ITEM 1. BUSINESS.
Gamma Biologicals, Inc. (which, together with its subsidiaries is herein referred to as the "company" or "Gamma") manufactures reagents and systems used for IN-VITRO diagnostic testing. The reagents are sold to transfusion departments of hospitals, blood collection centers, medical laboratories and research institutions where they are used to detect the presence of diagnostically significant substances in biological fluids, primarily human blood. The company also develops test systems, which use certain of the company's reagents and serve to standardize test procedures. See "New Technology - - Gamma ReACT-TM- Test System".
The company's current products are used in a number of applications, including:
- grouping donor and patient bloods and performing compatibility tests prior to transfusion - detecting hemolytic disease of the newborn - identifying antibodies and certain inherited blood group antigens
Gamma markets its products to over 3,500 hospitals, blood centers and laboratories in the United States and Canada, and to dealers in approximately 50 countries. Domestic sales are made through the company's direct sales force, as well as through independent distributors. Internationally, the company sells its products and products manufactured by others through its subsidiary, Gamma Biologicals, B.V., and independent distributors.
CURRENT PRODUCTS
Most of the company's sales are derived from products used in tests performed to determine the ABO and Rh groups of hospital patients and blood donors, to detect and identify antibodies, to confirm compatibility between blood donors and patients, and in routine prenatal care. Antibodies are serum components produced in reaction to the introduction of foreign substances into the body through transfusion, pregnancy or other mechanisms. The company's reagent red cell products are used to test patients' blood specimens for antibodies and, if antibodies are present, to determine their identity, thereby enabling suitable donor blood to be selected. The selection of proper donor blood is also aided by testing with the company's line of other blood grouping reagents. Blood grouping reagents are products prepared from serum (the liquid portion) of blood drawn from immunized human donors, from antibodies secreted by monoclonal cell lines (hybridomas), and from certain seed extracts (lectins). After an appropriate donor blood has been selected for transfusion to a patient, a direct test of compatibility is commonly performed using patient and donor bloods. The company's antiglobulin reagents (commonly known as "Coombs reagents") are used in all stages of these procedures beyond initial blood grouping.
BLOOD BANK PRODUCTS. This group includes blood grouping reagents, Coombs reagents, antibody potentiators, test cell products, the ReACT Test System, quality control systems and certain specialty products.
BLOOD GROUPING REAGENTS are used to determine the four major blood groups (A, B, AB and O) and six factors in the Rh blood group system, and include other products utilized to detect blood group factors in the eight other blood group systems.
COOMBS REAGENTS are used in blood grouping, antibody detection and identification procedures and in the diagnosis of hemolytic disease of the newborn, as well as autoimmune hemolytic anemia. The company presently markets five Coombs products in three different specificities.
ANTIBODY POTENTIATORS are solutions added to blood testing systems to enhance their sensitivity. Improved sensitivity is also achieved by the use of certain proteolytic enzymes. The company presently markets six antibody potentiators and two enzyme reagents.
REAGENT RED CELL PRODUCTS are used in conjunction with Coombs reagents or with the Gamma ReACT Test System to detect and identify antibodies during pregnancy and in patient and donor blood serums. The company presently manufactures and sells 34 test cell products processed from human blood.
REAGENT QUALITY CONTROL (RQC-Registered Trademark-) KIT is a product comprising three selected reagents, designed to enable hospital laboratories and blood banks to test the effectiveness of reagents and to provide an organized permanent record of the test results, as required by various regulatory agencies.
SPECIALTY REAGENTS include a screening test for the detection of significant fetal-maternal hemorrhage, a self-evaluation system that is designed both to determine technical proficiency and to provide educational content, a simpler system for competency testing, and seven products for the resolution of unusual blood groups or antibody detection problems.
GAMMA PRODUCT GROUP TABLE
NEW TECHNOLOGY
GAMMA REACT-TM- TEST SYSTEM. Gamma has developed and received a patent, in September 1997, on a microcolumn technology to be used for red cell affinity testing. Products based on this technology should help Gamma compete with other microcolumn tests marketed very successfully in Europe since 1988 and recently introduced in the United States. The acronym ReACT (Red Cell AdherenCe Technology) has been chosen as a commercial trade name for the product line.
