-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Kv1ZKKBfx22mox/Yj0CGRml68fLQK+UFzsFVr4p8wh/EFRaqT9yTKmLtGt0e5+Po rudPKp1HPV0vinYP/wvKlQ== 0000946644-03-000004.txt : 20030415 0000946644-03-000004.hdr.sgml : 20030415 20030415150029 ACCESSION NUMBER: 0000946644-03-000004 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20021231 FILED AS OF DATE: 20030415 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HEMISPHERX BIOPHARMA INC CENTRAL INDEX KEY: 0000946644 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 520845822 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13441 FILM NUMBER: 03650389 BUSINESS ADDRESS: STREET 1: 1617 JFK BLVD #660 STREET 2: ONE PENN CENTER CITY: PHILADELPHIA STATE: PA ZIP: 19104 BUSINESS PHONE: 2159880080 MAIL ADDRESS: STREET 1: 1617 JFK BLVD STREET 2: ONE PENN CENTER CITY: PHILADELPHIA STATE: PA ZIP: 19103 10-K 1 r10k-2002.txt 10K-2002 HEMISPHERX BIOPHARMA, INC. FORM 10-K SECURITIES AND EXCHANGE COMMISSION [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2002 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File No. 0-27072 HEMISPHERX BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 52-0845822 _ (State or other jurisdiction of (I.R.S. Employer Identification incorporation or organization) Number) 1617 JFK Boulevard Phila., Pennsylvania 19103 _ (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (215) 988-0080 Securities registered pursuant to Section 12(b) of the Act: Common Stock, $.001 par value Securities registered pursuant to Section 12(g) of the Act: (Title of Each Class) NONE Indicate by check mark whether the registrant (1) has filed all reports to be filed by Section 13 or 15(d) of the Securities and Exchange Act of 1934 during the preceding 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 disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. Yes ( ) No (X) The aggregate market value of Common Stock held by non-affiliates at June 30, 2002 was $80,226,755. For purposes of this calculation, it was assumed that all Common Stock is valued at the closing price of the stock as of June 30, 2002. The number of shares of the registrant's Common Stock outstanding as of March 31, 2003 was 32,941,445. DOCUMENTS INCORPORATED BY REFERENCE None. TABLE OF CONTENTS Page PART I Item 1. Business 1 Item 2. Properties 31 Item 3. Legal Proceedings 31 Item 4. Submission of Matters to a Vote of Security Holders 32 PART II Item 5. Market for the Registrant's Common Equity and Related Stockholder Matters 32 Item 6. Selected Financial Data 36 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations _36 Item 7A. Quantitative and Qualitative Disclosure About Market Risk ___ 46 Item 8. Financial Statements and Supplementary Data 47 Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure 47 PART III Item 10. Directors and Executive Officers of the Registrant _ 47 Item 11. Executive Compensation 50 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 58 Item 13. Certain Relationships and Related Transactions 60 Item 14. Controls and Procedures 61 PART IV Item 15. Principal Accountant Fees and Services 61 Item 16. Exhibits, Financial Statement Schedules, and Reports on Form 8-K 61 SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS Certain statements in this Annual Report on Form 10-K (this "Form 10-K"), including statements under "Item 1. Business," "Item 3 Legal Proceedings" and "Item 7. Management's Discussion and Analysis of Financial Condition and Result of Operations," constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (collectively, the "Reform Act"). Certain, but not necessarily all, of such forward-looking statements can be identified by the use of forward-looking terminology such as "believes," "expects," "may," "will," "should," or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. All statements other than statements of historical fact included in this Form 10-K regarding our financial position, business strategy and plans or objectives for future operations are forward-looking statements. Without limiting the broader description of forward-looking statements above, we specifically note that statements regarding potential drugs, their potential therapeutic effect, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, market acceptance or our ability to earn a profit from sales or licenses of any drugs or our ability to discover new drugs in the future are all forward-looking in nature. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Hemispherx Biopharma, Inc. and its subsidiaries (collectively, the "Company", "we or "us") to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements and other factors referenced in this Form 10-K. We do 1 not undertake and specifically declines any obligation to publicly release the results of any revisions which may be made to any forward-looking statement to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events. PART I ITEM 1. Business. GENERAL We were founded in the early 1970s as a contract researcher for the National Institutes of Health (NIH). Dr. William A. Carter, M.D., joined the Company in 1976 and ultimately become its CEO in 1988. He has focused the Company on exploring, understanding and mastering the mechanism of nucleic acid technology to produce a promising new class of drugs for treating chronic viral diseases and disorders of the immune system. In the course of almost three decades, we have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids to enhance the natural antiviral defense system of the human body and the development of therapeutic products for the treatment of chronic diseases. Our strategy is to use our proprietary drug, Ampligen(R), to treat diseases for which adequate treatment is not available. We seek the required regulatory approvals which will allow the progressive introduction of Ampligen(R) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ("ME/CFS"), HIV, Hepatitis C ("HCV") and Hepatitis B ("HBV") in the U.S., Canada, Europe and Japan. Ampligen(R) is currently in phase III clinical trials in the U.S. for use in treatment of ME/CFS and is in Phase IIb clinical trials in the U.S. for the treatment of newly emerged multi-drug resistant HIV, and for the induction of cell mediated immunity in HIV patients that are under control using potentially toxic drug cocktails. In March, 2003, the Company acquired from Interferon Sciences Inc. ("ISI"), all of ISI's raw materials, work-in-progress and finished product of Alferon N Injection(R), together with a limited license for the production, manufacture, use, marketing and sale of the product. Alferon N Injection(R) [interferon alfa- n3 (human derived)] is a natural alpha interferon that has been approved by the U.S. Food and Drug Administration ("FDA") for commercial sale for the treatment of certain types of genital warts. We intend to market this product in the United State through sales facilitated via third party marketing agreements. Additionally, we intend to implement studies, beyond those conducted by ISI, for testing the potential treatment of HIV, Hepatitis C and other indications, including multiple sclerosis. This acquisition not withstanding, our primary focus remains the development to Ampligen(R) for treating ME/CFS and HIV diseases. In March, 2003, we entered into an agreement with ISI subject to certain events that would grant us global rights to sell Alferon N Injection(R) as well as acquire certain other assets of ISI which include but are not limited to real estate and property, plant and equipment. We outsource certain components of our research and development, manufacturing, marketing and distribution while maintaining control over the entire process through our quality assurance group and our clinical monitoring group. AMPLIGEN(R) Our proprietary drug technology Ampligen(R) utilizes specially configured ribonucleic acid ("RNA") and is protected by more than 350 patents worldwide with over 80 additional patent applications pending to provide further proprietary protection in various international markets. Certain patents apply to the use of Ampligen(R) alone and certain patents apply to the use of Ampligen(R) in combination with certain other drugs. Some composition of matter patents pertain to other new medications which have a similar mechanism of action. The main U.S. ME/CFS treatment patent (#6130206) expires January 23, 2015. Our main patents covering HIV treatment (#4795744,#4820696, #5063209, and #5091374) expire on August 26, 2006, September 30, 2008, August 10, 2010, respectively; Hepatitis treatment coverage is conveyed by U.S. patent #5593973 which expires on October 15, 2014. The U.S. Ampligen(R) Trademark (#1,515,099) expires on December 6, 2008 and can be renewed thereafter for an additional 10 years. The U.S. FDA has granted us "orphan drug status" for our nucleic acid-derived therapeutics for ME/CFS, HIV, and renal cell carcinoma and malignant melanoma. Orphan drug status grants the Company protection against competition for a period of seven years following FDA approval, as well as certain federal tax incentives, and other regulatory benefits. Nucleic acid compounds represent a potential new class of pharmaceutical products that are designed to act at the molecular level for treatment of human diseases. There are two forms of nucleic acids, DNA and RNA. DNA is a group of 2 naturally occurring molecules found in chromosomes, the cell's genetic machinery. RNA is a group of naturally occurring informational molecules which orchestrate a cell's behavior and which regulate the action of groups of cells, including the cells which comprise the body's immune system. RNA directs the production of proteins and regulates certain cell activities including the activation of an otherwise dormant cellular defense against virus and tumors. The Company's drug technology utilizes specially configured RNA. Our double-stranded RNA drug product, trademarked Ampligen(R), which is administered intravenously, is (or has been) in human clinical development for various disease indications, including treatment for ME/CFS, HIV, renal cell carcinoma and malignant melanoma. Further studies are planned in cancer but initiation dates have not been set. Based on the result of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen(R) may have broad-spectrum anti-viral and anti-cancer properties. Over 500 patients have received Ampligen(R) in clinical trials authorized by the FDA at over twenty clinical trial sites across the U.S., representing the administration of more than 45,000 doses of this drug. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) ME/CFS is a debilitating disease that is difficult to diagnose and for which, at present, there is no cure. People suffering from this illness experience, among other symptoms, a constant tiredness, recurring dull headaches, joint and muscle aches, a feeling of feverishness and chills low grade fever, depression, difficulty in concentrating on tasks, and tender lymph glands. With progression of the disease they can become bed-ridden, lose their jobs and become dependent upon the state for support and medical care. ME/CFS has been given official recognition by the U.S. Social Security Administration, and some European nations, rendering ME/CFS patients eligible for disability benefits and heightening awareness of this debilitating disease in the medical community. Further scientific publication by independent academicians on the accurate laboratory diagnosis of ME/CFS appeared in a peer-reviewed journal (American Journal of Medicine) in February 2000. The U.S. Centers of Disease Control ("CDC") reconfirmed its research commitment to ME/CFS following an audit by the U.S. Government Accounting Office ("GAO") which was announced July 28, 1999. Estimates of ME/CFS patient numbers in the Unites States range from a low of 500,000 (1995-Centers for Disease Control, Atlanta, GA) to a high of 1,000,000 (1999-DePaul University study). Estimates of patient numbers in Europe range from 600,000 to 2,200,000 as reported in the British Medical Journal in January 2000. It is believed worldwide patient totals may be as high as ten million. In 1989, we received FDA authorization to conduct a Phase II study of Ampligen(R) for ME/CFS. In 1991, we completed a 24-week, 92 patient, randomized, placebo-controlled, double-blinded, multi-center trial of Ampligen(R) for treating patients with ME/CFS. The results, published in a peer review journal in 1994, suggested enhanced physical performance, greater cognitive functions and improved ability to perform daily living activities. Patients required reduced hospitalization and medical care, while suffering little or no significant adverse side effects. The FDA raised certain issues with respect to this clinical trial which required further study. These issues were reviewed and satisfactorily resolved. 3 In February 1993, Hemispherx presented results of its Phase II study of Ampligen(R) for ME/CFS to a FDA Advisory Committee and these results were published in early 1994 in Clinical Infectious Diseases, a peer reviewed medical journal, which emphasizes the understanding and potential treatment of infectious diseases. The results suggested that patients on Ampligen(R), in contrast to those receiving a placebo, showed significant improvement in physical capacity as determined by performance on treadmill testing. The Ampligen(R) treated patient group also required less pain medication than did the placebo group. In late 1998, we were authorized by the FDA to initiate a Phase III multicenter, placebo-controlled, randomized, double blind clinical trial to treat 230 patients with ME/CFS in the U.S. The objective of this Phase III, clinical study, deemed as Amp 516, is to evaluate the safety and efficacy of Ampligen(R) as a treatment for ME/CFS. As of April 1, 2003 we have engaged the services of eleven (11) clinical investigators at Medical Centers in California, New Jersey, Florida, North Carolina, Wisconsin, Nevada, Illinois and Connecticut. These clinical investigators are medical doctors with special knowledge of ME/CFS who have recruited, prescreened and enrolled ME/CFS patients for inclusion in the Phase III Amp 516 ME/CFS clinical trial. This clinical trial now has over 230 ME/CFS patients participating. The patients complete a stage I, forty week, double-blind, randomized, placebo-controlled portion of the clinical trial and then move into the stage II or the open label treatment portion of the clinical trial. To date there have been no serious adverse events reported related to the study medication. Additional ME/CFS patients have been recruited by the clinical investigators to, in effect, over enroll the program. We expect to have in excess of the full enrollment in order to compensate for potential patient "drop outs", i.e.; patients that discontinue the program prematurely for various reasons. The next stage in our program is final data collection, quality assurance of data to insure its accuracy and analysis of the data according to regulatory guidelines to facilitate filing for commercial approval to sell. Human Immunodeficiency Virus (HIV) About fifteen antiviral drugs are currently approved by the FDA for the treatment of HIV infection. All target the specific HIV enzymes, reverse transcriptase ("RT") and protease. The use of various combinations of three or more of these drugs is often referred to as Highly Active Anti-Retroviral Therapy ("HAART"). HAART involves the utilization of several antiretrovirals with different mechanisms of action to decrease viral loads in HIV-infected patients. The goal of these combination treatments is to reduce the amount of HIV in the body ("viral load") to as low as possible. Treatments include different classes of drugs, but they all work by stopping parts of the virus so the virus cannot reproduce. Experience has shown that using combinations of drugs from different classes is a more effective strategy than using only one or two drugs. HAART has provided dramatic decreases in morbidity and mortality of HIV infection. Reduction of the viral load to undetectable levels in patients with wild type virus (i.e., non-drug-resistant virus)is routinely possible with the appropriate application of HAART. HIV mainly infects important immune system cells called CD4 cells. After HIV has infected a CD4 cell, the CD4 cell becomes damaged and is eventually destroyed. Fewer CD4 cells means more damage to the immune system and, ultimately, results in AIDS. Originally, reduction of HIV loads was seen as possibly allowing the reconstitution of the immune system and led to early speculation that HIV might be eliminated by HAART. 4 Subsequent experience has provided a more realistic view of HAART and the realization that chronic HIV suppression using HAART, as currently practiced, would require treatment for life with resulting significant cumulative toxicities. The various reverse transcriptase and protease inhibitor drugs that go into HAART have significantly reduced the morbidity and mortality connected with HIV; however there has been a significant cost due to drug toxicity. It is estimated that 50% of HIV deaths are from the toxicity of the drugs in HAART. Current estimates suggest that it would require as many as 60 years of HAART for elimination of HIV in the infected patient. Thus the toxicity of HAART drugs and the enormous cost of treatment makes this goal impractical. Although more potent second generation drugs are under development that target the reverse transcriptase and protease genes as well as new HIV targets, the problem of drug toxicities, the complex interactions between these drug classes, and the likelihood of life-long therapy will remain a serious drawback to their usage. Failure of antiretroviral therapies over time and the demonstration of resistance have stimulated intensive searches for appropriate combinations of agents, or sequential use of different agents, that act upon the same or different viral targets. This situation has created interest in our drug technology which operates by a different mechanism. We believe that the concept of Strategic Therapeutic Interruption ("STI") of HAART provides a unique opportunity to minimize the current deficiencies of HAART while retaining the HIV suppression capacities of HAART. STI is the cessation of HAART until HIV again becomes detectable (i.e., rebounds) followed by resumption of HAART with subsequent suppression of HIV. By re-institution of HAART, HIV is suppressed before it can inflict damage to the immune system of the patient. Based on recent publications (AIDS 2001,15: E19-27 and AIDS 2001, 15:1359-1368) in peer reviewed medical literature, it is expected that in just 30 days after stopping HAART approximately 80% to 90%, of the patients will suffer a relapse evidencing detectable levels of HIV. The Company believes that Ampligen(R) combined with the STI (strategic treatment interruption) approach may offer a unique opportunity to retain HAART's superb ability to suppress HIV while potentially minimizing its deficiencies. All present approved drugs block certain steps in the life cycles of HIV. None of these drugs address the immune system, as Ampligen(R) potentially does, although HIV is an immune-based disease. By using Ampligen(R) in combination with STI of HAART, we will undertake to boost the patients' own immune system's response to help them control their HIV when they are off of HAART. The Company's minimum expectation is that Ampligen(R) has potential to lengthen the HAART-free time interval with a resultant decrease in HAART-induced toxicities. The ultimate potential, which of course requires full clinical testing to accept or reject the hypothesis, is that Ampligen(R) may potentiate STI of HAART to the point that the cell mediated immune system will be sufficient to eliminate requirement for HAART. We plan to present the follow on clinical results of using our technology at several International AIDS Scientific Forums in 2003, including the VI International Viroteg Conference an Antiviral research in Savannah, Georgia in April 2003. Our AMP 720 HIV Clinical Trial is being conducted with individuals infected with HIV who are responding well to HAART at the moment. Patients in this study are required to meet minimum immune system requirements of CD4 cell levels greater than 400, maximum HIV infection levels of less that 50 copies/ml, and a 5 HAART regimen containing at least one anti-viral drug showing therapeutic synergy with Ampligen(R) based on recently reported ex vivo studies in peer-reviewed scientific journals. All patients are chronically HIV infected and will have been receiving the indicated HAART regimen prior to starting the STI. The trial applies strategic treatment interruption of HAART based on the hypothesis that careful management of HIV rebound following STI may have potential to result in the development of protective immune responses to HIV in order to achieve control of HIV replication. The Company believes that the addition of Ampligen(R), with its potential immunomodulatory properties, may reasonably achieve this outcome. Half of the participants in the trial are given 400 mg of Ampligen(R) twice a week and once they start the STI will remain off of HAART until such time as their HIV rebounds. The other half of the participants (the control group) are on STI, but they are given no Ampligen(R) during the "control" portion of the clinical test. The targeted enrollment in the AMP 720 Clinical Trial is 120 HIV-infected persons who meet the criteria. We expect to have 60 people on STI with Ampligen(R) and 60 people on STI without Ampligen(R). Presently, this study is approximately 35% enrolled at ten medical centers around the U.S. The Company expects enrollment in this clinical trial to accelerate as we recruit more investigators and based on the analysis and presentation of results in Prague, Czech Republic, Barcelona, Spain and Naples, FL (December, 2002). The length of this stage of the trial will be determined by an analysis of the interim results. Hepatitis C Virus (HCV) We currently have an informal arrangement with the California Institute of Molecular Medicine ("CIMM") to collaborate and assist their efforts to replicate human Kupffer's cells obtained from HCV infected patients. This proprietary CIMM approach involves the in vitro growth of hepatic macrophages (called Kupffer's cells) from the failing liver of a patient and reinfusion of the in vitro grown Kupffer's liver cells into the same patient. The ability to grow HCV in long term culture that would allow the testing of, potential anti-HCV drugs in vitro would permit us to conduct and obtain valuable research data in using Ampligen(R) to treat HCV prior to engaging and clinical trial. This would not raise the question of immunological incompatibility. Testing by CIMM indicates that their process of Kupffers's cell application in vitro is reproducible (>95% efficacy) from individual patients. CIMM is also developing a process for maintaining and propagating Kuffer's cells reproducibly in defined cell cultures from fine needle liver aspirates from living human volunteers with potential as patients with failing liver due to a variety of etiologies. In January 2001 CIMM filed a notice of Invention with the U.S. patent office. As a result, a patent titled "Replication of Human Kupffer's cell obtained from HCV infected patients by Fine Needle Biopsy Technique" was issued. This method can potentially salvage critically needed liver function without major surgery or aggressive medical intervention. The immediate and potential market for the Kupffer's maintenance and propagation techniques will be more than 14,000 people in the U.S. actively seeking a liver transplant. Additional thousands are progressing towards a failing liver and will soon need transplantation or a successful alternative method to restore function. Several hundred thousand who have alcoholic cirrhosis may also benefit from the proprietary process. Medical costs of a liver transplant are approximately $300,000 and are far beyond the financial reserves of most families. Reimbursement of these costs by Health Insurance carriers is problematic at best. We have a 30% equity position in CIMM, which is located in California and recently opened a new state-of-the-art research laboratory in Ventura, California. 6 We are also evaluating potential novel clinical programs which would involve using Ampligen(R) to treat both HCV and HIV when they coexist on the same patient. We expect to commence these studies in collaboration with one or more prospective corporate partners. A collaborative Clinical study in Europe, in conjunction with Laboratorios Del Dr. Esteve S.A., is expected to commence during the first half of 2003. We have acquired a series of patents on Oragen(TM), potentially an oral broad spectrum antiviral, Immunological enhancers through a licensing agreement with Temple University. We were granted an exclusive worldwide license from Temple for the Oragen(TM) products. Pursuant to the arrangement, we are obligated to pay royalties of 2% on sales of Oragen(TM), depending on how much technological assistance is required of Temple. We currently pay minimum royalties of $30,000 per year to Temple. These compounds have been evaluated in various academic and government laboratories for application to Chronic viral and immunological disorders. Research and development of Oragen(TM) is on hold at this time. Other Diseases An FDA authorized Phase I/II study of Ampligen(R) in cancer including patients with renal cell carcinoma was completed in 1994. The results of this study indicated that patients receiving high doses (200-500mg) twice weekly experienced an increase in medium survival compared to the low dose group and as compared to an historical control group. We received authorization from the FDA to initiate a phase II study using Ampligen(R) to treat patients with metastatic renal cell carcinoma. Patients with Metastatic Melanoma were included in the Phase I/II study of Ampligen(R) in cancer. The FDA has authorized us to conduct a Phase II clinical trial using Ampligen(R) in melanoma. We do not expect to devote any significant resources to funding these studies in the near future. Other Antiviral/ Immunologic Treatments After the terrorist acts of September 11, 2001 and the resultant International concern for bio-terrorism (including Smallpox), we filed a regulatory application with the FDA for permission to conduct a clinical trial, in the event of Smallpox dissemination, using Ampligen(R) therapy as a treatment. This proposed study was based on an earlier peer reviewed laboratory study from Yale University in Partnership with the U.S. Military Command at Fort Detrick, the U.S. Biological defense Specialty Research Center. The result of this study indicated Ampligen(R) to be promising in a laboratory model of smallpox. Based on these and other recent positive results (see below), we have retained FDA regulatory counsel in Wash., D.C. , to advise us on a commercialization path and to arrange relevant meetings with the FDA. During the thirty day review period of our Clinical application by the FDA, we became aware of a new ongoing laboratory study of Ampligen(R) in smallpox at the Riga Medical Institute in Belgium. Our Medical Director had authorized the Institute to use samples of Ampligen(R) for Research purposes only. The result of this study became available in the early 2003. In the interim, we withdrew our FDA application to review the result of the Belgium study and incorporate such data into our Clinical study design and protocol before resubmission. Positive new results on Ampligen(R) were thereafter reported by branches of the U.S. government using animal models of smallpox and new guidelines on bio-terrorism approvals were established which mandated only animal studies for full commercialization. 7 ALFERON N INJECTION(R) Interferon is a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. The ALFERON N Injection product contains a multi-species form of alpha interferon. The worldwide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. In the United States, all three of these types of alpha interferon are approved for commercial sale. Our Natural Alpha Interferon is produced from human white blood cells. The potential advantages of Natural Alpha Interferon over recombinant interferon may be based upon their respective molecular compositions. Natural Interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, recombinant alpha interferon each contain only a single species. Researchers have reported that the various species of interferon may have differing antiviral activity depending upon the type of virus. Natural Alpha Interferon presents a broad complement of species which the Company believes may account for its higher efficacy in laboratory studies. Natural Alpha Interferon is also glycosylated (partially covered with sugar molecules). Such glycosylation is not present on the currently marketed recombinant alpha interferons. The Company believes that the absence of glycosylation may be, in part, responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from the Company's Natural Alpha Interferon. On October 10, 1989, the FDA approved ALFERON N Injection for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Certain types of human papillomaviruses ("HPV") cause genital warts, a sexually transmitted disease ("STD"). A published report estimates that approximately eight million new and recurrent causes of genital warts occur annually in the United States alone. Basically, our interest in acquiring Alferon N was driven by two factors; 1) our belief that its use in combination with Ampligen(R) has the potential to increase the positive therapeutic responses in chronic life threatening viral diseases. Combinational therapy is evolving to the standard of acceptable medical care based on a detailed examination of the Biochemistry of the body's natural antiviral immune response; and 2) new knowledge about the competitive products in the Interferon arena that we believe imply a large untapped market and potential new therapeutic indication for Alferon N which could accelerate its revenues in the near term. Specifically, the recombinative DNA derived alpha interferon are now reported to have dramatically decreased effectiveness after one year, probably due to antibody formation and other severe toxicities. These detrimental effects have not been reported with Alferon N which could allow this product to assume a much 8 larger market share. These revenues would provide operational capital to complete the Phase III Clinical trials of our experimental drug, Ampligen(R) in a more cost effective, non-dilutive manner on a shareholder's equity. Alferon N Injection(R) [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multispecies alpha interferon product. There are essentially no antibodies observed against natural interferon to date and the product has a relatively low side-effect profile. Alferon is the only natural-source, multispecies alpha interferon currently sold in the U.S. and is also approved for sale in Mexico, Germany, Singapore and Hong-Kong. The Alferon targeted market consists of urologists, proctologists, dermatologists, and Obstetricians/Gynecologists. These physicians normally see patients with papilloma concondylomas (genital warts) in their practice. This will be done in existing partnership with our strategic partners including Gentiva Health Services, Biovail Corporation and Esteve Laboratories, all have proven marketing expertise. According to the NIH, there are one million new cases of venereal warts every year. Pipeline products (alpha interferon) The following products, together with other assets are to be acquired upon the closing of the second ISI agreement which is anticipated to occur in May 2003. ALFERON N Injection(R) -Other applications ALFERON N Injection(R) [Interferon alfa-n3 (human leukocyte derived)] has been approved by the U.S. FDA for the treatment of certain types of genital warts and has been studied for the potential treatment of HIV, Hepatitis C and other indications. ISI, the Company from which we obtained our rights to ALFERON N Injection(R) had conducted clinical trials with regard to the use of ALFERON N Injection(R) in the treatment of HIV and Hepatitis C. While ISI found the results to be encouraging, in both instances, the FDA determined that additional trials were necessary. ALFERON N Gel(R) ALFERON N GEL(R) is the Company's registered trademark for its topical (dermatological) Natural Alpha Interferon preparation in a hydrophilic gel base. This product is still in research and development. ALFERON LDO(R) ALFERON LDO(R) is the registered trademark for the low-dose, oral liquid formulation of Natural Alpha Interferon. Two Phase 2 clinical trials using ALFERON LDO for the treatment of HIV-infected patients have been completed. There can be no assurance that any of these proposed products will be cost-effective, safe, and effective or that the Company will be able to obtain FDA approval for such use. Furthermore, even if such approval is obtained, there can be no assurance that such products will be commercially successful or will produce significant revenues or profits for the Company. 9 EUROPEAN OPERATIONS Our European operations were setup to prepare for the introduction of Hemispherx products and to accelerate market penetration into the European market once full approval is obtained from the European Medicine Evaluation Agency ("EMEA"). The EMEA is the equivalent of the United States FDA. From a regulatory point of view the member countries of the European Economic Union ("EEU") represent a common market under the jurisdiction of the EMEA. However, from a practical point of view, every country is different regarding developing relations with the medical community, patient associations and obtaining reimbursement for treatment from the equivalent of Social Security Agencies and insurance carriers. This program will be integrated into our new commercial asset, ALFERON N Injection, as well. Our European operations have assisted the growth of a number of patient/physician educational associations. The French Chronic Fatigue Syndrome Association has grown from 10 members in the year 2000 to 800 currently. Every major country now has an active educational association with substantial numbers of members who regularly meet and "network". These programs have been modeled on the successful experience in the U.S. of conducting twice a year meetings on ME/CFS with Health and Human Services, FDA, NIH and Centers for Disease Control. We maintain contact with the EMEA, keeping the agency aware of our activities, as well as the health ministries in numerous countries in the European Union. In early 2001,our application for "orphan" drug status for the use of Ampligen(R) in ME/CFS was rejected because the Board found that the prevalence of ME/CFS was significantly above the 5 person per 10,000 limit required to grant orphan drug status in the European Union. In addition, we are exploring various ways to accelerate the commercial availability of our products in the various nations of the EEU, including potential appreciation of the "foreign import" rule for accepting products already approved in the U.S. Limited number ME/CFS patients were treated during 2002 with Ampligen(R) in the United Kingdom, Austria and Belgium under existing regulatory procedures in these countries which allow the therapeutic use of an experimental drug under certain conditions. These procedures allowed us to recover the cost of Ampligen(R) used as well as to collect additional clinical data. Corresponding procedures are being considered in several other countries at the request of locally based physicians. Our European operations are considering implementing clinical trials in Europe for the use of Ampligen(R) in the treatment of HIV/AIDS on the basis of the new U.S. Protocols involving the use of the drug either in combination with "cocktail" therapies or as part of a strategic interruption of the "cocktail" therapies. We plan to present these programs at European scientific conferences in 2003. The Efforts of our European Operation has started to produce results. In March 2002, our European Subsidiary Hemispherx Biopharma Europe, S.A. ("Hemispherx, S.A.") entered into a Sales and Distribution agreement with Laboratorios Del Dr. Esteve S.A. ("Esteve"). Pursuant to the terms of the agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra ("Territory") for the treatment of ME/CFS. In addition to other terms and other projected payments, Esteve paid an initial and non-refundable fee of 625,000 Euros (approximately $563,000) to Hemispherx S.A. on April 24, 2002 Esteve is to pay a fee of 1,000,000 Euros after U.S. Food and Drug Administration approval of Ampligen(R) for the treatment of ME/CFS and a fee of 10 1,000,000 Euros upon Spain's approval of the final marketing authorization for using Ampligen(R) for the treatment of ME/CFS. The agreement runs for the longer of 10 years from the date of first arms-length sale in the Territory, the expiration of the last Hemispherx patent exploited by Esteve or the period of regulatory data protection for Ampligen(R) in the applicable territory. Pursuant to the terms of the agreement Esteve is to conduct clinical trials using Ampligen(R) to treat patients with both HCV and HIV and is required to purchase certain minimum annual amounts of Ampligen(R). The agreement is terminable by either party if Ampligen(R) is withdrawn form the territory for a specified period due to serious adverse health or safety reasons; bankruptcy, insolvency or related issues of one of the parties; or material breach of the agreement. Hemispherx may transform the agreement into a non-exclusive agreement or terminate the agreement in the event that Esteve does not meet specified percentages of its annual minimum purchase requirements under the agreement. Esteve may terminate the agreement in the event that Hemispherx fails to supply Ampligen(R) to the territory for a specified period of time or certain clinical trials being conducted by Hemispherx are not successful. MANUFACTURING We outsource the manufacturing of Ampligen(R) to certain contractor facilities in the United States and South Africa while maintaining full quality control and supervision of the process. Nucleic Acid polymers constitute the raw material used in the production of Ampligen(R). We acquire our raw materials from Ribotech, Ltd. ("Ribotech') located in South Africa. Ribotech, is jointly owned by us (24.9%) and Bioclones, proprietary, Ltd (75.1%). Bioclones manages and operates Ribotech. Two manufacturers in the United States are available to provide the polymers if Ribotech is unable to supply our needs. Sourcing our needs from other suppliers could result in a cost increase for our raw materials. Until 1999, we distributed Ampligen(R) in the form of a freeze-dried powder to be formulated by pharmacists at the site of use. We perfected a production process to produce ready to use liquid Ampligen(R) in a dosage form which will mainly be used upon commercial approval of Ampligen(R). At the present time, we have engaged the services of Schering-Plough Products to mass produce ready-to-use Ampligen(R) doses. There are other pharmaceutical processing companies that can supply our production needs. Bioclones (PTY) Ltd. has also successfully completed a series of production runs for liquid Ampligen(R) doses. This was done at Ribotech's facility in South Africa that has inspection approval by both the US FDA and the Medicine Control Authority of the United Kingdom. Bioclones (PTY) Ltd. Is headquartered in South Africa and is the majority owner in Ribotech, Ltd. (the Company owns 24.9%) which produces most of the polymers used in manufacturing Ampligen(R). The licensing agreement with Bioclones presently includes South Africa, South America, Ireland, New Zealand and the United Kingdom. We currently occupy and use the New Brunswick, New Jersey laboratory and production facility owned by ISI. We are in the process of acquiring title to these facilities pursuant to our second asset acquisition agreement with ISI (see RECENT FINANCING AND ASSET ACQUISITIONS below for more details). This facility is approved by the FDA for the manufacture of Alferon N. 11 All production facilities employ Good Manufacturing Practices.(EGMP) Good Manufacturing Practices (GMP) require that a product be consistently manufactured to an identical potency (strength) and purity with each lot, and that the manufacturing facility itself and all the equipment therein, be certified to operate within a strict set performance standards. MARKETING/DISTRIBUTIONS Our marketing strategy for Ampligen(R) reflects the differing health care systems around the world, and the different marketing and distribution system that are used to supply pharmaceutical products to those systems. In the United States, we expect that, subject to receipt of regulatory approval, Ampligen(R) will be utilized in three medical arenas: physicians' offices, clinics, hospitals and the home treatment setting. We currently plan to use a service provide in the home infusion (non-hospital) segment of the U.S. market to execute direct marketing activities, conduct physical distribution of product and handle billing and collections. Accordingly, we are developing marketing plans to facilitate the product distribution and medical support for indication, if and when they are approved, in each arena. We believe that this approach will facilitate the generation of revenue without incurring the substantial costs associated with a sales forces. Furthermore, management believes that the approach will enable us to retain many options for future marketing strategies. In February 1998, the Company and Gentiva Health Services (formerly Olstein Heatlh services) entered into a distribution/specialty agreement for the distribution of Ampligen(R) for the treatment of ME/CFS patients under the U.S. treatment protocols. In Europe, we plan to adopt a country-by-country and, in certain cases, an indication-by-indication marketing strategy due to the heterogeneity regulation and alternative distribution systems in these area. We also plan to adopt and indication-by-indication strategy in Japan. Subject to receipt of regulatory approval, we plan to seek strategic partnering arrangement with pharmaceutical companies to facilitate introductions in these areas. The relative prevalence of people from target indications for Ampligen(R) varies significantly by geographic region, and we intend to adjust our clinical and marketing planning to reflect the special of each area. In countries in South America, the United Kingdom, Ireland, Africa, Australia, Tasmania, New Zealand, and certain other countries and territories, we contemplate marketing our product through our relationship with Bioclones pursuant to the Bioclones Agreement. Our marketing and distribution plan for Alferon N is focused on increasing the sales of Alferon N Injection for the intralesional treatment of refractory and recurring external genital warts in adults. We will reach out to a targeted audience of physicians consisting of Ob/GYNSs, Urologists, Proctologists and Dermatologists and simultaneously create product awareness in the patient population through several media and health organizations. Different regional meetings and seminars are scheduled during which guest speakers will explain the therapeutic benefits and safety profile of Alferon. Additional exposure will be created by exhibiting at several STD related conferences, expanded web presence, mailings and publications. We also plan to engage a contact sales organization in order to build up a nationwide network of dedicated representatives in the U.S. and Europe. This will be done while working with our strategic partners including Gentiva Health Services, Biovail Corporation an Esteve Laboratories. For more information about our arrangements with Gentiva Health Services, Bioclones, Esteve and Biovail see below."RESEARCH AND DEVELOPMENT/COLLABORATIVE AGREEMENTS" 12 COMPETITION Our potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we have. These companies and their competing products may be more effective and less costly than our products. In addition, conventional drug therapy, surgery and other more familiar treatments will offer competition to our products. Furthermore, our competitors have significantly greater experience than we in preclinical testing and human clinical trials of pharmaceutical products and in obtaining FDA, EMEA Health Protection Branch ("HPB") and other regulatory approvals of products. Accordingly, our competitors may succeed in obtaining FDA EMEA and HPB product approvals more rapidly than us. If any of our products receive regulatory approvals and we commence commercial sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have no experience. Our competitors may possess or obtain patent protection or other intellectual property rights that prevent, limit or otherwise adversely affect our ability to develop or exploit our products. The major competitors with drugs to treat HIV diseases include "Gilead Pharmaceutical, Pfizer, Bristol-Myers, Abbott Labs and Schering-Plough Corp. ("Schering"). ALFERON N Injection currently competes with a product produced by Schering for treating genital warts. 3m Pharmaceutical also has received FDA approval for its immune response modifier product for the treatment of genital and perianal warts. GOVERNMENT REGULATION Regulation by governmental authorities in the U.S. and foreign countries is and will be a significant factor in the manufacture and marketing of ALFERON N products and our ongoing research and product development activities. Ampligen(R) and the products developed from the ongoing research and product development activities will require regulatory clearances prior to commercialization. In particular, human new drug products for human are subject to rigorous preclinical and clinical testing as a condition for clearances by the FDA and by similar authorities in foreign countries. The lengthy process of seeking these approvals, and the ongoing process of compliance with applicable statutes and regulations, has required and will continue to require the expenditure of substantial resources. Any failure by us or our collaborators or licensees to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect the marketing of any products developed by the Company and its ability to receive product or royalty revenue. We have received orphan drug designation for certain therapeutic indications which might, under certain conditions, accelerate the process of drug commercialization. ALFERON N is only approved for use in treating genital warts. Use of Alferon N for other applications requires regulatory approval. A "Fast-Track" designation by the FDA, while not affecting any clinical development time per se, has the potential effect of reducing the regulatory 13 review time by 50 percent (50%)from the time that a commercial drug application is actually submitted for final regulatory review. Regulatory agencies may apply a "Fast Track" designation to a potential new drug to accelerate the approval and commercialization process. Criteria for "Fast Track" include: a) a devastating disease without adequate therapy and b) laboratory or clinical evidence that the candidate drug may address the unmet medical need. As of March 31, 2003, we have not received a Fast-Track designation for any of our potential therapeutic indications although we have received "Orphan Drug Designation" for both ME/CFS and HIV/AIDS in the United States. We will continue to present data from time to time in support of obtaining accelerated review. We have not yet submitted any New Drug Application (NDA) for Ampligen(R) or any other drug to a North American regulatory authority. There are no assurances that such designation will be granted, or if granted, there are no assurances that Fast Track designation will materially increase the prospect of a successful commercial application. In 2000 we submitted an emergency treatment protocol for clinically-resistant HIV patients which was withdrawn by us during the statutory 30 day regulatory review period in favor of a set of individual physician-generated applications. There are no assurances that authorizations to commence such treatments will be granted by any regulatory authority or that the resultant treatments, if any, will support drug efficacy and safety. In 2001, we did receive FDA authorization for two separate Phase IIb HIV treatment protocols in which the Company's drug is combined with certain presently available antiretroviral agents. Interim results were presented in 2002 at various international scientific meetings. We are subject to various federal, state and local laws, regulations and recommendations relating to such matters as safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use of and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work. We believe that our Rockville, Maryland manufacturing and quality assurance/control facility is in substantial compliance with all material regulations applicable to these activities as advanced by European Union Inspections team which conducted detailed audits in year 2000. However, we cannot give assurances that facilities owned and operated by third parties, that are utilized in the manufacture of our products, are in substantial compliance, or if presently in substantial compliance, will remain so. These third party facilities include manufacturing operations in San Juan, Puerto Rico; Capetown, South Africa; Columbia, Maryland; Melbourne, Australia; and potential expansion within the United States to new and larger facilities in 2003. RESEARCH AND DEVELOPMENT/COLLABORATIVE AGREEMENTS In 1994, we entered into a licensing agreement with Bioclones (Property) limited ("Bioclones") for manufacturing and international market development in Africa, Australia, New Zealand, Tasmania, the United Kingdom, Ireland and certain countries in South Africa, of Ampligen(R) and Oragen(TM). Bioclones is to pursue regulatory approval in the areas of its franchise and is required to conduct Hepatitis clinical trials, based on international GMP and GLP standards. Thus far, these Hepatitis studies have not yet commenced to a meaningful level. Bioclones has been given the first right of refusal, subject to pricing, to manufacture that amount of polamers utilized in the production of Ampligen(R) sufficient to satisfy at least one-third of the worldwide sales requirement of Ampligen(R) and other nucleic acid-derived drugs. Pursuant to this arrangement, we received 1)access to worldwide markets 2)commercial-scale manufacturing resources, 3)a $3 million cash payment in 1995 from Bioclones,4) a 24.9% ownership in Ribotech, 14 Ltd. a company set up by Bioclones to develop and manufacture RNA drug compounds, and 5) royalties of 8% on Bioclones nucleic acid-derived drug sales in the licensed territories. The agreement with Bioclones terminates three years after the expiration of the last of the patents supporting the license granted to Bioclones, subject to earlier termination by the parties for uncured defaults under the agreement, or bankruptcy or insolvency of either party. In August, 1998, we entered into a strategic alliance with Gentiva Health Services (formerly known as Olsten Health Care Services) to develop certain marketing and distribution capacity for Ampligen(R) in the United States. Gentiva is one of the nation's largest home health care companies with over 400 offices and sixty thousand caregivers nationwide. Pursuant to the agreement, Gentiva assumed certain responsibilities for distribution of Ampligen(R) for which they receive a fee. Through this arrangement, Hemispherx may mitigate the necessity of incurring certain up-front costs. Gentiva also works with us in connection with the Amp 511 ME/CFS cost recovery treatment program, Amp 516 ME/CFS PHASE III clinical trial and the Amp 719(combining Ampligen with other antiviral drugs in HIV-salvage therapy and Amp 720 HIV Phase IIb clinical trials now under way. There can be no assurances that this alliance will develop a significant commercial position in any of its targeted chronic disease markets. The agreement had an initial one year term from February 9, 1998 with successive additional one (1) year terms unless either party notifies the other not less than one hundred eighty (180) days prior to the anniversary date of its intent to terminate the agreement. Also, the agreement may be terminated for the uncured defaults, or bankruptcy or insolvency of either party and will automatically terminate upon our receiving New Drug Approval for Ampligen(R) from the FDA, at which time, a new agreement will need to be negotiated with Gentiva or another major drug distributor. We have acquired a series of patents on Oragen(TM), potentially an oral broad spectrum antiviral, Immunological enhancers through a licensing agreement with Temple University. We were granted an exclusive worldwide license from Temple for the Oragen(TM) products. Pursuant to the arrangement, we are obligated to pay royalties of 2% to 4% on sales of Oragen(TM), depending on how much technological assistance is required of Temple. We currently pay minimum royalties of $30,000 per year to Temple. These compounds have been evaluated in various academic and government laboratories for application to Chronic viral and immunological disorders. This agreement is to remain in effect until the date that the last licensed patent expires unless terminated sooner by mutual consent or default due to royalties not being paid. In December, 1999, we entered into an agreement with Biovail Corporation International ("Biovail"). Biovail is an international full service pharmaceutical company engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery systems. Biovail is headquartered in Toronto, Canada. The agreement grants Biovail the exclusive distributorship of our product in the Canadian territories subject to certain terms and conditions. In return, Biovail agrees to conduct certain pre-marketing clinical studies and market development programs, including without limitation, expansion of the Emergency Drug Release Program in Canada with respect to our products. In addition, Biovail agrees to work with us in preparing and filing a New Drug Submission with Canadian Regulatory Authorities. Biovail invested several million dollars in Hemispherx equity at prices above the then current market price and agreed to make further payments based on reaching certain regulatory milestones. The Agreement requires Biovail to buy exclusively from us and penetrate certain market segments at specific 15 rates in order to maintain market exclusivity. The agreement terminates on December 15, 2009, subject to successive two (2) year extensions by the parties and subject to earlier termination by the parties for uncured defaults under the agreement, bankruptcy or insolvency of either party, or withdrawal of our product from Canada for a period of more than ninety (90) days for serious adverse health or safety reasons. In 1998, the Company invested $1,074,000 for a 3.3% equity interest in R.E.D. Laboratory ("R.E.D."). R.E.D. is a privately held biotechnology company for the development of diagnostic markers for Chronic Fatigue Syndrome and other chronic immune diseases. Primarily, R.E.D.'s research and development is based on certain technology owned by Temple University and licensed to R.E.D. We have a research collaboration agreement with R.E.D. to assist in this development. R.E.D. is headquartered in Belgium. The investment was recorded at cost in 1998. During three months ended June 2002 and December 2002 respectively, we recorded a non-cash charge of $678,000 and $396,000 respectively, to operations with respect to our investment in R.E.D. These charges were the result of our determination that R.E.D.'s business and financial position had deteriorated to the point that our investment had been permanently impaired. In May 2000, we acquired an interest in Chronix Biomedical Corp. ("CHRONIX"). Chronix focuses upon the development of diagnostics for chronic diseases. We issued 100,000 shares of common stock to Chronix toward a total equity investment of $700,000. Pursuant to a strategic alliance agreement, we provided Chronix with $250,000 to conduct research in an effort to develop intellectual property on potential new products for diagnosing and treating various chronic illnesses such as ME/CFS. The strategic alliance agreement provides us certain royalty rights with respect to certain diagnostic technology developed from this research and a right of first refusal to license certain therapeutic technology developed from this research. The strategic alliance agreement provides us with a royalty payment of ten per cent (10%) of all net sales of diagnostic technology developed by Chronix for diagnosing Chronic Fatigue Syndrome, Gulf War Syndrome and Human Herpes Virus-6 associated diseases. The royalty continues for the longer of twelve years from September 15, 2000 or the life of any patent(s) issued with regard to the diagnostic technology. The strategic alliance agreement also provides us with the right of first refusal to acquire an exclusive worldwide license for any and all therapeutic technology developed by Chronix on or before September 14, 2012 for treating Chronic Fatigue Syndrome, Gulf War Syndrome and Human Herpes Virus-6 associated. During the quarter ended December 31, 2002, we recorded a noncash charge of $292,000 with respect to our investment in Chronix. This impairment reduces our carrying value to reflect a permanent decline in Chronix's market value based on their current proposed equity offerings. In April, 1999 we acquired a 30% equity position in the California Institute of Molecular Medicine ("CIMM") for $750,000. CIMM'S research is focused on developing therapies for use in treating patients affected by Hepatitis C ("HCV"). We use the equity method of accounting with respect to this investment. During the fourth quarter of 2001 we recorded a non-cash charge of $485,000 with respect to our investment in CIMM. This was a result of our determination that CIMM's operations have not yet evolved to the point where the full carrying value of our investment could be supported based on that company's financial position and operating results. The amount represented the unamortized balance of goodwill included as part of our investment. During 2002, we wrote down to zero our remaining investment based on that company's continuing operating losses. These charges are reflected in the Consolidated Statements of 16 Operations under the caption "Equity loss in unconsolidated affiliate".We still believe CIMM will succeed in their efforts to advance therapeutic treatment of HCV. We believe that CIMM's Hepatitis C diagnostic technology has great promise and will fill a long-standing global void in the collective abilities to diagnose and treat Hepatitis C infection at an early stage of the disorder. In March 2002, our European subsidiary Hemispherx S.A. entered into a Sales and Distribution agreement with Esteve. Pursuant to the terms of the agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of ME/CFS. In addition to other terms and other projected payments, Esteve agreed to conduct certain clinical trials using Ampligen(R) in the patient population coinfected with hepatitis C and HIV viruses. The agreement runs for the longer of 10 years from the date of first arms-length sale in the Territory, the expiration of the last Hemispherx patent exploited by Esteve or the period of regulatory data protection for Ampligen(R) in the applicable territory. Pursuant to the terms of the agreement Esteve is to conduct clinical trials using Ampligen(R) to treat patients with both HCV and HIV and is required to purchase certain minimum annual amounts of Ampligen(R). The agreement is terminable by either party if Ampligen(R) is withdrawn form the territory for a specified period due to serious adverse health or safety reasons; bankruptcy, insolvency or related issues of one of the parties; or material breach of the agreement. Hemispherx may transform the agreement into a non-exclusive agreement or terminate the agreement in the event that Esteve does not meet specified percentages of its annual minimum purchase requirements under the agreement. Esteve may terminate the agreement in the event that Hemispherx fails to supply Ampligen(R) to the territory for a specified period of time or certain clinical trials being conducted by Hemispherx are not successful. The development of our Nucleic Acid Based products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market and to establish commercial-scale production and marketing capabilities. During our last three fiscal years, we have directly spent approximately $16,862,000 in research and development, of which approximately $4,946,000 was expended in the year ended December 31, 2002. These direct costs do not include the overhead and administrative costs necessary to support the research and development effort. Our European subsidiary has an exclusive license on all the technology and support from us concerning Ampligen(R) for the use of ME/CFS and other applications for all countries of the European Union (excluding the UK where Bioclones has a marketing license) and Norway, Switzerland, Hungary, Poland, the Balkans, Russia, Ukraine, Romania, Bulgaria, Slovakia, Turkey, Iceland and Liechtenstein. As mentioned above, Hemispherx S.A. entered into a Sales and distribution Agreement with Esteve. Pursuant to the terms of this agreement, Esteve has been granted the exclusive right in Spain, Portugal and Andorra to market Ampligen(R) for the treatment of ME/CFS. See "EUROPEAN OPERATIONS" above for more detailed information. HUMAN RESOURCES As of March 31, 2003 we had 40 personnel working on the development of Ampligen(R) consisting of 19 full time, 3 part-time employees and 18 regulatory/research medical personnel on a part-time basis. Part time parties are paid on a per diem or monthly basis. 