketed by many of the major international cosmetic companies. Many of Guardian's products are marketed through collaborative agreements with larger companies. The pharmaceutical products are principally sold through drug wholesalers and surgical supply houses, as well as directly to the Veteran's Administration, other government agencies, hospitals, and physicians. One of Registrant's pharmaceutical products, CLORPACTIN(R) WCS-90, is also being marketed by VascA, Inc., a Massachusetts-based company that intends to market the product in connection with the marketing of its subcutaneous kidney dialysis access port. VascA's marketing in the U.S. is subject to the FDA's acceptance of its 510(k) pre-market notification, after which full marketing may begin. During 1998, Guardian's sales accounted for approximately 82% of Registrant's total product sales. Guardian's products are sold under trademarks or trade names owned by the Registrant. The marks for the most important products, LUBRAJEL and RENACIDIN, are registered as trademarks in the United States Patent and Trademark Office ("Patent Office"). In 1998 sales from these two product lines accounted for approximately 84% of Guardian's sales, and 70% of the sales of the Registrant as a whole. LUBRAJEL LUBRAJEL is a line of nondrying water-based moisturizing and lubricating gels that have applications in the cosmetic industry primarily as a moisturizer and as a base for other cosmetic products, and in the medical field primarily as a lubricant. In the cosmetic industry it is used primarily as a stable gel for application around the eyes and on the face and as an ingredient in skin creams and moisturizers, makeup, body lotions, hair preparations, salves, and ointments. As a medical lubricant it has been used on prelubricated enema tips and thermometers, and as a lubricant for catheters. During 1998, sales of LUBRAJEL products increased by 7% compared with 1997. During 1998, sales of LUBRAJEL products represented 61% of Guardian's sales and 50% of the sales of the Registrant as a whole. Revenue from the sale of the Registrant's LUBRAJEL products increased compared with the previous year as a result of (a) greater marketing success on the part of Registrant's distributors, and (b) the expansion of Registrant's marketing efforts as a result of Registrant's marketing alliance with International Specialty Products ("ISP") (discussed in more detail in the "Marketing" section below). In particular, sales of LUBRAJEL MS (the most popular form of Lubrajel) increased 10% from $1,211,883 in 1997 to $1,333,786 in 1998, and sales of LUBRAJEL CG (the original form of LUBRAJEL) increased 7% from $1,164,727 in 1997 to $1,246,523 in 1998. Both of these increases were attributable to increases in volume and not price increases. As a result of the continuing efforts of its marketing partners and distributors Registrant believes that LUBRAJEL sales will continue to increase in 1999 in the United States and Europe. These sales increases will be offset somewhat by continuing competition from products introduced by European manufacturers, as well as decreased sales into Asia due to continuing economic problems in that part of the world. Registrant still believes that there will be an overall increase in sales, but that amount of that increase will depend on whether Asian sales stabilize or continue to decrease in 1999. Registrant believes that LUBRAJEL'S reputation for quality and customer service will enable it to continue to compete effectively in the marketplace. The Registrant is developing other uses for LUBRAJEL. See "Item 1. Description of Business-Development Activities". RENACIDIN RENACIDIN is a urological prescription drug used to prevent the formation of and to dissolve calcifications in catheters implanted in the urinary bladder. It is marketed as a ready to use 10% sterile solution under the name "RENACIDIN IRRIGATION". The product was also sold for many years in powder form that was reconstituted into a liquid by the pharmacist, but that form of the product was discontinued in favor of the sterile liquid in May, 1997. RENACIDIN IRRIGATION is also approved for use in dissolving certain types of kidney stones. Sales of RENACIDIN IRRIGATION in 1998 accounted for 24% of Guardian's sales and 20% of the sales of the Registrant as a whole. Sales of RENACIDIN IRRIGATION increased 29% from $1,336,629 in 1997 to $1,728,279 in 1998. Some of this increase in sales was attributable to a continuing conversion of customers from the powder form to the new sterile liquid form. In addition, the diversification of the advertising program for this product in 1998 also contributed to this increase. On October 9, 1990, the Patent Office issued to the Registrant a patent covering the method of manufacturing RENACIDIN IRRIGATION. Other Products Other significant products that are manufactured and sold by Guardian but which did not individually comprise more than 5% of the Registrant's sales in 1998 are as follows: CLORPACTIN(R) WCS-90 is a microbicidal product used primarily in urology and surgery as an antiseptic for treating a wide range of localized infections in the urinary bladder, the peritoneum, the abdominal cavity, the eye, ear, nose and throat, and sinuses. The product is a white powder that is made into a liquid prior to use. It is a powerful disinfectant, fungicide, deodorizer, bleach, and detergent. In late 1998 the Registrant entered into a new marketing agreement with VascA, Inc. for sale of the product as an adjunct to VascA's subcutaneous kidney dialysis access port. VascA is in the process of preparing a 510(k) premarket notification to the F.D.A. to enable it to market their port along with Clorpactin. They expect to file this in the second quarter of 1999 and hope to receive marketing approval by the end of the third quarter of 1999. The product will be used to disinfect the port and surrounding tissue before and after every dialysis treatment. Sales of CLORPACTIN amounted to $269,247 in 1998 compared to $287,011 in 1997, a decrease of 6%. KLENSOFT(TM)is a surfactant that can be used in shampoos, makeup removers, and other cosmetic formulations. The primary customer for Klensoft over the past few years was in Taiwan. As a result of the problems in the Asian economies, sales of Klensoft decreased from $253,836 in 1997 to $41,712 in 1998, a decrease of 84%. The Registrant believes that some of this decrease will be reversed in 1999 as the Taiwanese economy recovers. PHOSPHOCHOLATE (TM) is a mouth moisturizer used primarily by cancer patients. The product was developed for, and is being marketed exclusively by, Sage Products, Inc., an Illinois health care company with which the Registrant had been working since 1993. Phosphocholate is a significant improvement over a product previously marketed by Sage for many years, and has replaced all of the sales of the previous formulation. Shipments to Sage began in November 1994, and amounted to $239,474 in 1998 compared to $243,771 in 1997, a decrease of 2%. LUBRAJEL PF (TM) is a preservative-free version of LUBRAJEL currently being marketed primarily by Societe D'Etudes Dermatologiques ("Sederma") under the tradename "Norgel". Sederma is the Registrant's distributor of LUBRAJEL in France and a major European cosmetic supplier. Tests conducted by Sederma indicate that the product self-preserves, and aids in the preservation of other cosmetic ingredients with which it is formulated. Sales of Norgel amounted to $236,600 in 1998 compared to $199,344 in 1997, an increase of 19%. CONFETTI DERMAL ESSENTIALS (TM) is a product line introduced in 1996 that incorporates various functional oil-soluble ingredients into colorful flakes that can be added to and suspended in various water-based products. The product color and ingredients can be customized to the needs of individual customers. Registrant believes that its product is unique and that it has excellent market potential based on sales increases experienced in 1998. The first commercial products using Confetti appeared in 1997. Sales in 1998 amounted to $152,294, compared to $60,034 in 1997, an increase of 154%. LUBRAJEL RR and RC are special grades of LUBRAJEL that can withstand sterilization by gamma radiation, which is the preferred method of sterilizing medical and hospital products. In September, 1994 the Registrant entered into a marketing agreement with Horizon Medical, Inc., a California company engaged in the development and manufacturing of products and services to the medical device and pharmaceutical industries. Horizon has been actively marketing the product since January, 1996. On April 11, 1995, the Registrant was granted a U.S. patent for this unique form of LUBRAJEL. Sales of LUBRAJEL RC to Horizon amounted to $208,693 in 1998 compared to $155,133 in 1997, an increase of 35%. Other products that do not have significant sales at the present time but have the potential for increased sales in the future, and which as a group constituted approximately 3% of Registrant's sales in 1998, are as follows: OIL OF ORCHIDS(TM) is a base for skin creams, lotions, cleansers, and other cosmetics. This product is an extract of fresh orchids, modified by extractants, stabilizers, and preservatives. It is soluble in water and alcohol and acts as a supplementary moisturizer. It is also an enhancer for fragrances in perfumes and toiletries. It is sold in two forms, water-soluble and oil soluble. LUBRASIL (TM) and LUBRASIL DS are special types of LUBRAJEL in which silicone oil is incorporated into a LUBRAJEL base by microemulsification, while maintaining much of the clarity of regular LUBRAJEL. The products have a silky feel, and are water resistant while moisturizing the skin. DERMA-SURE (TM) PROTECTIVE LOTION is an alcohol-based product applied to the skin which protects the skin against grease, oil, paint, stain, and many other chemicals. The product can be both a consumer and industrial product, and is currently produced in two formulations. The Registrant is discussing the marketing of this product with two companies at the present time, one looking at the possibility of selling if for consumer use via one of the home shopping channels, and the other a major producer of consumer and industrial products that is interested in marketing the product for industrial use. RAZORIDE (TM) is a clear, water-based, soap-free shaving product with excellent lubricity and moisturizing properties. The Registrant is currently looking into potential marketing avenues for this product. DESELEX(R) is a replacement for phosphates in detergents. LUBRASLIDE(TM) and a related product, B-122(TM), are powders used in the manufacture of cosmetics such as pressed powders, eye shadows, and rouges. FOAMBREAKER(TM) is a defoamer for cleansing solutions in the electroplating, painting, and electronics industries. The product does not leave the typical "fish-eye" residues associated with silicone defoamers. It is an industrial product that does not require governmental registrations or approvals. It is an unpatented, proprietary product. UNITWIX(TM) is a cosmetic additive used as a thickener for oils and oil-based liquids. It is a proprietary, unpatented product that does not require government approval to market. Development Activities Guardian's Research and Development Department has developed a large number of products that can be used in many different industries, including the pharmaceutical, medical, cosmetic, health care, and specialty chemical industries. These products are in various stages of development, some being currently marketable and some being in the very early stages of development requiring a substantial amount of development work to bring them to market. New uses for currently marketed products are also being developed. Once a product is created, the initial development work on it may consist of one or more of the following: (a) laboratory refinements and adjustments to suit the intended uses of the product; (b) stability studies to determine the effective shelf-life of the product and suitable storage and transportation conditions for the product; and (c) laboratory efficacy tests to determine the effectiveness of the product under different conditions. After the Research and Development Department has completed its initial work on a product and is satisfied with the results of that work, further development work to bring the product to market will continue, including some or all of the following: (a) animal and human clinical studies needed to determine safety and effectiveness of drug or medical device products, which would be needed for submissions to the appropriate regulatory agencies, such as the United States Food and Drug Administration ("FDA") or the United States Environmental Protection Agency ("EPA"); (b) preparatory work for the filing of Investigational New Drug Applications or New Drug Applications; (c) market research to determine the marketability of the product, including the potential market size and most effective method of marketing the product; (d) scaling up from laboratory production batches to pilot batches, and then to full scale production batches, including the determination of the type of equipment necessary to produce the product; (e) upgrading or purchasing new equipment to manufacture the products; and (f) the negotiation of joint venture or distribution agreements to develop and/or market the product. Some of the foregoing work may be done by outside contractors. While there can be no assurance that any particular project will result in a new marketable product or a commercially successful product, the Registrant believes that a number of its development projects, including those discussed below, may have commercial potential. LUBRAJEL Preliminary studies indicated that LUBRAJEL may help to accelerate the healing of wounds, such as leg ulcers, when applied daily and used in conjunction with a Spandex or similar bandage. The Registrant believes that an additional study done on a larger group of patients is warranted. Horizon Medical, Inc. (see "LUBRAJEL RR" discussion above) had done some work with the product for this use, and received authorization from the FDA to market the product as an accessory to a medical device for specific wound healing uses. Registrant is continuing to look for other potential marketers for this product. The Registrant is also engaged in a major new project with a company based in the United Kingdom for the use of one of its Lubrajels in a globally marketed consumer health product. The exact nature of this project cannot yet be disclosed due to confidentiality agreements between the Registrant and this U.K. company. CLORONINE Cloronine is a powerful disinfectant, germicide, and sanitizer for disinfecting medical and surgical instruments and equipment (particularly where autoclaves are not available), and for the purification of water supplies. The product has been approved for certain uses in France and Canada. Before this product can be marketed in the United States for any purpose, additional tests will have to be done to determine if the product can be registered with the EPA as a sterilant or germicide. These tests would comprise laboratory microbiological studies, compatibility studies, and specific studies on its intended uses. The product will also have to be registered with the FDA as an accessory to a medical device. Neither registration process has yet begun. Due to the expense and time required, the Registrant hopes to work jointly with other companies to obtain these registrations. The Registrant is currently discussing this product with a major producer of consumer and industrial products. The Registrant was granted two patents for this product. FELINE HEALTH PRODUCTS In March, 1996 Registrant entered into a research & development agreement with Feline Health Products ("FHP") to develop a new animal health care product. The product is a combination of pH indicators that indicate when a cat may have a potential health problem that could lead to the formation of urinary stones. The project has been delayed for various reasons and is now on hold temporarily, but is expected to be resumed in the second quarter of 1999. If FHP is able to find a marketing partner for the project, the terms of the marketing agreement would provide for the Registrant to manufacture the key component. LIDOCAINE GEL Registrant has developed a new Lidocaine-based urological anaesthetic gel. This product was originally developed for a company in the United Kingdom, but has not yet been brought to market by them. Registrant has not yet decided whether it will market this product itself or look for other potential marketers for it. SONARITE Sonarite is a product developed by the Registrant to reduce the severity of snoring. It is a soft tissue lubricant that reduces the surface tension in obstructed airways and allows for increased air flow. In 1997 the Registrant secured the exclusive right to market the product from a group of investors who had initially funded the product development work. The product has been in clinical testing since that time. In October, 1998 the development work on this product resumed after the Registrant learned through its additional clinical testing that the then current formulation was not working as well as an earlier prototype formulation. The product is currently in testing in several locations throughout the U.S. One of the tests is being conducted by a company that currently markets another breathing aid to determine the relative effectiveness of the two products in reducing snoring, and to determine if there is any synergy between them. Registrant hopes that if its clinical results are satisfactory it will be able to use the results to interest another company in entering into a joint venture to market the product. Registrant believes that the marketing of the product to reduce the severity of snoring would only require the filing of a 510(k) pre-market notification to the FDA. The product continues to be tested for use in reducing the incidence and severity of sleep apnea, a sleep disorder affecting millions of people. Some initial clinical work has indicated that the product may be effective for this use as well, and clinical tests are continuing. However, since the marketing of the product for this use would require a New Drug Application, the Registrant is trying to find a partner that is interested in completing the additional clinical work that will be required before the product can be marketed for this