The principle of ReACT is based on the affinity adherence of red cells to an immunologically active matrix. The matrix consists of specially treated agarose beads. Custom designed disposables and dedicated centrifuge equipment have been developed to provide customers with an easy-to-use and inexpensive testing system.
The company's first ReACT products are used for antibody detection and identification. Products to be used for red cell antigen typing in the ReACT Test System are currently under development. The company has contracted with a medical equipment manufacturer to provide automated dispensing and reading devices for use with the ReACT Test System, and plans to develop a fully automated system in the future. Gamma received FDA clearance to market the first ReACT products in the United States in September 1997. Sales of ReACT to international distributors began in September 1997; active U.S. sales efforts began April 1, 1998, although a few systems were placed with U.S. customers late in fiscal 1998. See "Item 3. - Legal Proceedings" regarding a claim of patent infringement by the company.
PRODUCTS UNDER DEVELOPMENT
GAMMA-CLONE-Registered Trademark- (MONOCLONAL) REAGENTS. The development of hybridoma technology has led to a ready availability of monoclonal antibodies, which have had a major impact on the design and manufacture of immunodiagnostic reagents. The company has recognized the potential for the application of this new technology to several of its blood bank product lines, and has pursued a program of introducing monoclonal-based products wherever the technology proves to be advantageous.
The company currently markets eighteen FDA-licensed blood grouping reagents manufactured by hybridoma technology. Its five monoclonal Coombs reagents include the first FDA-licensed Anti-IgG. The company owns or has exclusive use of the raw material sources (clones) for twelve of the blood grouping reagents and all of the Coombs products; these clones are grown in-house to produce source material for manufacturing the relevant products. A license supplement was approved during fiscal 1998 for an Anti-e reagent manufactured from raw material purchased from another company. Raw materials for the remaining products are also purchased from a single supplier. Should the supply of these materials from this source be interrupted, the company anticipates that it could locate alternative sources of supply. The company is committed to a program aimed at developing clones for all blood grouping reagents.
In May 1996, Gamma filed a license application for a monoclonal Anti-c reagent based on a cell line of which the company has exclusive use. This application is still awaiting approval. The company's premarket notification submission for a product intended to assist in the testing of patients with auto-immune hemolytic anemia (EGA-TM-Kit) has been cleared by the FDA, along with the non-licensable components of the ReACT Test System.
We have contracted with Olympus America, Inc. to develop blood grouping reagents and reagent red blood cells ready to use on that company's PK7200 immunohematology analyzers. Applications for the necessary license supplements were made before the end of calendar 1997. Reagents for Rh phenotyping and typing for the K antigen on the PK7200 have been developed, and field-test studies to provide data to support an application to the FDA started in June 1998.
PRODUCTION AND QUALITY CONTROL
The company believes that its reputation in the industry as a source of quality products and services is largely attributable to the expertise of its technical employees and its maintenance of rigid quality control procedures at every step of the manufacturing process.
Raw materials for the FDA-licensed products manufactured and sold by the company are obtained from several sources. The sources for many of the company's blood grouping reagent products are human plasma obtained from FDA-licensed establishments and monoclonal antibodies. Test cell products are manufactured from whole blood drawn from local donors or purchased from licensed blood banks. The company believes that the available sources of supply for all raw materials are adequate for its present and anticipated needs. The company is not dependent on any single source for any of its raw materials, other than six of its current Gamma-clone-Registered Trademark- products (see above).
Once received, raw materials are subjected to a series of manufacturing and quality control steps, which vary according to the product. FDA regulations require samples of each finished lot of all blood grouping and Coombs reagents to be submitted to the Center for Biologics Evaluation and Research for approval of release prior to shipment. The FDA has granted the company exemptions from the lot release requirements for Coombs reagents, for one of its Rh reagents, for three of its other monoclonal blood grouping reagents, and also for two of its monoclonal ABO reagents. The remaining blood grouping reagents remain subject to this provision of the regulations. Test cell products, though also licensed, do not require prior FDA approval on a lot-by-lot basis.