30 personnel are engaged in our research, development, clinical, manufacturing effort. Ten of our personnel perform regulatory, general administration, data processing, including bio-statistics, financial and investor relations functions. 17 In addition to the foregoing personnel, on March 11, 2003, pursuant to our agreement with ISI, we added personnel from ISI to our payroll consisting of 12 part-time and 17 full-time employees. We believe that the combination of Hemispherx and ISI Scientific employees has 1) significantly strengthened our overall organization, 2) added expertise to monitor and complete our ongoing clinical trials and 3) improved our data management and system administration. While we have been successful in attracting skilled and experienced scientific personnel, there can be no assurance that the Company will be able to attract or retain the necessary qualified employees and/or consultants in the future. RECENT FINANCING AND ASSET ACQUISITIONS On March 12, 2003, We issued an aggregate of $5,426,000 in principal amount of 6% Senior Convertible Debentures due January 31, 2005 and an aggregate of 743,288 Warrants to two investors in a private placement for aggregate anticipated gross proceeds of $4,650,000. Pursuant to the terms of the Debentures, $1,550,000 of the proceeds from the sale of the Debentures have been held back and will be released to us if, and only if, we acquire ISI's facility with in a set timeframe (see the discussion below). The Debentures mature on January 31, 2005 and bear interest at 6% per annum, payable quarterly in cash or, subject to satisfaction of certain conditions, common stock. Any shares of common stock issued to the investors as payment of interest shall be valued at 95% of the average closing price of the common stock during the five consecutive business days ending on the third business day immediately preceding the applicable interest payment date. Pursuant to the terms and conditions of the Senior Convertible Debentures, we have pledged all of our assets other than intellectual property, as collateral and are subject to comply with certain financial and negative covenants, which include but are not limited to the repayment of principal balances upon achieving certain revenue milestone. The Debentures are convertible at the option of the investors at any time through January 31, 2005 into shares of our common stock. The conversion price under the Debentures is fixed at $1.46 per share, subject to adjustment for anti-dilution protection for issuance of common stock or securities convertible or exchangeable into common stock at a price less than the conversion price then in effect. The investors also received Warrants to acquire at any time through March 12, 2008 an aggregate of 743,288 shares of common stock at a price of $1.68 per share. On March 12, 2004, the exercise price of the Warrants will reset to the lesser of the exercise price then in effect or a price equal to the average of the daily price of the common stock between March 13, 2003 and March 11, 2004 (but in no event less than $1.176 per share). The exercise price (and the reset price) under the Warrants also is subject to similar adjustments for anti-dilution protection. We entered into a registration rights agreement with the investors in connection with the issuance of the Debentures and the Warrants. The registration rights agreement requires that we register the shares of common stock issuable upon conversion of the Debentures, as interest shares under the Debenture and upon exercise of the Warrants. In accordance with this agreement, we filed a registration statement on form S-3 with the Securities and Exchange 18 Commission. If the registration statement is not declared effective within the time period required by the agreement or, after it is declared effective and subject to certain exceptions, sales of all shares required to be registered thereon cannot be made pursuant thereto, then we will be required to pay to the investors their pro rata share of $3,635 for each day any of the above conditions exist with respect to this registration statement. On March 11, 2003, we executed two agreements with ISI to purchase certain assets of ISI. In the first agreement with ISI, the Company acquired ISI's inventory of ALFERON N Injection(R), and a limited license for the production, manufacture, use, marketing and sale of this product. For these assets, the Company: (i) issued 487,028 shares of its common stock; and (ii) agreed to pay ISI 6 % of the net sales of the Product. The Company also is required to pay ISI a service fee and pay certain of ISI's obligations related to the product. In the second agreement with ISI, ISI has agreed to sell to the Company all of ISI's rights to the product and other assets related to the product including, but not limited to, real estate and machinery. For these assets, the Company will: (i) issue an additional 487,028 shares of its common stock; and (ii) continue to pay ISI 6 % of the net sales of the product. In addition, the Company will be required to satisfy three obligations of ISI. The Company will satisfy two of these obligations, pursuant to forbearance agreements with The American National Red Cross and GP Strategies Corporation, two of ISI's creditors, by issuing an aggregate of 581,761 shares of common stock to these creditors. The third obligation is approximately $521,000 and is secured by a lien on the property. Pursuant to the agreements with ISI and its creditors, the Company is in the process of registering the foregoing shares issued and to be issued to ISI and its creditors for public sale in the registration statement on form S-3 mentioned above. Except for 125,000 of the shares issued and to be issued to ISI, the Company has guaranteed the market value of the shares retained by ISI and the two creditors through March 11, 2005 to be $1.59 per share. ISI and the creditors are permitted to periodically sell certain amounts of their shares. We will account for these transactions as a Business Combination under Statement of Financial Accounting Standards ("SFAS") No. 141 Accounting for Business Combinations. During March 2002, Hemispherx Biopharma Europe, S.A., our Luxembourg subsidiary, was authorized to issue up to 22,000,000 Euros of seven percent (7%) convertible preferred securities. Such securities will be guaranteed by the Company and will be converted into a specified number of shares pursuant to the securities agreement. Conversion is to occur on the earlier of an initial public offering of Hemispherx S.A. on a European stock exchange or September 30, 2003. On March 13, 2003, we issued 347,445 shares of our common stock to Provesan 19 SA, an affiliate of Esteve, in exchange for 1,000,000 Euros of convertible preferred equity certificates of Hemispherx Biopharma Europe, S.A., owned by Esteve, and all dividends earned and to be earned through September 30, 2003. We agreed to register the shares issued to Provesan SA, and we are in the process of registering these shares for public sale in the registration statement of form S-3 mentioned above. On March 31, 2003 we settled our outstanding claim with an insurance company relating to reimbursement of expenses in connection with our Asensio law suits. See Legal Proceedings for more detailed information. We have applied the net proceeds of approximately $1,050,000 as a reduction in general and administrative expenses in our statement of operations for the year ended December 31, 2002. As of December 31, 2002, we had approximately $2,811,000 in cash and short term investments. We believe that these funds plus 1) the anticipated infusion of approximately $4.4 million in net proceeds from the Debenture placement, 2) projected net cash flow from the acquisition of ALFERON N and 3) the funds received from the insurance settlement should be sufficient to meet our operating requirements for the next 12 months. In addition, we may raise additional funds through additional equity or debt financing, collaborative arrangements with corporate partners, lease financing or from other sources in order to complete the necessary clinical trials and the regulatory approval processes and begin commercializing our products. If adequate funds are not available from operations and if we are not able to secure additional sources of financing on acceptable terms, we would be materially adversely affected in our commercialization process. RISK FACTORS The following cautionary statements identify important factors that could cause our actual result to differ materially from those projected in the forward-looking statements made in this Form 10-K. Among the key factors that have a direct bearing on our results of operations are: No assurance of successful product development Ampligen(R) and related products. The development of Ampligen(R) and our other related products is subject to a number of significant risks. Ampligen(R) may be found to be ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture on a commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties. Our related products are in various stages of clinical and pre-clinical development and, require further clinical studies and appropriate regulatory approval processes before any such products can be marketed. We do not know when, or if ever, Ampligen(R) or our other related products will be generally available for commercial sale for any indication. Generally, only a small percentage of potential therapeutic products are eventually approved by the U.S. Food and Drug Administration ("FDA") for commercial sale. ALFERON N Injection(R). Although ALFERON N Injection is approved for marketing for the treatment of genital warts, to date it has not been approved for other applications. We face many of the risks discussed above, with regard to developing this product for use to treat other ailments such as multiple sclerosis and cancer. 20 Our drug and related technologies are investigational and subject to regulatory approval. If we are unable to obtain regulatory approval, our operations will be significantly affected. All of our drugs and associated technologies other than ALFERON N Injection are investigational and must receive prior regulatory approval by appropriate regulatory authorities for general use and are currently legally available only through clinical trials with specified disorders. At present, ALFERON N Injection is only approved for the treatment of genital warts. Use of ALFERON N Injection for other applications will require regulatory approval. In this regard, Interferon Sciences, Inc., the Company from which we obtained our rights to ALFERON N Injection, conducted clinical trials related to use of ALFERON N Injection for treatment of HIV and Hepatitis C. In both instances, the FDA determined that additional studies were necessary. Our principal development efforts are currently focused on Ampligen(R), which has not been approved for commercial use. Our products, including Ampligen(R), are subject to extensive regulation by numerous governmental authorities in the U.S. and other countries, including, but not limited to, the FDA in the U.S., the Health Protection Branch("HPB") of Canada, and the European Medical Evaluation Agency ("EMEA") in Europe. Obtaining regulatory approvals is a rigorous and lengthy process and requires the expenditure of substantial resources. In order to obtain final regulatory approval of a new drug, we must demonstrate to the satisfaction of the regulatory agency that the product is safe and effective for its intended uses and that we are capable of manufacturing the product to the applicable regulatory standards. We require regulatory approval in order to market Ampligen(R) or any other proposed product and receive product revenues or royalties. We cannot assure you that Ampligen(R) will ultimately be demonstrated to be safe or efficacious. In addition, while Ampligen(R) is authorized for use in clinical trials in the United States and other countries, we cannot assure you that additional clinical trial approvals will be authorized in the United States or in other countries, in a timely fashion or at all, or that we will complete these clinical trials. If Ampligen(R) or one of our other products does not receive regulatory approval in the U.S. or elsewhere, our operations will be materially adversely effected. We may continue to incur substantial losses and our future profitability is uncertain. We began operations in 1966 and last reported net profit from 1985 through 1987. Since 1987, we have incurred substantial operating losses, as we pursued our clinical trial effort and expanded our efforts in Europe. As of December 31, 2002 our accumulated deficit was approximately $99,000,000. We have not yet generated significant revenues from our products and may incur substantial and increased losses in the future. We cannot assure that we will ever achieve significant revenues from product sales or become profitable. We require, and will continue to require, the commitment of substantial resources to develop our products. We cannot assure that our product development efforts will be successfully completed or that required regulatory approvals will be obtained or that any products will be manufactured and marketed successfully, or profitability. We may require additional financing which may not be available. The development of our products will require the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. 21 In March 2003, we received $2,873,000 in initial net proceeds from the sale of the Debentures and Warrants and, pursuant to the terms of these Debentures when we close on the second Interferon Sciences asset acquisition, we will receive additional net proceeds of $1,550,000. We anticipate receipt of revenues and proceeds from the sales of Ampligen(R) under the Cost Recovery Clinical Programs and, possibly, from the exercise of outstanding non-public warrants. We also anticipate significant revenues from our recently acquired commercial product, Alferon N. As of December 31, 2002, we had approximately $2,811,000 in cash and short term investments. We believe that these funds plus 1) the anticipated infusion of approximately $4.4 million in net proceeds from the Debenture placement, 2) projected net cash flow from the acquisition of ALFERON N Business and 3) the funds received from the Insurance settlement should be sufficient to meet our operating requirement for the next 12 months. Anticipated sales from the newly acquired Alferon N could significantly extend our present cash reserves. We may need to raise additional funds through additional equity or debt financing or from other sources in order to complete the necessary clinical trials and the regulatory approval processes and begin commercializing our products. There can be no assurances that we will raise adequate funds from these or other sources, which may have a material effect on our ability to develop our products. If we do not complete the second Interferon Sciences asset acquisition, our ability to generate revenues from the sale of ALFERON N Injection and our financial condition will be adversely affected. Although we acquired Interferon Sciences' inventory of ALFERON N Injection and a limited license for the production, manufacture, use, marketing and sale of this product, our ability to develop additional applications for the product and generate sustained revenues from sales of this product is dependent, among other things, on our completing the acquisition from Interferon Sciences of the balance of its rights to this product and other assets related to the product including, but not limited to, Interferon Science's facility for purifying the drug concentrate utilized in the formulation of ALFERON N Injection. In addition, pursuant to the terms of the Debentures, $1,550,000 of the proceeds from the sale of the Debentures have been held back and, if we do not acquire Interferon Sciences' facility, we will not receive these funds. Accordingly, if we do not complete the second Interferon Sciences asset acquisition, our financial condition will be adversely affected. The limited number of unissued and unreserved authorized shares of Common Stock severely restricts our ability to raise funds through the sale of our securities. We have a limited number of shares of Common Stock authorized but not issued or reserved for issuance upon conversion or exercise of outstanding convertible and exercisable securities such as debentures, options and warrants. As of March 31, 2003, only approximately 749,770 shares of our authorized shares of Common Stock will not be issued or reserved for issuance. Unless and until we are able to increase the number of authorized shares of Common Stock, our ability to raise funds through the sale of Common Stock or instruments that are convertible into or exercisable for Common Stock will be severely restricted. Although we intend to ask our stockholders at our next annual meeting to approve an amendment to our Certificate of Incorporation to increase the shares of Common Stock we are authorized to issue, we cannot assure you that we will be able to obtain this approval. We may not be profitable unless we can protect our patents and/or receive approval for additional pending patents. 22 We need to preserve and acquire enforceable patents covering the use of Ampligen(R) for a particular disease in order to obtain exclusive rights for the commercial sale of Ampligen(R) for such disease. If and when we obtain all rights to ALFERON N Injection, we will need to preserve and acquire enforceable patents covering its use for a particular disease too. Our success depends, in large part, on our ability to preserve and obtain patent protection for our products and to obtain and preserve our trade secrets and expertise. Certain of our know-how and technology is not patentable, particularly the procedures for the manufacture of our drug product which are carried out according to standard operating procedure manuals. We have been issued certain patents including those on the use of Ampligen(R) and Ampligen(R) in combination with certain other drugs for the treatment of HIV. We also have been issued patents on the use of Ampligen(R) in combination with certain other drugs for the treatment of chronic hepatitis B virus, chronic hepatitis C virus, and a patent which affords protection on the use of Ampligen(R) in patients with chronic fatigue syndrome. We have not yet been issued any patents in the United States for the use of Ampligen(R) as a sole treatment for any of the cancers which we have sought to target. With regard to ALFERON N Injection, Interferon Sciences, Inc. has a patent for Natural Alpha Interferon produced from human peripheral blood leukocytes and its production process and has additional patent applications pending. We will acquire this patent and related patent applications if and when we close on the second Interferon Sciences asset acquisition We cannot assure you that any of these applications will be approved or that our competitors will not seek and obtain patents regarding the use of our products in combination with various other agents, for a particular target indication prior to us. If we cannot protect our patents covering the use of our products for a particular disease, or obtain additional pending patents, we may not be able to successfully market our products. The patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions. To date, no consistent policy has emerged regarding the breadth of protection afforded by pharmaceutical and biotechnology patents. There can be no assurance that new patent applications relating to our products or technology will result in patents being issued or that, if issued, such patents will afford meaningful protection against competitors with similar technology. It is generally anticipated that there may be significant litigation in the industry regarding patent and intellectual property rights. Such litigation could require substantial resources from us and we may not have the financial resources necessary to enforce the patent rights that we hold. No assurance can be made that our patents will provide competitive advantages for our products or will not be successfully challenged by competitors. No assurance can be given that patents do not exist or could not be filed which would have a materially adverse effect on our ability to develop or market our products or to obtain or maintain any competitive position the we may achieve with respect to our products. Our patents also may not prevent others from developing competitive products using related technology. There can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent rights we may hold. In addition, the failure of third parties from whom we currently license certain proprietary information or may be required to obtain such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect the value of such licenses to us. If we cannot enforce the patent rights we currently hold we may be required to obtain licenses from others to develop, manufacture or market our products. 23 There can be no assurance that we would be able to obtain any such licenses on commercially reasonable terms, if at all. We currently license certain proprietary information from third parties, some of which may have been developed with government grants under circumstances where the government maintained certain rights with respect to the proprietary information developed. No assurances can be given that such third parties will adequately enforce any rights they may have or that the rights, if any, retained by the government will not adversely affect the value of our license. There is no guarantee that our trade secrets will not be disclosed or known by our competitors. To protect our rights, we require certain employees and consultants to enter into confidentiality agreements with us. There can be no assurance that these agreements will not be breached, that we would have adequate and enforceable remedies for any breach, or that any trade secrets of ours will not otherwise become known or be independently developed by competitors. If our distributors do not market our product successfully, we may not generate significant revenues or become profitable. We have limited marketing and sales capability. We need to enter into marketing agreements and third party distribution agreements for our products in order to generate significant revenues and become profitable. To the extent that we enter into co-marketing or other licensing arrangements, any revenues received by us will be dependent on the efforts of third parties, and there is no assurance that these efforts will be successful. Our agreement with Gentiva Health Services offers the potential to provide significant marketing and distribution capacity in the United States while licensing and marketing agreements with certain foreign firms should provide an adequate sales force in South America, Africa, United Kingdom, Australia and New Zealand, Canada, Austria, Spain and Portugal. We cannot assure that our domestic or our foreign marketing partners will be able to successfully distribute our products, or that we will be able to establish future marketing or third party distribution agreements on terms acceptable to us, or that the cost of establishing these arrangements will not exceed any product revenues. The failure to continue these arrangements or to achieve other such arrangements on satisfactory terms could have a materially adverse effect on us. No Guaranteed Source Of Required Materials. A number of essential materials are used in the production of ALFERON N Injection, including human white blood cells, and we have a limited number of sources from which to obtain such materials. We do not have long-term agreements for the supply of any of such materials. There can be no assurance we can enter into long-term supply agreements covering essential materials on commercially reasonable terms, if at all. If we are unable to obtain the required raw materials, we may be required to scale back our operations or stop manufacturing ALFERON N Injection. The costs and availability of products and materials we need for the commercial production of ALFERON N Injection and other products which we may commercially produce are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology, and FDA and other governmental regulations and there can be no assurance that we will be able to obtain such products and materials on terms acceptable to us or at all. 24 There is no assurance that successful manufacture of a drug on a limited scale basis for investigational use will lead to a successful transition to commercial, large-scale production. Small changes in methods of manufacturing may affect the chemical structure of Ampligen(R) and other RNA drugs, as well as their safety and efficacy. Changes in methods of manufacture, including commercial scale-up may affect the chemical structure of Ampligen(R) and, can, among other things, require new clinical studies and affect orphan drug status, particularly, market exclusivity rights , if any, under the Orphan Drug Act. The transition from limited production of pre-clinical and clinical research quantities to production of commercial quantities of our products will involve distinct management and technical challenges and will require additional management and technical personnel and capital to the extent such manufacturing is not handled by third parties. There can be no assurance that our manufacturing will be successful or that any given product will be determined to be safe and effective, capable of being manufactured economically in commercial quantities or successfully marketed. We have limited manufacturing experience and capacity. Ampligen(R) is currently produced only in limited quantities for use in our clinical trials and we are dependent upon certain third party suppliers for key components of our products and for substantially all of the production process. The failure to continue these arrangements or to achieve other such arrangements on satisfactory terms could have a material adverse affect on us. Also, to be successful, our products must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs. To the extent we are involved in the production process, our current facilities are not adequate for the production of our proposed products for large-scale commercialization, and we currently do not have adequate personnel to conduct commercial-scale manufacturing. We intend to utilize third-party facilities if and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities. We will need to comply with regulatory requirements for such facilities, including those of the FDA and HPB pertaining to current Good Manufacturing Practices ("cGMP") regulations. There can be no assurance that such facilities can be used, built, or acquired on commercially acceptable terms, or that such facilities, if used, built, or acquired, will be adequate for our long-term needs. The purified drug concentrate utilized in the formulation of ALFERON N Injection is manufactured in Interferon Science's facility and ALFERON N Injection is formulated and packaged at a production facility operated by Abbott. if and when we close on the second Interferon Sciences asset acquisition, we will acquire this facility. We still will be dependent upon Abbott Laboratories and/or another third party for product formulation and packaging. We may not be profitable unless we can produce Ampligen(R) or other products in commercial quantities at costs acceptable to us. We have never produced Ampligen(R) or any other products in large commercial quantities. Ampligen(R) is currently produced for use in clinical trials. We must manufacture our products in compliance with regulatory requirements in large commercial quantities and at acceptable costs in order for us to be profitable. We intend to utilize third-party manufacturers and/or facilities if and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities. If we cannot manufacture commercial quantities of Ampligen(R) or enter into third party agreements for its manufacture at costs acceptable to us, our operations will be significantly affected. 25 Rapid technological change may render our products obsolete or non-competitive. The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change. Technological competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase. Most of these entities have significantly greater research and development capabilities than us, as well as substantial marketing, financial and managerial resources, and represent significant competition for us. There can be no assurance that developments by others will not render our products or technologies obsolete or noncompetitive or that we will be able to keep pace with technological developments. Our products may be subject to substantial competition. Ampligen(R) . Competitors may be developing technologies that are, or in the future may be, the basis for competitive products. Some of these potential products may have an entirely different approach or means of accomplishing similar therapeutic effects to products being developed by us. These competing products may be more effective and less costly than our products. In addition, conventional drug therapy, surgery and other more familiar treatments may offer competition to our products. Furthermore, many of our competitors have significantly greater experience than us in pre-clinical testing and human clinical trials of pharmaceutical products and in obtaining FDA, HPB and other regulatory approvals of products. Accordingly, our competitors may succeed in obtaining FDA, HPB or other regulatory product approvals more rapidly than us. There are no drugs approved for commercial sale with respect to treating ME/CFS and we have no knowledge of any ME/CFS drugs being developed by others. The dominant competitors with drugs to treat HIV diseases include Gilead Pharmaceutical, Pfizer, Bristol-Myers, Abbott Labs and Schering-Plough Corp. ("Shering"). These potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we have. Although we believe our principal advantage is the unique mechanism action of Ampligen(R) on the immune system, we cannot assure that we will be able to compete. ALFERON N Injection(R). Many potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we have. ALFERON N Injection currently competes with Schering's injectable recombinant alpha interferon product (INTRON(R) A) for the treatment of genital warts. 3M Pharmaceuticals also received FDA approval for its immune-response modifier, Aldara(R), a self-administered topical cream, for the treatment of external genital and perianal warts. ALFERON N Injection also competes with surgical, chemical, and other methods of treating genital warts. We cannot assess the impact products developed by our competitors, or advances in other methods of the treatment of genital warts, will have on the commercial viability of ALFERON N Injection. If and when we obtain additional approvals of uses of this product, we expect to compete primarily on the basis of product performance. Our potential competitors have developed or may develop products (containing either alpha or beta interferon or other therapeutic compounds) or other treatment modalities for those uses. In the United States, two recombinant forms of beta interferon have been approved for the treatment of relapsing-remitting multiple sclerosis. There can be no assurance that, if we are able to obtain regulatory approval of ALFERON N Injection for the treatment of new indications, we will be 26 able to achieve any significant penetration into those markets. In addition, because certain competitive products are not dependent on a source of human blood cells, such products may be able to be produced in greater volume and at a lower cost than ALFERON N Injection. Currently, Interferon Sciences' wholesale price on a per unit basis of ALFERON N Injection is substantially higher than that of the competitive recombinant alpha and beta interferon products. General. Other companies may succeed in developing products earlier than we do, obtaining approvals for such products from the FDA more rapidly than we do, or developing products that are more effective than those we may develop. While we will attempt to expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others or other medical advances will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop. Possible side effects from the use of Ampligen(R) or ALFERON N Injection could adversely effect potential revenues and physician/patient acceptability of our product. Ampligen(R). We believe that Ampligen(R) has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating or life threatening diseases that have been treated. A mild flushing reaction has been observed in approximately 15% of patients treated in our various studies. This reaction is occasionally accompanied by a rapid heart beat, a tightness of the chest, urticaria (swelling of the skin), anxiety, shortness of breath, subjective reports of "feeling hot," sweating and nausea. The reaction is usually infusion-rate related and can generally be controlled by slowing the infusion rate. Other adverse side effects include liver enzyme level elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash, transient visual disturbances, irregular heart rate, decreased visual activity in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within several months. One or more of the potential side effects might deter usage of Ampligen(R) in certain clinical situations and therefore, could adversely effect potential revenues and physician/patient acceptability of our product. ALFERON N Injection(R). At present, ALFERON N Injection is only sold for the intralesional (with in the lesion) treatment of refractory or recurring external genital warts in adults. In clinical trials conducted for the treatment of genital warts with ALFERON N Injection, patients did not experience serious side effects; however, there can be no assurance that unexpected or unacceptable side effects will not be found in the future for this use or other potential uses of ALFERON N Injection which could threaten or limit such product's usefulness. We may be subject to product liability claims from the use of Ampligen(R) or other of our products which could negatively affect our future operations. We face an inherent business risk of exposure to product liability claims in the event that the use of Ampligen(R) or other of our products results in adverse effects. This liability might result from claims made directly by patients, hospitals, clinics or other consumers, or by pharmaceutical companies or others manufacturing these products on our behalf. Our future operations may be negatively effected from the litigation costs, settlement expenses and lost 27 product sales inherent to these claims. While we will continue to attempt to take appropriate precautions, we cannot assure that we will avoid significant product liability exposure. Although we currently maintain product liability insurance coverage, there can be no assurance that this insurance will provide adequate coverage against product liability claims. A successful product liability claim against us in excess of our $1,000,000 in insurance coverage or for which coverage is not provided could have a negative effect on our business and financial condition. The loss of Dr. Carter's services could hurt our chances for success. Our success is dependent on the continued efforts of Dr. William A. Carter because of his position as a pioneer in the field of nucleic acid drugs, his being the co-inventor of Ampligen(R), and his knowledge of our overall activities, including patents, clinical trials. The loss of Dr. Carter's services could have a material adverse effect on our operations and chances for success. While we have an employment agreement with Dr. Carter, and have secured key man life insurance in the amount of $2 million on the life of Dr. Carter, the loss of Dr. Carter or other personnel, or the failure to recruit additional personnel as needed could have a materially adverse effect on our ability to achieve our objectives. Uncertainty of health care reimbursement for our products. Our ability to successfully commercialize our products will depend, in part, on the extent to which reimbursement for the cost of such products and related treatment will be available from government health administration authorities, private health coverage insurers and other organizations. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time to time legislation is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers of pharmaceutical products. We cannot predict what, if any, legislation will ultimately be adopted or the impact of such legislation on us. There can be no assurance that third party insurance companies will allow us to charge and receive payments for products sufficient to realize an appropriate return on our investment in product development. There are risks of liabilities associated with handling and disposing of Hazardous materials. Our business involves the controlled use of hazardous materials, carcinogenic chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply in all material respects with the standards prescribed by applicable regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident or the failure to comply with applicable regulations, we could be held liable for any damages that result, and any such liability could be significant. We do not maintain insurance coverage against such liabilities. The market price of our stock may be adversely affected by market volatility. The market price of our common stock has been and is likely to be volatile. In addition to general economic, political and market conditions, the price and trading volume of our stock could fluctuate widely in response to many factors, including: 28 * announcements of the results of clinical trials by us or our competitors; * adverse reactions to products; * governmental approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory agency concerns regarding the safety or effectiveness of our products; * changes in U.S. or foreign regulatory policy during the period of product development; * developments in patent or other proprietary rights, including any third party challenges of our intellectual property rights; * announcements of technological innovations by us or our competitors; * announcements of new products or new contracts by us or our competitors; * actual or anticipated variations in our operating results due to the level of development expenses and other factors; * changes in financial estimates by securities analysts and whether our earnings meet or exceed the estimates; * conditions and trends in the pharmaceutical and other industries; * new accounting standards; and * the occurrence of any of the risks described in these "Risk Factors." Our common stock is listed for quotation on the American Stock Exchange. For the 12-month period ended December 31, 2002, the price of our common stock has ranged from $0.74 to $4.95. We expect the price of our common stock to remain volatile. The average daily trading volume in our common stock varies significantly. Our relatively low average volume and low average number of transactions per day may affect the ability of our stockholders to sell their shares in the public market at prevailing prices and a more active market may never develop. In the past, following periods of volatility in the market price of the securities of companies in our industry, securities class action litigation has often been instituted against companies in our industry. If we face securities litigation in the future, even if without merit or unsuccessful, it would result in substantial costs and a diversion of management attention and resources, which would negatively impact our business. Our stock price may be adversely affected if a significant amount of shares are sold in the public market. As of April 1, 2003, approximately 834,473 shares of our common stock, constituted "restricted securities" as defined in Rule 144 under the Securities Act of 1933. In addition, we have registered 5,967,820 shares issuable upon the conversion of 135% of the Debentures and as payment of interest thereon. All of these shares are being registered in the form S-3 registration statement discussed above pursuant to agreements between us and the purchasers in our recent private placements, requiring us to register their shares for resale under the Securities Act. This permits the sale of registered shares of common stock in the open market or in privately negotiated transactions without compliance with the requirements of Rule 144. In addition, as of March 31, 2003, we had options and warrants outstanding for the purchase of an aggregate of approximately 9,265,914 shares of our common stock, which includes 135% of the shares issuable upon exercise of the Warrants. To the extent the exercise price of the options and warrants is less than the market price of the common stock, the holders of the options and warrants are likely to exercise them and sell the underlying shares of common stock and to the extent that the conversion price and exercise price of these securities are adjusted pursuant to anti-dilution protection, the securities could be exercisable or convertible for even more 29 shares of common stock. Moreover, we anticipate that we will be issuing and registering for public resale 1,068,789 shares if and when we acquire additional assets from Interferon Sciences, Inc. and, possibly, additional shares to raise funding or compensate employees, consultants and/or directors We are unable to estimate the amount, timing or nature of future sales of outstanding common stock. Sales of substantial amounts of our common stock in the public market could cause the market price for our common stock to decrease. Furthermore, a decline in the price of our common stock would likely impede our ability to raise capital through the issuance of additional shares of common stock or other equity securities. Provisions of our Certificate of Incorporation and Delaware law could defer a change of our management which could discourage or delay offers to acquire us. Provisions of our Certificate of Incorporation and Delaware law may make it more difficult for someone to acquire control of us or for our stockholders to remove existing management, and might discourage a third party from offering to acquire us, even if a change in control or in management would be beneficial to our stockholders. For example, our Certificate of Incorporation allows us to issue shares of preferred stock without any vote or further action by our stockholders. Our Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock. Our Board of Directors also has the authority to issue preferred stock without further stockholder approval. As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock. In this regard, in November, 2002 we adopted a shareholder rights plan and, under the Plan, our Board of Directors declared a dividend distribution of one Right for each outstanding share of Common Stock to stockholders of record at the close of business on November 29, 2002. Each Right initially entitles holders to buy one unit of preferred stock for $30.00. The Rights generally are not transferable apart from the common stock and will not be exercisable unless and until a person or group acquires or commences a tender or exchange offer to acquire, beneficial ownership of 15% or more of our common stock. However, for William A. Carter, M.D., our chief executive officer, who already beneficial owns 11.4% of the our common stock, the Plan's threshold will be 20%, instead of 15%. The Rights will expire on November 19, 2012, and may be redeemed prior thereto at $.01 per Right under certain circumstances. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us, you should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Our research in clinical efforts may continue for the next several years and we may continue to incur losses due to clinical costs incurred in the development of Ampligen(R) for commercial application. Possible losses may fluctuate from quarter to quarter as a result of differences in the timing of significant expenses incurred and receipt of 30 licensing fees and/or cost recovery treatment revenues in Europe, Canada and in the United States. ITEM 2. Properties. We currently lease and occupy a total of approximately 18,850 square feet of laboratory and office space in two states and some office space in Paris, France. Our headquarters is located in Philadelphia, Pennsylvania consisting of a suite of offices of approximately 15,000 square feet. We also lease space of approximately 3,850 square feet in Rockville, Maryland for research of development, our pharmacy, packaging, quality assurance and quality control laboratories, as well as additional office space. Approximately 2,000 square feet are dedicated to the pharmacy, packaging, quality assurance and control functions. The Company believes that its Rockville facilities will meet its requirements, for planned clinical trials and treatment protocols, through 2004 and possibly longer after which time it may need to increase its Rockville facilities either through third parties or by building or acquiring commercial-scale facilities. We currently occupy and use the New Brunswick, New Jersey Laboratory and Production Facility owned by ISI. We are in the process of acquiring title to these facilities pursuant to our second asset acquisition agreement with ISI (see Financial And Asset Acquisition in Item 1 above for more details). This acquisition consists of two buildings located on 2.8 acres. One Building is a two story facility consisting of a total of 31,300 square feet. This facility has offices, laboratories production space, and shipping receiving area. Building two has 11,670 square feet consisting of offices, laboratories and warehouse space. The property has parking space for approximately 100 vehicles. We also have a 24.9% interest in Ribotech, Ltd. located in South Africa. Ribotech was established by Bioclones to develop and operate a manufacturing facility. Manufacturing at the pilot facility commenced in 1996. We expect that Ribotech will start construction on a new commercial production facility in the future, although no assurance can be given that this will occur. The Company has no obligation to fund this construction. Our interest in Ribotech, is a result of the marketing and manufacturing agreement executed with Bioclones in 1994. ITEM 3. Legal Proceedings. On September 30, 1998, we filed a multi-count complaint against Manuel P. Asensio, Asensio & Company, Inc. ("Asensio"). The action included claims of defamation, disparagement, tortuous interference with existing and prospective business relations and conspiracy, arising out of the Asensio's false and defamatory statements. The complaint further alleged that Asensio defamed and disparaged us in furtherance of a manipulative, deceptive and unlawful short-selling scheme in August and September, 1998. In 1999, Asensio filed an answer and counterclaim alleging that in response to Asensio's strong sell recommendation and other press releases, we made defamatory statements about Asensio. We denied the material allegations of the counterclaim. In July 2000, following dismissal in federal court for lack of subject matter jurisdiction, we transferred the action to the Pennsylvania State Court. In March 2001, the defendants responded to the complaints as amended and a trial commenced on January 30, 2002. A jury verdict disallowed the claims against the defendants for defamation and disparagement and the court granted us a directed verdict on 31 the counterclaim. On July 2, 2002 the Court entered an order granting us a new trial against Asensio for defamation and disparagement. Thereafter, Asensio appealed the granting of a new trial. This appeal is now pending in the Superior Court of Pennsylvania. In June 2002, a former ME/CFS clinical trial patient and her husband filed a claim in the Superior Court of New Jersey, Middlesex County, against us, one of our clinical trial investigators and others alleging that she was harmed in the ME/CFS clinical trial as a result of negligence and breach of warranties. We believe the claim is without merit and we are defending the claim against us through our product liability insurance carrier. In June 2002, a former ME/CFS clinical trial patient in Belgium filed a claim in Belgium, against Hemispherx Biopharma Europe, NV/SA, our Belgian subsidiary, and one of our clinical trial investigators alleging that she was harmed in the Belgium ME/CFS clinical trial as a result of negligence and breach of warranties. We believe the claim is without merit and we are defending the claim against us through our product liability insurance carrier. In July 2002, we filed suit in the United States District Court for the Eastern District of Pennsylvania against Federal Insurance Company ("Federal") seeking (1) a judicial order declaring our rights and the obligations of Federal under the insurance policy Federal sold to us (2) monetary damage for breach of contract resulting from Federal's refusal to fully defend us in connection with the Asensio litigation (3) monetary damages to compensate us for Federal's breach of its fiduciary duty faith and dealing and (4) monetary damages, interest, costs, and attorneys fees to compensate us for Federal's violation of the Pennsylvania Bad Faith Statute. On March 31, 2003 we settled our outstanding claim with our insurance company relating to reimbursement of expenses in connection with our Asensio law suits. The net settlement amount of approximately $1,050,000 is recorded as a reduction in General and Administrative expenses in our statement of operations for the year ended December 31, 2002. In March 2003, the law firm of Schnader, Harrison, Segal & Lewis, LLP filed a complaint in the Court of Common Pleas of Philadelphia County against us for alleged legal fees in the sum of $65,051. We believe the claim is without merit and we are defending the claim. ITEM 4. Submission of Matters to a Vote of Security Holders. No matters were submitted to a vote of the security holders during the last quarter of the year ended December 31, 2002. PART II ITEM 5. Market for Registrant's Common Equity and Related Stockholder Matters. In the year 2002, we acquired 27,500 shares of common stock on the open market at an average cost of $1.82 per share. The acquisition of the shares was authorized under a stock buy-back program authorized by the board of directors. In fiscal 2002, we issued 11,300 new shares of common stock to warrant holders exercising non-public warrants at an average exercise price of $3.30. The warrants exercised were granted by us in the period covering 1993 through 1996. In addition, we issued 48,392 shares in settlement of debt of $154,000. 32 In addition, as discussed in greater detail in "RECENT FINANCING AND ASSET ACQUISITIONS" above in Item 1. Business, we 1) issued convertible debentures and warrants to two investors for cash, we issued shares to ISI for assets, 2) issued shares to an affiliate of Esteve in exchange for convertible preferred equity certificates of our Luxembourg subsidiary and 3) we plan to issue shares of common stock to ISI and to two creditors of ISI for additional assets. Cardinal Securities LLC was placement agent on the sale of the Debentures and Warrants and received a placement fee equal to 7% of the proceeds from that offering (up to 1.75% of which is payable in Company Common Stock) and common stock purchase warrants to purchase 25,000 shares for each $1,000,000 received by the Company. The foregoing issuances of securities were private transactions and exempt from registration under section 4(2) of the Securities Act and/or regulation D rule 506 promulgated under the Securities Act. Since October 1997 our common stock and Class A warrants have been listed and traded on the American Stock Exchange ("AMEX") under the symbol HEB and HEBws, respectively. The Class A Warrants expired on November 2, 2001. The following table sets forth the high and low list prices for our Common Stock for the last two fiscal years and the first quarter of fiscal 2003 as reported by the AMEX. Such prices reflect inter-dealer prices, without retail markup, mark downs or commissions and may not necessarily represent actual transactions. COMMON STOCK High Low Time Period: January 1, 2001 through March 31, 2001 $5.75 $3.01 April 1, 2001 through June 30, 2001 7.15 3.96 July 1, 2001 through September 30, 2001 6.85 3.89 October 1, 2001 through December 31, 2001 5.29 3.41 Time Period: January 1, 2002 through March 31, 2002 4.76 3.45 April 1, 2002 through June 30, 2002 3.97 2.50 July 1, 2002 through September 30, 2002 2.63 .80 October 1, 2002 through December 31, 2002 2.86 1.40 As of March 27, 2003 there were approximately 259 holders of record of our Common Stock. This number was determined from records maintained by the Company's transfer agent and does not include beneficial owners of the Company's securities whose securities are held in the names of various dealers and/or clearing agencies. 33 As of April 4, 2003, the last sale price for our common stock on the AMEX was $1.35 per share. We have not paid any dividends on our Common Stock in recent years. It is management's intention not to declare or pay dividends on our Common Stock, but to retain earnings, if any, for the operation and expansion of the Company's business. 34 The following table gives information about our Common Stock that may be issued upon the exercise of options, warrants and rights under all of our equity compensation plans as of December 31, 2002.