use. Trademarks and Patents The Registrant strongly believes in protecting its intellectual property and intends whenever possible to make efforts to obtain patents in connection with its product development program. The Registrant currently owns many United States patents relating to its products. The Registrant has patent applications pending with respect to a number of its research and development products. Patents formerly held by the Registrant on certain products have expired. There can be no assurance that any patents held by the Registrant will be valid or otherwise of value to the Registrant or that any patent applied for will be granted. However, the Registrant believes that its proprietary manufacturing techniques and procedures with respect to certain products offer it some protection from duplication by competitors regardless of the patent status of the products. The various trademarks and trade names owned or used by the Registrant in Guardian's business are of varying importance to the Registrant. The most significant products for which the Registrant has a registered trademark are LUBRAJEL, RENACIDIN, and CLORPACTIN. Set forth below is a table listing certain information with respect to all unexpired U.S. patents held by the Registrant: PATENT NAME PATENT # ISSUE DATE EXPIRATION DATE --------- ---------- ---------- Stabilization of ethanol/gasoline mixtures 4,328,004 5/4/82 5/4/99 Treatment of Hazardous Waste 4,581,130 4/8/86 4/8/03 Treatment of Hazardous Materials; Dehalogenation 4,601,817 7/22/86 7/22/03 with sodium-copper-lead alloy Treatment of Hazardous Waste - ternary alloy and oil 4,695,400 9/22/87 9/22/04 slurry thereof; sodium, copper, lead Iodophor; Polyethylene Glycol Alkylaryl-sulfonate 4,873,354 10/10/89 10/10/06 Iodine complex Thermal Resistant Microbial Agent ("Cloronine") 4,954,316 9/4/90 9/4/07 Method of Preparing Time-Stable Solutions of Non- 4,962,208 10/9/90 10/9/07 Pyrogenic Magnesium Gluconocitrate ("Renacidin Irrigation") Use of Clorpactin for the Treatment of Animal 4,983,634 1/8/91 1/8/08 Mastitis & the applicator used in that treatment (owned jointly by the Registrant and Diversey Ltd.) Iodophor; biocide; reacting polyethylene glycol, 5,013,859 5/7/91 5/7/08 alkylarylsulfonate and Iodine water-propylene glycol solvent refluxing Stabilized Beta Carotene 5,023,355 6/11/91 6/11/08 Stable, Active Chlorine Containing Anti-microbial 5,128,342 7/7/92 7/7/09 Compositions ("Cloronine") Gamma Radiation Resistant Lubricating Gel 5,405,622 4/11/95 4/11/12 The Registrant requires all employees and consultants who may receive proprietary information to agree in writing to keep such proprietary information confidential. Eastern Chemical Corporation Eastern Chemical Corporation is a wholly owned subsidiary of the Registrant. It distributes an extensive line of fine organic chemicals, research chemicals, test solutions, indicators, dyes and stains, and reagents. In 1998, Eastern's sales accounted for approximately 18% of the total product sales of the Registrant versus 20% in 1997. Marketing Guardian markets its products through (a) distributors; (b) advertising in medical and trade journals, by mailings to physicians and to the trade; and (c) exhibitions at appropriate medical meetings. The pharmaceutical products are generally sold in the United States to drug wholesalers, surgical supply houses and drug stores for resale, and directly to hospitals, physicians, the Veteran's Administration, and other government agencies. The proprietary cosmetic and specialty chemical products are sold to distributors for resale and directly to manufacturers for use as ingredients or additives in the manufacture or compounding of other cosmetic or chemical products. Eastern's products are marketed through advertising in trade publications and direct mailings. They are sold to distributors and directly to users in a wide variety of applications. Eastern does not sell any unique products and is not dependent on any single customer or group of customers on a continuous basis. Domestic Sales In the United States Registrant's cosmetic products are marketed exclusively by ISP in accordance with a marketing agreement entered into in 1996 (see "Marketing Agreements" below). ISP also has the right to sell some of Registrant's other industrial and medical products. In 1998 ISP's purchases for distribution in the United States were estimated to be approximately $900,000* , and accounted for approximately 10% of the Registrant's sales in 1998. Registrant's domestic sales of pharmaceutical products are handled primarily through the major full-line drug wholesalers and account for approximately 23% of Registrant's sales. Registrant's other products, such as its industrial products, are sold directly to end-users by the Registrant and account for less than 2% of Registrant's sales. (*Note: this figure is an estimate based on sales information provided to Registrant by ISP. Registrant has no way of independently determining which of ISP's purchases are intended for domestic sale and which are intended for foreign sale.) Foreign Sales In 1998 the Registrant derived approximately 44% of its sales from customers in foreign countries, primarily from sales of its cosmetic products in Europe, compared to 43% in 1997. The Registrant currently has 8 distributors for its cosmetic products outside the United States: S. Black (Import & Export) Ltd. in the United Kingdom ("S. Black"); Sederma and Warwick France in France; S.A. de Especialidades Quimicas in Spain; Luigi & Felice Castelli S.R.L. in Italy; Mimox AG in Switzerland; C&M International in Korea; and ISP in Germany, Eastern Europe, the Benelux countries, Canada, Mexico, South & Central America, Asia (with the exception of Korea), and most of the remaining foreign markets. The percentage of Registrant's sales by its largest foreign distributors were as follows: Sederma: 13%; ISP (for sales outside of the United States): 9% (an estimate based on sales figures provided to the Registrant by ISP); S. Black: 8%; and C&M International: 3%. Marketing Agreements ISP In 1994 Registrant entered into an agreement with ISP whereby ISP would market certain of Registrant's products, primarily its cosmetic products, in Europe and Asia. That agreement established an alliance with ISP that was intended to bring the Registrant's products to many regions of the world where either they had not been marketed before, or where previous marketing efforts had been unsatisfactory. The major focus of that agreement was the Far East, but also included Eastern Europe, Russia, and some countries in Western Europe, most importantly Germany. The agreement provided for exclusivity in those areas as long as minimum purchase requirements were met. ISP manufactures and markets an extensive line of personal care, pharmaceutical, and industrial products on a global basis. ISP's sales during 1998 were negatively impacted by the economic problems experienced in Asia, and will most likely continue to be impacted in 1999 until those affected economies recover. However, the Registrant does not believe that it will experience any further sales declines in 1999 due to the economic problems in that part of the world. In 1996 Registrant entered into an additional marketing agreement with ISP whereby ISP became Registrant's exclusive distributor of its cosmetic products in the United States, Canada, Mexico, and Central and South America, thereby significantly expanding ISP's territory. As with its earlier agreement, this agreement provided for exclusivity as long as yearly minimum purchase levels are attained. Accompanying this agreement was a modification to the 1994 agreement to provide consistency between the two agreements. Registrant believes that in the event that ISP were to cease marketing Registrant's products, that alternative arrangements could be made to continue to supply product to the customers currently using Registrant's products without any significant interruption of supply. CREATIVE TECHNOLOGIES In an effort to accelerate the marketing of some of Registrant's other products, Registrant in late 1995 entered into an agreement with Creative Technologies, Inc., ("Creative") a marketing consulting company. Since that time Registrant has been working with Creative to place some of Guardian's products with companies not previously contacted by the Registrant, as well as to provide Guardian with market information that will enable it to develop products to fill existing market needs. The agreement with Creative was for an initial six-month period that ended May 31, 1996, which was extended until November 30, 1996. Since that time Creative is continuing to work on behalf of the Registrant based on a commission schedule relating to the volume of business that Creative brings to the Registrant. At the present time Registrant is actively working with Creative to bring more of Guardian's products to the attention of Creative's clients, in particular Kimberly Clark. VASCA, INC. In December, 1998, Registrant entered into a marketing agreement with VascA, Inc. whereby VascA will promote the use of Registrant's Clorpactin WCS-90 as a disinfecting agent for use with VascA's subcutaneous kidney dialysis access port. The Clorpactin will be used to disinfect the tissue surrounding the port as well as the port itself. VascA's port is currently approved in parts of Europe and VascA is in the process of obtaining approval for the use of Clorpactin there. In the United States, VascA is currently working with the FDA to obtain approval to market both their access port and the Clorpactin. Approval in the U.S. is expected by the fourth quarter of 1999, and applications are pending in Europe as well. VascA also will be providing funding to the Registrant to further improve the product and/or its packaging. The agreement provides for VascA to take over all marketing of Clorpactin once they achieve certain sales levels. Most of Registrant's other marketing arrangements are not in the form of long-term contracts and can be terminated at any time. Raw Materials The principal raw materials used by the Registrant consist of common industrial organic chemicals, laboratory reagents, and common inorganic chemicals. Most of these materials are available in ample supply from numerous sources. The Registrant's principal raw material suppliers are Callahan Chemical Company, Van Waters & Rogers, Inc., Protameen Chemicals Inc., Alzo, Inc., Vitusa Products, Inc., B.A.S.F., DSM Fine Chemicals Inc., Eastman Chemical, Clariant Corp., Ishihara U.S.A., Nissei Trading Co., and Varessa, Ltd. Inventories; Returns and Allowances The Registrant's business requires that it maintain large inventories of certain of its finished goods. Historically, returns and allowances have not been a significant factor in the Registrant's business. Backlog The Registrant currently does not have any significant backlog. Competition Guardian has many products or processes that are either unique in their field or have some unique characteristics, and therefore are not in direct competition with the products or processes of other pharmaceutical, chemical, or health care companies. However, the pharmaceutical, health care, and cosmetic industries are all highly competitive, and the Registrant expects competition to intensify as advances in the field are made and become widely known. There may be many domestic and foreign companies that are engaged in the same or similar areas of research as those in which the Registrant is engaged, many of which have substantially greater financial, research, manpower, marketing and distribution resources than the Registrant. In addition, there are many large, integrated and established pharmaceutical, chemical and cosmetic companies that have greater capacity than the Registrant to develop and to commercialize types of products upon which the Registrant's research and development programs are based. The Registrant believes that manufacturing, regulatory, distribution and marketing expertise will be increasingly important competitive factors. In this regard, the Registrant believes that arrangements with major health care and medical or hospital products suppliers will be important factors in the commercialization of many of the products which it is currently developing. Eastern faces competition from many other chemical manufacturers and distributors, many of which have much greater financial resources than those of the Registrant. Eastern's competition is based primarily upon price, service and quality. Eastern attempts to maintain its competitive position in the industry through its ability to (i) locate and make wholesale arrangements to purchase the chemicals with suppliers located all over the world, (ii) maintain a sufficient inventory of each of its items at all times, and (iii) customize each order as to quantity of the item requested and to tailor the price of the order to such quantity. Eastern's primary competitors are Fluka Chemicals, Sigma Chemical Company, Aldrich Chemical Co., Inc., Acros Organics, Pfaltz & Bauer, Inc., and Spectrum Chemical Mfg. Corp. ISO-9000 REGISTRATION On November 24, 1998 the Registrant earned ISO-9002 registration from Underwriters Laboratories, Inc., indicating that the Registrant's documented procedures and overall operations had attained the high level of quality needed to receive ISO registration. Government Regulation Regulation by governmental authorities in the United States and other countries is a significant factor in the manufacturing and marketing of many of the Registrant's products. The Registrant and many of Registrant's products are subject to certain government regulations. Products that may be developed and sold by the Registrant in the United States may require approval from federal regulatory agencies, such as the FDA, as well as state regulatory agencies. Products that may be developed and sold by the Registrant outside of the United States may require approval from foreign regulatory agencies. Any medical device products developed by the Registrant will be subject to regulation by the Center for Devices and Radiological Health of the FDA, and will usually require a 510(k) pre-market notification. Most pharmaceutical products will require clinical evaluation under an Investigational New Drug ("IND") application prior to submission of a New Drug Application ("NDA") for approval of a new drug product. A drug product normally must go through several phases in order to obtain FDA approval. The research phase involves work up to and including discovery, research, and initial production. Next is the pre-clinical phase, which involves studies in animal models necessary to support an IND application to the FDA and foreign health registration authorities to commence clinical testing in humans. Clinical trials for pharmaceutical products are conducted in three phases. In Phase I, studies are conducted to determine safety and dosages. In Phase II, studies are conducted to gain preliminary evidence as to the efficacy of the product. In Phase III, studies are conducted to provide sufficient data for the statistical proof of safety and efficacy, including dose regimen. Phase III is the final stage of such clinical studies prior to the submission of an application for approval of an NDA. The amount of time necessary to complete any of these phases cannot be predicted with any certainty. In all cases, the Registrant is required to comply with all pertinent Good Manufacturing Practices of the FDA for medical devices and drugs. Accordingly, the regulations to which the Registrant and certain of its products may be subject, and any changes with respect thereto, may materially affect the Registrant's ability to produce and market new products developed by the Registrant. The Registrant's present and future activities are, and will likely continue to be, subject to varying degrees of additional regulation under the Occupational Safety and Health Act, Environmental Protection Act, import, export and customs regulations, and other present and possible future foreign, federal, state and local regulations. Portions of the Registrant's operating expenses are directly attributable to complying with federal, state, and local environmental statutes and regulations. In 1998 and 1997 the Registrant incurred approximately $46,000 and $45,000 respectively, in environmental compliance costs. Research and Development Expense Portions of the Registrant's operating expenses are directly attributable to research and development the Registrant performs. In 1998 and 1997, the Registrant incurred approximately $234,000 and $285,000 respectively, in research and development expenses. The expenses consist of direct costs as well as factory overhead. No portion of the research and development expenses was directly paid by the Registrant's customers. Revenue and Earnings The tables below set forth, for the years indicated, the revenue (including fees and retainers), and earnings from operations attributable to the Registrant and to the Registrant's business segments: YEAR ENDED YEAR ENDED December 31, December 31, 1998 1997 ---------- ---------- Revenue: Guardian $7,230,783 $6,964,060 Eastern 1,538,955 1,788,073 --------- --------- $8,769,738 $8,752,133 ========= ========== Earnings from Operations: Guardian $1,819,443 $1,526,310 Eastern (103,934) (45,308) Corporate (166,238) (161,123) --------- --------- $1,549,271 $1,319,879 ========= ========= Identifiable Assets The table below sets forth as of the dates indicated the identifiable assets of the Registrant as a whole, as well as the identifiable assets of the Registrant's business segments: As of: December 31, December 31, 1998 1997 --------- ---------- Guardian $2,659,964 $2,650,668 Eastern 591,550 772,401 Corporate 3,542,819 2,702,777 --------- --------- $6,794,333 $6,125,846 ========= ========= For certain additional financial information concerning the Registrant's industry segments see Note J of Notes to Consolidated Financial Statements of the Registrant contained in Item 7 herein. Employees The Registrant presently employs 44 people, 6 of whom serve in an executive capacity, 23 in research, quality control and manufacturing, 5 in maintenance and construction and 10 in office and administrative work. Of the total number of employees, 40 are full time employees. None of the Registrant's employees are covered by a collective bargaining agreement. The Registrant believes that its relations with its employees are satisfactory. Item 2. Description of