The products sold by the company that are not required to be licensed by the FDA (including antibody potentiators, diagnostic and specialty reagents) fall into two categories: those manufactured by the company from raw materials acquired from various sources, and those purchased from outside manufacturers for distribution by the company. All such products are manufactured in accordance with a Quality System as promulgated by the FDA. See "Regulation". The company is actively pursuing ISO 9001 certification and expects to obtain certification by the end of fiscal 1999.
The company maintains product liability insurance against bodily injury and property damage in the amount of $10,000,000.
MARKETING AND SERVICES
The company's marketing strategy is to build a broad base of customer loyalty by providing a wide variety of quality products, marketed by a highly qualified sales force and supported by in-house technical assistance. The company believes that responsiveness to customer needs, both in the provision of services and the introduction of new products, is the key to success.
The company sells its products to hospitals, blood banks, the United States armed forces, and university and private research institutions throughout the world. In the United States and Canada, the company is directly represented by 19 full-time salespersons. Most members of the sales force have degrees in medical technology or blood banking experience. Each salesperson makes direct calls on pathologists, chief blood bank technologists and purchasing agents at institutions in defined geographic areas. The company also markets its products domestically through selected distributors, who sell to small hospitals, laboratories and doctors' offices. Internationally, the company is represented by its subsidiary, Gamma Biologicals, B.V., and independent dealers.
Management believes that timely delivery of its products to customers is an important element of its marketing and sales strategy. The company maintains an inventory sufficient to allow prompt response to customer needs. The company sells test cell products and its RQC and Tech-Chek Kits on standing orders for shipment every two, three or four weeks. The RiSE educational product is shipped quarterly. All contracts for company products may be terminated at any time without penalty by either the customer or the company.
To support its sales force and dealers, the company participates in a number of educational programs, with management and employees serving as speakers or faculty members in numerous domestic and international workshops and conventions. This participation provides visibility for the company and enhances its reputation in the scientific community. The company also conducts in-house training programs for blood bank personnel. In addition, the company maintains a reference laboratory, recognized by the American Association of Blood Banks, which employs four persons (including two persons registered as blood bank specialists by the American Society of Clinical Pathologists) and provides consulting services for hospitals and blood banks with rare or difficult blood testing problems. The reference laboratory often serves as a means of introducing the company and its products to potential customers, generating new products in response to customer needs and providing ongoing quality control of the company's blood bank products. New discoveries made in the course of investigating problems referred for consultation are regularly reported in scientific literature or at scientific meetings.
Sales to the company's six largest domestic customers (two of which are regional laboratory supply dealers) represented 5.5% of the company's net sales for fiscal 1998, 5.7% for fiscal 1997 and 5.8% for fiscal 1996.
Approximately 35% of the company's net sales in fiscal 1998 were made to foreign customers. In fiscal 1998 the company's export sales were to customers in Japan ($781,000), the Netherlands ($688,000), Spain ($559,000), Italy ($417,000), Brazil ($396,000), and over 50 other countries worldwide.
REGULATION
The company operates under U.S. Government Establishment License No. 435, granted by the National Institutes of Health in 1971. The terms of the license subject the company to stringent manufacturing and quality control standards, and the license may be suspended or revoked by the FDA for cause at any time. Such revocation would cause the company to cease business. The company's blood grouping and Coombs reagents, as well as its test cell products, must be licensed by the FDA pursuant to the Public Health Service Act and are manufactured in accordance with defined standards.
In addition, the Federal Food, Drug and Cosmetic Act and the Safe Medical Devices Act, together with regulations issued or authorized thereunder, provide for regulation by the FDA of the marketing, manufacture, labeling, packaging and distribution of medical devices, including most of the company's non-licensed products. Among the applicable regulations are requirements that medical device manufacturers register with the FDA, list devices manufactured by them, and file various reports. Regulations covering The Quality System for Medical Devices set forth requirements for, among other things, the company's manufacturing processes and associated record-keeping and maintenance. Certain requirements must be met before initial marketing of medical devices, ranging from a minimum obligation to notify the FDA before commencing marketing of a product substantially equivalent to devices already in commerce, to a maximum obligation to comply with the potentially expensive and time-consuming process of testing necessary to support an application for premarket approval. The FDA also has the authority, which it has so far exercised only to a limited degree, to issue performance standards to be met by most of the types of non-licensed products manufactured by the company. The company anticipates no difficulty in meeting the performance standards for the products as promulgated by the FDA.