Number of Number of securities Securities to be Remaining available issued upon Weighted-average For future issuance exercise of Exercise price of under equity outstanding Outstanding compensation plans options, warrants Options, warrants (excluding securities Plan Category and rights And rights Reflected in column (a)) ============================= ======================== ================= ============================ (a) (b) (c) ======================== ================= ============================ Equity compensation plans approved by security holders: 294,665 $ 3.57 258,293 Equity compensation plans not approved by security _ _ _ holders: =================== ============= ==================== Total 294,665 $ 3.57 258,293 =================== ============= ==================== ===================================================================================================================
35 ITEM 6. Selected Financial Data (in thousands except for share and per share data). Year Ended December 31 1998 1999 2000 2001 2002 ------ ------- ------- -------- ------- Statement of Operations Data Revenues and License fee Income $ 401 $ 678 $ 788 $ 390 $ 904 Net loss (7,324) (12,298) (8,552) (9,083) (7,424) Basic and diluted loss per share (0.32) (0.47) (0.29) (0.29) (0.23) Shares used in computing basic and diluted net loss per share. 22,724,913 26,380,351 29,251,846 31,433,208 32,085,776 Balance Sheet Data Total Assets $ 16,327 $ 14,168 $ 13,067 $ 12,035 $6,040 Common Stockholders' Equity 15,185 12,657 11,572 10,763 3,630 Other Cash Flow Data Cash used in operating activities (5,751) (6,990) (8,074) (7,281) (6,409) Capital expenditures (151) (251) (171) - -
ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis is related to our financial condition and results of operations for the three years ended December 31, 2002. This information should be read in conjunction with Item 6 - "Selected Financial Data" and our consolidated financial statements and related notes thereto beginning on F-1 of this Form 10-K. Statement of Forward-Looking Information Certain statements in the section are "forward-looking statements". You should read the information before Part I above, "Special Note" Regarding Forward-Looking Statements" for more information about our presentation of information. Background We have reported net income only from 1985 through 1987. Since 1987, we have incurred, as expected, substantial operating losses due to our conducting clinical testing. Prior to completing an Initial Public Offering ("IPO") in 36 November 1995,we financed operations primarily through the private placement of equity and debt securities, equipment lease financing, interest income and revenues from licensing, royalty agreements and cost recovery treatment programs. We have established a strong foundation of laboratory, pre-clinical data with respect to the development of nucleic acid to enhance the natural antiviral defense system of the human body and the development of the therapeutic products for the treatment of chronic disease. Our strategy is to obtain the required regulatory approval which will allow the progressive introduction of Ampligen(R) (our proprietary drug) for treating Myalgic encephalomyelitis Chronic Syndrome (ME/CFS"), HIV, hepatitis C ("HCV") and hepatitis B ("HBV") in the U.S., Canada, Europe and Japan. Ampligen(R) is currently in phase III clinical trials in the U.S. for use in treatment of ME/CFS and is in Phase IIb Clinical trials in the U.S. for the treatment of newly emerged multi-drug resistant HIV, and for the induction of Cell mediated immudity in HIV patients that are under control using potentially toxic drug cocktail. Our proprietary drug technology utilizes specifically configured ribonucleic acid ("RNA") and is protected by more than 350 patents worldwide. With over 80 additional patent application pending to provide further proprietary protection in various international markets. Certain patents apply to the use of Ampligen(R) alone and certain patent apply to the use of Ampligen(R) in combination with certain other drugs. Some composition of matter patents pertain to other new medication, which have a similar mechanism of action. In March, 2003, the Company acquired from Interferon Sciences Inc. ("ISI"), all of ISI's raw materials, work-in-progress and finished product of Alferon N Injection(R), together with a limited license for the production, manufacture, use, marketing and sale of the product. Alferon N Injection(R) [interferon alfa- n3 (human derived)] is a natural alpha interferon that has been approved by the U.S. Food and Drug Administration ("FDA") for commercial sale for the treatment of certain types of genital warts. We intend to market this product in the United State through sales facilitated via third party marketing agreements. Additionally, we intend to implement studies, beyond those conducted by ISI, for testing the potential treatment of HIV, Hepatitis C and other indications, including multiple sclerosis. This acquisition not withstanding, our primary focus remains the development to Ampligen(R) for treating ME/CFS and HIV diseases. We are incorporated in Maryland in 1996 under the name HEM research, Inc., and originally served as a supplier of research support products. Our business was redirected in the early 1980's to the development of nucleic acid pharmaceutical technology and the commercialization of RNA drugs. We were reincorporated in Delaware and changed our name to Hem Pharmaceutical Corp. in 1991 and to Hemispherx Biopharma, Inc., in June 1995. We have three domestic subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp., all of which are incorporated in Delaware. Our foreign subsidiaries include Hemispherx Biopharma Europe N.V./S.A. established in Belgium in 1998 and Hemispherx Biopharma Europe S.A. incorporated in Luxembourg in 2002. 37 Result of Operations Years Ended December 31, 2002 vs. 2001 Net loss Our net loss was approximately $7,424,000 for the year ended December 31, 2002 versus a net loss of $9,083,000 in 2001. Per share losses in 2002 was 23 cents versus a per share loss of 29 cents in 2001. This year to year decrease in losses of $1,659,000 is primarily due to higher revenues and lower costs in 2002. Revenues were up $514,000 in 2002 and total expenses were down by $2,231,000 offset by a write down in the carrying value of our investments in the amount of $1,366,000 for a net cost decrease of $865,000. Revenues Our revenues have come from our ME/CFS cost recovery treatment programs principally underway in the U.S., Canada and Europe. These clinical programs allow us to provide Ampligen(R) therapy at our cost to severely debilitated ME/CFS patients. Under this program the patients pay for the cost of Ampligen(R) doses infused. These costs total approximately $7,200 for a 24 weeks treatment program. Revenues from cost recovery treatment programs totaled some $341,000 in 2002. In 2001, these revenues were $390,000 or 14% higher than 2002 revenues. We expected revenues in the U.S. to decline due to the focus of our clinical resources on conducting and completing the AMP 516 ME/CFS Phase III clinical trial as well as the start up of the AMP 719 and AMP 720 HIV clinical trials. The clinical data collected from treating patients under the cost recovery treatment programs will augment and supplement the data collected in the U.S. Phase III ME/CFS trial. We received a licensing fee of 625,000 Euros (some $563,000) from Esteve. Pursuant to a sales and distribution agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of ME/CFS in turn we provided to Esteve technical scientific and commercial information. The agreement terms require no additional performance by us. Our total revenues, including this licensing fee, in 2002 was $904,000 compared to revenues of $390,000 in 2001. Revenues for non-refundable license fees are recognized under the performance method. This method recognizes revenue to the extent of performance to date under a licensing agreement. In computing earned revenue, it considers only the amount of non-refundable cash actually received to date. This method considers future payments to be contingent and thus ignores the possibility of future milestone payments when computing the amount of revenue earned in a current period. Research and Development costs Our efforts in Research and Development are fully directed toward conducting and completing our ongoing clinical trials, a Phase III study for the treatment of ME/CFS an two Phase IIb studies for the treatment of HIV. Our R&D direct costs were $4,946,000 in 2002 compared with $5,780,000 in 2001. The Phase III study, AMP 516 for the treatment of ME/CFS is a multi center, placebo controlled, randomized, double blind study to evaluate the efficacy and safety of treating ME/CFS patients with Ampligen(R). As of December, 2002 the study was fully enrolled. More than 175 patients have finished the study and we expect to finish with the current groups by the Fourth Quarter of 2003. Expenses related to the ME/CFS Phase III study are expected to decrease in 2003 because of fewer patients to be treated in the cost-intensive segment of the program as the trial nears completion. The Phase IIb Clinical Trail AMP 719 "Salvage Therapy" for the treatment of HIV evaluates the use of Ampligen in adjunct to HAART Therapy. The Phase IIb Clinical Trial AMP 720, "Strategic Treatment therapy" evaluates the 38 effect of Ampligen(R) during HAART treatment interruptions, or so-called drug holidays. As of February, 2003 approximately 55 patients have been enrolled in both studies combined and are being treated in approximately 10 different active sites. We expect an acceleration in enrollment in the months ahead, now that more data about the trials is known by the Medical Community. Therefore, the lower cost of the ME/CFS program will be partially offset by an increase due to spending related to the acceleration of our two HIV Clinical Trials. The rate of enrollment depends on patient availability and on other products being in placed in clinical trials for the treatment of HIV. There could be competition for the same patient population. Overall, we expect our Research and Development costs to be lower by over $1,000,000 in 2003 as compared to 2002. Upon completion of the ME/CFS study, we will start analyzing the clinical data to determine the results of the study in anticipation of submitting an application to the FDA in early to mid 2004. The HIV trials will continue into 2004. Delays in patient recruiting for the HIV trials could delay the completion of the clinical trial. General and Administrative Expenses Excluding stock compensation expense, general and administrative expenses were approximately $1,882,000 in 2002 versus $2,741,000 in 2001. This decease in expenses of $859,000 in 2002, is due to several factors including the recovery of certain legal expenses of approximately $1,050,000 relating to the Asensio lawsuit from our insurance carrier and lower overall legal expenses due to less litigation, partially offset by higher Insurance premiums. Stock compensation expenses was $133,000 or $538,000 lower than recorded in the year 2001. The compensation reflects the imputed non-cash expense recorded to reflect the cost of warrants granted to outside parties for services rendered to the Company. Equity Loss-Unconsolidated Affiliates During the three months ended June 2002 and December 2002, we recorded a non-cash charge of $678,000 and $396,000 respectively, to operations with respect to our $1,074,000 investment in R.E.D. These charges were the result of our determination that R.E.D.'s business and financial position had deteriorated to the point that our investment had been permanently impaired. Please see "RESEARCH AND DEVELOPMENT/COLLABORATIVE AGREEMENTS" in Part 1 for more details on these transactions. In May 2000, we acquired an equity interest in Chronix Biomedical Corp. ("CHRONIX"). for $700,000. During the quarter ended December 31, 2002, we recorded a noncash charge of $292,000 with respect to our investment in Chronix. This impairment reduces our carrying value to reflect a permanent decline in Chronix's market value based on their current proposed equity offerings. Please see "RESEARCH AND DEVELOPMENT/COLLABORATIVE AGREEMENTS" in Part 1 for more details on these transactions. In April, 1999 we acquired a 30% equity position in the California Institute of Molecular Medicine ("CIMM") for $750,000. During the fourth quarter of 2001 we recorded a non-cash charge of $485,000 with respect to our investment in CIMM. This was a result of our determination that CIMM's operations have not yet evolved to the point where the full carrying value of our investment could 39 be supported based on that Company's financial position and operating results. This amount represented the unamortized balance of goodwill included as part of our investment. During 2002, we wrote down to zero our remaining investment based on that Company's continuing operating losses. These charges are reflected in the Consolidated Statements of Operations under the caption "Equity loss in unconsolidated affiliate." Please see "RESEARCH AND DEVELOPMENT/ COLLABORATIVE AGREEMENTS" in Part 1 for more details on these transactions. Other Income/Expense Interest and other income totaled $103,000 in 2002 compared to $284,000 recorded in 2001. Significantly lower interest rates on money market accounts and lower cash available for investment basically account for the difference. All funds in excess of our immediate need are invested in short term high quality securities which earned much lower interest income in 2002. Years Ended December 31, 2001 vs. 2000 Net loss We reported a net loss of approximately $9,083,000 for the year ended December 31, 2001 versus a net loss of approximately $8,552,000 for the year 2000. The increase in losses of $531,000 in 2001 was basically due to lower ME/CFS Cost Recovery Treatment Revenues and Interest Income. In addition we recorded a non-operating, non-cash charge of $485,000 with respect to our investments in unconsolidated affiliates. This amount represents the unamortized balance of Goodwill included in the investments. Overall operating expenses in 2001 were $639,000 lower than operating expenses experienced in 2000. Our loss per share was $0.29 in 2001 and 2000. Revenues At this time, (prior to the acquisition of Alferon N) our revenues come from our ME/CFS cost recovery treatment programs principally underway in the U.S., Canada and Europe. These clinical programs allow us to provide Ampligen(R) therapy at our cost to severely debilitated ME/CFS patients. Under this program the patients pay for the cost of Ampligen(R) doses infused. These costs total approximately $7,200 for a 24 weeks treatment program. Revenues from cost recovery treatment programs totaled some $788,000 in 2000. In 2001, these revenues declined by $398,000 or 51%. We expected revenues in the U.S. to decline due to the focus of our clinical resources on conducting and completing the AMP516 ME/CFS Phase III clinical trial as well as the start up of the AMP 719 and AMP 720 HIV clinical trials. Revenues from the European cost recovery treatment programs were lower than expected primarily due to our European investigators spending a great deal of time in reviewing and analyzing the clinical data collected in the treatment of some 150 patients in Belgium. The clinical data collected from treating patients under the cost recovery treatment programs will augment and supplement the data collected in the U.S. Phase III ME/CFS trial. Research and Development costs As previously noted, our research and development is primarily directed at developing our lead product, Ampligen(R), as a therapy for use in treating various chronic illnesses as well as cancer. In 2000 and 2001, most of this effort was directed toward conducting and supporting clinical trials involving patients affected with ME/CFS. Our research and development direct costs were $5,780,000 in 2001 compared to $6,136,000 spent in 2000. The lower research and 40 development costs basically reflect the net sum of less costs related to lower cost recovery treatment revenues and lower expenses related to the ME/CFS clinical trials offset by increased purchases of polymers and increased expenses relating to the HIV trials initiated in 2001. As to be expected, costs related to the cost recovery treatment programs were down approximately $275,000 due to lower revenues recorded in 2001. Also expenses relating to the ME/CFS Phase III clinical trial were down some $863,000 in 2001 versus 2000 due to fewer patients being treated in the cost-intensive segment of the program as the clinical trial nears completion. This clinical trial is a multicenter, placebo-controlled, randomized, double blind study to evaluate the efficacy and safety of treating 230 ME/CFS patients with Ampligen(R). As of February 2002, more than 220 patients have been enrolled. These lower costs relating to our ME/CFS programs were partially offset by an increase in polymer purchase in 2001 in the amount of $317,000 and an increase due to spending on the new HIV clinical trials now underway. The polymer purchase increase was needed to boost our on hand inventory for the production of Ampligen(R). The HIV clinical trials were initiated to evaluate the use of Ampligen(R) in concert with other antiviral drugs in treating patients severely afflicted with AIDS. We expect levels of these clinical trials to continue throughout 2002. Refer to part I, Item 1 (BUSINESS) for more information on our Research and Development for programs. General and Administrative Expenses Excluding stock compensation expense, general and administrative expenses were approximately $2,741,000 in 2001 versus $3,298,000 in 2000. The decrease in expense is primary due to lower professional fees in 2001. All other general and administrative expenses were slightly less than recorded in 2000. Stock compensation expenses were $671,000 or some $274,000 higher than recorded in the year 2000. The compensation reflects the imputed non-cash expense recorded to reflect the cost of warrants granted to outside parties for services rendered to the Company. Equity Loss-Unconsolidated Affiliates During the fourth quarter of 2001, we recorded a non-cash charge of $485,000 with respect to our investment in CIMM. The amount represents the unamortized balance of goodwill included as part of our investment. This was a result of management's determination that CIMM's operations had not yet evolved to the point where our full carrying value of its investment could be supported based on their financial position and operating results. Other Income/Expense Interest and other income of $284,000 in 2001 was lower than the $572,000 recorded in 2000. Significantly lower interest rates on money market accounts and lower cash available for investment basically account for the difference. All funds in excess of our immediate need are invested in short term high quality securities which earned much lower interest income in 2001. LIQUIDITY AND CAPITAL RESOURCES Cash, cash equivalents and short term investments at December 31, 2002 were approximately $2,811,000. Cash used for operating activities in 2002 was $6,409,000. Additional uses of cash included expenditures of $176,000 for patent acquisition cost, and $50,000 to acquire 27,500 shares of our stock. 41 Cash proceeds from financing activities in 2002 were approximately $966,000. $65,000 was received from stock subscriptions and $946,000 was received from the issuance of preferred equity certificates of our European subsidiary. Our net operating cash "burn rate" for the last three months of fiscal year 2002 approximated $547,000 per month or $6,564,000 on an annualized basis. All clinical trial drug supplies produced in 2002 were fully expensed although some costs are expected to be recovered under the expanded access cost recovery programs authorized by FDA and regulatory bodies in other countries. Our operating cash "burn rate" should decline in 2003 as the AMP 516 ME/CFS clinical trial nears completion and the cost of European market development activity is reduced. On March 20, 2002, our European subsidiary Hemispherx Biopharma Europe, S.A. ("Hemispherx S.A.") entered into a sales and Distribution agreement with Laboratories Del Dr. Esteve S.A. ("Esteve"). Pursuant to the terms of the agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of Myalgic/Chronic Fatigue Syndrome ("ME/CFS"). In addition to other terms and other projected payments., Esteve paid an initial and non-refundable fee of 625,000 Euros (approximately $563,000) to Hemispherx S.A. on April 24, 2002. Esteve is to pay a fee of 1,000,000 Euros after U.S. Food and Drug Administration approval of Ampligen(R) for the treatment of ME/CFS and a fee of 1,000,000 Euros upon Spain's approval of the final marketing authorization for using Ampligen(R) for the treatment of ME/CFS. Also Esteve purchased 1,000,000 Euros of Hemispherx S.A.'s convertible preferred equity certificates. These securities paid a 7% dividend and were to be converted into .00114% of the outstanding common stock of Hemispherx S.A. upon the earlier of the completion of an initial public offering ("IPO") on a European stock exchange or September 30, 2003. However, at our request, on January 9, 2003, Esteve agreed to convert the preferred equity certificates into shares of our common stock and, on March 13, 2003, we issued 347,445 shares of our common stock to Provesan SA, an affiliate of Esteve, in exchange for the 1,000,000 Euros of convertible preferred equity certificates owned by Esteve. We agreed to registered the shares issued to Provesan SA and we have registered these shares for public sale. On March 12, 2003, we issued an aggregate of $5,426,000 in principal amount of 6% Senior Convertible Debentures due March 2005 and an aggregate of $743,288 warrants to two investors in a private placement for aggregate anticipated gross proceeds of $4,650,000. Pursuant to the terms of the Debentures, $1,550,000 of the proceeds from the sale of the Debentures have been held back and will be released to us if, and only if, we acquire ISI's facility with in a set timeframe (see the discussion below). The Debentures mature on January 31, 2005 and bear interest at 6% per annum, payable quarterly in cash or, subject to satisfaction of certain conditions, common stock. Any shares of common stock issued to the investors as payment of interest shall be valued at 95% of the average closing price of the common stock during the five consecutive business days ending on the third business day immediately preceding the applicable interest payment date. Pursuant to the terms and conditions of the Senior Convertible Debentures, we have pledged all of our assets, other than our intellectual property, as collateral and are subject to comply with certain financial and negative covenants, which include but are not limited to the repayment of principal balances upon achieving certain revenue milestone. 42 The Debentures are convertible at the option of the investors at any time through January 31, 2005 into shares of our common stock. The conversion price under the Debentures is fixed at $1.46 per share, subject to adjustment for anti-dilution protection for issuance of common stock or securities convertible or exchangeable into common stock at a price less than the conversion price then in effect. The investors also received Warrants to acquire at any time through March 12, 2008 an aggregate of 743,288 shares of common stock at a price of $1.68 per share. On March 12, 2004, the exercise price of the Warrants will reset to the lesser of the exercise price then in effect or a price equal to the average of the daily price of the common stock between March 13, 2003 and March 11, 2004 (but in no event less than $1.176 per share). The exercise price (and the reset price) under the Warrants also is subject to similar adjustments for anti-dilution protection. We entered into a registration rights agreement with the investors in connection with the issuance of the Debentures and the Warrants. The registration rights agreement requires that we register the shares of common stock issuable upon conversion of the Debentures, as interest shares under the Debenture and upon exercise of the Warrants. In accordance with this agreement, we filed a registration statement on form S-3 with the Securities and Exchange Commission. The investors include Portside Growth & Opportunity Fund Ltd. and Leonardo, L.P. the Debentures mature on March 12, 2005 and bear interest at 6% per annum, payable quarterly in cash or common stock. Any shares of common stock issued to the investors as payment of interest shall be valued at 95% of the average closing price of the common stock during the five consecutive business days ending on the third business day immediately preceding the applicable interest payment date. On March 11, 2003, we acquired from Interferon Sciences, Inc. ("ISI") ISI's inventory of ALFERON N Injection(R), a pharmaceutical product used for the treatment of certain types of genital warts, and a limited license for the production, manufacturing, use, marketing and sale of this product. As partial consideration, we issued 487,028 shares of our common stock to ISI. Pursuant to our agreements with ISI, we are in the process of registering the foregoing shares for public sale. On March 11, 2003, we also entered into an agreement to purchase from ISI all of its rights to the product and other assets related to the product including, but not limited to, real estate and machinery. For these assets, we have agreed to issue to ISI an additional 487,028 shares and to issue 314,465 shares and 267,296 shares, respectively to the American National Red Cross and GP Strategies Corporation, two creditors of ISI. The Company also will be required to satisfy real estate taxes and utility expenses of ISI which totaled $520,751 as of December 31, 2002 and which are secured by a lien on the real estate to be acquired by the Company. We have guaranteed the market value of all but 62,500 of these share on terms substantially similar to those for the initial acquisition of the ISI assets. As of December 31, 2002, we had approximately $2,811,000 in cash and short term investments. We believe that these funds plus 1) the anticipated infusion of approximately $4.4 million in net proceeds from the debenture placement, 2) projected net cash flow from the acquisition of the ALFERON N business and 3) the funds received from the insurance settlement should be sufficient to meet our operating requirement during the next 12 months. Also, we have the ability to curtail discretionary spending, including research and development activities, if required to conserve cash. 43 Because of our long-term capital requirements, we may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. Any additional funding may result in significant dilution and could involve the issuance of securities with rights which are senior to those of existing stockholders. We may also need additional funding earlier than anticipated, and our cash requirements, in general, may vary materially from those now planned, for reasons including, but not limited to, changes in our research and development programs, clinical trials, competitive and technological advances, the regulatory process, and higher than anticipated expenses and lower than anticipated revenues from certain of our clinical trials for which cost recovery from participants has been approved. Contractual Obligations (dollars in thousands) Obligations Expiring by Period ========================================== Total 2003 2004-2005 2006-2007 ======== ======== =========== ========= Operating leases $1,063 $ 279 $ 526 $ 258 ======= ======== =========== ========= Total $1,063 $ 279 $ 526 $ 258 ======= ======== =========== ========== NEW ACCOUNTING PRONOUNCEMENTS In January 2003, the FASB issued Interpretation No. 46,, "Consolidation of Variable Interest Entities" ("Interpretation No. 46"), that clarifies the application of Accounting Research Bulletin No. 51, Consolidated Financial Statements, "to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. Interpretation No. 46 is applicable immediately for variable interest entities created after January 31, 2003. For variable interest entities created to January 31, 2003, the provision of Interpretation No. 46 are applicable no later than July 1, 2003. The Company does not expect this Interpretation to have an effect on the consolidated financial statements. In August 2001, the FASB issued Statement No. 143, "Accounting for Asset Retirement Obligation" ("SFAS 143"), which provides the accounting requirements for retirement obligation associated with tangible long-lived assets. SFAS 143 requires entities to record the fair value of the liability for an asset retirement obligation in the period in which it is incurred and is effective for the Company's 2003 fiscal year. The adoption of SFAS 143 is not expected to have a material impact on the Company's consolidated results of operations, financial position or cash flows. In October 2001, the FASB issued Statement No. 144, "Accounting for the Impairment or Disposal of Long-lived Assets" ("SFAS 144"). SFAS 144 addresses financial accounting and reporting for the impairment or disposal of long-lived assets. This statement supersedes SFAS Statement No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of, " 44 and the accounting and reporting provision of APB Opinion No. 30,"Reporting the Results of Operations-Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and transactions. "This new pronouncement also amends Accounting Research Bulletin (ARB) No. 51 "Consolidated Financial Statements, "to eliminate the exception to consolidation for a subsidiary for which control is likely to be temporary. SFAS 144 required that one accounting model be used for long-lived assets to be disposed of by sale, whether previously held and used or newly acquired and also broadens the presentation of discontinued operation to include more disposal transactions. SFAS 144 is effective for fiscal years beginning after December 15, 2001 and interim periods within those fiscal years. Adoption of SFAS 144 on January 1, 2002, did not have impact on the Company's financial position, cash flows or results of operation for the year ended December 31, 2002. In June 2002, the FASB issued Statement No. 146, "Accounting for Cost Associated with Exit or Disposal Activities" ("SFAS 146"), which addresses financial accounting and reporting for costs associated with exit or disposal activities, and nullifies Emerging Task Force (EITF) Issue No. 94-3, "Liability Recognition for Certain Employee termination Benefits and Other Costs to Exit and Activity (including Certain Costs Incurred in a Restructuring)" which previously governed the accounting treatment for restructuring activities. SFAS 146 applies to costs associated with an exit activity that does not involve an entity newly acquired in a business combination or with disposal activity covered by SFAS 144. Those costs include, but are not limited to, the following: (1) termination benefits provide to current employees that are involuntarily terminated under the terms of a benefit arrangement that, in substance, is not an ongoing benefit arrangement or individual deferred-compensation contract,(2) costs to terminate a contract that is not a capital lease, and (3) costs to consolidated facilities or relocated employees. SFAS 146 does not apply to costs associated with the retirement of long-lived assets covered by SFAS 143. SFAS 146 will be applied prospectively and is effective for exit or disposal activities after December 31, 2002. In December 2002, the FASB issued Statement No. 148, "Accounting for Stock-Based Compensation-Transition and Disclosure", and amendment of FASB Statement No. 123 ("SFAS"). SFAS 148 amends FASB Statement No. 123, Accounting for Stock-Based Compensation, to provide alternative method of transition for an entity that voluntarily changes to the fair value based of accounting for stock-based employee compensation. It also amends the disclosure provisions of that Statement to require prominent disclosure about the effects on reported net income of an entity's accounting policy decisions with respect to stock-based employee compensation. Finally, this Statement amends Accounting Principles Board ("APB") Opinion No. 28, Interim Financial Reporting to require disclosure about those effects in interim financial information. SFAS 148 is effective for financial statements for fiscal years ending after December 15, 2002. The Company will continue to account for stock-based compensation using the intrinsic value method of APB Opinion No. 25, "Accounting for Stock Issued to Employees, "but has adopted the enhance disclosure requirements of SFAS 148 (See Note 10). Critical Accounting Policies Financial Reporting Release No. 60., which was recently released by the Securities And Exchange Commission, requires all companies to include a discussion of critical accounting policies or method used in the preparation of financial statements. Our significant accounting policies are described in Notes to the Consolidated Financial Statements. The significant accounting policies that we believe are most critical to aid in fully understanding our reported financial results are the following: 45 Revenue Revenues for non-refundable license fees are recognized under the performance method. This method recognizes revenue to the extent of performance to date under a licensing agreement. In computing earned revenue, it considers only the amount of non-refundable cash actually received to date. This method considers future payments to be contingent and thus ignores the possibility of future milestone payments when computing the amount of revenue earned in a current period. Revenue from the sale of Ampligen(R) under cost recovery clinical treatment protocols approved by the FDA is recognized when treatment is provided to the patient. Patents and Trademarks Effective October 1, 2001, we adopted a 17 year estimated useful life for the amortization of our patents and trademark rights in order to more accurately reflect their useful life. Prior to October 1, 2001, we were using a ten year estimated useful life. Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight line method over the life of the assets. The Company reviews its patents and trademark rights periodically to determine whether they have continuing value. Such review includes an analysis of the patent and trademark's ultimate revenue and profitability potential on an undiscounted cash basis to support the realizability of its respective capitalized cost. In addition, management's review addresses whether each patent continues to fit into Company's strategic business plans. Research and Developments Costs Research and development costs are direct costs related to both future and present products and are charged to operations as incurred. The Company recognized research and development costs of $6,136,000 $5,780,000 and $4,946,000 in 2000, 2001 and 2002 respectively. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. 46 ITEM 7a. Quantitative and Qualitative Market Risk. Market Risk We had $2.8 million in cash, cash equivalents and short term investments at December 31, 2002. To the extent that our cash and cash equivalents exceed our near term funding requirements, the excess cash was invested in three (3) to six (6) month high quality financial instruments. We employ established policies and procedures to manage any risks with respect to any investment exposure. ITEM 8. Financial Statements and Supplementary Data. The consolidated balance sheets as of December 31, 2001 and 2002, and our consolidated statements of operations, changes in stockholders' equity (deficit) and comprehensive loss and cash flows for each of the years in the three year period ended December 31, 2002, together with the reports of BDO Seidman, LLP, independent public accountants, are included at the end of this report. Reference is made to the "Index to Financial Statements and Financial Statement Schedule" on page F-1. ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures. None. PART III Item 10. Directors and Executive Officers of the Registrant. Directors and Executive Officers of the Registrant The following sets forth biographical information about each of our directors and executive officers as of the date of this Agreement: Name Age Position William A. Carter, M.D. 65 Chairman, Chief Executive Officer, and President Robert E. Peterson 65 Chief Financial Officer David R. Strayer, M.D. 55 Medical Director, Regulatory Affairs Carol A. Smith, Ph.D. 51 Director of Manufacturing and Process Development Richard C. Piani 76 Director William M. Mitchell, M.D. 67 Director Ransom W. Etheridge 63 Director and Secretary Eraj Kiani 58 Director Each director has been elected to serve until the next annual meeting of stockholders, or until his earlier resignation, removal from office, death or incapacity. Each executive officer serves at the discretion of the Board of Directors, subject to rights, if any, under contracts of employment. WILLIAM A. CARTER, M.D., the co-inventor of Ampligen, joined Hemispherx in 1978, and has served as: (a) Hemispherx's Chief Scientific Officer since May 1989; (b) the Chairman of Hemispherx's Board of Directors since January 1992; 47 (c) Hemispherx's Chief Executive Officer since July 1993; (d) Hemispherx's President since April, 1995; and (e) a director since 1987. From 1987 to 1988, Dr. Carter served as Hemispherx's Chairman. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. Dr. Carter received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the U.S. under his supervision. From 1985 to October 1988, Dr. Carter served as Hemispherx's Chief Executive Officer and Chief Scientist. He received his M.D. degree from Duke University and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. Dr. Carter served as Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a professor at Johns Hopkins School of Medicine and the State University of New York at Buffalo. Dr. Carter is a Board certified physician and author of more than 200 scientific articles, including the editing of various textbooks on anti-viral and immune therapy. ROBERT E. PETERSON has served as Chief Financial Officer of the Company since April, 1993 and served as an Independent Financial Advisor to the Company from 1989 to April, 1993. Also, Mr. Peterson has served as Vice President of the Omni Group, Inc., a business consulting group based in Tulsa, Oklahoma since 1985. From 1971 to 1984, Mr. Peterson worked for PepsiCo, Inc. and served in various financial management positions including Vice President and Chief Financial Officer of PepsiCo Foods International and PepsiCo Transportation, Inc. Mr. Peterson is a graduate of Eastern New Mexico University. DAVID R. STRAYER, M.D. who served as Professor of Medicine at the Medical College of Pennsylvania and Hahnemann University, has acted as the Medical Director of the Company since 1986. He is Board Certified in Medical Oncology and Internal Medicine with research interests in the fields of cancer and immune system disorders. Dr. Strayer has served as principal investigator in studies funded by the Leukemia Society of America, the American Cancer Society, and the National Institutes of Health. Dr. Strayer attended the School of Medicine at the University of California at Los Angeles where he received his M.D. in 1972. CAROL A. SMITH, PH.D has served as the Company's Director of Manufacturing and Process Development since April 1995, as Director of Operations since 1993 and as the Manager of Quality Control from 1991 to 1993, with responsibility for the manufacture, control and chemistry of Ampligen(R). Dr. Smith was Scientist/Quality Assurance Officer for Virotech International, Inc. from 1989 to 1991 and Director of the Reverse Transcriptase and Interferon Laboratories and a Clinical Monitor for Life Sciences, Inc. from 1983 to 1989. She received her Ph.D. from the University of South Florida College of Medicine in 1980 and was an NIH post-doctoral fellow at the Pennsylvania State University College of Medicine. RICHARD C. PIANI has been a director of Hemispherx since 1995. Mr. Piani has been employed as a principal delegate for Industry to the City of Science and Industry, Paris, France, a billion dollar scientific and educational complex. Mr. Piani provided consulting to Hemispherx in 1993, with respect to general business strategies for Hemispherx's European operations and markets. Mr. Piani served as Chairman of Industrielle du Batiment-Morin, a building materials corporation, from 1986 to 1993. Previously Mr. Piani was a Professor of International Strategy at Paris Dauphine University from 1984 to 1993. From 1979 to 1985, Mr. Piani served as Group Director in Charge of International and Commercial Affairs for Rhone-Poulenc and from 1973 to 1979 he was Chairman and 48 Chief Executive Officer of Societe "La Cellophane", the French company which invented cellophane and several other worldwide products. Mr. Piani has a Law degree from Faculte de Droit, Paris Sorbonne and a Business Administration degree from Ecole des Hautes Etudes Commerciales, Paris. RANSOM W. ETHERIDGE has been a director of Hemispherx since October 1997, and presently serves as our Secretary. Mr. Etheridge first became associated with Hemispherx in 1980 when he provided consulting services to Hemispherx and participated in negotiations with respect to Hemispherx's initial private placement through Oppenheimer & Co., Inc. Mr. Etheridge has been practicing law since 1967, specializing in transactional law. Mr. Etheridge is a member of the Virginia State Bar, a Judicial Remedies Award Scholar, and has served as President of the Tidewater Arthritis Foundation. He is a graduate of Duke University, and received his Law degree from the University of Richmond School of Law. WILLIAM M. MITCHELL, M.D. has been a director of Hemispherx since July 1998. Dr. Mitchell is a Professor of Pathology at Vanderbilt University School of Medicine. Dr. Mitchell earned a M.D. from Vanderbilt and a Ph.D. from Johns Hopkins University, where he served as an Intern in Internal Medicine, followed by a Fellowship at its School of Medicine. Dr. Mitchell has published over 200 papers, reviews and abstracts dealing with viruses and anti-viral drugs. Dr. Mitchell has worked for and with many professional societies, including the International Society for Interferon Research, and committees, among them the National Institutes of Health, AIDS and Related Research Review Group. Dr. Mitchell previously served as a director of Hemispherx from 1987 to 1989. IRAJ E. KIANI, M.B.A., PHD., was appointed to the Board of Directors on May 1, 2002. Dr. Kiani is a citizen of England and resides in Newport, California. Dr. Kiani served in various local government position including the Governor of Yasoi, Capital of Boyerahmand, Iran. In 1980, Dr. Kiani moved to England, where he establish and managed several trading companies over a period of some 20 years. Dr. Kiani is a planning and logistic specialist who is now applying his knowledge and experience to build a worldwide immunology network which will use the Company's proprietary technology. Dr. Kiani received his Ph.D. degree from the University of Warwick in England. Compliance with Section 16(a) of the Exchange Act Section 16(a) of the Exchange Act requires our officers and directors, and persons who own more than ten percent of a registered class of equity securities, to file reports with the Securities and Exchange Commission reflecting their initial position of ownership on Form 3 and changes in ownership on Form 4 or Form 5. Based solely on a review of the copies of such forms received by us, we believe that, during the fiscal year ended December 31, 2002, all of our officers, directors and ten percent stockholders complied with all applicable Section 16(a) filing requirements on a timely basis. Audit Committee Expert Our Audit Committee of the Board of Directors consists of Richard Piani, Committee Chairman, William Mithcell, MD and Ransom Etheridge. Mr. Piani and Dr. Mitchell are Independent Directors. Mr. Etheridge is Secretary of our Company and is considered to be an insider. We do not have a financial expert on the 49 committee in the true sense of the description. However, Mr. Piani is a Businessman and has 40 years of experience of working with budgets, analyzing financials and dealing with financial institutions. Code of Ethics Our Board of Directors have not yet adopted a Code of Ethics that would apply to the Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer. However, we are in the process of preparing a Code of Ethics to be presented to the Board of Directors at the next meeting. Item 11. Executive Compensation. The summary compensation table below sets forth the aggregate compensation paid or accrued by us for the fiscal years ended December 31, 2002, 2001 and 2000 to (i) our Chief Executive Officer and (ii) our four most highly paid executive officers other than the CEO who were serving as executive officers at the end of the last completed fiscal year and whose total annual salary and bonus exceeded $100,000 (collectively, the "Named Executives"). 50
EXECUTIVE COMPENSATION SUMMARY COMPENSATION TABLE Name and Principal Position Year Salary ($) Restricted Stock Warrants & All Other Awards Options Awards Compensation (1) - ----------------------------- -------- ------------------ ------------------ ------------------- --------------- William A. Carter 2002 $468,830 - (8)1,000,000 $25,747 Chairman of 2001 (4) 456,608 - (2) 386,650 22,917 the Board and CEO 2000 (4) 539,620 - (5) 100,000 17,672 Robert E. Peterson 2002 $151,055 - (8) 200,000 - Chief 2001 146,880 - (3) 40,000 - Financial 2000 145,944 - - - Officer David R. Strayer, M.D. 2002 $178,594 - (8) 50,000 - Medical Director 2001 174,591 - (7) 10,000 - 2000 (6) 172,317 - - - Carol A. Smith, Ph.D. 2002 $128,346 - (8) 20,000 - Director 2001 124,800 - (7) 10,000 - of 2000 124,800 - - - Manufacturing
- ---------------------- (1)Consists of insurance premiums paid by Hemispherx with respect to term life and disability insurance for the benefit of the named executive officer. (2)Consists of 188,325 warrants to purchase common stock at $6.00 per share and 188,325 warrants to purchase common stock at $9.00 per share. Also includes a stock option grant of 10,000 shares exercisable at $4.03 per share. (3)Consist of a stock option grant of 10,000 shares exercisable at $4.03 per share and 30,000 warrants to purchase common stock at $5.00 per share. (4)Includes a bonus of $90,397 paid in 2000. Also includes funds previously paid to Dr. Carter by Hahnemann Medical University where he served as a professor until 1998. This compensation was continued by the Company and totaled $79,826 in 2000 and 2001, and $82,095 in 2002. (5)Represents warrants to purchase common stock exercisable at $6.25 per share. (6)Includes $98,926 paid by Hahnemann Medical University where Dr. Strayer served as a professor until 1998. This compensation was continued by the Company in 2000, 2001 and 2002. 51 (7)Consist of stock option grant of 10,000 shares exercisable at $4.03 per share. (8)Represents number of warrants to purchase shares of common stock at $2 per share. The following table sets forth certain information regarding stock warrants granted during 2002 to the executive officers named in the Summary Compensation Table.