Property. The Registrant maintains its principal offices and conducts most of its research at 230 Marcus Boulevard, Hauppauge, New York 11788. These premises, which the Registrant owns, contain approximately 30,000 square feet of manufacturing space, 15,000 square feet of warehouse space, and 5,000 square feet of office and laboratory space on approximately 2.7 acres of land. The Registrant has now fully developed the 2.7 acres, and fully utilizes the buildings occupying the land. The Registrant believes that the aforementioned property is adequate for its immediately foreseeable needs. The property is presently unencumbered and is adequately insured. Item 3. Legal Proceedings. None Item 4. Submission of Matters to a Vote of Security Holders. None. PART II Item 5. Market for Common Equity and Related Stockholder Matters. Market Information The Common Stock of the Registrant is traded on the American Stock Exchange (the "AMEX") under the symbol "UG". The following table sets forth for the periods indicated the high and low closing sale prices of the shares of Common Stock, as reported by the AMEX Market Statistics for the period January 1, 1997 to December 31, 1998. The quotations represent prices between dealers and do not include retail markup, markdown or commission: Year Ended Year Ended December 31, 1998 December 31, 1997 Quarters High Low High Low ------------------ ------- -------- ------ ------- First (1/1 - 3/31) $ 5 $ 4 1/8 $ 2 3/8 $ 1 3/4 Second (4/1 - 6/30) 6 11/16 4 7/8 5 1 15/16 Third (7/1 - 9/30) 5 1/2 3 11/16 4 7/8 3 3/4 Fourth (10/1 - 12/31) 5 3/4 3 1/2 6 1/8 3 3/4 Holders of Record As of March 8, 1999 there were 1,604 holders of record of Common Stock. Cash Dividends On January 5, 1999 the Registrant paid a $.07 per share dividend to all stockholders of record as of December 10, 1998. On January 5, 1998 the Registrant paid a $.06 per share dividend to all stockholders of record as of December 12, 1997. Item 6. Management's Discussion and Analysis or Plan of Operation Results Of Operations: Year Ended December 31,1998 Compared to Year Ended December 31,1997 Revenue Revenue in 1998 increased by $17,605 compared to 1997 due to revenue increases in the Guardian Division of $266,723 (4%) and a decrease in the Eastern Division of $249,118 (14%). The Guardian sales increase was due mainly to increases in sales of Guardian's core product lines in the United States and Europe, which offset some decreases experienced by the Company in Asian markets. The sales increases in the cosmetic product lines were the result of an expansion of the marketing of the Company's core product lines in conjunction with the Company's marketing partners in the United States and Europe. The Eastern decrease was due primarily to a slight downsizing of the Eastern operations intended to streamline Eastern's business, which resulted in a reduction in inventory and the consequent loss of some sales. Costs and Expenses Costs and expenses in 1998 decreased by $211,787 (3%) compared to the 2prior year due to decreases in cost of sales of $395,121 (7%) which were partially offset by increases in operating expenses of $183,334 (9%). Costs of sales as a percentage of sales decreased to 57% in 1998 as compared to 62% in 1997. Of the 5% decrease in cost of sales as a percentage of sales, approximately 2% was attributable to a decrease in the cost of the Company's RENACIDIN IRRIGATION due to the larger volumes purchased in 1998 versus 1997. Another 1% of the decrease was attributable to a reduction in cost of one of the Company's largest volume raw materials in 1998 compared to 1997. Other reductions were attributable to (a) a change in product mix of the Guardian division, with some higher cost items being replaced by sales of lower cost items, and (b) reduced sales of lower margin products of the Eastern division that were replaced by additional sales of higher margin products by the Guardian division. The increase in operating expenses in 1998 was primarily due to a non-cash charge of approximately $204,000 relating to the unamortized costs of the Registrant's Sonarite technology. In October, 1998 the Registrant determined that the then current formulation required further development and testing before the product could be marketed. Other Income (Expense) Interest expense decreased from $31,505 to $523 due to a reduction in outstanding borrowings. Investment income and other increased from $38,492 to $66,466 principally due to the investing of excess cash provided from operations. The Registrant realized gain on sale of assets of $31,000 in 1998 while there was no gain or loss in 1997. Provision for Income Taxes The provision for income taxes increased from $502,620 in 1997 to $632,677 in 1998. This increase is primarily due to the increase in earnings before income taxes of $319,348 (24%) between years. The Registrant's effective rates remained consistent at approximately 38%. Liquidity and Capital Resources Working capital increased from $2,973,768 as of the end of 1997 to $3,926,106 as of the end of 1998, an increase of $952,338 (32%). The current ratio increased from 4.6 to 1 at December 31, 1997 to 5.9 to 1 at December 31, 1998. The increase in working capital was due primarily to increases in cash provided by operations. The Registrant has a line of credit agreement with a bank for borrowings of up to $700,000. As of December 31, 1998, there were no outstanding borrowings on this line of credit. The Registrant generated cash from operations of $1,234,272 in 1998 compared to $1,497,078 in 1997. The decrease in 1998 was primarily due to an increase in accounts receivable. During each of the years 1998 and 1997 the Registrant invested approximately $271,000 and $291,000 respectively for plant and equipment. Cash used in investing activities was $482,871 and $703,151 in the years ended December 31, 1998 and 1997 respectively. The decrease was mainly due to reduction in the purchase of marketable securities. Cash used in financing activities was $253,387 and $797,410 in the years ended December 31, 1998 and 1997 respectively. The decrease was primarily due to the repayment of substantially all of Registrant's long term debt that was outstanding in 1997. While the Registrant believes that its working capital is sufficient to support its operating requirements for the next fiscal year, the Registrant's long-term liquidity position will be dependent upon its ability to generate sufficient cash flow from operations. The Registrant has no material commitments for future capital expenditures. Impact of Inflation, Changing Prices, and Seasonality While it is difficult to assess the impact of inflation on the Registrant's operations, management believes that, because of the proprietary nature of the majority of its product line, inflation has had little impact on net sales. Sales have changed as a result of volume and product mix. While inflation has had an impact on the cost of sales and payroll, these increases have been recaptured by price increases to the greatest extent possible. Registrant's products and sales are not considered to be a seasonal, and are generally distributed evenly throughout the year. Impact of the "Year 2000" Issue The Registrant has evaluated the impact of the Year 2000 ("Y2K") issue on its business and does not expect to incur any significant costs associated with Year 2000 compliance or that the Year 2000 issue will have a material impact on the Registrant's business, results of operations, or financial condition. In 1998 the Registrant purchased new computer equipment to enable it to run a new Y2K compliant version of its accounting software. This software has been certified by the vendor to be Y2K compliant, and the Registrant has independently verified that the date fields have been expanded to four digits instead of two, and is satisfied that the software will function properly after December 31, 1999. All of Registrant's inventory, purchase orders, sales, receivables, and general ledger are handled by this Y2K compliant software. The underlying operating system on which this software works has been certified Y2K compliant. Registrant's cost to bring its computer systems into Y2K compliance during 1998 was approximately $30,000. The Registrant is not aware of any problems that its customers or suppliers may have in regard to the Y2K issue. Registrant does not at the present time conduct any direct data transfer with any of its customers or suppliers that would be affected by their failure to be Y2K compliant, and has no reason to believe that any Y2K compliance problems that any of its suppliers or customers might have will have any material adverse impact on the Registrant. The Registrant is in the process of trying to obtain second sources of supply for as many of its raw materials as possible before the end of 1999, and believes that it currently has enough alternative suppliers for its key products that it will not be materially affected by the failure of one or more of its current raw material suppliers to become Y2K compliant. Registrant has requested information on Y2K compliance from those suppliers and customers with which it considers itself to have a material relationship and where their failure to attain Y2K compliance could have a material impact on the Registrant. Registrant has requested final responses by March 31, 1999. To date all of those customers and vendors that have responded to Registrant's request for Y2K information have indicated that either they already are Y2K compliant or will be so by the end of 1999. Registrant has investigated its key non-information technology systems for Y2K compliance and has determined that they are either already Y2K compliant or will be so by the end of the year without material expense to the Registrant. The following material non-information technology system providers have already given the Registrant assurances that the systems or services they provide are Y2K compliant: Registrant's primary bank; the company that handles Registrant's payroll; the company that handles its security system; and the Registrant's registrar and stock transfer agent. The company that handles Registrant's telephone system has assured the Registrant that, with the exception of its voice mail system, which will be made Y2K compliant by mid-1999 at no cost to the Registrant, all of the rest of Registrant's telephone system is already Y2K compliant. Registrant believes that it has already made all of the material expenditures necessary to attain Y2K compliance internally, and does not expect to expend any material amounts during 1999 or thereafter for this purpose. Item 7. Financial Statements. Annexed hereto starting on page F-1 Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Not Required. PART III Item 9. Directors, Executive Officers, Promoters and Control Persons; Compliance With Section 16(a) of the Exchange Act. Directors and Executive Officers Set forth in the table below is certain information as of March 8, 1999 with respect to the executive officers and directors of the Registrant: Name Age Position(s) with the Registrant -------------------- ----- ---------------------------------------------- Dr. Alfred R. Globus 78 Chairman of the Board, Chief Executive Officer and Director Kenneth H. Globus 47 President, Chief Financial Officer, General Counsel and Director Robert S. Rubinger 56 Executive Vice President, Secretary, Treasurer and Director Charles W. Castanza 66 Vice President and Director Derek Hampson 59 Vice President Joseph J. Vernice 40 Vice President Lawrence Maietta 41 Director Henry P. Globus 76 Director Benjamin Wm. Mehlman 88 Director Alan E. Katz 55 Director Arthur Dresner 57 Director Dr. Alfred Globus has been Chairman of the Board and Chief Executive Officer of the Registrant since July, 1988. He served as Chairman of the Board and President of the Registrant from the inception of the Registrant in 1942 until July, 1988. He has been a director of the Registrant since 1942. Kenneth H. Globus has been President and General Counsel of the Registrant since July, 1988. He served as Vice President and General Counsel of the Registrant from July, 1983 until July, 1988. He has been a director of the Registrant since 1984. He became the Chief Financial Officer in November, 1997. Robert S. Rubinger has been Executive Vice President and Secretary of the Registrant since July, 1988, and Treasurer since May, 1994. He served as Vice President and Secretary of the Registrant from February, 1982 until July, 1988. He has been a director of the Registrant since 1982. Charles W. Castanza has been a Vice President of the Registrant since April, 1986. He served as Operations Manager of Chemicals and Pharmaceuticals of the Registrant from February, 1982 until April, 1986. He has been a director of the Registrant since 1982. Derek Hampson has been a Vice President of the Registrant since October, 1987. He has served as Manager of the Eastern Chemical Corp. subsidiary since 1971. Joseph J. Vernice has been a Vice President of the Registrant since February, 1995. He served as Assistant Vice President of the Registrant from November, 1991 until February, 1995. Lawrence Maietta has been a partner in the public accounting firm of Bonamassa & Maietta, C.P.A.s in Brooklyn, NY since October, 1991. For more than five years prior to that he was a partner in the public accounting firm of Wilfred, Wyler & Co. in New York, NY. He was controller for the Registrant from October, 1991 until November, 1997, and a director of the Registrant since February, 1994. Henry P. Globus has been a consultant to the Registrant since July, 1988. He served as Executive Vice President of the Registrant from 1982 until July, 1988. He has been a director of the Registrant since 1947. Benjamin William Mehlman was formerly a judge and attorney in private practice until he retired from the practice of law in February, 1999. From 1984 to 1998 he had been counsel to the law firm of William T. Friedman and its predecessor, Friedman and Shaftan. He has been a director of the Registrant since 1964. Alan E. Katz has been a partner in the law firm of Greenfield Stein & Senior, LLP, New York, NY since November, 1984. He has been a director of the Registrant since February, 1994. Arthur Dresner is an attorney in private practice and an independent business consultant. From June 1998 to the present he has been engaged as "Of Counsel" to the law firm of McAulay Nissen Goldberg Kiel & Hand in New York City. From 1974 until 1997 he was employed as a Vice President in the corporate development area and general management of ISP. He has been a director of the Registrant since April, 1997. Dr. Alfred R. Globus and Henry P. Globus are brothers. Kenneth H. Globus is the son of Henry P. Globus and the nephew of Dr. Alfred R. Globus. There are no other family relationships between any directors or officers of the Registrant. Compliance with Section 16(a) of the Exchange Act The information required by this section is incorporated herein by reference to the section entitled "Directors and Executive Officers - Section 16(a) Beneficial Ownership Reporting Compliance" of the 1999 Proxy Statement. Item 10. Executive Compensation. The information required by this Item is incorporated herein by reference to the section entitled "Compensation of Directors and Executive Officers - Summary Compensation Table" of the 1999 Proxy Statement. Item 11. Security Ownership of Certain Beneficial Owners and Management. The information required by this Item is incorporated herein by reference to the section entitled "Voting Securities and Principal Stockholders - Security Ownership of Management" of the 1999 Proxy Statement. Item 12. Certain Relationships and Related Transactions. The Registrant has a split dollar life insurance arrangement with Alfred R. Globus, its Chairman and Chief Executive Officer ("Insured"). For fiscal years 1995 through 1998 Registrant made non-interest bearing advances of approximately $87,000 per year (approximately 87% of the annual cost of the $1,500,000 policy), on behalf of a trust of which the Insured is the grantor and another officer, Kenneth H. Globus is one of the beneficiaries. Under a collateral assignment agreement the proceeds from the policy will first be paid to the Registrant to repay all of the advances it made. If the policy is terminated prior to the death of the Insured, the Registrant will be entitled to the cash surrender value of the policy at that time, and any shortfall between that amount and the amount of the advances made by the Registrant will be repaid to the Registrant by the Insured. As of December 31, 1998 and 1997, cumulative advances of $348,161 and $261,559, respectively, are recorded in the Consolidated Balance Sheets under "Other Assets". The trust is currently in the process of looking into modifications to the policy that might decrease the amount of the yearly advances being made by the Registrant. Item 13. Exhibits, List and Reports on Form 8-K (a) Exhibits 3(a) Certificate of Incorporation of the Registrant as filed April 22, 1987. Incorporated by reference to Exhibit 4.1 to the Registrant's Current Report on Form 8-K, dated September 21, 1987 (the "1987 8-K"). 3(b) Certificate of Merger of United-Guardian, Inc. (New York) with and into the Registrant as filed with the Secretary of State of the State of Delaware on September 10, 1987. Incorporated by reference to Exhibit 3(b) to the Registrant's Annual Report on Form 10-K for the fiscal year ended February 29, 1988 (the "1988 10-K"). 3(c) By-laws of the Registrant. Incorporated by reference to Exhibit 4.2 to the 1987 8-K. 4(a) Specimen Certificate for shares of common stock of the Registrant. Incorporated by reference to Exhibit 4(a) to the 1988 10-K. 10(a) Qualified Retirement Income Plan for Employees of the Registrant, as restated April 1, 1976. Incorporated by reference to Exhibit 11(c) of the Registrant's Registration Statement on Form S-1 (Registration No. 2-63114) declared effective February 9, 1979. 10(b) Employment Termination Agreement dated July 8, 1988 between the Registrant and Henry Globus. Incorporated by reference to Exhibit 10(i) to the Registrant's Annual Report on Form 10-K for the 10-month transition period from March 1, 1991 to December 31, 1991. 10(c) Distribution Agreement between the Registrant and Societe D'Etudes Dermatologies, dated November 20, 1991. Incorporated by reference to Exhibit 10(k) to the Registrant's Annual Report on Form 10-K for the 10-month transition period from March 1, 1991 to December 31, 1991. 