None of the company's current or proposed products, except those labeled for forensic use only, can be marketed in the United States without the licenses or registrations required by the FDA. Unscheduled FDA inspections of the company's facilities occur from time to time to determine compliance with applicable FDA regulations. To date, the company believes that it has satisfactorily complied with requirements imposed by the FDA, OSHA, EEOC and other government agencies. The company also believes that the manufacturing and quality control procedures it employs conform to requirements of the Quality System regulations.
MARKETS AND COMPETITION
Management believes that the world market for blood bank reagent products is more than $160 million per year, with about 40% of the market being in the United States. There are three other domestic companies that actively compete with the company, one of which is Ortho Diagnostic Systems, a division of Johnson and Johnson, Inc., which the company believes accounts for about 50% of all domestic sales. Other competitors include Immucor, Inc. and BCA, a division of Biopool International.
Competition is based on quality of product, price, the size and talent of sales forces, ability to furnish a range of existing and new products, customer services and continuity of product supply. During the past several years, the industry has experienced aggressive price competition, particularly among manufacturers that target large hospitals and institutions as key customers. In spite of this competitive environment, the company has maintained its worldwide sales and increased market share outside the U.S., particularly in Latin America. Management believes that this is due to the company's emphasis on product quality, the introduction of new products, specialty products, customer service and training.
RESEARCH AND DEVELOPMENT
The company's strategy for growth includes internal research and development, technology acquisition and worldwide marketing. The research and development program is based upon the allocation of available resources among new product development, process development, product and process improvement, and technical services to manufacturing and marketing.
Any new product developed by the company will require, prior to its domestic sale, licensing or clearance to market by the FDA. There can be no assurance that any such product will be so licensed or cleared, or that it will gain acceptance in the marketplace.
In fiscal 1998, 1997, and 1996, the company expended $1,247,000, $1,449,000, and $1,349,000 respectively, for research and development on monoclonal, microcolumn and electro-biosensor technologies. The company engaged in no customer-sponsored research during these periods.
The company's funding of electro-biosensor research at the University of Wollongong, Australia, was discontinued in fiscal 1998. Although feasibility and specificity of the test system were proven in a laboratory setting, estimates of additional time and cost required to commercialize the technology exceeded the company's expectations. Management believes that currently available resources will be better utilized in projects with greater short and intermediate term potential, such as the development of additional microcolumn products and the automation of the ReACT Test System.
PATENTS AND TRADEMARKS
In May 1994, the company applied for United States and international patents covering a new antigen/antibody detection procedure using an affinity adherence technology; the U.S. patent was issued in September 1997. See "New Technology- Gamma ReACT-TM- Test System"and "Item 3. - Legal Proceedings" regarding a claim of patent infringement by the company. An additional patent application has been submitted covering the ReACT technology.
The company's trademark rights to the mark "Gamma" have been federally registered. The company holds nine different trademark registrations for various uses of "Gamma" and claims trademark rights in respect of other brand names utilized to identify the company's products. The company presently owns a number of federal and state registrations and has an aggressive policy of registering its trademark rights, where such is deemed available. There can be no assurance that any of the company's registrations will be enforceable.
EMPLOYEES
The company has 134 full-time employees, of whom 38 hold advanced technical degrees or certifications in medical technology. Of the total, 45 are sales, marketing and customer-support personnel, 58 are engaged in manufacturing and quality control, and the remainder serve in other capacities. The company has experienced a low turnover rate among its employees and considers its employee relations to be excellent. None of the company's employees is represented by a union.
FINANCIAL INFORMATION ABOUT INDUSTRY SEGMENTS
The company operates in one industry segment and two geographic areas, the United States and Europe.
ITEM 2.
ITEM 2. PROPERTIES.
The principal manufacturing, research, shipping, sales and administrative functions of the company are conducted in a 41,000 square foot building located in northwest Houston on a three-acre tract of land owned by the company. The land and building are subject to a first lien mortgage. Management believes that the facility is both suitable and adequate for current production needs and has no plans for expanding its domestic facilities in fiscal 1999. Gamma Biologicals, B.V. leases approximately 900 square feet of office and warehouse space in Amsterdam, the Netherlands, which management believes is adequate for current needs.