- --------------------- -------------------------------------- ------------------ ---------------- -------------------------------- INDIVIDUAL GRANTS - --------------------- -------------------------------------- ------------------ ---------------- -------------------------------- - --------------------- ------------------- ------------------ ------------------ ---------------- -------------------------------- NAME NUMBER OF PERCENTAGE OF EXERCISE PRICE EXPIRATION DATE POTENTIAL REALIZABLE VALUE AT TOTAL WARRANTS SECURITIES GRANTED TO UNDERLYING EMPLOYEES IN WARRANTS GRANTED FISCAL YEAR ASSUMED RATES OF STOCK PRICE (1) 2002(2) PER SHARE (3) APPRECIATION FOR WARRANTS TERM - --------------------- ------------------- ------------------ ------------------ ---------------- -------------------------------- - -------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- 5% (4) 10%(4) - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- Carter, W.A. 1,000,000 61.6% $2 8/13/07 $1,879,500 $1,969,000 - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- Peterson, R. 200,000 12.3% $2 8/13/07 $375,900 $393,800 - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- Smith, C. 20,000 1.2% $2 8/13/07 $37,590 $39,380 - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- ----------------- Strayer, D. 50,000 3.1% $2 8/13/07 $93,975 $98,450 - --------------------- ------------------- ------------------ ------------------ ---------------- -------------- -----------------
(1) Warrants vest over a period ranging from two to four years. (2) Total warrants issued to employees in 2002 were 1,622,000. (3) The exercise price is equal to the closing price of the Company's common stock at the date of issuance. (4) Potential realizable value is based on an assumption that the market price of the common stock appreciates at the stated rates compounded annually, from the date of grant until the end of the respective option term. These values are calculated based on requirements promulgated by the Securities and Exchange Commission and do not reflect the Company's estimate of future stock price appreciation. 52 The following table sets forth certain information regarding the stock options held as of December 31, 2002 by the individuals named in the above Summary Compensation Table. AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR AND FISCAL YEAR-END OPTION VALUE
Securities Underlying Unexercised Value of Unexercised Options at Fiscal Year End number In-the-Money-Options At Fiscal Year Enddollars(1) Name Shares Value Exercisable Unexercisable Exercisable Unexercisable Acquired on Realized ($) Exercise (#) - ----------------- -------------- --------------- ------------------- --------------------- ------------------- ---------------- - ----------------- -------------- --------------- ------------------- --------------------- ------------------- --------------- William Carter - - 3,552,044(2) 753,334(3) $209,200 $97,500 Robert Peterson - - 314,240(4) 103,334(5) 6,300 6,300 David Strayer - - 101,666(6) 28,334(7) 3,250 3,250 Carol Smith - - 28,457(8) 13,334(9) 1,300 1,300 - ----------------------------
(1)Computation based on $2.13, the December 31, 2002 closing bid price for the common stock on the American Stock Exchange. (2) Consist of (i) 250,000 warrants exercisable at $2.00 per share expiring on August 13, 2007 (ii) 188,325 warrants exercisable at $6.00 per share expiring on February 22, 2006 (iii) 188,325 warrants exercisable at $9.00 per share expiring on February 22, 2006 (iv) 100,000 warrants exercisable at $6.25 per share expiring on April 8, 2004 (v) 25,000 warrants exercisable at $6.50 per share expiring on September 17, 2004 (vi) 25,000 warrants exercisable at $8.00 per share expiring on September 17, 2004 and 6,666 stock option exercisable at $4.03 per share expiring on January 3, 2011. Also include 2,768,728 warrants and options held in the name of Carter Investments, L.C. of which W.A. Carter in the principal beneficiary. These securities consist of (i)340,000 warrants exercisable at $4.00 per share expiring on January 1, 2008,(ii) 170,000 warrants exercisable at $5.00 per share expiring on January 1, 2005,(iii) 300,000 warrants exercisable a t $6.00 per share expiring on January 1, 2005 (iv) 20,000 warrants exercisable at $4.00 per share expiring on 2008,(v) 465,000 warrants exercisable at $1.75 expiring on June 3, 2005,(vi) 1,400,000 warrants 53 exercisable at $3.50 per share expiring on October 16, 2004 and 73,728 stock options exercisable at $2.71 per share until exercised. (3) Consist of (i) 750,000 warrants exercisable at $2.00 per share expiring on August 13, 2007, and (ii) 3,334 start options exercisable at $4.03 per share expiring on January 3, 2011. (4) Consist of (i) 6,666 stock options exercisable at $4.03 per share expiring on January 3, 2011 (ii) 13,750 stock options exercisable at $3.50 per share expiring on January 22, 2007, (iii) 13,824 stock option exercisable at $4.34 per share expiring on July 17, 2003, (iv) 100,000 warrants exercisable at $2.00 per share expiring on August 13, 2007, (v) 50,000 warrants exercisable at $3.50 expiring on March 1, 2006, (vi) 100,000 warrants exercisable at $5.00 per share expiring on April 14, 2006 and (vii) 30,000 warrants exercisable at $5.00 per share expiring on February 28, 2009. (5) Consist of (I) 100,000 warrants exercisable at $2.00 per share expiring on August 13, 2007 and (ii) 3,334 stock options exercisable at $4.03 per share expiring on January 3, 2011. (6) Consist of (i) 25,000 warrants exercisable at $2.00 per share expiring on August 13, 2007, (ii) 50,000 warrants exercisable at $4.00 per share expiring on February 28, 2008, (iii) 6,666 stock options exercisable at $4.08 expiring on January 3, 2011 and (iv) 20,000 stock options exercisable at $3.50 per share expiring on January 22, 2007. (7) Consist of 25,000 warrants exercisable at $2.00 per share expiring on August 13, 2007 and 3,334 stock options exercisable at $4.03 per share expiring on August 13, 2007. (8) Consist of (I) 10,000 warrants exercisable at $2.00 per share expiring on August 13, 2007, (ii) 5,000 warrants exercisable at $4.00 per share expiring on June 7, 2008, (iii) 6,666 stock options exercisable at $4.03 per share expiring on January 3, 2016, and (iv) 6,791 stock options exercisable at $3.50 per share expiring on January 22, 2007. (9) Consist of 10,000 warrants exercisable at $2.00 per share and 3,334 stock options exercisable at $4.03 per share expiring on January 3, 2004. Employment Agreements Hemispherx entered into an amended and restated employment agreement with its President and Chief Executive Officer, Dr. William A. Carter, dated as of December 3, 1998, which provided for his employment until May 8, 2004 at an initial base annual salary of $361,586, subject to annual cost of living increases. In addition, Dr. Carter could receive an annual performance bonus of up to 25% of his base salary, at the sole discretion of the board of directors. Dr. Carter will not participate in any discussions concerning the determination of his annual bonus. Dr. Carter is also entitled to an incentive bonus of 0.5% of the gross proceeds received by Hemispherx from any joint venture or corporate partnering arrangement, up to an aggregate maximum incentive bonus of $250,000 for all such transactions. Dr. Carter's agreement also provides that he be paid a base salary and benefits through May 8, 2004 if he is terminated without "cause", as that term is defined in the agreement. This agreement was extended 54 to May 8, 2008. Pursuant to his original agreement, as amended on August 8, 1991, Dr. Carter was granted options to purchase 73,728 shares of Hemispherx's common stock at an exercise price of $2.71 per share. Hemispherx entered into an amended and restated engagement agreement with Robert E. Peterson dated April 1, 2001 which provides for Mr. Peterson's employment as Hemispherx's Chief Financial Officer until December 31, 2003 at an annual base salary of $155,988 per year, subject to annual cost of living increases. In addition, Mr. Peterson shall receive bonus compensation upon Federal Drug Administration approval of Ampligen based on the number of years of his employment by Hemispherx up to the date of such approval. During 2002, Mr. Peterson also received 200,000 warrants to purchase shares of common stock with an exercise price of $2.00. Compensation of Directors The existing compensation package was put in place in 2000. Board member compensation consists of an annual retainer to $35,000 plus $1,000 per meeting attended. Committee chairmen each receive an additional retainer of $5,000 per year and committee members each receive an additional retainer of $3,000 per year. All non-employee directors received some compensation in 2001 for special project work performed on behalf of Hemispherx. All directors have been granted options to purchase common stock under Hemispherx's 1990 Stock Option Plan and/or Warrants to purchase common stock. Hemispherx believes such compensation and payments are necessary in order for Hemispherx to attract and retain qualified outside directors. 1993 Stock Option Plan Hemispherx's 1993 Stock Option Plan ("1993 Plan"), provides for the grant of options for the purchase of up to an aggregate of 138,240 shares of common stock to Hemispherx's employees, directors, consultants and others whose efforts are important to the success of Hemispherx. The 1993 Plan is administered by the Compensation Committee of the board of directors, which has complete discretion to select the eligible individuals to receive and to establish the terms of option grants. The 1993 Plan provides for the issuance of either non-qualified options or incentive stock options, provided that incentive stock options must be granted with an exercise price of not less than fair market value at the time of grant and that non-qualified stock options may not be granted with an exercise price of less than 85% of the fair market value at the time of grant. The number of shares of common stock available for grant under the 1993 Plan is subject to adjustment for changes in capitalization. This plan terminates as of July 7, 2003. To date, no options have been granted under the 1993 Plan. 1992 Stock Option Plan Hemispherx's 1992 Stock Option Plan ("1992 Plan"), provides for the grant of options for the purchase of up to an aggregate of 92,160 shares of common stock to Hemispherx's employees, directors, consultants and others whose efforts are important to the success of Hemispherx. The 1992 Plan is administered by the 55 Compensation Committee of the board of directors, which has complete discretion to select the eligible individuals to receive and to establish the terms of option grants. The 1992 Plan provides for the issuance of either non-qualified options or incentive stock options, provided that incentive stock options must be granted with an exercise price of not less than fair market value at the time of grant and that non-qualified stock options may not be granted with an exercise price of less than 50% of the fair market value at the time of grant. The number of shares of common stock available for grant under the 1992 Plan is subject to adjustment for changes in capitalization. This plan expired as of December 3, 2002. No options were granted under the 1992 Plan. 1990 Stock Option Plan Hemispherx's 1990 Stock Option Plan, as amended ("1990 Plan"), provides for the grant of options to employees, directors, officers, consultants and advisors of Hemispherx for the purchase of up to an aggregate of 460,798 shares of common stock. The 1990 plan is administered by the Compensation Committee of the board of directors, which has complete discretion to select eligible individuals to receive and to establish the terms of option grants. The number of shares of common stock available for grant under the 1990 Plan is subject to adjustment for changes in capitalization. As of December 31, 2001, options to acquire an aggregate of 154,535 shares of the common stock were available for grants under the 1990 plan. This plan remains in effect until terminated by the Board of Directors or until all options are issued. 401(K) Plan In December 1995, Hemispherx established a defined contribution plan, effective January 1, 1995, entitled the Hemispherx Biopharma employees 401(K) Plan and Trust Agreement. All full time employees of Hemispherx are eligible to participate in the 401(K) plan following one year of employment. Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions) per annum. Participants' contributions to the 401(K) plan may be matched by Hemispherx at a rate determined annually by the board of directors. Each participant immediately vests in his or her deferred salary contributions, while Hemispherx contributions will vest over one year. In 2002 Hemispherx provided matching contributions to each employee for up to 6% of annual pay for a total of $38,000 for all employees. Compensation Committee Interlocks and Insider Participation During the fiscal year ended December 31, 2002, the members of Hemispherx's Compensation Committee were Ransom W. Etheridge and Richard Piani. Mr. Etheridge serves as the Company's Secretary and he is an attorney in private practice and has rendered legal services to Hemispherx for which he received a fee. Mr. Piani received fees for certain consulting work performed in Europe on behalf of the Company. Refer to Item 13. "Certain Relationships and Related Transactions" for more information. Compensation Committee Report on Compensation The Compensation Committee makes recommendations concerning salaries and compensation for employees of and consultants to Hemispherx. The following report of the compensation committee discusses our executive 56 compensation policies and the basis of the compensation paid to our executive officers in 2002. In general, the compensation committee seeks to link the compensation paid to each executive officer to the experience and performance of such executive officer. Within these parameters, the executive compensation program attempts to provide an overall level of executive compensation that is competitive with companies of comparable size and with similar market and operating characteristics. There are three elements in Hemispherx executive total compensation program, all determined by individual and corporate performance as specified in the various employment agreements; base salary, annual compensation, and long-term incentives. Base Salary The Summary Compensation Table shows amounts earned during 2002 by our executive officers. The base compensation of such executive officers is set by terms of the employment agreement entered into with each such executive officer. The Company established the base salaries for Chief Executive Officer, Dr. William A. Carter under an employment agreement in December 3, 1998 (as amended on August 14, 2003), which provides for a base salary of $361,586 until May 8, 2008. Also we entered into an extended employment agreement with Robert E. Peterson, Chief Financial Officer for a base salary of $155,988 until December 31, 2003. Dr. Carter and Mr. Peterson's agreements allow for annual cost of living increases. Dr. Carter's compensation also includes funds previously paid to Dr. Carter by Hahneman Medical University where he served as a professor until 1998. This compensation was continued by the Company and totaled $79,826 in each of 2000 and 2001, and $82,095 in 2002. Annual Incentive Our Chief Executive Officer and our Chief Financial Officer are entitled to an annual incentive bonus as determined by the compensation committee based on such executive officers' performance during the previous calendar year. The cash bonus awarded to the company's Chief Executive Officer in 1999 and 2000 was determined based on this provision of his employment agreement. Performance Graph ANNUAL RETURN PERCENTAGE Years Ending Company Name / Index Dec98 Dec99 Dec00 Dec01 Dec02 - ------------------------------------------------------------------------------- HEMISPHERX BIOPHARMA INC 69.25 44.55 -52.20 -5.26 -52.67 S&P SMALLCAP 600 INDEX -1.31 12.40 11.80 6.54 -14.63 PEER GROUP 6.85 13.61 54.46 63.31 -7.96 INDEXED RETURNS Base Years Ending Period Company Name / Index Dec97 Dec98 Dec99 Dec00 Dec01 Dec02 - ------------------------------------------------------------------------------ HEMISPHERX BIOPHARMA INC 100 169.25 244.65 116.94 110.78 52.44 S&P SMALLCAP 600 INDEX 100 98.69 110.94 124.03 132.13 112.80 PEER GROUP 100 106.85 121.39 187.50 306.22 281.85 Peer Group Companies - ------------------------------------------------------------------------------ GILEAD SCIENCES INC ISIS PHARMACEUTICALS INC 57 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The following table sets forth as of April 1, 2003 the number and percentage of outstanding shares of common stock beneficially owned by each of our Directors and the Named Executives, and all of our executive officers and directors as a group. As of December 31, 2002, there were no other persons, individually or as a group, known to the Hemispherx to be deemed the beneficial owners of five percent or more of the issued and outstanding common stock. 58 OFFICERS, DIRECTORS AND % OF SHARES PRINCIPAL STOCKHOLDERS SHARES BENEFICIALLY OWNED BENEFICIALLY OWNED (1) - ------------------------- -------------------------- ---------------------- William A. Carter, M.D. 4,246,034 (2) 11.4 Robert E. Peterson 314,074 (3) * Ransom W. Etheridge 214,316 (4) * Richard C. Piani 196,747 (5) * William M. Mitchell, M.D. 200,640 (6) * David R. Strayer, M.D. 87,246 (7) * Carol A. Smith, Ph.D 28,457 (8) * Araj-Eghbal Kiani 12,000 (9) All directors and executive officers as a group (8 persons) 5,299,514 13.7 - -------------------- * Less than 1% (1) For purposes of this table, a person or group of persons is deemed to have "beneficial ownership" of any shares of common stock which such person has the right to acquire within 60 days of April 1, 2003. For purposes of computing the percentage of outstanding shares of common stock held by each person or group of persons named above, any security which such person or persons has or have the right to acquire within such date is deemed to be outstanding but is not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. Except as indicated in the footnotes to this table and pursuant to applicable community property laws, Hemispherx believes based on information supplied by such persons, that the persons named in this table have sole voting and investment power with respect to all shares of common stock which they beneficially own. (2) Includes (i) an option to purchase 73,728 shares of common stock from Hemispherx at an exercise price of $2.71 per share and expiring on August 8, 2004, (ii) Rule 701 Warrants to purchase 1,400,000 shares of common stock at a price of $3.50 per share, originally expiring on September 30, 2002 was extended to September 30,2007; (iii) warrants to purchase 465,000 shares of common stock at $1.75 per share issued in connection with the 1995 Standby Financing Agreement and expiring on June 30, 2005; (iv) 340,000 common stock warrants exercisable at $4.00 per share and originally expiring on January 1, 2003 was extended to January 1, 2008; (v) 170,000 common stock warrants exercisable at $5.00 per share and expiring on January 2, 2005;(vi) 25,000 warrants to purchase common stock at $6.50 per share and expiring on September 17, 2004;(vii) 25,000 warrants to purchase common stock at $8.00 per share and expiring on September 17, 2004;(viii) 100,000 warrants to purchase common stock at $6.25 per share and expiring on April 8, 2004; (ix) 20,000 warrants to purchase common stock at $4.00 per share originally expiring January 1, 2003 was extended to January 1, 2008, (x) 188,325 common stock warrants exercisable at $6.00 per share and expiring on February 22, 2006; (xi) 188,325 common stock warrants exercisable at $9.00 per share and expiring on February 22, 2006 (xii) 300,000 common stock warrants granted in 1998 that are exercisable at $6.00 per share and expiring on January 1, 2006 (xiii) options to purchase 6,666 shares of common stock at $4.03 per share and expiring on January 3, 2011 (XIV) 250,000 warrants exercisable $2.00 per share in August 13, 2007 and 693,990 shares of common stock. (3) Includes (i) 27,574 options to purchase common stock at an average 59 exercise price of $3.92 per share, expiring on July 17, 2003; (ii) warrants to purchase 50,000 shares of Common stock at an exercise price of $3.50 per share, expiring on March 1, 2006; (iii) warrants to purchase 100,000 shares of common stock at $5.00 per share, expiring on April 14, 2006; (iv) 30,000 warrants to purchase common stock at $5.00 per share an expiring on February 28, 2009 (v) options to purchase 6,000 shares at $4.03 per share that expire on January 3, 2011 (VI) 200,000 warrants exercised at $2.00 per share expiring on November 13, 2007 and (v) 500 shares of common stock. (4) Includes 20,000 warrants to purchase common stock at $4.00 per share, originally expiring on January 1, 2003 and was extended to January 1, 2008; 25,000 warrants to purchase common stock at $6.50 per share; 25,000 warrants to purchase common stock at $8.00 per share, all expiring on September 12, 2004; 100,000 warrants exercisable $2.00 per share expiring on August 13, 2007 and 44,316 shares of common stock. (5) Includes (i) 20,000 warrants to purchase common stock at $4.00 per share; (ii) warrants to purchase 25,000 shares of common stock at $6.50 per share; (iii) 25,000 warrants to purchase common stock at $8.00 per share, all expiring on September 17, 2004;(vi) 100,000 warrants exercisable at $2.00 per share expiring on August 13, 2007, (vi) 8,847 shares of common stock owned by Mr. Piani (vi) 12,900 shares of common stock owned jointly by Mr. and Mrs. Piani; and (vii) 5000 shares of common stock owned by Mrs. Piani. (6) Includes (I) warrants to purchase 12,000 shares of common stock at $6.00 per share, expiring on August 25, 2003; (ii) 25,000 warrants to purchase common stock at $6.50 per share; (iii) 25,000 warrants to purchase common stock at $8.00 per share all expiring on September 17, 2004; (iv) 100,000 warrants exercisable at $2.00 per share expiring in August 13, 2007 and 13,640 shares of common stock. (7) Includes (i) stock options to purchase 20,000 shares of common stock at $3.50 per share; (ii) 50,000 warrants to purchase common stock at $4.00 per share; (iii) 2,500 stock options exercisable at $4.03 per share and expiring on January 3, 2011 and; (iv)14,746 shares of common stock. (8) Consists of 5,000 warrants to purchase common stock at $4.00 per share expiring June 7, 2003; 6,791 stock options exercisable at $3.50 expiring January 22, 2007 10,000 warrants exercisable at $2.00 per share expiring in August 13, 2007 and options to purchase 6,666 shares of common stock at $ 4.03 per share expiring on January 3, 2011. (9) Consist of 12,000 warrants exercisable at $3.86 per share expiring on April 30, 2005. Item 13. Certain Relationships and Related Transactions. We have employment agreements with certain of our executive officers and have granted such officers and directors of the Company options and warrants to purchase common stock of the Company, as discussed under the headings, "Item 11. Executive Compensation," and "Item 12. Security Ownership of Certain Beneficial Owners and Management," above. Ransom W. Etheridge, a director of the Company, is an attorney in private practice who has rendered corporate legal services to us from time to time, for which he has received fees. Richard Piani, a Director of the Company, lives in Paris, France and assists our European subsidiary in their dealings with medical institutions and the European Medical Evaluation Authority. William Mitchell, 60 M.D. a Director of the Company, works with David Strayer, M.D. (our Medical Director) in establishing clinical trail protocols as well as performs other scientific work for us from time to time. For these services, these Directors were paid an aggregate of $170,150 in the year 2002. No individual Director was paid in excess of $60,000.00. William A. Carter, Chief Executive Officer of the Company, received an aggregate of $12,486 in short term advances which were repaid as of December 31, 2001. All advances bear interest at 6% per annum. The Company loaned $60,000 to Ransom W. Etheridge, a Director of the Company in November, 2001 for the purpose of exercising 15,000 class A redeemable warrants. This loan bears interest at 6% per annum. Dr. Carter's short term advances and Mr. Etheridge's loan was approved by the board of Directors. We paid $33,450 to Carter Realty for the rent of property used at various times in 2002 by us. The property is owned by others and managed by Carter Realty. Carter Realty is owned by Robert Carter, the brother of William A. Carter. ITEM 14. Controls and Procedures. Our management, including the Chairman of the Board (serving as the principal executive officer) and the Chief Financial Officer, have conducted an evaluation of the effectiveness of disclosure controls and procedures pursuant to Exchange Act Rule 13a-14. Based on that evaluation, the Chairman of the Board and the Chief Financial Officer concluded that the disclosure controls and procedures are effective in ensuring that all material information required to be filed in this annual report has been made known to them in a timely fashion. There have been no significant changes in internal controls, or in other factors that could significantly affect internal controls, subsequent to the date the Chairman of the Board and Chief Financial Officer completed their evaluation. ITEM 15. Principal Accounting Fees and Services. All work to be performed by our independent accountants is put forth in engagement letters which also includes estimates of the cost of performing the work. All engagement letters are presented to the Audit Committee for review and approval. During 2002, our independent Accountants, BDO Seidman, LLP have billed us $102,707 for services consisting of the annual audit and reviews of the Company's quarterly financial statements and $4,435 for the review of the Company's proxy materials, other SEC filings and other services. We did not retain BDO Seidman, LLP for any professional services relating to financial information system design or implementation. PART IV ITEM 16. Exhibits, Financial Statement Schedules and Reports on Form 8-K (a)(1)(2)Financial Statements and Schedules - See index to financial statements on page F-1 of this Annual Report. (a)(3) Exhibits - See exhibit index below. (b) Exhibits and Reports on Form 8K 61 During the fourth quarter 2002, we filed the following Current Reports on Form 8-K: Report filed on March 12, 2003, concerning events that occurred on March 11, 2003. (c) As of the date of the filing of this Annual Report on Form 10-K no proxy materials have been furnished to security holders. Copies of all proxy materials will be sent to the Commission in compliance with its rules. Except as disclosed in the footnotes, the following exhibits were filed with the Securities and Exchange Commission as exhibits to the Company's Form S-1 Registration Statement (No. 33-93314) or amendments thereto and are hereby incorporated by reference: Exhibit No. Description 2.1 First Asset Purchase Agreement dated March 11, 2003, by and between the Company and ISI.* 2.2 Second Asset Purchase Agreement dated March 11, 2003, by and between the Company and ISI.* 3.1 Amended and Restated Certificate of Incorporation of the Company, as amended, along with Certificates of Designations 3.1.1 Series E Preferred Stock 3.2 By-laws of Registrant, as amended 4.1 Specimen certificate representing our Common Stock 4.2 Form of Class A Redeemable Warrant Certificate 4.3 Form of Underwriter's Unit Option Purchase Agreement 4.4 Form of Class A Redeemable Warrant Agreement with Continental Stock and transfer and Trust Company 4.5 Rights Agreement, dated as of November 19, 2002, between the Company and Continental Stock Transfer & Trust Company. The Right Agreement includes the Form of Certificate of Designation, Preferences and Rights of the Series A Junior Participating Preferred Stock, the Form of Rights Certificate and the Summary of the Right to Purchase Preferred Stock.** 10.1 1990 Stock Option Plan 10.2 1992 Stock Option Plan 10.3 1993 Employee Stock Purchase Plan 10.4 Form of Confidentiality, Invention and Non-Compete Agreement 10.5 Form of Clinical Research Agreement 10.6 Form of Collaboration Agreement 10.7 Amended and Restated Employment Agreement by and between the Company and Dr. William A. Carter, dated as of July 1, 1993 10.8 Employment Agreement by and between the Registrant and Harris Freedman, dated August 1, 1994 10.9 Employment Agreement by and between the Company and Sharon Will dated August 1, 1994 10.10 License Agreement by and between the Company and The Johns Hopkins University, dated December 31, 1980 10.11 Technology Transfer, Patent License and Supply Agreement by and between the Company, Pharmacia LKB Biotechnology Inc., Pharmacia P-L Biochemicals Inc. and E.I. du Pont de Nemours and Company, dated November 24, 1987 10.12 Pharmaceutical Use Agreement, by and between the Company and Temple University, dated August 3, 1988 62 10.13 Assignment and Research Support Agreement by and between the Company, Hahnemann University and Dr. David Strayer, Dr. lsadore Brodsky and Dr. David Gillespie, dated June 30, 1989 10.14 Lease Agreement between the Company and Red Gate Limited Partnership, dated November 1, 1989, relating to the Company's Rockville, Maryland facility 10.15 Agreement between the Company and Bioclones (Proprietary) Limited 10.16 Amendment, dated August 3, 1995, to Agreement between the Company and Bioclones (Proprietary) Limited (contained in Exhibit (10.46) 10.17 Amended employment agreement by and between the Company and Robert E. Peterson dated April 1, 2001 10.18 Forbearance Agreement dated March 11, 2003, by and between ISI, the American National Red Cross and the Company.* 10.19 Forbearance Agreement dated March 11, 2003, by and between ISI, GP Strategies Corporation and the Company.* 10.20 Securities Purchase Agreement, dated March 12, 2003, by and among the Company and the Buyers named therein.* 10.21 Form of 6% Convertible Debenture of the Company.* 10.22 Form of Warrant for Common Stock of the Company.* 10.23 Registration Rights Agreement, dated March 12, 2003, by and among the Company and the Buyers named therein.* 10.24 Agreement with Esteve. 10.25 Agreement with Gentiva Health Services. 21 Subsidiaries of the Registrant 23.01 BDO Seidman, LLP consent 99.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 99.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. * Filed with the Securities and Exchange Commission as an exhibit to the Company's Current Report on Form 8-K (No. 0-27072) dated March 12, 2003 and is hereby incorporated by reference. ** Filed with the Securities and Exchange Commission on November 20, 2002 as an exhibit to the Company's Registration Statement on Form 8-A (No. 0-27072) dated March 12, 2003 and is hereby incorporated by reference. *** Filed herewith. 63 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. HEMISPHERx BIOPHARMA, INC. By: /S/William A. Carter, M.D. William A. Carter, M.D. Chief Executive Officer April 11, 2003 We, the undersigned officers and directors of Hemispherx Biopharma, Inc. hereby severally constitute William A. Carter, our true and lawful attorney with full power to him, and to him singly, to sign for us and in our names in the capacities indicated below, any and all reports (including any amendments thereto), with all exhibits thereto and any and all documents in connection therewith, and generally do all such thing in our name and on our behalf in such capacities to enable Hemispherx Biopharma, Inc. to comply with the applicable provision of Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission, and we hereby ratify and confirm our signatures as they may be signed by our said attorneys, to any and all such reports (including any Amendments thereto) and other documents in connection therewith. Pursuant to the requirements of Section 13 or (d) of the Securities Exchange of 1934, as amended, this report has been signed below by the following persons on behalf of this Registrant and in the capacities and on the dates indicated. /S/William A. Carter Chairman of the Board, Chief Executive - ---------------------- William A. Carter, M.D. Officer and Director April 11 2003 /s/Richard Piani Director April 11 2003 - ---------------------- Richard Piani /S/Robert E. Peterson Chief Financial Officer April 11 2003 - ---------------------- Robert E. Peterson /S/Ransom Etheridge Secretary And Director April 11 2003 - ---------------------- Ransom Etheridge /s/William Mitchell Director April 14 2003 - ---------------------- William Mitchell,M.D.,Ph.D. /s/Iraj Kiani Director April 14 2003 - ---------------------- Iraj Kiani 64 CERTIFICATIONS Certifications pursuant to Securities and Exchange Act of 1934 Rule 13a-14 as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002: I, William A. Carter, M.D., Chief Executive Officer of Hemispherx Biopharma, Inc. (the "Company") certify that: (1) I have reviewed this annual report on Form 10-K of the Company; (2) Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report; and (3) Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this annual report. /S/William A. Carter ----------------------- William A. Carter, M.D. Chief Executive Officer April 11, 2003 I, Robert Peterson, Chief Financial Officer of Hemispherx Biopharma, Inc. (the "Company") certify that: (1) I have reviewed this annual report on Form 10-K of the Company; (2) Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report; and (3) Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this annual report. S/ Robert E. Peterson ---------------------- Robert Peterson Chief Financial Officer April 11, 2003 1 HEMISPHERx BIOPHARMA, INC AND SUBSIDIARIES Index to Consolidated Financial Statements Page Report of Independent Certified Public Accountants. . . . . F-2 Consolidated Balance Sheets at December 31, 2001 and 2002 . . F-3 Consolidated Statements of Operations for each of the years in the three-year period ended December 31, 2002. . . . . . . F-4 Consolidated Statements of Changes in Stockholders' Equity and Comprehensive (Loss) for each of the years in the three-year period ended December 31, 2002 . . . . . . F-5 Consolidated Statements of Cash Flows for each of the years in the three-year period ended December 31, 2002 . . . . . . .F-6 Notes to Consolidated Financial Statements . . . . . .. . . . F-8 F-1 Report of Independent Certified Public Accountants The Board of Directors and Stockholders Hemispherx Biopharma, Inc. We have audited the accompanying consolidated balance sheets of Hemispherx Biopharma, Inc. and subsidiaries as of December 31, 2001 and 2002 the related consolidated statements of operations, changes in stockholders' equity and comprehensive (loss) and cash flows for each of the three years in the period ended December 31, 2002. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Hemispherx Biopharma, Inc. and subsidiaries as of December 31, 2001 and 2002 and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2002 in conformity with accounting principles generally accepted in the United States of America. /s/ BDO SEIDMAN, LLP Philadelphia, Pennsylvania March 13, 2003, except for note 12, which is as of March 31, 2003 F-2
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Balance Sheets December 31, 2001 and 2002 (in thousands) December 31, ------------------------ 2001 2002 ------- ------- ASSETS Current assets: Cash and cash equivalents. . . . . $3,107 $ 2,256 Short term investments (Note 3). . 5,310 555 Other receivables (Note 12) 8 1,507 Prepaid expenses and other current assets . . . . . . 381 71 ------- --------- Total current assets . . . . . . 8,806 4,389 Property and equipment, net . . . . 246 155 Patent and trademark rights, net. . 1,025 995 Investments in unconsolidated affiliates 1,878 408 Other assets . . . . . . . . . 80 93 ------- --------- Total assets. . . . . . . . . . $12,035 $ 6,040 ======= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable . . . . . . . . . $ 979 $ 786 Accrued expenses (Note 4). . . . . 293 678 ------- --------- Total current liabilities . . . 1,272 1,464 ------- --------- Commitments and contingencies (Notes 7,9, 10 and 12) Minority Interest in subsidiary (Note)(5c) - 946 Stockholders' equity (Note 5): Common stock. . . . . . . . . . . 33 33 Additional paid-in capital. . . . 106,832 107,155 Accumulated other comprehensive income (Note 2i). . . . . . . . . 17 35 Accumulated deficit . . . . . . . . (91,649) (99,073) Treasury stock . . . . . . . . . . (4,470) (4,520) -------- ---------- Total stockholders' equity. . . 10,763 3,630 -------- ---------- Total liabilities and stockholders' equity . . . . . $12,035 $ 6,040 ======== ==========
See accompanying notes to consolidated financial statements. F-3
HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Statements of Operations For each of the years in the three-year period ended December 31, 2002 (in thousands, except share and per share data) December 31, --------------------------------- 2000 2001 2002 ------- ------- ------ Revenue: . . . . . . . . . . $788 $390 $341 License Fee income (Note9) - - 563 ------- ------- ------ 788 390 904 Costs and expenses: Research and development . . . . 6,136 5,780 4,946 General and administrative . . . . . . . 3,695 3,412 2,015 ------- ------- ------- Total costs and expenses . . . 9,831 9,192 6,961 Equity loss and write offs of investments in unconsolidated affiliates (Note 2c) (81) (565) (1,470) Interest and other income . . . . 572 284 103 ------- ------- ------- Net loss. . . . . . . . . . . $ (8,552) $ (9,083) $(7,424) ======== ======== ======== Basic and diluted loss per share. . $(.29) $(.29) $(.23) ======= ======== ======= Weighted average shares outstanding. . . . . . . . . . 29,251,846 31,433,208 32,085,776 ========== ========== ===========
See accompanying notes to consolidated financial statements. F-4 HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders' Equity and Comprehensive (loss)-beginning For each of the years in the three-year period ended December 31, 2002 (in thousands except share data )
Common Common Additional Stock Stock paid in Deferred Accumulated other Shares .001 Par capital Compensarion Comprehensive Value Income (loss) ---------- ------------- ------------ ------------- -------------- Balance at December 31, .. 27,974,507 $ 28 $ 87,972 $ (310) $ -- Common stock issued ...... 2,393,381 9,860 -- -- 2 Purchase of equity ....... -- -- 67 -- -- investment Treasury stock purchased . -- -- -- -- -- Treasury stock issued in -- -- 8 -- -- settlement of debt Stock compensation and ... -- -- 87 310 -- service expense, net Registration costs ....... -- -- (10) -- -- Net comprehensive (loss) -- -- -- -- 34 ---------- ------------- ------------ ------------- -------------- Balance at December 31, .. 30,367,888 30 97,984 -- 34 Common stock issued ...... 2,155,900 3 8,072 -- -- Purchase of equity investment ............... 12,000 -- 72 -- -- Treasury stock purchased . -- -- -- -- -- Note issued for purchase of stock ................. -- -- (60) -- -- Stock issued in settlement of debt ....... 21,198 -- 91 -- -- Stock and stock warrant .. 19,000 -- 673 -- -- compensation expense Net comprehensive (loss) . -- -- -- -- (17) ---------- ------------- ------------ ------------- -------------- Balance at December 31,2001 32,575,986 33 106,832 -- 17 Common stock issued ..... -- -- 37 -- -- Treasury stock Purchased . -- -- -- -- -- Stock issued in settlement of debt ....... 48,392 -- 154 -- -- Stock and stock warrant .. -- -- compensation expense ..... -- -- 132 Net comprehensive (loss) . -- 18 ----------- ------------- ------------ ------------- -------------- Balance at December 31,2002 32,650,178 $ 33 $ 107,155 $ -- $ 35 =========== ============= ============ ============= ============= F-5a See accompanying notes to consolidated financial statements
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders' Equity and Comprehensive (loss)-continued For each of the years in the three-year period ended December 31, 2002 (in thousands except share data ) Treasury Total Accumulated stock Treasury stockholders' deficit shares stock equity ----------- -------- --------- ------------- Balance at December 31, .. $(74,014) 167,935 $ (1,019) $12,657 Common stock issued ...... -- (20,000) 123 9,985 Purchase of equity ....... -- (100,000) 551 618 investment Treasury stock purchased . -- 350,800 (3,591) (3,591) Treasury stock issued in settlement of debt ....... -- (3,089) 26 34 Stock compensation and service expense, net...... -- -- -- 397 Registration costs ....... -- -- -- (10) Net comprehensive (loss) (8,552) -- -- (8,518) ---------- -------- --------- ------------ Balance at December 31,2000 (82,566) 395,646 (3,910) 11,572 Common stock issued ...... -- -- -- 8,075 Purchase of equity investment ............... -- -- -- 72 Treasury stock purchased . -- 120,060 (560) (560) Note issued for purchase of stock ................. -- -- -- (60) Stock issued in settlement of debt ....... -- -- -- 91 Stock and stock warrant .. -- -- -- 673 Net comprehensive (loss) . (9,083) -- -- (9,100) ---------- -------- --------- ------------ Balance at December 31,2001 (91,649) 515,706 (4,470) 10,763 Common stock issued ..... -- -- -- 37 Treasury stock Purchased . -- 27,500 (50) (50) Stock issued in settlement of debt ....... -- -- -- 154 Stock and stock warrant .. -- -- -- 132 Net comprehensive (loss) . (7,424) -- -- (7,424) ---------- -------- --------- ------------ Balance at December 31,2002 $(99,073) 543,206 $(4,520) $3,630 ========== ========= ========= ============ F-5b See accompanying notes to consolidated financial statements
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows for each of the years in the three-year period ended December 31, 2002 (in thousands)
December 31, ----------------------------- 2000 2001 2002 ------ ------ ------ Cash flows from operating activities: Net loss . . . . . . . . . . . . . $ (8,552) $(9,083) $(7,424) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation of property and equipment. . . . . . . . . . . 131 127 91 Amortization of patent and trademark rights . . . . . . . . 356 397 206 Equity loss and write offs of investments in unconsolidated affiliates. . 81 565 1,470 Stock compensation and service expense . . . . . . . . . 397 673 132 Changes in assets and liabilities: Other receivables. . . . . . . . 15 52 (1,293) Prepaid expenses and other current assets. . . (463) 202 104 Accounts payable . . . . . . . . . 210 (271) (67) Accrued expenses . . . . . . . . . (266) 139 385 Security deposits. . . . . . . . . 17 (82) (13) -------- --------- -------- Net cash used in operating activities. . . . . . (8,074) (7,281) (6,409) --------- --------- -------- Cash flows from investing activities: Purchase of property and equipment . (171) - - Additions to patent and trademark rights . (197) (218) (176) Maturity of short term investments . 2,157 4,613 5,293 Purchase of short term investments . (4,589) (5,293) (520) Investments in unconsolidated affiliates (411) (22) - Other investments. . . . . . . . . . (34) - - ------- --------- -------- Net (used in) cash provided by investing activities . . (3,245) (920) 4,597 -------- --------- --------
F-6
(CONTINUED) HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows (Continued) (in thousands) December 31, ----------------------------- 2000 2001 2002 ------ ------ ------ Cash flows from financing activities: Proceeds from stock subscriptions and issuance of common stock, net. . . . 2,250 72 $ 65 Proceeds from issuance of preferred stock of - - 946 subsidiary Proceeds from exercise of stock warrants . . . . . 9,985 8,075 - Purchase of treasury stock . . . . . (3,591) (560) (50) ---------- --------- ------- Net cash provided by financing activities. . . . . . 8,644 7,587 961 -------- ---------- ------- Net decrease in cash and cash equivalents. . . . . . . . (2,675) (614) (851) Cash and cash equivalents at beginning of year. . . . 6,396 3,721 3,107 ---------- -------- ------- Cash and cash equivalents at end of year . . $ 3,721 $ 3,107 $2,256 ========== ======== ======= Supplemental disclosures of cash flow information: Issuance of treasury stock for Investment . . . . . . . $ 618 $ - $ - ========== ======== ======= Issuance of common stock for accrued expenses. . . . . . $ 34 $ 91 $ 154 ========== ======== ======= Issuance of common stock for note receivable . . . . . . $ - $ 60 $ - ========== ======== =======