10(d) Exclusive Distributor Agreement between the Registrant and ISP (Switzerland) A.G. dated December 9, 1994. Incorporated by reference to Exhibit 10(m) of the 1994 10-KSB. The Registrant has been granted confidential treatment of portions of some of the schedules to this Agreement. 10(e) Exclusive Distributor Agreement between the Registrant and ISP Technologies Inc. dated September 20, 1996. The Registrant has been granted confidential treatment of portions of some of the schedules to this Agreement. Incorporated by reference to Exhibit 10(h) to the Registrant's Annual Report on Form 10-KSB for the year ending December 31, 1996 ("1996 10-KSB") 10(f) Marketing and Supply Agreement between the Registrant and VascA, Inc. dated January 1, 1999.(filed herewith) 21 Subsidiaries of the Registrant: Name Under Jurisdiction of Which it does Name Incorporation Business Eastern Chemical Corporation New York Eastern Chemical Corporation Transcontinental Processes Australia N/A (Pty.) Ltd.* Dieselite Corporation** Delaware N/A Paragon Organic Chemicals, New York Paragon Organic Chemicals Inc. * Inactive without assets ** Inactive 27 Financial Data Schedule (b) Reports on Form 8-K None SIGNATURES In accordance with Section 13 or 15(d) of the Exchange Act, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. UNITED-GUARDIAN, INC. Dated: March 17, 1999 By: /s/ Alfred R. Globus --------------------- Alfred R. Globus Chief Executive Officer & Director In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date ----------------------- --------------------------------- --------------- By:/s/ Alfred R. Globus Chief Executive Officer, Director March 17, 1999 ------------------------ (Principal Executive Officer) Alfred R. Globus By:/s/ Kenneth H. Globus President, General Counsel, March 17, 1999 ------------------------ Director, Chief Financial Kenneth H. Globus Officer(Principal Financial and Accounting Officer) By:/s/ Robert S. Rubinger Executive Vice President, March 17, 1999 ------------------------ Secretary, Treasurer, Director Robert S. Rubinger By:/s/ Charles W. Castanza Vice President, Director March 17, 1999 ------------------------ Charles W. Castanza By:/s/ Henry P. Globus Director March 17, 1999 ------------------------ Henry P. Globus By:/s/ Benjamin Wm. Mehlman Director March 17, 1999 ------------------------ Benjamin Wm. Mehlman By:/s/ Lawrence F. Maietta Director March 17, 1999 ------------------------ Lawrence F. Maietta By:/s/ Alan Katz Director March 17, 1999 ------------------------ Alan E. Katz By:/s/ Arthur Dresner Director March 17, 1999 ------------------------ Arthur Dresner INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page ---------- Report of Independent Certified Public Accountants F-2 Financial Statements Consolidated Balance Sheets as of December 31, 1998 and 1997 F-3 - F-4 Consolidated Statements of Earnings for the Years Ended December 31, 1998 and 1997 F-5 Consolidated Statements of Stockholders' Equity and Comprehensive Income for the Years Ended December 31, 1998 and 1997 F-6 Consolidated Statements of Cash Flows for the Years Ended December 31, 1998 and 1997 F-7 Notes to Consolidated Financial Statements F-8 - F-25

INDEX TO FINANCIAL STATEMENTS:



F-1 REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS Board of Directors and Stockholders United-Guardian, Inc. and Subsidiaries We have audited the accompanying consolidated balance sheets of United-Guardian, Inc. (a Delaware corporation) and subsidiaries as of December 31, 1998 and 1997, and the related consolidated statements of earnings, stockholders' equity and comprehensive income, 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 United-Guardian Inc. and subsidiaries as of December 31, 1998 and 1997, and the results of their operations and their cash flows for the years then ended in conformity with generally accepted accounting principles. GRANT THORNTON LLP Melville, New York March 4, 1999 F-2 United-Guardian, Inc. and Subsidiaries
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CONSOLIDATED BALANCE SHEETS December 31, ASSETS 1998 1997 --------- --------- CURRENT ASSETS Cash and cash equivalents ........................ $1,320,610 $ 822,596 Marketable securities............................. 604,314 361,723 Accounts receivable, net of allowance for doubtful accounts of $52,894 and $32,300, respectively 1,300,118 905,896 Inventories ...................................... 1,150,132 1,372,067 Prepaid expenses and other current assets ........ 169,786 225,854 Deferred income taxes ............................ 176,318 107,111 ---------- ---------- Total current assets ............... 4,721,278 3,795,247 ---------- ---------- PROPERTY, PLANT AND EQUIPMENT Land ............................................. 69,000 69,000 Factory equipment and fixtures ................... 2,407,200 2,333,654 Building and improvements ........................ 1,964,646 1,843,171 Waste disposal plant ............................. 133,532 133,532 ---------- ---------- 4,574,378 4,379,357 Less accumulated depreciation .................... 3,041,694 2,847,870 ---------- --------- 1,532,684 1,531,487 Assets under capital leases, net ................. -- 1,444 ---------- --------- 1,532,684 1,532,931 ---------- --------- OTHER ASSETS Processes and patents, net ....................... 190,685 533,984 Split dollar life insurance ...................... 348,161 261,559 Other ............................................ 1,525 2,125 ---------- --------- 540,371 797,668 ---------- --------- $6,794,333 $6,125,846 ========== ========== The accompanying notes are an integral part of these statements. F-3 United-Guardian, Inc. and Subsidiaries
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CONSOLIDATED BALANCE SHEETS December 31, LIABILITIES AND STOCKHOLDERS' EQUITY 1998 1997 -------- --------- CURRENT LIABILITIES Dividends payable ............................ $341,820 $292,610 Accounts payable ............................. 317,973 292,632 Accrued expenses ............................. 119,855 165,841 Taxes payable ................................ 5,524 70,396 Current portion of long-term debt ............ 10,000 -- -------- -------- Total current liabilities ............... 795,172 821,479 -------- -------- LONG-TERM DEBT, net of current portion ........... 16,229 -- -------- -------- DEFERRED INCOME TAXES ............................ 10,000 20,116 -------- -------- COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY Common stock, $.10 par value; authorized, 10,000,000 shares; issued and outstanding, 4,883,139 and 4,876,839 shares, respectively ...................... 488,314 487,684 Capital in excess of par value ............... 3,330,874 3,314,210 Accumulated other comprehensive (loss) (330) - Retained earnings ............................ 2,154,074 1,482,357 ---------- ---------- 5,972,932 5,284,251 ---------- ---------- $6,794,333 $6,125,846 ========== ========== The accompanying notes are an integral part of these statements. F-4 United-Guardian, Inc. and Subsidiaries CONSOLIDATED STATEMENTS OF EARNINGS Year ended December 31, 1998 1997 ----------- ----------- Revenue Net sales ....................... $ 8,769,738 $ 8,752,133 ----------- ----------- Costs and expenses Cost of sales ................... 5,009,463 5,404,584 Operating expenses .............. 2,211,004 2,027,670 ----------- ----------- 7,220,467 7,432,254 ----------- ----------- Earnings from operations ... 1,549,271 1,319,879 Other income (expense) Interest expense ................ ( 523) (31,505) Investment income................ 66,488 34,829 Gain on sale of assets .......... 31,000 -- Other ........................... (22) 3,663 ----------- ----------- Earnings before income taxes 1,646,214 1,326,866 Provision for income taxes .......... 632,677 502,620 ----------- ----------- NET EARNINGS ............... $ 1,013,537 $ 824,246 =========== =========== Earnings per common share (Basic and Diluted)...................... $ .21 $ .17 =========== =========== Basic weighted average shares ....... 4,880,343 4,832,783 =========== =========== Diluted weighted average shares ..... 4,904,587 4,852,641 =========== =========== The accompanying notes are an integral part of these statements. F-5 United-Guardian, Inc. and Subsidiaries
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CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE INCOME Accumulated Common stock Capital in other ----------------------- excess of comprehensive Retained Comprehensive Shares Amount par value (loss) earnings Total income --------- ----------- ----------- --------------- ----------- --------- ------------- Balance, January 1, 1997 4,762,889 $ 476,289 $ 3,089,380 -- $ 950,721 $4,516,390 Issuance of common stock in connection with exercise of stock options ...... 13,950 1,395 28,580 -- 29,975 Issuance of common stock for purchase of technology. 100,000 10,000 196,250 -- 206,250 Net earnings ............. 824,246 824,246 $ 824,246 Dividends declared ....... -- -- -- (292,610) (292,610) --------- Comprehensive income 824,246 --------- ----------- ----------- --------------- ----------- ---------- ========= Balance, December 31, 1997 4,876,839 $ 487,684 $ 3,314,210 -- $ 1,482,357 $5,284,251 Issuance of common stock in connection with exercise of stock options ...... 6,300 630 12,364 -- 12,994 Income tax benefits on stock options exercised 4,300 4,300 Unrealized loss on marketable securities $ (330) (330) (330) Net earnings ............. 1,013,537 1,013,537 1,013,537 Dividends declared ....... -- -- -- (341,820) (341,820) ---------- Comprehensive income $1,013,207 --------- ----------- ----------- --------------- ----------- --------- ========== Balance, December 31, 1998 4,883,139 $ 488,314 $ 3,330,874 $ (330) $ 2,154,074 $5,972,932 ========= =========== =========== =============== =========== ========= The accompanying notes are an integral part of this statement. F-6 United-Guardian, Inc. and Subsidiaries
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CONSOLIDATED STATEMENTS OF CASH FLOWS Year ended December 31, 1998 1997 --------- --------- Cash flows from operating activities Net earnings ....................................$1,013,537 $ 824,246 Adjustments to reconcile net earnings to net cash provided by operating activities Depreciation and amortization ............... 614,826 394,164 Net gain on sale of equipment ............... (31,000) -- Provision for doubtful accounts ............. 20,568 22,140 Deferred income taxes ....................... (79,323) (2,380) Unrealized loss on marketable securities..... (330) -- Provision for inventory obsolescence ........ 165,000 180,000 Increases (decreases) in cash resulting from changes in operating assets and liabilities Accounts receivable .................... (414,790) (68,890) Inventories ............................ 56,935 260,562 Prepaid expenses and other assets ...... (29,934) (112,887) Accounts payable ....................... 25,341 69,889 Accrued expenses and taxes payable ..... (106,558) (69,766) ---------- ---------- Net cash provided by operating activities .. 1,234,272 1,497,078 ---------- ---------- Cash flows from investing activities Acquisition of plant and equipment, net ......... (271,280) (291,428) Proceeds from the sale of plant and equipment ... 31,000 -- Purchase of technology .......................... -- (50,000) Purchase of marketable securities net............ (242,591) (361,723) --------- --------- Net cash used in investing activities .... (482,871) (703,151) --------- --------- Cash flows from financing activities Proceeds from long-term debt .................... 30,339 -- Principal payments on long-term debt ............ (4,110) (589,241) Proceeds from exercise of stock options ......... 12,994 29,975 Dividends paid .................................. (292,610) (238,144) --------- --------- Net cash used in financing activities ...... (253,387) (797,410) --------- --------- Net increase (decrease) in cash and cash equivalents 498,014 (3,483) Cash and cash equivalents, beginning of year ........ 822,596 826,079 --------- --------- Cash and cash equivalents, end of year ..............$1,320,610 $ 822,596 ========= ========= The accompanying notes are an integral part of these statements. F-7 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS December 31, 1998 and 1997 NOTE A - NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Business United-Guardian, Inc. (the "Company") is a Delaware corporation that operates in two business segments: (1) the Guardian Laboratories Division which conducts research, product development, manufacturing and marketing of pharmaceuticals, cosmetics, health care products, medical devices and proprietary industrial products, and (2) the Eastern Chemical Division which distributes a line of fine organic chemicals, research chemicals, test solutions, indicators, dyes and reagents. Sales from the Company's two major product lines, Lubrajel and Renacidin, accounted for approximately 70% and 63% of consolidated sales for the years ended December 31, 1998 and 1997 respectively. Principles of Consolidation The consolidated financial statements of the Company include the accounts of United-Guardian, Inc. and its wholly-owned subsidiaries, Eastern Chemical Corporation and Paragon Organic Chemicals, Inc. All intercompany accounts and transactions have been eliminated. Statements of Cash Flows For financial statement purposes (including cash flows), the Company considers as cash equivalents all highly liquid investments with an original maturity of three months or less. During 1998 the Company declared a cash dividend of $.07 payable on January 4, 1999 to stockholders of record as of December 10, 1998 aggregating $341,820. During 1997, the Company declared a dividend of $.06 payable on January 5, 1998 to stockholders of record as of December 12, 1997 aggregating $292,610. Cash payments for interest were $523 and $34,635 for the years ended December 31, 1998 and 1997, respectively. Cash payments for income taxes were $772,572 and $586,608 for the years ended December 31, 1998 and 1997, respectively. Marketable Securities Marketable securities include investments in certificates of deposit, which mature in less than a year, and investments in mutual funds. Certificates of deposit are classified as "Held to Maturity" securities and are reported at their amortized cost which approximates market value. Investment in equity mutual funds are classified as "Available for Sale" securities and are reported at their fair values. Unrealized gains and losses on "Available for Sale" securities are reported as accumulated other comprehensive (loss) in stockholders' equity, net of related tax effects. F-8 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE A (continued) Inventories Inventories are valued at the lower of cost or current market value. Cost is determined using the average cost method (which approximates FIFO). Inventory costs include material, labor and factory overhead. Property, Plant and Equipment Property, plant and equipment are carried at cost, less accumulated depreciation. Major replacements and betterments are capitalized while routine maintenance and repairs are expensed as incurred. Assets are depreciated under both accelerated and straight-line methods. Depreciation charged to earnings as a result of using accelerated methods was not materially different than that which would result from using the straight-line method for all periods presented. Certain factory equipment and fixtures are constructed by the Company using purchased materials and in-house labor. Such assets are capitalized and depreciated on a basis consistent with the Company's purchased fixed assets. Estimated useful lives are as follows: Factory equipment and fixtures 5 - 7 years Building 40 years Building improvements Lesser of useful life or 20 years Waste disposal plant 7 years Processes and Patents Processes and patents are amortized over periods ranging from 5 to 15 years. Amounts are shown net of accumulated amortization. Long-Lived Assets It is the Company's policy to evaluate and recognize an impairment to its long-lived assets if it is probable that the recorded amounts are in excess of anticipated undiscounted future cash flows.(See Note D) Fair Value of Financial Instruments The Company has estimated the fair value of financial instruments using available market information and other valuation methodologies in accordance with SFAS No. 107, "Disclosures About Fair Value of Financial Instruments." Management of the Company believes that the fair value of financial instruments, consisting of accounts receivable and payable and long-term debt, approximates carrying value due to the short payment terms associated with its accounts receivable and payable and the interest rates associated with its long-term debt. F-9 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE A (continued) Concentration of Credit Risk Accounts receivable potentially expose the Company to concentrations of credit risk. The Company routinely addresses the financial strength of its customers and, as a consequence, believes that its receivable credit risk exposure is limited. Two customers accounted for 30% and 18% of the accounts receivable at December 31, 1998. Two customers accounted for 22% and 11% at December 31, 1997. Income Taxes Deferred tax assets and liabilities reflect the future tax consequences of the differences between the financial reporting and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Research and Development The Company's research and development expenses are recorded in the year incurred. Research and development expenses were approximately $234,000 and $285,000 for the years ended December 31, 1998 and 1997, respectively. Earnings Per Share Information Basic earnings per share is based on the weighted average number of common shares outstanding without consideration of potential common stock. Diluted earnings per share is based on the weighted average number of common and potential common shares outstanding. The calculation takes into account the shares that may be issued upon exercise of stock options, reduced by the shares that may be repurchased with the funds received from the exercise, based on the average price during the year. Use of Estimates In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reporting period. Actual results could differ from those estimates. F-10 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE A (continued) Segment Reporting The Company adopted the Statement of Financial Accounting Standards ("SFAS") No. 131, "Disclosures About Segments of an Enterprise and Related Information" for the year ended December 31, 1998. SFAS No. 131 requires that the Company disclose certain information about its business segments defined as "components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance." NOTE B - MARKETABLE SECURITIES Marketable securities are carried at fair value. A summary of investments in marketable securities and reconciliation of amortized cost to the fair value follow: Gross Amortized Unrealized Fair Cost loss Value ---------- ---------- --------- December 30, 1998 Available for sale Mutual funds $ 81,452 $ (330) $ 81,122 Held to Maturity Certificates of deposit 523,192 523,192 --------- ---------- -------- Total $ 604,644 $ (330) $ 604,314 ========= ========== ======== December 30, 1997 Available for sale Mutual funds $ 30,208 $ -- $ 30,208 Held to Maturity Certificates of deposit 331,515 331,515 --------- ---------- -------- Total $ 361,723 $ -- $ 361,723 ========= ========== ======== Certificates of deposit, classified as "Held to Maturity", at December 31, 1998 and 1997, are due in less than one year. Investment income, including realized gains from mutual funds, was $9,776 and $2,168 for the years ended December 31,1998 and 1997. Net unrealized losses from marketable securities were $330 and $0 at December 31, 1998 and 1997. F-11 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE C - INVENTORIES Inventories consist of the following: December 31, December 31, 1998 1997 ----------- ----------- Raw materials and work-in-process ...... $ 364,969 $ 272,833 Finished products and fine chemicals ... 