ITEM 3.
ITEM 3. LEGAL PROCEEDINGS.
On May 12, 1998, the company received notification that a claim of patent infringement had been filed on that date in U.S. District Court, Southern District of Florida, Miami Division, by Micro Typing Systems, Inc. and Stiftung fur Diagnostiche Forschung (the Foundation). The claim alleges that the recently introduced Gamma ReACT Test System (See "New Technology - Gamma ReACT-TM- Test System") infringes U.S. patent No. 5,512,432 granted to the Foundation April 30, 1996. The plaintiffs seek a preliminary and permanent injunction against the continued alleged infringement by the company, an award of treble damages, with interest and costs and reasonable attorney's fees. Management is confident that the ReACT technology does not infringe any claims made in the Foundation's patent; however, an unfavorable outcome in this action could have a material adverse effect upon the business and the results of operations in a given reporting period. Since this matter is in the earliest stage of proceedings and due to uncertainties involved in litigation, management cannot predict the likelihood of a particular outcome or estimate the financial impact of an unfavorable resolution.
On January 23, 1998, a former employee filed a suit in the District Court of Harris County, Texas, alleging that the company breached a verbal contract to provide certain post-employment benefits. The plaintiff seeks specific performance of the contract or, in the alternative, money damages in an amount not less than $1,500,000. Management denies that it has breached any obligations to the plaintiff, and believes that it is unlikely that the outcome of this case will have a material impact on the financial condition of the company. The Company is vigorously contesting this claim and believes that its positions are sustainable.
The company is involved in various other legal actions that are in various stages of litigation and investigation by the company and its legal counsel. After reviewing all other actions pending or threatened involving the company, management believes that while the resolution of any matter may have an impact on the financial results of the period in which the matter is settled, their ultimate resolution will not have any material adverse effect upon the business or consolidated financial position of the company. Since these matters are in various stages of proceedings, future developments could cause management to revise its assessment of these matters.
ITEM 4.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
During the fourth quarter of fiscal 1998, no matter was submitted to a vote of security holders of the company.
PART II
ITEM 5.
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
The information contained under "Market for Registrant's Common Equity and Related Shareholder Matters" on page 36 of the company's annual report to shareholders for the year ended March 31, 1998, is incorporated herein by reference. See also Notes 6 and 7 of Notes to Consolidated Financial Statements on pages 30 and 31 of the company's annual report to shareholders for the year ended March 31, 1998, which is incorporated herein by reference.
ITEM 6.
ITEM 6. SELECTED FINANCIAL DATA.
The information contained under "11-year Summary of Selected Financial Data" on the inside front cover and page 1 of the company's annual report to shareholders for the year ended March 31, 1998, is incorporated herein by reference.
ITEM 7.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The information contained under "Management's Discussion and Analysis of Financial Condition and Results of Operations" on pages 17 through 22 of the company's annual report to shareholders for the year ended March 31, 1998, is incorporated herein by reference.
ITEM 8.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The following consolidated financial statements of the company and its subsidiaries, included on pages 23 through 35 of the company's annual report to shareholders for the year ended March 31, 1998, are incorporated herein by reference:
Statements of Consolidated Income -- Years ended March 31, 1998, 1997 and
Consolidated Balance Sheets -- March 31, 1998 and 1997
Statements of Changes in Shareholders' Equity -- Years ended March 31, 1998, 1997 and 1996
Statements of Consolidated Cash Flows -- Years ended March 31, 1998, 1997 and 1996
Notes to Consolidated Financial Statements
The information contained under "Quarterly Financial Data (unaudited)" on page 36 of the company's annual report to shareholders for the year ended March 31, 1998, is incorporated herein by reference.
ITEM 9.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
PART III
ITEM 10.
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT.
The information contained under "Proposal No. 1 - Election of Directors", "Executive Officers" and "Section 16(a) Beneficial Ownership Reporting Compliance" on pages 3, 4, 5, 6 and 12 of the company's proxy statement dated June 30, 1998, which has been filed with the Securities and Exchange Commission, is incorporated herein by reference.