See accompanying notes to consolidated financial statements. F-7 HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (1) Business Hemispherx BioPharma, Inc. and subsidiaries (the Company) is a pharmaceutical company using nucleic acid technologies to develop therapeutic products for the treatment of viral diseases and certain cancers. The Company's drug technology uses specially configured ribonucleic acid (RNA). The Company's double-stranded RNA drug product, trademarked Ampligen(R) , is in human clinical development for various therapeutic indications. The potential efficacy and safety of Ampligen(R) is being evaluated clinically for three anti-viral indications: myalgic encephalomyelitis, also known as chronic fatigue syndrome ("ME/CFS"), human immunodeficiency virus (HIV) associated disorders, and chronic hepatitis C (HVC) virus infection. The Company also has clinical experience with Ampligen(R) used in treating patients with certain cancers including renal cell carcinoma (kidney cancer) and metastatic malignant melanoma. The Company has other compounds to be evaluated. The consolidated financial statements include the financial statements of Hemispherx BioPharma, Inc. and its wholly-owned subsidiaries BioPro Corp., BioAegean Corp. and Core BioTech Corp. which were incorporated in September 1994, and are inactive, and Hemispherx Biopharma-Europe N.V./S.A. which was incorporated in 1998 and Hemispherx Biopharma Europe S.A., which was incorporated during 2002. All significant intercompany balances and transactions have been eliminated in consolidation. The Company also has investments in unconsolidated affiliates which are accounted for on the equity or cost method of accounting (see note 2c). On March 11, 2003, we acquired from Interferon Sciences, Inc. ("ISI") ISI's inventory of ALFERON N Injection(R), a pharmaceutical product used for the treatment of certain types of genital warts, and a limited license for the production, manufacturing, use, marketing and sale of this product. As partial consideration, we issued 487,028 shares of our common stock to ISI. Pursuant to our agreements with ISI, we are in the process of registering the foregoing shares for public sale. Except for 62,500 of the shares issued to ISI, we have guaranteed the market value of the shares retained by ISI through March 11, 2005 to be $1.59 per share. On March 11, 2003, we also entered into an agreement to purchase from ISI all of its rights to the product and other assets related to the product including, but not limited to, real estate and machinery. This purchase is contingent on us receiving appropriate Governmental approval for the real estate transaction. For these assets, we have agreed to issue to ISI an additional 487,028 shares and to issue 314,465 shares and 267,296 shares, respectively to two creditors of ISI. The Company will be required to satisfy other liabilities of ISI which aggregate approximately $521,000 and which are secured by a lien on ISI's real estate. We have guaranteed the market value of all but 62,500 of these shares on terms substantially similar to those for the initial acquisition of the ISI assets. We will account for these transactions as a Business Combination under Statement of Financial Accounting Standards ("SFAS") No. 141 Accounting for Business Combinations. On May 1, 1997, the Company received permission from the U.S. Food and Drug Administration ("FDA") to recover the cost of Ampligen(R) from patients enrolled in the Company's AMP-511 ME/CFS open-label treatment protocol. The cost of Ampligen(R) to the patient is $2,100 for the first eight weeks of treatment and $2,400 for each additional eight-week period thereafter. In 1998, the Company initiated the recruitment of clinical investigators to enroll ME/CFS patients in the confirmatory Phase III double blind placebo-controlled clinical study of Ampligen(R). This clinical trial was approved by the FDA in 1998 and is designed to test the safety and efficiency of Ampligen(R) in treating ME/CFS. F-8 The ME/CFS Cost Recovery Treatment Program in Belgium was started in 1994 with the approval of the Belgian Regulatory authorities. Since its inception, over 150 patients have participated in this program. Clinical data collected in the treatment of these ME/CFS patients will be used to support the Company's European Medical Evaluation Agency ("EMEA") Drug Approval Application and in applications in other regulatory jurisdictions. A similar program underway in Austria is undergoing expansion. (2) Summary of Significant Accounting Policies (a) Cash and Cash Equivalents Cash equivalents consist of money market certificates and overnight repurchase agreements collateralized by money market securities with original maturities of less than three months, with both a cost and fair value of $2,552,000 and $1,404,000 at December 31, 2001 and 2002, respectively. (b) Short-term Investments Investments with original maturities of more than three months and marketable equity securities are considered available for sale. The investments classified as available for sale include debt securities and equity securities carried at estimated fair value of $5,310,000 and $555,000 at December 31, 2001 and 2002 respectively. The unrealized gains and losses are recorded as a component of shareholders' equity. (c) Investments in unconsolidated affiliates Investments in Companies in which the Company owns 20% or more and not more than 50% are accounted for using the equity method of accounting. Investments in Companies in which the Company owns less than 20% of and does not exercise a significant influence are accounted for using the cost method of accounting. In 1998, the Company invested $1,074,000 for a 3.3% equity interest in R.E.D. Laboratory ("R.E.D."). R.E.D. is a privately held biotechnology company for the development of diagnostic markers for Chronic Fatigue Syndrome and other chronic immune diseases. We have a research collaboration agreement with R.E.D. to assist in this development. R.E.D. is headquartered in Belgium. The investment was recorded at cost. During the three months ended June 30, 2002 and December 31, 2002 we recorded non-cash charges of $678,000 and $396,000 respectively, to operations with respect to our investment in R.E.D. These charges were the result of our determination that R.E.D.'s business and financial position had deteriorated to the point that our investment had been permanently impaired. In April, 1999 we acquired a 30% equity position in the California Institute of Molecular Medicine ("CIMM") for $750,000 and entered into a research and development arrangement. CIMM'S research is focused on developing therapies for use in treating patients affected by Hepatitis C ("HCV"). We use the equity method of accounting with respect to this investment. During the fourth quarter of 2001 we recorded a non-cash charge of $485,000 with respect to our investment in CIMM. This was a result of our determination that CIMM's operations have not yet evolved to the point where the full carrying value of our investment could be supported based on that company's financial position and operating results. The amount represented the unamortized balance of goodwill F-9 included as part of our investment. During 2002, we wrote down to zero our remaining investment based on that Company's continuing operating losses. These charges are reflected in the Consolidated Statements of Operations under the caption "Equity loss in unconsolidated affiliates". We still believe CIMM will succeed in their efforts to advance therapeutic treatment of HCV. We believe that CIMM's Hepatitis C diagnostic technology has great promise and fills a long-standing global void in the collective abilities to diagnose and treat Hepatitis C infection at an early stage of the disorder. The Company's investment in Ribotech, Ltd. is also accounted for using the equity method of accounting. The Company received 24.9% of Ribotech, Ltd. as partial compensation under the license agreement described in note 10. Ribotech, Ltd. has incurred net losses since inception. The Company does not share in those losses in accordance with the licensing agreement and is not obligated to fund such losses. The net investment in Ribotech is zero as of December 31, 2001 and 2002. During 2000, the Company prepaid $500,000 to Ribotech, Ltd. for raw material purchases. $110,000 of materials were delivered in 2000 and the balance of $390,000 was applied towards the purchase of materials during 2001. Investments in unconsolidated affiliates also includes an equity investment in Chronix Biomedical ("Chronix"). Chronix focuses upon the development of diagnostics for chronic diseases. The initial investment was made in May 31, 2000 through the issuance of 50,000 shares of Hemispherx Biopharma, Inc. common stock from the treasury. On October 12, 2000 an additional 50,000 shares of common stock were issued from the treasury for a total investment of approximately $678,000. During 2001 additional common stock plus cash were given to Chronix for a total investment at $700,000. The percentage ownership in Chronix is approximately 5.4% and is accounted for under the cost method of accounting. During the quarter ended December 31, 2002, we recorded a noncash charge of $292,000 with respect to our investment in Chronix. This impairment reduces our carrying value to reflect a permanent decline in Chronix's market value based on their current proposed investment offerings. Pursuant to a strategic alliance agreement, the Company provided Chronix with $250,000 during 2000 to conduct research in an effort to develop intellectual property on potential new products for diagnosing and treating various chronic illnesses including chronic fatigue syndrome. The strategic alliance agreement provides the Company certain royalty rights with respect to certain diagnostic technology developed from this research and a right of first refusal to license certain therapeutic technology developed from this research. The payment of $250,000 was charged to research and development expense during 2000. (d) Property and Equipment (000 omitted) December 31, 2001 2002 ---- ---- Furniture, fixtures, and equipment $ 1,178 $ 760 Leasehold improvements 96 85 ------- ---------- Total property and equipment 1,274 845 Less accumulated depreciation 1,028 690 ------- ---------- Property and equipment, net $ 246 $ 155 ======= ========== Property and equipment consists of furniture, fixtures, office equipment, and leasehold improvements and is recorded at cost. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets, ranging from five to seven years. F-10 Depreciation and amortization expense was $131,000, $127,000 and $91,000 for 2000, 2001 and 2002, respectively. In 2002, fully depreciated equipment in the amount of $418,000 and fully depreciated leasehold improvements in Europe in the amount of $12,000 were written-off due to the closing of European offices. (e) Patent and Trademark Rights Effective October 1, 2001, the Company adopted a 17 year estimated useful life for amortization of its patent and trademark rights in order to more accurately reflect their useful life. Prior to October 1, 2001, the Company was using a 10 year estimated useful life. The adoption of the 17 year life had been accounted for as a change in accounting estimate. Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight line method over the life of the assets. The Company reviews its patents and trademark rights periodically to determine whether they have continuing value. Such review includes an analysis of the patent and trademark's ultimate revenue and profitability potential on an undiscounted cash flow basis to support the realizability of its respective capitalized cost. Management's review addresses whether each patent continues to fit into the Company's strategic business plans. During the years ended December 31, 2000, 2001 and 2002, the Company decided not to pursue the technology in certain countries for strategic reasons and recorded charges of $32,000, $38,000 and $5,000, respectively. Amortization expense was $324,000, $359,000 and $201,000 in 2000, 2001 and 2002, respectively. The accumulated amortization as of December 31, 2001 and 2002 is $2,096,000 and $1,996,000, respectively. (f) Revenue Revenue from the sale of Ampligen(R) under cost recovery clinical treatment protocols approved by the FDA is recognized when the treatment is provided to the patient. Revenues for non-refundable license fees are recognized under the performance method. This method recognizes revenue to the extent of performance to date under a licensing agreement. In computing earned revenue, it considers only the amount of non-refundable cash actually received to date. This method considers future payments to be contingent and thus ignores the possibility of future milestone payments when computing the amount of revenue earned in a current period. During the periods ending December 31, 2000, 2001 and 2002 the Company did not receive any grant monies from local, state and or Federal Agencies. The terms of the agreement granting the licensee marketing rights for Ampligen(R) for the treatment of myalgic/chronic fatigue syndrome ("ME/CFS") in Spain, Portugal and Andorra require the Company to provide the licensee with technical, scientific and commercial information. The Company fulfilled the requirements during the first quarter of 2002. The agreement terms required no additional performance on the part of the Company. The agreement also requires the licensee to pay of 1,000,000 Euros after FDA approval of Ampligen(R) for the treatment of ME/CFS and a fee of 1,000,000 after issuance in Spain of final marketing approval authorization for Ampligen(R) for the treatment of ME/CFS. See Note 6 for more detailed information. F-11 (g) Net Loss Per Share Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of stock options and warrants, are excluded from a calculation of diluted net loss per share since their effect is antidilutive. (h) Accounting for Income taxes Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets and Liabilities and are measured using the enacted tax rates and laws in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. (i) Comprehensive (loss) On January 1, 1998, the Company adopted SFAS No. 130, Reporting Comprehensive Income. Statement of Financial Accounting Standards (SFAS) No. 130 establishes standards for reporting and presentation of the Company's comprehensive (loss) and its components in a full set of financial statements. Comprehensive (loss) consists of net loss and net unrealized gains (losses) on securities and is presented in the consolidated statements of changes in stockholders' equity and comprehensive (loss). (j) Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. (k) Foreign currency translations Assets and liabilities of the Company's foreign operations are generally translated into U.S. dollars at current exchange rates as of balance sheet date. Revenues and expenses are translated at average exchange rates during each period. Transaction gains and losses that arise from exchange rate fluctuations are included in the results of operations as incurred. The resulting translation adjustments are immaterial for all years presented. (l) Recent Accounting Standard and Pronouncements: In January 2003, the Financial Accounting Standards Board (FASB) issued Interpretation No. 46,, "Consolidation of Variable Interest Entities" ("Interpretation No. 46"), that clarifies the application of Accounting Research Bulletin No. 51, Consolidated Financial Statements, "to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. Interpretation No. 46 is applicable immediately for variable interest entities created after January 31, 2003. For variable interest entities created to January 31, 2003, the provision of Interpretation No. 46 are F-12 applicable no later than July 1, 2003. The Company does not expect this Interpretation to have an effect on the consolidated financial statements. In August 2001, the FASB issued Statement No. 143, "Accounting for Asset Retirement Obligation" ("SFAS 143"), which provides the accounting requirements for retirement obligation associated with tangible long-lived assets. SFAS 143 requires entities to record the fair value of the liability for an asset retirement obligation in the period in which it is incurred and is effective for the Company's 2003 fiscal year. The adoption of SFAS 143 is not expected to have a material impact on the Company's consolidated results of operations, financial position or cash flows. In October 2001, the FASB issued Statement No. 144, "Accounting for the Impairment or Disposal of Long-lived Assets" ("SFAS 144"). SFAS 144 addresses financial accounting and reporting for the impairment or disposal of long-lived assets. This statement supersedes SFAS Statement No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of, " and the accounting and reporting provision of APB Opinion No. 30, "Reporting the Results of Operations-Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and transactions. "This new pronouncement also amends Accounting Research Bulletin (ARB) No. 51 "Consolidated Financial Statements, "to eliminate the exception to consolidation for a subsidiary for which control is likely to be temporary. SFAS 144 required that one accounting model be used for long-lived assets to be disposed of by sale, whether previously held and used or newly acquired and also broadens the presentation of discontinued operation to include more disposal transactions. SFAS 144 is effective for fiscal years beginning after December 15, 2001 and interim periods within those fiscal years. Adoption of SFAS 144 on January 1, 2002, did not have impact on the Company's financial position, cash flows or results of operation for the year ended December 31, 2002. In June 2002, the FASB issued Statement No. 146, "Accounting for Cost Associated with Exit or Disposal Activities" ("SFAS 146"), which addresses financial accounting and reporting for costs associated with exit or disposal activities, and nullifies Emerging Task Force (EITF) Issue No. 94-3, "Liability Recognition for Certain Employee termination Benefits and Other Costs to Exit and Activity (including Certain Costs Incurred in a Restructuring)" which previously governed the accounting treatment for restructuring activities. SFAS 146 applies to costs associated with an exit activity that does not involve an entity newly acquired in a business combination or with disposal activity covered by SFAS 144. Those costs include, but are not limited to, the following: (1) termination benefits provide to current employees that are involuntarily terminated under the terms of a benefit arrangement that, in substance, is not an ongoing benefit arrangement or individual deferred-compensation contract,(2) costs to terminate a contract that is not a capital lease, and (3) costs to consolidated facilities or relocated employees. SFAS 146 does not apply to costs associated with the retirement of long-lived assets covered by SFAS 143. SFAS 146 will be applied prospectively and is effective for exit or disposal activities after December 31, 2002. In December 2002, the FASB issued Statement No. 148, "Accounting for Stock-Based Compensation-Transition and Disclosure", and amendment of FASB Statement No. 123 ("SFAS"). SFAS 148 amends FASB Statement No. 123, Accounting for Stock-Based Compensation, to provide alternative method of transition for an entity that voluntarily changes to the fair value based of accounting for stock-based employee compensation. It also amends the disclosure provisions of that Statement to require prominent disclosure about the effects on reported net income of an entity's accounting policy decisions with respect to stock-based employee compensation. Finally, this Statement amends Accounting Principles Board ("APB") Opinion No. 28, Interim Financial Reporting to require disclosure F-13 about those effects in interim financial information. SFAS 148 is effective for financial statements for fiscal years ending after December 15, 2002. The Company will continue to account for stock-based compensation using the intrinsic value method of APB Opinion No. 25, "Accounting for Stock Issued to Employees, "but has adopted the enhance disclosure requirements of SFAS 148 (See Note 10). (m) Research and Development Costs Research and development related to both future and present products are charged to operation as incurred. (n) Stock Compensation The Company applies the intrinsic value method in accordance Accounting Principles Bulletin (APB) Opinion No. 25, "Accounting for Stock Issued to Employees" in accounting for stock-based compensation of its employees and, accordingly, no compensation cost has been recognized for stock purchase warrants and options issued to employees. Had the Company determined compensation cost based on the fair value at the grant date for its stock-based compensation of its employees in accordance with FASB 123 the Company's net loss would have been increased to the pro forma amounts indicated below: (In Thousands except for per share data) For the years ended December 31, 2000 2001 2002 ---- ---- ---- Net loss-as reported $(8,552) $(9,083) $(7,424) Add: Stock based compensation included in net loss as reported, net of related tax effects - - - Deduct: Stock based compensation determined under fair value based method for all awards, net of related tax effects (237) (632) (1,085) Net loss - pro forma $(8,789) $(9,715) $(8,509) Basic and diluted loss per share - as reported $(.29) $(.29) $(.23) Basic and diluted loss per share - pro forma $(.30) $(.31) $(.27) In 1999, the Company granted 275,000 warrants to employees in recognition of services performed and services to be performed. The fair value of the stock purchase warrants granted during 1999 was also determined using the Black-Scholes option pricing model with a rate of 5.18%, volatility of 135.4%-294.31%, and expected lives of 2 years. These warrants are included in the 2,633,000 non-public warrants outstanding as of December 31, 2000 as described in footnote 5 (ii). There were no warrants granted to employees during 2000. During 2001 the Company granted 406,650 warrants to employees. The Company granted to employees 8,000 options in 2000 and 94,000 options in 2001. See F-14 footnote 5(i).The fair value of stock options and warrants granted during 2001 was determined using Black Scholes Option Pricing Model with a rate of 4.23%, volatility of 69.7% to 74.9% and expected life of three years. In 2002 1,622,000 warrants were issued to employees in recognition of services performed and services to be performed. The fair value of the warrants granted during 2002 was determined using Black Scholes Option Pricing model with a rate of 5.23%, volatility of 63.17%, and expected life of 2.5 and 4 years. The weighted average fair value of those options and warrants granted during the years ended December 31, 2002, 2001 and 2000, were estimated as $0.62, $1.57 and $1.09,respectively. For stock warrants granted to non-employees, the Company measures fair value of the equity instruments utilizing the Black-Scholes method if that value is more reliably measurable than the fair value of the consideration or service received. The Company amortizes such cost over the related period of service. The exercise price of all stock warrants granted was equal to the fair market value of the underlying common stock as defined by APB 25 on the date of the grant. (3) Short-term investments: Securities classified as available for sale are summarized below: (000's omitted) December 31, 2001 --------------- Unrealized --------------- Adjusted Carrying cost Gains (Losses) Value --------- ----- ------- -------- General Motors Commercial Paper $ 3,977 $ 13 $ - $ 3,990 Ford Motors commercial paper 795 1 - 796 Calamos Mutual Market 521 3 - 524 --------- ----- ------- -------- Total $ 5,293 $ 17 $ - $ 5,310 ========= ===== ======= ======== December 31, 2002 --------------- Unrealized --------------- Adjusted Carrying cost Gains (Losses) Value --------- ----- ------- -------- Calamos Mutual Market $ 521 $ 34 $ - $ 555 --------- ----- ------- -------- Total $ 521 $ 34 $ - $ 555 ========= ===== ======= ======== F-15 (4) Accrued Expenses Accrued expenses at December 31, 2001 and 2002 consists of the following: (000's omitted) December 31, ------------- 2001 2002 ----- ------ Salaries . . . . . . . . . . . . . . . . . $ 85 $ 6 Other Accrued expenses . . . . . . . . . . 208 222 Fees Associated with Litigation Settlement. _ 450 ------ ------- $ 293 $ 678 ====== ======= (5) Stockholders' Equity (a) Preferred Stock The Company is authorized to issue 5,000,000 shares of $.01 per value preferred stock with such designations, rights and preferences as may be determined by the board of directors. There were no preferred shares issued and outstanding at December 31, 2001 and 2002. (b) Common Stock and Exercise of Stock Warrants The Company is authorized to issue 50,000,000 shares of $.001 par value Common Stock. As of December 31, 2001 and 2002, 32,060,280 and 32,106,972 shares, net of shares held in the treasury, were outstanding, respectively. The exercise of stock warrants generated $9,985,000 and $8,075,000 in net proceeds to the Company in 2000 and 2001, respectively. There were no exercises during 2002. (c) New Equity Financing On March 20, 2002 our European Subsidiary Hemispherx Biopharma Europe, S.A. ("Hemispherx, S.A.") entered into a Sales and Distribution agreement with Laboratorios del Dr. Esteve S.A. ("Esteve"). Pursuant to the terms of the Agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain Portugal and Andorra for the treatment of Myalgic Encephalitis/Chronic Fatigue Syndrome ("ME/CFS"). In addition to other terms and other projected payments, Esteve paid an initial and non refundable fee of 625,000 Euros (approximately $563,000) to Hemispherx S.A. on April 24, 2002 as the first part of a series of milestone based payments. During March 2002, Hemispherx Biopharma Europe , S.A. (Hemispherx S.A.) was authorized to issue up to 22,000,000 Euros of seven percent (7%) convertible preferred securities. Such securities will be guaranteed by the parent company and will be converted into a specified number of shares of Hemispherx S.A. pursuant to the securities agreement. Conversion is to occur on the earlier of an initial public offering of Hemispherx S.A. on a European stock exchange or September 30, 2003. Esteve purchased 1,000,000 Euros of Hemispherx Biopharma Europe S.A.'s F-16 convertible preferred equity certificates on May 23, 2002. During 2002, the terms and conditions of these securities were changed so that these preferred equity certificates will be converted into the common stock of Hemispherx Biopharma, Inc. (HEB) in the event that a European IPO is not completed by September 30, 2003. The conversion rate is to be 300 shares of Hemispherx Biopharma, Inc.'s common shares for each 1,000 Euro convertible preferred certificate. As a result the Company recorded approximately $946,000 as minority interest in subsidiary on its balance sheet. On December 18, 2002, we proposed that Esteve convert their convertible preferred equity certificates into Hemispherx common stock pursuant to the terms of the agreement and all unpaid dividends at the market price on that conversion date. On January 9, 2003, Esteve accepted our proposal. We are in the process of registering these shares for public sale. On March 13, 2003, we issued 347,445 shares of our common stock to Provesan SA, an affiliate of Esteve S.A., in exchange for 1,000,000 Euros of convertible preferred equity certificates and any unpaid dividends. As a result of the exchange, the minority interest in subsidiary was transfered to stockholders' equity on such date. The contingent conversion price was more than the then market value of the parent company's or subsidiaries' common stock at each of that respective measurement dates. As a result and in accordance with Emerging Issues Task Force (EITF) No. 00-27 "Application of Issue No. 98-5 (Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios) to Certain Convertible Instruments", the Company did not ascribe any value to any contingent conversion feature. (d) Common Stock Options and Warrants (i) Stock Options The 1990 Stock Option Plan provides for the grant of options to purchase up to 460,798 shares of the Company's Common Stock to employees, directors, and officers of the Company and to consultants, advisors, and other persons whose contributions are important to the success of the Company. The recipients of options granted under the 1990 Stock Option Plan, the number of shares to be converted by each option, and the exercise price, vesting terms, if any, duration and other terms of each option shall be determined by the Company's board of directors or, if delegated by the board, its Compensation Committee. No option is exercisable more than 10 years and one month from the date as of which an option agreement is executed. These shares become vested through various periods not to exceed four years from the date of grant. The option price represents the fair market value of each underlying share of Common Stock at the date of grant, based upon the public trading price. F-17 Information regarding the options approved by the Board of Directors under the 1990 Stock Option Plan is summarized below:
___________2000___________ ___________2001___________ ________2002________ Weighted Weighted Weighted Average Option Average Average Option Exercise Price Exercise Option Exercise Shares Price Price Shares Price Shares Price Price ------- ------- ------- ------ ------ -------- ------- ------ ------- Outstanding, beginning of year 294,000 $1.06-6.00 $3.60 218,567 $1.06-6.81 $3.45 306,263 $1.06-4.34 $3.58 Granted 8,000 $3.00-6.81 $ 4.88 94,000 $4.03 $4.03 - - - Canceled (76,677) $3.50-4.34 $ 4.09 (6,304) $4.34-6.81 $5.91 (11,598) $3.00-4.34 $3.71 Exercised (6,756) $1.06-3.50 $ 2.75 - - - - - ------- ------ ------- Outstanding, end of year 218,567 $1.06-6.81 $ 3.45 306,263 $1.06-4.34 $3.58 294,665 $1.06-434 $3.57 ======= ====== ======= Exercisable 198,717 $1.06-6.81 $ 3.48 234,263 $1.06-4.34 $4.67 252,746 $1.06-4.34 $3.50 ======= ====== ======= Weighted average remaining contractual life (years) 3.83 years 3.57 years 3.68 years ======= ====== ======= Exercised in current and prior years (37,791) (37,791) (37,791) Available for future grants 204,440 116,744 170,261 ======= ======= =======
In December 1992, the Board of Directors approved the 1992 Stock Option Plan (the 1992 Stock Option Plan) which provides for the grant of options to purchase up to 92,160 shares of the Company's Common Stock to employees, directors, and officers of the Company and to consultants, advisers, and other persons whose contributions are important to the success of the Company. The recipients of the options granted under the 1992 Stock Option Plan, the number of shares to be covered by each option, and the exercise price, vesting terms, if any, duration and other terms of each option shall be determined by the Company's board of directors. No option is exercisable more than 10 years and one month from the date as of which an option agreement is executed. To date, no options have been granted under the 1992 Stock Option Plan. The Company's 1993 Employee Stock Purchase Plan (the 1993 Purchase Plan) was approved by the board of directors in July 1993. The outline of the 1993 Purchase Plan provides for the issuance, subject to adjustment for capital changes, of an aggregate of 138,240 shares of Common Stock to employees. The 1993 Purchase Plan is administered by the Compensation Committee of the board of directors. Under the 1993 Purchase Plan, Company employees are eligible to participate in semi-annual plan offerings in which payroll deductions may be used to purchase shares of Common Stock. The purchase price for such shares is equal to the lower of 85% of the fair market value of such shares on the date of grant or 85% of its fair market value of such shares on the date such right is exercised. There have been no offerings under the 1993 Purchase Plan to date and no shares of Common Stock have been issued thereunder. F-18 (ii) Stock warrants Number of warrants exercisable into shares of common stock
___________2000___________ ___________2001__________ _______2002_______ Weighted Weighted Weighted Average Average Average Option Exercise Option Exercise Option Exercise Shares Price Price Shares Price Price Shares Price Price -------- -------- --------- ---------- --------- --------- ----------- -------- -------- Outstanding, . beginning of year 14,058,010 $1.75-10.85 $3.90 11,624,168 $1.75-12 00 $4.05 6,927,110 $1.75-16.00 $4.77 Granted 293,800 $6.00-12.00 6.40 856,650 $5.00-16,00 $9.89 1,802,000 $2.00-600 $2.07 Canceled (341,017) $2.00-10.85 6.01 (3,396,508) $2.50-4.00 $3.89 (750,000) $3.50-6.00 $3.72 Exercised (2,386,625) $1.75-4.00 4.19 (2,157,200) $1.75-4.00 $3.75 (11,300) $1.75-7.50 $3.30 --------- ---------- -------- Outstanding, end of . year 11,624,168 $1.75-12.00 $4.05 6,927,110 $1.75-16 00 $4.77 7,967,810 $1.75-16.00 $3.18 ========= ========== ========= Exercisable 11,624,168 $1.75-12.00 $4.05 6,927,110 $1.75-16.00 $4.77 6,345,810 $1.75-16.00 $3.48 ========= ========== ========= Weighted average remaining contractual life (years) 2.66 years 4.05 years 4.03 years ========== ========== ========== Years exercisable 2001-2006 2002-2006 2003-2008 ========== ========== ==========
Certain of the stock warrants outstanding are subject to adjustments for stock splits and dividends. Warrants issued to stockholders In 2000, 149,807 warrants expired and 147,000 warrants were converted to common stock. At December 31, 2000, there were 305,160 warrants remaining. In 2001, 73,000 were converted to common stock. At December 31, 2001 there were 232,160 warrants remaining. In 2002, 10,000 were converted to common stock. At December 31, 2002 there were 222,160 warrants remaining. These warrants have an exercise price of $3.50 per share and expire in October 2004. Other stock warrants In addition, the Company has other issued warrants outstanding - totaling 7,745,650 which consists of the following: In November 1994, the Company granted Rule 701 Warrants to purchase an aggregate of 2,080,000 shares of Common Stock to certain officers and directors. These Warrants are exercisable at $3.50 per share and, if not exercised, were to expire in September, 1999. On February 19, 1999 the Board of Directors extended the expiration date for three more years. This extension resulted in a non-cash charge of approximately $3,097,000. In 1999 235,000 warrants were exercised and 5,000 warrants were exercised in 2000. At December 31, 2000, there were 1,840,000 Rule 701 warrants remaining. In 2001 20,000 of these warrants expired, leaving a balance of 1,820,000 in warrants outstanding at December 31, 2001. During 2002, 420,000 warrants expired and the Company extended the expiration F-19 date of the remaining balance of 1,400,000 for a period of five years to now expire on September 30, 2007. These stock warrants have an exercise price of $3.50. In accordance with FASB Interpretation No. 44, Accounting for Certain Transactions involving Stock Compensation, no compensation expense was recognized as the exercise price at the extension date exceeded the fair value of the underlying common stock. In May 1995, the Company and certain officers, directors and shareholders entered into a standby finance agreement pursuant to which the parties agreed to provide an aggregate of $5,500,000 in financing to the Company during 1995 in the event that existing and additional financing was insufficient to cover the cash needs of the Company through December 31, 1996. In exchange, the Company issued warrants to purchase an aggregate of 2,750,000 shares of Common Stock at $1.75 per share to the parties. In 1999, 290,000, in 2000, 216,500, in 2001, 200,000 and in 2002, 1,300 of these warrants were exercised, leaving a balance of these warrants of 1,450,200. These warrants expire June 30, 2005. In connection with the stock issued in September, 1997, the Company issued 385,067 warrants to several entities to purchase common stock at $4 per share, 149,034 of these warrants were exercised in 1998, 173,300 were exercised in 1999, and 34,333 were exercised in 2000. The remaining 28,400 warrants expired December 31, 2001. In the years 2000, 2001 and 2002 the Company issued 293,800, 450,000 and 25,000 warrants, respectively, to investment banking firms for services performed on behalf of the Company. Accordingly, the company recorded stock compensation expense of $397,000, $673,000 and $133,000 for the years 2000, 2001 and 2002 respectively. These warrants have various vesting dates and exercise prices ranging from $4.00 to $16.00 per share. In 2000, 75,000 of these warrants were exercised. 1,193,800 warrants were outstanding at December 31, 2002. These warrants are exercisable in five years from the date of issuance. In 2000 2001 and 2002 the Company had non-public warrants outstanding of 2,633,000 2,254,650 and 3,701,650 respectively. These warrants are exercisable at rates of $2.50 to $10.00 per share of common stock. The exercise price was equal to the fair market value of the stock on the date of grant. During 2002, the Company granted 1,777,000 warrants to employees for services performed. These warrants have a weighted average exercise price of $2.07 per share, and have been included in the pro-forma loss calculation in note 2(n). During 2001, 370,000 of the non public warrants were exercised and 415,000 expired without being exercised. 2,254,650 of the non-public warrants were outstanding at December 31, 2001. During 2002, none of these warrants were exercised and 750,000 expired. 3,701,650 of the non-public warrants were outstanding at December 31, 2002. During 2002 the Company also extended the expiration date of 322,000 of these warrants for a period of five years to now expire in the years ending 2007 and 2008. These stock warrants have exercise prices ranging from $3.50 to $4.00 In accordance FASB Interpretation No. 44, Accounting for Certain Transactions involving Stock Compensation, no compensation expense was recognized as the exercise price at the extension date exceeded the fair value of the underlying common stock. (e) Stock Repurchase On February 19, 1999, the Board of Directors authorized the repurchase of up to 200,000 shares of the Company's common stock on the open market. On February 8, 2000, the Board authorized the repurchase of another 200,000 shares. The Company's repurchases of shares of common stock are recorded as "Treasury Stock" and result in a reduction of "Stockholders' equity." When F-20 treasury shares are reissued, the Company uses a first-in, first-out method and the excess of repurchase cost over reissuance price is treated as a reduction of "Additional paid-in capital." (f) Rights offering On November 19, 2002, the Board of Directors of Hemispherx Biopharma, Inc. (the "Company") declared a dividend distribution of one Right for each outstanding share of Common Stock to stockholders of record at the close of business on November 29, 2002 (the "Record Date"). Each Right entitles the registered holder to purchase from the Company a unit consisting of one one-hundredth of a share (a "Unit") of Series A Junior Participating Preferred Stock, par value $.01 per share (the "Series A Preferred Stock") at a Purchase Price of $30.00 per Unit, subject to adjustment. The description and terms of the Rights are set forth in a Rights Agreement (the "Rights Agreement") between the Company and Continental Stock Transfer & Trust Company, as Rights Agent. Initially, the Rights are attached to all Common Stock certificates representing shares then outstanding, and no separate Rights Certificates will be distributed. Subject to certain exceptions specified in the Rights Agreement, the Rights will separate from the Common Stock and a Distribution Date will occur upon the earlier of (i) 10 days following a public announcement that a person or group of affiliated or associated persons (an "Acquiring Person") has acquired beneficial ownership of 15% or more (or 20% or more for William A. Carter, M.D.) of the outstanding shares of Common Stock (the "Stock Acquisition Date"), other than as a result of repurchases of stock by the Company or certain inadvertent actions by institutional or certain other stockholders or (ii) 10 business days (or such later date as the Board shall determine) following the commencement of a tender offer or exchange offer that would result in a person or group becoming an Acquiring Person. Until the Distribution Date, (i) the Rights will be evidenced by the Common Stock certificates and will be transferred with and only with such Common Stock certificates, (ii) new Common Stock certificates issued after the Record Date will contain a notation incorporating the Rights Agreement by reference and (iii) the surrender for transfer of any certificates for Common Stock outstanding will also constitute the transfer of the Rights associated with the Common Stock represented by such certificate. Pursuant to the Rights Agreement, the Company reserves the right to require prior to the occurrence of a Triggering Event (as defined below) that, upon any exercise of Rights, a number of Rights be exercised so that only whole shares of Preferred Stock will be issued. (6) Segment and Related Information The Company operates in one segment, which is the performance of research and development activities related to Ampligen(R) and other drugs under development. F-21 The following table present revenues by country based on the location of the use of the product services. (000's omitted) ------------------------------------ 2000 2001 2002 ----- ------ ----- United States $506 $274 $237 Belgium 272 107 74 Other 10 9 30 ----- ------ ------ $788 $ 390 $341 ===== ====== ====== In addition, the Company recorded License Fee Income in the amount of $563,000 from a Company located in Europe. The Company employs an insignificant amount of net property and equipment in its foreign operations. (7) Research, Consulting and Supply Agreements In December, 1999, the Company entered into an agreement with Biovail Corporation International ("Biovail"). Biovail is an international full service pharmaceutical company engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery systems. Biovail is headquartered in Toronto, Canada. The agreement grants Biovail the exclusive distributorship of the Company's product in the Canadian territories subjects to certain terms and conditions. In return, Biovail agrees to conduct certain pre-marketing clinical studies and market development programs, including without limitation, expansion of the Emergency Drug Release Program in Canada with respect to the Company' products. Biovail agrees to work with the Company in preparing and filing of a New Drug Submission with Canadian Regulatory Authorities. Biovail invested $2.25 million in Hemispherx equity at prices above the then current market price and agreed to make further payments based on reaching certain regulatory milestones. The Agreement requires Biovail to penetrate certain market segments at specific rates in order to maintain market exclusivity. The Company has entered into agreements for consulting services which are performed at medical research institutions and by medical and clinical research individuals. The Company's obligation to fund these agreements can be terminated after the initial funding period, which generally ranges from one to three years or on an as-needed monthly basis. During the year ending December 31, 2000, 2001 and 2002 the Company incurred approximately $924,000, $595,000 and $395,000 respectively, of consulting service fees under these agreements. These costs are charged to research and development expense as incurred. (8) 401(K) Plan The Company has a defined contribution plan, entitled the Hemispherx BioPharma Employees 401(K) Plan and Trust Agreement (the 401(K) Plan). Full time employees of the Company are eligible to participate in the 401(K) Plan following one year of employment. Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions) per annum. Participants' F-22 contributions to the 401(K) Plan may be matched by the Company at a rate determined annually by the Board of Directors. Each participant immediately vests in his or her deferred salary contributions, while Company contributions will vest over one year. In 2000, 2001 and 2002 the Company provided matching contributions to each employee for up to 6% of annual pay aggregating $48,000, $48,000 and $38,000 respectively. (9) Royalties, License, and Employment Agreements The Company also has entered into a licensing agreement with a group of individuals and Hahnemann University relating to their contributions to the development of certain compounds, including Ampligen(R), and to obtain exclusive information and regulatory rights relating to these compounds. Under this agreement, the Company will pay 2% of net sales proceeds of Ampligen(R) not to exceed an aggregate amount of $6 million per year through 2005. In August 1988, the Company entered into a pharmaceutical use license agreement with Temple University (the Temple Agreement). In July, 1994, Temple terminated the Temple Agreement. In November 1994, the Company filed suit against Temple in the Superior Court of the State of Delaware seeking a declaratory judgment that the agreement was unlawfully terminated by Temple and therefore remained in full force and effect. Temple filed a separate suit against the Company seeking a declaratory judgment that its agreement with the Company was properly terminated. These legal actions have now been settled. Under the settlement, the parties have entered into a new pharmaceutical use license agreement (New Temple Agreement) that is equivalent in duration and scope to the previous license. Under the terms of the New Temple Agreement, Temple granted the Company an exclusive world-wide license for the term of the agreement for the commercial sale of Oragen products using patents and related technology held by Temple, which license is exclusive except to the extent Temple is required to grant a license to any governmental agency or non-profit organization as a condition of funding for research and development of the patents and technology licensed to the Company. The Company has contractual agreements with two of its officers. The aggregate annual base compensation under these contractual agreements for 2000, 2001 and 2002 was $686,000, $603,000 and $620,000 respectively. In addition, certain of these officers are entitled to receive performance bonuses of up to 25% of the annual base salary (in addition to the bonuses described below). In 2000, 2001 and 2002 no performance bonuses were granted. In 2001, Certain officers were granted warrants and options to purchase 426,650 shares of Common Stock at $4.01 per share. In 2002, certain officers were granted warrants and option to purchase 1,220,000 shares of common stock at $2.00 - $4.03 per share. One of the employment agreements provides for bonuses based on gross proceeds received by the Company from any joint venture or corporate partnering agreement. In October 1994, the Company entered into a licensing agreement with Bioclones (Propriety) Limited (SAB/Bioclones) with respect to co-development of various RNA drugs, including Ampligen(R) , for a period ending three years from the expiration of the last licensed patents. The licensing agreement provides SAB/Bioclones with an exclusive manufacturing and marketing license for certain southern hemisphere countries (including certain countries in South America, Africa and Australia as well as the United Kingdom and Ireland (the licensed territory). In exchange for these marketing and manufacturing rights, the licensing agreement provides for: (a) a $3 million cash payment to the Company, all of which was received during the year ended December 31, 1995; (b) the formation and issuance to the Company of 24.9% of the capital stock of Ribotech, Ltd., a company which developed and operates a new manufacturing facility that F-23 produces raw material components of Ampligen(R) and(c) royalties of 6% to 8% of net sales of the licensed products in the licensed territories as defined, after the first $50 million of sales. SAB/Bioclones will be granted a right of first refusal to manufacture and supply to the Company licensed products for not less than one third of its world-wide sales of Ampligen(R), excluding SAB/Bioclones related sales. In addition, SAB/Bioclones will have the right of first refusal for oral vaccines in the licensed territory. In 2000, the Company paid to Ribotech a total of $500,000 for the current and future purchases and delivery of polymers. Of the $500,000 advanced in 2000, a balance of $390,000 was included in other assets in 2000 and was used for purchases of polymers in 2001. In 2002, $262,000 was paid to Ribotech for delivery at Polymers. In October 1994, the Board of Directors granted a director of the Company the right to receive 3% of gross proceeds of any licensing fees received by the Company pursuant to the SAB/Bioclones licensing agreement, a fee of .75% of gross proceeds in the event that SAB Bioclones makes a tender offer for all or substantially all of the Company's assets, including a merger, acquisition or related transaction, and a fee of 1% on all products manufactured by SAB Bioclones. The Company may prepay in full its obligation to provide commissions within a ten year period. On March 20, 2002, our European subsidiary Hemispherx Biopharma Europe, S.A. ("Hemispherx S.A.") entered into a sales and Distribution agreement with Laboratories Del Dr. Esteve S.A. ("Esteve"). Pursuant to the terms of the agreement, Esteve was granted the exclusive right to market Ampligen(R) in Spain, Portugal and Andorra for the treatment of Myalgic/Chronic Fatigue Syndrome ("ME/CFS"). In addition to other terms and other projected payments., Esteve paid an initial and non-refundable fee of 625,000 Euros (approximately $563,000) to Hemispherx S.A. on April 24, 2002. Esteve is to pay a fee of 1,000,000 Euros after U.S. Food and Drug Administration approval of Ampligen(R) for the treatment of ME/CFS and a fee of 1,000,000 Euros upon Spain's approval of the final marketing authorization for using Ampligen(R) for the treatment of ME/CFS. In connection with the two agreements entered into with ISI (See Note 1), the Company is obligated to pay ISI a 6% royalty on the net sales of the Alferon N Injection product. (10) Leases The Company has several noncancelable operating leases for the space in which its principal offices are located and certain office equipment. Future minimum lease payments under noncancelable operating leases are as follows: (000's omitted) Year ending Operating December 31, leases ----------- --------- 2003. . . . . . . . . . . . . . . . . . . . $ 279 2004. . . . . . . . . . . . . . . . . . . . 