785,163 1,099,234 ---------- ---------- $1,150,132 $1,372,067 ========== ========== NOTE D - PROCESSES AND PATENTS Processes and patents consist of the following: December 31, December 31, 1998 1997 ----------- ----------- Capitalized technology - Renacidin (1).......... $513,000 $513,000 Deferred costs - Renacidin (2).................. 154,370 154,370 Capitalized technology - Sonarite (3)........... -- 306,250 Patents ........................................ 8,177 8,177 ------- -------- 675,547 981,797 Less accumulated amortization .................. 484,862 447,813 -------- -------- $190,685 $533,984 ======== ======== (1) On October 1, 1984, a partnership agreed to provide the Company with funding of $454,800 for a liquid Renacidin research and development project. In 1985, funds of $154,800 were received, and the balance was payable by a $300,000 note due on November 30, 1992 bearing interest at 12%. On August 14, 1992, the Company and the partnership terminated the agreement. Pursuant to the termination agreement, the partnership conveyed its interest in the technology to the Company in exchange for cancellation of the note plus accrued interest which together amounted to $513,000. The technology is being amortized by the Company under the straight-line method over a ten-year period commencing in 1992. Additionally, during 1993, the Company and a stockholder issued warrants to the two partners of the partnership to purchase a total of 104,000 shares of the Company's common stock at $6.00 per share, which approximated market value at that time. During 1994, the Company renegotiated its warrant agreement (64,000 warrants) to reflect a reduced price of $4.00 per share with an expiration date of December 31, 1998. The warrants previously issued in 1993 by a stockholder to purchase 40,000 shares of the Company's common stock were cancelled. F-12 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE D (continued) (2) During 1991, the Company contracted with Abbott Laboratories, Inc. ("Abbott") for the production of Renacidin Irrigation. Such production was to commence following approval by the Food and Drug Administration ("FDA") of Abbott as the producer. In conjunction with this agreement, the Company paid a nonrefundable fee of $154,370 to Abbott for their assistance in obtaining an approved supplement to the Company's New Drug Application ("NDA") for Renacidin Irrigation. The NDA supplement covers the manufacture of Renacidin Irrigation at the Abbott plant in North Carolina. During 1993, FDA approval was granted and production commenced. Amounts paid to Abbott have been recorded as deferred costs, and are being amortized over a five-year period consistent with the initial term of the production agreement. (3) In August, 1985 the Company entered into an agreement with three private investors to develop a product to reduce snoring. The investors provided $275,000 to fund the project, and in exchange received majority ownership interest in the technology. The Company successfully developed the product, which was known as "Sonarite", but shortly thereafter one of the key raw materials was discontinued and the project did not proceed further until 1996 when a satisfactory replacement was found. In February, 1997 the investors filed suit claiming breach of the development agreement. That lawsuit was settled in April, 1997. As part of the settlement the Company purchased from the investors their interest in the Sonarite technology in exchange for $100,000 and 100,000 shares of restricted stock of the Company, thereby giving the Company the exclusive right to commercialize the technology. In October 1998, after results of additional product testing of the technology in its present formulation, the Company determined that further modification of the technology was necessary in order to make it commercially marketable. Based on such facts, the unamortized balance of approximately $204,000 was expensed. Such amount is included in amortization expense in operating expenses. F-13 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE E - NOTES PAYABLE - BANKS The Company has a line of credit agreement with one bank which provides for borrowings of up to $700,000 and expires on May 31, 1999. It is the Company's intention to renew the line of credit agreement before it expires. Interest under each line is at the bank's prime rate plus 1/2%. The outstanding line of credit agreement contains financial covenants relating to minimum net worth, working capital, current ratio, debt to capitalization and maintenance of compensating balances. There were no outstanding borrowings at December 31, 1998 and 1997. NOTE F - LONG-TERM DEBT During 1998, the Company financed the purchase of transportation equipment with proceeds of an installment loan. The loan, which is collateralized by the underlying equipment, requires monthly payments of $868 including interest through July 31, 2001. Principal payments under this financing are $10,000 in 1999, $10,193 in 2000 and $6036 in 2001. NOTE G - INCOME TAXES The provision for income taxes consists of the following: Year ended Year ended December 31, December 31, 1998 1997 --------- --------- Current Federal .......................... $ 607,000 $ 435,000 State ............................ 105,000 70,000 --------- --------- 712,000 505,000 --------- --------- Deferred Federal .......................... (68,689) (5,266) State ............................ (10,634) 2,886 --------- --------- (79,323) (2,380) --------- --------- Total provision ............ $ 632,677 $ 502,620 ========= ========= F-14 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE G (Continued) The following is a reconciliation of the Company's effective income tax rate to the Federal statutory rate: Year ended Year ended December 31, December 31, 1998 1997 -------------- -------------- (000's) % (000's) % ------- --- ------- --- Tax expense at statutory Federal income tax rate .............................. $ 559 34% $ 451 34% State income taxes, net of Federal benefit 72 4 48 4 Nondeductible expenses.................... 1 -- 2 -- Other, net ............................... 1 -- 1 -- ----- ----- ----- ----- Actual tax expense ....................... $ 633 38% $ 502 38% ===== ===== ===== ===== The tax effects of temporary differences which comprise the deferred tax assets and liabilities are as follows: December 31, December 31, 1998 1997 ----------- ------------ Deferred tax assets Accounts receivable .................... $ 19,731 $ 12,069 Inventories ............................ 146,216 84,671 Accrued vacation ....................... 3,171 3,171 State net operating loss carryforward .. 7,200 7,200 --------- --------- 176,318 107,111 --------- --------- Deferred tax liabilities Deferred costs - Renacidin ............. -- (10,116) Other .................................. (10,000) (10,000) --------- ---------- (10,000) (20,116) --------- ---------- Net deferred tax asset ..................... $ 166,318 $ 86,995 ========= ========== F-15 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE H - BENEFIT PLANS Pension Plan In 1998, the Company adopted SFAS No. 132 "Employers' Disclosures about Pensions and Other Postretirement Benefits". The provisions of SFAS No. 132 revise employers' disclosures about pension plans. It does not change the measurement or recognition of these plans. It standardizes the disclosure requirements for pensions to the extent practicable. The Company has a noncontributory defined benefit pension plan which covers substantially all of its employees. Benefits are based on years of service and employees' compensation prior to retirement. Amounts are funded in accordance with the requirements of ERISA (Employee Retirement Income Security Act of 1974) and the plan is administered by a trustee who is responsible for payments to retirees. The plan assets primarily consist of cash equivalents, bonds, commercial paper and mortgage-backed securities, and are recorded at fair value within the plan. The following table sets forth the plan's funded status: Year ended Year ended December 31, December 31, 1998 1997 --------- --------- Change in Benefit Obligation Benefit obligation at beginning of year............. $1,412,269 $1,329,659 Service cost........................................ 66,164 57,887 Interest cost....................................... 90,800 95,960 Actuarial loss...................................... 39,173 80,764 Benefits paid....................................... (288,423) (151,911) --------- --------- Benefit obligation at end of year................... $1,319,983 $1,412,269 ========= ========= Change in Plan Assets Fair value of plan assets at beginning of year..... $1,192,657 $1,132,370 Actual return on plan assets....................... 92,746 115,115 Employer contributions............................. 89,940 97,083 Benefits paid...................................... (288,423) (151,911) --------- --------- Fair value of plan assets at end of year........... $1,086,920 $1,192,657 ========= ========= Reconciliation of Funded Status Funded status (underfunded)........................ $ (233,063) $ (219,612) Unrecognized net actuarial loss.................... 199,422 204,728 Unrecognized transition obligation................. 17,789 22,286 Unrecognized prior service cost.................... 62,489 67,775 --------- -------- Prepaid benefit cost............................... $ 46,637 $ 75,177 ========= ======== F-16 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE H (continued) The Net Periodic Benefit Cost for the years ending December 31 includes the following components: December 31, December 31, 1998 1997 ----------- ----------- Components of Net Periodic Benefit Cost Service cost....................................... $ 66,164 $ 57,887 Interest cost...................................... 90,800 95,960 Expected return on plan assets..................... (94,928) (104,821) Recognized net actuarial loss...................... 46,661 102 Amortization of transition obligation.............. 4,497 4,497 Amortization of prior service cost................. 5,286 5,286 --------- ------- Net periodic benefit cost.......................... $ 118,480 $ 58,911 ========= ======= NOTE H (continued) Weighted-average assumptions as of December 31: 1998 1997 ----------- ----------- Discount rate...................................... 6.50% 6.50% Expected long term rate of return.................. 8.00% 8.00% Weighted average rate of compensation increase..... 5.73% 5.73% Amortization method................................ Straight-Line Straight-Line 401(k) Plan The Company maintains a 401(k) Plan for all of its employees. Under the plan, employees may defer up to 15% of their weekly pay as a pretax investment in a savings plan. In addition, the Company makes a contribution of 50% of each employee's elective deferral up to 2% of weekly pay for a 4% employee deferral. Employees become fully vested in Company contributions after one year of employment. 401(k) Company contributions were approximately $30,000 and $26,000 for the years ended December 31, 1998 and 1997, respectively. Stock Option Plans The Company maintains two stock option plans, the 1993 Employee Incentive Stock Option Plan ("EISOP") and the Non-Statutory Stock Option Plan for Directors ("NSSOPD"), each of which provides for the issuance of up to 100,000 shares of common stock. Such options are exercisable either upon grant or after a waiting period specified in the agreement. The Company has adopted only the disclosure provisions of SFAS No. 123, "Accounting for Stock-based Compensation" It applies APB Opinion No. 25 "Accounting for Stock Issued to Employees," and related Interpretations in accounting for its plans. Accordingly, no compensation costs have been recognized for either plan. F-17 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE H (continued) If the Company had elected to recognize compensation expense based upon the fair value at the grant date for awards under these plans consistent with the methodology prescribed by SFAS No. 123, the Company's net income and basic and diluted earnings per share as of December 31, 1998 and 1997 would be reduced to the pro forma amounts indicated below: 1998 1997 ---------- ---------- Net income As reported $ 1,013,537 $ 824,246 Pro forma 1,009,433 795,148 Basic and diluted earnings per common share As reported $ .21 $ .17 Pro forma .21 .16 The pro forma amounts may not be representative of future disclosure because they do not take into account pro forma compensation expense related to grants made before 1995. The fair value of these options was estimated at the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions for the year ended December 31, 1997: expected volatility of 56.30%; risk-free interest rates of 5.82% to 5.95%; expected life of three to five years; and expected dividends of 1.2%. No stock options were granted under either of the plans in 1998. F-18 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE H (continued) The following summarizes the stock option transactions under both Plans: Weighted average Fair value Number exercise at date EISOP outstanding price of grant Options outstanding, January 1, 1997 35,500 $3.99 Granted 22,200 2.06 $1.13 Exercised (7,950) 2.28 Surrendered/Expired (1,000) 5.00 ------- Options outstanding, and exercisable December 31, 1997 48,750 3.38 ------- Exercised (4,300) 2.06 ------- Options outstanding, and exercisable at December 31, 1998 44,450 $3.49 ======= Available for grant, December 31, 1998 43,300 ======= NSSOPD ------ Options outstanding, January 1, 1997 22,000 $2.82 Granted 8,000 2.06 $.83 Exercised (6,000) 1.96 Expired (2,000) 5.00 ------ Options outstanding at December 31, 1997 22,000 2.58 ------ Expired (4,000) 5.00 Exercised (2,000) 2.06 ------ Options outstanding and exercisable at December 31, 1998 16,000 $2.04 ====== Available for grant December 31, 1998 72,000 ====== F-19 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE H (continued) Summarized information about stock options outstanding under the two plans at December 31, 1998 is as follows: Options Outstanding Options Exercisable --------------------------------------------- ------------------------- Range of Number Weighted Weighted Number Weighted Exercise Outstanding Average Average Exercisable Average Prices at Remaining Exercise at Exercise December 31,1998 Contractual Price December 31,1998 Price Life EISOP ----- $1.88 - $2.13 22,700 7.41 $2.05 22,700 $2.05 $5.00 21,750 5.09 5.00 21,750 5.00 ------------- ------ ---- ----- ------ ----- $1.88 - $5.00 44,450 6.29 $3.49 44,450 $3.49 NSSOPD -------- $1.88 - $2.13 16,000 2.06 $2.04 16,000 $2.04 F-20 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE I - RELATED PARTY TRANSACTION The Company has a split dollar life insurance arrangement with Alfred R. Globus, its Chairman and Chief Executive Officer (the "Insured"). On an annual basis the Company makes non-interest bearing advances of approximately $86,000 or 87% of the cost of a $1,500,000 life insurance policy, which is owned by a trust of which the Insured is the grantor and another officer, Kenneth H. Globus, is a beneficiary. Under a collateral assignment agreement the proceeds from the policy will first be paid to the Company to repay the advances it made. If the policy is terminated prior to the death of the Insured, the Company will be entitled to the cash surrender value of the policy at that time, and any shortfall between that amount and the amount of the advances made by the Company will be repaid to the Company by the Insured. As of December 31, 1998 and 1997, advances of $348,161 and $261,559, respectively, are recorded in the Consolidated Balance Sheets under "Other Assets". NOTE J - COMPREHENSIVE INCOME During 1998 the Company adopted SFAS No. 130, "Reporting Comprehensive Income." SFAS No. 130 establishes new rules for the reporting and display of comprehensive income and its components; however, the adoption of SFAS No. 130 had no impact on the Company's net earnings or stockholders' equity. SFAS No. 130 requires unrealized gains or losses on marketable securities, which had been reported separately in stockholder's equity, to be included in accumulated other comprehensive (loss). Prior year financial statement have been reclassified to confirm to the requirements of SFAS No. 130. The components of comprehensive income are as follows: 1998 1997 ------ ------ Net Income $ 1,013,537 $ 824,246 Change in unrealized (loss) on marketable securities (330) -- ------------ ----------- Comprehensive income $ 1,013,207 $ 824,246 ============ =========== The components of accumulated other comprehensive (loss) are unrealized losses on marketable securities of $330 and $0 at December 31, 1998 and 1997, respectively. F-21 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE K - EARNINGS PER SHARE The following table sets forth the computation of basic and diluted earnings per share at December 31, 1998 and 1997: 1998 1997 ---------- ---------- Numerator: Net earnings $1,013,537 $ 824,246 Denominator: Denominator for basic earnings per share ( weighted average shares) 4,880,343 4,832,783 Effect of dilutive securities: Employee stock options 24,244 19,858 --------- --------- Denominator for diluted earnings per share (adjusted weighted-average shares) and assumed conversions 4,904,587 4,852,641 ========= ========= Basic earnings per share $ 0.21 $ 0.17 ========= ========= Diluted earnings per share $ 0.21 $ 0.17 ========= ========= NOTE L - NATURE OF BUSINESS AND SEGMENT INFORMATION The Company has the following two reportable business segments: Guardian Laboratories and Eastern Chemical. The Guardian segment conducts research, development and manufacturing of pharmaceuticals, medical devices, cosmetics, products and proprietary specialty chemical products. The Eastern segment distributes fine chemicals, solutions, dyes and reagents. The accounting polices used to develop segment information correspond to those described in the summary of significant accounting policies. Segment earnings or loss is based on earnings or loss from operations before income taxes. The reportable segments are distinct business units operating in different industries. They are separately managed, with separate marketing and distribution systems. The following information about the two segments is for the years ended December 31, 1998 and 1997. F-22 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE L (continued) 1998 1997 ---------------------------------- ---------------------------------- GUARDIAN EASTERN TOTAL GUARDIAN EASTERN TOTAL ------------ ----------- ----------- ----------- ----------- ---------- Earnings from external customers $ 7,230,783 $ 1,538,955 $ 8,769,738 $ 6,964,060 $ 1,788,073 $ 8,752,133 Depreciation and amortization 483,030 - 483,030 266,181 - 266,181 Segment earnings (loss) before income taxes 1,819,443 (103,934) 1,715,509 1,526,310 (45,308) 1,481,002 Segment assets 2,659,964 591,550 3,251,514 2,650,668 772,401 3,423,069 Expenditure for segment assets 88,627 - 88,627 203,202 - 203,202 Reconciliation to Consolidated Amounts Earnings before income taxes ---------------------------- Total earnings for reportable segments $ 1,715,509 $ 1,481,002 Other earnings 96,943 6,987 Corporate headquarters expense (166,238) (161,123) --------- --------- Consolidated earnings before income taxes $ 1,646,214 $ 1,326,866 Assets ------ Total assets for reportable segments $ 3,251,514 $ 3,423,069 Corporate headquarters 3,542,819 2,702,777 --------- --------- Total consolidated assets $ 6,794,333 $ 6,125,846 ========= ========= F-23 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE L (continued) Other Significant Items ----------------------- 1998 1997 -------------------------------------- -------------------------------------- Segment Consolidated Segment Consolidated Totals Adjustments Totals Totals Adjustments Totals ---------- ----------- ------------ ----------- ----------- ------------ Interest expense $ - $ 523 $ 523 $ - $ 31,505 $ 31,505 Expenditures for assets 88,627 182,653 271,280 203,202 88,226 291,428 Depreciation and amortization 483,030 131,796 614,826 266,181 127,983 394,164 Geographic Information ---------------------- 1998 1997 ---------------------- ---------------------- Revenues Long-Lived Revenues Long-Lived Assets Assets ---------- ----------- ----------- ----------- United States $ 4,911,053 $ 1,723,369 $ 4,988,716 $ 2,066,915 France 1,219,667 1,070,843 Other countries 2,639,018 2,692,574 --------- --------- --------- --------- $ 8,769,738 $ 1,723,369 $ 8,752,133 $ 2,066,915 ========= ========= ========= ========= Major Customers --------------- Customer A (Guardian) $ 1,702,079 $ 2,045,016 Customer B (Guardian) 1,146,414 982,849 All other customers 5,921,245 5,724,268 --------- --------- $ 8,769,738 $ 8,752,133 ========= ========= F-24 United-Guardian, Inc. and Subsidiaries
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued) December 31, 1998 and 1997 NOTE M - CONTINGENCIES While the Company has product claims arise from time to time in the ordinary course of its business, the Company is not currently involved in any material product claims. Historically, the settlement of such claims has not had a material adverse effect on the Company's financial position and results of operations. F-25 EXHIBIT 10(f) ------------- MARKETING AND SUPPLY AGREEMENT THIS AGREEMENT, effective as of January 1, 1999, is between VascA, Inc., a Delaware corporation located at 3 Highwood Drive, Tewksbury, MA 01876 (hereinafter referred to as "VascA") and United-Guardian, Inc., a Delaware corporation located at 230 Marcus Blvd., Hauppauge, NY 11788 (hereinafter referred to as "UGI"). WHEREAS, UGI is the co-owner of certain patents and the exclusive owner of certain other proprietary technical information relating to the pharmaceutical product known as Clorpactin and related technologies; WHEREAS, VascA is developing implantable valves and other products designed for vascular access and other applications; WHEREAS, VascA is desirous of obtaining from UGI exclusive, worldwide marketing and distribution rights to Clorpactin and related technologies under UGI's patents and technical information in accordance with the terms and conditions hereof; and WHEREAS, UGI is willing to grant such rights to VascA upon the terms and conditions hereof; NOW, THEREFORE, the parties hereto have mutually agreed as follows: 1. Definitions. The following definitions will control the construction of each of the following terms wherever they appear in this Agreement: "Affiliate" shall mean, as to a Party hereto, any person, corporation, company, partnership, joint venture, firm and/or other entity (a "Person") which controls, is controlled by or is under common control with such Party. For these purposes, "control" shall refer to the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of a Person, whether through the ownership of voting securities, by contract or otherwise. "Cost of Goods" shall mean fully-allocated cost of goods according to U.S. generally accepted accounting principles, and shall include without limitation material costs, allocable compensation costs of manufacturing personnel, manufacturing overhead (including without limitation such items as rent, utility expenses, depreciation and amortization) and royalties and other amounts payable to third parties in respect of patents and other intellectual property rights licensed in connection with the manufacture or sale of Licensed Products, but shall not include any allocation of non-manufacturing managerial or non-manufacturing employee overhead or of selling or general and administrative expenses. "Current Uses" shall mean all uses for which Clorpactin is currently being marketed as more fully described on Exhibit A attached hereto. "EPA" shall mean the United States Environmental Protection Agency. "Event of Interruption" shall mean any of the following: (a) the failure by UGI to ship any order for the Licensed Product within three (3) months following receipt of a purchase order; or (b) the filing by UGI of any petition for bankruptcy pursuant to the United States Bankruptcy Code; or (c) the filing against UGI of any petition or assignment in bankruptcy pursuant to the United States Bankruptcy Code, if such petition or assignment is consented to by UGI or is not vacated or dismissed within sixty (60) days of the date of filing; or (d) the initiation or consent or failure to defend any proceeding by or against UGI which is intended to lead to its final liquidation, or the entering of any judgment against UGI the consequence of which will be UGI's final liquidation. "FDA" shall mean the United States Food and Drug Administration. "Improvements" shall mean any invention, enhancement, improvement, next generation product, discovery or other development, whether patentable or not, developed or discovered by UGI or licensed to UGI and applicable or related to a Licensed Product or any component thereof. "Licensed Products" shall mean Clorpactin and any other product, whether currently sold or under development, relating to, derived from or based in whole or in part on the Technology. "Net Sales" shall mean, with respect to a Licensed Product and a specified period, the gross revenues collected by a Party, its Affiliates or its sublicensees from or on account of sales of such Licensed Product during that period to third parties, less deduction for (a) credits or allowances, if any, actually granted on account of price adjustments, rejection or return of items previously sold, whether during the specific period or not, rebates and discounts, (b) excises, sales taxes, duties or other taxes imposed upon and paid with respect to such sales (excluding income or other taxes levied with respect to gross receipts), and (c) separately itemized insurance and transportation costs incurred in shipping products to third parties. "New Uses" shall mean all medical applications other than Current Uses, including but not limited application of the product as a site care treatment with VascA's implantable valve products. "Party" shall mean either UGI or VascA, as the context may require. "Patents" shall mean all present and future domestic and foreign patents, patent applications, provisional patent applications, patent extensions, certificates of invention, or applications for certificates of invention, together with any divisions, continuations or continuations-in-part and renewals thereof, or substitutions therefor, and all reissues, reexaminations or extensions thereof, which are owned or controlled by or licensed to, UGI, and which are necessary or useful for the development, manufacture, use or sale of Licensed Products, including without limitation the patents and patent applications listed on Exhibit B hereto. "Registrations" shall mean (1) in the United States, approval from the FDA, the EPA and/or other governmental authorities, as necessary, for the manufacturing, marketing, promotion and sale of the Licensed Products, and (2) outside of the United States, analogous orders by the relevant governmental agencies which require regulatory approval prior to marketing, promotion and sale of the Licensed Products in such non-U.S. country. "Steering Committee" shall have the meaning set forth in Section 6.5 below "Technology" shall mean all present and future inventions, trade secrets, trademarks, copyrights, data, regulatory submissions and other intellectual property of any kind, including all confidential technical information in the possession of UGI as of the date hereof and during the term of this Agreement (and any renewal thereof), which are owned or controlled by, or licensed to, UGI, and which are necessary or useful for the development, manufacture, use or sale of the Licensed Products. "Territory" shall mean worldwide. "Valid Claim" shall mean a claim of an unexpired or pending Patent which (a) shall not have been withdrawn, cancelled or disclaimed or held invalid by a court of competent jurisdiction in an unappealed or unappealable decision or revoked by opposition proceedings where there is no further right to appeal or the time period for appeal has elapsed, and (b) in the case of a patent application, (i) has not been on file with the relevant patent office for more than five years without having been allowed or issued, and (ii) is not a claim as to which UGI's outside patent counsel has advised in writing clearly will not be allowed or issued. The singular shall include the plural and vice versa as may be required by the context of this Agreement. 2. License Grant. 2.1 UGI hereby grants to VascA an exclusive, royalty-free license, including the right to grant sublicenses, under the Patents and the Technology, to develop, use, market, distribute and sell Licensed Products in the Territory for New Uses. 2.2 UGI hereby grants to VascA a non-exclusive, royalty-free license, including the right to grant sublicenses, under the Patents and the Technology, to use, market, distribute and sell Licensed Products in the Territory for Current Uses. The non-exclusive license granted in this Section 2.2 shall, at VascA's election, become exclusive at such time as the number of units of Licensed Product purchased by VascA in any contract year under this Agreement is greater than sixty percent (60%) of UGI's total unit sales, whether direct or indirect, of Licensed Product for such contract year. During the term of this Agreement and any renewal thereof, UGI shall not grant licenses under the Patents and Technology to distribute, market or sell Licensed Products to any third party, nor directly sell any Licensed Products to any party that is not a customer of UGI as of the date hereof and identified on Exhibit C hereto, with the exception of new drug wholesalers, without VascA's prior written consent, which consent shall not be unreasonably withheld, unless UGI reasonably believes that the sale is for a drug (and not a device) use that is not covered under the definition of "New Uses" and provides notice thereof to VascA prior to effecting such sale. In the event UGI cannot determine with a reasonable degree of certainty that the intended use is a drug use that would not be covered under the definition of "New Uses," then it will not make the direct sale to that customer and will instead refer the customer to VascA or, with VascA's approval, to a drug wholesaler. VascA agrees to sell Licensed Products to new customers referred to VascA by UGI (or to current customers of UGI in the event that such customers are unable to obtain product from drug wholesalers) on comparable pricing, terms and other conditions as it sells to other customers at similar levels of distribution. 2.3 UGI hereby grants to VascA an exclusive, royalty-free license, including the right to grant sublicenses, under the Patents and the Technology, to make and have made Licensed Products for New Uses; provided, however, that VascA agrees that it may not exercise such license with respect to any Licensed Product unless UGI fails to fulfill its supply obligations with respect to such Licensed Product as set forth in Section 3.1. 2.4 In the event other marketers of implantable valve products similar to, or competitive with, VascA's device ("Competitors") desire to purchase Licensed Products, VascA agrees to sell them Licensed Products provided they comply with the following requirements: (a) VascA must be given the opportunity to review any regulatory submissions or marketing and training materials related to the use of Licensed Products by Competitors, prior to submission, to assure that they are consistent with the filings being made by VascA. This will not include any proprietary information not relevant to VascA's use of the Licensed Products. VascA will have no obligation to sell to Competitors if it finds that the information being submitted, or which has been submitted, to regulatory agencies by those Competitors is incorrect or inconsistent with VascA's submissions. (b) VascA's price of Licensed Products to Competitors shall be consistent with the prices it charges to other customers for Licensed Products at the same level of distribution. 2.5 In the event VascA takes over the exclusive distribution of Licensed Product for Current Uses in accordance with Section 2.2, VascA agrees that it will continue to sell Licensed Products to UGI's customer base on the same pricing, terms, and conditions, for the same level of distribution, as they were getting from UGI, subject to reasonable price increases that will be mutually agreed upon by VascA and UGI. If, at some point in the future, VascA decides to distribute Licensed Products directly to customers instead of through the full line drug wholesalers currently used by UGI, such decision shall only be made with the approval of UGI, and such approval may be withheld by UGI only in circumstances in which UGI demonstrates, to VascA's reasonable satisfaction, that such approval would have a material adverse effect on UGI's business. 2.6 UGI represents and warrants to VascA that there are no restrictions on UGI's rights to grant the licenses contemplated hereunder with respect to any of the Licensed Products, except that UGI's rights in regard to the use of Clorpactin to treat animal mastitis are owned jointly with the Diversey Corporation and, therefore, are specifically excluded from this Agreement unless otherwise agreed at a later time by the parties hereto. 2.7 VascA shall have the right to sublicense the licenses granted hereunder so long as each sublicensee agrees to be bound mutatis mutandis by all of the terms and conditions of this Agreement. 3. Supply of Licensed Products; Security of Supply; Samples; Orders. 