ITEM 11.
ITEM 11. EXECUTIVE COMPENSATION.
The information contained under "Executive Officers", "Severance Agreements", and "Split-Dollar Agreements" on pages 5 through 12 (except for the Compensation/Stock Option Committee Report and Performance Graph therein) of the company's proxy statement dated June 30, 1998, which has been filed with the Securities and Exchange Commission, is incorporated herein by reference.
ITEM 12.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
The information contained under "Common Stock Outstanding and Principal Holders Thereof" on pages 2 and 3 of the company's proxy statement dated June 30, 1998, which has been filed with the Securities and Exchange Commission, is incorporated herein by reference.
ITEM 13.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
The information contained under "Certain Relationships and Related Transactions" on page 12 of the company's proxy statement dated June 30, 1998, which has been filed with the Securities and Exchange Commission, is incorporated herein by reference.
PART IV
ITEM 14.
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K.
(a) (1) AND (2) FINANCIAL STATEMENTS AND RELATED SCHEDULES The response to this portion of Item 14 is submitted as a separate section of this report. (3) EXHIBITS The response to this portion of Item 14 is submitted as a separate section of this report.
(b) REPORTS ON FORM 8-K No Report on Form 8-K was filed by the company during the quarter ended March 31, 1998.
(c) EXHIBITS See Item 14(a)(3), above.
(d) FINANCIAL STATEMENT SCHEDULES Such schedules are not required or are disclosed in the financial statements.
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED.
GAMMA BIOLOGICALS, INC.
By: DAVID E. HATCHER -------------------------------------------------- (DAVID E. HATCHER, CHAIRMAN OF THE BOARD OF DIRECTORS, PRESIDENT AND CHIEF EXECUTIVE OFFICER)
Dated: June 26, 1998
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THIS REPORT HAS BEEN SIGNED BELOW BY THE FOLLOWING PERSONS ON BEHALF OF THE REGISTRANT AND IN THE CAPACITIES AND ON THE DATES INDICATED.
ANNUAL REPORT ON FORM 10-K
ITEM 14(a)(1) and (2)
GAMMA BIOLOGICALS, INC. AND SUBSIDIARIES
MARCH 31, 1998
List of Financial Statements and Financial Statement Schedules
The following consolidated financial statements of the registrant and its subsidiaries, included on pages 23 through 35 of the annual report of the registrant to its shareholders for the year ended March 31, 1998, are incorporated by reference in Item 8.
Statements of Consolidated Income -- Years ended March 31, 1998, 1997 and
Consolidated Balance Sheets -- March 31, 1998 and 1997
Statements of Changes in Shareholders' Equity -- Years ended March 31, 1998, 1997 and 1996
Statements of Consolidated Cash Flows -- Years ended March 31, 1998, 1997 and 1996
Notes to Consolidated Financial Statements
All other schedules for which provision is made in the applicable accounting regulation of the Securities and Exchange Commission are not required under the related instructions or are inapplicable, and therefore have been omitted.
ANNUAL REPORT ON FORM 10-K
ITEM 14(a)(3)
EXHIBIT INDEX
EXHIBITS
YEAR ENDED MARCH 31, 1998
GAMMA BIOLOGICALS, INC.
HOUSTON, TEXAS
ANNUAL REPORT ON FORM 10-K
ITEM 14(a)(3)
GAMMA BIOLOGICALS, INC. AND SUBSIDIARIES
MARCH 31, 1998
EXHIBIT NUMBER - ------- 3(a) -- Restated Articles of Incorporation of the Company dated June 20, 1996. Incorporated by reference to Exhibit 3(a) to the Company's Annual Report on Form 10-K for the year ended March 31, 1996 (the "1996 Form 10-K").
(b) -- Amended and Restated Bylaws of the Company dated April 13, 1990. Incorporated by reference to Exhibit 3(b) to the Company's Annual Report on Form 10-K for the year ended March 31, 1990 (the "1990 Form 10-K").
4(a) -- Specimen Common Stock certificate of the Company. Incorporated by reference to Exhibit 4(a) to the 1990 Form 10-K.