286 2005. . . . . . . . . . . . . . . . . . . . 240 2006. . . . . . . . . . . . . . . . . . . . 193 2007. . . . . . . . . . . . . . . . . . . . 65 ---------- Total minimum lease payments. . . . . . . . $ 1,063 ========== F-24 Rent expense charged to operations for the years ended December 31, 2000, 2001 and 2002 amounted to approximately $347,000, $294,000 and $307,000 respectively. The term of the lease for the Rockville, Maryland facility is through June, 2005 with an average rent of $8,000 per month, plus applicable taxes and charges. The term of the lease for the Philadelphia, Pennsylvania offices is through April, 2007 with an average rent of $15,000 per month, plus applicable taxes and charges. (11) Income Taxes As of December 31, 2002, the Company has approximately $66,000,000 of federal net operating loss carryforwards (expiring in the years 2004 through 2022) available to offset future federal taxable income. The Company also has approximately $15,000,000 of state net operating loss carryforwards (expiring in the years 2003 through 2007) available to offset future state taxable income. The utilization of certain state net operating loss carryforwards may be subject to annual limitations. Under the Tax Reform Act of 1986, the utilization of a corporation's net operating loss carryforward is limited following a greater than 50% change in ownership. Due to the Company's prior and current equity transactions, the Company's net operating loss carryforwards may be subject to an annual limitation generally determined by multiplying the value of the Company on the date of the ownership change by the federal long-term tax exempt rate. Any unused annual limitation may be carried forward to future years for the balance of the net operating loss carryforward period. Deferred income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial reporting purposes and the carrying amounts used for income tax purposes. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Due to the uncertainty of the Company's ability to realize the benefit of the deferred tax asset, the deferred tax assets are fully offset by a valuation allowance at December 31, 2001 and 2002. The components of the net deferred tax asset of December 31, 2001 and 2002 consists of the following: (000,s omitted) Deferred tax assets: 2001 2002 ------ ------ Net operating losses $20,790 $22,440 Accrued Expenses and Other 21 (16) Capitalized Research and development costs 4,634 3,763 ------ ------ 25,445 26,187 Less: Valuation Allowance 25,445 26,187 ------ ------ Balance $ -0- $ -0- ====== ====== F-25 (12) Contingencies On September 30, 1998, we filed a multi-count complaint against Manuel P. Asensio, Asensio & Company, Inc. ("Asensio"). The action included claims of defamation, disparagement, tortuous interference with existing and prospective business relations and conspiracy, arising out of the Asensio's false and defamatory statements. The complaint further alleged that Asensio defamed and disparaged us in furtherance of a manipulative, deceptive and unlawful short-selling scheme in August and September, 1998. In 1999, Asensio filed an answer and counterclaim alleging that in response to Asensio's strong sell recommendation and other press releases, we made defamatory statements about Asensio. We denied the material allegations of the counterclaim. In July 2000, following dismissal in federal court for lack of subject matter jurisdiction, we transferred the action to the Pennsylvania State Court. In March 2001, the defendants responded to the complaints as amended and a trial commenced on January 30, 2002. A jury verdict disallowed the claims against the defendants for defamation and disparagement and the court granted us a directed verdict on the counterclaim. On July 2, 2002 the Court entered an order granting us a new trial against Asensio for defamation and disparagement. Thereafter, Asensio appealed the granting of a new trial. This appeal is now pending in the Superior Court of Pennsylvania. In June 2002, a former ME/CFS clinical trial patient and her husband filed a claim in the Superior Court of New Jersey, Middlesex County, against us, one of our clinical trial investigators and others alleging that she was harmed in the ME/CFS clinical trial as a result of negligence and breach of warranties. We believe the claim is without merit and we are defending the claim against us through our product liability insurance carrier. In June 2002, a former ME/CFS clinical trial patient in Belgium filed a claim in Belgium, against Hemispherx Biopharma Europe, NV/SA, our Belgian subsidiary, and one of our clinical trial investigators alleging that she was harmed in the Belgium ME/CFS clinical trial as a result of negligence and breach of warranties. We believe the claim is without merit and we are defending the claim against us through our product liability insurance carrier. In July 2002, we filed suit in the United States District Court for the Eastern District of Pennsylvania against our insurance company seeking (1) a judicial order declaring our rights and the obligations of our insurance carrier under the insurance policy our insurance carrier sold to us (2) monetary damage for breach of contract resulting from our insurance carrier refusal to fully defend us in connection with the Asensio litigation (3) monetary damages to compensate us for our insurance carrier breach of its fiduciary duty faith and dealing and (4) monetary damages, interest, cost, and attorneys fees to compensate us for violation of the Pennsylvania Bad Faith Statute. On March 31, 2003 we settled our outstanding claim with our insurance carrier for $1,500,000 relating to reimbursement of expenses in connection with our Asensio law suits. We expect to realize approximately $1,050,000 of this amount after payment of expenses related to the settlement. Such amount was recorded during the fourth quarter 2002 as a reduction in General and Administrative expenses in our statement of operations. In March 2003, one of our former law firms filed a complaint in the Court of Common Pleas of Philadelphia County against us for alleged legal fees in the sum of $65,051. We believe the claim is without merit and are defending the matter. (13) Related Party Transactions We have employment agreements with certain of our executive officers and have granted such officers and directors of the Company options and warrants to purchase common stock of the Company, as discussed in Notes 2(n) and 9. F-26 A director of the Company, is an attorney in private practice, who has rendered corporate legal services to us from time to time, for which he has received fees. A Director of the Company, lives in Paris, France and assists our European subsidiaries in their dealings with medical institutions and the European Medical Evaluation Authority. A Director of the Company, assists us in establishing clinical trail protocols as well as performs other scientific work for us from time to time. For these services, these Directors were paid an aggregate of $173,500, $144,955 and $170,150 for the years ending December 31, 2000, 2001 and 2002 respectively. William A. Carter, Chief Executive Officer of the Company, received an aggregate of $12,486 in short term advances which were repaid as of December 31, 2001. All advances bare interest at 6% per annum. The Company loaned $60,000 to, a Director of the Company in November, 2001 for the purpose of exercising 15,000 class A redeemable warrants. This loan bears interest at 6% per annum. We paid $42,775, $57,750 and $33,450 for the years ending December 31, 2000, 2001 and 2002, respectively to Carter Realty for the rent of property used at various times in 2002 by us. The property is owned by others and managed by Carter Realty. Carter Realty is owned by Robert Carter, the brother of William A. Carter. (14) Concentrations of credit risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash. The Company places its cash with high-quality financial institutions. At times, such amount may be in excess of Federal Deposit Insurance Corporation insurance limits of $100,000. F-28 (15) Quarterly Results of Operation (unaudited) (in thousand except per share data) 2001 --------------------------------------------- First Second Third Fourth Quarter Quarter Quarter Quarter Total ------- -------- ------- -------- ------- Revenue 127 $ 101 $ 76 $ 86 $ 390 Costs and expenses 2,676 2,504 2,262 1,750 9,192 Net loss (2,480) (2,343) (2,145) (2,115) (9,083) ------- -------- ------- -------- ------- Basic and diluted loss per share $(.08) $(.08) $(.07) $(.07) $(.29) ------- -------- ------- -------- ------- 2002 (1) --------------------------------------------- First Second Third Fourth Quarter Quarter Quarter Quarter Total ------- -------- ------- -------- ------- Revenues and license fee income $ 613 $ 134 $ 79 $ 78 $ 904 Costs and expenses 2,121 2,097 1,961 782 6,961 Net loss (1,488) (2,634) (1,891) (1,411) (7,424) ------- -------- ------- -------- ------- Basic and diluted loss per share $(.05) $(.08) $(.06) $(.04) $(.23) ------- -------- ------- -------- ------- (1) During the fourth quarter of 2002, the Company recorded write offs of certain investments in unconsolidated affiliates of approximately $688,000. (See note 2(c)). Additionally, during the fourth quarter of 2002, the Company recorded, as a reduction of general and administrative expenses, an amount of $1,050,000 representing the net settlement with its insurance carrier. (See Note 12) (16) Debenture Financing On March 12, 2003, We issued an aggregate of $5,426,000 in principal amount of 6% Senior Convertible Debentures due January 31, 2005 and an aggregate of 743,288 Warrants to two investors in a private placement for aggregate anticipated gross proceeds of $4,650,000. Pursuant to the terms of the Debentures, $1,550,000 of the proceeds from the sale of the Debentures have been held back and will be released to us if, and only if, we acquire ISI's facility with in a set timeframe. The Debentures mature on January 31, 2005 and bear interest at 6% per annum, payable quarterly in cash or, subject to satisfaction of certain conditions, common stock. Any shares of common stock issued to the investors as payment of interest shall be valued at 95% of the average closing price of the common stock during the five consecutive business days ending on the third business day immediately preceding the applicable interest payment date. Pursuant to the terms and conditions of the Senior Convertible Debentures, we have pledged all of our assets as collateral and are subject to comply with certain financial and negative covenants, which include but are not limited to the repayment of principal balances upon achieving certain revenue milestone. F-28 The Debentures are convertible at the option of the investors at any time through January 31, 2005 into shares of our common stock. The conversion price under the Debentures is fixed at $1.46 per share, subject to adjustment for anti-dilution protection for issuance of common stock or securities convertible or exchangeable into common stock at a price less than the conversion price then in effect. The investors also received Warrants to acquire at any time through March 12, 2008 an aggregate of 743,288 shares of common stock at a price of $1.68 per share. On March 12, 2004, the exercise price of the Warrants will reset to the lesser of the exercise price then in effect or a price equal to the average of the daily price of the common stock between March 13, 2003 and March 11, 2004 (but in no event less than $1.176 per share). The exercise price (and the reset price) under the Warrants also is subject to similar adjustments for anti-dilution protection. We entered into a registration rights agreement with the investors in connection with the issuance of the Debentures and the Warrants. The registration rights agreement requires that we register the shares of common stock issuable upon conversion of the Debentures, as interest shares under the Debenture and upon exercise of the Warrants. In accordance with this agreement, we filed a registration statement on form S-3 with the Securities and Exchange Commission. If the registration statement is not declared effective within the time period required by the agreement or, after it is declared effective and subject to certain exceptions, sales of all shares required to be registered thereon cannot be made pursuant thereto, then we will be required to pay to the investors their pro rata share of $3,635 for each day any of the above conditions exist with respect to this registration statement. F-29 Exhibit 99.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Hemispherx Biopharma, Inc. (the "Company") on Form 10-K for the fiscal year ended December 31, 2002 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, William A. Carter, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. /S/ William A. Carter ------------------------ William A. Carter Chief Executive Officer April 15, 2003 F-30 Exhibit 99.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Hemispherx Biopharma, Inc. (the "Company") on Form 10-K for the fiscal year ended December 31, 2002 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Robert Peterson, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. /S/ Robert Peterson ---------------------- Robert Peterson Chief Financial Officer April 15, 2003 F-31
EX-99.2N OTH CONSENT 3 r10k-bdo_02.txt BDO CONSENT LETTER Exhibit 23.01 CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS Hemispherx Biopharama, Inc. Philadelphia, Pennsylvania We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (SEC File No. 333-57134) of our report dated March 13, 2003, except for Note 12 which is of March 31, 2003, relating to the consolidated financial statements of Hemispherx Biopharma, Inc. and subsidiaries for the year ended December 31, 2002 appearing in the Company's Annual Report on Form 10-K. /x/ BDO Seidman, LLP Philadelphia, Pennsylvania April 15, 2003 EX-99.D CONTRACTS 4 resteve.txt ESTEVE AGREEMENT SALES AND DISTRIBUTION AGREEMENT THIS AGREEMENT (this "Agreement") is made effective as of March 20, 2002 (the "Effective Date"), by and between HEMISPHERX BIOPHARMA EUROPE, S.A. 26-28 rue Marius Aufan 92300 Levallois-Perret Paris, France ("Hemispherx") - -and LABORATORIOS DEL DR. ESTEVE, S.A. Av. Mare de Deu de Montserrat, 221 08041 Barcelona, Espana ("Esteve") (each a "Party" and collectively the "Parties"). WITNESSETH: WHEREAS Hemispherx has certain rights relating to a specially configured ribonucleic acid which is being developed for marketing under the trademark "Ampligenr"; WHEREAS Esteve is in the business of Marketing pharmaceutical products in Spain, Portugal and Andorra; WHEREAS Esteve desires to obtain certain marketing rights for Ampligenr in Spain, Portugal and Andorra; WHEREAS in consideration for Esteve's commitment to pay to Hemispherx the payments specified in this Agreement, and to provide for the development and Marketing of Ampligenr in Spain, Portugal and Andorra, Hemispherx desires to grant to Esteve an exclusive distributorship to Market the Product in Spain, Portugal and Andorra; and WHEREAS the Parties hereto desire to set forth the terms and conditions of such Marketing; NOW THEREFORE, in consideration of the premises and the covenants and promises contained herein, and intending to be legally bound hereby, the Parties agree as follows: 1. DEFINITIONS 1.01 For purposes of this Agreement, the following terms, when used with initial capital letters, shall have the meaning set forth below. Other terms are defined elsewhere in this Agreement and those terms, when used with initial capital letters, shall also have the defined meanings whenever they appear in this Agreement. As to the terms defined and used herein, the singular shall be understood to include the plural and vice-versa, unless the context clearly indicates to the contrary. 1.02 "Affiliate" means any corporation, company, firm, partnership, or other entity which Controls, is Controlled by or is under common Control with a Party. Any entity which buys all, or substantially all, of the assets of Hemispherx shall be deemed to be an affiliate of Hemispherx. 1.03 "REGULATORY APPROVAL" means approval by EMEA or by a national regulatory authority of the Territory of the commercial sale of the Product for use in the treatment of patients with ME/CFS. 1.04 "Commercial Year" means the twelve-month period commencing on the Product Launch and each succeeding twelve-month period thereafter. 1.05 "Control" means the ability of any entity (the "Controlling" entity), directly or indirectly, through ownership of securities, by agreement or by any other method, to direct the manner in which more than fifty percent (50%) of the outstanding voting rights of any other entity (the "Controlled" entity), whether or not represented by securities, shall be cast, or the right to receive over fifty percent (50%) of the profits or earnings of, or to otherwise control the management decisions of, such other entity (also a `Controlled" entity). 1.06 "Esteve's Distribution Center" means Esteve's distribution facilities in Spain and Portugal, as designated by Esteve. 1.07 "EMEA" means the European Medicines Evaluation Agency. 1.08 "Market" means to promote, distribute, market, advertise and/or sell, and Marketing shall have a corresponding meaning. 1.09 "Oragens" means certain low molecular weight, broad spectrum antiviral compounds, typically consisting of three nucleotides held together with special back bone (or phosphodiester) linkages. These compounds act in part via enhancement of the body's own 2-5A/RnaseL cellular pathways. 1.10 "ME/CFS" means myalgic encephalitis/chronic fatigue syndrome. 1.11 "Other Indication/s" means indications other than ME/CFS. 1.12 "Party" means each of Hemispherx and Esteve. 2 1.13 "Patents" means the patents and/or patent applications held by Hemispherx or an Affiliate of Hemispherx regarding the Product in the Territory, as listed in Schedule 1.13, and any patents and patent applications on the Product which Hemispherx or an Affiliate of Hemispherx may hold in the Territory including any reissues substitutions, confirmations, registrations, revalidations, additions, continuations in part, divisions, extensions, renewals, and restorations thereof and any supplemental protection certificates. 1.14 "Product" means any product developed and/or acquired by Hemispherx based on Poly I Poly C12 U, the chemical name of which is polyriboinosinic: polyribocytidylic (12:1) uridylic acid in all forms in which it may be approved in Spain, Portugal and Andorra, including, without limitation, lyophilized and liquid forms. 1.15 "Product Launch" means the date of the first commercial sale of Product by Esteve to an arm's length customer in the Territory. 1.16 "Territory" means Spain, Portugal and Andorra. 1.17 "Trademark" means the trademark to be registered by Hemispherx for the commercialization of the Product in the Territory. 2. GRANT OF EXCLUSIVE DISTRIBUTORSHIP 2.01 Subject to the terms of this Agreement, Hemispherx hereby grants to Esteve an exclusive right to Market the Product in the Territory during the term of this Agreement, for use in the treatment of patients with ME/CFS. Esteve shall purchase the Product for Marketing in the Territory only from Hemispherx. 2.02 In the event that, during the term of this Agreement, Hemispherx decides to develop the Product for Other Indications, Hemispherx shall, at the time of initiation of phase III clinical trials for any such indication, so notify Esteve in writing and shall provide Esteve with information on such Other Indications as is reasonably necessary for Esteve's evaluation of interest. Upon receipt of such notice and information, Esteve shall have a period of sixty (60) days to deliver to Hemispherx a written notice of its interest in distributing, marketing and selling the Product for each such Other Indication in the Territory. If Esteve does not deliver such notice to Hemispherx within such period, Hemispherx shall thereafter have no further obligation to Esteve with respect to each such Other Indication. If Esteve delivers to Hemispherx a notice confirming its interest in such Product, for ninety (90) days following Hemispherx's receipt of Esteve's notice, the Parties shall engage in exclusive, good-faith negotiations for the terms upon which Hemispherx would appoint Esteve as the licensee of the Product in such Other Indications in the Territory which shall be consistent, insofar as reasonably possible, with the terms of this Agreement. If the Parties have failed to reach agreement on such terms by the end of such ninety (90)-day period, then Hemispherx shall thereafter have no further obligations to Esteve with respect to such Other Indications; provided, however, that in such event, Hemispherx will not enter into any agreement relating to the distribution, marketing and sale of the Product for the same indications in the Territory with a third party on terms 3 which, taken as a whole, are materially more favorable to such third party than those last offered in writing by Hemispherx to Esteve. 2.03 Hemispherx shall, at the time of the conclusion of Phase II clinical trials for any indication of Oragens, notify Esteve in writing and shall provide Esteve with a copy of the relevant Phase II clinical study final report(s) together with any additional existing information under the custody, possession or control of Hemispherx on Oragens and such indication as is necessary for Esteve's evaluation of interest in a manner that is reasonably intended to provide a basis for Esteve's decision as to whether to exercise its option hereunder. At Esteve's request, Hemispherx shall provide Esteve with any additional existing information under the custody, possession or control of Hemispherx to the extent that such additional information is reasonably necessary for Esteve to evaluate its possible interest in Oragens. Upon receipt of such notice and information, Esteve shall have a period of ninety (90) days to deliver to Hemispherx a written notice of its interest in distributing, marketing and selling Oragens for each such indication in the Territory. If Esteve does not deliver such notice to Hemispherx within such period, Hemispherx shall thereafter have no further obligation to Esteve with respect to the use of Oragens for each such indication. If Esteve delivers to Hemispherx a notice confirming its interest in Oragens for such indication, for ninety (90) days following Hemispherx's receipt of Esteve's notice, the Parties shall engage in exclusive, good-faith negotiations for the terms upon which Hemispherx would appoint Esteve as the licensee of Oragens in such indication in the Territory which shall be consistent, insofar as reasonably possible, with the terms of this Agreement for the licensing of the Product. If the Parties have failed to reach agreement on such terms by the end of such ninety (90)-day period, then Hemispherx shall thereafter have no further obligations to Esteve with respect to the use of Oragens for such indication; provided, however, that in such event, Hemispherx will not enter into any agreement relating to the distribution, marketing and sale of Oragens for the same indication in the Territory with a third party on. terms which, taken as a whole, are materially more favorable to such third party than those last offered in writing by Hemispherx to Esteve. 3. MANUFACTURE AND SUPPLY OF THE PRODUCT Supply of Product 3.01 Hemispherx shall supply all quantities of the Product required by Esteve for Marketing in the Territory, in final packaged and labeled form, and in accordance with the provisions of this Agreement. 3.02 Hemispherx shall satisfy Esteve's requirements for and fill all Esteve's orders for the Product in the Territory. In the event of any temporary shortfall in the availability of the Product, Hemispherx's available supply of Product shall be allocated proportionately according to the sales of the Product in the Territory and in the European Union not including the Territory during the most recently ended six (6) month period. In the event that the Parties should not reach an agreement on the allocation of Product, the issue shall be submitted to an independent third party designated by mutual agreement, whose 4 decision shall be final. The costs arising from its intervention shall be borne by the Party whose statements were incorrect. Product Quality 3.03 Hemispherx warrants that upon delivery of Product in accordance with this Agreement, Esteve shall have good title to the Product and that the Product: (a)shall have been manufactured, stored and shipped in accordance with all applicable good manufacturing practices, all other applicable laws, rules, regulations and regulatory requirements in the country of manufacture and in the Territory, and shall conform to the specifications as may be amended from time to time set forth in a REGULATORY APPROVAL; (b)shall not be adulterated or misbranded as provided for under any applicable law, order or regulation in effect in the country of manufacture and the Territory; (c)shall have a shelf life of at least twenty-four (24) months from the date of shipping to Esteve, provided the Product, after delivery, is stored in accordance with all good manufacturing practices, all other applicable laws, rules, regulations and regulatory requirements; (d)shall be labeled, packaged and shipped in accordance with labeling, packaging and shipping standards mutually agreed upon by the parties and in accordance with all applicable laws and regulatory requirements in the Territory; and (e)shall comply in all respects with a REGULATORY APPROVAL and the product monograph for the Product. Inspection and Right of Return of Product 3.04 Hemispherx shall provide to Esteve within thirty (30) days after the issuance of a REGULATORY APPROVAL all of the technical data and methodologies necessary for Esteve to perform any finished product quality control testing that Esteve may wish to conduct on the Product. 3.05 Hemispherx shall make any arrangements necessary for the conducting of finished product quality control testing within thirty (30) days after the issuance of a REGULATORY APPROVAL. Hemispherx shall conduct or shall have conducted in a laboratory located in a European Union country, at its own expense, all tests required by a REGULATORY APPROVAL for the Product to determine the compliance of the Product supplied to Esteve with the requirements of paragraph 3.03 of this Agreement and with a REGULATORY APPROVAL, and shall provide the results of all such testing to Esteve together with each Product shipment delivered to Esteve. 5 3.06 Esteve may conduct, but shall not be obliged to conduct, such tests as it deems necessary to determine the compliance of the Product with the requirements of a REGULATORY APPROVAL and this Agreement. Esteve may notify Hemispherx within thirty (30) days of its actual receipt of each shipment of the Product of any non-compliance of the Product with the requirements of paragraph 3.03 of this Agreement revealed by such testing. If no notice of non-compliance is delivered to Hemispherx within such thirty (30) day period, the Product so delivered shall be deemed to comply with paragraph 3.04 of this Agreement. 3.07 The provisions of paragraph 3.06 do not apply to any deficiencies in the Product that could not reasonably be detected through visual inspection by Esteve, within thirty (30)days of actual receipt of the Product by Esteve (a "latent defect"). Esteve shall notify Hemispherx of any such deficiencies within thirty (30) days after they become known to Esteve. 3.08 Within thirty (30) days after receipt of any notice delivered by Esteve pursuant to paragraphs 3.06 or 3.07, Hemispherx and Esteve shall confer on the matter, and Hemispherx shall notify Esteve as to whether or not it concurs with Esteve's determination. If Hemispherx concurs with Esteve's determination, Esteve shall, at Hemispherx's request and expense, return the rejected Product to Hemispherx, and Esteve shall not be responsible to pay Hemispherx for such Product. 3.09 If Hemispherx disagrees with Esteve's determination under paragraph 3.08 the matter shall be submitted to an independent third party tester acceptable to both parties. If the third-party tester concurs with Esteve's determination, Esteve shall, at Hemispherx's request and expense, return the rejected Product to Hemispherx and Esteve shall not be responsible to pay Hemispherx for such Product. If the arbitrator concurs with Hemispherx's determination, Esteve shall be responsible to pay Hemispherx for such Product. 3.10 Except as set forth in paragraph 3.03, Hemispherx shall have no obligation to Esteve for breach of any of the warranties as to the quality of any Product determined to be defective under paragraphs 3.06 or 3.07. 4. DISCLOSURE OF KNOW-HOW AND TECHNICAL AND CLINICAL SUPPORT 4.01 Promptly after the signature of this Agreement and from time to time as it becomes available during the term of this Agreement, Hemispherx shall provide Esteve with such technical, scientific and commercial information, documentation and data relating to the Product which may be developed or acquired by Hemispherx, its Affiliates and other distributors and which may be required or useful for the exercise by Esteve of its rights and obligations under this Agreement. 4.02 Hemispherx shall, upon adequate notice at the request of Esteve, provide free of charge, except for out of pocket expenses incurred for travel, lodgings and meals, reasonable training regarding the proper administration of the Product to patients, to 6 employees, consultants and sub-contractors of Esteve or any Affiliate of Esteve, at such locations as Esteve may reasonably specify. 5. MARKETING OF THE PRODUCT Esteve's Marketing Obligations 5.01 Esteve shall introduce the Product in the Territory within ninety (90) days after issuance of the REGULATORY APPROVAL for the Product in the Territory (including price and reimbursement approvals) subject to receipt of the Product from Hemispherx. 5.02 Esteve shall use diligent efforts and shall devote to Marketing the Product such resources as are necessary to Market the Product in the Territory, including using its best efforts to obtain pricing approval in the Territory for sale of each 400 mg unit of the Product at a laboratory selling price of ?230 and of each 200 mg unit of the Product at a laboratory selling price of ?161. Training and Promotional Materials 5.03 Hemispherx shall during the term of this Agreement make available to Esteve all promotional, advertising, educational and training materials developed by Hemispherx or its Licensees for use with the Product, which materials may be used by Esteve in developing promotional materials for use in the Territory. 5.04 Esteve shall during the term of this Agreement make available to Hemispherx all promotional, advertising, educational and training materials developed by Esteve for use with the Product which materials may be used by Hemispherx in developing promotional materials. 5.05 Esteve shall comply with all applicable laws and regulations governing the sale, promotion and advertising of the Product in the Territory. 6. REGULATORY AFFAIRS Dealings with Regulatory Bodies 6.01 Hemispherx shall agree with Esteve on the strategy and procedures to be followed in the Territory in seeking commercial approval of the Product for ME/CFS with any regulatory authority based in the Territory. Hemispherx shall consult with Esteve on the strategy and procedures to be followed in seeking commercial approval of the Product for ME/CFS with the European Medicines Evaluation Agency and for other jurisdictions within the European Union and shall provide to Esteve for comment and review all registration packages and applications relating to same prior to the filing with any regulatory authority. 6.02 Hemispherx will be responsible, at its cost and expense, for preparing registration packages and filing for the Product and for obtaining in the Territory the REGULATORY APPROVAL for the Product for the treatment of ME/CFS in the name of Hemispherx. 7 When filing for the REGULATORY APPROVAL, Hemispherx will designate Esteve as its distributor for the Product for the treatment of ME/CFS in the Territory. Hemispherx will endeavor in good faith to obtain the REGULATORY APPROVAL for the Product for the treatment of ME/CFS as expeditiously as possible, and shall, at its own cost and expense, conduct such studies, including, without limitation, chemical manufacturing control, toxicology, dose-finding, pharmacokinetic and other clinical work as may reasonably be necessary. Hemispherx will be responsible for maintaining the REGULATORY APPROVAL at its expense during the term of this Agreement and will promptly notify Esteve in writing of any change in the status of such approvals 6.03 All communications by Esteve with any drug regulatory authority in the Territory relating to the Product as Marketed in the Territory shall be confirmed by Esteve in writing to Hemispherx, and Esteve shall provide to Hemispherx copies of all documents sent to or received from any drug regulatory authority in the Territory regarding the Product. 6.04 Esteve shall be responsible for responding to all Product-related inquiries, Product quality complaints, and reports received from lay persons and/or Health Care professionals from within the Territory. 6.05 Each Party shall obtain and maintain, at its own cost and expense, all other licenses, permits and authorizations necessary to perform its respective duties under this Agreement, and shall cooperate with the other in applying for and obtaining any governmental approvals necessary to implement the terms of this Agreement. 6.06 Esteve shall, at its own expense, apply for any establishment license necessary to enable it to carry out its obligations under this Agreement. 7. QUARTERLY FORECASTS AND ORDERS Forecasts 7.01 At least one hundred and twenty (120) days before the anticipated issuance of a REGULATORY APPROVAL upon Hemispherx's request, and within ten (10) business days following the end of each calendar quarter thereafter during the term of this Agreement, Esteve shall supply to Hemispherx, a twelve (12) month rolling forecast of Esteve's projected requirements for the Product in the Territory. 7.02 Within sixty (60) days of Esteve's initial purchase order, Hemispherx shall supply to Esteve all quantities of the Product required for the Product Launch as specified in Esteve's initial purchase order. 7.03 Esteve shall deliver subsequent purchase orders for the Product to Hemispherx no less than ninety (90) days prior to the required date of delivery. Within ten (10) days of receipt of an order, Hemispherx shall send to Esteve a written confirmation of such order, at which point such order shall be binding upon Esteve and Hemispherx. Each order shall state the date and location where delivery shall be made. Hemispherx shall dispatch to Esteve the requisite quantity of Product to fulfill such orders. In the event that Esteve's 8 orders exceed projected requirements for the Product Hemispherx shall use its best efforts, to provide the full amount of Esteve's requested quantities of Product and to meet Esteve's requested delivery dates. 7.04 All Product shall be shipped by Hemispherx, DDP (Incoterms 2000) to Esteve's Distribution Center as Esteve may specify in its purchase order for the Product. Minimum Purchase Requirements 7.05 Provided that Hemispherx has complied with its obligations under this Agreement, Esteve shall, commencing in the year of Product Launch and in each Commercial Year thereafter throughout the term of this Agreement, purchase from Hemispherx the minimum amount of the Product specified in Schedule 7.05. 8. PAYMENTS, RECORDS, REPORTS AND AUDITS Initial and Subsequent Fees 8.01 Esteve shall pay to Hemispherx: (a) A fee of 625,000 Euros within thirty (30) days of receipt of Hemispherx's invoiced issued upon execution of this Agreement. (b) A fee of 1,000,000 Euros within thirty (30) days of receipt of Hemispherx's invoice issued after approval by the United States Food and Drug Administration of the commercial sale of the Product in the United States for use in the treatment of patients with ME/CFS. (c) A fee of 1,000,000 Euros within thirty (30) days of receipt of Hemispherx's invoice issued after the issuance of the final marketing authorization (including price and reimbursement) for the Product in Spain. In the event any tax or withholding is levied by any taxing authority in connection with the accrual or payment of any sum hereunder, Esteve shall have the right to pay such tax or withholding to the relevant taxing authorities on behalf of Hemispherx and to deduct from amounts due to Hemispherx the amount paid for such taxes or withholding, provided that Esteve shall deliver to Hemispherx evidence of such payment. The above amounts shall be non-refundable, except if this Agreement is terminated by Esteve in accordance with the provisions of paragraph 14.05 at a time when Esteve is not in material breach of any term or provision of this Agreement. Initial Investment 8.02 Within thirty (30) days of execution of this Agreement, Esteve shall purchase from Hemispherx, and Hemispherx shall sell to Esteve, ?1,000,000 of Hemispherx's seven percent (7%) Convertible Bonds due 30 September, 2003. 9 Clinical Trial Support 8.03 (a) Promptly following execution of this Agreement Hemispherx and Esteve shall formulate a Strategic Alliance Committee ("SAC") to be chaired by William A. Carter, M.D. and co-chaired by Dr. Antoni Esteve. The SAC shall meet promptly upon formation, and at least quarterly thereafter, and shall (a) devise and approve a protocol for a pilot Clinical Trial ("Pilot Trial") for the treatment of patients with HIV and HCV to be conducted by Esteve in the Territory (b) select the same or other targeted indication(s) of clinical research trial(s) ("Clinical Trial(s)") to be conducted by Esteve in the Territory utilizing the Product (c) devise and approve protocol(s) for the Clinical Trial(s), and (d) maintain~ oversight and ultimate control of the Pilot Trial and the Clinical Trial(s). The representatives of Esteve shall be collectively entitled to one (1) vote and the representatives of Hemispherx shall be collectively entitled to one (1) vote. The decisions of the SAC shall be adopted unanimously. In the event that within thirty (30) business days a dispute cannot be amicably resolved within the SAC despite the good faith efforts of the Parties, the Parties agree to refer the dispute to the decision of an external expert suitably qualified to resolve such dispute which is mutually acceptable to both Parties, whose decision shall be final. In resolving the dispute, the appointed expert shall take into account clinical development practices and procedures common in the pharmaceutical industry and appropriate with reference to the specific Pilot Trial and Clinical Trial Hemispherx shall provide Esteve, free of charge, with all necessary Products in order to conduct both the Pilot Trial and the Clinical Trial(s). Esteve shall, promptly following receipt of the appropriate authorizations and the necessary Products to conduct the Pilot Trial, diligently initiate, implement and administer the Pilot Trial in the Territory under the oversight and ultimate control of the SAC. In initiating, implementing and administering the Pilot Trial Esteve shall, under the direction of the SAC, establish a budget, in accordance with generally accepted accounting principles, reflecting no overhead costs and only direct costs, and shall expend not less than approximately ?300,000 of Esteve's funds on the Pilot Trial. Esteve shall, promptly following commercial approval of the Product for the treatment of ME/CFS in the United States by the United States Food and Drug Administration ("FDA Approval") and after receipt of the appropriate authorizations and the necessary Products to conduct the Clinical Trial(s), diligently initiate, implement and administer the Clinical Trial(s) in the Territory under the oversight and ultimate control of the SAC. In initiating, implementing and administering the Clinical Trial(s) Esteve shall, under the direction of the SAC, establish a budget, in accordance with generally accepted accounting principles, reflecting no overhead costs and only direct costs, and shall expend ?2,000,000, subject to a credit for all sums expended on the Pilot Trial, of Esteve's funds on the Clinical Trial(s) within twenty four (24) months of FDA Approval, or such longer term as may be considered appropriate by the SAC taking into consideration the Protocol of the Clinical Trial(s). 10 Notwithstanding the foregoing Esteve may, at its sole discretion, initiate, implement, administer the Clinical Trial(s) in the Territory as well as expend the amounts referred to in the preceding paragraph before obtaining the FDA Approval Esteve shall, no less frequently than once each six (6) months, provide to the SAC an updated projected budget, including a report on all disbursements to date, on the Pilot Trial and the Clinical Trials(s), all in accordance with generally accepted accounting principles. Additionally, Esteve shall provide to Hemispherx such support, assistance and cooperation in the preparation and prosecution of REGULATORY APPROVAL based on the Pilot Trial and the Clinical Trial(s) as may then reasonably be requested by Hemispherx. (b) Such economic expenditure by Esteve shall be taken into consideration when establishing the economic terms for the license of the targeted indication under the conditions provided in paragraph 2.02. (c) Hemispherx shall have and retain ownership of and title to all trademarks, patents and other intellectual property rights in all inventions, discoveries and other intellectual property (all herein "Intellectual Property") which are made, conceived, reduced to practice or generated by the Pilot Trial and the Clinical Trial(s) and Esteve shall cooperate with Hemispherx in perfecting and protecting said Intellectual Property. Price 8.04 The price of the Product shall be ?115 per 400mg unit and ?80.5 per 200 mg unit and Esteve shall pay to Hemispherx 115 Euros for each 400mg unit and 80.5 Euros for each 200 mg unit of Product purchased. Such prices shall be DDP Esteve's Distribution Centers in the Territory. In the event that Esteve, utilizing its best efforts, is only able to obtain pricing approval for sale of the Product in the Territory ("Approved Pricing") at prices less than those set forth in paragraph 5.02, and, provided the Approved Pricing is not less than the then lowest approved pricing of the Product by any other nation a member of the European Union as of the Effective Date, Hemispherx agrees to meet with Esteve to explore in good faith the possibility of an adjustment of the price of the Product to be paid by Esteve to Hemispherx in order to preserve Esteve's fifty percent (50%) gross margin. 8.05 Hemispherx shall invoice Esteve for each shipment of Product ordered by Esteve. Esteve shall pay each such invoice within thirty (30) days of the date of the invoice. 8.06 Esteve shall be responsible for the payment of any duties, levies or taxes applied to the sale of the Product into the Territory by any relevant Spanish, Portuguese or Andorran tax authority(s). 8.07 Hemispherx shall determine the appropriate carrier to be used to ship the Product to Esteve and shall bear the cost of shipment and insurance. Esteve shall be responsible for all cost of shipping the Product from an Esteve Distribution Center to the customers. 11 8.08 All sums due to Hemispherx under this Agreement shall be paid by Esteve to Hemispherx in immediately available funds by wire transfer to the bank account as Hemispherx may specify in writing. 9. ADVERSE REACTIONS AND RECALLS Adverse Reaction Reporting and Product Complaints 9.01 Each of Esteve and Hemispherx shall comply with (a) all adverse reaction reporting systems in force in the Territory, and (b) the adverse reaction reporting requirements of EMEA and/or the relevant authorities, as applicable. 9.02 Esteve shall promptly advise Hemispherx of any adverse reaction information that comes to its attention. Hemispherx shall submit adverse reaction reports to EMEA and/or to the relevant authorities in the Territory in accordance with the applicable regulations, and provide a copy of all such submissions to Esteve. Hemispherx shall be solely responsible for compiling such adverse event information and making any reports required to EMEA and/or to the relevant authorities in the Territory. Hemispherx shall promptly notify Esteve of all adverse reaction information and reports received by Hemispherx from its licensees outside the Territory and copies of all correspondence with any regulatory authority concerning such reports. 