3.1 (a) Except as otherwise permitted by Section 2.3, each of the Licensed Products shall be supplied by UGI in accordance with the procedure specified in Section 3.2 to VascA, VascA Affiliates or VascA sublicensees as VascA may designate, and VascA, VascA Affiliates and VascA sublicensees shall each purchase its requirements for each of the Licensed Products exclusively from UGI. UGI shall be responsible as provided in this Agreement for all Licensed Products supplied by it even if such Licensed Products are manufactured, in whole or in part, for UGI by third parties. (b) The parties acknowledge the importance of VascA having a continuing source of supply of Licensed Products and wish to provide for VascA to be able to source or manufacture Licensed Products in situations where UGI becomes or is likely to become unable to supply the Licensed Products to VascA in quantities sufficient to meet VascA's requirements. VascA will use reasonable efforts to maintain at all times, under refrigeration, a stock of Licensed Product equal to three (3) months of sales volume, based on the annual projections provided to UGI. UGI will cause a full and complete copy of the most current formula and manufacturing instructions for the Licensed Product in form and scope sufficient to enable VascA to manufacture the Licensed Product without further assistance (the "Formula"), to be kept by an officer of UGI at a secure location other than UGI's manufacturing site in Hauppauge, New York. Upon the occurrence of any Event of Interruption (as defined in Section 1), VascA will have the right to require UGI to deliver the Formula to VascA for its use in manufacturing the Licensed Product, or having the Licensed Product manufactured, during the Event of Interruption. VascA will use the Formula and manufacturing instructions to source or manufacture the Licensed Product only for the purposes specified herein, and only during the Event of Interruption. Upon the correction or termination of an Event of Interruption, VascA will promptly return the Formula and manufacturing instructions to UGI without keeping any copies, and will certify to UGI that it has done so and will resume purchasing the Licensed Product from UGI. (c) VascA will pay UGI a royalty, at the rate of 50% of VascA's gross profit VascA's Net Sales less VascA's Cost of Goods, on all Licensed Product sourced or produced by VascA, rather than purchased from UGI, and sold by VascA during any Event of Interruption. (d) Any quantities of Licensed Products sourced or manufactured by VascA during any Event of Interruption shall be counted toward VascA's Minimum Purchase Requirement for the applicable contract year as more fully described in Section 10 below. (e) VascA's rights hereunder are in addition to, and not in substitution for, its rights under Section 14 hereof. In addition, if an Event of Interruption continues for more than twelve (12) months, UGI shall deliver to VascA all of UGI's right, title and interest in the Registrations referred to in Section 6.1 below and VascA shall be entitled to the rights of a licensee under Section 14 hereof, in addition to such other legal and equitable rights and remedies as may be available. In such event, VascA shall pay to UGI a royalty of 10% of VascA's Net Sales of Licensed Products during such time as VascA is manufacturing and selling Licensed Products in accordance with this Section. 3.2 The Licensed Products will in VascA's discretion be shipped to VascA in powder form in 2-gram bottles packed five to a box, or in such form and packaging as may be specified by VascA; provided, however, that UGI shall not be obligated to make any changes in the specifications of the bottle or cap in which any Licensed Product is sold as of the date hereof. 3.3 UGI hereby warrants that the Licensed Products supplied by it hereunder shall comply in all material respects with all applicable laws, rules, regulations and registrations. VascA hereby acknowledges that the regulatory status of Clorpactin is not clear due to the age of the product, and that it will be VascA's responsibility to determine whether the marketing of the product for any particular use or uses would be considered acceptable by the FDA. UGI warrants that each shipment or other delivery of each Licensed Product, when supplied by UGI to VascA, VascA Affiliates and VascA sublicensees hereunder and through the product expiration date thereafter, shall (i) be or merchantable quality, fit for the purpose intended by this Agreement and free from defects, (ii) meet in all material respects the product specifications of UGI therefor and (iii) be produced, packaged and labeled in accordance with approved standards of the FDA and the EPA, and in compliance with all applicable rules and regulations of all other relevant regulatory authorities, including compliance with good manufacturing practices. UGI's only liability for breach of its obligations under this Section 3.3 shall be to replace the defective Licensed Product as provided in Section 3.4. EXCEPT FOR THE CONTRACTUAL PROVISIONS EXPRESSLY SET FORTH IN THIS AGREEMENT, UGI DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO LICENSED PRODUCTS. Except as stated in Section 7.1 (Product Liability Indemnity) and Section 7.4 (Infringement Indemnity), UGI's liability to VascA for damages arising out of the manufacture, use or sale of a Licensed Product shall not exceed the actual purchase price paid by VascA for such Licensed Product. In no event shall UGI be liable to VascA for special, incidental or consequential damages arising out of the manufacture, use or sale of any Licensed Product. Nothing in this Section 3.3 shall be construed to limit UGI's obligations under Sections 7.1 and 7.4. 3.4 Claims relating to quality defects in the Licensed Products supplied by UGI shall be submitted to UGI within a reasonable time, not to exceed 90 days, after VascA, the VascA Affiliate or the VascA sublicensee hereunder has received delivery of the Licensed Product. UGI shall replace free of charge the defective quantities. Nothing in this Section 3.4 shall be construed to limit UGI's obligations under Sections 7.1 and 7.2. 3.5 As to each Licensed Product, VascA shall provide UGI with a written forecast (the "Forecast") of the requirements of VascA, its Affiliates and sublicensees for such Licensed Product at least 90 days prior to each 12-month period during the term of the Agreement, except that VascA shall provide UGI with the Forecast of its requirements for the first contract year within thirty days of the execution of this Agreement. VascA, its Affiliates and sublicensees shall provide UGI with at least 90 days' notice of each requested delivery date of any Licensed Product. 4. VascA's Marketing Efforts. VascA, VascA Affiliates and VascA sublicensees each shall use its reasonable efforts, subject to governmental laws, regulations and requirements and the terms and provisions of this Agreement(TM), to identify Licensed Products (a) as a recommended site care treatment for use with its LifeSite product in the Territory, and (b) for such other New Uses as VascA shall determine to be commercially viable from time to time. VascA will also use its reasonable efforts to pursue any necessary registration and pricing approval of each Licensed Product in the Territory. VascA may market and sell Licensed Products under it own label and packaging and under its own trademarks; provided, however, that such label or packaging shall include the name Clorpactin and shall indicate that such Licensed Product has been manufactured by UGI. 5. Prices; Payments. 5.1 The price at which UGI shall supply any unit of Licensed Product to VascA and its Affiliates and sublicensees hereunder shall be the lowest price at which UGI sells units from time to time to any of its distributors or licensees; provided, however, that VascA may elect to procure, directly or indirectly, packaging materials and labels for Licensed Products and to deduct from the purchase price payable to UGI hereunder the cost of such materials up to an amount not in excess of UGI's cost for such materials as long as the substitute packaging materials and labels are of comparable quality and size to UGI's current packaging materials and labels and can be accommodated on UGI's current filling and labeling equipment without modification. In the event modifications are required in order to accommodate VascA's packaging materials or labels, such modifications shall be made at VascA's expense. In the event new packaging and/or labeling equipment is required it will be purchased by VascA, will be maintained at VascA's expense, and will remain the property of VascA. UGI will obtain VascA's written authorization prior to making any modifications to existing equipment or purchasing new equipment in accordance with this paragraph. All shipments will be made with carriers approved by VascA, which approval shall not be unreasonably withheld or delayed. All amounts payable under this Section 5 shall be paid in full within 30 days after the date of delivery of the Licensed Products. 5.2 In consideration of VascA's marketing and other obligations hereunder, UGI shall pay to VascA an amount equal to 10% of the amount by which UGI's Net Sales of Licensed Products (excluding, for this purpose, sales to VascA under this Agreement) exceeds $280,000 during each contract year of this Agreement (the "Base Amount"). The Base Amount will remain the same each contract year unless UGI puts through a price increase, in which case the Base Amount will be increased by the same percentage as the price increase, prorated for the year. In the event UGI begins to sell Licensed Product in other types of units, the increase in the Base Amount will be calculated by applying the percentage increase only to the percentage of sales in the prior year attributable to the current unit size (one box of five 2-gram bottles). 5.3 In the event that UGI enters into an agreement with a third party for a purpose similar to this Agreement, and the provisions of such third party agreement are more favorable to such third party than the corresponding provisions of this Agreement, then UGI will agree to offer VascA such more favorable terms and amend this Agreement accordingly. 6. Development of Products; Technical Information; Research Program. 6.1 VascA will be responsible for the administrative handling of Registrations in all countries of the Territory in which VascA deems obtaining such Registrations to be necessary or appropriate. VascA will pay all fees and expenses related thereto. VascA shall keep UGI informed on an ongoing and timely basis and seek UGI's consent as to all material matters relating to the Registrations of Licensed Products, which consent shall not be unreasonably withheld or delayed. In the event it is necessary for UGI to submit proprietary information in support of a Registration, VascA will arrange for such information to be submitted directly to the regulatory agencies involved. UGI will be obligated to provide information in support of VascA's Registrations only to the extent such information is in the possession of UGI. UGI will only be responsible for the accuracy of the information that it has provided, and shall not be responsible in the event such information is not sufficient for the Registration to be granted. VascA shall be the sole holder of the Registrations and will, at its own expense, be responsible for all administrative matters necessary to compile and submit the Registrations for each Licensed Product in each country of the Territory. VascA shall also be responsible for maintaining the Registrations and will bear the registration renewal fees for the Registrations of Licensed Products in each country of the Territory. Subject to compliance with applicable laws and regulations, VascA shall promptly report to UGI any adverse drug reactions associated with the use of any Licensed Product in the Territory. 6.2 Any changes of the Licensed Products shall only be made by UGI or VascA after (i) prior written approval of the other Party, which approval shall not be unreasonably withheld or delayed, and (ii) if required, the authorization of the relevant authorities. 6.3 UGI shall provide VascA, on a regular and continuing basis, with all technical information, sales and marketing materials and other information that is reasonably necessary for VascA to have hereunder, including but not limited to Improvements, in order for VascA to be able to follow the developmental progress of each of the Licensed Products that is under development by UGI and to otherwise perform under this Agreement. 6.4 During the initial term of this Agreement, VascA and UGI shall collaborate on a research program to examine, among other things, the shelf life, product stability, toxicology and formulation improvements for Clorpactin and other Licensed Products (the "Research Program"). The Research Program and related budget, objectives, resource commitments and timetable shall be as more fully set forth on Exhibit D attached hereto. VascA agrees to provide funding for the Research Program in an amount not less than $50,000 for the first contract year and $75,000 for each of the second and third contract years. Activities under the Research Program shall be conducted by UGI personnel or third party contractors, in each case, reasonably satisfactory to VascA. All right, title and interest in any Improvements or other inventions ("Research Program Inventions"), and patent rights thereon, that are discovered, made or conceived during the term of the Research Program shall be jointly owned by UGI and VascA; provided, however, that neither party shall have the right to make use of such Research Program Inventions, other than in connection with the performance of its rights and obligations under this Agreement, without the approval of the other party. 6.5 The Research Program shall be directed, managed and administered by a steering committee consisting of one representative of UGI and one representative of VascA (the "Steering Committee"). The Steering Committee shall initially consist of Rick Andrews and Ken Globus. The Steering Committee shall meet not less than once every six months during the term hereof or at such other times, either in person or by telephone conference, as may be agreed upon by members of the Committee. The specific tasks of the Research Program may be reduced, modified or supplemented from time to time by unanimous consent of the Steering Committee. During the term of the Research Program, UGI shall provide the Steering Committee with quarterly written reports of the status of the Research Program, including a summary of results to date. Members of the Steering Committee or their designees shall have reasonable access to the facilities of each party where Research Program activities are in progress, but only during normal business hours and with reasonable prior notice. Any disputes among members of the Steering Committee shall be resolved by referring the matter for resolution to the Chief Executive Officers of the respective companies (or, if either Chief Executive Officer is then a member of the Steering Committee, to the Chairman of the Board). If, after 30 days, the dispute remains unresolved, it shall be referred to arbitration in accordance with Section 23 below. 7. Liability and Indemnification. 7.1 UGI shall indemnify, defend and hold harmless VascA, its Affiliates and sublicensees and all officers, directors, employees and agents thereof (collectively, "VascA Indemnitees") from all damages, losses, claims, judgements, liabilities, cost and expenses, including without limitation, reasonable attorneys' fees and expenses (collectively, "Costs"), whether the foregoing are based in contract, tort, negligence or product liability, incurred by or assessed against any VascA Indemnitees that arise out of or incident to injury or death of persons or damage to or destruction of any property caused or alleged to be caused by any Licensed Product supplied by UGI. In the event of any such claim against or Costs incurred by any of the VascA Indemnitees, VascA shall promptly notify UGI of such claim or Costs. UGI shall manage and control, at its sole expense, the defense and/or settlement of any such claim against a VascA Indemnitee. The VascA Indemnitees shall cooperate with UGI and may, at their option and expense, be represented in (but not control) any such action or proceeding. UGI shall not be liable for any settlement entered into or cost or expense incurred by the VascA Indemnitees in relation to any such action or proceeding without UGI's written authorization (unless UGI shall have failed to assume management and control of the defense and settlement of the matter as provided above in this Section 7.1). 7.2 VascA shall indemnify, defend and hold harmless UGI, its Affiliates and sublicensees and all officers, directors, employees and agents thereof (collectively, "UGI Indemnitees") from all Costs, whether the foregoing are based in contract, tort, negligence or product liability, incurred by or assessed against any UGI Indemnitees that arise out of or incident to injury or death of persons or damage to or destruction of property caused or alleged to be caused by any Licensed Product manufactured by VascA, VascA Affiliates or VascA sublicensees pursuant to the license grant set forth in Section 2.2. In the event of any such claim against or Costs incurred by any of the UGI Indemnitees, UGI shall promptly notify VascA of such claim or Costs. VascA shall manage and control, at its sole expense, the defense and/or settlement of any such claim against a UGI Indemnitee. The UGI Indemnitees shall cooperate with VascA and may, at their option and expense, be represented in (but not control) any such action or proceeding. VascA shall not be liable for any settlement entered into or cost or expense incurred by the UGI Indemnitees in relation to any such action or proceeding without VascA's written authorization (unless VascA shall have failed to assume management and control of the defense and settlement of the matter as provided above in this Section 7.2). 7.3 During the term of this Agreement and for four (4) years thereafter, each of the Parties shall maintain an insurance policy, to the extent available on commercially reasonable terms and subject to customary deductibles, issued by a reputable insurance company, naming the other Party as an additional insured, which policy shall insure against any and all claims, liabilities, costs and expenses in connection with the obligations of the insured Party under Section 7.1 or 7.2, as applicable, in an amount of at least $2,000,000 per claim. 7.4 UGI shall indemnify, defend and hold harmless the VascA Indemnitees from all Costs incurred by or assessed against any VascA Indeninitees that arise out of or incident to any intellectual property infringement claim made by any third party with respect to any Licensed Products, whether manufactured by UGI or by or under authority of VascA pursuant to Section 3.1, provided that the VascA Indemnitees shall not have modified the relevant Licensed Product. In the event of any such claim against or Costs incurred by any of the VascA Indemnitees, VascA shall promptly notify UGI of such claim or Costs. UGI shall manage and control, at its sole expense, the defense and/or settlement of any such claim against a VascA Indemnitee. The VascA Indemnitees shall cooperate with UGI and may, at their option and expense, be represented in (but not control) any such action or proceeding. UGI shall not be liable for any settlement entered into or cost or expense incurred by the VascA Indemnitees in relation to any such action or proceeding without UGI's written authorization (unless UGI shall have failed to assume management and control of the defense and settlement of the matter as provided above in this Section 7.4). Without waiving any rights it may have against UGI in respect of this obligation to indemnify the VascA Indemnitees hereunder, VascA shall have the continuing right to deduct from and offset against amounts otherwise payable to UGI under Section 3 any Costs not paid or reimbursed by UGI as required by this Section 7.4, including, without limitation, any royalty or other compensation that VascA and/or its Affiliates and sublicensees are required to pay to a third party in settlement in order to continue to exercise VascA's license rights as set forth in this Agreement. 