(b) -- Shareholder Rights Plan dated as of September 5, 1989. Incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K dated September 5, 1989.
10(a) -- Restated and Amended Split-Dollar Agreement dated May 29, 1990 between the Company and David E. Hatcher. Incorporated by reference to Exhibit 10(a) to the 1990 Form 10-K.
(b) -- Restated and Amended Split-Dollar Agreement dated May 29, 1990 between the Company and Betty F. Hatcher. Incorporated by reference to Exhibit 10(b) to the 1990 Form 10-K.
(c) -- Restated and Amended Split-Dollar Agreement dated May 29, 1990 between the Company and Bryan J. Brieden. Incorporated by reference to Exhibit 10(c) to the 1990 Form 10-K.
(d) -- Restated and Amended Split-Dollar Agreement dated May 29, 1990 between the Company and Larry E. Letwin. Incorporated by reference to Exhibit 10(d) to the 1990 Form 10-K.
(e) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and David E. Hatcher. Incorporated by reference to Exhibit 10(e) to the Company's Annual Report on Form 10-K for the year ended March 31, 1991 (the "1991 Form 10-K").
(f) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and David E. Hatcher. Incorporated by reference to Exhibit 10(f) to the 1991 Form 10-K.
EXHIBIT NUMBER - -------- (g) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and Betty F. Hatcher. Incorporated by reference to Exhibit 10(g) to the 1991 Form 10-K.
(h) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and Betty F. Hatcher. Incorporated by reference to Exhibit 10(h) to the 1991 Form 10-K.
(i) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and Bryan J. Brieden. Incorporated by reference to Exhibit 10(i) to the 1991 Form 10-K.
(j) -- Amendment to Restated and Amended Split-Dollar Agreement dated May 8, 1991 between the Company and Larry E. Letwin. Incorporated by reference to Exhibit 10(j) to the 1991 Form 10-K.
(k) -- Split-Dollar Agreement dated March 25, 1993 between the Company and Margaret J. O'Bannion. Incorporated by reference to Exhibit 10(l) to the Company's Annual Report on Form 10-K for the year ended March 31, 1993 (the "1993 Form 10-K").
(l) -- Split-Dollar Agreement dated March 25, 1993 between the Company and Jimmie L. Turner. Incorporated by reference to Exhibit 10(m) to the 1993 Form 10-K.
(m) -- Split-Dollar Agreement dated March 25, 1993 between the Company and Jimmie L. Turner. Incorporated by reference to Exhibit 10(n) to the 1993 Form 10-K.
(n) -- Split-Dollar Agreement dated May 5, 1995 between the Company and Gary L. Parrish. Incorporated by reference to Exhibit 10(o) to the 1996 Form 10-K.
(o) -- Split-Dollar Agreement dated October 23, 1996 between the Company and Raul Alvarez. Incorporated by reference to Exhibit 10(p) to the Company's Annual Report on Form 10-K for the year ended March 31, 1997 (the "1997 Form 10-K").
(p) -- Split-Dollar Agreement dated October 21, 1996 between the Company and Susan A. Batcha. Incorporated by reference to Exhibit 10(q) to the 1997 Form 10-K.
(q) -- Split-Dollar Agreement dated October 17, 1996 between the Company and Thomas H. Frame. Incorporated by reference to Exhibit 10(r) to the 1997 Form 10-K.
(r) -- Split-Dollar Agreement dated October 17, 1996 between the Company and Marilyn K. Moulds. Incorporated by reference to Exhibit 10(s) to the 1997 Form 10-K.
(s) -- Incentive Stock Option Plan of the Company. Incorporated by reference to the Company's Proxy Statement dated June 25, 1987, Exhibit A.
EXHIBIT NUMBER - --------
(t) -- 1991 Employee Stock Option Plan of the Company. Incorporated by reference to Exhibit 28.2 to the Company's Registration Statement on Form S-8 (File No. 33-44950) dated January 6, 1992.
(u) -- 1991 Outside Director Stock Option Plan of the Company. Incorporated by reference to Exhibit 28.3 to the Company's Registration Statement on Form S-8 (File No. 33-44950) dated January 6, 1992.