9.03 Each of Hemispherx and Esteve shall immediately notify the other of any information it receives regarding any threatened or pending action by EMEA or other regulatory agency which may affect the safety or efficacy claims of the Product or the continued marketing of the Product in the Territory. Upon receipt of any such information, Hemispherx will consult with Esteve in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting the ability of Hemispherx or Esteve to make a timely report of such matter to any governmental agency or take other action that it deems to be appropriate or required by applicable law or regulation. For the sake of clarity, the Product shall only be withdrawn from the Territory for the reasons stated in 9.06 below. Each of Hemispherx and Esteve shall provide such information regarding the Product to the other. 9.04 Each of the Parties shall throughout the duration of this Agreement maintain records and otherwise establish procedures to assure compliance with all regulatory, professional, and other legal requirements which apply to the promotion and marketing of the Product in the Territory. Recalls 9.05 Esteve shall notify Hemispherx immediately of any recall or withdrawal of the Product from the market in the Territory required by EMEA or the regulatory authorities in the Territory. At Hemispherx's request, Esteve shall perform any recall required and shall obtain and receive any Product that has been recalled. 12 9.06 In the event that either Party proposes to recall or withdraw the Product from the market for health and safety reasons, the Party desiring such recall or withdrawal shall notify the other Party immediately. Both Parties shall then meet and discuss such proposal with a view to reach a consensus on the pertinence of the recall, provided, however, that each Party shall eventually be entitled to recall the Product if it considers in good faith that the recall is necessary due to serious health and safety reasons. 9.07 In the event that any batches or shipments of the Product are subject to a recall, Hemispherx shall, subject to the provisions of paragraph 9.05, conduct the recall and shall bear the cost and expense of any recall, except that Esteve shall bear the cost and expense of any recall shown to have been required as the result of any breach by Esteve of this Agreement. If the recall is not attributable to the fault of one Party only, the cost of the recall shall be shared equally by the Parties. 10. PRE AND NON REGULATORY APPROVAL Prior to and in the event of non REGULATORY APPROVAL of the Product for the treatment of ME/CFS in the Territory Esteve shall have the right to provide the Product for the treatment of ME/CFS in the Territory on a named patient and/or a foreign medication sale basis, with the price to be paid by Esteve to Hemispherx for the Product to be negotiated in good faith with consideration being given to Esteve's gross margin on such sales. 11. INTELLECTUAL PROPERTY Ownership of Intellectual Property 11.01 Hemispherx or its Affiliates shall have and retain ownership of and title to all trademarks, patents and other intellectual property rights in the Product, including without limitation all inventions, discoveries and improvements and other intellectual property relating to the Product which are made, conceived, reduced to practice or generated by the Parties or their respective Affiliates, including employees, agents and other representatives or contractors, in the course of work performed under this Agreement and/or any other agreements between the Parties relating to the Product. Hemispherx shall own the Trademark in the Territory. Hemispherx shall register the Trademark in the Territory and shall maintain such registration in force during the term of this Agreement. Patent and Trademark 11.02 Hemispherx or its Affiliates shall have the exclusive right and obligation to prepare, file, prosecute and maintain at its or their own expense all patent and trademark applications and patents and trademarks relating to the Product and shall use reasonable efforts to file such applications as may be required to protect the intellectual property associated with the Product in the Territory. At Hemispherx's expense, Esteve shall provide reasonable assistance to Hemispherx to facilitate the filing and maintenance of all such patent and trademark applications and patents and trademarks, and shall execute all 13 documents which Hemispherx deems necessary or desirable therefor. Without limiting the foregoing, Hemispherx shall file a Certificate of Addition on Spanish patent number ES 2.018.903 for the purpose of expanding the present coverage in Spain to the Product's use in the treatment of ME/CFS. Retention of Certain Rights 11.03 Subject to paragraph 11.02 above, each Party (i) shall retain ownership of all intellectual property rights in its own trademarks, logos and other intellectual property used in the Marketing of the Product and to the extent necessary to permit the other Party to lawfully fulfill its obligations in relation to Marketing the product in the Territory pursuant to the terms of this Agreement, and (ii) hereby grants to the other Party a gratuitous, royalty-free license (or sublicense, as the case may be) to use such intellectual property for the sole purpose of so Marketing the Product in the Territory pursuant to the terms of this Agreement. 11.04 Hemispherx hereby grants Esteve an exclusive right to use the Trademark to be registered by Hemispherx in the Territory. Infringement by Third Parties 11.05 Each Party shall promptly notify the other following the discovery of any infringement or unauthorized use of the other Party's intellectual property rights used in the promotion of the Product. The Party whose rights are infringed shall determine within sixty (60) days following such notice whether to prosecute the alleged infringement and whether to enforce its intellectual property rights against the alleged infringer. If the Party whose rights are infringed determines to prosecute the infringement, that Party shall bear the costs and expenses of the prosecution. Should the Party whose rights are infringed fail to determine whether to prosecute within the sixty (60) day period set forth above, or determine not to initiate any action against the alleged infringer, the other Party shall have the right to initiate such action at its own expense, and in the name of the other Party if advisable. In the event either Party brings an action pursuant to this paragraph 11.05, the other Party shall provide the Party bringing such action with reasonable assistance at the prosecuting Party's expense. Any recovery from any such action shall first be applied in satisfaction of expenses and legal fees incurred by the Parties in connection with the action, and any balance remaining from any such recovery shall be divided between the Parties pro rata according to the losses incurred by the Parties by reason of the infringement that was the subject of the action. Claims of Infringement 11.06 Either Party shall notify the other promptly in the event of the receipt of notice of any action, suit or claim alleging infringement of any intellectual property right held by a third party. Defense of all such claims shall be subject to Article 13. 11.07 If Hemispherx, Esteve or any of their respective Affiliates or customers shall be sued by a third party for infringement of a patent, or a claim shall be made of infringement of a patent because of the manufacture, use or sale of the Product or any regulatory or other 14 action is initiated by a third party to delay or affect the sale of the Product then the Party which has been sued or becomes aware of such a suit or regulatory or other action shall promptl~7 notify the other Party in writing of the institution of such suit or regulatory or other action. Hemispherx shall have the right to defend at its own expense, and have control over any such litigation or suit. Esteve shall have the right to participate in such suit or action at its own expense. If Hemispherx declines to defend any action relating to or arising from the Marketing of the Product in the Territory promptly and diligently, Esteve may, at its own expense, defend such action in the name of Hemispherx if necessary, subject to Hemispherx's unqualified right to assume the defense and control of any such suit or action at its own expense. 11.08 Either Hemispherx or Esteve may at its own expense conduct all negotiations for the settlement of any claim in respect of which it has agreed to indemnify the other, and the defense and settlement of any litigation that may arise therefrom, but shall not at any time make any admission or take any steps which might be prejudicial to the settlement or successful defense by the other of any claim unless and until the other has been notified of the claim and has stated its intention in writing not to negotiate or defend the claim. No Implied License 11.09 Except as specifically provided herein, nothing in the Agreement does, or is intended to, or shall be construed to create, confer, give effect to or otherwise imply in Esteve or anyone claiming through Esteve any license, right, or property interest in the Product the Patents, the Trademark, or any trade secrets, know how or property relating to the Product. 12. CONFIDENTIALITY 12.01 "Confidential Information" means any confidential or proprietary information, knowledge, intellectual property, pre-clinical and clinical information or data, technical and/or non-technical material or property, relating to the Product and/or Oragens, their manufacture, or Marketing delivered by one Party ("Supplier") to the other Party ("Recipient"). 12.02 Recipient will employ the same degree of care to keep all Confidential Information confidential as it employs with respect to its own information of like importance, and will not disclose any Confidential Information to any third party, except to consultants and employees of themselves or Affiliates who need or are entitled to know such Confidential Information for the purposes of carrying out the object of this Agreement, and who are under an obligation to keep that information confidential The Recipient shall maintain a written list of the identity of each such third party, including employees of Recipient, to whom confidential information is disclosed. Confidential Information may be disclosed to Esteve's Licensees and potential Licensees only with Hemispherx prior written approval, which approval shall not be unreasonably withheld or delayed. 12.03 All Confidential Information shall remain the property of Supplier. Upon the written request of Supplier upon termination or expiration of this Agreement, all tangible Confidential Information received from Supplier (including all copies thereof and samples) 15 shall be promptly returned to Supplier; provided that Recipient may provide one (1) copy of such tangible Confidential Information to its General Counsel to be retained in a secure location for purposes of identifying its obligations under this Agreement. 12.04 The obligations of confidentiality and non-use set forth in this Article 12 of this Agreement shall not apply to any portion of the Confidential Information that: (a)is or becomes public or available to the general public otherwise than through the act or default of Recipient or any authorized third party; or (b)is obtained by Recipient from a third party who is lawfully in possession of such Confidential Information and is not subject to an obligation to Supplier of confidentiality or non- use; or (c)is previously known to Recipient prior to disclosure to Recipient by Supplier; or (d)is furnished to others by Supplier without restrictions on confidentiality and non-use similar to those contained in this Agreement; or (e)is acquired, independently developed, discovered or arrived at by the party possessing the information, or which is independently developed, discovered or arrived at by the Recipient, without use of the Confidential Information received from the Supplier; or (1)is used by Hemispherx or Esteve in the Marketing of the Product and/or Oragens. 12.05 In the event that either Party is requested or required (by deposition, interrogatories, requests for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process) to disclose any of the Confidential Information of the other Party, the Party to whom such request or requirement applies (the "Mandated Party") shall provide the other Party (the "Protected Party") with prompt written notice of any such request or requirement so that Protected party may seek a protective order or other appropriate remedy and/or waive compliance with the provisions of this Confidentiality obligation. If, in the absence of a protective order or other remedy or the receipt of a waiver by Protected Party, the Mandated Party or its representatives are nonetheless, in the opinion of their counsel, legally compelled to disclose Confidential Information to any tribunal or else stand liable for contempt or suffer other censure or penalty, the Mandated Party may, without liability hereunder, disclose to such tribunal only that portion of the Confidential Information which such counsel advises the Mandated Party is legally required to be disclosed, provided that Mandated party exercises commercially reasonable efforts to preserve the confidentiality of the Confidential Information and provides to the Protected Party a copy of any written opinion relied on. 12.06 Nothing in this Agreement shall be construed as giving Recipient any right, title, interest in or. ownership of the Confidential Information. 16 12.07 The provisions of this Article 12 shall survive any termination or expiry of this Agreement for a period of five (5) years. 13. INDEMNIFICATION 13.01 Hemispherx, together with its successors and assigns, hereby agrees to indemnify and hold Esteve harmless from and against all losses, costs, claims, actions, liabilities, including liability for death or personal injury, and expenses (including reasonable attorneys' fees), incurred by Esteve which result from or arise in connection with (a)the breach of any representation, covenant or warranty of Hemispherx contained in this Agreement. (b)any product liability claim relating to the Product including without limitation, any claim based upon any use of Product, or any defect in the Product that was manufactured by, or for Hemispherx or by an Affiliate or licensee thereof; or (c)any act or omission of Hemispherx or of Hemispherx's officers, directors, employees or agents (including, without limitation, statements or representations that are inconsistent with, or contrary to the Product labeling), or (d)any claims or allegations by a third party that the sale or use of the Product or the use of the Trademark infringes that third party's intellectual property rights, except to the extent that any such liability, cost, loss or expense is attributable to the negligent or intentional malfeasance of Esteve in connection with the performance of its duties and obligations hereunder. 13.02 Esteve, together with its successors and assigns, hereby agrees to indemnify and hold Hemispherx harmless from and against any and all losses, costs, claims, actions, liabilities, including liability for death or personal injury, and expenses (including reasonable attorneys' fees) incurred by Hemispherx which result from or arise in connection with (a)the breach by Esteve of any representation, covenant or warranty of Esteve contained in this Agreement; (b)the Marketing of the Product in the Territory by Esteve, its Affiliates, and the directors, officers, employees and agents thereof, except to the extent that the losses, costs claims, actions, liabilities and expenses result from an infringement of Hemispherx's warranties provided for in Article 16.01, or (c)any act or omission of Esteve or of Esteve's officers, directors, employees or agents (including without limitation statements or representations that are inconsistent with, or contrary to the Product labeling) 17 except to the extent that any such liability, cost, loss or expense is attributable to the negligent or intentional malfeasance of Hemispherx in connection with the performance of its duties and obligations hereunder. Procedure for Indemnification 13.03 Upon receiving notice of any claim or suit under paragraph 13.01 or 13.02 above, the indemnified Party shall immediately notify the indemnifying Party and shall allow the indemnifying party and/or its insurer the opportunity (subject to Hemispherx's obligations to assume control of any and all third party infringement claims as described in paragraph 11.06) to assume direction and control of any and all third party infringement claim, including, without limitation the settlement thereof at the sole option of the indemnifying Party or its insurer. The indemnified Party agrees to cooperate with the indemnifying Party in the conduct of any negotiations, dispute resolution or litigation of any such claim or suit; and the indemnifying Party shall inform the indemnified Party of the progress of the claim or suit at such time and in such manner as is reasonable under the circumstances. Insurance 13.04 During the period of time beginning with the Product Launch and continuing for five (5) years after the expiration or termination of this Agreement, the Parties shall each maintain in force product liability insurance coverage, with commercially reasonable limits adequate to cover their obligations under this Agreement under ordinary terms and conditions which are customary in the pharmaceutical sector. A certificate of insurance shall be provided by each Party to the other promptly upon request from the other Party. 14. TERM AND TERMINATION Term and Renewal 14.01 This Agreement shall become effective immediately, and, unless terminated pursuant to the provisions of this Agreement, shall continue in effect for the longer of (a) a period of ten (10) years from the date of Product Launch, or (b) a period until the date of expiration of the last to expire of the Patents exploited by Esteve hereunder, or (c) the period of regulatory data protection for the Product in accordance with the applicable regulations in the Territory. 14.02 Upon expiration of the term set forth in Article 14.01, Esteve shall have the right to extend the term of this Agreement for successive periods of two (2) years, provided that it has complied with its contractual obligations under this Agreement. If Esteve wishes to exercise such right, it shall so notify Hemispherx in writing no later than one hundred and eighty (180) days prior to the expiration of the initial term of this Agreement or of the relevant extension. Should the term of this Agreement be extended in accordance with the provisions of the preceding paragraph, the parties shall discuss in good faith the supply price of the Product taking into consideration the market situation prevailing at that time. 18 Termination by Either Party 14.03 Either Party may terminate this Agreement immediately upon written notice if, after issuance of a REGULATORY APPROVAL, the Product is withdrawn from the Territory for a period of more than ninety (90) days for serious adverse health or safety reasons. 14.04 Either Party may terminate this Agreement immediately upon written notice if, at any time, the other Party: (a)files in any court a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such Party or of its assets; (b)proposes a written agreement of composition for extension of its debts; (c)is served with an involuntary petition against it filed in any insolvency proceeding, and such petition is not dismissed within sixty (60) days after the filing thereof; (d)proposes or is a party to any dissolution or liquidation; or (e)makes an assignment for the benefit of its creditors. 14.05 Except as otherwise provided in this Agreement, either party may terminate this Agreement if the other party materially breaches any term or provision of this Agreement, ninety (90) days after giving the breaching Party written notice of such breach, unless: (a)the breaching Party cures the breach within such ninety (90) day period; or (b)if a cure of such breach cannot reasonably be effected within such ninety (90) day period, the breaching party commences the cure of such breach within such ninety (90) day period and diligently prosecutes such cure to completion Termination by Hemispherx 14.06 (a) In the event that Esteve fails to meet eighty percent (80%) of the minimum purchase requirement of Schedule 7.05 in any Commercial Year, and provided that per capita sales of the Product in the Territory for the treatment of patients with ME/CFS in such Commercial Year do not exceed per capita sales of the Product in France for the treatment of patients with ME/CFS in such calendar year, Hemispherx may within ninety (90) days of the end of that Commercial Year and upon thirty (30) days written notice to Esteve elect to transform `Esteve's exclusive right to Market the Product in the Territory to a non exclusive right to Market Product in the Territory. 19 Upon receipt of written notice of an election by Hemispherx to elect to transform Esteve's exclusive right to Market the Product in the Territory to a non exclusive right to Market Product in the Territory Esteve may retain its exclusive right to Market the Product in the Territory if within thirty (30) days of the receipt of such notice Esteve purchases sufficient Product from Hemispherx to make up the shortfall in its minimum purchase requirements. (1!) In the event that Esteve fails to meet sixty percent (60%) of the minimum purchase requirements of paragraph 7.05 in any Commercial Year, and provided that per capita sales of the Product in the Territory for the treatment of patients with ME/CFS in such Commercial Year do not exceed per capita sales of the Product in France for the treatment of patients with ME/CFS in such calendar year, Hemispherx may within ninety (90) days of the end of that Commercial Year and upon thirty (30) days written notice to Esteve terminate this Agreement. Upon receipt of written notice of an election by Hemispherx to terminate this agreement Esteve may retain its exclusive right to Market the Product in the Territory, and this Agreement shall not be terminated if within thirty (30) days of the receipt of such notice Esteve purchases sufficient Product from Hemispherx to make up the shortfall in its minimum purchase requirements. Termination by Esteve 14.07 In the event Hemispherx does not supply the Product for the Territory for a period of ninety (90) consecutive days for any reason other than as contemplated by paragraph 9.06 (serious adverse health or safety reasons) or Article 15 (force majeure), Esteve may, within thirty (30) days from the expiration of the ninety (90) day period referenced in this paragraph, terminate this Agreement upon thirty (30) days written notice to Hemispherx. In the event Esteve does not elect to terminate this Agreement pursuant to this Article 14.07, the Agreement shall remain in full force and effect and Esteve's minimum purchase requirements and other factors, as appropriate, shall be adjusted appropriately for the period in which the supply of the Product was interrupted. 14.08 Esteve may further terminate forthright this Agreement if the results of the clinical trial being conducted by Hemispherx which is described in Schedule 14.08 (hereinafter, the "Clinical Trial") are not positive, such results being essential to Esteve to maintain its interest in the Product. The Parties agree that the results of the Clinical Trial will be considered positive if efficacy is established as determined in paragraph 3.1. of the Protocol (Primary Endpoints). To such purpose, Hemispherx shall immediately provide to Esteve the final report of the Clinical Trial, together with any other relevant information to assess the results of the Clinical Trial Should Hemispherx not receive a termination notice from Esteve within thirty (30) days following reception of the final report by Esteve, it shall be considered that Esteve has waived any termination rights it may have pursuant to this Article 14.08. In the event of termination of this Agreement pursuant to this Article 14.08, it is agreed that: 20 (i) Hemispherx may retain any amounts already paid by Esteve hereunder prior to the termination of this Agreement, and (ii) Esteve shall not pay any additional amount (nor perform any activity) hereunder, in particular pursuant to Articles 8.01, 8.02 and 8.03 hereinabove, and Hemispherx shall not claim any such additional amounts (nor request the performance of any such activities). Effect of Expiration of Termination 14.09 Expiration or termination of this Agreement for any reason shall not release any Party from any obligation and any liability which, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination, nor shall it preclude either Party from pursuing all rights and remedies it may have hereunder with respect to any breach of this Agreement. 14.10 The rights and obligations of the Parties set forth in Articles 11, 12 and 13 and this Article 14.09, 14.10 and 14.11 shall survive expiration or termination of this Agreement for any reason. 14.11 Upon expiration or termination of this Agreement, Esteve shall have the right to continue to sell its existing inventory of Product in the Territory for a period of six (6) months from the effective date of such expiration or termination. 15. FORCE MAJEURE 15.01 Neither Party shall be liable for failure to perform any of its obligations hereunder if such failure is due to strikes, locks-outs or other labor disturbances, riots, floods, fires, accidents, wars, embargoes, delays of carriers, inability to obtain materials from sources for supply, acts, injunctions, or restraints of governments (whether or not now threatened) or any other cause beyond the reasonable control of such Party, which was not reasonably foreseeable on the date this Agreement was entered into, and which could not reasonably have been avoided (each a "Force Majeure Event"). Upon the occurrence of any Force Majeure Event, the Party whose performance is affected shall immediately give written notice of such Force Majeure Event, the Party whose performance is affected shall immediately give written notice of such Force Majeure Event to the other Party, and shall thereafter exert all reasonable efforts to overcome the Force Majeure Event and resume performance of this Agreement. If, despite such efforts, the Party is unable to overcome the Force Majeure Event and resume performance of this Agreement within six (6) months following notification given hereunder, then the other Party may terminate this Agreement upon expiration of such six (6) month period by written notice to the non- performing Party. 15.02 No Party shall have the right to avail itself of this Article 15 in the event the Force Majeure Event arises from an act or from any negligence of the Party. 15.03 Each Party shall bear its own costs arising out of or resulting from the occurrence of any Force Majeure Event. 21 16. REPRESENTATIONS AND WARRANTIES 16.01 Unless specifically stated below, each Party hereby represents and warrants to the other Party as follows: (a) Such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is organized; has the corporate or other power and authority and the legal right to conduct its business as it is now being conducted; and is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, or financial or other condition of such Party and would not materially adversely affect such Party's ability to perform its obligations under this Agreement. (b) Such Party has the corporate or other power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and has taken all necessary corporate or other action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation, enforceable against such Party in accordance with its terms, except as such enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other similar laws affecting the enforcement of creditors' rights generally from time to time in effect and general principles of equity. (c) Such Party shall comply with all applicable laws and regulations in the Territory in connection with the performance of its duties hereunder. (d) The execution and delivery of this Agreement and the performance of such Party's obligations hereunder shall not conflict with, violate the provisions of, constitute a default or give rise to rights of any entity under (a) the party's Articles of Incorporation or Bylaws; (b) any requirement of applicable laws or reg~1ations; (c) any judgment, decree or order of any court or governmental or regulatory agency applicable to the Party, its subsidiaries, its Affiliates or their respective assets; or (d) any agreement, commitment or contractual obligation of such Party or of any of its subsidiaries or Affiliates by which they or their respective assets are bound, except such conflicts that do not materially adversely affect such Party's ability to perform its obligations under this Agreement. (e) Hemispherx specifically represents and warrants that there is no pending or threatened lawsuit or proceeding of any governmental or regulatory authority against or concerning Hemispherx in connection with the respective obligations to be performed hereunder, which if adversely determined, would (a) prohibit the execution, delivery or performance of this Agreement or (b) have a material, adverse effect on Hemispherx or on the 22 ability of Hemispherx to consummate the transactions contemplated hereby or to perform its obligations under this Agreement. (I) Hemispherx warrants and represents that to the best of its knowledge the manufacture, sale or use of the Product and the use of Hemispherx's Confidential Information and the Trademarks in the Territory do not infringe any third parties rights. (g) Hemispherx warrants and represents that prior to the execution of this Agreement it has disclosed to Esteve all information known to Hemispherx (including such information on the Products, Patents and patent rights of third parties) reasonably relevant to Esteve in order to assess its interest in entering into this Agreement, and that no material information actually known to Hemispherx as of the Effective Date regarding the foregoing has been withheld from Esteve to Hemispherx. (h) Hemispherx warrants and represents that it will pursue the applications for the REGULATORY APPROVAL for the Product in the Territory. (i) Esteve specifically represents that, in entering into this Agreement, Esteve is relying solely upon its independent investigation of Hemispherx's business and its independent consultation with such professional, legal and accounting advisors as it deems necessary, and is not acting in reliance on any statements, instruments, certificates, documents representations or warranties other than those contained or referred to in this Agreement. (j) Esteve specifically represents and warrants that there is no pending or threatened lawsuit or proceeding of any governmental or regulatory authority against or concerning Esteve in connection with the respective obligations to be performed hereunder, which if adversely determined, would (a) prohibit the execution, delivery or performance of this Agreement or (b) have a material adverse effect on Esteve or on the ability of Esteve to consummate the transactions contemplated hereby or to perform its obligations under this Agreement. (k) Esteve warrants and represents that prior to the execution of this Agreement it has disclosed to Hemispherx all information known to Esteve reasonably relevant to Hemispherx in order to assess its interest in entering into this Agreement, and that no material information actually known to Esteve as of the Effective Date regarding the foregoing has been withheld from Hemispherx to Esteve. 23 17. MISCELLANEOUS Changes in Regulatory or Market Conditions 17.01 In the event of a material change of regulatory or market circumstances in the Territory in respect of those originally anticipated as of the date of the execution of this Agreement, which may adversely affect the commercial basis of this Agreement, the party affected by such material change shall notify the other and the parties shall meet to discuss the altered circumstances and re-negotiate in good faith the terms of this Agreement which may be affected by such material change (i.e. minimum purchases and/or supply prices, as may be appropriate). Notices 17.02 Except as otherwise provided herein, any notice or other communication sent or delivered hereunder shall be in writing and shall be effective if hand delivered or if sent by facsimile transmission (confirmed by overnight courier) or overnight courier and addressed as follows. if to Hemispherx: Hemispherx BioPharma Europe, S.A. 26-28 rue Marius Aufan 92300 Levallois-Perret Paris, France Attention: Richard C. Piani Facsimile: 01133147152719 With a copy to: Hemispherx Biopharma, Inc. 1617 JFK Blvd. Philadelphia, Pennsylvania 19103 U.S.A. Attention: William A. Carter, M.D. Facsimile: (215) 988-1739 If to Esteve: LABORATORIOS DR. ESTEVE, S.A. Av. Mare de Deu de Montserrat, 221 08041 Barcelona, Espana Attention: Director, Business Development & Licensing Facsimile: 34.93.433.00.72 24 or to such address as either Party shall hereafter designate by like notice to the other Party. A notice shall be deemed to have been given on the date of receipt by the Party. Allocation of Costs 17.03 Each of the Parties shall employ, at its own costs and expense, such personnel, computer and communications support, facilities and expertise as is reasonably necessary for the performance of its responsibilities under this Agreement. Except as otherwise provided by this Agreement, each Party shall bear all expenses related to the performance of its obligations under this Agreement, including without limitation all out-of-pocket and administrative costs and expenses. Assignment 17.04 Neither Party may assign this Agreement or any rights hereunder except upon prior written consent of the other Party, which consent may be withheld in such other Party's sole discretion. Notwithstanding the foregoing, either Party may assign its rights and obligations to its Affiliates, although no such assignment shall relieve the Party of its primary responsibility for performance hereunder. Esteve is hereby entitled, subject to written approval by Hemispherx, which approval shall not be unreasonably withheld, to appoint a local sub- distributor for the Product in Madeira (Portugal), in which case Esteve shall be responsible for ensuring compliance of any such sub-distributor with all applicable obligations or duties under this Agreement. Esteve shall further be entitled, subject to written approval by Hemispherx, which approval shall' not be unreasonably withheld, to sub-contract the storage and physical distribution of the Products in Portugal to a third party, in which case Esteve shall be responsible for ensuring compliance of any such third party with all applicable obligations or duties under this Agreement. This Agreement shall be binding upon, and inure to the benefit of, the permitted assigns and successors of the Parties hereto. Waiver 17.05 The failure of either Party hereto at any time to require performance by the other Party of any provision of this Agreement shall not affect the right of such Party to require future performance of that provision. Except as otherwise provided herein, any waiver by either Party of any breach of any provision of this Agreement must be in writing to be effective and shall not be construed as a waiver of any continuing or succeeding breach of such provision or a waiver of any other right under this Agreement. Entire Agreement 17.06 This Agreement constitutes the entire understanding of the Parties hereto and supersedes all previous agreements between the Parties with respect to the matters 25 contained herein. No modifications of this Agreement shall be binding upon either Party unless approved in writing by an authorized representative of each of the Parties. Partial Invalidity 17.07 In case any one or more of the provisions contained herein shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, but this Agreement shall be construed as if such invalid, illegal or unenforceable provision or provisions had never been contained herein unless the deletion of such provision or provisions would result in such a material change as to cause consummation of the transactions contemplated hereby to be impossible. Execution in Counterparts 17.08 This Agreement may be executed in counterparts, including counterparts transmitted by telecopier or facsimile, each of which shall constitute an original and all of which shall be considered one and the same Agreement. Counterparts or facsimile copies executed by all Parties shall have the same effect as if the signatures to each counterpart or facsimile copy were on the same document and copies of such documents shall be deemed valid as originals. The Parties agree that all such signatures may be transferred to a single document. Language 17.09 This Agreement is in the English language, which language shall be controlling in all respects. All communications and notices to be made or given pursuant to this Agreement shall be in the English language. Remedies Not Exclusive 17.10 The rights and remedies contained in this Agreement are not intended to waive or preclude any other claims, rights or remedies which may exist at law (whether statutory or otherwise) or in equity with respect to the matters covered hereby: Governing Law 17.11 This Agreement shall be construed, interpreted and enforced in accordance with the laws of the State of Pennsylvania, United States, without regard to the choice of law principles thereof, unless otherwise provided for in this Agreement. Arbitration 17.12 Subject to the provisions of 17.13 and 8.03, all disputes arising in connection with this Agreement shall be finally settled by arbitration, in Geneva, Switzerland under the provisions of the International Chamber of Commerce by one or more arbitrators 26 appointed in accordance with the law of the State of Pennsylvania, United States. The Parties commit themselves to accept and comply with the decision of the arbitrator or arbitrators. 17.13 Any disputes with respect to the application of, or the compliance of either party with, any provisions of this Agreement shall be resolved in an arbitration conducted pursuant to the provisions of Schedule 17.13. This provision shall not preclude the right of either party to address any competent court or tribunal in order to obtain interim measures. Announcements 17.14 Neither Party shall make any public announcement or press release regarding the content or signature of this Agreement without the other party's prior written consent other than as may be required by law. If such public announcement or press release is required by law the Parties shall use their reasonable endeavours to agree to the text and content thereof prior to making such public announcement or press release. IN WITNESS WHEREOF, and intending to be bound hereby, each of the Parties hereto have caused this Agreement to be executed by its duly authorized officer as of the day and year first above written. Hemispherx Biopharma Europe, S.A. Laboratorios del Dr. Esteve, S.A., /s/ William a. Carter /s/ Juan Esteve By: ________________________ By: ________________ CEO Vice-President Title: _____________________ Title:_________________ 27 SCHEDULE 1.13 - PATENTS COUNTRY PATENT NO. Spain ES 2.018.903 Spain ES 2.098.273 Portugal PT 9 1.094 Portugal PT 95.601 28 SCHEDULE 17.13 - ARBITRATION Any arbitration conducted pursuant to the provisions of Article 17 of this Agreement shall be in accordance with the following terms. Either Party may elect to commence the arbitration. Such election shall be effective if made by written notice (the "Arbitration Notice") transmitted by facsimile to the other Party hereto and further sent in the manner set forth in accordance with the notice provisions of this Agreement. The date on which the Arbitration Notice is received via facsimile is the notice date ("Notice Date"). The arbitration shall be conducted and determined in accordance with the then prevailing commercial arbitration rules of the International Chamber of Commerce, or its successor, for arbitration of commercial disputes, except that the procedure mandated by said rules shall be modified as follows: A. A single arbitrator to be mutually agreed upon by the parties within five (5) business days of the Arbitration Notice Date shall conduct the arbitration. If the parties are unable to agree upon a single arbitrator within five (5) business day period, the parties shall request that the International Chamber of Commerce appoint a single qualified arbitrator in accordance with its procedures. B. The location, and any procedural rules the arbitrator wishes to establish, for the arbitration will `be determined by the arbitrator within five (5) business days of the appointment of the arbitrator. The arbitrator shall commence the arbitration hearing within fifteen (15) business days of the Notice Date, and the arbitration shall be completed within seven (7) business days of the date that it is commenced. The arbitrator shall render a decision in the matter within five (5) business days after the arbitration is completed. Such decision shall be final and binding and neither Party shall appeal the decision on any basis to any Court. C. Upon any failure, refusal or inability of an arbitrator to act, his or her successor shall be appointed in the same manner as provided for his or her original appointment. The arbitrator shall render his decision and award in writing with counterpart copies to both parties. The arbitrator shall have no right to modify the provisions of this Agreement. The arbitrator shall have the right to award interest. The costs of the arbitration, including the fees and' expenses of counsel, expert and witness fees and costs of the arbitrator shall be in the discretion of the arbitrator, who shall have the power to make any award which is just in the circumstances. 29 SCHEDULE 7.05 - MINIMUM PURCHASE REQUIREMENTS Esteve shall purchase Product in each of the years indicated in the following minimum quantities: Minimum Number of 400mg Equivalent Units* Commercial Year of Product to be Purchased ________________________________________________________________ Year 1:** 102,320 Year 2: 255,920 Year 3: 307,040 Year 4: 409,440 Year 5: and each succeeding Commercial Year of the Agreement. 424,000 *Each 490 mg equivalent unit shall consist of either (a) one 400 mg unit, or (b) two 200 mg units **For the purposes of the computation of the purchases made by Esteve, the amounts of Product purchased prior to the date of Product Launch shall be considered as purchased during Year 1. 30 SCHEDULE 14.08 - CLINICAL TRIAL CONDUCTED BY HEMISPHERX PROTOCOL NO.: AMP-516 TITLE: A multi-center, double-blind, randomized, placebo-controlled study of the efficacy and safety of Poly I:Poly C12U (Ampligenr) 400 mg iv twice weekly versus placebo in patients with severely debilitating chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME). 31 EX-99.D CONTRACTS 5 rgentiva.txt GENTIVA AGREEMENT TREATMENT PROTOCOL DISTRIBUTION AGREEMENT THIS DISTRIBUTION AGREEMENT (the "Agreement") is entered into this 9 day of February, 1998, by and between Hemispherx Biopharma, Inc. ("HEB"), a Delaware corporation, and Kimberly Home Health Care, Inc., d/b/a Olsten Health Services ("Olsten"), a Missouri corporation. RECITALS HEB has developed Poly I, Poly C12U, a pharmaceutical product for the treatment of Chronic Fatigue Syndrome ("CFS") and other indications to be marketed under the brand name AmpligenTM ("Product"); HEB has developed a protocol with respect to the Product ("AMP- 511 Protocol" attached hereto as Exhibit "A" for reference only) and has received authorization from the Food and Drug Administration ("FDA") in a letter from Dr. Janet Woodcock, dated May 1, 1997 approving HEB's request for distribution of the Product in accordance with the AMP-511 (all hereinafter the "Authorization") on a cost recovery basis; Olsten is a wholesale and retail distributor of numerous pharmaceutical products, has a nationwide retail and certain international wholesale distribution networks in place, and has the ability and desire to serve as a preferred distributor for HEB's Product; HEB wishes to appoint Olsten to distribute the Product to Patients under the AMP-511 protocol for CFS on a distributor basis and wishes to appoint Olsten as one of their distributors of the Product on the terms and conditions set forth below, and Olsten desires to accept such non-exclusive appointment, on the terms and conditions set forth below. NOW THEREFORE, the parties agree as follows: 1. Definitions. For purposes of this Agreement, the following terms shall have the meanings set forth below, unless the context clearly requires otherwise. 1.1 "Affiliate" of a Party shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with such Party. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns or directly or indirectly controls at least forty percent (40%) of the voting stock of the other corporation, or (a) in the absence of the ownership of at least forty percent (40%) of the voting stock of a corporation or (b) in the case of a non-corporate business entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable. 1.2 "Contract Year" shall mean the period of twelve consecutive calendar months commencing upon the Effective Date and each subsequent successive twelve-month period. 1.3 "Effective Date" shall mean the date first written above. 1.4 An "Event of Default" with respect to a Party shall mean any of the following event. (i) Any material breach of this Agreement by such Party; or (ii) The entry of a decree or order for relief by a court of competent jurisdiction in respect of such Party in an involuntary case under the Federal Bankruptcy Code, as now or hereafter constituted, or any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive dates; or (iii) The filing by such Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law. 1.5 "Patient" shall mean a person recommended by a MD or a DO for the treatment of Chronic Fatigue Syndrome (CFS) with Ampligen, and accepted in writing by HEB under the AMP-511 Protocol, on either a cost recovery or gratis basis. 1.6 "Party" shall mean either party to this Agreement. 