8. Third Party Infringement/Misappropriation. 8.1 If either Party becomes aware of any infringement of Patents or misappropriation of Technology by a third party in the Territory for New Uses, such Party shall promptly give notice thereof to the other Party and shall provide the other Party with any evidence or other information in its possession relating to such infringement or misappropriation. The Parties shall thereupon consult together as to the action to be taken. 8.2 UGI shall have the first right, but not the obligation, to commence legal proceedings against any infringer of any Patent or misappropriator of Technology in the Territory for New Uses and in this case (subject to the provisions of the next two sentences) any damages recovered shall belong to UGI. In the event UGI commences such legal proceedings, VascA may join in such proceedings within 60 days after its receipt of notice from UGI of the commencement of such proceedings if VascA agrees to pay an amount equal to 50% of the cost of such proceedings. In such event, any damages, settlement fees or other consideration for past infringement received as a result of such proceedings shall be shared by UGI and VascA equally. If UGI is not willing to undertake legal proceedings against the infringer or misappropriator in the Territory for New Uses, VascA may at its own cost and expense in its own name commence such legal proceedings and in such case any damages recovered shall belong to VascA. In such event, (a) VascA shall be free to settle the dispute on an amicable basis, (b) UGI shall cooperate with VascA as reasonably requested by VascA and at VascA's expense, and (c) with respect to any legal proceedings brought by VascA, UGI shall agree to be named as a party thereto, provided that VascA agrees to indemnify, defend and hold harmless UGI from all Costs incurred by or assessed against UGI in connection with any actions or counterclaims relating to such legal proceedings, except for costs incurred by or assessed against UGI as a result of UGI's negligence or willful misconduct directly related to such proceedings. 9. Representations and Warranties. 9.1 UGI warrants and represents that it is the owner of the entire right, title and interest in and to the Technology (or holds requisite rights as licensee thereof) and that it has the right to grant licenses and distribution rights under the Technology of the scope set forth herein. 9.2 UGI warrants and represents that to the best of its knowledge (i) there are no patent rights owned by third parties relevant and material to an evaluation of VascA's freedom to operate with respect to the use of rights licensed hereunder, and (2) each patent included within the Patents was not fraudulently procured from the relevant governmental patent granting authority. 9.3 Each Party hereto represents and warrants to the other that its execution and delivery hereof has been duly authorized by all necessary corporate action and that the terms and conditions of this Agreement, and its obligations hereunder, do not conflict with or violate any terms or conditions of any other agreement or commitment to which it is a signatory or by which it is bound. 10. Minimum Purchase Requirements. UGI may, by sixty (60) days' advance notice to VascA, convert to non-exclusive the license granted to VascA under Section 2.1 hereof as set forth below at the end of any contract year if VascA does not purchase from UGI in any contract year a quantity of Licensed Products equal to the following (the "Minimum Purchase Requirement"): Year 1: 50,000 grams Year 2: 70,000 grams Year 3 85,000 grams Years 4 through 6: 7% above the average annual purchases during the preceding two contract years, but in no event less than 102,000 grams in Year 4, 130,000 grams in Year 5 and 150,000 grams in Year 6. Year 7 and all subsequent contract years: 5% above the average annual purchase during the preceding two contract years but in no event less than 170,000 grams. If VascA fails to satisfy the Minimum Purchase Requirement in any contract year, VascA's rights under this Agreement shall become non-exclusive and UGI shall be obligated to continue supplying VascA's requirements for Licensed Products. 11. Effective Date and Term. This Agreement will be effective as of the day and year first above written and will remain in effect until and expire upon the third anniversary of the date hereof. Following the initial term hereof, the Agreement will be automatically renewed for successive three (3) year terms unless terminated by either Party upon delivery of notice to the other Party within six (6) months prior to the end of the initial term or any subsequent term. 12. Termination. 12.1 Failure by UGI or VascA to comply with any of the obligations and conditions contained in this Agreement shall entitle the other Party to give notice to the Party in default requiring the defaulting Party to cure such default. If such default is not cured within thirty (30) days in the case of payment defaults involving amounts in excess of $25,000 or within forty-five (45) days in the case of all other defaults, after the receipt of such notice, the notifying Party shall be entitled (without prejudice to any of its other rights conferred on it by this Agreement) to terminate this Agreement by giving notice to take effect immediately. The right of either Party to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver of, or failure to take action with respect to, any previous default. 12.2 VascA shall have the right to terminate this Agreement at any time upon not less than six (6) months prior written notice to UGI. In the event of termination by VascA pursuant to this Section 12.2, VascA shall reimburse UGI the Cost of Goods for all Licensed Products then in UGI's inventory and allocated for delivery to VascA, up to an amount of inventory not to exceed 20% of the Forecast furnished to UGI under Section 3.5 hereof for the relevant period, except in the case of inventory packaged or labeled specifically for VascA that is different from the packaging or labeling of UGI's regular Clorpactin, in which case VascA shall be responsible for paying for all such existing inventory. 12.3 Notwithstanding anything else in this Agreement to the contrary, the Parties agree that Sections 3.3, 7.1, 7.2, 7.3, 7.4, 13.1, 13.2 and 14 shall survive the termination or expiration of this Agreement, as the case may be, to the extent required thereby for the full observation and performance by either or both of the Parties hereto. 12.4 In the event a Party breaches or defaults on any of its obligations hereunder, the non-breaching Party's remedies shall be limited to any or all of the following: (a) collecting any and all amounts then due and payable from the breaching Party pursuant to this Agreement; (b) seeking injunctive or similar equitable relief to compel the breaching Party to comply with its obligations and other terms and conditions of this Agreement; and (c) initiating procedures for termination of this Agreement pursuant to Section 12.1 hereof. In the event of any termination of this Agreement by UGI pursuant to Section 10 or 12.1 hereof or by VascA pursuant to Section 12.2 hereof, VascA, VascA Affiliates and VascA sublicensees shall, upon the request of UGI, (i) transfer and assign to UGI all clinical and other data in their possession that relate to any Licensed Products, and all regulatory filings relating thereto, (ii) cooperate with UGI in the transfer of all Registrations of Licensed Products to UGI and execute and deliver any and all instruments required to effect such transfers, and (iii) until such time as such Registrations have been transferred to UGI, take all actions reasonably requested by UGI to enable UGI to market the Licensed Products under the Registrations therefor held by VascA, including executing and filing any necessary amendments, supplements or other documents with the relevant regulatory agencies. UGI shall reimburse VascA for VascA's documented out-of-pocket costs reasonably incurred in connection with VascA's compliance with the immediately preceding sentence. 13. Rights and Obligations During, Upon and Following Termination; Confidentiality. 13.1 Termination of this Agreement, by expiration or for any other reason, shall be without prejudice to (a) UGI's rights to receive all payments due and accrued hereunder and unpaid on the effective date of such termination, and (b) any other remedies which either Party may then have hereunder. Except as provided in the previous sentence, VascA shall upon termination or expiration of this Agreement have no obligation to make any further payments to UGI. 13.2 During the term of this Agreement and for a period of five (5) years from any termination or expiration hereof, the Parties agree to keep in confidence and not to disclose to any third party, or use for any purpose, except pursuant to, and in order to carry out, the terms and objectives of this Agreement, any Confidential Information. As used herein, "Confidential Information" shall mean all trade secrets or confidential or proprietary information designated as such in writing by the disclosing Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such trade secret or confidential or proprietary information is disclosed by the disclosing Party to the receiving Party. Notwithstanding the foregoing, information which is orally or visually disclosed to the receiving Party by the disclosing Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information if the disclosing Party, within 30 days after such disclosure, delivers to the receiving Party a written document or documents describing such information and referencing the place and date of such oral, visual or written disclosure and the names of the employees or officers of the receiving Party to whom such disclosure was made. The restrictions on the disclosure and use of Confidential Information set forth in the first sentences of this Section 13.2 shall not apply to any Confidential Information which (a) was known by the receiving Party (as evidenced by the receiving Party's written records) prior to disclosure by the disclosing Party hereunder; (b) is or becomes part of the public domain through no fault of the receiving Party; (c) is disclosed to the receiving Party by a third party having a legal right to make such a disclosure; or (d) is required to be disclosed by law or legal process (provided that the other Party has received prior notice of such intended disclosure if practicable under the circumstances). This Agreement shall supersede any prior agreements as to the protection of confidential information. 13.3 In order to enable VascA to exercise its rights to market the Licensed Products, UGI hereby grants VascA a royalty-free license throughout the Territory to use any trademark which UGI applied to the Licensed Products at any time prior to the date hereof (the "Licensed Trademarks"). 14. Bankruptcy. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be, deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual property" as defined under Section 101(52) of the U.S. Bankruptcy Code. The parties to this Agreement shall retain and may fully exercise all of their respective rights and elections under the U.S. Bankruptcy Code. The parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a party licensor under the U.S. Bankruptcy Code, the licensee shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and, to the extent necessary for the exercise of the applicable license rights, all embodiments of such intellectual property, and same, if not already in its possession, shall be promptly delivered to the licensee (a) upon any such commencement of a bankruptcy proceeding upon written request therefor by the licensee, unless the licensor elects to continue to perform all its obligations under this Agreement, or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the licensor upon written request therefor by the licensee; provided, however, that upon the licensor's (or its successor's) written notification to the licensee that it is again willing and able to perform all its obligations under this Agreement, the licensee shall promptly return all such tangible materials to the licensor. 15. Force Majeure. Neither Party shall be considered in default or be liable to the other Party for any delay in performance or non-performance caused by circumstances beyond the reasonable control of such Party, including but not limited to acts of God, explosion, fire, flood, war, whether declared or not, accident, labor strike, sabotage order or decrees or any court or action of governmental authority. 16. Succession and Assignment. This Agreement may not be assigned or otherwise transferred by either Party, whether voluntarily or by operation of law, without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed; provided, that VascA may assign this Agreement or any of its rights hereunder to any of its Affiliates (although, in such event, VascA shall remain primarily responsible for all of its obligations and agreements set forth herein, notwithstanding such assignment). Any purported assignment in violation of the preceding sentence shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve either Party of responsibility for the performance of any accrued obligation which such Party then has hereunder. 17. Notices. Any notice or report required or permitted to be given or made under this Agreement by one of the Parties to the other shall be in writing and shall be deemed to have been delivered upon personal delivery or (a) in the case of notices provided between Parties in the continental United States, 48 hours after deposit in the mail or noon on the business day next following deposit with a reputable overnight courier, or (b) in the case of notices provided by telecopy (which notice shall be followed immediately by an additional notice pursuant to clause (a) or (b) above if the notice is of a default hereunder), upon completion of transmissions to the addressee's telecopier, as follows (or at such other addresses or facsimile numbers as may have been furnished in writing by one of the Parties to the other as provided in this Section 17): If to UGI: United-Guardian, Inc. 230 Marcus Blvd. P.O. Box 18050 Hauppauge, NY 11788 Attention: Ken Globus, President Facsimile No.: (516) 273-0858 If to VascA: VascA, Inc. 3 Highwood Drive Tewksbury, MA 01876 Attention: Richard Andrews, Vice President Facsimile No.: (978) 863-4401 With a copy to: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 Attention: William T. Whelan, Esq. Facsimile No.: (617) 542-2241 18. Affiliates. To the extent that any obligations or agreements are imposed upon Affiliates of a Party under this Agreement, such Party shall cause such Affiliates to fulfill such obligations and agreements. 19. Waiver. Failure of either Party to require, in one or more instances, performance by the other Party in strict accordance with the terms and conditions of this Agreement shall not be deemed a waiver or relinquishment of the future performance of any such terms and conditions or of any other term and condition of this Agreement. 20. Entire Agreement and Amendment; Titles. 20.1 This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof. It cancels and supersedes all prior written and oral agreements, understandings and declarations between the Parties in respect of the subject matter of this Agreement. 20.2 The titles of the Sections of this Agreement are for general reference and convenience only and this Agreement shall not be construed and interpreted by reference to such titles. 21. Severability. In case one or several provisions of this Agreement should be declared ineffective or void by any court of competent jurisdiction or a government agency having jurisdiction, such declaration shall not affect the remainder of this Agreement which will remain in full force and effect. The provisions ineffective or void shall be replaced by new effective ones which shall be in their sense and regarding the intentions of the Parties in respect of this Agreement as similar as possible to the provisions ineffective or void. 22. No Agency. Nothing herein shall be deemed to constitute either Party as the agent or representative of the other Party, or both Parties as joint venturers or partners for any purpose. Except as set forth herein, neither Party shall be responsible for the acts or omissions of the other Party, and neither Party will have authority to act on behalf of, represent or obligate the other Party in any way without prior written authority from the other Party. 23. Governing Law; Dispute Resolution. 23.1 This Agreement is governed by, and construed in accordance with, the laws of the State of Delaware without reference to choice of law principles. 23.2 This Agreement is made on the basis of mutual confidence, and it is understood that the differences, if any, during the duration of this Agreement should freely be discussed between the two Parties. Any dispute, controversy or claim arising out of, or relating to, this Agreement, or the breach, termination or invalidity thereof, shall be settled by arbitration conducted in New York, New York in accordance with the rules of the American Arbitration Association. Notwithstanding the foregoing, nothing in this Section 23.2 shall be construed as limiting in any way the right of a Party to seek injunctive relief with respect to any actual or threatened breach of this Agreement, which breach would cause irreparable harm to the Party seeking such relief, from a court of competent jurisdiction. 24. Modifications. Any modification or addition to this Agreement shall be valid only if it is confirmed in writing by the duly authorized officers of both Parties. IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their duly authorized representatives as of the date first above written. UNITED-GUARDIAN, INC. By:/s/ Kenneth H. Globus -------------------- Kenneth H. Globus Title: President Date: December 4, 1998 VASCA, INC. By:/s/ Richard Andrews ------------------- Richard Andrews Title: Vice President Date: December 7, 1998 © Copyright 1995-1999 EDGAR Online, Inc. All rights reserved.