(v) -- 1995 Employee Stock Option Plan of the Company. Incorporated by reference to the Company's Registration Statement on Form S-8 (File No. 333-01147) dated February 21, 1996.
(w) -- 1997 Outside Director Stock Option Plan of the Company. Incorporated by reference to Exhibit 99.1 to the Company's Registration Statement on Form S-8 (File No. 333-40367) dated November 17, 1997.
(x) -- 401(k) Retirement Savings Plan of the Company adopted July 1, 1992. Incorporated by reference to Exhibit 10(r) to the 1993 Form 10-K.
(y) -- Patent License Agreement effective May 12, 1997 between the Company and Pasteur Sanofi Diagnostics. Incorporated by reference to Exhibit 10(y) to the 1997 Form 10-K.
(z) -- Warrant to Purchase Common Stock dated June 19, 1997. Incorporated by reference to Exhibit 10(a) to the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1997 (the "June 30, 1997 Form 10-Q").
(aa) -- Registration Rights Agreement dated June 19, 1997 between the Company and Cyn Del & Company, Inc. Incorporated by reference to Exhibit 10(b) to the June 30, 1997 Form 10-Q.
(bb) -- Term and Revolving Line of Credit Loan Agreement dated August 17, 1990 between Sterling Bank and the Company. Incorporated by reference to Exhibit 10(v) to the 1991 Form 10-K.
(cc) -- Promissory Note dated November 2, 1990 payable to the order of Sterling Bank by the Company. Incorporated by reference to Exhibit 10(w) to the 1991 Form 10-K.
(dd) -- Employment Contract dated January 29, 1976 between the Company and John Case. Incorporated by reference to Exhibit 10(aa) to the Company's Annual Report on Form 10-K for the year ended March 31, 1986.
(ee) -- Amended and Restated Severance Agreement dated February 19, 1996 between Betty F. Hatcher and the Company. Incorporated by reference to Exhibit 10(y) to the 1996 Form 10-K.
(ff) -- Amended and Restated Severance Agreement dated February 19, 1996 between David E. Hatcher and the Company. Incorporated by reference to Exhibit 10(aa) to the 1996 Form 10-K.
EXHIBIT NUMBER - --------
(gg) -- Amended and Restated Severance Agreement dated February 19, 1996 between Margaret J. O'Bannion and the Company. Incorporated by reference to Exhibit 10(bb) to the 1996 Form 10-K.
(hh) -- Amended and Restated Severance Agreement dated February 19, 1996 between Jimmie L. Turner and the Company. Incorporated by reference to Exhibit 10(cc) to the 1996 Form 10-K.
(ii) -- Severance Agreement dated December 19, 1995 between Gary L. Parrish and the Company. Incorporated by reference to Exhibit 10(dd) to the 1996 Form 10-K.
(jj) -- Severance Agreement dated August 12, 1996 between Raul F. Alvarez and the Company. Incorporated by reference to Exhibit 10(ii) to the 1997 Form 10-K.
(kk) -- Severance Agreement dated August 12, 1996 between Susan A. Batcha and the Company. Incorporated by reference to Exhibit 10(jj) to the 1997 Form 10-K.
(ll) -- Severance Agreement dated August 12, 1996 between Thomas H. Frame and the Company. Incorporated by reference to Exhibit 10(kk) to the 1997 Form 10-K.
(mm) -- Severance Agreement dated August 12, 1996 between Marilyn K. Moulds and the Company. Incorporated by reference to Exhibit 10(ll) to the 1997 Form 10-K.
11 -- Statement Regarding Computation of per Share Earnings. Incorporated by reference to the Company's Statements of Consolidated Income for the years ended March 31, 1998, 1997 and 1996 on page 23 of the Company's Annual Report to Shareholders for the year ended March 31, 1998 and to Note 1 of Notes to Consolidated Financial Statements on pages 27 and 28 of the Company's Annual Report to Shareholders for the year ended March 31, 1998.
13 -- The Company's Annual Report to Shareholders for the year ended March 31, 1998.
21 -- Subsidiaries of the Company.
23 -- Consent of Deloitte & Touche LLP.
27 (a) -- Financial Data Schedule for the year ended March 31, 1998
(b) -- Restated Financial Data Schedule for the six months ended September 30, 1995.