1.7 "Person" shall refer to any natural person, corporation, partnership or association. 1.8 "Supplies" shall mean the equipment and other supplies necessary for the safe and effective use of the Product. Said equipment and other supplies shall include, but not be limited to, those items set forth on Appendix I. 1.9 "Territory" refers to all of the fifty (50) states in the United States. 2. APPOINTMENT OF DISTRIBUTOR; SUPPLY ARRANGEMENT. 2.1 (a) HEB hereby appoints Olsten as a distributor of HEB's Product in and for the Territory for the treatment of Patients with CFS in the U.S. under treatment protocol AMP-511. 2.2 Subject to the termination provisions in Article 13, Olsten hereby agrees to serve as HEB's distributor of HEB's Product in and for the Territory during the term of this Agreement. 2.3 In the event that HEB obtains FDA approval of its New Drug Application for the Product in the treatment of CFS ("Product Approval"), the parties shall negotiate, in good faith the terms and conditions of an agreement whereby Olsten is a distributor of the Product in the Territory for HEB ("Distribution Agreement"). If FDA Product Approval is obtained, and the parties do not enter into a Distribution Agreement within six (6) months of the date of the FDA Product Approval, HEB shall pay to Olsten an amount up to but not to exceed, in the aggregate, the sum of $500,000.00 for all documented costs and expenses incurred by Olsten in connection with the pharma-economic EPI-Q Study and dedicated personnel (including salary and benefits) referred to in Section 2.17 below. HEB shall pay such amount to Olsten within thirty (30) business days following HEB's receipt of a documented invoice from Olsten for such costs and expenses. 2.4 Within thirty days following the Effective Date of this Agreement, HEB shall deliver to Olsten its drug utilization forecast for the first Contract Year and will provide a list of current and potential clinical sites. At least two (2) months prior to the beginning of each subsequent Contract Year, HEB shall furnish Olsten with a good faith forecast for such Contract Year. In return, Olsten will advance payment at the start of each month for that month's forecasted drug utilization based on HEB `s Patient forecast; provided however, that reconciliation of forecast and actual utilization will be made on a monthly basis and any under utilization will reduce the next months required advanced payment. 2.5 Olsten agrees to purchase the Product, and to reconstitute/thaw the Product at the fee schedule set forth in Appendix I. In addition, if the Product receives FDA approval, then HEB agrees that the fee schedule shall be in effect for Patients enrolled in the AMP-S 11 Protocol at the time of FDA Product Approval and Olsten shall be entitled to purchase the Product for said Patients at the prices set forth therein. The fee schedule shall continue for those Patients for the lesser of one (1) year following the date of the FDA Product Approval, or the date upon which the parties execute the Distributorship Agreement described in Section 2.3 above. 2.6 HEB agrees to use its best efforts to provide Olsten's requirements for the Product in a timely fashion without interruption. HEB agrees that if it exercises its rights under Section 13.3, it will continue to be bound by this Section until the effective date of the termination of this Agreement. 2.7 Olsten will provide those Distribution and Warehousing Services described in Appendix II. 2.8 Olsten shall make such Supplies as are required for the infusion of the Product available for purchase by any Patient serviced by Olsten Health Services pharmacies or infusion units. In no event, however, shall Olsten directly or indirectly require any Person (including without limitation any Patient) to purchase Supplies or any other goods or services from Olsten or from any other particular source as a condition of receiving Product. 2.9 Olsten shall make available to each Patient, in accordance with the Authorization, the Product Services and the Reimbursement Services described in Appendix III hereto for the fees set forth below. 2.10 Olsten shall maintain on a current basis in computer databases and in such other format as may be reasonably requested by HEB (taking into account Olsten's current information systems capabilities) the information set forth in Appendix VI. All such information shall be maintained in duplicate and at least one copy shall be stored in a safe and secure environment. Olsten shall provide periodic reports to HEB of such information as provided in Appendix IV. 2.11 Olsten shall have the right to return any expired, defective or damaged Product to HEB for replacement of the same Product or for a credit against future purchases (at Olsten's discretion); provided, however, that any Product with an obvious defect that could reasonably be expected to be discovered by Olsten in the ordinary course of business (e.g., a damaged box) may be returned not later than thirty (30) days after its receipt by Olsten. There will be no additional charge to Olsten for replacement of the Product. 2.12 Olsten shall take title to the Product when it receives the Product from HEB, HEB's designated agent, or assignment thereof from the Patient. 2.13 The medication charges, which will be billed to Patients by Olsten, without additional markup, are set forth in Appendix I. 2.14 Olsten agrees to distribute the Product in the Territory through any means it determines to be reasonably appropriate and which are in compliance with any and all applicable federal or state statutes and regulations. 2.15 Olsten agrees to administer HEB's corporate Compassionate Care Program in accordance with the written guidelines and protocols of HEB. Eligibility guidelines will be set by HEB. The Parties agree that Olsten shall not be obligated to pay for the Product provided by Olsten to such indigent Patients under the Compassionate Care Program. 2.16 Olsten agrees to provide a certain amount of nursing services without charge to such indigent Patients that HEB has identified to Olsten in accordance with HEB's written Compassionate Care Program and to whom Olsten has provided the Product (as set forth in Section 2.17). The Parties agree that Olsten shall only be obligated to provide nursing services without charge to a number of Patients equal to five (5%) percent of the total number of Patients, and shall not be obligated for any free nursing services beyond the five (5%) percent referenced herein. 2.17 Olsten agrees to provide financial support up to a maximum amount of Five Hundred Thousand Dollars ($500,000) in the aggregate to HEB in connection with the AMP-511 Protocol upon such payment schedule as the parties may mutually agree and attach to this Agreement as Appendix V. This financial support shall be used only for any of the three purposes set forth herein: (a) To provide to HEB a pharma-economic study of the cost/benefit of the Product in comparison with other commercially available products and services for the treatment of CFS (under PE-100 Protocol). The parties agree that EPI-Q shall be used to perform this study and that Olsten shall be entitled to review any material relating to this study and to receive any drafts and final product produced by EPI-Q. The parties further agree that HEB shall have the right to audit, on an ongoing basis, all services and obligations to be performed by Olsten and EPI-Q in relation to the pharma-economic study to be performed in accordance with the PE-100 Protocol. Olsten shall make payment directly to EPI-Q pursuant to the EPI-Q contract. (b) To compensate one Project Manager (employed by OHS), experienced in clinical trials and knowledgeable about FDA rules and regulations regarding clinical trials, whose obligations and responsibilities shall, without limiting same, include: overseeing and coordinating the performance of all Olsten and Epi-Q obligations under the Agreement with the AMP-511 and the PE100 Protocols, FDA regulations and any applicable Federal or State laws or regulations; (c) To provide adequate coverage by one or more Clinical Research Nurse(s) (employed by Olsten) at six (6) clinical sites to carry out the Studies under AMP-511 and the PE- 100 Protocols identified to Olsten by HEB. The Clinical Research Nurse's obligations and responsibilities shall without limiting same, include: (1) assisting and performing tasks with regard to the AMP-511 and PE- 100 Protocols at the direction of Hemispherx Medical Director; (2) recording, or causing to be recorded, all data required by the AMP-S 11 and PE-100 Protocols and the Patient Case Book. The parties acknowledge that Clinical Research Nurse(s) may be employed by Olsten on a full-time or part-time basis, provided they meet Olsten's obligations hereunder. 2.18 In the event that the aggregate amount of funds required to support the three activities described in Section 2.17 (a) - (c) above exceed Olsten's commitment of $500,000, Olsten shall have no further obligation to provide additional funding to or on behalf of HEB or to continue to support any of the activities described therein. 3. COMPENSATION. 3.1 Olsten agrees to pay for the Product based on the purchase price fee schedule set forth in Appendix I, as set forth in paragraph 2.4. 3.2 Fees to Distributor. (a) Warehousing and Distribution Services Fee. For the Warehousing and Distribution Services provided by Olsten (as described in Appendix II hereto), HEB agrees to pay to Olsten every calendar quarter a fee equal to five (5%) percent of the net wholesale price of each unit of Product distributed by Olsten during such quarter. (b) Product and Reimbursement Services Fee. For the Product and Reimbursement Services and reports provided by Olsten (as described in Appendix III hereto), HEB agrees to pay to Olsten every calendar quarter a services fee equal to five (5%) percent of the net wholesale price of each unit of Product distributed by Olsten during such quarter. (c) Information Services Fee. For the Information Services and reports provided by Olsten (as described in Appendix IV hereto), HEB agrees to pay to Olsten every calendar quarter a services fee equal to two (2%) percent of the net wholesale price of each unit of Product distributed by Olsten during such quarter. (d) Payment Terms. Promptly after the end of each quarter, Olsten shall deliver to HEB an invoice showing the amount of such Product distributed and the calculation of the fee owing for such quarter. Such invoice shall be due and payable within thirty (30) days following HEB `s receipt of such invoice. (e) Post-FDA Approval Fees. In the event that HEB obtains FDA approvalfor the Product, the parties agree that the fees set forth above shall be in effect and Olsten shall be entitled to receive such fees for Patients enrolled in the AMP-S 11 Protocol, for the lesser of one (1) year from the date of FDA approval, or the date upon which the parties execute a definitive Distributorship Agreement. 4. PATENT, LICENSE AND OTHER INTELLECTUAL PROPERTY RIGHTS. 4.1 HEB represents that it is the exclusive owner of various United States issued patents which concern the compound Poly I :PolyC12U (Hereinafter referred to as Ampligenr), which validly issued patents concern the clinical utilization of the product in various chronic viral disorders, including without limitation Chronic Fatigue Syndrome. Also, HEB represents that it is the exclusive owner of an orphan drug designation for the disorder CFS, which designation specifically prohibits for a period of 7 years other pharmaceutical manufacturers from introducing this product for the treatment of CFS. HEB also represents that it is the holder of various IND's with the FDA which permit clinical evaluation of the test compound, and also the company is in good standing with respect to various manufacturing documents which are necessary to file with the FDA from time-to-time to support the utilization of the product in clinical investigation within the United States. To the Company's knowledge, no other pharmaceutical manufacturers have similar patents issued in the United States or similar regulatory status with the FDA with respect to this product. HEB further warrants that Olsten, by virtue of any of its actions taken pursuant to this Agreement, and the patent/licensing rights described herein, will not infringe upon or violate the rights of any third parties. As set forth in Section 8, HEB agrees to protect, indemnify, and hold Olsten harmless from any and all claims of infringement based on patent, trademark, copyright, or trade secrets which may be brought by third parties against Olsten in. respect of the Product. (a) HEB specifically warrants that there are no other agreements, amendments or licenses that affect HEB's authority or ability to enter into this Agreement. (b) HEB further warrants that it has obtained any and all necessary governmental and contractual consents for ownership and distribution rights to the Product under the AMP-511 Protocol, including all dosage and administration forms (e.g., injectable, IV) described in the protocol. 4.2 HEB warrants that, prior to the execution of this Agreement, it has not assigned, encumbered, pledged, mortgaged, used as collateral, granted a security interest or lien in or otherwise engaged in any action that affects its ability to grant Olsten the right to distribute the Product in the Territory. 4.3 HEB agrees that, during the term of this Agreement, it will not engage in any action that could be anticipated to adversely affect HEB's ability to grant Olsten the right to distribute the Product as provided in Sections 2.1 and 2.2. 4.4 Olsten will distribute the Product under a trademark(s) designated by HEB. HEB warrants and represents that the designated trademark(s) shall not infringe the rights of any third parties. HEB also warrants that it will register all trademark designated by it in the United States Patent and Trademark Office, and further that, it has within the last three (3) years made commercial use in the United States of the trademarks Ampligen and that to its knowledge, no third-party is presently using Ampligen in connection with any product in the United States. 4.5 Olsten agrees that it will distribute the Product in original packaging (except under the practice of pharmacy) bearing a notice of copyright and which shall be registered in the United States Copyright Office. HEB warrants and represents that this original packaging will not infringe the rights of any third parties. 5. GENERAL WARRANTIES. 5.1 HEB warrants that the Product shall: (i) be free from defects in design, material and workmanship; (ii) be in compliance with applicable law and all regulatory requirements of the Food and Drug Administration ("FDA"), including but not limited to those related to the adulteration or misbranding of products within the meaning of Section 501 and 502 of the Food Drug and Cosmetics Act; (iii) not be articles which may not be introduced into interstate commerce pursuant to the requirements of Section 505, 514, 515, 516 or 520 thereof; (iv) be manufactured in accordance with current FDA Good Manufacturing Practices as required by 21 C.F.R. 210 and 820. 5.2 Olsten warrants that it possesses all federal and state licenses and permits necessary to its performance of this Agreement and agrees to comply, in all material respects, with all federal and state laws applicable to it for retail distribution and is a licensed exporter of pharmaceuticals internationally. 5.3 HEB warrants that it possesses or will possess at time of Patient treatment all federal and state licenses and permits necessary to its performance of this Agreement and agrees to comply, in all material respects, with all federal and state laws applicable to it. 6. REGULATORY MATTERS. 6.1 HEB represents that the Product has received clearance from the FDA to be administered in the Territory for the indication of chronic fatigue syndrome, in accordance with the "Authorization", that current sites in the United States have received Institutional Review Board approval and that all federal and state permits for the manufacture, importation, design, testing, inspection, labeling, warning, instructions for use, sale and distribution of all the Product in the Territory under the protocol have been obtained. HEB agrees that it shall be solely responsible for, and comply with, all applicable federal and state laws governing the regulation of the manufacture, importation, design, testing, inspection, labeling, sale, warning and instructions for use of all the Product in the Territory. 6.2 Olsten shall notify HEB promptly of any inspection by any federal, state or local regulatory representative concerning the Product and shall provide HEB with a summary of the results of such inspection and such actions, if any, taken to remedy conditions cited in such inspections. 6.3 Olsten shall disclose all fees required to be disclosed under any state or federal program which provides cost or charge based reimbursement to Olsten for the Product provided under this Agreement as required by the applicable provisions of 42 U.S.C. 1320a-7b. Olsten further represents and warrants that it, and any of its Affiliates, are in compliance with, and during the term of this Agreement covenants that it and its Affiliates shall remain in compliance with, any federal or state laws applicable to the fees paid by HEB pursuant to this Agreement, including without limitation, any laws requiring the proper disclosure and/or reporting of fees. 6.4 Each party agrees to inform the other party promptly (but in no event no later than forty-eight (48) hours after becoming aware of same) of any information concerning any complaint involving the Product or any adverse drug experience (as defined in 21 CFR 314.80), injury, toxicity, or sensitivity reaction associated with the clinical use of the Product, whether or not considered related to the Product. If the adverse drug experience is serious, as defined in 21 CFR 314.80 (including an adverse drug reaction as detailed in AMP-511 Protocol (Appendix VI,) then each party shall notify the other party within twenty-four (24) hours. All notifications to HEB shall be made via facsimile. 6.5 If there is a recall or withdrawal of the Product, then Olsten agrees to stop shipping recalled lots immediately, and in no event later than twenty-four (24) hours after Olsten receives written notification of such recalls. Olsten shall cooperate in any such recall, at HEB's expense if the recall was prompted by events preceding Olsten's receipt of product. 6.6 Olsten agrees to reasonably cooperate with any inspection of the Product shipment conducted by a governmental agency. Olsten shall promptly give notice to HEB of any Product shipment inspected by a government agency. 6.7 HEB agrees to reimburse Olsten for any costs or expenses (including attorneys' fees) Olsten may incur due to recalls, withdrawals, replacements or government inspections of any the Product if the recall was prompted by events preceding Olsten' s receipt of product. Olsten shall prepare an invoice of such costs which invoice shall be paid by HEB within thirty (30) days of its receipt of such invoice. 6.8 Olsten shall at all times during the Term of the Agreement comply, in all material respects, with all federal and state laws, regulations and orders applicable to its operations as a wholesale and/or retail distributor. 7. INDEMNIFICATION. 7.1 HEB will indemnify, defend, and hold harmless Olsten, its affiliates, parents, subsidiaries, directors, officers, agents and employees (collectively, "Olsten Indemnitees") from and against, and reimburse Olsten Indemnitees for, any and all claims, demands, actions, causes of action, losses, judgements, damages, costs and expenses (including, but not limited to, attorneys' fees, court costs and costs of settlement) arising out of claims against a Olsten Indemnitee based on: (a) HEB's manufacture of the Product; (b) the death of, or bodily injury to, any person on account of the use of the Product, to the extent such death or bodily injury results from a defect relating to the Product or arising out of any negligence or wrongful conduct of HEB; (c) any recall or withdrawal of the Product if the recall was prompted by events preceding Olsten's receipt of product; (d) HEB's violation of any applicable law or government regulation; (e) any claims that Olsten's distribution or sale of the Product infringes the patent or other proprietary rights of any third party; or (f) any breach by HEB of any of its representations, warranties, covenants or agreements in this Agreement. 7.2 Olsten will indemnify, defend, and hold harmless HEB, its affiliates, parents, subsidiaries, directors, officers, agents and employees (collectively "HEB Indemnitees") from and against, and reimburse HEB Indemnitees for, any and all claims, demands, actions, causes of action, losses, judgements, damages, costs and expenses (including, but not limited to, attorneys' fees, court costs and costs of settlement) arising out of claims against a HEB Indemnitee based on: (a) the death of, or bodily injury to, any person on account of the use of the Product, to the extent such death or bodily injury results from Olsten's negligence or willful misconduct; (b) Olsten's violation of any applicable law or govermnental regulation as it relates to the distribution of the Product, the Product Services, and Reimbursement Services; (c) any breach by Olsten of any of its representations, warranties, covenants or agreements in this Agreement; or (d) any recall or withdrawal if the recall was prompted by events following Olsten's receipt of product. 7.3 Olsten agrees that upon receipt of any claim or liability asserted in writing against it which would give rise to a claim against HEB under this Section, it shall promptly notify HEB in writing of the same within fourteen (14) business days. HEB agrees that Olsten is entitled to retain counsel of its own choosing at Olsten's expense to the extent necessary, in Olsten's sole discretion, to protect Olsten's interests and to act as co-counsel in the litigation or settlement of any claim or threatened claim. Olsten agrees that so long as HEB does not enter any settlement agreement or consent judgment that admits liability on the part of Olsten or which fails to include an unconditional release of Olsten from all liability from all asserted or threatened claims, HEB shall have the right to control the defense, settlement, and prosecution of any litigation. Anything in this section notwithstanding: (i) If there is a reasonable probability in the opinion of Olsten's counsel that a claim may materially and adversely affect Olsten other than as a result of monetary damages or other monetary payments for which HEB will be able to indemnify Olsten, Olsten shall have the right to defend, and with HEB's prior consent, compromise and settle such claim. Olsten's right to indemnification in such cases shall be limited to its attorney's fees and costs plus any monetary settlement amount. (ii) In the event that Olsten determines in its sole discretion, based upon the written advice of counsel, that there is a conflict in the position or defenses to be asserted by HEB and Olsten regarding liability, Olsten shall be entitled to its own defense, including the right, with HEB's prior consent, to settle or compromise all or any of the claims against it, at HEB's expense. 7.4 HEB agrees that upon receipt of any claim or liability asserted in writing against it which would give rise to a claim against Olsten under this Section, it shall promptly notify Olsten in writing of the same within fourteen (14) days. Olsten agrees that HEB is entitled to retain counsel of its own choosing at HEB's expense to the extent necessary, in HEB's sole discretion, to protect HEB's interests and to act as co-counsel in the litigation or settlement of any claim or threatened claim. HEB agrees that so long as Olsten does not enter any settlement agreement or consent judgment that admits liability on the part of HEB or which fails to include an unconditional release of HEB from all liability from all asserted or threatened claims, Olsten shall have the right to control the defense, settlement, and prosecution of any litigation. Anything in this section notwithstanding: (i) If there is a reasonable probability in the opinion of HEB's counsel that a claim may materially and adversely affect HEB other than as a result of monetary damages or other monetary payments for which Olsten will be able to indemnify HEB, HEB shall have the right to defend, and with Olsten's prior consent, compromise and settle such claim. HEB's right to indemnification in such cases shall be limited to its reasonable attorney's fees and costs plus any monetary settlement amount. (ii) In the event that HEB determines in its sole discretion, based upon the written advice of counsel, that there is a conflict in the position or defenses to be asserted by HEB and Olsten regarding liability, HEB shall be entitled to its own defense, including the right, with Olsten's prior consent, to settle or compromise all or any of the claims against it, at Olsten's expense. 7.5 The obligation of an indemnifying party under this Section 7.0 shall not be diminished by the indemnifying party's failure to provide the notice required above except to the extent such failure actually and materially adversely affects the indemnifying party's ability to defend such matter. 8. RECORDS AND ACCOUNTING. 8.1 During the term hereof and for three (3) years thereafter, or such longer period as may be required by law, Olsten shall maintain accurate records as required to meet applicable local, state and federal laws and regulations. Except as otherwise required by any such laws or regulations, Olsten shall provide HEB access to any requested documentation related to this Agreement during reasonable business hours. HEB shall give Olsten seven (7) business days' prior written notice of such examination. Such examinations will not occur more than twice annually, and such examination will be undertaken only to such extent necessary to verify that Olsten has complied with the terms of this Agreement. 9. ASSIGNMENT. 9.1 Neither party may assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the other party, except in connection with the sale of substantially all of a party's assets, in which case the party shall assign this Agreement to the buyer of the assets, and which shall not require consent. Notwithstanding the previous sentence, either party may assign its rights or delegate its duties to any of its parents, subsidiaries, or affiliates without written consent of the other party. Any unauthorized attempted assignment or delegation shall be null and void and of no force or effect, unless ratified by the other party once it learns of the attempted assignment or delegation. 10. INSURANCE. 10.1 HEB will maintain in effect during the term of this Agreement a comprehensive general liability policy and products liability policy and HEB shall immediately after the Effective Date of this Agreement designate Olsten as an additional named insured on such policies. The General Liability Insurance policy shall be in an amount not less than One Million Dollars ($1,000,000) per incident, and Two Million Dollars ($2,000,000) in the aggregate. The Product Liability Insurance policy shall be in an amount not less than One Million Dollars ($1,000,000) per incident with a deductible of no less than $10,000. These policies shall provide for ten (10) days notice to Olsten by the Insurer by Registered or Certified Mail, return receipt requested, in the event of any modifications, cancellation, or termination thereof. HEB agrees to provide Olsten with a certificate of insurance evidencing compliance with this section within fifteen (15) days of execution of this Agreement. Olsten will maintain in effect during the term of this agreement a comprehensive general liability policy and Olsten shall immediately after the effective date of this Agreement designate HEB as an additional insured on such policy. The General Liability Insurance Policy shall be in an amount not less than one million Dollars ($1,000,000) per incident and two million Dollars ($2,000,000) in the aggregate. The policy shall provide for ten (10) days notice to HEB by the Insurer by Registered or Certified Mail, return receipt requested in the event of any modifications, cancellation, or termination thereof. Olsten agrees to provide HEB with a certificate of insurance evidencing compliance with this section within fifteen (15) days of execution of this Agreement. 11. CONFIDENTIALITY AND REPORTS. 11.1 "Confidential Information" of a party shall mean any and all information including, but not limited to, the terms and conditions of this Agreement, and any other information that is or has been disclosed in writing or orally by such party to the other party which is either confidential or proprietary in nature; provided, however, that "Confidential Information" shall not include information which: (i) Is or becomes generally available to the public through no fault of the receiving party; (ii) Was known to the receiving party before such party received it under this Agreement and was not acquired, directly or indirectly, from the disclosing party; or (iii) Is disclosed in good faith to the receiving party by a third party lawfully in possession of such information and who was not under an obligation of nondisclosure with respect of such information. 11.2 Each party acknowledges that it may have heretofore received and may from time to time hereafter receive Confidential Information of the other party, and such party receiving such Confidential Information shall do the following: (1) Maintain such Confidential Information in confidence and shall not disclose such Information to any third party; (ii) Not use such Confidential Information other than in performance of this Agreement; and (iii) Disclose such Confidential Information to its employees or to employees of its affiliates only to the extent that such employees need to know such Confidential Information to carry out the receiving party's obligations under this Agreement. 11.3 Each party agrees to maintain confidential both during the term of this Agreement and for a period of five (5) years thereafter all Confidential Information provided to it pursuant to this Agreement and shall not, without the specific written consent of the other party, disclose it to any third party (except as required by law) or use it for its own purpose (except as contemplated herein). 12. JOINT PUBLICITY. 12.1 If either party wishes to make a public disclosure concerning or the relationship established hereunder and such disclosure mentions the other party by name or description, such other party shall be provided with an advance copy of the disclosure and shall have ten (10) business days within which to approve or disapprove such use of its name or description (including mention of the name of the Product). Either party shall not unreasonably withhold or delay approval. Failure to respond within such twenty-one (21) business days shall be deemed to be approval. Absent approval, no public disclosure shall use the name of or otherwise describe such party except to the extent required by law, or to the extent that the description of the other party is limited to public information about the availability of the Product. Notwithstanding the foregoing, the parties acknowledge that Olsten and HEB are publicly traded companies, and they hereby consent to disclosure of this Agreement and their relationship (to the extent necessary or desirable in the disclosing party's judgment) in the disclosing party's filings with the Securities and Exchange Commission and its respective disclosures to its stockholders. 13. TERM AND TERMINATION OF AGREEMENT. 13.1 This Agreement shall become effective on the date first written above and shall have a term of one (1) year calculated from the Effective Date. This Agreement shall automatically renew for successive additional one (1) year terms unless, not less than one hundred eighty (180) days prior to the anniversary date, either party notifies the other of its intent to terminate this Agreement as of the anniversary date. 13.2 The initial term of this Agreement or any renewal term may be terminated only as follows: (i) This Agreement may be terminated at any time upon the mutual written consent of both parties. (ii) At any time after the first Contract Year, either HEB or Olsten shall have the right to terminate this Agreement without cause upon not less than one hundred eighty (180) days prior written notice to the other. (iii) This agreement will automatically terminate when HEB receives New Drug Approval for commercial sales of the Product. 13.3 This Agreement may be terminated by either Party upon the occurrence of an Event of Default with respect to the other Party, provided that such Party shall first give to the defaulting Party written notice of the proposed termination or cancellation of this Agreement, specifying the grounds therefor, and the other Party shall have sixty (60) days after such notice is given to cure such default. Termination or cancellation of this Agreement pursuant to this Section 13.3 shall not affect any other rights or remedies which may be available to the non defaulting Party nor shall it relieve either Party of obligations incurred prior to termination, including Olsten's obligation to pay for Product ordered by and delivered to it pursuant to this Agreement. 13.4 This Agreement may be terminated by either party immediately upon notice to the other, if the other party shall make an assignment for the benefit of creditors, shall file a petition in bankruptcy, is adjudicated insolvent or bankrupt, or if a receiver or trustee is appointed with respect to a substantial part of such other party's property or a proceeding is commenced against it which will substantially impair its ability to perform hereunder. 13.5 Notwithstanding anything to the contrary, all rights granted under or pursuant to this Agreement by HEB to Olsten are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, or replacement provision therefore (the "Code"), licenses to rights to "intellectual property" as defined in the Code. The parties agree that Olsten, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code. The parties further agree that, in the event of the commencement of bankruptcy proceedings by or against HEB under the Code, Olsten shall be entitled, at its option, to retain all of its rights under the Agreement, in accordance with the provisions of the Code. 13.6 Each of the parties to this Agreement shall be entitled to enforce its rights under this Agreement to recover damages and costs (including reasonable attorney's fees) caused by any breach of any provision of this Agreement and to exercise all other rights existing in its favor, regardless of any termination of this Agreement by such breaching party pursuant to Section 13. The parties hereto agree and acknowledge that money damages would not be an adequate remedy for a breach of any provisions in Articles 2, 4, 11, and 12 of this Agreement and that any party may, in its sole discretion, apply to any court of law or equity of competent jurisdiction (without posting any bond or deposit) for specific performance and/or other injunctive relief in order to enforce, or prevent any violations of, these Sections of this Agreement. 14. NON-SOLICITATION. 14.1 HEB agrees that during the term of this Agreement, and for two (2) years thereafter, it shall not employ or retain on an independent contractor basis, or solicit for employment or for an independent contracting basis, any person who was, at any time during the immediately preceding twelve (12) month period, employed by Olsten or any of its affiliates, subsidiaries, or parents. 15. ENFORCEMENT OF EXCLUSIVITY VIS-A-VIS THIRD PARTIES. 15.1 Olsten shall not, directly or indirectly, sell or distribute or cause to be distributed, the Product outside the Territory. 16. MISCELLANEOUS. 16.1 Choice of Law. This Agreement shall be governed by and construed under the laws of the State of New York regardless of any conflicts-of-laws rule to the contrary. 16.2 Waiver. No waiver of any default hereunder by either party or any failure to enforce any rights hereunder shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the party granting the waiver. 16.3 Force Majeure. Notwithstanding any provision contained herein to the contrary, neither part shall be deemed to be in default hereunder for failing to perform or provide any of the services or other obligations to be performed or provided pursuant to this Agreement if such failure is the result of any labor dispute, act of God, inability to obtain labor or materials, governmental restrictions or any other event which is beyond the reasonable control of the party. 16.4 Notice. All notices and other communications made or given under or in connection with this Agreement shall be validly given or made if in writing and shall be effective either (a) when delivered in person to the other party, or (b) on the same business day that it is transmitted by facsimile to the facsimile number(s) set forth below, if transmitted prior to 5:00 p.m. Eastern Time on such business day, or on the first business day following such transmission if transmitted after 5:00 p.m. Eastern Time or if transmitted on a day other than a business day; provided a hard copy is deposited within one (1) day after such transmissions in the U.S. mail, postage prepaid, and addressed as set forth below for notices by U.S. mail; or (c) on the third business day following its deposit in the U.S. mail, postage prepaid, and addressed as follows: If to HEB: Hemispherx Biopharma One Penn Center 1617 JFK Boulevard Philadelphia, PA 19103 Attn.: William A. Carter, M.D., F.A.C.P, CEO and Chairman Facsimile No.: (215) 988-1739 If to OLSTEN: Olsten Health Services 175 Broad Hollow Rd. Melville, NY 11747 Attn.: ____________________ Facsimile No.:_____________ With a copy to: Olsten Health Services 175 Broad Hollow Rd. Melville, NY 11747 Attn.: Health Care Law Dept. Facsimile No.: (516) 844-7414 16.5 Amendment. Neither this Agreement nor any of the terms hereof may be terminated, amended, supplemented, waived or modified orally, except by an instrument in writing signed by each party. 16.6 Survival of Provisions. Notwithstanding anything to the contrary, Sections 2.3, 2.5, 2.11, and Article 8 (Records and Accounting), shall survive the expiration or other termination of this Agreement for the respective periods set forth therein and Article 7 (Indemnification), and Article 11 (Confidentiality) shall survive the expiration or other termination of this Agreement for a period of three (3) years and five (5) years respectively. 16.7 Relationship of Parties. Olsten's relationship with HEB hereunder shall be that of independent contractor, and neither party shall be considered the agent, partner or employee of or a joint venture with the other party, in its Performance of all duties under this Agreement. 16.8 Cumulative Remedies. Except as expressly provided in this Agreement, and to the extent permitted by law, any remedies described in this Agreement are cumulative and not alternative to any other remedies available at law or in equity. 16.9 Severability. In the event that any one or more of the provisions contained in this Agreement are for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision or provisions had never been included. The parties shall, in good faith, amend this Agreement to provide, to the extent possible, each party with the benefits provided by such invalid or unenforceable provision. 16.10 Headings. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. 16.11 Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which, when taken together, shall constitute one and the same instrument. 16.12 Signature Authority. Each signatory to this Agreement has signature authority and is empowered on behalf of his or her respective party to execute this Agreement. 16.13 Integration. This Agreement, together with all appendices attached hereto, constitutes the entire agreement between the parties with respect to the subject matter hereof, and supersedes all prior oral or written agreements, commitments or understandings with respect thereto. In consideration of the mutual promises and covenants contained herein and other good and valuable consideration, the undersigned have agreed to be bound by this Agreement between Kimberly Home Health Care, Inc., d/b/a Olsten Health Services and Hemispherx Biopharma, Inc. KIMBERLY HOME HEALTH CARE, INC., HEMISPHERX BIOPHARMA, INC. D/B/A OLSTEN HEALTH SERVICES By: __/s/ Robert A. Fusco_____ By: _/s/ William A. Carter_____ Its: President Its: CEO ________________________________ _________________________________ APPENDIX I Fee Schedule for Product THIS SCHEDULE IS REFERENCED IN 2.5 AS THE P1UCE OLSTEN AGREES TO PURCHASE THE PRODUCT FROM HEB. 1) Lyophilized 50mg vials of AmpligenTM -- $18.75 per 50mg vial a) 200 mg dose -- $75.00 (4 x 50mg vials) b) 400 mg dose -- $150.00 (8 x 50mg vials) 2) Frozen AmpligenT solution a) 200 mg dose -- $75.00 b) 400 mg dose -- $150.00 3) AmpligenT solution a) 200 mg dose - TBD b) 400 mg dose - TBD Pharmacy Fees The Patient will be billed $75.00 (seventy-five dollars) per prescription for preparation of the drug. Preparation of Ampligenr solution from bottles will be according to procedures specified by HEB document, Procedures for Receiving, Storing, and Using Ampligenr Solution. Supplies The supplies listed below are needed for infusion of the Ampligenr solution. These supplies will be shipped to the Patient with the drug as needed. Patients without insurance coverage will be billed Olsten's usual and customary price. If a Patient has insurance coverage, the Patients will be billed the price the insurance company would allow for these supplies. Item Inventory Number Item Inventory Number - ----------- ---------------- ------------------ ---------------- Hiblcleanse soap ST-0576-04 3M plastic 1" tape 3M-1530-t IV Pole MS---0500 78" gravity tubing AB-1859-48 Univ. adapter pin AB17015-48 IV catheter 24g DG---8324 Gloves(non-sterile) JJ---5885 Sabratek 3030 pump RL-3030-R Sharps container WM-01861 7" ext. clave set IC-C2002 IV start kit RMG-5000 Opsites 4 X 5 SAN-4973 Alcohol pads CL---01 10 Non-sterile drapes GR-0187 3m1 syringes BD---9585 APPENDIX II Warehousing and Distribution Services 1.Reconstitution, storage, and delivery to the Patient of the Product shall be in a secure location and under the physical (temperature, humidity, etc.) conditions specified by HEB document, Procedures for Receiving, Storing, and Using Ampligenr Solution. 2.Cost to HEB for the Services hereunder is 5% of monthly total cost of goods sold as outlined in section 3.2 (a). APPENDIX III Product and Reimbursement Services Product Services. 1.Payor Education Services. Olsten shall provide payer (excluding Medicaid and Medicare) education information and presentations from time to time as necessary to secure reimbursement or otherwise to affect or improve reimbursement for Product and/or associated costs. 2.Clinical Site Education Services. Education services in conjunction with Medical Director of HEB and/or HEB's Manager of Clinical Research to educate the principal investigator, clinical study nurse and/or other support health professionals at the investigators site, to include distribution of HEB's clinical education material. 3.Clinical Monitoring Services. Clinical monitoring services, including without limitation, services required by JCAHO, federal law and state pharmacy laws; monitoring of IV line maintenance, drug to food and drug to drug interactions, Patient compliance, proper dose and concentration rates; and Patient counseling as required. 4.Program Manager. Olsten will assign a program manager to insure the success of this project. II. Reimbursement and Hotline Services. 1.Olsten will bill the Patient for drug, dispensing fee, and supplies. Nursing services will also be billed to the Patient if an Olsten nurse admimstrates the drug. 2.Olsten shall confirm initially whether a Patient, shipped by Olsten, has insurance coverage or will otherwise be entitled to reimbursement with respect to the Product or Supplies. 3.Olsten shall provide broad statement comprehensive counseling services to Patients with respect to insurance coverage, claims, or other reimbursement issues. 4.Olsten shall use reasonable efforts to assist the Patient or the Patient's representative, as necessary, in securing insurance coverage or other means of reimbursement for the Product and Supplies, including without limitation assisting such Patient in pursuing claims for reimbursement or coverage. APPENDIX III (continued) 5.Olsten shall advise and counsel the Olsten Health Services study Patient or such Patient's representative with respect to such Patient's insurance coverage and copayment requirements, if any, with respect to the Product and Supplies. 6.Olsten shall obtain, set up, operate, staff, and maintain a 1- 800 telephone assistance service. Such telephone service shall be staffed 24 hours a day with qualified personnel to take calls from Patients and Patient representatives regarding the Product and use of the Product and emergency treatment issues. Title to the telephone number shall be in the name of HEB, but during the term of this Agreement Olsten shall have responsibility for the cost of maintaining, staffing, and operating this 1-800 number. Within (15) days after the end of each calendar month, Olsten shall deliver to HEB a report containing a summary of calls and activity on the 1-800 hotline. Such report shall include the number of calls received, the number of callers by type of caller (e.g., Patient, physician, nurse, relative, Medicaid/Medicare personnel, indemnity insurer, etc), the purpose of the calls and such other information which HEB may reasonably request. Cost to HEB is 5% of monthly total COGS as outlined in section 3.2 (b). APPENDIX IV Information Services and Requirements Within fifteen (15) days after the end of each calendar month, Olsten shall deliver to HEB a report containing the following information with respect to Patients serviced by Olsten Health Services: 1. Study identification number of the Patient. 2. Exact date each Olsten Health Services Patient-using Product started on the Product. 3. Current dosing for each Olsten Patient using Product. 4. Insurance coverage type of the Patient. *Coverage Types: Medicare payers, Medicaid payers, private payers, third party payers, no insurance coverage, Patient Assistance Patients. Cost to HEB 5% of monthly total COGS as outlined in section 3.2(C)
-----END PRIVACY-ENHANCED MESSAGE-----